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clinicalnlplab

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[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Melasma ( or chloasma ) is a common disorder of cutaneous hyperpigmentation predominantly affecting sun-exposed areas in women . The pathogenesis of melasma is not fully understood and treatments are frequently disappointing and often associated with side effects . Pycnogenol is a st and ardized extract of the bark of the French maritime pine ( Pinus pinaster ) , a well-known , potent antioxidant . Studies in vitro show that Pycnogenol is several times more powerful than vitamin E and vitamin C. In addition , it recycles vitamin C , regenerates vitamin E and increases the endogenous antioxidant enzyme system . Pycnogenol protects against ultraviolet ( UV ) radiation . Therefore its efficacy in the treatment of melasma was investigated . Thirty women with melasma completed a 30-day clinical trial in which they took one 25 mg tablet of Pycnogenol with meals three times daily , i.e. 75 mg Pycnogenol per day . These patients were evaluated clinical ly by parameters such as the melasma area index , pigmentary intensity index and by routine blood and urine tests . After a 30-day treatment , the average melasma area of the patients decreased by 25.86 + /- 20.39 mm(2 ) ( p < 0.001 ) and the average pigmentary intensity decreased by 0.47 + /- 0.51 unit ( p < 0.001 ) . The general effective rate was 80 % . No side effect was observed . The results of the blood and urine test parameters at baseline and at day 30 were within the normal range . Moreover , several other associated symptoms such as fatigue , constipation , pains in the body and anxiety were also improved . To conclude , Pycnogenol was shown to be therapeutically effective and safe in patients suffering from melasma The objective of the present study was to assess the toxicology of melatonin ( 10 mg ) , administered for 28 days to 40 volunteers r and omly assigned to groups receiving either melatonin ( N = 30 ) or placebo ( N = 10 ) in a double-blind fashion . The following measurements were performed : polysomnography ( PSG ) , laboratory examinations , including complete blood count , urinalysis , sodium , potassium and calcium levels , total protein levels , albumin , blood glucose , triglycerides , total cholesterol , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and very low-density lipoprotein ( VLDL ) , urea , creatinine , uric acid , glutamic-oxalacetic transaminase ( GOT ) , glutamic-pyruvate transaminase ( GPT ) , bilirubin , alkaline phosphatase , gama-glutamic transaminase ( GGT ) , T3 , T4 , TSH , LH/FSH , cortisol , and melatonin serum concentrations . In addition , the Epworth Somnolence Scale ( ESS ) and a sleep diary ( SD ) were also applied to the volunteers 1 wk before each PSG . In addition , the volunteers were asked about possible side effects ( SE ) that appeared during the treatment . The study was carried out according to the following timetable : Visit 0 , filling out the term of consent and inclusion criteria ; Visit 1 , PSG , laboratory examinations , ESS , SD , melatonin serum concentrations ; Visit 2 , SD , melatonin serum concentrations , SE ; Visit 3 , melatonin serum concentrations , PSG , ESS , SE ; Visit 4 , laboratory examinations , SE , melatonin serum concentrations , SD ; and Visit 5 , PSG , ESS , SE . Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group . No other differences between the placebo and melatonin groups were obtained . In the present study we did not observe , according to the parameters analyzed , any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study BACKGROUND Glutathione ( GSH ) is a naturally occurring thiol that has been reported to cause skin lightening in a manner for which several mechanisms have been proposed . Highest plasma concentrations are achieved with IV administration but are accompanied by greater levels of risk . Oral administration has been less successful in elevating plasma GSH levels . OBJECTIVES The use of a lozenge containing GSH was investigated in order to evaluate the buccal mucosa as a route for GSH administration . Substances that are absorbed through the buccal route go directly into the systemic circulation , effectively bypassing the gastrointestinal tract . METHODS Thirty Filipino females with Fitzpatrick skin types IV or V received a glutathione-containing lozenge daily for eight weeks . RESULTS Findings showed a significant decrease in melanin indices from baseline to endpoint that became evident in as little as two weeks . There were no serious adverse events , and laboratory examination findings remained normal . CONCLUSIONS The authors conclude that the lozenge containing glutathione was safe and effective in lightening the skin of Filipino women BACKGROUND UV radiation induces damage to human skin . Protection of skin by an oral photoprotective agent would have substantial benefits . Objective We investigated the photoprotective effect of oral administration of an extract of the natural antioxidant Polypodium leucotomos ( PL ) . METHODS A total of 9 healthy participants of skin types II to III were exposed to varying doses of artificial UV radiation without and after oral administration of PL ( 7.5 mg/kg ) . At 24 hours after exposure the erythema reaction was assessed and paired biopsy specimens were obtained from PL-treated and untreated skin . RESULTS A significant decrease in erythema was found in PL-treated skin ( P < .01 ) . Histologically , PL-treated biopsy specimens showed less sunburn cells ( P < .05 ) , cyclobutane pyrimidine dimers ( P < .001 ) , proliferating epidermal cells ( P < .001 ) , and dermal mast cell infiltration ( P < .05 ) . A trend toward Langerhans cell preservation was seen . CONCLUSION Oral administration of PL is an effective systemic chemophotoprotective agent leading to significant protection of skin against UV radiation BACKGROUND Melasma is associated with epidermal hyperpigmentation , weak basement membrane , vascular proliferation and increased numbers of mast cell . Tranexamic acid ( TXA ) , a plasmin inhibitor , is reported to improve melasma when injected locally . However , the effects of oral and topical TXA on melasma have not been well studied and the underlying mechanism remains unclear . OBJECTIVES To eluci date the effects of oral and topical TXA on melasma . METHODS A clinical study was conducted with 25 women for 8 weeks from March to July 2010 . Volunteers were instructed to take two TXA tablets three times a day and apply a TXA topical agent twice a day for 8 weeks . Skin pigmentation and erythema was measured using a Mexameter ( ® ) during each visit and skin biopsies were collected from eight subjects before and 8 weeks after treatment . Fontana-Masson , anti-CD31 , antitryptase and antitype IV collagen staining was performed . RESULTS Twenty-two subjects completed the study and no serious adverse events occurred during the study period . The mean lesional melanin index ( MI ) scores decreased significantly . Interestingly , the MI scores for the perilesional skin increased . The erythema index scores of lesional and perilesional skin also showed a similar pattern . Histological analysis showed significant reduction of epidermal pigmentation , vessel numbers and mast cell counts . Type IV collagen staining was not observed in all specimens . CONCLUSION TXA decreased epidermal pigmentation associated with melasma and also reversed melasma-related dermal changes , such as vessel number and increased numbers of mast cells Abstract Objective : To determine whether orally administered glutathione , 500 mg per day for 4 weeks , affects the skin melanin index , when compared with placebo . Methods : This r and omized , double-blind , two-arm , placebo-controlled study was set in the King Chulalongkorn Memorial Hospital , Bangkok , Thail and , a teaching hospital affiliated with a medical school . Sixty otherwise healthy medical students were r and omized to receive either glutathione capsules , 500 mg/day in two divided doses , or placebo for 4 weeks . The main outcome was mean reduction of melanin indices measured at six different sites . Several secondary outcomes , including UV spots , were recorded by VISIA ™ . Efficacies of glutathione and placebo were compared by ANCOVA with baseline values as co-variates . Results : Sixty participants enrolled and completed the study . At 4 weeks , the melanin indices decreased consistently at all six sites in subjects who received glutathione . The reductions were statistically significantly greater than those receiving placebo at two sites , namely the right side of the face and the sun-exposed left forearm ( p-values = 0.021 and 0.036 , respectively ) . This was similarly reflected in the changes in the number of UV spots , as measured by VISIA . Both glutathione and placebo were very well tolerated . Conclusion : Oral glutathione administration results in a lightening of skin color in a small number of subjects . However , long-term safety has not been established and warrants more extensive clinical trials BACKGROUND Melasma is a common , acquired , symmetric hypermelanosis characterized by irregular brown to gray-brown macules on the cheeks , forehead , nasal bridge , cutaneous part of the upper lip , m and ible , and the upper arms . Few trials have been conducted regarding the potential benefits of oral procyanidin in melasma . AIM To assess the safety and efficacy of oral procyanidin + vitamins A , C , E among Filipino patients with epidermal melasma . METHODS A r and omized , double-blind , placebo-controlled trial lasting 8 weeks , involving 60 adult female volunteers with bilateral epidermal melasma , Fitzpatrick skin types III-V , was conducted at the Section of Dermatology , Research Institute for Tropical Medicine , Department of Health , Manila , Philippines . Patients received either the test drug or placebo , twice daily with meals . Changes in pigmentation were measured using a mexameter , the melasma area and severity index ( MASI ) , and a global evaluation by the patient and investigator . Safety evaluations were performed at each follow-up visit . RESULTS Fifty-six patients completed the trial . Mexameter results demonstrated a significant decrease in the degree of pigmentation in the left malar ( 165.85 + /- 70.909 ) and right malar ( 161.33 + /- 61.824 ) regions ( P < 0.0001 ) . MASI scores showed a significant improvement in the left malar ( 2.4862 + /- 1.67816 ) and right malar ( 1.8889 + /- 1.67110 ) regions ( P = 0.001 ) . Procyanidin + vitamins A , C , E proved to be safe and well tolerated , with minimal adverse events . CONCLUSIONS In this 8-week trial period , oral procyanidin + vitamins A , C , E proved to be safe and effective among Filipino women with epidermal melasma Background : Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy . Tranexamic acid , a plasmin inhibitor , has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results . Objectives : To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients . Material s and Methods : 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study . Participants were r and omly divided into two groups with 20 patients in each group . Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01 % , tretinoin 0.05 % , and hydroquinone 2 % once daily for 8 weeks . Response was evaluated using melasma area severity index ( MASI ) at baseline , 4 weeks , and 8 weeks . Results : 40 patients completed the study . The MASI scores at baseline , 4 weeks and 8 weeks in group A were 15.425 + 1.09 , 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05 , 6.135 + 4.94 and 2.19 + 3.38 . Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks ( P value 0.014 ) and 8 weeks ( P value 0.000 ) . The efficacy was maintained throughout the 6-month follow-up period . Conclusion : Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma OBJECTIVE The objective of this study was to determine the safety of oral Polypodium leucotomos extract administered twice daily to healthy adults for 60 days and assess its ability to provide protection against exposure to ultraviolet radiation . DESIGN This was a r and omized , double-blind , placebo- \n Output:\n " }, { "from": "agent", "value": "These agents appear to have a beneficial effect on melasma improvement .\nIn conclusion , oral medications have a role in melasma treatment and have been shown to be efficacious and tolerable with a minimal number and severity of adverse events ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration . We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit grade d compression stocking . METHODS Patients with a first episode of venogram-proven proximal deep-vein thrombosis were r and omly assigned no stockings ( the control group ) or made-to-measure grade d compression elastic stockings for at least 2 years . Post-thrombotic syndrome was assessed with a st and ard scoring system that combined clinical characteristics and objective leg measurements . Patients were assessed every 3 months during the first 2 years , and every 6 months thereafter for at least 5 years . The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure . FINDINGS Of the 315 consecutive out patients considered for inclusion , 44 were excluded and 77 did not consent to take part . 194 patients were r and omly assigned compression stockings ( n = 96 ) or no stockings ( n = 98 ) . The median follow-up was 76 months ( range 60 - 96 ) in both groups . Mild-to-moderate post-thrombotic syndrome ( score > or = 3 plus one clinical sign ) occurred in 19 ( 20 % ) patients in the stocking group and in 46 ( 47 % ) control-group patients ( p < 0.001 ) . 11 ( 11 % ) patients in the stocking group developed severe post-thrombotic syndrome ( score > or = 4 ) , compared with 23 ( 23 % ) patients in the control group ( p < 0.001 ) . In both groups , most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event . INTERPRETATION About 60 % of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years . A sized-to-fit compression stocking reduced this rate by about 50 % Fibrinolytic treatment of acute deep vein thrombosis ( DVT ) of the leg with high-dose streptokinase ( SK ) ( 100,000 U/h ) in 39 cases , or low-dose SK ( approx 10,000 U/h ) in combination with low-dose heparin in 41 cases , was studied in a prospect i ve r and omized trial . The degree of thrombolysis was similar in both groups and did not correlate with age or size of the thrombus or with fibrinogen level . The degree of late recanalization was also similar in both groups . There were however significantly more patients with postthrombotic changes in the low-dose group than in the high-dose group after a mean follow-up time of 31 and 38 months respectively . In the low-dose group 2 intracranial hemorrhages occurred ( one was fatal ) and one patient died of pulmonary embolism , but there were significantly less allergic side effects to SK . There were no cases of such serious side effects in the highdose group . Although low-dose SK has equal thrombolytic effect it seems inferior to high-dose SK , since it probably causes more severe hemorrhagic side-effects In a prospect i ve study , 174 patients ( 118 women and 56 men , average age 44 years , range 14 to 82 ) with proximal extensive thrombosis received streptokinase ( 100,000 U/hour ) for an average of 2.8 days ( range 0.5 to 7 ) through the catheter of a temporary caval filter . Twenty-seven of 45 ( 60 % ) patients with nonocclusive clots were completely free of clots at the second phlebography versus 17 of 116 ( 14 % ) with occlusive clots ( p less than 0.001 ) . Among nonocclusive clots , proximal ones ( caval , iliac and femoral ) were more easily lysed than popliteal clots ( 88 of 116 [ 76 % ] vs 26 of 58 [ 45 % ] ; p less than 0.001 ) . In 41 of 132 ( 31 % ) patients , a daily injection of contrast medium through the filter-carrying catheter enabled the observation of a clot in the filter , which was lysed by streptokinase . Seventy patients with follow-up greater than 2 years ( median 34 months ) were examined clinical ly . Nineteen of 22 ( 86 % ) patients with venograms free of clots at discharge were free of clinical sequelae versus 16 of 48 ( 33 % ) without normal venograms ( p less than 0.001 ) . It is concluded that : ( 1 ) in the case of occlusive clots , only a few patients were normalized after streptokinase ; ( 2 ) proximal nonocclusive clots were most effectively lysed ; ( 3 ) when venograms were free of clots at discharge , the majority of patients did not have venous sequelae at follow-up ; and ( 4 ) embolic migration seems to occur frequently with streptokinase Twenty patients with clinical signs of deep vein thrombosis of a duration not exceeding 72 hours , and with the condition confirmed phlebographically , were r and omly allocated to one of two groups in a double-blind study . In group 1 the patients received urokinase in a low-dose regimen of 200 000 Ploug units during the first 24 hours , followed by infusion of heparin , 40 000 units daily during the next 5 days . Patients in group 2 received heparin only , 40 000 units daily for 6 days . The clinical course was assessed daily . When the infusion period was completed , the phlebography was repeated , and the results of the two examinations were compared with respect to extent of filling defects and the degree of non-filling of the deep veins . We found no superiority in the regimen consisting of urokinase preceding heparin infusion , compared with that of heparin infusion alone . Most of the patients improved clinical ly during the 6-day infusion period , but the degree of thrombosis , evaluated phlebographically , was unaltered or even deteriorated during the period in all patients except two . Overt bleeding was noted in 6 patients Nineteen cases were reinvestigated 8 - 14 years after treatment with SK or heparin . Judging from personal interviews , foot volumometry and phlebography , treatment with SK appears to be more preferable since it was less often followed by late severe postthrombotic changes In a prospect i ve study all positive phlebographies within the well-defined population of the city of Malmö , Sweden , during 1987 were studied in order to determine the incidence of deep venous thrombosis ( DVT ) . Epidemiological data were analysed for the detection of patient groups at increased risk of DVT . The incidence was found to be equal for both sexes , i.e. 1.6 per 1000 inhabitants a year . Risk factors were found to be in accordance with earlier studies . The median age for men was 66 years , compared to 72 years for women . At diagnosis of DVT , 19 % of subjects had a known malignancy and within 1 year 5 % ( 19 cases ) developed a new malignancy . Of the men , 29 % had postoperative or post-traumatic ( fracture ) DVT , compared to 46 % of the women . Fewer patients with DVT than expected ( 39 % ) belonged to blood group 0 ( 31 % ) ( P less than 0.005 ) . Pulmonary embolism ( PE ) was clinical ly suspected in only 5 % of cases , and diagnosis was verified scintigraphically in 2 % of cases . None of these died of PE , but of 6 patients who were found to have PE at autopsy , four died about 4 weeks after the DVT was diagnosed In a prospect i ve and r and omized multicenter trial the efficacy of intermittent regional and systemic thrombolytic therapy for DVT was evaluated . 137 patients with phlebographically confirmed acute DVT above the calf region were treated with 20 mg of rt-PA for 4 h each day . Thrombolysis was applied either locally via a dorsal pedal vein of the firmly b and aged affected leg or systemically using a cubital vein . Treatment lasted for 4 - 7 days , and during this time unfractionated heparin was applied continuously with the dosage adjusted according to aPTT ( 1.5 - 2.0 times the normal value ) . A second phlebography was performed within 24 h after the end of treatment . Results were evaluated by an independent radiologist who was unaware of the treatment given . Significant thrombolytic results ( e.g. lysis of more than 50 % of the original thrombus and complete recanalization of all affected veins ) were reached in only 1/3 of all patients . Rates of recanalization did not differ in both groups and bleeding complications occurred in 26.5 % . We conclude that intermittent local or systemic application of 20 mg rt-PA seems to be ineffective in the treatment of DVT Bolus urokinase ( Abbokinase ) is effective for initial treatment of deep venous thrombosis but is associated with a high rate of rigors . This r and omized controlled trial was undertaken among patients with deep venous thrombosis to evaluate the efficacy and safety of a novel thrombolytic agent , recombinant urokinase ( rUK ) , administered as three bolus infusions of 1 million U over a 24-hour period versus heparin alone . Of 361 patients with DVT screened , 17 ( 5 % ) were enrolled . Recent surgery was the most common reason for exclusion ( n = 113 , 31 % ) . Images of the patients were obtained at baseline , 24 to 48 hours after r and omization , and before hospital discharge . Two patients in each treatment group had minor clot progression . One patient in the heparin group had no change ; all other patients showed mild ( < 50 % ; n = 5 in each group ) or moderate ( > 50 % ; n = 1 in each group ) improvement . No bleeding complications or rigors developed in patients r and omized to rUK . Mean bleeding times among patients given rUK were not significantly different from mean values of patients given heparin at any of the measured time points available for comparison ( 331 vs 387 seconds at baseline and 381 vs 416 seconds at 24 hours ) . However , mean fibrinogen levels declined with successive urokinase boluses and were significantly lower than levels in patients treated with heparin at 24 ( 233 mg/dl vs 466 mg/dl , p = 0.01 ) and 48 hours ( 270 mg/dl vs 474 mg/dl , p = 0.02 ) . Although bolus rUK had a favorable safety profile , rUK was no more effective than heparin in achieving clot lysis at the doses used in this trial A controlled , prospect i ve study comparing streptokinase and heparin treatment has been completed in 51 patients presenting with acute proximal venous thrombosis of less than 8 days ' clinical duration . Patients were studied by means of pre‐treatment , post‐treatment , 3‐ and 12‐monthly phlebography and pulmonary perfusion scanning and were followed up at 3‐monthly intervals PURPOSE To compare the efficacy and safety of recombinant human tissue-type plasminogen activator ( rt-PA , supplied as Activase ) with heparin alone or rt-PA plus heparin in the treatment of venographically documented proximal deep venous thrombosis ( DVT ) of the leg . PATIENTS AND METHODS Sixty-four patients underwent 65 r and omizations to rt-PA alone ( n = 36 ) , rt-PA plus heparin ( n = 17 ) , or heparin alone ( n = 12 ) in a prospect i ve , multicenter , r and omized , open-label trial , with efficacy assessed by a radiology panel unaware of treatment assignment . Patients r and omly assigned to rt-PA received 0.05 mg/kg/hour for 24 hours via a peripheral vein , with a maximum dose of 150 mg . All patients then received heparin and warfarin for the remainder of the hospitalization . Follow-up venography was performed 24 to 36 hours after initiation of therapy . RESULTS Complete or more than 50 % lysis occurred in 10 ( 28 % ) patients treated with rt-PA , five ( 29 % ) patients with rt-PA plus heparin , and no patient treated with heparin . No lysis occurred in 16 ( 44 % ) patients treated with rt-PA plus heparin , and 10 ( 83 % ) patients who received heparin alone ( p = 0.04 ) . There was one major complication , a nonfatal intracranial hemorrhage in a patient who received rt-PA alone . At 7 to 10 days after initiation of treatment , the level of serum glutamic oxaloacetic transaminase nearly doubled among all patients , including those assigned to receive heparin alone . CONCLUSION ( 1 ) rt-PA and rt-PA plus heparin cause more clot lysis than heparin alone ; ( 2 ) the addition of heparin to rt-PA does not improve the lysis rate ; ( 3 ) DVT treated with heparin is commonly associated with a rise in the transaminase level ; ( 4 ) \n Output:\n " }, { "from": "agent", "value": "The authors determined that thrombolysis therapy results in greater lysis and complication rates than does anticoagulation alone .\nThe authors also found that PTS incidence is lower in patients treated with thrombolytics .\nTherefore , the authors conclude that although the lysis rate is greater for thrombolytic agents , they can not be recommended routinely for DVT treatment" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The necessity of tendon interposition for the maintenance of joint space after basal joint resection arthroplasty with ligament reconstruction has not been established . A prospect i ve , r and omized study was performed . In Group I ( nine patients ) , ligament reconstruction was performed to suspend the first metacarpal in addition to placement of a rolled tendon interposition to fill the void created by resection of the trapezium . In Group II ( 11 patients ) , ligament reconstruction alone was performed , with use of a Mitek suture anchor . No tendon interposition was performed . This allowed use of a more limited incision and shorter length of tendon graft . Average followup was 23 months . There was no difference between the two groups in range of motion of the thumb , grip strength , lateral pinch strength , the ability to perform activities of daily living , or subjective satisfaction with the procedure . Two- and three-point pinch strength was statistically significantly greater in Group II . Lateral radiographs of the basal joint at followup , at rest and with pinch , showed maintenance of the joint space , and no difference between the two groups . Tendon interposition is not necessary for maintenance of joint space after basal joint resection arthroplasty if ligament reconstruction is performed Seventy-three thumbs in 67 women with osteoarthritis of the trapeziometacarpal joint were assessed prospect ively . The patients were r and omly allocated for treatment by either trapeziectomy alone ( n = 26 ) or trapeziectomy with tendon interposition ( n = 23 ) or ligament reconstruction ( n = 24 ) . A K-wire was passed through the thumb metacarpal base and across the trapezial space into the distal pole of the scaphoid in all procedures ; this held the base of the metacarpal away from the scaphoid for 4 weeks . St and ard thumb radiographs were used to calculate the trapezial space ratio before surgery and at 1-year follow-up examination . The trapezial space ratio decreased significantly from a preoperative mean of 0.40 ( range , 0.20 - 0.56 ) to a mean of 0.18 ( range , 0.08 - 0.30 ) after trapeziectomy , 0.16 ( range , 0.07 - 0.30 ) after trapeziectomy with tendon interposition , and 0.20 ( range , 0.00 - 0.33 ) after trapeziectomy with ligament reconstruction . There was no significant difference between these 1-year follow-up trapezial space ratios , suggesting that the placement of a K-wire across the trapezial void is as effective as tendon interposition or ligament reconstruction in creating a trapezial space in the short term at least . However , the need to create a trapezial space and maintain thumb length is question ed because the trapezial space height did not correlate with thumb strength at 1-year follow-up examination Forty-three h and s in 41 adults with osteoarthrosis of the trapeziometacarpal joint were allocated r and omly to undergo a trapeziectomy through either an anterior approach or the posterior ( dorsoradial ) approach . Forty h and s were available for review at a median of 33 months postoperatively . The demographic characteristics , severity of disease and pre-operative measurements of the two groups were indistinguishable . Trapeziectomy result ed in significantly improved objective and subjective function in both groups , but the anterior approach group had better outcomes for power , scar tenderness and satisfaction . Scar-related complications were three times more common in the posterior group . Trapeziectomy is a good method of treating osteoarthritis of the thumb base , but outcomes for the anterior approach are equally good or better than with the posterior PURPOSE A new spacer for the trapeziometacarpal joint ( TMC ) based on a biological and tissue-preserving concept for the treatment of TMC osteoarthritis ( OA ) has been evaluated . The purpose was to combine a spacing effect with stabilization of the TMC joint . METHODS Artelon ( Artimplant AB , Sweden ) TMC Spacer is synthesized of a degradable polyurethaneurea ( Artelon ) , which has been shown to be biocompatible over time and currently is used in ligament augmentation procedures . Fibers of the polymer were woven into a T-shaped device in which the vertical portion separates the bone edges of the TMC joint and the horizontal portion stabilizes the joint . Fifteen patients with disabling pain and isolated TMC OA were included in the study . Ten patients received the spacer device and the remaining 5 ( control group ) were treated with a trapezium resection arthroplasty with abductor pollicis longus ( APL ) stabilization . The median ages of the 2 groups were 60 and 59 years , respectively . Pain , strength , stability , and range of motion were measured before and after surgery . Radiographic examination was performed in all patients before and after surgery . At follow-up evaluation 3 years after surgery an unbiased observer evaluated all patients . Biopsy specimens were obtained from 1 patient 6 months after surgery . RESULTS All patients were stable clinical ly without signs of synovitis . In both groups all patients were pain free . The median values for both key pinch and tripod pinch increased compared with before surgery in the spacer group but not in the APL group . The biopsy examinations showed incorporation of the device in the surface of the adjacent bone and the surrounding connective tissue . No signs of foreign-body reaction were seen . CONCLUSIONS This study showed significantly better pinch strength after Artelon TMC Spacer implantation into the TMC joint compared with APL arthroplasty Twenty-six h and s in 26 adults with osteoarthrosis of the thumb trapeziometacarpal joint were r and omised to undergo either trapeziectomy alone ( control ) or with the interposition of porcine dermal collagen xenograft ( Permacol ™ ) . The study was terminated prematurely because of apparent reactions to the implants in six of 13 patients . The collagen interposition group required more frequent review on clinical grounds and were discharged later after surgery . Three of the implants have been removed and histology revealed foreign body reactions in all . There was no difference in thumb movement or power after surgery between the two groups . However , improved grip strength was observed and improved function were reported only in the control group . Permacol patients reported greater pain and were less satisfied with their operations than control patients . We conclude that interposition of Permacol is detrimental to the results of trapeziectomy This r and omized prospect i ve study compared the results of trapeziectomy alone , or combined with tendon interposition or ligament reconstruction in 76 women with basal thumb osteoarthritis . At 3 month and 1 year follow-up the results of the three procedures were indistinguishable in terms of pain relief , h and function and thumb strength . In the short term at least , tendon interposition and ligament reconstruction do not improve the results of trapeziectomy Forty-three patients were r and omly allocated to undergo either trapeziectomy alone ( control ) or with a ligament reconstruction and tendon interposition ( LRTI ) using an abductor pollicis longus tendon slip . The patients were review ed at a median 13 ( range , 7–29 ) months after surgery . The demographic characteristics , severity of disease and pre-operative clinical measurements of the two study groups were indistinguishable but LRTI lengthened the operation by approximately 15 minutes . Both groups expressed equal satisfaction with the operation and there were no significant differences between the two treatment groups . Simple trapeziectomy is an effective operation for osteoarthrosis at the base of the thumb and the addition of a ligament reconstruction was not shown to confer any additional benefit \n Output:\n " }, { "from": "agent", "value": "2 ) Trapeziectomy with ligament reconstruction or trapeziectomy with ligament reconstruction and tendon interposition ( LRTI ) is not superior to any of the other techniques .\nIn addition , trapeziectomy with LRTI seems associated with a higher complication rate .\n( 3 ) Because the studies on thumb carpometacarpal ( CMC ) arthrodesis were of less method ological quality and had inconsistent outcomes , we are not able to conclude whether CMC arthrodesis is superior to any other technique .\n4 ) A study on joint replacement showed that total joint prosthesis might have better short-term results compared to trapeziectomy with LRTI .\nIn addition , there is no evidence that the Artelon spacer is superior to trapeziectomy with LRTI .\nWe conclude that , at this time , no surgical procedure is proven to be superior to another .\nHowever , based on good results of CMC arthrodesis and total joint prostheses , we postulate that there could be differences between the various surgical procedures ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Chromoendoscopy can accurately differentiate neoplastic from nonneoplastic polyps in the colon . Narrow b and imaging ( NBI ) has been described as \" electronic chromoendoscopy , \" but it is unclear whether pit patterns seen with chromoendoscopy are identical to those with NBI . OBJECTIVE Pilot study to compare features of diminutive polyps assessed with magnification NBI and chromoendoscopy . DESIGN Prospect i ve polyp series . SETTING Single tertiary referral center in the United Kingdom . PATIENTS Twenty patients seen for routine colonoscopy . INTERVENTION Digital images of each polyp recorded with NBI and chromoendoscopy were subsequently assessed as single images in a r and om order and as paired polyp images by experienced European- and Japanese-trained endoscopists . MAIN OUTCOME MEASUREMENTS Pit pattern ( Kudo classification ) ; vascular pattern intensity ( weak , normal , strong ) ; predicted histology ; pit pattern and vessel network clarity ( scale 1 - 3 , 1 poor , 3 excellent ) . RESULTS A total of 33 polyps < or=6 mm were assessed . Chromoendoscopic and NBI pit patterns were different for 12 and 20 of 33 polyps ( Japanese and European , respectively ) , combined kappa 0.23 , P < .001 compared with published intraobsever variation . Sensitivity , specificity , and accuracy for neoplasia were comparable for chromoendoscopic and NBI pit patterns and vascular pattern intensity for both observers . Vessel network clarity was better with NBI , P < .001 ( both ) , as was pit pattern clarity , P = .04 ( European ) . LIMITATIONS Small sample size ; pilot study . CONCLUSIONS Pit patterns were not always identical with NBI and chromoendoscopy . The Kudo classification may need to be modified and revali date d before it can be used with confidence with NBI . Vascular pattern intensity , a simple color change , appears as accurate as pit pattern Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat An important determinant in interpreting the results of colorectal polyp chemoprevention trials is the rate of polyps missed during colonscopic examination . We prospect ively examined 90 patients by t and em colonoscopy performed by two alternating examiners . In 69 ( 76.7 % ) patients , 221 neoplastic lesions were documented histologically . Of a total of 58 lesions detected in 31 patients , no neoplastic lesion greater than or equal to 10 mm in size was missed ; 16 % of diminutive ( less than or equal to 5 mm ) neop \n Output:\n " }, { "from": "agent", "value": "We could not find convincing evidence that NBI is significantly better than high definition WLC for the detection of patients with colorectal polyps , or colorectal adenomas .\nWe found evidence that NBI might be better than st and ard definition WLC and equal to high definition WLC for detection the patients with colorectal polyps , or colorectal adenomas" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The aim was to prove the low identification rate of sentinel lymph node biopsy ( SNB ) and to determine the feasibility of replacing axillary lymph node dissection ( AND ) in axillary lymph node positive patients after chemotherapy . Methods From October 2001 to July 2005 , 875 consecutive patients with primary operable breast cancer underwent SNB and AND . Among them , 238 received pre-operative chemotherapy . We compared the identification rate , false negative rate ( FNR ) , negative predictive value ( NPV ) , and accuracy of SNB in clinical ly node-positive patients with or without chemotherapy . Results The identification rate was significantly lower in patients received chemotherapy ( 77.6 % ) than in those not received it ( 97.0 % ) ( P < 0.001 ) . In those received the therapy , the FNR was 5.6 % , the NPV was 86.8 % , and the accuracy was 95.9 % . In those not received therapy , the FNR was 7.4 % and the accuracy was 92.6 % ( differences not statistically significant ) . Conclusion The identification rate in confirmed axillary lymph node-positive patients was significantly lower in patients received pre-operative chemotherapy , but accuracy did not differ significantly between the two groups . Thus , for patients who achieve complete axillary clearance by chemotherapy , SNB could replace AND PURPOSE To determine the detection rate , the false-negative rate , and the accuracy of sentinel lymph node ( SLN ) detection after neoadjuvant chemotherapy ( NAC ) for advanced breast cancer . PATIENTS AND METHODS A prospect i ve multicentric study was initiated to evaluate the results of SLN biopsy with the combined method after NAC for advanced large operable breast cancer . RESULTS From September 2003 to March 2007 , 195 patients enrolled from 12 institutions were found suitable for evaluation . The detection rate was 90 % ( 176 of 195 patients ) , and the false-negative rate was 11.5 % ( six of 52 patients ) . Patients without axillary palpable nodes ( N0 ) before NAC had a better detection rate compared with patients with axillary suspicious nodes ( N1 , 94.6 % v 81.5 % ; P = .008 ) . The false-negative rate was not correlated with clinical nodal status before NAC ( 9.4 % v 15 % ; P = .66 ) . CONCLUSION This study confirms the feasibility of SLN biopsy after NAC in the case of large operable breast cancer . The detection rate , false-negative rate , and accuracy do not differ from those obtained in the case of early breast cancer without NAC , thus demonstrating the feasibility of SLN biopsy after NAC Abstract Background : We evaluated the accuracy of sentinel lymph node dissection ( SLND ) in patients with stage II and III breast cancer who had received preoperative therapy . Methods : A prospect i ve clinical trial evaluated 122 patients who had SLND followed by axillary lymph node dissection . Thirty-two women had stage II or III breast cancer and received preoperative doxorubicin-based chemotherapy or paclitaxel and radiotherapy . Results : A sentinel lymph node ( SLN ) was identified in 31 ( 97 % ) of 32 patients . The SLN predicted the status of the axillary nodes in 30 ( 97 % ) of 31 patients . Eighteen ( 58 % ) of 31 had metastases in the SLN . Eighteen of 19 patients with axillary metastases had a tumor-positive SLN ( sensitivity , 95 % ; false-negative rate , 5 % ) . Eight ( 44 % ) of 18 women with metastases in the SLN also had metastases in 1 or more nonsentinel nodes . Conclusions : In this relatively small study , the accuracy of SLND in women with stage II or III breast cancer treated with preoperative therapy was similar to that achieved in early-stage breast cancer . If these results are confirmed in a larger cohort , it may be feasible to substitute SLND for routine axillary lymph node dissection in this population . This approach could reduce the morbidity of surgical therapy while preserving the accuracy of axillary staging and maintaining regional control in this high-risk population Abstract Background : Sentinel lymph node dissection ( SLND ) for small , early-stage breast cancer is well accepted . However , the role of SLND for large primary breast cancer is controversial . We investigated the feasibility and clinical applicability of SLND in patients with large ( ≥5 cm ) breast cancers and clinical ly negative axillae . Methods : A prospect ively entered data base was used to identify all patients who underwent surgical management of histopathologically confirmed primary breast carcinomas ≥5 cm in diameter between September 1991 and August 2000 . Patients who had clinical ly negative axillae and underwent SLND followed by completion axillary lymph node dissection ( ALND ) were selected for the study . The positivity rate , accuracy rate , and false-negative rate of SLND were determined . Results : Of the 41 patients selected for the study , 24 had infiltrating ductal carcinoma and 17 had infiltrating lobular carcinoma . Mean tumor size was 7.12 cm ( range , 5–23 cm ) . At least one sentinel lymph node ( SLN ) was identified in all cases . Thirty patients had tumor-positive SLNs . Axillary metastasis was also identified in one patient who did not have a positive SLN . Thus , SLN status accurately predicted regional nodal status in 98 % ( 40 of 41 ) of cases . The false-negative rate of SLND was 3 % ( 1 of 31 ) . None of the three patients with SLN micrometastasis , defined as a tumor focus ≤2 mm , had tumor deposits in nonsentinel axillary lymph nodes . Only SLN macrometastasis ( > 2-mm tumor deposit ) and primary tumor size ≥7 cm predicted nonsentinel axillary metastasis with significance on multivariate analysis ( P = .008 and P = .046 , respectively ) . Conclusions : SLND is feasible and accurate in patients with large breast cancers and clinical ly negative axillae . Axillary lymph node dissection can be avoided in nearly one third of patients by focused examination of the SLN Background : In a prospect i ve study , upper limb morbidity and perceived disability/activities of daily life ( ADLs ) were assessed before and 1 year after sentinel lymph node biopsy ( SLNB ) or axillary lymph node dissection ( ALND ) . Methods : A total of 204 patients with stage I/II breast cancer ( mean age , 55.6 years ; SD , 11.6 years ) entered the study , and 189 patients ( 93 % ) could be evaluated after 1 year . Fifty-eight patients ( 31 % ) underwent only SLNB , and 131 ( 69 % ) underwent ALND . Assessment s performed before surgery ( t0 ) and 1 year after surgery ( t1 ) , included pain , shoulder range of motion , muscle strength , upper arm/forearm circumference , and perceived shoulder disability/ADL . Results : Considerable treatment-related upper limb morbidity was observed . Significant ( P < .05 ) changes between t0 and t1 were found in all assessment s except strength of elbow flexors . Patients in the ALND group showed significantly more changes in the range of motion in forward flexion , abduction , and abduction/external rotation ; grip strength and strength of shoulder abductors ; circumference of upper arm and forearm ; and perceived shoulder disability in ADLs compared with the SLNB group . Multivariate linear regression analysis showed that ALND could predict a decrease of range of motion in forward flexion , abduction , strength of shoulder abductors , grip strength , and shoulder-related ADLs and an increase in the circumference of the upper arm . Radiation of the axilla ( 19 patients ) predicts an additional decrease in shoulder range of motion . Conclusions : One year after treatment of breast cancer , there is significantly less upper limb morbidity after SLNB compared with ALND . ALND is a predictor for upper limb morbidity The aim of this study was to analyse the accuracy of scintigraphic and gamma probe sentinel node ( SN ) localization in breast cancer patients who have been su bmi tted to neoadjuvant chemotherapy ( NC ) . Seventy-six patients with single breast cancer were included in the study , and were classified into two groups . Group 1 consisted of 40 women who had received NC , and Group 2 consisted of 36 women who did not receive NC . All patients received 111 MBq ( 3 mCi ) of 99Tcm-nanocolloid in 3 ml , by peritumoural injection . Anterior and lateral thoracic scans were obtained 2 h post-injection . The following day ( 18 - 24 h post-injection ) the patients underwent surgery and sentinel nodes were localized by using a gamma probe . Complete axillary lymph node dissection was performed in all patients . Histological analysis included haematoxylin-eosin in all cases and immunohistochemistry in 10 cases . In Group 1 , SNs were localized in 36/40 patients , histological analysis was performed in 34 and there were four false negatives ( 22 % ) . In Group 2 , SNs were localized in 32/36 patients , histological analysis was performed in 29 and there were two false negatives ( 9 % ) . Predictive negative values were 78 % and 90 % in Groups 1 and 2 , respectively . In summary , sentinel node localization in breast cancer patients su bmi tted to previous neoadjuvant chemotherapy is less accurate than in patients who do not receive this therapy . The procedure is not sufficiently accurate to localize the sentinel node , thus it can not be recommended in these patients PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Purpose : Sentinel node ( SN ) biopsy is a reliable method for improved staging of breast cancer , offering an alternative to routine axillary dissection . Perhaps preoperative chemotherapy could increase the rate of false‐negative SN because of induced lymphatic changes . The aim of the study was to evaluate the utility of lymphoscintigraphy and of h and ‐held probe detection in the SN approach after chemotherapy , correlating it with histologic analysis of the axilla . Methods : Eighty‐three patients ( mean age , 53 years ; TNM stage I ) were studied prospect ively . They were separated into two groups : group 1 ( G1 ) , 37 patients with preoperative chemotherapy and group 2 ( G2 ) , 46 patients without chemotherapy . Mean tumor size was 2 cm in both groups . Lymphoscintigraphy was performed 3 to 4 hours after peritumoral injection of Tc‐99 m dextran‐70 in a 0.2‐ml volume and activity of 14.8 MBq ( 0.4 mCi ) , performed under ultrasound or mammographic control . On the following day , each patient underwent tumor resection with axillary dissection , included the SN . Results : The SN was detected by scintigraphy in 78 patients ( 94 % ) . The failure of SN to predict the axillary histologic status was significantly higher ( P = 0.01 ) in G1 than in G2 ( 7 and 1 false‐negative result , respectively ) . Conclusion : Preoperative chemotherapy seems to impair axillary evaluation by SN biopsy and should be used cautiously in this subset of patients Objective : The aim of this multicenter r and omized trial was to assess the efficacy and safety of sentinel lymph node ( SLN ) biopsy compared with axillary lymph node dissection ( ALND ) . Background : All studies on SLN biopsy in breast cancer report a variable false negative rate , whose prognostic consequences are still unclear . Methods : From May \n Output:\n " }, { "from": "agent", "value": "The reported SN success rates were heterogeneous and several variables were reported to be associated with decreased SN accuracy , i.e. initially positive clinical nodal status .\nThere is a potential role for SN biopsy following NAC which could be considered on an individual basis .\nHowever , there is insufficient evidence to recommend this as a st and ard procedure ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Disease management programs ( DMPs ) that use multidisciplinary teams and specialized clinics reduce hospital admissions and improve quality of life and functional status . Evaluations of cardiac DMPs delivered by home health nurses are required . METHODS Between August 1999 and August 2000 we identified consecutive patients admitted to hospital with elevated cardiac enzymes . Patients who agreed were r and omly assigned to participate in a DMP or to receive usual care . The DMP included 6 home visits by a cardiac-trained nurse , a st and ardized nurses ' checklist , referral criteria for specialty care , communication with the family physician and patient education . We measured readmission days per 1000 follow-up days for angina , congestive heart failure ( CHF ) and chronic obstructive pulmonary disease ( COPD ) ; all-cause readmission days ; and provincial cl aims for emergency department visits , physician visits , diagnostic or therapeutic services and laboratory services . RESULTS We screened 715 consecutive patients admitted with elevated cardiac markers between August 1999 and August 2000 . Of those screened 71 DMP and 75 usual care patients met the diagnostic criteria for myocardial infa rct ion , were eligible for visits from a home health nurse and consented to participate in the study . Readmission days for angina , CHF and COPD per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( incidence density ratio [ IDR ] = 1.59 , 95 % confidence interval [ CI ] 1.27 - 2.00 , p < 0.001 ) . All-cause readmission days per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( IDR = 1.53 , 95 % CI 1.37 - 1.71 , p < 0.001 ) . The difference in emergency department encounters per 1000 follow-up days was significant ( IDR = 2.08 , 95 % CI 1.56 - 2.77 , p < 0.001 ) . During the first 25 days after discharge , there were significantly fewer provincial cl aims su bmi tted for DMP patients than for usual care patients for emergency department visits ( p = 0.007 ) , diagnostic or therapeutic services ( p = 0.012 ) and laboratory services ( p = 0.007 ) . INTERPRETATION The results provide evidence that an appropriately developed and implemented community-based inner-city DMP delivered by home health nurses has a positive impact on patient outcomes Prehospital delay is a major problem in the management of patients with acute cardiac ischemia . The authors created a patient teaching program consisting of an educational video and written instructions design ed to reduce prehospital delays in patients with chest pain . Patients who received st and ard discharge instructions served as the control group , whereas those who received the new patient teaching in addition to st and ard discharge instructions served as the intervention group . Of the 500 enrolled , 19 % were rehospitalized within 1 year . Analysis of rehospitalizations showed no significant difference between the two groups on the three outcome variables : percentage who presented within the first hour of pain , use of ambulance , and time from anginal onset to emergency department arrival . In a comparison of the index hospitalization to the rehospitalization , there was a significant increase in the use of ambulances for the intervention group , p = .03 , but not for the control group For this study a r and omized clinical trial was design ed to test the effects of an early home recovery information intervention on physical functioning , psychological distress , and symptom frequency 1 month following coronary artery bypass graft surgery ( CABG ) . Recovery outcomes were compared between two groups : those receiving an audiotape of information on expected physical sensations and their management ( Cardiac Home Information Program [ CHIP ] ) in addition to the usual care , and those receiving the usual cardiac discharge information protocol . A nonprobability sample of 180 patients ( 84 women and 96 men ; mean age = 62 years ) was equally distributed between the two study groups . When controlling for age , comorbidity , and cardiac functional status , the results showed positive effects on physical functioning in women and psychological distress , vigor and fatigue in men . Consistent with other studies , women had worse physical functioning and more symptom frequency than men . These findings indicate that the CHIP intervention is an effective method to prepare CABG patients for home recovery A study of a r and om sample of hospitals in Engl and that provide information leaflets for women undergoing hysterectomy indicates a large variation in quality . In general , the findings reveal that written information for patients is given a relatively low priority . Production and dissemination of information for hysterectomy patients is somewhat ad hoc . It is not clear that any evaluation of the leaflets has been conducted to prove the efficacy of the available literature . While the majority of leaflets include information deemed essential by past hysterectomy patients , the presentation of the recovery process often implies no control for the patient , and conceives normality with a narrow perspective about what healthy behaviour means for women . The provision of a specific timetable for resumption of housework duties in 65 % of the leaflets is a case in point . On the basis of the results of the survey , recommendations are made concerning the improvement of the st and ard of patient information leaflets The purpose of this study was to investigate the impact of a supportive-educative telephone program on the levels of knowledge and anxiety of patients undergoing coronary artery bypass graft surgery during the first 6 weeks after hospital discharge . With a posttest-only control group design , the first 74 patients scheduled , between September 1986 and February 1987 , for coronary artery bypass graft surgery in a large , western Canadian teaching hospital were r and omly assigned to either an experimental or a control group . The effect of the intervention , which was implemented by a cardiac rehabilitation nurse specialist , was assessed by a knowledge test and a state anxiety inventory . Data were collected without knowledge of the participants ' group assignment . As hypothesized , data analysis with independent t tests revealed a statistically significant ( p less than 0.05 ) difference between the knowledge level of the experimental and the control group in the areas of coronary artery disease , diet , medications , physical activity restrictions , exercise , and rest . A statistically significant difference between the state anxiety level of the experimental and the control group was also evident , as was a statistically significant inverse relationship between participants ' knowledge and anxiety levels . From these findings , several implication s and recommendations for nursing practice and research have been generated BACKGROUND This study evaluated the relative effects on compliance with recommended lifestyle changes of two experimental videotapes that involved different approaches for preparing coronary artery bypass graft ( CABG ) patients for the posthospital recovery period . The tapes differed in the extent to which they portrayed the recovery period as a steady , forward progression versus a series of \" ups and downs . \" METHODS Two hundred sixteen male and female CABG patients were assigned r and omly either to view one of the two videotapes before discharge from the hospital or to receive only the st and ard discharge preparation provided by the hospital . All patients completed measures of anxiety and self-efficacy at discharge , 1 month and 3 months after discharge from the hospital . Patients also completed measures of dietary fat consumption and activity level 1 and 3 months after discharge . RESULTS Relative to controls , patients who viewed either of the videotapes before hospital release reported higher self-efficacy for adhering to the recommended low-fat diet both at discharge and 1 month after surgery . Viewing either of the videotapes also result ed in significantly less dietary fat intake 1 month after hospital release compared with controls . Patients who viewed the tape that portrayed the recovery period as consisting of ups and downs also reported significantly more frequent moderate exercise at 1 month and more frequent strenuous exercise 3 months after discharge . CONCLUSIONS The experimental videotapes proved to be an effective method for increasing dietary and exercise compliance during the first 3 months after CABG Shortened hospitalizations following cardiac surgery necessitate re-evaluation of how pertinent information for self-care management and reduction of coronary artery disease risk factors can be incorporated into an effective inpatient cardiac patient teaching program . This study investigated the effect of three different teaching approaches ( i.e. , an inpatient teaching program , a postdischarge telephone follow-up program , and a postdischarge group teaching program ) among 90 patients who had undergone coronary artery bypass graft surgery . Teaching outcomes were evaluated in this study by use of the Heart Disease Management Question naire and Cardiac Surgical Patient Teaching Satisfaction Inventory . Analyses of the data revealed similar patient teaching outcomes regardless of the type of teaching intervention the participant received . Findings supported the effectiveness of the inpatient teaching protocol which focused on \" survival skills \" for self-care management postdischarge . The findings are important in the re design of teaching programs which are efficient yet meaningful to the patient within today 's health care environment . Additional findings indicated that patients who had longer lengths of stay and those with more vessels bypassed were the least satisfied with their teaching . Further implication s for nurses involved in patient teaching are discussed The impact of patient education follow-up by telephone on the knowledge of the postmyocardial infa rct ion ( MI ) patient was investigated in this study . On the basis of Orem 's self-care framework , subjects ' levels of knowledge in six criterion areas were assessed according to measurement criteria developed by Horn and Swain . Fifty-one subjects from the total population of MI patients admitted to the coronary care unit of the study hospital during the period of research who met study criteria were r and omly assigned to experimental and control groups . Statistically significant differences ( p less than 0.05 ) were found in the knowledge level of the experimental group in the areas of the disease , its effects , related self-care measures , recommended exercises , and all teaching areas together . Although significant differences were not found in the teaching areas of therapeutic diet , medications , physical activity restrictions , and recommended rest , a higher mean was produced for the experimental group in all but one area . These findings demonstrate that a telephone teaching program for MI patients 6 to 8 weeks after hospital discharge can be effective in increasing knowledge relative to the disease , self-care , and therapeutic regimen PURPOSE Patients who have undergone coronary artery bypass graft surgery ( CABG ) are obvious c and i date s for rehabilitation programs because of the potential for progression of disease . Such programs have been shown to foster risk-factor modification , improve quality of life , and prolong survival among post-myocardial infa rct ion ( MI ) patients . However , the efficacy of these programs has not been established among patients who have undergone CABG . METHODS A r and omized controlled trial was employed to evaluate whether a behavioral and educational cardiac rehabilitation program was effective in modifying cardiovascular disease risk factors and improving quality of life in a cohort of 86 patients after CABG . Patients were recruited from the cardiac ward of a large teaching hospital and were block-r and omized to either an intervention group or routine care . Subjects in the intervention group attended 6 weekly group sessions following hospital discharge , and booster sessions at 8 months and 1 year . They also received a personalized behavior modification program based on their baseline risk factors . Risk factor and quality of life measures were recorded at baseline ( 6 weeks after surgery ) , 4 months , 8 months , and 1 year . RESULTS The results indicated few differences between the study groups . However , the intervention group 's aerobic capacity ( VO2max ) improved over that of the routine care group . With regard to the quality of life variables , all patients tended to improve steadily over time . CONCLUSIONS The relatively moderate success of this intervention program compared with various post-MI studies may be indicative of differences between the treatment needs of patients after acute myocardial infa rct ion or CABG . Future post-CABG rehabilitation research should explore these patients ' unique treatment needs , and investigate a variety of program strategies The purpose of this study was to investigate primary nursing , discharge teaching and patient satisfaction in a group of ambulatory cataract patients . A sample ( n = 72 ) of subjects was divided r and omly into a primary group ( n = 36 ) and a control group ( n = 36 ) . Data on patient knowledge and satisfaction was collected by telephone 24 - 48 hours after surgery . Knowledge levels were high , and there was no significant difference between the primary and control groups in total score or in sub-scores on self-care , normal side effects , or complications . Women had significantly higher total scores than men ( p > .05 ) . There was a very high level of satisfaction with care , and almost all patients felt ready to go home when discharged OBJECTIVE To establish whether the provision of commercially produced written information in addition to routine hospital information can improve patients ' knowledge and satisfaction and affect their health-related quality of life . METHODS Elective surgical patients were r and omised into an experimental group ( N = 54 ) who received three commercially produced information booklets at pre- assessment , before surgery and at discharge , and a control group ( N = 55 ) who received st and ard hospital information only . RESULTS The experimental group were significantly less anxious immediately before their operation , and reported greater perceived control compared to controls post-operatively . Two weeks after discharge , health status for the two groups was similar except the experimental group reported significantly less pain . Overall satisfaction was fairly high and similar in both groups . The experimental group demonstrated greater knowledge at pre-admission , but not at discharge or follow-up . DISCUSSION Patients increasingly expect written information ; however amount , quality and timeliness vary considerably . Combining commercially produced information with st and ard hospital information may be to the patient 's benefit . PRACTICE IMPLICATION S Providing patients with commercially produced st and ardised information in addition to internally produced hospital information could have an additional , though limited , benefit to patients ' health outcomes . This could be a way of incorporating the expertise of both providers to the patient 's benefit OBJECTIVE To examine functional status outcomes among patients with a coronary artery bypass graft ( CABG ) over time ( ie , at baseline ; 3 months , 6 \n Output:\n " }, { "from": "agent", "value": "Major results : Findings indicate that delivery of postoperative patient education through the individualization of content , use of combined media for delivery , provision of education on a one-on-one basis , and in multiple sessions is associated with improvement in educational/health outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT Three fourths of US men older than 50 years have been screened with prostate-specific antigen ( PSA ) for prostate cancer . OBJECTIVE To estimate the receiver operating characteristic ( ROC ) curve for PSA . DESIGN , SETTING , AND PARTICIPANTS Calculation of PSA ROC curves in the placebo group of the Prostate Cancer Prevention Trial , a r and omized , prospect i ve study conducted from 1993 to 2003 at 221 US centers . Participants were 18 882 healthy men aged 55 years or older without prostate cancer and with PSA levels less than or equal to 3.0 ng/mL and normal digital rectal examination results , followed up for 7 years with annual PSA measurement and digital rectal examination . If PSA level exceeded 4.0 ng/mL or rectal examination result was abnormal , a prostate biopsy was recommended . After 7 years of study participation , an end-of- study prostate biopsy was recommended in all cancer-free men . MAIN OUTCOME MEASURES Operating characteristics of PSA for prostate cancer detection , including sensitivity , specificity , and ROC curve . RESULTS Of 8575 men in the placebo group with at least 1 PSA measurement and digital rectal examination in the same year , 5587 ( 65.2 % ) had had at least 1 biopsy ; of these , 1225 ( 21.9 % ) were diagnosed with prostate cancer . Of 1213 cancers with Gleason grade recorded , 250 ( 20.6 % ) were Gleason grade 7 or greater and 57 ( 4.7 % ) were Gleason grade 8 or greater . The areas under the ROC curve ( AUC ) for PSA to discriminate any prostate cancer vs no cancer , Gleason grade 7 or greater cancer vs no or lower- grade cancer , and Gleason grade 8 or greater cancer vs no or lower- grade cancer were 0.678 ( 95 % confidence interval [ CI ] , 0.666 - 0.689 ) , 0.782 ( 95 % CI , 0.748 - 0.816 ) , and 0.827 ( 95 % CI , 0.761 - 0.893 ) , respectively ( all P values < .001 for AUC vs 50 % ) . For detecting any prostate cancer , PSA cutoff values of 1.1 , 2.1 , 3.1 , and 4.1 ng/mL yielded sensitivities of 83.4 % , 52.6 % , 32.2 % , and 20.5 % , and specificities of 38.9 % , 72.5 % , 86.7 % , and 93.8 % , respectively . Age-stratified analyses showed slightly better performance of PSA in men younger than 70 years vs those 70 years or older with AUC values of 0.699 ( SD , 0.013 ) vs 0.663 ( SD , 0.013 ) ( P = .03 ) . CONCLUSION There is no cutpoint of PSA with simultaneous high sensitivity and high specificity for monitoring healthy men for prostate cancer , but rather a continuum of prostate cancer risk at all values of PSA BACKGROUND Although the first laparoscopic radical prostatectomy was performed in 1997 , few midterm oncologic data have been published for the extraperitoneal procedure . OBJECTIVE To determine the oncologic outcome of extraperitoneal laparoscopic radical prostatectomy ( ELRP ) . DESIGN , SETTING , AND PARTICIPANTS From 2000 to 2007 , 1115 consecutive patients underwent ELRP for a localized prostate cancer at our department . Follow-up was scheduled and st and ardized for all patients and recorded into a prospect i ve data base . Median postoperative follow-up was 35.6 mo . INTERVENTION All ELRP were performed by three surgeons at the Department of Urology , Hospital Henri Mondor , Créteil , France . MEASUREMENTS Biochemical recurrence was defined by prostate-specific antigen level > or = 0.2 ng/ml . RESULTS AND LIMITATIONS In pN0/pNx cancers , postoperative stage was pT2 in 664 patients ( 59.5 % ) , pT3 in 350 patients ( 31.4 % ) , and pT4 in 77 patients ( 6.9 % ) . Positive lymph nodes were reported in 24 patients ( 2.2 % ) . Margins were positive in 16.1 % and 34.6 % of pT2 and pT3 cancers , respectively . Final Gleason score was < 7 in 288 men ( 25.8 % ) , = 7 in 701 men ( 62.9 % ) , and > 7 in 126 men ( 11.3 % ) . Overall prostate-specific antigen ( PSA ) recurrence-free survival was 83 % at 5 yr . The 5-yr progression-free survival rates were 93.4 % for pT2 , 74.5 % for pT3a , and 55.0 % for pT3b tumors , respectively . Multivariate Cox model showed that PSA , Gleason score , pT category , nodal status , and surgical margins were significant independent predictors of biochemical recurrence-free survival . CONCLUSIONS This assessment of oncologic results demonstrates that ELRP is a safe and effective procedure . On the basis of midterm follow-up data , the prognostic factors of PSA after ELRP failure are the same as those described previously in transperitoneal or open retropubic approaches . The oncologic results of ELRP also are in line with those reported with the use of the retropubic or the transperitoneal laparoscopic approaches PURPOSE To prospect ively evaluate multiparametric magnetic resonance imaging ( MRI ) for accurate localization of intraprostatic tumor nodules , with whole-mount histopathology as the gold st and ard . MATERIAL S AND METHODS Seventy-five patients with biopsy-proven , intermediate , and high-risk prostate cancer underwent preoperative T2-weighted ( T2w ) , dynamic contrast-enhanced ( DCE ) and diffusion-weighted ( DW ) MRI at 1.5 T . Localization of suspicious lesions was recorded for each of 24 st and ardized regions of interest on the different MR images and correlated with the pathologic findings . Generalized estimating equations ( GEE ) were used to estimate the sensitivity , specificity , accuracy , positive , and negative predictive value for every MRI modality , as well as to evaluate the influence of Gleason score and pT-stage . Tumor volume measurements on histopathological specimens were correlated with those on the different MR modalities ( Pearson correlation ) . RESULTS DW MRI had the highest sensitivity for tumor localization ( 31.1 % vs. 27.4 % vs. 44.5 % for T2w , DCE , and DW MRI , respectively ; P < 0.005 ) , with more aggressive or more advanced tumors being more easily detected with this imaging modality . Significantly higher sensitivity values were obtained for the combination of T2w , DCE , and DW MRI ( 58.8 % ) as compared to each modality alone or any combination of two modalities ( P < 0.0001 ) . Tumor volume can most accurately be assessed by means of DW MRI ( r = 0.75 ; P < 0.0001 ) . CONCLUSION Combining T2w , DCE , and DW imaging significantly improves prostate cancer localization PURPOSE The biology of prostate cancer may be influenced by the index lesion . The definition of index lesion volume is important for appropriate decision making , especially for image guided focal treatment . We determined the accuracy of magnetic resonance imaging for determining index tumor volume compared with volumes derived from histopathology . MATERIAL S AND METHODS We evaluated 135 patients ( mean age 59.3 years ) with a mean prostate specific antigen of 6.74 ng/dl who underwent multiparametric 3 T endorectal coil magnetic resonance imaging of the prostate and subsequent radical prostatectomy . Index tumor volume was determined prospect ively and independently by magnetic resonance imaging and histopathology . The ellipsoid formula was applied to determine histopathology tumor volume , whereas manual tumor segmentation was used to determine magnetic resonance tumor volume . Histopathology tumor volume was correlated with age and prostate specific antigen whereas magnetic resonance tumor volume involved Pearson correlation and linear regression methods . In addition , the predictive power of magnetic resonance tumor volume , prostate specific antigen and age for estimating histopathology tumor volume ( greater than 0.5 cm(3 ) ) was assessed by ROC analysis . The same analysis was also conducted for the 1.15 shrinkage factor corrected histopathology data set . RESULTS There was a positive correlation between histopathology tumor volume and magnetic resonance tumor volume ( Pearson coefficient 0.633 , p < 0.0001 ) , but a weak correlation between prostate specific antigen and histopathology tumor volume ( Pearson coefficient 0.237 , p = 0.003 ) . On linear regression analysis histopathology tumor volume and magnetic resonance tumor volume were correlated ( r(2 ) = 0.401 , p < 0.00001 ) . On ROC analysis AUC values for magnetic resonance tumor volume , prostate specific antigen and age in estimating tumors larger than 0.5 cm(3 ) at histopathology were 0.949 ( p < 0.0000001 ) , 0.685 ( p = 0.001 ) and 0.627 ( p = 0.02 ) , respectively . Similar results were found in the analysis with shrinkage factor corrected tumor volumes at histopathology . CONCLUSIONS Magnetic resonance imaging can accurately estimate index tumor volume as determined by histology . Magnetic resonance imaging has better accuracy in predicting histopathology tumor volume in tumors larger than 0.5 cm(3 ) than prostate specific antigen and age . Index tumor volume as determined by magnetic resonance imaging may be helpful in planning treatment , specifically in identifying tumor margins for image guided focal therapy and possibly selecting better active surveillance c and i date A variety of malignant neoplasms have been shown to induce capillary neovascularization , and in some cases the degree of vascularization appears to correlate with aggressive behavior and risk of metastasis . We hypothesized that carcinoma of the prostate also induces the formation of new capillaries , and we developed a method to quantify the relative density of microscopic vessels in carcinoma of the prostate compared with benign prostatic gl and ular tissue . The number of microvessel profiles in tissue sections was quantified by marking the vascular endothelial cells with antibodies to factor VIII-related antigen using st and ard immunohistochemistry techniques and comparing fields of adenocarcinoma with benign gl and ular tissue in 15 radical prostatectomy specimens . The analysis was facilitated by using the Optimas computerized image analysis system ( Bioscan , Seattle , WA ) with software written for this investigation . Fourteen of the 15 cases demonstrated significantly higher vascular density in the areas of carcinoma than in the benign tissues . Overall , the ratio of vessels per unit area in sections of carcinoma versus benign tissue was approximately double ( ratio = 2.02 ; P < .001 ) . In benign tissues the capillaries are restricted for the most part to the perigl and ular stroma immediately adjacent to the epithelium , whereas the distribution in carcinoma appears to be more r and om . The data demonstrate the increased density of capillaries in prostatic carcinoma when compared with benign prostate tissue BACKGROUND The prostate component of the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality from screening using serum prostate-specific antigen ( PSA ) testing and digital rectal examination ( DRE ) . Mortality after 7 - 10 years of follow-up has been reported previously . We report extended follow-up to 13 years after the trial . METHODS A total of 76 685 men , aged 55 - 74 years , were enrolled at 10 screening centers between November 1993 and July 2001 and r and omly assigned to the intervention ( organized screening of annual PSA testing for 6 years and annual DRE for 4 years ; 38 340 men ) and control ( usual care , which sometimes included opportunistic screening ; 38 345 men ) arms . Screening was completed in October 2006 . All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31 , 2009 , were ascertained . Relative risks ( RRs ) were estimated as the ratio of observed rates in the intervention and control arms , and 95 % confidence intervals ( CIs ) were calculated assuming a Poisson distribution for the number of events . Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age , comorbidity status , and pretrial PSA testing . All statistical tests were two-sided . RESULTS Approximately 92 % of the study participants were followed to 10 years and 57 % to 13 years . At 13 years , 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm . Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 \n Output:\n " }, { "from": "agent", "value": "These use quantitative elasticity values to differentiate benign from malignant areas of the prostate .\nThis method of assessment has shown that the elasticity changes for differing Gleason grade s and T stages of disease within the prostate .\nQuantitative elasticity values offer the potential of using ' threshold ' elasticity values under which the prostate is benign .\nTissue elasticity has great potential as a diagnostic and prognostic biomarker for prostate cancer and can be assessed using various methods .\nCurrently transrectal sonoelastography has the most evidence supporting its use in clinical practice" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND We conducted a r and omized , placebo-controlled , double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non-small-cell lung cancer after the failure of first-line or second-line chemotherapy . METHODS Patients with stage IIIB or IV non-small-cell lung cancer , with performance status from 0 to 3 , were eligible if they had received one or two prior chemotherapy regimens . The patients were stratified according to center , performance status , response to prior chemotherapy , number of prior regimens , and prior platinum-based therapy and were r and omly assigned in a 2:1 ratio to receive oral erlotinib , at a dose of 150 mg daily , or placebo . RESULTS The median age of the 731 patients who underwent r and omization was 61.4 years ; 49 percent had received two prior chemotherapy regimens , and 93 percent had received platinum-based chemotherapy . The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group ( P<0.001 ) ; the median duration of the response was 7.9 months and 3.7 months , respectively . Progression-free survival was 2.2 months and 1.8 months , respectively ( hazard ratio , 0.61 , adjusted for stratification categories ; P<0.001 ) . Overall survival was 6.7 months and 4.7 months , respectively ( hazard ratio , 0.70 ; P<0.001 ) , in favor of erlotinib . Five percent of patients discontinued erlotinib because of toxic effects . CONCLUSIONS Erlotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy PURPOSE To evaluate the efficacy and tolerability of two doses of gefitinib ( Iressa [ ZD1839 ] ; AstraZeneca , Wilmington , DE ) , a novel epidermal growth factor receptor tyrosine kinase inhibitor , in patients with pretreated advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS This was a r and omized , double-blind , parallel-group , multicenter phase II trial . Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens ( at least one containing platinum ) were r and omly assigned to receive either 250-mg or 500-mg oral doses of gefitinib once daily . RESULTS Efficacy was similar for the 250- and 500-mg/d groups . Objective tumor response rates were 18.4 % ( 95 % confidence interval [ CI ] , 11.5 to 27.3 ) and 19.0 % ( 95 % CI , 12.1 to 27.9 ) ; among evaluable patients , symptom improvement rates were 40.3 % ( 95 % CI , 28.5 to 53.0 ) and 37.0 % ( 95 % CI , 26.0 to 49.1 ) ; median progression-free survival times were 2.7 and 2.8 months ; and median overall survival times were 7.6 and 8.0 months , respectively . Symptom improvements were recorded for 69.2 % ( 250 mg/d ) and 85.7 % ( 500 mg/d ) of patients with a tumor response . Adverse events ( AEs ) at both dose levels were generally mild ( grade 1 or 2 ) and consisted mainly of skin reactions and diarrhea . Drug-related toxicities were more frequent in the higher-dose group . Withdrawal due to drug-related AEs was 1.9 % and 9.4 % for patients receiving gefitinib 250 and 500 mg/d , respectively . CONCLUSION Gefitinib showed clinical ly meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients . At 250 mg/d , gefitinib had a favorable AE profile . Gefitinib 250 mg/d is an important , novel treatment option for patients with pretreated advanced NSCLC [ corrected Purpose : Elevated levels or increases in circulating tumor cells ( CTC ) portend poor prognosis in patients with epithelial cancers . Less is known about CTCs as surrogate endpoints or their use for predictive biomarker evaluation . This study investigated the utility of CTC enumeration and characterization using the Cell Search platform , as well as mutation detection in circulating tumor DNA ( ctDNA ) , in patients with advanced non – small cell lung cancer ( NSCLC ) . Experimental Design : Forty-one patients were enrolled in a single-arm phase II clinical trial of erlotinib and pertuzumab . Peripheral blood was analyzed for CTC enumeration , EGFR expression in CTCs , and detection of oncogenic mutations in CTCs and ctDNA . Changes in CTC levels were correlated with 2[18F]fluoro-2-deoxy-d-glucose – positron emission tomographic ( FDG-PET ) and computed tomographic ( CT ) imaging and survival endpoints . Results : CTCs were detected ( ≥1 CTC ) at baseline in 78 % of patients . Greater sensitivity for mutation detection was observed in ctDNA than in CTCs and detected mutations were strongly concordant with mutation status in matched tumor . Higher baseline CTC counts were associated with response to treatment by Response Evaluation Criteria in Solid Tumors ( RECIST , P = 0.009 ) and decreased CTC counts upon treatment were associated with FDG-PET and RECIST response ( P = 0.014 and P = 0.019 ) and longer progression-free survival ( P = 0.050 ) . Conclusion : These data provide evidence of a correlation between decreases in CTC counts and radiographic response by either FDG-PET or RECIST in patients with advanced NSCLC . These findings require prospect i ve validation but suggest a potential role for using CTC decreases as an early indication of response to therapy and ctDNA for real-time assessment of mutation status from blood . Clin Cancer Res ; 18(8 ) ; 2391–401 . © 2012 AACR CONTEXT More persons in the United States die from non-small cell lung cancer ( NSCLC ) than from breast , colorectal , and prostate cancer combined . In pre clinical testing , oral gefitinib inhibited the growth of NSCLC tumors that express the epidermal growth factor receptor ( EGFR ) , a mediator of cell signaling , and phase 1 trials have demonstrated that a fraction of patients with NSCLC progressing after chemotherapy experience both a decrease in lung cancer symptoms and radiographic tumor shrinkages with gefitinib . OBJECTIVE To assess differences in symptomatic and radiographic response among patients with NSCLC receiving 250-mg and 500-mg daily doses of gefitinib . DESIGN , SETTING , AND PATIENTS Double-blind , r and omized phase 2 trial conducted from November 2000 to April 2001 in 30 US academic and community oncology centers . Patients ( N = 221 ) had either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimens . INTERVENTION Daily oral gefitinib , either 500 mg ( administered as two 250-mg gefitinib tablets ) or 250 mg ( administered as one 250-mg gefitinib tablet and 1 matching placebo ) . MAIN OUTCOME MEASURES Improvement of NSCLC symptoms ( 2-point or greater increase in score on the summed lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung [ FACT-L ] instrument ) and tumor regression ( > 50 % decrease in lesion size on imaging studies ) . RESULTS Of 221 patients enrolled , 216 received gefitinib as r and omized . Symptoms of NSCLC improved in 43 % ( 95 % confidence interval [ CI ] , 33%-53 % ) of patients receiving 250 mg of gefitinib and in 35 % ( 95 % CI , 26%-45 % ) of patients receiving 500 mg . These benefits were observed within 3 weeks in 75 % of patients . Partial radiographic responses occurred in 12 % ( 95 % CI , 6%-20 % ) of individuals receiving 250 mg of gefitinib and in 9 % ( 95 % CI , 4%-16 % ) of those receiving 500 mg . Symptoms improved in 96 % of patients with partial radiographic responses . The overall survival at 1 year was 25 % . There were no significant differences between the 250-mg and 500-mg doses in rates of symptom improvement ( P = .26 ) , radiographic tumor regression ( P = .51 ) , and projected 1-year survival ( P = .54 ) . The 500-mg dose was associated more frequently with transient acne-like rash ( P = .04 ) and diarrhea ( P = .006 ) . CONCLUSIONS Gefitinib , a well-tolerated oral EGFR-tyrosine kinase inhibitor , improved disease-related symptoms and induced radiographic tumor regressions in patients with NSCLC persisting after chemotherapy Purpose : Activating mutations in the epidermal growth factor receptor ( EGFR ) are associated with enhanced response to EGFR tyrosine kinase inhibitors in non-small cell lung cancer ( NSCLC ) , whereas KRAS mutations translate into poor patient outcomes . We hypothesized that analysis of plasma for EGFR and KRAS mutations from shed tumor DNA would have clinical utility . Methods : An allele-specific polymerase chain reaction assay using Scorpion-amplification refractory mutation system ( DxS , Ltd ) was used to detect mutations in plasma DNA from patients with advanced stage NSCLC treated as second- or third-line therapy on a phase I/II trial of docetaxel plus intercalated erlotinib . Results : EGFR mutations were detected in 10 of 49 patients ( 20 % ) . Six ( 12 % ) had single activating mutations in EGFR , associated with improved progression-free survival ( median , 18.3 months ) , compared with all other patients ( median , 3.9 months ; p = 0.008 ) , or those with wild-type EGFR ( median , 4.0 months ; p = 0.012 ) . Four of 49 patients harbored a de novo T790 M resistance mutation ( median progression-free survival , 3.9 months ) . EGFR mutational status was associated with clinical response ( 45 assessable , p = 0.0001 ) ; in the six patients with activating mutations , all achieved complete ( 33 % ) or partial ( 67 % ) response . All CR patients had E19del detectable in both tumor and plasma . KRAS mutations were detected in two of 49 ( 4 % ) patients , both of whom had rapid progressive disease . Conclusions : Activating EGFR mutations detected in shed DNA in plasma are significantly associated with favorable outcomes in patients with advanced NSCLC receiving docetaxel plus intercalated erlotinib . The addition of docetaxel in this schedule did not diminish the efficacy of erlotinib against patients with EGFR activating mutations Introduction : In IPASS ( IRESSA Pan-Asia Study ) , clinical ly selected patients with pulmonary adenocarcinoma received first-line gefitinib or carboplatin/paclitaxel . This preplanned , exploratory analysis was conducted to increase underst and ing of the use of surrogate sample s , such as serum , versus tumor biopsy sample s for determining EGFR mutation status in the Japanese cohort ( n = 233 ) . Methods : EGFR mutations were assessed using tumor tissue-derived DNA ( n = 91 ) and circulating free ( cf ) DNA from pretreatment serum sample s ( n = 194 ) . Results : Fewer patients were EGFR mutation positive when assessed using pretreatment cfDNA ( 23.7 % ) versus tumor tissue-derived DNA ( 61.5 % ) . cfDNA results identified no false positives but a high rate of false negatives ( 56.9 % ) . There was a significant interaction between cfDNA EGFR mutation status and treatment for progression-free survival ( PFS ) ( p = 0.045 ) . PFS was significantly longer and objective response rate ( ORR ) higher with gefitinib than carboplatin/paclitaxel in the cfDNA EGFR mutation-positive subgroup ( PFS : hazard ratio [ HR ] , 0.29 ; 95 % confidence interval [ CI ] , 0.14–0.60 ; p < 0.001 ; ORR : odds ratio [ OR ] , 1.71 ; 95 % CI , 0.48–6.09 ; 75.0 % versus 63.6 % ; p = 0.40 ) . There was a slight numerical advantage in PFS and ORR for gefitinib over carboplatin/paclitaxel in the cfDNA EGFR mutation-negative subgroup , likely due to the high rate of false negatives within this subgroup . Conclusions : These results merit further investigation to determine whether alternative sources of tumor DNA , such as cfDNA in serum , could be used for determining EGFR mutation status in future ; currently , where a sample is available , analysis of tumor material is recommended BACKGROUND Patients with non- \n Output:\n " }, { "from": "agent", "value": "Importantly , the association of the mutations with the 3 clinical outcomes for serum was similar to that for tumor tissue and higher than that for plasma .\nBlood , in particular serum , is a good substitute when tumor tissue is absent or insufficient for testing EGFR mutations to guide EGFR TKIs treatment in patients with NSCLC ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Cardiopulmonary bypass ( CPB ) contributes to the secretion of anti-inflammatory cytokines that mediate the inflammatory response observed during open heart surgery . In addition to many factors , type of anesthesia management affects immune response and central nervous system in cardiac surgery . The aim of this study was to assess the effect of propofol versus desflurane anesthesia on systemic immune modulation and central nervous system on patients undergoing coronary artery bypass grafting . Forty patients undergoing elective coronary artery bypass graft surgery with CPB were included in this prospect i ve r and omized study . Patients were allocated to receive propofol ( n = 20 ) or desflurane ( n = 20 ) for maintenance of anesthesia . The blood sample s for IL-6 , IL-8 , TNF-α , and S100β were drawn just prior to the operation before the induction of anesthesia , second before cardiopulmonary bypass , third after CPB , fourth 4 h postoperatively at the ICU . Major finding in our study is that S100β levels were lower in propofol group when compared to desflurane anesthesia . And also immune reaction was less in patients exposed to desflurane anesthesia when compared to propofol anesthesia as indicated by lower plasma concentrations of IL-8 and IL-6 . Propofol is more preferable in terms of S100β for anesthetic management for CABG OBJECTIVES Neuropsychological disorders are some of the most common complications of coronary artery bypass graft ( CABG ) surgery . The early diagnosis of postoperative brain damage is difficult and mainly based on the observation of specific brain injury markers . The aim of this study was to analyze the effects of volatile anesthesia ( VA ) on plasma total and ionized arteriovenous magnesium concentrations in the brain circulation ( a-vtMg and a-viMg ) , plasma matrix metalloproteinase-9 ( MMP-9 ) , and glial fibrillary acidic protein ( GFAP ) in adult patients undergoing CABG surgery . DESIGN An observational study . SETTING The Department of Cardiac Surgery in a Medical University Hospital . PATIENTS AND METHODS Studied parameters were measured during surgery and in the early postoperative period . Patients were assigned to 3 groups : group O , patients who did not receive VA ; group ISO , patients who received isoflurane ; and group SEV , patients who received sevoflurane . RESULTS Ninety-two patients were examined . CABG surgery increased MMP-9 and GFAP . The highest MMP-9 , GFAP , and the most dramatic disorders in a-vtMg and a-viMg were noted in group O. CONCLUSIONS Cardiac surgery increased plasma MMP-9 and GFAP concentrations . Changes in MMP-9 , GFAP , and arteriovenous tMg and iMg were significantly higher in group O. Volatile anesthetics , such as ISO or SEV , reduced plasma MMP-9 , GFAP concentrations , and disturbances in a-vtMg and a-viMg We investigated the long-term effects of sevoflurane on histopathologic injury and key proteins of apoptosis in a rat hemispheric ischemia/reperfusion model . Sixty-four male Sprague-Dawley rats were r and omly assigned to Group 1 ( fentanyl and N2O/O2 ; control ) and Group 2 ( 2.0 vol% sevoflurane and O2/air ) . Ischemia ( 45 min ) was produced by unilateral common carotid artery occlusion plus hemorrhagic hypotension ( mean arterial blood pressure 40 mm Hg ) . Animals were killed after 1 , 3 , 7 , and 28 days . In hematoxylin and eosin-stained brain sections eosinophilic hippocampal neurons were counted . Activated caspase-3 and the apoptosis-regulating proteins Bax , Bcl-2 , Mdm-2 , and p53 were analyzed by immunostaining . No eosinophilic neurons were detected in sevoflurane-anesthetized rats over time , whereas 9%–38 % of the hippocampal neurons were eosinophilic ( days 1–28 ) in control animals . On days 1 and 3 , the concentration of Bax was 140%–200 % larger in fentanyl/N2O-anesthetized animals compared with sevoflurane . Bcl-2 was 100 % less in control animals during the first 3 days . Activated caspase-3 was detected in neurons of both groups ( 0.75%–2.2 % ) . These data support a sustained neuroprotective potency of sevoflurane related to reduced eosinophilic injury after cerebral ischemia/reperfusion BACKGROUND A recent study demonstrated that almost 75 % of strokes after coronary artery revascularization surgery occur in patients classified preoperatively as low to medium risk . Thus , despite the use of risk classification , most strokes can occur when not expected . We hypothesized that optimization of cerebral oxygen delivery variables by using noninvasive cerebral oximetry could reduce the incidence of stroke . METHODS Cerebral oximetry was used by all surgeons to monitor cerebral oxygen saturation in all cardiac surgery patients from January 1 , 2002 , until June 30 , 2003 ( n = 1034 ; 18 months , treatment group ) . Cerebral oxygen delivery was optimized during surgery by modifying oxygen delivery and consumption variables to maintain oximetry values at or near the patient 's preinduction baseline . Stroke was defined according to guidelines of the Society of Thoracic Surgeons . The incidence of stroke in the treatment group was compared with that for patients who underwent cardiac surgery between July 1 , 2000 , and December 31 , 2001 , ( n = 1245 ; 18 months , control group ) before cerebral oximetry was incorporated . RESULTS Age and sex distribution were similar in the 2 groups . The study group had significantly more patients in New York Heart Association ( NYHA ) classes III and IV than the control group , and patients in the study group were sicker overall . Despite this difference , the study group overall had fewer permanent strokes ( 10 [ 0.97 % ] versus 25 [ 2.5 % ] ; P < .044 ) . This difference remained significant when the results were controlled for NYHA class and on-pump or off-pump surgery . When the patients were examined by NYHA class , the proportion of patients requiring prolonged ventilation was significantly smaller in the study group ( 6.8 % versus 10.6 % ; P < .0014 ) , as was the length of hospital stay ( P < .046 ) . CONCLUSIONS The treatment group , which underwent all cardiac surgeries with optimized cerebral oxygen delivery using cerebral oximetry monitoring , demonstrated a significantly lower incidence of permanent stroke . Because our study is retrospective , a prospect i ve r and omized trial is warranted BACKGROUND Previously , we reported that there was no significant difference at 30 days in the rate of a primary composite outcome of death , myocardial infa rct ion , stroke , or new renal failure requiring dialysis between patients who underwent coronary-artery bypass grafting ( CABG ) performed with a beating-heart technique ( off-pump ) and those who underwent CABG performed with cardiopulmonary bypass ( on-pump ) . We now report results on quality of life and cognitive function and on clinical outcomes at 1 year . METHODS We enrolled 4752 patients with coronary artery disease who were scheduled to undergo CABG and r and omly assigned them to undergo the procedure off-pump or on-pump . Patients were enrolled at 79 centers in 19 countries . We assessed quality of life and cognitive function at discharge , at 30 days , and at 1 year and clinical outcomes at 1 year . RESULTS At 1 year , there was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG ( 12.1 % and 13.3 % , respectively ; hazard ratio with off-pump CABG , 0.91 ; 95 % confidence interval [ CI ] , 0.77 to 1.07 ; P=0.24 ) . The rate of the primary outcome was also similar in the two groups in the period between 31 days and 1 year ( hazard ratio , 0.79 ; 95 % CI , 0.55 to 1.13 ; P=0.19 ) . The rate of repeat coronary revascularization at 1 year was 1.4 % in the off-pump group and 0.8 % in the on-pump group ( hazard ratio , 1.66 ; 95 % CI , 0.95 to 2.89 ; P=0.07 ) . There were no significant differences between the two groups at 1 year in measures of quality of life or neurocognitive function . CONCLUSIONS At 1 year after CABG , there was no significant difference between off-pump and on-pump CABG with respect to the primary composite outcome , the rate of repeat coronary revascularization , quality of life , or neurocognitive function . ( Funded by the Canadian Institutes of Health Research ; CORONARY Clinical Trials.gov number , NCT00463294 . ) In this study , we examined the cerebral oxygenation effects of two methods of pharmacologic burst suppression during cardiopulmonary bypass ( CPB ) in valvular heart surgery patients . Patients were r and omly entered into one of three groups : control ( n = 13 , fentanyl and midazolam ) , control plus burst suppression doses of thiopental ( n = 15 ) , or control plus burst suppression doses of isoflurane ( n = 16 ) . Burst suppression ( 80 % suppression ) was accomplished in the thiopental and isoflurane groups 15 min before aortic cannulation and was maintained through aortic decannulation . Cerebral physiologic measurements were made during hypothermia ( 27 - 28[degree sign]C ) and on rewarming to 36[degree sign]C. During hypothermia , burst suppression produced significant ( P < 0.005 ) differences with regard to cerebral vascular resistance ( P = 0.003 ) , cerebral arterial venous oxygen difference [ C(a-v)O2 ] ( P = 0.032 ) , cerebral blood flow ( CBF ) ( P = 0.009 ) , and cerebral oxygen delivery ( P = 0.027 ) . There was a similar pattern on rewarming , with groups differing significantly ( P < 0.05 ) with respect to CBF ( P = 0.016 ) , cerebral vascular resistance ( P = 0.008 ) , oxygen delivery ( P = 0.004 ) , C(a-v)O2 ( P = 0.043 ) , and cerebral oxygen extraction ( P = 0.046 ) . Rewarming rates were similar among groups . There was no difference in neurologic outcome or requirement for inotropic support among groups . The time to awakening was increased ( P = 0.0005 ) in the thiopental group . The thiopental group had lower cerebral oxygen delivery , but not lower cerebral metabolic rate of oxygen consumption , compared with the control group , result ing in widening C(a-v)O2 during CPB . This lack of coupling of oxygen delivery and consumption suggests that pharmacologic neuroprotective mechanisms are complex and involve more than an improvement in the ratio of global cerebral oxygen supply to dem and . Implication s : This study demonstrates that the balance of cerebral oxygen delivery to consumption during cardiopulmonary bypass is altered differently by thiopental and isoflurane . As others have noted , it seems that cerebral protection is more complex than a simple improvement in the balance of oxygen delivery and consumption . ( Anesth Analg 1998;86:246 - 51 BACKGROUND Because the time available for cooling and rewarming during deliberate mild hypothermia is limited , studies of the rate of the cooling and rewarming are useful . The decrease in core hypothermia caused by heat redistribution depends on the anaesthetic agent used . We therefore investigated possible differences between sevoflurane and propofol on the decrease and recovery of core temperature during deliberate mild hypothermia for neurosurgery . METHODS After institutional approval and informed consent , 26 patients were assigned r and omly to maintenance of anaesthesia with propofol or sevoflurane . Patients in the propofol group ( n=13 ) received propofol induction followed by a continuous infusion of propofol 3 - 5 mg kg(-1 ) h(-1 ) . Patients in the sevoflurane group ( n=13 ) received propofol induction followed by sevoflurane 1 - 2 % . Nitrous oxide and fentanyl were also used for anaesthetic maintenance . After induction of anaesthesia , patients were cooled and tympanic membrane temperature was maintained at 34.5 degrees C. After surgery , patients were actively rewarmed . RESULTS There was no difference in the rate of decrease and recovery of core temperature between the groups . There was also no difference in skin surface temperature gradient ( forearm to fingertip ) , heart rate and mean arterial blood pressure between the groups . CONCLUSIONS Sevoflurane-based anaesthesia did not affect cooling and rewarming for deliber \n Output:\n " }, { "from": "agent", "value": "Among secondary outcome variables , mini-mental state examination scores of the inhalation anaesthesia group were significantly higher than those of the TIVA group 24 hours after operation ( WMD ( 95 % CI ) : 1.87 ( 0.82 to 2.92 ) ) , but no significant difference was found in arteriovenous oxygen content difference , cerebral oxygen extraction ratio and jugular bulb venous oxygen saturation , which were assessed at cooling and rewarming during CPB .\nThis study demonstrates that anaesthesia with volatile agents appears to provide better cerebral protection than TIVA for patients undergoing cardiac surgery with CPB , suggesting that inhalation anaesthesia may be more suitable for patients undergoing cardiac surgery" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Pain after coronary artery bypass surgery persists for several days . A continuous intravenous infusion of an opioid adequately accomplishes good pain control in the intensive care unit , but it is often not suitable on the ordinary ward . Patient‐controlled analgesia ( PCA ) with intermittent injections delivered by one of the new devices now available could be an alternative to conventional nurse‐controlled analgesia ( NCA ) based on intermittent injections . The aim was to compare these two techniques with respect to efficacy and the amount of opioid used The purpose of this comparative study was to examine differences in pain intensity , sleep disturbance , sleep effectiveness , fatigue , and vigor between patients undergoing cholecystectomy who received either patient-controlled analgesia ( PCA ) or intramuscular ( IM ) injections of narcotics for postoperative pain . The PCA group consisted of 16 women , aged 22 - 58 ; the IM group consisted of 10 women , aged 22 - 60 . Data were collected on patients ' postoperative days 1 and 2 . Findings indicated that patients receiving PCA reported less pain on postoperative day 1 and less fatigue on postoperative day 2 than patients receiving IM injections of narcotics BACKGROUND In previous studies comparing patient-controlled-analgesia and intramuscular pain management have been unable to provide conclusive evidence of the benefits of either method of postoperative pain control . AIM The purpose of the study was to compare the efficacy and cost-effectiveness of intravenous patient-controlled-analgesia with intermittent intramuscular morphine for Chinese women in the first 24 hours following elective gynaecological surgery . METHODS A r and omized control design was used . The main outcomes were level of pain and cost for the two types of pain management . Participants indicated their level of pain at rest and when deep breathing or coughing on a 100 mm Visual Analogue Scale , on seven occasions within 24 postoperative hours . Costs for the two types of pain management were based on the costs of equipment , drugs and nursing time . RESULTS A total of 125 women participated in the study . Mean pain level over the 24 hours in the patient-controlled-analgesia group was significantly lower than in the intramuscular group ( P < 0.001 ) . Mean pain level over the seven occasions for the patient-controlled-analgesia group was 11.83 points ( 95 % CI 7.14 - 16.52 ) lower when at rest and 11.73 points ( 95 % CI 5.96 - 17.50 ) lower during motion than the intramuscular group . Cost per patient was $ 81.10 ( Hong Kong ) higher for patient-controlled-analgesia than for intramuscular pain management . Women in the patient-controlled-analgesia group had significantly greater satisfaction with pain management than those in the intramuscular group ( P < 0.001 ) , but reported significantly more episodes of nausea ( P < 0.05 ) . CONCLUSIONS While patient-controlled-analgesia was more costly , it was also more effective than conventional on-dem and intramuscular opioid injections after laparotomy for gynaecological surgery Background and Objectives : To compare the use of patient-controlled analgesia to intermittent intramuscular injections of morphine following major gynecological laparoscopic procedures in order to assess differences in level of pain , sedation , episodes of nausea and /or vomiting , hospitalization time and patient satisfaction with their postoperative analgesia . Methods : Seventy-two patients undergoing major gynecological laparoscopic surgery were r and omized to receive either postoperative analgesia via intermittent intramuscular injection of morphine ( Group 1 ) or patient controlled analgesia ( PCA - Group 2 ) . All patients received anesthesia via a st and ardized protocol . Postoperative pain levels were recorded via a 10 cm visual analogue scale , and sedation scores were recorded on a st and ard PCA form . Episodes of nausea and vomiting were also recorded on the same form . Results : There were no statistically significant differences between intramuscular analgesia and PCA for any of the factors studied . Most significantly it was found that most patients ceased to require either form of parenteral analgesia within 24 hours of their procedure , regardless of the operating time . Conclusion : It is important for the surgeon to be aware of the effects of postoperative analgesia on his or her patients ' level of satisfaction . We do not recommend the use of PCA analgesia following major laparoscopic gynecological surgery After open prostatectomy , 52 patients were r and omly allocated to two treatment groups . Group A ( 26 patients ) received buprenorphine sublingually , and in group B ( 26 patients ) the analgesia was induced using a patient-controlled analgesia system with morphine . The total dose of morphine given during the first 24 h was 72 + /- 8 mg compared to 1.6 + /- 0.45 mg of buprenorphine . The total dose of buprenorphine on days 2 and 3 was significantly lower than the total dose of morphine ( p < 0.01 ) . There were no significant differences in visual pain scores , side effects , mean arterial blood pressure , pulse rate and respiration rate between the two groups . Sublingual application of buprenorphine offers an effective and easy alternative to the parenteral route of morphine for the management of postoperative pain A r and omized , controlled clinical trial was conducted on 66 patients undergoing elective cardiac surgery to compare patient-controlled analgesia ( PCA ) to nurse-controlled analgesia ( NCA ) with continuous morphine infusion . Hourly assessment of pain ( at rest and on movement ) using a visual analogue scale ( VAS ) , of respiratory rate , and level of sedation took place for the 24 h following extubation . The incidence of nausea was also recorded . Mean pain scores were calculated , and peak pain and sedation scores , together with lowest respiratory rates , were identified . Morphine consumption was measured at 24 h. No significant differences were found between the groups ' scores for pain or sedation . The PCA group had significantly lower respiratory rates ( P = 0.02 ) and a lower incidence of nausea ( P = 0.008 ) . The PCA group also consumed significantly more morphine ( P = 0.0001 ) . The study suggests a beneficial effect from PCA after cardiac surgery in reducing nausea , compared to NCA . It confirms nurse-controlled infusion analgesia as an effective form of pain relief in an intensive care and high-dependency setting Intranasal administration of lipophilic opioids has been shown to be an effective method of administration which is devoid of major side‐effects . Whether it is as effective as intravenous administration for patientcontrolled analgesia ( PCA ) has been investigated for fentanyl and pethidine , but not for diamorphine . This study reports a r and omised controlled trial design ed to compare the effectiveness of diamorphine administered as PCA utilising either the intranasal or intravenous routes . We investigated 52 consecutive patients undergoing primary lower limb joint replacement surgery . Patients were r and omly allocated to receive PCA diamorphine , administered either intravenously ( 0.5 mg bolus , 3 min lockout ) or intranasally ( 1.0 mg bolus , 3 min lockout ) . Pain was assessed using a Visual Analogue Score ( VAS ) at rest and on movement on five occasions over the first 36 h postoperatively . The results demonstrated that patients in the intranasal PCA group had significantly higher VAS scores than the intravenous group , both at rest ( intranasal median 35.5 vs. intravenous median 20 ; p = 0.030 ) and on movement ( intranasal median 64 vs. intravenous median 50 ; p = 0.016 ) . However , significantly fewer patients in the intranasal group compared with the intravenous group suffered episodes of vomiting ( intranasal 0/24 vs. intravenous 6/24 patients ; p = 0.022 ) . We suggest that if a maximal reduction in pain score is considered the goal of PCA management , the intravenous route is preferable to the intranasal route We have evaluated the level of state and trait anxiety , neuroticism , extroversion and coping style as predictors of the effectiveness of patient-controlled analgesia ( PCA ) in 110 patients undergoing total abdominal hysterectomy . After operation patients were allocated to receive pain control with either PCA or i.m . injections ( IMI ) . Pain was assessed using the short form McGill pain question naire at 6 , 18 and 24 h after operation , and by recording the amount of analgesic consumed in the first 24 h after surgery . Both state anxiety and coping style were significant predictors of postoperative pain , irrespective of the method of analgesia used . Patients using PCA experienced significantly better pain control than those receiving IMI . However , it was those with high levels of state anxiety who experienced the greatest reduction in pain with PCA . In addition to achieving better pain control , patients who received PCA used significantly less analgesia and were discharged earlier than patients who received IMI We have compared patients ' and nurses ' assessment s of postoperative pain and anxiety after different analgesic treatments . Sixty orthopaedic patients were allocated r and omly to receive i.v . piritramide ( either nurse-controlled or patient-controlled ) or subarachnoid bupivacaine ( nurse-controlled or patient-controlled ) . Patients and nurses assessed pain and anxiety using a visual analogue scale ( VAS ; 1 - 100 mm ) . Pain and anxiety ratings of patients and nurses were significantly correlated ( Spearman 's r > or = 0.69 ; P < 0.001 ) . In general , patients ' pain scores were higher than nurses ' scores ( patients ' median VAS = 34 ( range 1 - 76 ) mm ; nurses VAS 21 ( 1 - 59 ) mm ) and for all groups except the patient-controlled subarachnoid bupivacaine group , where they were significantly higher ( P < 0.01 ) . Discrepancy in pain estimates between patients and nurses increased with the level of pain . The relationship between patients ' and nurses ' anxiety scores was less clearly defined and did not depend on the level of anxiety OBJECTIVES To assess the economics of patient-controlled analgesia ( PCA ) treatment versus regular intramuscular ( i.m . ) injections of opioid analgesia for pain management after hysterectomy . METHODS Cost-minimization analysis was used based on the comparable pain control results achieved in the two treatment groups . Observations were taken of treatment-related events with personnel ( mostly nursing ) time implication s during the trial . Times were then associated with these events in an independent study of personnel activity . Costs were linked by using average wage rates for the various personnel for the Montreal area during the time of the study . Drug and material costs were hospital acquisition costs for all items . The cost of the PCA pump itself was not included in the analysis . Several analyses were performed to test the sensitivity of the results to various assumptions . RESULTS The results for total costs of the two therapies generally showed PCA to be more costly than regular i.m . injections despite no costs of the pump being included in the analyses . These results were robust with respect to changes in assumptions . Even when intentionally biasing the analysis against i.m . therapy , it was difficult to obtain results that favored PCA . CONCLUSIONS Based upon the institutions and assumptions in this analysis , PCA offers no cost advantages over regular i.m . therapy in the pain management after hysterectomy . Regular i.m . injections provided less costly analgesia This prospect i ve , r and omized study compared the effects of two methods of morphine administration after abdominal surgery in 62 adults . All patients were offered intravenous morphine in the Postanesthesia Care Unit . On the ward , one group ( PCA-CI ) received a continuous infusion of morphine that could be supplemented by a patient-controlled bolus every 10 minutes . The other group ( IM ) received intramuscular morphine ( 0.08 - 0.12 mg/kg ) as often as every 3 hours when requested . During three postoperative interviews , patients were question ed about pain relief ( visual analogue scale ) , adverse opioid effects , and satisfaction with the method of analgesia . Total dose of morphine ( mg , mg/kg body weight ) , time to first oral analgesic medication , length of hospital stay , and cost were calculated following discharge . There was a wide interindividual variation in reported pain intensity and morphine usage in both groups . Comparison of both groups demonstrated no significant differences in analgesia , incidence of adverse opioid effects , 24 and 36 hour morphine dose , time to first oral analgesic medication , operating cost , and length of hospital stay . Patients in the PCA-CI group received a slightly greater dose of morphine in relation to body weight ( 24 hr , P = 0.03 ; 36 hr , P = 0.05 ) and reported a greater degree of satisfaction at each assessment ( P = 0.005 , P = 0.02 , P = 0.01 ) . These data support the greater patient satisfaction associated with patient-controlled analgesia but suggest that the wide range of reported pain scores and morphine requirements makes it difficult to demonstrate , in a small population , superior pain relief from patient-controlled analgesia when nurses are encouraged to administer intramuscular pain medication more effectively The postoperative analgesia afforded after colonic surgery by IV opioid , clonidine and lignocaine given intra- and postoperatively was evaluated . In a double-blind r and omised trial , 80 male patients scheduled for colonic resection under general anaesthesia received fentany 15 μg.kg−1 at induction and another 4 μg.kg−1 before skin inc \n Output:\n " }, { "from": "agent", "value": "PCA provided better pain control and greater patient satisfaction than conventional parenteral ' as-needed ' analgesia .\nPatients using PCA consumed higher amounts of opioids than the controls and had a higher incidence of pruritus ( itching ) but had a similar incidence of other adverse effects .\nThere was no difference in the length of hospital stay .\nAUTHORS ' CONCLUSIONS This review provides evidence that PCA is an efficacious alternative to conventional systemic analgesia for postoperative pain control" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study examined the relationship between objective ly measured nocturnal hot flashes and objective ly measured sleep in breast cancer survivors with insomnia . Twenty-four women who had completed treatment for non-metastatic breast cancer participated . All were enrolled in a study of cognitive-behavioral treatment for chronic insomnia . Nocturnal hot flashes and sleep were measured by skin conductance and polysomnography , respectively . The 10-minute periods around hot flashes were found to have significantly more wake time , and more stage changes to lighter sleep , than other 10-minute periods during the night . Nights with hot flashes had a significantly higher percentage of wake time , a lower percentage of Stage 2 sleep , and a longer REM latency compared to nights without hot flashes . Overall , hot flashes were found to be associated with less efficient , more disrupted sleep . Nocturnal hot flashes , or their underlying mechanisms , should be considered as potential contributors to sleep disruption in women with breast cancer who report poor sleep ABSTRACT Epidemiological and animal studies have suggested an association between habitual sleep patterns and cardiovascular ( CV ) disease , but the results are still controversial . Therefore , the aims of this study are to investigate the relationships between habitual sleep patterns and CV disease based on Prospect i ve Urban Rural Epidemiology ( PURE ) China study . PURE China study recruited 46 285 participants , aged 35–70 , from 12 provinces and 115 communities in China . Habitual sleep patterns and CV disease were self-reported . Multilevel logistic regression was used in our analysis . In this study , 39 515 participants were eligible in our analysis , including 23 345 ( 59.1 % ) women and 16 170 ( 40.9 % ) men . Sleeping ≥9 h per day was associated with increased odds of CV disease ( OR = 1.16 , 95 % CI : 1.01–1.32 , p = 0.033 ) compared with sleeping 7–8 h per day . Taking daytime naps was also associated with an increased odds of CV disease , and the CV odds increased with increasing napping duration ( p for trend < 0.001 ) . For the sleeping < 6 h per day , we only found an association with coronary artery disease ( CAD ) ( OR = 1.58 , 95 % CI : 1.01–2.48 , p = 0.046 ) . Participants with only 7–8 h sleep per night had lowest prevalence of CV disease ( OR = 0.77 , 95 % CI : 0.65–0.90 , p = 0.001 ) compared with other sleep patterns . Napping , long and short duration of habitual sleep may increase the odds of CV disease . Only participants sleeping 7–8 hours at night are recommended in this study , and large longitudinal studies are needed to confirm these results Hypotheses . Sleep disorders are associated with an increased risk of cancer , including breast cancer ( BC ) . Physical activity ( PA ) can produce beneficial effects on sleep . Study design . We design ed a r and omized controlled trial to test the effect of 3 months of physical activity on sleep and circadian rhythm activity level evaluated by actigraphy . Methods . 40 BC women , aged 35 - 70 years , were r and omized into an intervention ( IG ) and a control group ( CG ) . IG performed a 3 month of aerobic exercise . At baseline and after 3 months , the following parameters were evaluated both for IG and CG : anthropometric and body composition measurements , energy expenditure and motion level ; sleep parameters ( Actual Sleep Time-AST , Actual Wake Time-AWT , Sleep Efficiency-SE , Sleep Latency-SL , Mean Activity Score-MAS , Movement and Fragmentation Index-MFI and Immobility Time-IT ) and activity level circadian rhythm using the Actigraph Actiwatch . Results . The CG showed a deterioration of sleep , whereas the IG showed a stable pattern . In the CG the SE , AST and IT decreased and the AWT , SL , MAS and MFI increased . In the IG , the SE , IT , AWT , SL , and MAS showed no changes and AST and MFI showed a less pronounced change in the IG than in the CG . The rhythmometric analysis revealed a significant circadian rhythm in two groups . After 3 months of PA , IG showed reduced fat mass % , while CG had improved weight and BMI . Conclusion . Physical activity may be beneficial against sleep disruption . Indeed , PA prevented sleep worsening in IG . PA can represent an integrative intervention therapy able to modify sleep behaviour Background Many breast cancer survivors experience fatigue , mood , and sleep disturbances . Purpose This study aims to compare a meditative movement practice , Qigong/Tai Chi Easy ( QG/TCE ) with sham Qigong ( SQG ) , testing effects of meditation/breath aspects of QG/TCE on breast cancer survivors ’ persistent fatigue and other symptoms . Methods This double-blind , r and omized controlled trial tested 12 weeks of QG/TCE versus SQG on fatigue , depression , and sleep among 87 postmenopausal , fatigued breast cancer survivors , stages 0–III , age 40–75 . Results Fatigue decreased significantly in the QG/TCE group compared to control at post-intervention ( p = 0.005 ) and 3 months follow-up ( p = 0.024 ) , but not depression and sleep quality . Improvement occurred over time for both interventions in depression and sleep quality ( all p < 0.05 ) . Conclusions QG/TCE showed significant improvement over time compared to SQG for fatigue , but not depression or sleep . Both QG/TCE and SQG showed improvement for two prevalent symptoms among breast cancer survivors , depression and sleep dysfunction OBJECTIVE To investigate the associations between sleep duration and mortality in the elderly by controlling for sleep quality . METHOD Data were collected from participants in a cohort study in Shizuoka , Japan . A total of 14,001 elderly residents ( aged 65 - 85 years ) , r and omly chosen from all 74 municipalities in the prefecture , completed question naires that evaluated sleep duration , sleep complaints , and the use of hypnotics . Participants were followed from 1999 to 2006 . We analyzed 11,395 subjects to estimate the hazard ratios ( HR ) for mortality from all causes and cardiovascular disease ( CVD ) . RESULTS With 60,252 person-years , 1004 deaths were identified . While short sleep duration and mortality were not associated , longer sleep duration was associated with higher risk of mortality in both sexes . Compared with those who slept 7 h , the multivariate HR and 95 % confidence interval of CVD mortality for those who slept > or = 10 h was 1.95 ( 1.18 - 3.21 ) and , for those who slept < or = 5 h , it was 1.10 ( 0.62 - 1.93 ) . Although no clear association was found between sleep quality and mortality , long sleep duration was associated with higher risk of CVD mortality among those with poor sleep quality . CONCLUSION Long sleep duration is associated with higher risk of CVD mortality among the elderly with poor sleep quality OBJECTIVE To improve mechanistic underst and ing , this pilot r and omized controlled trial examined mediators of an exercise intervention effects on sleep in breast cancer survivors ( BCS ) . METHODS Forty-six postmenopausal BCS ( ≤Stage II , off primary treatment ) were r and omized to a 3-month exercise intervention or control group . Intervention included 160 min/week of moderate intensity aerobic walking , twice weekly resistance training ( resistance b and s ) , and six discussion groups ( to improve adherence ) . Blinded assessment s at baseline and post-intervention included sleep disturbance ( PSQI and PROMIS ® ) , objective sleep quality ( accelerometer ) , serum cytokines , accelerometer physical activity , cardiorespiratory fitness , body composition , fatigue , and psychosocial factors . Mediation was tested using Freedman-Schatzkin difference-in-coefficients tests . RESULTS When compared with control , the intervention group demonstrated a significant increase in PSQI sleep duration ( i.e. , fewer hours of sleep/night ) ( d = 0.73 , p = .03 ) . Medium to large but non-significant st and ardized effect sizes were noted for PSQI daytime somnolence ( d = -0.63 , p = .05 ) and accelerometer latency ( d = -0.49 , p = .14 ) . No statistically significant mediators were detected for PSQI sleep duration score or accelerometer latency . Daytime somnolence was mediated by tumor necrosis factor-alpha ( mediated 23 % of intervention effect , p < .05 ) , interleukin (IL)-6:IL-10 ( 16 % , p < .01 ) , IL-8:IL-10 ( 26 % , p < .01 ) , and fatigue ( 38 % , p < .05 ) . Mediating or enhancing relationships for several of the sleep outcomes were noted for accelerometer physical activity , PROMIS ® fatigue , exercise social support , and /or physical activity enjoyment . CONCLUSIONS Inflammation and psychosocial factors may mediate or enhance sleep response to our exercise intervention . Further study is warranted to confirm our results and translate our findings into more effective interventions aim ed at improving sleep quality in BCS Background Cancer-related fatigue ( CRF ) and insomnia are major complaints in breast cancer survivors ( BC ) . Aerobic training ( AT ) , the st and ard therapy for CRF in BC , shows only minor to moderate treatment effects . Other evidence -based treatments include cognitive behavioral therapy , e.g. , sleep education/restriction ( SE ) and mindfulness-based therapies . We investigated the effectiveness of a 10-week multimodal program ( MT ) consisting of SE , psycho-education , eurythmy- and painting-therapy , administered separately or in combination with AT ( CT ) and compared both arms to AT alone . Methods In a pragmatic comprehensive cohort study BC with chronic CRF were allocated r and omly or by patient preference to ( a ) MT , ( b ) CT ( MT + AT ) or ( c ) AT alone . Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention ( T1 ) ; a second endpoint was a follow-up assessment 6 months later ( T2 ) . The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1 . A closed testing procedure preserved the global α-level . The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment , respectively . Results Altogether 126 BC were recruited : 65 were r and omized and 61 allocated by preference ; 105 started the intervention . Socio-demographic parameters were generally balanced at baseline . Non-inferiority of MT to AT at T1 was confirmed ( p < 0.05 ) , yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT ( p = 0.119 ) . In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 ( MT ) or T2 alone ( CT ) , respectively . Conclusions The multimodal CRF-therapy was found to be confirmatively non-inferior to st and ard therapy and even yielded exploratively sustained superiority . A r and omized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted . Trial registerDRKS-ID : DRKS00003736 . Recruitment period June 2011 to March 2013 . Date of registering 19 June 2012 PURPOSE S/ OBJECTIVES To test the hypothesis that women participating in a walking exercise program during radiation therapy treatment for breast cancer would demonstrate more adaptive responses as evidence d by higher levels of physical functioning and lower levels of symptom intensity than women who did not participate . DESIGN Experimental , two-group pretest , post-test . SETTING Two university teaching hospital outpatient radiation therapy departments . SAMPLE 46 women beginning a six-week program of radiation therapy for early stage breast cancer . METHODS Following r and om assignment , subjects in the exercise group maintained an individualized , self-paced , home-based walking exercise program throughout treatment . The control group received usual care . Dependent variables were measured prior to and at the end of radiation therapy . In addition , symptoms were assessed at the end of three weeks of treatment . MAIN RESEARCH VARIABLES Participation in the walking exercise program , physical functioning fatigue , emotional distress , and difficulty sleeping . FINDINGS Hypothesis testing by multivariate analysis of covariance , with pretest scores as covariates , indicated significant differences between groups on outcome measures ( p < 0.001 ) . The exercise group scored significantly higher than the usual care group on physical functioning ( p = 0.003 ) and symptom intensity , particularly fatigue , anxiety , and difficulty sleeping . Fatigue was the most frequent and intense subjective symptom reported . CONCLUSIONS A self-paced , home-based walking exercise program can help manage symptoms and improve physical functioning during radiation therapy . IMPLICATION S FOR NURSING PRACTICE Nurse-prescribed and -monitored exercise is an effective , convenient , and low-cost self-care activity that reduces symptoms and facilitates adaptation to breast cancer diagnosis and treatment PURPOSE Interventions to increase physical activity among breast cancer survivors are needed to improve health and quality of life and possibly to reduce the risk of disease recurrence and early mortality . Therefore , we report the feasibility and preliminary outcomes of a pilot r and omized trial design ed to increase physical activity in sedentary breast cancer survivors receiving horm \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses revealed no clear differences between interventions conducted during versus after breast cancer treatment .\nRegarding the objective measurements , no significant effects were found .\nConclusions Physical as well as mind – body exercise can improve subjective sleep problems in breast cancer patients .\nIn contrast , there was no effect of exercise on objective sleep measures ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT Illness and hospitalization often trigger functional decline among older persons . Home care services implemented for functional decline provide an opportunity to intervene to improve outcomes . OBJECTIVE To compare functional status and the likelihood of remaining at home for persons receiving restorative care vs usual home care . DESIGN AND SETTING Intervention using prospect i ve individual matching conducted between November 1 , 1998 , and April 30 , 2000 . Six offices of a home care agency in Connecticut were used . One branch office served as the restorative care unit and the other 5 served as usual care offices . PARTICIPANTS Patients receiving home care through the restorative care office who were 65 years or older ; in receipt of Medicare-covered home care lasting at least 7 days ; with absence of severe cognitive impairment ; and not terminal , bedridden , or requiring total care were matched with patients from 1 of the usual care offices . The matching factors included age , sex , race , baseline self-care function , cognitive status , whether hospitalization preceded the home care episode , and date of the home care episode . Of the 712 eligible restorative care patients , 691 ( 97 % ) were matched with a usual care patient . INTERVENTION Restorative care , provided by the home care agency nursing , therapy , and home health aide staff , was based on principles from geriatric medicine , nursing , rehabilitation , and goal attainment . MAIN OUTCOME MEASURES Remaining at home , functional status at completion of the home care episode , and duration and intensity of home care episode . RESULTS Compared with usual care , and after adjusting for baseline characteristics and other factors , restorative care was associated with a greater likelihood of remaining at home ( 82 % vs 71 % ; odds ratio [ OR ] , 1.99 ; 95 % confidence interval [ CI ] , 1.47 - 2.69 ) and a reduced likelihood of visiting an emergency department ( 10 % vs 20 % ; OR , 0.44 ; 95 % CI , 0.32 - 0.61 ) . Home care episodes were shorter ( mean [ SD ] , 24.8 [ 26.8 ] days vs 34.3 [ 44.2 ] days ; S = -17 821 ; P<.001 ) . Restorative care patients had better mean ( SD ) scores than usual care patients in self-care ( 11.0 [ 2.1 ] vs 10.7 [ 2.5 ] ; P = .07 after adjustment ) , home management ( 9.5 [ 2.9 ] vs 9.2 [ 3.0 ] ; P = .05 after adjustment ) , and mobility ( 3.3 [ 0.8 ] vs 3.2 [ 0.9 ] ; P = .02 after adjustment ) . CONCLUSIONS This trial suggests that reorganizing the structure and goals of home care can enhance health outcomes of older patients without increasing health care utilization STUDY QUESTION Did the Medicare Alzheimer 's Disease Demonstration , with its goal of improving caregiver outcomes through case management and subsidized community services , affect the nursing home entry rate of treatments with dementia compared to controls ? DATA SOURCES Interviews conducted at baseline and six months thereafter . Measures include date of nursing home entry , client and caregiver health , and income . STUDY DESIGN The demonstration r and omly assigned voluntary applicants into treatment and control groups . Treatment group cases were eligible for case management and for an 80 percent discount on community care benefits , up to about $ 600 per month . DATA COLLECTION All cases received baseline and semi-annual assessment interviews for up to three years after enrollment . Analyses are among cases that remained in the demonstration for more than 30 days after enrollment ( n = 8,095 ) . PRINCIPAL FINDINGS The intervention of case management and subsidized community service had no effect on nursing home entry rates for treatments overall , compared to those of controls , and few effects on treatment subgroups , with the exception of one site where it may have increased nursing home entry rates . CONCLUSIONS Providing case management and subsidized community services with the goal of improving caregiver outcomes may have little effect on nursing home entry rates for people with dementia Objectives The aim was to evaluate the effects of integrated home care and discharge practice on the functional ability ( FA ) and health-related quality of life ( HRQoL ) of home care patients . Methods A cluster r and omised trial ( CRT ) with Finnish municipalities ( n=22 ) as the units of r and omisation . At baseline the sample included 669 patients aged 65 years or over . Data consisted of interviews ( at discharge , and at 3-week and 6-month follow-up ) , medical records and care registers . The intervention was a generic prototype of care/case management- practice ( IHCaD- practice ) that was tailored to municipalities needs . The aim of the intervention was to st and ardize practice s and make written agreements between hospitals and home care administrations , and also within home care and to name a care/case manager pair for each home care patient . The main outcomes were HRQoL — as measured by a combination of the Nottingham Health Profile ( NHP ) and the EQ-5D instrument for measuring health status— and also Activities of Daily Living ( ADL ) . All analyses were based on intention-to-treat . Results At baseline over half of the patient population perceived their FA and HRQoL as poor . At the 6-month follow-up there were no improvements in FA or in EQ-5D scores , and no differences between groups . In energy , sleep , and pain the NHP improved significantly in both groups at the 3-week and at 6-month follow-up with no differences between groups . In the 3-week follow-up , physical mobility was higher in the trial group . Conclusions Although the effects of the new practice did not improve the patients ' FA and HRQoL , except for physical mobility at the 3-week follow-up , the workers thought that the intervention worked in practice . The intervention st and ardised practice s and helped to integrate services . The intervention was focused on staff activities and through the changed activities also had an effect on patients . It takes many years to achieve permanent changes in every worker 's individual practice and it is also likely that changes in working practice s would be visible before effects on patients . The use of other outcome measures , such as the use of services , may be clearer in showing a positive impact of the intervention rather than FA or STUDY QUESTION Did the Medicare Alzheimer 's Disease Demonstration with its case management and community service waivers affect the use of community-based long-term care services among people with dementia and their primary caregivers ? DATA SOURCES Baseline and periodic caregiver interviews . Measures include client and caregiver attributes and self-reported service use . STUDY DESIGN The demonstration r and omly assigned voluntary applicants into treatment and control groups . Treatment group cases were eligible for case management and for up to $ 699 per month in community care benefits . The actual monthly entitlement varied among the eight demonstration communities due to regional cost and inflation adjustments over time . Analyses are for the year after enrollment . DATA COLLECTION Analyses are of cases surviving six months or more in the community after enrollment ( n = 5,209 ) . Cases received baseline and semi-annual assessment s. PRINCIPAL FINDINGS The intervention of case management and community service reimbursement had a strong , consistent , and positive effect on the likelihood of using home care ( including homemaker/chore services , personal care services , companion services ) and adult day care . Treatment group clients were at least twice as likely as control group clients to be using any of the four community-based services . A similar , but less pervasive effect was achieved with caregiver training and support group participation . Reimbursement provided by the demonstration 's Medicare waiver was generally not sufficient to exceed the level of control group service acquired through private payment . CONCLUSIONS Reimbursement levels within the demonstration may have enabled more individuals to purchase some services , but they were not sufficient to increase the average level of use over those in the control group . No consistent differences between demonstration models were found in service use likelihood or average use among users Abstract Objective : To evaluate the impact of a programme of integrated social and medical care among frail elderly people living in the community . Design : R and omised study with 1 year follow up . Setting : Town in northern Italy ( Rovereto ) . Subjects : 200 older people already receiving conventional community care services . Intervention : R and om allocation to an intervention group receiving integrated social and medical care and case management or to a control group receiving conventional care . Main outcome measures : Admission to an institution , use and costs of health services , variations in functional status . Results : Survival analysis showed that admission to hospital or nursing home in the intervention group occurred later and was less common than in controls ( hazard ratio 0.69 ; 95 % confidence interval 0.53 to 0.91 ) . Health services were used to the same extent , but control subjects received more frequent home visits by general practitioners . In the intervention group the estimated financial savings were in the order of £ 1125 ( $ 1800 ) per year of follow up . The intervention group had improved physical function ( activities of daily living score improved by 5.1 % v 13.0 % loss in controls ; P<0.001 ) . Decline of cognitive status ( measured by the short portable mental status question naire ) was also reduced ( 3.8 % v 9.4 % ; P<0.05 ) . Conclusion : Integrated social and medical care with case management programmes may provide a cost effective approach to reduce admission to institutions and functional decline in older people living in the community . Key messages Responsibility for management of care of elderly people living in the community is poorly defined Integration of medical and social services together with care management programmes would improve such care in the community In a comparison of this option with a traditional and fragmented model of community care the integrated care approach reduced admission to institutions and functional decline in frail elderly people living in the community and also reduced OBJECTIVE To examine how a new model of consumer-directed care changes the way that consumers with disabilities meet their personal care needs and , in turn , affects their well-being . STUDY SETTING Eligible Medicaid beneficiaries in Arkansas , Florida , and New Jersey volunteered to participate in the demonstration and were r and omly assigned to receive an allowance and direct their own Medicaid supportive services as Cash and Counseling consumers ( the treatment group ) or to rely on Medicaid services as usual ( the control group ) . The demonstration included elderly and non-elderly adults in all three states and children in Florida . DATA SOURCES Telephone interviews administered 9 months after r and om assignment . METHODS Outcomes for the treatment and control group were compared , using regression analysis to control for consumers ' baseline characteristics . PRINCIPAL FINDINGS Treatment group members were more likely to receive paid care , had greater satisfaction with their care , and had fewer unmet needs than control group members in nearly every state and age group . However , among the elderly in Florida , Cash and Counseling had little effect on these outcomes because so few treatment group members actually received the allowance . Within each state and age group , consumers were not more susceptible to adverse health outcomes or injuries under Cash and Counseling . CONCLUSIONS Cash and Counseling substantially improves the lives of Medicaid beneficiaries of all ages if consumers actually receive the allowance that the program offers OBJECTIVES To compare the effects of nurse case management with usual care provided to community-dwelling frail older people in regard to quality of life , satisfaction with care , functional status , admission to hospital , length of hospital stay , and readmission to emergency department . DESIGN R and omized controlled trial . SETTING University hospital and two proximal community health centers . PARTICIPANTS 427 frail older people ( > or = 70 years of age and at risk for repeated hospital admissions ) discharged home from the emergency department . INTERVENTIONS EXPERIMENTAL Nurse case management , which consisted of coordination and provision of healthcare services by nurses , both in and out of hospital , for a 10-month period . CONTROL Usual care , which varied by healthcare provider and community health center . MEASUREMENTS Outcomes were assessed 10 months post-r and omization by telephone and /or home interview and by medical record review . Question naires included the SF-36 , CSQ-8 , and OARS . RESULTS No significant differences were found in quality of life , satisfaction with care , functional status , admission to hospital , or length of hospital stay . Nurse-case-managed older adults were readmitted to the emergency department significantly more often than their usual care counterparts . CONCLUSIONS Frail older people receiving nurse case management are more likely to use emergency health services without a concomitant increase in health benefits Context Dementia is an incurable chronic disease , but assistance to caregivers can reduce the severity of patients ' symptoms and delay institutionalization . Because this assistance requires provision of multiple health care and social services , patients and caregivers might benefit from a coordinated system of care . Contribution The investigators r and omly assigned patients with dementia and their caregivers to usual care or to a coordinated system of care . In the coordinated system , care managers regularly assessed patient and caregiver pairs and coordinated guideline -recommended provision of services by health care providers and community agencies using computerized information systems . The study found that pairs cared for in the coordinated system received higher- quality health care and more needed assistance than those who received usual care . Caution s The study focused on a relatively homogeneous population of white , well-educated , otherwise healthy , noninstitutionalized patients with health insurance . The findings might not apply to other population s. Implication s The quality of care for patients with dementia and their caregivers can be improved with a model of care in which services provided by the health system and community agencies are coordinated by a care manager . The Editors Dementia has enormous health and financial consequences for affected individuals , their family caregivers , and society ( 15 ) . Although most dementia is currently neither preventable nor reversible , existing practice guidelines reflect evidence from r and omized , controlled trials that caregiver assistance \n Output:\n " }, { "from": "agent", "value": "Evidence from r and omized controlled trials showed that case management improves function and appropriate use of medications , increases use of community services and reduces nursing home admission .\nEvidence , mostly from non-r and omized trials , showed that integrated care increases service use ; r and omized trials reported that integrated care does not improve clinical outcomes .\nThe lowest quality evidence was for consumer directed care which appears to increase satisfaction with care and community service use but has little effect on clinical outcomes .\nConclusions The outcomes of each model of care differ and correspond to the model 's focus .\nCombining key elements of all three models may maximize outcomes" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES . Although bronchiolitis is the leading cause of hospitalization for infants , there are limited data describing the epidemiology of bronchiolitis hospitalizations , and the associated cost is unknown . Our objective was to determine nationally representative estimates of the frequency of bronchiolitis hospitalizations and its associated costs . PATIENTS AND METHODS . We analyzed the 2002 Health Care Utilization Project-National Inpatient Sample , a federal , stratified r and om survey of hospital discharges . For admissions age < 2 years with a discharge diagnosis of bronchiolitis ( International Classification of Diseases , Ninth Revision , Clinical Modification , code 466.1 ) , we used nationally representative weighted estimates to determine frequency and total hospital charges . Costs were estimated from reported charges by applying hospital-specific cost/charge ratios based on all-payer inpatient cost . RESULTS . In 2002 , an estimated 149000 patients were hospitalized with bronchiolitis . Frequency of hospitalizations was higher among children age < 1 year of age , male gender , and nonwhite race . Mean length of stay was 3.3 days . Total annual costs for bronchiolitis-related hospitalizations were $ 543 million , with a mean cost of $ 3799 per hospitalization . Mean cost of bronchiolitis with a codiagnosis of pneumonia was $ 6191 . In a multivariate analysis controlling for 3 confounding factors ( including length of stay ) , cost per hospitalization was higher for children ≥1 year and lower for those in the South versus Northeast . CONCLUSIONS . Bronchiolitis admissions cost more than $ 500 million annually . A codiagnosis of bronchiolitis and pneumonia almost doubles the cost of the hospitalization . Inpatient health care costs of bronchiolitis are higher than estimated previously and highlight the need for initiatives to safely reduce bronchiolitis hospitalizations and thereby decrease health care costs OBJECTIVE High incidence , rising admission rates , and relatively ineffective therapies make the management of bronchiolitis controversial . Since 1980 , the rate of hospitalization for children with bronchiolitis has increased by nearly 250 % , whereas mortality rates for the disease have remained constant . It has been speculated that the increasing use of pulse oximetry has lowered the threshold for admission and may have contributed to the rise in bronchiolitis-related admissions . The objective of this study was to describe pediatric emergency medicine physicians ' management preferences regarding infants with moderately severe bronchiolitis and to assess the influence of specific differences in oxygen saturation as measured by pulse oximetry ( SpO2 ) and respiratory rate ( RR ) on the decision to admit . METHODS Physicians who are members of the American Academy of Pediatrics Section of Emergency Medicine and living in the United States were r and omized into 4 groups and mailed a survey that contained 1 of 4 vignettes . Vignettes were identical except for given SpO2 values ( 94 % or 92 % ) and RR ( 50/min or 65/min ) . Subjects were asked to answer questions regarding laboratory tests , treatment options , and the decision to admit for the patient in their vignette . RESULTS We received completed surveys from 519 ( 64 % ) of the 812 physicians contacted . Most respondents recommended use of bronchodilators ( 96 % ) , nasal suction ( 82 % ) , and supplemental oxygen ( 57 % ) . Few respondents recommended decongestants ( 9 % ) , steroids ( 8 % ) , or antibiotics ( 2 % ) . When asked to rank therapies , respondents gave nasal suction 182 number 1 votes ; bronchodilators received 164 . The decision to admit varied with SpO2 and RR . Forty-three percent of respondents who received a vignette featuring SpO2 of 94 % and a RR of 50/min recommended admission for the infant in their vignette . Fifty-eight percent recommended admission when the vignette SpO2 was 94 % and RR was 65/min ( chi2 = 5.021 ) . Respondents who received a vignette with SpO2 of 92 % were nearly twice as likely to recommend admission : 83 % recommended admission when vignette RR was 50/min , and 85 % recommended admission when vignette RR was 65/min ( chi2 = 0.126 ) . CONCLUSIONS When treating infants with moderately severe bronchiolitis , pediatricians who work in emergency departments frequently use bronchodilators and nasal suction , 2 practice s for which supporting data are either conflicting ( bronchodilators ) or nonexistent ( nasal suction ) . In addition , their decisions to admit differ markedly on the basis of only a 2 % difference in SpO2 . It is possible that increased reliance on pulse oximetry has contributed to the increase in bronchiolitis hospitalization rates seen during the past 2 decades \n Output:\n " }, { "from": "agent", "value": "REVIEW ER 'S CONCLUSIONS There is insufficient evidence to support the use of epinephrine for the treatment of bronchiolitis among in patients .\nThere is some evidence to suggest that epinephrine may be favourable to salbutamol and placebo among out patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To explore the effectiveness and safety of laparoscopic presacral neurectomy ( LPN ) in treating endometriosis-associated pain . METHODS Totally 64 patients with endometriosis were divided into two groups using prospect i ve non-r and om method . Patients in the control group received only the conventional laparoscopic resection of endometriosis lesions , while patients in the LPN group underwent LPN in addition to the resection of endometriosis lesions . The pre-operative pain scores , intra-operative staging results , surgical duration , intra-surgical blood loss , post-operative pain relief were compared between these two groups . RESULTS These two groups showed no significant differences in terms of age , body weight , pre-operative pain score , surgery staging , surgical duration , and intra-operative blood loss ( all P > 0.05 ) . All patients were followed up for 6 to 18 months ( median : 12.8 months ) . The post-operative pain relief rate was 89.28 % ( 25/ 28 ) in LPN group and 61.29 % ( 19/31 ) in the control group ( P = 0.030 ) . CONCLUSION LPN can effectively and safely in treating endometriosis and its associated pain OBJECTIVE The purpose of this study was to assess the effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis that was treated with conservative surgical intervention . STUDY DESIGN One hundred forty-one sexually active women of fertile age with chronic severe dysmenorrhea caused by endometriosis were treated with conservative laparoscopic surgery . Patients were assigned r and omly to not receive ( group A ) or receive ( group B ) presacral neurectomy . At 6 and 12 months after the surgical procedures , the cure rate was evaluated in each patient . The frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain were also evaluated at the same time intervals . RESULTS The cure rate was significantly higher in group B compared with group A at a follow-up examination at 6 months ( 87.3 % vs 60.3 % ) and 12 months ( 85.7 % vs 57.1 % ) . At follow-up visits , the frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain were significantly lower in both groups compared with baseline values ; in particular , significantly lower values were observed in group B versus group A for the severity . CONCLUSION Presacral neurectomy improves the cure rate in women who are treated with conservative laparoscopic surgery for severe dysmenorrhea caused by endometriosis A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis STUDY OBJECTIVE To assess the long-term effectiveness of presacral neurectomy ( PSN ) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention . DESIGN R and omized , controlled trial ( Canadian Task Force classification I ) . SETTING University-affiliated department of obstetrics and gynecology . PATIENTS One hundred forty-one sexually active women of reproductive age . INTERVENTION Conservative laparoscopic surgery without ( group A ) or with ( group B ) PSN . MEASUREMENTS AND MAIN RESULTS At entry and 24-months after surgical procedures , cure rates ; frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain ; and quality of life were evaluated . At follow-up visit , the cure rate was significantly ( P<0.05 ) higher in group B ( 83.3 % ) than in group A ( 53.3 % ) . The frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain were significantly ( P<0.05 ) lower in both groups compared with baseline values , and only severity was significantly ( P<0.05 ) lower in group B. A significant ( P<0.05 ) improvement in quality of life was observed after surgery in both groups and was significantly ( P<0.05 ) increased in group B compared with group A. CONCLUSION PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis OBJECTIVE Our objective was to evaluate the efficacy of presacral neurectomy combined with conservative surgery for the treatment of pelvic pain associated with endometriosis . STUDY DESIGN In a r and omized , controlled study performed in a tertiary institution 71 patients with moderate or severe endometriosis and midline dysmenorrhea were r and omly assigned to conservative surgery alone ( n = 36 ) or conservative surgery and presacral neurectomy ( n = 35 ) . Main outcome measures were relief of dysmenorrhea , pelvic pain , and deep dyspareunia after surgery according to a multidimensional and an analog pain scale . RESULTS Presacral neurectomy markedly reduced the midline component of menstrual pain , but no statistically significant differences were observed between the two groups in the frequency and severity of dysmenorrhea , pelvic pain , and dyspareunia in the long-term follow-up . After presacral neurectomy , constipation developed or worsened in 13 patients and urinary urgency occurred in three and a painless first stage of labor in two . CONCLUSION Presacral neurectomy should be combined \n Output:\n " }, { "from": "agent", "value": "Overall , in well-selected patients , conservative surgery with adjunctive PN may provide greater relief from midline pain and a similarly low rate of operative complications relative to conservative surgery alone but may increase the risk of constipation postoperatively ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different PURPOSE To compare the efficacy of cediranib ( a vascular endothelial growth factor receptor tyrosine kinase inhibitor [ VEGFR TKI ] ) with that of bevacizumab ( anti-VEGF-A monoclonal antibody ) in combination with chemotherapy as first-line treatment for advanced metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS HORIZON III [ Cediranib Plus FOLFOX6 Versus Bevacizumab Plus FOLFOX6 in Patients With Untreated Metastatic Colorectal Cancer ] had an adaptive phase II/III design . Patients r and omly assigned 1:1:1 received mFOLFOX6 [ oxaliplatin 85 mg/m(2 ) and leucovorin 400 mg/m(2 ) intravenously followed by fluorouracil 400 mg/m(2 ) intravenously on day 1 and then continuous infusion of 2,400 mg/m(2 ) over the next 46 hours every 2 weeks ] with cediranib ( 20 or 30 mg per day ) or bevacizumab ( 5 mg/kg every 14 days ) . An independent end-of-phase II analysis concluded that mFOLFOX6/cediranib 20 mg met predefined criteria for continuation ; subsequent patients received mFOLFOX6/cediranib 20 mg or mFOLFOX6/bevacizumab ( r and omly assigned 1:1 ) . The primary objective was to compare progression-free survival ( PFS ) . RESULTS In all , 1,422 patients received mFOLFOX6/cediranib 20 mg ( n = 709 ) or mFOLFOX6/bevacizumab ( n = 713 ) . Primary analysis revealed no significant difference between arms for PFS ( hazard ratio [ HR ] , 1.10 ; 95 % CI , 0.97 to 1.25 ; P = .119 ) , overall survival ( OS ; HR , 0.95 ; 95 % CI , 0.82 to 1.10 ; P = .541 ) , or overall response rate ( 46.3 % v 47.3 % ) . Median PFS and OS were 9.9 and 22.8 months for mFOLFOX6/cediranib and 10.3 and 21.3 months for mFOLFOX6/bevacizumab . The PFS upper 95 % CI was outside the predefined noninferiority limit ( HR < 1.2 ) . Common adverse events with more than 5 % incidence in the cediranib arm included diarrhea , neutropenia , and hypertension . Cediranib-treated patients completed fewer chemotherapy cycles than bevacizumab-treated patients ( median 10 v 12 cycles ) . Patient-reported outcomes ( PROs ) were significantly less favorable in cediranib-treated versus bevacizumab-treated patients ( P < .001 ) . CONCLUSION Cediranib activity , in terms of PFS and OS , was comparable to that of bevacizumab when added to mFOLFOX6 ; however , the predefined boundary for PFS noninferiority was not met . The cediranib safety profile was consistent with previous studies but led to less favorable PROs compared with bevacizumab . Investigation of oral TKIs in CRC continues PURPOSE Patients with advanced , incurable thyroid cancer not amenable to surgery or radioactive iodine ( (131)I ) therapy have few satisfactory therapeutic options . This multi-institutional study assessed the activity and safety of axitinib , an oral , potent , and selective inhibitor of vascular endothelial growth factor receptors ( VEGFR ) 1 , 2 , and 3 in patients with advanced thyroid cancer . PATIENTS AND METHODS Patients with thyroid cancer of any histology that was resistant or not appropriate for (131)I were enrolled onto a single-arm phase II trial to receive axitinib orally ( starting dose , 5 mg twice daily ) . Objective response rate ( ORR ) by Response Evaluation Criteria in Solid Tumors was the primary end point . Secondary end points included duration of response , progression-free survival ( PFS ) , overall survival , safety , and modulation of soluble ( s ) VEGFR . RESULTS Sixty patients were enrolled . Partial responses were observed in 18 patients , yielding an ORR of 30 % ( 95 % CI , 18.9 to 43.2 ) . Stable disease lasting > or = 16 weeks was reported in another 23 patients ( 38 % ) . OBJECTIVE responses were noted in all histologic subtypes . Median PFS was 18.1 months ( 95 % CI , 12.1 to not estimable ) . Axitinib was generally well tolerated , with the most common grade > or = 3 treatment-related adverse event being hypertension ( n = 7 ; 12 % ) . Eight patients ( 13 % ) discontinued treatment because of adverse events . Axitinib selectively decreased sVEGFR-2 and sVEGFR-3 plasma concentrations versus sKIT , demonstrating its targeting of VEGFR . CONCLUSION Axitinib is a selective inhibitor of VEGFR with compelling antitumor activity in all histologic subtypes of advanced thyroid cancer BACKGROUND No effective systemic therapy exists for patients with advanced hepatocellular carcinoma . A preliminary study suggested that sorafenib , an oral multikinase inhibitor of the vascular endothelial growth factor receptor , the platelet-derived growth factor receptor , and Raf may be effective in hepatocellular carcinoma . METHODS In this multicenter , phase 3 , double-blind , placebo-controlled trial , we r and omly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib ( at a dose of 400 mg twice daily ) or placebo . Primary outcomes were overall survival and the time to symptomatic progression . Secondary outcomes included the time to radiologic progression and safety . RESULTS At the second planned interim analysis , 321 deaths had occurred , and the study was stopped . Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group ( hazard ratio in the sorafenib group , 0.69 ; 95 % confidence interval , 0.55 to 0.87 ; P<0.001 ) . There was no significant difference between the two groups in the median time to symptomatic progression ( 4.1 months vs. 4.9 months , respectively , P=0.77 ) . The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group ( P<0.001 ) . Seven patients in the sorafenib group ( 2 % ) and two patients in the placebo group ( 1 % ) had a partial response ; no patients had a complete response . Diarrhea , weight loss , h and -foot skin reaction , and hypophosphatemia were more frequent in the sorafenib group . CONCLUSIONS In patients with advanced hepatocellular carcinoma , median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo . ( Clinical Trials.gov number , NCT00105443 . PURPOSE We performed this phase III study to compare the irinotecan , leucovorin ( LV ) , and fluorouracil ( FU ) regimen ( FOLFIRI ) versus the oxaliplatin , LV , and FU regimen ( FOLFOX4 ) in previously untreated patients with advanced colorectal cancer . PATIENTS AND METHODS A total of 360 chemotherapy-naive patients were r and omly assigned to receive , every 2 weeks , either arm A ( FOLFIRI : irinotecan 180 mg/m(2 ) on day 1 with LV 100 mg/m(2 ) administered as a 2-hour infusion before FU 400 mg/m(2 ) administered as an intravenous bolus injection , and FU 600 mg/m(2 ) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [ LV5FU2 ] ) or arm B ( FOLFOX4 : oxaliplatin 85 mg/m(2 ) on day 1 with LV5FU2 regimen ) . RESULTS One hundred sixty-four and 172 patients were assessable in arm A and B , respectively . Overall response rates ( ORR ) were 31 % in arm A ( 95 % CI , 24.6 % to 38.3 % ) and 34 % in arm B ( 95 % CI , 27.2 % to 41.5 % ; P = .60 ) . In both arms A and B , median time to progression ( TTP ; 7 v 7 months , respectively ) , duration of response ( 9 v 10 months , respectively ) , and overall survival ( OS ; 14 v 15 months , respectively ) were similar , without any statistically significant difference . Toxicity was mild in both groups : alopecia and gastrointestinal disturbances were the most common toxicities in arm A ; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms , and no statistical significant difference was observed . CONCLUSION There is no difference in ORR , TTP , and OS for patients treated with the FOLFIRI or FOLFOX4 regimen . Both therapies seemed effective as first-line treatment in these patients . The difference between these two combination therapies is mainly in the toxicity profile PURPOSE This phase II study evaluated efficacy and safety of single-agent axitinib , an oral , potent , selective inhibitor of vascular endothelial growth factor receptors ( VEGFR ) -1 , -2 , and -3 , in patients with advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS This was an open-label , single-arm , multicenter , phase II study with a Simon two-stage minimax design . Patients received a starting dose of axitinib 5 mg orally BID . The primary end point was Response Evaluation Criteria in Solid Tumors ( RECIST ) -defined objective response rate . Secondary end points included safety and tolerability , overall survival ( OS ) , and progression-free survival ( PFS ) . RESULTS Thirty-two patients were enrolled , with a median age of 66.5 years . The majority of patients ( 75 % ) had adenocarcinoma . Nine patients ( 28 % ) had received no prior chemotherapy for metastatic disease , and 23 ( 72 % ) had received > or = one regimen . Three patients ( 9 % ) had a RECIST investigator-assessed , confirmed partial response ( PR \n Output:\n " }, { "from": "agent", "value": "In conclusion , the addition of VEGFR TKIs to chemotherapy result ed in a modest but significantly shorter PFS but not in OS and ORR compared with bevacizumab .\nThe VEGFR TKIs group showed a less favorable AE profile with higher rates of diarrhea , fatigue , hypertension , neutropenia and thrombocytopenia , whereas a higher incidence of peripheral neuropathy associated with the bevacizumab was observed" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In a modified , double‐blind controlled study , 163 prepubertal boys ( aged 1.8–13.0 years ) with bilateral and 94 ( aged 1.5–13.1 years ) with unilateral cryptorchidism were allocated to treatment with either human chorionic gonadotropin ( i m ) , gonadotrophin releasing hormone ( intranasally ) or placebo ( intranasally ) . In individuals with the bilateral condition treatment with human chorionic gonadotrophin result ed in complete descent of both testes in 23 % of patients . Treatment with human chorionic gonadotrophin in unilateral cryptorchidism result ed in complete descent in 19 % of patients ; all results were significantly better than those obtained with gonadotrophin releasing hormone or placebo . Linear and logistic regression analysis of the results obtained by treatment of bilateral disease showed that all treatments were more successful the younger the age of the boys . The data indicated that bilateral and unilateral cryptorchidism respond differently to hormonal treatment . We suggest that human chorionic gonadotrophin should be the first choice of treatment for prepubertal boys older than one year The effects of hormonal treatment ( LH-RH , LH-RH plus hCG ) on undescended testis were studied on 42 testicles in 37 boys under 3 years of age . Descensus was achieved primarily in 40 % but eight testicles reascended . A new course of hCG result ed in descensus in three cases . Altogether , therefore , full descensus could be achieved in 29 % of cases with hormonal treatment . Hormonal treatment is recommended before surgery This r and omized double-blind placebo-controlled study was initiated to analyze the behavior of epididymis , processus vaginalis and testicular descent in cryptorchid boys treated with a low dose ( 20 μg ) of a luteinizing hormone-releasing hormone analogue ( Buserelin ) , administered daily , as a nasal spray , for a short period ( 28 days ) . Fifty-nine true cryptorchid boys were r and omly assigned to 3 groups : buserelin , treatment [ 22 ] , surgical treatment [ 18 ] or placebo control group [ 19 ] . The 3 groups of patients were similar before treatment in regard to testicular position , chronological and bone age , height and weight , luteinizing hormone , follicle-stimulating hormone , testosterone , penile size and the volume of the contralateral descended testis . None of the patients had retractile testes . Buserelin significantly induced testicular descent compared to the boys treated with a placebo ( P<0.01 ) . A normal epididymis was found more often in boys with successful descent ( P<0.003 ) . A closed processus vaginalis was also more frequently observed in the group treated with buserelin than in surgically treated one ( P<0.05 ) . In conclusion , buserelin was capable of inducing testicular descent besides provoking further development of the epididymis and closing the processus vaginalis Fifty unilaterally cryptorchid boys aged 3 to 8 years were r and omly and blindly allocated to treatment with luteinizing hormone releasing hormone or placebo intranasally . In the treated group , no significant descent of the undescended testis was found , whereas a minor downward movement of the scrotal testis occurred ( P less than 0.001 ) , probably as a result of decreased retraction by the cremaster muscle . Basal serum testosterone concentrations and testicular volume increased after treatment ( P less than 0.01 and P less than 0.001 , respectively ) . The response to an acute LHRH test , 100 micrograms/m2 body surface IV , before and after treatment , showed an increase in the luteinizing hormone peak value and a decrease in the follicle-stimulating hormone response in a significant number of patients ( P less than 0.001 ) . In the individual patient , there was a positive correlation between the increase in basal serum testosterone concentration and the degree of downward movement of the undescended testis ( P less than 0.05 ) In a double‐blind placebo‐controlled study in 49 boys with cryptorchidism the effect of intranasal synthetic LHRH was studied . After 8 weeks improvement in testicular location was found in 13 testes ( 37 % ) , but this improvement was considered sufficient of only six testes . Placebo result ed in an improved location in 18 % of the testes . The mean change in testicular position ( expressed in cm ) after LHRH therapy was slightly greater than after placebo but only in the squatting position did this difference reach significance . Aggressive behaviour was reported in 23 % of the children treated with LHRH . A second LHRH course did not result in significant improvement in any of the patients . At follow‐up reascent was frequently seen . The final results in unilateral cryptorchidism are poorer than those in bilateral cryptorchidism . LHRH therapy leads to higher plasma LH levels and a lower FSH in response to an intravenous LHRH test . In 15 boys plasma testosterone levels rose above 0.4 nmol/1 . We conclude that intranasal LHRH application has a limited value for the treatment of cryptorchidism but may be suitable as a diagnostic test The effect of intranasal luteinising-hormone releasing hormone ( L.H.R.H. ) in 84 boys with unilateral or bilateral cryptorchidism was evaluated in a double-blind controlled trial . Boys with retractile testes were not studied . L.H.R.H. caused no side-effects ; plasma antibodies to L.H.R.H. were never demonstrated . Four weeks ' therapy with intranasal L.H.R.H. administered in six doses daily ( 1.2 mg/day ) led to complete descent in 38 % of a total of 61 testes , an improved position in 28 % , and no response in 19 % ; 15 % of testes were never palpated . After placebo the position of 25 % of testes was improved ; there was no response in 75 % of a total of 51 testes . The success-rate seemed to be independent of age , but was related to the initial testicular position , with complete descent in only 11 % of testes not previously palpated compared with 48 % of testes found in the inguinal region We have conducted a modified double-blind study on the effect of human chorionic gonadotropin ( hCG ) , gonadotropin releasing hormone ( GnRH ) and placebo on bilateral and unilateral maldescended testes . One hundred and fifty-five boys with bilateral and 88 boys with unilateral cryptorchidism fulfilled the inclusion criteria and completed the treatment protocol . The boys were between 1 and 13 years of age . hCG was administered as intramuscular injections twice weekly for 3 weeks . GnRH and placebo were given intranasally . hCG was superior to GnRH and placebo in the treatment of bilateral maldescended testes ( p = 0.0009 ) . Both testes descended in 25 % of the boys following treatment with hCG , and improvement in the position of the testes was obtained in a further 25 % of the cases . hCG administration result ed in complete testicular descent in 14 % of boys with unilateral cryptorchidism compared with 3 and 0 % after placebo and GnRH , respectively ( p = 0.07 ) . The testis had moved to a more distal position in 46 % of the boys treated with hCG . There was no significant difference between the treatment groups with regard to age or initial position of the testes . We conclude that a success rate of 25 % justifies the use of hCG in the treatment of maldescended testes , whereas the study did not support a general use of GnRH administered intranasally In a double-blind , placebo-controlled multicentre study , the effect of luteinizing-hormone-releasing-hormone ( LHRH ) in 141 boys was analysed after 4-week treatment period with 0.4 mg LHRH nasal spray or placebo nasal spray three times daily . Data from 123 boys was analysed , with 62 boys in the treatment group and 61 in the placebo group . Full response i.e. the testis at the bottom of the scrotum on both sides in boys with bilaterally undescended testes , was found in six patients , one of them in the placebo group [ Therapeutic gain of LHRH with 95 % CI : 8.1 % ( 0.1 - 16.6 % , P = 0.12 ) ] . Only in these boys could surgery be avoided . Considering the number of testes ( and not the number of boys ) a significant effect was found on at least one testis in 25 % of boys with bilaterally undescended testes [ Therapeutic gain with 95 % CI : 24.0 % ( 13.2 - 34.8 % , P = 0.001 ) ] . In unilateral undescended testes , the LHRH treatment showed no effect ( P = 1.00 ) . The inclusion of retractile testes did not affect our results . In our opinion LHRH has a limited place in treatment of the non-descended testis We conducted a r and omized , double-blind study comparing intranasal gonadotropin-releasing hormone ( 1.2 mg per day for 28 days ) with parenteral human chorionic gonadotropin ( 3300 IU per week for four weeks ) in the treatment of cryptorchidism in 33 boys one to five years old ( 29 with unilateral and 4 with bilateral cryptorchidism ) . Testicular descent into the scrotum occurred in 3 of the 16 patients ( 19 percent ) treated with gonadotropin-releasing hormone and in 1 of the 17 ( 6 percent ) treated with human chorionic gonadotropin ( P = 0.23 ) . The mean luteinizing hormone and testosterone levels were similar in both groups before treatment . During treatment , the testosterone levels were significantly increased in both groups , but higher levels occurred in the group treated with human chorionic gonadotropin ( P less than 0.05 ) . In a parallel ( but uncontrolled ) study of five boys with retractile testes ( defined as a nonscrotal testis that could be manipulated into the bottom of the scrotum ) who were originally excluded from the main protocol but were treated with the same regimen of human chorionic gonadotropin , descent into the scrotum occurred in all patients . We conclude that hormonal therapy with either gonadotropin-releasing hormone or human chorionic gonadotropin is , in most cases , ineffective in promoting testicular descent of true cryptorchid testes . However , short-term treatment with human chorionic gonadotropin is very effective in producing descent of retractile testes . These results suggest that the wide discrepancies in apparent efficacy in previous trials of hormonal therapy of cryptorchidism may have been due to inclusion in those studies of various proportions of patients with retractile testes Synthetic LHRH ( HOE 471 ) administered intranasally over a period of 4 weeks for treatment of uni‐ or bilateral cryptorchidism in nineteen otherwise healthy prepubertal boys led to increased basal and peak LH values and to markedly decreased peak FSH values in the i.v . LHRH test . Basal testosterone remained unchanged . Sixteen cryptorchid boys treated with placebo served as a control group . The reduced FSH response to i.v . LHRH could be due to induction of a gonadal feedback mechanism rather than pituitary depletion of FSH , in view of the favourable therapeutic effect and the increased LH secretion seen in some of our patients . Pretreatment LHRH tests were available in twenty successfully and in twenty‐eight unsuccessfully treated boys . LH values were similar in both groups , whereas FSH peak values were significantly higher in boys who responded successfully to subsequent therapy . Testicular descent occurred most readily in boys with a large pool of easily releasable FSH and without a significant rise in testosterone ( in contrast to HCG treatment ) . We suggest that FSH induces changes that potentiate the local action of testosterone A r and omized study of two protocol s of human chorionic gonadotropin ( hCG ) treatment was performed in 183 prepubertal boys between 7 months and 12 years of age : protocol I , in which the boys were given 7 injections of 1,500 IU every other day , and protocol II consisting of 4 injections of 100 IU/kg at 4- to 5-day intervals . In both protocol s , by the end of the test , testosterone had risen significantly to values within the normal adult male range . However , the amplitude of the rise was slightly but significantly lower using protocol II ( 4.08 + /- 2.07 ng/ml ) than protocol I ( 5.16 + /- 2.73 ng/ml ) . It would thus appear that repetition of the hCG injection at intervals of less than 4 days is unnecessary , and that a total stimulation period of 2 - 3 weeks is sufficient . Although not correlated with testosterone levels , the success rates for treatment were similar in both protocol s and comparable to rates reported in the literature \n Output:\n " }, { "from": "agent", "value": "With the information analyzed until the present , the evidence for the use of hCG vs. GnRH shows advantages for hCG , and this review also shows that there is evidence that luteinizing hormone releasing hormone ( LHRH ) is more effective than placebo .\nBut because this evidence is based on few trials , with small sample sizes and moderated risk of bias , this treatment can not be recommended for everyone , and there is no evidence that supports hCG ’s use in larger doses and larger intervals ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : There is no single generally accepted clinical definition of frailty . Previously developed tools to assess frailty that have been shown to be predictive of death or need for entry into an institutional facility have not gained acceptance among practising clinicians . We aim ed to develop a tool that would be both predictive and easy to use . Methods : We developed the 7-point Clinical Frailty Scale and applied it and other established tools that measure frailty to 2305 elderly patients who participated in the second stage of the Canadian Study of Health and Aging ( CSHA ) . We followed this cohort prospect ively ; after 5 years , we determined the ability of the Clinical Frailty Scale to predict death or need for institutional care , and correlated the results with those obtained from other established tools . Results : The CSHA Clinical Frailty Scale was highly correlated ( r = 0.80 ) with the Frailty Index . Each 1-category increment of our scale significantly increased the medium-term risks of death ( 21.2 % within about 70 mo , 95 % confidence interval [ CI ] 12.5%–30.6 % ) and entry into an institution ( 23.9 % , 95 % CI 8.8%–41.2 % ) in multivariable models that adjusted for age , sex and education . Analyses of receiver operating characteristic curves showed that our Clinical Frailty Scale performed better than measures of cognition , function or comorbidity in assessing risk for death ( area under the curve 0.77 for 18-month and 0.70 for 70-month mortality ) . Interpretation : Frailty is a valid and clinical ly important construct that is recognizable by physicians . Clinical judgments about frailty can yield useful predictive information Applicants for a newly opened special unit for dementia sufferers were r and omly allocated to full-time care in the unit or placed on a waiting list and offered periodic respite care in the meantime . All applicants were living in the community at the time of r and om assignment . Both groups were followed up for three months to assess the effects on the dementia sufferers and on their family care-givers . Care-givers initially had a high level of psychological symptoms , which was greatly reduced after admission of the dementia sufferer to full-time care . By contrast , the care-givers of the community care group of sufferers continued to have a high level of symptoms . Dementia sufferers continued to deteriorate with both forms of care , with little difference between the two groups . Admission of dementia sufferers to full-time care in a special unit appears to be of great benefit to the psychological health of their care-givers and has no adverse effects on the dementia sufferers themselves A program for elderly persons with cognitive impairment and their caregivers was evaluated for its effectiveness and efficiency with regard to caregiver burden , sense of coherence , satisfaction , and cost to the health-care system . The program consisted of a weekly 2-hour visit and walk by volunteers . During a 9-month period in 1997 , all eligible referrals were r and omly assigned to receive the service immediately ( experimental group ) or be placed on a waiting list to receive it 6 weeks later ( control group ) . Eleven caregivers/recipients formed the experimental group ; 10 caregivers/recipients formed the control group . All completed question naires at r and omization and at 6-week follow-up . Perceived burden decreased by 8 % only for the caregivers in the experimental group ( F = 6.8 , p = .02 ) . They indicated that they appreciated the respite and support and that the care recipient enjoyed the visit/walk . Although this study was short in duration and small in sample size , improvements were noted in perceived caregiver burden and caregivers expressed satisfaction with the program . The program did not result in additional health and social-service expenditures Family units ( N = 541 ) of impaired elderly persons and caregivers were r and omly assigned to a control group or one of five treatment groups eligible for a variety of respite or educational services . After 12 months of service eligibility , caregivers of elderly persons remaining in the community reported lower levels of subjective burden . Services appeared to delay nursing home placement among families with adult child caregivers , but encouraged placement by spouse caregivers This article summarizes the study results and presents an evaluative summary of the implementation of study methods design ed to provide guidance in the degree of confidence with which the results may be accepted and generalized to other situations . Patients who were offered VA-ADHC services in the first phase of this study had significantly higher VA health care costs on average than patients assigned to customary care , with no apparent incremental health benefit to themselves or their care givers . One can have a high level of confidence in these results . The ADHC clinical services were implemented as planned , the r and omized controlled trial was implemented successfully , and such threats to validity as insufficient numbers of patients and differential attrition were not present . Certain subgroups of patients assigned to VA-ADHC had VA costs of care that were not significantly higher than those assigned to customary care , although these results must be interpreted with caution . The findings of the second phase of the study evaluating contract ADHC provide no support for choosing to provide either contract ADHC or VA-ADHC over the other . The nonr and omized design and smaller sample size suggest that inferences from the contract ADHC evaluation should be drawn with more caution than those from the VA-ADHC evaluation OBJECTIVES This study reports the findings of an evaluation of the psychological benefits of use of adult day care by family caregivers assisting a relative with dementia . METHODS The study used a quasi-experimental design in which caregivers in the treatment group used substantial amounts of services , whereas caregivers in a control group did not use day care at any point during the evaluation and only small amounts of other respite services . The evaluation was guided by the stress process model of caregiving which distinguishes between appraisal s of primary stressors and well-being . RESULTS Results after 3 months of day care use showed that the treatment group had significantly lower scores than the control group on two of the three measures of primary appraisal s ( overload and strain ) and two of the three measures of well-being ( depression and anger ) . Findings at one year showed that the treatment group had significantly lower scores on overload and depression than the control group . DISCUSSION These results demonstrate that use of adult day care by caregivers of dementia patients results in lower levels of caregiving-related stress and better psychological well-being when compared to that of controls Collaborative working in care for older people is often seen as a desirable goal . However , there can be problems with this approach . This paper reports on a single blind r and omized controlled trial which was carried out to compare outcomes of rehabilitation in two setting s : a day hospital and social services day centres augmented by visiting therapists . The subjects were 105 older patients . Principal outcome measures were the Barthel Index , Philadelphia Geriatric Centre Morale Scale and the Caregiver Strain Index . Two aspects of the trial are examined here . Firstly , we investigated whether trial patients were more disabled than regular day centre attendees . Levels of health and well being amongst trial patients were compared with those of a r and om sample of 20 regular attendees from both of the participating day centres and an additional voluntary sector day centre . Secondly , key staff from the different setting s were interviewed to assess how well the day centre model had worked in practice . Trial patients were significantly more disabled than regular day centre attendees according to the Barthel Index ( P < 0.001 ) , but this difference was no longer significant after three months of treatment . The day centre model had several problems , principally discharge policy , acceptability , facilities and attitudes of staff and regular attendees . Positive aspects of the day centre model , as well as successful rehabilitation , included shared skills , knowledge and re sources . This paper suggests that collaborative working in day centres requires multi purpose facilities . If health staff maintain a permanent presence , benefits can include improved joint working , easier access to health care and the use of rehabilitative therapy as a preventative strategy . Day care setting s can be analyzed as representing different types of communities . Allowing older users a greater degree of choice in facilities may increase the acceptability of care Objectives : To assess outcomes and satisfaction among frail elderly day care clients and their informal caregivers and the impact of adult day care on the cost of health services . Methods : One-hundred eight elderly participants were r and omly assigned to the experimental group ( immediate admission to an adult day care center ) and 104 participants to the control group ( 3 months on a waiting list ) . Results : Participants ’ and caregivers ’ subjective perceptions of the day center ’s effects were positive . However , using st and ard research instruments , there was no evidence of an effect of day center attendance on the client ’s anxiety , depression , or functional status ; on caregiver burden ; or on the cost of health services . Discussion : It is difficult to demonstrate objective ly the benefits of programs and interventions that are perceived by clients , caregivers , and staff to have positive effects . In future studies , maintenance of high levels of participation should be incorporated as an explicit program goal After a baseline interview of 642 caregivers of aged Alzheimer 's disease victims , half were offered formal respite care . Over 12 months , families with respite care maintained their impaired relative significantly longer in the community ( 22 days ) . Although respite was ineffective for caregiver burden and mental health , satisfaction was very high . Although not a strong intervention , respite care can increase caregivers ' quality of life \n Output:\n " }, { "from": "agent", "value": "For all types of respite , the effects upon caregivers were generally small , with better-controlled studies finding modest benefits only for certain subgroups , although many studies reported high levels of caregiver satisfaction .\nNo reliable evidence was found that respite care delays entry to residential care or adversely affects frail older people .\nThe economic evaluations all assessed day care , which tended to be associated with similar or higher costs than usual care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This is the first study to investigate the associations of IGF-1 , IGF-2 and IGFBP-3 concentrations with the risk of colorectal cancer in prospect ively collected blood sample s from an Oriental population . Between 1986 and 1989 serum sample s were collected at baseline from 18 244 men , aged 45–65 years , without a history of cancer and living in Shanghai , China . IGF-1 , IGF-2 and IGFBP-3 were measured in the serum of 135 men who developed colorectal cancer over 12 years of follow-up and 661 control subjects drawn from the cohort , who were matched to the index cases by neighbourhood of residence , age , and year and month of sample collection . Serum IGF-1 was not associated with risk of colorectal cancer . IGF-2 and IGFBP-3 , on the other h and , exhibited statistically significant , positive associations with colorectal cancer risk when cases were confined to those diagnosed within a relatively short time period after enrolment ( within 8 years ) . After adjustment for body mass index , cigarette smoking and alcohol intake , men in the highest versus the lowest quintile of IGF-2 and IGFBP-3 showed odds ratios of 2.74 ( 95 % Cl = 1.67–4.50 ; 2-sided P for trend = 0.0008 ) and 2.85 ( 95 % Cl = 1.69–4.81 ; 2-sided P for trend = 0.01 ) , respectively . Our data thus suggest that circulating IGF-2 and IGFBP-3 can serve as early indicators of impending colorectal cancer . © 2001 Cancer Research Campaign There is some evidence that glucose and other factors related to glucose metabolism , such as insulin and insulin-like growth-factors ( IGFs ) may contribute to breast cancer development . The present study analyzed the hypothesis that serum glucose , insulin levels , and IGF-I pattern are associated with breast cancer using a nested case-control study . Between 1987 and 1992 , 10,786 women ages 35 - 69 were recruited in a prospect i ve study in Italy . Women with history of cancer and on hormone therapy were excluded at baseline . At recruitment , blood sample s were collected after a 12-h fast between 7:30 and 9:00 a.m. from all of the study participants . After 5.5 years , 144 breast cancer cases were identified among the participants of the cohort . Four matched controls were chosen for each breast cancer case from members of the cohort who did not develop breast cancer during the follow-up period . In premenopausal women , glucose was associated with breast cancer risk : the age , body mass index , and reproductive variable adjusted relative risk ( RR ) for the highest quartile of serum glucose versus the lowest was 2.8 [ 95 % confidence interval ( CI ) , 1.2 - 6.5 ] , and P for trend was 0.02 . Insulin showed a weaker association with breast cancer , the adjusted RR of the highest quartile versus the lowest was 1.7 ( 95 % CI , 0.7 - 4.1 ) , and P for trend was 0.14 , whereas the adjusted RR of the highest quartile of IGF-I was 3.1 ( 95 % CI , 1.1 - 8.6 ) , and P for trend was 0.01 . Increased levels of insulin-like growth factor binding protein-3 (IGFBP)-3 were related to breast cancer risk : the adjusted RR for the highest quartile was 2.1 ( 95 % CI , 0.95 - 4.75 ) , and P for trend was 0.02 . In postmenopausal women , the associations of glucose , insulin , and IGF-1 pattern were associated with breast cancer risk in heavier subjects characterized by a body mass index higher than 26 . These results indicate that chronic alteration of glucose metabolism is related to breast cancer development Blood concentrations of insulin-like growth factor-I ( IGF-I ) and insulin-like growth factor binding protein-3 ( IGFBP-3 ) have recently been associated with breast cancer risk , notably in women who developed breast cancer at a young age . Prospect i ve studies published so far , however , were relatively small and odds ratio ( OR ) estimates imprecise . We present the results of a large prospect i ve case-control study nested within the European Prospect i ve Investigation into Cancer and Nutrition on total IGF-I , IGFBP-3 and breast cancer risk including 1081 incident cases of invasive breast cancer and 2098 matched control subjects . Increasing IGF-I and IGFBP-3 concentrations were associated with a significant increase in breast cancer risk in women who developed breast cancer after 50 years of age ( highest vs lowest quintile OR 1.38 ( 95 % confidence interval ( CI ) 1.02 - 1.86 ) , P = 0.01 , and 1.44 ( 95 % CI 1.04 - 1.98 ) , P = 0.01 , respectively ) , but no relationship was observed in younger women ( OR = 1.03 ( 95 % CI 0.60 - 1.77 ) , P = 0.81 for IGF-I , and OR = 0.92 ( 95 % CI 0.50 - 1.70 ) , P = 0.69 for IGFBP-3 ) . There was , however , significant heterogeneity in the relationship of breast cancer with serum IGF-I and IGFBP-3 levels depending on the time interval between blood donation and tumor diagnosis . A reduction in breast cancer risk with increasing IGF-I concentrations was observed in cases with a diagnosis of cancer less than 2 years after blood donation , ( OR = 0.76 ( 95 % CI 0.57 - 1.03 ) ) , while an increase in risk was observed for women with a later diagnosis ( above or equal to two years after blood collection , OR = 1.51 ( 95 % CI 1.19 - 1.91 ) ) . A similar pattern was observed for IGFBP-3 . This study confirms previous findings for an association of serum IGF-I and IGFBP-3 concentrations with breast cancer risk , particularly for women with a later diagnosis of cancer , but it does not support the hypothesis of an involvement of IGF-I in younger women BACKGROUND Insulin-like growth factor I ( IGF-I ) stimulates cell proliferation and inhibits apoptosis in the lung and other tissues by interacting with the IGF-I receptor . The major binding protein for IGF-I , insulin-like growth factor-binding protein 3 ( IGFBP-3 ) , modulates the effects of IGF-I but also inhibits cell growth and induces apoptosis independent of IGF-I and its receptor . In a prospect i ve study of men in Shanghai , China , we examined the association between serum levels of IGF-I and IGFBP-3 and the subsequent risk of lung cancer . METHODS From 1986 to 1989 , serum was collected from 18,244 men aged 45 - 64 years living in Shanghai without a history of cancer . We analyzed IGF-I and IGFBP-3 levels in serum from 230 case patients who developed incident lung cancer during follow-up and from 740 control subjects . RESULTS Among 230 case patients and 659 matched control subjects , increased IGF-I levels were not associated with increased risk of lung cancer . However , for subjects in the highest quartile relative to the lowest quartile of IGFBP-3 , the odds ratio ( OR ) for lung cancer , adjusted for smoking and IGF-I , was 0.50 ( 95 % confidence interval [ CI ] = 0.25 to 1.02 ) . When the analysis was restricted to ever smokers ( 184 case patients and 344 matched control subjects ) , the OR for lung cancer in men in the highest quartile of IGFBP-3 relative to those in the lowest quartile , adjusted for smoking and IGF-I , was 0.41 ( 95 % CI = 0.18 to 0.92 ) . CONCLUSIONS In this prospect i ve study of Chinese men , higher serum levels of IGF-I did not increase the risk of lung cancer . However , subjects with higher serum levels of IGFBP-3 were at reduced risk of lung cancer . This finding is consistent with experimental data that indicate that IGFBP-3 can inhibit cellular proliferation and induce apoptosis independent of IGF-I and the IGF-I receptor Insulin-like growth factor (IGF)-I induces growth in pancreatic cancer cells and blockade of the IGF-I receptor has antitumour activity . The association of plasma IGF-I and IGF binding protein-3 ( IGFBP-3 ) with pancreatic cancer risk has been investigated in two small studies , with conflicting results . We conducted a nested case – control study within four large , prospect i ve cohorts to investigate whether prediagnostic plasma levels of IGF-I , IGF-II , and IGFBP-3 were associated with pancreatic cancer risk . Plasma levels in 212 cases and 635 matched controls were compared by conditional logistic regression , with adjustment for other known pancreatic cancer risk factors . No association was observed between plasma levels of IGF-I , IGF-II , or IGFBP-3 and incident diagnosis of pancreatic cancer . Relative risks for the highest vs the lowest quartile of IGF-I , IGF-II , and IGFBP-3 were 0.94 ( 95 % confidence interval ( CI ) , 0.60–1.48 ) , 0.96 ( 95 % CI , 0.61–1.52 ) , and 1.21 ( 95 % CI , 0.75–1.92 ) , respectively . The relative risk for the molar ratio of IGF-I and IGFBP-3 , a surrogate measure for free IGF-I , was 0.84 ( 95 % CI , 0.54–1.31 ) . Additionally , no association was noted in stratified analyses or when requiring longer follow-up . In four prospect i ve cohorts , we found no association between the risk of pancreatic cancer and prediagnostic plasma levels of IGF-I , IGF-II , or IGFBP-3 BACKGROUND Insulin-like growth factor-I ( IGF-I ) is a potent mitogen for normal and neoplastic cells , whereas IGF-binding protein-3 ( IGFBP-3 ) inhibits cell growth in many experimental systems . Acromegalics , who have abnormally high levels of growth hormone and IGF-I , have higher rates of colorectal cancer . We therefore examined associations of plasma levels of IGF-I and IGFBP-3 with the risk of colorectal cancer in a prospect i ve case-control study nested in the Physicians ' Health Study . METHODS Plasma sample s were collected at baseline from 14916 men without diagnosed cancer . IGF-I , IGF-II , and IGFBP-3 were assayed among 193 men later diagnosed with colorectal cancer during 14 years of follow-up and among 318 age- and smoking-matched control subjects . All P values are two-sided . RESULTS IGFBP-3 levels correlated with IGF-I levels ( r=.64 ) and with IGF-II levels ( r=.90 ) . After controlling for IGFBP-3 , age , smoking , body mass index ( weight in kg/[height in m]2 ) , and alcohol intake , men in the highest quintile for IGF-I had an increased risk of colorectal cancer compared with men in the lowest quintile ( relative risk [RR]=2.51 ; 95 % confidence interval [CI]=1.15 - 5.46 ; P for trend = .02 ) . After controlling for IGF-I and other covariates , men with higher IGFBP-3 had a lower risk ( RR=0.28 ; 95 % CI=0.12 - 0.66 ; P for trend = .005 , comparing extreme quintiles ) . The associations were consistent during the first and the second 7-year follow-up intervals and among younger and older men . IGF-II was not associated with risk . CONCLUSIONS Our findings suggest that circulating IGF-I and IGFBP-3 are related to future risk of colorectal cancer Insulin-like growth factors ( IGFs ) may play a role in prostate growth , hyperplasia , and malignancy . High plasma IGF-I has been associated with increased prostate cancer risk . In a prospect i ve , cohort , case-control study in the Baltimore Longitudinal Study on Aging population , we examined prostate volume by magnetic resonance imaging , and prostate-specific antigen ( PSA ) , IGF-I , IGF-II , and IGF-binding protein-3 ( IGFBP-3 ) in sera obtained approximately 9 yr before diagnosis of prostate cancer in cases ( n = 72 ) or age-matched controls ( n = 127 ) and in 76 additional Baltimore Longitudinal Study on Aging men ( normal subjects ) with measured prostate volumes and no prostate cancer . We calculated adjusted odds ratios ( OR ) by logistic regression , relative risks for significant ORs , and receiver operator curves for prostate cancer , using serum measures alone and in combination . Adjusted ORs for the high vs. low tertile were : for IGF-I , 3.1 [ confidence interval ( CI ) , 1.1 - \n Output:\n " }, { "from": "agent", "value": "Our meta- analysis provides comprehensive support for a role of circulation IGF-I and IGF-II in the etiology of CRC" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Whether velocity-specific resistance training is important for improving functional sporting performance was investigated by study ing the effect of isoinertial training velocity on netball chest pass throwing velocity . Twenty-one female netball players were r and omly assigned to a strength-trained group ( 80 % 1RM - average training velocity = .308 m/s ) , power-trained group ( 60 % 1RM - average training velocity = .398 m/s ) and a control group . Resistance training was combined with sport specific motion training for both groups over a ten-week training duration . Pre- and post-training testing revealed that the training velocity associated with the strength-trained group produced significantly greater improvement in mean volume of weight lifted ( 85 kg ) and mean power output ( 13.25 W ) as compared to the power and control groups ( P < 0.05 ) . The strength-trained and power-trained groups significantly improved netball throw velocity by 12.4 % and 8.8 % respectively . There was no significant difference between the two groups . The validity of velocity-specific training and subsequent adaptations to improve functional sporting performance appears highly question able , due to the disparity between training velocity and actual movement velocity ( 11.38 m x s(-1 ) ) for a given sport specific task such as the netball throw it was proposed that the repeated intent to move an isoinertial load as rapidly as possible coupled with performance of the sport-specific movement promote efficient coordination and activation patterns . Such mechanisms might be more important determinants of sport-specific high velocity adaptation Bishop , DC , Smith , RJ , Smith , MF , and Rigby , HE . Effect of plyometric training on swimming block start performance in adolescents . J Strength Cond Res 23(7 ) : 2137 - 2143 , 2009-This study aim ed to identify the effect of plyometric training ( PT ) , when added to habitual training ( HT ) regimes , on swim start performance . After the completion of a baseline competitive swim start , 22 adolescent swimmers were r and omly assigned to either a PT ( n = 11 , age : 13.1 ± 1.4 yr , mass : 50.6 ± 12.3 kg , stature : 162.9 ± 11.9 cm ) or an HT group ( n = 11 , age : 12.6 ± 1.9 yr , mass : 43.3 ± 11.6 kg , stature : 157.6 ± 11.9 cm ) . Over an 8-week preseason period , the HT group continued with their normal training program , whereas the PT group added 2 additional 1-hour plyometric-specific sessions , incorporating prescribed exercises relating to the swimming block start ( SBS ) . After completion of the training intervention , post-training swim start performance was reassessed . For both baseline and post-trials , swim performance was recorded using videography ( 50Hz Canon MVX460 ) in the sagital plane of motion . Through the use of Silicon Coach Pro analysis package , data revealed significantly greater change between baseline and post-trials for PT when compared with the HT group for swim performance time to 5.5 m ( −0.59 s vs. −0.21 s ; p < 0.01 ) and velocity of take-off to contact ( 0.19 ms−1 vs. −0.07 ms−1 ; p < 0.01 ) . Considering the practical importance of a successful swim start to overall performance outcome , the current study has found that inclusion of suitable and safely implemented PT to adolescent performers , in addition to HT routines , can have a positive impact on swim start performance Crewther , BT , Kilduff , LP , Cook , CJ , Middleton , MK , Bunce , PJ , and Yang , G-Z. The acute potentiating effects of back squats on athlete performance . J Strength Cond Res 25(12 ) : 3319–3325 , 2011—This study examined the acute potentiating effects of back squats on athlete performance with a specific focus on movement specificity and the individual timing of potentiation . Nine subelite male rugby players performed 3 protocol s on separate occasions using a r and omized , crossover , and counterbalanced design . Each protocol consisted of performance testing before a single set of 3 repetition maximum ( 3RM ) back squats , followed by retesting at ∼15 seconds , 4 , 8 , 12 , and 16 minutes . The 3 tests were countermovement jumps ( CMJs ) , sprint performance ( 5 and 10 m ) , and 3-m horizontal sled pushes with a 100-kg load . Relationships between the individual changes in salivary testosterone and cortisol concentrations and performance were also examined . The 3RM squats significantly ( p < 0.001 ) improved CMJ height at 4 ( 3.9 ± 1.9 % ) , 8 ( 3.5 ± 1.5 % ) , and 12 ( 3.0 ± 1.4 % ) minutes compared with baseline values , but no temporal changes in sprinting and sled times were identified . On an individual level , the peak relative changes in CMJ height ( 6.4 ± 2.1 % , p < 0.001 ) were greater than the 3-m sled ( 1.4 ± 0.6 % ) , 5-m ( 2.6 ± 1.0 % ) , and 10-m sprint tests ( 1.8 ± 1.0 % ) . In conclusion , a single set of 3RM squats was found effective in acutely enhancing CMJ height in the study population , especially when the recovery period was individualized for each athlete . The study results also suggest that the potentiating effects of squats may exhibit some degree of movement specificity , being greater for those exercises with similar movement patterns . The current findings have practical implication s for prescribing warm-up exercises , individualizing training programs , and for interpreting postactivation potentiation research Abstract Cuenca-Fernández , F , López-Contreras , G , and Arellano , R. Effect on swimming start performance of two types of activation protocol s : Lunge and YoYo squat . J Strength Cond Res 29(3 ) : 647–655 , 2015—The purpose of this study was to compare the effects of 2 protocol s of postactivation potentiation ( PAP ) on swimming start perfomance ( SS ) . Fourteen trained swimmers ( 10 men and 4 women ) volunteered for this study . An intragroup design of r and omized repetitive measurements was applied . A previous SS trial , performed after a st and ard warm-up ( SWU ) , served as a reference . Two methods of PAP , performed after 1 hour of rest , were r and omly added to the SWU : ( a ) 3 lunges at 85 % of 1 repetition maximum ( LWU ) and ( b ) 4 repetitions on the flywheel device YoYo squat ( YWU ) . Swimmers were tested in an SS 8 minutes after the PAP warm-ups . Kinematic variables were collected using 3 underwater digital video cameras fixed poolside and operating at 25 Hz , and 1 high-speed camera focused on the block and operating at 300 Hz . Data obtained from the video analysis were processed using a repeated measures analysis of the variance . The mean horizontal velocity of the swimmer 's flight improved after both PAP methods , with the greatest improvement after YWU ( F 2,12 = 47.042 , p < 0.001 ; SWU = 3.63 ± 0.11 ; LWU = 4.15 ± 0.122 ; YWU = 4.89 ± 0.12 m·s−1 ) . After YWU , it took the subjects less time to cover a distance of 5 m ( F 2,12 = 24.453 , p < 0.001 ) and 15 m ( F 2,12 = 4.262 , p < 0.04 ) . Subjects also achieved a higher mean angular velocity of the knee extension ( F 2,12 = 23.286 , p < 0.001 ) and a reduction of the time on the block ( F 2,12 = 6.595 , p ⩽ 0.05 ) . These results demonstrate that muscle performance in the execution of an SS is enhanced after a warm-up with specific PAP protocol s. YWU leads to the greatest improvement in the performance of the swimmer 's start and , therefore , may be especially beneficial in short events PURPOSE To quantify the effects of a 12-wk isolated core-training program on 50-m front-crawl swim time and measures of core musculature functionally relevant to swimming . METHODS Twenty national-level junior swimmers ( 10 male and 10 female , 16±1 y , 171±5 cm , 63±4 kg ) participated in the study . Group allocation ( intervention [ n=10 ] , control [ n=10 ] ) was based on 2 preexisting swim-training groups who were part of the same swimming club but trained in different groups . The intervention group completed the core training , incorporating exercises targeting the lumbopelvic complex and upper region extending to the scapula , 3 times/wk for 12 wk . While the training was performed in addition to the normal pool-based swimming program , the control group maintained their usual pool-based swimming program . The authors made probabilistic magnitude-based inferences about the effect of the core training on 50-m swim time and functionally relevant measures of core function . RESULTS Compared with the control group , the core-training intervention group had a possibly large beneficial effect on 50-m swim time ( -2.0 % ; 90 % confidence interval -3.8 to -0.2 % ) . Moreover , it showed small to moderate improvements on a timed prone-bridge test ( 9.0 % ; 2.1 - 16.4 % ) and asymmetric straight-arm pull-down test ( 23.1 % ; 13.7 - 33.4 % ) , and there were moderate to large increases in peak EMG activity of core musculature during isolated tests of maximal voluntary contraction . CONCLUSION This is the first study to demonstrate a clear beneficial effect of isolated core training on 50-m front-crawl swim performance BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good . Cuenca-Fernández , F , Ruiz-Teba , A , López-Contreras , G , and Arellano , R. Effects of 2 types of activation protocol s based on postactivation potentiation on 50-m freestyle performance . J Strength Cond Res XX(X ) : 000 - 000 , 2018-Postactivation potentiation ( PAP ) is a phenomenon which improves muscle contractility , strength , and speed in sporting performances through previously applied maximal or submaximal loads on the muscle system . This study aim ed to assess the effects of 2 types of activation protocol s based on PAP , on sprint swimming performance . A repeated- measures design was used to compare 3 different scenarios before a 50-m race . First , all of the participants performed a st and ard warm-up ( SWU ) , consisting of a 400-m swim followed by dynamic stretching . This protocol acted as the control . Subsequently , the swimmers were r and omly assigned into 2 groups : the swimmers in the first group performed the SWU followed by a PAP one-repetition maximum warm-up ( RMWU ) , consisting of 3 \" lunge \" and 3 \" arm stroke \" repetitions , both at 85 % of the one-repetition maximum . The swimmers in the second group performed the SWU followed by a PAP eccentric flywheel warm-up ( EWU ) , consisting of one set of 4 repetitions of exercises of both the lower and upper limbs on an adapted eccentric flywheel at the maximal voluntary contraction . The time required for the swimmers to swim 5 and 10 m was shorter with the PAP protocol s. The swimming velocity of the swimmers who underwent the EWU and RMWU protocol s was faster at 5 and 10 m. The best total swimming time was not influenced by any of the protocol s. When isolating swimming ( excluding start performance and turn ) , best time was achieved \n Output:\n " }, { "from": "agent", "value": "Post-activation potentiation and plyometrics were found to produce significant improvements in acute and chronic swim start performance , respectively ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To evaluate the current range of hydrophilic‐coated catheters for intermittent self‐catheterization , focusing on the adherence of the catheter to the urethral mucosa at the end of catheterization OBJECTIVE The frequency of bacteriuria is high in children with neurogenic bladder on intermittent catheterization for bladder emptying . In an effort to decrease bacteriuria , we examined whether the method of catheter care was responsible for the high rate of bacteriuria . For this , the frequency of bacteriuria was examined in the same patient on single-use sterile catheters and on reused clean catheters . METHODS A prospect i ve , r and omized , crossover trial was conducted with 10 patients who were r and omized to 4 months of a new , sterile catheter for intermittent catheterization and 4 months of reuse of a clean catheter for intermittent catheterization . Each week , a urine sample was collected and symptoms of infection and medication use were recorded . RESULTS A total of 158 urine sample s were collected during 164 patient-weeks on the new catheter method for each void ; 115 ( 73 % ) were positive for a pathogen . Of the 161 sample s collected during 169 patient-weeks on the st and ard , reuse method for voiding , 123 ( 76 % ) were positive ( 115 [ 73 % ] of 158 vs 123 [ 76 % ] of 161 ) . Escherichia coli was the most common pathogen detected during both method periods . CONCLUSION A new , sterile catheter for each void did not decrease the high frequency of bacteriuria in patients with neurogenic bladder on intermittent catheterization PURPOSE We compared a recently developed hydrophilic catheter to the st and ard polyethylene catheter in regard to hematuria , infection and patient satisfaction . MATERIAL S AND METHODS A hydrophilic LoFric or st and ard Mentor catheter was assigned at r and om to 17 and 16 boys , respectively , who were skilled in intermittent self-catheterization . They were evaluated by weekly urinalysis and a question naire . RESULTS Significantly fewer episodes of microscopic hematuria occurred in the LoFric than Mentor catheter group ( 9 episodes in 6 subjects versus 19 episodes in 11 , p < 0.05 ) . There were also fewer episodes of bacteriuria in the LoFric group but the difference was not statistically significant . Mean scores plus or minus st and ard deviation on a visual analogue scale with 0 equal to most and 10 equal to least favorable were LoFric 3.3 + /- 2.8 versus Mentor 4.9 + /- 2.7 for catheter convenience and 2.7 + /- 2.4 versus 4.2 + /- 2.6 for insertion comfort , significantly favoring the LoFric group ( p < 0.05 for both ) . Of the 16 LoFric subjects 13 preferred to continue its use , particularly those with a history of urethral trauma or sphincteric spasm . CONCLUSIONS In boys the LoFric catheter appears to cause less trauma . Although it is not reusable and is more expensive than the st and ard catheter , satisfaction is higher with the LoFric device and for select patients it has significant advantages OBJECTIVES To compare the safety and cost of clean versus sterile intermittent bladder catheterization in male nursing home residents . To provide evidence to support the hypothesis that intermittent catheterization is a valid , alternative method of bladder management in male residents of long-term care in whom urinary retention is a documented problem . DESIGN R and omized clinical trial . SETTING Three long-term care sites having predominantly male population s. PARTICIPANTS Eighty male veterans , residents of three long-term care facilities , ranging in age from 36 to 96 years with a mean age of 72 . INTERVENTIONS St and ardized procedures for clean and sterile intermittent catheterization ( IC ) were implemented by staff nurses at each site . Patients were r and omized into clean and sterile IC groups . Nursing time and catheterization equipment usage were recorded using bar code readers . Clinical data were collected from the medical chart . Treatment of urinary tract infection was prescribed by the medical personnel responsible for each individual resident . MEASUREMENTS We compared the number of treatment episodes for symptomatic bacteriuria between groups r and omized to receive either clean or sterile intermittent catheterization . Laboratory analysis of blood and urine was done on predetermined days . Control variables were research site and patient history of urinary tract infection within the last 6 months . A cost comparison of nursing time and equipment usage for the two catheterization techniques was also performed . RESULTS No significant differences were found between clean and sterile groups with regard to number of treatment episodes , time to first infection , type of organism cultured , or cost of antibiotic treatment . The cost of sterile technique was considerably higher both in terms of nursing time and supplies . CONCLUSIONS Findings from this study demonstrate that clean technique intermittent catheterization is a safe and cost-effective bladder management technique with male , nursing home residents , despite the frailty of this high risk population . An annual savings of approximately $ 1460 per patient in nursing time and catheterization supplies could be anticipated if a patient were catheterized an average of four times per day substituting clean IC technique for sterile IC technique Monthly urine cultures were analyzed at the University of Alberta Department of Medical Microbiology and Infectious Diseases to determine whether single-use sterile catheters and clean technique reduced the incidence of bacterial colonization in those using long-term intermittent self-catheterization . Thirty subjects with spina bifida , ages 3 years to 16 years , entered a crossover study with r and om assignment to 6 months of sterile single-use catheters or clean reused catheters . Seventeen subjects were catheterized by a parent or caregiver ; 13 were responsible for self-catheterization and cleaning of the catheters . Six months of descriptive data were also collected at Alberta Children 's Hospital from a similar group of subjects with spina bifida who used sterile catheters only . In the crossover group , 38 % of all urine cultures were positive regardless of whether sterile single-use or clean reused catheters were employed . The other group using only sterile catheters had a 36 % positive culture rate . No difference in positive cultures was found between males and females or between children who catheterized themselves and children whose parents catheterized them . The authors concluded that plastic urethral catheters may be reused OBJECTIVES To compare the performance of SpeediCath hydrophilic-coated catheters versus uncoated polyvinyl chloride ( PVC ) catheters , in traumatic spinal cord injured patients presenting with functional neurogenic bladder-sphincter disorders . METHODS A 1-year , prospect i ve , open , parallel , comparative , r and omised , multi centre study included 123 male patients , > or = 16 y and injured within the last 6 months . Primary endpoints were occurrence of symptomatic urinary tract infection ( UTI ) and hematuria . Secondary endpoints were development of urethral strictures and convenience of use . The main hypothesis was that coated catheters cause fewer complications in terms of symptomatic UTIs and hematuria . RESULTS 57 out of 123 patients completed the 12-month study . Fewer patients using the SpeediCath hydrophilic-coated catheter ( 64 % ) experienced 1 or more UTIs compared to the uncoated PVC catheter group ( 82 % ) ( p = 0.02 ) . Thus , twice as many patients in the SpeediCath group were free of UTI . There was no significant difference in the number of patients experiencing bleeding episodes ( 38/55 SpeediCath ; 32/59 PVC ) and no overall difference in the occurrence of hematuria , leukocyturia and bacteriuria . CONCLUSIONS The results indicate that there is a beneficial effect regarding UTI when using hydrophilic-coated catheters Local reactions of the urethral wall are known to occur by repeated introduction of a catheter in the urethra . Urethritis was found in 2 - 19 % of patients practising intermittent catheterisation . Although the use of catheters of smaller size and the liberal use of lubricants may prevent urethral irritation and trauma , it was postulated that hydrophilic catheters ( LoFric , Astra Tech Ltd , Stroud , Engl and ) induce significantly less trauma than PVC catheters because of the binding of the water molecules to the catheter surface which consists of polyvinylpyrrolidone and sodium chloride . Although urethritis and urethral stricture may represent one end of the spectrum of repeated urethral trauma , minor degrees of inflammation need to be quantitatively determined while assessing two different catheters for intermittent catheterisation . The degree of urethral inflammation in patients practising intermittent catheterisation was studied by urethral cytology and staining the smear by Papanicolaou 's method . The number of neutrophil polymorphs and epithelial cells in three r and om high power fields in the urethral smear was counted and the percentage ratio of polymorphs to epithelial cells was calculated . Group 1 comprised 14 patients practising intermittent catheterisation with a PVC catheter and group 2 comprised 17 patients performing intermittent catheterisation with a LoFric catheter . There was no significant difference between the two groups as regards the age , diagnosis , size of the catheter used for intermittent catheterisation and the number of times that they performed catheterisation during a 24 hour period . Urethral cytology revealed a percentage ( mean ratio ) ratio of polymorphs to epithelial cells of 66 in group 1 and 0.04 in group 2 . ( < 0.0005 ) . Urethral cytology also revealed a significantly greater number of bacteria in group 1 as compared to group 2 ( p < 0.01 ) . In conclusion , use of a LoFric catheter for intermittent catheterisation was associated with significantly lesser degree of urethral inflammatory response when compared to the use of a PVC catheter This study was design ed to determine the effect of sterile and nonsterile intermittent catheterization on the incidence of urinary tract infection ( UTI ) in patients after spinal cord injury . The study included 29 patients with neurogenic bladder dysfunction treated with intermittent catheterization . One group of 14 patients was on sterile catheterization ; another group of 15 patients was on nonsterile catheterization . On a weekly basis , urine sample s were obtained and analyzed . A total of 122 urine sample s were analyzed . The patients on sterile catheterization had a 28.6 % UTI incidence ; the group using a nonsterile catheterization technique had a UTI incidence of 42.4 % . The most common urinary pathogen in both groups was E. coli ( 65 % ) . The cost of antibiotics for patients on the sterile catheterization program was only 43 % of the cost of antibiotics for those on the nonsterile program . However , the sterile kits cost 371 % of the cost of the catheterization kits for the patients in the nonsterile program , so the total cost of managing neurogenic bladder on the sterile program was 277 % of the cost of the nonsterile program To evaluate whether patients performing clean intermittent self‐catheterization ( CISC ) for a short period preferred a prelubricated , hydrophilic , disposable polyvinyl chloride ( PVC ) catheter or a non‐hydrophilic PVC catheter which could be used several times and that had to be lubricated by the patient PURPOSE We compared the safety and patient acceptance of a conventional Nélaton and a prelubricated nonhydrophilic catheter in 18 spinal cord injured patients on intermittent catheterization . MATERIAL S AND METHODS In a prospect i ve crossover study each catheter was used for 7 weeks and the initial course was r and omized . Urinalysis and urine culture were performed at 2 , 4 and 7 weeks . Urethral trauma was evaluated by urethral cell count on the surface of each catheter used on the last day of each study period . Patient satisfaction was assessed at the end of the study by a question naire using multiple visual analog scales . RESULTS Urinary tract infection was identified in 12 and 4 patients on a Nélaton and a prelubricated nonhydrophilic catheter ( p = 0.03 ) , while asymptomatic bacteruria was identified in 18 and 8 ( p = 0.0244 ) , respectively . The mean urethral cell count plus or minus st and ard deviation on the catheter surface was 6.7 + /- 2.8 x 10(4 ) and 15.1 + /- 8.9 x 10(4 ) for the prelubricated nonhydrophilic and the Néelaton catheter , respectively ( p = 0.01 ) . The prelubricated nonhydrophilic catheter result ed in a better mean satisfaction score than the Nélaton catheter ( 2.33 + /- 1.06 versus 4.72 + /- 2.13 , p = 0.022 ) . Urethral bleeding was reported in 2 patients during the study period while using the Nélaton catheter . CONCLUSIONS The prelubricated nonhydrophilic cath \n Output:\n " }, { "from": "agent", "value": "There are no definitive studies illustrating that incidence of UTIs is affected by sterile single-use or coated catheters compared to clean reused catheters ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We examined the effects of an 8-week exercise intervention on aerobic fitness , and roid and gynoid fat mass , and blood lipids in overweight and obese participants . Twenty-four sedentary participants ( average BMI = 30 ± 2 kg/m2 ; 18 females , 6 males ) were r and omized into either interval training and diet education ( INT group ) , continuous aerobic exercise and diet education ( CON group ) , or diet education only ( DIET group ) . Duration s of exercise sessions were similar ( ∼30 minutes ) , with both exercise groups completing the same amount of work . The INT and CON groups demonstrated significant improvements over time for ( p < 0.01 and p < 0.05 , ES = 1.1 and 1.2 , respectively ) and time to exhaustion on a grade d exercise test ( p < 0.01 and ES = 0.8 for both groups ) . Further , a large effect size ( 0.7 ) was recorded for the loss in and roid fat mass over time in the INT group only Regular exercise training is recognized as a powerful tool to improve work capacity , endothelial function and the cardiovascular risk profile in obesity , but it is unknown which of high-intensity aerobic exercise , moderate-intensity aerobic exercise or strength training is the optimal mode of exercise . In the present study , a total of 40 subjects were r and omized to high-intensity interval aerobic training , continuous moderate-intensity aerobic training or maximal strength training programmes for 12 weeks , three times/week . The high-intensity group performed aerobic interval walking/running at 85 - 95 % of maximal heart rate , whereas the moderate-intensity group exercised continuously at 60 - 70 % of maximal heart rate ; protocol s were isocaloric . The strength training group performed ' high-intensity ' leg press , abdominal and back strength training . Maximal oxygen uptake and endothelial function improved in all groups ; the greatest improvement was observed after high-intensity training , and an equal improvement was observed after moderate-intensity aerobic training and strength training . High-intensity aerobic training and strength training were associated with increased PGC-1alpha ( peroxisome-proliferator-activated receptor gamma co-activator 1alpha ) levels and improved Ca(2 + ) transport in the skeletal muscle , whereas only strength training improved antioxidant status . Both strength training and moderate-intensity aerobic training decreased oxidized LDL ( low-density lipoprotein ) levels . Only aerobic training decreased body weight and diastolic blood pressure . In conclusion , high-intensity aerobic interval training was better than moderate-intensity aerobic training in improving aerobic work capacity and endothelial function . An important contribution towards improved aerobic work capacity , endothelial function and cardiovascular health originates from strength training , which may serve as a substitute when whole-body aerobic exercise is contra-indicated or difficult to perform Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies BACKGROUND Peak oxygen uptake ( Vo(2peak ) ) strongly predicts mortality in cardiac patients . We compared the effects of aerobic interval training ( AIT ) versus moderate continuous training ( MCT ) on Vo(2peak ) and quality of life after coronary artery bypass grafting ( CABG ) . METHODS Fifty-nine CABG patients were r and omized to either AIT at 90 % of maximum heart rate or MCT at 70 % of maximum heart rate , 5 d/wk , for 4 weeks at a rehabilitation center . Primary outcome was Vo(2peak ) , at baseline , after rehabilitation ( 4 weeks ) , and after 6 months of home-based exercise ( 6 months ) . RESULTS Vo(2peak ) increased between baseline and 4 weeks in AIT ( 27.1 + /- 4.5 vs 30.4 + /- 5.5 mL.kg(-1).min(-1 ) , P < .001 ) and MCT ( 26.2 + /- 5.2 vs 28.5 + /- 5.6 mL.kg(-1).min(-1 ) , P < .001 ; group difference , not significant ) . Aerobic interval training increased Vo(2peak ) between 4 weeks and 6 months ( 30.4 + /- 5.5 vs 32.2 + /- 7.0 mL.kg(-1).min(-1 ) , P < .001 ) , with no significant change in MCT ( 28.5 + /- 5.6 vs 29.5 + /- 5.7 mL.kg(-1).min(-1 ) ) . Quality of life improved in both groups from baseline to 4 weeks , remaining improved at 6 months . There were no changes in echocardiographic systolic and diastolic left ventricular function . Adiponectin increased between 4 weeks and 6 months in both groups ( group differences , not significant ) . CONCLUSIONS Four weeks of intense training increased Vo(2peak ) significantly after both AIT and MCT . Six months later , the AIT group had a significantly higher Vo(2peak ) than MCT . The results indicate that AIT and MCT increase Vo(2peak ) similarly in the short term , but with better long-term effect of AIT after CABG PURPOSE Autonomic dysfunction including sympathetic activation and vagal withdrawal has been reported in patients with chronic heart failure ( CHF ) . We tested the hypotheses that high-intensity interval exercise ( HIIE ) in CHF patients would enhance vagal modulation and thus decrease arrhythmic events . METHODS Eighteen CHF patients underwent a baseline assessment ( CON ) and were then r and omized to a single session of HIIE and to an isocaloric moderate-intensity continuous exercise ( MICE ) . We evaluated the HR , HR variability parameters , and arrhythmic events by 24-h Holter ECG recordings after HIIE , MICE , and CON sessions . RESULTS We found that HR was significantly decreased after HIIE ( 68 ± 3 bpm , P < 0.01 ) when compared with CON and MICE values ( 71.1 ± 2 and 69 ± 3 bpm , respectively ) . HIIE led to a significant increase in normalized high-frequency power ( 35.95 % ± 2.83 % vs 31.56 % ± 1.93 % and 24.61 % ± 2.62 % for CON and MICE , respectively , P < 0.01 ) . Both exercise conditions were associated with an increase in very low frequency power comparative to CON . After HIIE , premature ventricular contractions were significantly decreased ( 531 ± 338 vs 1007 ± 693 and 1671 ± 1604 for CON and MICE , respectively , P < 0.01 ) . An association was found between the changes in premature ventricular contraction and the changes in low-frequency/high-frequency ratio ( r = 0.66 , P < 0.01 ) in patients exposed to HIIE . CONCLUSION We demonstrate that a single session of HIIE improves autonomic profile of CHF patients , leading to significant reductions of HR and arrhythmic events in a 24-h posttraining period . Cardioprotective effects of HIIE in CHF patients need to be confirmed in a larger study population and on a long-term basis This study determined the cellular energetic and structural adaptations of elderly muscle to exercise training . Forty male and female subjects ( 69.2 + /- 0.6 yr ) were assigned to a control group or 6 mo of endurance ( ET ) or resistance training ( RT ) . We used magnetic resonance spectroscopy and imaging to characterize energetic properties and size of the quadriceps femoris muscle . The phosphocreatine and pH changes during exercise yielded the muscle oxidative properties , glycolytic ATP synthesis , and contractile ATP dem and . Muscle biopsies taken from the same site as the magnetic resonance measurements were used to determine myosin heavy chain isoforms , metabolite concentrations , and mitochondrial volume densities . The ET group showed changes in all energetic pathways : oxidative capacity ( + 31 % ) , contractile ATP dem and ( -21 % ) , and glycolytic ATP supply ( -56 % ) . The RT group had a large increase in oxidative capacity ( 57 % ) . Only the RT group exhibited change in structural properties : a rise in mitochondrial volume density ( 31 % ) and muscle size ( 10 % ) . These results demonstrate large energetic , but smaller structural , adaptations by elderly muscle with exercise training . The rise in oxidative properties with both ET and RT suggests that the aerobic pathway is particularly sensitive to exercise training in elderly muscle . Thus elderly muscle remains adaptable to chronic exercise , with large energetic changes accompanying both ET and RT Objective : To determine the effects of a 15-week high-intensity intermittent exercise ( HIIE ) program on subcutaneous and trunk fat and insulin resistance of young women . Design and procedures : Subjects were r and omly assigned to one of the three groups : HIIE ( n=15 ) , steady-state exercise ( SSE ; n=15 ) or control ( CONT ; n=15 ) . HIIE and SSE groups underwent a 15-week exercise intervention . Subjects : Forty-five women with a mean BMI of 23.2±2.0 kg m−2 and age of 20.2±2.0 years . Results : Both exercise groups demonstrated a significant improvement ( P<0.05 ) in cardiovascular fitness . However , only the HIIE group had a significant reduction in total body mass ( TBM ) , fat mass ( FM ) , trunk fat and fasting plasma insulin levels . There was significant fat loss ( P<0.05 ) in legs compared to arms in the HIIE group only . Lean compared to overweight women lost less fat after HIIE . Decreases in leptin concentrations were negatively correlated with increases in VO2peak ( r=−0.57 , P<0.05 ) and positively correlated with decreases in TBM ( r=0.47 ; P<0.0001 ) . There was no significant change in adiponectin levels after training . Conclusions : HIIE three times per week for 15 weeks compared to the same frequency of SSE exercise was associated with significant reductions in total body fat , subcutaneous leg and trunk fat , and insulin resistance in young women Background Increased aerobic exercise capacity appears to reduce both all-cause mortality and cardiovascular disease mortality . Physical exercise to improve peak oxygen uptake ( VO2peak ) is thus strongly recommended , however evidence regarding the most efficient training intensity for patients with coronary artery disease ( CAD ) is still lacking . The purpose of this r and omized study was therefore to assess the effects of high intensity aerobic interval exercise compared to moderate intensity exercise , representing the same total training load , for increasing VO2peak in stable CAD- patients . Methods Twenty-one stable CAD- patients were r and omized to supervised treadmill walking at either high intensity ( 80–90 % of VO2peak ) or moderate intensity ( 50–60 % of VO2peak ) three times a week for 10 weeks . Results After training VO2peak increased by 17.9 % ( P = 0.012 ) in the high intensity group and 7.9 % ( P = 0.038 ) in the moderate intensity group \n Output:\n " }, { "from": "agent", "value": "In spite of the method ological shortcomings of the primary studies included in the systematic review , we reasonably conclude that implementation of high intensity aerobic interval training in subjects with metabolic syndrome , leads to increases in peak oxygen consumption" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: New psychiatric out- patients with depressive , phobic , and anxiety neurosis were r and omly allocated to out-patient care or to one of two types of day hospital treatment , one specialising in psychotherapy and the other offering all forms of day care . Of 106 patients who entered the study , 78 had assessment s of psychiatric symptomatology and social adjustment both before treatment and after 4 , 8 and 24 months . There was no significant difference in outcome between depressive , phobic , and anxiety neurosis , and no overall difference in response to treatment between the three types of care . Suicidal symptoms were significantly less common in out- patients . In many respects , neurotic disorder can be regarded as a single syndrome A one-year cohort of patients from a defined catchment area with acute functional disorders were allocated at r and om to brief care ( experimental group ) or st and ard care ( control group ) in hospital to examine the effect of shortening hospital stay on the clinical and social functioning of patients and the distress abnormal functioning caused to others . A total of 127 patients were interviewed on entry to the study , and 106 were followed up . The brief care group had significantly shorter mean and median lengths of stay than the control group , but there was no difference between the groups in the number of days spent in hospital during subsequent admissions . The groups were well matched for clinical and social variables . Rates of improvement over 13 weeks were essentially the same by all measures of outcome , including the Present State Examination and Patient 's Behaviour Assessment Scale , which was developed for the study to measure deterioration in behaviour and social functioning and adverse effects and distress on others . There was no difference between the two groups in burden to the community supporting services , social security requirements , or GP attendances . Improvement rates were nearly identical on all measures within and across diagnostic subgroups . Brief care result ed in a 33 % reduction in average length of stay compared with the year before but was associated with a corresponding increase in day hospital use . The short-stay policy continued the year after the study finished . The findings confirm the value of shortening hospital stay and improving day care facilities for most localities The effects of day care therapy for a period of 6 months upon patients with schizophrenia were studied through comparison with schizophrenia out patients at four facilities in Japan . The clinical features of the 31 day care patients and 30 out patients were evaluated by the hospital staff using the Positive and Negative Syndrome Scale ( PANSS ) and Global Assessment Scale ( GAS ) , and by the patients ' close relatives using the Katz Adjustment Scale ( KAS ) before and after 6 months of treatment . Day care patients showed a significant decrease in the general pathological score of PANSS and GAS , but out patients did not show any comparable improvement . As for KAS scores , similar improvement was observed for both the day care patients and out patients After 6 months , 43 % of the day care patients improved on the post-/pre- PANSS total scores ratio , as against only 13 % of the out patients . In addition , 13 % of the out patients were readmitted due to an exacerbation of their symptoms , whereas all day care patients were able to remain at home for 6 months . This study clearly demonstrated that day care therapy for patients with schizophrenia was more effective than the usual out patients treatment setting . Further therapeutic efforts ( e.g. psycho-education ) in day care therapy are needed in order to improve family member 's evaluation of the patient Ninety-one patients admitted as emergencies , suffering from neurosis , personality disorder , or adjustment reaction , were r and omly allocated to day hospital or to continued in-patient care . Follow-up was for up to one year . Clinical outcome was similar in the day care and in-patient groups , but patient satisfaction was significantly greater in day patients . Day hospital care was only about two-thirds of the cost of the cheaper of the two in-patient regimes , even though contact with it was on average twice as long as for in- patients Emerging models of cognitive-behavioral treatment ( CBT ) offer promising new intervention strategies in the psychotherapy of schizophrenia . These models , however , have not been integrated into community support programs and evaluated in comparison to st and ard community treatments . This study examined differences in outcomes of clients who received long-term day treatment program services ( DTP ) compared to clients who received individual CBT that was included as part of their DTP treatment . Twenty-four clients were r and omly assigned to DTP treatment or CBT/DTP treatment . Data on st and ardized measures of psychosocial functioning , symptomatology and rehospitalizations were collected over the course of three years of treatment . Analysis of variance with repeated measures was conducted to evaluate the effects of type of treatment ( CBT/DTP and DTP ) and time ( dependent variable scores taken at the end of treatment years one , two and three ) on the three outcome variables . Results indicate significant improvement for the CBT/DTP group compared to the DTP group in the patterns of change over time for psychosocial functioning and symptomology . In addition to this significant group/time interaction the time factor was also significant for both variables . For rehospitalizations the time factor was significant and the group/time factor was nonsignificant . Implication s for service delivery to persons with schizophrenia and suggestions for future research are discussed BACKGROUND Postnatal depression affects one in ten women within 6 months of childbirth . The most effective treatment strategy for postnatal depression is not clear . METHODS This prospect i ve , naturalistic study of the treatment of postnatal depression compared 30 women treated at a specialised psychiatric day hospital with 30 women treated using routine primary care ( RPC ) . Clinical , marital and social adjustment were assessed on three occasions over 6 months using : the Edinburgh Postnatal Depression Question naire ( EPDS ) ; the Clinical Interview schedule ( CIS ) ; the Anxiety Subscale of the Hospital Anxiety and Depression Scale ; the Dyadic Adjustment Scale ( DAS ) ; and the Work Leisure and Family Life Question naire-Modified ( WLFLQ-M ) . RESULTS There were no significant differences between the two groups at baseline . However , there were significant differences in outcome at 3 and 6 months follow-up for all outcome measures except the DAS . At 6 month follow-up 21 of the PBDU group were no longer depressed compared with 7 of the RPC group . CONCLUSIONS A specialised day hospital is a more effective treatment setting for postnatal depression than routine primary care . LIMITATIONS OF THE STUDY The study is not an RCT , so systematic bias is possible . The sample size is relatively small and the duration of follow-up relatively short The authors r and omly assigned 79 in patients with nonchronic schizophrenia or affective disorder to either an intensive experimental day program called \" transitional treatment \" or a control treatment -- weekly clinical ly believed to require intensive posthospital treatment to make the transition to the community . Although initially there was a significantly higher dropout rate from the control condition , at the point of discharge from the two programs as well as at 6- and 12-month follow-up there was no difference in outcome . Direct costs for the transitional treatment , however , were much higher A prospect i ve r and omized comparative study on the effectiveness of psychiatric day treatment and inpatient treatment is described . The target population consisted of patients who would normally have been admitted to an open inpatient unit . Outcome indicators were psychopathology , social functioning , interpersonal functioning , social network and social support . No differences in effectiveness were found between the two forms of treatment , although more patients accepted and completed day treatment , and day patients were more satisfied . Although a uniform treatment programme for both departments was established , distinct differences did arise in the actual treatment programme offered to the patients . The duration of treatment for the day patients was considerably longer , and the intensity of treatment was more low‐key . No striking differences in the amount of medication prescribed and in the occurrence of crisis situations ( including suicide ) were found . Day treatment turns out to be a realistic alternative for 33 % of all patients admitted for inpatient treatment . It was not possible to predict which type of patient in particular is suitable for day treatment The authors compared treatment results for 141 schizophrenic patients r and omly assigned to short-term or long-term hospitalization . Test results indicated that the long-term group was functioning significantly better one year after admission according to global measures only . The authors caution that the differences between the two groups , although statistically reliable , were modest and may have been confounded by the amount of psychotherapy the patients received after hospitalization . Although there appears to be a general advantage to the long-term approach , further work will be needed to identify patient subgroups for whom this more expensive treatment is cost effective The feasibility of day treatment with community care for schizophrenic patients was tested by means of a longitudinal r and omized experiment with 34 experimentals and 16 controls : 38 percent could be treated satisfactorily in a day program that included a very active ambulatory service . The new approach did not improve prognosis with respect to psychiatric symptomatology , social role disabilities , or number of readmissions during the first year of followup . Total cost of treatment was less for day-treatment patients than for ordinary clinical patients A controlled , prospect i ve , two-year follow-up study examined the relative effectiveness of short-term vs long-term psychiatric hospitalization . Results of the inpatient phase for a sample of 74 nonschizophrenic patients are reported here . About four weeks after admission the patients hospitalized for a short stay were discharged , and at that time were functioning better than the patients in the long-stay group . When the patients hospitalized for a long stay were discharged , three to fur months after admission , they were then functioning as well as , but not noticeably better than , the patients in the short-stay group had been at their earlier time of discharge . Patients with affective disorders were more impaired at admission and improved more than patients with other diagnoses , regardless of length of stay OBJECTIVE The authors investigated the clinical feasibility and the outcome for patients of a program design ed as an alternative to acute hospitalization . METHOD This was a r and om- design study comparing a conventional inpatient program for urban , poor , severely ill voluntary patients who usually require hospitalization to an alternative experimental program consisting of a day hospital linked to a crisis residence . Patients were assessed with st and ardized measures of symptoms , functioning , social adjustment , quality of life , and satisfaction with clinical services upon admission to the study , at discharge from the index admission , and at follow-ups 2 , 5 , and 10 months after discharge . RESULTS One hundred ninety-seven patients were enrolled in the 2-year research program and followed for 10 months . Of the voluntary patients who would have been admitted to the hospital , 83 % were appropriate for the experimental program . The clinical , functional , social adjustment , quality of life , and satisfaction outcome measures were not statistically different for the patients in the two treatment conditions ; however , there was a slightly more positive effect of the experimental program on measures of symptoms , overall functioning , and social functioning . CONCLUSIONS The experimental condition , a combined day hospital/crisis respite community residence , seems to have had the same treatment effectiveness as acute hospital care for urban , poor , acutely ill voluntary patients with severe mental illness Previous attempts at program evaluation of partial hospitalization programs have consisted largely of descriptive and anecdotal reports of programs and patient characteristics . There have been no comparative or experimental studies of the effectiveness of differing day treatment programs . In the current study , Goal Attainment Scaling , a goal -oriented program evaluation system , was used with 56 r and omly selected partial hospitalization patients who attended two day hospitals : one program was based on behavioral-educational methods , and the other was an eclectic program based on the concepts of a therapeutic community . Patients attending the behavioral-educational program showed greater attainment of their therapeutic goals than did the patients involved in the eclectic program . The greater effectiveness of the behavioral-educational day program increased from the 3-month follow-up to the 2-year follow-up The effect of a treatment program ( E ) providing inpatient care , a day hospital , community housing , and sheltered work are compared with a program ( C ) emphasizing rapid discharge . A group of 94 male general psychiatric patients were r and omized to the two units . Outcome data collected at 18 months from admission revealed small but significant differences between the total sample s in employment , maintenance of treatment contact , use of medication , and social adjustment . More C than E patients were in the hospital after the 14th month . Program effects varied considerably with patient type . Patients with less social disability had somewhat better employment outcomes with the E program , but no differences in use of services . Patients with a better prognosis by measure of psychopathology ( Minnesota Multiphasic Personality Inventory cluster and diagnosis of schizophrenia ) spent less inpatient time in the E program , but were not helped to better employment outcomes . Patients with greater social h and icap were not differentially affected . More E patients than C with a poorer prognosis stayed in outpatient treatment and used antipsychotic medications . Patients in the E group with better previous employment and more social isolation used the E day hospital and community housing more heavily than other E subgroups OBJECTIVE The authors compared service utilization and costs for acutely ill psychiatric patients treated in a day hospital/crisis respite program or in a hospital inpatient program . METHOD The patients ( N = 197 ) were r and omly assigned to one of the two programs and followed for 10 months after discharge . Both programs were provided by a community mental health center ( CMHC ) in a poor urban community . Data were collected for developing service utilization profiles and estimates of per-unit costs of the inpatient , day hospital , and outpatient services provided by the CMHC . RESULTS On average , the day hospital/crisis respite program cost less than inpatient hospitalization . The average saving per patient was + 7,100 , or roughly 20 % of the total direct costs . There were no significant differences between programs in service utilization or costs during the follow-up phase . Cost savings accrued in the index episode because per-unit costs were lower for day hospital/crisis respite and the average stay was shorter . Significant differences in cost were found among patient groups with psychosis , affective disorders , and dual diagnoses ; psychotic patients had the highest costs in both programs . \n Output:\n " }, { "from": "agent", "value": "REVIEW ER 'S CONCLUSIONS There is only limited evidence to justify the provision of day treatment programmes and transitional day hospital care , and no evidence to support the provision of day care centres" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Use of the low-energy helium-neon laser ( LEL ) appears to be a simple atraumatic technique for the prevention and treatment of mucositis of various origins . Preliminary findings , and significant results obtained for chemotherapy-induced mucositis in a previous phase III study , prompted a r and omized multicenter double-blind trial to evaluate LEL in the prevention of acute radiation-induced stomatitis . Irradiation by LEL corresponds to local application of a high-photon-density monochromatic light source . Activation of epithelial healing for LEL-treated surfaces , the most commonly recognized effect , has been confirmed by numerous in vitro studies . The mechanism of action at a molecular and enzymatic level is presently being studied . From September 1994 to March 1998 , 30 patients were r and omized . Technical specification : 60 mW ( 25 mW at Reims , 1 patient ) , He-Ne , wavelength 632.8 nm . The trial was open to patients with carcinoma of the oropharynx , hypopharynx and oral cavity , treated by radiotherapy alone ( 65 Gy at a rate of 2 Gy/fraction , 5 fractions per week ) without prior surgery or concomitant chemotherapy . The malignant tumor had to be located outside the tested laser application areas ( 9 points ) : posterior third of the internal surfaces of the cheeks , soft palate and anterior tonsillar pillars . Patients were r and omized to LEL or placebo light treatment , starting on the first day of radiotherapy and before each session . The treatment time ( t ) for each application point was given by the equation : t (s)=energy (J/cm2) × surface (cm2)/Power ( W ) . Objective assessment of the degree of mucositis was recorded weekly by a physician blinded to the type of treatment , using the WHO scale for grading of mucositis and a segmented visual analogue scale for pain evaluation . Protocol feasibility and compliance were excellent . Grade 3 mucositis occured with a frequency of 35.2 % without LEL and of 7.6 % with LEL ( P<0.01 ) . The frequency of \" severe pain \" ( grade 3 ) was 23.8 % without LEL , falling to 1.9 % with LEL ( P<0.05 ) . Pain relief was significantly reduced throughout the treatment period ( weeks 2–7 ) . LEL therapy is capable of reducing the severity and duration of oral mucositis associated with radiation therapy . In addition , there is a tremendous potential for using LEL in combined treatment protocol s utilizing concomitant chemotherapy and radiotherapy Background . Oral mucositis is a common complication of bone marrow transplantation ( BMT ) conditioning therapy . Sequelae consist of increased risk for infection , moderate to severe pain , compromised oral function , and bleeding . This study investigated helium‐neon laser treatment for prevention of conditioning‐induced oral mucositis in BMT patients . Patterns and severity of mucositis for specific conditioning drug regimens also were analyzed Background Low-energy laser ( LEL ) treatment has been suggested as an effective and safe method to prevent and /or treat oral mucositis induced by chemotherapy and /or radiotherapy ; however , it has not gained wide acceptance so far . Material s and methods We conducted two clinical trials testing the LEL technique : firstly , as a secondary prevention in patients with various solid tumors treated with chemotherapy who all developed severe mucositis after a previous identical chemotherapy and , secondly , as therapeutic intervention ( compared to sham illumination in a r and omized way ) in patients with hematological tumors receiving intensive chemotherapy and having developed low- grade oral mucositis . Results We entered 26 eligible patients in the first study and 36 were r and omized in the second study . The success rate was 81 % ( 95%CI = 61–93 % ) when LEL was given as a preventive treatment . In the second study , in patients with existing lesions , the therapeutic success rate was 83 % ( 95%CI = 59–96 % ) , which was significantly different from the success rate reached in the sham-treated patients ( 11 % ; 95%CI = 1–35 % ) ; the time to development of grade 3 mucositis was also significantly shorter in the sham-treated patients ( p < 0.001 ) . Conclusion Our results strongly support the already available literature , suggesting that LEL is an effective and safe approach to prevent or treat oral mucositis result ing from cancer chemotherapy Abstract Background and Objective : As Light Emitting Diode ( LED ) devices are commercially introduced as an alternative for Low Level Laser ( LLL ) Therapy , the ability of LED in influencing wound healing processes at cellular level was examined . Study Design / Material s and Methods : Cultured fibroblasts were treated in a controlled , r and omized manner , during three consecutive days , either with an infrared LLL or with a LED light source emitting several wavelengths ( 950 nm , 660 nm and 570 nm ) and respective power outputs . Treatment duration varied in relation to varying surface energy densities ( radiant exposures ) . Results : Statistical analysis revealed a higher rate of proliferation ( p ≤ 0.001 ) in all irradiated cultures in comparison with the controls . Green light yielded a significantly higher number of cells , than red ( p ≤ 0.001 ) and infrared LED light ( p ≤ 0.001 ) and than the cultures irradiated with the LLL ( p ≤ 0.001 ) ; the red probe provided a higher increase ( p ≤ 0.001 ) than the infrared LED probe and than the LLL source . Conclusion : LED and LLL irradiation result ed in an increased fibroblast proliferation in vitro . This study therefore postulates possible stimulatory effects on wound healing in vivo at the applied dosimetric parameters We investigated the clinical effects of low-power laser therapy ( LPLT ) on prevention and reduction of severity of conditioning-induced oral mucositis ( OM ) for hematopoietic stem cell transplantation ( HSCT ) . We r and omized 38 patients who underwent autologous ( AT ) or allogeneic ( AL ) HSCT . A diode InGaAlP was used , emitting light at 660 nm , 50 mW , and 4 J/cm2 , measured at the fiberoptic end with 0.196 cm2 of section area . The evaluation of OM was done using the Oral Mucositis Assessment Scale ( OMAS ) and the World Health Organization ( WHO ) scale . In the LPLT group , 94.7 % of patients had an OM grade ( WHO ) lower than or equal to grade 2 , including 63.2 % with grade 0 and 1 , whereas in the controls group , 31.5 % of patients had an OM grade lower than or equal to grade 2 ( P < .001 ) . Remarkably , the hazard ratio ( HR ) for grade s 2 , 3 , and 4 OM was 0.41 ( range , 0.22 - 0.75 ; P = .002 ) and for grade s 3 and 4 it was 0.07 ( range , 0.11 - 0.53 ; P < .001 ) . Using OMAS by the calculation of ulcerous area , 5.3 % of the laser group presented with ulcers of 9.1 cm2 to 18 cm2 , whereas 73.6 % of the control group presented with ulcers from 9.1 cm2 to 18 cm2 ( P = .003 ) . Our results indicate that the use of upfront LPLT in patients who have undergone HSCT is a powerful instrument in reducing the incidence of OM and is now st and ard in our center OBJECTIVE A pilot clinical study was conducted to evaluate the efficacy and feasibility of low-level laser therapy ( LLLT ) in the prevention and treatment of chemotherapy (CT)-induced oral mucositis ( OM ) in young patients . BACKGROUND DATA Besides compromising the patient 's nutrition and well-being , oral mucositis represents a portal of entry into the body for microorganisms present in the mouth , which may lead to sepsis if there is hematological involvement . Oncologic treatment tolerance decreases and systemic complications may arise that interfere with the success of cancer treatment . LLLT appears to be an interesting alternative to other approaches to treating OM , due to its trophic , anti-inflammatory , and analgesic properties . MATERIAL S AND METHODS Patients undergoing chemotherapy ( 22 cycles ) without mucositis were r and omized into a group receiving prophylactic laser-irradiation ( group 1 ) , and a group receiving placebo light treatment ( group 2 ) . Patients who had already presented with mucositis were placed in a group receiving irradiation for therapeutic purpose s ( group 3 , with 10 cycles of CT ) . Serum granulocyte levels were taken and compared to the progression of mucositis . RESULTS In group 1 , most patients ( 73 % ) presented with mucositis of grade 0 ( p = 0.03 when compared with the placebo group ) , and 18 % presented with grade 1 . In group 2 , 27 % had no OM and did not require therapy . In group 3 , the patients had marked pain relief ( as assessed by a visual analogue scale ) , and a decrease in the severity of OM , even when they had severe granulocytopenia . CONCLUSION The ease of use of LLLT , high patient acceptance , and the positive results achieved , make this therapy feasible for the prevention and treatment of OM in young patients Goal of workThe aim of this study was to investigate the mechanisms whereby low-intensity laser therapy may affect the severity of oral mucositis . Material s and methods A hamster cheek pouch model of oral mucositis was used with all animals receiving intraperitoneal 5-fluorouracil followed by surface irritation . Animals were r and omly allocated into three groups and treated with a 35 mW laser , 100 mW laser , or no laser . Clinical severity of mucositis was assessed at four time-points by a blinded examiner . Buccal pouch tissue was harvested from a subgroup of animals in each group at four time-points . This tissue was used for immunohistochemistry for cyclooxygenase-2 ( COX-2 ) , vascular endothelial growth factor ( VEGF ) , and factor VIII ( marker of microvessel density ) and the result ing staining was quantified . Main results Peak severity of mucositis was reduced in the 35 mW laser group as compared to the 100 mW laser and control groups . This reduced peak clinical severity of mucositis in the 35 mW laser group was accompanied by a significantly lower level of COX-2 staining . The 100 mW laser did not have an effect on the severity of clinical mucositis , but was associated with a decrease in VEGF levels at the later time-points , as compared to the other groups . There was no clear relationship of VEGF levels or microvessel density to clinical mucositis severity . Conclusion The tissue response to laser therapy appears to vary by dose . Low-intensity laser therapy appears to reduce the severity of mucositis , at least in part , by reducing COX-2 levels and associated inhibition of the inflammatory response BACKGROUND AND OBJECTIVES Several studies have suggested that low-level laser therapy ( LLLT ) can ameliorate oral mucositis ; however , the mechanisms involved are not well understood . The aim of this study was to investigate the mechanisms of action of LLLT on chemotherapy-induced oral mucositis , as related to effects on collagen expression and inflammation . MATERIAL S AND METHODS A hamster cheek pouch model of oral mucositis was used with all animals receiving intraperitoneal 5-fluorouracil , followed by surface irritation . Animals were r and omly allocated into three groups , and treated with an InGaAIP diode laser at a wavelength of 660 nm and output power of 35 or 100 mW laser , or no laser . Clinical severity of mucositis was assessed at four time-points by a blinded examiner . Buccal pouch tissue was harvested from a subgroup of animals in each group at four time-points . Collagen was qualitatively and quantitatively evaluated after picrosirius staining . The density of the neutrophil infiltrate was also scored . RESULTS Peak clinical severity of mucositis was reduced in the 35 mW laser group as compared to the 100 mW and control groups . The reduced peak clinical severity of mucositis in the 35 mW laser group was accompanied by a decrease in the number of neutrophils and an increase in the proportion of mature collagen as compared to the other two groups . The total quantity of collagen was significantly higher in the control ( no laser ) group at the day 11 time-point , as compared to the 35 mW laser group , consistent with a more prolonged inflammatory response in the control group . CONCLUSION This study supports two mechanisms of action for LLLT in reducing mucositis severity . The increase in collagen organization in response to the 35 mW laser indicates that LLLT promotes wound healing . In addition , LLLT also appears to have an anti-inflammatory effect , as evidence d by the reduction in neutrophil infiltrate The purpose of this prospect i ve study was to determine the effect of the low-level laser in the prevention and treatment of mucositis in head and neck cancer patients . A total of 70 patients with malignant neoplasms in the \n Output:\n " }, { "from": "agent", "value": "Conclusions The increasing evidence in favor of low-level laser therapy allowed for the development of two new guidelines supporting this modality in the population s listed above .\nEvidence for other population s was also generally encouraging over a range of wavelengths and intensities ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract OBJECTIVE : Adherence to combination antiretroviral therapy is critical for clinical and virologic success in HIV-infected patients . To combat poor adherence , clinicians must identify nonadherent patients so they can implement interventions . However , little is known about the accuracy of these assessment s. We sought to describe the accuracy of clinicians ’ estimates of patients ’ adherence to combination antiretroviral therapy . SETTING : Public HIV clinic . DESIGN : Prospect i ve cohort study . During visits , we asked clinicians ( nurse practitioners , residents and fellow , and their supervising attending physicians ) to estimate the percentage of antiretroviral medication taken by patients over the last 4 weeks and predicted adherence over the next 4 weeks . Adherence was measured using electronic monitoring devices , pill counts , and self-reports , which were combined into a composite adherence measure . PATIENTS AND PARTICIPANTS : Clinicians estimated 464 episodes of adherence in 82 patients . RESULTS : Among the 464 adherence estimates , 264 ( 57 % ) were made by principal care providers ( 31 % by nurse practitioners , 15 % by fellows , 6 % by residents , and 5 % by staff physicians ) and 200 ( 43 % ) by supervising attending physicians . Clinicians ’ overestimated measured adherence by 8.9 % on average ( 86.2 % vs 77.3 % ) . Greater clinician inaccuracy in adherence prediction was independently associated with higher CD4 count nadir ( 1.8 % greater inaccuracy for every 100 CD4 cells , P=.005 ) , younger patient age ( 3.7 % greater inaccuracy for each decade of age , P=.02 ) , and visit number ( P=.02 ) . Sensitivity of detecting nonadherent patients was poor ( 24 % to 62 % , depending on nonadherence cutoff ) . The positive predictive value of identifying a patient as nonadherent was 76 % to 83 % . CONCLUSIONS : Clinicians tend to overestimate medication adherence , inadequately detect poor adherence , and may therefore miss important opportunities to intervene to improve antiretroviral adherence Recent studies suggest that involving pharmacists is an effective strategy for improving patient adherence and blood pressure ( BP ) control . To date , few controlled studies have tested the cost-effectiveness of specific models for improving patient adherence and BP control in community pharmacies , where most Americans obtain prescriptions . We hypothesized that a team model of adherence monitoring and intervention in corporately owned community pharmacies can improve patient adherence , prescribing , and BP control among hypertensive black patients . The Team Education and Adherence Monitoring ( TEAM ) Trial is a r and omized controlled trial testing a multistep intervention for improving adherence monitoring and intervention in 28 corporately owned community pharmacies . Patients in the 14 control pharmacies received \" usual care , \" and patients in the 14 intervention pharmacies received TEAM Care by trained pharmacists and pharmacy technicians working with patients and physicians . Data collectors screened 1250 patients and enrolled 597 hypertensive black patients . The primary end points were the proportion of patients achieving BP control and reductions in systolic and diastolic BP measured after 6 and 12 months . Secondary end points were changes in adherence monitoring and intervention , patient adherence and barriers to adherence , prescribing , and cost-effectiveness . Research ers also will examine potential covariates and barriers to change . Involving pharmacists is a potentially powerful means of improving BP control in blacks . Pharmacists are in an excellent position to monitor patients between clinic visits and to provide useful information to patients and physicians BACKGROUND Immunosuppression nonadherence increases the risk for kidney transplant loss after transplantation . Wireless-enabled pill bottles have created the opportunity to monitor medication adherence in real time . Reminders may help patients with poor memory or organization . Provision of adherence data to providers may motivate patients to improve adherence and help providers identify adherence barriers . STUDY DESIGN R and omized controlled trial . SETTING & PARTICIPANTS Kidney transplant recipients ( n=120 ) at a single center . INTERVENTION Participants were provided wireless pill bottles to store tacrolimus and record bottle openings . Participants were r and omly assigned 1:1:1 to adherence monitoring with customized reminders ( including alarms , texts , telephone calls , and /or e-mails ) , monitoring with customized reminders plus provider notification ( every 2 weeks , providers received notification if adherence decreased to < 90 % during that period ) , or wireless pill bottle use alone ( control ) . OUTCOMES The main outcome was bottle-measured tacrolimus adherence during the last 90 days of the 180-day trial . A secondary outcome was tacrolimus whole-blood concentrations at routine clinical visits . MEASUREMENTS Adherence for the primary outcome was assessed via wireless pill bottle openings . RESULTS Mean participant age was 50 years ; 60 % were men , and 40 % were black . Mean adherence was 78 % , 88 % , and 55 % in the reminders , reminders-plus-notification , and control arms ( P<0.001 for comparison of each intervention to control ) . Mean tacrolimus levels were not significantly different between groups . LIMITATIONS The study did not assess clinical end points . Participants and study coordinators were not blinded to intervention arm . CONCLUSIONS Provider notification and customized reminders appear promising in helping patients achieve better medication adherence , but these strategies require evaluation in trials powered to detect differences in clinical outcomes Background Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence . Purpose To test the reactive effect of electronic monitoring in a r and omized controlled trial . Methods A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were r and omized to receiving their main oral glucose lowering medication in electronic containers or st and ard packaging . The primary outcomes were self-reported adherence measured with the MARS ( Medication Adherence Report Scale ; range 5–25 ) and HbA1c at 8 weeks . Results Non-significantly higher adherence and lower HbA1c were observed in the electronic container group ( differences in means , adjusting for baseline value : MARS , 0.4 [ 95 % CI −0.1 to 0.8 , p = 0.11 ] ; HbA1c ( mmol/mol ) , −1.02 [ −2.73 to 0.71 , p = 0.25 ] ) . Conclusions Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages . Our findings support electronic monitoring as the method of choice in research on medication adherence . ( Trial registration Current Controlled Trials IS RCT N30522359 Objective : Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients . However , estimates show that nearly half of these patients have poor adherence . The Brief Adherence Rating Scale ( BARS ) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio ( AAR ) is about 49.5 % in schizophrenia . The aim of the study was to test if an electronic pill dispenser named DoPill ® improved AAR of schizophrenic patients . Furthermore , we compared AAR obtained by the DoPill ® and the BARS , in order to verify whether the DoPill ® provides reliable assessment of medication adherence . Methods : The DoPill ® is a smart pill dispenser that beeps and flashes at the appropriate time of the day . Each of its 28 compartments is covered by a plastic lamina that , when taken off , sends a signal to the pharmacist . Patients were r and omized to the DoPill ® or treatment as usual groups for 6 weeks . The BARS was used as a reference measure . Results : Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication . The mean AAR was 67 % after 6 weeks . DoPill ® recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found . Conclusion : These results suggest that DoPill ® is a valid tool that provides more reliable and objective data for the clinician about their patient ’s adherence , than existing assessment tools like the BARS . Furthermore , the device may help patients successfully manage their medication regimen CONTEXT In order for patients to benefit from a multidisciplinary treatment approach , diverse providers must communicate on patient care . OBJECTIVE We sought to examine the effect of information exchange across multidisciplinary human immunodeficiency virus ( HIV ) care providers on patient health outcomes . DESIGN R and omized controlled trial , r and omized at the patient level . SETTING Six infectious disease clinics paired with 9 ancillary care setting s ( eg , HIV case management ) . PARTICIPANTS Two hundred fifty-four patients with HIV receiving care at the infectious disease clinics . INTERVENTION Health information was exchanged for 2 years per patient between medical and ancillary care providers using electronic health records and printouts inserted into charts . Medical care providers gave ancillary care providers HIV viral loads , CD4 values , current medications , and appointment attendance . Ancillary care providers gave medical providers the information on medication adherence and major changes ( eg , loss of housing ) . MAIN OUTCOME MEASURES We abstract ed from medical records HIV viral loads , CD4 counts , and antiretroviral medication prescriptions before and during the intervention . From 0- , 12- , and 24-month patient surveys , we assessed hospitalizations , emergency department use , and health-related quality of life measured by the Medical Outcomes Study Short Form-36 ( SF-36 ) . RESULTS No statistically significant differences between cases and controls were found across time for the following : proportion with suppressed viral load , changes in viral load or CD4 values , patients being prescribed antiretroviral medication , hospitalizations , emergency department visits , or any scale of the SF-36 . Trends were mixed but leaned toward better health for control participants . CONCLUSIONS The exchange of this specific set of information between HIV medical and ancillary care providers was neutral on a variety of patient health outcomes Nonadherence to medication is a widespread problem in schizophrenia and is associated with poor clinical outcomes and inappropriate management and utilization of re sources . The aim of the current investigation was to assess the impact of telemonitoring of medication adherence on symptomatology and service use in patients with schizophrenia . A total of 108 schizophrenia patients were r and omized into three equal groups according to the approaches used to assess medication adherence ; self-report , pill counting , and telemonitoring . Telementoring was achieved through an innovative new platform called @HOME . This platform offers clinicians early warnings about impeding nonadherence as well as information about the pattern of medication taking . Patient 's adherence was observed over an 8-week period , during which patient 's clinical status and service use were recorded . In comparison to the other two groups , patients using @HOME showed improvement in the Global Clinical Impression Scale and a significant reduction in emergency visits and medical appointments . The @HOME platform was highly acceptable by patients , caregivers , and professionals , and required minimal training for implementation . The results of the study suggest that the use of telemonitoring in psychiatric setting s was both feasible and acceptable and may be associated with significant clinical and service related benefits OBJECTIVE To assess if the use of biological marker of bone resorption ( CTX ) feedback is a mean to improve persistence on monthly oral ib and ronate . METHODS One year prospect i ve multicenter study using a cluster r and omisation design with physicians as r and omized units into two groups , A and B ; in group B , physicians used results of CTX and two st and ardized messages according to CTX changes from baseline : suboptimal if decrease less than 30 % at week 6 , positive otherwise . In group A , the follow-up was st and ard of care . Patients were postmenopausal women , initiating a treatment with ib and ronate 150 mg monthly . They were blinded to the study hypotheses and outcome . The outcome was the proportion of patients persistent at 1-year visit . RESULTS Eighty-eight physicians were r and omized in group A and included 346 patients , 75 in group B included 250 patients . The persistence at 1-year was high and not different between the two groups ( 75.1 and 74.8 % P=0.932 ) . There was no difference in the proportion of persistent patients according to the message delivered in the group of patient with CTX information : 77.4 and 74.8 % in patients with a suboptimal or positive message respectively . CONCLUSION This study failed to demonstrate that supporting monitoring of CTX could improve persistence to ib and ronate treatment in postmenopausal osteoporosis . KEY MESSAGES Persistence is a strong determinant of anti-osteoporotic treatments efficacy . Monitoring of bone markers is not a mean to improve persistence of an oral bisphosphonate . There is a discrepancy between levels of persistence in clinical studies and real life This study investigates the impact of measuring adherence and providing feedback on medication usage by children with unstable asthma . Adherence was measured using an electronic monitoring device . Subjects were r and omized to either being told of their adherence during review consultations or for their adherence to remain undisclosed to their parents and treating physician . \n Output:\n " }, { "from": "agent", "value": "Across nine studies , we observed little or no evidence that provision of feedback to physicians regarding their patients adherence to prescribed medication improved medication adherence , patient outcomes , or health re source use .\nFeedback about medication adherence may improve processes of care , but due to the small number of studies assessing this outcome and high risk of bias , we can not draw firm conclusions on the effect of feedback on this outcome ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The cause of pancreatitis is unknown in as many as 30 % of cases of recurrent acute pancreatitis , even after ERCP . OBJECTIVE To investigate the role of intraductal US ( IDUS ) for managing idiopathic recurrent pancreatitis ( IRP ) . DESIGN Prospect i ve study . SETTING Tertiary referral hospital . PATIENTS Thirty-one patients with suspicious IRP with negative findings on ERCP . INTERVENTIONS IDUS during ERCP . MAIN OUTCOME MEASUREMENTS IDUS findings showing any possible cause of pancreatitis . RESULTS IDUS revealed small bile duct stones ( ≤3 mm ) in 5 patients ( 16.1 % ) and sludge in 3 patients ( 9.7 % ) . The detection rate for a bile duct stone and sludge was significantly higher in patients with a dilated CBD than a nondilated CBD on ERCP ( 71.4 vs 12.5 % ; P < .05 ) . Recurrent pancreatitis did not develop in 7 of 8 patients with biliary stones or sludge after an endoscopic sphincterotomy ( EST ) . Two patients ( 6.5 % ) demonstrated a small polypoid lesion on the distal end of the pancreatic duct . One patient underwent surgery for intra-ampullary cancer , and another one underwent EST without another attack of pancreatitis . Three patients ( 9.7 % ) showed evidence of chronic pancreatitis with small pancreatic stones and /or calcifications on IDUS . LIMITATIONS Small number of patients . IDUS results were not compared with those of conventional EUS . There was no reference st and ard for chronic pancreatitis as diagnosed by IDUS . CONCLUSIONS IDUS identified a possible cause of idiopathic recurrent pancreatitis in 42 % of patients with negative findings on ERCP . The IDUS-guided approach combined with ERCP and EST may be useful for decreasing recurring attacks of pancreatitis BACKGROUND The aim of this study was to evaluate the use of endoscopic ultrasonography ( EUS ) in detecting occult cholelithiasis and determining a probable etiology in patients classified as having idiopathic pancreatitis by conventional radiologic methods . METHODS A prospect i ve study was performed in 89 consecutive patients with acute pancreatitis . Transcutaneous ultrasonography ( US ) , CT , or both was performed on all patients within 24 hours of admission . Endoscopic retro grade cholangiopancreatography ( ERCP ) was performed in all patients with confirmed or suspected biliary pancreatitis . EUS was performed in patients classified as having idiopathic pancreatitis . RESULTS Cholelithiasis was identified in 64 patients ( 72 % ) by conventional radiologic methods . Eighteen patients ( 20 % ) were classified as having idiopathic pancreatitis after evaluation by US ( all 18 patients ) , repeated US ( 9 patients ) , CT ( 6 patients ) and ERCP ( 13 patients ) . EUS performed in these 18 patients revealed small gallbladder stones ( 1 to 9 mm ) in 14 patients ; 3 were found to have concomitant choledocholithiasis . All stones were confirmed by subsequent ERCP and cholecystectomy . The remaining 4 patients in whom no etiology was identified had no clinical or radiologic evidence of cholelithiasis at a median follow-up of 22 months . CONCLUSION Cholelithiasis is detected by EUS in a large number of patients classified as having idiopathic pancreatitis by conventional radiologic examinations . With identification of a biliary cause of acute pancreatitis , treatment can be initiated early , thereby reducing the risk of recurrent pancreatitis with its associated morbidity and mortality . EUS is a valuable diagnostic modality in the management of patients with acute pancreatitis BACKGROUND Alcohol and gallstone are the 2 most common etiologies of acute pancreatitis ( AP ) . In Thail and , alcohol has been believed to be the leading etiology of AP . However , a thorough and systematic search may discover real etiology of AP . MATERIAL AND METHOD During 2006 to 2007 , seventy-eight patients with AP were prospect ively search ed for the etiology by : 1 . Performing liver chemistry tests and transabdominal ultrasonography ( US ) for gallstone in every case ; 2 . Measuring serum triglyceride and calcium in every case ; 3 . Investigating definite drugs use or other identified etiology ; 4 . Asking about the amount of alcohol ingestion ( amount > 80 g/day for > 5 years was required for alcoholic AP ; 5 . Performing CT scan ( if age > 40 years ) and EUS if no etiology was identified . Results were compared with the retrospective data from medical records of 66 AP patients during 2003 - 2005 . RESULTS Of the 78 patients , the etiologies were alcohol in 32 ( 41 % ) , gallstones in 29 ( 37 % ) , miscellaneous in 13 ( 17 % ) and idiopathic AP in 4 patients ( 5 % ) . When compared with the retrospective data of the 66 patients over the past 3 years , the etiologies were alcohol 53 % , gallstone 22 % , miscellaneous 11 % and idiopathic 14 % . Among the 45 patients of the study period ( 58 % ) who consumed alcohol more than the defined threshold for alcoholic AP , 13 ( 29 % ) were found to have other explainable causes of AP , i.e gallstones in 10 , hypertriglyceridemia in 2 and AIDS cholangiopathy in 1 patient . CONCLUSION Alcohol was probably over-diagnosed as a leading etiology of AP in the past . A systematic search of the etiologies lowered the frequency of alcoholic and idiopathic AP but discovered more patients with gallstone pancreatitis . One-fourth of AP patients who were heavy drinkers had other explainable etiologies of AP Background The efficacy of endoscopic ultrasonography ( EUS ) to diagnose idiopathic acute pancreatitis has been demonstrated but that of magnetic-resonance cholangiopancreatography ( MRCP ) remains unclear . Aims The aim of our study was to prospect ively compare the results of EUS and MRCP to diagnose idiopathic acute pancreatitis when performed later after an acute attack . Methods All patients admitted to our center for acute pancreatitis over a 2-year period received first-line investigations that included medical history , st and ard biological measurements , abdominal ultrasound , and computerized tomography . If no etiology was found , second-line investigations were scheduled at 2 months ( or more if there was severe pancreatitis ) , which included clinical examinations , biological parameters , EUS , and MRCP . Results A total of 128 consecutive patients were included ( male : 80 , mean age : 55.3 years ) . After first-line investigations , 41 patients with idiopathic acute pancreatitis underwent second-line investigations and were followed-up ( 38 patients had both EUS and MRCP ) . EUS and /or MRCP led to recognize a possible etiology of pancreatitis in 19 patients ( 50 % ) . The diagnostic yield for EUS was higher than for MRCP ( 29 vs. 10.5 % ) . EUS more accurately detected biliary stones whereas MRCP identified pancreatic duct abnormalities , such as intraductal papillary mucinous neoplasm of the pancreas or chronic pancreatitis . Conclusions The combination of EUS and MRCP , when performed later after idiopathic acute pancreatitis , revealed 50 % of etiologies . The association of these two procedures and the subsequent follow-up reduced the rate of idiopathic pancreatitis by ~66 % PURPOSE No underlying cause is found in as many as 30 % of patients with acute pancreatitis . The aim of this study was to evaluate the usefulness of endoscopic ultrasonography in the diagnosis of biliary tract pathology or chronic pancreatitis in these patients . SUBJECTS AND METHODS We evaluated 168 patients who were referred with idiopathic pancreatitis . Diagnoses obtained by endoscopic ultrasonography were prospect ively compared with those obtained at surgery in 101 patients , by endoscopic cholangiopancreatography in 49 patients , or by bile crystal analysis and medical follow-up in 18 patients . RESULTS Endoscopic ultrasonography was abnormal in 135 ( 80 % ) patients , 124 of whom had biliary tract disease . When the results of endoscopic ultrasonography were compared with those made after multidisciplinary investigations , endoscopic ultrasonography correctly identified the cause-most commonly biliary tract disease-of the \" idiopathic \" pancreatitis in 155 ( 92 % ) of the 168 patients . CONCLUSIONS Endoscopic ultrasonography is valuable in determining the cause of acute pancreatitis in patients initially considered to have idiopathic pancreatitis OBJECTIVES New modalities , namely , endoscopic ultrasonography ( EUS ) , magnetic resonance cholangiopancreatography ( MRCP ) , and helical computed-tomographic cholangiography ( HCT-C ) , have been introduced recently for the detection of common bile duct ( CBD ) stones and shown improved detectability compared to conventional ultrasound or computed tomography . We conducted this study to compare the diagnostic ability of EUS , MRCP , and HCT-C in patients with suspected choledocholithiasis . METHODS Twenty-eight patients clinical ly suspected of having CBD stones were enrolled , excluding those with cholangitis or a definite history of choledocholithiasis . Each patient underwent EUS , MRCP , and HCT-C prior to endoscopic retro grade cholangio-pancreatography ( ERCP ) , the result of which served as the diagnostic gold st and ard . RESULTS CBD stones were detected in 24 ( 86 % ) of 28 patients by ERCP/IDUS . The sensitivity of EUS , MRCP , and HCT-C was 100 % , 88 % , and 88 % , respectively . False negative cases for MRCP and HCT-C had a CBD stone smaller than 5 mm in diameter . No serious complications occurred while one patient complained of itching in the eyelids after the infusion of contrast agent on HCT-C. CONCLUSIONS When examination can be scheduled , MRCP or HCT-C will be the first choice because they were less invasive than EUS . MRCP and HCT-C had similar detectability but the former may be preferable considering the possibility of allergic reaction in the latter . When MRCP is negative , EUS is recommended to check for small CBD stones Objectives : The objectives of the study were to compare endoscopic ultrasonography ( EUS ) and magnetic resonance cholangiopancreatography ( MRCP ) in the etiological diagnosis of patients initially diagnosed with idiopathic acute pancreatitis and to determine the clinical and analytical factors related to the end result of these techniques . Methods : Forty-nine patients , initially diagnosed with idiopathic acute pancreatitis , were evaluated prospect ively with EUS and MRCP . Diagnoses were compared between the 2 procedures . The clinical -evolutionary characteristics of these patients with regard to the results obtained with these techniques were compared . Results : In twenty-eight patients ( 57 % ) , EUS and /or MRCP diagnosed at least 1 possible cause of acute pancreatitis . The diagnostic yield of EUS was higher than that of MRCP ( 51 % vs 20 % ; P = 0.001 ) . Cholelithiasis and biliary sludge ( 24 % ) were the most frequent EUS diagnoses , and pancreas divisum ( 8 % ) was the most frequent MRCP diagnosis . Only in 3 cases ( 6 % ) did MRCP identify additional features in patients etiologically undiagnosed using EUS . The EUS yield was lower in patients who had a previous cholecystectomy ( 11 % vs 60 % ; P = 0.008 ) . Conclusions : Endoscopic ultrasonography and MRCP are useful techniques in the etiological diagnosis of acute pancreatitis of nonestablished cause . Endoscopic ultrasonography should be preferred for establishing a possible biliary etiology in patients who have not had a cholecystectomy Gallstone pancreatitis is usually related to small stones , which may not be detected by conventional cholecystographic techniques . In the current study , it was hypothesized that some patients with acute pancreatitis of unknown cause could harbor occult microstones in the gallbladder . Therefore , evidence was sought prospect ively of missed gallstones by biliary drainage and microscopic examination of centrifuged duodenal bile in 51 patients recovering from an attack of acute pancreatitis , including 24 patients with relapsing episodes . Clusters of cholesterol monohydrate crystals , calcium bilirubinate granules , and /or CaCO3 microspheroliths were found in 67 % of the patients . Biliary drainage showed no abnormal findings in 12 patients convalescing from a bout of known alcoholic pancreatitis . Examination of gallbladder bile at cholecystectomy and /or serial ultrasonography of the gallbladder for up to 12 months showed that 73 % of the patients with unexplained pancreatitis had biliary sludge or microlithiasis ; the prior finding of biliary crystal/solid markers predicted their existence with both a sensitivity and a specificity of 86 % and a \n Output:\n " }, { "from": "agent", "value": "EUS more accurately detected biliary stones , whereas magnetic resonance cholangiopancreatography more often identified pancreatic duct abnormalities .\nThe yield of EUS was lower in patients postcholecystectomy but was not influenced by gender , severity of pancreatitis , or recurrent disease ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To evaluate the effectiveness and tolerability of pregabalin in the management of the discontinuation of benzodiazepines in long-term users . SUBJECTS AND METHODS We performed a 12-week , prospect i ve , uncontrolled , non-interventional , and observational study in patients aged 18 years old or above , who met DSM-IV-TR criteria for benzodiazepine dependence without other major psychiatry disorder . Evaluations included the Benzodiazepine Withdrawal Symptom Question naire , the Hamilton Anxiety Rating Scale , the Clinical Global Impression Scale , and the Sheehan Disability Scale . A urine drug screen for benzodiazepines was performed at baseline and every 4 weeks thereafter . The primary effectiveness variable was success rate , defined as achievement of benzodiazepine-free status at week 12 according to the urine drug screen . RESULTS AND DISCUSSION The mean dose at week 12 was 315 ( ±166 ) mg/day . The success rate of the benzodiazepine taper in the primary efficacy population ( n=282 ) was 52 % ( 95 % confidence interval [ CI ] , 46 - 58 ) . Success rates for women and men were 58 % ( 95 % CI , 49 - 67 ) and 46 % ( 95 % CI , 38 - 55 ) , respectively . The success rates did not differ according to either the benzodiazepine of abuse or the presence of other substance use disorders . Significant and clinical ly relevant improvements were observed in withdrawal and anxiety symptoms , as well as in patients ' functioning . At week 12 , tolerability was rated as good or excellent by 90 % and 83 % of the clinicians and patients , respectively . CONCLUSION Our results suggest that pregabalin is an efficacious and well-tolerated adjunctive treatment for benzodiazepine withdrawal Chronic normal-dose benzodiazepine users requesting drug withdrawal were allocated to substitution with either the new anxiolytic alpidem ( n = 13 ) or placebo ( n = 12 ) . During the first 2 weeks of the tapering programme , the dose of benzodiazepine was kept constant ; for the next 2 weeks it was halved and half-dose alpidem ( 25 mg twice daily ) or placebo substituted ; for weeks 5 and 6 , the benzodiazepine was discontinued and full-dose alpidem or placebo given ; next alpidem or placebo were tapered to half-dose and then finally discontinued . Regular anxiety and tranquillizer withdrawal ratings were made . Nine of 12 patients given placebo withdrew successfully compared with four of 13 alpidem-treated patients . Anxiety and other symptom levels increased in the alpidem but not the placebo patients . It was concluded that alpidem is not helpful in helping patients withdrawing from a benzodiazepine withdrawal perhaps because of partial agonist properties . These actions may imply a lesser propensity to induce dependence on long-term use Abstract Twenty-four volunteers ( 19 women and five men ) with insomnia and a history of chronic use of benzodiazepine hypnotics participated in a r and omized , double blind , controlled clinical trial . The study was design ed to assess the effects of substituting zopiclone ( ZOP ) – as an hypnotic – among chronic users of flunitrazepam ( FLU ) , and to compare the subsequent withdrawal of ZOP with placebo controlled withdrawal of FLU . During the 5 weeks of a withdrawal protocol , sleep and physiological parameters were assessed by polysomnographic measures for 11 nights and by nightly actigraphic recordings for weeks 1 , 3 , and 5 . Subjective effects of the withdrawal process were evaluated with daily sleep diaries , and with various weekly self-report symptom checklists . Paired t-tests performed on differences in objective sleep parameters between baseline and the last weeks of the withdrawal program showed a significant decrease in sleep quality within the FLU group , but not in the ZOP group . Subjective sleep diaries consistently reflected the objective ly measured changes in sleep throughout the withdrawal program , indicating significant changes in sleep parameters only in the FLU group . The results obtained from the self report inventories aim ed at assessing withdrawal symptoms , however , revealed no differences between the baseline week and the termination week of the program in any of the groups . After completing the pharmacological withdrawal , all subjects received a short-term cognitive behavioral intervention focused on improving their coping strategies with symptoms of insomnia ; they were evaluated immediately after concluding the intervention , and at 3 and 12 month follow-ups Objective To evaluate the association between use of benzodiazepines and incident dementia . Design Prospect i ve , population based study . Setting PAQUID study , France . Participants 1063 men and women ( mean age 78.2 years ) who were free of dementia and did not start taking benzodiazepines until at least the third year of follow-up . Main outcome measures Incident dementia , confirmed by a neurologist . Results During a 15 year follow-up , 253 incident cases of dementia were confirmed . New use of benzodiazepines was associated with an increased risk of dementia ( multivariable adjusted hazard ratio 1.60 , 95 % confidence interval 1.08 to 2.38 ) . Sensitivity analysis considering the existence of depressive symptoms showed a similar association ( hazard ratio 1.62 , 1.08 to 2.43 ) . A secondary analysis pooled cohorts of participants who started benzodiazepines during follow-up and evaluated the association with incident dementia . The pooled hazard ratio across the five cohorts of new benzodiazepine users was 1.46 ( 1.10 to 1.94 ) . Results of a complementary nested case-control study showed that ever use of benzodiazepines was associated with an approximately 50 % increase in the risk of dementia ( adjusted odds ratio 1.55 , 1.24 to 1.95 ) compared with never users . The results were similar in past users ( odds ratio 1.56 , 1.23 to 1.98 ) and recent users ( 1.48 , 0.83 to 2.63 ) but reached significance only for past users . Conclusions In this prospect i ve population based study , new use of benzodiazepines was associated with increased risk of dementia . The result was robust in pooled analyses across cohorts of new users of benzodiazepines throughout the study and in a complementary case-control study . Considering the extent to which benzodiazepines are prescribed and the number of potential adverse effects of this drug class in the general population , indiscriminate widespread use should be caution ed against Withdrawal from hypnotics can produce a variety of problems , especially sleep difficulties , some of which may arise from the multiple actions of most hypnotics , thus producing a range of rebound effects . This study examined whether switching patients to a hypnotic with a narrower range of action and of a different class would reduce these problems . One hundred and thirty-four patients participated ; they were r and omly allocated to one of three methods of switching from \" previous hypnotic \" to zopiclone ( a cyclopyrrolone ) . The methods were gap ( an interval between taking the two drugs ) ; abuttal ( taking zopiclone immediately on stopping previous drug ) ; and overlap ( gradually reducing previous drug after starting zopiclone ) . The main findings were that zopiclone was associated with better sleep and increased alertness ; the abuttal method was the best method of switching ; and no serious side effects from zopiclone were reported . It was concluded that zopiclone has a useful role in benzodiazepine withdrawal , and that immediate substitution is the best method ABSTRACT Background : Benzodiazepine use disorders are a common clinical problem among methadone maintenance treatment patients and have adverse effects on clinical outcomes . Objectives : To evaluate gabapentin for the outpatient treatment of benzodiazepine abuse or dependence in methadone maintenance patients . Methods : Participants ( n = 19 ) using benzodiazepines at least 4 days per week were enrolled into an 8-week r and omized double-blind placebo-controlled outpatient pilot trial . All participants received a manual-guided supportive psychotherapy aim ed to promote abstinence . Study medication was titrated over a 2-week period to a maximum dose of gabapentin 1200 mg or placebo three times a day . Benzodiazepine use was assessed using urine toxicology confirmed self-report . Benzodiazepines were not provided as part of study participation ; participants were provided guidance to gradually reduce benzodiazepine intake . Results : Sixteen participants had post-r and omization data for analysis . Retention at week eight was 50 % . The mean dose of gabapentin achieved by titration was 2666 mg/day ( SD = ± 1446 ) . There were no significant between group differences on benzodiazepine use outcomes ( amount benzodiazepine per day [ Mann-Whitney U = 27 , p = 0.745 ] , abstinent days per week [ U = 28 , p = 0.811 ] ) and Clinical Instrument Withdrawal Assessment (CIWA)-benzodiazepines scale ( U = 29.0 , p = 0.913 ) . One participant in the gabapentin group discontinued study medication because of peripheral edema . Two participants in the placebo group requested admission for inpatient detoxification treatment . Conclusion : In outpatient methadone-maintained patients with benzodiazepine use disorder , gabapentin did significantly decrease benzodiazepine use relative to placebo . The small sample recruited for this trial may have limited the ability to detect a group difference Ten long-term users of benzodiazepines ( average daily dose , 20 mg of diazepam or equivalent ) who had experienced problems in withdrawing from the drugs were given an i.v . challenge with either the benzodiazepine antagonist flumazenil ( 1 mg injected over 30 s ) or placebo ( vehicle solution ) in a r and omized double-blind design . There were no ' pseudo withdrawal ' responses to either single-blind or double-blind placebo injections , whereas flumazenil produced dramatic panic reactions in all four subjects tested , followed by characteristic benzodiazepine withdrawal symptoms . There were also small but significant rises in pulse rate and blood pressure , but no change in serum cortisol . Flumazenil-induced panic could not be entirely accounted for by a past or present diagnosis of panic disorder , and did not seem to be related to previous withdrawal problems , present benzodiazepine dosage , or to the severity of withdrawal symptoms precipitated by flumazenil in the same challenge test . Attempts to reduce benzodiazepine intake over the next 3 weeks tended to be more successful in the flumazenil group . The results are discussed with reference to possible changes in the GABA-benzodiazepine system in long-term benzodiazepine users Objectives . We assessed if prolonged-release melatonin can facilitate withdrawal of long-term benzodiazepine usage in patients with schizophrenia or bipolar disorder . Methods . R and omised , placebo-controlled , blinded , parallel superiority trial of 24 weeks duration . Participants were r and omised to prolonged-release melatonin 2 mg daily versus matching placebo and were continuously guided to gradually reduce their usual benzodiazepine dosage . The primary outcome was mean benzodiazepine daily dosage at 24 weeks . Secondary outcomes included pattern of benzodiazepine dosage over time , benzodiazepine cessation proportion , and benzodiazepine withdrawal symptoms . Results . In total , 86 patients ( 21–74 years ) were enrolled : 42 were r and omised to melatonin versus 44 to placebo . We found no significant effect of melatonin on mean benzodiazepine dosage at 24 weeks ( melatonin group 8.01 mg versus placebo group 5.72 mg diazepam equivalents ; difference between means –2.29 ; 95 % CI –5.78 to 1.21 ; P = 0.20 ) . Benzodiazepine cessation proportion was 38.1 % ( 16/42 ) in the melatonin group versus 47.7 % ( 21/44 ) in the placebo group ( OR 0.64 ; 95 % CI 0.26 to 1.56 ; P = 0.32 ) . Prolonged-release melatonin had no effect on benzodiazepine withdrawal symptoms . Conclusions . Benzodiazepine dosage was comparably low between the groups after 24 weeks of guided gradual dose reduction . In this context , prolonged-release melatonin did not seem to further facilitate benzodiazepine discontinuation Since recent research has suggested that the major metabolites of progesterone are barbiturate-like modulators of GABAergic function , we undertook a pilot study of the efficacy of micronized progesterone in attenuating withdrawal and facilitating discontinuation in benzodiazepine-dependent patients with a minimum of 1 year of continuous daily use . Forty-three patients taking a mean daily dose of 16.2 mg of diazepam ( or its equivalent ) were assigned , double-blind , to treatment with either placebo ( n=13 ) or progesterone ( n=30 ) . Progesterone was titrated to a mean daily dose of 1983 mg , and was co-administered for 3 weeks , after which the benzodiazepine was tapered by 25 % per week . Progesterone ( or placebo ) was then continued for 4 weeks before being discontinued . There was no progesterone versus placebo difference \n Output:\n " }, { "from": "agent", "value": "Likewise , magnesium aspartate decreased the proportion of participants discontinuing benzodiazepines ( 1 study , 144 participants ; RR 0.80 , 95 % CI 0.66 to 0.96 ; NNTH 5.8 ; very low- quality evidence ) .Generally , adverse events were insufficiently reported .\nAUTHORS ' CONCLUSIONS Given the low or very low quality of the evidence for the reported outcomes , and the small number of trials identified with a limited number of participants for each comparison , it is not possible to draw firm conclusions regarding pharmacological interventions to facilitate benzodiazepine discontinuation in chronic benzodiazepine users ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : To assess the prevalence of urinary incontinence and associated vaginal squeeze pressure in primiparous women with and without previous gestational diabetes mellitus two years post-cesarean delivery . METHODS : Primiparous women who delivered by cesarean two years previously were interviewed about the delivery and the occurrence of incontinence . Incontinence was reported by the women and vaginal pressure evaluated by a Perina perineometer . Sixty-three women with gestational diabetes and 98 women without the disease were screened for incontinence and vaginal pressure . Multiple logistic regression models were used to evaluate the independent effects of gestational diabetes . RESULTS : The prevalence of gestational incontinence was higher among women with gestational diabetes during their pregnancies ( 50.8 % vs. 31.6 % ) and two years after a cesarean ( 44.8 % vs. 18.4 % ) . Decreased vaginal pressure was also significantly higher among women with gestational diabetes ( 53.9 % vs. 37.8 % ) . Maternal weight gain and newborn weight were risk factors for decreased vaginal pressure . Maternal age , gestational incontinence and decreased vaginal pressure were risk factors for incontinence two years after a cesarean . In a multivariate logistic model , gestational diabetes was an independent risk factor for gestational incontinence . CONCLUSIONS : The prevalence of incontinence and decreased vaginal pressure two years post-cesarean were elevated among women with gestational diabetes compared to women who were normoglycemic during pregnancy . We confirmed an association between gestational diabetes mellitus and a subsequent decrease of vaginal pressure two years post-cesarean . These results may warrant more comprehensive prospect i ve and translational studies In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Background Antenatal preparation programmes are recommended worldwide to promote a healthy pregnancy and greater autonomy during labor and delivery , prevent physical discomfort and high levels of anxiety . The objective of this study was to evaluate effectiveness and safety of a birth preparation programme to minimize lumbopelvic pain , urinary incontinence , anxiety , and increase physical activity during pregnancy as well as to compare its effects on perinatal outcomes comparing two groups of nulliparous women . Methods A r and omized controlled trial was conducted with 197 low risk nulliparous women aged 16 to 40 years , with gestational age ≥ 18 weeks . Participants were r and omly allocated to participate in a birth preparation programme ( BPP ; n=97 ) or a control group ( CG ; n=100 ) . The intervention was performed on the days of prenatal visits , and consisted of physical exercises , educational activities and instructions on exercises to be performed at home . The control group followed a routine of prenatal care . Primary outcomes were urinary incontinence , lumbopelvic pain , physical activity , and anxiety . Secondary outcomes were perinatal variables . Results The risk of urinary incontinence in BPP participants was significantly lower at 30 weeks of pregnancy ( BPP 42.7 % , CG 62.2 % ; relative risk [ RR ] 0.69 ; 95 % confidence interval [ CI ] 0.51 - 0.93 ) and at 36 weeks of pregnancy ( BPP 41.2 % , CG 68.4 % ; RR 0.60 ; 95%CI 0.45 - 0.81 ) . Participation in the BPP encouraged women to exercise during pregnancy ( p=0.009 ) . No difference was found between the groups regarding to anxiety level , lumbopelvic pain , type or duration of delivery and weight or vitality of the newborn infant . Conclusions The BPP was effective in controlling urinary incontinence and to encourage the women to exercise during pregnancy with no adverse effects to pregnant women or the fetuses . Trial registration Clinical trials.gov , ( NCT01155804 OBJECTIVE We have studied the effect of moderate physical activity that is performed by healthy women during their entire pregnancy on their perception of health status . STUDY DESIGN Eighty sedentary women were assigned r and omly to either an exercise group ( n = 40 ) or a control group ( n = 40 ) . Maternal perception of health status and several pregnancy outcomes were recorded . RESULTS Significant differences ( P = .03 ) were found between study groups in the percentage of women who perceived their health status as \" very good \" ; the values that corresponded to the exercise group ( n = 18 ; 54.5 % ) were better than those of the control group ( n = 9 ; 27.3 % ) . In addition , the women of the exercise group gained less weight ( 11,885 ± 3146 g ) than those of the control group ( 13,903 ± 2113 ; P = .03 ) . CONCLUSION A moderate physical activity program that is performed over the first , second , and third trimester of pregnancy improves the maternal perception of health status OBJECTIVE : To compare , in an unselected population of nulliparous pregnant women , the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence ( UI ) . METHODS : In a r and omized controlled trial in two parallel groups , 282 women were recruited from five university teaching hospitals in France and r and omized during the second trimester of pregnancy . The physiotherapy group received prenatal individually supervised exercises . Both groups received written instructions about how to perform exercises at home . Women were blindly assessed at baseline , end of pregnancy , and 2 and 12 months postpartum . The primary outcome measured was UI severity , assessed with an International Consultation on Incontinence Question naire-Urinary Incontinence Short Form score ( range 0–21 ; 1–5 is slight UI ) at 12 months postpartum ; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered question naires . To give a 1-point difference in UI severity score , we needed 91 women in each group ( st and ard deviation 2.4 , & agr;=0.05 , & bgr;=0.20 , and bilateral analysis ) . RESULTS : Between February 2008 and June 2010 , 140 women were r and omized in the physiotherapy group and 142 in the control group . No difference was observed between the two groups in UI severity , prevalence , or pelvic floor troubles at baseline , end of pregnancy , and at 2 and 12 months postpartum . At 12 months postpartum , the primary outcome was available for 190 women ( 67.4 % ) ; mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group ( P=.38 ) . CONCLUSION : Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov ; www . clinical trials.gov , NCT00551551 . LEVEL OF EVIDENCE : Background Stress urinary incontinence ( SUI ) is a prevalent and costly condition which may be treated surgically or by physical therapy . The aim of this review was to systematic ally assess the literature and present the best available evidence for the efficacy and effectiveness of pelvic floor muscle training ( PFMT ) performed alone and together with adjunctive therapies ( eg biofeedback , electrical stimulation , vaginal cones ) for the treatment of female SUI . Methods All major electronic sources of relevant information were systematic ally search ed to identify peer- review ed English language abstract s or papers published between 1995 and 2005 . R and omised controlled trials ( RCTs ) and other study design s eg non-r and omised trials , cohort studies , case series , were considered for this review in order to source all the available evidence relevant to clinical practice . Studies of adult women with a urodynamic or clinical diagnosis of SUI were eligible for inclusion . Excluded were studies of women who were pregnant , immediately post-partum or with a diagnosis of mixed or urge incontinence . Studies with a PFMT protocol alone and in combination with adjunctive physical therapies were considered . Two independent review ers assessed the eligibility of each study , its level of evidence and the method ological quality . Due to the heterogeneity of study design s , the results are presented in narrative format . Results Twenty four studies , including 17 RCTs and seven non- RCTs , met the inclusion criteria . The method ological quality of the studies varied but lower quality scores did not necessarily indicate studies from lower levels of evidence . This review found consistent evidence from a number of high quality RCTs that PFMT alone and in combination with adjunctive therapies is effective treatment for women with SUI with rates of ' cure ' and ' cure/improvement ' up to 73 % and 97 % respectively . The contribution of adjunctive therapies is unclear and there is limited evidence about treatment outcomes in primary care setting s. Conclusion There is strong evidence for the efficacy of physical therapy for the treatment for SUI in women but further high quality studies are needed to evaluate the optimal treatment programs and training protocol s in subgroups of women and their effectiveness in clinical practice We have studied the pelvic floor musculature and its innervation in 14 of 24 ( 58 per cent ) multiparous women who had been recruited into a study of the effect of childbirth on the pelvic floor as part of a prospect i ve investigation that began in 1983 . These 24 women had all delivered by the vaginal route without forceps assistance . Five of the 14 had developed clinical symptoms of stress incontinence 5 years later ; two of them had had a further uncomplicated vaginal delivery during this time . There was manometric and neurophysiological evidence of weakness because of partial denervation of the pelvic floor striated sphincter musculature , with pudendal neuropathy , which was more marked in those women with incontinence . These findings provide direct evidence for the hypothesis that pudendal neuropathy due to vaginal delivery persists and may worsen with time AIMS To investigate the effect of pelvic floor muscle training ( PFMT ) taught in a general exercise class during pregnancy on the prevention of urinary incontinence ( UI ) in nulliparous continent pregnant women . METHODS This was a unicenter two armed r and omized controlled trial . One hundred sixty-nine women were r and omized by a central computer system to an exercise group ( EG ) ( exercise class including PFMT ) ( n = 73 ) or a control group ( CG ) ( n = 96 ) . 10.1 % loss to follow-up : 10 from EG and 7 from CG . The intervention consisted of 70 - 75 sessions ( 22 weeks , three times per week , 55 - 60 min/session including 10 min of PFMT ) . The CG received usual care ( which included follow up by midwifes including information about PFMT ) . Questions on prevalence and degree of UI were posed before ( week 10 - 14 ) and after intervention ( week 36 - 39 ) using the International Consultation on Incontinence Question naire-Urinary Incontinence Short Form ( ICIQ-UI SF ) . RESULTS At the end of the intervention , there was a statistically significant difference in favor of the EG . Reported frequency of UI [ Never : CG : 54/60.7 % , EG : 60/95.2 % ( P < 0.001 ) ] . Amount of leakage [ None : CG : 45/60.7 % , EG : 60/95.2 % ( P < 0.001 ) ] . There was also a statistically significant difference in ICIQ-UI SF Score between groups after the intervention period [ CG : 2.7 ( SD 4.1 ) , EG : 0.2 ( SD 1.2 ) ( P < 0.001 ) ] . The estimated effect size was 0.8 . CONCLUSION PFMT taught in a general exercise class three times per week for at least 22 weeks , without former assessment of ability to perform a correct contraction was effective in primary prevention of UI in primiparous pregnant women AIM This article is a report of a study of the effects of a pelvic floor muscle exercise programme on the severity of stress urinary incontinence in pregnant women . BACKGROUND Pregnancy is main risk factor for the development of stress urinary incontinence . Stress urinary incontinence can be cured by pelvic floor muscle exercise which is a safe inexpensive treatment with no complications and does not require the use of instruments . METHODOLOGY A quasi-experimental study , pre-post test with \n Output:\n " }, { "from": "agent", "value": "When we analysed the data by whether women were continent or incontinent prior to the intervention , exercise was beneficial at preventing the development of UI in women with continence , but not effective in treating UI in women with incontinence .\nConclusion Prenatal exercise including PFMT reduced the odds and symptom severity of prenatal and postnatal UI .\nThis was the case for women who were continent before the intervention .\nAmong women who were incontinent during pregnancy , exercise training was not therapeutic" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE A recent theory of motivation ( PRIME theory ) has proposed that the formation of a ' non-smoker ' identity is necessary for long-term abstinence . This study aim ed to explore how a smoker 's sense of identity changes following smoking cessation . DESIGN This was a qualitative , semi-structured interview study with a purposive sample of individuals who had quit smoking . An interpretative phenomenological approach was taken to elicit in-depth accounts of the participants ' underst and ing of smoking , stopping , and maintaining abstinence . METHODS Ten participants who quit smoking with the support of a National Health Service ( NHS ) stop-smoking service in Engl and and were still abstinent a year later were interviewed . An interpretative phenomenological analysis of the interview transcripts was conducted . Prospect i ve context ual detail of motivational and other variables pre-quit were also obtained from the clinic assessment form that participants completed at the first group session . RESULTS A process of identity change was observed towards that of a ' non-smoker ' , assisted initially by a transient identity of ' team stop-smoker ' accompanied by a sense of achievement . All participants retained a residual attraction to smoking suggesting that the process was not complete and reflecting an ' ex-smoker ' identity . Participants labelled themselves as non-smokers regardless of how much transition had occurred . CONCLUSIONS It appears useful to distinguish two levels of ' non-smoker ' identity : a surface level comprising the simple label and a deep level made up of often conflicting thoughts and feelings about oneself in relation to smoking . A total coherent ' non-smoker ' identity does not appear to be necessary for long-term abstinence An intrinsic-extrinsic model of motivation for smoking cessation was evaluated with 2 sample s ( ns = 1.217 and 151 ) of smokers who requested self-help material s for smoking cessation . Exploratory and confirmatory principal components analysis on a 36-item Reasons for Quitting ( RFQ ) scale supported the intrinsic-extrinsic motivation distinction . A 4-factor model , with 2 intrinsic dimensions ( concerns about health and desire for self-control ) and 2 extrinsic dimensions ( immediate reinforcement and social influence ) , was defined by 20 of the 36 RFQ items . The 20-item measure demonstrated moderate to high levels of internal consistency and convergent and discriminant validity . Logistic regression analyses indicated that smokers with higher levels of intrinsic relative to extrinsic motivation were more likely to achieve abstinence from smoking OBJECTIVE To assess whether perceived changes in postpartum support were associated with postpartum return to smoking . STUDY DESIGN This is a prospect i ve repeated measures , mixed methods observational study . Sixty-five women who smoked prior to pregnancy were recruited at delivery and surveyed at 2 , 6 , 12 , and 24 weeks postpartum ; in-depth interviews were conducted when participants reported smoking . RESULTS Fifty-two percent self identified as White , non-Hispanic . Forty-seven percent resumed smoking by 24 weeks postpartum . Women who had returned to smoking by 24 weeks had a significantly larger decrease in perceived smoking-specific support than women who remained abstinent ( p<0.001 ) . By 24-week postpartum follow-up , only 24 % of women reported that an obstetric clinician had discussed how to quit/stay quit . When qualitatively interviewed , more than half of women reported having no one to support them to stay quit or quit smoking . CONCLUSION Following delivery , women lack needed smoking-specific support . Decline in perceived smoking-specific support from family and friends is associated with postpartum smoking resumption A significant proportion of women who self-quit smoking during pregnancy subsequently relapse to smoking post-partum . This study examined free-text responses describing attributions of smoking relapse or maintained abstinence at 1 , 8 , and 12 months post-partum . This study reports secondary analyses from a r and omized clinical trial ( N = 504 ) for preventing post-partum smoking relapse . At each follow-up , one survey item asked the participant to describe why she resumed smoking or what helped her maintain abstinence . A thematic content analysis was conducted on responses from the 472 participants ( 94.0 % of the original sample ) who returned at least 1 survey . Content analyses revealed several themes for participants ’ reasons for relapse and abstinence . Stress was the most frequently cited reason for smoking relapse across all follow-ups . Health concerns for children and family was the most common reason provided for remaining abstinent . Chi square analyses revealed differences in written responses related to income , age , and depressive symptoms . Overall , these findings suggest that during the post-partum period , stress and familial health concerns are perceived contributors to smoking relapse and abstinence , respectively . These results confirmed key risk and protective factors that have been identified through other assessment modalities ( e.g. , quantitative surveys and focus groups ) . They also provide support for targeting these variables in the development , content , and delivery of future post-partum smoking relapse-prevention interventions . The high response rate to these open-ended attribution questions suggests that future studies would benefit from including these and similar items to allow for additional insight into participant perspectives AIMS To investigate associations between maternal stress and smoking prior to , during and 6 months after the pregnancy . DESIGN A prospect i ve population -based cohort study . SETTING Norway . PARTICIPANTS A total of 71 757 women in the Norwegian Mother and Child Cohort Study ( MoBa ) participating twice during pregnancy and at 6 months postpartum . MEASUREMENTS Respondents ' estimates of anxiety and depression , relationship discord and negative life events were measured , along with self-reports of smoking behaviour and demographic variables . Smoking was assessed at gestation weeks 17 and 30 and at 6 months postpartum . FINDINGS Of the 27.5 % women who smoked at conception , 55.8 % quit smoking during pregnancy . At 6 months postpartum , 28.9 % of quitters had relapsed to smoking . In total , 12.9 % of the sample reported smoking during the pregnancy . Adjusted for well-known risk factors , women reporting high levels of anxiety and depression had a decreased likelihood of quitting smoking during pregnancy [ odds ratio ( OR ) 0.80 , 95 % confidence interval ( CI ) : 0.73 , 0.88 ) and an increased likelihood of relapsing after delivery ( OR 1.26 , 95 % CI : 1.11 , 1.44 ) . Both relationship discord ( OR 0.82 , 95 % CI : 0.75 , 0.90 ) and exposure to negative life events ( OR 0.93 , 95 % : CI 0.90 , 0.96 ) had a negative influence on quitting smoking during pregnancy but had no influence on relapse to smoking postpartum . CONCLUSIONS Maternal stress and relationship discord may inhibit smoking cessation during pregnancy and promote resumption of smoking after pregnancy in women who have achieved abstinence OBJECTIVE Motivation plays an important role in a variety of behaviors , including smoking cessation , and is integral to theory and treatment of smoking . For many women , pregnancy offers a motivational shift that helps them stop smoking and maintain abstinence during pregnancy . However , women 's motivation to maintain smoking abstinence postpartum is not well-understood and may play a role in high postpartum relapse rates . The current study utilized multiple measures of prepartum motivation to maintain smoking abstinence to predict postpartum smoking abstinence . METHODS As part of a r and omized clinical trial on postpartum smoking relapse prevention , pregnant women who quit smoking during pregnancy reported their motivation to continue smoking abstinence at a prepartum baseline session . Biochemically verified continued smoking abstinence was assessed at 8 and 26 weeks postpartum . RESULTS Direct relationships among multiple measures of motivation were significant , and ranged in strength from weak to moderate . All motivation measures individually predicted continuous smoking abstinence , after controlling for treatment group , demographics , and prequit tobacco use . When tested simultaneously , a global motivation measure and parenthood motives for quitting remained significant predictors of abstinence . Backward selection modeling procedures result ed in a reduced model of prepartum predictors of postpartum abstinence including global motivation , parenthood motives , and stage of change . CONCLUSIONS Global motivation for smoking abstinence and parenthood motives for quitting are particularly important motivational constructs for pregnant women 's continued smoking abstinence INTRODUCTION The aim of this prospect i ve repeated measures , mixed- methods observational study was to assess whether depressive , anxiety , and stress symptoms are associated with postpartum relapse to smoking . METHODS A total of 65 women who smoked prior to pregnancy and had not smoked during the last month of pregnancy were recruited at delivery and followed for 24 weeks . Surveys administered at baseline and at 2 , 6 , 12 , and 24 weeks postpartum assessed smoking status and symptoms of depression ( Beck Depression Inventory [ BDI ] ) , anxiety ( Beck Anxiety Inventory [ BAI ] ) , and stress ( Perceived Stress Scale [ PSS ] ) . In-depth interviews were conducted with women who reported smoking . RESULTS Although 92 % of the participants reported a strong desire to stay quit , 47 % resumed smoking by 24 weeks postpartum . Baseline factors associated with smoking at 24 weeks were having had a prior delivery , not being happy about the pregnancy , undergoing counseling for depression or anxiety during pregnancy , and ever having struggled with depression ( p < .05 ) . In a repeated measures regression model , the slope of BDI scores from baseline to the 12-week follow-up differed between nonsmokers and smokers ( -0.12 vs. + 0.11 units/week , p = .03 ) . The slope of PSS scores also differed between nonsmokers and smokers ( -0.05 vs. + 0.08 units/week , p = .04 ) . In qualitative interviews , most women who relapsed attributed their relapse and continued smoking to negative emotions . DISCUSSION Among women who quit smoking during pregnancy , a worsening of depressive and stress symptoms over 12 weeks postpartum was associated with an increased risk of smoking by 24 weeks OBJECTIVE To evaluate the efficacy of a brief smoking cessation intervention with pregnant women practicable routinely by midwives . DESIGN Midwives were r and omized to deliver the experimental intervention or usual care . The 10 - 15-minute intervention was based on brief counselling , written material s , arrangements for continuing self-help support and feedback on expired-air carbon monoxide levels . The intervention was tailored to the women 's needs : those who did not want to stop smoking received a brief motivational intervention , those who wanted to stop received an intervention design ed to assist them and those that had stopped recently ( recent ex-smokers ) received a relapse prevention intervention . SETTING Booking interviews with pregnant women in nine hospital and community trusts . SUBJECTS A total of 1120 pregnant women in the third month of pregnancy ( 249 recent ex-smokers and 871 current smokers ) . MAIN OUTCOME MEASURES Three indicators of biochemically vali date d abstinence were collected . Continuous abstinence for at least 3 months prior to delivery , point prevalence abstinence immediately post-delivery , and continuous abstinence from 3 months pre-delivery to 6 months post-delivery . RESULTS Only a small proportion of the women who would have been eligible to take part in the trial were actually recruited by 178 recruiting midwives , with lack of time being cited as the main barrier . The intervention and usual care groups differed in post-delivery point prevalence abstinence rates for recent ex-smokers ( 65 % vs. 53 % , p < 0.05 , one-tailed ) , but not in other outcome measures . Overall , 54 % of \" recent ex-smokers \" at booking and 7 % of \" current smokers \" at booking had been abstinent for at least 3 months at the time of delivery , and 23 % and 3 % , respectively , were still abstinent by the time the child was 6 months old ( i.e. 12 months post-intervention ) . Smoking status at follow-up was predicted by dependence indexed by time to first cigarette in the morning . CONCLUSIONS A brief \" one-off \" smoking cessation intervention by midwives does not seem to be a practicable or effective method of helping pregnant smokers to stop . Other options such as tailored self-help material s and telephone counselling and other specialist treatments should be examined . Current smoking cessation rates in pregnancy are very low BACKGROUND The purpose of this study was to describe women 's smoking experience during pregnancy and postpartum . Primiparous women recruited during a r and omized controlled trial to assess the effectiveness of postpartum visiting were invited to participate in a qualitative study . METHODS A semistructured protocol guided the face-to-face interview . Interviews were audiotaped and transcribed . Data were coded independently by the authors , and the final coding system for emergent themes was developed through a consensus process . RESULTS Of the 47 women invited to participate , 22 agreed to be interviewed . Three major themes emerged from the analysis : pregnancy as a context for stopping smoking , returning to smoking , and social pressures on smoking behavior . Concerns about the baby 's health were cited as central reasons for stopping . Breastfeeding provided a reason for continued smoking cessation , whereas social events often demarcated a resumption of \n Output:\n " }, { "from": "agent", "value": "Factors affecting relapse and barriers and facilitators to relapse prevention were identified around the key themes of beliefs , social influences , motivation , physiological factors and identity .\nWomen 's beliefs about smoking as a means of coping with stress and the need for social support , especially from a partner , emerged as important .\nExtrinsic motivation to quit during the pregnancy ( for the health of the fetus ) appeared to be a factor in prompting relapse after the baby was born .\nDuring the immediate postpartum period women believed that physiological changes influence cigarette cravings .\nThe stress of caring for a newborn , sleeplessness and adjusting to a new mothering identity were also reported to be important .\nAmong women who quit smoking during pregnancy , those who relapse postpartum talk commonly about no longer needing to protect the baby and the effects of stress .\nPartner support and a sense of changed identity are cited as factors preventing relapse" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The optimal dose infusion of 0.125 % bupivacaine via a femoral catheter after total knee replacement ( TKR ) has not been defined . This study examined various dose infusions of bupivacaine to determine the analgesic quality in patients receiving a continuous femoral nerve block ( CFNB ) . Methods Patients were r and omized to receive a single-injection femoral nerve block ( SFNB ) or CFNB performed with 20 ml of 0.125 % bupivacaine , followed by a continuous infusion of 0.125 % bupivacaine in four groups ( n = 20 per group ) : 1 ) 0 ml/h ( SFNB ) , 2 ) 2 ml/h , 3 ) 4 ml/h , and 4 ) 6 ml/h . The pain intensity at rest and on knee movement was assessed using a visual analog scale ( VAS ) for the first 2 postoperative days . The cumulative bolus use of IV patientcontrolled analgesia ( PCA ) with a morphine-ketorolac combination was evaluated . Results A lower cumulative bolus of IV PCA was noted in all CFNB groups compared to SFNB on postoperative days ( PODs ) 1 and 2 , respectively ( P < 0.05 ) . Lower VAS scores at rest were observed in the 4 ml/h and 6 ml/h groups than in the SFNB group on PODs 1 and 2 , respectively , but only on POD 2 in the 2 ml/h group ( P < 0.05 ) . Lower VAS scores on movement were noted in the 4 ml/h than the SFNB group on PODs 1 and 2 , but only on POD 1 in 6 ml/h ( P < 0.05 ) . Conclusions The minimum effective infusion rate of 0.125 % bupivacaine for CFNB after TKR appears to be 4 ml/h according to the VAS pain scores Background : The authors tested the hypotheses that , compared with an overnight continuous femoral nerve block ( cFNB ) , a 4-day ambulatory cFNB increases ambulation distance and decreases the time until three specific readiness-for-discharge criteria are met after tricompartment total knee arthroplasty . Methods : Preoperatively , all patients received a cFNB ( n = 50 ) and perineural ropivacaine 0.2 % from surgery until the following morning , at which time they were r and omly assigned to either continue perineural ropivacaine or switch to perineural normal saline . Primary endpoints included ( 1 ) time to attain three discharge criteria ( adequate analgesia , independence from intravenous analgesics , and ambulation of at least 30 m ) and ( 2 ) ambulatory distance in 6 min the afternoon after surgery . Patients were discharged with their cFNB and a portable infusion pump , and catheters were removed on postoperative day 4 . Results : Patients given 4 days of perineural ropivacaine attained all three discharge criteria in a median ( 25th–75th percentiles ) of 25 ( 21–47 ) h , compared with 71 ( 46–89 ) h for those of the control group ( estimated ratio , 0.47 ; 95 % confidence interval , 0.32–0.67 ; P < 0.001 ) . Patients assigned to receive ropivacaine ambulated a median of 32 ( 17–47 ) m the afternoon after surgery , compared with 26 ( 13–35 ) m for those receiving normal saline ( estimated ratio , 1.21 ; 95 % confidence interval , 0.71–1.85 ; P = 0.42 ) . Conclusions : Compared with an overnight cFNB , a 4-day ambulatory cFNB decreases the time to reach three important discharge criteria by an estimated 53 % after tricompartment total knee arthroplasty . However , the extended infusion did not increase ambulation distance the afternoon after surgery . ( Clinical Trials.gov No. NCT00135889 . Although the analgesic effects of periarticular multimodal drug injection ( PMDI ) after TKA have been well documented , there is little information about additional pain relieving effects of PMDI incorporated to contemporary multimodal pain control protocol s which have been proved to provide excellent analgesia . We performed a parallel-group , r and omised , controlled study to determine whether PMDI provides additional clinical benefits on contemporary multimodal analgesic protocol s including preemptive analgesics , continuous femoral nerve block , and IV-PCA . Eighty-seven patients were r and omized to a PMDI group ( n=45 ) or to a No-PMDI group ( n=42 ) . Pain level and opioid consumption were compared as primary outcomes . The incidences of narcotic and ropivacaine related side effects and complications , functional recovery , and satisfaction were also compared . The PMDI group experienced less pain during the operation night and the 1st postoperative day and showed lower opioid consumption over 24h after surgery . However , the PMDI group had a higher VAS pain score on the 1st postoperative day than during the operation night . No group differences in side-effects and complication incidences , functional recovery , and satisfaction were found . This study demonstrates that PMDI provides additional pain relief and reduces opioid consumption only during the early postoperative period in patients managed by the contemporary pain management protocol following TKA STUDY OBJECTIVE To investigate the effects of single-injection femoral nerve block ( FNB ) in postoperative pain after total knee replacement ( TKR ) and anterior cruciate ligament ( ACL ) reconstruction . DESIGN Prospect i ve , r and omized , double-blind study . PATIENTS 96 ASA physical status I , II , and III patients , scheduled for TKR or ACL reconstruction . INTERVENTIONS All patients received a st and ard spinal anesthetic , then were r and omly divided into three treatment groups as follows : Group B ( n = 30 ) received an FNB with 40 mL of 0.25 % bupivacaine containing epinephrine , 1:200,000 ; Group R ( n = 32 ) received an FNB with 40 mL of 0.25 % ropivacaine ; and Group C ( n = 28 ) received no FNB . MEASUREMENTS The following clinical outcomes were assessed at up to 6 hours ( T1 ) , 6 to 10 hours ( T2 ) , and 10 to 24 hours ( T3 ) after spinal anesthesia was given : visual analog scale ( VAS ) for pain , both at rest and on movement ( no or mild pain , moderate pain , or severe pain ) ; morphine use ; sensory block in the femoral , obturator , and lateral femoral cutaneous nerve dermatomes ; and motor block of the femoral and obturator nerves . MAIN RESULTS Except for VAS during rest and on movement at time T3 , there were more Group C patients who experienced moderate or severe pain than those who had no pain or mild pain , when compared with Groups R and B. Sensory block in the femoral and lateral femoral cutaneous nerve dermatomes did not differ between Groups R and B at any times . However , sensory block in the obturator nerve dermatome was lower in Group R than Group B only at T3 . We observed a lower , significant use of morphine at T2 when comparing Groups R and B with Group C. No Group R patient and about 30 % of Group B patients remained with motor block of femoral and obturator nerves at T3 . Except for frequency of nausea , which was highest in Group C , the frequency of other side effects was similar among the three groups . CONCLUSIONS Femoral nerve block using 0.25 % ropivacaine or 0.25 % bupivacaine is an effective method of postoperative analgesia after TKR and ACL reconstruction , particularly for the first 10 hours after spinal anesthesia Total knee arthroplasty ( TKA ) may result in severe pain , and single-injection femoral nerve blocks ( SFNB ) have been demonstrated to have a limited duration of analgesia . Continuous femoral nerve blocks ( CFNB ) can prolong the analgesic duration of SFNB . We prospect ively r and omized 36 patients undergoing TKA to CFNB versus SFNB and evaluated the effect on hospital length of stay ( LOS ) as the primary outcome within a st and ardized clinical pathway . Secondary outcomes included visual analog scale ( VAS ) pain scores , opioid consumption , and long-term functional recovery at 12 wk . Mean VAS resting scores were significantly lower among patients who received CFNB versus SFNB : first day ( 1.7 vs 3.3 [ P = 0.002 ] ) and second day ( 0.9 vs 3.2 [ P < 0.0001 ] ) after surgery . Mean maximal VAS scores during physical therapy were significantly lower among patients who received CFNB versus SFNB : first day ( 4.7 vs 6.3 [ P = 0.01 ] ) and second day ( 3.9 vs 6.1 [ P = 0.0005 ] ) after surgery . Mean oxycodone consumption was significantly lower among patients who received CFNB versus SFNB : 15 mg versus 40 mg ( P = < 0.0001 ) on the first day after surgery ; 20 mg versus 43 mg ( P = 0.0004 ) on the second day after surgery . There was no difference in hospital LOS ( 3.8 vs 3.9 days ) or long-term functional recovery ( 117 ° versus 113 ° knee flexion at 12 wk ) between the two groups . The lack of effect provided by increased duration of analgesia ( from CFNB ) after TKA may now have minimal impact on hospital LOS and long-term functional recovery in the contemporary healthcare environment within the United States The objective of this prospect i ve , r and omized , double-blind study was to determine if preoperative administration of a femoral nerve block reduces the amount of morphine needed for postoperative analgesia after total knee arthroplasty ( TKA ) . Forty-two patients undergoing TKA were r and omly assigned to receive either a femoral nerve block ( 0.50 % bupivacaine hydrochloride with epinephrine 1:200,000 ) or matching placebo . Results showed postoperative morphine use was significantly lower in patients who received the nerve block ( 25.5 vs 37.5 mg , P = .016 ) ; however , the 2 groups had similar pain scores and rehabilitative outcomes . In general , a preoperative femoral nerve block is a safe and effective adjunct for decreasing morphine use for post-TKA analgesia Epidural analgesia remains the “ gold st and ard ” of pain relief after total knee replacement . However , peripheral nerve block is gaining popularity because the incidence of side effects may be reduced . Our study tests this postulate . Sixty patients were prospect ively r and omized to receive either epidural infusion or combined continuous femoral and sciatic nerve blocks . Ropivacaine 2 mg/mL plus sufentanil 1 & mgr;g/mL was given either epidurally or through the femoral nerve catheter , and ropivacaine 0.5 mg/mL was given through the sciatic nerve catheter using elastomeric infusers ( delivering 5 mL/h for 55 h ) . The primary outcome measure was the total incidence of side effects ( urinary retention and moderate to severe degrees of dizziness , pruritus , sedation , and nausea/vomiting on the first postoperative day ) . Intensity of motor blockade , pain at rest and on mobilization , and rehabilitation indices were also registered for 72 h. One or more side effects were present in 87 % of patients in the epidural group whereas only 35 % of patients in the femoral and sciatic block groups were affected on the first postoperative day ( P = 0.0002 ) . Motor blockade was more intense in the operated limb on the day of surgery and the first postoperative day in the peripheral nerve block group ( P = 0.001 ) , whereas the non-operated limb was more blocked in the epidural group on the day of surgery ( P = 0.0003 ) . Pain on mobilization was well controlled in both groups and there were no differences in the length of hospital stay . Rehabilitation indices were similar . The results demonstrate a reduced incidence of side effects in the femoral/sciatic nerve block group than in the epidural group on the first postoperative day Continuous femoral \" 3-in-1 \" nerve blocks are commonly used for analgesia after total knee arthroplasty ( TKA ) . There are conflicting data as to whether additional sciatic blockade is needed . Our routine use of both continuous femoral ( CFI ) and sciatic ( CSI ) peripheral nerve blocks was changed because of concerns that sciatic blockade , and its motor consequences in particular , might obscure diagnosis of perioperative sciatic nerve injury . The revised protocol includes placing single-shot blocks and perineural catheters at both sites , but infusing local anesthetic postoperatively only in the CFI . CSI is reserved for patients having poorly controlled posterior knee or calf pain . A sample group of 12 patients treated with this protocol was followed . Ten of 12 patients required use of the CSI . Within 1 h of a 5 - 10 mL CSI bolus of 0.2 % ropivacaine and beginning an infusion of the same drug at 5 mL/h , patients ' median pain by verbal analog scale decreased from 7.5 to 2.0 ( mean scores from 7.3 to 2.4 ) . It was possible to maintain this level of analgesia until the third postoperative day when catheters were discontinued . Our experience suggests that , in most patients , adequate analgesia after TKA can not be \n Output:\n " }, { "from": "agent", "value": "Pain was also less in each FNB subgroup : single-shot FNB , continuous FNB and continuous FNB + sciatic block , compared with PCA .\nAvailable evidence was insufficient to allow determination of the comparative safety of the various analgesic techniques .\nAUTHORS ' CONCLUSIONS Following TKR , FNB ( with or without concurrent treatments including PCA opioid ) provided more effective analgesia than PCA opioid alone , similar analgesia to epidural analgesia and less nausea/vomiting compared with PCA alone or epidural analgesia .\nThe review also found that continuous FNB provided better analgesia compared with single-shot FNB .\nRCTs were insufficient to allow definitive conclusions on the comparison between FNB and local infiltration analgesia or oral analgesia" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Chronic pain in the cervical zygapophyseal joints is a common problem after a whiplash injury . Treatment with intraarticular injections of corticosteroid preparations has been advocated , but the value of this approach has not been established . We compared the efficacy of a depot injection of a corticosteroid preparation with the efficacy of an injection of a local anesthetic agent in patients with painful cervical zygapophyseal joints . METHODS Sixteen men and 25 women with pain in one or more cervical zygapophyseal joints after automobile accidents ( mean age , 43 years ; median duration of pain , 39 months ) were r and omly assigned to receive an intraarticular injection of either bupivacaine ( 0.5 percent ) or betamethasone ( 5.7 mg ) under double-blind conditions . The patients were followed by means of regular telephone contact and clinic visits until they reported a return to a level of pain equivalent to 50 percent of the preinjection level . The time from treatment to a 50 percent return of pain was compared in the two groups with the use of a survival analysis . RESULTS Less than half the patients reported relief of pain for more than one week , and less than one in five patients reported relief for more than one month , irrespective of the treatment received . The median time to a return of 50 percent of the preinjection level of pain was 3 days in the 21 patients in the corticosteroid group and 3.5 days in the 20 patients in the local-anesthetic group ( P = 0.42 ) . CONCLUSIONS Intraarticular injection of betamethasone is not effective therapy for pain in the cervical zygapophyseal joints after a whiplash injury BACKGROUND Chronic pain in the cervical zygapohyseal joints is a common problem after whiplash injury , but treatment is difficult . Percutaneous radiofrequency neurotomy can relieve the pain by denaturing the nerves innervating the painful joint , but the efficacy of this treatment has not been established . METHODS In a r and omized , double-blind trial , we compared percutaneous radio-frequency neurotomy in which multiple lesions were made and the temperature of the electrode making the lesions was raised to 80 degrees C with a control treatment using an identical procedure except that the radio-frequency current was not turned on . We studied 24 patients ( 9 men and 15 women ; mean age , 43 years ) who had pain in one or more cervical zygapophyseal joints after an automobile accident ( median duration of pain , 34 months ) . The source of their pain had been identified with the use of double-blind , placebo-controlled local anesthesia . Twelve patients received each treatment . The patients were followed by telephone interviews and clinic visits until they reported that their pain had returned to 50 percent of the preoperative level . RESULTS The median time that elapsed before the pain returned to at least 50 percent of the preoperative level was 263 days in the active-treatment group and 8 days in the control group ( P=0.04 ) . At 27 weeks , seven patients in the active-treatment group and one patient in the control group were free of pain . Five patients in the active-treatment group had numbness in the territory of the treated nerves , but none considered it troubling . CONCLUSIONS In patients with chronic cervical zygapophyseal-joint pain confirmed with double-blind , placebo-controlled local anesthesia , percutaneous radio-frequency neurotomy with multiple lesions of target nerves can provide lasting relief STUDY DESIGN A prospect i ve double-blind r and omized trial in 31 patients . OBJECTIVES To assess the clinical efficacy of percutaneous radiofrequency denervation of the lumbar zygapophysial joints in reducing pain , functional disability , and physical impairment in patients with back pain originating from the lumbar zygapophysial joints . SUMMARY OF BACKGROUND DATA Chronic low back pain is a major health problem in the industrialized world . A treatment option is percutaneous radiofrequency denervation of the lumbar zygapophysial joints . Its clinical efficacy has never been formally tested in a controlled trial . METHODS Thirty-one patients with a history of at least 1 year of chronic low back pain were selected on the basis of a positive response to a diagnostic nerve blockade and subsequently r and omly assigned to one of two treatment groups . Each patient in the radiofrequency treatment group ( 15 patients ) received an 80 C radiofrequency lesion of the dorsal ramus of the segmental nerve roots L3 , L4 , and L5 . Patients in the control group ( n = 16 ) underwent an the same procedure but without use of a radiofrequency current . Both the treating physician and the patients were blinded to the group assignment . Before treatment , physical impairment , rating of pain , the degree of disability , and quality of life were assessed by a blinded investigator . RESULTS Eight weeks after treatment , there were 10 success patients in the radiofrequency group ( n = 15 ) and 6 in the sham group ( n = 16 ) . The unadjusted odds ratio was 3.3 ( P = 0.05 , not significant ) , and the adjusted odds ratio was 4.8 ( P < 0.05 , significant ) . The differences in effect on the visual analog scale scores , global perceived effect , and the Oswestry disability scale were statistically significant . Three , 6 , and 12 months after treatment , there were significantly more success patients in the radiofrequency group compared with the sham group . CONCLUSIONS Radiofrequency lumbar zygapophysial joint denervation results in a significant alleviation of pain and functional disability in a select group of patients with chronic low back pain , both on a short-term and a long-term basis Radiofrequency neurolysis of lumbar medial branch is currently the only proven way to treat patients with chronic lumbar zygapophysial joint pain , however , in some patients it can cause transient postoperative pain due to an inflammation caused by trauma of the electrode insertion and the thermal lesion around the target nerves . The aim of this study was to assess the effectiveness of intraoperative injection of methylprednisolone or pentoxifylline in comparison with placebo ( saline ) to prevent this process . 45 consecutive patients seen by one physician at one pain management clinic were included . Patients were r and omly assigned to 3 groups of 15 patients treated with radiofrequency neurotomy procedure with an addition of methylprednisolone , pentoxifylline or saline , respectively , and were observed for 6 months . Pain intensity , summed pain intensity difference , minimum 50 % reduction of pain intensity , Patients Satisfaction Score , and local tenderness were determined . The 50 % reduction of pain intensity was achieved in 80 % of patients one week after the procedure , and at 6 months such results were reported by 60 % of patients . There was a significant reduction of pain intensity in all three groups at all time points compared to baseline , however , there were no differences between the three groups . There was a significant difference in local tenderness as a measure of postoperative pain indicating effectiveness of both , methylprednisolone and pentoxifylline . No other complications were noted in any of the patients . Radiofrequency neurotomy is a safe and effective method to treat patients with zygapophysial joint pain . An addition of pentoxifylline and methylprednisolone can reduce postoperative pain commonly appearing within a short time after the procedure , however , neither pentoxifylline nor methylprednisolone influences long-term follow-up results & NA ; One hundred and seventy‐six consecutive patients with chronic low back pain and no history of previous lumbar surgery were studied to determine the false‐positive rate of single diagnostic blocks of the lumbar zygapophysial joints . All patients underwent diagnostic blocks using lignocaine . Those patients who obtained definite or complete relief from these blocks subsequently underwent confirmatory blocks using bupivacaine . Eighty‐three patients ( 47 % ) had a definite or greater response to the initial , lignocaine injection at one or more levels but only 26 ( 15 % ) had a 50 % or greater response to a confirmatory injection of 0.5 % bupivacaine . Using the response to confirmatory blocks as the criterion st and ard , the false‐positive rate of uncontrolled diagnostic blocks was 38 % and the positive predictive value of these blocks was only 31 % . Because the positive predictive value of a test is lower when the pre‐test probability ( prevalence ) is low , and because the prevalence of lumbar zygapophysial joint pain is likely to be less than 50 % , uncontrolled diagnostic blocks will always be associated with an unacceptably low positive predictive value . These features render uncontrolled diagnostic blocks unreliable for the diagnosis of lumbar zygapophysial joint pain not only in epidemiologic studies but also in any given patient Cervicogenic headache is still a controversial disease entity , and good and reliable treatment is lacking . In the present r and omized , sham-controlled , patient- and evaluator-blinded study , 12 patients with a disabling , long-st and ing and treatment-resistant strictly unilateral cervicogenic headache were included . The diagnosis was based on purely clinical criteria . Six were r and omized to receive radiofrequency neurotomy of facet joints C2-C6 ipsilateral to the pain , and six were r and omized to sham treatment . Patients were followed for 2 years with diary registration of pain for 14-days periods after 1 , 3 , 6 , 12 , 18 and 24 months , and also followed with algometry and neck mobility measurements at 3 , 12 and 24 months . Side-effects were minor and short-lasting , and those patients who were treated with neurotomy were somewhat improved at 3 months , but later there were no marked differences between the groups . In conclusion , the procedure is probably not beneficial in cervicogenic headache Background and Objectives The use of radiofrequency ( RF ) procedures in the peripheral nervous system to treat chronic spinal pain has been the subject of controversy . Publications concerned only uncontrolled studies , and irreversible nervous tissue damage was believed to be responsible for the effect , if any . In recent years , r and omized , controlled studies have appeared , which have attested to an increasing use of these techniques . This is a systematic review of r and omized controlled trials on RF procedures for spinal pain . Methods We performed a st and ardized literature search for r and omized , controlled trials . Three adjudicators independently registered trial methodology and outcome using vali date d and subject-related instruments . Interadjudicator disagreement was resolved by discussion . It was found necessary to devise additional parameters of study assessment . Results Six trials met the inclusion criteria . This small number , along with clinical and technical heterogeneity precluded statistical analysis . All studies , whether high or low quality , reported positive outcomes . Conclusions We conclude that there is moderate evidence that RF lumbar facet denervation is more effective for chronic low back pain than placebo . Limited evidence exists for efficacy of RF neurotomy in chronic cervical zygapophyseal joint pain after flexion-extension injury . There is limited evidence that RF heating of the dorsal root ganglion is more effective than placebo in chronic cervicobrachialgia . We recommend the systematic application of our additional parameter assessment s for future evaluations of RF studies . These additional parameters should also be used in the preparation of future trial protocol s of RF procedures for the treatment of chronic pain Study Design . A prospect i ve double-blind r and omized controlled trial was performed . Objective . To assess the efficacy of percutaneous radiofrequency articular facet denervation for low back pain . Summary of Background Data . Uncontrolled observational studies in patients with low back pain have reported some benefits from the use of facet joint radiofrequency denervation . Because the efficacy of percutaneous radiofrequency had not been clearly shown in previous studies , a r and omized controlled trial was conducted to assess the efficacy of the technique for improving functional disabilities and reduce pain . Methods . For this study , 70 patients with low back pain lasting of more than 3 months duration and a good response after intraarticular facet injections under fluoroscopy were assigned r and omly to receive percutaneous radiofrequency articular facet denervation under fluoroscopic guidance or the same procedure without effective denervation ( sham therapy ) . The primary outcomes were functional disabilities , as assessed by the Oswestry and Rol and -Morris scales , and pain indicated on a visual analog scale . Secondary outcomes included spinal mobility and strength . Results . At 4 weeks , the Rol and -Morris score had improved by a mean of 8.4 % in the neurotomy group and 2.2 % in the placebo group , showing a treatment effect of 6.2 % ( P = 0.05 ) . At 4 weeks , no significant treatment effect was reflected in the Oswestry score ( 0.6 % change ) or the visual analog pain score ( 4.2 % change ) . At 12 weeks , neither functional disability , as assessed by the Rol and -Morris scale ( 2.6 % change ) and Oswestry scale ( 1.9 % change ) , nor the pain level , as assessed by the visual analog scale ( −7.6 % change ) , showed any treatment effect . Conclusions . Although radiofrequency facet joint denervation may provide some short-term improvement in functional disability among patients with chronic low back pain , the efficacy of this treatment has not been established Facet joints have been described as an important source of low back pain . The value of medial branch blocks in the diagnosis of facet joint mediated pain is considered important . However , the therapeutic value of medial branch blocks has not been determined . This study was design ed to evaluate the duration of relief obtained and therapeutic value following controlled medial branch blocks with or without adjuvant agents Sarapin ( High Chemical Company , Levittown , PA ) and Depo-medrol ( Pharm \n Output:\n " }, { "from": "agent", "value": "With regard to pharmacotherapy , most , but not all , systematic review s have found tricyclic antidepressants to be beneficial , although the effect size is small , and the studies are limited to short-term follow-up .\nThe authors found that the pre-RF injection of any type of fluid significantly increased all relevant lesion parameters , namely , horizontal diameter , vertical diameter , distal radius from tip , and maximal" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Thalidomide plus dexamethasone ( TD ) is a st and ard induction therapy for myeloma . We aim ed to assess the efficacy and safety of addition of bortezomib to TD ( VTD ) versus TD alone as induction therapy before , and consolidation therapy after , double autologous stem-cell transplantation in newly diagnosed multiple myeloma . METHODS Patients ( aged 18 - 65 years ) with previously untreated symptomatic myeloma were enrolled from 73 sites in Italy between May , 2006 , and April , 2008 , and data collection continued until June 30 , 2010 . Patients were r and omly allocated ( 1:1 ratio ) by a web-based system to receive three 21-day cycles of thalidomide ( 100 mg daily for the first 14 days and 200 mg daily thereafter ) plus dexamethasone ( 40 mg daily on 8 of the first 12 days , but not consecutively ; total of 320 mg per cycle ) , either alone or with bortezomib ( 1·3 mg/m(2 ) on days 1 , 4 , 8 , and 11 ) . The r and omisation sequence was computer generated by the study coordinating team and was stratified by disease stage . After double autologous stem-cell transplantation , patients received two 35-day cycles of their assigned drug regimen , VTD or TD , as consolidation therapy . The primary endpoint was the rate of complete or near complete response to induction therapy . Analysis was by intention to treat . Patients and treating physicians were not masked to treatment allocation . This study is still underway but is not recruiting participants , and is registered with Clinical Trials.gov , number NCT01134484 , and with EudraCT , number 2005 - 003723 - 39 . FINDINGS 480 patients were enrolled and r and omly assigned to receive VTD ( n=241 patients ) or TD ( n=239 ) . Six patients withdrew consent before start of treatment , and 236 on VTD and 238 on TD were included in the intention-to-treat analysis . After induction therapy , complete or near complete response was achieved in 73 patients ( 31 % , 95 % CI 25·0 - 36·8 ) receiving VTD , and 27 ( 11 % , 7·3 - 15·4 ) on TD ( p<0·0001 ) . Grade 3 or 4 adverse events were recorded in a significantly higher number of patients on VTD ( n=132 , 56 % ) than in those on TD ( n=79 , 33 % ; p<0·0001 ) , with a higher occurrence of peripheral neuropathy in patients on VTD ( n=23 , 10 % ) than in those on TD ( n=5 , 2 % ; p=0·0004 ) . Resolution or improvement of severe peripheral neuropathy was recorded in 18 of 23 patients on VTD , and in three of five patients on TD . INTERPRETATION VTD induction therapy before double autologous stem-cell transplantation significantly improves rate of complete or near complete response , and represents a new st and ard of care for patients with multiple myeloma who are eligible for transplant . FUNDING Seràgnoli Institute of Haematology at the University of Bologna , Bologna , Italy BACKGROUND Lenalidomide is an immunomodulatory drug that is also currently used in transplant-eligible patients with multiple myeloma . Previous studies have suggested a negative impact of lenalidomide on the mobilization of CD34 + cells . No data are available regarding the more detailed composition of blood grafts after lenalidomide . STUDY DESIGN AND METHODS In a multicenter , prospect i ve study , we analyzed the mobilization of CD34 + cells , graft cellular composition , and post-transplant hematologic recovery in 26 patients with multiple myeloma after lenalidomide-based induction and in 34 lenalidomide-naive controls with multiple myeloma . All patients were mobilized with low-dose cyclophosphamide plus granulocyte-colony-stimulating factor . The cellular composition of the grafts was analyzed from thawed , cryopreserved sample s with flow cytometry . Graft function was evaluated by engraftment data and by complete blood counts until 12 months after the graft infusion . RESULTS Patients in the lenalidomide arm had lower median peak CD34 + counts and approximately 40 % lower CD34 + cell yields from the first apheresis session , but these differences were not significant . The median total number of CD34 + cells collected was comparable ( 6.4 vs. 7.5 × 106 /kg ) . The number of apheresis sessions was higher in the lenalidomide group ( 2 vs. 1 ; p = 0.039 ) . The blood graft composition was comparable between the groups . Hematologic recovery within 12 months post-transplant did not differ between the groups . CONCLUSION Lenalidomide-based induction seems to have an impact on the number of aphereses performed , but not on the total yields of the CD34 + cells in the graft . Neither cellular composition of the grafts nor post-transplant recovery was affected by the limited pre-transplant exposure to lenalidomide This follow‐up extension of a r and omised phase II study assessed differences in long‐term outcomes between bortezomib‐thalidomide‐dexamethasone ( VTD ) and VTD‐cyclophosphamide ( VTDC ) induction therapy in multiple myeloma . Newly diagnosed patients ( n = 98 ) were r and omised 1:1 to intravenous bortezomib ( 1·3 mg/m2 ; days 1 , 4 , 8 , 11 ) , thalidomide ( 100 mg ; days 1–21 ) , and dexamethasone ( 40 mg ; days 1–4 , 9–12 ) , with/without cyclophosphamide ( 400 mg/m2 ; days 1 , 8) , for four 21‐day cycles before stem‐cell mobilisation/transplantation . After a median follow‐up of 64·8 months , median time‐to‐next therapy was 51·8 and 47·9 months with VTD and VTDC , respectively . Type of subsequent therapy was similar in both arms . After adjusting for asymmetric censoring , median time to progression was not significantly different between VTD and VTDC [ 35·7 vs. 34·5 months ; Hazard ratio ( HR ) 1·26 , 95 % confidence interval : 0·76–2·09 ; P = 0·370 ] . Five‐year survival was 69·1 % and 65·3 % with VTD and VTDC , respectively . When analysed by minimal residual disease ( MRD ) status , overall survival was longer in MRD‐negative versus MRD‐positive patients with bone marrow‐confirmed complete response ( HR 3·66 , P = 0·0318 ) . VTD induction followed by transplantation provides long‐term disease control and , consistent with the primary analysis , there is no additional benefit from adding cyclophosphamide . This study was registered at Clinical Trials.gov ( NCT00531453 ) Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE Bortezomib-thalidomide-dexamethasone ( VTD ) is an effective induction therapy in multiple myeloma ( MM ) . This phase II , noncomparative study sought to determine whether addition of cyclophosphamide to this regimen ( VTDC ) could further increase efficacy without compromising safety . PATIENTS AND METHODS Patients age 18 to 70 years with previously untreated , measurable MM , who were eligible for high-dose chemotherapy-autologous stem-cell transplantation ( HDCT-ASCT ) , were r and omly assigned to bortezomib 1.3 mg/m(2 ) , thalidomide 100 mg , and dexamethasone 40 mg , with ( n = 49 ) or without ( n = 49 ) cyclophosphamide 400 mg/m(2 ) for four 21-day cycles , followed by HDCT-ASCT . The primary end point was postinduction combined rate of near-complete response ( nCR ) or better ( including complete response [ CR ] with normalized serum κ : λ free light chain ratio , CR , and nCR ) . RESULTS Postinduction , 51 % ( VTD ) and 44 % ( VTDC ) of patients achieved combined CR/nCR , with bone marrow-confirmed CR in 29 % and 31 % , overall response rates of 100 % and 96 % , respectively , and very good partial response or better rates of 69 % per arm . Post-HDCT-ASCT , combined CR/nCR rates were 85 % ( VTD ) and 77 % ( VTDC ) . In all , 35 % ( VTD ) and 27 % ( VTDC ) of patients were negative for minimal residual disease ( MRD ) during induction and postinduction . Three-year overall survival was 80 % ( both arms ) . Grade 3 to 4 adverse events ( AEs ) and serious AEs were observed in 47 % and 22 % ( VTD ) and 57 % and 41 % ( VTDC ) of patients , respectively . The primary health-related quality of life end point ( European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 [ EORTC QLQ-C30 ] Global Health score ) steadily increased with VTD during induction and reached a clinical ly relevant difference post-transplantation versus baseline . CONCLUSION Both VTD and VTDC are highly active induction regimens producing high combined CR/nCR and MRD-negative rates ; however , VTDC was associated with increased toxicity and suggestion of transient decreases in Global Health score , without an increase in activity Pegylated liposomal doxorubicin has pharmacologic and safety advantages over conventional doxorubicin Whilst infusional vincristine , adriamycin and dexamethasone ( VAD ) is an effective treatment for patients with multiple myeloma ( MM ) , administration may be complicated by line‐associated infections and thromboses . The oral regime , Z‐Dex ( idarubicin and dexamethasone ) has been shown to be efficacious in MM . We conducted a r and omized study comparing Z‐Dex with VAD as induction therapy in newly diagnosed MM patients . A total of 106 patients ( median age , 56 years ; range : 37–73 ; Durie‐Salmon stage II/III ) were r and omized to receive four to six cycles of Z‐Dex or VAD . Central line complications were reported in 38 patients on 57 cycles , primarily because of infection . Neutropenia ( all grade s ) was more common in the Z‐Dex arm ( P = 0·009 ) although grade III/IV neutropenia was not significantly different between the treatment groups ( P = 0·06 ) . Infections ( all grade s ) were more commonly seen in the VAD arm ( P = 0·001 ) although grade III/IV infections were not significantly different between the two groups ( P = 0·081 ) . The responses to therapy ( complete/partial response ) in evaluable patients were : VAD 74 % vs. Z‐Dex 58 % , with an estimated difference in response of 16 % ( 95 % CI −2–33 , P = 0·075 ) . VAD recipients ( 15 % ) suffered early treatment‐related mortality compared with 12 % of Z‐Dex recipients . Overall , 45 patients have died : disease progression ( Z‐Dex n = 13 , VAD n = 10 ) , regimen‐related toxicity ( Z‐Dex n = 2 , VAD n = 2 ) , infection ( Z‐Dex n = 0 , VAD n = 3 ) , other causes ( Z‐Dex n = 7 , VAD n = 2 ) , unknown ( Z‐Dex n = 3 , VAD n = 2 ) . This study demonstrated that Z‐Dex might be a suitable oral alternative to VAD for treating newly diagnosed MM patients , although definitive evidence for equivalence is not provided The phase 3 trial HOVON-50 was design ed to evaluate the effect of thalidomide during induction treatment and as maintenance in patients with \n Output:\n " }, { "from": "agent", "value": "Bortezomib/thalidomide regimens were not superior to lenalidomide , considering these outcomes .\nRisk of thrombotic events was higher with TAD ( thalidomide-doxorubicin-dexamethasone ) , neurological with PAD ( bortezomib-doxorubicin-dexamethasone ) , infectious with Dex , hematological with Z-Dex , gastrointestinal with VTD , and cardiac with PAD regimens .\nOur study endorses current recommendations on combined immunomodulatory drugs and proteasome inhibitors frontline regimens ( in triplets ) in transplant-eligible multiple myeloma patients , but also formally demonstrates the favorable performance of lenalidomide in overall and progression-free survival , when compared with bortezomib/thalidomide protocol" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : The aim of this study was to assess the reduction in the incidence of parastomal hernia ( PH ) after placement of prophylactic synthetic mesh using a modified Sugarbaker technique when a permanent end-colostomy is needed . Summary of Background Data : Prevention of PH formation is crucial given the high prevalence of PH and difficulties in the surgical repair of PH . Methods : A r and omized , prospect i ve , double-blind , and controlled trial . Rectal cancer patients undergoing laparoscopic abdominoperineal resection with permanent colostomy were r and omized ( 1 : 1 ) to the mesh and nonmesh arms . In the mesh group , a large-pore lightweight composite mesh was placed in the intraperitoneal/onlay fashion using a modified Sugarbaker technique . PH was detected by computed tomography ( CT ) after a minimum follow-up of 12 months . Analysis was per- protocol . Results : The mesh group included 24 patients and the control group 28 . Preoperative data , surgical time , and postoperative morbidity were similar . The median follow-up was 26 months . After CT examination , 6 of 24 PHs ( 25 % ) were observed in the mesh group compared with 18 of 28 ( 64.3 % ) in the nonmesh group ( odds ratio 0.39 , 95 % confidence interval 0.18–0.82 ; P = 0.005 ) . The Kaplan-Meier curves showed significant differences in favor of the mesh group ( long-rank = 4.21 , P = 0.04 ) . The number needed to treat was 2.5 , which confirmed the effectiveness of the intervention . Conclusions : Placement of a prosthetic mesh by the laparoscopic approach following the modified Sugarbaker technique is safe and effective in the prevention of PH , reducing significantly the incidence of PH Parastomal hernia ( PSH ) is the most common complication of an end‐colostomy and about one‐quarter of patients need operative repair , which is often unsuccessful . A r and omized trial was carried out to compare the results of using mesh or no mesh at the time of formation of a colostomy with the clinical identification of PSH as the primary outcome Objective : The aim of this study was to determine whether parastomal hernia ( PSH ) rate can be reduced by using synthetic mesh in the sublay position when constructing permanent end colostomy . The secondary aim was to investigate possible side-effects of the mesh . Background : Prevention of PSH is important as it often causes discomfort and leakage from stoma dressing . Different methods of prevention have been tried , including several mesh techniques . The incidence of PSH is high ; up to 78 % . Methods : R and omized controlled double-blinded multicenter trial . Patients undergoing open colorectal surgery , including creation of a permanent end colostomy , were r and omized into 2 groups , with and without mesh . A lightweight polypropylene mesh was placed around the colostomy in the sublay position . Follow up after 1 month and 1 year . Computerized tomography and clinical examination were used to detect PSH at the 1-year follow up . Data were analyzed on an intention-to-treat basis . Results : After 1 year , 211 of 232 patients underwent clinical examination and 198 radiologic assessment s. Operation time was 36 minutes longer in the mesh arm . No difference in rate of PSH was revealed in the analyses of clinical ( P = 0.866 ) and radiologic ( P = 0.748 ) data . There was no significant difference in perioperative complications . Conclusions : The use of reinforcing mesh does not alter the rate of PSH . No difference in complication rate was seen between the 2 arms . Based on these results , the prophylactic use of mesh to prevent PSH can not be recommended Purpose Prevention of parastomal hernia represents an important aim when a permanent stoma is necessary . The objective of this work is to assess whether implantation of a prophylactic prosthetic mesh during laparoscopic abdominoperineal resection contributed to reduce the incidence of parastomal hernia . Methods Rectal cancer patients undergoing elective laparoscopic abdominoperineal resection with permanent colostomy were r and omized to placement of a large-pore lightweight mesh in the intraperitoneal/onlay position by the laparoscopic approach ( study group ) or to the control group ( no mesh ) . Parastomal hernia was defined radiologically by a CT scan performed after 12 months of surgery . The usefulness of subcutaneous fat thickness measured by CT to discriminate patients at risk of parastomal hernia was assessed by ROC curve analysis . Results Thirty-six patients were r and omized , 19 to the mesh group and 17 to the control group . Parastomal hernia was detected in 50 % of patients in the mesh group and in 93.8 % of patients in the control group ( P = 0.008 ) . The AUC for thickness of the subcutaneous abdominal was 0.819 ( P = 0.004 ) and the optimal threshold 23 mm . Subcutaneous fat thickness ≥23 mm was a significant predictor of parastomal hernia ( odds ratio 15.7 , P = 0.010 ) , whereas insertion of a mesh was a protective factor ( odds ratio 0.06 , P = 0.031 ) . Conclusions Use of prophylactic large-pore lightweight mesh in the intraperitoneal/onlay position by a purely laparoscopic approach reduced the incidence of parastomal hernia formation . Subcutaneous fat thickness ≥23 mm measured by CT was an independent predictor of parastomal hernia Background : The prevalence of terminal parastomal hernia ( PH ) after colostomy placement may be as high as 50 % . The effect of the PH may range from discomfort to life-threatening complications . Surgical procedures for repairing PH are difficult to perform and present a high-failure rate . Objective : To reduce the incidence of PH by implanting a lightweight mesh in the sublay position . Material and Methods : R and omized , controlled , prospect i ve study . Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum , performed by the same colorectal surgery team . An Ultrapro lightweight mesh was inserted in the sublay position in the study group . Using simple r and omization , the sample size required was estimated to be 27 per group . Patients were followed-up clinical ly and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study , 1 month and every 6 months after surgery . Results : The groups were homogeneous in terms of their clinical and demographic characteristics . Surgical time and postoperative morbidity were similar in the 2 groups . Mortality was 0 . No mesh intolerance was reported . In the clinical follow-up ( median : 29 months , range : 13–49 ) , 11/27 ( 40.7 % ) hernias were recorded in the control group compared with 4/27 ( 14.8 % ) in the study group ( P = 0.03 ) . Abdominal computed tomography identified 14/27 ( 44.4 % ) hernias in the control group compared with 6/27 ( 22.2 % ) in the study group ( P = 0.08 ) . Conclusions : Parastomal placement of a mesh reduces the appearance of PH . The technique is safe , well-tolerated , and does not increase morbidity rates BACKGROUND : A large proportion of patients with a colostomy or an ileostomy develop parastomal hernias . The placement of a reinforcing material at the stoma site may reduce parastomal hernia incidence . OBJECTIVE : We aim ed to assess the safety and efficacy of stoma reinforcement with sublay placement of non-cross-linked porcine-derived acellular dermal matrix at the time of stoma construction . DESIGN : This is a r and omized , patient- and third-party assessor-blind , controlled trial . SETTING S : This study took place in colorectal/general surgery institutions . INTERVENTIONS : Patients were prospect ively r and omly assigned to undergo st and ard end-stoma construction with or without porcine-derived acellular dermal matrix reinforcement . PATIENTS : Patients undergoing construction of a permanent stoma were eligible . A total of 113 patients ( 59 men , 54 women ; mean age , 60 years ; mean BMI , 25.4 kg/m2 ) participated : 58 controls and 55 with reinforcement . MAIN OUTCOMES MEASURES : The incidence of parastomal hernia , safety , and stoma-related quality of life were assessed . RESULTS : Intraoperative complications and blood loss were similar between groups . Quality -of-life scores were similar through 24 months of follow-up . At 24 months of follow-up , the incidence of parastomal hernias was similar for both groups ( 12.2 % of the porcine-derived acellular dermal matrix group and 13.2 % of controls ) . LIMITATIONS : Study limitations include the inclusion of ileostomy and colostomy patients , open and laparoscopic techniques , and small numbers of patients at follow-up . CONCLUSIONS : Safety and quality -of-life data from this r and omized control trial show similar outcomes in both groups . Prosthetic reinforcement of stomas was safe , but it did not significantly reduce the incidence of parastomal hernia formation . Clinical Trial Registration : Identification no. NCT00771407 Background Parastomal hernia is a major clinical problem . In a r and omized , clinical trial , a prosthetic mesh in a sublay position at the index operation reduced the rate of parastomal hernia at 12-month follow-up , without any increase in the rate of complications . This study was design ed to evaluate the rate of complications after 5 years . Methods Between January 2001 and April 2003 , 54 patients who had a permanent ostomy were r and omized to a conventional stoma or to a stoma with the addition of a mesh in a sublay position . A large-pore , lightweight mesh with a reduced polypropylene content and a high proportion of absorbable material was used . Results After 5 years , 21 patients with a conventional stoma were alive and parastomal herniation was recorded in 17 patients , of whom repair had been dem and ed in 5 . In 15 patients operated on with the addition of a mesh herniation , that did not require repair , was present in 2 ( P < 0.001 ) . No fistulas or strictures developed . No mesh infection was noted and no mesh was removed during the study period . Conclusions At stoma formation , a prophylactic low-weight mesh in a sublay position is a safe procedure that reduces the rate of parastomal hernia Background Parastomal hernias can be prevented or repaired using synthetic mesh ; however , reported complications include infection , fibrosis and potential bowel erosion . The study aim was to assess the safety , feasibility and potential efficacy of using a prophylactic collagen implant . Methods Twenty patients undergoing defunctioning stomas were r and omised to a conventional procedure or reinforcement with the implant . Follow-up included regular symptom question naires , clinical examination , stoma site ultrasound , and serum inflammatory markers . Results Ten patients ( four males ; mean BMI 26.3 ) had a conventional stoma , and ten ( three males ; mean BMI 26.3 ) received the implant . At a median of 6.5 months follow-up , a parastomal hernia was clinical ly evident in three of ten patients without the implant , and in none of ten patients with the implant . There were no clinical complications , ultrasound evidence of chronic seromas or serological evidence of a systemic inflammatory response . Conclusions Xenogeneic collagen has been demonstrated to aid soft tissue reinforcement . In this study , in contrast to published data relating to the use of conventional synthetic mesh , there were no complications related to infection or the implant ’s proximity to the bowel . This trial demonstrates that the implant is safe , feasible to use and has the potential to prevent parastomal herniation Objective : The aim of this study was to investigate the incidence of parastomal hernias ( PSHs ) after end-colostomy formation using a polypropylene mesh in a r and omized controlled trial versus conventional colostomy formation . Background : A PSH is the most frequent complication after stoma formation . Symptoms may range from mild abdominal pain to life-threatening obstruction and strangulation . The treatment of a PSH is notoriously difficult and recurrences up to 20 % have been reported despite the use of mesh . This has moved surgical focus toward prevention . Methods : Augmentation of the abdominal wall with a retro-muscular lightweight polypropylene mesh was compared with the traditional formation of a colostomy . In total , 150 patients ( 1:1 ratio ) were included . The incidence of a PSH , morbidity , mortality , quality of life , and cost-effectiveness was measured after 1 year of follow-up . Results : There was no difference between groups regarding demographics and predisposing factors for PSH . Three out of 67 patients ( 4.5 % ) in the mesh group and 16 out of 66 patients ( 24.2 % ) in the nonmesh group developed a PSH ( P = 0.0011 ) . No statistically significant difference was found in infections , concomitant hernias , SF-36 question naire , Von Korff pain score , and cost-effectiveness between both study groups . Conclusion : Prophylactic augmentation of the abdominal wall with a retromuscular lightweight polypropylene \n Output:\n " }, { "from": "agent", "value": "Reductions persisted for synthetic and composite meshes .\nOperative time was similar , with zero incidence of mesh infection/fistulation , and fewer peristomal complications .\nSynthetic mesh demonstrated a favourable cost profile , with composite approximately cost neutral , and biological incurring net costs .\nConclusions Reinforcing elective stomas with mesh ( primarily synthetic ) reduces subsequent PSH rates , complications , repairs and saves money ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Overweight and physical inactivity are associated with elevated reactive oxygen species and chronic low- grade inflammation . Exercise training studies have measured changes in systemic inflammatory and oxidative/antioxidative biomarkers but predominantly at moderate-high intensities . Few low-intensity , lifestyle-based physical activity ( PA ) studies have been conducted . The purpose of this study was to determine whether improvements in lifestyle-oriented PA result ing from a 16-wk Internet-delivered PA program [ Active Living Every Day-Internet ( ALED-I ) ] elicit cardioprotective improvements in measures of inflammation , oxidation , or antioxidant enzyme capacity . Forty-one men and women ( age 23 - 62 yr ) were r and omized to either the ALED-I intervention [ n = 19 ; age = 40.4 + /- 1.9 yr ; body mass index ( BMI ) = 31.4 + /- 1.1 kg/m(2 ) ] or a delayed intent-to-treat control condition ( n = 22 ; age = 46.6 + /- 1.3 yr ; BMI = 31.0 + /- 0.7 kg/m(2 ) ) . TNF-alpha , C-reactive protein , myeloperoxidase , superoxide dismutase , catalase , total antioxidative capacity , change in PA , and other cardiometabolic disease risk factors were measured at baseline and postintervention . The ALED-I group increased PA and decreased central adiposity without changes in the control group . There was no change in the control group for any inflammation , oxidation , or antioxidant biomarkers . TNF-alpha decreased ( P = 0.01 ) in the intervention group but was not statistically different from the control group . In conclusion , modest improvements in daily low-intensity ambulatory PA as a result of an Internet-delivered lifestyle PA intervention may be cardioprotective in sedentary and overweight adults through reductions in central adiposity and inflammation . However , the absence of favorable changes in other inflammation , oxidation , and antioxidant biomarkers highlights the need for further attention to the dose response of lifestyle-structured PA promotion strategies for health maintenance/improvement The independent effects of exercise and weight loss on markers of inflammation ( MOI ) in obese individuals have not been clearly characterized . The objectives of this study were to : ( i ) identify the independent effects of exercise and weight loss on MOI and ( ii ) determine whether changes in MOI were associated with changes in fat distribution . Subjects were 126 healthy , premenopausal women , BMI 27 - 30 kg/m(2 ) . They were r and omized to one of three groups : diet only , diet + aerobic- , or diet + resistance training until a BMI < 25 kg/m(2 ) was achieved . Fat distribution was measured with computed tomography , and body composition with dual-energy X-ray absorptiometry . Serum concentrations of tumor necrosis factor (TNF)-α , soluble TNF receptor 1 ( sTNF-R1 ) , soluble TNF receptor 2 ( sTNF-R2 ) , C-reactive protein ( CRP ) , and interleukin (IL)-6 were assessed . Results of repeated- measures ANOVA indicated a significant effect of time on MOI , such that MOI decreased with weight loss . Results of mixed-model analysis indicated that adjusting for intra-abdominal adipose tissue ( IAAT ) and total fat mass explained the decreases in TNF-α and sTNF-R1 , whereas only total fat mass explained the decreases in sTNF-R2 , IL-6 , and CRP . In conclusion , weight loss was associated with decreases in MOI . The effect of weight loss appeared to be mediated by changes in total fat mass or IAAT . Addition of exercise did not alter the response , suggesting that weight loss has a more profound impact for reducing MOI in overweight women than exercise The activity of the hypothalamic-pituitary-adrenal axis is usually modulated by several stress factors , including exercise . Different responses are induced by physical training according to duration and intensity of exercise . During prolonged training , cortisol remains normal or decreased as a consequence of altered cortisol secretion , metabolism and excretion , and possibly by changes in glucocorticoid sensitivity . The aim of this study was to evaluate the impact of prolonged physical training on the glucocorticoid sensitivity . Eighteen cadets of the Air Force Academy , mean ( SD ) age : 18.7 ( 1.0 ) years , underwent an intensive 6-week preparatory training-period considered adequate by inducing significant changes on body composition measured by bioelectrical impedance . Measurement of individual 's pituitary glucocorticoid sensitivity was done by an intravenous very low dose dexamethasone suppression test ( 20 microg/m ( 2 ) ) that was performed before and after the training period . Cortisol levels were obtained at basal condition and 120 minutes after the dexamethasone infusion . Basal cortisol showed a significant decrease after prolonged training . The percent cortisol suppression after dexamethasone tended to be lower after the training period . Overall , our data suggest that prolonged physical training is able to reduce glucocorticoid sensitivity , which can have a beneficial impact in chronic stress conditions Increased circulating adiponectin and insulin sensitivity are usually observed after body fat loss induced by a weight-loss diet . Progressive resistance training ( PRT ) without a concomitant weight-loss diet significantly decreases visceral fat , thus improving insulin sensitivity . Therefore , the purpose of this study was to ascertain the effects of combined 16-week PRT and weight-loss diet on circulating adiponectin and insulin sensitivity index . Thirty-four obese ( BMI : 30 - 40 kg/m(2 ) ) women , aged 40 - 60 year , were r and omized to three groups : a control group ( C ; n = 9 ) ; a diet group ( WL ; n = 12 ) with a caloric restriction of 500 kcal/d ; and a diet plus resistance training group ( WL+RT ; n = 13 ) with the same caloric restriction as group WL and a 16-week supervised whole body PRT of two sessions/week . Both WL and WL+RT groups showed similar decreases in body mass ( -6.3 % and -7.7 % ) and visceral fat ( -19.9 % and -20.5 % ) . WL result ed in an expected increase in circulating levels of adiponectin ( P = 0.07 ) and insulin sensitivity . However , circulating total adiponectin decreased ( P < 0.05 ) in WL+RT group , whereas an improvement in different cardiovascular risk factors ( insulin sensitivity , low-density lipoprotein cholesterol ( LDL-C ) , etc . ) was observed . In conclusion , in obese women a 16-week combined PRT and weight-loss diet is accompanied by significant improvements in different cardiovascular risk factors in spite of a significant decrease of circulating adiponectin Background —Visceral fat is a key regulator site for the process of inflammation , and atherosclerotic lesions are essentially an inflammatory response . Methods and Results —Fifty-six healthy premenopausal obese women ( age range 25 to 44 years , body mass index 37.2±2.2 , waist to hip ratio range 0.78 to 0.92 ) and 40 age-matched normal weight women were studied . Compared with nonobese women , obese women had increased basal concentrations of tumor necrosis factor-&agr ; ( TNF-&agr ; , P < 0.01 ) , interleukin-6 ( IL-6 , P < 0.01 ) , P-selectin ( P < 0.01 ) , intercellular adhesion molecule-1 ( ICAM-1 , P < 0.02 ) , and vascular adhesion molecule-1 ( VCAM-1 , P < 0.05 ) . Vascular responses to l-arginine ( 3 g IV ) , the natural precursor of nitric oxide , were impaired in obese women : reductions in mean blood pressure ( P < 0.02 ) , platelet aggregation to adenosine diphosphate ( P < 0.05 ) , and blood viscosity ( P < 0.05 ) were significantly lower as compared with those in the nonobese group . Concentrations of TNF-&agr ; and IL-6 were related ( P < 0.01 ) to visceral obesity , as well as to adhesin levels and responses to l-arginine . After 1 year of a multidisciplinary program of weight reduction ( diet , exercise , behavioral counseling ) , all obese women lost at least 10 % of their original weight ( 9.8±1.5 kg , range 7.5 to 13 kg ) . Compared with baseline , sustained weight loss was associated with reduction of cytokine ( P < 0.01 ) and adhesin ( P < 0.02 ) concentrations and with improvement of vascular responses to l-arginine . Conclusion —In obese women , endothelial activation correlates with visceral body fat , possibly through inappropriate secretion of cytokines . Weight loss represents a safe method for downregulating the inflammatory state and ameliorating endothelial dysfunction in obese women QUESTIONS Does the PEDro scale measure only one construct ie , the method ological quality of clinical trials ? What is the hierarchy of items of the PEDro scale from least to most adhered to ? Is there any effect of year of publication of trials on item adherence ? Are PEDro scale ordinal scores equivalent to interval data ? DESIGN Rasch analysis of two independent sample s of 100 clinical trials from the PEDro data base scored using the PEDro scale . RESULTS Both sample s of PEDro data showed fit to the Rasch model with no item misfit . The PEDro scale item hierarchy was the same in both sample s , ranging from the most adhered to item r and om allocation , to the least adhered to item therapist blinding . There was no differential item functioning by year of publication . Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores ( r = 0.99 ) . CONCLUSION The PEDro scale is a valid measure of the method ological quality of clinical trials . It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists BACKGROUND Cross-sectional studies suggest that regular exercise has anti-inflammatory effects , leading to lower levels of several proatherogenic inflammatory markers . However , this has yet to be confirmed by r and omized prospect i ve trials . We performed a r and omized controlled trial to assess whether exercise training decreases levels of 5 inflammatory markers linked to future cardiovascular risk : white blood cell count , fibrinogen , C-reactive protein , soluble intercellular adhesion molecule 1 , and soluble CD40 lig and . METHODS One hundred fifty-two healthy female smokers were r and omized to either 12 weeks of exercise training or health education as part of a smoking cessation program . Smoking was held steady for the first 6 weeks , and thereafter , smoking cessation was actively attempted . One hundred four participants completed 6 weeks , and 88 completed 12 weeks . Fitness and circulating inflammatory marker levels were measured at baseline , 6 weeks , and 12 weeks . To avoid potential confounding from changes in smoking exposure during the second 6 weeks of the trial , the primary end point was change in inflammatory marker levels from baseline to 6 weeks . Change in inflammatory markers from baseline to 12 weeks was a secondary end point . RESULTS At baseline , greater physical fitness was associated with lower white blood cell , fibrinogen , and C-reactive protein levels , but these associations were not statistically significant after adjusting for body mass index ( P > .1 for all ) . Fitness improved significantly in the exercise group at both 6 and 12 weeks . However , there were no differences in levels of any inflammatory marker between the exercise and control groups at either 6 weeks ( primary end point ) or 12 weeks ( secondary end point ) ( P > .05 for all comparisons ) . CONCLUSION In female smokers , baseline associations between fitness and inflammatory markers were largely attributable to differences in body fat ; regular exercise did not reduce levels of any of the inflammatory markers studied despite a significant improvement in fitness at both 6 and 12 weeks CONTEXT Obesity is an independent risk factor for cardiovascular disease , which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue . OBJECTIVE To determine the effect of a program of \n Output:\n " }, { "from": "agent", "value": "Integrative interventions , including diet , moderate aerobic ( 60 % to 80 % of maximum heart rate , or 50 % to 60 % of VO2max ) and circuit resistance training ( 8 to 10 exercises , 8 to 12 repetitions ) , health education , and counseling , used together , appeared to be effective strategies to improve inflammatory biomarkers in women" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We recently published the results of a r and omised controlled trial of a nurse telephone consultation service in primary care out of hours.1 The new service , operating at evenings and weekends , significantly reduced general practitioners ’ workload and was at least as safe as the existing out of hours service . Contacts diminish sharply after about 10 pm,2 and , anecdotally , a higher proportion of night calls necessitate consultation with a general practitioner . We report here a parallel trial aim ed at establishing whether nurse telephone consultation was equally effective in managing workload at night Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first Health visitors were employed specifically to care for two years for a r and om sample of patients in general practice who were aged over 70 . Independent assessment s made at the beginning and end of the study showed that the health visitor in an urban practice had some impact on her caseload of patients ; she provided more services for them , their mortality was reduced , and their quality of life improved , though the last measure just failed to be statistically significant . The health visitor working in a rural practice had no such effect BACKGROUND We set out to investigate whether community nurses could be trained in problem-solving therapy and , once trained , how effective they would be in treating emotional disorders in primary care . METHOD Seventy patients with an emotional disorder in primary care were r and omly allocated to receive either problem-solving therapy from a trained community nurse or treatment as usual from their general practitioner . Interview and self-rated assessment s of clinical and economic outcome were made pretreatment , at eight weeks and at 26 weeks after treatment . RESULTS There was no difference in clinical outcome between patients who received problem-solving treatment and patients who received the general practitioner 's usual treatment . However , patients who received problem-solving treatment had fewer disability days and fewer days off work . The health care cost of problem-solving was greater than that of the general practitioner 's usual treatment but this was more than offset by savings in the cost of days off work . CONCLUSIONS Problem-solving treatment can be given by trained community nurses . The clinical effectiveness and cost-benefit of the treatment will depend on the selection of appropriate patients OBJECTIVE To evaluate the effect of a nurse-based intervention for patients with high total cholesterol ( TC ) levels in a community practice . DESIGN Clinical trial without a control followed by a nonr and omized control trial . SETTING Suburban primary care practice . PATIENTS White patients with TC higher than 6.21 mmol/L ( 240 mg/dL ) . In the initial trial , 82 patients with a mean TC level of 6.80 mmol/L ( 263 mg/dL ) . Fifty-three preponderantly female patients in the nonr and omized control trial with a mean TC level of 6.83 mmol/L ( 264 mg/dL ) . INTERVENTION Counseling by office nurses using the Eating Pattern Assessment Tool and h and outs with br and -specific food advice . In the initial study , patients attended up to 5 nurse counseling visits . In a follow-up study , intervention patients attending 2 or more counseling sessions were matched with other patients in the practice . MAIN OUTCOME MEASURES Eating Pattern Assessment Tool scores in the initial study and TC levels in both trials . RESULTS Mean Eating Pattern Assessment Tool scores at baseline in both studies demonstrated that intervention patients were already following a diet consistent with the National Cholesterol Education Program Step I Diet . In the initial study , mean TC levels of the patients declined 2 % ( P < .05 ) and mean Eating Pattern Assessment Tool score improved from 23.4 to 20.4 ( P < .001 ) . In the follow-up study , the mean TC level of all patients improved significantly ( P = .002 ) . However , the improvement of the intervention patients was no better than that of the comparison patients . CONCLUSION The nurse counseling intervention was not effective in patients already following a Step I Diet Practice nurses are playing an increasingly prominent role in preventive care , including the provision of anti-smoking advice during routine health checks . A r and omized controlled trial was design ed to assess the effectiveness of anti-smoking advice provided by nurses in helping smokers to stop smoking . A total of 14,830 patients aged 16 - 65 years from 11 general practice s completed a brief question naire on general health , including smoking status , at surgery attendance . The doctor identified 4330 smokers and r and omly allocated 4210 to control or intervention groups . The doctor asked those in the intervention group to make an appointment with the practice nurse for a health check . The attendance rate at the health check was 26 % . Smokers were sent follow-up question naires at one month and one year , and those who did not respond to two reminders were assumed to have continued to smoke . There was no significant difference in reported cessation between the intervention and control groups at one month or one year . However , there was a significant difference in the proportion of patients who reported giving up within one month and who had not lapsed by one year--0.9 % in controls and 3.6 % in the intervention group ( P less than 0.01 ) . Nevertheless , the effect of the nurse intervention itself may be small as the sustained cessation rate in attenders was only 42.4 % higher than in non-attenders . The deception rate in reporting cessation , as measured by urinary cotinine , was of the order of 25 % Objective To examine the impact on general practitioners ' workload of adding nurse practitioners to the general practice team . Design R and omised controlled trial with measurements before and after the introduction of nurse practitioners . Setting 34 general practice s in a southern region of the Netherl and s. Participants 48 general practitioners . Intervention Five nurses were r and omly allocated to general practitioners to undertake specific elements of care according to agreed guidelines . The control group received no nurse . Main outcome measures Objective workload , derived from 28 day diaries , included the number of contacts per day for each of three conditions ( chronic obstructive pulmonary disease or asthma , dementia , cancer ) , by type of consultation ( in practice , telephone , home visit ) , and by time of day ( surgery hours , out of hours ) . Subjective workload was measured by using a vali date d question naire . Outcomes were measured six months before and 18 months after the intervention . Results The number of contacts during surgery hours increased in the intervention group compared with the control group ( P < 0.06 ) , particularly for patients with chronic obstructive pulmonary disease or asthma ( P < 0.01 ) . The number of consultations out of hours declined slightly in the intervention group compared with the control group , but this difference did not reach significance . No significant changes became apparent in subjective workload . Conclusion Adding nurse practitioners to general practice teams did not reduce the workload of general practitioners , at least in the short term . This implies that nurse practitioners are used as supplements , rather than substitutes , for care given by general practitioners OBJECTIVE To compare the effects of three brief methods of reducing alcohol consumption among family practice patients . DESIGN Patients r and omly assigned to one of three interventions were assessed initially and at 3- , 6- , and 12-month follow-up appointments . SETTING Family practice clinic composed of 12 primary care physicians seeing approximately 6000 adults monthly in a small urban community , population 40,000 . PARTICIPANTS Through a screening question naire , 134 men and 131 women were identified as hazardous drinkers ( five or more drinks at least once monthly ) during an 11-month screening of 1420 patients . Of 265 patients approached , 180 agreed to participate and 159 ( 83 men and 76 women ) actually participated in the study . INTERVENTIONS Three interventions were studied : brief physician advice ( 5 minutes ) , two 30-minute sessions with a physician using cognitive behavioural strategies or two 30-minute sessions with a nurse practitioner using identical strategies . MAIN OUTCOME MEASURES Quantity and frequency ( QF ) of drinking were used to assess reduction in hazardous drinking and problems related to drinking over 12 months of follow up . RESULTS No statistical difference between groups was found . The QF of monthly drinking was reduced overall by 66 % ( among men ) and 74 % ( among women ) for those reporting at least one hazardous drinking day weekly at assessment ( N = 96 ) . Men reported drinking significantly more than women . CONCLUSIONS These results indicated that offering brief , specific advice can motivate patients to reduce their alcohol intake . There was no difference in effect between brief advice from their own physician or brief intervention by a physician or a nurse Abstract Objective : To determine the effectiveness of health checks , performed by nurses in primary care , in reducing risk factors for cardiovascular disease and cancer . Design : R and omised controlled trial . Setting : Five urban general practice s in Bedfordshire . Subjects : 2205 men and women who were r and omly allocated a first health check in 1989 - 90 and a re-examination in 1992 - 3 ( the intervention group ) ; 1916 men and women who were r and omly allocated an initial health check in 1992 - 3 ( the control group ) . All subjects were aged 35 - 64 at recruitment in 1989 . Main outcome measures : Serum total cholesterol concentration , blood pressure , body mass index , and smoking prevalence ( with biochemical validation of cessation ) ; self reported dietary , exercise , and alcohol habits . Results : Mean serum total cholesterol was 3.1 % lower in the intervention group than controls ( difference 0.19 mmol/l ( 95 % confidence interval 0.12 to 0.26 ) ; in women it was 4.5 % lower ( P<0.0001 ) and in men 1.6 % ( P<0.05 ) , a significant difference between the sexes ( P<0.01 ) . Self reported saturated fat intake was also significantly lower in the intervention group . Systolic and diastolic blood pressures and body mass index were respectively 1.9 % , 1.9 % , and 1.4 % lower in the intervention group ( P<0.005 in all cases ) . There was a 3.9 % ( 2.4 to 5.3 ) difference in the percentage of subjects with a cholesterol concentration > /=8 mmol/l , but no significant differences in the number with diastolic blood pressure > /=100 mm Hg or body mass index > /=30 kg/m2 . There was no significant difference between the two groups in prevalence of smoking or excessive alcohol use . Annual rechecks were no more effective than a single recheck at three years , but health checks led to a significant increase in visits to the nurse according to patients ' degree of cardiovascular risk . Conclusions : The benefits of health checks were sustained over three years . The main effects were to promote dietary change and reduce cholesterol concentrations ; small differences in blood pressure may have been attributable to accommodation to measurement . The benefits of systematic health promotion in primary care are real , but must be weighed against the costs in relation to other priorities . Key messages Key messages There is little effect on smoking or alcohol use , and more targeted approaches to modifying these behaviours may be appropriate Systematic implementation of health checks might lead to a reduction in risk of myocardial infa rct ion among those who attend of about 5 - 15 % ; men , who are at higher risk , show less change than women Health checks consume substantial re sources , and their effect is attenuated by non-attendance The benefits of health promotion through primary care must be weighed against their costs and in relation to other The Oxford and Collaborators Health CHECK Trial ( OXCHECK ) was a r and omized controlled trial of the effectiveness of nurse-administered health checks in the general practice setting . It was design ed primarily to influence risk factors for cardiovascular disease and cancer . The fourth and final year has now been completed , and the data analysis on over 8,100 health checks is under way . The \n Output:\n " }, { "from": "agent", "value": "Patient health outcomes were similar for nurses and doctors but patient satisfaction was higher with nurse-led care .\nNurses tended to provide longer consultations , give more information to patients and recall patients more frequently than did doctors .\nThe impact on physician workload and direct cost of care was variable .\nIn general , no appreciable differences were found between doctors and nurses in health outcomes for patients , process of care , re source utilisation or cost .\nAUTHORS ' CONCLUSIONS The findings suggest that appropriately trained nurses can produce as high quality care as primary care doctors and achieve as good health outcomes for patients .\nWhile doctor-nurse substitution has the potential to reduce doctors ' workload and direct healthcare costs , achieving such reductions depends on the particular context of care .\nDoctors ' workload may remain unchanged either because nurses are deployed to meet previously unmet patient need or because nurses generate dem and for care where previously there was none .\nSavings in cost depend on the magnitude of the salary differential between doctors and nurses , and may be offset by the lower productivity of nurses compared to doctors" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS AND OBJECTIVES To detect problems when classifying pressure ulcers and to examine whether an e-learning program is able to increase the classification skills of qualified nurses and nursing students . BACKGROUND Both the distinction between pressure ulcer grade s and the differentiation between moisture lesions is difficult . Misclassification and incorrect identification of the lesions results in inadequate preventive and therapeutic measures . Education and training are important for spreading evidence -based insights about this topic . DESIGN Repeated measure design , consisting of one pretest and three posttests . METHODS The experimental intervention consisted of a one-hour session during which the participants independently went over an e-learning program . The control intervention consisted of a one-hour lecture . Both interventions had the same learning contents . A convenience sample of 212 qualified nurses and 214 final-year nursing students was r and omly assigned to an experimental- and a control group . RESULTS In the pretest , the classification skills were low . After the intervention , these skills improved significantly in both groups . The nursing students achieved better results when using the e-learning program . Among the qualified nurses , there was no difference between the learning methods . Although the classification skills decreased in the posttests , they did not drop under the level of the pretest . CONCLUSION The actual classification system does not provide the necessary information about the severity of a pressure ulcer . The differential diagnosis between a moisture lesion was complicated . The classification skills of the qualified nurses and nursing students increased by both learning methods . Repetition remains , however , necessary . RELEVANCE TO CLINICAL PRACTICE Both instruction methods are adequate to acquire the knowledge about the differences between moisture lesions and pressure ulcers . E-learning allows study ing in one 's own time and place , and could therefore be very suitable for repetition of the training . How to organise this training could be a subject for further research BACKGROUND Pressure ulcers ( PUs ) are a problem in health care . Staff competency is paramount to PU prevention . Education is essential to increase skills in pressure ulcer classification and risk assessment . Currently , no pressure ulcer learning programs are available in Norwegian . OBJECTIVES Develop and test an e-learning program for assessment of pressure ulcer risk and pressure ulcer classification . METHODS DESIGN , PARTICIPANTS AND SETTING Forty-four nurses working in acute care hospital wards or nursing homes participated and were assigned r and omly into two groups : an e-learning program group ( intervention ) and a traditional classroom lecture group ( control ) . Data was collected immediately before and after training , and again after three months . The study was conducted at one nursing home and two hospitals between May and December 2012 . ANALYSIS Accuracy of risk assessment ( five patient cases ) and pressure ulcer classification ( 40 photos [ normal skin , pressure ulcer categories I-IV ] split in two sets ) were measured by comparing nurse evaluations in each of the two groups to a pre-established st and ard based on ratings by experts in pressure ulcer classification and risk assessment . Inter-rater reliability was measured by exact percent agreement and multi-rater Fleiss kappa . A Mann-Whitney U test was used for continuous sum score variables . RESULTS An e-learning program did not improve Braden subscale scoring . For pressure ulcer classification , however , the intervention group scored significantly higher than the control group on several of the categories in post-test immediately after training . However , after three months there were no significant differences in classification skills between the groups . CONCLUSION An e-learning program appears to have a greater effect on the accuracy of pressure ulcer classification than classroom teaching in the short term . For proficiency in Braden scoring , no significant effect of educational methods on learning results was detected The Braden Scale for Predicting Pressure Sore Risk was developed to foster early identification of patients at risk for forming pressure sores . The scale is composed of six subscales that reflect sensory perception , skin moisture , activity , mobility , friction and shear , and nutritional status . Content and construct validity were established by expert opinion and empirical testing . Three studies of reliability are reported here , using raters who varied in level of educational preparation and geographic region . Two prospect i ve studies of predictive validity were completed to determine the scale 's sensitivity and specificity . Reliability ranged from r = .83 to r = .94 for nurses ' aides and licensed practical nurses ; when used by registered nurses , the reliability increased to r = .99 . Predictive validity was calculated for each cut-off point of the scale . Using a cutoff point of 16 , sensitivity was 100 % in both studies . Specificity ranged from 64 % to 90 % . This instrument has highly satisfactory reliability when used by RNs , and greater sensitivity and specificity than instruments previously reported Abstract Background / Objective : To describe characteristics of recurrent pressure ulcers ( PrUs ) in veterans with spinal cord injury ( SCI ) . Design : Descriptive , cohort study . Setting s and Participants : Twenty-four veterans with SCI from 6 SCI centers in the Department of Veterans Affairs . Methods : Data from a prospect i ve study evaluating PrUs were analyzed for 24 veterans with 29 recurrent PrUs during 9 months . Additional retrospective medical record data were analyzed for 15 veterans who received inpatient treatment . Results : Participants were male , 50 % non-Hispanic white , with paraplegia ( 63 % ) , complete SCI ( 83 % ) , a mean age of 56 years , and mean time since SCI of 21 years . Most PrUs recurred ( 63 % , n = 15 patients ) in the same location as the most recent ulcer and at the ischial tuberosities ( 63 % ) . Mean time to recurrence was 16.6 weeks . PrUs were stage III ( 28 % , n = 8) or IV ( 45 % , n = 13 ) with undermining ( 48 % ) , necrotic slough ( 50 % ) , and minimal exu date . One third were ( n = 9 ) larger than 16 cm2 . Mean Bates-Jensen Wound Assessment Tool Score was 33.63 . Inpatient medical record data ( n = 15 ) showed 73 % with documentation indicating infection treated with antibiotics ( 53 % , n = 8 patients ) , osteomyelitis ( 47 % , n = 7 ) , and /or cellulitis ( 1 3 % , n = 2 ) noted . Plastic surgery consultation was obtained for 67 % with surgery as an option for 73 % ( 1 without consultation ) . Scheduled repositioning was documented for 21 % . Conclusions : Most PrUs were severe , located at the same anatomic site , and recurred within 4 months , suggesting that the recurrent ulcers were more likely incomplete healing of the initial PrUs . This sample of veterans with SCI provides early data on recurrent PrU characteristics OBJECTIVE : This article assesses the comparative prevention-effectiveness and economic implication s of a Pressure Ulcer Prevention Program ( PUPP ) against st and ard practice of prevention using Agency for Health Care Policy and Research ( now the Agency for Healthcare Research and Quality [ AHRQ ] ) guidelines and a mixture of commercial products . DESIGN : The study is a r and omized , controlled , prospect i ve cohort study with an accompanying economic evaluation . The economic evaluation is performed from the perspective of the nursing and rehabilitation centers . SETTING S : Two nursing and rehabilitation centers under the same quality and safety support organization . Both institutions are experiencing high nursing staff turnover and incidence of pressure ulcers ( PrUs ) . PARTICIPANTS : 133 residents at risk of developing PrUs ( EQUIP-for- Quality Risk Score Moderate to Very High [ MVH ] ) . All are Medicare-eligible residents with Minimum Data Set ( MDS ) 2.0 evaluations . INTERVENTIONS : The PUPP includes a strategic product bundle and decision algorithms driven by MDS 2.0 Resident Assessment Scores to assist in reducing or preventing PrUs and incontinence-associated skin conditions . The control group utilizes a different br and and assortment of commercial skin care products , briefs , pads , and mattresses , but without use of the decision algorithms driven by MDS 2.0 Resident Assessment Scores . Pressure ulcer prevention education was done for all nurses by a nurse certified in the PUPP program at the beginning and ad libitum by trained senior nursing staff at the end of the study . MAIN OUTCOME MEASURES : Comparative reduction in the incidence of nosocomial PrUs and average 6-month net cost savings per MVH-risk resident . METHODS : Residents were assessed for PrU risk using EQUIP-for- Quality risk assessment algorithm based on data from their Minimum Data Set ( MDS 2.0 ) , then assigned to either the PUPP program or control group ( st and ard practice following AHRQ guidelines ) . Residents were followed until discharge , death , development of PrU , or a maximum time period of 6 months . Direct medical costs of prevention and PrU treatment were recorded using a modified activity-based costing method . A decision model was used to estimate the net cost savings attributed to the PUPP program over a 6-month period . RESULTS : A 67 % reduction in the incidence of nosocomial pressure ulcers is attributable to the PUPP strategy over a 6-month period for MVH residents . The average 6-month cost for a MVH Medicare resident is $ 1928 and $ 1130 for the control group and PUPP group respectively . Mean difference ( net cost savings per resident at risk of pressure ulceration ) is $ 798 per resident for PUPP . CONCLUSIONS : PUPP assisted in reducing the incidence of PrUs by 67 % in a 6-month period in nursing home facilities . The estimated annual net cost savings attributed to PUPP for 300 MVH residents is estimated at approximately $ PURPOSE The purpose of the study was to determine if simply providing nursing facilities with comparative quality performance information and education about quality improvement would improve clinical practice s and subsequently improve resident outcomes , or if a stronger intervention , expert clinical consultation with nursing facility staff , is needed . DESIGN AND METHODS Nursing facilities ( n = 113 ) were r and omly assigned to one of three groups : workshop and feedback reports only , workshop and feedback reports with clinical consultation , and control . Minimum Data Set ( MDS ) Quality Indicator ( QI ) feedback reports were prepared and sent quarterly to each facility in intervention groups for a year . Clinical consultation by a gerontological clinical nurse specialist ( GCNS ) was offered to those in the second group . RESULTS With the exception of MDS QI 27 ( little or no activity ) , no significant differences in resident assessment measures were detected between the groups of facilities . However , outcomes of residents in nursing homes that actually took advantage of the clinical consultation of the GCNS demonstrated trends in improvements in QIs measuring falls , behavioral symptoms , little or no activity , and pressure ulcers ( overall and for low-risk residents ) . IMPLICATION S Simply providing comparative performance feedback is not enough to improve resident outcomes . It appears that only those nursing homes that sought the additional intensive support of the GCNS were able to effect enough change in clinical practice to improve resident outcomes significantly OBJECTIVE To identify the independent effect of pressure ulcers on excess length of stay and control for all observable factors that may also contribute to excess length of stay . Hospitalized patients who develop a pressure ulcer during their hospital stay are at a greater risk for increased length of stay as compared with patients who do not . DESIGN Cross-sectional , observational study . SETTING Tertiary-care referral and teaching hospital in Australia . PATIENTS Two thous and hospitalized patients 18 years and older who had a minimum stay in the hospital of 1 night and admission to selected clinical units . METHODS Two thous and participants were r and omly selected from 4,500 patients enrolled in a prospect i ve survey conducted between October 2002 and January 2003 . Quantile median robust regression was used to assess risk factors for excess length of hospital stay . RESULTS Having a pressure ulcer result ed in a median excess length of stay of 4.31 days . Twenty other variables were statistically significant at the 5 % level in the final model . CONCLUSIONS Pressure ulcers make a significant independent contribution to excess length of hospitalization beyond what might be expected based on admission diagnosis . However , our estimates were substantially lower than those currently used to make predictions of the economic costs of pressure ulcers ; existing estimates may overstate the true economic cost BACKGROUND Patients in hospitals and nursing homes are at risk for the development of often preventable adverse events . Guidelines for the prevention of many types of adverse events are available , however compliance with these guidelines appears to be lacking . As a result many patients do not receive appropriate care . We developed a patient safety program that allows organisations to implement multiple guidelines simultaneously and therefore facilitates guideline use to improve patient safety . This program was developed for three frequently occurring nursing care related adverse events : pressure ulcers , urinary tract infections and falls . For the implementation of this program we developed educational activities for nurses as a main implementation strategy . OBJECTIVES The aim of this study is to describe the effect of interactive and tailored education on the knowledge levels of nurses . DESIGN A cluster r and omised trial was conducted between September 2006 and July 2008 . SETTING S Ten hospital wards and ten nursing home wards participated in this study . Prior to baseline , r and omisation of the wards to an intervention or control group was stratified for centre and type of ward . PARTICIPANTS All nurses from participating wards . METHODS A knowledge test measured nurses ' knowledge on the prevention of pressure ulcers , urinary tract infections and falls , during baseline en follow-up . The results were analysed for hospitals and nursing homes separately . RESULTS After correction for baseline , the mean difference between the intervention and the control group on hospital nurses ' knowledge on the prevention of the three adverse events was 0.19 points \n Output:\n " }, { "from": "agent", "value": "None of the included studies explored our other primary outcome : change in health professionals ' clinical behaviour .\nWe are uncertain whether educating healthcare professionals about pressure ulcer prevention makes any difference to pressure ulcer incidence , or to nurses ' knowledge of pressure ulcer prevention ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy , a common and distressing experience . We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter . METHODS We conducted a multicentre r and omized , double-blind trial to compare the efficacy of 0.3 % nifedipine and 1.5 % lidocaine ointment versus 1.5 % lidocaine ointment alone in reducing pain after hemorrhoidectomy . A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale ( ACCS ) at baseline ; soon after surgery ; at 2 , 4 , 6 , 8 and 24 hours after surgery ; on day 7 after surgery ; and at a final visit 14 days after surgery . The physician also noted the time to first analgesic administration within 24 hours after surgery . RESULTS In all , 135 patients per group participated ( 270 total ) . Evaluation of the delta ACCS score versus basal value , a covariate for rescue analgesic administration time , revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 ( p < 0.011 and p < 0.054 , respectively ) . We noticed no difference between groups for time of administration of rescue analgesic , blood pressure , heart rate or frequency of headache . CONCLUSION Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy , the patients ' assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery . Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended . Further research focusing on these outcomes is warranted Background Milligan-Morgan excision haem-orrhoidectomy remains a very popular treatment modality for third and fourth degree haemorrhoids due to its cost effectiveness and good long-term results . The LigaSure tissue-sealing device is an alternative technique used in haemorrhoidectomy that has been shown to produce favourable results . The aim of this study was to assess the effectiveness of the LigaSure tissue sealing device in comparison with conventional diathermy haemorrhoidectomy Methods A prospect i ve clinical trial was conducted . Patients with newly diagnosed haemorrhoids requiring haemorrhoidectomy were r and omized to either LigaSure haemorrhoidectomy or diathermy haemorrhoidectomy . Surgical technique and postoperative care was st and ardized . Outcome measures were operative time and bleeding , postoperative pain ( measured on a visual analogue scale ) and rate of wound healing Results We r and omized 44 patients , 22 to LigaSure and 22 to diathermy ; 43 patients were evaluated . They were aged between 19 and 71 years . There were no differences in patient demographics or type of haemorrhoid being operated on . LigaSure haemorrhoidectomy had a significantly lower mean operative time and intraoperative bleeding . At 3 weeks after surgery , haemorrhoidectomy performed with LigaSure had an odds ratio for complete epithelialization of 3.1 over diathermy ( 95 % CI 1.2–8.2 ) . There was no difference in postoperative pain Conclusion LigaSure haemorrhoidectomy is superior to diathermy for open Objective To determine whether a combination of topical anesthetic ( EMLA ) and local injection with lidocaine is better than lidocaine alone for pain relief after Ferguson hemorrhoidectomy . Methods Sixty patients scheduled for hemorrhoidectomy were r and omized into 2 groups : ( 1 ) control group ( CG , n=30 ) received neomycin ointment ( 5 g ) , and ( 2 ) EMLA group ( EG , n=30 ) received EMLA ( 5 g ) , both agents applied topically after surgery . Before the surgical incision was made , lidocaine ( 10 mL of a 1 % solution ) was locally injected into all 60 patients . After surgery , analgesics were provided when necessary . The visual analog scale score was recorded at 4 time points : ( 1 ) upon arrival in the postanesthesia room , ( 2 ) 2 hours after arriving in the postanesthesia room , ( 3 ) between 9 and 10 PM on the first postoperative evening , and ( 4 ) on the first postoperative morning . The frequency of meperidine requests , 1-time catheterizations for urinary retention , and patient satisfaction with postoperative pain management , were also recorded . Results The median visual analog scale scores and cumulative dosages of meperidine were significantly lower in the EG than the CG ( P<0.05 ) . Patient satisfaction with postoperative pain control was also significantly higher in the EG than the CG ( P<0.01 ) . No systemic complications occurred . Discussion EMLA is considered a breakthrough in cutaneous analgesia , capable of reducing pain in many cutaneous procedures . Because Ferguson hemorrhoidectomy has been performed for years with ongoing concerns over postoperative pain , we felt that using EMLA could lower postoperative pain intensity and the number of requests for additional medication Purpose We compared the efficacy and side effects of diclofenac and a topical eutectic mixture of local anesthetics ( EMLA ) for pain relief after hemorrhoidectomy . Methods Ninety patients , nominated for elective hemorrhoidectomy , were recruited for this r and omized clinical trial and were r and omly categorized into three groups ( 30 patients in each group ) . After surgery , the patients in the first group received one 100 mg diclofenac suppository , those in the second group received 5 g of EMLA , and those in the third group received 5 g of petrolatum ointment ( control group ) . The pain intensity was measured using a visual analog scale ( VAS ) . Twenty-five mg of intramuscular pethidine was administered upon the patient ’s request . Pain measurements were performed on the patient ’s transfer to the recovery ward , 2 h after surgery , the evening and the morning after surgery . Results The EMLA group yielded the lowest VAS score on transfer to recovery and at 2 h after surgery ( p < 0.05 ) . The diclofenac group reported the lowest VAS score in the evening and the morning after surgery ( p < 0.05 ) . Conclusions Topical use of an EMLA cream is appropriate for short-term pain control following hemorrhoidectomy , while diclofenac yields a more sustainable pain control OBJECTIVES Control of postoperative symptoms is of paramount importance in proctologic surgery . Phlebotropic activity , protective effect on the capillaries and anti-inflammatory properties of the flavonoids have been reported in several studies . They have been used to treat a variety of conditions including chronic venous insufficiency , lymphedema and hemorrhoids . Numerous trials , assessing the effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease , suggest that there is a potential benefit . Our trial was conducted to evaluate whether the flavonoids reduce postoperative bleeding , pain and other symptoms after hemorrhoidectomy . PATIENTS AND METHODS We compared the results obtained in 24 patients undergoing open hemorrhoidectomy with radiofrequency scalpel . Our study cohort was r and omized in two groups : the Group A received flavonoids in the postoperative period , the Group B has constituted the control group , without administration of study drug . Follow-up outpatient visits were performed on 7 , 15 and 30 postoperative day ( POD ) . During the visits the patients expressed trough a list of specific questions , based on a scoring system ( 1 to 10 ) , their opi-nion about the extent of postoperative symptoms as pain , bleeding , tenesmus , pruritus and perianal weight . RESULTS We observed that the results obtained after 7 days of surgery are similar in both study groups . Even after 15 and 30 days no significant changes were observed between the two groups about pain and bleeding . Instead , we observed significant differences regarding tenesmus ( group A : 8.0±1.1 vs Group B : 5.4 ± 1.5 at 15 POD , p < 0.05 ; group A : 9.1±0.8 vs Group B : 5.7 ± 0.9 at 30 POD , p < 0.05 ) , pruritus ( group A : 7.1 ± 1.4 vs Group B : 4.8 ± 1 at 15 POD , p < 0.05 ; group A : 9.5 ± 0.5 vs Group B : 6.6 ± 0.8 at 30 POD , p < 0.05 ) and perianal weight ( group A : 7.2 ± 0.9 vs Group B : 6.2 ± 0.8 at 15 POD , p < 0.05 ; group A : 9.75 ± 0.4 vs Group B : 7.3 ± 0.9 at 30 POD , p < 0.05 ) . CONCLUSIONS Our results confirm the usefulness of this drug to reduce the prevalence and the importance of post-hemorrhoidectomy symptoms and make more comfortable the postoperative period Background In the past decade , several new surgical tools have revived the hope for an improved technique to treat radically hemorrhoids with less postoperative pain . Among these radiofrequency ( RF ) , excisional surgery seems to be safe , fast , and accompanied by less postoperative pain . The aim of this study was to evaluate and compare RF ( ligasure TM ) to conventional diathermy Milligan-Morgan hemorrhoidectomy ( MMH ) . Patients and methods Between January 2003 and July 2009 , 210 symptomatic patients were r and omized to undergo RF ( 118 patients ) or diathermy MMH ( 92 patients ) . Mean follow-up was 39 ± 16 months . Clinical outcome was assessed by vali date d question naire on postoperative symptoms and satisfaction . Primary endpoints were pain and wound healing . Secondary endpoints were operative time , early and late complications ( including recurrences ) , and patient satisfaction . Data was analyzed using chi-squared test and Fisher ’s exact test . Results Despite postoperative pain was less after RF , this difference was significant only for severe pain ( expressed as VAS score > 7 ) . Significant differences were observed in terms of wound healing . The two techniques were similar in terms of early and late complications . Conclusions RF hemorrhoidectomy is followed by reduced severe pain and better wound healing . However , in our experience , this is not followed by earlier return to daily activities Background Hemorrhoid is one of the most common surgical diseases occurring in the anorectal region . In this study , we evaluated the effect of ischiorectal fossa block on alleviating post hemorrhoidectomy pain . Methods In this study , 90 patients suffering from hemorrhoids were evaluated . They were r and omly divided into 3 groups . The first group had no block , the second group an ischiorectal block with placebo ( normal saline ) , and the third group a preemptive ischiorectal block with bupivacaine . Postoperative variables such as pain intensity , pethidine consumption , nausea , and vomiting were compared between the groups . Results The postoperative pain score in group 1 was 8.5 ± 1.3 and 8.1 ± 0.9 ( P = NS ) in group 2 . The post operative analgesic dem and was 3.1 ± 1.5 and 3.3 ± 1.8 hours in groups 1 and 2 , respectively ( P = NS ) . The post operative pain score and analgesic dem and were 4.2 ± 2.1 and 9.3 ± 2.7 hours , respectively , in group 3 ( P < 0.0001 ) . Conclusions Preemptive ischiorectal block reduces the posthemorrhoidectomy pain and opioid dem and INTRODUCTION Hemorrhoidal disease occurs in 50 % of people aged > 40 years and is the most common reason for anorectal surgery . Pain is the main complication . Multiple topical and systemic drugs have been investigated for pain control , but there is no ideal treatment . Metronidazole has been shown to decrease postoperative pain but is not used widely . OBJECTIVE To evaluate the effect of oral metronidazole versus placebo and to assess postoperative pain following hemorrhoidectomy . MATERIAL AND METHODS Controlled clinical trial in adult patients who underwent elective hemorrhoidectomy for grade III/IV hemorrhoids . Patients were assigned to receive metronidazole ( 500 mg q8 h orally ; study group , SG ) or placebo ( control group , CG ) for 7 days after surgery . Pain was assessed using a visual analog scale after surgery . Analgesic administration ( time and use of analgesics ) and resumption of daily life activities were also assessed . RESULTS Forty-four patients were included , 22 in each group . Postoperative pain differed significantly between the SG and CG at 6 h ( 3.86 ± 0.56 , 6.64 ± 1.49 ) , 12 h ( 5.59 ± 1.33 , 8.82 ± 0.79 ) , 24 h ( 6.86 ± 1.49 , 9.73 ± 0.45 ) , day 4 ( 5.32 ± 2.10 , 9.50 ± 0.59 ) , day 7 ( 3.14 \n Output:\n " }, { "from": "agent", "value": "Conclusion Pudendal nerve block , with or without general anaesthesia , is recommended for all patients undergoing haemorrhoidal surgery .\nEither closed haemorrhoidectomy , or open haemorrhoidectomy with electrocoagulation of the pedicle is recommended as the primary procedure ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A double-blind controlled therapeutic trial of factorial design was used to study the therapeutic effects of lorazepam , hyoscine butylbromide , and ispaghula husk in 12 r and omised blocks of eight patients with the irritable bowel syndrome ( IBS ) . Each of the three agents caused a sustained symptomatic improvement in some of the patients , although only with ispaghula was the difference between the real and dummy preparation statistically significant . When the eight possible combinations of treatment were analysed none of the 12 patients who received only dummy preparations of the three agents had maintained any improvement over the three months of the trial . Seven patients improved among the 12 who received potent preparations of all three agents , and between four and six patients improved in the groups receiving one or two of the potent preparations . These therapeutic results , though far from perfect , show that the types of drug commonly used to treat IBS are of some value and may be additive in their effects . Similar combinations of other therapeutic agents may be more effective , but it will be possible to determine this only by carrying out factorial therapeutic trials This placebo controlled , double-blind , cross-over trial involving 20 patients was conducted to assess the effect of ispaghula husk on the major bowel symptoms and the whole gut transit time in irritable bowel syndrome ( IBS ) and to determine if changes in these parameters were related to global improvement . All 20 patients were interviewed at the end of the treatment periods and 14 patients kept concurrent daily records . Ispaghula therapy result ed in improvement in global symptoms and satisfying bowel movements ( P less than 0.001 ) but produced no change in abdominal pain or flatulence . There was a correlation between the improvement of well-being and the number of days of satisfying bowel movements ( P less than 0.001 ) but not with the indexes of pain , stool frequency or changes in the transit time . The easing of bowel dissatisfaction appears to be a major reason for the therapeutic success of ispaghula in IBS A double blind placebo controlled trial of ispaghula husk in 80 patients with irritable bowel syndrome is reported . Global assessment judged treatment to be satisfactory in 82 % of patients receiving ispaghula and 53 % of the placebo group ( p less than 0.02 ) . Bowel habit was unchanged in the placebo group , while constipation significantly improved in patients taking ispaghula ( p = 0.026 ) . Transit time decreased significantly in those taking ispaghula compared with placebo ( p = 0.001 ) , especially in patients with initially high transit times . Abdominal pain and bloating improved in both groups , with no significant differences between ispaghula and placebo . Four of the eight withdrawals on ispaghula and 10 of the 15 withdrawals on placebo were because of treatment failure . Ispaghula significantly improves overall well being in patients with irritable bowel syndrome , and in those with constipation favourably affects bowel habit and transit time Comment Our results confirm that the natural defences of the peritoneum can deal successfully with infection if unhampered by the dialysis fluid . ' Temporary interruption of dialysis avoids protein loss and fluid retention due to peritoneal inflammation , limits the use of costly or toxic antibiotics , and preserves remaining renal function . We found that our patients , having been treated by interruption of dialysis once , subsequently tended to refer themselves early in the hope of being able to receive this short treatment again . The treatment avoids the loss of phagocytic cells and opsonins that occurs during dialysis and allows these cells to be concentrated into a small volume of peritoneal fluid , thus increasing the chance of phagocytosis . It also avoids the detrimental effect of dialysis fluid on phagocytic cells,2 which may enhance survival of bacteria within leucocytes,3 and on the mesothelial cells.4 Interruption of dialysis was regularly effective and was not detrimental to peritoneal function . We believe that this was because of our careful selection of cases and recommend that the treatment is used only in the absence of contraindications . Immediate failure of this treatment was unusual . If not due to the presence of unusual pathogens it would suggest persisting infection from colonisation of the catheter or , if infection were present at the exit site , covert infection around the catheter . In either case the catheter should be removed , as in relapse of peritonitis after conventional A r and omized , double-blind trial of a psyllium preparation was initiated in 77 patients with painful irritable bowel syndrome . Sixty- patients finished and su bmi tted symptom data for 8 weeks while taking placebo ( n = 34 ) or psyllium ( n = 26 ) . Increase in normal stools and decrease in pain severity ( p less than 0.05 ) occurred equally in both groups . Subjective improvement was reported by 24 of 34 patients on placebo and 20 or 26 on psyllium ( p greater than 0.05 ) . Five symptom variables were significantly correlated ( p less than 0.05 ) with patient 's subjective global assessment ( R = 0.64 ) . Discriminant analysis of Minnesota Multiphasic Personality Inventory variables yielded overall rates of correct prediction of 66.1 % for whether patients got \" much better \" and 77.9 % for whether they voluntarily dropped from the study . A major placebo effect occurs in patients with painful irritable bowel syndrome and is probably responsible for the efficacy of psyllium . Personality factors influence the magnitude of therapeutic response and whether patients discontinue treatment within 8 weeks \n Output:\n " }, { "from": "agent", "value": ": Soluble fiber is effective in treating IBS .\nBran did not appear to be of benefit , although we did not uncover any evidence of harm from this intervention , as others have speculated from uncontrolled data" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Immunosuppressive regimens with the fewest possible toxic effects are desirable for transplant recipients . This study evaluated the efficacy and relative toxic effects of four immunosuppressive regimens . METHODS We r and omly assigned 1645 renal-transplant recipients to receive st and ard-dose cyclosporine , mycophenolate mofetil , and corticosteroids , or daclizumab induction , mycophenolate mofetil , and corticosteroids in combination with low-dose cyclosporine , low-dose tacrolimus , or low-dose sirolimus . The primary end point was the estimated glomerular filtration rate ( GFR ) , as calculated by the Cockcroft-Gault formula , 12 months after transplantation . Secondary end points included acute rejection and allograft survival . RESULTS The mean calculated GFR was higher in patients receiving low-dose tacrolimus ( 65.4 ml per minute ) than in the other three groups ( range , 56.7 to 59.4 ml per minute ) . The rate of biopsy-proven acute rejection was lower in patients receiving low-dose tacrolimus ( 12.3 % ) than in those receiving st and ard-dose cyclosporine ( 25.8 % ) , low-dose cyclosporine ( 24.0 % ) , or low-dose sirolimus ( 37.2 % ) . Allograft survival differed significantly among the four groups ( P=0.02 ) and was highest in the low-dose tacrolimus group ( 94.2 % ) , followed by the low-dose cyclosporine group ( 93.1 % ) , the st and ard-dose cyclosporine group ( 89.3 % ) , and the low-dose sirolimus group ( 89.3 % ) . Serious adverse events were more common in the low-dose sirolimus group than in the other groups ( 53.2 % vs. a range of 43.4 to 44.3 % ) , although a similar proportion of patients in each group had at least one adverse event during treatment ( 86.3 to 90.5 % ) . CONCLUSIONS A regimen of daclizumab , mycophenolate mofetil , and corticosteroids in combination with low-dose tacrolimus may be advantageous for renal function , allograft survival , and acute rejection rates , as compared with regimens containing daclizumab induction plus either low-dose cyclosporine or low-dose sirolimus or with st and ard-dose cyclosporine without induction . ( Clinical Trials.gov number , NCT00231764 [ Clinical Trials.gov ] . ) OBJECTIVES Basiliximab is used alongside tacrolimus-based immunosuppression for routine induction therapy , even for well-matched living-donor renal transplant recipients . Because tacrolimus is a different drug from cyclosporine , this study examined the utility of tacrolimus-based immunosuppression without basiliximab for well-matched living-donor renal transplant recipients . MATERIAL S AND METHODS This prospect i ve study evaluated 36 patients who underwent 1 to 3 human leukocyte antigens mismatched living-donor renal transplants without basiliximab induction therapy between April 2012 and March 2015 ( group 1 ) . All transplants were ABO compatible and T-flow negative and were followed until April 2015 . Tacrolimus-based triple therapy was used for maintenance immunosuppression . The control group comprised 72 age- and sex-matched patients who underwent 1 to 3 human leukocyte antigens mismatched living-donor renal transplants with basiliximab induction therapy during the same period ( group 2 ) . RESULTS Two patients in group 1 and 12 patients in group 2 had infection , with cytomegalovirus infection and Pneumocystis pneumonia infection occurring only in group 2 and BK virus and urinary tract infection reported in both groups , with a similar incidence . One patient from group 2 had sepsis . Although the incidence of infection tended to be lower in group 1 than in group 2 ( 5.6 % vs 16.7 % ) , the overall incidence of infection was not significantly different ( P=.135 ) . In addition , there were no significant differences in incidence of acute rejection between groups 1 and 2 ( 2.8 % vs 4.2 % ; P=.699 ) . All patients showed stable renal function after treatment . CONCLUSIONS Tacrolimus-based triple drug maintenance immunosuppression without basiliximab might be an optimal treatment choice for individuals undergoing well-matched living-donor renal transplant Background . Sequential anti-thymocyte globulins (ATG)/cyclosporine immunosuppression has two main advantages : delayed introduction of the nephrotoxic drug cyclosporine and prevention of acute rejection . Basiliximab , a recently developed chimeric monoclonal antibody that selectively depletes the minor sub population of activated T lymphocytes , has been shown to reduce the incidence of acute rejection when used with cyclosporine introduced on day 1 . Methods . This open , r and omized , multicenter study was undertaken to compare the safety and efficacy of ATG versus basiliximab induction therapy ( IT ) with delayed introduction of cyclosporine for microemulsion ( Neoral ) in 105 low immunologic risk renal-transplant patients receiving mycophenolate mofetil and steroids . Results . One-year patient and graft survival rates were 98.1 % and 94.2 % , respectively , in the basiliximab group ( n=52 ) , and 98.1 % and 96.2 % in the ATG group ( n=53 ) . The incidence of biopsy-confirmed acute rejection was comparable ( basiliximab 9.6 % , ATG 9.4 % ) , as were key parameters of renal function , notably serum creatinine levels , time-to-nadir serum creatinine , and the number of patients requiring posttransplantation dialysis ( basiliximab 28.8 % , ATG 30.2 % ) . However , significantly fewer patients in the basiliximab group experienced cytomegalovirus ( CMV ) infection , leukopenia , and thrombocytopenia , and this without any significant difference in any other key safety parameters ( including the incidences of serum sickness , fever , lymphoma , and infections in general ) . Conclusions . Both ATG and basiliximab , when used for IT in a sequential protocol , are equally effective in terms of graft and patient survival as well as at preventing acute rejection . However , basiliximab is associated with a lower incidence of certain key adverse events , namely CMV infection , leukopenia , and thrombocytopenia BACKGROUND Monoclonal antibodies that block the high-affinity interleukin-2 receptor expressed on alloantigen-reactive T lymphocytes may cause selective immunosuppression . Daclizumab is a genetically engineered human IgG1 monoclonal antibody that binds specifically to the alpha chain of the interleukin-2 receptor and may thus reduce the risk of rejection after renal transplantation . METHODS We administered daclizumab ( 1.0 mg per kilogram of body weight ) or placebo intravenously before transplantation and once every other week afterward , for a total of five doses , to 260 patients receiving first cadaveric kidney grafts and immunosuppressive therapy with cyclosporine , azathioprine , and prednisone . The patients were followed at regular intervals for 12 months . The primary end point was the incidence of biopsy-confirmed acute rejection within six months after transplantation . RESULTS Of the 126 patients given daclizumab , 28 ( 22 percent ) had biopsy-confirmed episodes of acute rejection , as compared with 47 of the 134 patients ( 35 percent ) who received placebo ( P=0.03 ) . Graft survival at 12 months was 95 percent in the daclizumab-treated patients , as compared with 90 percent in the patients given placebo ( P=0.08 ) . The patients given daclizumab did not have any adverse reactions to the drug , and at six months , there were no significant differences between the two groups with respect to infectious complications or cancers . The serum half-life of daclizumab was 20 days , and its administration result ed in prolonged saturation of interleukin-2alpha receptors on circulating lymphocytes . CONCLUSIONS Daclizumab reduces the frequency of acute rejection in kidney-transplant recipients BACKGROUND Currently available immunosuppressive regimens for cadaver-kidney recipients are far from ideal because acute-rejection episodes occur in about 30 % to 50 % of these patients . In the phase III study described here we assessed the ability of basiliximab , a chimeric interleukin (IL)-2 receptor monoclonal antibody , to prevent acute-rejection episodes in renal allograft recipients . METHODS 380 adult recipients of a primary cadaveric kidney transplant were r and omly allocated , in this double-blind trial , to receive a 20 mg infusion of basiliximab on day 0 ( day of surgery ) and on day 4 , to provide IL-2-receptor suppression for 4 - 6 weeks ( n=193 ) , or to receive placebo ( n=187 ) . Both groups received baseline dual immunosuppressive therapy with cyclosporin and steroids throughout the study . The primary outcome measure was incidence of acute-rejection episodes during the 6 months after transplantation . Safety and tolerability were monitored over the 12 months of the study . FINDINGS 376 patients were eligible for intention-to-treat analysis ( basiliximab , n=190 ; placebo , n=186 ) . No significant differences in patient characteristics were apparent . The incidence of biopsy-confirmed acute rejection 6 months after transplantation was 51 ( 29.8 % ) of 171 in the basiliximab group compared with 73 ( 44.0 % ) of 166 in the placebo group ( 32 % reduction ; 14.2 % difference [ 95 % Kaplan-Meier CIs 3 % to 24 % ] , p=0.012 ) . The incidence of steroid-resistant first rejection episodes that required antibody therapy was significantly lower in the basiliximab group ( 10 % vs 23.1 % , 13.1 % difference [ 5.4 % to 20.8 % ] , p<0.001 ) . At weeks 2 and 4 post-transplantation , the mean daily dose of steroids was significantly higher in the placebo group ( p<0.001 with one-way analysis of variance ) . The incidence of graft loss at 12 months post-transplantation was 23 ( 12.1 % ) of 190 in the basiliximab group and 25 ( 13.4 % ) of 186 in the placebo group ( 1.3 % difference [ -5 % to 9 % ] , p=0.591 ) . The incidence of infection and other adverse events was similar in the two treatment groups . The acute tolerability of basiliximab was excellent , with no evidence of cytokine-release syndrome . 14 deaths ( basiliximab n=9 ; placebo n=5 ; -2.0 % difference [ -6 % to 2 % ] , p=0.293 ) occurred during the 12-month study and a further three deaths ( basiliximab n=1 ; placebo n=2 ) occurred within the 380-day cut-off period . One post-transplantation lymphoproliferative disorder was recorded in each group . INTERPRETATION Prophylaxis with 40 mg basiliximab reduces the incidence of acute rejection episodes significantly , with no clinical ly relevant safety or tolerability concerns There is little experience on the use of monoclonal antibodies that block the high-affinity interleukin-2 receptor ( basiliximab and daclizumab ) in sequential therapy in renal transplants with risk of delayed graft function . This study sougth to test the efficacy and safety of the substitution of anticalcineurins with two doses of basiliximab or daclizumab in the immediate posttransplant period for recipients at risk of delayed renal graft function . Immunosuppression consisted of steroids , mycophenolate mofetil , and two doses of basiliximab ( 20 mg/day ) on days 0 and 4 posttransplant or daclizumab ( 1 mg/kg per day ) on days 0 and 15 posttransplant . Anticalcineurins were not administered until the beginning of graft function . Among 49 recipients ( mean age 63.5 + /- 10.5 years ) , 40 received a kidney from a donor over 60 years of age , three from a non-heart-beating donor , and six from donors with an acute elevation of serum creatinine to 2.4 + /- 0.86 ( 1.7 - 3.7 ) . At a mean follow-up of 14.2 + /- 8.4 months , five patients experienced acute rejection episodes . Only 15 patients \n Output:\n " }, { "from": "agent", "value": "Forest plot analysis for rate of rejection during the follow-up period post-transplant showed no significant difference between the groups .\nConclusion IL-2R antibody induction therapy has no significant effect on the rate of rejection or patient or graft survival in st and ard-risk renal transplant recipients on tacrolimus-based maintenance immunotherapy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Patients with isolated limb injuries are often required to wait a long time for treatment and investigation in emergency departments . It was hypothesized that allowing triage nurses to initiate X-rays would reduce transit times for these patients . A prospect i ve , r and omized comparison trial of 175 patients was conducted , comparing transit times between a group of patients who had X-rays initiated at triage and a group which did not . No statistically significant reduction in transit time was demonstrated by this change in practice , either for a group who had sustained fractures or for one which had not . Despite this finding , staff and patient satisfaction with this change in procedure was high . This justifies continuation of the practice and further research OBJECTIVE To compare outcomes of nurse initiated X-rays ( NIX ) with emergency physician ( EP ) initiated X-rays ( EPIX ) of isolated lower limb injuries in patient transit time ( from triage to discharge ) through the emergency department ( ED ) . METHOD A prospect i ve , interventional study using a historical control group . Data were collected at each contact point from triage ( including time of EP 's initial assessment of patient , X-ray request and review , patient disposition decision and discharge time ) . Initially , data were collected as patients proceeded through the ED having X-rays requested after EP assessment . Following nurse education on use of pre-vali date d foot , ankle and knee X-ray decision instruments , similar data were collected following nurse X-ray request . Time differences between the two groups were compared . RESULTS A total of 206 patients were enrolled , with 105 having EPIX and 101 NIX . Group characteristics were not significantly different . Fractures were identified in 26.7 % of EPIX compared to 34.7 % of NIX ( p=0.300 ) . Despite an observed reduction in the mean transit time ( 172.9minutes ( min ) for EPIX to 158.6min for NIX ) this did not achieve statistical significance ( p=0.230 ) . There were significant differences in times from triage to initial assessment by EP ( mean 57.6min EPIX , 93.4min NIX , p<0.001 ) ( median 45.0min in EPIX , 78.0min in NIX group , p<0.001 ) which delayed transit time in the NIX group . CONCLUSION Although NIX reduced patient transit times , this did not reach statistical significance . In an ED with substantial access block , this suggests that corresponding systems changes are required to improve ED flow Aims : To compare the clinical effectiveness and costs of minor injury services provided by nurse practitioners with minor injury care provided by an accident and emergency ( A&E ) department . Methods : A three part prospect i ve study in a city where an A&E department was closing and being replaced by a nurse led minor injury unit ( MIU ) . The first part of the study took a sample of patients attending the A&E department . The second part of the study was a sample of patients from a nurse led MIU that had replaced the A&E department . In each of these sample s the clinical effectiveness was judged by comparing the “ gold st and ard ” of a research assessment with the clinical assessment . Primary outcome measures were the number of errors in clinical assessment , treatment , and disposal . The third part of the study used routine data whose collection had been prospect ively configured to assess the costs and cost consequences of both models of care . Results : The minor injury unit produced a safe service where the total package of care was equal to or in some cases better than the A&E care . Significant process errors were made in 191 of 1447 ( 13.2 % ) patients treated by medical staff in the A&E department and 126 of 1313 ( 9.6 % ) of patients treated by nurse practitioners in the MIU . Very significant errors were rare ( one error ) . Waiting times were much better at the MIU ( mean MIU 19 minutes , A&E department 56.4 minutes ) . The revenue costs were greater in the MIU ( MIU £ 41.1 , A&E department £ 40.01 ) and there was a great difference in the rates of follow up and with the nurses referring 47 % of patients for follow up and the A&E department referring only 27 % . Thus the costs and cost consequences were greater for MIU care compared with A&E care ( MIU £ 12.7 per minor injury case , A&E department £ 9.66 per minor injury case ) . Conclusion : A nurse practitioner minor injury service can provide a safe and effective service for the treatment of minor injury . However , the costs of such a service are greater and there seems to be an increased use of outpatient services OBJECTIVE --To evaluate whether waiting time in accident and emergency ( A&E ) departments is shortened when experienced nurses request peripheral limb radiographs before a patient is assessed by a doctor . DESIGN --Simultaneous prospect i ve trial in four A&E departments in the United Kingdom with doctors and nurses requesting radiographs ; 2000 patients were r and omly allocated to either a \" Nurse First \" or \" Doctor First \" category . SUBJECTS-- Patients older than 5 years presenting with recent peripheral limb injuries . MAIN OUTCOME MEASURES --Timing of the various stages of a patient 's passage through the A&E department comparing the orthodox route with a group of patients in whom an experienced A&E nurse had the option of requesting a radiograph before a medical assessment . RESULTS --There was a significant reduction in the time spent in A&E when no radiograph was requested ( P < < 0.001 ) . The mean time saved in the \" Doctor First \" ( DF ) group was 51 min , and in the \" Nurse First \" ( NF ) group 36 min . For those who were sent for an x ray 14 min was saved by getting the patient to see the nurse first . However , because the overall referral rate for x rays was greater in the NF group , ( 78 % of patients compared with 74 % of the DF group , a significant 4 % increase ( P = 0.05 ) this potential benefit was largely lost . Overall the average waiting time in the DF group of 92.5 min ( 95 % confidence interval : 89.2 to 96.1 min ) was reduced to 88.5 min ( 95 % CI:85.2 to 91.8 min ) in the NF group , a non-significant saving of 4 min . There was no overall difference between the proportion of relevant abnormalities reported by the radiologists for the DF or NF groups ( G2 = 0.739 , 1df , P = 0.30 ) ; however , there was a significant association between the number of relevant abnormalities reported by the radiologists and the different hospitals ( G2 = 9.7626 , 3df , P = 0.02 ) . Hospital C had the highest abnormality rate reported by the radiologists in both the DF ( 45 % ) and the NF ( 51 % ) groups . The most time saved in A&E was in the DF category when comparing those who did not have an x ray [ 58 ( CI 54 - 63 ) min ] with those who did [ 109 ( CI 104 - 114 ) min ] , a saving of 51 min . The corresponding time saved in the NF category between those who did not have an x ray [ 59 ( CI 53 - 65 ) min ] and those who did [ 95 ( CI 91 - 99 ) min ] was 36 min . CONCLUSIONS --14 min can be saved by getting the patient to see the nurse first ; however , because nurses in three out of four hospitals requested more radiological examinations than doctors , overall only 4 min waiting time was saved when peripheral limb radiographs were requested by nurses . The findings are somewhat against expectations but do identify that specific training and constant monitoring is essential if nurses are to request peripheral limb radiographs , as reflected in hospital C results In the emergency department ( ED ) Registered Nurses ( RNs ) often perform triage , i.e. the sorting and prioritizing of patients . The allocation of acuity ratings is commonly based on a triage scale . To date , three reliable 5-level triage scales exist , of which the Canadian Triage and Acuity Scale ( CTAS ) is one . In Sweden , few studies on ED triage have been conducted and the organization of triage has been found to vary considerably with no common triage scale . The aim of this study was to investigate the accuracy and concordance of emergency nurses acuity ratings of patient scenarios in the ED setting . Totally , 423 RNs from 48 ( 62 % ) Swedish EDs each triaged 18 patient scenarios using the CTAS . Of the 7,550 triage ratings , 57.6 % were triaged in concordance with the expected outcome and no scenario was triaged into the same triage level by all RNs . Inter-rater agreement for all RNs was kappa = 0.46 ( unweighted ) and kappa = 0.71 ( weighted ) . The fact that the kappa-values are only moderate to good and the low concordance between the RNs call for further studies , especially from a patient safety perspective Objectives : To assess whether initial patient consult by senior clinicians reduces numbers of patients waiting to be seen as an indirect measure of waiting time throughout the emergency department ( ED ) . Methods : An emergency medicine consultant and a senior ED nurse ( G or F grade ) , known as the IMPACT team , staffed the triage area for four periods of four hours per week , Monday to Friday between 9 am to 5 pm for three months between December 2001 and February 2002 when staffing levels permitted . Patients normally triaged by a nurse in this area instead had an early consultation with the IMPACT team . Data were collected prospect ively on all patients seen by the IMPACT team . The number of patients waiting to be seen ( for triage , in majors and in minors ) was assessed every two hours during the IMPACT sessions and at corresponding times when no IMPACT team was operational . Results : There was an overall reduction in the number of patients waiting to be seen in the department from 18.3 to 5.5 ( p<0.0001 ) at formal two hourly assessment s. The largest difference was seen in minors . Of the patients seen at triage by the IMPACT team , 48.9 % were discharged home immediately after assessment and treatment . With the IMPACT team present , no patient waited more than four hours for initial clinical consult . Conclusions : By using a senior clinical team for initial patient consultation , the numbers of patients waiting fell dramatically throughout the ED . Many patients can be effectively treated and discharged after initial consult by the IMPACT team This study examined the emergency nurse practitioner c and i date ( ENPC ) scope of practice in a Victorian emergency department ( ED ) . The emergency nurse practitioner ( ENP ) role is relatively new in Victoria and the scope of the ENP(C ) practice is yet to be defined . International research literature regarding the ENP role has focused on outcomes such as patient satisfaction , waiting times and /or ED length of stay , accuracy and adequacy of documentation , use of radiography , and patient education , health promotion and communication issues . A prospect i ve exploratory design was used to conduct this cohort study . There were 476 ENPC-managed patients between 14 July 2004 and 31 March 2005 with an average age of 29 years . The majority ( 77.2 % ) of ENPC-managed patients were discharged from the ED . The majority of the ENPC time was devoted to clinical practice ( 55 % ) and development of clinical practice guidelines ( 25 % ) . Of patients managed by the ENPC , 49.6 % required medications , 51 % required diagnostic imaging and 8.6 % required pathology testing during their ED stay . The most common discharge referrals were made to local medical officers ( 73.5 % ) and the most common referrals made for patients requiring admission were made to the plastic surgery ( 37.3 % ) and orthopaedic ( 35.5 % ) units . Extensions to the current scope of emergency nursing practice are pivotal to effective management of specific patient groups by ENP . The ENP model of care is an important strategy for the management of increased service dem and s in Victoria ; however , little is known about the scope of the ENPC practice and many outcomes of the ENP care are yet to be defined . Further research to better underst and the relationships between ENP outcomes is required if the contribution that ENPs make to emergency care is to be accurately quantified Objective —To study an established triage nurse x ray requesting system to determine whether sending defined groups of patients for radiography before assessment by doctors or emergency nurse practitioners ( ENPs ) result ed in shorter waiting times for patients without compromising quality of care . Methods — Prospect i ve r and omised controlled study of “ walking wounded ” patients attending a district general hospital . Data were collected over two separate two week periods , six months apart , in the middle of two senior house officer appointment periods . A total of 675 patients were entered into the study . Analysis of results was achieved using st and ard statistical methods . Results —Altogether 335 patients were in the nurse x ray group and 340 in the control group . The triage categories of the groups were similar . A 36 % mean time reduction of 37.2 min ( 95 % confidence interval 30.2 to 44.2 , p=0.000 ) from time of triage to time of treatment decision was achieved in the nurse requested group . Triage nurses requested 8 % ( p=0.002 ) fewer x rays than doctors or ENPs and had a 6 % higher positive “ hit ” rate ( p=0.03 ) . In 7.8 % ( 26 cases ) , patients in the triage nurse group were judged to require radiographs or further views by the doctor or ENP ; of these , 11 cases showed a positive finding on radiography . The time from triage to assessment by doctor or ENP was not lengthened by prior requesting of radiography ( nurse x ray group 64.4 min , control group 6 \n Output:\n " }, { "from": "agent", "value": "Advanced practice nursing roles , physician-assisted triage and medical assessment units are models of care that can positively impact ED throughput .\nThey have been shown to decrease ED LOS and DNW rates .\nConfounding factors , such as site specific staffing requirements , patient acuity and rest-of-hospital processes , can also impact on patient throughput through the ED" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND In contrast to st and ard video endoscopy , magnifying endoscopy after local acetic acid application enables recognition of mucosal surface architecture . OBJECTIVE To investigate the diagnostic yield of magnifying endoscopy with acetic acid-targeted biopsies compared to r and om , 4-quadrant biopsies . DESIGN Prospect i ve r and omized trial ( ratio 1:1 ) with crossover design . SETTING Two referral hospitals in Germany . PATIENTS Thirty-one patients with Barrett 's esophagus or visible columnar-lined lower esophagus . INTERVENTIONS Patients were r and omized to undergo either st and ard video endoscopy with 4-quadrant biopsies or magnifying endoscopy in conjunction with acetic acid application . All patients were re-examined 14 days after the initial endoscopy with the corresponding procedure . MAIN OUTCOME MEASUREMENTS Primary outcome analysis ( per protocol and per biopsy ) was the histological proof of Barrett 's epithelium . Secondary outcome analysis was the correlation between the surface architecture and the presence of Barrett 's epithelium and the needed number of biopsies to confirm Barrett 's epithelium for the 2 different procedures . RESULTS Magnifying endoscopy enabled the prediction of Barrett 's epithelium with a sensitivity of 100 % and a specificity of 66 % , respectively ( accuracy 83.8 % ) . Acetic acid-guided biopsies obtained a significantly higher percentage of tissues containing SCE ( 78 % ; 188/241 ) compared to r and om biopsies ( 57 % ; 159/280 ) . LIMITATIONS No data on the diagnosis of Barrett 's dysplasia . CONCLUSION Magnifying endoscopy with acetic acid-guided biopsies is superior to st and ard video endoscopy with r and om biopsies , and the number of biopsies needed to confirm Barrett 's epithelium is half as much when compared to r and om biopsies BACKGROUND AND STUDY AIMS Validation of a simplified classification of mucosal morphology in prediction of histology in Barrett 's esophagus using narrow-b and imaging with magnification ( NBI-Z ) and assessing its reproducibility by endoscopists experienced in the use of NBI ( NBI-experts ) and by endoscopists who were new to NBI ( non-NBI-experts ) . PATIENTS AND METHODS In a prospect i ve cohort study of 109 patients with Barrett 's esophagus at a single tertiary referral center , mucosal patterns visualized in Barrett 's esophagus on NBI-Z were classified into four easily distinguishable types : A , round pits with regular microvasculature ; B , villous/ridge pits with regular microvasculature ; C , absent pits with regular microvasculature ; D , distorted pits with irregular microvasculature . The NBI-Z grading was compared with the final histopathological diagnosis , and positive ( PPV ) and negative predictive values ( NPV ) were calculated . The reproducibility of the grading was then assessed by NBI-expert and non-NBI-expert endoscopists , and interobserver and intraobserver agreement were calculated using kappa statistics . RESULTS Per-biopsy analysis : In 903 out of 1021 distinct areas ( 87.9 % ) the NBI-Z grading corresponded to the histological diagnosis . Per-patient analysis : The PPV and NPV for type A pattern ( columnar mucosa without intestinal metaplasia ) were 100 % and 97 % respectively ; for types B and C ( intestinal metaplasia ) they were 88 % and 91 % respectively , and for type D ( high- grade dysplasia ) 81 % and 99 % respectively . Inter- and intraobserver agreement : The mean kappa values in assessing the various patterns were 0.71 and 0.87 in the non-expert group ; 0.78 and 0.91 in the expert group . CONCLUSIONS This study has vali date d a simplified classification of the various morphologic patterns visualized in Barrett 's esophagus and confirmed its reproducibility when used by NBI-expert and non-NBI-expert endoscopists BACKGROUND & AIMS Endoscopic tri-modal imaging ( ETMI ) incorporates high-resolution endoscopy ( HRE ) , autofluorescence imaging ( AFI ) , and narrow b and imaging ( NBI ) . A recent uncontrolled study found that ETMI improved the detection of high- grade dysplasia ( HGD ) and early carcinoma ( Ca ) in Barrett 's esophagus ( BE ) . The aim was to compare ETMI with st and ard video endoscopy ( SVE ) for the detection of HGD/Ca with the use of a r and omized cross-over design . METHODS Patients referred for work-up of inconspicuous HGD/Ca were eligible and underwent both SVE and ETMI in r and omized order within an interval of 6 - 12 weeks . During ETMI , inspection with HRE was followed by AFI . Detected lesions were inspected in detail with NBI and biopsied , followed by r and om biopsies . During SVE , any visible lesion was biopsied followed by r and om biopsies . RESULTS Eighty-seven patients with BE underwent ETMI and SVE . No significant difference was observed in overall histologic yield between ETMI and SVE . ETMI had a significantly higher targeted yield compared with SVE because of AFI . However , the yield of targeted biopsies of ETMI was significantly inferior to the overall yield of SVE . Detailed inspection with NBI reduced the false-positive rate of HRE + AFI from 71 % to 48 % but misclassified 17 % of HGD/Ca lesions as not suspicious . CONCLUSIONS ETMI statistically significant improves the targeted detection of HGD/Ca compared with SVE . Subsequent characterization of lesions with NBI appears to be of limited value . At this stage , ETMI can not replace r and om biopsies for detection of lesions or targeted biopsies for characterization of lesions in a high-risk population BACKGROUND The optimal management of high- grade dysplasia in patients with Barrett 's esophagus is controversial . The aim of this study was to assess the prevalence of unsuspected carcinoma at esophagectomy in patients with Barrett 's esophagus with high- grade dysplasia after endoscopic surveillance with jumbo biopsy forceps compared with st and ard biopsy forceps . METHODS Twelve patients with high- grade dysplasia in Barrett 's esophagus without gross or microscopic evidence of carcinoma underwent esophagectomy after preoperative endoscopy with 4-quadrant jumbo biopsies at 2-cm intervals . The findings in this group were compared with those in a group of patients with Barrett 's esophagus who underwent esophagectomy for high- grade dysplasia after biopsies obtained at 2-cm intervals with st and ard biopsy forceps . RESULTS Unsuspected cancer was found in 4 of 12 ( 33 % ) patients in the jumbo biopsy group compared with 6 of 16 ( 38 % ) in the st and ard biopsy group ( p = NS ) . All 6 cancers in the st and ard biopsy group were intramucosal , whereas 2 were intramucosal and 2 were submucosal in the jumbo biopsy group . No patients in either group had lymph node metastases . CONCLUSIONS Unsuspected cancer is found frequently in patients with Barrett 's esophagus who are undergoing esophagectomy for high- grade dysplasia despite the use of a rigorous jumbo biopsy protocol . Esophageal resection is still indicated in appropriately selected patients with high- grade dysplasia until better markers of cancer risk are available OBJECTIVE : The optimal management of Barrett 's esophagus ( BE ) is controversial . Little is known about current practice patterns or associated direct medical costs . METHODS : In a national cross-sectional survey , we asked a r and om sample of gastroenterologists how they would manage patients with BE and various degrees of dysplasia . We used logistic regression to identify factors associated with so-called “ frequent ” ( at least every 12 months ) surveillance . We calculated direct medical costs using Medicare payments and population -based estimates of the number of BE patients under surveillance . RESULTS : Approximately 50 % of 555 gastroenterologists responded . More than 96 % of respondents recommended endoscopic surveillance for BE . For BE without dysplasia , 30 % would perform frequent surveillance ; this was the case particularly gastroenterologists older than age 45 yr ( odds ratio = 1.91 , p= 0.038 ) or those receiving primarily fee-for-service reimbursement ( odds ratio = 2.57 , p= 0.004 ) . For BE with low- grade dysplasia , the frequency of endoscopy was highly variable ( range , 1–24 months ) . For BE with high- grade dysplasia , 73 % of gastroenterologists recommended esophagectomy and the remainder recommended endoscopic surveillance . Approximately 95 % of the gastroenterologists who recommended surveillance for high- grade dysplasia , however , were not in agreement with recommended protocol s. We estimated the national annual expenditure for surveillance endoscopy every 24 months for BE without dysplasia to be at least $ 22 million . Increase in surveillance intensity from low frequency ( every 36 months ) to high frequency ( every 12 months ) strategies would escalate costs by $ 29 million annually . CONCLUSIONS : Physician age and reimbursement influence BE surveillance practice , suggesting the influence of non clinical factors on clinical decisionmaking . The majority of clinicians who would recommend surveillance for high- grade dysplasia may not be using an appropriately aggressive strategy . Variations in surveillance strategies can have large cost implication BACKGROUND Confocal laser endomicroscopy ( CLE ) enables in vivo microscopic imaging of the GI tract mucosa . However , there are limited data on endoscope-based CLE ( eCLE ) for imaging Barrett 's esophagus ( BE ) . OBJECTIVE To compare high-definition white-light endoscopy ( HDWLE ) alone with r and om biopsy ( RB ) and HDWLE + eCLE and targeted biopsy ( TB ) for diagnosis of BE neoplasia . DESIGN Multicenter , r and omized , controlled trial . SETTING Academic medical centers . PATIENTS Adult patients with BE undergoing routine surveillance or referred for early neoplasia . INTERVENTION Patients were r and omized to HDWLE + RB ( group 1 ) or HDWLE + eCLE + TB ( group 2 ) . Real-time diagnoses and management plans were recorded after HDWLE in both groups and after eCLE in group 2 . Blinded expert pathology diagnosis was the reference st and ard . MAIN OUTCOME MEASUREMENTS Diagnostic yield , performance characteristics , clinical impact . RESULTS A total of 192 patients with BE were studied . HDWLE + eCLE + TB led to a lower number of mucosal biopsies and higher diagnostic yield for neoplasia ( 34 % vs 7 % ; P < .0001 ) , compared with HDWLE + RB but with comparable accuracy . HDWLE + eCLE + TB tripled the diagnostic yield for neoplasia ( 22 % vs 6 % ; P = .002 ) and would have obviated the need for any biopsy in 65 % of patients . The addition of eCLE to HDWLE increased the sensitivity for neoplasia detection to 96 % from 40 % ( P < .0001 ) without significant reduction in specificity . In vivo CLE changed the treatment plan in 36 % of patients . LIMITATIONS Tertiary-care referral centers and expert endoscopists limit generalizability . CONCLUSION Real-time eCLE and TB after HDWLE can improve the diagnostic yield and accuracy for neoplasia and significantly impact in vivo decision making by altering the diagnosis and guiding therapy . ( CLINICAL TRIAL REGISTRATION NUMBER NCT01124214 . ) BACKGROUND A narrow b and imaging ( NBI ) endoscopy system has been developed that allows superficial surface imaging of esophageal tissue in vivo . OBJECTIVE The objective was to assess the potential of NBI for prediction of histology during screening and surveillance endoscopy in patients with Barrett 's esophagus ( BE ) . DESIGN A prospect i ve cohort study . SETTING Veterans Affairs Medical Center . PATIENTS Fifty-one patients with known or suspected BE . METHODS NBI images were grade d according to mucosal pattern ( ridge/villous , circular and irregular/distorted ) and vascular pattern ( normal and abnormal ) , and correlated with histology in a prospect i ve , blinded manner . MAIN OUTCOME MEASUREMENTS Biopsy-confirmed intestinal metaplasia ( IM ) and dysplasia were used as the outcome measures . RESULTS Of 51 patients ( mean BE length 3.5 cm ) , 28 had IM without dysplasia , 8 had low- grade dysplasia ( LGD ) , 7 had high- grade dysplasia ( HGD ) , and 8 had cardiac-type mucosa . The sensitivity , specificity , and positive predictive value of ridge/villous pattern for diagnosis of IM without HGD were 93.5 % , 86.7 % , and 94 \n Output:\n " }, { "from": "agent", "value": "Our meta- analysis indicates that targeted biopsies with acetic acid chromoendoscopy , electronic chromoendoscopy by using narrow-b and imaging , and endoscope-based CLE meet the thresholds set by the ASGE PIVI , at least when performed by endoscopists with expertise in advanced imaging techniques ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Introduction : The psychological impact of strabismus is well recognized . Patients with strabismus have lower levels of psychological well being compared to normal controls . Few studies have evaluated the relationship between levels of psychological distress and the angle of deviation , age , sex , presence of diplopia , visual acuity and direction of deviation . Methods : 50 patients with strabismus who attended the adult strabismus clinic were included in this question naire based prospect i ve study . The Psychological Impact question naire was used to assess the psychological impact of noticeable strabismus . We measured the angle of deviation , age , sex , presence of diplopia , visual acuity and direction of deviation and correlated these with psychological impact scores . Student ’s t-test and Pearson ’s correlation coefficient ( r ) were used in statistical analysis . Results : The average age was 48 years ( range 15 - 84 ) and there were 26 females and 24 males . There was no correlation between psychological impact score and the maximum degree of horizontal deviation r = 0.02 ( 95 % CI −0.26 to 0.29 ) , p = 0.9 , the maximum angle of vertical deviation r = 0.26 ( 95 % CI −0.01 to 0.51 ) , p = 0.06 , age r = −0.09 ( 95 % CI −0.36 to 0.19 ) , p = 0.5 , sex ( p = 0.96 ) , presence of diplopia ( p = 0.6 ) , visual acuity of the worse eye r = −0.01 ( 95 % CI −0.29 to 0.27 ) , p = 0.9 and direction of deviation ( p = 0.8 for eso-deviations compared to exo-deviations , p = 0.4 for horizontal compared to vertical deviations ) . There was a slight negative correlation between psychological impact score and visual acuity of the better eye r = −0.28 ( 95 % CI −0.52 to −0.01 ) , p = 0.04 . Conclusion : The psychological impact of strabismus does not appear to be related to the patient ’s angle of deviation , age , sex , presence of diplopia , visual acuity or direction of deviation . Larger studies are required using strabismus specific tools for evaluating psychological impact to further investigate these findings Aim : To analyse psychological causes for low compliance with occlusion therapy for amblyopia . Method : In a r and omised trial , the effect of an educational programme on electronically measured compliance had been assessed . 149 families who participated in this trial completed a question naire based on the Protection Motivation Theory after 8 months of treatment . Families with compliance less than 20 % of prescribed occlusion hours were interviewed to better underst and their cause for non-compliance . Results : Poor compliance was most strongly associated with a high degree of distress ( p<0.001 ) , followed by low perception of vulnerability ( p = 0.014 ) , increased stigma ( p = 0.017 ) and logistical problems with treatment ( p = 0.044 ) . Of 44 families with electronically measured compliance less than 20 % , 28 could be interviewed . The interviews confirmed that lack of knowledge , distress and logistical problems result ed in non-compliance . Conclusion : Poor parental knowledge , distress and difficulties implementing treatment seemed to be associated with non-compliance . For the same domains , the scores were more favourable for families who had received the educational programme than for those who had not OBJECTIVE To develop a question naire to assess the acceptability of amblyopia treatment and its effect on the child and family . METHODS A 20-item parental survey was developed and pilot tested on 64 subjects , aged 3 to 6 years , participating in the Amblyopia Treatment Study , a r and omized trial comparing patching and atropine as treatments for moderate amblyopia . The survey was administered after 4 weeks of treatment . A descriptive item analysis and an internal consistency reliability analysis were performed . RESULTS Nineteen of the 20 items demonstrated adequate variability as evidence d by the frequency distributions for item responses . Only 4 ( < 1 % ) of 1280 possible item responses were missing , one each by 4 different respondents . Factor analysis identified 3 treatment-related factors--\"adverse effects , \" \" compliance , \" and \" social stigma \"-- among 11 of the 20 items . The internal-consistency reliability alpha for the 5-item adverse effects subscale was 0.82 , the 4-item compliance subscale alpha was 0.81 , and the 2-item social stigma subscale alpha was 0.84 . CONCLUSIONS The Amblyopia Treatment Index appears to be a useful instrument for assessing the impact of amblyopia treatment in 3- to 6-year-old children PURPOSE To evaluate the ability of strabismus surgery to improve the health-related quality of life ( HRQOL ) assessment scores of children with intermittent exotropia and their parents . METHODS For this prospect i ve , r and omized , parallel group study , 130 children ( 8 - 17 year of age ) with intermittent exotropia were recruited and r and omized to undergo either corrective strabismus surgery or active monitoring without surgery . Each child was accompanied by a parent . HRQOL was assessed with 3 intermittent exotropia question naires (IXTQ)--the child self-report , parental proxy report , and parental self-report -- administered at enrollment and 3 months after intervention . The primary outcome was change in IXTQ score after 3 months for both groups . RESULTS At enrollment the scores of the surgery group ( n = 63 ) and monitoring group ( n = 57 ) did not differ significantly ( P > 0.05 ) . The sex of the reporting parent had no significant influence on the proxy or parental scores at enrollment or at 3 months ( P > 0.05 , multivariate analysis ) . Strabismus surgery significantly improved all parts of the IXTQ scores ( P < 0.0001 , repeated measures analysis of variance ) . No significant changes were found for the child scores at 3 months in the monitoring group ( P = 0.33 ) . However , the parental and proxy scores were significantly decreased ( P < 0.0001 ) . CONCLUSIONS Corrective strabismus surgery significantly improved the HRQOL scores of the children with intermittent exotropia and their parents OBJECTIVE To provide objective information on patient discomfort after strabismus surgery . DESIGN Prospect i ve cohort study . PARTICIPANTS Forty-nine consecutive adult patients undergoing strabismus surgery . METHODS A question naire was used to evaluate the following on a scale of 0 ( absent ) to 10 ( very severe ) : patients ' expectations of pain , blurred vision , daily life disruption , diplopia , conjunctival redness , foreign body sensation , eyelid swelling , postoperative nausea and vomiting ( PONV ) , and preoperative cosmetic satisfaction . Patients answered the question naire at 6 hours , 1 day , 2 days , 3 days , 1 week , 2 weeks , 1 month , and 3 months after surgery , focusing on the actual experience . Patient was also investigated according to previous surgical history and the surgery type . RESULTS In the 42 patients included in the analyses , postoperative pain ( p = 0.049 ) and PONV ( p = 0.039 ) occurred at significantly lower-than-anticipated levels . Blurred vision ( p = 0.019 ) , daily life disruption ( p = 0.009 ) , and conjunctival redness ( p < 0.001 ) occurred at significantly higher-than-expected levels , and patients felt that conjunctival redness was the most severe symptom occurring immediately after surgery . Patients who required vertical or oblique muscle procedures ( p = 0.046 ) or had undergone previous ophthalmic surgery ( p = 0.025 ) experienced higher levels of postoperative pain than they had preoperatively anticipated . CONCLUSIONS Preoperative anticipations were quite different from actual postoperative experiences in adults undergoing strabismus surgery . Our results will allow surgeons to objective ly educate patients before the operation about the postoperative course and to explain the inconveniences and minor side effects expected during the recovery process PURPOSE To characterize the relationship between binocular summation ( BiS ) and binocular inhibition ( BI ) on the quality of life of adults and children with strabismus . METHODS Strabismus patients at a single center from 2010 to 2012 were prospect ively enrolled . A BiS score was measured using ETDRS and Sloan low-contrast visual acuity ( LCA ) protocol s at 2.5 % and 1.25 % contrast . Patients were categorized as having BiS ( binocular better than better-eye visual acuity by ≥5 letters ) , BI ( binocular worse than better-eye visual acuity by ≥5 letters ) , or otherwise indeterminate visual acuity ( a difference between binocular visual acuity and monocular visual acuity of the better eye of < 5 letters ) . Quality of life was evaluated by the National Eye Institute Visual Functioning Question naire 25 ( VFQ-25 ) , 20-item Adult Strabismus Question naire ( AS-20 ) , and the Amblyopia and Strabismus Question naire . RESULTS A total of 108 patients were included . There was no significant BiS or BI for high-contrast ETDRS or 2.5 % LCA tests ; however , a mean BiS score of -2.14 ± 7.0 letters for 1.25 % LCA demonstrated significant binocular inhibition ( P = 0.004 ) for this contrast level . The mean composite VFQ-25 score was significantly lower in subjects with BI on ETDRS ( 80 ± 19 vs 57 ± 7 for subjects with BiS and BI , resp . [ P = 0.03 ] ) , 2.5 % LCA ( 81 ± 14 vs 66 ± 16 for subjects with BiS and BI , resp . [ P = 0.01 ] ) , and 1.25 % LCA tests ( 91 ± 9 vs 72 ± 14 for subjects with BiS and BI , resp . [ P = 0.005 ] ) . After accounting for potential covariates , significant association persisted for BI , demonstrated by 1.25 % LCA ( P = 0.01 ) . With BI demonstrable at 2.5 % , AS-20 scores were also significantly lower ( P = 0.04 ) . CONCLUSIONS Strabismic patients with BI had significantly lower quality -of -life scores than those who did not , even after accounting for potential covariates and the absence of diplopia Introduction Quantification of the psychosocial effects of manifest strabismus has been made possible by the introduction of the Adult Strabismus 20 ( AS-20 ) question naire . We investigated the effects of strabismus surgery and patient demographics on the pre- and postoperative AS-20 scores . Methods A prospect i ve , cohort study of adult patients undergoing strabismus surgery . Full pre- and postoperative orthoptic measurements were analysed and compared with the AS-20 total scores and its subscales ( psychosocial and functional ) . Any relationship between : gender ; direction ; and size of preoperative deviation and the changes in AS-20 score was investigated . Results Eighty-six patients were included with a follow-up of 91 days following surgery . Median deviation preoperatively was 30.5 prism diopters ( PD ) and the median preoperative AS-20 score was 45 . Postoperatively , the median deviation was 8 PD and the AS-20 score was significantly ( Z=−7.83 , P<0.0001 ) higher at 73.1 . Females have a lower preoperative AS-20 score ( P=0.01 ) but show a greater improvement in scores following surgery compared with males ( P=0.058 ) . There is a close correlation between change in AS-20 score and change in deviation size ( r=0.291 , P=0.006 ) . ConclusionS trabismus surgery gives a highly significant improvement in quality -of-life scores . Females gain more benefit from surgery and there is a greater improvement in the score with larger changes in deviation size . The smaller the postoperative angle , the larger the final AS-20 score PURPOSE As a first step in the development of a health-related quality of life ( HRQOL ) instrument , we conducted in-depth interviews to identify the specific concerns of adults with strabismus . DESIGN Prospect i ve cross-sectional study . METHODS Thirty adults with strabismus , 17 with diplopia , and 13 without were recruited . Individual interviews , using 11 open-ended questions , were audiotaped , transcribed , and transcripts review ed independently by three investigators . Phrases regarding how strabismus affected everyday life were grouped into topic areas and the frequency of each topic analyzed for subjects with and without diplopia . RESULTS A total of 1,508 phrases were extracted : 207 ( 14 % ) of 1,508 were excluded because they did not pertain to HRQOL . From the remaining 1,301 phrases , 48 topic areas were apparent . For patients with diplopia , the most frequently occurring topics were : nonspecific negative feeling ( 15/17 ; 88 % ) ( \" really hard \" ) ; general disability ( 15/17 ; 88 % ) ( \" affects everything \" ) ; and driving ( 14/17 ; 82 % ) . In those without diplopia , the most frequently mentioned topics were appearance to others ( 12/13 ; 92 % ) ( \" people notice my eyes \" ) followed by problems with eye contact ( 10/13 ; 77 \n Output:\n " }, { "from": "agent", "value": "Out of all the disease-specific instruments , just four have been subjected to modern psychometric tests and only the adult strabismus question naire ( AS-20 ) demonstrated good measurement properties .\nMost of the amblyopia-specific instruments measured the impact of the treatment of amblyopia on children , while most of the strabismus-specific instruments measured concerns related to appearance and treatment outcome in adults .\nAll instruments have gaps in their content and failed to address QoL comprehensively .\nAll the existing amblyopia- and /or strabismus-specific instruments fall short of desired quality and /or comprehensiveness of content ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: IMPORTANCE Macrolide antibiotics have been shown beneficial in cystic fibrosis ( CF ) and diffuse panbronchiolitis , and earlier findings also suggest a benefit in non-CF bronchiectasis . OBJECTIVE To determine the efficacy of macrolide maintenance treatment for adults with non-CF bronchiectasis . DESIGN , SETTING , AND PARTICIPANTS The BAT ( Bronchiectasis and Long-term Azithromycin Treatment ) study , a r and omized , double-blind , placebo-controlled trial conducted between April 2008 and September 2010 in 14 hospitals in The Netherl and s among 83 out patients with non-CF bronchiectasis and 3 or more lower respiratory tract infections in the preceding year . INTERVENTIONS Azithromycin ( 250 mg daily ) or placebo for 12 months . MAIN OUTCOME MEASURES Number of infectious exacerbations during 12 months of treatment . Secondary end points included lung function , sputum bacteriology , inflammatory markers , adverse effects , symptom scores , and quality of life . RESULTS Forty-three participants ( 52 % ) received azithromycin and 40 ( 48 % ) received placebo and were included in the modified intention-to-treat analysis . At end of study , the median number of exacerbations in the azithromycin group was 0 ( interquartile range [ IQR ] , 0 - 1 ) , compared with 2 ( IQR , 1 - 3 ) in the placebo group ( P < .001 ) . Thirty-two ( 80 % ) placebo-treated vs 20 ( 46 % ) azithromycin-treated individuals had at least 1 exacerbation ( hazard ratio , 0.29 [ 95 % CI , 0.16 - 0.51 ] ) . In a mixed-model analysis , change in forced expiratory volume in the first second of expiration ( percent of predicted ) over time differed between groups ( F1,78.8 = 4.085 , P = .047 ) , with an increase of 1.03 % per 3 months in the azithromycin group and a decrease of 0.10 % per 3 months in the placebo group . Gastrointestinal adverse effects occurred in 40 % of patients in the azithromycin group and in 5 % in the placebo group ( relative risk , 7.44 [ 95 % CI , 0.97 - 56.88 ] for abdominal pain and 8.36 [ 95 % CI , 1.10 - 63.15 ] for diarrhea ) but without need for discontinuation of study treatment . A macrolide resistance rate of 88 % was noted in azithromycin-treated individuals , compared with 26 % in the placebo group . CONCLUSIONS AND RELEVANCE Among adults with non-CF bronchiectasis , the daily use of azithromycin for 12 months compared with placebo result ed in a lower rate of infectious exacerbations . This could result in better quality of life and might influence survival , although effects on antibiotic resistance need to be considered . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00415350 Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Patients with bronchiectasis suffer from sputum production , recurrent exacerbations , and progressive airway destruction . Erythromycin is effective in diffuse panbronchiolitis , another suppurative airway disorder , although its efficacy is unknown in idiopathic bronchiectasis . A double-blind placebo-controlled study was therefore conducted to evaluate the effects of 8-week administration of low dose erythromycin ( 500 mg b.i.d . ) in steady-state idiopathic bronchiectasis . Patients in the erythromycin group ( n=11 , 8 female , mean age 50+/-15 yrs ) , but not the placebo group ( n=10 , 8 female , mean age 59+/-16 yrs ) had significantly improved forced expiratory volume in one second , forced vital capacity and 24-h sputum volume after 8 weeks ( p<0.05 ) . There was no parallel improvement in sputum pathogens , leukocytes , interleukin (IL)-1alpha and IL-8 , tumour necrosis factor-alpha , or leukotriene B4 . The results of this pilot study show that low-dose erythromycin improves lung function and sputum volume in bronchiectasis . Further studies are indicated to evaluate the efficacy of long-term erythromycin therapy in bronchiectasis Introduction Bronchiectasis is a chronic pulmonary process characterized by recurrent respiratory infections leading to destruction of airways secondary to inflammation . We investigated whether the addition of 6-months ’ twice-weekly azithromycin to the existing treatment regimen in patients with pulmonary bronchiectasis decreased the number of exacerbations and improved pulmonary function compared with a similar period of time without concurrent azithromycin . Methods Thirty patients with high-resolution computed tomography scan-confirmed bronchiectasis were to be recruited . In r and om order , patients received usual medications for 6 months , and usual medications plus oral azithromycin 500 mg twice weekly for 6 months . Patients receiving azithromycin first had a 1-month washout period prior to entering the second phase . Patients recorded weekly peak flow ( PF ) measurements . Pulmonary function tests ( PFTs ) , 24-hour sputum volume , and needs for intervention with medication or ancillary support were collected at baseline and every 3 months . Exacerbation incidence and sputum volume measurements were compared from baseline to the end of each study phase . Results Twelve patients were enrolled ; 11 were included in the analysis . Owing to r and omization , most patients received the azithromycin first , which was fairly well tolerated . PFTs did not change significantly during either study phase and PFs appeared to remain stable during azithromycin therapy and throughout the subsequent control phase . Azithromycin significantly decreased the incidence of exacerbations compared with usual medications ( 5 vs 16 ; p = 0.019 ) . Mean 24-hour sputum volume significantly decreased ( 15 % [ p = 0.005 ] ) during the active treatment phase , and remained decreased during the control phase ( p = 0.028 ) . Subjectively , patients reported increased energy and quality of life while receiving treatment with azithromycin . Conclusions The addition of twice-weekly azithromycin significantly decreased the incidence of exacerbation and 24-hour sputum volume and may have stabilized the PFTs and PFs in this 11-patient pilot study . The results of this study justify further investigation of adding azithromycin to the treatment regimens of patients with bronchiectasis for its disease-modifying effects BACKGROUND AND OBJECTIVE To explore the effect of long-term therapy with azithromycin in regards to airway oxidative stress markers in exhaled breath condensate ( EBC ) of adult patients with stable non-cystic fibrosis ( CF ) bronchiectasis . METHODS Open-label prospect i ve study of 30 patients r and omized to azithromycin 250 mg three times per week during 3 months ( 16 patients ) or control ( 14 patients ) . Primary outcome were changes in nitric oxide , 8-isoprostane , pH , nitrites and nitrates in EBC . Secondary outcomes were changes in exacerbation rates , dyspnoea ( Borg scale ) , sputum volume ( cc ) , sputum colour ( 15-point scale ) , bacterial infection , health-related quality of life ( St George 's Respiratory Question naire ) , lung function and radiological extension . RESULTS Azithromycin produced a significant decrease in sputum volume ( 8.9 ( 1.8 ) mL vs 2.1 ( 3.4 ) mL ) and number of exacerbations ( 0.1 ( 0.6 ) vs 1.2 ( 0.9 ) ) . Dyspnoea ( 0.4 ( 0.1 ) vs 0.1 ( 0.2 ) ) and health-related quality of life also improved after therapy . However , oxidative stress markers in EBC , systemic inflammatory markers as well as functional respiratory tests did not differ from the control group after therapy . A post-hoc analysis comparing patients infected or not with Pseudomonas aeruginosa revealed that these effects were more pronounced in infected patients . In this subgroup , treatment was followed by a significant reduction in sputum volume , number of exacerbations , dyspnoea and St George 's Respiratory Question naire total score . Of all airway oxidative stress markers , only nitrates in EBC were reduced after therapy . CONCLUSIONS Long-term azythromicin treatment has some clinical benefits in patients with non-CF stable bronchiectasis , but it does not affect airway oxidative stress markers BACKGROUND Azithromycin is a macrolide antibiotic with anti-inflammatory and immunomodulatory properties . We tested the hypothesis that azithromycin would decrease the frequency of exacerbations , increase lung function , and improve health-related quality of life in patients with non-cystic fibrosis bronchiectasis . METHODS We undertook a r and omised , double-blind , placebo-controlled trial at three centres in New Zeal and . Between Feb 12 , 2008 , and Oct 15 , 2009 , we enrolled patients who were 18 years or older , had had at least one pulmonary exacerbation requiring antibiotic treatment in the past year , and had a diagnosis of bronchiectasis defined by high-resolution CT scan . We r and omly assigned patients to receive 500 mg azithromycin or placebo three times a week for 6 months in a 1:1 ratio , with a permuted block size of six and sequential assignment stratified by centre . Participants , research assistants , and investigators were masked to treatment allocation . The co primary endpoints were rate of event-based exacerbations in the 6-month treatment period , change in forced expiratory volume in 1 s ( FEV(1 ) ) before bronchodilation , and change in total score on St George 's respiratory question naire ( SGRQ ) . Analyses were by intention to treat . This study is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12607000641493 . FINDINGS 71 patients were in the azithromycin group and 70 in the placebo group . The rate of event-based exacerbations was 0·59 per patient in the azithromycin group and 1·57 per patient in the placebo group in the 6-month treatment period ( rate ratio 0·38 , 95 % CI 0·26 - 0·54 ; p<0·0001 ) . Prebronchodilator FEV(1 ) did not change from baseline in the azithromycin group and decreased by 0·04 L in the placebo group , but the difference was not significant ( 0·04 L , 95 % CI -0·03 to 0·12 ; p=0·251 ) . Additionally , change in SGRQ total score did not differ between the azithromycin ( -5·17 units ) and placebo groups ( -1·92 units ; difference -3·25 , 95 % CI -7·21 to 0·72 ; p=0·108 ) . INTERPRETATION Azithromycin is a new option for prevention of exacerbations in patients with non-cystic fibrosis bronchiectasis with a history of at least one exacerbation in the past year . FUNDING Health Research Council of New Zeal and and Auckl and District Health Board Charitable Trust IMPORTANCE Macrolide antibiotics such as erythromycin may improve clinical outcomes in non-cystic fibrosis ( CF ) bronchiectasis , although associated risks of macrolide resistance are poorly defined . OBJECTIVE To evaluate the clinical efficacy and antimicrobial resistance cost of low-dose erythromycin given for 12 months to patients with non-CF bronchiectasis with a history of frequent pulmonary exacerbations . DESIGN , SETTING , AND PARTICIPANTS Twelve-month , r and omized ( 1: \n Output:\n " }, { "from": "agent", "value": "This meta- analysis suggested that long-term treatment with macrolides significantly reduced the incidence of non-CF bronchiectasis exacerbation .\nMoreover , azithromycin is more efficient than roxithromycin and erythromycin in preventing exacerbation" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Pathologists are under increasing pressure to su bmi t fresh tissue for ancillary studies and research protocol s. In several tumor types ( breast , lung , melanoma , colorectal , prostate ) , increased interest in detecting su bmi croscopic nodal metastases through reverse transcriptase polymerase chain reaction analysis of mRNA from portions of lymph nodes has precluded histologic analysis of the entire node for metastases . A retrospective review was undertaken of 227 breast cancer patients prospect ively entered on a research protocol examining the usefulness of sentinel lymph node surgery . All of the patients ultimately underwent complete lymph node dissection . The research protocol required that all nodes greater than 8 mm in size be bisected and su bmi tted separately . Positive lymph nodes were evaluated for unilateral or bilateral involvement in the node sections . Sixty node-positive patients were identified , yielding 230 positive nodes . One hundred seven of these nodes were confirmed to have been bisected . Carcinoma was identified in both lymph node sections in 64 ( 59.8 % ) nodes and in only one-half of the bisected lymph node in 43 ( 40.2 % ) nodes . Involvement of both sections was more likely when patients had multiple nodes positive . In 12 patients , involvement of one-half of the bisected nodes was the only evidence of metastatic disease ( 20.0 % of node-positive patients ) . This evidence suggests that su bmi ssion of less than the complete lymph node for histologic evaluation of metastatic disease decreases the accuracy of lymph node staging . Furthermore , a significant proportion of patients may be erroneously classified as histologically node negative Background Internationally , there is no consensus on the pathology protocol to be used to examine the sentinel lymph node ( SN ) . At present , therefore , various hospitals use different SN pathology protocol s of which the effect has not been fully eluci date d. We hypothesized that differences between hospitals in SN pathology protocol s affect subsequent surgical treatment strategies . Methods Patients from four hospitals ( A – D ) were prospect ively registered when they underwent an SN biopsy . In hospitals A , B , and C , three levels of the SN were examined pathologically , whereas in hospital D , at least seven additional levels were examined . In the absence of apparent metastases with hematoxylin and eosin examination , immunohistochemical examination was performed in all four hospitals . Results In total , 541 eligible patients were included . In hospital D , more patients were diagnosed with a positive SN ( P < .001 ) as compared with hospitals A , B , and C , mainly because of increased detection of isolated tumor cells . This led to more completion axillary lymph node dissections in hospital D ( 66.3 % of patients ( P < .0001 ) , compared with 29.0 % in hospitals A , B , and C combined ) . Positive non-SNs were detected in 13.9 % of patients in hospital D , compared with 9.7 % in hospitals A , B , and C ( P = .70 ) . That is , in 52.4 % of patients in hospital D , a negative completion axillary lymph node dissection was performed , compared with 19.3 % of patients in hospitals A , B , and C combined . Conclusions Differences in SN pathology protocol s between hospitals do have a substantial effect on SN findings and subsequent surgical treatment strategies . Whether ultrastaging and , thus , additional surgery can offer better survival remains to be determined PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Background Routine axillary lymph node dissection ( ALND ) after selective sentinel lymphadenectomy ( SSL ) in the treatment of breast cancer remains controversial . We sought to determine the need for routine ALND by exploring the relationship between sentinel lymph node ( SLN ) and non-SLN ( NSLN ) status . We also report our experience with disease relapse in the era of SSL and attempt to correlate this with SLN tumor burden . Methods This was a retrospective study of 390 patients with invasive breast cancer treated at a single institution who underwent successful SSL from November 1997 to November 2002 . Results Of the 390 patients , 115 received both SSL and ALND . The percentage of additional positive NSLNs in the SLN-positive group ( 34.2 % ) was significantly higher than in the SLN-negative group ( 5.1 % ; P = .0004 ) . The SLN macrometastasis group had a significantly higher rate of positive NSLNs ( 39.7 % ) compared with the SLN-negative group ( 5.1 % ; P = .0001 ) . Sixteen patients developed recurrences during follow-up , including 6.1 % of SLN-positive and 3.3 % of SLN-negative patients . Among the SLN macrometastasis group , 8.7 % had recurrence , compared with 2.2 % of SLN micrometastases over a median follow-up period of 31.1 months . One regional failure developed out of 38 SLN-positive patients who did not undergo ALND . Conclusions ALND is recommended for patients with SLN macrometastasis because of a significantly higher incidence of positive NSLNs . Higher recurrence rates are also seen in these patients . However , the role of routine ALND in patients with a low SLN tumor burden remains to be further determined by prospect i ve r and omized trials BACKGROUND Examination was performed on pathologic material from patients enrolled in the National Surgical Adjuvant Breast Project ( NSABP ) protocol B-18 , in which the clinical effects of preoperative ( preop ) and postoperative ( postop ) doxorubicin and cyclophosphamide ( AC ) were compared . METHODS Of the total number of 1523 patients , 1234 patients ( 81 % ) were in the pathologically evaluable cohort . Six hundred twenty-six patients had been r and omized prospect ively to receive AC postop and 608 had been r and omized to receive AC preop . Preentry diagnosis was made by fine-needle aspiration ( FNA ) and /or Tru-cut biopsy ( TC ) . AC-induced and other pathologic changes were identified , and their relation to pathologic response and overall survival ( OS ) and disease-free survival ( DFS ) was determined . Frequencies of the number of lymph node metastases , their size , stromal reaction , and extracapsular extension ( ECE ) were compared in the two treatment groups , as was their correlation with OS and DFS . Survival estimates were based on 9 years of follow-up . RESULTS Approximately 13 % of primary breast carcinoma cases exhibited both a clinical complete response ( cCR ) and a pathologic complete response ( absence of invasive tumor [ pCR ] ) to preop AC . An additional 7 % of patients exhibited a pCR in the absence of a cCR . A pCR occurred in 38 % of those patients determined to have achieved a cCR . Poor nuclear grade of the tumor cells in the pre-entry FNA and /or TC specimens significantly predicted a pCR . Patients with the latter exhibited a better OS and DFS compared with those with a pathologic partial response ( presence of sparse invasive tumor [ pPR ] ) or no pathologic response ( pNR ) . Epithelial alterations considered to be induced in tumors by preop AC were comprised of types 1 and 2 giant cells with meganuclei , apocrine metaplasia , and cytoplasmic vacuolation . They had a high degree of specificity ( range , 86 - 99 % ) but a low sensitivity ( range , 7 - 38 % ) . All were predictive of a pPR and were found to be related adversely to OS and DFS . A fibrous stromal reaction noted in tumors or their putative sites in the preop group was found to have only modest degrees of specificity ( 63 % ) and sensitivity ( 74 % ) . Moderate/marked sclerosis of basement membranes of the ductal and ductular elements of the terminal ductolobular unit ( TDLU ) was significantly more frequent in nontumor-bearing areas of breasts from patients in the preop treatment group compared with those in the postop treatment group ( 67 % vs. 48 % ; P < 0.0001 ) . The degrees of change in the TDLU in patients in the postop treatment group were found to be unrelated to age . Lymphatic tumor extension in the primary tumor , as well as a positive lymph node status , were less frequent in the preop treatment group compared with the postop treatment group . The OS and DFS were nearly identical in both treatment groups , being 69 % and 55 % and 70 % and 53 % in the preop and postop treatment groups , respectively , at 9 years . A fibrous stromal response to lymph node metastases was found to be significant for DFS but not OS . ECE was similar in both groups ( 55 % vs. 48 % ; P = 0.12 ) . Only 1 % of ECE was found to be related to axillary failure in both treatment arms combined . There was no significant difference with regard to the parameters of survival for patients in the postop treatment group whose lymph nodes contained micrometastases ( < 2.0 mm ) or mini micrometastases ( < 1.0 mm ) ( the latter detected immunohistochemically with anticytokeratin ) , and a true-negative lymph node status ( not immunohistochemically converted to positive ) . Conversely , there was no apparent difference with regard to OS in preop treated patients with lymph node micrometastases , mini micrometastases , and macrometastases ( P = 0.19 ) . Those with mini micrometastases had a significantly worse OS compared with those with a true-negative lymph node status ( P = 0.0007 ) . DFS remained worse for patients in that treatment group with micrometastases and mini micrometastases compared with those with negative lymph nodes , although it was better than that for patients with macrometastases ( P = 0.02 ) . CONCLUSIONS Poor nuclear grade of tumor cells in the preentry FNA or TC specimens in the preop group was predictive of a pCR . AC-induced meganuclear giant cells and apocrine changes and nuclear and histologic grade s of the primary tumors also were found to be prognostically significant in patients in the preop treatment group , and the latter two variables were found to be significant for those patients in the postop treatment group . No evidence was found to support the need for axillary lymph node radiation for ECE of lymph node metastases . Extended pathologic or immunohistochemical procedures also appear to be unnecessary for the detection of lymph node mini micrometastases , at least when traditional postop chemotherapy is used . The adverse relation between such small metastases and OS and DFS after preop AC appears to be related to the timing of the chemotherapy administration rather than any pathobiologic reasons The current findings completely affirm the validity of our original observations indicating the appropriateness of grouping primary breast cancer patients into those with negative , 1 to 3 , or ≫4 positive nodes . Results , however , reveal that there is a risk in combining all patients with ≫4 positive nodes into a single group . Since there was a 25 % greater disease‐free survival and an 18 % greater survival in those with 4 to 6 than in those with ≫13 positive axillary nodes , such a unification may provide misleading information regarding patient prognosis , as well as the worth of a therapeutic regimen when compared with another from a putatively similar patient population . Of particular interest were findings relating the conditional probability , i.e. , the hazard rate , of a treatment failure or death each year during the 5‐year period following operation to nodal involvement with tumor . Whereas the hazard rate for those with negative , or 1 to 3 positive nodes , was relatively low and constant , in those with ≫4 positive nodes the risk in the early years was much greater , but by the fifth year it was similar to that occurring when 1‐3 nodes were involved , and not much different \n Output:\n " }, { "from": "agent", "value": "The presence ( vs the absence ) of metastases of 2 mm or less in diameter in axillary lymph nodes detected on single-section examination was associated with poorer disease-free and overall survival" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction : Accurate prognosis assessment after non – small-cell lung cancer ( NSCLC ) diagnosis is an essential step for making effective clinical decisions . This study is aim ed to develop a prediction model with routinely available variables to assess prognosis in patients with NSCLC in the U.S. Military Health System . Methods : We used the linked data base from the Department of Defense ’s Central Cancer Registry and the Military Health System Data Repository . The data set was r and omly and equally split into a training set to guide model development and a testing set to vali date the model prediction . Stepwise Cox regression was used to identify predictors of survival . Model performance was assessed by calculating area under the receiver operating curves and construction of calibration plots . A simple risk scoring system was developed to aid quick risk score calculation and risk estimation for NSCLC clinical management . Results : The study subjects were 5054 patients diagnosed with NSCLC between 1998 and 2007 . Age , sex , tobacco use , tumor stage , histology , surgery , chemotherapy , peripheral vascular disease , cerebrovascular disease , and diabetes mellitus were identified as significant predictors of survival . Calibration showed high agreement between predicted and observed event rates . The area under the receiver operating curves reached 0.841 , 0.849 , 0.848 , and 0.838 during 1 , 2 , 3 , and 5 years , respectively . Conclusions : This is the first NSCLC prognosis model for quick risk assessment within the Military Health System . After external validation , the model can be translated into clinical use both as a web-based tool and through mobile applications easily accessible to physicians , patients , and research ers 7556 Background : Prognostic index for second-line chemotherapy of NSCLC was previously developed , based on individual patient data ( IPD ) of 9 r and omized trials ( Table ) ( Di Maio et al , Eur J Cancer 2010 ; 46 : 735 - 743 ) . In this study , we aim ed to vali date the prognostic score , with the use of an external data set . METHODS We analyzed IPD of patients ( pts ) enrolled in a non-inferiority phase III trial comparing vinflunine vs. docetaxel in second-line treatment of advanced NSCLC . The study showed similar efficacy for both agents . Primary endpoint of this analysis was overall survival ( OS ) . The following variables were considered for survival analysis and score calculation : gender , performance status ( PS ) , extent of disease , tumor histotype , type of first-line treatment , response to first-line treatment . Cox model , stratified by treatment arm , was used for multivariate analysis . Individual prognostic scores were derived according to our scoring system , and pts were divided into 3 categories according to the score : < 5 ( best ) , 5 - 9 ( intermediate ) , > 9 ( worst ) . RESULTS All 551 pts enrolled in the trial had complete information for prognostic score calculation . Median OS in all pts was 6.9 months . Median OS was 12.9 , 6.9 and 3.8 months for the best , intermediate and worst categories , respectively . Cox model analysis showed a significant effect for intermediate vs. best category comparison ( hazard ratio 1.79 , 95%CI 1.31 - 2.47 , p=0.0003 ) and for worst vs. best category comparison ( hazard ratio 3.25 , 95%CI 2.18 - 4.83 , p<0.0001 ) . The C-index of the model was high ( 0.926 ) , indicating a good discrimination according to the proposed risk categories . CONCLUSIONS Prognostic ability of our score for c and i date s to second-line treatment in advanced NSCLC was vali date d. Subgroups of patients with more vs. less favorable prognosis were identified . Prognostic score could be useful in clinical practice . [ Table : see text ] Objectives Previous studies have shown that Glasgow prognostic score ( GPS ) and prognostic index ( PI ) are also powerful prognostic tool for patients with advanced non-small cell lung cancer ( NSCLC ) . The aim of this study was to compare the prognostic value between GPS and PI . Methods We enrolled consecutive patients with advanced NSCLC in this prospect i ve cohort . GPS and PI were calculated before the onset of chemotherapy . The prognosis outcomes included 1- , 3- , and 5-year progression-free survival and overall survival ( OS ) . The performance of two scores in predicting prognosis was analyzed regarding discrimination and calibration . Results 138 patients were included in the study . The area under the receiver operating characteristic curve for GPS predicting 1-year DFS was 0.62 ( 95 % confidence interval ( CI ) 0.56–0.68 , P < 0.05 ) , and the area under curve for PI predicting 1-year DFS was 0.57 ( 95 % CI 0.52–0.63 ) . Delong ’s test showed that GPS was more accurate than PI in predicting 1-year DFS ( P < 0.05 ) . Similar results of discriminatory power were found for predicting 3-year DFS , 1-year OS , and 3-year OS . The predicted 1-year DFS by GPS 0 , GPS 1 , and GPS 2 were 62.5 , 42.1 , and 23.1 % , respectively , while actual 1-year DFS by GPS 0 , GPS 1 , and GPS 2 were 61.1 , 43.8 , and 27.2 % , respectively . Calibration of the Hosmer and Lemeshow statistic showed good fit of the predicted 1-year DFS to the actual 1-year DFS by GPS ( χ2 = 4.326 , P = 0.462 ) , while no fit was found between the predicted 1-year DFS and the actual 1-year DFS by PI ( χ2 = 15.234 , P = 0.091 ) . Similar results of calibration power were found for predicting 3-year DFS , 5-year DFS , 1-year OS , 3-year OS , and 5-year OS by GPS and PI . Conclusions GPS is more accurate than PI in predicting prognosis for patients with advanced NSCLC . GPS can be used as a useful and simple tool for predicting prognosis in patients with NSCLC . However , GPS only can be used for preliminary assessment because of low predicting accuracy Early identification and treatment of nutritional deficiencies can lead to improved outcomes in the quality of life ( QoL ) and survival of patients with nonsmall cell lung cancer ( NSCLC ) . Noninvasive techniques are needed to evaluate changes in body composition as part of determining nutritional status . The aim of the study was to evaluate the association of nutritional parameters in health-related quality of life ( HRQL ) and survival in patients with advanced NSCLC . Chemotherapy-naïve patients with advanced NSCLC with good performance status Eastern Cooperative Oncology Group ( ECOG ) 0–2 were included prospect ively in the study . We evaluated inflammatory parameters such as C-reactive protein , platelet/lymphocyte index , neutrophil/lymphocyte index , serum interleukin (IL)-6 , and tumor necrosis factor-α , and nutritional variables such as body mass index ( BMI ) and serum albumin levels . Bioelectrical impedance analysis including phase angle was obtained before cisplatin-based chemotherapy was started . HRQL was assessed by application of the European Organization for Research and Treatment of Cancer Quality of Life Question naire (QLQ)-C30 and QLQ-LC13 instruments at baseline . Overall survival ( OS ) was calculated with the Kaplan-Meier method and analyzed with log-rank and Cox proportional hazard models . One hundred nineteen patients were included . Mean BMI was 24.8 ± 4.5 kg/m2 , average weight loss of patients was 8.4 % , and median phase angle was 5.8 ° . Malnutrition measured by subjective global assessment ( SGA ) , weight loss > 10 % , BMI > 20 was associated with lower HRQL scales . Patients with ECOG 2 , high content serum IL-6 , lower phase angle , and malnutrition parameters showed lower OS ; however , after multivariate analysis , only ECOG 2 [ Hazard ratio ( HR ) , 2.7 ; 95 % confidence interval ( 95 % CI ) , 1.5–4.7 ; P = 0.001 ] , phase angle ≤5.8 ° ( HR = 3.02 ; 95 % CI : 1.2–7.11 ; P = 0.011 ) , and SGA ( HR = 2.7 ; 95 % CI , 1.31–5.5 ; P = 0.005 ) were associated with poor survival . Patients were divided into low- , intermediate- , and high-risk groups according to regression coefficients ; OS at 1 yr was 78.4 , 53 , and 13.8 % , respectively . Malnutrition is associated with low HRQL and is an independent prognostic factor in advanced NSCLC . The results warrant prospect i ve trials to evaluate the impact of different nutritional interventions on HRQL and survival Recent advances in the treatment of non-small cell lung cancer ( NSCLC ) have led to improvements in patient survival and quality of life . It is unclear whether molecular abnormalities associated with NSCLC cell survival , growth and proliferation are useful in predicting treatment benefit . We conducted a systematic review to establish which biomarkers contribute meaningfully to the management of NSCLC . A team of research ers search ed PubMed and conference proceedings ( ASCO , ESMO , IASLC , USCAP ) using MESH terms for NSCLC and r and omized trials ( RCT ) , plus keywords for variables of interest . Evidence from multiple RCTs confirmed that histologic subtype is prognostic for survival and predictive of treatment efficacy and /or toxicity in NSCLC . Likewise , activating mutations of the epidermal growth factor receptor ( EGFR ) are associated with benefit from EGFR tyrosine kinase inhibitors in patients with advanced non-squamous NSCLC and should be assessed routinely . No biomarkers to date reliably predict response to anti-Vascular Endothelial Growth Factor ( VEGF ) therapies . There are inconsistent data on the role of ERCC1 , BRCA , Beta tubulin III , RRM1 , K-RAS , or TP-53 in treatment decisions . These tests should not be routinely used in selecting treatment at this time , whereas EML4/ALK translocations predict responses to specific targeted agents , the optimal assessment of this molecular abnormality has yet to be established . Personalized care of patients with NSCLC based on biomarkers is increasingly important to both clinical practice and research Introduction : BR.21 demonstrated significant survival benefit for non-small cell lung cancer patients receiving erlotinib compared with placebo . We undertook to characterize , by exploratory subset analysis , patients less likely to benefit from erlotinib . Methods : Using stratification and potential prognostic factors , Cox regression with stepwise selection with minimum Akaike Information Criteria was used to separate erlotinib patients into risk categories based on 10th , 50th , and 90th percentiles of prognostic index scores . The hypothesis was that characteristics of treated patients in the highest risk group would be predictive of lack of benefit from erlotinib when comparing erlotinib to placebo patients in the same risk group . Results : Ten factors ( smoking history , performance status , weight loss , anemia , lactic dehydrogenase , response to prior chemotherapy , time from diagnosis , number of prior regimens , epidermal growth factor receptor copy , and ethnicity ) were predictive of overall survival for erlotinib-treated patients and were used in the final model . Four risk groups were derived from the index score of the Prognostic Model : Low Risk ( HR = 0.34 , p < 0.001 ) , Intermediate Low and Intermediate High Risk ( HR 0.76 , p = 0.05 ; HR 0.92 ; p = 0.51 ) and High Risk ( HR 1.07 ; p = 0.78 ) . Median survivals for erlotinib ( placebo ) patients in each group were 20.6 ( 8.9 ) , 10.4 ( 7.6 ) , 4.0 ( 4.1 ) , 1.9 ( 2.3 ) months . The trend test showed that higher risk was associated with shorter survival ( p < 0.001 ) and less treatment effect ( p = 0.03 ) . Conclusions : By establishing a prognostic model , we identified a small group of patients who did not seem to benefit from erlotinib in this study . This model requires prospect i ve validation to confirm that it is both prognostic and predictive of outcome BACKGROUND Lung cancer is the commonest cause of death due to cancer in the world . Non-small-cell lung carcinoma ( NSCLC ) represents about 80 % of overall lung cancer cases worldwide . An accurate predictive model of mortality in patients with NSCLC could be useful to clinicians , policy makers , and research ers involved in risk stratification . The objective of this study was to develop and vali date a simple prognostic index for 4-year mortality in patients with NSCLC by use of information obtained at the time of lung cancer diagnosis . METHODS In 2000 , 4669 patients with histologically or cytologically proven NSCLC were enrolled prospect ively from 137 pneumology departments in French general hospitals . Patients not lost to follow-up ( n=4479 ) were r and omly assigned to the development cohort ( n=2979 ) or the validation cohort ( n=1500 ) . Every patient 's physician completed a st and ard and anonymous question naire . We used a Cox model to identify variables independently associated with mort \n Output:\n " }, { "from": "agent", "value": "The 39 identified DSS aim to predict overall survival and /or progression-free survival , but give no information about toxicity or cost-effectiveness .\nConclusions Many DSS have been developed for incurable NSCLC patients , but DSS are still lacking that are up-to- date with a good model performance , while covering the entire treatment spectrum ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Transcranial direct current stimulation ( tDCS ) of the human motor cortex results in polarity-specific shifts of cortical excitability during and after stimulation . Anodal tDCS enhances and cathodal stimulation reduces excitability . Animal experiments have demonstrated that the effect of anodal tDCS is caused by neuronal depolarisation , while cathodal tDCS hyperpolarises cortical neurones . However , not much is known about the ion channels and receptors involved in these effects . Thus , the impact of the sodium channel blocker carbamazepine , the calcium channel blocker flunarizine and the NMDA receptor antagonist dextromethorphane on tDCS-elicited motor cortical excitability changes of healthy human subjects were tested . tDCS- protocol s inducing excitability alterations ( 1 ) only during tDCS and ( 2 ) eliciting long-lasting after-effects were applied after drug administration . Carbamazepine selectively eliminated the excitability enhancement induced by anodal stimulation during and after tDCS . Flunarizine result ed in similar changes . Antagonising NMDA receptors did not alter current-generated excitability changes during a short stimulation , which elicits no after-effects , but prevented the induction of long-lasting after-effects independent of their direction . These results suggest that , like in other animals , cortical excitability shifts induced during tDCS in humans also depend on membrane polarisation , thus modulating the conductance of sodium and calcium channels . Moreover , they suggest that the after-effects may be NMDA receptor dependent . Since NMDA receptors are involved in neuroplastic changes , the results suggest a possible application of tDCS in the modulation or induction of these processes in a clinical setting . The selective elimination of tDCS-driven excitability enhancements by carbamazepine proposes a role for this drug in focussing the effects of cathodal tDCS , which may have important future clinical applications Weak transcranial direct current stimulation ( tDCS ) induces persisting excitability changes in the human motor cortex . These plastic excitability changes are selectively controlled by the polarity , duration and current strength of stimulation . To reveal the underlying mechanisms of direct current (DC)-induced neuroplasticity , we combined tDCS of the motor cortex with the application of Na(+)-channel-blocking carbamazepine ( CBZ ) and the N-methyl-D-aspartate (NMDA)-receptor antagonist dextromethorphan ( DMO ) . Monitored by transcranial magnetic stimulation ( TMS ) , motor cortical excitability changes of up to 40 % were achieved in the drug-free condition . Increase of cortical excitability could be selected by anodal stimulation , and decrease by cathodal stimulation . Both types of excitability change lasted several minutes after cessation of current stimulation . DMO suppressed the post-stimulation effects of both anodal and cathodal DC stimulation , strongly suggesting the involvement of NMDA receptors in both types of DC-induced neuroplasticity . In contrast , CBZ selectively eliminated anodal effects . Since CBZ stabilizes the membrane potential voltage-dependently , the results reveal that after-effects of anodal tDCS require a depolarization of membrane potentials . Similar to the induction of established types of short- or long-term neuroplasticity , a combination of glutamatergic and membrane mechanisms is necessary to induce the after-effects of tDCS . On the basis of these results , we suggest that polarity-driven alterations of resting membrane potentials represent the crucial mechanisms of the DC-induced after-effects , leading to both an alteration of spontaneous discharge rates and to a change in NMDA-receptor activation The aim of our study was to test if the electrical stimulation of the prefrontal cortex ( PFC ) could modify probabilistic classification learning ( PCL ) . Transcranial direct current stimulation ( tDCS ) was administered to the left prefrontal and to the primary visual cortex of 22 healthy subjects while they performed a PCL task . In this task subjects learned which of two outcomes would occur on each trial after presentation of a particular combination of cues . Ten minutes of anodal , but not cathodal , stimulation improved implicit learning only when the left PFC was stimulated . Our results show that implicit PLC can be modified by weak anodal tDCS , which probably increases neural excitability , as has been shown in the motor and visual cortices previously . Our results suggest that further studies on the facilitation of learning and memory processes by tDCS are warranted OBJECTIVE To evaluate the importance of the distance between stimulation electrodes , in various montages , on the ability to induce sustained cortical excitability changes using transcranial direct and r and om noise stimulation . METHODS Twelve healthy subjects participated in four different experimental conditions . The stimulation electrode was always placed over the primary motor cortex ; the reference electrode was placed at the contralateral orbit or at the ipsilateral/contralateral arm . MEPs were recorded in order to measure changes in cortical excitability over time . RESULTS The distance between the two electrodes correlates negatively with the duration and magnitude of induced after-effects . CONCLUSIONS In particular when using extracephalic reference electrodes with transcranial electric stimulation techniques , the stimulation intensity has to be adapted to account for interelectrode distance . SIGNIFICANCE Electrode distance plays a critical role in the induction for stimulation after-effects in tDCS and tRNS studies , and must be taken into account in future studies and also when making comparisons with the published literature Somatosensory integration is a critical cognitive function for human social interaction . Though somatosensory integration has been highly explored in cognitive studies ; only a few studies have explored focal modulation of cortical excitability using a speech perception paradigm . In the current study , we aim ed to investigate the effects of tDCS applied over the temporal cortex of healthy subjects during a go-no-go task in which stimuli were shapes and non-words . Twenty-eight subjects were r and omized to receive cathodal , anodal or sham tDCS bilaterally over the superior temporal cortex ( the reference electrode was on deltoid ) in a counterbalanced order . The effects on judgment of congruency between shapes and non-words in healthy volunteers were measured by a go-no-go task . Our findings show a significant modification of performance according to the polarity of stimulation , task and subject gender . We found that men performed worse on the no-go condition for congruent stimuli during cathodal tDCS . For reaction time , on the other h and , there was a similar effect for anodal and cathodal stimulation . There were significantly faster responses on incongruent trials during both anodal and cathodal tDCS . Along with previous literature showing gender differences in tasks associated with speech perception , the findings of this study provide additional evidence suggesting that men may have a more focal and restricted neural processing in this multisensory integration task In this paper we demonstrate in the intact human the possibility of a non-invasive modulation of motor cortex excitability by the application of weak direct current through the scalp . Excitability changes of up to 40 % , revealed by transcranial magnetic stimulation , were accomplished and lasted for several minutes after the end of current stimulation . Excitation could be achieved selectively by anodal stimulation , and inhibition by cathodal stimulation . By varying the current intensity and duration , the strength and duration of the after-effects could be controlled . The effects were probably induced by modification of membrane polarisation . Functional alterations related to post-tetanic potentiation , short-term potentiation and processes similar to postexcitatory central inhibition are the likely c and i date s for the excitability changes after the end of stimulation . Transcranial electrical stimulation using weak current may thus be a promising tool to modulate cerebral excitability in a non-invasive , painless , reversible , selective and focal way OBJECTIVE Some 25%–30 % of patients with schizophrenia have auditory verbal hallucinations that are refractory to antipsychotic drugs . Outcomes in studies of repetitive transcranial magnetic stimulation suggest the possibility that application of transcranial direct-current stimulation ( tDCS ) with inhibitory stimulation over the left temporo-parietal cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect hallucinations and negative symptoms , respectively . The authors investigated the efficacy of tDCS in reducing the severity of auditory verbal hallucinations as well as negative symptoms . METHOD Thirty patients with schizophrenia and medication-refractory auditory verbal hallucinations were r and omly allocated to receive 20 minutes of active 2-mA tDCS or sham stimulation twice a day on 5 consecutive weekdays . The anode was placed over the left dorsolateral prefrontal cortex and the cathode over the left temporo-parietal cortex . RESULTS Auditory verbal hallucinations were robustly reduced by tDCS relative to sham stimulation , with a mean diminution of 31 % ( SD=14 ; d=1.58 , 95 % CI=0.76–2.40 ) . The beneficial effect on hallucinations lasted for up to 3 months . The authors also observed an amelioration with tDCS of other symptoms as measured by the Positive and Negative Syndrome Scale ( d=0.98 , 95 % CI=0.22–1.73 ) , especially for the negative and positive dimensions . No effect was observed on the dimensions of disorganization or gr and iosity/excitement . CONCLUSIONS Although this study is limited by the small sample size , the results show promise for treating refractory auditory verbal hallucinations and other selected manifestations of schizophrenia \n Output:\n " }, { "from": "agent", "value": "First , different montages that are used to target a specific brain area such as dorsolateral prefrontal cortex ( DLPFC ) could have different effects ; therefore providing a unified classification enables us to take these differences into account ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In a prior study of 54 relatives of patients with schizophrenia and 72 control participants , 3 neuropsychological functions met the criteria for risk indicators of the schizophrenia genotype : executive functioning , memory , and auditory attention . In an assessment of the stability of these findings , the sample was reexamined 4 years after the initial assessment . Three test scores were found to differ between groups ( Immediate Verbal Memory , Delayed Verbal Memory , and Dichotic Listening Digits Detected ) or to show a significant Group x Gender interaction ( immediate and delayed verbal and visual memories ) . None of the test scores showed Group x Time interactions , suggesting that the discriminating power of the tests was stable over time . Evidence for deficits in working memory and rule learning on the object alternation test was also found . These results support the idea that neuropsychological dysfunction among relatives of patients with schizophrenia is a stable trait caused by the familial predisposition to schizophrenia Imaging genetics provides an enormous amount of functional-structural data on gene effects in living brain , but the sheer quantity of potential phenotypes raises concerns about false discovery . Here , we provide the first empirical results on false positive rates in imaging genetics . We analyzed 720 frequent coding SNPs without significant association with schizophrenia and a subset of 492 of these without association with cognitive function . Effects on brain structure ( using voxel-based morphometry , VBM ) and brain function , using two archival imaging tasks , the n-back working memory task and an emotional face matching task , were studied in whole brain and regions of interest and corrected for multiple comparisons using st and ard neuroimaging procedures . Since these variants are unlikely to impact relevant brain function , positives obtained provide an upper empirical estimate of the false positive association rate . In a separate analysis , we r and omly permuted genotype labels across subjects , removing any true genotype-phenotype association in the data , to derive a lower empirical estimate . At a set correction level of 0.05 , in each region of interest and data set used , the rate of positive findings was well below 5 % ( 0.2 - 4.1 % ) . There was no relationship between the region of interest and the false positive rate . Permutation results were in the same range as empirically derived rates . The observed low rates of positives provide empirical evidence that the type I error rate is well controlled by current commonly used correction procedures in imaging genetics , at least in the context of the imaging paradigms we have used . In fact , our observations indicate that these statistical thresholds are conservative Rationale First generation antipsychotics induce extrapyramidal motor symptoms ( EPS ) , presumably through dopamine D2 receptor blockade at the dorsal striatum . This may also produce impairment of cognitive processes , such as procedural learning , that are dependent on this region . Haloperidol and , to a lesser extent , risperidone , are active in the dorsal striatum and may induce EPS and impairment of procedural learning . In contrast , the prototypical second-generation antipsychotic , clozapine , is less active in the dorsal striatum and does not induce EPS or impair procedural learning . Olanzapine is pharmacologically similar to clozapine and has a low incidence of EPS induction . Objectives To assess the hypothesis that olanzapine would not have a deleterious effect on procedural learning . Methods Thirty-nine subjects with early phase schizophrenia were r and omly assigned to double blind treatment with haloperidol , risperidone , or olanzapine . They were administered the Tower of Toronto test at an unmedicated baseline and again following 6 weeks and 6 months of treatment . Results Procedural learning , defined as the improvement observed between two blocks of five trials of the Tower of Toronto , was preserved after 6 weeks of all three treatments but showed a substantial decline after 6 months of treatment with haloperidol or risperidone . Conclusions These data are consistent with the differential activity of the three medications in dorsal striatum structures and suggest that the advantages of olanzapine over haloperidol and risperidone in relation to extrapyramidal syndromes may also generalize to procedural learning . The results also suggest that the procedural learning disadvantages of haloperidol and risperidone accrue slowly but are apparent after 6 months of treatment The striatum is known to play a primary role in procedural learning . In this study , the authors simultaneously assessed the effects of two antipsychotic drugs on procedural learning and on striatal dopamine ( D2 ) receptor occupancy . Twenty-seven patients receiving either olanzapine or haloperidol as antipsychotic medication were assessed with the Computed Visual Tracking Task ( CVTT ) and Single Photon Emission Computed Tomography ( SPECT ) following the administration of Iodine 123-IBZM ( 123I-IBZM ) , a radiolig and with a high affinity and specificity for the D2 receptors . The results showed poorer procedural learning in the haloperidol-treated patients than in normal control subjects , while no difference could be found between olanzapine-treated patients and normal control subjects . In the haloperidol but not the olanzapine group , significant correlations were found between procedural learning deficits and striatal D2 receptor occupancy . However , there was no significant difference in D2 receptor occupancy between olanzapine- and haloperidol-treated patients , and this may be related to the high doses of olanzapine and low doses of haloperidol administered . The authors concluded that : 1 ) striatal D2 receptor blockade may alter procedural learning in humans ; and 2 ) olanzapine may have a protective effect on procedural learning , even at doses that produce striatal D2 receptor occupancy as high as that found with haloperidol . This protective effect of olanzapine may be related to its atypical pharmacological properties BACKGROUND Prospect i ve studies of young individuals at high risk of schizophrenia allow the investigation of whether neural abnormalities pre date development of illness and , if present , have the potential to identify those who may become ill . METHODS We studied young individuals with at least two relatives with the disorder . At baseline functional magnetic resonance imaging ( fMRI ) scan , none met criteria for any psychiatric disorder , but four subjects subsequently developed schizophrenia . We report the baseline functional imaging findings in these subjects performing a sentence completion task compared with normal control subjects ( n = 21 ) and those at high risk with ( n = 21 ) and without ( n = 41 ) psychotic symptoms who have not developed the disorder . RESULTS High-risk subjects who became ill demonstrated increased activation of the parietal lobe , decreased activation of the anterior cingulate , and smaller increases in activation with increasing task difficulty in the right lingual gyrus and bilateral temporal regions . The hypothesized predictive power of parietal activation was supported only in combination with lingual gyrus activity , which gave a positive predictive value in this sample of .80 . CONCLUSIONS Although these findings should be considered cautiously , as only four subjects who had an fMRI scan subsequently became ill , they suggest functional abnormalities are present in high-risk subjects who later became ill , which distinguish them not only from normal control subjects but also those at high risk who had not developed the disorder . These differences are detectable with fMRI and may have clinical utility BACKGROUND First-degree relatives of persons with schizophrenia carry elevated genetic risk for the illness and show deficits on high-load information processing tasks . We used functional magnetic resonance imaging ( fMRI ) to test whether nonpsychotic relatives show altered functional activation in the prefrontal cortex ( PFC ) , thalamus , hippocampus , and anterior cingulate during a working memory task requiring interference resolution . METHODS Twelve nonpsychotic relatives of persons with schizophrenia and 12 healthy control subjects were administered an auditory , verbal working memory version of the Continuous Performance Test during fMRI . An asymmetric , spin-echo , T2 * -weighted sequence ( 15 contiguous , 7-mm axial slices ) was acquired on a full-body MR scanner . Data were analyzed by Statistical Parametric Mapping ( SPM ) . RESULTS Compared with control subjects , relatives showed greater task-elicited activation in the PFC and the anterior and dorsomedial thalamus . When task performance was controlled , relatives showed significantly greater activation in the anterior cingulate . When effects of other potentially confounding variables were controlled , relatives generally showed significantly greater activation in the dorsomedial thalamus and anterior cingulate . CONCLUSIONS This pilot study suggests that relatives of persons with schizophrenia have subtle differences in brain function in the absence of psychosis . These differences add to the growing literature identifying neurobiological vulnerabilities to schizophrenia Studies of high-risk offspring ( HR ) of schizophrenic patients have found abnormalities in attention , working memory and executive functions , suggesting impaired integrity of the prefrontal cortex and related brain regions . The authors conducted a preliminary high-field ( 3 T ) functional magnetic resonance imaging ( fMRI ) study to assess performance and activation during a memory-guided saccade ( MGS ) task , which measures spatial working memory . HR subjects showed significant decreases in fMRI-measured activation in the dorsolateral prefrontal cortex ( Brodmann 's areas 8 and 9/46 ) and the inferior parietal cortex ( Brodmann 's area 40 ) compared to age- and sex-matched healthy controls ( HC ) . Abnormal functional integrity of prefrontal and parietal regions of the heteromodal association cortical ( HAC ) regions in subjects at genetic risk for schizophrenia is consistent with findings observed in adults with the illness [ Callicott et al. , Cereb . Cortex 10 ( 2000 ) 1078 ; Manoach et al. , Biol . Psychiatry 48 ( 2000 ) 99 . ] . These abnormalities need to be prospect ively investigated in nonpsychotic individuals at risk for schizophrenia in order to determine their predictive value for eventual emergence of schizophrenia or related disorders \n Output:\n " }, { "from": "agent", "value": "The most consistent increases in activation within hemisphere were found in right ventral prefrontal cortex ( PFC ) and right parietal cortex .\nThe diversity of findings in studies of patients ' relatives may derive from differences between the cognitive dem and s across studies ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Short-term high-carbohydrate ( HC ) diets induce metabolic alterations , including hypertriacylglycerolemia , in both the fasting and postpr and ial states . The underlying tissue-specific alterations in fatty acid metabolism are not well understood . OBJECTIVE We investigated alterations in exogenous and endogenous fatty acid metabolism by using stable isotope tracers to label meal triacylglycerol and plasma fatty acids . DESIGN Eight healthy subjects consumed isocaloric diets containing a high percentage of energy from carbohydrates or a higher percentage of energy from fat for 3 d in a r and omized crossover dietary intervention study . A test meal containing [ U-13C ] palmitate was combined with intravenous infusion of [ 2H2 ] palmitate to label plasma fatty acids and VLDL triacylglycerol . Blood and breath sample s were taken before the meal and for 6 h postpr and ially . Blood sample s were drawn from the femoral artery and from veins draining subcutaneous adipose tissue and forearm muscle for monitoring of tissue-specific metabolic substrate partitioning . RESULTS Systemic triacylglycerol concentrations were increased in both fasting ( P = 0.02 ) and postpr and ial ( P = 0.02 ) periods , and a greater amount of infused labeled fatty acid appeared in VLDL triacylglycerol after the HC diet than after the higher-fat diet ( P = 0.05 ) . Significantly less 13CO2 was exhaled after the HC diet ( P = 0.04 ) and significantly less production of 13CO2 was seen across forearm muscle ( P = 0.04 ) . Systemic 3-hydroxybutyrate was significantly lower , postpr and ially , after the HC diet ( P = 0.02 ) . CONCLUSION Metabolic alterations suggestive of repartitioning of fatty acids away from oxidation toward esterification in both liver and muscle occur in response to short-term adaptation to a HC diet Dietary guidelines for the general population and for the management of obesity , diabetes and heart disease suggest a reduction in dietary fat , and in particular dietary saturated fatty acids ( SFA ) . In order to achieve the recommended levels , changes in food choice patterns are required . Foods are consumed in combination with other foods , and these combinations are often recognizable as cuisine patterns . In this study we examined the food choice patterns of a group of 63 adults with existing type 2 diabetes mellitus who completed a 12 month dietary intervention trial aim ed at changing dietary fat under ' free living ' conditions . In both lower fat ( LF , 27 % ) and modified fat ( MF , 37%E ) groups , a reduction in dietary SFA and an increase in polyunsaturated fat were required , with an additional requirement to increase dietary monounsaturated fat in the MF group . The usual diets of the study sample were on average low in total fat ( 27%E ) , but high in saturated fat ( 12%E ) . Those already consuming total fat at the level concordant with their allocation ( LF or MF ) achieved targets faster than those with a discordant allocation , but there was no significant effect of usual diet on time of target achievement at 12 months . At 6 months , those achieving dietary fat targets had changed to low fat dairy products and leaner meats , were having more spreads , oils , and nuts and were consuming takeaway meals less than twice a week . Contributions to dietary fat shifted from takeaway foods , meat , dairy products and cakes to spreads , oils and nuts . The modified fat and low fat groups chose more Mediterranean and South East Asian cuisines respectively . In this study sample , usual dietary patterns had an initial impact on change in the diet , but identifiable changes in food choice patterns and the adoption of certain cuisines that combined foods indicative of the dietary guidelines result ed in successful achievement of dietary fat targets BACKGROUND The efficacy of ad libitum low-fat diets in reducing body weight and fat in overweight and obese adults remains controversial . METHODS We examined the effect of a 12-week low-fat , high-complex carbohydrate diet alone ( HI-CHO ) and in combination with aerobic exercise training ( HI-CHO + EX ) on body weight and composition in 34 individuals with impaired glucose tolerance ( 20 women and 14 men ; mean + /- SEM age , 66 + /- 1 years ) . Participants were r and omly assigned to a control diet ( 41 % fat , 14 % protein , 45 % carbohydrates , and 7 g of fiber per 1000 kcal ) , a HI-CHO diet ( 18 % fat , 19 % protein , 63 % carbohydrates , and 26 g of fiber per 1000 kcal ) , or a HI-CHO diet plus endurance exercise 4 d/wk , 45 min/d , at 80 % peak oxygen consumption ( HI-CHO + EX ) . Participants were provided 150 % of estimated energy needs and were instructed to consume food ad libitum . Total food intake , body composition , resting metabolic rate , and substrate oxidation were measured . RESULTS There was no significant difference in total food intake among the 3 groups and no change in energy intake over time . The HI-CHO + EX and HI-CHO groups lost more body weight ( -4.8 + /- 0.9 kg [ P=.003 ] and -3.2 + /- 1.2 kg [ P=.02 ] ) and a higher percentage of body fat ( -3.5 % + /- 0.7 % [ P=.01 ] and -2.2 % + /- 1.2 % [ P=.049 ] ) than controls ( -0.1 + /- 0.6 kg and 0.2 % + /- 0.6 % ) . In addition , thigh fat area decreased in the HI-CHO ( P=.003 ) and HI-CHO + EX ( P<.001 ) groups compared with controls . High carbohydrate intake and weight loss did not result in a decreased resting metabolic rate or reduced fat oxidation . CONCLUSION A high-carbohydrate diet consumed ad libitum , with no attempt at energy restriction or change in energy intake , results in losses of body weight and body fat in older men and women \n Output:\n " }, { "from": "agent", "value": "Results : There was no evidence that variations of a typical , non-experimental diet influenced rate or ratio of substrate utilization , however there may be an upper and lower threshold for when macronutrient composition may directly alter preferences for fuel oxidation rates during a fasted state .\nConclusion : This review indicates that macronutrient composition of a wide range of typical , non-experimental dietary fat and carbohydrate intakes has no effect on fasting substrate oxidation .\nThis suggests that strict control of dietary intake prior to fasting indirect calorimetry measurements may be an unnecessary burden for study participants ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Whether asthma morbidity in minority groups can be reduced by preventative health care measures delivered in the relevant ethnic dialects requires further evaluation . This study reports clinical outcomes and quality of life from a community based project investigating white European ( W/E ) and Indian subcontinent ( ISC ) ethnic groups with asthma living in deprived inner city areas of Birmingham , UK . METHODS Six hundred and eighty nine asthmatic subjects ( 345 W/E , 344 ISC ) of mean ( SD ) age 34.5 ( 15 ) years ( range 11–59 ) and mean forced expiratory volume in one second ( FEV1 ) of 80 % predicted were interviewed in English , Punjabi , Hindi , or Urdu . Subjects r and omised to the active limb of a prospect i ve , open , r and omised , controlled , parallel group , 12 month follow up study underwent individually based asthma education and optimisation of drug therapy with four monthly follow up ( active intervention ) . Control groups were seen only at the beginning and end of the study . Urgent or emergency interactions with primary and secondary health care ( clinical outcomes ) and both cross sectional and longitudinal data from an Asthma Quality of Life Question naire ( AQLQ ) were analysed . RESULTS Clinical outcomes were available for 593 subjects . Fewer of the active intervention group consulted their GP ( 41.8 % versus 57.8 % , odds ratio ( OR ) 0.52 ( 95 % CI 0.37 to 0.74 ) ) or were prescribed antibiotics ( 34.9 % versus 51.2 % , OR 0.51 ( 95 % CI 0.36 to 0.72 ) ) , but by ethnicity statistically significant changes occurred only in the W/E group with fewer also attending A&E departments and requiring urgent home visits . Active intervention reduced the number of hospital admissions ( 10 versus 30 ) , GP consultations ( 341 versus 476 ) , prescriptions of rescue oral steroids ( 92 versus 177 ) , and antibiotics ( 220 versus 340 ) , but again significant improvements by ethnicity only occurred in the active W/E group . AQLQ scores were negatively skewed to the higher values ; regression analysis showed that lower values were associated with ISC ethnicity . Longitudinal changes ( for 522 subjects ) in the mean AQLQ scores were small but statistically significant for both ethnic groups , with scores improving in the active and worsening in the control groups . CONCLUSIONS Active intervention only improved clinical outcomes in the W/E group . AQLQ scores , although lower in the ISC group , were improved by active intervention in both ethnic groups A prospect i ve r and omised trial was performed to evaluate the effectiveness of an asthma education programme administered by an asthma nurse specialist in an out-patient setting . Sixty asthmatic patients ( mean age 28.5 years ) were enrolled , 30 to a usual care control group and 30 to an education group . The education group underwent an individual education programme lasting at least one hour . The following variables were measured at baseline , one month after the education programme and at one year follow-up : asthma knowledge by MCQ ( 36 point question naire ) , inhaler technique ( 7 point scale ) , peak expiratory flow rate ( PEFR ) and symptomatology by visual analogue score ( 0 to 10 score ) . The education group 's inhaler technique and MCQ score both improved significantly at one month , from 5.4 ( 0.3 ) ( mean [ SEM ] ) to 6.5 ( 0.3 ) , p < 0.001 , and from 7.5 ( 2.4 ) to 22 ( 1.8 ) , p < 0.0001 respectively . Both of these improvements were significantly greater than in the control group , and both were maintained at one year follow-up . The symptom score improved over one year in the education group , from 5.4 ( 0.6 ) to 7.6 ( 0.5 ) , p < 0.05 , and was unchanged in the control group . There was no change in the PEFR in either group . This study shows clear objective benefits to an out-patient asthma education programme conducted by an asthma nurse specialist The purpose was to compare the short-term cost-effectiveness of intensive vs conventional education and supervision for the self-management of mild asthmatic patients . Consecutive newly diagnosed asthmatic patients ( n = 162 ) were r and omized into an intervention group ( IG ) and a control group ( CG ) with 1 yr of treatment and follow-up . Intensive education was given to 77 patients at visits every third month in the outpatient clinic . Eighty CG patients received conventional education and advice at the baseline visit only . All patients received similar inhaled anti-inflammatory treatment . At baseline and at 12 months st and ard clinical lung functions and health-related quality of life ( HRQOL ) were measured , the latter by the disease-specific St George 's Respiratory Question naire and the generic 15D . Furthermore , the use of extra health care services , medication and sickness days were recorded . The IG experienced a significant improvement in all clinical and HRQOL outcome variables . The same applied to the CG except spirometric values . The groups differed significantly only in terms of FEV1 ( P < 0.05 ) in favour of the IG . There was a significant difference between the groups in extra costs . The mean cost was FIM 2351 per patient ( 294 Pounds sterling ) in the CG and FIM 2757 per patient ( 345 Pounds ) in the IG , of which the intervention cost was FIM 1978 per patient ( 247 Pounds ) . In 1 yr follow-up the intensive education programme did not prove to be cost effective but was dominated by the conventional one regardless of what effectiveness measure was used . Also , a purely monetary cost-benefit calculation showed that the intervention result ed in a negative net benefit ( loss ) of FIM 406 per patient ( 51 Pounds ) . A longer follow-up may be needed before definitive conclusions about the cost-effectiveness of this kind of intervention can be drawn The effects on self management of asthma of a specially prepared book and audiocassette tape with similar contents were observed in a controlled study of 177 patients with asthma in general practice . After a run in period of six months patients were r and omly given the book , the tape , both the book and tape , or neither . Patients ' knowledge of the use of drugs , perceptions of their disability , skill in using an inhaler , consumption of drugs , consultations with their general practitioners , morbidity ( from patients ' entries on diary cards ) , and use of the educational material were measured . Knowledge about the use of drugs was significantly increased in the groups who received the material after three months and persisted after 12 months . Patients who had been given the tape or the book and tape increased their scores of knowledge of drugs more than patients given the book alone . Patients in all groups given the material considered that their disability was reduced . There were no other significant changes . Patients given both the book and the tape preferred the book . Patients with asthma can obtain useful information from such material . The paradoxical result whereby patients learnt more from the tape but preferred the book suggests that a distinction can be made between information that patients need , which may be acquired better from an audiocassette , and information that they want , which may be acquired better from a book BACKGROUND Many patients with asthma or chronic obstructive pulmonary disease use their medication inhalers incorrectly . General practitioners , pharmacists and other health care providers do not always have the opportunity to instruct patients in correct inhaler technique . OBJECTIVE To find out whether the inhaler technique and respiratory symptoms of patients can be improved after instruction by practice assistants . METHODS Single blind , r and omized intervention study in which 48 patients who had been using a dry powder inhaler for at least one month took part . Their inhaler technique was videotaped on two visits with a two-week interval between visits . The inhaler technique on the videos was subsequently scored by two experts on nine criteria . At both visits the patients completed a question naire about their respiratory symptoms . After the first video , 25 patients were r and omly chosen to receive instruction from one of six practice assistants who had followed a one evening course about inhaler instruction , and who had been issued an instruction-set . RESULTS The patients who received instruction had a significantly greater reduction in number of mistakes at the second visit than the patients who did not ( P = 0.01 ) . The instructed patients also reported less dyspnoea at the second visit ( P = 0.03 ) . No effect of instruction was found on wheezing , cough and sputum production . CONCLUSION The inhaler technique of patients can be improved significantly by the instruction of patients by trained practice assistants , possibly result ing in less dyspnoea Abstract Objectives : To evaluate the effectiveness of an asthma re source centre in improving treatment and quality of life for asthmatic patients Design : Community based r and omised controlled trial Setting : 41 general practice s in Greenwich with a practice nurse Subjects : All registered patients aged 15 - 50 years Intervention : Nurse specialists in asthma who educated and supported practice nurses , who in turn educated patients in the management of asthma according to the British Thoracic Society 's guidelines Main outcome measures : Quality of life of asthmatic patients , attendance at accident and emergency departments , admissions to local hospitals , and steroid prescribing by general practitioners Results : Of 24 400 patients r and omly selected and surveyed in 1993 , 12 238 replied ; 1621 were asthmatic of whom 1291 were sent a repeat question naire in 1996 and 780 replied . Of 24 400 patients newly surveyed in 1996 , 10 783 ( 1616 asthmatic ) replied . No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practice s compared with control practice s. Neither was there evidence of an improvement in other measures of the quality of asthma care . Weak evidence was found for an improvement in quality of life in intervention practice s among asthmatics registered with study practice s in 1993 and followed up in 1996 . Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practice s over the study period . Steroid prescribing rates rose steadily during the study period . The average annual increase in steroid prescribing was 3 % per year higher in intervention than control practice s ( 95 % confidence interval −1 % to 6 % , P=0.10 ) Conclusions : This model of service delivery is not effective in improving the outcome of asthma in the community . Further development is required if cost effective management of asthma is to be BACKGROUND Despite improved underst and ing of the pathophysiology of asthma , morbidity and mortality continue to rise , with disproportionate increases occurring among urban , indigent minorities . New approaches in the management of asthma are therefore necessary to reverse these dramatic and costly trends . OBJECTIVE To determine if patients who are admitted to the hospital with acute asthma and receive inpatient education will have improved outpatient follow-up and clinical outcome measures compared with those receiving conventional care . METHODS Patients enrolled in the study had a primary admission diagnosis of asthma and were between ages 18 and 45 years . Exclusion criteria included comorbid disease , inability to speak English , absence of a telephone in the primary residence , or pregnancy . Seventy-seven patients admitted from the emergency department with asthma were r and omized to either the inpatient educational program ( IEP ) or routine care ( control group ) . Patients in the IEP received asthma education , bedside spirometry , a telephone call 24 hours after discharge , and scheduled follow-up in an outpatient asthma program within 1 week of discharge . Those individuals r and omized to the routine management group received conventional inpatient asthma care and routine follow-up . RESULTS The patients enrolled in the IEP had a markedly higher follow-up rate compared with outpatient appointments ( 60 % vs. 27 % ; P = .01 ) and significantly fewer emergency department visits ( P = .04 ) and hospitalizations ( P = .04 ) for asthma in the 6 months following IEP intervention , as compared with control patients . This represented a substantial cost savings to the managed care organization . CONCLUSION Our study suggests that an IEP in the treatment of indigent , inner-city patients hospitalized with asthma reduces the need for subsequent emergent care and improves outpatient follow-up in a cost-effective manner A prospect i ve controlled trial of home monitoring of peak expiratory flow rate ( PEFR ) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma . Thirty-five patients managed themselves , using peak flow readings as the basis for the therapeutic plan coupled with educational intervention , whereas 35 control patients used symptoms and spirometric data for following physicians ' treatment plans . After a 6-mo study period , patients in the experimental group showed statistically significant improvements in morbidity parameters ( days lost from work , acute asthma attacks , days on antibiotic therapy , physician consultations , and emergency room admissions for asthma ) , increases in FVC , FEV1 , and FEV1/FVC , mean PEFR and mean morning PEFR , decrease in percentage of the mean PEFR amplitude , and a reduction in the use of inhaled beta-agonists , oral theophylline , and oral prednisone . Although improvements in some of these parameters were also found in the control group , they did not reach the levels of significance obtained in the experimental group . The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient 's condition BACKGROUND Although patient education is \n Output:\n " }, { "from": "agent", "value": "There was no effect on doctor visits , lung function and medication use .\nThe effects on asthma symptoms were variable .\nREVIEW ER 'S CONCLUSIONS Use of limited asthma education as it has been practice d does not appear to improve health outcomes in adults with asthma ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this study was to evaluate the antimicrobial properties of a new formulation containing silver nanoparticles , named Nano Silver Fluoride ( NSF ) , to inhibit Streptococcus mutans biofilm formation on children 's dental enamel . The variations in dental biofilm pH and in the Simplified-Oral-Hygiene-Index ( OHI-S ) also were evaluated after the treatment with NSF . This was a r and omized , double-blind , crossover and prospect i ve pilot clinical trial study in which 12 schoolchildren , aged between 7 - 8 years , had their dental enamel treated with two solutions : S1 - Nano Silver Fluoride and S2 - negative control ( saline solution ) , in different experimental moments . The dental biofilm adhered to enamel treated with NSF had lower values of S. mutans viability ( absorbance ) and colony forming units ( CFU ) than the S0 ( baseline ) and S2 . There was a statistically significant difference between the OHI-S mean values of S0 and S1 . There were no differences between the biofilm pH ( both before and after the use of the test substances ) and among the different groups . These properties suggest that NSF has bactericidal effect against S. mutans biofilm and it may be used for clinical control and prevention of dental biofilm formation In the copper metallurgy workplace air is polluted with condensation aerosols , which a significant fraction of is presented by copper oxide particles < 100 nm . In the scientific literature , there is a lack of their in vivo toxicity characterization and virtually no attempts of enhancing organism ’s resistance to their impact . A stable suspension of copper oxide particles with mean ( ±SD ) diameter 20 ± 10 nm was prepared by laser ablation of pure copper in water . It was being injected intraperitoneally to rats at a dose of 10 mg/kg ( 0.5 mg per mL of deionized water ) three times a week up to 19 injections . In parallel , another group of rats was so injected with the same suspension against the background of oral administration of a “ bio-protective complex ” ( BPC ) comprising pectin , a multivitamin-multimineral preparation , some amino acids and fish oil rich in ω-3 PUFA . After the termination of injections , many functional and biochemical indices for the organism ’s status , as well as pathological changes of liver , spleen , kidneys , and brain microscopic structure were evaluated for signs of toxicity . In the same organs we have measured accumulation of copper while their cells were used for performing the R and om Amplification of Polymorphic DNA ( RAPD ) test for DNA fragmentation . The same features were assessed in control rats infected intraperitoneally with water with or without administration of the BPC . The copper oxide nanoparticles proved adversely bio-active in all respects considered in this study , their active in vivo solubilization in biological fluids playing presumably an important role in both toxicokinetics and toxicodynamics . The BPC proposed and tested by us attenuated systemic and target organs toxicity , as well as genotoxicity of this substance . Judging by experimental data obtained in this investigation , occupational exposures to nano-scale copper oxide particles can present a significant health risk while the further search for its management with the help of innocuous bioprotectors seems to be justified Background The purpose of this in-vitro study was to examine the effect of incorporating different concentrations of Zirconium oxide-Titanium dioxide ( ZrO2-TiO2 ) nanoparticles , which can have antibacterial properties , on the mechanical properties of an orthodontic adhesive . Methods ZrO2-TiO2 ( Zirconium oxide , HWNANO , Hongwu International Group Ltd , China ) -Titanium dioxide , Nanoshell , USA ) nanopowder were incorporated into orthodontic adhesive ( Transbond XT , 3 M Unitek , Monrovia , USA ) with different concentrations ( 0.5 % weight nonofiller and 1 % weight nanofiller ) . The size of nanoparticle was 70–80 nm for ZrO2 and less than 50 nm for TiO2 . For measuring the shear bond strength of the three groups of orthodontic adhesives [ Transbond ( control ) , Transbond mixed with 0.5 % weight ZrO2-TiO2 , and Transbond mixed with 1 % weight ZrO2-TiO2 ] , 30 freshly extracted human first premolars were used and bonded with stainless steel metal brackets ( Dentaurum ® , Discovery ® , Deutschl and ) , using the 3 orthodontic adhesives and 3 M Unitek ; Transbond TM Plus Self-Etching Primer ( 10 sample s in each group ) . The recorded values of compressive strength and tensile strength ( measured separately on 10 sample s of orthodontic adhesives ( add the 3 D size of sample , light cured for 40 s on both sides ) of each orthodontic adhesives ) , as well as the shear bond strength in Mega Pascal unit ( MPa ) were collected and exposed to one-way analysis of variance ( ANOVA ) and Tukey ’s post-hoc tests . Results orthodontic adhesive with 1 % weight ZrO2-TiO2 showed the highest mean compressive ( 73.42 ± 1.55 MPa , p : 0.003 , F : 12.74 ) , tensile strength ( 8.65 ± 0.74 MPa , p : 0.001 , F : 68.20 ) , and shear bond strength ( 20.05 ± 0.2 MPa , p : 0.001 , F : 0.17 ) . Conclusions Adding ZrO2-TiO2 nanoparticle to orthodontic adhesive increased compressive strength , tensile strength , and shear bond strength in vitro , but in vivo studies and r and omized clinical trials are needed to vali date the present findings Objective The potential risk of a nanoparticle as a medical application has raised wide concerns , and this study aims to investigate silver nanoparticle (AgNP)-induced acute toxicities , genotoxicities , target organs and the underlying mechanisms . Methods Sprague-Dawley rats were r and omly divided into 4 groups ( n = 4 each group ) , and AgNP ( containing Ag nanoparticles and released Ag+ , 5 mg/kg ) , Ag+ ( released from the same dose of AgNP , 0.0003 mg/kg ) , 5 % sucrose solution ( vechicle control ) and cyclophophamide ( positive control , 40 mg/kg ) were administrated intravenously for 24 h respectively . Clinical signs and body weight of rats were recorded , and the tissues were subsequently collected for biochemical examination , Ag+ distribution detection , histopathological examination and genotoxicity assays . Results The rank of Ag detected in organs from highest to lowest is lung > spleen > liver > kidney > thymus > heart . Administration of AgNP induced a marked increase of ALT , BUN , TBil and Cre . Histopathological examination results showed that AgNP induced more extensive organ damages in liver , kidneys , thymus , and spleen . Bone marrow micronucleus assay found no statistical significance among groups ( p > 0.05 ) , but the number of aberration cells and multiple aberration cells were predominately increased from rats dosed with Ag+ and AgNP ( p < 0.01 ) , and more polyploidy cells were generated in the AgNP group ( 4.3 % ) compared with control . Conclusion Our results indicated that the AgNP accumulated in the immune system organs , and mild irritation was observed in the thymus and spleen of animals treated with AgNP , but not with Ag+ . The liver and kidneys could be the most affected organs by an acute i.v . dose of AgNP , and significantly increased chromosome breakage and polyploidy cell rates also implied the potential genotoxicity of AgNP . However , particle-specific toxicities and potential carcinogenic effect remain to be further confirmed in a chronic toxicity study Gold nanoparticles have shown great prospect i ve in cancer diagnosis and therapy , but they can not be metabolized and prefer to accumulate in liver and spleen due to their large size . The gold nanoclusters with small size can penetrate kidney tissue and have promise to decrease in vivo toxicity by renal clearance . In this work , we explore the in vivo renal clearance , biodistribution , and toxicity responses of the BSA- and GSH-protected gold nanoclusters for 24 h and 28 days . The BSA-protected gold nanoclusters have low-efficient renal clearance and only 1 % of gold can be cleared , but the GSH-protected gold nanoclusters have high-efficient renal clearance and 36 % of gold can be cleared after 24 h. The biodistribution further reveals that 94 % of gold can be metabolized for the GSH-protected nanoclusters , but only less than 5 % of gold can be metabolized for the BSA-protected nanoclusters after 28 days . Both of the GSH- and BSA-protected gold nanoclusters cause acute infection , inflammation , and kidney function damage after 24 h , but these toxicity responses for the GSH-protected gold nanoclusters can be eliminated after 28 days . Immune system can also be affected by the two kinds of gold nanoclusters , but the immune response for the GSH-protected gold nanoclusters can also be recovered after 28 days . These findings show that the GSH-protected gold nanoclusters have small size and can be metabolized by renal clearance and thus the toxicity can be significantly decreased . The BSA-protected gold nanoclusters , however , can form large compounds and further accumulate in liver and spleen which can cause irreparable toxicity response . Therefore , the GSH-protected gold nanoclusters have great potential for in vivo imaging and therapy , and the BSA-protected gold nanoclusters can be used as the agent of liver cancer therapy Objective . The aim of this study was to evaluate the effect of incorporation of glass fiber , zirconia , and nano-zirconia on the transverse strength of repaired denture base . Material s and Methods . Eighty specimens of heat polymerized acrylic resin were prepared and r and omly divided into eight groups ( n = 10 ) : one intact group ( control ) and seven repaired groups . One group was repaired with autopolymerized resin while the other six groups were repaired using autopolymerized resin reinforced with 2 wt% or 5 wt% glass fiber , zirconia , or nano-zirconia particles . A three-point bending test was used to measure the transverse strength . The results were analyzed using SPSS and repeated measure ANOVA and post hoc least significance ( LSD ) test ( P ≤ 0.05 ) . Results . Among repaired groups it was found that autopolymerized resin reinforced with 2 or 5 wt% nano-zirconia showed the highest transverse strength ( P ≤ 0.05 ) . Repairs with autopolymerized acrylic resin reinforced with 5 wt% zirconia showed the lowest transverse strength value . There was no significant difference between the groups repaired with repair resin without reinforcement , 2 wt% zirconia , and glass fiber reinforced resin . Conclusion . Reinforcing of repair material with nano-zirconia may significantly improve the transverse strength of some fractured denture base polymers Introduction Dental caries is still prevailing worldwide , although different anti caries products have been introduced . Each remineralizing agent has its own shortcomings . Therefore , looking for new agents to have benefits of previous ones with lesser side effects is worthwhile . Aim To determine the remineralization ability of NaF varnish , nano-Hydroxyapatite Serum ( n-HAP ) and Nano Silver Fluoride ( NSF ) on enamel of primary anterior teeth . Material s and Methods Incipient caries were induced in primary sound anterior teeth by storing each specimen in demineralization solution for 72 hours . Then they were r and omly divided into four groups of 15 sample s each : ( 1 ) NaF varnish ; ( 2 ) n-HAP repairing serum ; ( 3 ) NSF and ( 4 ) no treatment ( control ) . Surface Microhardness ( SMH ) was assessed with Vickers micro hardness tester before and after demineralization and after 10 days of pH-cycling . A total of 12 r and om specimens from groups 1 to 4 ( 3 r and om sample s of each group ) were examined by Atomic Force Microscopy ( AFM ) . The SMH values were analysed with one-way and repeated measures ANOVA . Level of significance was set at p=0.05 . Results Post lesion SMH values significantly decreased in all groups ( p<0.001 ) . Post treatment SMH values significantly increased in comparison to post lesion ones ( p<0.001 ) except for control group which was not different statistically ( p=0.86 ) . The highest SMH values were observed in NSF group ( mean 222.90 ± 28.79 ) . Statistically significant differences were shown between all groups ( p<0.05 ) . However , NaF varnish and n-HAP groups were not statistically different ( p=0.165 ) . AFM images demonstrated protective layers in all treated groups . Conclusion The results of this in vitro study suggest that NSF could have the greatest remineralization efficacy . NaF varnish and n-HAP serum were similar in remineralizing initial caries . Future clinical studies are recommended for selection of the most appropriate remineralizing agent in primary \n Output:\n " }, { "from": "agent", "value": "They were associated with cytotoxicity , genotoxicity altered inflammatory processes , and reticuloendothelial system toxicity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To determine the efficacy of epidural corticosteroid injections for sciatica . Methods : Three epidural injections ( two day intervals ) of 2 ml prednisolone acetate ( 50 mg ) or 2 ml isotonic saline were administered to patients with sciatica presumably due to a disk herniation lasting 15–180 days . Self evaluation was the main judgment criterion at day 20 . Patients who recovered or showed marked improvement were considered as success . Pain measured by VAS , the SLR test , Schober ’s test , Dallas pain question naire , and the Rol and -Morris index were evaluated at days 0 , 5 , 20 , and 35 . Only analgesics were authorised , patients requiring non-steroidal anti-inflammatory drugs ( NSAIDs ) before day 20 were considered as failure . Results : 42 patients were included in the control group ( CG ) , 43 in the steroid group ( SG ) . On an intention to treat analysis 15/42 ( 36 % ) in the CG and 22/43 ( 51 % ) in the SG ( p=0.15 ) were considered as success ( difference 15.5 % , 95 % CI ( −5.4 to 36.3 ) ) . Among the 48 failures , 14 patients ( 6 CG , 8 SG ) required NSAIDs , 3 ( 2 CG , 1 SG ) required surgery , and 7 ( 3 CG , 4 SG ) other treatments . On analysis according to protocol , in 74 remaining patients 12/35 ( 34 % ) in the CG and 22/39 ( 56 % ) in the SG ( p=0.057 ) were considered as success ( difference 22.1 % , 95 % CI ( 0.0 to 44.2 ) ) . For all secondary end points intragroup improvement with time was significant , but intergroup differences were not . Conclusion : The efficacy of isotonic saline administered epidurally for sciatica can not be excluded , but epidural steroid injections provide no additional improvement Two controlled studies for a new epidural , perineural , singleshot , selective nerve root injection with a double-needle approach to the anterior epidural space of the lumbar spinal canal are presented . The results were analysed to determine the effectiveness of the new epidural perineural injection technique . The trial comprised two controlled studies on 182 patients . One study compared prospect ively r and omized results of patients with lumbar radicular syndromes who received epidural perineural injections ( n = 47 ) , conventional posterior epidural injections ( n = 40 ) and , as a control group , paravertebral local anaesthetic ( n = 46 ) . A second , prospect i ve , double-blind study compared the effect of epidural perineural injections with triamcinolone ( n = 24 ) and pure saline ( n = 25 ) . Epidural perineural injections were more effective than conventional posterior epidural injections . Both epidural groups had better results than the paravertebral local injection group . Epidural perineural injections with steroids ( 10 mg triamcinolone ) were more effective than saline alone . A systemic steroid effect was excluded by additional intramuscular steroid injections in the saline group . There were no severe complications or side effects in any of the three groups . The studies concluded that single-shot epidural perineural injection is effective in the treatment of lumbar radicular pain . It is a “ one drop only ” therapy to the source of pain Study Design . We r and omized 200 patients after lumbar discectomy to receive epidural steroid or none with a 2-year follow-up . Objective . To evaluate the outcome , neurologic impairment and safety of epidural steroid following lumbar discectomy for herniated disc disease . Summary of Background Data . Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response . Previous studies in arthroscopic and abdominal surgery demonstrate steroids , which reduce the inflammatory response and enhance recovery . Here we report a 2-year follow-up of a r and omized trial of epidural steroid following lumbar discectomy . Methods . Through 2001 and 2003 200 patients undergoing discectomy for herniated disc disease were r and omly allocated to receive epidural methylprednisolone 40 mg or none . In the control group ( 62 males and 38 females , median age 41 years , 18–66 ) 48 L5 , 50 L4 , and 6 L3 discectomies were performed and in the intervention group ( 60 males and 40 females , median age 45 years , 15–53 ) 56 L5 , 46 L4 , and 3 L3 discectomies . Contemporary with r and omization to epidural steroid or none both groups received preoperative prophylactic antibiotics and the same multimodal pain treatment . Results . Hospital stay was reduced from 8 to 6 days ( P = 0.0001 ) and the number of patients with neurologic signs were reduced more ( 70 % vs. 44 % , P = 0.0004 ) by epidural steroid . Incidence of reoperation at 1 year was 6 % in both groups and 8 % in the control group and 7 % in the intervention group after 2 years . No infections were registered . Conclusion . Epidural methylprednisolone enhances recovery after discectomy for herniated disc disease without apparent side effects The management of sciatica due to lumbar nerve root compromise remains controversial , probably because few well-controlled studies of conservative management have been performed . This preliminary study assesses the efficacy of epidural injections of 80 mg triamcinolone acetonide plus 0.5 % procaine hydrochloride in saline , administered via the caudal route , in a double-blind , placebo controlled trial with 1 year follow-up . Twenty-three patients were entered into the study : 12 received treatment and 11 placebo . The active group showed significant pain relief ( P=0.02 ) and a significant increase in mobility ( P=0.01 ) at 4 weeks , which result ed in improved quality of life ( P=0.02 ) . At 1 year , subjective and objective measures improved in both groups . The improvement was greater in the actively treated group , but only the objective assessment ( straight leg raise ) was statistically significant A BSTRACT Background Although epidural corticosteroid injections are commonly used for sciatica , their efficacy has not been established . Methods In a r and omized , double-blind trial , we administered up to three epidural injections of methylprednisolone acetate ( 80 mg in 8 ml of isotonic saline ) or isotonic saline ( 1 ml ) to 158 patients with sciatica due to a herniated nucleus pulposus . All patients had Oswestry disability scores higher than 20 ( on a scale of 1 to 100 , with scores of 20 or less indicating minimal disability , and higher scores greater disability ) . Results At three weeks , the Oswestry score had improved by a mean of 8.0 in the methylprednisolone group and 5.5 in the placebo group ( 95 percent confidence interval for the difference , 7.1 to 2.2 ) . Differences in improvements between the groups were not significant , except for improvements in the finger-to-floor distance ( P 0.006 ) and sensory deficits ( P 0.03 ) , which were greater in the methylprednisolone group . After six weeks , the only significant difference was the improvement in leg pain , which was greater in the methylprednisolone group ( P 0.03 ) . After three months , there were no significant differences between the groups . The Oswestry score had improved by a mean of 17.3 in the methylprednisolone group and 15.4 in the placebo group ( 95 percent confidence interval for the difference , 9.3 to 5.4 ) . At 12 months , the cumulative probability of back surgery was 25.8 percent in the methylprednisolone group and 24.8 percent in the placebo group ( P 0.90 ) . Conclusions Although epidural injections of methylprednisolone may afford short-term improvement in leg pain and sensory deficits in patients with sciatica due to a herniated nucleus pulposus , this treatment offers no significant functional benefit , nor does it reduce the need for surgery . ( N Engl J Med 1997 ; 336:1634 - 40 . Study Design . Subgroup analysis of prospect i ve , r and omized data base from the Spine Patient Outcomes Research Trial ( SPORT ) Objective . The hypothesis of this study was that patients who received ESI during initial treatment as part of SPORT ( The Spine Patient Outcomes Research Trial ) would have improved clinical outcome and a lower rate of crossover to surgery than patients who did not receive ESI . Summary of Background Data . The use of epidural steroid injection ( ESI ) in patients with lumbar spinal stenosis is common , although there is little evidence in the literature to demonstrate its long-term benefi t in the treatment of lumbar stenosis . Methods . Patients with lumbar spinal stenosis who received ESI within the first 3 months of enrollment in SPORT ( ESI ) were compared with patients who did not receive epidural injections during the first 3 months of the study ( no-ESI ) . Results . There were 69 ESI patients and 207 no-ESI patients . There were no significant differences in demographic factors , baseline clinical outcome scores , or operative details between the groups , although there was a significant increase in baseline preference for nonsurgical treatment among ESI patients ( ESI 62 % vs. no-ESI 33 % , P < 0.001 ) . There was an average 26-minute increase in operative time and an increased length of stay by 0.9 days among the ESI patients who ultimately underwent surgical treatment . Averaged over 4 years , there was significantly less improvement in 36-Item Short Form Health Survey ( SF-36 ) Physical Function among surgically treated ESI patients ( ESI 14.8 vs. no-ESI 22.5 , P = 0.025 ) . In addition , there was significantly less improvement among the nonsurgically treated patients in SF-36 Body Pain ( ESI 7.3 vs. no-ESI 16.7 , P = 0.007 ) and SF-36 Physical Function ( ESI 5.5 vs. no-ESI 15.2 , P = 0.009 ) . Of the patients assigned to the surgical treatment group , there was a significantly increased crossover to nonsurgical treatment among patients who received an ESI ( ESI 33 % vs. no-ESI 11 % , P = 0.012 ) . Of the patients assigned to the nonoperative treatment group , there was a significantly increased crossover to surgical treatment in the ESI patients ( ESI 58 % vs. no-ESI 32 % , P = 0.003 ) . Conclusion . Despite equivalent baseline status , ESIs were associated with significantly less improvement at 4 years among all patients with spinal stenosis in SPORT . Furthermore , ESIs were associated with longer duration of surgery and longer hospital stay . There was no improvement in outcome with ESI whether patients were treated surgically or nonsurgically BACKGROUND Epidural steroid injections ( ESIs ) are commonly used to treat low back pain , including symptomatic lumbar spinal stenosis ( LSS ) . Reports on LSS treatment with ESIs have not differentiated between neurogenic claudication , which is believed to result from nerve root compression , and lumbar radicular pain , thought to be caused by inflammation . While there is overlap between these groups , the clinical relevance of ESI treatment can not be generalized between these 2 distinct diseases with completely different pathophysiological causes . METHODS This was a double-blind , r and omized , prospect i ve study of ESI vs. the mild procedure in patients with symptomatic LSS , conducted at a single pain management center . Patient reported outcome measures included Visual Analog Scale , Oswestry Disability Index , and Zurich Claudication Question naire ( ZCQ ) patient satisfaction . RESULTS Thirty-eight patients were r and omized into 2 treatment groups , 21 in mild and 17 in ESI . At 6- and 12-week follow-up , patients treated with mild reported significantly greater pain decrease over time ( P < 0.0001 ) , and significantly greater functional mobility improvement over time ( P < 0.0018 ) than ESI patients . At week 6 , mild ZCQ patient satisfaction score of 2.2 indicated a higher level of satisfaction than for ESI with a score of 2.8 . In addition , 12-week ZCQ satisfaction score was 1.8 , demonstrating sustained near-term satisfaction in the mild group . No major mild or ESI device or procedure-related complications were reported . CONCLUSIONS This study demonstrated that in LSS patients suffering with neurogenic claudication , mild provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI The effect of extradural corticosteroid injection in patients with nerve root compression syndromes associated with degenerative disease of the lumbar intervertebral discs was assessed in a double-blind controlled trial on 100 consecutive in patients assigned by r and om allocation to treatment and control groups . Assessment during admission and at three months revealed statistically highly significant differences in respect of relief of pain and resumption of normal occupation in favour of the group treated by extradural injection . This treatment seems to be a valuable adjunct to the management of lumbar nerve root compression syndromes associated with degenerative disc disease OBJECTIVE To determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections ( ESI ) in \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Epidural steroid injections may provide a small surgery-sparing effect in the short term compared with control injections and reduce the need for surgery in some patients who would otherwise proceed to surgery" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Whether marked LDL reduction to levels well below 100 mg/dL would further reduce the burden of cardiovascular disease is controversial . We compared the effects of 2 statins with widely differing potencies for LDL reduction ( pravastatin 40 mg/d and atorvastatin 80 mg/d ) on carotid intima-media thickness ( CIMT ) . Methods and Results —This was a single-center , r and omized , clinical trial of 161 patients ( mean age , 60 years ; 71.4 % male ; 46 % with known cardiovascular disease ) that met National Cholesterol Education Program ( NCEP ) II criteria for lipid-lowering therapy . The effects of atorvastatin ( 80 mg/d ; n=79 ) and pravastatin ( 40 mg/d ; n=82 ) on CIMT were compared using blinded , serial assessment s of the far wall of the distal common carotid artery . Baseline CIMT and other characteristics were similar between study groups . As anticipated , atorvastatin was substantially more potent for LDL reduction after 12 months : in the atorvastatin group , LDL cholesterol was 76±23 mg/dL after 12 months ( −48.5 % ) ; LDL cholesterol was 110±30 mg/dL in the pravastatin group ( −27.2%;P < 0.001 ) . Atorvastatin induced progressive CIMT regression over 12 months ( change in CIMT , −0.034±0.021 mm ) , whereas CIMT was stable in the pravastatin group ( change of 0.025± 0.017 mm;P = 0.03 ) . Conclusions —Marked LDL reduction ( < 100 mg/dL ) with a high-potency statin provides superior efficacy for atherosclerosis regression at 1 year . This early effect on CIMT , a surrogate for clinical benefit , suggests that marked LDL reduction with synthetic statins may provide enhanced reduction in clinical coronary event rates Background and Purpose — Multifocal signal loss lesions ( MSLLs ) on T2 * -weighted gradient-echo ( GE ) MRI are believed to be microbleeds histopathologically . Previous epidemiological studies suggested that low serum cholesterol is associated with the increased risk of intracerebral hemorrhage . We investigated risk factors of MSLLs and the relationship between lipid profiles and MSLLs on GE-MRI . Methods — We included consecutively 172 patients who underwent brain MRI . MSLLs on GE-MRI were counted by 2 neurologists separately and grade d by consensus . The concentrations of lipid profiles were categorized as quartiles , and the MSLLs were grade d as absent ( total count , 0 ) , mild ( 1 to 2 ) , moderate ( 3 to 10 ) , and severe ( > 10 ) . Results — The mean concentrations of total cholesterol and low-density lipoprotein cholesterol were significantly lower in patients with a severe degree of MSLLs than in those without MSLL ( P < 0.05 ) . By multivariate analysis , MSLLs were significantly correlated with hypertension ( odds ratio [ OR ] , 3.42 ; 95 % CI , 1.17 to 9.97 ) , leukoaraiosis ( OR , 4.62 ; 95 % CI , 2.87 to 7.41 ) , the lowest quartile of serum total cholesterol ( < 4.27 mmol/L ; OR , 10.91 ; 95 % CI , 3.98 to 25.57 ) , and the highest quartile of high-density lipoprotein ( > 1.47 mmol/L ; OR , 3.5 ; 95 % CI , 1.45 to 8.29 ) . Conclusions — Our results suggest that both the lipid profile levels and the severity of hypertension may be closely associated with MSLLs on GE-MRI The Pravastatin , Lipids , and Atherosclerosis in the Carotids trial ( PLAC-II ) was initiated in 1987 and is the first double-masked r and omized clinical trial with progression of early extracranial carotid atherosclerosis as an outcome variable . The trial will compare a lipid-lowering agent ( pravastatin , a hydroxymethylglutaryl CoA reductase inhibitor ) with placebo for ability to retard the rate of progression of extracranial carotid atherosclerosis over 3 years . Inclusion criteria consisted of prevalent coronary artery disease , moderately elevated low-density lipoprotein ( LDL ) cholesterol ( between the 60th and 90th percentiles ) , and the presence of at least one extracranial carotid artery atherosclerotic plaque that had an intimal-medial thickness ( IMT ) > or = 1.3 mm as visualized by B-mode ultrasound . Of approximately 650 patients who qualified on the basis of coronary disease and elevated LDL cholesterol , 55 % were excluded because of B-mode criteria . One hundred and fifty-one males and females 50 - 75 years of age were recruited . R and om allocation produced placebo-treated and test-treated groups that were similar for baseline historical data , physical findings , laboratory tests , lipid values , and B-mode characteristics . Baseline concentrations of plasma total cholesterol , LDL cholesterol , and high-density lipoprotein ( HDL ) cholesterol were 234 , 166 , and 41 mg/dl , respectively . Baseline plasma concentration of triglyceride was 170 mg/dl . Despite selection of participants whose arteries , overall , were suitable for the trial , individual segments in some participants could not be visualized . Ninety-seven percent of the individual carotid artery segments were visualized in the common carotid , 88 % in the bifurcation , and 63 % in the internal carotid artery . Far walls were slightly more often visualized than near walls , and nonvisualization was most common for the near wall of the internal carotid . Nonvisualized segments were comparable between both treatment groups . The distribution of arterial walls with qualifying plaque of > or = 1.3 mm IMT was similar for the two groups , and the two groups were also comparable for the primary outcome determinant , mean maximum IMT ( mean of maximum of all visualizable sites , 1.32 mm for each treatment group ) . There are special problems related to recruitment and evaluation of patients for a clinical trial such as this , but the atherosclerosis outcome measurement markedly enhances power and compensates for difficulty in recruitment BACKGROUND Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals , their efficacy and safety in elderly people is not fully established . Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with , or at high risk of developing , cardiovascular disease and stroke . METHODS We did a r and omised controlled trial in which we assigned 5804 men ( n=2804 ) and women ( n=3000 ) aged 70 - 82 years with a history of , or risk factors for , vascular disease to pravastatin ( 40 mg per day ; n=2891 ) or placebo ( n=2913 ) . Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke . Analysis was by intention-to-treat . FINDINGS Pravastatin lowered LDL cholesterol concentrations by 34 % and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo ( hazard ratio 0.85 , 95 % CI 0.74 - 0.97 , p=0.014 ) . Coronary heart disease death and non-fatal myocardial infa rct ion risk was also reduced ( 0.81 , 0.69 - 0.94 , p=0.006 ) . Stroke risk was unaffected ( 1.03 , 0.81 - 1.31 , p=0.8 ) , but the hazard ratio for transient ischaemic attack was 0.75 ( 0.55 - 1.00 , p=0.051 ) . New cancer diagnoses were more frequent on pravastatin than on placebo ( 1.25 , 1.04 - 1.51 , p=0.020 ) . However , incorporation of this finding in a meta- analysis of all pravastatin and all statin trials showed no overall increase in risk . Mortality from coronary disease fell by 24 % ( p=0.043 ) in the pravastatin group . Pravastatin had no significant effect on cognitive function or disability . INTERPRETATION Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals . PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival . The present trial was design ed to evaluate the effect of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease ( CHD ) . 4444 patients with angina pectoris or previous myocardial infa rct ion and serum cholesterol 5.5 - 8.0 mmol/L on a lipid-lowering diet were r and omised to double-blind treatment with simvastatin or placebo . Over the 5.4 years median follow-up period , simvastatin produced mean changes in total cholesterol , low-density-lipoprotein cholesterol , and high-density-lipoprotein cholesterol of -25 % , -35 % , and + 8 % , respectively , with few adverse effects . 256 patients ( 12 % ) in the placebo group died , compared with 182 ( 8 % ) in the simvastatin group . The relative risk of death in the simvastatin group was 0.70 ( 95 % CI 0.58 - 0.85 , p = 0.0003 ) . The 6-year probabilities of survival in the placebo and simvastatin groups were 87.6 % and 91.3 % , respectively . There were 189 coronary deaths in the placebo group and 111 in the simvastatin group ( relative risk 0.58 , 95 % CI 0.46 - 0.73 ) , while noncardiovascular causes accounted for 49 and 46 deaths , respectively . 622 patients ( 28 % ) in the placebo group and 431 ( 19 % ) in the simvastatin group had one or more major coronary events . The relative risk was 0.66 ( 95 % CI 0.59 - 0.75 , p < 0.00001 ) , and the respective probabilities of escaping such events were 70.5 % and 79.6 % . This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged 60 or more . Other benefits of treatment included a 37 % reduction ( p < 0.00001 ) in the risk of undergoing myocardial revascularisation procedures . This study shows that long-term treatment with simvastatin is safe and improves survival in CHD patients BACKGROUND Elevated levels of C-reactive protein , even in the absence of hyperlipidemia , are associated with an increased risk of coronary events . Statin therapy reduces the level of C-reactive protein independently of its effect on lipid levels . We hypothesized that statins might prevent coronary events in persons with elevated C-reactive protein levels who did not have overt hyperlipidemia . METHODS The level of C-reactive protein was measured at base line and after one year in 5742 participants in a five-year r and omized trial of lovastatin for the primary prevention of acute coronary events . RESULTS The rates of coronary events increased significantly with increases in the base-line levels of C-reactive protein . Lovastatin therapy reduced the C-reactive protein level by 14.8 percent ( P<0.001 ) , an effect not explained by lovastatin-induced changes in the lipid profile . As expected , lovastatin was effective in preventing coronary events in participants whose base-line ratio of total cholesterol to high-density lipoprotein ( HDL ) cholesterol was higher than the median ratio , regardless of the level of C-reactive protein ( number needed to treat for five years to prevent 1 event , 47 ; P=0.005 ) . However , lovastatin was also effective among those with a ratio of total to HDL cholesterol that was lower than the median and a C-reactive protein level higher than the median ( number needed to treat , 43 ; P=0.02 ) . In contrast , lovastatin was ineffective among participants with a ratio of total to HDL cholesterol and a C-reactive protein level that were both lower than the median ( number needed to treat , 983 ; P=0.80 ) . CONCLUSIONS Statin therapy may be effective in the primary prevention of coronary events among subjects with relatively low lipid levels but with elevated levels of C-reactive protein CONTEXT Patients experience the highest rate of death and recurrent ischemic events during the early period after an acute coronary syndrome , but it is not known whether early initiation of treatment with a statin can reduce the occurrence of these early events . OBJECTIVE To determine whether treatment with atorvastatin , 80 mg/d , \n Output:\n " }, { "from": "agent", "value": "Statin size effect was closely associated with LDL-C reduction .\nStatins may reduce the incidence of all strokes without any increase in hemorrhagic strokes , and this effect is mainly driven by the extent of between-group LDL-C reduction .\nCarotid IMT progression also strongly correlated with LDL-C reduction" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE A subset of head and neck cancers is associated with the human papillomavirus ( HPV ) . Viral infection is closely correlated with expression of p16(INK4A ) in these tumors . We evaluated p16(INK4A ) as a prognostic marker of treatment response and survival in a well-defined and prospect ively collected cohort of patients treated solely with conventional radiotherapy in the Danish Head and Neck Cancer Group ( DAHANCA ) 5 trial . PATIENTS AND METHODS Immunohistochemical expression of p16(INK4A ) was analyzed in pretreatment paraffin-embedded tumor blocks from 156 patients treated with conventional primary radiotherapy alone . The influence of p16(INK4A ) status on locoregional tumor control , disease-specific survival , and overall survival after radiotherapy was evaluated . RESULTS p16(INK4A ) positivity was found in 35 tumors ( 22 % ) . Tumor-positivity for p16(INK4A ) was significantly correlated with improved locoregional tumor control ( 5-year actuarial values 58 % v 28 % ; P = .0005 ) , improved disease-specific survival ( 72 % v 34 % ; P = .0006 ) , and improved overall survival ( 62 % v 26 % ; P = .0003 ) . In multivariate analysis , p16(INK4A ) remained a strong independent prognostic factor for locoregional failure ( hazard ratio [ HR ] , 0.35 ; 95 % CI , 0.19 to 0.64 ) , disease-specific death ( HR , 0.36 ; 95 % CI , 0.20 to 0.64 ) , and overall death ( HR , 0.44 ; 95 % CI , 0.28 to 0.68 ) . CONCLUSION Expression of p16(INK4A ) has a major impact on treatment response and survival in patients with head and neck cancer treated with conventional radiotherapy The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : \" 0 \" , 12 % ( 181 ) ; \" 1 - 2 \" , 26 % ( 225 ) ; \" 3 - 4 \" , 52 % ( 71 ) ; and \" greater than or equal to 5 \" , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : \" 0 \" , 8 % ( 588 ) ; \" 1 \" , 25 % ( 54 ) ; \" 2 \" , 48 % ( 25 ) ; \" greater than or equal to 3 \" , 59 % ( 18 ) . With each increased level of the comorbidity index , there were stepwise increases in the cumulative mortality attributable to comorbid disease ( log rank chi 2 = 165 ; p less than 0.0001 ) . In this longer follow-up , age was also a predictor of mortality ( p less than 0.001 ) . The new index performed similarly to a previous system devised by Kaplan and Feinstein . The method of classifying comorbidity provides a simple , readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies . Further work in larger population s is still required to refine the approach because the number of patients with any given condition in this study was relatively small CONTEXT Patients with cancer often have other medical ailments , referred to as comorbidity . Comorbidity may impact treatment decision-making , prognosis , and quality of care assessment . OBJECTIVE To assess whether comorbidity information can provide important prognostic information in a hospital-based cancer registry . DESIGN , SETTING , AND PARTICIPANTS An observational prospect i ve cohort study using comorbidity data collected by trained hospital-based cancer registrars . Comorbidity was obtained through medical record review using the Adult Comorbidity Evaluation 27 , a vali date d chart-based comorbidity instrument . A total of 17,712 patients receiving care between January 1 , 1995 , and January 31 , 2001 , for the primary diagnosis of new cancer of the prostate , lung ( nonsmall cell ) , breast , digestive system , gynecological , urinary system , or head and neck were included . MAIN OUTCOME MEASURE Duration in months of overall survival . RESULTS A total of 19,268 patients were included in the study ; median duration of follow-up was 31 months . Of these patients , 1556 ( 8.0 % ) were excluded due to missing or unknown data . Severity of comorbidity strongly influenced survival in a dose-dependent fashion and the impact of comorbidity was independent of cancer stage . Compared with patients without comorbidity , the adjusted hazard ratio associated with mild comorbidity was 1.21 ( 95 % confidence interval [ CI ] , 1.13 - 1.30 ) , moderate comorbidity was 1.86 ( 95 % CI , 1.73 - 2.00 ) , and severe comorbidity was 2.56 ( 95 % CI , 2.35 - 2.81 ) . Adjusted Kaplan-Meier survival curves revealed that at any point in time the patients with more severe levels of comorbidity had worse survival ( partial chi2(3 ) due to comorbidity , 523.54 ; P<.001 ) . Model discrimination ranged from 0.71 for head and neck to 0.86 for prostate cancers . CONCLUSIONS Comorbidity is an important independent prognostic factor for patients with cancer . The inclusion of comorbidity in hospital-based cancer registries will increase the value and use of observational research BACKGROUND The best treatment for advanced head and neck cancer remains unclear . Proponents of various therapeutic regimens continue to debate this issue with inconclusive and frequently biased data and with carefully selected patients in controlled trials to support their approach . To assess the outcome of patients in a real-world situation , we review ed a prospect ively maintained data base of patients with head and neck cancer . METHODS We review ed data from 591 consecutive patients with stage III or IV squamous cell carcinoma treated at a university medical center from January 1 , 1992 , through December 31 , 2000 , and analyzed survival using the Kaplan-Meier method . RESULTS Overall survival was 48 % , 40 % , and 33 % at 2 , 3 , and 5 years , respectively . We found a significant death rate due to comorbid conditions . The primary tumor was treated surgically ( with or without postoperative radiation ) in 363 patients , with survival of 55 % , 46 % , and 38 % at 2 , 3 , and 5 years , respectively . The tumor was treated primarily with radiation therapy ( with or without neck dissection ) in 193 patients , with survival of 40 % , 33 % , and 27 % at 2 , 3 , and 5 years , respectively . Overall survival in the surgical group was better than in the radiation group ( P = .005 , log-rank chi 2 test ) . The radiation group was subcategorized into those who underwent radiation because the tumor was so advanced as to be unresectable ( n = 86 ) , because they were too unhealthy to undergo radical surgery ( n = 23 ) , and because they elected radiation therapy ( n = 84 ) . Survival in each of the radiation subgroups at 2 , 3 , and 5 years was 28 % , 20 % , and 14 % , respectively , in the unresectable group ; 34 % , 22 % , and 11 % , respectively , in the unhealthy group ; and 57 % , 53 % , and 46 % , respectively , in the elective group . Thus , survival in the elective radiation subgroup exceeded that of the surgical group , although not statistically . We analyzed data regarding T and N stages , age , race , surgical margin status , postoperative radiation therapy , chemotherapy , radiation dose , and tumor site . Multivariate analysis of the surgical group and elective radiation subgroup showed that N stage and age were the strongest predictors of survival and that the method of therapy was not significant . For oropharyngeal cancer , the patients in the elective radiation subgroup did as well as the surgical group . Many patients were noncompliant with portions of therapy , with a result ing reduction in survival . CONCLUSIONS The data demonstrate the value of analyzing a consecutive series of patients with advanced head and neck cancer . By including patients with comorbidities and those who are noncompliant , we determined a realistic expectation of patient outcomes . By including all patients , the data dramatically show the impact of age , comorbidity , and advanced stage on survival . The survival of patients who underwent elective radiation therapy in combination with neck dissection was similar to that of patients treated with primary tumor surgery . This was particularly true for oropharyngeal tumors . The site and stage-specific data are useful in counseling patients with advanced head and neck cancer regarding treatment choices BACKGROUND In head and neck cancer , the locoregional failure of patients with positive margins , vascular or perineural invasion , and extracapsular spread is high and results in poor survival . OBJECTIVE To assess the effect of adjuvant chemoradiotherapy in improving treatment outcomes among older patients with head and neck cancer . METHODS Forty patients undergoing radical surgery ( median age , 73.5 years [ range , 70 - 78 years ] ) were enrolled ( 35 men and 5 women ; Eastern Cooperative Oncology Group performance status , grade 0 - 2 ) . Disease sites included the oral cavity ( 10 patients ) , oropharynx ( 12 patients ) , hypopharynx ( 8 patients ) , and larynx ( 10 patients ) ; pathological TNM classifications included T1 N2 ( 8 patients ) , T2 N1 - 2 ( 12 patients ) , T3 N0 - 2 ( 8 patients ) , and T4 N0 - 2 ( 12 patients ) , with the following poor prognostic factors : positive margins ( 6 patients ) , vascular invasion ( 14 patients ) , neural invasion ( 16 patients ) , and extracapsular spread ( 26 patients ) . All patients were treated with carboplatin ( 30 mg/m2 on days 1 - 5 of weeks 1 , 3 , and 5 ) concomitant with radiotherapy ( 54.0 Gy to all risk volumes plus 10.0 Gy to high-risk volumes ; 5 daily fractions of 1.8 Gy each per week ) . RESULTS No grade 4 toxicity was observed . Grade 3 toxicity included mucositis ( 10 patients ) , neutropenia ( 6 patients ) , dermatitis ( 2 patients ) , and thrombocytopenia ( 1 patient ) . The radiotherapy dose administered was 52.0 Gy to all risk volumes plus 10.0 Gy to high-risk volumes . Thirty-two patients ( 80 % ) received 3 cycles , 6 ( 15 % ) received 2 cycles , and 2 ( 5 % ) received 1 cycle . Three-year survival was as follows : disease-free survival , 58 % ; overall survival , 64 % ; and local control , 79 % . CONCLUSIONS Adjuvant chemoradiotherapy may be successful in fit older patients . The results of adjuvant chemoradiotherapy were better than those observed in a comparable group treated with radiotherapy alone and were similar to those observed in a younger group with the same poor prognostic factors treated with adjuvant carboplatin plus radiotherapy The elderly are often treated less aggressively in an attempt to preserve their quality of life with regards to toxicity . However , there are few data regarding the acute and late toxicity of radiotherapy ( RT ) in elderly patients . From February 1980 to March 1995 , 1589 patients with head and neck cancers who enrolled in EORTC trials received RT and were available for analysis on RT toxicity . Patients over 65 years of age were in excess of 20 % . Data regarding age and acute objective mucosal reactions were available for 1307 patients and 1288 had toxicity > or = grade 1 . Age and acute functional mucosal reactions were registered for 838 patients and 824 patients had toxicity > or = grade 1 . Bodyweight alteration during treatment was available in 1252 patients ; it increased in 153 patients and decreased in 1099 patients . Late toxicities were examined only if they occurred before an eventual tumour failure in order to avoid confusion between effects of first- and second-line treatments . 749 patients were available for analysis of which 646 had late toxicity grade > or = 1 . Survival and toxicity were examined in different age ranges from 50 to 75 years and over . There was no significant difference in survival between each age group . A trend test was performed to assess any correlation between age and the acute occurring toxicity . There was no significant difference in acute objective mucosal reactions ( P = 0.1 ) and in weight loss > 10 % ( P = 0.441 ) . In contrast , older patients had more severe ( grade 3 and 4 ) functional acute toxicity ( P < 0.001 ) than younger patients . We evaluated the probability of late toxicity \n Output:\n " }, { "from": "agent", "value": "The prevalence of comorbidity increased with age and the presence of comorbidity influenced treatment and treatment selection .\nFurthermore , comorbidity was associated with lower socio economic status and increased the risk of early retirement after treatment .\nIncreasing comorbidity-score was associated with increased risk of death .\nComorbidity is important in HNSCC and significantly impacts on overall survival ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To determine the feasibility and efficacy of a six-month , cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease ( COPD ) following pulmonary rehabilitation . Methods Participants who completed a two-week run-in were r and omly assigned to either MOBILE-Coached ( n = 9 ) or MOBILE-Self-Monitored ( n = 8) . All participants met with a nurse to develop an individualized exercise plan , were issued a pedometer and exercise booklet , and instructed to continue to log their daily exercise and symptoms . MOBILE-Coached also received weekly reinforcement text messages on their cell phones ; reports of worsening symptoms were automatically flagged for follow-up . Usability and satisfaction were assessed . Participants completed incremental cycle and six minute walk ( 6MW ) tests , wore an activity monitor for 14 days , and reported their health-related quality of life ( HRQL ) at baseline , three , and six months . Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18 % predicted . Participants reported that logging their exercise and symptoms ( FEV1 ) of 40 ± was easy and that keeping track of their exercise helped them remain active . There were no differences between groups over time in maximal workload , 6MW distance , or HRQL ( p > 0.05 ) ; however , MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months ( p = 0.04 ) . Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring . The latter finding needs to be interpreted with caution since this was a purely exploratory study . Trial registration Clinical Trials.gov ( NCT00373932 ) OBJECTIVE To investigate whether patients with chronic obstructive pulmonary disease on long-term oxygen therapy would benefit from an early 8-week rehabilitation programme in terms of exercise performance , health-related quality of life and activities of daily living . METHODS Two weeks after onset of oxygen therapy , 20 patients were r and omized to rehabilitation ( group A ) or not ( group B ) . Exercise performance was measured using a 6-minute walking test . Health-related quality of life was measured with the Chronic Respiratory Disease Question naire . Activity of daily living ability was measured with the Stanford Health Assessment Question naire . RESULTS The mean 6-minute walking distance increased by 35 % ( p < 0.01 ) in group A after rehabilitation . The mean increase in group B was only 8 % ( n.s . ) . Patients in group A reported less overall dyspnoea after rehabilitation ( p < 0.05 ) and , compared with group B , reported better activity of daily living ability ( p < 0.01 ) . CONCLUSION Patients with chronic obstructive pulmonary disease on long-term oxygen treatment may improve their walking distance , experience less dyspnoea and improve activity of daily living ability with an early rehabilitation programme Background COPD is characterized by variability in exercise capacity and physical activity ( PA ) , and acute exacerbations ( AEs ) . Little is known about the relationship between daily step count , a direct measure of PA , and the risk of AEs , including hospitalizations . Methods In an observational cohort study of 169 persons with COPD , we directly assessed PA with the StepWatch Activity Monitor , an ankle-worn accelerometer that measures daily step count . We also assessed exercise capacity with the 6-minute walk test ( 6MWT ) and patient-reported PA with the St. George 's Respiratory Question naire Activity Score ( SGRQ-AS ) . AEs and COPD -related hospitalizations were assessed and vali date d prospect ively over a median of 16 months . Results Mean daily step count was 5804±3141 steps . Over 209 person-years of observation , there were 263 AEs ( incidence rate 1.3±1.6 per person-year ) and 116 COPD -related hospitalizations ( incidence rate 0.56±1.09 per person-year ) . Adjusting for FEV1 % predicted and prednisone use for AE in previous year , for each 1000 fewer steps per day walked at baseline , there was an increased rate of AEs ( rate ratio 1.07 ; 95%CI = 1.003–1.15 ) and COPD -related hospitalizations ( rate ratio 1.24 ; 95%CI = 1.08–1.42 ) . There was a significant linear trend of decreasing daily step count by quartiles and increasing rate ratios for AEs ( P = 0.008 ) and COPD -related hospitalizations ( P = 0.003 ) . Each 30-meter decrease in 6MWT distance was associated with an increased rate ratio of 1.07 ( 95%CI = 1.01–1.14 ) for AEs and 1.18 ( 95%CI = 1.07–1.30 ) for COPD -related hospitalizations . Worsening of SGRQ-AS by 4 points was associated with an increased rate ratio of 1.05 ( 95%CI = 1.01–1.09 ) for AEs and 1.10 ( 95%CI = 1.02–1.17 ) for COPD -related hospitalizations . Conclusions Lower daily step count , lower 6MWT distance , and worse SGRQ-AS predict future AEs and COPD –related hospitalizations , independent of pulmonary function and previous AE history . These results support the importance of assessing PA in patients with COPD , and provide the rationale to promote PA as part of exacerbation-prevention strategies Background : Chronic obstructive pulmonary disease ( COPD ) is a leading cause of death and 70 % of the cost of COPD is due to hospitalizations . Self-reported daily physical activity and health status have been reported as predictors of a hospitalization in COPD but are not routinely assessed . Objectives : We tested the hypothesis that self-reported daily physical activity and health status assessed by a simple question were predictors of a hospitalization in a well-characterized cohort of patients with severe emphysema . Methods : Investigators gathered daily physical activity and health status data assessed by a simple question in 597 patients with severe emphysema and tested the association of those patient-reported outcomes to the occurrence of a hospitalization in the following year . Multiple logistic regression analyses were used to determine predictors of hospitalization during the first 12 months after r and omization . Results : The two variables tested in the hypothesis were significant predictors of a hospitalization after adjusting for all univariable significant predictors : > 2 h of physical activity per week had a protective effect [ odds ratio ( OR ) 0.60 ; 95 % confidence interval ( 95 % CI ) 0.41–0.88 ] and self-reported health status as fair or poor had a deleterious effect ( OR 1.57 ; 95 % CI 1.10–2.23 ) . In addition , two other variables became significant in the multivariate model : total lung capacity ( every 10 % increase ) had a protective effect ( OR 0.88 ; 95 % CI 0.78–0.99 ) and self-reported anxiety had a deleterious effect ( OR 1.75 ; 95 % CI 1.13–2.70 ) . Conclusion : Self-reported daily physical activity and health status are independently associated with COPD hospitalizations . Our findings , assessed by simple questions , suggest the value of patient-reported outcomes in developing risk assessment tools that are easy to use BACKGROUND Daily physical activity ( DPA ) level is reduced in patients with COPD . The aim of this study was to investigate the association of DPA with functional and psychological variables in these patients . METHODS 155 COPD patients ( 102 males , median ( IQR ) age 62 years ( 54 - 69 years ) , predicted FEV1 60 % ( 40 - 75 % ) were included . We assessed DPA ( DigiWalker SW-200 ) , functional capacity and psychological factors . RESULTS DPA level was significantly associated with all functional capacity variables and two psychological variables ( Perceived Physical Ability Subscale , depression subscale of the Hospital Anxiety and Depression Scale ) . The six-minute walking distance and St. George Respiratory Question naire activity score explained 37 % of the variance of DPA in a regression analysis . A structural equations model revealed that psychological variables indirectly explained DPA through functional capacity variables . DPA was stronger associated with functional capacity variables and weaker with psychological variables in patients with lower functional status than in patients with higher functional status . CONCLUSIONS Higher levels of DPA are associated with better functional capacity , but interestingly , DPA is also affected by psychological factors , though only indirectly , via functional capacity . The effect of specific treatment addressing psychological factors on DPA level and exercise tolerance needs further investigation . CLINICAL TRIAL REGISTRATION Clinical Trials.gov , NCT00614796 UNLABELLED Multidimensional instruments for determining the severity and prognosis of chronic obstructive pulmonary disease ( COPD ) must be used in daily clinical practice . OBJECTIVE To develop and vali date a new COPD severity score using variables readily obtained in clinical practice and to compare its predictive capacity with that of other multidimensional indexes . Data collected from a prospect i ve cohort of 611 stable COPD patients were used to derive a clinical prediction rule that was later vali date d in a separate prospect i ve cohort of 348 patients . In the multivariate analyses , six independent predictive factors were correlated with overall and respiratory mortality : health status , physical activity , dyspnea , airway obstruction ( FEV(1 ) ) , age , and hospitalizations for COPD exacerbations in the previous two years . These create the HADO-AH score . Based on the β parameter obtained in the multivariate model , a score was assigned to each predictive variable . The area under the curve for 5-year mortality was 0.79 ( 95 % CI , 0.74 - 0.83 ) in the derivation cohort and 0.76 ( 95 % CI , 0.71 - 0.81 ) in the validation cohort . The HADO-AH score was a significantly better predictor of mortality than the HADO-score and the Body-mass index , Obstruction , Dyspnea , Exercise-index were statistically significant ( p < 0.0004 and p = 0.021 , respectively ) , but was similar to the Age , Dyspnea , and Obstruction-index ( p = 0.345 ) . The HADO-AH score provides estimates of all-cause and respiratory mortality that are equal to , or better than , those of other multidimensional instruments . Because it uses only easily accessible measures , it could be useful at all levels of care In 159 chronic obstructive pulmonary disease ( COPD ) patients ( 139 males , mean age 62 + /- 8 yrs , arterial oxygen tension ( PaO2 ) 7.2 + /- 0.9 kPa ) , on long-term oxygen therapy ( LTOT ) , we evaluated the effects of portable oxygen therapy both on the daily duration of oxygen therapy and on daily activities . They were given two types of LTOT at r and om : group A ( n = 75 ) , oxygen concentrators only ( OC ) ; group B ( n = 84 ) , either small oxygen cylinders plus OC ( B1 = 51 ) or liquid oxygen ( B2 = 33 ) . The patients were followed-up for one year by means of : a ) medical examination every three months ; b ) monthly home interviews concerning the daily duration of oxygen therapy , the utilization of the devices and the daily activities of the patients ; c ) a measurement of the daily oxygen usage . The results show that : 1 ) there are no significant clinical and functional differences between groups A and B at the onset of and throughout the study ; 2 ) in group B the daily use of oxygen therapy is significantly longer than in group A ( 17 + /- 3.5 h.day-1 vs 14 + /- 3 h.day-1 , p less than 0.01 ) without any difference between groups B1 and B2 ; 3 ) outdoor walking activities are different between groups A and B , at least in those patients using oxygen more than 18 h.day-1 . Only 60 % of patients in group B ( 55 % of B1 ; 67 % of B2 ) use their portable devices outdoors and for walking . No strict predictive criterion of this use is found in our study . ( ABSTRACT TRUNCATED AT 250 WORDS Background The current mainstay of therapy for chronic obstructive pulmonary disease ( COPD ) is long-acting bronchodilators . To date , the effect of indacaterol , a β2-agonist , on activities of daily living in COPD patients is not well understood . The aim of this study was to evaluate the efficacy of indacaterol with regard to activities of daily living in patients with COPD . Methods In this nonr and omized open-label study , 23 patients with COPD were instructed to carry an accelerometer for 4 weeks without indacaterol therapy and then for another period of 4 weeks while receiving indacaterol therapy . Results The number of steps , duration of moderate or greater physical activity , and energy expenditure were significantly increased after treatment with indacaterol compared with baseline data in all patients with COPD ; the metabolic equivalent of task was also significantly enhanced after treatment with indacaterol . Conclusion This study provides early evidence that indacaterol improves daily physical activity in patients with COPD Little is known about effects of community-based physiotherapeutic exercise programmes incorporated \n Output:\n " }, { "from": "agent", "value": "Hyperinflation , exercise capacity , dyspnoea , previous exacerbations , gas exchange , systemic inflammation , quality of life and self-efficacy were consistently related to physical activity , but often based on cross-sectional studies and low- quality evidence .\nAs outcomes , COPD exacerbations and mortality were consistently associated with low levels of physical activity based on moderate quality evidence .\nPhysical activity was associated with other outcomes such as dyspnoea , health-related quality of life , exercise capacity and FEV1 but based on cross-sectional studies and low to very low quality evidence .\nPhysical activity level in COPD is consistently associated with mortality and exacerbations , but there is poor evidence about determinants of physical activity , including the impact of treatment" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Purpose — High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population . Methods — We used a national , multicenter , cluster-r and omized controlled trial in which 47 hospitals were r and omized to either a structured care program group ( n=23 ) or a usual care group ( n=24 ) . The structured care program consisted of a specialist-administered , guideline -recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke . The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge . This trial is registered with Clinical Trial.gov ( NCT00664846 ) . Results — At 12 months , 1287 ( 72.1 % ) patients in the St and ard Medical Management in Secondary Prevention of Ischemic Stroke in China ( SMART ) group and 1430 ( 72 % ) patients in the usual care group had completed the 12-month follow-up ( P=0.342 ) . Compared with the usual care group , those in the SMART group showed higher adherence to statins ( 56 % versus 33 % ; P=0.006 ) but no difference in adherence to antiplatelet ( 81 % versus 75 % ; P=0.088 ) , antihypertensive ( 67 % versus 69 % ; P=0.661 ) , or diabetes mellitus drugs ( 73 % versus 67 % ; P=0.297 ) . No significant difference in the composite end point ( new-onset ischemic stroke , hemorrhagic stroke , acute coronary syndrome , and all-cause death ) was observed ( 3.56 % versus 3.59 % ; P=0.921 ) . Conclusions — The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible , but these programs had only a limited impact on adherence and no impact on 1-year outcomes . Further development of a structured program to reduce vascular events after stroke is needed . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00664846 Background Community-based health education programs may be helpful in improving health outcomes in patients with chronic illnesses . This study aim ed to evaluate community-based health education strategies in the management of hypertensive patients with low socioeconomic status in Dongguan City , China . Methods This was a r and omized , non-blinded trial involving 360 hypertensive patients enrolled in the community health service centre of Liaobu Town , Dongguan City , China . Participants were r and omized to receive one of the three community-based health education programs over 2 years : self-learning reading ( Group 1 ) , monthly regular didactic lecture ( Group 2 ) , monthly interactive education workshop ( Group 3 ) . Outcomes included the changes in the proportion of subjects with normalized blood pressure ( BP ) , hypertension-related knowledge score , adherence to antihypertensive treatment , lifestyle , body mass index and serum lipids . Results After the 2-y intervention , the proportion of subjects with normalized BP increased significantly in Group 2 ( from 41.2 % to 63.2 % , p<0.001 ) , and increased more substantially in Group 3 ( from 40.2 % to 86.3 % , p<0.001 ) , but did not change significantly in Group 1 . Improvements in hypertension-related knowledge score , adherence to regular use of medications , appropriate salt intake and regular physical activity were progressively greater from group 1 to group 2 to group 3 . Group 3 had the largest reductions in body mass index and serum LDL cholesterol levels . Conclusion Interactive education workshops may be the most effective strategy in community-based health promotion education programs for hypertensive patients in improving patients ’ knowledge on hypertension and alleviating clinical risk factors for preventing hypertension-related complications Limited data are available on epidemiology and drug use in Chinese hypertensive patients with chronic kidney disease ( CKD ) . We determined the prevalence ; awareness , treatment , and control rates of hypertension ; anti-hypertensive use , expenditure pattern ; and factors associated with hypertension prevalence and control in Chinese patients with CKD . This was one of the largest cross-sectional surveys that enrolled 6079 CKD participants ( mean age , 51.0 ± 16.37 years ) with or without hypertension from 22 centres across China . The prevalence , awareness , and treatment rates were 71.2 % , 95.4 % , and 93.7 % , respectively . Control rates 1 and 2 ( Blood pressure , BP < 140/90 and < 130/80 mmHg ) were 41.1 % and 15.0 % , respectively . Patients were treated mostly with monotherapy ( 37.7 % ) or 2-drug anti-hypertensive combination ( 38.7 % ) . Factors associated with prevalence of hypertension included age ; smoking ; body mass index ; physical exercise ; family history of hypertension ; hyperuricaemia ; and CKD . Control rate was associated with CKD stage , BP monitoring at home , and use of drug combinations . Despite high rates of awareness and treatment , the control rates are low . CKD stages 4 and 5 adversely affect the control rate . The results suggest the immediate need of comprehensive controlling measures to improve the control of hypertension in Chinese patients with CKD This study aims to develop a nurse-led hypertension management model in the community setting and pilot it to an experimental trial . A total of 73 recruited participants were r and omly allocated into two groups . The study group received a home visit and 2 - 4 telephone follow-ups from the trained community nurses assisted by nursing student volunteers . The control group received doctor-led hypertension management . Data was collected at recruitment and immediately after the 8-week program . Outcome measures included blood pressure readings , self-care adherence , self-efficacy , quality of life , and patient satisfaction . Participants from the study group led by nurses had significant improvement in self-care adherence , patient satisfaction post-intervention than those from the control group led by doctors . However , there were no statistical significant differences in blood pressure readings , quality of life and self-efficacy between the two groups . The findings show that the nurse-led hypertension management appears to be a promising way to manage hypertensive patients at the community level , particularly when the healthcare system is better integrated BACKGROUND The prevalence of hypertension is high , but the overall control rate is low . Poor control of , hypertension is associated with a number of diseases , such as stroke , heart and renal failure , and high , mortality rates . Studies have shown the separate effects of nurse clinics and telephone follow-up on , blood pressure control , but the incremental effect of combining the two interventions is unknown . OBJECTIVES This study examines whether there is an incremental effect on blood pressure control when using a nurse clinic combined with telephone follow-up . METHODS This was a r and omised controlled trial . The primary outcome measure was blood pressure reading . The secondary outcome measures included adherence to home blood pressure monitoring , exercise , diet , medication , and satisfaction with care . RESULTS There were no significant differences in the baseline measures between the control and study groups . Significant differences were found at 8 weeks after intervention was initiated between groups in , systolic blood pressure ( control -7.97 vs study -19.03 , t=2.35 , p=0.022 , CI 1.66 - 20.47 ) and diastolic , blood pressure ( control -3.72 vs study -11.68 , t=3.02 , p=0.004 , CI 2.68 - 13.24 ) . Other variables with a significant between-group differences ( p<0.05 ) were blood pressure control rate , adherence , to home blood pressure monitoring , exercise and satisfaction with care . Further analysis using , regression showed that home blood pressure monitoring is the most significant predictor for improved , systolic blood pressure . CONCLUSIONS This study showed that nurse clinics have positive effects on blood pressure control and adherence to healthy lifestyle , but telephone follow-up after such clinics augments the effects of the clinic consultation . This combined mode of services is worth considering for other chronic disease , management programmes OBJECTIVE This study tests the effectiveness of motivational interviewing compared with the usual care for Chinese hypertensive patients . METHODS A r and omised controlled trial was used . One hundred and twenty eligible participants were r and omly assigned to either the control group ( usual care group ) or the intervention group ( motivational interviewing group ) . RESULTS The results of this study demonstrated that the total scores and the mean scores for each dimension of the adherence question naire were increased in the intervention group ( P<0.05 ) , and the systolic blood pressure and diastolic blood pressure of the hypertensive patients greatly decreased in the intervention group during the six months of the motivational interviewing counselling ( P<0.05 ) . CONCLUSION The application of motivational interviewing for hypertensive patients is a promising approach for sustaining the clinical benefits of adherence behaviour . PRACTICE IMPLICATION S Motivational interviewing should be provided to hypertensive patients at hospitals and community health centres to assist patients in controlling their BP and to enhance treatment adherence . A series of training courses on the motivational interviewing technique should be provided to nurses AIM The aim of this study was to examine the effect of a cardiac rehabilitation programme on health behaviours and physiological risk parameters in patients with coronary heart disease in Chengdu , China . BACKGROUND Epidemiological studies indicate a dose- , level- and duration -dependent relationship exists between cardiac behavioural and physiological risks and coronary heart disease incidence as well as subsequent cardiac morbidity and mortality . Cardiac risk factor modification has become the very primary goal of modern cardiac rehabilitation programmes . DESIGN METHODS A r and omized controlled trial was conducted . Coronary heart disease patients ( n = 167 ) who met the sampling criteria in two tertiary medical centres in Chengdu , south-west China , were r and omly assigned to either an intervention group ( the cardiac rehabilitation programme ) or control group ( the routine care ) . The change of health behaviours ( walking performance , step II diet adherence , medication adherence , smoking cessation ) and physiological risk parameters ( serum lipids , blood pressure , body weight ) were assessed to evaluate the programme effect . RESULTS Patients in the intervention group demonstrated a significantly better performance in walking , step II diet adherence , medication adherence ; a significantly greater reduction in serum lipids including triglyceride , total cholesterol , low-density lipoprotein ; and significantly better control of systolic and diastolic blood pressure at three months . The majority of these positive impacts were maintained at six months . The effect of the programme on smoking cessation , body weight , serum high-density lipoprotein , was not confirmed . CONCLUSIONS A cardiac rehabilitation programme led by a nurse can significantly improve the health behaviours and cardiac physiological risk parameters in coronary heart disease patients . Nurses can fill significant treatment gaps in the risk factor management of patients with coronary heart disease . RELEVANCE TO CLINICAL PRACTICE This study raises attention regarding the important roles nurses can play in cardiac rehabilitation and the unique way for nurses to meet the rehabilitative care needs of coronary heart disease patients . Furthermore , the hospital-home bridging nature of the programme also created a model for interfacing the acute care and community rehabilitative care Adherence to antihypertensive medications represents a crucial success factor for optimal blood pressure ( BP ) control in clinical practice . This study evaluated whether an additional pharmacist-led medication counseling could achieve better optimal BP control and enhance compliance . In a design ated family clinic in a region with similar resident characteristics to Hong Kong , patients taking ≥ one antihypertensive agent with suboptimal compliance were r and omly allocated to a brief 3-minute drug advice ( control ; n = 161 ) or pharmacist counseling ( intervention ; n = 113 ) . The two groups were compared by repeated measure ANOVA at 3-months and 6-months with BP control and medication compliance as outcome variables , respectively . The proportions of patients having optimal compliance increased from 0 % to 41.1 % at 3 months and 61.9 % at 6 months ( P < 0.001 ) . The proportion of patients having optimal BP control improved from 64.1 % at baseline to 74.0 % at 3 months and 74.5 % at 6 months ( P = 0.023 ) . There were no significant differences between the two groups in the changes of BP control and compliance levels . This study implied that even a brief 3-minute drug advice might lead to improved BP levels among patients on antihypertensive medications in general practice , but did not demonstrate additional effects by pharmacist counseling Empirical evidence has suggested that social support from family can help patients take their medicines correctly . This study aims to evaluate the role of a family member-based supervision package in the management of hypertension using a cluster r and omized trial in rural China . We recruited patients with hypertension from four villages in Yangzhong and r and omly allocated them to the control group ( n=288 ) and the intervention group ( n=266 ) . A family member-based supervision package was applied to the intervention group , while the usual service was applied to the controls . Patients were followed for 12 months and completed face-to-face interviews at the end of 6 and 12 months . The primary outcomes were patients ’ medication adherence and frequency of blood pressure measurement . Secondary outcomes included changes in blood pressure , altered risk behaviours and occurrence of hypertension \n Output:\n " }, { "from": "agent", "value": "Longer duration of intervention gave better effectiveness .\nPhysician as interventionist , regular follow-up visits and interventions conducted at a hospital were associated with better effectiveness .\nAdherence interventions improve MA and reduce uncontrolled BP among Chinese patients with hypertension ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Lactate has been shown to be a prognostic biomarker in trauma . Although lactate clearance has already been proposed as an intermediate endpoint in r and omized trials , its precise role in trauma patients remains to be determined . Methods : Blood lactate levels and lactate clearance ( LC ) were calculated at admission and 2 and 4 h later in trauma patients . The association of initial blood lactate level and lactate clearance with mortality was tested using receiver-operating characteristics curve , logistic regression using triage scores , Trauma Related Injury Severity Score as a reference st and ard , and reclassification method . Results : The authors evaluated 586 trauma patients ( mean age 38 ± 16 yr , 84 % blunt and 16 % penetrating , mortality 13 % ) . Blood lactate levels at admission were elevated in 327 ( 56 % ) patients . The lactate clearance should be calculated within the first 2 h after admission as LC0–2 h was correlated with LC0–4 h ( R2 = 0.55 , P < 0.001 ) but not with LC2–4 h ( R2 = 0.04 , not significant ) . The lactate clearance provides additional predictive information to initial blood lactate levels and triage scores and the reference score . This additional information may be summarized using a categorical approach ( i.e. , less than or equal to −20 % /h ) in contrast to initial blood lactate . The results were comparable in patients with high ( 5 mM/l or more ) initial blood lactate . Conclusions : Early ( 0–2 h ) lactate clearance is an important and independent prognostic variable that should probably be incorporated in future decision schemes for the resuscitation of trauma patients Objective . To evaluate 2-hour lactate clearance as a prognostic marker in acute cardiorespiratory insufficiency . Design . Prospect i ve observational study . Setting . Emergency Department ( ED ) and 16-bed medical High Dependency Unit ( HDU ) . Methods and Main Results . 95 consecutive admissions from the ED for acute cardiorespiratory insufficiency were prospect ively enrolled . Arterial lactate concentration was assessed at ED arrival and 1 , 2 , 6 , and 24 hours later . The predictive value of 2-hour lactate clearance was evaluated for negative outcomes defined as hospital mortality or need for endotracheal intubation versus positive outcomes defined as discharge or transfer to a general medical ward . Logistic regression and ROC curves found 2-hour lactate clearance > 15 % was a strong predictor of negative outcome ( P < .0001 ) with a sensitivity of 86 % ( 95%CI = 67%–95 % ) and a specificity of 91 % ( 95%CI = 82%–96 % ) , Positive predictive value was 80 % ( 95%CI = 61%–92 % ) , and negative predictive value was 92 % ( 95%CI = 84%–98 % ) . Conclusions . Systematic monitoring of lactate clearance at 2 hours can be used in to identify patients at high risk of negative outcome and perhaps to tailor more aggressive therapy . Equally important is that a 2-hour lactate clearance > 15 % is highly predictive of positive outcome and may reassure clinicians that the therapeutic approach is appropriate Abstract Background Blood lactate levels and central venous oxygen saturation ( ScvO2 ) are known to be useful indicators of global tissue hypoxia . However , it is unclear whether ScvO2 correlates with lactate levels when measured simultaneously and whether changes in ScvO2 or lactate levels in serial measurements have prognostic value . We investigated the correlation between ScvO2 and lactate levels measured simultaneously and their association with clinical outcomes . Methods We performed a prospect i ve observational study of patients with severe systemic inflammatory response syndrome ( SIRS ) and severe sepsis who were admitted to the medical intensive care unit . ScvO2 and lactate levels were measured simultaneously at the time of study enrollment , every 6 h for 24 h , and then every 24 h until the goal was reached . Results Twenty-five patients were enrolled in the study ; 13 have died and 12 have survived . There was no correlation between lactate levels and ScvO2 . Neither lactate levels nor ScvO2 at the time of admission differed between nonsurvivors and survivors . Normalization of lactate levels within 48 h was significantly associated with survival . Conclusions In patients with severe SIRS and severe sepsis , simultaneously measured ScvO2 and lactate levels showed no correlation , and normalization of lactate levels within 48 h was a predictive factor for survival OBJECTIVE To compare the efficacy of fluid resuscitation as guided by lactate clearance rate ( LCR ) and central venous oxygen saturation ( ScvO2 ) in patients with sepsis . METHODS A prospect i ve r and omized control study was conducted . Fifty patients diagnosed with severe sepsis or septic shock from January 2011 to February 2012 in department of critical care medicine of Fourth Hospital of Hebei Medical University were enrolled in the study . The patients were r and omly divided into two groups according to the sequence ( each n=25 ) : ScvO2 group and LCR group . After ICU admission , the patients were treated symptomatically timely , and fluid resuscitation was started as early as possible according to Surviving Sepsis Campaign guidance for management of severe sepsis and septic shock 2008 . Central venous pressure (CVP)≥8 mm Hg ( 1 mm Hg=0.133 kPa ) , mean arterial pressure (MAP)≥65 mm Hg and ScvO2≥0.70 served as goal values to accomplish the fluid resuscitation therapy in ScvO2 group , while CVP≥8 mm Hg , MAP≥65 mm Hg , LCR≥10 % served as goal value to accomplish the fluid resuscitation therapy in LCR group . The general condition and clinical characteristics on arrival in ICU , changes in CVP , MAP , ScvO2 , lactate level and /or LCR before ( 0 hour ) and 3 , 6 , 72 hours after the start of fluid resuscitation and the other related conditions during the therapy were recorded . RESULTS There was no significant difference in general data or clinical characteristics before the start of therapy , occurrence of organ dysfunction , or treatment measures during different time periods after start of fluid resuscitation . Compared with the condition immediately before fluid resuscitation , at 3 hours after start of fluid resuscitation , CVP were improved in LCR and ScvO2 groups ( 8.58±1.17 mm Hg vs. 6.33±1.21 mm Hg , 9.08±2.43 mm Hg vs. 5.33±0.98 mm Hg , both P<0.05 ) ; at 6 hours after start of fluid resuscitation , heart rate ( HR ) and respiratory rate ( RR ) were lowered in LCR and ScvO2 groups ( HR : 96±18 bpm vs. 127±13 bpm , 98±13 bpm vs. 116±19 bpm , RR : 23±3 times/min vs. 33±9 times/min , 24±5 times/min vs. 35±6 times/min , all P<0.05 ) , oxygenation index ( PaO2/FiO2 ) was increased in LCR and ScvO2 groups ( 179±41 mm Hg vs. 86±21 mm Hg , 202±33 mm Hg vs. 95±17 mm Hg , both P<0.05 ) , and there was no significant difference in MAP in both groups . There was no significant difference in all indexes between two groups . In LCR group , 3 hours after start of fluid resuscitation , lactate level was significantly decreased ( 2.81±0.18 mmol/L vs. 3.43±1.31 mmol/L , P<0.05 ) . Compared with the value 3 hours after start of fluid resuscitation , LCR was significantly improved at 6 hours and 72 hours after start of fluid resuscitation in LCR group [ (42.69±8.75)% , (48.87±9.69)% vs. (20.32±4.58)% , both P<0.05 ] . Compared with that immediately before fluid resuscitation , ScvO2 was significant improved in ScvO2 group at 3 hours after start of fluid resuscitation ( 0.65±0.04 vs. 0.53±0.06 , P<0.05 ) . There was no significant difference in success rate of fluid resuscitation comparing that of 6 hours and that of 72 hours [ 6 hours : 72 % ( 18/25 ) vs. 64 % ( 16/25 ) , χ(2)=0.368 , P=0.762 ; 72 hours : 88 % ( 22/25 ) vs. 88 % ( 22/25 ) , χ(2)=0.000 , P=1.000 ] , length of ICU stay ( 8±3 days vs. 10±4 days , t=0.533 , P=0.874 ) , length of hospital stay ( 29±11 days vs. 35±16 days , t=0.692 , P=0.531 ) , improvement rate [ 84 % ( 21/25 ) vs. 76%(19/25 ) , χ(2)=0.500 , P=0.480 ] or 28-day mortality [ 20 % ( 5/25 ) vs. 28 % ( 7/25 ) , χ(2)=0.439 , P=0.742 ] between LCR and ScvO2 groups . CONCLUSIONS Both LCR and ScvO2 can be taken as the index in confirming the endpoint of fluid resuscitation for patients with severe sepsis and septic shock . Fluid resuscitation therapy under the guidance of LCR is accurate and reliable in patients with severe sepsis and septic shock Introduction Dynamic changes in lactate concentrations in the critically ill may predict patient outcome more accurately than static indices . We aim ed to compare the predictive value of dynamic indices of lactatemia in the first 24 hours of intensive care unit ( ICU ) admission with the value of more commonly used static indices . Methods This was a retrospective observational study of a prospect ively obtained intensive care data base of 5,041 consecutive critically ill patients from four Australian university hospitals . We assessed the relationship between dynamic lactate values collected in the first 24 hours of ICU admission and both ICU and hospital mortality . Results We obtained 36,673 lactate measurements in 5,041 patients in the first 24 hours of ICU admission . Both the time weighted average lactate ( LACTW24 ) and the change in lactate ( LACΔ24 ) over the first 24 hours were independently predictive of hospital mortality with both relationships appearing to be linear in nature . For every one unit increase in LACTW24 and LACΔ24 the risk of hospital death increased by 37 % ( OR 1.37 , 1.29 to 1.45 ; P < 0.0001 ) and by 15 % ( OR 1.15 , 1.10 to 1.20 ; P < 0.0001 ) respectively . Such dynamic indices , when combined with Acute Physiology and Chronic Health Evaluation II ( APACHE II ) scores , improved overall outcome prediction ( P < 0.0001 ) achieving almost 90 % accuracy . When all lactate measures in the first 24 hours were considered , the combination of LACTW24 and LACΔ24 significantly outperformed ( P < 0.0001 ) static indices of lactate concentration , such as admission lactate , maximum lactate and minimum lactate . Conclusions In the first 24 hours following ICU admission , dynamic indices of hyperlactatemia have significant independent predictive value , improve the performance of illness severity score-based outcome predictions and are superior to simple static indices of lactate concentration Background The decision of when to stop septic shock resuscitation is a critical but yet a relatively unexplored aspect of care . This is especially relevant since the risks of over-resuscitation with fluid overload or inotropes have been highlighted in recent years . A recent guideline has proposed normalization of central venous oxygen saturation and /or lactate as therapeutic end-points , assuming that these variables are equivalent or interchangeable . However , since the physiological determinants of both are totally different , it is legitimate to challenge the rationale of this proposal . We design ed this study to gain more insights into the most appropriate resuscitation goal from a dynamic point of view . Our objective was to compare the normalization rates of these and other potential perfusion-related targets in a cohort of septic shock survivors . Methods We design ed a prospect i ve , observational clinical study . One hundred and four septic shock patients with hyperlactatemia were included and followed until hospital discharge . The 84 hospital-survivors were kept for final analysis . A multimodal perfusion assessment was performed at baseline , 2 , 6 , and 24 h of ICU treatment . Results Some variables such as central venous oxygen saturation , central venous-arterial pCO2 gradient , and capillary refill time were already normal in more than 70 % of survivors at 6 h. Lactate presented a much slower normalization rate decreasing significantly at 6 h compared to that of baseline ( 4.0 [ 3.0 to 4.9 ] vs. 2.7 [ 2.2 to 3.9 ] mmol/L ; p < 0.01 ) but with only 52 % of \n Output:\n " }, { "from": "agent", "value": "A decrease in lactate levels over time was consistently associated with lower mortality rates in all subgroups of patients .\nLactate kinetics did not appear very different in patients with sepsis and other types of patients .\nA few studies suggested that therapy could be guided by these measurements .\nConclusions The observation of a better outcome associated with decreasing blood lactate concentrations was consistent throughout the clinical studies , and was not limited to septic patients .\nIn all groups , the changes are relatively slow , so that lactate measurements every 1–2 hrs are probably sufficient in most acute conditions .\nThe value of lactate kinetics appears to be valid regardless of the initial value" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To compare the treatment outcomes of sorafenib plus transarterial chemoembolization ( TACE ) vs TACE alone in patients with hepatocellular carcinoma ( HCC ) and hepatic vein tumor thrombus ( HVTT ) . Methods Twenty patients who were initially diagnosed with HCC and HVTT and received TACE combined with sorafenib during February 2009 to October 2013 were included in the study . To minimize selection bias , these patients were compared with 60 case-matched controls selected from a pool of 81 patients ( in a 1:3 ratio ) who received TACE alone during the same period . The primary end point was overall survival ( OS ) . The secondary end points were time to progression , disease control rate , and adverse events . Results After a median follow-up period of 12.5 months ( range , 1.03–44.23 months ) , the OS of the combined group was found to be significantly higher compared with the monotherapy group ( 14.9 vs 6.1 months , P=0.010 ) . The time to progression was found to be significantly longer in the combined group ( 4.9 vs 2.4 months , P=0.016 ) . Univariate and multivariate analyses revealed that the treatment allocation was an independent predictor of OS . Conclusion Sorafenib plus TACE was well tolerated and was more effective in treating patients with advanced HCC and HVTT . Future trials with prospect i ve larger sample s are required to vali date these results BACKGROUND In Japan and South Korea , transarterial chemoembolisation ( TACE ) is an important locoregional treatment for patients with unresectable hepatocellular carcinoma ( HCC ) . Sorafenib , a multikinase inhibitor , has been shown effective and safe in patients with advanced HCC . This phase III trial assessed the efficacy and safety of sorafenib in Japanese and Korean patients with unresectable HCC who responded to TACE . METHODS Patients ( n=458 ) with unresectable HCC , Child-Pugh class A cirrhosis and ≥25 % tumour necrosis/shrinkage 1 - 3 months after 1 or 2 TACE sessions were r and omised 1:1 to sorafenib 400 mg bid or placebo and treated until progression/recurrence or unacceptable toxicity . Primary end-point was time to progression/recurrence ( TTP ) . Secondary end-point was overall survival ( OS ) . FINDINGS Baseline characteristics in the two groups were similar ; > 50 % of patients started sorafenib>9 weeks after TACE . Median TTP in the sorafenib and placebo groups was 5.4 and 3.7 months , respectively ( hazard ratio ( HR ) , 0.87 ; 95 % confidence interval ( CI ) , 0.70 - 1.09 ; P=0.252 ) . HR ( sorafenib/placebo ) for OS was 1.06 ( 95 % CI , 0.69 - 1.64 ; P=0.790 ) . Median daily dose of sorafenib was 386 mg , with 73 % of patients having dose reductions and 91 % having dose interruptions . Median administration of sorafenib and placebo was 17.1 and 20.1 weeks , respectively . No unexpected adverse events were observed . INTERPRETATION This trial , conducted prior to the reporting of registration al phase III trials , found that sorafenib did not significantly prolong TTP in patients who responded to TACE . This may have been due to delays in starting sorafenib after TACE and /or low daily sorafenib doses BACKGROUND AND OBJECTIVES To compare the impact of concurrent TACE + sorafenib versus TACE alone on overall survival ( OS ) and time to progression ( TTP ) in patients with unresectable hepatocellular carcinoma ( uHCC ) . A secondary goal was to determine if sorafenib use increases the interval between courses of TACE . METHODS This study enrolled 150 patients with uHCC from June 2011 to June 2014 , including 50 treated with TACE + sorafenib and 100 treated with TACE alone . Factors associated with OS and TTP were identified by univariate and multivariate Cox-regression model analyses . Average TACE interval was defined as TTP/TACE frequency . RESULTS The median OS ( 21.7 vs. 11.5 months ) and TTP ( 10.2 vs. 6.7 months ) were longer in the TACE + sorafenib group compared to the TACE group . Patients receiving combination therapy had higher survival rate ( P < 0.032 ) and longer average interval to TACE ( P < 0.001 ) , but lower progression rate ( P < 0.001 ) . TACE + sorafenib therapy was associated with improved OS ( P ≤ 0.009 ) and TTP ( P ≤ 0.021 ) . The majority of AEs identified in patients receiving the combination therapy were classified as Grade s 1 and 2 , and skin-related reactions and fatigue were the most common . CONCLUSION Concurrent sorafenib with TACE provides survival benefits over TACE monotherapy , which may be related to a prolonged interval between subsequent TACE courses . J. Surg . Oncol . 2016;113:672 - 677 . © 2016 Wiley Periodicals , BACKGROUND & AIMS Transarterial chemoembolization with doxorubicin-eluting beads ( DC Bead ® ; DEB-TACE ) is effective in patients with Barcelona clinic liver cancer stage B hepatocellular carcinoma ( HCC ) . The multikinase inhibitor sorafenib enhances overall survival ( OS ) and time-to-tumor progression ( TTP ) in patients with advanced HCC . This exploratory phase II trial tested the efficacy and safety of DEB-TACE plus sorafenib in patients with intermediate stage HCC . METHODS Patients with intermediate stage multinodular HCC without macrovascular invasion ( MVI ) or extrahepatic spread ( EHS ) were r and omized 1:1 to DEB-TACE ( 150 mg doxorubicin ) plus sorafenib 400 mg twice daily or placebo . The primary endpoint was TTP by blinded central review . Secondary endpoints included time to MVI/EHS , OS , overall response rate ( ORR ) using modified response evaluation criteria in solid tumors , disease control rate ( DCR ) , time to unTACEable progression ( TTUP ) , and safety . RESULTS Of 307 patients r and omized , 154 received sorafenib and 153 received placebo . Median TTP for subjects receiving sorafenib plus DEB-TACE or placebo plus DEB-TACE was similar ( 169 vs. 166 days , respectively ; hazard ratio ( HR ) 0.797 , p=0.072 ) . Median time to MVI/EHS ( HR 0.621 , p=0.076 ) and OS ( HR 0.898 , p=0.29 ) had not been reached . The ORRs for patients in the sorafenib and placebo groups with post-baseline scans were 55.9 % and 41.3 % , respectively , and the DCRs were 89.2 % and 76.1 % , respectively . TTUP was lower with sorafenib than with placebo ( HR 1.586 ; 95 % confidence intervals , 1.200 - 2.096 ; median 95 vs. 224 days ) . No unexpected adverse events related to sorafenib were observed . CONCLUSION Sorafenib plus DEB-TACE was technically feasible , but the combination did not improve TTP in a clinical ly meaningful manner compared with DEB-TACE alone This prospect i ve non‐r and omized controlled trial aim ed to compare the efficacy of sorafenib in combination with transarterial chemoembolization ( TACE ) vs TACE alone for the treatment of patients with unresectable intermediate or advanced hepatocellular carcinoma PURPOSE To determine the safety and efficacy of transarterial chemoembolization ( TACE ) combined with sorafenib ( hereafter , TACE-sorafenib ) in patients with hepatocellular carcinoma ( HCC ) and portal vein tumor thrombus ( PVTT ) . MATERIAL S AND METHODS This study was approved by the institutional review board , and the requirement for informed consent was waived . The medical records of consecutive patients with HCC and PVTT who underwent TACE-sorafenib or TACE alone from January 2010 to December 2012 were retrospectively evaluated . Sorafenib ( 400 mg ) was administered twice daily . Outcomes of patients who underwent TACE-sorafenib were compared with outcomes of patients who underwent TACE by using the Kaplan-Meier method according to types of PVTT : PVTT in the main portal vein ( type A ) , PVTT in the first-order portal vein branch ( type B ) , and PVTT in second- or lower-order portal vein branches ( type C ) . RESULTS Ninety-one patients were included in the analysis ; 46 patients underwent TACE-sorafenib and 45 underwent TACE . TACE-sorafenib showed significant survival benefits compared with TACE in patients with type B ( median survival , 13 months vs 6 months ; P = .002 ) or type C ( median survival , 15 months vs 10 months ; P = .003 ) PVTT . TACE-sorafenib and main PVTT were the independent prognostic factors for survival at uni- and multivariate analysis . Liver function after TACE-sorafenib worsened only in patients with main PVTT . Sorafenib-related adverse events of grade 3 or higher occurred in 16 patients ( 35 % ) . CONCLUSION TACE-sorafenib side effects were acceptable , and this treatment may improve overall survival in patients with HCC with first-order or lower-branch PVTT when compared with patients who underwent TACE alone The oncologic community is faced with a steady increase in the incidence of hepatocellular carcinoma ( HCC ) [ 1 ] . Liver cancer represents the sixth most common cancer in the world ( 749 000 new cases ) and the third cause of cancer-related death ( 692 000 cases ) . The incidence varies from 3 out of 100 000 in Western countries , to more than 15 out of 100 000 in certain areas of the world , mapping the geographical distribution of viral hepatitis B ( HBV ) and hepatitis C ( HCV ) , the most important causes of chronic liver disease and HCC [ 2 ] . Most cases arise in those regions with limited re sources . The incidence of HCC increases progressively with advancing age in all population s , with a strong male preponderance . The association of chronic liver disease and HCC represents the basis for preventive strategies , including universal vaccination at birth against hepatitis B , programs to stop transmission and early antiviral eradication of viral hepatitis B and C [ III , A ] . It is unclear whether HBV vaccination will result in a decline in HCC as was seen in Taiwan , given the importance of other risk factors in Europe , such as alcoholic and non-alcoholic fatty liver disease . The control of other risk factors for chronic liver disease and cancer is more difficult to implement , such as cutting down on the consumption of alcohol and programs aim ing at a healthier lifestyle in the light of the obesity p and emic [ 3 , 4 ] . In Africa , reduction of exposure to aflatoxin B1 , especially in HBV-infected individuals , may lower the risk of HCC . HCC may evolve from subclasses of adenomas , and in < 10 % of cases HCC occurs in a normal liver . Surveillance of HCC involves the repeated application of screening tools in patients at risk for HCC and aims for the reduction in mortality of this patient population . The success of surveillance is influenced by the incidence of HCC in the target population , the availability and acceptance of efficient diagnostic tests and the availability of effective treatment . Costeffectiveness studies suggest surveillance of HCC is warranted in cirrhotic patients irrespective of its etiology [ 5 ] . Surveillance of non-cirrhotic patients is also advocated , especially in HBV carriers with serum viral load > 10 000 copies/ml [ 6 ] or HCVinfected patients with bridging fibrosis ( F3 ) [ III , A ] . Patients with HCV infection and advanced fibrosis remain at risk for HCC even after achieving sustained virological response following antiviral treatment [ III , A ] . Japanese cohort studies have shown that surveillance by abdominal ultrasound result ed in an average size of the detected tumors of 1.6 ± 0.6 cm , with < 2 % of the cases exceeding 3 cm [ 7 ] . In the Western world and in less experienced centers , sensitivity of finding early-stage HCC by ultrasound is considerably less effective [ 8 ] . There are no data to support the use of contrast-enhanced computed tomography ( CT ) or magnetic resonance imaging ( MRI ) for surveillance . In many centers , ultrasound surveillance is complemented with the determination of serum alphafetoprotein ( AFP ) , which can lead to a 6%–8 % gain in the tumor detection rate but at the price of false-positive results . A r and omized , controlled trial ( RCT ) of Chinese patients with chronic hepatitis B infection compared surveillance ( ultrasound and serum AFP measurements every 6 months ) versus no surveillance [ 9 ] . Despite low compliance with the surveillance program ( 55 % ) , HCC-related mortality was reduced by 37 % in the surveillance arm . Considering the most appropriate surveillance interval , a r and omized study comparing a 3 \n Output:\n " }, { "from": "agent", "value": "Conclusions The combination of transarterial chemoembolizaiton and sorafenib significantly improves outcomes of unresectable hepatocellular carcinoma compared with transarterial chemoembolization monotherapy , especially in Asian region" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To report on anatomical and visual outcomes after vitrectomy and internal limiting membrane peeling for idiopathic macular hole repair . METHODS Forty patients with stage II to IV idiopathic macular holes were r and omly assigned ( 1:1 ) in a 2-arm , single-center , r and omized controlled . Internal limiting membrane delamination was performed using indocyanine green ( ICG ) solution ( n = 20 ) or trypan blue ( TB ) ( n = 20 ) . Two patients did not complete the study , for a total of 19 in each group . Follow-up examinations included Early Treatment of Diabetic Retinopathy Study visual acuity , scanning laser ophthalmoscope microperimetry , optical coherence tomography , and fluorescein angiography . Main Outcome Measure Visual acuity 3 months after surgery . RESULTS Visual acuity did not show a significant difference between study groups ( 95 % confidence interval [ CI ] , -2 to 1 lines ) . The rate of macular hole closures was identical ( 84 % ; 95 % CI , 60 % to 97 % ) . Within-group visual recovery was significant only in the TB group . Central scotomata despite hole closure persisted in 8 patients ( 42 % ) in the ICG group and in 5 ( 26 % ) in the TB group . CONCLUSION Although no statistically significant difference was detected for the primary end point , the better visual recovery in the TB group and the higher rate of persistent central scotomata in the ICG group justify a larger clinical trial . Application to Clinical Practice No statistically significant difference in visual acuity between ICG and TB in the used concentrations and application method could be proved in macular hole surgery Background Our aim was to analyze outcomes of idiopathic macular hole surgeries in relation to staging and the use of indocyanine green ( ICG ) or brilliant blue ( BB ) for internal limiting membrane ( ILM ) peel . Methods Baseline , surgical , and outcome data for 351 consecutive primary macular hole surgeries was prospect ively collected using electronic medical record software between 2001 and 2011 . The outcomes for these cases were analysed in relation to staging and the use of ICG ( 0.5 mg/ml ) or BB for ILM peel . Results Mean age was 68.9 years ( range 39–87 ) with 66.4 % females and 54.1 % right eyes . Follow-up duration was median 0.55 years . Vision was significantly improved from logMAR 0.97 ( SD 0.45 ) ( Snellen equivalent 20/185 ) preoperatively to 0.65 ( SD 0.51 ) ( 20/90 ) at final follow-up . One hundred and eighteen patients had stage 2 macular holes , 185 stage 3 , and 48 stage 4 . Mean duration of symptoms varied with stage of hole : stage 2 0.53 years ( SD 0.43 ) , stage 3 0.79 years ( SD 0.68 ) , and stage 4 1.20 years ( SD 1.26 ) , p = 0.0002 . Closure rates of the holes were significantly different , with stage 2 closing in 95.8 % , stage 3 in 73.0 % , and stage 4 in 56.3 % , p < 0.0001 . At final follow-up , mean visual acuity ( VA ) was 0.42 ( SD 0.33 ) ( 20/50 ) for stage 2 , 0.75 ( SD 0.53 ) ( 20/110 ) for stage 3 , and 0.87 ( SD 0.60 ) ( 20/145 ) for stage 4 holes , p < 0.0001.Postoperative VA was 0.71 ( SD 0.53 ) ( 20/100 ) for patients in whom ICG was used , and 0.52 ( SD 0.43 ) ( 20/70 ) for BB , p = 0.003 . The proportion of patients who achieved a closed hole was less for ICG ( 73.2 % ) than BB ( 89.9 % ) , p = 0.0005 . For those patients with stage 2 hole who achieved hole closure , mean improvement in VA was significantly better for BB ( 0.47 , SD 0.36 ) than for ICG ( 0.30 , SD 0.31 ) , p = 0.01 . Conclusions Macular hole stage is a useful measure to help predict the chance of postoperative hole closure and visual outcome . The relationship between duration of symptoms and increasing stage suggests macula hole patients require prompt referral for consideration of early surgery . Better visual outcomes were achieved with BB for ILM peel than with ICG Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed PURPOSE To describe comparatively the outcomes of macular hole surgery followed by internal limiting membrane removal with and without indocyanine green staining . METHODS We evaluated 142 consecutive macular hole surgeries with internal limiting membrane removal performed in the period from January 2001 to March 2004 . These were divided into two groups , based on the use or not of indocyanine green staining . RESULTS Both studied groups were similar concerning the patients ' profile and preoperative stage of the macular holes . Mean preoperative visual acuity was 0.12+/-0.15 in the group with indocyanine green staining and 0.18+/-0.18 in the group without internal limiting membrane staining ( p=0.02 ) . Mean postoperative visual acuity was 0.27+/-0.27 in the group with internal limiting membrane staining and 0.43+/-0.25 in the group without internal limiting membrane staining ( p=0.0002 ) . We observed improvement of visual acuity in 63 % of cases in the group in which internal limiting membrane staining was performed and in 80.3 % of cases in the group without internal limiting membrane staining . Macular hole closure rates were 76.5 % in the group treated with internal limiting membrane staining and 95.1 % in the group treated without internal limiting membrane staining . CONCLUSIONS Macular hole surgeries followed by internal limiting membrane removal without use of staining have better visual and anatomic results when compared to macular hole surgeries followed by internal limiting membrane removal guided by indocyanine green staining . We recommend caution in using indocyanine green staining in macular hole surgeries due to its possible toxic effect Purpose : To provide a spectral-domain optical coherence tomography (SD-OCT)-based analysis of retinal layers thickness and nasal displacement of closed macular hole after internal limiting membrane peeling in macular hole surgery . Methods : In this nonr and omized prospect i ve interventional study , 36 eyes of 32 patients were subjected to pars plana vitrectomy and 3.5 mm diameter internal limiting membrane ( ILM ) peeling for idiopathic macular hole ( IMH ) . Nasal and temporal internal retinal layer thickness were assessed with SD-OCT . Each scan included optic disc border so that distance between optic disc border and fovea were measured . Results : Thirty-six eyes had a successful surgery with macular hole closure . Total nasal retinal thickening ( p<0.001 ) and total temporal retinal thinning ( p<0.0001 ) were observed . Outer retinal layers increased thickness after surgery ( nasal p<0.05 and temporal p<0.01 ) . Middle part of inner retinal layers ( mIRL ) had nasal thickening ( p<0.001 ) and temporal thinning ( p<0.05 ) . The mIRL was obtained by deducting ganglion cell layer ( GCL ) and retinal nerve fiber layer ( RNFL ) thickness from overall thickness of the inner retinal layer . Papillofoveal distance was shorter after ILM peeling in macular hole surgery ( 3,651 ± 323 μm preoperatively and 3,361 ± 279 μm at 6 months ; p<0.0001 ) . Conclusions : Internal limiting membrane peel is associated with important alteration in inner retinal layer architecture , with thickening of mIRL and shortening of papillofoveal distance . These factors may contribute to recovery of disrupted foveal photoreceptor and vision improvement after IMH closure Purpose : To compare the long-term anatomic closure rate and visual outcome in patients who underwent internal limiting membrane ( ILM ) peeling with and without indocyanine green ( ICG ) dye staining for idiopathic macular hole repair . Design : Retrospective , nonr and omized , comparative study of consecutive case series . Methods : A total of 190 eyes of 182 patients with idiopathic macular holes underwent macular hole repair between March 1998 and June 2003 . Surgery consisted of pars plana vitrectomy , lensectomy if phakic , ILM peeling , intravitreal gas tamponade , and 1 week ’s face-down positioning . In the initial 94 consecutive eyes , ILM peeling was performed without adjuvants ( non-ICG group ) . The subsequent 96 eyes underwent surgery with ICG-stained ILM peeling ( ICG group ) , in which the ILM was stained with intravitreal application of 0.1 to 0.2 mL of 0.1 % ICG solution . Results : Two groups of patients had comparable clinical background s preoperatively . Mean follow-up time was 30.7 months in non-ICG group and 26.2 months in ICG group . Anatomic closure of the macular hole was achieved in 99 % of the cases in both groups , with both groups showing statistically significant visual improvement . There was no statistically significant difference in visual acuity between the two groups at each follow-up visit . There were also no intraoperative or postoperative complications attributed to the use of ICG . Conclusions : Long-term follow-up of patients undergoing ILM peeling for idiopathic macular hole repair shows equivalent anatomic and visual outcomes with and without the use of ICG Purpose : To report the 1-year results of macular hole surgery with triamcinolone acetonide (TA)–assisted internal limiting membrane ( ILM ) peeling and to compare those with results of indocyanine green (ICG)–assisted ILM peeling . Methods : In a nonr and omized , retrospective , interventional case series , 40 eyes of 39 consecutive patients with idiopathic full-thickness macular holes underwent macular hole surgery with TA-assisted ILM peeling . Surgical results 1 year after surgery , including changes in best-corrected visual acuity ( BCVA ) and macular hole closure , were evaluated . Moreover , we compared the results for these 40 eyes ( TA group ) with those for 27 eyes of 27 consecutive patients who had undergone macular hole surgery with 0.25 % ICG-assisted ILM peeling ( ICG group ) . Results : In the TA group , macular holes were closed in 39 ( 98 % ) of 40 eyes . Mean BCVA ± SD significantly improved from 0.78 ± 0.31 logarithm of the minimal angle of resolution ( logMAR ) preoperatively to 0.20 ± 0.30 logMAR ( P < 0.001 ) . BCVA improved by ≥0.2 logMAR in 37 eyes ( 93 % ) . BCVA was 20/40 or better in 33 ( 83 % ) of 30 eyes . In the ICG group , macular holes were closed in all 27 eyes ( 100 % ) , and mean BCVA ± SD significantly improved from 0.81 ± 0.4 logMAR preoperatively to 0.34 ± 0.2 logMAR 1 year postoperatively ( P < 0.001 ) . BCVA improved by ≥0.2 logMAR in 22 eyes ( 81 % ) . BCVA was 20/40 or better in 16 ( 59 % ) of 27 eyes . Significant differences between groups were seen in mean BCVA 1 year after surgery ( P = 0.049 ) but not in BCVA of 20/40 or better ( P = 0.17 ) or change in BCVA by ≥0.2 logMAR ( P = 0.05 ) . Conclusion : TA is useful as an adjuvant for ILM peeling in macular hole surgery , and BCVA 1 year after surgery might be more favorable when compared with ICG-assisted ILM peeling PURPOSE To evaluate the possible toxicity of indocyanine green ( ICG ) dye in macular hole surgery by comparing functional results after successful \n Output:\n " }, { "from": "agent", "value": "The improvement rate of visual acuity after using BBG was significantly higher than ICG .\nThe improvement rate of visual acuity was more favorable with TB than ICG , TA , and no dye .\nBBG can contribute to better anatomical and functional outcomes compared to other dyes for ILM peeling in patients with IMH .\nThe results show that the best treatment of ILM peeling with dyes is BBG" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Women who exchange sex for money or other goods , that is , female sex workers , are at increased risk of experiencing physical and sexual violence from both paying and intimate partners . Exposure to violence can be exacerbated by alcohol use and HIV/STI risk . The purpose of this study is to examine the efficacy of a HIV/STI risk reduction and enhanced HIV/STI risk reduction intervention at decreasing paying and intimate partner violence against Mongolian women who exchange sex and engage in harmful alcohol use . Women are recruited and r and omized to either ( a ) four sessions of a relationship-based HIV/STI risk reduction intervention ( n = 49 ) , ( b ) the same HIV/STI risk reduction intervention plus two additional motivational interviewing sessions ( n = 58 ) , or ( c ) a four session control condition focused on wellness promotion ( n = 59 ) . All the respondents complete assessment s at baseline ( preintervention ) as well as at immediate posttest , 3 and 6 months postintervention . A multilevel logistic model finds that women who participated in the HIV/STI risk reduction group ( OR = 0.14 , p < .00 ) , HIV/STI risk reduction and motivational interview group ( OR = 0.46 , p = .02 ) , and wellness ( OR = 0.20 , p < .00 ) group reduced their exposure to physical and sexual violence in the past 90 days . No significant differences in effects are observed between conditions . This study demonstrates the efficacy of a relationship-based HIV/STI risk reduction intervention , a relationship-based HIV/STI risk reduction intervention combined with motivational interviewing , and a wellness promotion intervention in reducing intimate and paying partner violence against women who exchange sex in Mongolia . The findings have significant implication s for the impact of minimal intervention and the potential role of peer networks and social support in reducing women ’s experiences of violence in re source poor setting Objective We evaluate the effect of clinic-based support by HIV-positive Peer Mentors , in addition to st and ard clinic care , on maternal and infant well-being among Women Living with HIV ( WLH ) from pregnancy through the infant 's first year of life . Methods In a cluster r and omized controlled trial in KwaZulu-Natal , South Africa , eight clinics were r and omized for pregnant WLH to receive either : a St and ard Care condition ( SC ; 4 clinics ; n = 656 WLH ) ; or an Enhanced Intervention ( EI ; 4 clinics ; n = 544 WLH ) . WLH in the EI were invited to attend four antenatal and four postnatal meetings led by HIV-positive Peer Mentors , in addition to SC . WLH were recruited during pregnancy , and at least two post-birth assessment interviews were completed by 57 % of WLH at 1.5 , 6 or 12 months . EI 's effect was ascertained on 19 measures of maternal and infant well-being using r and om effects regressions to control for clinic clustering . A binomial test for correlated outcomes evaluated EI 's overall efficacy . Findings WLH attended an average of 4.1 sessions ( SD = 2.0 ) ; 13 % did not attend any sessions . Significant overall benefits were found in EI compared to SC using the binomial test . Secondarily , over time , WLH in the EI reported significantly fewer depressive symptoms and fewer underweight infants than WLH in the SC condition . EI WLH were significantly more likely to use one feeding method for six months and exclusively breastfeed their infants for at least 6 months . Conclusions WLH benefit by support from HIV-positive Peer Mentors , even though EI participation was partial , with incomplete follow-up rates from 6–12 months . Trial Registration Clinical Trials.gov Objective : To assess effects of a combined microfinance and training intervention on HIV risk behavior among young female participants in rural South Africa . Design : Secondary analysis of quantitative and qualitative data from a cluster r and omized trial , the Intervention with Microfinance for AIDS and Gender Equity study . Methods : Eight villages were pair-matched and r and omly allocated to receive the intervention . At baseline and after 2 years , HIV risk behavior was assessed among female participants aged 14–35 years . Their responses were compared with women of the same age and poverty group from control villages . Intervention effects were calculated using adjusted risk ratios employing village level summaries . Qualitative data collected during the study explored participants ' responses to the intervention including HIV risk behavior . Results : After 2 years of follow-up , when compared with controls , young participants had higher levels of HIV-related communication ( adjusted risk ratio 1.46 , 95 % confidence interval 1.01–2.12 ) , were more likely to have accessed voluntary counseling and testing ( adjusted risk ratio 1.64 , 95 % confidence interval 1.06–2.56 ) , and less likely to have had unprotected sex at last intercourse with a nonspousal partner ( adjusted risk ratio 0.76 , 95 % confidence interval 0.60–0.96 ) . Qualitative data suggest a greater acceptance of intrahousehold communication about HIV and sexuality . Although women noted challenges associated with acceptance of condoms by men , increased confidence and skills associated with participation in the intervention supported their introduction in sexual relationships . Conclusions : In addition to impacts on economic well being , women 's empowerment and intimate partner violence , interventions addressing the economic and social vulnerability of women may contribute to reductions in HIV risk behavior OBJECTIVES We examined the effect of a peer-delivered educational intervention , the Malawi Male Motivator intervention , on couples ' contraceptive uptake . We based the intervention design on the information-motivation-behavioral skills ( IMB ) model . METHODS In 2008 we recruited 400 men from Malawi 's Mangochi province who reported not using any method of contraception . We r and omized them into an intervention arm and a control arm , and administered surveys on contraceptive use at baseline and after the intervention . We also conducted in-depth interviews with a subset of intervention participants . RESULTS After the intervention , contraceptive use increased significantly within both arms ( P < .01 ) , and this increase was significantly greater in the intervention arm than it was in the control arm ( P < .01 ) . Quantitative and qualitative data indicated that increased ease and frequency of communication within couples were the only significant predictors of uptake ( P < .01 ) . CONCLUSIONS Our findings indicate that men facilitated contraceptive use for their partners . Although the IMB model does not fully explain our findings , our results show that the intervention 's content and its training in communication skills are essential mechanisms for successfully enabling men to help couples use a contraceptive Background Violence against female sex workers ( FSWs ) can impede HIV prevention efforts and contravenes their human rights . We developed a multi-layered violence intervention targeting policy makers , secondary stakeholders ( police , lawyers , media ) , and primary stakeholders ( FSWs ) , as part of wider HIV prevention programming involving > 60,000 FSWs in Karnataka state . This study examined if violence against FSWs is associated with reduced condom use and increased STI/HIV risk , and if addressing violence against FSWs within a large-scale HIV prevention program can reduce levels of violence against them . Methods FSWs were r and omly selected to participate in polling booth surveys ( PBS 2006 - 2008 ; short behavioural question naires administered anonymously ) and integrated behavioural-biological assessment s ( IBBAs 2005 - 2009 ; administered face-to-face ) . Results 3,852 FSWs participated in the IBBAs and 7,638 FSWs participated in the PBS . Overall , 11.0 % of FSWs in the IBBAs and 26.4 % of FSWs in the PBS reported being beaten or raped in the past year . FSWs who reported violence in the past year were significantly less likely to report condom use with clients ( zero unprotected sex acts in previous month , 55.4 % vs. 75.5 % , adjusted odds ratio ( AOR ) 0.4 , 95 % confidence interval ( CI ) 0.3 to 0.5 , p < 0.001 ) ; to have accessed the HIV intervention program ( ever contacted by peer educator , 84.9 % vs. 89.6 % , AOR 0.7 , 95 % CI 0.4 to 1.0 , p = 0.04 ) ; or to have ever visited the project sexual health clinic ( 59.0 % vs. 68.1 % , AOR 0.7 , 95 % CI 0.6 to 1.0 , p = 0.02 ) ; and were significantly more likely to be infected with gonorrhea ( 5.0 % vs. 2.6 % , AOR 1.9 , 95 % CI 1.1 to 3.3 , p = 0.02 ) . By the follow-up surveys , significant reductions were seen in the proportions of FSWs reporting violence compared with baseline ( IBBA 13.0 % vs. 9.0 % , AOR 0.7 , 95 % CI 0.5 to 0.9 p = 0.01 ; PBS 27.3 % vs. 18.9 % , crude OR 0.5 , 95 % CI 0.4 to 0.5 , p < 0.001 ) . Conclusions This program demonstrates that a structural approach to addressing violence can be effectively delivered at scale . Addressing violence against FSWs is important for the success of HIV prevention programs , and for protecting their basic human rights The aim of this study is to assess whether the Government of Kenya 's Cash Transfer for Orphans and Vulnerable Children ( Kenya CT-OVC ) can reduce the risk of HIV among young people by postponing sexual debut . The program provides an unconditional transfer of US$ 20 per month directly to the main caregiver in the household . An evaluation of the program was implemented in 2007–2009 in seven districts . Fourteen Locations were r and omly assigned to receive the program and fourteen were assigned to a control arm . A sample of households was enrolled in the evaluation in 2007 . We revisited these households in 2011 and collected information on sexual activity among individuals between 15–25 years of age . We used logistic regression , adjusted for the respondent 's age , sex and relationship to caregiver , the age , sex and schooling of the caregiver and whether or not the household lived in Nairobi at baseline , to compare rates of sexual debut among young people living in program households with those living in control households who had not yet entered the program . Our results , adjusted for these covariates , show that the program reduced the odds of sexual debut by 31 percent . There were no statistically significant effects on secondary outcomes of behavioral risk such as condom use , number of partners and transactional sex . Since the CT-OVC provides cash to the caregiver and not to the child , and there are no explicit conditions associated with receipt , these impacts are indirect , and may have been achieved by keeping young people in school . Our results suggest that large-scale national social cash transfer programs with poverty alleviation objectives may have potential positive spillover benefits in terms of reducing HIV risk among young people in Eastern and Southern Africa This article presents the results of a r and omized trial in South Africa of an adapted evidence -based Woman-Focused intervention on condom use with primary sex partners . The preliminary findings show that regardless of HIV status , condom negotiation was significantly associated with condom use at the 3- and 6-month follow-ups . By intervention group , significant intervention effects were found at 6-month follow-up for HIV-positive and HIV-unknown status women in the Woman-Focused intervention who were more likely than women in the St and ard intervention to report condom use with a primary male partner . Among HIV-positive women , those in the Woman-Focused group and those with greater sexual control were more likely to report condom use at the 6-month follow-up . The findings indicate that gender-based interventions for women may result in increased condom negotiation skills This cost-effectiveness study analyzes the cost per quality -adjusted life year ( QALY ) gained in a r and omized controlled trial that tested school support as a structural intervention to prevent HIV risk factors among Zimbabwe orphan girl adolescents . The intervention significantly reduced early marriage , increased years of schooling completed , and increased health-related quality of life . By reducing early marriage , the literature suggests the intervention reduced HIV infection . The intervention yielded an estimated US$ 1,472 in societal benefits and an estimated gain of 0.36 QALYs per orphan supported . It cost an estimated US$ 6/QALY gained , about 1 % of annual per capita income in Zimbabwe . That is well below the maximum price that the World Health Organization ( WHO ) Commission on Macroeconomics and Health recommends paying for health gains in low and middle income countries . About half the girls in the intervention condition were boarded when they reached high school . For non-boarders , the intervention ’s financial benefits exceeded its costs , yielding an estimated net cost savings of $ 502 per pupil . Without boarding , the intervention would yield net savings even if it were 34 % less effective in replication . Boarding was not cost-effective . It cost an additional $ 1,234 per girl boarded ( over the 3 years of the study , discounted to present value at a 3 % discount rate ) but had no effect on any of the outcome measures relative to girls in the treatment group who did not board . For girls who did not board , the average cost of approximately 3 years of school support was US$ 973 BACKGROUND Measurement of the global burden of disease with disability-adjusted life-years ( DALYs ) requires disability weights that quantify health losses for all non-fatal consequences of disease and injury \n Output:\n " }, { "from": "agent", "value": "The findings suggest that couple counselling for the prevention of vertical transmission ; gender empowerment , community mobilization , and female condom promotion for female sex workers ; exp and ed female condom distribution for the general population ; and post-exposure HIV prophylaxis for rape survivors are cost-effective HIV interventions .\nCash transfers for schoolgirls and school support for orphan girls may also be cost-effective in generalized epidemic setting s. CONCLUSIONS There has been limited research to assess the cost-effectiveness of interventions that seek to address women 's needs and transform harmful gender norms .\nOur review identified several promising , cost-effective interventions that merit consideration as critical enablers in HIV investment approaches , as well as highlight that broader gender and development interventions can have positive HIV impacts ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND A new intravenous lipid emulsion ( ILE ) prepared from a mixture of soybean and olive oils contains only long-chain triacylglycerols , with a low proportion ( 20 % ) of polyunsaturated fatty acids and 60 % monounsaturated fatty acids . OBJECTIVE The goal of this r and omized , double-blind clinical trial was to assess in children the efficacy and safety of this new ILE compared with a control group receiving a soybean-oil emulsion . DESIGN Eighteen children received for 2 mo 24 % of nonprotein energy ( 1.80 g kg (-)(1 ) d(-)(1 ) ) either as the new ILE or a soybean oil-based emulsion . Assessment s were performed on days -30 , 0 , 30 , and 60 and the changes ( day 60 - day 0 ) assessed by analysis of variance . RESULTS There were no significant differences in triacylglycerol , apolipoproteins A-I and B , or HDL cholesterol between the 2 groups , whereas total and LDL cholesterol were higher in the soybean oil group on day 60 . The pattern of 20:4n-6 in erythrocyte membranes did not change significantly , nor did the ratio of 20:3n-9 to 20:4n-6 . On day 60 , 18:1n-9 was significantly higher in the olive oil group , the ratio of Sigma(n)-6 > C(18 ) + 18:3n-6 to 18:2n-6 was 2.20 + /- 0.09 in the olive oil group and 1.33 + /- 0.16 in the soybean-oil group , and Sigma(n)-3 > C(18 ) was 3.83 + /- 0.30 in the olive oil group and 4 . 03 + /- 0.33 in the soybean-oil group . The peroxidation index was lower after the olive oil treatment . CONCLUSIONS The olive oil-based emulsion was well tolerated , maintained a normal EFA status , and may be more suitable for prevention of lipid peroxidation than the soybean-oil-based emulsion BACKGROUND & AIMS This study assessed the effects of administering a lipid emulsion containing eicosapentaenoic and docosahexaenoic acid before and after open-heart surgery on cytokine production and length of hospital stay in infants . METHODS Thirty-two infants ( 40 ± 2.3 weeks gestational age ; 10.6 days at time of surgery ) undergoing open-heart surgery with cardiopulmonary bypass were r and omized to receive an intravenous lipid emulsion with ( treatment ) or without ( control ) eicosapentaenoic and docosahexaenoic acid in this prospect i ve , r and omized , double-blind , controlled trial . RESULTS Mean plasma TNF-α concentration was significantly ( p = 0.003 ) lower in the treatment ( 5.9 pg/mL ) compared to the control group ( 14.8 pg/mL ) . In infants without sepsis , plasma TNF-α did not differ according to treatment , however when sepsis developed , mean plasma TNF-α was 21.1 pg/mL and 1.5 pg/mL ( p = 0.0007 ) in control and treatment groups , respectively . Plasma TNF-α was positively correlated with length of hospital stay in the control group ( p = 0.01 ) , and negatively correlated with length of stay in the treatment group ( p = 0.004 ) , with a significant time by treatment interaction ( p = 0.02 ) . CONCLUSIONS Providing a lipid emulsion containing eicosapentaenoic and docosahexaenoic acid reduces TNF-α concentrations in infants undergoing open-heart surgery . Lipid emulsions containing eicosapentaenoic and docosahexaenoic acid may ameliorate the inflammatory response among critically ill infants Background / Objectives : The aim of this study was to research and draw conclusions about the effect of a parenteral nutrition ( PN ) fat emulsion , rich in ω-3 fatty acids , on the antioxidant markers of preterm infants , when compared with a st and ard fat emulsion . This was a double-blind , parallel-group study conducted in Athens , Greece , using an equal r and omization method .Subjects/ Methods : Thirty-eight infants were selected using a double-blind method and a computer-generated r and omization list . Both groups received PN , based on the same protocol s. Group A received SMOFlipid fat emulsion , while group B received the st and ard fat emulsion ( Intralipid ) . Serum levels of vitamin A , E and total antioxidant potential ( TAP ) were measured on days 0 , 7 and 14 of PN support . Clinical and biochemical data were collected on days 0 , 14 and on the day of discharge . Results : Serum levels of vitamin E and A were significantly increased in group A , while only vitamin A serum level was increased in group B on the fourteenth day ( group A : vitamin E : P-value=0.002 , vitamin A : P-value=0.000 , group B : vitamin E : P-value=0.065 , vitamin A : P-value=0.000 ) . TAP was increased only in the intervention group ( group A : P-value=0.000 , group B : P-value=0.287 ) . Mild anemia was developed in both groups , while no differences were detected in the infection rate , days of hospitalization , days of ventilator support and days of phototherapy . Conclusions : Oxidative stress was significantly reduced in those neonates fed with ω-3 fatty acids , whereas no effect was observed in the neonates fed with st and ard lipids . Intervention had no effect on infants ’ growth and clinical outcome BACKGROUND Preliminary studies suggest that fish-oil lipid emulsion given parenterally to very preterm infants reduces the severity of retinopathy ( ROP ) and cholestasis . METHODS Infants weighing < 1250 g at birth were r and omly allocated to 2 groups : an experimental group of 60 infants that received an intravenous ( IV ) soybean , olive oil , and fish oil emulsion , and a control group of 70 infants that was given a parenteral soybean and olive oil emulsion . Plasma and erythrocyte concentrations of docosahexaenoic acid ( DHA ) were determined using a high-performance liquid chromatography-mass spectrometry analysis . RESULTS Nine infants in the fish oil group required laser therapy for ROP compared with 22 infants in the st and ard intralipid group ( risk ratio [ RR ] , 0.48 ; 95 % confidence interval [ CI ] , 0.24 - 0.96 ) . Three infants in the fish oil group developed cholestasis compared with 20 infants in the st and ard intralipid group ( RR , 0.18 ; 95 % CI , 0.055 - 0.56 ) . The mean plasma DHA concentrations in treated infants were 2.9-fold higher in the fish oil group than in control infants on the 7th and 14th days of life . The mean DHA content in erythrocytes of treated infants was 4.5-fold and 2.7-fold higher compared with controls at 7 and 14 days of age . CONCLUSIONS Premature infants receiving an IV fat emulsion containing fish oil had less ROP requiring laser treatment and less cholestasis than those receiving a st and ard lipid emulsion . These infants also had higher plasma and erythrocyte DHA levels at 7 and 14 days , suggesting potential long-term neurodevelopmental benefits Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND & AIMS Previous studies reported a wide range of estimated malnutrition prevalence ( 6 - 30 % ) in paediatric in patients based on various anthropometric criteria . We performed anthropometry in hospitalised children and assessed the relationship between malnutrition and length of hospital stay ( LOS ) and complication rates . METHODS In a prospect i ve multi-centre European study , 2567 patients aged 1 month to 18 years were assessed in 14 centres in 12 countries by st and ardised anthropometry within the first 24 h after admission . Body mass index ( BMI ) and height/length < -2 st and ard deviation scores ( SDS , WHO reference ) were related to LOS ( primary outcome ) , frequency of gastrointestinal ( diarrhoea and vomiting ) and infectious complications ( antibiotic use ) , weight change during stay ( secondary outcomes ) and quality of life . RESULTS A BMI < -2 SDS was present in 7.0 % of the patients at hospital admission ( range 4.0 - 9.3 % across countries ) with a higher prevalence in infants ( 10.8 % ) and toddlers aged 1 - 2 years ( 8.3 % ) . A BMI < -2 to ≥-3 SDS ( moderate malnutrition ) and a BMI < -3 SDS ( severe malnutrition ) was associated with a 1.3 ( CI95 : 1.01 , 1.55 ) and 1.6 ( CI95 : 1.27 , 2.10 ) days longer LOS , respectively ( p = 0.04 and p < 0.001 ) . Reduced BMI < -2 SDS was also associated to lower quality of life , and more frequent occurrence of diarrhoea ( 22 % vs 12 % , p < 0.001 ) and vomiting ( 26 % vs 14 % , p < 0.001 ) . CONCLUSION Disease associated malnutrition in hospitalised children in Europe is common and is associated with significantly prolonged LOS and increased complications , with possible major cost implication s , and reduced quality of life . This study was registered at clinical trials.gov as NCT01132742 Background : New olive oil – based ( OL ) lipid emulsions ( olive : soy oil = 4:1 ) have lower polyunsaturated fatty acid ( PUFA ) ( 20 % vs 60 % ) and higher vitamin E content ( an antioxidant ) compared with traditional soybean oil ( SO ) emulsions . Objective : Compare efficacy and safety of OL with SO emulsions in preterm neonates ( < 28 weeks ) at high risk for oxidative stress . Patients and Methods : Preterm neonates ( gestation 23–<28 weeks ) were r and omised to receive OL or SO emulsion for 5 days using a st and ard protocol in a tertiary perinatal centre ( King Edward Memorial Hospital for Women , Perth , Western Australia ) . Investigators and outcome assessors were masked to allocation . Plasma F2-isoprostanes ( lipid peroxidation marker ) , plasma , and red blood cell fatty acids were measured before and after the study . Safety was monitored by liver function tests . Results : Forty-four of 50 participants ( OL-23 , SO-21 ) completed the study . Both emulsions were well tolerated with no significant adverse events . F2-isoprostane levels were comparable at baseline and study end . Oleic and linoleic acid levels were significantly high on day 6 in OL and SO groups , respectively . Long-chain PUFA levels were similar between groups despite the lower PUFA content of OL . The olive oil – based group had significantly higher levels of C18:4n-3 , suggesting Δ6-desaturase enzyme inhibition in the SO group . Conclusions : Olive oil – based emulsion was safe and well tolerated by preterm neonates . Similar long-chain PUFA levels were achieved in the OL group despite significantly lower amount of PUFA content ; however , there was no difference in lipid peroxidation ( F2-isoprostane levels ) . Large trials are needed to confirm these benefits Background : For premature neonates needing parenteral nutrition ( PN ) , a balanced lipid supply is crucial . The authors hypothesized that a lipid emulsion containing medium-chain triglycerides ( MCTs ) and soybean , olive , and fish oils would be as safe and well tolerated as a soybean emulsion while beneficially influencing the fatty acid profile . Methods : Double-blind , controlled study in 53 neonates ( < 34 weeks ’ gestation ) r and omized to receive at least 7 days of PN containing either an emulsion of MCTs and soybean , olive , and fish oils or a soybean oil emulsion . Target lipid dosage was 1.0 g fat/kg body weight [BW]/d on days 1–3 , 2 g/kg BW/d on day 4 , 3 g/kg BW/d on day 5 , and 3.5 g/kg BW/d on days 6–14 . Results : Test emulsion vs control , mean ± SD : baseline triglyceride concentrations were 0.52 ± 0.16 vs 0.54 ± 0.19 mmol/L and increased similarly in both groups to 0.69 ± 0.38 vs 0.67 ± 0.36 on day 8 of treatment ( P = .781 for change ) . A significantly higher decrease in total and direct bilirubin vs baseline was seen in the test group compared with the control group P < .05 between groups ) . In plasma and red blood cell phospholipids , eicosapentaenoic acid and docosahexaenoic acid were \n Output:\n " }, { "from": "agent", "value": "LEs containing fish oil , a source of omega-3 fatty acids , improved outcome of retinopathy of prematurity , decreased liver cholestasis and increased blood omega-3 fatty acid levels .\nLEs containing olive oil increased blood oleic acid level and had a cholesterol lowering effect .\nCONCLUSION Blood fatty acids are influenced by the nature of the intravenous LE used in hospitalised paediatric patients .\nMost studies suggest limited differences in relevant laboratory or clinical outcomes or in growth in paediatric patients receiving different LEs , although several studies do find benefits from including fish oil or olive oil ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate the screening accuracy of pregnancy hypertensive disorders by maternal serum biomarkers and uterine artery Doppler in the first trimester . STUDY DESIGN Prospect ively enrolled nulliparous women had uterine artery Doppler and serum measured at 11 - 13 weeks . Maternal characteristics , uterine artery Doppler , and serum placental biomarkers ( pregnancy-associated plasma protein-A , Inhibin-A , placental protein 13 , A disintegrin and metalloprotease 12 , free β-hCG , placental growth factor ) were recorded . RESULTS Among 893 women , 20 ( 2.2 % ) had gestational hypertension developed and 40 ( 4.5 % ) had preeclampsia developed , including 9 ( 1.0 % ) early-onset preeclampsia and 16 ( 1.8 % ) severe preeclampsia . A combined screening model with clinical characteristics , pregnancy-associated plasma protein-A , Inhibin-A , and placental growth factor could detect 75 % of early-onset preeclampsia at a 10 % false-positive rate . After adjustment for clinical variables , uterine artery Doppler , placental protein 13 , and A disintegrin and metalloprotease 12 did not improve the diagnostic accuracy . CONCLUSION A combination of clinical characteristics and first-trimester maternal serum biomarkers ( pregnancy-associated plasma protein-A , Inhibin-A , and placental growth factor ) provides an accurate screening for early-onset preeclampsia in nulliparous women Angiogenic factors like placental growth factor and its antiangiogenic antagonist soluble fms-like tyrosine kinase 1 ( sFlt1 ) are closely related to the pathogenesis of preeclampsia and intrauterine growth restriction . Because it is known that altered maternal sFlt1 and placental growth factor levels are detectable weeks before the onset of these pregnancy complications , it was the aim of the study to investigate the predictive value of these markers in high-risk second trimester pregnancies characterized by abnormal uterine perfusion . This prospect i ve study includes 63 second trimester pregnant women with abnormal uterine perfusion . Twenty five of them developed a later complication ( 12 with preeclampsia , 11 with intrauterine growth restriction , and 2 with intrauterine death ) , whereas 38 had a normal course of pregnancy . Pregnancies with adverse pregnancy outcome showed in the second trimester significantly higher sFlt1 ( 1403.6±555 versus 451.8±42 pg/mL ; P<0.05 ) and lower placental growth factor ( 139.6±24 versus 184.1±21 pg/mL ) levels compared with those with normal outcome . These alterations were more pronounced in pregnancies with subsequent preeclampsia compared with intrauterine growth restriction and early onset diseases ( delivery < 34 weeks ) compared with late-onset diseases . The combination of Doppler and sFlt1 increases the sensitivity of Doppler alone for iatrogenic preterm delivery from 64 % up to 79 % and the specificity from 63 % up to 80 % . Using both factors , sFlt1 and placental growth factor , early onset preeclampsia can be predicted with 83 % sensitivity and 95 % specificity . We conclude that the concurrent measurement of uterine perfusion and angiogenic factors allows an efficient prediction of early onset pregnancy complications , particularly preeclampsia OBJECTIVES To examine the performance of screening for hypertensive disorders in pregnancy at 11 - 13 weeks by a combination of the maternal history , uterine artery Doppler imaging and blood pressure . METHODS This was a prospect i ve screening study for pre-eclampsia ( PE ) requiring delivery before 34 weeks ( early PE ) , late PE and gestational hypertension ( GH ) in women attending for their routine first hospital visit in pregnancy at 11 + 0 to 13 + 6 weeks of gestation . Maternal history was recorded , color flow Doppler imaging was used to identify the uterine artery with the lowest pulsatility index ( L-PI ) and automated devices were used to measure the mean arterial pressure ( MAP ) . The performance of screening for PE and GH by a combination of the maternal factor-derived a-priori risk , the uterine artery L-PI and MAP was determined . RESULTS There were 8061 ( 96.4 % ) cases unaffected by PE or GH , 165 ( 2.0 % ) that developed PE including 37 that required delivery before 34 weeks ( early PE ) and 128 with late PE , and 140 ( 1.7 % ) that developed GH . The MAP was higher in early PE , late PE and GH than in the unaffected group ( P < 0.0001 ) , and in early PE than in GH ( P = 0.002 ) . The uterine artery L-PI was significantly higher in early PE and late PE than in the unaffected group ( P < 0.0001 ) , in early PE than late PE or GH ( P < 0.0001 ) , and in GH than in the unaffected group ( P = 0.014 ) . In screening by a combination of the maternal factor-derived a-priori risk , uterine artery L-PI and MAP , the estimated detection rate at a 10 % false-positive rate was 89.2 % ( 95 % CI , 74.6 - 96.9 % ) for early PE , 57.0 % ( 95 % CI , 48.0 - 65.7 % ) for late PE and 50.0 % ( 95 % CI , 41.4 - 58.6 % ) for GH . CONCLUSIONS Effective screening for hypertensive disorders in pregnancy is provided by a combination of maternal history , uterine artery Doppler imaging and blood pressure at 11 - 13 weeks Objective . To examine the value of one-step uterine artery Doppler at 20 weeks of gestation in the prediction pre-eclampsia ( PE ) and /or intrauterine growth restriction ( IUGR ) . Methods . A prospect i ve multicentre study that included all women with singleton pregnancies at 19–22 weeks of gestation ( w ) . The mean pulsatility index ( mPI ) of both uterine arteries was calculated . Receiver-operating characteristics curves ( ROC ) were drawn to compare uterine artery Doppler and maternal risk factors for the prediction of early-onset PE and /or IUGR ( before 32 w ) and late-onset PE and /or IUGR . Results . 6,586 women were included in the study . Complete outcome data was recorded for 6,035 of these women ( 91.6 % ) . PE developed in 75 ( 1.2 % ) and IUGR in 69 ( 1.1 % ) cases . Uterine Doppler mPI was 0.99 and the 90th centile was 1.40 . For 10 % false-positive rate , uterine Doppler mPI identified 70.6 % of pregnancies that subsequently developed early-onset PE and 73.3 % of pregnancies that developed early-onset IUGR . The test had a lower detection rate for the late-onset forms of the disease ( 23.5 % for PE and 30 % for IUGR ) . Maternal history has a low sensitivity in the detection of early-onset cases , although it is better at detecting late-onset PE . Conclusion . Uterine artery Doppler and maternal risk factors seem to select two different population s - early and late-onset PE which might suggest a different pathogenesis OBJECTIVES To calculate the risk of developing pre-eclampsia ( PET ) in a consecutive series of low-risk women at 18 - 24 weeks ' gestation , using recently published logistic regression models . METHODS This was a prospect i ve study , with complete follow-up , in a consecutive series of unselected low-risk singleton pregnancies . Uterine artery pulsatility index as well as a combination of maternal factors were recorded at 18 - 24 weeks ' gestation . The distribution of the estimated risks for the 16 PET patients was compared with that obtained for 136 women who had a normal pregnancy , as assessed by routine testing . A receiver-operating characteristics ( ROC ) curve was plotted to evaluate the detection rate at fixed false-positive rates ( FPRs ) of 5 % , 10 % and 20 % and the corresponding odds cut-offs . RESULTS Just 1/16 ( 6.2 % ) women with PET developed the disease before the 34(th ) week of gestation . Using the ' All PET ' logistic regression model , for 16 PET cases the overall median odds was 1 : 1454 , higher compared with that of 1 : 41635 estimated for controls . Using the ' PET > or= 34 weeks ' model , the median odds of the 15 women who developed PET late was 1 : 3405 , compared with 1 : 40785 for controls . In the case of PET before 34 weeks , the risk was 1 : 426373 vs. 1 : 4159823126 estimated for controls ( ' PET < 34 weeks ' model ) . Detection rates for the All PET model were 18 % , 50 % and 62 % at a FPR of 5 % , 10 % and 20 % , respectively . For the PET > or= 34 weeks model these detection rates were 6 % , 46 % and 60 % , respectively . CONCLUSION Even though the individual odds estimation is too low to represent the real risk of PET , the recently published logistic regression models detected more than 60 % of PET at a FPR of 20 % for both All PET and PET > or= 34 weeks models . Using these models in clinical practice does not seem to give any significant improvement over Doppler alone in the prediction of PET , but the use of a PET-specific odds instead of an actual Doppler value alone seems to be useful for clinical management OBJECTIVE The purpose of this study was to evaluate possible relationships between placental markers and endothelial dysfunction in preeclampsia and intrauterine growth restriction . STUDY DESIGN A prospect i ve study was conducted in 76 patients with preeclampsia and 37 patients with intrauterine growth restriction that were classified as early onset ( < 34 weeks of gestational age ) or late onset , and 40 control subjects . Plasma levels of placental growth factor , soluble fms-like tyrosine kinase-1 , vascular cell adhesion molecule-1 , and uterine artery Doppler indices were measured . RESULTS In early-onset preeclampsia and intrauterine growth restriction , placental growth factor was lower and soluble fms-like tyrosine kinase-1 and vascular cell adhesion molecule-1 higher than in control subjects , although all changes were more pronounced in preeclampsia . In late-onset preeclampsia , those patients with abnormal uterine artery Doppler indices had higher soluble fms-like tyrosine kinase-1 and vascular cell adhesion molecule-1 levels . CONCLUSION Biochemical changes in early-onset preeclampsia and intrauterine growth restriction point to a common placental disorder and a state of endothelial dysfunction , which may require interaction with other factors to explain the maternal disease in preeclampsia . Data in late-onset preeclampsia suggest that a proportion of them may occur with minimal placental involvement OBJECTIVES To examine the performance of screening for hypertensive disorders in pregnancy by a combination of the maternal factor-derived a-priori risk with the uterine artery ( UtA ) pulsatility index ( PI ) and to determine whether it is best in such screening to use the mean PI of the two arteries , the highest PI or the lowest PI . METHODS This was a prospect i ve screening study for pre-eclampsia ( PE ) requiring delivery before 34 weeks ( early PE ) , late PE and gestational hypertension ( GH ) in women attending their routine first hospital visit in pregnancy at 11 + 0 to 13 + 6 weeks of gestation . Maternal history was recorded and color flow Doppler imaging was used to measure the left and right UtA-PI . The performance of screening for PE and GH by a combination of the maternal factor-derived a-priori risks determined in a previous study and the UtA-PI was assessed . RESULTS There were 8061 ( 96.4 % ) cases unaffected by PE or GH , 37 ( 0.4 % ) that developed early PE , 128 ( 1.5 % ) with late PE and 140 ( 1.7 % ) with GH . The lowest , mean and highest UtA-PI were significantly higher in early PE and late PE than in the controls ( P < 0.0001 ) and in early PE than late PE ( P < 0.0001 ) . The lowest UtA-PI was higher in GH than in controls ( P = 0.014 ) . The best performance in screening was provided by the lowest PI . The detection rate of early PE at a 10 % false-positive rate increased from 47 % in screening by maternal factors alone to 81 % in screening by maternal factors and the lowest UtA-PI . The respective \n Output:\n " }, { "from": "agent", "value": "Results : Several tests provided moderate or convincing prediction of early PE , but screening for late PE was poor .\nAlthough UAD is more accurate in the second trimester , we found encouraging results for first-trimester screening when it was combined with other markers .\nPerformance of screening was consistently lower in population s with risk factors for PE in the maternal history .\nConclusions : We present encouraging results for the prediction of early PE , even in the first trimester of pregnancy .\nThe different performance of tests in screening for early vs. late PE , and of low- vs. high-risk population s , supports the concept that PE is a heterogeneous disease" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism has been investigated in a multicentre prospect i ve r and omised trial . 4121 patients over the age of forty years undergoing a variety of elective major surgical procedures were included in the trial ; 2076 of these were in the control group and 2045 patients received heparin . The two groups were well matched for age , sex , weight , blood-group , and other factors which could predispose to the development of venous thromboembolism . 180 ( 4 - 4 % ) patients died during the postoperative period , 100 in the control and 80 in the heparin group : 72 % of deaths in the control and 66 % in the heparin group had necropsy examination . 16 patients in the control group and 2 in the heparin group were found at necropsy to have died due to acute massive pulmonary embolism ( P smaller than 0 - 005 ) . In addition , emboli found at necropsy in 6 patients in the control group and 3 in the heparin group were considered either contributory to death or an incidental finding since death in these patients was attributed to other causes . Taking all pulmonary emboli together , the findings were again significant ( P smaller than 0 - 005 ) . Of 1292 patients in whom the 125-I-fibrinogen test was performed to detect deep-vein thrombosis ( D.V.T. ) 667 were in the control group and 625 in the heparin group . The frequency of isotopic D.V.T. was reduced from 24 - 6 % in the control group 7 - 7 % in the heparin group ( P smaller 0 - 005 ) . In 30 patients D.V.T. was detected at necropsy ; 24 in the control and 6 in the heparin group ( P smaller 0 - 005 ) . 32 patients in the control group and 11 in the heparin group developed clinical ly diagnosed D.V.T. which was confirmed by venography ( P smaller than 0 - 005 ) . In addition , 24 patients in the control and 8 in the heparin group were treated for clinical ly suspected pulmonary emoblism . The difference in the number of patients requiring treatment for D.V.T. and /or pulmonary embolism in the two groups was again significant ( P smaller than 0 - 005 ) . 9 patients were found at necropsy to have died from haemorrhage ; 5 were in the control and 4 in the heparin group . A careful objective analysis of operative and postoperative bleeding in 1475 patients showed no statistically significant difference in the blood-transfusion requirements or in the fall in the postoperative haemoglobin level either in the individual operative groups or in the group as a whole . However , the difference in the number of patients who developed wound haematoma in the heparin and control groups was significant ( P smaller 0 - 01 ) . The results of the trial indicate that this form of prophylaxis can now be recommended for use on a large scale in \" high-risk \" patients undergoing major surgery Venous thromboembolism is a serious complication following gynecologic surgery and is particularly common in patients with malignancy . A previous study of subcutaneous low-dose heparin given as one dose preoperatively and every 12 hours postoperatively failed to show a benefit in gynecologic oncology patients . In the present study , two more intense regimens of low-dose heparin were evaluated . Three hundred four patients were assigned r and omly to receive no prophylaxis ( controls ) , subcutaneous heparin 5000 units 2 hours before surgery and every 8 hours postoperatively ( low-dose heparin ) ( regimen I ) , or 5000 units heparin subcutaneously every 8 hours preoperatively ( between two and nine doses ) and every 8 hours postoperatively ( regimen II ) . All patients had thromboembolism surveillance with the fibrinogen uptake test and clinical evaluation . Eighty-four percent had a malignancy . Thromboemboli were diagnosed in 19 of 103 control patients , ten of 104 regimen I patients , and six of 97 regimen II patients , a statistically significant difference ( P < .008 ) . When compared with the control group , the study groups had no evidence of increased bleeding complications or alteration of laboratory coagulation indicators . ( Obstet Gynecol 75 : 684 , 1990 Summary Background Data : The epidemiology of venous thromboembolism ( VTE ) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis ( DVT ) . However , the clinical relevance of asymptomatic venography-detected DVT is unclear , and the population of these clinical trials is not necessarily representative of the overall cancer surgery population . Objective : The aim of this study was to evaluate the incidence of clinical ly overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE . Methods : @RISTOS was a prospect i ve observational study in patients undergoing general , urologic , or gynecologic surgery . Patients were assessed for clinical ly overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days . All outcome events were evaluated by an independent Adjudication Committee . Results : A total of 2373 patients were included in the study : 1238 ( 52 % ) undergoing general , 685 ( 29 % ) urologic , and 450 ( 19 % ) gynecologic surgery . In-hospital prophylaxis was given in 81.6 % and postdischarge prophylaxis in 30.7 % of the patients . Fifty patients ( 2.1 % ) were adjudicated as affected by clinical ly overt VTE ( DVT , 0.42 % ; nonfatal pulmonary embolism , 0.88 % ; death 0.80 % ) . The incidence of VTE was 2.83 % in general surgery , 2.0 % in gynecologic surgery , and 0.87 % in urologic surgery . Forty percent of the events occurred later than 21 days from surgery . The overall death rate was 1.72 % ; in 46.3 % of the cases , death was caused by VTE . In a multivariable analysis , 5 risk factors were identified : age above 60 years ( 2.63 , 95 % confidence interval , 1.21–5.71 ) , previous VTE ( 5.98 , 2.13–16.80 ) , advanced cancer ( 2.68 , 1.37–5.24 ) , anesthesia lasting more than 2 hours ( 4.50 , 1.06–19.04 ) , and bed rest longer than 3 days ( 4.37 , 2.45–7.78 ) . Conclusions : VTE remains a common complication of cancer surgery , with a remarkable proportion of events occurring late after surgery . In patients undergoing cancer surgery , VTE is the most common cause of death at 30 days after surgery A prospect i ve study of a series of 77 patients on adjuvant radiochemotherapy following surgery for high- grade gliomas was conducted to evaluate the risk of deep vein thrombosis and identify risk factors . We found a 20.8 % risk of deep vein thrombosis at 12 months ( st and ard error = 4.8 % ) and a 31.7 % risk ( st and ard error = 7.4 % ) at 24 months ( Kaplan-Meier method ) . Twenty patients ( 26 % ) developed deep vein thrombosis with a maximum incidence within the first 7 months after surgery when chemotherapy was still being administered , often with corticosteroids . The risk factors identified were histology ( glioblastoma versus anaplastic astrocytoma , P = 0.032 , log rank test ; 0.0485 L-ratio ) and the presence of paresis ( P = 0.010 , log rank test ; 0.0161 L-ratio ) . A borderline tendency was found for an association between the deep vein thrombosis site and the side of paresis ( P = 0.103 , Fisher 's exact test ) . Four patients ( 5 % ) had massive pulmonary embolism , which was fatal in 3 ( 4 % ) BACKGROUND Hemato-oncology patients treated with intensive chemotherapy usually require the placement of a central venous catheter ( CVC ) . CVCs are frequently complicated by catheter-related central venous thrombosis ( CVT ) , which has been associated with an increased risk of pulmonary embolism and catheter-related infection . OBJECTIVES To determine the efficacy and safety of thromboprophylaxis with s.c . low-molecular-weight heparin ( nadroparin ) administered once daily in a r and omized placebo-controlled , double-blind trial in patients with hematologic malignancies . PATIENTS AND METHODS Consecutive patients with hematologic malignancies requiring intensive chemotherapy including autologous stem cell transplantation were eligible . The patients were r and omized to receive nadroparin 2850 antifactor Xa units once daily or placebo s.c . for 3 weeks . Venography was performed on day 21 after CVC insertion . Secondary outcomes were bleeding and catheter-related infection . RESULTS In total , 113 patients were r and omized to nadroparin or placebo , and 87 patients ( 77 % ) underwent venography . In total , 11 venographically proven catheter-related CVTs were diagnosed . The frequency of catheter-related CVT was not significantly different between study groups , namely four catheter-related CVTs in the placebo group [ 9 % ; 95 % CI : 0.002 - 0.16 ] vs. seven catheter-related CVTs in the nadroparin group ( 17 % ; 95 % CI : 0.06 - 0.28 ) . In addition , no difference in the incidence of catheter-related infection or bleeding was observed between the groups . CONCLUSION This study showed that the actual risk for catheter-related CVT in patients with hematologic malignancies is lower than suggested in earlier studies in cancer patients . Although prophylactic administration of nadroparin appeared to be safe in this group of patients with a high risk of bleeding , it can not be recommended for the prevention of catheter-related CVT or catheter-related infection in patients with hematologic malignancies BACKGROUND An intravenous course of st and ard ( unfractionated ) heparin with the dose adjusted to prolong the activated partial-thromboplastin time to a desired length is the st and ard initial in-hospital treatment for patients with deep-vein thrombosis , but fixed-dose subcutaneous low-molecular-weight heparin appears to be as effective and safe . Because the latter treatment can be given on an outpatient basis , we compared the two treatments in symptomatic out patients with proximal-vein thrombosis but no signs of pulmonary embolism . METHODS We r and omly assigned patients to adjusted-dose intravenous st and ard heparin administered in the hospital ( 198 patients ) or fixed-dose subcutaneous low-molecular-weight heparin administered at home , when feasible ( 202 patients ) . We compared the treatments with respect to recurrent venous thromboembolism , major bleeding , quality of life , and costs . RESULTS Seventeen of the 198 patients who received st and ard heparin ( 8.6 percent ) and 14 of the 202 patients who received low-molecular-weight heparin ( 6.9 percent ) had recurrent thromboembolism ( difference , 1.7 percentage points ; 95 percent confidence interval , -3.6 to 6.9 ) . Major bleeding occurred in four patients assigned to st and ard heparin ( 2.0 percent ) and one patient assigned to low-molecular-weight heparin ( 0.5 percent ; difference , 1.5 percentage points ; 95 percent confidence interval , -0.7 to 2.7 ) . Quality of life improved in both groups . Physical activity and social functioning were better in the patients assigned to low-molecular-weight heparin . Among the patients in that group , 35 percent were never admitted to the hospital at all , and 40 percent were discharged early . This treatment was associated with a mean reduction in hospital days of 67 percent , ranging from 29 percent to 86 percent in the various study centers . CONCLUSIONS In patients with proximal-vein thrombosis , treatment with low-molecular-weight heparin at home is feasible , effective , and safe BACKGROUND The finding of a decrease in contralateral breast cancer incidence following tamoxifen administration for adjuvant therapy led to the concept that the drug might play a role in breast cancer prevention . To test this hypothesis , the National Surgical Adjuvant Breast and Bowel Project initiated the Breast Cancer Prevention Trial ( P-1 ) in 1992 . METHODS Women ( N=13388 ) at increased risk for breast cancer because they 1 ) were 60 years of age or older , 2 ) were 35 - 59 years of age with a 5-year predicted risk for breast cancer of at least 1.66 % , or 3 ) had a history of lobular carcinoma in situ were r and omly assigned to receive placebo ( n=6707 ) or 20 mg/day tam \n Output:\n " }, { "from": "agent", "value": "Marik PE , And rews L , Maini B. The incidence of deep venous thrombosis in ICU patients .\nCook D , Meade M , Guyatt G , et al. Dalteparin versus unfractionated heparin in critically ill patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND We concluded a program in which we administered radiotherapy only to clinical stages I and II Hodgkin 's disease patients at st and ard risk , with the addition of 4 cycles of combination chemotherapy before radiotherapy for high-risk patients . PATIENTS AND METHODS From 1980 to 1991 , 313 patients with clinical stages I or II Hodgkin 's disease underwent treatment in our hospital . Fifty percent of the patients in groups previously identified as being at high risk for relapse received 4 cycles of combination chemotherapy before radiotherapy . The remaining half of the patients received radiotherapy only . RESULTS Low- and high-risk patients aged 15 - 59 years had , respectively , complete remission ( CR ) rates of 97 % and 94 % , 5-year survivals of 95 % and 91 % , and 5-year freedom from relapse ( FFR ) rates of 78 % and 89 % . Older low- and high-risk groups had CR rates of 97 % and 93 % , 5-year survivals of 60 % and 56 % and 5-year FFR of 77 % and 93 % , respectively . CONCLUSION Here we present our favorable results after treating st and ard-risk patients with clinical stages I and II Hodgkin 's disease with radiotherapy only . With the addition of chemotherapy , the rate of relapse in the high-risk patients was reduced below that of the st and ard-risk patients . Overall survival was the same for the high- and st and ard-risk patients Abstract 57 patients with advanced Hodgkin 's Summary disease who entered a complete remission after chemotherapy with mustine ( nitrogen mustard ) , vincristine ( ' Oncovin ' ) , procarbazine , and prednisone ( M.O.P.P. ) were allocated at r and om to one of three regimens — no additional therapy , intermittent therapy with M.O.P.P. , or intermittent therapy with 1,3-bis(2-chloroethyl)-1-nitrosourea ( B.C.N.U. ) . 24 % of those patients receiving no further therapy have relapsed , as have 25 % of those on intermittent M.O.P.P. and 13 % of those on intermittent B.C.N.U. ; the differences are not significant . The median duration of initial remissions will be > 48 months for all the patients , and there is no significant difference between the individual groups . Complications and infections were more frequently seen in the patients receiving maintenance therapy , especially in those on B.C.N.U. Only 1 patient in each of the three groups has died of Hodgkin 's disease , and survival is not significantly influenced by maintenance therapy . The projected 5-year survival for the entire group of patients is 86 % PURPOSE At present , treatment results for patients with advanced-stage Hodgkin 's disease remain unsatisfactory . St and ard chemotherapy M(C)OPP ( nitrogen mustard ( cyclophosphamide ) . vincristine , procabazine , and prednisone ) . ABVD ( adriamycine , bleomycine , vinblastine , and dacarbacine ) or M(C)OPP/ABVD + /- radiotherapy fail to achieve long-term complete remission in 35 % to 50 % of these patients . The BEACOPP ( bleomycin , etoposide , adriamycine , cyclophosphamide , vincristine , procarbazine , and prednisone ) regimen was developed to improve treatment results by dose intensification achieved by reduced duration of treatment ( time intensification ) and addition of etoposide . PATIENTS AND METHODS Thirty untreated patients with advanced Hodgkin 's disease stage IIB IV according to the Ann Arbor classification were treated with the time intensified BEACOPP regimen . Each patient was scheduled to receive eight cycles of chemotherapy with consolidating radiotherapy to sites of initial bulk disease and to residual tumor remaining after chemotherapy . RESULTS All patients were evaluable for assessment of toxicity , treatment response , freedom from treatment failure ( FFTF ) and survival ( SV ) . Of 30 treated patients , 29 patients received the intended eight cycles of BEACOPP . One patient in clinical CR , terminated the chemotherapy at his own request after six cycles and is at this time , 48 months after the end of treatment , in complete remission . Toxicity was tolerable with WHO grade 3/4 leucopenia in 28 % of chemotherapy cycles and one severe ( WHO grade 3 ) infection . No treatment-related death occurred . Cycles could generally be given on schedule . Complete remission ( CR ) was achieved in all but two patients ( 93 % ) . At present , only one patient has relapsed . At a median follow-up of 40 months , FFTF-rate is 89 % ( lower confidence limit : 80 % ) . One patient died due to progressive disease . CONCLUSION The BEACOPP regimen is feasible at moderate hematopoeitic toxicity . With a FFTF-rate of 89 % at a median follow-up of 40 months , the treatment results are very encouraging . A prospect i ve r and omised trial has been initiated to compare the BEACOPP regimen with the st and ard COPP/ABVD regimen in advanced-stage Hodgkin 's disease PURPOSE To evaluate two regimens of chemotherapy followed by high dose total or subtotal nodal irradiation in advanced Stages of Hodgkin 's disease . METHODS AND MATERIAL S From October 1980 to September 1985 , 70 patients with Hodgkin 's disease , with clinical Stages IIIB ( 35 cases ) and IV ( 35 cases ) were treated with combined modality therapy . Patients were r and omly assigned to receive four cycles of chemotherapy , mechlorethamine , vincristine , procarbazine and prednisone ( MOPP ) versus the same regimen alternating with adriamycin , bleomycin , vinblastine and dacarbazine , ABVD-derived regimen , followed by high-dose ( 40 Gy ) total or subtotal nodal irradiation . Because of partial response , 13 patients ( 18.5 % ) got additional chemotherapy ( 1 - 4 cycles ) . RESULTS After chemotherapy , 49 patients ( 70 % ) achieved complete remission or good partial response and 15 patients ( 21.5 % ) partial response . Five primary failures ( 7 % ) and one death ( 1.5 % ) occurred . After combined modality therapy , 59 patients ( 84 % ) achieved complete remission , one patient partial response ( 1.5 % ) and eight patients ( 11.5 % ) failed to primary treatment . Two toxic deaths ( 3 % ) were observed during initial treatment . There was no significant difference in response rates between MOPP/radiotherapy and MOPP/ABVD/radiotherapy . Nine patients relapsed ( 15 % ) . A total of 21 patients died , 13 because of Hodgkin 's disease and eight from other causes . High dose total or subtotal nodal irradiation following four courses of chemotherapy was feasible , although hematological toxicity grade > or = 2 ( World Health Organization ) was observed in one-third of the patients , particularly in patients aged over 40 . The median duration of follow-up was 75 months . Actuarial survival curves indicate a 8 years disease-free survival and survival of 70 % and 65 % respectively , without any significant difference between the two regimens . Because of hematological toxicity , the percentage of planned full treatment was lower in MOPP/radiotherapy regimen . CONCLUSION These results lead to recommend the alternating regimen . Patients restaged as poor responders after initial chemotherapy did not survive for long . More intensive treatment is now proposed for this subgroup of patients From 1964 to 1987 , the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages I and II Hodgkin 's disease in which 1,579 patients were entered . From the onset the main aim of these trials was to identify the subsets of patients who could be treated safely by regional radiotherapy ( RT ) . Therefore , several prognostic indicators were prospect ively registered and progressively used in the trial protocol s for the delineation of the favorable and unfavorable subgroups as soon as they were recognized of high predictive value . In the H2 trial ( 1972 to 1976 ) , the histologic subtype was the only variable taken into account for the therapeutic strategy and the staging laparotomy findings were found to be of prognostic value only in patients with favorable prognostic indicators . In the H5 trial ( 1977 to 1982 ) , patients were subdivided into two subgroups according to six prognostic indicators . Patients with favorable features were su bmi tted to a staging laparotomy ( lap ) ; lap negative patients were r and omized between mantle field RT and mantle field plus paraaortic RT . Disease free survival ( DFS ) and total survival ( S ) were similar in the two arms . Among patients with unfavorable features , DFS and S were significantly higher in the arm treated by combination of mechlorethamine , vincristine , procarbazine , prednisone ( MOPP ) chemotherapy ( CT ) and RT than in the arm treated by total nodal irradiation . Nevertheless , in patients below the age of 40 , the overall survival rates were equivalent in the two arms . In the H6 trial , the delineation of the favorable subgroup was based on ( a ) absence of systemic symptoms and elevated ESR , ( b ) no more than one or two lymph node areas involved . The aim of the study was to assess the impact on survival of a therapeutic strategy including staging laparotomy . At a 4-year follow-up , no difference in survival was evidence d. In patients with unfavorable prognostic indicators , 3 MOPP-RT-3 MOPP were compared with 3 ABVD-RT-3 ABVD . From H1 to H5 trials , the proportion of patients having received CT during the course of the disease gradually decreased ; the data suggest that a further reduction in the proportion of patients aggressively treated is conceptually possible . On the basis of the prognostic factors identified , one can delineate three subsets of patients and modulate toxic cost of the initial treatment according to the characteristics of these subsets . In the most favorable subgroup , RT alone produces high survival and CT is not justified . ( ABSTRACT TRUNCATED AT 400 WORDS One hundred and fourteen untreated patients with pathological stage ( PS ) IA-IIB supradiaphragmatic Hodgkin 's Disease were r and omised to mantle radiotherapy alone ( 55 ) or mantle radiotherapy followed by 6 courses of adjuvant chemotherapy with mustine , vinblastine , prednisolone and procarbazine- MVPP ( 59 ) . Patients excluded were those outside the age range 16 - 65 years and those with massive mediastinal disease precluding laparotomy . Bulk disease was defined as a mass of lymph nodes measuring five centimetres or more in any axis . Mediastinal bulk was present if the ratio of the maximum width of mediastinal disease to the maximal chest diameter was more than one third . All patients achieved a complete remission . Median duration of follow-up was 62 months ( range 16 - 97 ) . The relapse free survival ( RFS ) was 81 % ; 69 % for radiotherapy alone and 93 % for adjuvant chemotherapy ( P = 0.002 ) . RFS was also shown to be adversely affected by B symptoms ( P = 0.0003 ) , bulk disease ( P = 0.018 ) , abnormal CXR ( P = 0.037 ) , and increasing stage ( P = 0.039 ) . Age , sex , histology , and number of sites involved had no significant effect upon RFS . A Cox multivariate analysis showed that only three variables had a significant adverse effect on RFS - radiotherapy alone , the presence of bulk disease , and B symptoms . The overall 5 year survival was 93 % with no statistically significant difference between the two treatment groups ( P = 0.54 ) . Survival was adversely affected by three variables - B symptoms ( P = 0.02 ) , the presence of bulk disease ( P = 0.002 ) , and pathological stage ( P = 0.05 ) . High risk groups for relapse are those with bulk and B symptoms . This analysis has shown that RFS was significantly improved by adjuvant chemotherapy , but that overall survival was not High-dose chemotherapy with autologous bone marrow transplantation is used in the treatment of relapsed or high-risk Hodgkin 's disease . As prospect i ve r and omised studies have proved difficult to accrue to , current recommendations are based on the reports of large series of prospect ively collected data . We have looked at the outcome of 89 patients treated in this way at a single institution and have developed an index to predict outcome . Of 89 patients , with a median age of 29 years ( range 15 - 51 years ) , eight patients were in first complete remission/partial remission ( CR/PR ) , 17 in second or later CR , 37 were responding relapses , 13 resistant relapses , 11 primary refractory and three untested relapses . Combinations of melphalan , BCNU and etoposide were given in all cases except in ten patients who received melphalan alone . The median follow-up was 43 months ( range 6 - 77 months ) . A total of 24 patients were in CR at the time of autologous bone marrow transplantation ( ABMT ) , 33 achieved CR with ABMT , 16 PR , to give a response rate to ABMT of 49/65 = 74 % ( 95 % \n Output:\n " }, { "from": "agent", "value": "For the majority of patients with relapse after radiotherapy , chemotherapy is curative and the total proportion of cured early stage patients is 75 - 90 % .\nChemotherapy in addition to extended field radiotherapy reduces recurrences but does not improve long-term survival .\nIt is likely that chemotherapy will play a greater role in the future in the treatment also of early stage patients in order to reduce late consequences from extended field radiotherapy .\nSeveral chemotherapy regimens containing four to eight drugs are effective in HD .\nThe results of chemotherapy are more favourable in young than in elderly patients .\nPersistent side-effects of treatment are common among long-term survivors , although most patients have an apparently normal life ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To explore the possibility that endometrial injury modulates the expression of specific genes that may increase uterine receptivity . DESIGN Controlled clinical study . SETTING Clinical IVF unit and academic research center . PATIENT(S ) IVF patients with 28- to 30-day menstrual cycles . INTERVENTION(S ) Endometrial biopsies from two groups of patients were collected on days 20 - 21 of their spontaneous menstrual cycle . The experimental , but not the control , group underwent biopsies on days 11 - 13 and 21 - 24 of their preceding cycle . MAIN OUTCOME MEASURE(S ) Global endometrial gene expression and specific analysis of uroplakin Ib ( UPIb ) mRNA level throughout the menstrual cycle . RESULT ( S ) Local injury modulated the expression of a wide variety of genes . One of the prominently up-regulated genes was the bladder transmembranal protein , UPIb , whose expression by the endometrium is shown here for the first time . Endometrial UPIb mRNA increases after biopsy in the same cycle wct 2with an additional elevation in the following cycle . Immunohistochemical analysis localized the UPIb protein to the gl and ular-epithelial cells . Genes encoding other membrane proteins such as adipose differentiation-related protein and mucin 1 , transmembrane , were also up-regulated . CONCLUSION ( S ) The biopsy-induced increase in the expression of UPIb and other genes encoding membrane proteins supports the possible importance of the membrane structure and stability during implantation . The specific role of UPIb in uterine receptivity should be eluci date It has been speculated that controlled ovarian hyperstimulation ( COH ) , as performed during in vitro fertilization therapy , may negatively affect embryo implantation . The objective of this prospect i ve and r and omized study was to investigate gene expression profiles of the human endometrium during the window of implantation of gonadotropin-stimulated COH cycles compared with temporally matched natural cycles ( d 21 ) . Analysis was performed with high-density oligonucleotide microarrays . In addition , other structural and functional features of the endometrium were investigated . Results corroborated that COH cycles depicted advancement of pinopodes appearance , histological features , and steroid receptor down-regulation when compared with natural cycles . These changes were associated with significant , albeit small , variations in gene expression ( 18 genes/expressed sequence tags and -1.55- to + 3.40-fold changes ) . Second , there were significant changes in gene expression when comparing cycles using a GnRH agonist vs. a GnRH antagonist ( 13 genes/expressed sequence tags and + 1.42- to + 2.10-fold changes ) . This is the first attempt to eluci date gene expression profiles of the endometrium during COH cycles . The observed differences in gene expression in COH cycles using state-of-the-art protocol s may not have a major functional impact on embryo implantation BACKGROUND In this prospect i ve r and omized blinded clinical trial , we examined gene expression profiles of the human endometrium during the early and mid-luteal phases of the natural cycle . METHODS An endometrial biopsy was performed on day 16 ( LH + 3 ) or on day 21 ( LH + 8) , followed by RNA extraction and microarray analysis using an Affymetrix HG-U95A microchip . Data analysis was carried out using pairwise multiple group comparison with the significance analysis of microarrays ( SAM ) software . RESULTS With a false discovery rate of 0 , the analysis revealed that 107 genes were significantly and differently expressed ( > or = 2-fold ) during the early versus the mid-luteal phase of the cycle . Forty-five of these genes have not been previously linked to endometrial receptivity . Validation of the microarray data was accomplished using semiquantitative RT-PCR . We demonstrated the presence of estrogen and progesterone response elements ( ERE and PRE ) by analysis of the 5'-flanking regions of a subset of differentially regulated genes . CONCLUSIONS Using a strict bioinformatics approach of microarray data , we demonstrated significant changes in c and i date genes during the transition of the early to the mid-luteal phase of the human endometrium that may have functional significance for the opening and maintenance of the window of implantation OBJECTIVE Our purpose was to evaluate the early luteal phase of assisted reproductive cycles utilizing controlled ovarian hyperstimulation and to compare these results with those obtained in unstimulated cycles . STUDY DESIGN We undertook a descriptive study analyzing luteal phase serum progesterone levels , endometrial histologic features , and endometrial surface ultrastructure by scanning electron microscopy of cycles utilizing controlled ovarian hyperstimulation . Study sample s were obtained from 7 oocyte donors undergoing controlled ovarian hyperstimulation for the purpose of follicle aspiration in oocyte donation . Control ( unstimulated ) serum progesterone sample s were obtained from 19 patients undergoing in vitro fertilization in unstimulated cycles . Prospect i ve recipients of oocyte donation ( n = 20 ) undergoing mock cycles of exogenous estradiol and progesterone acted as controls for the endometrial biopsies . RESULTS Serum progesterone levels on the day of human chorionic gonadotropin administration were twofold higher in the study group than in the unstimulated group ( 1.1 + /- 0.6 vs 0.5 + /- 0.2 ng/ml , mean + /- SD , p < 0.01 ) . On the day of follicle aspiration , progesterone levels were much higher in the study group ( 8.5 + /- 2.2 vs 0.5 + /- 0.1 ng/ml , p < 0.001 ) . Histologic dating of endometrial biopsies revealed that the study group was advanced by nearly 2 days as compared with the group having artificial cycles . Pinopods , ultrastructural markers of the implantation window , were present in only one of seven study cycles as compared with all of the four artificial cycles . CONCLUSIONS The early luteal phase of cycles undergoing controlled ovarian hyperstimulation is characterized by markedly elevated serum progesterone levels during the periovulatory period , advanced endometrial histologic features , and an absence of endometrial pinopods at the time of embryo implantation . We speculate that these high levels of progesterone in the early luteal phase cause premature endometrial luteinization and a premature appearance of the implantation window , thus providing an explanation for the observed decrease in endometrial receptivity The study was conducted to evaluate if the diagnosis and treatment of intrauterine lesions with office hysteroscopy is of value in improving the pregnancy outcome in patients with recurrent in-vitro fertilization and embryo transfer failure . Four hundred and twenty-one patients who had undergone two or more failed IVF-embryo transfer cycles were prospect ively r and omized into two groups . Group I ( n = 211 ) did not have office hysteroscopic evaluation , Group II ( n = 210 ) had office hysteroscopy . The patients who had normal hysteroscopic findings were included in Group IIa ( n = 154 ) and patients who had abnormal hysteroscopic findings were included in Group IIb ( n = 56 ) . Intrauterine lesions diagnosed were operated during the office procedure . Fifty-six ( 26 % ) patients in Group II had intrauterine pathologies and the treatment was performed at the same time . No difference existed in the mean number of oocyte retrieved , fertilization rate , number of embryos transferred or first trimester abortion rates among the patients in groups . Clinical pregnancy rates in Group I , Group IIa and Group IIb were 21.6 % , 32.5 % and 30.4 % respectively . There was a significant difference in the clinical pregnancy rates between patients in Group I and Group IIa ( 21.6 % and 32.5 % , P = 0.044 , respectively ) and Group I and Group IIb ( 21.6 % and 30.4 % , P = 0.044 , respectively ) . There was no significant difference in the clinical pregnancy rate of patients in Groups IIa and IIb . Patients with normal hysterosalpingography but recurrent IVF-embryo transfer failure should be evaluated prior to commencing IVF-embryo transfer cycle to improve the clinical pregnancy rate Objective : The aim of the study was to evaluate if the diagnosis and treatment of uterine cavity abnormalities by hysteroscopy in patients undergoing IVF programme is of any value in improving clinical pregnancy outcome . Methods : 520 patients participated in this prospect i ve r and omized study and were classified into two groups . Group I ( n = 265 ) without office hysteroscopy . Group II ( n = 255 ) had office hysteroscopy and was sub classified into Group II a and Group II b. Group II a ( n = 160 ) had normal hysteroscopic findings whereas Group II b ( n = 95 ) had abnormal office hysteroscopy findings , which were corrected at the same time . Result : There was no difference in the mean number of oocytes retrieved , fertilization rate , and number of embryos transferred among the patients in different groups . Statistically significant difference was observed in terms of clinical pregnancy rates between Group I and Group II a ( 26.2 and 44.44 % , P < 0.05 ) , and Group I and Group II b ( 26.2 and 39.55 % , P < 0.05 ) , respectively . Conclusion : Patients with recurrent IVF embryo transfer failures after normal hysterosalpingography findings should also be reevaluated using hysteroscopy prior to further commencing IVF-embryo transfer cycles in order to enhance the clinical pregnancy rates OBJECTIVE To explore the possibility that local injury to the endometrium in controlled ovarian hyperstimulation cycle improves the incidence of embryo implantation and to analyze the gene expression profile in the endometria of pregnant and nonpregnant patients in in vitro fertilization/embryo transfer ( IVF-ET ) . DESIGN Prospect i ve study . SETTING A clinical assisted reproductive center of a university hospital . PATIENT(S ) Women undergoing fresh IVF-ET cycles ( n = 121 ) , treated with a long protocol for controlled ovarian hyperstimulation , whose endometrium were diagnosed by B-ultrasound showing irregular echo . INTERVENTION(S ) Local injury to the endometrium of 60 patients in controlled ovarian hyperstimulation cycle , who were r and omly selected from a total of 121 patients . Seven endometrial biopsies sample s from day 10 were analyzed by Affymetrix U133 plus 2.0 gene chip . MAIN OUTCOME MEASURE(S ) Outcomes of IVF-ET and gene expression assayed by gene chip technology . RESULT ( S ) Transfer of the same number of embryos ( 135 in the experimental and control patients , respectively ) result ed in rates of implantation ( 33.33 % vs. 17.78 % ) , clinical pregnancy ( 48.33 % vs. 27.86 % ) , and ongoing or live births per ET ( 41.67 % vs. 22.96 % ) that were higher in the experimental group compared with controls . Statistically significant differences of the expression level of 218 genes ( 41 up-regulated and 177 down-regulated ) were detected in the endometrial biopsy sample s from clinical pregnant patients and nonpregnant patients . CONCLUSION ( S ) The results suggested local injury to the endometrium during a COH cycle improved the rates of embryo implantation , clinical pregnancy and live birth in ART . We also demonstrated a statistically significant difference in the messenger RNA ( mRNA ) expression profiles in the endometrium of pregnant and nonpregnant patients . Further studies on the genes identified herein will assist in predicting implantation competence Local injury to the endometrium prior to controlled ovarian stimulation may considerably improve implantation rates and pregnancy outcomes in intracytoplasmic sperm injection patients with high-order implantation failure ( > or = 4 IVF trials and > or = 12 transferred embryos ) OBJECTIVE Exploration of the possibility that local injury of the endometrium increases the incidence of implantation . DESIGN Prospect i ve study . SETTING Clinical IVF unit . PATIENT(S ) A group of 134 patients , defined as good responders to hormonal stimulation , who failed to conceive during one or more cycles of IVF and embryo transfer ( ET ) . INTERVENTION(S ) The IVF treatment and ET were preceded by repeated endometrial biopsies , in a r and omly selected 45 of a total of 134 patients . MAIN OUTCOME MEASURES Outcome of IVF-ET treatments . RESULT ( S ) Transfer of a similar number of embryos ( 3.4 + /- 1.0 and 3.1 + /- 0.9 in the experimental and control patients , respectively ) result ed in rates of implantation ( 27.7 % vs. 14.2 % , P = .00011 ) , clinical pregnancy ( 66.7 % vs. 30.3 % , P = .00009 ) , and live births per ET ( 48.9 % vs. 22.5 % , P = .016 ) that were more than twofold higher in the experimental group as compared to controls . CONCLUSION ( S ) These results suggest that IVF treatment that is preceded by endometrial biopsy doubles the chance for a take-home baby \n Output:\n " }, { "from": "agent", "value": "However , current evidence suggests that endometrial injury before IVF among women with previous repeated IVF failure is associated with increased rates of implantation , clinical pregnancy , and live birth .\nCONCLUSION ( S ) Endometrial injury may have a beneficial role in implantation and improve the pregnancy rate ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract . Glucocorticoid-induced osteoporosis has been reported to be caused by enhanced bone resorption and suppressed bone formation . To clarify whether administration of vitamin K , which enhances bone formation , prevents prednisolone-induced loss of bone mineral density ( BMD ) , a r and omized , prospect i ve , controlled study was conducted on 20 patients with chronic glomerulonephritis scheduled for treatment with prednisolone . All patients were initially treated with 0.8 mg/kg body weight/day of prednisolone ( maximum of 40 mg ) for 4 weeks , tapering to 20 mg/day over approximately 6 weeks . Ten patients received prednisolone alone ( Group 1 ) , and the other 10 patients received prednisolone plus 15 mg of menatetrenone , vitamin K , three times per day ( Group 2 ) . BMD of the lumbar spine measured by dual-energy X-ray absorptiometry ( DXA ) and biochemical markers of bone metabolism in blood and urine were evaluated before and 10 weeks after administration of prednisolone alone or with menatetrenone . In Group 1 , treatment with prednisolone significantly reduced BMD of the lumbar spine from 1.14 ± 0.12 to 1.10 ± 0.11 g/cm2 ( P= 0.0029 ) . Serum intact osteocalcin and procollagen type I C-peptide ( PICP ) concentrations , biochemical markers of bone formation , were markedly reduced . A biochemical marker of bone resorption , urinary excretion of deoxypyridinoline , was significantly reduced . In Group 2 , prednisolone-induced reduction of BMD was prevented by menatetrenone administration ( 1.09 ± 0.09 to 1.07 ± 0.07 g/cm2 , P= 0.153 ) . Menatetrenone prevented reduction of PICP concentration by prednisolone but not in serum intact osteocalcin concentration and urinary excretion of deoxypyridinoline . Thus , treatment with prednisolone result ed in loss of BMD of the lumbar spine associated with suppression of both bone formation and bone resorption . Menatetrenone is a useful agent in preventing prednisolone-induced loss of BMD We have recently demonstrated that glucocorticoid ( GC ) suppresses bone formation and enhances bone resorption , with result ant bone loss . This altered bone turnover is not due to the action of parathyroid hormone ( PTH ) , but appears to be related to the suppression of osteoprotegerin ( OPG ) . As vitamin K2 ( menatetrenone ) has been used for the treatment of osteoporosis , the present study was carried out to evaluate the effect of vitamin K2 on GC-induced bone loss . Twenty patients with chronic glomerulonephritis treated with GC for the first time were chosen for this study . Ten patients received GC alone ( group A ) and the other 10 patients each received 15 mg of vitamin K2 per day in addition to GC ( group B ) . Markers of bone metabolism , including serum OPG , osteocalcin ( OC ) , bone-specific alkaline phosphatase activity ( BAP ) , PTH , tartrate-resistant acid phosphatase ( TRAP ) , and bone mineral density ( BMD ) , were measured before and during the treatment . OPG was significantly decreased in group A ( P < 0.001 ) , while no significant change was seen in group B. TRAP was markedly increased in both groups , more particularly in group A ( P < 0.01 ) . PTH was decreased in group A , but was increased in group B. OC was decreased at month 1 but subsequently increased until month 12 in both groups . BAP had decreased at month 3 in group A ( P < 0.05 ) , but not in group B. BMD of the lumbar spine was significantly reduced after 6 months ( P < 0.01 ) , and 12 months ( P < 0.001 ) of treatment in group A , whereas there was no remarkable change in group B. The present study demonstrated that the inhibition exerted by vitamin K2 of the reduction in OPG induced by GC may , at least in part , play a role in the prevention and treatment of GC-induced bone loss The purpose of this study was to evaluate the influence of gamma-glutamyl transferase ( GGCX ) gene polymorphisms on the response of serum undercarboxylated osteocalcin ( ucOC ) and bone turnover markers 3 months after treatment with menatetrenone . One hundred and forty postmenopausal Thai women were enrolled and assigned to receive 45 mg/day treatment of menatetrenone ( MK-4 ) concurrently with calcium 1.2 g and vitamin D 400 IU for 3 months . Demographic characteristics , GGCX genotyping , serum bone turnover markers and ucOC levels were obtained from all participants at baseline . We evaluated the reduction of ucOC at 3 months and the reduction of beta-CTx and P1NP at 1 and 3 months . The responses were compared between the different genotypes of GG and GA + AA groups . There was a significant reduction of serum ucOC , beta-CTx and P1NP from the baseline at 3 months ( p < 0.001 ) though there was no significant difference between genotypes ( GG vs. GA + AA ; p > 0.05 ) . Nonetheless , a subgroup analysis of postmenopausal women who 65 years of age or over ( N = 37 ) revealed a significant difference between the two groups in the reduction of ucOC . Menatetrenone significantly reduced serum ucOC as well as beta-CTX and P1NP from the baseline . GGCX polymorphism appeared to have an influence over the reduction of ucOC especially in older women ( age ≥65 ) . Furthermore , the groups which have “ A ” allele trend to being more efficient in reducing the serum ucOC level than the group which does not have it Vitamin K contributes to bone health , probably through its role as cofactor in the carboxylation of osteocalcin . Intervention studies in adults have demonstrated that markedly higher osteocalcin carboxylation is obtained by intakes of vitamin K well above the current recommended dietary intake . However , the relationship between increased vitamin K2 intake and enhanced osteocalcin carboxylation has never been shown in healthy children . The objective was to study the effect of 45 microg menaquinone-7 ( MK-7 ; one of the vitamin K2 species ) on the circulating levels of undercarboxylated osteocalcin ( ucOC ) and carboxylated osteocalcin ( cOC ) in healthy prepubertal children . We hypothesised that MK-7 supplementation will reduce the ucOC : cOC ratio ( UCR ) , indicating an improved vitamin K status . The present study is a double-blind r and omised placebo-controlled trial examining the effect of 8 weeks MK-7 supplementation on the carboxylation of osteocalcin in healthy children ( n 55 ) . Serum levels of ucOC , cOC and MK-7 were measured at baseline and after 8 weeks , together with bone markers and coagulation parameters . The UCR was used as an indicator of vitamin K status . In the MK-7-supplemented group ( n 28 ) , the circulating concentration of inactive ucOC reduced and the UCR improved whereas the concentration of MK-7 increased . Within the placebo group , ucOC , cOC , UCR and MK-7 did not significantly change over time . In both groups , bone markers and coagulation parameters remained constant over time . These findings demonstrate that in healthy , prepubertal children , modest supplementation with MK-7 increases circulating concentrations of MK-7 and increases osteocalcin carboxylation It has been previously shown that the level of circulating undercarboxylated osteocalcin ( ucOC ) is elevated in elderly women in comparison with young , healthy , premenopausal ones . To underst and the mechanism of the increase in the ucOC in the elderly and to assess its potential consequences on bone fragility , we have measured ucOC in the sera of 195 elderly institutionalized women 70 - 101 yr of age . In 45 women ( 23 % ) serum ucOC was above the upper limit of the normal range for young women . The level of ucOC was negatively correlated with 25OHD ( r = -0.32 , P < 0.001 ) even after excluding the effect of age , parathyroid hormone ( PTH ) , and creatinine by partial correlation ( r = -0.24 , P < 0.002 ) . During an 18-mo follow-up , 15 women sustained a hip fracture and their baseline ucOC level was higher ( P < 0.01 ) in women who subsequently sustained hip fracture than in the nonfracture group contrasting with no significant differences for serum calcium , phosphate , alkaline phosphatase , creatinine , PTH , 250HD , and total and carboxylated OC . The risk of hip fracture was increased in women with elevated ucOC ( relative ratio 5.9 , 99.9 % Cl 1.5 - 22.7 , P < 0.001 ) . During 1 yr of calcium/vitamin D2 treatment , ucOC decreased ( P < 0.05 ) , especially in those with the initially increased values ( from 2.22 + /- 0.35 to 1.41 + /- 0.29 ng/ml , P < 0.005 ) contrasting with an increase in the placebo group ( P < 0.05 ) . In conclusion , the increase in ucOC in the elderly reflects not only some degree of vitamin K deficiency but also their poor vitamin D status , suggesting that vitamin D may be important , either directly or indirectly through its effect on bone turnover , for achieving a normal gamma-carboxylation of OC . The ucOC , but not conventional calcium metabolism parameters , predicts the subsequent risk of hip fracture , suggesting that serum ucOC reflects some changes in bone matrix associated with increased fragility BACKGROUND Vitamin K mediates the gamma-carboxylation of glutamyl residues on several bone proteins , notably osteocalcin . High serum concentrations of undercarboxylated osteocalcin and low serum concentrations of vitamin K are associated with lower bone mineral density and increased risk of hip fracture . However , data are limited on the effects of dietary vitamin K. OBJECTIVE We investigated the hypothesis that high intakes of vitamin K are associated with a lower risk of hip fracture in women . DESIGN We conducted a prospect i ve analysis within the Nurses ' Health Study cohort . Diet was assessed in 72327 women aged 38 - 63 y with a food-frequency question naire in 1984 ( baseline ) . During the subsequent 10 y of follow-up , 270 hip fractures result ing from low or moderate trauma were reported . RESULTS Women in quintiles 2 - 5 of vitamin K intake had a significantly lower age-adjusted relative risk ( RR : 0.70 ; 95 % CI : 0.53 , 0.93 ) of hip fracture than women in the lowest quintile ( < 109 microg/d ) . Risk did not decrease between quintiles 2 and 5 and risk estimates were not altered when other risk factors for osteoporosis , including calcium and vitamin D intakes , were added to the models . Risk of hip fracture was also inversely associated with lettuce consumption ( RR : 0.55 ; 95 % CI : 0.40 , 0.78 ) for one or more servings per day compared with one or fewer servings per week ) , the food that contributed the most to dietary vitamin K intakes . CONCLUSIONS Low intakes of vitamin K may increase the risk of hip fracture in women . The data support the suggestion for a re assessment of the vitamin K requirements that are based on bone health and blood coagulation Vitamin K is required for the carboxylation of Gla-proteins in the liver ( coagulation factors ) and extra-hepatic tissues , such as bone ( osteocalcin , OC ) , and arterial wall ( matrix Gla-protein , MGP ) . Although the coagulation factors are essentially fully carboxylated under normal conditions , 10 - 40 % of OC and MGP remains undercarboxylated . We were therefore interested to study the dose-response effects of extra intake of menaquinones on the carboxylation of the extra-hepatic Gla-proteins . A total of forty-two healthy Dutch men and women aged between 18 and 45 years were r and omised into seven groups to receive : placebo capsules or menaquinone-7 ( MK-7 ) capsules at a daily dose of 10 , 20 , 45 , 90 , 180 or 360 μg . Circulating uncarboxylated OC ( ucOC ) , carboxylated OC ( cOC ) and desphospho-uncarboxylated MGP were measured by ELISA . The ucOC : cOC ratio was calculated from circulating ucOC and cOC values . Endogenous thrombin potential and peak height were determined by calibrated automated thrombography . To increase the statistical power , we collapsed the treatment groups into three dosage groups : placebo , low-dose supplementation ( doses below RDA , Commission Directive 2008/100/EC ) , and high-dose supplementation ( doses around RDA , Commission Directive 2008/100/EC ) . MK-7 supplementation at doses in the order of the RDA ( Commission Directive 2008/100/EC ) increased the carboxylation \n Output:\n " }, { "from": "agent", "value": "A meta- analysis study , but not a systematic review study , showed efficacy against vertebral and non-vertebral fractures mainly in postmenopausal women with osteoporosis .\nThere was no available evidence for men with osteoporosis .\nThe present review of the literature revealed some evidence of a positive effect of menatetrenone on the skeleton of postmenopausal women and in patients treated with glucocorticoid .\nEXPERT OPINION Menatetrenone is considered to be a second-line medicine for postmenopausal osteoporotic women with an increased risk for vertebral fractures" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Objective To estimate the effect of adding exercise classes , spinal manipulation delivered in NHS or private premises , or manipulation followed by exercise to “ best care ” in general practice for patients consulting with back pain . Fig 1 Progress of the UK BEAM trial Design Pragmatic r and omised trial with factorial design . Setting 181 general practice s in Medical Research Council General Practice Research Framework ; 63 community setting s around 14 centres across the United Kingdom . Participants 1334 patients consulting their general practice s about low back pain . Main outcome measures Scores on the Rol and Morris disability question naire at three and 12 months , adjusted for centre and baseline scores . Results All groups improved over time . Exercise improved mean disability question naire scores at three months by 1.4 ( 95 % confidence interval 0.6 to 2.1 ) more than “ best care . ” For manipulation the additional improvement was 1.6 ( 0.8 to 2.3 ) at three months and 1.0 ( 0.2 to 1.8 ) at 12 months . For manipulation followed by exercise the additional improvement was 1.9 ( 1.2 to 2.6 ) at three months and 1.3 ( 0.5 to 2.1 ) at 12 months . No significant differences in outcome occurred between manipulation in NHS premises and in private premises . No serious adverse events occurred . Conclusions Relative to “ best care ” in general practice , manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months ; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months ; and exercise achieved a small benefit at three months but not 12 months This study examined the supplemental value of a cognitive coping skills training when added to an operant-behavioral treatment for chronic low-back pain patients . The complete treatment package ( OPCO ) was compared with an operant program + group discussion ( OPDI ) and a waiting-list control ( WLC ) . After the WL period , the WLC patients received a less protocol ized operant program usually provided in Dutch rehabilitation centers ( OPUS ) . Regression analyses showed that , compared with WLC , both OPCO and OPDI led to less negative affect , higher activity tolerance , less pain behavior , and higher pain coping and pain control . At posttreatment , OPCO led to better pain coping and pain control than OPDI . Calculation of improvement rates revealed that OPCO and OPDI had significantly more improved patients than OPUS on all the dependent variables . The discussion includes findings regarding treatment credibility , compliance , and contamination bias Study Design . A prospect i ve clinical trial was conducted that involved six groups of patients with chronic low back pain selected from a large cohort ( N = 816 ) . Objectives . To correlate pretreatment baseline variables with outcome parameters after treatment in a functional restoration program or in control programs , to identify possible factors predictive of the need for functional restoration . Summary of Background Data . Since the functional restoration program was first described , research has focused on identifying patients who will or will not benefit from such a program . The value of previous studies is limited , however , because predictive factors from a control group were not \" subtracted . \" Methods . Eight hundred sixteen patients with chronic low back disability were included . All had a structured medical examination , including various physical tests before participation in either a functional restoration program ( n = 621 ) or shorter \" control \" outpatient programs ( n = 144 ) . A smaller group of the cohort ( n = 51 ) had no treatment and served as a pure control group . Six groups were selected from the cohort : Three underwent an identical functional restoration program and three underwent different outpatient control programs . Several baseline demographic , physical , and socioeconomic variables were correlated to 1‐year outcome parameters . Results . Age , days of sick leave , connection to the work force , and back pain intensity , were significantly correlated to success 1 year after entry into the study in all groups , no matter what kind of treatment was administered . Back muscle endurance , sports activity , activity of daily living scores , and vibrations were of importance in some outcome parameters for success after functional restoration . Smoking was positively correlated to disability pension . Days of sick leave and , in functional restoration , ability to work were the only factors that were correlative with statistics for people who withdrew . Conclusions . Different factors can be identified as predictive of outcome in a functional restoration program , but most of these factors were also shown to predict success for shorter control outpatient programs or of no treatment Introduction The Multinational Musculoskeletal Inception Cohort Study ( MMICS ) Statement is a consensus statement aim ed at improving the quality of prospect i ve investigations into the transition from early stages of low back pain ( LBP ) to persistent problems . The statement aims to help improve the quality of such studies by recommending an agreed minimal list of measures for inclusion in baseline data collection . The MMICS Statement is primarily aim ed at research ers who want to investigate prognosis in LBP , and this will allow data from cohorts to be pooled and will facilitate comparisons between different health care systems . One approach to preventing acute new episodes of LBP ( up to 3 weeks from onset ) from developing into persistent disabling pain is to identify those individuals with LBP who are most likely to progress to chronic disability . Targeting interventions at those at highest risk could reduce the population burden of chronic LBP . A wide range of baseline parameters have been associated with poor outcome in inception cohort studies ( 1–6 ) . Few existing studies have been of sufficient size and method ologic rigor to produce conclusive findings . Even in method ologically robust studies , baseline factors only account for a small proportion of the variance in outcome ( 7 ) , typically around 30 % . Systematic review s of the literature could not pool data because studies used different measurements ( 1–3 ) . Despite some information on physical , psychosocial , and work-related risk factors , it has not been possible to adequately estimate the comparative impact of individual psychosocial and societal factors on the transition from acute to persistent disabling LBP . How to address this problem was one focus of the VI International Forum for Primary Care Research in Low Back Pain held in April 2003 . A steering group for the collaboration was appointed , and 8 national team leaders volunteered to recruit teams of national experts . Three additional team leaders were recruited by the steering group ( Australia , France , and Germany ) . Independent experts were invited to advise on the quality of the MMICS process . The MMICS steering group , located in the UK , met regularly and included expert research ers in clinical and outcome factors in back pain ( AB ) , work-related issues in back pain ( AKB ) , psychosocial aspects of back pain ( TP and RS ) , and general practice aspects of back pain ( MU ) . The MMICS Statement set out to include 1 ) a minimal but comprehensive number of predictor factors based on current evidence and theory ; 2 ) appropriate measurement instruments for agreed predictor factors based on their clinometric properties , availability , and practical characteristics ; and 3 ) a minimum set of followup measures , including recommendations about measurement and timing Objective To determine the effectiveness of lessons in the Alex and er technique , massage therapy , and advice from a doctor to take exercise ( exercise prescription ) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain . Design Factorial r and omised trial . Setting 64 general practice s in Engl and . Participants 579 patients with chronic or recurrent low back pain ; 144 were r and omised to normal care , 147 to massage , 144 to six Alex and er technique lessons , and 144 to 24 Alex and er technique lessons ; half of each of these groups were r and omised to exercise prescription . Interventions Normal care ( control ) , six sessions of massage , six or 24 lessons on the Alex and er technique , and prescription for exercise from a doctor with nurse delivered behavioural counselling . Main outcome measures Rol and Morris disability score ( number of activities impaired by pain ) and number of days in pain . Results Exercise and lessons in the Alex and er technique , but not massage , remained effective at one year ( compared with control Rol and disability score 8.1 : massage −0.58 , 95 % confidence interval −1.94 to 0.77 , six lessons −1.40 , −2.77 to −0.03 , 24 lessons −3.4 , −4.76 to −2.03 , and exercise −1.29 , −2.25 to −0.34 ) . Exercise after six lessons achieved 72 % of the effect of 24 lessons alone ( Rol and disability score −2.98 and −4.14 , respectively ) . Number of days with back pain in the past four weeks was lower after lessons ( compared with control median 21 days : 24 lessons −18 , six lessons −10 , massage −7 ) and quality of life improved significantly . No significant harms were reported . Conclusions One to one lessons in the Alex and er technique from registered teachers have long term benefits for patients with chronic back pain . Six lessons followed by exercise prescription were nearly as effective as 24 lessons . Trial registration National Research Register N0028108728 . How does the Alex and er Technique work ? What are the authors findings about the clinical and cost effectiveness of the treatment ? Watch this video to find out ( 12 mins ) . Many manual therapists assess and treat spinal stiffness of people with low back pain . The objectives of this study were to investigate : ( i ) whether spinal stiffness changes after treatment ; ( ii ) the relationship between pre-treatment spinal stiffness and change in stiffness with treatment ; ( iii ) the relationship between spinal stiffness , pain , disability and global perceived effect of treatment ; ( iv ) whether spinal stiffness predicts outcome of treatment or response to treatment in chronic low back pain patients . One hundred and ninety-one subjects with chronic low back pain were r and omly allocated to groups that received either spinal manipulative therapy , motor control exercise , or a general exercise program . Spinal stiffness was assessed before and after intervention . All three groups showed a significant decrease in stiffness following treatment ( p<0.001 ) . No difference between groups was observed . There was a significant negative correlation between pre-treatment stiffness and change in stiffness ( r=-0.61 ; p<0.001 ) . There was a significant but weak correlation ( r=0.18 ; p=0.02 ) between change in stiffness and change in global perceived effect of treatment , and a significant but weak correlation between change in stiffness and change in function for subjects in the spinal manipulative therapy group ( r=-0.28 ; p=0.02 ) . No significant association was observed between initial stiffness score and any of the final outcome measures following treatment . Initial stiffness did not predict response to any treatment . In conclusion , spinal stiffness decreases over the course of an episode of treatment , more so in those with the stiffest spines , but the decrease is not dependent on treatment and is not generally related to outcome Background Current method ological guidelines provide advice about the assessment of sub-group analysis within RCTs , but do not specify explicit criteria for assessment . Our objective was to provide research ers with a set of criteria that will facilitate the grading of evidence for moderators , in systematic review s. Method We developed a set of criteria from method ological manuscripts ( n = 18 ) using snowballing technique , and electronic data base search es . Criteria were review ed by an international Delphi panel ( n = 21 ) , comprising authors who have published method ological papers in this area , and research ers who have been active in the study of sub-group analysis in RCTs . We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data . Free responses were coded for consensus and disagreement . In a subsequent round additional criteria were extracted from the Cochrane Review ers ' H and book , and the process was repeated . Results The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis . Confirmatory findings must only come from studies in which a specific theory/ evidence based a-priori statement is made . Exploratory findings may be used to inform future/subsequent trials . However , for inclusion in the meta- analysis of moderators , the following additional criteria should be applied to each study : Baseline factors should be measured prior to r and omisation , measurement of baseline factors should be of adequate reliability and validity , and a specific test of the interaction between baseline factors and interventions must be presented . Conclusions There is consensus from a group of 21 international experts that method ological criteria to assess moderators within systematic review s of RCTs is both timely and necessary . The consensus from the experts result ed in five criteria divided into two groups when synthesis ing evidence : confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research . These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies Background The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations : the deconditioning model , the cognitive behavioral model and the biopsychosocial model . There is evidence that rehabilitation of patients with chronic low back pain is more effective than no treatment , but information is lacking about the differential effectiveness of different kinds of rehabilitation . A direct comparison of a physical , a cognitive-behavioral treatment and a combination of both has never been carried out so far . Methods The effectiveness of active physical , cognitive-behavioral and combined treatment for chronic non-specific low back pain compared with a waiting list control group was determined by performing a r and omized controlled trial in three rehabilitation centers . Two hundred and twenty three patients were r and omized , using concealed block r and omization to one of the following treatments , which they attended three times a week for 10 weeks : Active Physical Treatment ( APT ) , Cognitive-Behavioral Treatment ( CBT ) , Combined Treatment of APT and CBT ( CT ) , or Waiting List ( WL ) . The outcome variables were self-reported functional limitations , patient 's main complaints , pain , mood , self-rated treatment effectiveness , treatment satisfaction and physical performance including walking , st and ing up , reaching forward , stair climbing and lifting . Assessment s were carried out by blinded research assistants at baseline and immediately post \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses performed in NSLBP trials have been severely underpowered , are only able to provide exploratory or insufficient findings , and have rather poor quality of reporting ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Approximately 80 percent of pregnant women suffer by some degree of nausea and vomiting . But the treatment of nausea and vomiting of pregnancy is rarely successful . Objectives The aim of this study was evaluation the effect of mint on nausea and vomiting during pregnancy that its treatment in some recent research has been effective . Material s and Methods In this double blind RCT , 60 pregnant women with nausea and vomiting of pregnancy were sample d and divided into two groups with Block-r and omized method . mint group , in addition to giving the routine training , for four consecutive nights , before sleeping , a bowel of water whit four drops of pure mint essential oil placed on the floor near their beds and in control groups were used four drops of normal saline . The severity of nausea by using Visual Analog Scale ( VAS ) and severity of vomiting by counting the number of its in 7 days prior , 4 days during , and 7 days after intervention were assessed . Results The results showed that the severity of nausea and vomiting did not differ between the two groups in 7days before and after intervention by using repeated measurement test . But during intervention , the severity of nausea showed a decreasing trend ( especially in 4th night ) in the mint and an increasing trend in the control group . The severity of nausea within 7 days after the intervention had a decreasing trend in both groups ; however , the intensity was lower in the mint than saline group but not statically significant . No meaningful relationship has been detected during and after intervention for the intensity of vomiting . Conclusions The results of study showed that peppermint essential oil has n't the effect on nausea and vomiting of pregnancy OBJECTIVE To evaluate the effectiveness of Diclectin ( doxylamine succinate 10 mg-pyridoxine hydrochloride 10 mg , delayed-release preparation ) as compared with placebo for nausea and vomiting of pregnancy . STUDY DESIGN A r and omized , double-blind , multicenter placebo controlled trial study ing pregnant women suffering from nausea and vomiting of pregnancy , analyzed by intention to treat . Women received Diclectin ( n = 131 ) or placebo ( n = 125 ) for 14 days . Nausea and vomiting of pregnancy symptoms were evaluated daily using the pregnancy unique quantification of emesis scale . RESULTS Diclectin use result ed in a significantly larger improvement in symptoms of nausea and vomiting of pregnancy compared with placebo based on both the pregnancy unique quantification of emesis score ( -4.8 ± 2.7 vs -3.9 ± 2.6 ; P = .006 ) and quality of life . After the trial , 64 ( 48.9 % ) women receiving Diclectin asked to continue compassionate use of their medication , as compared with 41 ( 32.8 % ) of placebo-treated women ( P = .009 ) . CONCLUSION Diclectin delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating nausea and vomiting of pregnancy This study assesses the effects of ginger on nausea and vomiting caused by pregnancy and compares it with metoclopramide medicine . This study was a r and omized double-blind controlled trial . Metoclopramide , Ginger and placebo were putted in similar capsules . The medicines were administered three times a day . Then the Rhodes question naire was completed and its score were calculated . Data were analyzed by Chi square test , ANOVA and Repeated measurement . The intensity of changes in nausea , vomiting and Rhodes during study were statistically different in two groups of ginger and metoclopramide compared with placebo ( p < 0.05 ) , but it was not statistically significant between two groups of ginger and metoclopramide . According to our study , ginger is less effective than metoclopramide in reducing nausea and vomiting but it could be a good alternative for metoclopramide OBJECTIVES Recent studies have concluded that acupuncture is safe in the h and s of a qualified practitioner . This study assessed the risk of adverse effects of acupuncture administered during pregnancy . METHODS 593 women with nausea and vomiting in early pregnancy volunteered to participate in a r and omised controlled trial , conducted at the Women 's and Children 's Hospital , in South Australia . Patients were given either traditional acupuncture , formula acupuncture , sham acupuncture or no acupuncture . OUTCOME MEASURES Data were collected on perinatal outcome , congenital abnormalities , pregnancy complications and the newborn . RESULTS No differences were found between study groups in the incidence of perinatal outcome , congenital abnormalities , pregnancy complications and other infant outcomes . CONCLUSION Our findings suggest that no serious adverse effects arise from acupuncture administered in early pregnancy OBJECTIVE Hyperemesis gravidarum , a severe form of nausea and vomiting due to pregnancy for which there is no proven pharmacological treatment , is the third leading cause for hospitalization during pregnancy . Corticosteroids are commonly used for the treatment of nausea and vomiting due to cancer chemotherapy – induced emesis and might prove useful in hyperemesis gravidarum . METHODS A r and omized , double-blind , placebo-controlled trial was conducted in 126 women who previously had not responded to outpatient therapy for hyperemesis gravidarum during the first half of pregnancy . Intravenous methylprednisolone ( 125 mg ) was followed by an oral prednisone taper ( 40 mg for 1 day , 20 mg for 3 days , 10 mg for 3 days , 5 mg for 7 days ) versus an identical-appearing placebo regimen . All women also received promethazine 25 mg and metoclopramide 10 mg intravenously every 6 hours for 24 hours , followed by the same regimen administered orally as needed until discharge . The primary study outcome was the number of women requiring rehospitalization for hyperemesis gravidarum . RESULTS A total of 110 women delivered at our hospital and had pregnancy outcomes available for analysis ; 56 were r and omized to corticosteroids and 54 were administered placebo . Nineteen women in each study group required rehospitalization ( 34 % versus 35 % , P = .89 , for corticosteroids versus placebo , respectively ) . CONCLUSION The addition of parenteral and oral corticosteroids to the treatment of women with hyperemesis gravidarum did not reduce the need for rehospitalization later in pregnancy Background . To determine whether low dosages of prednisolone are effective in the treatment of out patients with hyperemesis gravidarum Objective To compare the effectiveness of acupressure and vitamin B6 in the outpatient treatment of nausea and vomiting in early pregnancy . Study design Pregnant volunteers with symptoms of mild to moderate nausea and vomiting between 6 and 12 weeks ’ gestation participated in a 7-day clinical trial . Participants were r and omly assigned to receive a device for acupressure therapy and placebo drug or an otherwise identical but non-stimulating placebo device and vitamin B6 . The primary outcome measure was self-recorded symptoms according to Rhodes index . Secondary outcome measures were weight gain and medication use . Results The mean change in Rhodes index was not significantly different between the two groups . There were no statistically significant differences in weight gain and medication use between the two groups . Conclusion Acupressure therapy is not more effective than vitamin B6 in reducing nausea and vomiting in symptomatic women in the first trimester of pregnancy BACKGROUND Although the effectiveness of prednisolone therapy for severe hyperemesis gravidarum has been demonstrated , there is no consensus on how to assess severity to justify such treatment , nor any information on whether such therapy affects birth weight . AIM To document the effect of prednisolone therapy in women with defined severity of hyperemesis gravidarum . DESIGN Single centre , observational study of 30 consecutive pregnancies complicated by hyperemesis and weight loss of > 5 % of pre-pregnant weight between April 1995 and July 2000 . Comparison of birth weight with a contemporaneous control series of women admitted with hyperemesis that was judged insufficiently severe to require steroids . RESULTS Treatment with prednisolone 10 mg tid rapid resolved nausea and vomiting , allowing discharge in 3 ( range 1 - 6.5 ) days . Steroid therapy , which was reduced in a stepwise manner , was discontinued at a median gestation of 20 weeks . Maternal weight gain in pregnancy was restored to normal . Median birth weight in the severe , steroid-treated group was 3.33 ( range 2.80 - 3.27 ) kg vs. 3.27 ( range 3.04 - 3.53 ) kg in the less severe group . CONCLUSION Weight loss > 5 % served as a criterion to define a subset of women with severe hyperemesis gravidarum . In these women , steroid therapy was uniformly successful result ing in the prompt resolution of symptoms . Steroid therapy did not affect birth weight OBJECTIVE Our purpose was to investigate the efficacy of P6 acupressure in reducing or relieving symptoms of nausea with or without vomiting and retching during pregnancy . STUDY DESIGN Symptomatic pregnant volunteers ( n=161 ) participated in a 7-day community-based clinical trial . All participants were assigned to one of three groups ( i.e. , P6 acupressure , placebo [ acupressure b and s inappropriately placed ] , or control ) on the basis of a process of blocked r and omization . Data were analyzed by error bar charts and analysis of variance of difference scores . RESULTS Of 161 women , 149 ( 92.5 % ) completed the protocol . Irrespective of group assignment , participants reported significant decreases in nausea ( p<0.0009 ) and vomiting or retching ( p<0.0009 ) . However , there was no differential treatment effect as a result of acupressure . CONCLUSION There was no apparent medical benefit from the use of P6 acupressure . Our findings differ from other recently published studies that did not include a control group In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Objective To determine the effectiveness of ginger for the treatment of nausea and vomiting of pregnancy . Methods Women with nausea and vomiting of pregnancy , who first attended an antenatal clinic at or before 17 weeks ' gestation , were invited to participate in the study . During a 5-month period , 70 eligible women gave consent and were r and omized in a double-masked design to receive either oral ginger 1 g per day or an identical placebo for 4 days . Subjects grade d the severity of their nausea using visual analog scales and recorded the number of vomiting episodes in the previous 24 hours before treatment , and again during 4 consecutive days while taking treatment . At a follow-up visit 7 days later , five-item Likert scales were used to assess the severity of their symptoms . Results All participants except three in the placebo group remained in the study . The visual analog scores of posttherapy minus baseline nausea decreased significantly in the ginger group ( 2.1 ± 1.9 ) compared with the placebo group ( 0.9 ± 2.2 , P = .014 ) . The number of vomiting episodes also decreased significantly in the ginger group ( 1.4 ± 1.3 ) compared with the placebo group ( 0.3 ± 1.1 , P < .001 ) . Likert scales showed that 28 of 32 in the ginger group had improvement in nausea symptoms compared with 10 of 35 in the placebo group ( P < .001 ) . No adverse effect of ginger on pregnancy outcome was detected . Conclusion Ginger is effective for relieving the severity of nausea and vomiting of pregnancy OBJECTIVE The aim of this study was to determine the effects of ginger in nausea and vomiting of pregnancy . DESIGN This was a single blind clinical trial study . SETTING The study was conducted in a selected prenatal care clinic of Isfahan City hospitals . SUBJECTS The subjects included 67 pregnant women who complained of nausea and vomiting from Isfahan city hospitals participated in the study . INTERVENTION The participants were r and omly assigned to two groups , an experimental group and a control group . The groups were matched according to the age , gestational age , parity , occupational status , and educational level of the participants . The experimental group received ginger 250 mg capsules for 4 days , and the control group received placebo with the same prescription form . OUTCOME MEASURES Effects of treatment of nausea were evaluated twice daily for 4 days by a before- and - \n Output:\n " }, { "from": "agent", "value": "Diclectin ® [ Duchesnay Inc. ; doxylamine succinate ( 10 mg ) plus pyridoxine hydrochloride ( 10 mg ) slow release tablet ] is more effective than placebo and ondansetron is more effective at reducing nausea than pyridoxine plus doxylamine .\nDiclectin before symptoms of NVP begin for women at high risk of severe NVP recurrence reduces risk of moderate/severe NVP compared with taking Diclectin once symptoms begin .\nPromethazine is as , and ondansetron is more , effective than metoclopramide for severe NVP/HG .\nI.v .\nfluids help correct dehydration and improve symptoms .\nDextrose saline may be more effective at reducing nausea than normal saline .\nTransdermal clonidine patches may be effective for severe HG .\nEnteral feeding is effective but extreme method treatment for very severe symptoms .\nDay case management for moderate/severe symptoms is feasible , acceptable and as effective as inpatient care .\nThe economic analysis was limited by lack of effectiveness data , but comparison of costs between treatments highlights the implication s of different choices .\nThere was evidence of some improvement in symptoms for some treatments , but these data may not be transferable across disease severities ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE We assessed the prognostic importance of the level of thymidylate synthase ( TS ) expression in patients with primary rectal cancer and whether , for Dukes ' B and C cancer patients , the benefit of chemotherapy was associated with TS expression . PATIENTS AND METHODS The level of TS expression in the primary rectal cancers of 294 of 801 patients enrolled on protocol R-01 of the National Surgical Adjuvant Breast and Bowel Project ( NSABP ) was immunohistochemically assessed with the monoclonal antibody TS 106 . RESULTS Forty-nine percent of patients whose tumors had low TS levels ( n = 91 ) were disease free at 5 years compared with 27 % of patients with high levels of TS ( n = 203 ; P < .01 ) . Moreover , 60 % of patients with low TS levels were alive after 5 years compared with 40 % of patients with high TS levels ( P < .01 ) . The level of TS protein was significantly associated with Dukes ' stage ( P < .01 ) ; patients with a more advanced Dukes ' stage had a significantly higher level of TS . The level of TS expression remained prognostic for both disease-free survival ( P < .01 ) and survival ( P < .05 ) independent of Dukes ' stage and other pathologic characteristics evaluated . Thirty-eight percent and 54 % of patients with high TS levels ( n = 71 ) were disease free and alive , respectively , after 5 years when treated with chemotherapy , compared with 17 % and 31 % , respectively , of similar patients when treated with surgery alone ( n = 64 ) ( P < .01 ) . No difference was noted in disease-free survival ( P = .46 ) or survival ( P = .43 ) in patients with low TS levels . CONCLUSION The expression of TS is an important independent prognosticator of disease-free survival and survival in patients with rectal cancer . Adjuvant fluorouracil (5-FU)-based chemotherapy demonstrated significant improvement in disease-free and overall survival for patients with high TS levels . Prospect i ve studies measuring TS levels will be needed to underst and further the role of TS as a prognosticator of survival and chemotherapeutic benefit We performed a clinical study to identify biological markers useful for the treatment of resectable non-small-cell lung cancers ( NSCLCs ) . In all , 173 patients were studied . By immunohistochemistry , we evaluated the Ki-67 proliferation index , tumour vascularity , thymidylate synthase ( TS ) , vascular endothelial growth factor (VEGF)-A , VEGF-C , and E (epithelial)-cadherin . Concerning the survival of NSCLC patients , tumour vascularity ( P<0.01 ) , VEGF-A status ( P=0.03 ) , VEGF-C status ( P=0.03 ) , and E-cadherin status ( P=0.03 ) were significant prognostic factors in patients with stage I NSCLCs . The Ki-67 proliferation index ( P=0.02 ) and TS status ( P<0.01 ) were significant prognostic factors in patients with stage II – III NSCLCs . In patients with stage II – III NSCLCs , furthermore , the survival of UFT ( a combination of tegafur and uracil)-treated patients with TS-negative tumours was significantly better than those of any other patients . Biological markers associated with tumour angiogenesis or metastasis are useful for the detection of aggressive tumours among early-stage NSCLCs . Postoperative chemotherapy might be necessary in such tumours even in stage I. In contrast , tumour proliferation rate and TS status are useful markers for identifying less aggressive tumours in locally advanced NSCLCs . Thymidylate synthase expression is also a useful marker to evaluate responsiveness of UFT-based chemotherapy for these tumours Purpose : This phase II trial of pemetrexed explored potential correlations between treatment outcome ( antitumor activity ) and molecular target expression . Experimental Design : Chemonaïve patients with advanced breast cancer received up to three cycles of pemetrexed 500 mg/m2 ( 10-minute i.v . infusion ) on day 1 of a 21-day cycle , with folic acid and vitamin B12 supplementation . Tumors were surgically removed after the last cycle of pemetrexed as clinical ly indicated . Biopsies were taken at baseline , 24 hours after infusion in cycle 1 , and after cycle 3 . Results : Sixty-one women ( median age , 46 years ; range , 32 - 72 years ) were treated and were evaluable for response . Objective response rate was 31 % . Simple logistic regression suggested a potential relationship between mRNA expression of thymidylate synthase ( TS ) and pemetrexed response ( P = 0.103 ) . Based on threshold analysis , patients with “ low ” baseline TS ( ≤71 ) were more likely to respond to pemetrexed than patients with “ high ” baseline TS ( > 71 ) . Expression of baseline dihydrofolate reductase and glycinamide ribonucleotide formyl transferase tended to be higher in responders but this association was not significant ( P > 0.311 ) . TS expression increased significantly between baseline and biopsy 2 ( P = 0.004 ) and dropped to near baseline levels at biopsy 3 . Conversely , dihydrofolate reductase and glycinamide ribonucleotide formyl transferase decreased after pemetrexed chemotherapy . Conclusions : Our results suggest a potential association between “ low ” pretreatment TS expression levels and response to pemetrexed chemotherapy . Future trials examining expression levels of other genes important to the folate pathway and /or breast cancer may identify a more robust multigene profile that can better predict response to this novel antifolate The purpose of this study was to define the prognostic value of a group of molecular tumor markers in a well-staged population of patients treated with trimodality therapy for esophageal cancer . The original pretreatment paraffin-embedded endoscopic esophageal tumor biopsy material was obtained from 118 patients treated with concurrent cisplatin + 5-fluorouracil ( 5-FU ) + 45 Gy radiation followed by resection from 1986 until 1997 at the Duke University Comprehensive Cancer Center . Three markers of possible platinum chemotherapy association [ metallothionein ( MT ) , glutathione S-transferase-pi ( GST-pi ) , P-glycoprotein ( P-gp or multidrug resistance ) ] and one marker of possible 5-FU association [ thymidylate synthase ( TS ) ] were measured using immunohistochemistry . The median cancer-free survival was 25.0 months , with a significantly improved survival for the 38 patients who had a complete response ( P < 0.001 ) . High-level expression of GST-pi , P-gp , and TS were associated with a decreased survival . MT was not significant in this population . Multivariate analysis identified high-level expression in two of the platinum markers ( GST-pi and P-gp ) and the 5-FU marker TS as independent predictors of early recurrence and death . In conclusion , this investigation measured three possible markers associated with platinum and one possible marker associated with 5-FU in a cohort of esophageal cancer patients . Independent prognostic significance was observed , which suggests that it may be possible to predict which patients may benefit most from trimodality therapy . These data need to be reproduced in a prospect i ve investigation Introduction : In retrospective analyses of patients with nonsquamous non – small-cell lung cancer treated with pemetrexed , low thymidylate synthase ( TS ) expression is associated with better clinical outcomes . This phase II study explored this association prospect ively at the protein and mRNA-expression level . Methods : Treatment-naive patients with nonsquamous non – small-cell lung cancer ( stage IIIB/IV ) had four cycles of first-line chemotherapy with pemetrexed/cisplatin . Nonprogressing patients continued on pemetrexed maintenance until progression or maximum tolerability . TS expression ( nucleus/cytoplasm/total ) was assessed in diagnostic tissue sample s by immunohistochemistry ( IHC ; H-scores ) , and quantitative reverse-transcriptase polymerase chain reaction . Cox regression was used to assess the association between H-scores and progression-free/overall survival ( PFS/OS ) distribution estimated by the Kaplan – Meier method . Maximal & khgr;2 analysis identified optimal cutpoints between low TS- and high TS-expression groups , yielding maximal associations with PFS/OS . Results : The study enrolled 70 patients ; of these 43 ( 61.4 % ) started maintenance treatment . In 60 patients with valid H-scores , median ( m ) PFS was 5.5 ( 95 % confidence interval [ CI ] , 3.9–6.9 ) months , mOS was 9.6 ( 95 % CI , 7.3–15.7 ) months . Higher nuclear TS expression was significantly associated with shorter PFS and OS ( primary analysis IHC , PFS : p < 0.0001 ; hazard ratio per 1-unit increase : 1.015 ; 95%CI , 1.008–1.021 ) . At the optimal cutpoint of nuclear H-score ( 70 ) , mPFS in the low TS- versus high TS-expression groups was 7.1 ( 5.7–8.3 ) versus 2.6 ( 1.3–4.1 ) months ( p = 0.0015 ; hazard ratio = 0.28 ; 95%CI , 0.16–0.52 ; n = 40/20 ) . Trends were similar for cytoplasm H-scores , quantitative reverse-transcriptase polymerase chain reaction and other clinical endpoints ( OS , response , and disease control ) . Conclusions : The primary endpoint was met ; low TS expression was associated with longer PFS . Further r and omized studies are needed to explore nuclear TS IHC expression as a potential biomarker of clinical outcomes for pemetrexed treatment in larger patient cohorts Introduction : This study is to evaluate whether thymidylate synthase ( TS ) or thyroid transcription factor 1 ( TTF1 ) protein expression can predict clinical outcomes for pemetrexed-based chemotherapy in patients with nonsquamous non-small cell lung cancer ( NSCLC ) . Methods : Two hundred eighty-five consecutive patients with nonsquamous NSCLC treated with pemetrexed-based chemotherapy were immunohistochemically analyzed for the expressions of TS and TTF1 . Results : TS and TTF1 expression were successfully analyzed in 193 and 284 cases , respectively . Tumors with TS-negativity or TTF1-positivity were more frequent in patients who were female , younger , had adenocarcinoma , or had never smoked . Higher response rates for pemetrexed-based chemotherapy were associated with TS-negativity ( 33.7 % versus 14.1 % , p = 0.002 ) and TTF1-positivity ( 28.1 % versus 9.8 % , p < 0.001 ) . In univariate analysis , progression-free survival for pemetrexed-based chemotherapy was significantly longer in groups with adenocarcinoma ( 2.9 versus 1.4 months , p = 0.001 ) , TS-negativity ( 4.1 versus 2.0 months , p = 0.001 ) , and TTF1-positivity ( 3.8 versus 1.3 months , p < 0.001 ) . In multivariate analysis , TS-negativity ( hazard ratio [ HR ] = 0.70 ; 95 % confidence interval [ CI ] , 0.51–0.97 ) and TTF1-positivity ( HR = 0.51 ; 95 % CI , 0.35–0.73 ) were associated with longer progression-free survival . Patients with TTF1-positive tumors also had significantly longer overall survival times than patients with TTF1-negative tumors ( 25.4 versus 14.2 months , HR = 0.55 ; 95 % CI , 0.39–0.77 ) . Conclusions : Low TS or high TTF1 protein expression was significantly associated with better clinical outcomes in nonsquamous NSCLC patients who were treated with pemetrexed-based chemotherapy . The predictive role of TS or TTF1 expression should be further vali date d in a prospect i ve r and omized study BACKGROUND UFT ( tegafur + uracil ) has been reported to be effective as an adjuvant in postoperative chemotherapy for non-small cell lung cancer ( NSCLC ) in a r and omized prospect i ve study . Thymidylate synthase ( TS ) and dihydropyrimidine dehydrogenase ( DPD ) expression were investigated in resected tumors and the relationship between their expression and clinical factors in NSCLC patients was examined . PATIENTS AND METHODS Fifty-four NSCLC patients had undergone complete surgical resection and lymph node dissection , and had been administered UFT post-surgery . The TS and DPD expression in the tumor tissues was evaluated by immunohistochemical staining . The relationship between TS and /or DPD expression and clinicopathological factors was examined . RESULTS There were 38 TS-negative and 16 TS-positive cases , and 22 DPD-negative and 32 DPD-positive cases . There was no significant difference between the patients with TS \n Output:\n " }, { "from": "agent", "value": "Low TS protein expression is a favorable predictive factor for better OS/PFS in NSCLC patients treated with TS-targeted drugs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : This study investigated changes in the quality of life of men and women who participated in a primary care-based weight loss intervention program . Methods : Participants were enrolled in a 2-year r and omized clinical trial ( POWER-UP ) conducted at the University of Pennsylvania and in six affiliated primary care practice s. Inclusion criteria included the presence of obesity ( body mass index of 30–50 kg m−2 ) and at least two components of the metabolic syndrome . Main Outcome Measures : Quality of life was assessed by three measures : the Short Form Health Survey ( SF-12 ) ; the Impact of Weight on Quality of Life-Lite ; and the EuroQol-5D . Results : Six months after the onset of treatment , and with a mean weight loss of 3.9±0.3 kg , participants reported significant improvements on all measures of interest with the exception of the Mental Component Score of the SF-12 . These changes remained significantly improved from baseline to month 24 , with the exception of the EuroQol-5D . Many of these improvements were correlated with the magnitude of weight loss and , for the most part , were consistent across gender and ethnic group . Conclusions : Individuals with obesity and components of the metabolic syndrome reported significant improvements in most domains of the quality of life with a modest weight loss of 3.7 % of initial weight , which was achieved within the first 6 months of treatment . The majority of these improvements were maintained at month 24 , when participants had lost 3.0 % of their weight OBJECTIVES To investigate the relationship between cognitive performance , affective state , metabolic syndrome and 7-year follow-up self-rated health ( SRH ) and perceived life satisfaction ( PLS ) . DESIGN Analysis of a prospect i ve cohort study . SETTING The PROOF study , including 1011 elderly community residents . PARTICIPANTS Six hundred and fifty seven subjects completed metabolic syndrome ( Met S ) variables , neuropsychological and affective measurements at baseline , and then returned a 7-year follow-up question naire which included SRH and PLS . MEASUREMENTS The prospect i ve association between cognitive function , Met S and each of its components , and affective disorders and subsequent subjective health and quality of life was examined . Covariates included educational level and use of tobacco . The analyses were made in men and women separately . RESULTS In multivariate models , the presence of Met S was significantly associated to weaker SRH ( OR = 2.78 , p = 0.009 in men and OR = 2.0 , p = 0.02 in women ) . Higher triglycerides rate were associated with weaker SRH in men ( OR = 2.23 , p = 0.002 ) and higher fasting glucose in women ( OR = 2.54 , p = 0.006 ) . Global Met S and abdominal obesity was significantly associated to weaker PLS in women only ( respectively OR = 2.70 , p = 0.0002 and OR = 1.9 , p = 0.02 ) . Depressive symptoms were significantly associated to both weaker SRH and PLS in men ( OR = 1.30 , p = 0.002 ; OR = 1.44 , p < 0.0001 for SRH and PLS respectively ) and in woman ( OR = 1.09 , p = 0.04 ; OR = 1.26 , p < 0.0001 for SRH and PLS respectively ) . Anxiety was linked to both weaker SRH and PLS in women ( OR = 1.17 , p = 0.002 and 0R = 1.11 , p = 0.03 for SRH and PLS respectively ) . Finally , lower executive function was associated with weaker PLS in men ( OR = 0.43 , p = 0.0005 ) . CONCLUSION metabolic syndrome and certain of its components , anxiety and depressive symptoms , are independent predictors of poorer subjective health and quality of life as assessed over a period of 7 years in a population of a non-demented aging community . Moreover , executive performance was linked to subsequent quality of life in men . Many of these factors being treatable , our findings point to the necessity of providing preventive care strategies by the management of cardiovascular risk factors and anxio-depressive symptoms BACKGROUND Few r and omized controlled trials on lifestyle interventions have been reported in non-Western population s ; none have been reported in Arab population s. METHODS From 2 Muslim Arab communities in Israel , obese , nondiabetic women aged 35 to 54 years with 1 or more components of the metabolic syndrome were r and omized to either an intensive ( n = 100 ) or a moderate ( control ) ( n = 101 ) 12-month lifestyle intervention . Women in the intensive intervention had 11 individual and 11 group counseling sessions per year with a dietitian and 22 physical activity group sessions per year . Women in the moderate intervention had 3 individual and 2 group dietary counseling sessions per year and no guided physical activity . Cultural issues were addressed in the design and conduct of both interventions . The primary outcome measure was change in the metabolic syndrome and its components . RESULTS At 12 months , the intensive intervention group had median declines of 3.0 mg/dL ( to convert to millimoles per liter , multiply by 0.0555 ) in fasting plasma glucose and 4.5 mg/dL ( to convert to millimoles per liter , multiply by 0.0113 ) in triglyceride levels compared with median increases of 1 mg/dL in fasting plasma glucose and 5.8 mg/dL in triglyceride levels in the moderate intervention group ( P = .01 and P = .02 , respectively ) . The median waist circumference decreased by 5.4 cm in the intensive intervention group and by 3.1 cm in the moderate intervention group ( P = .10 ) . The prevalence of the metabolic syndrome decreased by 4.0 % in the intensive intervention group and increased by 5.2 % in the moderate intervention group ( P = .12 ) . CONCLUSION The 12-month culturally sensitive intensive lifestyle intervention was effective in improving some of the metabolic syndrome components in obese Arab women . Trial Registration clinical trials.gov Identifier : NCT00273572 \n Output:\n " }, { "from": "agent", "value": "Almost all studies suggested that metabolic syndrome is significantly associated with impaired quality of life .\nSome , however , found association only in women , or only if associated with depression or Body Mass Index .\nConclusion : although there are a few studies available about the relationship between metabolic syndrome and quality of life , a growing body of evidence has shown significant association between metabolic syndrome and the worsening of quality of life ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : Bronchopulmonary dysplasia ( BPD ) is the focus of many intervention trials , yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians . Thus , we wished to define BPD by a st and ardized oxygen saturation monitoring at 36 weeks corrected age , and compare this physiologic definition with the st and ard clinical definition of BPD based solely on oxygen administration . METHODOLOGY : A total of 199 consecutive very low birthweight infants ( VLBW , 501 to 1500 g birthweight ) were assessed prospect ively at 36±1 weeks corrected age . Neonates on positive pressure support or receiving > 30 % supplemental oxygen were assigned the outcome BPD . Those receiving ≤30 % oxygen underwent a stepwise 2 % reduction in supplemental oxygen to room air while under continuous observation and oxygen saturation monitoring . Outcomes of the test were “ no BPD ” ( saturations ≥88 % for 60 minutes ) or “ BPD ” ( saturation < 88 % ) . At the conclusion of the test , all infants were returned to their baseline oxygen . Safety ( apnea , bradycardia , increased oxygen use ) , inter-rater reliability , test – retest reliability , and validity of the physiologic definition vs the clinical definition were assessed . RESULTS : A total of 199 VLBW were assessed , of whom 45 ( 36 % ) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age . The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air . The physiologic definition diagnosed BPD in 30 ( 24 % ) of the cohort . All infants were safely studied . The test was highly reliable ( inter-rater reliability , κ=1.0 ; test – retest reliability , κ=0.83 ) and highly correlated with discharge home in oxygen , length of hospital stay , and hospital readmissions in the first year of life . CONCLUSIONS : The physiologic definition of BPD is safe , feasible , reliable , and valid and improves the precision of the diagnosis of BPD . This may be of benefit in future multicenter clinical trials OBJECTIVES This is a preliminary , single-center , prospect i ve study in the field of autologous cord blood transplant . We investigated the feasibility , safety , and tolerability of autologous whole cord blood transplant in extremely premature infants as a potential therapeutic modality to prevent developing complications related to prematurity . MATERIAL S AND METHODS This preliminary prospect i ve study ( Clinical Trials.gov identifier NCT02050971 ) included preterm infants born at less than 32 weeks of gestational age who developed anemia because of prematurity . Infants were assigned to 2 groups : ( 1 ) those receiving an autologous cord blood transfusion within 5 days postpartum ( n = 5 ) and ( 2 ) those who obtained only an allogeneic red blood cell transfusion when necessary ( n = 9 ; control group ) . Vital measurements were performed during and after transfusion , and peripheral blood pH , hematocrit , glucose , and calcium and potassium ion levels were measured over the next 4 days . RESULTS Oxygen saturation was significantly increased throughout the cord blood transfusion and in the subsequent 48 hours . No significant differences were found in vital measurements , such as arterial blood pressure ( mean , systolic , and diastolic ) or heart rate over the first 48 hours posttransfusion . Similarly , no significant differences were found in biochemical analyses of blood with the exception of pH level . We found initial pH level to be significantly augmented in the cord blood recipient group by the first day after transplant , which remained significantly higher for next 24 hours compared with that shown in the control group . CONCLUSIONS Collection , preparation , and short-term storage of unfrozen cord blood are feasible for clinical use . Our results showed general safety and tolerability of the procedure of whole autologous cord blood transplant in recruited preterm newborns . However , because our study group was small , these results need to be confirmed in further investigations with a larger patient cohort In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Background Mesenchymal stem cells ( MSC ) improve alveolar and vascular structures in experimental models of bronchopulmonary dysplasia ( BPD ) . Female MSC secrete more anti-inflammatory and pro-angiogenic factors as compared to male MSC . Whether the therapeutic efficacy of MSC in attenuating lung injury in an experimental model of BPD is influenced by the sex of the donor MSC or recipient is unknown . Here we tested the hypothesis that female MSC would have greater lung regenerative properties than male MSC in experimental BPD and this benefit would be more evident in males . Objective To determine whether intra-tracheal ( IT ) administration of female MSC to neonatal rats with experimental BPD has more beneficial reparative effects as compared to IT male MSC . Methods Newborn Sprague-Dawley rats exposed to normoxia ( RA ) or hyperoxia ( 85 % O2 ) from postnatal day ( P ) 2- P21 were r and omly assigned to receive male or female IT bone marrow (BM)-derived green fluorescent protein ( GFP+ ) MSC ( 1 x 106 cells/50 μl ) , or Placebo on P7 . Pulmonary hypertension ( PH ) , vascular remodeling , alveolarization , and angiogenesis were assessed at P21 . PH was determined by measuring right ventricular systolic pressure ( RVSP ) and pulmonary vascular remodeling was evaluated by quantifying the percentage of muscularized peripheral pulmonary vessels . Alveolarization was evaluated by measuring mean linear intercept ( MLI ) and radial alveolar count ( RAC ) . Angiogenesis was determined by measuring vascular density . Data are expressed as mean ± SD , and analyzed by ANOVA . Results There were no significant differences in the RA groups . Exposure to hyperoxia result ed in a decrease in vascular density and RAC , with a significant increase in MLI , RVSP , and the percentage of partially and fully muscularized pulmonary arterioles . Administration of both male and female MSC significantly improved vascular density , alveolarization , RVSP , percent of muscularized vessels and alveolarization . Interestingly , the improvement in PH and vascular remodeling was more robust in the hyperoxic rodents who received MSC from female donors . In keeping with our hypothesis , male animals receiving female MSC , had a greater improvement in vascular remodeling . This was accompanied by a more significant decrease in lung pro-inflammatory markers and a larger increase in anti-inflammatory and pro-angiogenic markers in male rodents that received female MSC . There were no significant differences in MSC engraftment among groups . Conclusions Female BM-derived MSC have greater therapeutic efficacy than male MSC in reducing neonatal hyperoxia-induced lung inflammation and vascular remodeling . Furthermore , the beneficial effects of female MSC were more pronounced in male animals . Together , these findings suggest that female MSC maybe the most potent BM-derived MSC population for lung repair in severe BPD complicated by PH Bone marrow ( BM ) and subcutaneous adipose tissue ( Ad ) are both considered being prospect i ve sources of MSC for therapeutic applications . However , functional properties and therapeutic efficacy of MSC derived from different tissues of the same patient are still poorly investigated . In our study , BM-MSC and F-MSC cultures from 43 adult donors were evaluated in successive passages for immunophenotype , secretion of VEGF , SDF1 , MCP1 , IL6 and TGFβ1 , frequency of colony-forming units ( CFU-F ) , frequency of adipo- and osteo-progenitors ( CFU-Ad , CFU-Ost ) , and for onset of in vitro replicative senescence . We have demonstrated that at early passages ( P2-P4 or up to 14 - 15 in vitro population doublings ) BM- and Ad- derived MSC cultures are comparable in such important characteristics as proliferation rate ( population doubling time : 3,4±0,2 % in BM-MSC , 3±0,3 % in F-MSC ) , clonogenity ( CFU-F frequency : 32±5 % in BM-MSC , 31±5 % in F-MSC ) , differentiation potential ( CFU-Ad frequency : 10,4±2 % in BM-MSC , 13±3 % in F-MSC ; CFU-Ost frequency : 18,5±5,5 % in BM-MSC , 18±5 % in F-MSC ) , but differ significantly in abundance of CD146 + fraction within the sample ( 25±5 % in BM-MSC , 7±3 % in F-MSC ) and in a level of VEGF , SDF-1 , MCP1 and TGFβ1 secretion . We have also demonstrated that BM-MSC enter senescence after P3 - 4 while most of F-MSC did not show senescence features up to P6 - 8 . Together , these data demonstrate that specific properties of MSC from different sources should be always taken into account , when developing and optimizing the specific protocol s for MSC expansion and evaluation for each particular clinical application OBJECTIVE To assess the safety and feasibility of allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell ( MSC ) transplantation in preterm infants . STUDY DESIGN In a phase I dose-escalation trial , we assessed the safety and feasibility of a single , intratracheal transplantation of hUCB-derived MSCs in preterm infants at high risk for bronchopulmonary dysplasia ( BPD ) . The first 3 patients were given a low dose ( 1 × 10(7 ) cells/kg ) of cells , and the next 6 patients were given a high dose ( 2 × 10(7 ) cells/kg ) . We compared their adverse outcomes , including BPD severity , with those of historical case-matched comparison group . RESULTS Intratracheal MSC transplantation was performed in 9 preterm infants , with a mean gestational age of 25.3 ± 0.9 weeks and a mean birth weight of 793 ± 127 g , at a mean of 10.4 ± 2.6 days after birth . The treatments were well tolerated , without serious adverse effects or dose-limiting toxicity attributable to the transplantation . Levels of interleukin-6 , interleukin-8 , matrix metalloproteinase-9 , tumor necrosis factor α , and transforming growth factor β1 in tracheal aspirates at day 7 were significantly reduced compared with those at baseline or at day 3 posttransplantation . BPD severity was lower in the transplant recipients , and rates of other adverse outcomes did not differ between the comparison group and transplant recipients . CONCLUSION Intratracheal transplantation of allogeneic hUCB-derived MSCs in preterm infants is safe and feasible , and warrants a larger and controlled phase II study IMPORTANCE Bronchopulmonary dysplasia ( BPD ) remains a serious morbidity in very low-birth-weight ( VLBW ) infants ( < 1500 g ) . Deregionalization of neonatal care has result ed in an increasing number of VLBW infants treated in community hospitals with unknown impact on the development of BPD . OBJECTIVE To identify individual risk factors for BPD development and hospital variation of BPD rates across all levels of neonatal intensive care units ( NICUs ) within the California Perinatal Quality Care Collaborative . DESIGN , SETTING , AND PARTICIPANTS Retrospective cohort study ( January 2007 to December 2011 ) from the California Perinatal Quality Care Collaborative including more than 90 % of California 's NICUs . Eligible VLBW infants born between 22 to 29 weeks ' gestational age . EXPOSURES Varying levels of intensive care . MAIN OUTCOMES AND MEASURES Bronchopulmonary dysplasia was defined as continuous supplemental oxygen use at 36 weeks ' postmenstrual age . A combined outcome of BPD or mortality prior to 36 weeks was used . Multivariable logistic regression accounting for hospital as a r and om effect and gestational age as a risk factor was used to assess individual risk factors for BPD . This model was applied to determine risk-adjusted rates of BPD across hospitals and assess associations between levels of care and BPD rates . RESULTS The study cohort included 15,779 infants , of which 1534 infants died prior to \n Output:\n " }, { "from": "agent", "value": "There is insufficient evidence to determine the safety and efficacy of MSCs in the treatment or prevention of BPD in premature infants ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A prospect i ve clinical trial comparing flushing and ice storage using a new hypertonic citrate solution , with machine preservation by continuous perfusion showed early graft function was similar with each method , and preservation times were comparable . Good early function occurred in half the grafts with preservation times up to 24 hours . Graft survival at three and 12 months was similar with each method of preservation . Graft survival at 12 months was worsened by poor early graft function , whereas patient survival at 12 months was unaffected by early function or by the method of preservation Outcome in eighty-eight recipients of cadaveric donor renal allografts preserved before implantation by machine perfusion with a solution of human albumin was compared to that for eighty-three recipients of similar kidneys implanted after simple cold storage . Average total ischaemic intervals for machine-perfused and cold-stored kidneys were 18 and 4 1/4 hours , respectively . Machine-perfused kidneys were implanted regardless of perfusion characteristics . Initial function and 1-month and 1-year graft survivals for the machine-perfused group ( 58 % , 85 % , 68 % , respectively ) were either similar or improved compared to those of cold-stored kidneys ( 58 % , 81 % , 52 % , respectively ) . Improved 1-year survival for machine-perfused grafts was dependent upon reduced rejection . Careful donor selection and management ensured good machine perfusion of kidneys on 90 % of occasions . In the other 10 % , despite poor perfusion characteristics , outcome for kidneys was similar to those with good perfusion characteristics . Antilymphocyte globulin treatment reduced rejection whether allografts were machine perfused or not . In the absence of antilymphocyte globulin treatment , machine-perfused kidneys did much better than cold-stored kidneys . Machine perfusion had important advantages and improved the results in kidney-graft recipients One third of deceased donor kidneys for transplantation in the UK are donated following cardiac death ( DCD ) . Such kidneys have a high rate of delayed graft function ( DGF ) following transplantation . We conducted a multicenter , r and omized controlled trial to determine whether kidney preservation using cold , pulsatile machine perfusion ( MP ) was superior to simple cold storage ( CS ) for DCD kidneys . One kidney from each DCD donor was r and omly allocated to CS , the other to MP . A sequential trial design was used with the primary endpoint being DGF , defined as the necessity for dialysis within the first 7 days following transplant . The trial was stopped when data were available for 45 pairs of kidneys . There was no difference in the incidence of DGF between kidneys assigned to MP or CS ( 58 % vs. 56 % , respectively ) , in the context of an asystolic period of 15 min and median cold ischemic times of 13.9 h for MP and 14.3 h for CS kidneys . Renal function at 3 and 12 months was similar between groups , as was graft and patient survival . For kidneys from controlled DCD donors ( with mean cold ischemic times around 14 h ) , MP offers no advantage over CS , which is cheaper and more straightforward Objective : Hypothermic machine perfusion may improve outcome after transplantation of kidneys donated after cardiac death ( DCD ) , but no sufficiently powered prospect i ve studies have been reported . Because organ shortage has led to an increased use of DCD kidneys , we aim ed to compare hypothermic machine perfusion with the current st and ard of static cold storage preservation . Methods : Eighty-two kidney pairs from consecutive , controlled DCD donors 16 years or older were included in this r and omized controlled trial in Eurotransplant . One kidney was r and omly assigned to machine perfusion and the contralateral kidney to static cold storage according to computer-generated lists created by the permuted block method . Kidneys were allocated according to st and ard rules , with concealment of the preservation method . Primary endpoint was delayed graft function ( DGF ) , defined as dialysis requirement in the first week after transplantation . All 164 recipients were followed until 1 year after transplantation . Results : Machine perfusion reduced the incidence of DGF from 69.5 % to 53.7 % ( adjusted odds ratio : 0.43 ; 95 % confidence interval 0.20–0.89 ; P = 0.025 ) . DGF was 4 days shorter in recipients of machine-perfused kidneys ( P = 0.082 ) . Machine-perfused kidneys had a higher creatinine clearance up to 1 month after transplantation ( P = 0.027 ) . One-year graft and patient survival was similar in both groups ( 93.9 % vs 95.1 % ) . Conclusions : Hypothermic machine perfusion was associated with a reduced risk of DGF and better early graft function up to 1 month after transplantation . Routine preservation of DCD kidneys by hypothermic machine perfusion is therefore advisable \n Output:\n " }, { "from": "agent", "value": "Pulsatile machine perfusion of donation after cardiac death kidneys appears to decrease the delayed graft function rate .\nWe noted no benefit in 1-year graft survival ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS Routine catheterization following vaginal prolapse surgery has advantages like prevention of postoperative retention of urine and prevention of any adverse effect on surgical outcome . However , it increases the risk of urinary tract infection ( UTI ) , prevent early ambulation and prolong hospital stay . This r and omized controlled trial was done on how best to minimize catheter related complication after prolapse surgery . METHODS 200 patients planned for vaginal prolapse surgery were recruited and r and omized into two groups . In group I and group II catheter was removed on 1(st ) and 4(th ) post operative day , respectively . After removal , if patient could not void or when residual urine volume exceeds 150 mL , recatheterisation was done for another three days . Sample of urine was sent for culture during catheter removal . RESULTS Age , parity , type of surgery and mean operation time did not differ significantly between the two groups . Mean duration of catheterization was significantly shorter ( 1.64 vs 4.09 ) and mean duration of hospital stay was shorter by 1.2 days , in first group . However a significantly higher number of retention of urine or residual urine more than 150 mL was found in the early removal group ( OR 3.10 ) but lesser chance of development of urinary tract infection ( OR 0.10 ) . CONCLUSIONS The early removal of catheter seems more advantageous , with lower incidence of urinary tract infection and a shorter hospital stay although associated with an increased risk of recatheterisation OBJECTIVE It is unclear if any catheterisation is necessary after vaginal surgery for pelvic organ prolapse . The aim of this study was to determine if indwelling catheterisation is necessary after these procedures . STUDY DESIGN A r and omised controlled trial of immediate post-operative removal of catheter compared to a suprapubic catheter ( SPC ) after vaginal prolapse surgery . In the Suprapubic group the catheter was left on free drainage until a voiding trial was commenced at 48h . Women in the immediate removal group underwent in/out catheterisation only if they had not voided by 8h after surgery to ensure the bladder did not over-distend . RESULTS 55 % ( n=17 ) of patients in the immediate removal group did not require catheterisation postoperatively . A further 13 ( 42 % ) patients only required one in/out catheterisation 8h post operatively . In the immediate removal group duration of catheterisation was significantly shorter ( median 0h , IQR 0 - 8h , range 0 - 16h ) vs ( 6days ( IQR 2 - 8days , range 2 - 19h ) p=0.001 ) . The duration of hospital stay ( 7days ( range 3 - 16 ) vs. 9 ( range 3 - 27 ) p=0.014 ) , day of first mobilisation ( Day 1 , range 0 - 2 , vs. Day 2 , range 1 - 4 , p=0.001 ) , and rate of Symptomatic bacturia ( 16 % vs. 52 % , p<0.01 ) were all significantly better with immediate catheter removal . CONCLUSIONS After vaginal surgery for pelvic organ prolapse , the majority of patients do not require extended catheterisation . Early removal of a catheter reduces urinary tract infection and significantly decreases hospital stay . Such a policy should result in improved patient satisfaction and reduced hospital costs Introduction and hypothesisThe purpose was to determine if pre-operative guided imagery ( GIM ) would help women to feel more prepared , less anxious , and have higher satisfaction scores 6 weeks after surgery compared with routine care . Methods Eligible women planning to undergo pelvic floor surgery were enrolled and r and omized . The GIM group received an institution-specific CD that uses GIM to detail day of surgery ( DOS ) events and expectations . Participants were asked to listen to the CD once daily during the week before surgery . At three time points ( surgical consent visit , DOS , and 6-weeks post-operatively ) , we measured anxiety using the State and Trait Anxiety Inventory for Adults ( STADI ) , in addition to preparedness for surgery and overall satisfaction ( ten-point Likert scales ) . Data were analyzed in SPSS 23 using two-tailed t tests . Results A total of 38 out of 44 ( 86 % ) enrolled participants completed the study ( GIM : 18 , control : 20 ) . The GIM self-reported compliance rate was 72 % , with an average use of 4.8 times ( range = 3–8 times ) . Women in the GIM group reported a significant increase from baseline in preparedness for surgery on both DOS and 6 weeks post-operatively ( 7.32 ± 1.81 vs 9.11 ± 1.13 , p = 0.001 ) and ( 7.32 ± 1.81 vs 9.22 ± 0.81 , p = 0.001 ) respectively ; a change that was not seen in the control group . Satisfaction was high in both the GIM and the control group ( 9.55 ± 0.85 and 9.05 ± 1.70 , p = 0.263 ) . In all patients , anxiety increased from baseline to DOS and dropped at 6 weeks post-operatively , and was not significantly different in the two groups . Conclusions Guided imagery improved patient preparedness for pelvic floor surgery with an overnight stay on their DOS and 6 weeks post-operatively Introduction and hypothesisThe aim of this study was to compare the number of temporary catheter replacements and urinary tract infections after indwelling catheterization for 2 versus 5 days following an anterior colporrhaphy . Methods Two hundred forty-six patients were r and omly assigned to 2 or 5 days of indwelling catheterization . Outcome measures were temporary catheter replacements because of post-voiding residual > 200 mL after removal of the indwelling catheter , urinary tract infections , and hospital stay . All patients were analyzed according to the intention to treat principle . Results Compared to the 5-day protocol group , in the 2-day protocol group more patients needed temporary catheter replacement ( 9 % versus 28 % , odds ratio ( OR ) 4.0 , confidence interval ( CI ) 1.9–8.3 , p < 0.01 ) , whereas less patients had a urinary tract infection ( 37 % versus 22 % , OR 0.5 , CI 0.3–0.9 , p = 0.02 ) and median hospital stay was lower . Conclusions Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements , but less urinary tract infections and a shorter hospital stay Introduction and hypothesisThere is evidence that in nonsurgical population s , pelvic floor muscle training ( PFMT ) and lifestyle advice improves symptoms and stage of pelvic organ prolapse ( POP ) . Some women , however , require surgery , after which de novo symptoms can develop or additional surgery is required due to recurrence . Robust evidence is required as to the benefit of perioperative PFMT in the postsurgery reduction of symptoms and POP recurrence . The aim of this study was to assess the feasibility of and collect pilot data to inform sample size ( SS ) calculation for a multicentre r and omised controlled trial ( RCT ) of perioperative PFMT following surgical intervention for POP . Methods Fifty-seven participants were recruited and r and omised to a treatment group ( one pre and six postoperative PFMT sessions ) or a control group ( usual care ) . The primary outcome measure was the Pelvic Organ Prolapse Symptom Score ( POP-SS ) at 12 months ; secondary outcome measures included measurement of prolapse , the pelvic floor and question naires relating to urinary and bowel incontinence . All outcomes were measured at 0 , 6 and 12 months . Results Information on recruitment , retention and appropriateness of outcome measures for a definitive trial was gathered , and data enabled us to undertake an SS calculation . When compared with the control group ( n = 29 ) , benefits to the intervention group ( n = 28 ) were observed in terms of fewer prolapse symptoms at 12 months [ mean difference 3.94 ; 95 % confidence interval ( CI ) 1.35–6.75 ; t = 3.24 , p = 0.006 ] ; however , these results must be viewed with caution due to possible selection bias . Conclusion With modifications to design identified in this pilot study , a multicentre RCT is feasible Objective To evaluate the use and effect of early administration of vaginal estrogen via a continuous low-dose estradiol vaginal ring placed immediately after pelvic reconstructive surgery . Methods This was a r and omized controlled trial of 65 postmenopausal women undergoing vaginal reconstructive surgery . The subjects were r and omly assigned to receive an estradiol-releasing vaginal ring , placebo vaginal ring , or control without vaginal ring for 12 weeks immediately after vaginal reconstructive surgery . The primary outcome was tissue quality based on vaginal maturation 3 months postoperatively . Secondary outcome measures were subjective and objective signs of atrophy ; vaginal pH ; the presence of granulation tissue , microscopic inflammation , and major healing abnormalities ; and the ability to tolerate an intravaginal ring . Results At 12 weeks , the estradiol ring group had a significantly improved maturation value ( P<0.01 ) and objective atrophy assessment ( P<0.01 ) compared with the placebo ring and control arms . Granulation tissue was increased in the placebo ring arm ( P<0.01 ) . Subjective atrophy scores did not differ among the groups ( P=0.39 ) . Conclusions Early administration of vaginal estrogen after vaginal surgery via an estradiol-releasing ring is feasible and results in improved markers of tissue quality postoperatively compared to placebo and controls OBJECTIVE : To compare surgeons ' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients ' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery . METHODS : In this single-blind , r and omized trial , women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block r and omization to an intervention or control group . Surgeons were blinded to patient allocation . One day before surgery , mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas ; the participants in the control group sustained a regular diet and nothing by mouth after midnight . The primary outcome was surgeons ' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale ( 1 , excellent ; 4 , poor ) . Secondary outcomes included participant satisfaction and bowel symptoms . The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol . RESULTS : Of the 150 women r and omized ( 75 women to intervention and control group ) , 145 completed the study . No differences existed in the demographic , clinical , and intraoperative characteristics between groups ( P>.05 ) . Surgeons ' intraoperative assessment rating was 85 % “ excellent or good ” with bowel preparation compared with 90 % for participants in the control group ( odds ratio [ OR ] 0.59 , 95 % confidence interval [ CI ] 0.21–1.61 ; P=.30 ) . The bowel preparation group was less likely to report “ complete ” satisfaction compared with the participants in the control group ( OR 0.11 , 95 % CI 0.04–0.35 ; P<.001 ) . Abdominal fullness and cramping , fatigue , anal irritation , and hunger pains were greater in the bowel preparation group ( all P<.01 ) . CONCLUSION : Before reconstructive vaginal surgery , mechanical bowel preparation conferred no benefit regarding surgeons ' intraoperative assessment of the operative field , reflected decreased patient satisfaction , and had increased abdominal symptoms . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT01431040 . LEVEL OF EVIDENCE : Introduction and hypothesisHydrodissection incorporating different types of vasoconstrictors is commonly used in vaginal prolapse surgery . There is little evidence as to whether it adds clinical value or whether it exposes the patient to unnecessary risk . The aim of this study was to compare the effect of a vasoconstrictor compared with saline alone on operative blood loss and cardiovascular parameters in a r and omised clinical trial setting . Methods Patients undergoing vaginal prolapse surgery were r and omised to an ornipressin ( Por-8 , Ferring ) solution or saline alone for hydrodissection . The surgeon and patient were blinded to the solution used . Operative blood loss was accurately quantified and blood pressure and pulse readings recorded Pre , intra- and postoperatively . Results Eighty women were r and omised . There was a statistically significant difference in the median blood loss : 35 ml ( 1 - 209 ml ) in the ornipressin group compared with 81 ml ( 2 - 328 ml ) in the saline group , p = 0.03 . There was no statistically significant difference in the median pre and postoperative blood pressure or pulse rate between groups . Conclusions The use of a vasoconstrictor ( ornipressin ) result ed in a statistically significant decrease in operative blood loss during vaginal prolapse surgery . This occurred without any significant changes in measured cardiovascular parameters INTRODUCTION This assessor-blinded r and omized controlled trial investigated the effect of a pre- and post-operative physiotherapy-supervised pelvic floor muscle ( PFM ) training program in women \n Output:\n " }, { "from": "agent", "value": "With regard to other interventions ( preoperative bowel preparation and injection of vasoconstrictor agent , ureteral stent placement during uterosacral ligament suspension , postoperative vaginal pack insertion , use of vaginal dilators , prophylactic antibiotics for postoperative catheter care ) , we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinical ly meaningful reductions in adverse effects , such as intraoperative or postoperative blood transfusion , intraoperative ureteral injury , or postoperative urinary tract infection" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences BACKGROUND : Surgical site infiltration and transversus abdominis plane ( TAP ) blocks are commonly used to improve pain relief after lower abdominal surgery . This r and omized , observer-blinded study was design ed to compare the analgesic efficacy of TAP blocks with surgical site infiltration in patients undergoing open total abdominal hysterectomy via a Pfannenstiel incision . METHODS : Patients were r and omized to receive either bilateral ultrasound-guided TAP blocks using bupivacaine 0.5 % 20 mL on each side ( n = 30 ) or surgical site infiltration with liposomal bupivacaine 266 mg diluted to 60 mL injected in the preperitoneal , subfascial , and subcutaneous planes ( n = 30 ) . The remaining aspects of the perioperative care were st and ardized . An investigator blinded to the group allocation documented pain scores at rest and with coughing , opioid requirements , nausea , vomiting , and rescue antiemetics in the postanesthesia care unit and at 2 , 6 , 12 , 24 , and 48 hours postoperatively . The primary outcome measure was pain scores on coughing at 6 hours postoperatively . RESULTS : One patient in each group was excluded from the analysis because of reoperation within 24 hours in the TAP block group and change of incision type in the infiltration group . The pain scores at rest and with coughing were significantly lower in the surgical site infiltration group at all postoperative time points ( P < 0.0001 ) except at rest in the postanesthesia care unit . The opioid requirements between 24 and 48 hours were significantly lower in the infiltration group ( P = 0.009 ) . The nausea scores , occurrence of vomiting , and need for rescue antiemetics were similar . CONCLUSIONS : Surgical site infiltration provided superior pain relief at rest and on coughing , as well as reduced opioid consumption for up to 48 hours . Future studies need to compare TAP blocks with liposomal bupivacaine with surgical site infiltration with liposomal bupivacaine Background Liposome bupivacaine ( Exparel ) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia . This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks . Methods Data from 6 controlled ( phases I-III ) studies were compiled involving single-injection ankle , femoral nerve , and intercostal nerve blocks ( 2 each ) . Adverse events ( AEs ) were monitored for 1 to 30 days after study drug administration . Results Of 575 subjects , 335 received liposome bupivacaine ( 2–310 mg ) , 33 received bupivacaine HCl ( 75–125 mg ) , and 207 received normal saline ( placebo ) . Overall , 76 % of subjects receiving liposome bupivacaine experienced 1 or more AEs compared with 61 % receiving bupivacaine HCl and 76 % receiving placebo . The most frequently reported AEs among subjects receiving liposome bupivacaine were nausea , pyrexia , pruritus , constipation , and vomiting . The most common treatment-related AE was hypesthesia among subjects treated with liposome bupivacaine or bupivacaine HCl . Incidence of nervous system AEs for liposome bupivacaine , bupivacaine HCl , and placebo was 21 % , 27 % , and 21 % , respectively . Similarly , incidence of cardiac AEs was 9 % , 0 % , and 12 % , respectively . At least 1 serious AE occurred in 8 % of subjects receiving liposome bupivacaine compared with 10 % of those receiving placebo ( none assessed by investigators as related to study medication ) . Conclusions Liposome bupivacaine has a similar safety and side effect profile to bupivacaine HCl and normal saline , suggesting that most of the more common AEs are related to either opioid rescue or the surgical procedure itself STUDY OBJECTIVES To explore the influence of liposomes on the pharmacodynamic action of bupivacaine and to determine whether postsurgical analgesic advantages can be obtained from epidural delivery of liposomal bupivacaine compared with the current formulation . DESIGN Open , nonr and omized study . SETTING Physiopathology laboratory , general operating theaters , and intensive care units of Reine Fabiola Hospital and Institut Médical de Traumatologie et Revalidation . PATIENTS 26 ASA physical status II and III patients who had undergone major surgery ( abdominal , vascular , urologic , thoracic , orthopedic ) . INTERVENTIONS After completion of the operation , the patients were divided into 2 groups to receive 1 of 2 bupivacaine preparations epidurally for postsurgical pain : Group 1 ( n = 12 ) received plain 0.5 % bupivacaine with 1:200,000 epinephrine ; Group 2 ( n = 14 ) received liposomal 0.5 % bupivacaine . MEASUREMENTS AND MAIN RESULTS The following observations were made : onset and quality of analgesia , quality of motor block according to the Bromage scale , and sympathetic block . Onset time of sensory block averaged 15 minutes in both groups . Pain relief duration s were 3.2 + /- 0.4 hours with plain bupivacaine and 6.25 + /- 1.13 hours with the liposomal preparation ( p < 0.05 ) . In the liposomal bupivacaine group , no motor block was recorded . Low sympathetic block occurred in all patients . Analgesia in a subset of patients following abdominal aortic surgery increased from 2.4 + /- 0.35 hours to 10.6 + /- 1.4 hours by encapsulation of bupivacaine ( p < 0.01 ) . There was no neurotoxicity or cardiotoxicity . CONCLUSIONS The liposomal formulation of bupivacaine increased duration of analgesia without motor block or adverse side effects INTRODUCTION Optimal pain control after major surgery contributes to a patient 's recovery and satisfaction . The use of liposomal bupivacaine in subcostal transversus abdominis plane ( TAP ) blocks for postoperative pain control after robot assisted abdominal surgery has yet to be studied . METHODS We conducted a prospect i ve r and omized controlled observer-blinded study comparing bilateral subcostal TAP blocks with bupivacaine to bilateral subcostal TAP blocks with liposomal bupivacaine . These were performed prior to the patient undergoing robot assisted hysterectomy . The patients ' pain scores , opioid use , side effects , and satisfaction were followed for 72h after injection . RESULTS Total opioid use in the first 72h after injection was significantly decreased in the group that received liposomal bupivacaine compared to bupivacaine . Patients in the liposomal bupivacaine group had significantly lower maximal pain scores at all time periods studied as well as decreased incidence of nausea/vomiting . There was a trend toward decreased length of stay in the liposomal bupivacaine group . CONCLUSION Subcostal TAP blocks with liposomal bupivacaine decreased the total opioid requirement for the first 72h after robot assisted hysterectomy when compared to subcostal TAP blocks with bupivacaine \n Output:\n " }, { "from": "agent", "value": "A lack of evidence has prevented an assessment of the efficacy of liposomal bupivacaine administered as a peripheral nerve block .\nAt present there is a lack of data to support or refute the use of liposomal bupivacaine administered as a peripheral nerve block for the management of postoperative pain ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND We have previously demonstrated that fluorodeoxyglucose-positron emission tomography ( FDG-PET ) can assess extent of pathologic response of primary rectal cancer to preoperative chemoradiation . Our goal was to determine the prognostic significance of FDG-PET assessment of rectal cancer response to preoperative chemoradiation . STUDY DESIGN Fifteen patients with locally advanced primary rectal cancer ( clinical ly bulky or tethered , or ultrasound evidence of T3 - 4 disease , N1 disease , or both ) deemed eligible for preoperative radiation and 5-FU-based chemotherapy ( 5,040 cGy to the pelvis and 2 cycles of bolus 5-FU/leucovorin ) were prospect ively enrolled from May 1997 to September 1998 . FDG-PET was performed before and 4 to 5 weeks after completion of preoperative chemoradiation . FDG-PET parameters included maximum st and ard uptake value ( SUV(max ) ) , total lesion glycolysis ( TLG ) , and visual response score . Patients were prospect ively followed after operation , and disease status was determined . RESULTS All patients demonstrated some degree of response to preoperative therapy based on pathologic examination . At a median followup of 42 months ( range 23 to 54 months ) , 11 patients had no evidence of disease and 4 had died of disease . The mean percentage decrease in SUV(max ) ( DeltaSUV(max ) ) was 69 % for patients free from recurrence and 37 % for patients with recurrence ( p = 0.004 ) . DeltaSUV(max ) > or= 62.5 and deltaTLG > or= 69.5 were the best predictors of no- evidence -of-disease status and freedom from recurrence . Patients with DeltaSUV(max ) > or= 62.5 and deltaTLG > or= 69.5 had significantly improved disease-specific and recurrence-free survival ( p = 0.08 , 0.02 and p = 0.03 , 0.01 , respectively ) . CONCLUSIONS Our results indicate that FDG-PET assessment of locally-advanced rectal cancer response to preoperative chemoradiation may predict longterm outcomes PURPOSE Changes in F-18 fluorodeoxyglucose ( FDG ) uptake in normal tissues after chemoradiation therapy ( CRT ) potentially limit the ability of positron emission tomography ( PET ) to provide early assessment of therapeutic response . This study evaluated whether such changes negatively impact interpretation of posttherapy PET performed within 6 weeks of CRT completion and before definitive surgery in patients with locally advanced rectal cancer . The positive predictive value ( PPV ) and specificity of post-CRT PET , read clinical ly , was determined in 63 consecutive rectal cancer patients who had undergone preoperative CRT . METHODS AND MATERIAL S A schema for identifying and scoring postradiation effects on PET was prospect ively defined and applied in a blinded manner . This was compared with initial clinical reporting of response . Histologic assessment of the operative specimens was used as the reference st and ard . Correlation between clinical proctitis during CRT and radiation changes on subsequent PET was also assessed . RESULTS Clinical reporting of post-CRT PET yielded a high PPV ( 94 % ; 95 % confidence interval , 89 - -100 % ) but may have been exaggerated by the low prevalence of complete tumor clearance ( 16 % ) . The specificity was 80 % with only two false-positive results . On blinded reading , significant post-CRT effects on PET were recorded in 4 of 63 patients ( 6 % 95 % confidence interval , 0 - 13 % ) , but pattern recognition converted both false-positive PET results to a complete metabolic response . Clinical CRT proctitis was not correlated with PET findings . CONCLUSION Postradiation effects do not appear to significantly compromise the interpretation of PET for therapeutic response assessment . The proposed PET pattern of response may further improve the specificity of PET In the management of rectal cancer after the combined therapy of the radiation and surgical operation , the evaluation of the prognosis is important . Although fluoro-18-deoxy glucose positron emission tomography ( FDG-PET ) is considered as a useful tool for evaluation of therapeutic effect of this cancer as well as the other cancers , however , there are few articles that clearly describe the appropriate procedure of the FDG-PET in order to obtain the best prognostic value . The purpose of the present study is to compare several variations of a semi-quantification method , the St and ardized Uptake Values ( SUV ) and to determine the most appropriate parameter for the prognostic prediction and to propose the quantitative guideline of the FDG-PET . Especially , the authors focused on the SUV after radiotherapy , which had not been considered as a key quantitative value , as it was rather taken as a mere indicator of the therapeutic ( radiotherapeutic ) effect , not a direct indicator of the prognosis for the cancer itself . Methods : Forty patients with rectal cancer in the lower rectal region underwent two series of FDG-PET study before and after pre-operative radiotherapy . Their SUVs were calculated from FDG-PET data and compared with the results of the long-term follow-up of the patients as well as with histopathological outcomes . Results : All 40 patients had high FDG uptake before radiotherapy . The mean value of SUV before radiotherapy ( SUV1 ) was 7.6 . After radiotherapy , the mean value of SUV ( SUV2 ) decreased to 4.2 . There was a significant difference in SUV2 between the groups with and without recurrence ( p<0.05 ) , however , SUV1 or SUV ratio ( SUV2/SUV1 ) displayed no significant difference with the incidence of recurrence . Conclusion : SUV2 was considered to be a good prognostic indicator for long-term prognosis of rectal cancer patients . SUV1 nor SUV ratio SUV2/SUV1 did not have the equivalent prognostic usefulness . Subsets of patients with SUV2 greater than 3.2 should be observed closely PURPOSE To quantify the influence of fluctuating blood glucose level ( BGLs ) and the timing of PET acquisition on PET-based predictions of the pathological treatment response in rectal cancer . MATERIAL AND METHODS Thirty patients , diagnosed with locally advanced-rectal-cancer ( LARC ) , were included in this prospect i ve study . Sequential FDG-PET-CT investigations were performed at four time points during and after pre-operative radiochemotherapy ( RCT ) . All PET- data were normalized for the BGL measured shortly before FDG injection . The metabolic treatment response of the tumor was correlated with the pathological treatment response . RESULTS During RCT , strong intra-patient BGL-fluctuations were observed , ranging from -38.7 to 95.6 % . BGL-normalization of the SUVs revealed differences ranging from -54.7 to 34.7 % ( p < 0.001 ) . Also , a SUV(max ) time-dependency of 1.30 + /- 0.66 every 10 min ( range : 0.39 - 2.58 ) was found during the first 60 min of acquisition . When correlating the percent reduction of SUV(max ) after 2 weeks of RCT with the pathological treatment response , a significant increase ( p = 0.027 ) in the area under the curve of ROC-curve analysis was found when normalizing the PET- data for the measured BGLs , indicating an increase of the predictive strength . CONCLUSIONS This study strongly underlines the necessity of BGL-normalization of PET- data and a precise time-management between FDG injection and the start of PET acquisition when using sequential FDG-PET-CT imaging for the prediction of pathological treatment response UNLABELLED 18F-FDG PET is a useful tool for assessing the effects of chemo- or radiotherapy . The aim of this study was to correlate the change in tumor 18F-FDG st and ardized uptake value ( SUV ) during and after preoperative radiochemotherapy , with the pathologic response achieved in locally advanced rectal cancer ( LARC ) patients . METHODS Thirty-three patients with LARC underwent total mesorectal excision after preoperative treatment , including 3 cycles of oxaliplatin , raltitrexed , 5-fluorouracil , and folinic acid during pelvic radiotherapy ( 45 Gy ) . Staging procedures included endoscopic ultrasound , MRI , and CT . 18F-FDG PET scans were performed at baseline and 12 d after starting radiochemotherapy ( intermediate ) in all patients . Seventeen patients also had a presurgical scan . For each scan , mean and maximum SUVs were measured . The percentages of SUV decrease from baseline to intermediate ( early change ) and to presurgical scan ( overall change ) were assessed and correlated with pathologic response classified as tumor regression grade ( TRG ) . RESULTS Eighteen tumors ( 55 % ) showed complete ( TRG1 ) or subtotal regression ( TRG2 ) and were classified as responders , whereas 15 cases ( 45 % ; TRG3 or TRG4 ) were considered nonresponders . The early median decrease of tumor SUV significantly differed between responders ( -62 % ; range , -44 % to -100 % ) and nonresponders ( -22 % ; range , -2 % to -48 % ) . A significant correlation was also found between TRGs and early SUV changes ( P < 0.0001 ) . Responders were identified correctly by an early decrease of the mean SUV of > or = 52 % . CONCLUSION This study shows that early 18F-FDG PET can predict pathologic response to preoperative treatment . These findings support the usefulness of (18)F-FDG PET during the management with radiochemotherapy of LARC patients Accurate response assessment after neoadjuvant therapy is essential in patients with rectal cancer . The aim of this study was to assess the value of fluorine-18 fluorodeoxyglucose positron emission tomography ( FDG-PET ) in predicting response of locally advanced rectal cancer to preoperative multimodal treatment . Twenty-two consecutive patients with locally advanced ( uT3/4 ) primary rectal cancer were entered in this prospect i ve pilot study . FDG-PET was performed before and after neoadjuvant radiochemotherapy ( RCT ) with combined regional hyperthermia ( RHT ) . Treatment consisted of external-beam radiotherapy ( 45 Gy ) , chemotherapy ( folinic acid and 5-fluorouracil ) and regional pelvic hyperthermia followed by curative tumour resection 6–8 weeks later . Semi-quantitative measurements ( SUV ) of tumour FDG uptake were made before and 2–4 weeks after completion of neoadjuvant treatment . Two patients who did not receive post-therapeutic restaging by FDG-PET were excluded from the analysis . Results were correlated with findings on endorectal ultrasound ( EUS , n=17 patients ) and histopathology . Histopathological evaluation of the resected tumour revealed complete response in one patient , partial response in 12 and stable disease in seven . SUV reduction in tumours was significantly greater in responders than in non-responders [ 60 % ( ±15 % ) vs 30 % ( ±18 % ) , P=0.003 , CI=95 % ) . Using a minimum post-therapeutic SUV reduction of 36 % to define response , FDG-PET revealed a sensitivity of 100 % ( EUS : 33 % ) and a specificity of 86 % ( EUS : 80 % ) in response prediction ; the corresponding positive and negative predictive values were 93 % ( EUS : 80 % ) and 100 % ( EUS : 33 % ) , respectively . FDG-PET results were statistically significant ( P<0.001 , CI=95 % ) . FDG-PET has great potential in the assessment of tumour response to neoadjuvant RCT in combination with RHT and is superior to EUS for this purpose PURPOSE To develop a positron emission tomography (PET)-based response prediction model to differentiate pathological responders from nonresponders . The predictive strength of the model was vali date d in a second patient group , treated and imaged identical to the patients on which the predictive model was based . METHODS AND MATERIAL S Fifty-one rectal cancer patients were prospect ively included in this study . All patients underwent fluorodeoxyglucose ( FDG ) PET-computed tomography ( CT ) imaging both before the start of chemoradiotherapy ( CRT ) and after 2 weeks of treatment . Preoperative treatment with CRT was followed by a total mesorectal excision . From the resected specimen , the tumor regression grade ( TRG ) was scored according to the M and ard criteria . From one patient group ( n = 30 ) , the metabolic treatment response was correlated with the pathological treatment response , result ing in a receiver operating characteristic ( ROC ) curve based cutoff value for the reduction of maximum st and ardized uptake value ( SUV(max ) ) within the tumor to differentiate pathological responders ( TRG 1 - 2 ) from nonresponders ( TRG 3 - 5 ) . The applicability of the selected cutoff value for new patients was vali date d in a second patient group ( n = 21 ) . RESULTS When correlating the metabolic and pathological treatment response for the first patient group using ROC curve analysis ( area under the curve = 0.98 ) , a cutoff value of 48 % SUV(max ) reduction was selected to differentiate pathological responders from nonresponders ( specificity of 100 % , sensitivity of 6 \n Output:\n " }, { "from": "agent", "value": "Based on the subgroup analyses , there was no significant difference between the response index , the st and ardized uptake value and the visual response score in predicting the therapy response .\nTherefore , FDG-PET is valuable for predicting the response of rectal carcinoma to neo-adjuvant therapy , and early evaluation of response during the therapy may be more promising ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The mechanisms of paraneoplastic thrombocytosis in ovarian cancer and the role that platelets play in abetting cancer growth are unclear . METHODS We analyzed clinical data on 619 patients with epithelial ovarian cancer to test associations between platelet counts and disease outcome . Human sample s and mouse models of epithelial ovarian cancer were used to explore the underlying mechanisms of paraneoplastic thrombocytosis . The effects of platelets on tumor growth and angiogenesis were ascertained . RESULTS Thrombocytosis was significantly associated with advanced disease and shortened survival . Plasma levels of thrombopoietin and interleukin-6 were significantly elevated in patients who had thrombocytosis as compared with those who did not . In mouse models , increased hepatic thrombopoietin synthesis in response to tumor-derived interleukin-6 was an underlying mechanism of paraneoplastic thrombocytosis . Tumor-derived interleukin-6 and hepatic thrombopoietin were also linked to thrombocytosis in patients . Silencing thrombopoietin and interleukin-6 abrogated thrombocytosis in tumor-bearing mice . Anti-interleukin-6 antibody treatment significantly reduced platelet counts in tumor-bearing mice and in patients with epithelial ovarian cancer . In addition , neutralizing interleukin-6 significantly enhanced the therapeutic efficacy of paclitaxel in mouse models of epithelial ovarian cancer . The use of an antiplatelet antibody to halve platelet counts in tumor-bearing mice significantly reduced tumor growth and angiogenesis . CONCLUSIONS These findings support the existence of a paracrine circuit wherein increased production of thrombopoietic cytokines in tumor and host tissue leads to paraneoplastic thrombocytosis , which fuels tumor growth . We speculate that countering paraneoplastic thrombocytosis either directly or indirectly by targeting these cytokines may have therapeutic potential . ( Funded by the National Cancer Institute and others . ) PURPOSE This study attempted to determine the prognostic value for survival of various pretreatment characteristics in patients with nonresectable non-small-cell lung cancer in the context of more than 10 years of experience of a European Cooperative Group . PATIENTS AND METHODS We included in the analysis all eligible patients ( N = 1,052 ) with advanced non-small-cell lung cancer registered onto one of seven trials conducted by the European Lung Cancer Working Party ( ELCWP ) during one decade . The patients were treated by chemotherapy regimens based on platinum derivatives . We prospect ively collected 23 variables and analyzed them by univariate and multivariate methods . RESULTS The global estimated median survival time was 29 weeks , with a 95 % confidence interval of 27 to 30 weeks . After univariate analysis , we applied two multivariate statistical techniques . In a Cox regression model , the selected explanatory variables were disease extent , Karnofsky performance status , WBC and neutrophil counts , metastatic involvement of skin , serum calcium level , age , and sex . These results were confirmed by application of recursive partitioning and amalgamation algorithms ( RECPAM ) , which led to classification of the patients into four homogeneous subgroups . CONCLUSION We confirmed by our analysis the role of well-known independent prognostic factors for survival , but also identified the effect of the neutrophil count , rarely studied , with the use of two methods : a classical Cox regression model and a RECPAM analysis . The classification of patients into the four subgroups we obtained needs to be vali date d in other series We have evaluated the prognostic value of 22 pretreatment attributes in 436 small cell lung cancer ( SCLC ) patients included in a prospect i ve multicenter study with a minimum 5-year follow-up . Pretreatment clinical and laboratory parameters were registered . Possible prognostic factors were evaluated by univariate analysis ( log rank test ) and by the Cox multivariate regression model . In the univariate analysis of all patients , only age , nodal metastasis , and skin metastasis were not associated with survival . The multivariate Cox model identified gender , extent of disease , performance status ( PS ) , weight loss , platelet count , LDH , and NSE as independent prognostic factors . In subset multivariate analyses according to extent of disease , we found haemoglobin level , PS , NSE , and total WBC as significant prognostic indicators for survival in limited-stage disease ( LD-SCLC ) , while PS , weight loss , LDH , number of metastases , liver metastases , and brain metastases were identified as independent prognostic factors in extensive-stage disease ( ED-SCLC ) . There was a significant correlation between serum LDH and NSE levels . In conclusion , gender , extent of disease , PS , weight loss , haemoglobin , WBC count , platelet count , LDH , and NSE were all found to be independent prognostic factors for SCLC survival . However , the prognostic value of these factors depends highly on whether all or subsets of SCLC patients are studied There is a sub clinical activation of coagulation and fibrinolysis system in lung cancer . Alterations in hemostatic system are seen frequently in lung cancer correlated with the prognosis of disease . In this prospect i ve study , our purpose was to investigate the prognostic significance of hemostatic markers in patients with lung cancer . The study comprised 58 patients ( 22 squamous cell carcinoma , 16 adenocarcinoma , 20 small cell carcinoma ) . There were 55 men ( 95 % ) and 3 women ( 5 % ) with a mean age of 61 years range ( 36 - 74 ) . Plasma level of platelets ( PLT ) , prothrombin time ( PT ) , active partial thromboplastin time ( aPTT ) , antithrombin III ( AT III ) , fibrinogen ( F ) and D-dimer level were measured before the initiation of any therapy . Patients were followed up for 17 ( 12 - 20 ) months . The median survival was determined as 6.4 months . Three histopathologic groups ; squamous cell carcinoma , adenocarcinoma and small cell carcinoma were compared for the hemostatic parameters . There were no statistically significant differences among the histopathologic types for any of the parameters ( P > 0.05 ) . Patients were divided into two groups as patients without distant metastasis ( stages I , II , III ) and with distant metastasis ( stage IV ) . The group with distant metastasis had higher level of D-dimer than the other group ( P < 0.05 ) . However , there were no statistically significant differences for D-dimer level between stages IIIB and IV ( P > 0.05 ) . Patients having high D-dimer and low AT III level had poor survival in our study . Thus , high level of D-dimer and low AT III level were determined as correlated with short survival ( P < 0.05 ) . These results suggest that elevated plasma level of D-dimer and low AT III level might be a sign of poor prognosis in patients with lung cancer INTRODUCTION FRAME was a prospect i ve observational study that captured real-world data on patients with advanced or metastatic non-small cell lung cancer ( NSCLC ) receiving platinum-based chemotherapies as first-line treatment ( FLT ) across Europe . As previously reported , most patients observed in the study had initiated FLT with either pemetrexed , gemcitabine , vinorelbine or taxanes in combination with a platinum . Baseline patient and disease characteristics including age , performance status , and histology varied ( all p<0.01 ) across cohorts . METHODS Consenting adult patients initiating FLT for advanced or metastatic NSCLC with platinum-based chemotherapy , with or without a targeted agent , entered the study between April 2009 and February 2011 . The choice of FLT was left to physicians ' discretion per routine clinical practice . The primary objective was to evaluate overall survival ( OS ) across platinum-based doublet chemotherapy cohorts and key secondary objectives included the evaluation of OS in patients with different histological subtypes of NSCLC . Survival outcomes were assessed using Kaplan-Meier analysis , and unadjusted estimates are presented . RESULTS Median OS in months was 10.3 across cohorts ( n=1524 ) , 10.7 for pemetrexed ( n=569 ) , 10.0 for gemcitabine ( n=360 ) , 9.1 for taxanes ( n=295 ) , and 10.7 for vinorelbine ( n=300 ) . For patients with non-squamous NSCLC who received cisplatin ( n=616 , 40 % of total ) , median OS in months was 10.6 across the cohorts , 11.6 for pemetrexed , 8.4 for gemcitabine , 9.6 for taxanes , and 9.9 for vinorelbine . CONCLUSIONS FRAME describes real-world treatment patterns and survival for patients initiating FLT for advanced or metastatic NSCLC between 2009 and 2011 across Europe Background : The aim of the present study was to investigate any prognostic value of pre-treatment anemia , leukocytosis and thrombocytosis in patients with advanced pretreated NSCLC . Methods : A r and omized , multicenter phase II study comparing the IGF-1R modulator AXL with st and ard docetaxel in the treatment of previously treated stage IIIB or IV NSCLC patients was conducted in 2011 - 2013 . Clinical and laboratory data were collected , including serum values for hemoglobin ( Hgb ) , white blood cells ( WBC ) and platelets ( Plt ) at baseline . These hematological parameters were studied in relation to overall survival using Kaplan – Meier product-limit estimates and multivariate Cox proportional hazards regression models . Results : The median overall survival for all patients was 8.9 months . Patients with leukocytosis ( WBC > 9 x 109/L ) had a significantly shorter median overall survival ( 4.2 months ) as compared with those with a WBC ≤ 9 x 109/L at baseline ( 12.3 months ) with a corresponding of HR 2.10 ( 95 % CI : 1.29 - 3.43 ) . Patients with anemia ( Hgb < 110 g/L ) had a non-significant ( p = 0.097 ) shorter median overall survival ( 6.1 months ) as compared with their counterparts with Hgb ≥ 110 g/L at baseline ( 9.4 months ) . As for thrombocytosis ( Plt > 350 x 109/L ) , there was no statistically significant impact on overall survival . Leukocytosis retained its prognostic significance in a multivariate model where other clinical factors such as age , sex and WHO performance status were taken into consideration ( HR : 1.83 , 95 % CI : 1.06 - 3.13 , p = 0.029 ) . Conclusion : Pre-treatment leukocytosis is a strong and independent prognostic marker for shorter overall survival in previously treated stage IIIB or IV NSCLC patients receiving docetaxel or AXL1717 . Combined use of pre-treatment leukocytosis assessment s together with established prognostic factors such as performance status could be of help when making treatment decisions in this clinical setting AIMS An elevated plasma D-dimer level indicates the activation of coagulation and fibrinolysis . In the present study , we investigated the association of pre-treatment haemostatic parameters ( D-dimer , fibrinogen and prothrombin fragment 1 + 2 ) with clinicopathological parameters and outcome in patients with lung cancer . MATERIAL S AND METHODS Plasma levels of D-dimer and other parameters were measured in 78 evaluable patients with lung cancer ( 60 non-small cell lung cancers , 18 small cell lung cancers ) . At diagnosis , 35 patients ( 44.9 % ) were locally advanced stage ( IIIA/B ) and 43 patients ( 55.1 % ) had metastatic disease ( IV ) . Multivariate statistical analysis was carried out using Cox 's proportional hazards model . The receiver operating characteristic curve was used to determine the cut-off values for D-dimer , fibrinogen and prothrombin fragment 1 + 2 . RESULTS The median survival for all patients was 264 days ( 95 % confidence interval 200 - 328 days ) . A significant association between the plasma levels of D-dimer and the response to chemotherapy was observed ( P=0.03 ) . With the univariate analysis , tumour stage , pre-treatment plasma levels of D-dimer , fibrinogen , platelet count , lactate dehydrogenase concentration and Karnofsky performance status were predictive for survival . With the multivariate analysis ( P < or = 0.1 ) , the plasma level of D-dimer ( P<0.001 ) , tumour stage ( P=0.01 ) and Karnofsky performance status ( P=0.02 ) were identified as independent predictive factors . The median survival times were 405 days ( 95 % confidence interval 165 - 644 days ) and 207 days ( 95 % confidence interval 146 - 267 days , P<0.001 ) , respectively , for patients with a low D-dimer level ( < or = 0.65 microg/ml ) and a high D-dimer level ( > 0.65 microg/ml ) . CONCLUSIONS Elevated plasma levels of D-dimer in patients with lung cancer are associated with decreased survival and a poor response to treatment . Pre-treatment for the D-dimer level may be useful in the prediction of survival \n Output:\n " }, { "from": "agent", "value": "In subgroup analyses , elevated pretreatment platelet counts were also associated with poorer OS and DFS/PFS/TTP in most subgroups .\nThis meta- analysis revealed that elevated pretreatment platelet counts were an independent predictor of OS and DFS/PFS/TTP in lung cancer patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate effectiveness of the Adolescent Coping With Depression ( CWD-A ) course , a cognitive-behavioral group intervention for depressed adolescents with comorbid conduct disorder . METHOD Between 1998 and 2001 , 93 nonincarcerated adolescents ( ages 13 - 17 years ) meeting criteria for major depressive disorder and conduct disorder were recruited from a county juvenile justice department and r and omly assigned to the CWD-A or a life skills/tutoring control condition . Participants were assessed post-treatment and at 6- and 12-month follow-up . Dichotomous outcomes were analyzed with logistic regression ; dimensional measures were analyzed using r and om effects regression . RESULTS Major depressive disorder recovery rates post-treatment were greater in CWD-A ( 39 % ) compared with life skills/tutoring control ( 19 % ) ( odds ratio 2.66 , 95 % confidence interval = 1.03 - 6.85 ) . CWD-A participants reported greater reductions in Beck Depression Inventory-II ( r2 = 0.055 , p = .033 ) and Hamilton Depression Rating Scale ( r2 = 0.047 , p = .039 ) scores and improved social functioning ( r2 = 0.064 , p = .019 ) post-treatment . Group differences in major depressive disorder recovery rates at 6- and 12-month follow-up were nonsignificant , as were differences in conduct disorder both post-treatment and during follow-up . CONCLUSIONS This is the first r and omized , controlled trial of a psychosocial intervention with adolescents with major depressive disorder and conduct disorder . Although the CWD-A appears to be an effective acute treatment for depression in adolescents with multiple disorders , findings emphasize the need to improve long-term outcomes for depressed adolescents with psychiatric comorbidity and imply that interventions for comorbid population s focus directly on each specific disorder OBJECTIVE To assess olanzapine 's efficacy and tolerability in adolescents with schizophrenia . METHOD One hundred seven inpatient and outpatient adolescents ( olanzapine , n = 72 , mean age 16.1 years ; placebo , n = 35 , mean age 16.3 years ) with schizophrenia participated in this r and omized ( 2:1 ) , international , multisite , industry-sponsored trial . All patients met DSM-IV-TR criteria for schizophrenia , and they were treated for up to 6 weeks with flexible doses of olanzapine ( 2.5 - 20.0 mg/day ) or placebo . Last-observation-carried-forward mean changes from baseline to endpoint on the anchored version of the Brief Psychiatric Rating Scale for Children , Clinical Global Impression Scale-Severity of Illness , and Positive and Negative Syndrome Scale ( PANSS ) were assessed . RESULTS More olanzapine-treated versus placebo-treated patients completed the trial ( 68.1 % versus 42.9 % , p = .020 ) . Compared with placebo-treated patients , olanzapine-treated adolescents had significantly greater improvement in Brief Psychiatric Rating Scale for Children total ( p = .003 ) , Clinical Global Impressions Scale-Severity of Illness ( p = .004 ) , PANSS total ( p = .005 ) , and PANSS positive scores ( p = .002 ) . Olanzapine-treated patients gained significantly more baseline-to-endpoint weight ( 4.3 kg versus 0.1 kg , p < .001 ) . Significantly more olanzapine-treated versus placebo-treated patients gained 7 % or greater of their body weight at any time during treatment ( 45.8 % versus 14.7 % , p = .002 ) . Prolactin and triglyceride mean baseline-to-endpoint changes were significantly higher in olanzapine-treated versus placebo-treated adolescents . The incidence of treatment-emergent significant changes in fasting glucose , cholesterol , or triglycerides did not differ between the groups at endpoint , but significantly more olanzapine-treated patients had high triglycerides at any time during treatment . CONCLUSIONS Olanzapine-treated adolescents with schizophrenia experienced significant symptom improvement . Significant increases in weight , triglycerides , uric acid , most liver function tests , and prolactin were observed during olanzapine treatment . Clinical trial registration information-Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia . URL : http://www . clinical trials.gov . Unique identifier : NCT00051298 OBJECTIVE To describe the development and initial evaluation of the Coping Course , a cognitive-behavioral group intervention design ed to enhance general coping and problem-solving skills among incarcerated youth . METHOD Between 2001 and 2002 , 76 male adolescents incarcerated at a youth correctional facility were assessed by question naire and r and omly assigned to either the Coping Course ( n = 46 ) or usual care ( n = 30 ) . Participants repeated the question naire after completion of the intervention . A second correctional facility served as an additional source of control group data ( n = 62 ) . RESULTS Significant condition x time effects were present for seven of the examined measures : Youth Self-Report externalizing scores , three measures from the Life Attitudes Scale , self-esteem , one measure of social adjustment , and cognitive-behavioral therapy knowledge . Age and race/ethnicity did not moderate effects . Comparing control group participants with youth at a separate correctional facility who did not receive the Coping Course indicated that change was uniquely associated with participation in the intervention . CONCLUSIONS Our goal was to take an efficacious adolescent depression group intervention and modify it for use with youth in correctional facilities . Preliminary findings are promising and provide evidence for future research of cognitive-behavioral group treatments with incarcerated youth Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . This prospect i ve study examines the predictive validity of the Dutch version of the Structured Assessment of Violence Risk in Youth ( SAVRY ) by examining relationships between SAVRY scores and various types of disruptive behavior during residential treatment . The SAVRY , a risk assessment instrument , was coded for 66 male adolescents on the basis of file information and interviews . The adolescents were referred to Rentray , a juvenile correctional and treatment facility , by the Dutch juvenile courts because of severe behavioral problems or serious offenses . Institutional infractions were retrieved from incident registration files , which included acts of physical violence , verbal threat , verbal abuse , and violation of institutional rules . The interrater reliability of the SAVRY scores was good . The predictive validity of the SAVRY for physical violence against persons was excellent ( Risk Total : AUC=.80 , r = .33 ; Summery Risk Rating : AUC = .86 , r = .48 ) . The SAVRY also had good predictive validity for violence against objects , verbal threats and violations of rules , but not for verbal abuse . Implication s for assessment and management of violent behavior among adolescents in residential treatment are discussed This study examined the effect of four treatment conditions on self-concept and reduction of psychological stress in adolescent delinquent females . The treatments were Rational State Directed Imagery , a cognitive behavioral approach that utilized intensive muscle relaxation and vivid-emotive-imagery , a rational ( cognitive ) restructuring treatment , a placebo condition , and a no treatment control . Ss were assigned r and omly to one of these treatment groups , which met 1 hour per week for 6 consecutive weeks , with in-vivo homework assignments also utilized . Statistically scale were noted for the RSDI group at the posttest and at a 2-month follow-up , which supports the therapeutic efficacy of this treatment . Support was found for the effectiveness of the rational ( cognitive ) restructuring approach immediately posttreatment ; however these effects disappeared at the 2-month follow-up . The placebo and control groups showed no significant effects at either posttreatment or the follow-up . These results suggest that RSDI has potential for use as a short-term psychotherapeutic approach when self-concept modification is a primary goal The purpose of this study is to test our hypothesis that muscle relaxation is effective on the psychological well-being of juvenile delinquents . Subjects were 16 juvenile delinquents who had entered a reform school . Subjects were divided into two groups . The muscle relaxation group received muscle relaxation therapy once a week for a total of 4 times . The control group spent an ordinary daily life in the reformatory . Psychological question naires used were the Rosenzweig Picture Frustration Study ( P-F study ) , the Psychological Stress Response Scale ( PSRS ) , and the Eysenck Personality Question naire ( EPQ ) . There was a significant Group × Time interaction of the Group Conformity Rating ( GCR ) of the P-F study ( F [ 1,14 ] = 10.1 , P=0.007 ) . There were no significant interactions in the other psychological subscales . Thus , muscle relaxation therapy may improve frustration tolerance among juvenile delinquents BACKGROUND New treatments for conduct disorder are sorely needed . We aim ed to test the efficacy of divalproex sodium for the treatment of conduct disorder . METHOD Seventy-one youths with conduct disorder according to DSM-IV criteria were enrolled in a r and omized , controlled , 7-week clinical trial . Subjects were all adolescent males with at least 1 crime conviction . Subjects were r and omized into high- and low-dose conditions and were openly managed by a clinical team . Subjects and independent outcome raters were blinded to condition . Clinical Global Impressions-Severity of Illness ( CGI-S ) and CGI-Improvement ( CGI-I ) ratings , Weinberger Adjustment Inventory ratings , and staff ratings of behavioral privilege were used to assess outcome . RESULTS Intent-to-treat analyses showed significant associations between assignment to the high-dose condition and ratings on the CGI-S ( p = .02 ) and CGI-I ( p = .0008 ) . Self-reported weekly impulse control was significantly better in the high-dose condition ( p < .05 ) , and association between improvement in self-restraint and treatment condition was of borderline statistical significance ( p < .06 ) . Parallel analyses comparing outcome by blood drug level achieved strengthened the results , as expected . CONCLUSION This preliminary study in a most difficult population suggests a role for divalproex sodium in the treatment of conduct disorder . Divalproex sodium improved self-reported impulse control and self-restraint , variables shown to be predictive of criminal recidivism . Studies are needed of longer-term impact and side-effect profiles . This is one of few controlled psychopharmacologic studies of conduct disorder BACKGROUND Successful treatment of conduct disorder remains difficult . On the basis of a positive response to divalproex among adolescent boys with conduct disorder , we conducted an analysis of the impact of baseline comorbid diagnoses and personality factors on the likelihood of treatment response to divalproex . METHOD Seventy-one adolescent boys with conduct disorder ( DSM-IV ) and a history of at least 1 offense against persons were r and omly assigned to receive high- or low-dose divalproex for 7 weeks . Evaluations included best estimate diagnoses , the Clinical Global Impressions-Severity of Illness scale ( CGI-S ) and CGI-Improvement scale ( CGI-I ) , the 62-item Weinberger Adjustment Inventory ( WAI-62 ) assessment of distress and restraint , the Response Evaluation Measure assessment of immature and mature defenses , and the Achenbach Youth Self-Report assessment of overall psychopathology . All were conducted at study entry and exit , and the WAI-62 was conducted weekly throughout the 7-week study period . Treatment response was defined as a rating of much improved or very much improved on the CGI-I. Data were collected from June 1997 to April 1998 . RESULTS Fifty-eight subjects completed the study and were eligible for inclusion in the analysis . Plasma divalproex level ( p = .003 ) and immature defenses ( p = .004 ) were significant positive predictors of treatment response , while restraint ( p = .01 ) and level and range of psychopathology ( p = .04 ) were significant predictors of nonresponse . Comorbidities or distress ( p = .06 ) were not significantly associated with treatment outcome . CONCLUSION Predictors of response to divalproex treatment for conduct disorder were identified , despite the small sample size in this study . The pattern of positive and negative predictors of response to divalproex , an antikindling agent , tends to support a model of kindling-reinforced reactive/affective/defensive/impulsive aggression among adolescent boys with conduct disorder . Additional studies are needed to identify more subtle predictors of treatment response and to clarify the mechanisms contributing to the development of conduct disorder OBJECTIVE To derive and test a series of brief diagnosis-specific scales \n Output:\n " }, { "from": "agent", "value": "Screening accuracy was typically modest .\nAn exemplar decision model was developed for depression , which identified a number of the likely key drivers of uncertainty , including the prevalence of unidentified mental health problems , the severity of mental health problems and their relationship to generic measures of outcome and the impact of treatment on recidivism .\nEvidence on the clinical effectiveness and cost-effectiveness of screening for mental health problems in young people who offend is currently lacking ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose We aim ed to reduce unnecessary prostatic biopsy in patients with high prostate-specific antigen ( PSA ) by consideration of prostatic inflammation . Material s and Methods The investigation was conducted prospect ively in 413 patients with a PSA level of 4 to 10 ng/ml from January 2004 to December 2009 . All patients underwent the expressed prostatic secretion ( EPS ) or voided bladder urine 3 ( VB3 ) test to be classified into two groups : positive group and negative group . Patients with a positive result on the EPS or VB3 test were treated with antibiotics for 2 months , and in cases in which the PSA level remained high , we performed prostate biopsy . In patients with a negative result on the VB3 test , we performed prostate biopsy directly . Results Of the 413 study patients , 215 ( 52 % ) patients had positive findings on the EPS or VB3 test . After 8 weeks of antibiotics therapy , 53 of the 215 men avoided prostate biopsy because their PSA level was normalized . The other patients ( 162 of 215 ) still had elevated PSA levels of more than 4 ng/ml , including 7 patients in whom the biopsy revealed cancer . Patients with negative findings ( 198 of 413 ) underwent prostate biopsy . Of the 198 patients , 41 were diagnosed with prostate cancer . The total prostate cancer detection rate was 11.6 % in our subjects , where as it was 20.7 % in the patients with negative findings on the EPS or VB3 and 3.3 % in the patients with positive findings , respectively . Conclusions In cases in which the PSA level is increasing , if we first exclude prostatitis and carry out a serial diagnostic procedure , it may help to reduce unnecessary prostatic biopsy Purpose We investigated the effect of antibiotics on PSA in asymptomatic patients with mild PSA elevation . Material s and Methods We prospect ively evaluated , in a non-r and omized design , 106 asymptomatic patients with PSA of 4 - 10ng/mL , with a negative digital rectal examination and with no urinary tract infection evidence for 2 years . Patients were divided into two groups : those treated with antibiotics for 3 weeks ( G1 ) and those who were not treated ( G2 ) . PSA was taken six weeks after and prostate biopsy was performed in all patients . Results PCa was diagnosed in 25 of 106 patients ( 23.6 % ) : 16 ( 25.0 % ) in G1 and 9 ( 21.4 % ) in G2 ( p>0.05 ) . PSA normalization was experienced in 24.5 % . In G1 , PSA returned to < 4ng/mL in 15 ( 23.4 % ) patients compared to 11 ( 26 % ) patients in G2 . In the patients with a positive biopsy , no significant variation was noted in PSA , fPSA , % fPSA and DPSA after antibiotic treatment . A significantly lower cancer detection rate was noted with decreased PSA , fPSA , and DPSA after antibiotic use . A PSA reduction rate of ≥10 % occurred in 58.5 % , and this was similar in both G1 and G2 groups . The sensibility , specificity and accuracy of PSA reduction of ≥10 % were 31 % , 23 % and 25 % , respectively . Conclusion Empirical antibiotic therapy in asymptomatic male patients is not related to PSA reduction . The greater than 10 % PSA reduction after antibiotic in this population can not postpone prostate biopsy PURPOSE This controlled prospect i ve study aims to investigate the possible effects of antibiotic treatment on prostate-specific antigen ( PSA ) and its derivatives , and consequently on the transrectal biopsy rates , in the diagnosis of prostate cancer . PATIENTS AND METHODS One hundred and forty patients aged 45 to 70 years old , with a PSA level between 2.5 and 10 ng/mL and normal digital rectal examinations ( DRE ) , were included in this study between June 2009 and November 2010 . The patients were r and omly assigned into two groups . The first group received oral levofloxacin 500 mg 1 * 1 for 21 days ; the second , the control group , was given no treatment . Initially , total PSA , free PSA , a DRE , urinary ultrasonography ( including prostate volume , postvoiding residual urine ) , uroflowmetry , International Prostate Symptom Score , National Institutes of Health Chronic Prostatitis Symptom Index , and International Index of Erectile Function tests were performed . All of these were repeated at the end of 3 weeks of antibiotic treatment . An additional PSA measurement was also performed at day 10 of the treatment . All patients underwent transrectal ultrasonography ( TRUS ) guided prostate biopsy at day 21 , just the day after the final ( third ) PSA sampling . RESULTS The mean age of the patients was 59.6 years . Overall , in 23 patients , prostate cancer was detected , including those found in the rebiopsies . Statistically , there were significant changes in values of PSA and its derivatives in the treatment group ( from 5.31 to 4.69 and 4.58 ng/mL , consecutively ) . Focusing on prostate cancer patients in both the treatment and control groups , however , we did not detect any significant change in the same parameters . CONCLUSION Antibiotic treatment given to the patients with a PSA level between 2.5 and 10 ng/mL can be beneficial , before a decision for TRUS guided prostate biopsy , just in a limited subgroup , by reducing the PSA levels below the threshold value . Considering the large population of patients in the gray zone , however , it still does not provide clear solid evidence for avoiding unnecessary prostate biopsies INTRODUCTION We investigated if antibiotherapy has any role on total PSA ( tPSA ) , free PSA ( fPSA ) and fPSA/tPSA ratio in patients with tPSA higher than 2.5ng/ml . We also analyzed if it has any relation with prostate cancer diagnosis rate . MATERIAL AND METHODS A total 108 patients older than 50 years of age with lower urinary system sypmtoms and tPSA > 2.5ng/ml were included in this study . Antibiotherapy was given to all the cases for three weeks . After that , transrectal ultrasound-guided prostate biopsies were taken from all the patients . Before and after antibiotherapy , \" The International Prostate Symptom Score \" ( IPSS ) and \" National Institutes of Health Chronic Prostatitis Symptom Index \" ( NIH-CPSI ) questinories are performed and serum tPSA , fPSA and fPSA/tPSA values were obtained . RESULTS TPSA , fPSA and fPSA/tPSA ratio alterations prior to and after antibiotherapy did not show any statistically significant difference ( p>0.05 ) . When prostate adenocarcinoma was excluded , an statistically significant decrease was found in IPSS and NIH-CPSI scores for all cases . CONCLUSIONS Antibiotherapy given to patients with PSA levels higher than threshold value has not led to significant change in prostate needle biopsy decision . Prostate biopsy should be considered without trying antibiotherapy in patients with high PSA values if a suspicion of prostatitis does not exist PURPOSE We compared baseline and post-therapy prostate specific antigen ( PSA ) in patients with chronic bacterial prostatitis who were treated with levofloxacin or ciprofloxacin . MATERIAL S AND METHODS Subset analysis was done using a r and omized , multicenter , double-blind , active control trial of 500 mg levofloxacin daily for 28 days vs 500 mg ciprofloxacin twice daily in 28 days in men with chronic bacterial prostatitis . RESULTS Of the 377 men in the intent to treat population , including 197 treated with levofloxacin and 180 treated with ciprofloxacin , 35 on levofloxacin and 37 on ciprofloxacin with baseline PSA greater than 4 ng/ml were included in this analysis . Excluded from analysis were 2 levofloxacin treated patients with extremely high PSA at baseline ( 62 and 103 ng/ml , respectively ) . Mean baseline PSA + /- SD in the patients analyzed was 8.33 + /- 4.46 ng/ml , which decreased to 5.36 + /- 3.82 ng/ml after therapy . There was no significant difference in the mean change in PSA between the levofloxacin and ciprofloxacin groups . Approximately 42 % of patients with increased baseline PSA had a post-therapy PSA of 4 ng/ml or less . Of patients who were microbiologically evaluable and had normalized PSA after therapy levofloxacin eradicated the pathogen in 90.9 % ( 10 of 11 ) . However , of patients in whom post-therapy PSA remained increased the microbiological eradication rate was 69.2 % ( 9 of 13 ) . Similarly 93.3 % of the ciprofloxacin group ( 14 of 15 patients ) with normalized post-therapy PSA experienced microbiological eradication compared with 61.5 % ( 8 of 13 ) with continued increased PSA after therapy . CONCLUSIONS Approximately 20 % of patients diagnosed with chronic bacterial prostatitis had increased PSA . A significant decrease in PSA was observed in these patients after treatment with levofloxacin or ciprofloxacin . An association was observed between bacterial persistence and the likelihood that PSA would return to normal PURPOSE We attempted to identify morphological parameters of benign prostatic hyperplastic inflammation that correlate with pre-biopsy prostate specific antigen ( PSA ) concentrations . MATERIAL S AND METHODS Patients undergoing prostate biopsy at our department were prospect ively studied between January 1995 and January 1996 . preoperative blood and 24-hour urine sample s were measured for PSA . Biopsy sample s harboring exclusively benign prostatic tissue were grade d on a 4-point scale for inflammation ( 0-no inflammatory cells , 1-scattered inflammatory cell infiltrate , 2-nonconfluent lymphoid nodules and 3-large inflammatory areas with confluence of infiltrate ) and aggressiveness ( 0-no contact between inflammatory cells and gl and ular epithelium ; 1-contact between inflammatory cell infiltrate and gl and ular epithelium ; 2-clear but limited , that is less than 25 % of the examined material , gl and ular epithelium disruption , and 3-gl and ular epithelium disruption on more than 25 % of the examined material ) . RESULTS A total of 66 patients with exclusively benign prostatic tissue on prostate biopsies was analyzed . Difference between inflammation grade d groups was not significant when considering serum or urinary PSA . There was a significant correlation between aggressiveness grading and serum PSA ( rho = 0.51 , p < 0.0001 ) , whereas aggressiveness grading and urinary PSA did not correlate ( rho = -0.06 , p = 0.6 ) . CONCLUSIONS Prostatic sub clinical inflammation is not associated with high urinary PSA . Unless associated with gl and ular epithelial disruption , density of prostatic interstitial inflammatory cell infiltrate is not significantly correlated with serum PSA concentration . We believe that this issue should be considered when interpreting a prostate biopsy Purpose We evaluated men with documented chronic prostatitis and elevated serum prostate-specific antigen ( PSA ) to determine whether treatment with antibiotics and anti-inflammatory drugs can lower serum PSA and the cancer detection rate in patients with post-treatment PSA < 4 ng/ml . Material s and Methods Eighty-six men who presented with serum PSA greater than 4 ng/ml and who were subsequently diagnosed with chronic prostatitis with greater than 10 white blood cells per high power field in expressed prostatic excretions were included in this prospect i ve study . Patients meeting these criteria underwent treatment with a 4-week course of antibiotics and nonsteroidal anti-inflammatory agents . Follow-up PSA and transrectal ultrasonography-guided prostate biopsy were performed within 2 months of treatment for all patients . Results Mean patient age was 56.2 years ( range , 37 - 72 years ) . Mean PSA ( ng/ml ) decreased by 33.8 % , from 8.12 ( range , 4.02 - 24.8 ) to 5.37 ( range , 1.35 - 12.94 ) , after treatment ( p=0.001 ) . Pathological studies revealed prostate cancer in 18 cases ( 20.9 % ) , chronic inflammation in 64 ( 74.4 % ) , and benign prostatic hypertrophy in 4 ( 4.7 % ) . The prostate cancer detection rate according to the follow-up PSA level , below 2.5 , from 2.5 to 4.0 , and above 4.0 , was 13.3 % ( 2/15 ) , 13.6 % ( 3/22 ) , and 26.5 % ( 13/49 ) , respectively . Conclusions When chronic prostatitis with elevated PSA is identified , antibiotic and anti-inflammatory treatment can lower these PSA levels . However , the possibility of prostate \n Output:\n " }, { "from": "agent", "value": "No cancer was detected if the PSA level decreased to < 4 ng/mL. Conclusion : Antibiotic therapy is clinical ly beneficial in patients with high PSA levels .\nPSA reduction or normalisation after medical therapy , either antibiotic and /or NSAID , for ≥ 2 weeks can avoid unnecessary PBx ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this study was to determine the response to CPT-11 administered every three weeks to adults with progressive malignant glioma , treated with or without enzyme-inducing antiepileptic drug ( EIAED ) therapy , at the recommended phase 2 dose determined from a previous phase 1 study . Adult patients age 18 or older with a KPS of 60 or higher who had measurable recurrent grade III anaplastic glioma ( AG ) or grade IV glioblastoma multiforme ( GBM ) were eligible . No more than one prior chemotherapy was allowed , either as adjuvant therapy or for recurrent disease . The CPT-11 dose was 350 mg/m(2 ) i.v . every three weeks in patients not on EIAED and 750 mg/m(2 ) in patients on EIAED therapy . Patients with stable or responding disease could be treated until tumor progression or a total of 12 months of therapy . The primary end point of the study was to determine whether CPT-11 could significantly delay tumor progression , using the rate of six-month progression-free survival ( PFS-6 ) . The trial was sized to be able to discriminate between a 15 % and 35 % rate for the GBM group alone and between a 20 % and 40 % rate for the entire cohort . There were 51 eligible patients , including 38 GBM and 13 AG patients , enrolled . The median age was 52 and 42 years , respectively . PFS-6 for the entire cohort was 17.6 % . PFS-6 was 15.7 % ( 95 % confidence interval [ CI ] , 0.07 - 0.31 ) for the GBM patients and 23 % ( 95 % CI , 0.07 - 0.52 ) for AG patients . Toxicity for the group included diarrhea and myelosuppression . We conclude that the recommended phase 2 dose of CPT-11 for patients with or without EIAED was ineffective on this schedule , in this patient population Purpose : Although patients with newly diagnosed WHO grade 3 malignant glioma have a more favorable prognosis than those with WHO grade 4 malignant glioma , salvage therapies following recurrence offer essentially palliative benefit . We did a phase II trial of bevacizumab , a monoclonal antibody to vascular endothelial growth factor , in combination with irinotecan for patients with recurrent grade 3 malignant glioma . Experimental Design : Upon documentation of adequate safety among an initial cohort of nine patients treated with bevacizumab ( 10 mg/kg ) and irinotecan every 14 days , a second cohort ( n = 24 ) was treated with bevacizumab ( 15 mg/kg ) every 3 weeks with irinotecan on days 1 , 8 , 22 , and 29 of each 42-day cycle . For both cohorts , the dose of irinotecan was 340 mg/m2 for patients on enzyme-inducing antiepileptic drugs ( EIAED ) and 125 mg/m2 for patients not on EIAEDs . After each 6-week cycle , patients were evaluated with a physical examination and magnetic resonance imaging . Results : The 6-month progression-free survival was 55 % ( 95 % confidence interval , 36 - 70 % ) . The 6-month overall survival was 79 % ( 95 % confidence interval , 61 - 89 % ) . Twenty patients ( 61 % ) had at least a partial response . Outcome did not differ between the two treatment cohorts . Significant adverse events were infrequent and included a central nervous system hemorrhage in one patient , and one patient who developed thrombotic thrombocytopenic purpura . Conclusion : Bevacizumab and irinotecan is an active regimen with acceptable toxicity for patients with recurrent WHO grade 3 malignant glioma PURPOSE Evaluation of treatment effects in malignant brain tumors is challenging because of the lack of reliable response predictors of tumor response . This study examines the predictive value of positron emission tomography ( PET ) using [ 18F ] fluorothymidine ( FLT ) , an imaging biomarker of cell proliferation , in patients with recurrent malignant gliomas treated with bevacizumab in combination with irinotecan . PATIENTS AND METHODS Patients with recurrent malignant gliomas treated with biweekly cycles of bevacizumab and irinotecan were prospect ively studied with FLT-PET at baseline , after 1 to 2 weeks , and after 6 weeks from start of treatment . A more than 25 % reduction in tumor FLT uptake as measured by st and ardized uptake value was defined as a metabolic response . FLT responses were compared with response as shown by magnetic resonance imaging ( MRI ) and patient survival . RESULTS Twenty-one patients were included , and 19 were assessable for metabolic response evaluation with FLT-PET . There were nine responders ( 47 % ) and 10 nonresponders ( 53 % ) . Metabolic responders survived three times as long as nonresponders ( 10.8 v 3.4 months ; P = .003 ) , and tended to have a prolonged progression-free survival ( P = .061 ) . Both early and later FLT-PET responses were more significant predictors of overall survival ( 1 to 2 weeks , P = .006 ; 6 weeks , P = .002 ) , compared with the MRI responses ( P = .060 for both 6-week and best responses ) . CONCLUSION FLT-PET as an imaging biomarker seems to be predictive of overall survival in bevacizumab and irinotecan treatment of recurrent gliomas . Whether FLT-PET performed as early as 1 to 2 week after starting treatment is as predictive as the study indicates at 6 weeks warrants further investigation Our objective is to assess treatment efficacy , safety and pattern of response and recurrence in patients with recurrent high- grade glioma treated with bevacizumab and irinotecan . We review ed retrospectively 51 patients with recurrent high- grade glioma treated with this combination at the Henry Ford Hermelin Brain Tumor Center from 11/15/2005 to 04/01/2008 . The 6-month progression-free survival ( PFS ) for anaplastic gliomas ( AGs ) was 78.6 and 63.7 % for glioblastoma . The median PFS was 13.4 months for AG and 7.6 months for those with glioblastoma . The overall survival rate ( OS ) at 6 months was 85.7 % for AG and 78.0 % for glioblastoma . The 12-month OS was 77.9 % for AG and 42.6 % for glioblastoma . The median OS time for AGs was not reached and was 11.5 months for those with glioblastoma . Thirty-six out of 51 ( 70.59 % ) patients demonstrated partial ( 32/51 ) or complete ( 4/51 ) radiographic response to treatment and 8/51 ( 15.69 % ) remained stable . Of the 38 who demonstrated progression on post-gadolinium studies , 23 showed distant progression with or without local recurrence . Seven patients showed progression on FLAIR without concordant findings on post-Gd sequences . Six patients ( 11.76 % ) discontinued treatment due to a treatment-emergent adverse event , including one with end-stage renal failure and another with gastric perforation . No symptomatic intracranial hemorrhages were reported . Patients with recurrent high- grade glioma treated with bevacizumab plus irinotecan demonstrate an excellent radiographic response rate and improved clinical outcome when compared to historical data . The high rate of distant tumor progression suggests that tumors may adapt to inhibition of angiogenesis by increased infiltration and vascular co-option Purpose : Recurrent grade III-IV gliomas have a dismal prognosis with minimal improvements in survival seen following currently available salvage therapy . This study was conducted to determine if the combination of a novel antiangiogenic therapy , bevacizumab , and a cytotoxic agent , irinotecan , is safe and effective for patients with recurrent grade III-IV glioma . Experimental Design : We conducted a phase II trial of bevacizumab and irinotecan in adults with recurrent grade III-IV glioma . Patients with evidence of intracranial hemorrhage on initial brain magnetic resonance imaging were excluded . Patients were scheduled to receive bevacizumab and irinotecan i.v . every 2 weeks of a 6-week cycle . Bevacizumab was administered at 10 mg/kg . The dose of irinotecan was determined based on antiepileptic use : patients taking enzyme-inducing antiepileptic drugs received 340 mg/m2 , whereas patients not taking enzyme-inducing antiepileptic drugs received 125 mg/m2 . Toxicity and response were assessed . Results : Thirty-two patients were assessed ( 23 with grade IV glioma and 9 with grade III glioma ) . Radiographic responses were noted in 63 % ( 20 of 32 ) of patients ( 14 of 23 grade IV patients and 6 of 9 grade III patients ) . The median progression-free survival was 23 weeks for all patients ( 95 % confidence interval , 15 - 30 weeks ; 20 weeks for grade IV patients and 30 weeks for grade III patients ) . The 6-month progression-free survival probability was 38 % and the 6-month overall survival probability was 72 % . No central nervous system hemorrhages occurred , but three patients developed deep venous thromboses or pulmonary emboli , and one patient had an arterial ischemic stroke . Conclusions : The combination of bevacizumab and irinotecan is an active regimen for recurrent grade III-IV glioma with acceptable toxicity PURPOSE OF REVIEW To critically assess the role of irinotecan ( Camptosar , CPT-11 ) and bevacizumab ( Avastin ) as a new treatment for glioblastoma and other malignant gliomas ( anaplastic forms of astrocytomas and oligodendrogliomas ) . RECENT FINDINGS Two prospect i ve phase II trials of bevacizumab and irinotecan have been reported . The observed high response rates ( 30 - 60 % ) had never been seen in this disease before . Gains in progression-free survival and overall survival ( OS ) were less impressive ( 6-month progression-free survival 30 - 50 % ; median OS : 9 - 10 months ) , but are still superior to historical controls . SUMMARY Bevacizumab is a welcome new weapon in the treatment of malignant gliomas and should be favored as a salvage treatment over cytotoxic chemotherapy for recurrent disease . However , survival results remain far from satisfactory . Once failure to treatment with bevacizumab is diagnosed by conventional radiographic methods , most patients experience rapid deterioration and die shortly afterward . New methods and radiographic criteria for detecting disease progression are needed . Patients willing to explore new treatment strategies through participation in clinical trials should do so prior to starting bevacizumab , as this may not be an option once treatment fails . Cost-effectiveness of bevacizumab in gliomas deserves further investigation . The role of irinotecan in this combination remains unclear . At this time , bevacizumab should only be used in newly diagnosed malignant gliomas in the setting of a clinical trial PURPOSE To evaluate single-agent activity of bevacizumab in patients with recurrent glioblastoma . PATIENTS AND METHODS Patients with recurrent glioblastoma were treated with bevacizumab 10 mg/kg every 2 weeks . After tumor progression , patients were immediately treated with bevacizumab in combination with irinotecan 340 mg/m(2 ) or 125 mg/m(2 ) every 2 weeks , depending on use of enzyme-inducing antiepileptic drugs . Complete patient evaluations were repeated every 4 weeks . RESULTS Forty-eight heavily pretreated patients were accrued to this study . Thromboembolic events ( 12.5 % ) , hypertension ( 12.5 % ) , hypophosphatemia ( 6 % ) , and thrombocytopenia ( 6 % ) were the most common drug-associated adverse events . Six patients ( 12.5 % ) were removed from study for drug-associated toxicity ( five thromboembolic events , one bowel perforation ) . Thirty-four patients ( 71 % ) and 17 patients ( 35 % ) achieved radiographic response based on Levin and Macdonald criteria , respectively . Median progression-free survival ( PFS ) was 16 weeks ( 95 % CI , 12 to 26 weeks ) . The 6-month PFS was 29 % ( 95 % CI , 18 % to 48 % ) . The 6-month overall survival was 57 % ( 95 % CI , 44 % to 75 % ) . Median overall survival was 31 weeks ( 95 % CI , 21 to 54 weeks ) . Early magnetic resonance imaging response ( first 96 hours and 4 weeks ) was predictive of long-term PFS , with the Levin criteria being more predictive than Macdonald criteria . Of 19 patients treated with bevacizumab plus irinotecan at progression , there were no objective radiographic responses . Eighteen patients ( 95 % ) experienced \n Output:\n " }, { "from": "agent", "value": "Conclusion The combination of bevacizumab and irinotecan might improve outcome in patients with recurrent malignant glioma ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To establish the relationship of cervical length at 23 weeks of gestation to the risk of spontaneous delivery before 33 weeks and to determine the possible additional risk if funneling is present . METHODS During a 36-month period , 6819 women with singleton pregnancies underwent transvaginal sonographic cervical assessment at 22 - 24 weeks as a screening test for preterm delivery . The distribution of cervical length and the prevalence of funneling , defined as dilatation of the internal os of > or = 5 mm in width , were established . Women who underwent cervical cerclage , iatrogenic preterm delivery or were lost to follow-up were excluded from further analysis . In the remaining 6334 pregnancies , logistic regression was used to examine the contribution of cervical length and funneling to the risk of spontaneous preterm delivery before 33 weeks . RESULTS The median cervical length was 36 mm and in 1.6 % of cases the length was < or = 15 mm . There was a significant inverse association between cervical length and percentage rate of spontaneous delivery before 33 weeks . Funneling of the internal os was present in about 4 % of pregnancies and the prevalence decreased with increasing cervical length from 98 % when the length was < or = 15 mm to about 25 % for lengths of 16 - 30 mm and less than 1 % at lengths of > 30 mm . The rate of preterm delivery was 6.9 % in those with funneling compared to 0.7 % in those without funneling ( chi2 = 86.7 ; P < 0.0001 ) . However , logistic regression analysis demonstrated that funneling did not provide a significant additional contribution to cervical length in the prediction of spontaneous delivery before 33 weeks ( odds ratio for short cervix = 24.9 , Z = 4.43 , P < 0.0001 ; odds ratio for funneling = 1.8 , Z = 0.84 , P = 0.40 ) . CONCLUSION In the prediction of preterm delivery , funneling does not provide any significant contribution in addition to cervical length OBJECTIVE This study was undertaken to determine whether progestational agents can prevent inflammation-induced preterm parturition and fetal demise . STUDY DESIGN The activation of contractile and inflammatory pathways in response to localized intrauterine inflammation was investigated by using quantitative polymerase chain reaction ( PCR ) . Serum progesterone ( P4 ) levels and alterations in progesterone receptor-B ( PR-B ) were determined with radioimmunoassay and quantitative PCR , respectively . With our in vivo model of intrauterine inflammation , animals were r and omly assigned to pretreatment with P4 or medroxyprogesterone acetate ( MPA ) before intrauterine lipopolysaccharide ( LPS ) . Animals were observed for preterm delivery . The number of live pups 48 hours after intrauterine LPS was recorded for each treatment group . The ability of MPA to alter signal transduction pathways leading to preterm parturition were investigated by quantitative PCR and histochemical studies . RESULTS Intrauterine inflammation is associated with decreased serum progesterone levels and decreased transcription of PR-B. Preterm delivery rates were 100 % for LPS alone , 63 % for LPS+P4 , and 0 % for LPS+MPA . No live pups remained at 48 hours in the LPS or LPS+P4 groups . Pretreatment with MPA significantly preserved fetal viability . MPA suppressed activation of contraction-associated genes and inflammatory mediators and prevented cervical ripening in response to intrauterine inflammation . CONCLUSION MPA , with its progestational and anti-inflammatory properties , prevented inflammation-induced preterm parturition and significantly preserved fetal viability A prior report suggested that active-duty pregnant women are at increased risk for low-birth weight infants and a higher perinatal mortality rate . The present double-blind investigation was design ed to prospect ively evaluate that risk and to test the efficacy of 17 alpha-hydroxyprogesterone caproate to prevent reported complications . Three groups of active-duty women were studied , beginning between 16 and 20 weeks ' gestation . They were similar for parity , previous abortion , race , cigarette smoking , and marital status . Of these , 80 were given 17 alpha-hydroxyprogesterone caproate , 88 received placebo , and 78 declined to participate in the protocol . There was no significant differences in the three groups when comparisons were made for low-birth weight infants and for perinatal mortality . However , when comparison was made to a military dependent population , they had a significantly worse outcome with regard to both perinatal mortality ( p = 0.001 ) and infants with a birth weight less than 2,500 gm ( p = 0.01 ) . We concluded that pregnant military personnel were at increased risk for adverse pregnancy outcome , but that this risk was not altered by therapy with 17 alpha-hydroxyprogesterone caproate OBJECTIVE On the basis of the recent Maternal Fetal Medicine Unit Networks clinical trial , the American College of Obstetricians and Gynecologists supports the administration of 17-alpha hydroxyprogesterone caproate to high-risk patients . Because inflammation/infection is believed to be a contributing factor in many cases of preterm birth , it is imperative to underst and the effect of 17-alpha hydroxyprogesterone caproate treatment in this clinical situation . STUDY DESIGN Using a mouse model of localized intrauterine inflammation , we investigated the ability of progestational agents to prevent preterm birth . On gestational day 15 ( E15 ) , dams were assigned r and omly to treatment with 17-alpha hydroxyprogesterone caproate , medroxyprogesterone acetate , or vehicle before intrauterine infusion of lipopolysaccharide . All dams were monitored for morbidity and preterm birth . Three separate sets of experiments were performed to assess different outcomes at 6 , 24 , and 96 hours . At 6 and 24 hours , C-reactive protein , interleukin-6 , and interleukin-10 levels were measured in maternal serum by enzyme-linked immunosorbent assay . RESULTS Pretreatment with 17-alpha hydroxyprogesterone caproate or medroxyprogesterone acetate before intrauterine lipopolysaccharide treatment significantly decreased the preterm birth rate , compared with lipopolysaccharide treatment alone . Medroxyprogesterone acetate treatment was more effective than 17-alpha hydroxyprogesterone caproate treatment in the prevention of preterm birth and result ed in live pups at term . Treatment with 17-alpha hydroxyprogesterone caproate was associated with significant maternal morbidity . CONCLUSION In the setting of intrauterine inflammation , progestational agents decrease the preterm birth rate but can result in maternal morbidity . 17-Alpha hydroxyprogesterone caproate should not be used in patients who are suspected of having sub clinical infection and /or acute preterm labor . The mechanisms by which progestational agents inhibit preterm birth warrants further investigations so that the use of this drug to appropriate population s could be pursued without undue fetal or maternal harm Objective To compare the effects of 50 mg or 200 mg of oral mifepristone with placebo on cervical ripening and induction of labor in primigravid women at term with unfavorable cervices . Methods This was a double-blind study in which 80 primigravidae at term with a modified Bishop score of 4 or less were r and omly assigned to one of three treatment groups . They were assessed at 24-hour intervals for 72 hours , after which labor was induced if it had not occurred spon-taneously . Results Two hundred milligrams of mifepristone result ed in a favorable cervix ( with a Bishop score greater than 6 or in spontaneous labor ) in significantly more women than placebo ( P = .01 ) . An improvement in cervical ripening was seen in the group given 50 mg of mifepristone , but this was not statistically significant . There were more cesarean deliveries performed for fetal distress in the group treated with 200 mg of mifepristone than placebo , but this was not statistically significant and was not associated with any differences between groups in terms of neonatal outcome . Conclusion Mifepristone , a progesterone antagonist , is known to cause softening and dilation of the human early pregnant cervix and an increase in uterine activity . It is theoretically attractive for use as an adjunct in cervical priming and labor induction . In this study , 200 mg of mifepristone was significantly more likely to result in a favorable cervix than placebo OBJECTIVE The purpose of this study was to evaluate whether 17-alpha-hydroxyprogesterone caproate ( 17P ) treatment affect changes in cervical length . STUDY DESIGN Women with singleton pregnancy , between 25 and 33 + 6 weeks of gestation , who were hospitalized for preterm labor were included . Patients with rupture of membranes and /or signs of chorioamnionitis were excluded . Sixty undelivered patients were allocated r and omly to either observation or to receive 341 mg of 17P intramuscularly , twice each week until gestational week 36 . Cervical length was measured by transvaginal ultrasound scanning at discharge and at day 7 and 21 after discharge . Statistical comparisons were done with analysis of variance and chi-square test . RESULTS Shortening of the cervix in the observation group ( 30 cases ) was higher than in the 17P group ( 30 cases ) both at day 7 ( 2.37 + /- 2.0 mm vs 0.83 + /- 1.74 mm ; P = .002 ) and day 21 ( 4.60 + /- 2.73 mm vs 2.40 + /- 2.46 mm ; P = .002 ) . Treatment with 17P was associated with both a reduction in the risk of cervical shortening of > or = 4 mm ( odds ratio , 0.18 ; 95 % CI , 0.04 - 0.66 ) and in the risk of preterm delivery ( odds ratio , 0.15 ; 95 % CI , 0.04 - 0.58 ) . CONCLUSION Undelivered patients after preterm labor undergo progressive shortening of the cervix , which is attenuated by 17P treatment OBJECTIVE The purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high-risk population . STUDY DESIGN A r and omized , double-blind , placebo-controlled study included 142 high-risk singleton pregnancies . Progesterone ( 100 mg ) or placebo was administered daily by vaginal suppository and all patients underwent uterine contraction monitoring with an external tocodynamometer once a week for 60 minutes , between 24 and 34 weeks of gestation . Progesterone ( n = 72 ) and placebo ( n = 70 ) groups were compared for epidemiologic characteristics , uterine contraction frequency , and incidence of preterm birth . Data were compared by chi(2 ) analysis and Fisher exact test . RESULTS The preterm birth rate was 21.1 % ( 30/142 ) . Differences in uterine activity were found between the progesterone and placebo groups ( 23.6 % vs 54.3 % , respectively ; P < .05 ) and in preterm birth between progesterone and placebo ( 13.8 % vs 28.5 % , respectively ; P < .05 ) . More women were delivered before 34 weeks in the placebo group ( 18.5 % ) than in the progesterone group ( 2.7 % ) ( P < .05 ) . CONCLUSION Prophylactic vaginal progesterone reduced the frequency of uterine contractions and the rate of preterm delivery in women at high risk for prematurity OBJECTIVE To investigate the efficacy of vaginal progesterone to prevent early preterm birth in women with sonographic evidence of a short cervical length in the midtrimester . METHODS This was a planned , but modified , secondary analysis of our multinational , multicenter , r and omized , placebo-controlled trial , in which women were r and omized between 18 + 0 and 22 + 6 weeks of gestation to receive daily treatment with 90 mg of vaginal progesterone gel or placebo . Cervical length was measured with transvaginal ultrasound at enrollment and at 28 weeks of gestation . Treatment continued until either delivery , 37 weeks of gestation or development of preterm rupture of membranes . Maternal and neonatal outcomes were evaluated for the subset of all r and omized women with cervical length < 28 mm at enrollment . The primary outcome was preterm birth at < /= 32 weeks . RESULTS A cervical length < 28 mm was identified in 46 r and omized women : 19 of 313 who received progesterone and 27 of 307 who received the placebo . Baseline characteristics of the two groups were similar . In women with a cervical length < 28 mm , the rate of preterm birth at < /= 32 weeks was significantly lower for those receiving progesterone than it was for those receiving the placebo ( 0 % vs. 29.6 % , P = 0.014 ) . With progesterone , there were fewer admissions into the neonatal intensive \n Output:\n " }, { "from": "agent", "value": "There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies .\nCONCLUSION Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Endothelial function is known to be abnormal in patients with diabetes and acute hyperglycaemia may play an aetiological role . AIMS The aim of this r and omised controlled study was to determine if acute systemic hyperglycaemia impairs endothelial function in normal subjects . METHODS Endothelial function was assessed by the change in brachial artery diameter in response to forearm ischaemia using B-mode ultrasound in ten healthy subjects ( eight male ) aged 19 - 35 years . Brachial artery blood flow velocity and diameter were measured before and after five minutes of forearm ischaemia . Measurements were performed in the supine position after an overnight fast , before and after 60 minute infusions of 0.9 % saline or 10 % dextrose . Measurements were made on two separate occasions at least 24 hours apart , and subjects were r and omised to saline first or dextrose first . The largest diameter measured after ischaemia was divided by the resting arterial diameter to calculate percent dilatation of the artery from baseline , and is reported as flow-mediated dilatation ( FMD ) . RESULTS Dextrose infusion result ed in a significant rise in mean ( SD ) serum glucose 5.2 ( 0.1 ) to 9.2 ( 0.3 ) mmol/L and insulin concentration 6.3 ( 1.4 ) to 20.6 ( 3.7 ) mU/L p<0.002 . Brachial artery blood flow velocity and diameter increased significantly from baseline after ischaemia ( p<0.002 ) . Mean FMD ( SEM ) before and after infusion were not , however , significantly different ( p=0.4 ) ( pre-saline 7.3 [1.0]% , post saline 5.2 [1.5]% and predextrose 8.1 [2.0]% , post dextrose 5.9 [1.7]% ) . CONCLUSIONS These data suggest that acute hyperglycaemia does not impair FMD in normal subjects Purpose Energy drinks are beverages containing vasoactive metabolites , usually a combination of caffeine , taurine , glucuronolactone and sugars . There are concerns about the safety of energy drinks with some countries banning their sales . We determined the acute effects of a popular energy drink , Red Bull , on cardiovascular and hemodynamic variables , cerebrovascular parameters and microvascular endothelial function . Methods Twenty-five young non-obese and healthy subjects attended two experimental sessions on separate days according to a r and omized crossover study design . During each session , primary measurements included beat-to-beat blood pressure measurements , impedance cardiography and transcranial Doppler measurements for at least 20 min baseline and for 2 h following the ingestion of either 355 mL of the energy drink or 355 mL of tap water ; the endothelial function test was performed before and two hours after either drink . Results Unlike the water control load , Red Bull consumption led to increases in both systolic and diastolic blood pressure ( p < 0.005 ) , associated with increased heart rate and cardiac output ( p < 0.05 ) , with no significant changes in total peripheral resistance and without diminished endothelial response to acetylcholine ; consequently , double product ( reflecting myocardial load ) was increased ( p < 0.005 ) . Red Bull consumption also led to increases in cerebrovascular resistance and breathing frequency ( p < 0.005 ) , as well as to decreases in cerebral blood flow velocity ( p < 0.005 ) and end-tidal carbon dioxide ( p < 0.005 ) . Conclusion Our results show an overall negative hemodynamic profile in response to ingestion of the energy drink Red Bull , in particular an elevated blood pressure and double product and a lower cerebral blood flow velocity Postpr and ial hyperglycemia induces oxidative stress responses , impairs vascular endothelial function ( VEF ) and increases the risk of cardiovascular disease . We hypothesized that the antioxidant and anti-inflammatory activities of a γ-tocopherol-rich mixture of tocopherols ( γ-TmT ) would protect against vascular dysfunction that is otherwise caused by postpr and ial hyperglycemia by decreasing oxidative stress and proinflammatory responses , and improving nitric oxide ( NO• ) homeostasis . In a r and omized , crossover study , healthy men ( n=15 ; 21.8 ± 0.8 years ) completed a fasting oral glucose challenge ( 75 g ) with or without prior supplementation of γ-TmT ( 5 days ) . Brachial artery flow-mediated dilation ( FMD ) , plasma glucose , insulin , antioxidants , malondialdehyde ( MDA ) , inflammatory proteins , arginine and asymmetric dimethylarginine ( ADMA ) were measured at regular intervals during a 3-h postpr and ial period . Supplementation of γ-TmT increased ( P<.05 ) plasma γ-T by threefold and γ-carboxyethyl-hydroxychroman by more than ninefold without affecting α-T , glucose , arginine or ADMA . Baseline FMD , MDA , arginine and ADMA were unaffected by γ-TmT ( P>.05 ) . Postpr and ial FMD decreased 30%-44 % ( P<.05 ) following glucose ingestion , but was maintained with γ-TmT. Supplementation of γ-TmT also attenuated postpr and ial increases in MDA that occurred following glucose ingestion . Plasma arginine decreased ( P<.05 ) in both trials to a similar extent regardless of γ-TmT supplementation . However , the ratio of ADMA/arginine increased time-dependently in both trials ( P<.05 ) , but to a lesser extent following γ-TmT supplementation ( P<.05 ) . Inflammatory proteins were unaffected by glucose ingestion or γ-TmT. Collectively , these findings support that short-term supplementation of γ-TmT maintains VEF during postpr and ial hyperglycemia possibly by attenuating lipid peroxidation and disruptions in NO• homeostasis , independent of inflammation An oral glucose challenge causes transient impairment of endothelial function , probably because of increased oxidative stress . During oxidative stress , endothelial nitric oxide ( NO ) synthase ( eNOS ) becomes uncoupled because of decreased bioavailability of tetrahydrobiopterin ( BH4 ) , an essential cofactor of eNOS . Therefore , we examined whether an acute supplement of BH4 could restore endothelial dysfunction induced by an oral glucose challenge . Healthy subjects were examined in 53 experiments . Forearm blood flow was measured by venous occlusion plethysmography . Dose-response studies were obtained during intra-arterial infusion of serotonin to elicit endothelium-dependent , NO-specific vasodilation and during sodium nitroprusside ( SNP ) infusion to elicit endothelium-independent vasodilation . Subjects were examined before ( fasting ) and 1 and 2 h after an oral glucose challenge ( 75 g ) with serotonin ( n = 10 ) and SNP ( n = 8) . On different days (6R)-5,6,7,8-tetrahydro-l-biopterin dihydrochloride ( 6R-BH4 ; n = 10 ) , the active cofactor of eNOS or its stereoisomer (6S)-5,6,7,8-tetrahydro-l-biopterin sulfate ( 6S-BH4 ; n = 10 ) , which is inactive as a cofactor , was added 10 min ( 500 microg/min ) before and during the 1-h postchallenge serotonin dose-response study . In vitro studies showed that 6R-BH4 and 6S-BH4 were equipotent antioxidants . Serotonin response was reduced by 24 + /- 7 % ( at the highest dose ) at 1 h postchallenge compared with fasting ( P = 0.001 ) and was restored 2 h postchallenge . The reduction was reversed by the administration of 6R-BH4 but not by 6S-BH4 . SNP responses were slightly increased 1 and 2 h postchallenge ( increased by 15 + /- 13 % at third dose 2 h postchallenge , P = 0.0001 ) . An oral glucose challenge causes transient , NO-specific , endothelial dysfunction , which may be reversed by BH4 . Transient postpr and ial endothelial dysfunction may be partly explained by reduced bioavailability of BH4 and NO Brachial artery vasoactivity ( BAVA ) is a reliable , noninvasive method of assessing endothelium-dependent vasodilatation ( EDV ) in vivo . Acute hyperglycemia , impaired glucose tolerance ( IGT ) , and diabetes mellitus impair EDV , a precursor to atherosclerosis . Thiamine is a coenzyme important in intracellular glucose metabolism . The purpose of this study was to evaluate the effect of thiamine on BAVA in the presence of hyperglycemia . Ten healthy subjects ( group H , mean age 27 years ) , 10 patients with impaired glucose tolerance by World Health Organization criteria ( group IGT , mean age 65 years ) , and 10 patients with non-insulin-dependent diabetes mellitus ( group NIDDM , mean age 50 years ) were studied . Duplex ultrasound was used to measure brachial artery flow changes in response to reactive hyperemia following brachial artery tourniquet occlusion for 5 min . This test was performed after a 10 hr fast and at 30 , 60 , and 120 min after a 75 g oral glucose challenge along with measurements of blood glucose level ( BGL ) . A week later , BAVA evaluation was repeated after administration of 100 mg of intravenous thiamine . BAVA ( % increased blood flow ) at peak and trough BGL was compared with and without thiamine . BAVA at peak glucose improved from 69.0 ± 6.4 % to 152.8 ± 22.9 % in group H ( p < 0.005 ) , from 57.6 ± 12.6 % to 139.7 ± 12.4 % in group IGT ( p < 0.005 ) , and from 57.8 ± 8.3 % to 167.8 ± 11.6 % in group NIDDM ( p < 0.005 ) following administration of thiamine . On the other h and , at trough glucose levels , BAVA remained essentially unchanged in group H ( prethiamine 83.8 ± 6.5 % vs. post-thiamine 83.8 ± 17.0 % , p > 0.05 ) as well as group IGT ( prethiamine 96.7 ± 8.5 % vs. post-thiamine 104.0 ± 17.4 % , p > 0.05 ) . BAVA at trough glucose was not measured in group NIDDM secondary to trough BGL > 140 mg/dL. EDV was improved by thiamine in the presence of hyperglycemia in healthy subjects and in patients with IGT and NIDDM . The mechanism by which thiamine improves EDV is not due to a glucose-lowering effect as thiamine had no effect on EDV under normoglycemic conditions . Routine administration of thiamine might improve endothelial function and therefore slow the development and progression of atherosclerosis , especially in patients with IGT and NIDDM who are prone to develop accelerated atherosclerosis In perinatal psychiatry , r and omized controlled trials are often not feasible on ethical grounds . Many studies are observational in nature , while others employ large data bases not design ed primarily for research purpose s. Quality assessment of the result ing research is complicated by a lack of st and ardized tools specifically for this purpose . The aim of this paper is to describe the Systematic Assessment of Quality in Observational Research ( SAQOR ) , a quality assessment tool our team devised for a series of systematic review s and meta‐analyses of evidence ‐based literature regarding risks and benefits of antidepressant medication during pregnancy . Copyright © 2011 John Wiley & Sons , Background Postpr and ial hyperglycemia is believed to affect vascular endothelial function . The aim of our study was to compare the effects of acarbose and nateglinide on postpr and ial endothelial dysfunction . Methods We recruited a total of 30 patients with newly diagnosed type 2 diabetes ( 19 men and 11 women , age 67.8 ± 7.3 years ) . Patients were r and omly assigned to 3 groups receiving either 300 mg/day acarbose , 270 mg/day nateglinide , or no medication . A cookie test ( consisting of 75 g carbohydrate , 25 g butter fat , and 7 g protein for a total of 553 kcal ) was performed as dietary tolerance testing . During the cookie test , glucose and insulin levels were determined at 0 , 30 , 60 , and 120 min after load . In addition , endothelial function was assessed by % flow-mediated dilation ( FMD ) of the brachial artery at 0 and 120 min after cookie load . Results Postpr and ial gluc \n Output:\n " }, { "from": "agent", "value": "Macrovascular endothelial function was inversely associated with age , blood pressure , and low-density lipoprotein cholesterol and was positively associated with the postocclusion interval of vascular assessment .\nIn healthy and diseased subjects , we found evidence for macrovascular but not microvascular endothelial dysfunction during acute hyperglycemia" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Recent r and omized trials and meta-analyses demonstrated that a complete revascularization of significant non culprit lesions in patients with ST elevation myocardial infa rct ion ( STEMI ) is superior to a culprit only revascularization approach in reducing major adverse cardiac events ( MACE ) , however the proportion of diabetic patients was low in these trials . OBJECTIVES To investigate whether a complete revascularization approach is associated with better outcomes in diabetic patients with STEMI and multi-vessel disease . METHODS One hundred diabetic patients with acute STEMI with at least one non-culprit lesion were r and omized to either complete revascularization ( n = 50 ) or culprit-only treatment ( n = 50 ) . Complete revascularization was performed either at the time of primary percutaneous coronary intervention ( PCI ) or within 72 hours during hospitalization . The primary endpoint was the composite of all-cause mortality , recurrent MI , and ischemia-driven revascularization at 6 months . RESULTS A complete revascularization approach was significantly associated with a reduction in the primary outcome ( 6 % vs. 24 % , P = 0.01 ) , primarily due to reduction in ischemia driven revascularization in the complete revascularization group ( 2 % vs. 12 % ; P = 0.047 ) . There was no significant reduction in death or MI ( 2 % vs. 8 % ; P = 0.17 ) and ( 2 % vs. 4 % ; P = 0.56 ) respectively , or in the safety endpoints of major or minor bleeding , contrast-induced nephropathy , or stroke between the groups . CONCLUSIONS In diabetic patients with multi-vessel coronary artery disease undergoing PPCI , complete revascularization is associated with significantly reduced risk of adverse cardiovascular events , as compared with culprit vessel only PCI . ( J Interven Cardiol 2016;29:241 - 247 ) Background There are conflicting data regarding optimal treatment of non-culprit lesions detected during primary percutaneous coronary intervention ( PCI ) in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multi-vessel disease ( MVD ) . We aim ed to investigate whether ischaemia-driven early invasive treatment improves the long-term outcome and prevents major adverse cardiac events ( MACE ) . Methods 121 patients with at least one non-culprit lesion were r and omised in a 2:1 manner , 80 were r and omised to early fractional flow reserve (FFR)-guided PCI ( invasive group ) , and 41 to medical treatment ( conservative group ) . The primary endpoint was MACE at 3 years . Results Three-year follow-up was available in 119 patients ( 98.3 % ) . There was no significant difference in all-cause mortality between the invasive and conservative strategy , 4 patients ( 3.4 % ) died , all in the invasive group ( P = 0.29 ) . Re-infa rct ion occurred in 14 patients ( 11.8 % ) in the invasive group versus none in the conservative group ( p = 0.002 ) . Re-PCI was performed in 7 patients ( 8.9 % ) in the invasive group and in 13 patients ( 32.5 % ) in the conservative group ( P = 0.001 ) . There was no difference in MACE between these two strategies ( 35.4 vs 35.0 % , p = 0.96 ) . Conclusions In STEMI patients with MVD , early FFR-guided additional revascularisation of the non-culprit lesion did not reduce MACE at three-year follow-up compared with a more conservative strategy . The rate of MACE in the invasive group was predominantly driven by death and re-infa rct ion , whereas in the conservative group the rate of MACE was only driven by repeat interventions Results of recent studies have suggested that routine cardiac catheterization may be unnecessary after reperfusion therapy for acute myocardial infa rct ion . Therefore to better define the short-term prognostic value of early coronary angiography , and specifically the prognostic significance of multivessel coronary artery disease , the angiographic findings of 855 patients consecutively enrolled in five phases of the TAMI study were correlated with their in-hospital outcome . All patients received intravenous thrombolytic therapy ( tissue plasminogen activator , urokinase , or both agents ) and underwent cardiac catheterization within 90 minutes of the initiation of therapy . Multivessel disease , defined as the presence of greater than or equal to 75 % luminal diameter stenosis in two or more major epicardial arteries , was documented in 236 patients . When compared with the group of patients without multivessel disease , this group had a higher prevalence of coronary risk factors and more frequently had a history of antecedent ischemic chest pain . Although the severity of the infa rct zone dysfunction was similar in the two groups ( -2.77 + /- 1.00 vs -2.50 + /- 1.09 SD/chord , p = NS ) , global left ventricular ejection fraction was lower in the group with multivessel disease ( 48.6 + /- 12.4 % vs 51.8 + /- 10.6 % , p less than 0.01 ) . This was associated with a significant difference in the function of the noninfa rct zone . Whereas this region was hyperkinetic in the group with minimal or single-vessel disease , it was hypocontractile or dyskinetic in those with multivessel disease ( + 0.66 + /- 1.53 vs -0.52 + /- 1.73 SD/chord , p = 0.0001 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Background : In the Preventive Angioplasty in Myocardial Infa rct ion trial ( PRAMI ; IS RCT N73028481 ) , immediate multivessel PCI ( MV-PCI ) of non-IRA ( infa rct related artery ) lesions in patients with acute ST elevation myocardial infa rct ion ( STEMI ) and multivessel coronary disease ( MVD ) improved long term prognosis . We assessed infa rct distribution and size in a pre-specified cardiac magnetic resonance ( CMR ) sub- study . Methods : In this single centre prospect i ve sub- study , PRAMI participants were invited to undergo 1.5 Tesla CMR 1 week and 1 year after primary PCI . The CMR scans were analysed using semi-automated software by a clinician blinded to treatment group assignment and clinical outcomes . The presence and extent of infa rct ion were assessed quantitatively with late gadolinium enhancement ( LGE ) imaging ( Gadovist , 0.1 mmol/kg ) . The infa rct was delineated as an area of myocardial enhancement ( cm2 ) using a signal intensity threshold of > 5SDs above a remote region , and expressed as a % of total LV mass . The incidence of new LGE in non-infa rct related artery territories at baseline and 1 year were assessed . Data were analysed by an independent statistician . Results : Of 465 r and omised trial participants in 6 UK hospitals , 138 ( 30 % ) were enrolled in Glasgow . Of these 80 patients underwent CMR 1 week post primary PCI of whom 41 ( 51 % ) were in the multi-vessel PCI group and 39 ( 49 % ) were in the IRA-only group . At 1 year , 69 ( 86 % ) patients had a follow up CMR scan . Infa rct size and distribution are described in Table 1 BACKGROUND In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infa rct ion , ischemic postconditioning has been shown to reduce infa rct size , but the effect on clinical outcome has not been tested in a large r and omized trial . In addition , deferring stent implantation in the infa rct -related lesion 1 to 3 days after acute opening of the infa rct -related artery could have protective effects , by reducing the risk of injury caused by distal embolization and microvascular obstruction . Finally , a considerable fraction of patients present with lesions in other coronary artery branches than the infa rct -related artery . Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain . STUDY DESIGN The DANAMI 3 trial program was design ed to investigate 3 different r and omized treatment strategies in patients with ST-segment elevation myocardial infa rct ion : ( 1 ) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure ; ( 2 ) deferring stent implantation in the infa rct -related lesion versus conventional treatment with a primary end point of death , hospitalization for heart failure , reinfa rct ion , and repeat revascularization ; and ( 3 ) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease , with a primary end point of death , reinfa rct ion , and repeat revascularization . SUMMARY The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization Background Few reports described outcomes of complete compared with infa rct -related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multivessel coronary artery disease ( CAD ) . Moreover , no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions ( staged revascularisation ) . Methods The outcomes of 214 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied . Before the first angioplasty patients were r and omly assigned to three different strategies : culprit vessel angioplasty-only ( COR group ) ; staged revascularisation ( SR group ) and simultaneous treatment of non-IRA ( CR group ) . Results During a mean follow-up of 2.5 years , 42 ( 50.0 % ) patients in the COR group experienced at least one major adverse cardiac event ( MACE ) , 13 ( 20.0 % ) in the SR group and 15 ( 23.1 % ) in the CR group , p<0.001 . Inhospital death , repeat revascularisation and re-hospitalisation occurred more frequently in the COR group ( all p<0.05 ) , whereas there was no significant difference in re-infa rct ion among the three groups . Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups . Conclusions Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment . Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA AIMS To examine the incidence of and propensity for non-culprit interventions performed at the time of the primary percutaneous coronary intervention ( PCI ) and its association with 90-day outcomes . METHODS AND RESULTS We examined the incidence , propensity for , and associated 90-day outcomes following non-culprit interventions performed at the time of primary PCI among ST-elevation myocardial infa rct ion patients with multi-vessel coronary artery disease ( MVD ) . Of the 5373 patients who underwent primary PCI in the APEX-AMI trial , 2201 had MVD . Of those , 217 ( 9.9 % ) underwent non-infa rct -related arteries ( IRA ) PCI , whereas 1984 ( 90.1 % ) underwent PCI of the IRA alone . Ninety-day death and death/CHF/shock were higher in the non-IRA group compared with the IRA-only PCI group ( 12.5 vs. 5.6 % , P ( log-rank ) < 0.001 and 17.4 vs. 12.0 % , P ( log-rank ) = 0.020 , respectively ) . After adjusting for patient and procedural characteristics as well as propensity for performing non-IRA PCI , this procedure remained independently associated with an increased hazard of 90-day mortality [ adjusted hazard ratio 2.44 , 95 % CI ( 1.55 - 3.83 ) , P < 0.001 ] . CONCLUSION Non-culprit coronary interventions were performed at the time of primary PCI in 10 % of MVD patients and were significantly associated with increased mortality . Our data support current guideline recommendations discouraging the performance of such procedures in stable primary PCI patients . Prospect i ve r and omized study of this issue may be warranted BACKGROUND Rapid recanalization of infa rct -related artery ( IRA ) has become the major target during primary percutaneous coronary intervention ( PCI ) for patients with ST-elevation myocardial infa rct ion ( MI ) , but strategy for treatment of non-IRA lesions in this setting remains unclear . This study aim ed to compare long-term effects between PCI for IRA only and that for both IRA and non-IRA in ST-elevation MI patients with multi-vessel disease . METHODS A total of 242 eligible patients with ST-elevation MI and at least two diseased coronary arteries ( luminal narrowing > or = 70 % ) undergoing primary PCI were included \n Output:\n " }, { "from": "agent", "value": "TSA of long-term all-cause mortality , long-term cardiovascular mortality , and long-term non-fatal myocardial infa rct ion showed that more RCTs are needed to reach more conclusive results on these outcomes .\nRegarding long-term repeat revascularisation more RCTs may not change our present result .\nTSA also supports the need for more RCTs in order to draw stronger conclusions regarding the effects of complete revascularisation on long-term all-cause mortality , long-term cardiovascular mortality , and long-term non-fatal myocardial infa rct ion" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Purpose — The role of uric acid as a risk factor for myocardial infa rct ion is controversial , and little is known about its role as a risk factor for stroke . Recent evidence suggests that uric acid may be an important causal agent in cardiovascular disease , for example , by inducing renal disease and hence hypertension . We investigated the association between serum uric acid and coronary heart disease and stroke in a large prospect i ve population -based study . Methods — The study was based on 4385 participants of the Rotterdam Study who , at baseline ( 1990 to 1993 ) , were ≥55 years of age , free from stroke and coronary heart disease , and had blood taken . Follow-up for incident stroke and myocardial infa rct ion was complete until January 1 , 2002 . Data were analyzed with Cox proportional hazards models with adjustment for relevant confounders . Results — Average follow-up was 8.4 years . High serum uric acid levels were associated with risk of myocardial infa rct ion and stroke ; age- and sex-adjusted hazard ratios ( 95 % CIs ) for highest versus lowest quintile of uric acid were 1.68 ( 1.24 to 2.27 ) for cardiovascular disease ( 515 cases ) , 1.87 ( 1.12 to 3.13 ) for myocardial infa rct ion ( 194 cases ) , 1.57 ( 1.11 to 2.22 ) for stroke ( 381 cases ) , 1.77 ( 1.10 to 2.83 ) for ischemic stroke ( 205 cases ) , and 1.68 ( 0.68 to 4.15 ) for hemorrhagic stroke ( 46 cases ) . Adjustment for other vascular risk factors only slightly attenuated these associations . Associations were stronger in persons without hypertension than in those with hypertension . Conclusions — Uric acid is a strong risk factor for myocardial infa rct ion and stroke BACKGROUND The role of serum uric acid ( SUA ) as a risk factor for cardiovascular disease ( CVD ) remains controversial . Little is known about its predictive value for mortality from congestive heart failure ( CHF ) and stroke , particularly in elderly , post-menopausal women . METHODS The relation of SUA to risk of death from total CVD , CHF , stroke and coronary heart disease ( CHD ) was examined prospect ively in a large cohort of 28613 elderly Austrian women ( mean age 62.3 years ) , followed-up for a median of 15.2 years . Adjusted Cox proportional hazards models were calculated to evaluate SUA as an independent predictor for fatal CVD events . RESULTS SUA in the highest quartile ( > or=5.41 mg/dL ) was significantly associated with mortality from total CVD ( p<0.0001 ) , showing a clear dose-response relationship ; the adjusted hazard ratio ( 95%CI ) in comparison to the lowest SUA quartile was 1.35 ( 1.20 - 1.52 ) . In subgroup analyses SUA was independently predictive for deaths from acute and subacute ( p<0.0001 ) and chronic forms ( p=0.035 ) of CHD , yielding adjusted hazard ratios for the highest versus lowest SUA quartile of 1.58 ( 1.19 - 2.10 ) and 1.25 ( 1.01 - 1.56 ) , respectively . SUA was further significantly related to fatal CHF ( p<0.0001 ) and stroke ( p=0.018 ) ; the adjusted hazard ratios for the highest versus lowest SUA quartile were 1.50 ( 1.04 - 2.17 ) and 1.37 ( 1.09 - 1.74 ) , respectively . CONCLUSIONS These findings , for the first time , demonstrate that SUA is an independent predictor for all major forms of death from CVD including acute , subacute and chronic forms of CHD , CHF and stroke in elderly , post-menopausal women Background — Although gout and hyperuricemia are related to several conditions that are associated with reduced survival , no prospect i ve data are available on the independent impact of gout on mortality . Furthermore , although many studies have suggested that hyperuricemia is associated with cardiovascular disease ( CVD ) , limited data are available on the impact of gout on CVD . Methods and Results — Over a 12-year period , we prospect ively examined the relation between a history of gout and the risk of death and myocardial infa rct ion in 51 297 male participants of the Health Professionals Follow-Up Study . During the 12 years of follow-up , we documented 5825 deaths from all causes , which included 2132 deaths from CVD and 1576 deaths from coronary heart disease ( CHD ) . Compared with men without history of gout and CHD at baseline , the multivariate relative risks among men with history of gout were 1.28 ( 95 % confidence interval [ CI ] , 1.15 to 1.41 ) for total mortality , 1.38 ( 95 % CI , 1.15 to 1.66 ) for CVD deaths , and 1.55 ( 95 % CI , 1.24 to 1.93 ) for fatal CHD . The corresponding relative risks among men with preexisting CHD were 1.25 ( 95 % CI , 1.09 to 1.45 ) , 1.26 ( 95 % CI , 1.07 to 1.50 ) , and 1.24 ( 95 % CI , 1.04 to 1.49 ) , respectively . In addition , men with gout had a higher risk of nonfatal myocardial infa rct ion than men without gout ( multivariate relative risk , 1.59 ; 95 % CI , 1.04 to 2.41 ) . Conclusions — These prospect i ve data indicate that men with gout have a higher risk of death from all causes . Among men without preexisting CHD , the increased mortality risk is primarily a result of an elevated risk of CVD death , particularly from CHD Study objective : To investigate the association of residence in mountainous or lowl and areas with total and coronary mortality , in a cohort with 15 years of follow up . Design and setting : Prospect i ve study , based on the adult population of two lowl and and one mountainous village in rural Greece . Baseline measurements on sociodemographic , lifestyle , somatometric , clinical , and biochemical variables were recorded in 1981 during a health survey and total and coronary deaths were ascertained on the basis of death certificates up to 1996 . Participants : 1198 men and women , who had participated in the 1981 survey . Analyses are based on 504 men and 646 women with complete data . Main results : There were 150 deaths among men and 140 among women ( coronary deaths : 34 and 33 respectively ) . In multivariate analysis with Cox regression , after adjustment for age , education , body weight , smoking , alcohol consumption , systolic blood pressure , serum total cholesterol , blood glucose , serum triglycerides , and serum uric acid , total and coronary mortality were lower for residents of the mountainous village in comparison with residents of the lowl and villages ( hazard ratios ( 95 % confidence intervals ) for men and women , respectively : total mortality , 0.57 ( 0.38 to 0.84 ) and 0.69 ( 0.47 to 1.02 ) ; coronary mortality , 0.39 ( 0.16 to 0.98 ) and 0.46 ( 0.20 to 1.05 ) ) . Conclusions : Residence in mountainous areas seems to have a “ protective effect ” from total and coronary mortality . Increased physical activity from walking on rugged terrains under conditions of moderate hypoxia among the mountain residents could explain these findings PURPOSE Approximately half of previous studies on serum uric acid have reported it to be an independent risk factor for coronary heart disease ( CHD ) . We tested this hypothesis in the Atherosclerosis Risk in Communities ( ARIC ) Study . METHODS A total of 13,504 healthy middle-aged men and women were followed prospect ively for up to eight years . We identified 128 fatal and nonfatal CHD events in women and 264 in men . RESULTS The age- , race- , and ARIC field center-adjusted relative risk of CHD for sex-specific quartiles of serum uric acid were 1.0 , 1.39 , 1.08 , and 2.35 in women ( p for trend = 0.009 ) and 1.0 , 1.03 , 0.89 , and 1.21 in men ( p for trend = 0.44 ) , respectively . However , serum uric acid was correlated positively with many risk factors , and after multivariable adjustment , there was little evidence of an association of uric acid with CHD in either sex . CONCLUSIONS Our results are not consistent with serum uric acid being an independent risk factor for CHD BACKGROUND The role of serum uric acid ( SUA ) as an independent risk factor for cardiovascular disease ( CVD ) remains controversial , and little is known about its prognostic importance for mortality from congestive heart failure ( CHF ) and stroke . Few large-scale epidemiologic studies with sufficient follow-up have addressed the association of SUA and CVD mortality in apparently healthy men across a wide age range . METHODS A cohort of 83 683 Austrian men ( mean age , 41.6 years ) was prospect ively followed for a median of 13.6 years . We used Cox proportional hazards models adjusted for established risk factors to evaluate SUA as an independent predictor for CVD mortality . RESULTS The highest quintile of SUA concentration ( > 398.81 mumol/L ) was significantly related to mortality from CHF ( P = 0.03 ) and stroke ( P < 0.0001 ) ; adjusted hazard ratios ( 95 % confidence interval ) for the highest vs lowest quintiles of SUA were 1.51 ( 1.03 - 2.22 ) and 1.59 ( 1.23 - 2.04 ) , respectively . SUA was not associated , however , with mortality from acute , subacute , or chronic forms of coronary heart disease ( CHD ) after adjustment for potential confounding factors ( P = 0.12 ) . Age was a significant effect modifier for the relation of SUA to fatal CHF ( P = 0.05 ) , with markedly stronger associations found in younger individuals . CONCLUSIONS Our study demonstrates for the first time in a large prospect i ve male cohort that SUA is independently related to mortality from CHF and stroke . Although increased SUA is not necessarily a causal risk factor , our results suggest the clinical importance of monitoring and intervention based on the presence of an increased SUA concentration , especially because SUA is routinely measured Background Increased blood and plasma viscosity , hematocrit , fibrinogen , and activation of coagulation and leukocytes have been reported in patients with claudication ; however , their associations with symptomatic and asymptomatic peripheral arterial disease have not been reported in an epidemiological study Methods and Results Blood and plasma viscosity , hematocrit , fibrinogen , urinary fibrinopeptide A , plasma leukocyte elastase , and uric acid were measured in a r and om sample of 1,581 men and women aged 55 - 74 years in Edinburgh , Scotl and , and related to peripheral arterial stenosis ( ankle-brachial systolic pressure index , ABPI ) and to lower limb ischemia ( intermittent claudication and reactive hyperemia test ) . Each variable ( except fibrinopeptide A ) was significantly related to prevalent symptomatic and asymptomatic peripheral arterial disease . On multivariate analysis , blood viscosity ( p<0.05 ) and fibrinogen ( p<0.01 ) were independently associated with peripheral arterial narrowing ( ABPI ) ; a positive interaction was found between fibrinogen and smoking in the association with ABPI . Plasma viscosity was associated with claudication in the presence of a given degree of arterial narrowing ( odds ratio of claudication in top quintile compared with bottom quintile of plasma viscosity , 3.35 ; 95 % CI , 1.32 , 8.51 ) . Leukocyte elastase and uric acid were each associated with reactive hyperemia independently of arterial narrowing ( p<0.01 ) . Conclusion Blood rheological factors and leukocyte activation as well as arterial narrowing are associated with lower limb ischemia in the general population and may be implicated in its pathogenesis Low serum cholesterol concentrations are associated with deaths from cancer . This association was found in a prospect i ve study of middle aged men in Malmö and consideration of possible explanations for the lowering of serum cholesterol prompted an analysis of serum urate in relation to deaths from cancer . A total of 127 of the 7725 participants in the Malmö study had died since screening . A weakly positive but significant correlation between raised serum urate concentration and total mortality was found . This correlation was wholly explained by neoplastic deaths ( p less than 0.01 ) , while there were no associations with alcohol related deaths or with deaths from coronary heart disease . When the deaths from cancer were classified as \" early \" or \" late \"-- that is , occurring less than or more than 2.5 years after the screening -- the correlation between raised urate concentr \n Output:\n " }, { "from": "agent", "value": "Hyperuricemia may marginally increase the risk of CHD events , independently of traditional CHD risk factors ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The present study investigated the influence of a weight loss reality TV show on body satisfaction , mood and food consumption . Young Australian women ( N = 99 ) first completed baseline measures of state body satisfaction and mood . They were then r and omly allocated to either a weight loss or a home renovation programme and were provided with snack foods during viewing . Post- measures included state body satisfaction , state mood and trait dietary restraint and snack food consumption . BMI moderated the relationship between condition and body satisfaction and mood . Larger women experienced less body satisfaction and less positive mood in response to the weight loss programme . Dietary restraint moderated the relationship between condition and food consumption . A greater percentage of women with lower dietary restraint ate in the control condition ; whilst a greater percentage of women with higher dietary restraint ate food whilst watching the weight loss programme . These findings highlight the potential negative impact of weight-focused reality TV on mood , body satisfaction and snack food consumption among some women Existing strategies for coping with food cravings are of unknown efficacy and rely on principles that have been shown to have paradoxical effects . The present study evaluated novel , acceptance-based strategies for coping with craving by r and omly assigning 48 overweight women to either an experimental psychological acceptance-oriented intervention or a st and ard cognitive re appraisal /distraction intervention . Participants were required to carry a box of sweets on their person for 72 h while abstaining from any consumption of sweets . Results suggested that the acceptance-based coping strategies result ed in lower cravings and reduced consumption , particularly for those who demonstrate greater susceptibility to the presence of food and report a tendency to engage in emotional eating The present research explored the effects of pre-exposure to temptation primes and dieting primes on food intake , goal accessibility and explicit automatic evaluations of food-enjoyment and dieting goals among restrained and unrestrained eaters . Participants ( n= 166 ) were r and omly assigned to three conditions : food-cue , dieting , or control , in which they were exposed to incidental presentation of gourmet , fashion or geographic magazines , respectively . Words related to the goals of dieting and /or food- enjoyment were presented in a computer decision task following the incidental presentation of gourmet , dieting , and geographic magazine photographs . The computer task and the presentation of food were counterbalanced . Participants ' food intake was assessed in a taste-rating task . Restrained eaters ate more than did unrestrained eaters across the three conditions . Restrained eaters who were exposed to food cues ate more than did restrained eaters in the control condition and they evaluated the goal of dieting more negatively compared to restrained eaters in the other two conditions . These findings were inconsistent with ' Counteractive Self-Control Theory ' but consistent with previous studies on the effects of food-cue exposure in restrained eaters Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more This study explored the efficacy of a mindfulness-based intervention for problematic eating behavior . A non- clinical sample of 26 women with disordered eating behavior was r and omly assigned to an 8-week MBCT-based eating intervention or a waiting list control group . Data were collected at baseline and after 8 weeks . Compared to controls , participants in the mindfulness intervention showed significantly greater decreases in food cravings , dichotomous thinking , body image concern , emotional eating and external eating . These findings suggest that mindfulness practice can be an effective way to reduce factors that are associated with problematic eating behaviour \n Output:\n " }, { "from": "agent", "value": "Cue type and level of engagement did not significantly moderate the effect ; however , specific cues ( low-calorie foods and thin models ) and attended engagement yielded significant effects .\nConclusions Based on the data available , weight control cues reduce food intake in individuals with strong weight control goals ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Cognitive decline leads to disability and increased health care expenditures . Methods : Effectiveness of an intervention to stimulate multiple cognitive domains was determined using a format combining traditional and computer-based activities ( Integrated Cognitive Stimulation and Training Program ) , 45 minutes a day , 2 days a week , for 6 weeks . Nonimpaired , mildly , and moderately-impaired participants > age 65 ( n = 32 ) were r and omly allocated into a control or experimental group . Using a repeated measures design participants were tested again postintervention and at 8 weeks follow-up . Results : Statistically significant improvement on Dementia Rating Scale scores occurred for mildly and moderately impaired treatment participants ( n = 15 ) . Statistical significance was demonstrated on subscales of the WMS-III : Logical Memory I and Logical Memory II . Conclusion : Blending computer-based with traditional cognitive stimulation activities shows promise in preserving cognitive function in elders . Future studies to explore efficacy in larger , more diverse sample s are needed Background Errorless learning ( EL ) is a method for optimizing learning , which uses feed-forward instructions in order to prevent people from making mistakes during the learning process . The majority of previous studies on EL taught patients with dementia artificial tasks of little or no relevance for their daily lives . Furthermore , only a few controlled studies on EL have so far been performed and just a h and ful of studies have examined the long-term effects of EL . Tasks were not always trained in the patients ’ natural or home environment , limiting the external validity of these studies . This multicenter parallel r and omized controlled trial examines the effects of EL compared with trial and error learning ( TEL ) on the performance of activities of daily living in persons with Alzheimer ’s or mixed-type dementia living at home . Methods Patients received nine 1-hour task training sessions over eight weeks using EL or TEL . Task performance was measured using video observations at week 16 . Secondary outcome measures were task performance measured at week 26 , satisfaction with treatment , need for assistance , challenging behavior , adverse events , re source utilization and treatment costs . Results A total of 161 participants were r and omized , of whom 71 completed the EL and 74 the TEL arm at week 11 . Sixty-nine EL patients and 71 TEL patients were assessed at the 16-week follow-up ( the primary measurement endpoint ) . Intention-to-treat analysis showed a significantly improved task performance in both groups . No significant differences between the treatment groups were found for primary or secondary outcomes . Conclusions Structured relearning improved the performance of activities of daily living . Improvements were maintained for 6 months . EL had no additional effect over TEL.Trial registration German Register of Clinical Trials DRKS00003117 . Registered 31 May 2011 [ Purpose ] The purpose of this study was to investigate the effect of cognitive rehabilitation including tasks of cognitive training on performance of everyday activities in elderly people with early-stage Alzheimer ’s disease . [ Subjects and Methods ] Forty-three elderly people ( 15 men , 28 women ) with a diagnosis of Alzheimer ’s disease who had a Mini-Mental State Examination ( MMSE ) score of 18 or above were r and omly assigned to two groups : the cognitive rehabilitation group ( experimental ) and control group . This study used a r and omized controlled trial design . Cognitive rehabilitation is consisted of 8 sessions , each lasting 60 minutes ( individual 30 min , group 30 min ) . The eight weekly individual sessions of cognitive rehabilitation were performed consisting of an individualized intervention focusing on a personally meaningful goal . The eight weekly group sessions involved practicing time- and -place orientation , matching faces and names , and learning memory and sustaining attention . [ Results ] Significant improvements were observed in rating of occupation performance and satisfaction , Quality of Life in Alzheimer ’s Disease ( QOL-AD ) , and the orientation subscale of the MMSE in the experimental group , whereas participants in the control group did not show any significant difference in any tests between before and after the intervention . [ Conclusion ] Cognitive rehabilitation including tasks of cognitive training is an effective intervention for improving performance and satisfaction with respect to activities of daily living and specific cognitive functions BACKGROUND Increasing evidence demonstrates the efficacy of cognitive stimulation ( CS ) in individuals with dementia . However , conducting studies in nursing homes engenders specific challenges that have limited the data gathered on this topic so far . OBJECTIVE The aim of this r and omized controlled trial was to investigate the effects of CS on cognition , quality of life ( QoL ) , behavioral symptoms , and activities of daily life in persons with dementia living in nursing homes . We further aim ed to identify predictors of the intervention 's benefits . METHODS Seventy-one persons with mild to moderate dementia were r and omly allocated to the experimental group ( EG ; n = 36 ) that visited a CS program twice weekly for eight weeks or to the control group ( CG ; n = 35 ) that was receiving usual care . Neuropsychological tests were conducted before and after the intervention period and at six-week follow-up . RESULTS There were no significant interaction effects Time × Group for the outcome measures . However , regression analysis revealed that a low cognitive baseline level predicted cognitive improvements . Furthermore , a low baseline level of QoL predicted a QoL benefit . For both findings , depression was a significant moderator , meaning that persons with fewer depressive symptoms had a higher probability of showing improvements . CONCLUSION This study provides data on profiles of patients who are most likely to profit from CS intervention in nursing-home setting s and demonstrates that treatment of depression is of the utmost relevance for a positive outcome of CS . Living conditions will have to be considered more thoroughly in future research The purpose of this study was to examine the beneficial effects of a new cognitive intervention program design ed for the care and prevention of dementia , namely Learning Therapy . The training program used systematized basic problems in arithmetic and Japanese language as training tasks . In study 1 , 16 individuals in the experimental group and 16 in the control group were recruited from a nursing home . In both groups , all individuals were clinical ly diagnosed with senile dementia of the Alzheimer type . In study 2 , we performed a single-blind , r and omized controlled trial in our cognitive intervention program of 124 community-dwelling seniors . In both studies , the daily training program using reading and arithmetic tasks was carried out approximately 5 days a week , for 15 to 20 minutes a day in the intervention groups . Neuropsychological measures were determined simultaneously in the groups both prior to and after six months of the intervention . The results of our investigations indicate that our cognitive intervention using reading and arithmetic problems demonstrated a transfer effect and they provide convincing evidence that cognitive training maintains and improves the cognitive functions of dementia patients and healthy seniors OBJECTIVE This study evaluates the efficacy at 12 months of a computer-based cognitive training ( CBCT ) program , adjunctive to traditional cognitive training ( TCT ) , on the basis of pen- and -paper exercises . METHODS Sixty patients with multi-domain mild cognitive impairment and mild Alzheimer 's disease who were already receiving cognitive training , recruited from a day hospital , were assigned into two groups following a simple r and omization procedure ( computerized r and om numbers ) : ( i ) a group that received CBCT during 3 months and TCT ( CBCT + TCT ) , n = 37 , and ( ii ) a group that received only TCT , n = 23 . Patients were assessed at baseline and after 3 and 12 months of treatment by a neuropsychologist blinded to group assignment , with a neuropsychological battery ( primary outcomes ) and measures of decision making , memory complaints , and emotional disturbances . RESULTS With the use of repeated- measures analyses of covariance , the CBCT + TCT group showed less anxiety symptoms ( F = 5.13 , p = 0.03 , d = 1.12 ) and less disadvantageous choices ( F = 4.70 , p = 0.04 , d = 0.89 ) in decision making than the TCT group at 12 months . No significant improvement or worsening was observed in the other measures examined . However , positive effect sizes favoring the CBCT + TCT group were observed in all variables . CONCLUSIONS The addition of a CBCT program was effective in anxiety and decision making but had no significant effects on outcomes in basic cognitive functions in patients who were already receiving cognitive training , possibly due to a ceiling effect . Future studies should compare the efficacy of CBCT with TCT in naïve patients Background Interventions that improve cognitive function in Alzheimer 's disease are urgently required . Aims To assess whether a novel cognitive training paradigm based on ‘ chunking ’ improves working memory and general cognitive function , and is associated with reorganisation of functional activity in prefrontal and parietal cortices ( trial registration : IS RCT N43007027 ) . Method Thirty patients with mild Alzheimer 's disease were r and omly allocated to receive 18 sessions of 30 min of either adaptive chunking training or an active control intervention over approximately 8 weeks . Pre- and post-intervention functional magnetic resonance imaging ( fMRI ) scans were also conducted . Results Adaptive chunking training led to significant improvements in verbal working memory and untrained clinical measures of general cognitive function . Further , fMRI revealed a bilateral reduction in task-related lateral prefrontal and parietal cortex activation in the training group compared with controls . Conclusions Chunking-based cognitive training is a simple and potentially scalable intervention to improve cognitive function in early Alzheimer 's disease We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy ( MCET ) consisting of cognitive training , cognitive stimulations , reality orientation , physical therapy , reminiscence therapy , and music therapy in combination in older people with mild cognitive impairment ( MCI ) or mild dementia . This study was a multi-center , double-blind , r and omized , placebo-controlled , two-period cross-over study ( two 8-week treatment phases separated by a 4-week wash-out period ) . Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were r and omized to the MCET group or the mock-therapy ( placebo ) group . Outcomes were measured at baseline , week 9 , and week 21 . Fifty-five patients completed the study . Mini-Mental State Examination ( effect size = 0.47 , p = 0.013 ) and Alzheimer 's Disease Assessment Scale-Cognitive Subscale ( effect size = 0.35 , p = 0.045 ) scores were significantly improved in the MCET compared with mock-therapy group . Revised Memory and Behavior Problems Checklist frequency ( effect size = 0.38 , p = 0.046 ) and self-rated Quality of Life - Alzheimer 's Disease ( effect size = 0.39 , p = 0.047 ) scores were significantly improved in the MCET compared with mock-therapy . MCET improved cognition , behavior , and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did BACKGROUND Cognitive Rehabilitation for Alzheimer 's disease ( AD ) is an integrative multimodal intervention . It aims to maintain autonomy and quality of life by enhancing the patients ' abilities to compensate for decreased cognitive functioning . OBJECTIVE We evaluated the feasibility of a group-based Cognitive Rehabilitation approach in mild AD dementia and assessed its effect on activities of daily living ( ADL ) . METHODS We included 16 patients with AD dementia in a controlled partial-r and omized design . We adapted the manual-guided Cognitive Rehabilitation program ( CORDIAL ) to a group setting . Over the course of three months , one group received the Cognitive Rehabilitation intervention ( n = 8) , while the other group received a st and ardized Cognitive Training as an active control condition ( n = 8) . ADL-competence was measured as primary outcome . The secondary outcome parameters included cognitive abilities related to daily living , functional cognitive state , and non-cognitive domains , e.g. , quality of life . For each scale , we assessed the interaction effect ' intervention by time ' , i.e. , from pre-to post-intervention . RESULTS We found no significant interaction effect of intervention by time on the primary outcome ADL-competence . The interaction effect was significant for quality of life ( Cohen 's d : -1.43 ) , showing an increase in the intervention group compared with the control group . CONCLUSIONS Our study demonstrates the feasibility of a group-based Cognitive Rehabilitation program for patients with mild AD dementia . The Cognitive Rehabilitation showed no significant effect on ADL , possibly reflecting a lack of transfer between the therapy setting and real life . However , the group setting enhanced communication skills and coping mechanisms . Effects on ADL may not have reached statistical significance due to a limited sample size . Furthermore , future studies might use an extended duration of the intervention and integrate caregivers to a greater extent to increase transfer to activities of daily living Background : Cognitive rehabilitation ( CR ) is a cognitive intervention for patients with Alzheimer ’s disease ( AD ) that aims to maintain everyday competences . The analysis of functional connectivity ( FC ) in resting-state functional MRI has been used to investigate the effects of cognitive interventions . Objectives : We evaluated the effect of CR on the default mode network FC in a group of patients with mild AD , compared to an active control group . Methods : We performed a three-month interventional study including 16 patients with a diagnosis of AD . The intervention group ( IG ) consisted of eight patients , performing twelve sessions of CR . The active control group ( CG ) performed a st and ardized cognitive training . We used a seed region placed in the posterior cingulate cortex ( PCC ) for FC analysis , comparing scans acquired before and after the intervention . Effects were thresholded at a significance of p < 0.001 ( uncorrected ) and a minimal cluster size of 50 voxels . Results : The interaction of group by time showed a higher increase \n Output:\n " }, { "from": "agent", "value": "In relation to many other outcomes , including our second primary outcome of clinical disease severity in the medium term , the quality of evidence was very low , so we were unable to determine whether CT was associated with any meaningful gains .\nThe quality of evidence in relation to many other outcomes at end of treatment and in the medium term was too low for us to determine whether CT was associated with any gains , but we are moderately confident that CT did not lead to any gains in mood , behavioural and psychological symptoms , or capacity to perform activities of daily living .\nAUTHORS ' CONCLUSIONS Relative to a control intervention , but not to a variety of alternative treatments , CT is probably associated with small to moderate positive effects on global cognition and verbal semantic fluency at end of treatment , and these benefits appear to be maintained in the medium term ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE We examined whether a shortened form of dialectical behavior therapy , dialectical behavior therapy for adolescents ( DBT-A ) is more effective than enhanced usual care ( EUC ) to reduce self-harm in adolescents . METHOD This was a r and omized study of 77 adolescents with recent and repetitive self-harm treated at community child and adolescent psychiatric outpatient clinics who were r and omly allocated to either DBT-A or EUC . Assessment s of self-harm , suicidal ideation , depression , hopelessness , and symptoms of borderline personality disorder were made at baseline and after 9 , 15 , and 19 weeks ( end of trial period ) , and frequency of hospitalizations and emergency department visits over the trial period were recorded . RESULTS Treatment retention was generally good in both treatment conditions , and the use of emergency services was low . DBT-A was superior to EUC in reducing self-harm , suicidal ideation , and depressive symptoms . Effect sizes were large for treatment outcomes in patients who received DBT-A , whereas effect sizes were small for outcomes in patients receiving EUC . Total number of treatment contacts was found to be a partial mediator of the association between treatment and changes in the severity of suicidal ideation , whereas no mediation effects were found on the other outcomes or for total treatment time . CONCLUSION DBT-A may be an effective intervention to reduce self-harm , suicidal ideation , and depression in adolescents with repetitive self-harming behavior . Clinical trial registration information-Treatment for Adolescents With Deliberate Self Harm ; http:// Clinical Trials.gov/ ; NCT00675129 Nonsuicidal self-injury ( NSSI ) has become a significant public health problem . Although numerous studies have examined cross-sectional psychological correlates of NSSI , there has been little research examining predictors of NSSI over time . The present study examined cross-sectional and longitudinal correlates of NSSI in 81 young adult self-injurers ( M age=19 , 74.1 % female , 51.9 % Caucasian ) , 51 of whom were followed up 1 year later . At baseline , participants completed self-report measures of NSSI , Axis-I disorders , borderline personality disorder ( BPD ) , and impulsivity , as well as an implicit measure of NSSI attitudes and identity . One year later , participants completed a Timeline Followback Method whereby they indicated their engagement in NSSI over the previous 12 months . Analyses replicated many known cross-sectional correlates of NSSI , including symptoms of several Axis-I disorders and BPD . However , many of these same variables failed to predict the course of NSSI over the 1-year follow-up . The only variables to prospect ively predict NSSI were past NSSI ( i.e. , frequency , methods , and recency of NSSI ) , participants ' behavioral forecast of their engagement in future NSSI , and BPD features . Findings suggest that many cross-sectional correlates of NSSI may not be useful for predicting subsequent NSSI . Instead , NSSI severity and BPD features appear to best predict continued engagement in NSSI Why do people 's impulse controls break down during emotional distress ? Some theories propose that distress impairs one 's motivation or one 's ability to exert self-control , and some postulate self-destructive intentions arising from the moods . Contrary to those theories , Three experiments found that believing that one 's bad mood was frozen ( unchangeable ) eliminated the tendency to eat fattening snacks ( Experiment 1 ) , seek immediate gratification ( Experiment 2 ) , and engage in frivolous procrastination ( Experiment 3 ) . The implication is that when people are upset , they indulge immediate impulses to make themselves feel better , which amounts to giving short-term affect regulation priority over other self-regulatory goals PURPOSE Little is known about the clinical characteristics and motivations for engaging in non-suicide self-injury ( NSSI ) behaviors in adolescence . The aim of this study was to examine the prevalence , characteristics and functions of NSSI among adolescents in community setting s , and to explore risk factors related to this behavior . SUBJECTS AND METHODS Two hundred and seventy-five adolescents aged 12 to 17 were recruited r and omly from different High Schools in Israel . They completed self-report question naires assessing NSSI ( Ottawa Self-Injury Inventory ) , depression ( Children 's Depression Inventory - CDI ) and impulsivity ( Barratt Impulsiveness Scale - BIS-II ) . RESULTS In the past year , 20.7 % of the participants reported engaging NSSI at least once . Among them , 42.1 % declared they are still engaging in NSSI at the present . Motives for NSSI were internal emotion regulation reasons , external emotion regulation reasons for social influences . In addition , the NSSI group reported significantly higher levels of depressive , impulsivity and suicidal ideations . Depressive symptoms were found as significant predictors of NSSI in the future . DISCUSSION AND CONCLUSIONS High rates of NSSI among community adolescents were found . Depression , impulsivity and suicidal ideation were found significantly related to NSSI . Mental health professionals in schools and in primary care should routinely assess NSSI among adolescents BACKGROUND Suicide is the third-leading cause of death among adolescents and nonsuicidal self-harm occurs in 13%-45 % of individuals within this age group , making these phenomena major public health concerns . Lesbian , gay , bisexual , and transgender ( LGBT ) youth particularly are at risk for engaging in these behaviors . Nevertheless , relatively little is known about the specific risk factors associated with suicidal ideation and self-harm behaviors in the population . PURPOSE This study provides a longitudinal evaluation of the relative contributions of general and LGBT-specific risk factors as well as protective factors to the occurrence of suicidal ideation and self-harm in an ethnically diverse sample of LGBT youth . METHODS A community sample of 246 LGBT youth ( aged 16 - 20 years ) was followed prospect ively over five time points at regular 6-month intervals . Participants completed a baseline structured interview assessing suicide attempt history and question naires measuring gender nonconformity , impulsivity , and sensation-seeking . At follow-up assessment s , participants completed a structured interview assessing self-harm and question naires for suicidal ideation , hopelessness , social support , and LGBT victimization . Data were collected from 2007 to 2011 , and HLM analyses were conducted in 2011 . RESULTS A history of attempted suicide ( p=0.05 ) ; impulsivity ( p=0.01 ) ; and prospect i ve LGBT victimization ( p=0.03 ) and low social support ( p=0.02 ) were associated with increased risk for suicidal ideation . Suicide attempt history ( p<0.01 ) ; sensation-seeking ( p=0.04 ) ; female gender ( p<0.01 ) ; childhood gender nonconformity ( p<0.01 ) ; and prospect i ve hopelessness ( p<0.01 ) and victimization ( p<0.01 ) were associated with greater self-harm . CONCLUSIONS General and LGBT-specific risk factors both uniquely contribute to likelihood of suicidal ideation and self-harm in LGBT youth , which may , in part , account for the higher risk of these phenomena observed in this population Self-mutilative behavior ( SMB ) is presented as a specific form of inwardly directed aggressiveness which is thought to be associated with problems of impulse control . Conceptual problems concerning impulsivity and impulsive aggression are discussed . Among different forms of dyscontrolled behavior , SMB is of special heuristic interest because of distinction can be made between patients committing impulsive and those committing premeditated self-harming actions . Psychometric and biological measures of impulsivity and aggressiveness were assessed in self-mutilators in comparison to depressives and normal prob and s. Self-mutilators were differentiated into two subgroups , those with an impulsive ( ISMB ) and those with a premeditated ( PSMB ) form of SMB , and depressives were also differentiated into two subgroups , those with a history of suicide attempts and those without . Only patients with ISMB ( and depressives with a history of suicide attempts ) showed an enduring tendency towards dyscontrolled patterns of behavior and cognition ; therefore , SMB can not be generally regarded as an indicator of high impulsivity or an impulse control disorder . Measures of impulsivity and aggressiveness did not behave analogically to each other and aggressive or autoaggressive modes of behavior should not be generally used as an index of impulsivity . A reduction of serotonergic activity , proved by a blunted prolactin response to D-fenfluramine , was found in all patient-groups in comparison to normal prob and s. Prolactin response after D-fenfluramine challenge turned out to be most blunted among self-mutilators with ISMB and among depressives with a history of suicide attempts Background An earlier r and omised controlled trial demonstrated improved treatment engagement in adolescents who received Therapeutic Assessment ( TA ) versus Assessment As Usual ( AAU ) , following an emergency presentation with self-harm . Objectives To determine 2-year outcomes for the same adolescents focusing on frequency of Accident and Emergency ( A&E ) self-harm presentations and treatment engagement . Method Patients in the TA groups ( n=35 ) and the AAU group ( n=34 ) were followed up 2 years after the initial assessment . Their primary and secondary care electronic records were analysed . Results There was no significant difference in the frequency of self-harm result ing in A&E presentations between the two groups ( OR 0.69 , 95 % CI 0.23 to 2.13 , p=0.53 ) . Treatment engagement remained higher in the TA group than the AAU group . Conclusions TA is not associated with a lower frequency of A&E self-harm presentations . The effect of TA on engagement is maintained 2 years after the initial assessment . Interventions to reduce self-harm in adolescents are needed . Trial registration IS RCT N 81605131 , http://www.controlled-trials.com/IS RCT Research suggests that self-control , affective lability , and negative urgency are associated with deliberate self-harm , problematic alcohol consumption , and eating problems . Few studies have fully examined how negative urgency might uniquely explain the effects of self-control and affective lability on these outcomes , as compared to other impulsivity-related traits . This was the goal of the current study . Of an initial group of 734 undergraduate students , 29 % indicated a history of deliberate self-harm . These 215 individuals were r and omly matched with a group of non-self-harmers ( total N=430 ; mean age=22.36 , SD=6.59 ; 76.2 % female ) . Self-harmers showed higher rates of alcohol use ( F(2 , 186)=5.48 , p<.001 ) and eating problems ( F(2 , 186)=7.74 , p<.001 ) . In a structural equation model , negative urgency was significantly associated with self-harming frequency ( β=3.81 , p<.001 ) , variety of self-harm methods ( β=5.79 , p<.001 ) , the number of years of self-harming ( β=2.75 , p<.001 ) , problematic alcohol use ( β=1.80 , p<.05 ) , and eating problems ( β=3.99 , p<.001 ) . Negative urgency was positively associated with affective lability ( β=7.71 , p<.001 ) and negatively associated with self-control ( β=-13.59 , p<.001 ) . Negative urgency is the only impulsivity-related trait that is a common risk factor associated with increased self-harm , problematic alcohol use , and eating problems \n Output:\n " }, { "from": "agent", "value": "Specifically , lifetime non-suicidal self-injury was most consistently associated with mood-based impulsivity-related traits .\nHowever , cognitive facets of impulsivity ( relating to difficulties maintaining focus or acting without forethought ) differentiated current self-harm from past self-harm .\nThese facets also distinguished those with thoughts of self-harm ( ideation ) from those who acted on thoughts ( enaction ) .\nThe findings suggested that mood-based impulsivity is related to the initiation of self-harm , while cognitive facets of impulsivity are associated with the maintenance of self-harm .\nIn addition , behavioural impulsivity is most relevant to self-harm under conditions of negative affect .\nCollectively , the findings indicate that distinct impulsivity facets confer unique risks across the life-course of self-harm .\nFrom a clinical perspective , the review suggests that interventions focusing on reducing rash reactivity to emotions or improving self-regulation and decision making may offer most benefit in supporting those who self-harm" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This article reports on the evidence for the validity of psychotic major depression as a distinct subtype based on cross-sectional and 1-year prospect i ve data from the Epidemiologic Catchment Area study . Consistent with findings from previous clinical studies , only about 14 % of major depressions were accompanied by psychotic features . Psychotic as compared with nonpsychotic depression had a more severe course , as reflected in increased risk of relapse , persistence over 1 year , suicide attempts , hospitalization , comorbidity , and financial dependency . These differences could not be explained by differences in demographic characteristics or by symptom severity , as assessed by symptom profile or number of symptoms . The boundary problem with schizophrenia and bipolar affective disorder that is seen in clinical studies was also found in this sample . To our knowledge , this is the first study to examine the validity of psychotic depression in a community sample ; the findings are consistent with those from clinical sample s. They support the clinical significance of psychotic depression and the continuation of its inclusion as a distinct subtype in DSM-IV OBJECTIVE To examine the association between baseline suicidality and outcome of major depression in a r and omized controlled trial of the pharmacotherapy of psychotic depression and to explore the interaction of suicidality , r and omized treatment assignment , and depression outcome . METHODS This study was a secondary analysis of data from 258 persons aged 18 years or older with DSM-IV-defined major depressive disorder with psychotic features who participated in a 12-week r and omized controlled trial ( RCT ) comparing olanzapine plus sertraline with olanzapine plus placebo ( the Study of the Pharmacotherapy of Psychotic Depression [ STOP-PD ] , which ran from 2002 to 2007 ) . The independent variable was baseline suicidality , defined by 4 groups ( suicide attempt in the current episode , active suicidal ideation , passive suicidal ideation , and no suicidality ) . The outcome variables were change in 16-item Hamilton Depression Rating Scale ( HDRS₁₆ ) total score ( excluding the suicide item ) over time and remission of psychotic depression over time . RESULTS Suicidality groups did not significantly differ on baseline HDRS₁₆ total score . Baseline suicidality group was significantly associated with change in HDRS₁₆ score over time in the sample as a whole ( F₃,₁₃₉₄ = 8.17 ; P < .0001 ) , but was not significantly associated with probability of remission over time . Among participants assigned to olanzapine and placebo , persons with no suicidality had a significantly greater reduction in HDRS₁₆ total score compared to those with passive suicidal ideation ( 7.5-point difference in change scores between the 2 groups ; 95 % CI , 4.3 - 10.7 t₁₃₉₄ = 4.61 , P < .0001 ) , active suicidal ideation ( 4.4 points ; 95 % CI , 1.4 - 7.4 ; t₁₃₉₄ = 2.85 , P = .0176 ) , or suicide attempts ( 6.1 points ; 95 % CI , 2.8 - 9.4 ; t₁₃₉₄ = 3.66 , P = .0015 ) . The 12-week change from baseline in HDRS₁₆ score for patients with no suicidality was not significantly different between the 2 treatment arms . However , the 12-week HDRS₁₆ improvement was significantly greater in the olanzapine plus sertraline arm , compared with the olanzapine plus placebo arm , for patients with suicide attempts ( 8.7-point difference in change scores between the 2 groups ; 95 % CI , 5.1 - 12.4 ; t₁₃₉₄ = 4.75 , P < .0001 ) , active suicidal ideation ( 8.1 points ; 95 % CI , 4.5 - 11.7 ; t₁₃₉₄ = 4.38 , P < .0001 ) , or passive suicidal ideation ( 5.7 points ; 95 % CI , 2.2 - 9.2 ; t₁₃₉₄ = 3.23 , P = .0012 ) , respectively . CONCLUSIONS Baseline suicidality predicted worse acute treatment outcome of psychotic depression . However , participants with suicidality had a better outcome when treated with the combination of olanzapine and sertraline than when treated with olanzapine plus placebo . TRIAL REGISTRATION Clinical Trials.gov identifier : Objective To compare the relative efficacy of electroconvulsive therapy ( ECT ) in psychotic and nonpsychotic patients with unipolar major depression . Methods The outcome of an acute ECT course in 253 patients with nonpsychotic ( n = 176 ) and psychotic ( n = 77 ) unipolar major depression was assessed in the first phase of an ongoing National Institute of Mental Health-supported four-hospital collaborative study of continuation treatments after successful ECT courses . ECT was administered with bilateral electrode placement at 50 % above the titrated seizure threshold . The remission criteria were rigorous : a score ≤10 on the 24-item Hamilton Rating Scale for Depression ( HRSD ) after 2 consecutive treatments , and a decrease of at least 60 % from baseline . Results The overall remission rate was 87 % for study completers . Among these , patients with psychotic depression had a remission rate of 95 % and those with nonpsychotic depression , 83 % . Improvement in symptomatology , measured by the HRSD , was more robust and appeared sooner in the psychotic patients compared with the nonpsychotic patients . Conclusion Bilateral ECT is effective in relieving severe major depression . Remission rates are higher and occur earlier in psychotic depressed patients than in nonpsychotic depressed patients . These data support the argument that psychotic depression is a distinguishable nosological entity that warrants separate treatment algorithms The authors report prospect i ve uniform clinical data differentiating 25 patients who committed suicide from 929 patients who did not in a group of 954 patients with major affective disorder followed for an average of 4 years in the Collaborative Program on the Psychobiology of Depression . Eight ( 32 % ) of the suicides occurred within 6 months and 13 ( 52 % ) within 1 year of entry into the study . Hopelessness , loss of pleasure or interest , and mood cycling during the index episode differentiated the suicide group . Diagnostic subcategories , suicidal ideation at entry to the study , suicide attempts during current or past episodes , and medical severity of prior attempts did not differentiate the suicide group OBJECTIVE The present study investigates how consistently DSM-IV major depressive disorder ( MDD ) with psychosis was diagnosed by research consensus across 10 years and the association of clinical characteristics with diagnostic consistency . METHOD The sample included 146 participants , part of a larger first-admission cohort ( N = 628 ) presenting to a psychiatric inpatient facility with psychosis , who were diagnosed with psychotic depression at least once across 4 assessment s spanning 10 years ( after first admission and at 6-month , 24-month , and 10-year follow-ups ) . The primary outcome of this prospect i ve epidemiologic study was retention of the best-estimate consensus diagnosis at each assessment . Diagnoses at each assessment were determined from semistructured interviews , medical records , and informant reports . The participants were recruited from 1989 to 1995 . RESULTS Fifty-five of the 146 participants ( 37.7 % ) were diagnosed with psychotic depression at each available assessment ; 13 ( 8.9 % ) switched from MDD to bipolar disorder , 24 ( 16.4 % ) switched from MDD to schizophrenia or schizoaffective disorder , and the remaining 54 ( 37.0 % ) had other patterns of diagnostic change . Only 47 of 80 participants ( 58.8 % ) diagnosed with MDD at baseline retained a mood disorder diagnosis 10 years later ( 36 [ 45.0 % ] had MDD and 11 [ 13.8 % ] had bipolar disorder ) , while 16 of 52 participants ( 30.8 % ) who ended the study with MDD were initially misdiagnosed . Compared to participants who were consistently diagnosed with MDD , those switching from MDD to bipolar disorder had better premorbid adjustment , more first-degree relatives with MDD , better functioning , and fewer negative symptoms at baseline , whereas those shifting to the schizophrenia spectrum had a more insidious onset , longer initial hospital stays , worse functioning , and more negative symptoms ( all P values < .05 ) . CONCLUSIONS The diagnosis of MDD with psychosis among in patients showed poor long-term consistency . For clinicians , results indicate that the diagnosis of MDD with psychosis based on a single assessment should be considered provisional OBJECTIVE Most efforts to describe the prognostic significance of psychotic features in depression have been limited to single assessment s 1 year or less after the initial evaluation . However , the various biological and treatment response differences between patients with psychotic and nonpsychotic depression suggest that prognostic differences may be very long-term . METHOD The 787 patients described here entered the study as they sought treatment at one of five academic medical centers ; they had either RDC major depressive disorder or schizo-affective depression ( other than the mainly schizophrenic subtype ) and completed at least 6 months of follow-up . Of these , 144 ( 18.3 % ) had psychotic depression as defined here . Patients provided follow-up interviews at 6-month intervals for 5 years and annually thereafter ; 98 of those with psychotic depression and 434 of those with non-psychotic depression were followed for 10 years . RESULTS Those who began follow-up with psychotic depression had fewer weeks with minimal symptoms in each of the 10 years of follow-up and reported more psychosocial impairment at both 5 and 10 years . Both the index episode and the first recurrence of psychotic depression lasted longer than nonpsychotic episodes , but nonpsychotic episodes among previously psychotic individuals were relatively brief . Intervals between episodes were significantly shorter for patients who had ever been psychotic . CONCLUSIONS Together with evidence that psychotic features are highly recurrent , these data show 1 ) that psychotic features denote a lifetime illness of greater severity and 2 ) that within individuals , psychotic features may emerge in only the more severe episodes To evaluate the role of severe depression , i.e. , depression with melancholic and /or psychotic features and alcohol dependence in suicide and undetermined death . The Lundby Study is a prospect i ve , longitudinal study of a population consisting of 3563 subjects . In a long-term follow up 1947–2006 there were 66 suicide cases , including 19 undetermined deaths . Depression and alcoholism were as expected the major contributors to suicide ( 44 % and 23 % respectively ) . Severe depression with psychotic and /or melancholic features was diagnosed in 66 % of all depressions and in 29 % of all suicide cases , as compared to 15 % for major depression only . Alcohol dependence was related to undetermined death . Major depressive disorder with melancholic and /or psychotic features appears to be an important contributor to accomplished suicide in the depression group , and alcohol dependence appears to be related to undetermined death This retrospective study compared the treatment responses of 34 primary , unipolar depressives without psychotic features and 30 with psychotic features . Patients were diagnosed by Research Diagnostic Criteria and received trials of tricyclic antidepressants , antipsychotics , the combination of the two , electroconvulsive therapy , or placebo and psychotherapy . Only three of 18 psychotic patients vs. 17 of 23 nonpsychotic patients responded to antidepressants alone . Electroconvulsive therapy and the combination of antipsychotic and antidepressant medication gave better responses . These data suggest that major depressive disorder with psychotic features is best considered as a distinct subtype rather than a severe variant of major depression OBJECTIVE The study explored the phenomenology and prognostic significance of delusions in major depressive disorder . METHOD From 452 patients with DSM-III major depression , we selected those with at least one belief fulfilling both DSM-III prerequisites for a delusion ( i.e. , being of \" delusional proportions \" and being maintained with \" delusional intensity \" ) . These patients were compared to the others with respect to demographic , historical , and index episode features ; time spent in a depressive episode during a prospect i ve observation period ; and 10-year outcome . The same comparisons were made between patients with mood-incongruent delusions and those with mood-congruent delusions only . The study covered the period between January 1 , 1978 , and December 31 , 2005 . RESULTS About 20 % of patients had at least one delusion in their index episode . An additional 5.3 % had a belief fulfilling only one of the DSM-III prerequisites for a delusion . In about one quarter of delusional patients , the index episode was not \" severe . \" Almost 10 % of delusional patients had both mood-congruent and mood-incongruent delusions . In patients with delusions , time to syndromal recovery from index episode was longer and antipsychotic medication was more frequently used ( both p < .0001 ) . The presence of delusions predicted a higher depressive morbidity during the prospect i ve observation period ( p < .05 ) , but not a poorer 10-year outcome . No variable discriminated patients with mood-incongruent delusions from those with mood-congruent delusions only . CONCLUSION The presence of delusions in a major depressive episode has significant therape \n Output:\n " }, { "from": "agent", "value": "Our meta- analysis may provide evidence that the presence of psychosis increases the risk of suicide in patients suffering from severe depression .\nConclusions The presence of psychosis in major depression should alert clinicians for the increased risk of completed suicide ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: There is no consensus regarding the effects of mixed antioxidant vitamin C and /or vitamin E supplementation on oxidative stress responses to exercise and restoration of muscle function . Thirty-eight men were r and omly assigned to receive either placebo group ( n = 18 ) or mixed antioxidant ( primarily vitamin C & E ) supplements ( n = 20 ) in a double-blind manner . After 6 weeks , participants performed 90 min of intermittent shuttle-running . Peak isometric torque of the knee flexors/extensors and range of motion at this joint were determined before and after exercise , with recovery of these variables tracked for up to 168 h post-exercise . Antioxidant supplementation elevated pre-exercise plasma vitamin C ( 93 ± 8 μmol l−1 ) and vitamin E ( 11 ± 3 μmol l−1 ) concentrations relative to baseline ( P < 0.001 ) and the placebo group ( P ≤ 0.02 ) . Exercise reduced peak isometric torque ( i.e. 9–19 % relative to baseline ; P ≤ 0.001 ) , which persisted for the first 48 h of recovery with no difference between treatment groups . In contrast , changes in the urine concentration of F2-isoprostanes responded differently to each treatment ( P = 0.04 ) , with a tendency for higher concentrations after 48 h of recovery in the supplemented group ( 6.2 ± 6.1 vs. 3.7 ± 3.4 ng ml−1 ) . Vitamin C & E supplementation also affected serum cortisol concentrations , with an attenuated increase from baseline to the peak values reached after 1 h of recovery compared with the placebo group ( P = 0.02 ) and serum interleukin-6 concentrations were higher after 1 h of recovery in the antioxidant group ( 11.3 ± 3.4 pg ml−1 ) than the placebo group ( 6.2 ± 3.8 pg ml−1 ; P = 0.05 ) . Combined vitamin C & E supplementation neither reduced markers of oxidative stress or inflammation nor did it facilitate recovery of muscle function after exercise-induced muscle damage ABSTRACT This investigation determined the efficacy of black currant nectar ( BCN ) in reducing symptoms of exercise-induced muscle damage ( EIMD ) . Sixteen college students were r and omly assigned to drink either 16 oz of BCN or a placebo ( PLA ) twice a day for eight consecutive days . A bout of eccentric knee extensions ( 3 × 10 sets @ 115 % of 1RM ) was performed on the fourth day . Outcome measures included muscle soreness ( subjective scale from 0 to 10 ) and blood markers of muscle damage ( creatine kinase , CK ) , inflammation ( interleukin-6 , IL-6 ) , and oxygen radical absorbance capacity ( ORAC ) . Although there were no differences in reported soreness between groups , consumption of BCN reduced CK levels at both 48 ( PLA = 82.13 % vs. BCN = −6.71 % , p = .042 ) and 96 h post exercise ( PLA = 74.96 % vs. BCN = −12.11 % , p = .030 ) . The change in IL-6 was higher in the PLA group ( PLA = 8.84 % vs. BCN = −6.54 % , p = .023 ) at 24 h post exercise . The change in ORAC levels was higher in the treatment group ( BCN = 2.68 % vs. PLA = −6.02 % , p = .039 ) at 48 h post exercise . Our results demonstrate that consumption of BCN prior to and after a bout of eccentric exercise attenuates muscle damage and inflammation Intensive physical exercise may cause muscular injury and increase oxidative stress . The purpose of this study was to examine the effect of an antioxidant , coenzyme Q10 ( CoQ10 ) , on muscular injury and oxidative stress during exercise training . Eighteen male students , all elite Japanese kendo athletes , were r and omly assigned to either a CoQ10 group ( n 10 ) or a placebo group ( n 8) in a double-blind manner . Subjects in the CoQ10 group took 300 mg CoQ10 per d for 20 d , while subjects in the placebo group took the same dosage of a placebo . All subjects practised kendo 5.5 h per d for 6 d during the experimental period . Blood sample s were taken 2 weeks before , during ( 1 d , 3 d , 5 d ) and 1 week after the training . Serum creatine kinase ( CK ) activity and myoglobin ( Mb ) concentration significantly increased in both groups ( at 3 d and 5 d ) . Serum CK ( at 3 d ) , Mb ( at 3 d ) and lipid peroxide ( at 3 d and 5 d ) of the CoQ10 group were lower than those of the placebo group . The leucocyte counts in the placebo group significantly increased ( at 3 d ) and neutrophils significantly increased in both groups ( at 3 d and 5 d ) . Serum scavenging activity against superoxide anion did not change in either group . These results indicate that CoQ10 supplementation reduced exercise-induced muscular injury in athletes Purpose Polyphenolic curcumin is known to have potent anti-inflammatory effects ; thus the present study investigated the hypothesis that curcumin ingestion would attenuate muscle damage after eccentric exercise . Methods Fourteen untrained young men ( 24 ± 1 years ) performed 50 maximal isokinetic ( 120 ° /s ) eccentric contractions of the elbow flexors of one arm on an isokinetic dynamometer and the same exercise with the other arm 4 weeks later . They took 150 mg of curcumin ( theracurmin ) or placebo ( starch ) orally before and 12 h after each eccentric exercise bout in a r and omised , crossover design . Maximal voluntary contraction ( MVC ) torque of the elbow flexors , range of motion of the elbow joint , upper-arm circumference , muscle soreness , serum creatine kinase ( CK ) activity , and plasma interleukin-6 ( IL-6 ) and tumor necrosis factor-α ( TNF-α ) concentration were measured before , immediately after , and 24 , 48 , 72 and 96 h after each eccentric exercise . Changes in these variables over time were compared between curcumin and placebo conditions by two-way repeated measures ANOVA . Results MVC torque decreased smaller and recovered faster ( e.g. , 4 days post-exercise : −31 ± 13 % vs. −15 ± 15 % ) , and peak serum CK activity was smaller ( peak : 7684 ± 8959 IU/L vs. 3398 ± 3562 IU/L ) for curcumin than placebo condition ( P < 0.05 ) . However , no significant differences between conditions were evident for other variables , and no significant changes in IL-6 and TNF-α were evident after exercise . Conclusion It is concluded that theracurmin ingestion attenuates some aspects of muscle damage such as MVC loss and CK activity increase Summary This study investigated the effects of antioxidant vitamin supplementation upon muscle contractile function following eccentric exercise and was performed double blind . Twenty-four physically active young subjects ingested either placebo ( 400 mg ; n = 8) , vitamin E ( 400 mg ; n=8 ) or vitamin C ( 400 mg ; n = 8) for 21 days prior to and for 7 days after performing 60 min of box-stepping exercise . Contractile function of the triceps surae was assessed by the measurement of maximal voluntary contraction ( MVC ) and the ratio of the force generated at 20 Hz and 50 Hz tetanic stimulation before and after eccentric exercise and for 7 days during recovery . Following eccentric exercise , MVC decreased to 75 ( 4 ) % [ mean ( SE ) ; n = 24 ; P < 0.05 ] of the preexercise values and the 20/50 Hz ratio of tetanic tension from 0.76 ( 0.01 ) to 0.49 ( 0.03 ) [ mean ( SE ) ; n = 24 ; P<0.05 ) . Compared to the placebo group no significant changes in MVC were observed immediately post-exercise , though recovery of MVC in the first 24 h post-exercise was greater in the group supplemented with vitamin C. The decrease in 20/50 Hz ratio of tetanic tension was significantly less ( P < 0.05 ) post-exercise and in the initial phase of recovery in subjects supplemented with vitamin C but not with vitamin E. These data suggest that prior vitamin C supplementation may exert a protective effect against eccentric exercise-induced muscle damage The aim of this study was to investigate whether post-exercise vitamin C supplementation influences recovery from an unaccustomed bout of exercise . Sixteen male subjects were allocated to either a placebo ( P ; n=8 ) or vitamin C ( VC ) group ( n=8 ) . Subjects performed a prolonged ( 90-min ) intermittent shuttle-running test , and supplementation began after the cessation of exercise . Immediately after exercise the VC group consumed 200 mg of VC dissolved in a 500 ml drink , whereas the subjects in the P group consumed the drink alone . Later on the same day and then in the morning and evening of the following 2 days , subjects consumed additional identical drinks . Plasma VC concentrations in the VC group increased above those in the P group 1 h after exercise and remained above P values for the 3 days after exercise . Nevertheless , post-exercise VC supplementation was not associated with improved recovery . Post-exercise serum creatine kinase activities and myoglobin concentrations were unaffected by supplementation . Muscle soreness and the recovery of muscle function in the leg flexors and extensors were not different in VC and P groups . Furthermore , although plasma concentrations of interleukin-6 and malondialdehyde increased following exercise , there was no difference between VC and P groups . These results suggest that either free radicals are not involved in delaying the recovery process following a bout of unaccustomed exercise , or that the consumption of VC wholly after exercise is unable to deliver this antioxidant to the appropriate sites with sufficient expediency to improve recovery PURPOSE Fourteen male cyclists were studied to compare the effect of carbohydrate-protein-antioxidant beverage ( CHOPA ) to an isocaloric carbohydrate-only ( CHO ) beverage on time to fatigue and muscle damage . METHODS Subjects performed two sets of rides to exhaustion on a cycle ergometer . In each set , the first ride was performed at 70 % VO2peak , and the second was performed 24 h later at 80 % . CHO or CHOPA was consumed every 15 min during exercise and immediately afterward . Plasma CK and LDH and muscle soreness were measured pre- and postexercise . RESULTS Time to fatigue was not different between CHO and CHOPA at 70 % VO2peak ( 95.8 + /- 29.7 vs 98.1 + /- 28.7 min ) , 80 % VO2peak ( 42.3 + /- 18.6 vs 42.9 + /- 21.8 min ) , or total performance time ( 138.1 + /- 39.3 vs 140.9 + /- 43.7 min ) . Postexercise CK was increased ( P < 0.05 ) from baseline in CHO ( 203 + /- 120 vs 582 + /- 475 U.L(-1 ) ) but not with CHOPA ( 188 + /- 119 vs 273 + /- 169 U.L(-1 ) ) . Similarly , LDH values increased over baseline in CHO ( 437 + /- 46 vs 495 + /- 64 U.L(-1 ) ) but not with CHOPA ( 432 + /- 40 vs 451 + /- 43 U.L(-1 ) ) . Postexercise CPK and LDH were higher after the CHO trial than after the CHOPA trial . Median postexercise muscle soreness was higher in CHO ( 3.0 + /- 5.0 ) than with CHOPA ( 1.0 + /- 3.0 ) . CONCLUSION No differences in time to fatigue were observed between the beverages , despite lower total carbohydrate content in the CHOPA beverage . The CHOPA beverage attenuated postexercise muscle damage , as evidence d by CK and LDH values , compared with an isocaloric CHO beverage PURPOSE Dietary supplementation with polyphenols , particularly ellagitannins , may attenuate the muscular damage experienced after eccentric exercise , producing delayed-onset muscle soreness . The purpose of this study was to determine whether ellagitannin supplementation from Wonderful variety pomegranate extract ( POMx ) improved recovery of skeletal muscle strength after eccentric exercise . METHODS Recreationally active males were r and omized into a crossover design with either pomegranate extract ( POMx ) or placebo ( PLA ) , each given during a period of 9 d . To produce delayed-onset muscle soreness , subjects performed two sets of 20 maximal eccentric elbow flexion exercises with one arm . Maximal isometric elbow flexion strength and muscle soreness as well as serum measures of creatine kinase , myoglobin , interleukin \n Output:\n " }, { "from": "agent", "value": "AUTHORS ' CONCLUSIONS There is moderate to low- quality evidence that high dose antioxidant supplementation does not result in a clinical ly relevant reduction of muscle soreness after exercise at up to 6 hours or at 24 , 48 , 72 and 96 hours after exercise .\nThere is no evidence available on subjective recovery and only limited evidence on the adverse effects of taking antioxidant supplements ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Honey is known , since antiquity , as an effective wound dressing . Emergence of resistant strains and the financial burden of modern dressings , have revived honey as cost-effective dressing particularly in developing countries . Its suitability for all stages of wound healing suggests its clinical effectiveness in diabetic foot wound infections . Thirty infected diabetic foot wounds were r and omly selected from patients presenting to Surgery Department , Suez Canal University Hospital , Ismailia , Egypt . Honey dressing was applied to wounds for 3 months till healing , grafting or failure of treatment . Changes in grade and stage of wounds , using University of Texas Diabetic Wound Classification , as well as surface area were recorded weekly . Bacterial load was determined before and after honey dressing . Complete healing was significantly achieved in 43.3 % of ulcers . Decrease in size and healthy granulation was significantly observed in another 43.3 % of patients . Bacterial load of all ulcers was significantly reduced after the first week of honey dressing . Failure of treatment was observed in 6.7 % of ulcers . This study proves that commercial clover honey is a clinical and cost-effective dressing for diabetic wound in developing countries . It is omnipresence and concordance with cultural beliefs makes it a typical environmentally based method for treating these conditions Aims /hypothesisThe aim of the present study was to investigate re source utilisation and associated costs in patients with diabetic foot ulcers and to analyse differences in re source utilisation between individuals with or without peripheral arterial disease ( PAD ) and /or infection . Methods Data on re source utilisation were collected prospect ively in a European multicentre study . Data on 1,088 patients were available for the analysis of re source use , and data on 821 patients were included in the costing analysis . Costs were calculated for each patient by multiplying the country-specific direct and indirect unit costs by the number of re sources used from inclusion into the study up to a defined endpoint . Country-specific costs were converted into purchasing power st and ards . Results Re source use and costs varied between outcome groups and between disease severity groups . The highest costs per patient were for hospitalisation , antibiotics , amputations and other surgery . All types of re source utilisation and costs increased with the severity of disease . The total cost per patient was more than four times higher for patients with infection and PAD at inclusion than for patients in the least severe group , who had neither . Conclusions /interpretationImportant differences in re source use and costs were found between different patient groups . The costs are highest for individuals with both peripheral arterial disease and infection , and these are mainly related to substantial costs for hospitalisation . In view of the magnitude of the costs associated with in-hospital stay , reducing the number and duration of hospital admissions seems an attractive option to decrease costs in diabetic foot disease OBJECTIVE To compare the efficacy and tolerability of a new ionic silver alginate matrix ( Askina Calgitrol Ag ) with that of a st and ard silver-free alginate dressing ( Algosteril ) . METHOD Patients with locally infected chronic wounds ( pressure ulcers , venous or mixed aetiology leg ulcers , diabetic foot ulcers ) or acute wounds were eligible for this prospect i ve , open-label , controlled and r and omised trial . Patients were r and omised to receive one of the two dressings for a two-week period . Criteria of efficacy were based on the evolution , from day 1 to day 15 , of local signs of infection using a clinical score ranging from 0 to 18 , and the evolution of the bacteriological status for each wound . The latter was determined by ( blind ) bacteriological examinations of results obtained from two biopsies performed at days 1 and 15 . A three-point scale ( deterioration , unchanged , improvement ) was also used . Acceptability , usefulness and tolerance were also assessed . RESULTS Forty-two patients ( 20 women and 22 men , 68.9 + /- 18.8 and 66.5 + /- 15.7 years old respectively ) were r and omly assigned to receive either Askina Calgitrol Ag ( n=20 ) or Algosteril ( n=22 ) . Most had chronic wounds such as pressure ulcers ( 57 % ) or venous or mixed aetiology leg ulcers and diabetic foot ulcers ( 29 % ) ; few had acute wounds ( 14 % ) . Clinical scores of infection were comparable in both groups at inclusion , 8.9 + /- 2.4 and 8.6 + /- 3.2 in the Askina Calgitrol Ag group and the Algosteril group respectively ( not significant ) , but decreased significantly in both groups at day 15 , 3.8 + /- 2.9 in the Askina Calgitrol Ag group ( p=0.001 ) and 3.8 + /- 3.4 in the Algosteril group ( p=0.007 ) . There was no significant difference between the two groups at day 15 . Although there was also no significant difference in bacteriological status between the treatment groups , a trend in favour of Askina Calgitrol Ag was found for the relative risk of improvement , especially in patients who were not treated with antibiotics either at the beginning of the study or during it . No differences between groups were observed regarding local tolerance , acceptability and usefulness of the dressings . CONCLUSION The regression of local signs of infection , local tolerance , acceptability and usefulness were similar for the two dressings . However , Askina Calgitrol Ag improved the bacteriological status of the wounds . Further trials are required to show that it has a positive impact on the healing process AIMS To investigate the accuracy of the sequential combination of the probe-to-bone test and plain X-rays for diagnosing osteomyelitis in the foot of patients with diabetes . METHODS We prospect ively compiled data on a series of 338 patients with diabetes with 356 episodes of foot infection who were hospitalized in the Diabetic Foot Unit of La Paloma Hospital from 1 October 2002 to 31 April 2010 . For each patient we did a probe-to-bone test at the time of the initial evaluation and then obtained plain X-rays of the involved foot . All patients with positive results on either the probe-to-bone test or plain X-ray underwent an appropriate surgical procedure , which included obtaining a bone specimen that was processed for histology and culture . We calculated the sensitivity , specificity , predictive values and likelihood ratios of the procedures , using the histopathological diagnosis of osteomyelitis as the criterion st and ard . RESULTS Overall , 72.4 % of patients had histologically proven osteomyelitis , 85.2 % of whom had positive bone culture . The performance characteristics of both the probe-to-bone test and plain X-rays were excellent . The sequential diagnostic approach had a sensitivity of 0.97 , specificity of 0.92 , positive predictive value of 0.97 , negative predictive value of 0.93 , positive likelihood ratio of 12.8 and negative likelihood ratio of 0.02 . Only 6.6 % of patients with negative results on both diagnostic studies had osteomyelitis . CONCLUSIONS Clinicians seeing patients in a setting similar to ours ( specialized diabetic foot unit with a high prevalence of osteomyelitis ) can confidently diagnose diabetic foot osteomyelitis when either the probe-to-bone test or a plain X-ray , or especially both , are positive OBJECTIVES To determine the comparative effectiveness and cost-effectiveness of three dressing products , N-A , Inadine and Aquacel , for patients with diabetic foot ulcers , as well as the feasibility and consequences of less frequent dressing changes by health-care professionals . DESIGN A multicentre , prospect i ve , observer-blinded , parallel group , r and omised controlled trial , with three arms . SETTING Established expert multidisciplinary clinics for the management of diabetic foot ulcers across the UK . PARTICIPANTS Patients over age 18 with type 1 or type 2 diabetes with a chronic ( present for at least 6 weeks ) full-thickness foot ulcer ( on or below the malleoli ) not penetrating to tendon , periosteum or bone , and with a cross-sectional area between 25 and 2500 mm(2 ) . INTERVENTIONS Participants were r and omised 1:1:1 to treatment with one of N-A ( a non-adherent , knitted , viscose filament gauze ) , Inadine ( an iodine-impregnated dressing ) , both traditional dressings , or Aquacel , a newer product . MAIN OUTCOME MEASURES The primary outcome measure was the number of ulcers healed in each group at week 24 . Secondary measures included time to healing , new ulcerations , major and minor amputations , and episodes of secondary infection . RESULTS A total of 317 patients were r and omised . After 88 withdrawals , 229 remained evaluable . A greater proportion of smaller ( 25 - 100 mm(2 ) ulcers healed within the specified time ( 48.3 % versus 37.3 % ; p = 0.048 ) . There was , however , no difference between the three dressings in terms of percentage healed by 24 weeks , or in the mean time to healing , whether analysed on the basis of intention to treat ( Inadine 44.4 % , N-A 38.7 % , Aquacel 44.7 % ; not significant ) or per protocol ( Inadine 55.2 % , N-A 59.4 % , Aquacel 63.0 % ; not significant ) . There was no difference in the quality of healing , as reflected in the incidence of recurrence within 12 weeks . Likewise , there was no difference in the incidence of adverse events , although a greater proportion of those r and omised to the non-adherent dressings were withdrawn from the study ( 34.9 % versus 29.1 % Aquacel and 19.4 % Inadine ; p = 0.038 ) . The only statistically significant difference found in the health economic analysis was the cost associated with the provision of dressings ( mean cost per patient : N-A 14.85 pounds , Inadine 17.48 pounds , Aquacel 43.60 pounds ) . The higher cost of Aquacel was not offset by the fewer dressings required . There was no difference in measures of either generic or condition-specific measures of quality of life . However , there was a significant difference in the change in pain associated with dressing changes between the first and second visits , with least pain reported by those receiving non-adherent dressings ( p = 0.012 ) . There was no difference in the costs of professional time , and this may relate to the number of dressing changes undertaken by non-professionals . Fifty-one per cent of all participants had at least one dressing change undertaken by themselves or a non-professional carer , although this ranged from 22 % to 82 % between the different centres . CONCLUSIONS As there was no difference in effectiveness , there is no reason why the least costly of the three dressings could not be used more widely across the UK National Health Service , thus generating potentially substantial savings . The option of involving patients and non-professional carers in changing dressings needs to be assessed more formally and could be associated with further significant reductions in health-care costs . TRIAL REGISTRATION Current Controlled Trials IS RCT N78366977 OBJECTIVE To evaluate the efficacy of manufactured shoes specially design ed for diabetic patients ( Podiabetes by Buratto Italy ) to prevent relapses of foot ulcerations . RESEARCH DESIGN AND METHODS A prospect i ve multicenter r and omized follow-up study of patients with previous foot ulcerations was conducted . Patients were alternatively assigned to wear either their own shoes ( control group , C ; n = 36 ) or therapeutic shoes ( Podiabetes group , P ; n = 33 ) . The number of ulcer relapses was recorded during 1-year follow-up . RESULTS Both C and P groups had similar risk factors for foot ulceration ( i.e. , previous foot ulceration , mean vibratory perception threshold > 25 mV ) . After 1 year , the foot ulcer relapses were significantly lower in P than in C ( 27.7 vs. 58.3 % ; P = 0.009 ; odds ratio 0.26 [ 0.2–1.54 ] ) . In a multiple regression analysis , the use of therapeutic shoes was negatively associated with foot ulcer relapses ( coefficient of variation = −0.315 ; 95 % confidence interval = −0.54 to −0.08 ; P = 0.009 ) . CONCLUSIONS The use of specially design ed shoes is effective in preventing relapses in diabetic patients with previous ulceration OBJECTIVE A limited number of clinical trials have shown that the total contact cast ( TCC ) is an effective treatment in neuropathic , noninfected , and nonischemic foot ulcers . In this prospect i ve data collection study , we assessed outcome and complications of TCC treatment in neuropathic patients with and without peripheral arterial disease ( PAD ) or ( superficial ) infection . RESEARCH DESIGN AND METHODS Ninety-eight consecutive patients selected for casting were followed until healing ; all had polyneuropathy , 44 % had PAD , and 29 % had infection . Primary outcomes were percentage healed with a cast , time to heal , and number of complications . RESULTS Ninety percent of all nonischemic ulcers without infection and 87 % with infection healed in the cast ( NS ) . In patients with PAD but without critical limb ischemia , 69 % of the ulcers without infection and 36 % with infection healed ( P < 0.01 ) . In multivariate analyses , PAD , infection , and heel ulcers were associated with a lower percentage healed ( all P < 0.05 ) . Median duration of cast treatment was 34 \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Whereas these guidelines have addressed five key areas in the care of DFUs , they do not cover all the aspects of this complex condition ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : Interferon ( IFN ) beta has repeatedly shown benefit in multiple sclerosis ( MS ) in reducing the rate of relapse , the disease activity as shown with magnetic resonance imaging and , to some degree , the progression of disability ; however , it is unknown how much the therapeutic response depends on the dose , the subgroup involved , and the disease stage . This multicentre , double blind , placebo controlled study explored the dose−response curve by examining the clinical benefit of low dose IFN beta-1a ( Rebif ® ) , 22 μg subcutaneously once weekly , in patients with secondary progressive MS . Methods : A total of 371 patients with clinical ly definite SPMS were r and omised to receive either placebo or subcutaneous IFN beta-1a , 22 μg once weekly , for 3 years . Clinical assessment s were performed every 6 months . The primary outcome was time to sustained disability , as defined by time to first confirmed 1.0 point increase on the Exp and ed Disability Status Scale ( EDSS ) . Secondary outcomes included a sensitive disability measure and relapse rate . Results : Treatment had no beneficial effect on time to confirmed progression on either the EDSS ( hazard ratio ( HR ) = 1.13 ; 95 % confidence interval ( CI ) 0.82 to 1.57 ; p = 0.45 for 22 μg v placebo ) or the Regional Functional Status Scale ( HR = 0.93 ; 95 % CI 0.68 to 1.28 ; p = 0.67 ) . Other disability measures were also not significantly affected by treatment . Annual relapse rate was 0.27 with placebo and 0.25 with IFN ( rate ratio = 0.90 ; 95 % CI 0.64 to 1.27 ; p = 0.55 ) . The drug was well tolerated with no new safety concerns identified . No significant gender differences were noted . Conclusions : This patient population was less clinical ly active than SPMS population s studied in other trials . Treatment with low dose , IFN beta-1a ( Rebif ® ) once weekly did not show any benefit in this study for either disability or relapse outcomes , including a subgroup with preceding relapses . These results add a point at one extreme of the dose−response spectrum of IFN beta therapy in MS , indicating that relapses in this phase may need treatment with higher doses than in the initial phases OBJECTIVE To assess efficacy , safety , and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis ( MS ) ( clinical ly isolated syndrome ) . METHODS We conducted a multicenter , r and omized , double-blind , placebo-controlled trial . Patients with a first clinical demyelinating event and at least two clinical ly silent brain MRI lesions were r and omized to interferon beta-1b ( IFNB-1b ) 250 mug subcutaneously ( SC ) every other day ( EOD ) ( n = 292 ) or placebo ( n = 176 ) , until clinical ly definite MS ( CDMS ) was diagnosed or they had been followed for 24 months . RESULTS After 2 years , 45 % of placebo patients had converted to CDMS ( Kaplan-Meier estimate ; primary outcome measure ) and 85 % fulfilled the McDonald criteria ( co- primary outcome measure ) . Overall interferon beta-1b delayed the time to diagnosis of CDMS ( p < 0.0001 ) and McDonald MS ( p < 0.00001 ) . Hazard ratios ( 95 % CI ) were 0.50 ( 0.36 to 0.70 ) for CDMS and 0.54 ( 0.43 to 0.67 ) for McDonald MS favoring treatment with IFNB-1b . Treatment was well tolerated , as indicated by the low rate of patients dropping out of the study before CDMS was reached ( 6.6 % overall , 7.2 % in the IFNB-1b group ) . CONCLUSIONS Interferon beta-1b 250 mug subcutaneously every other day delayed conversion to clinical ly definite multiple sclerosis , and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis Our previously reported multicenter , blinded , r and omized , controlled study of two doses of interferon beta-1b ( IFNB ) in 372 patients demonstrated a reduction in relapse frequency and severity and in MRI activity . We now report the results of the continuation of that study . The median time on study was 46.0 months for the placebo arm , 45.0 months for 1.6 million international units ( MIU ) , and 48.0 months for 8 MIU . IFNB had a persistent beneficial effect on exacerbation rate and MRI burden of disease and was relatively free of long-term side effects . There was a one-third reduction in exacerbation rate in the 8-MIU treatment arm , compared with placebo , in each of 5 years . Serial annual MRI was done in all patients , and 217 of the patients had either a fourth- or fifth-year scan . There was no significant progression of lesion burden in the 8-MIU arm in each successive year compared with baseline ( at 4 years , p = 0.917 ) , whereas a highly significant increase in lesion area occurred in the placebo arm ( p = 0.0001 ) . Among the 154 noncompleters , there was no systematic bias recognized that favored either treatment arm for the outcome measures of exacerbation rate , disability , or MRI activity . Dropouts in the placebo group had higher exacerbation rates and accumulation of MRI lesion burden than did dropouts in the other treatment arms , which probably reduced the power of the study to demonstrate treatment effects on these measures in the later years of the trial . ( ABSTRACT TRUNCATED AT 250 WORDS Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Major depressive disorder is associated with increases in infectious disease risk as well as the incidence of inflammatory disorders . Declines of natural killer ( NK ) cell activity are reliably found in depression , whereas other studies report evidence of inflammation in depressed patients . The potential association between NK activity and circulating markers of immune activation has not been previously examined in the context of major depression . In this study , we measured levels of NK activity , circulating levels of interleukin-6 ( IL-6 ) , soluble interleukin-2 receptor , and acute phase proteins in 25 male patients with current major depressive disorder and 25 age , gender , and body weight comparable controls . As compared to controls , patients with major depressive disorder showed lower NK activity ( p = .05 ) and higher circulating levels of IL-6 ( p < .05 ) . Levels of NK activity were not correlated with IL-6 or with other markers of immune activation . The independent effect of depression on inflammatory markers and natural killer immune responses has implication s for underst and ing individual differences in the adverse health effects of major depressive disorder The concentration of cytokines such as Interleukin-6 ( IL-6 ) has been reported to be elevated in depressed and schizophrenic patients and , in healthy persons , upon stress . Interleukin-6 plasma levels were determined in depressed ( n = 12 ) and schizophrenic ( n = 32 ) patients during the acute state of illness and after remission at approximately 8 weeks after admission and were compared with healthy controls ( n = 12 ) . Patients were diagnosed according to DSM-III-R by the Structured Clinical Interview ( SLID ) . Severity of illness was assessed for depression by the Montgomery Asberg Depression Rating Scale ( MADRS ) and for schizophrenia by the Brief Psychiatric Rating Scale ( BPRS ) . Interleukin-6 plasma concentrations were elevated during the acute state either of depression or of schizophrenia if compared to controls . After remission , IL-6 concentrations in depressed and in schizophrenic patients had decreased and did not differ significantly from controls . We hypothesize that the elevated IL-6 levels during the acute state of depression or schizophrenia may reflect an unspecific stress response The relationship between plasma kynurenine ( KYN ) concentration and anxiety and depression in psychiatric patients was examined . KYN has been reported as a probable endogenous anxiogen in animal models of anxiety . Thirty patients with affective states were studied . The Hamilton Anxiety Scale ( HAM-A ) , Hamilton Depression Scale ( HAM-D ) , Dexamethazone Suppression Test ( DST ) and Diazepam Test ( DT ) were used to differentiate two groups with prevalence of anxious or depressive symptomatology . It was found that in endogenous anxiety , the plasma KYN concentration is increased and in endogenous depression , it is decreased ( resp . , 1.94 micrograms/ml and 0.62 microgram/ml , versus normal 0.9 + /- 0.07 microgram/ml ) . After treatment this concentration became normal in both groups . In this study KYN concentration correlated significantly with the severity of anxiety . The results suggest that the increase of plasma KYN concentration in anxiety may be used as an additional criterion to differentiate endogenous anxiety with depressive mood from endogenous depression in clinical practice . DT and DST have also appeared to be reliable factors in differentiation of anxiety and depression BACKGROUND Treatment with interferon beta has been shown to help patients with established multiple sclerosis , but it is not known whether initiating treatment at the time of a first clinical demyelinating event is of value . METHODS We conducted a r and omized , double-blind trial of 383 patients who had a first acute clinical demyelinating event ( optic neuritis , incomplete transverse myelitis , or brain-stem or cerebellar syndrome ) and evidence of prior sub clinical demyelination on magnetic resonance imaging ( MRI ) of the brain . After initial treatment with corticosteroids , 193 patients were r and omly assigned to receive weekly intramuscular injections of 30 microg of interferon beta-1a and 190 were assigned to receive weekly injections of placebo . The study end points were the development of clinical ly definite multiple sclerosis and changes in findings on MRI of the brain . The trial was stopped after a preplanned interim efficacy analysis . RESULTS During three years of follow-up , the cumulative probability of the development of clinical ly definite multiple sclerosis was significantly lower in the interferon beta-1a group than in the placebo group ( rate ratio , 0.56 ; 95 percent confidence interval , 0.38 to 0.81 ; P=0.002 ) . As compared with the patients in the placebo group , patients in the interferon beta-1a group had a relative reduction in the volume of brain lesions ( P<0.001 ) , fewer new or enlarging lesions ( P<0.001 ) , and fewer gadolinium-enhancing lesions ( P<0.001 ) at 18 months . CONCLUSIONS Initiating treatment with interferon beta-1a at the time of a first demyelinating event is beneficial for patients with brain lesions on MRI that indicate a high risk of clinical ly definite multiple sclerosis There is now some evidence that i ) the availability of plasma tryptophan , the precursor of serotonin , is significantly lower in pregnant women at the end of term and the first few days after delivery than in nonpregnant women ; and ii ) both pregnancy and the early puerperium are accompanied by activation of the inflammatory response system . The aims of the present study were to examine the effects of pregnancy and delivery on plasma kynurenine , a major tryptophan catabolite synthesized after induction of indoleamine-2 , 3 dioxygenase ( IDO ) by pro-inflammatory cytokines . We measured plasma kynurenine and tryptophan and immune markers , such as serum interleukin-6 ( IL-6 ) , IL-8 and the leukemia inhibitory factor-receptor ( LIF-R ) in healthy , nonpregnant and pregnant women at the end of term and one and three days after delivery . Plasma kynurenine was significantly lower in pregnant women at the end of term than in nonpregnant women , findings which may be attributed to lower plasma tryptophan at the end of term . The kynurenine/tryptophan ( K/T ) quotient was significantly higher in the pregnant women at the end of term and in the early puerperium than in nonpregnant women . In the early puerperium there was a significant increase in plasma kynurenine and the K/T quotient . The increases in plasma kynurenine and the K/T quotient were significantly more pronounced in women whose anxiety and depression scores significantly increased in the puerperium . The changes from the end of term to the early puerperium in plasma kynurenine and the K/T quotient were significantly related to those in the immune markers . It is concluded that 1 ) lower plasma kynurenine at the end of term is the consequence of lower plasma tryptophan ; 2 ) the increased K/T quotient at the end of term and in the early puerperium indicates inflammation-induced degradation of tryptophan along the kynurenine pathway ; and 3 ) that depressive and anxiety symptoms in the early puerperium are ( causally ) related to an increased catabolism of tryptophan into kynurenine , a phenomenon which probably results from immune activation Background : The beneficial effect of interferon beta on exacerbations in relapsing-remitting MS has been demonstrated repeatedly , but results concerning disability vary . Object \n Output:\n " }, { "from": "agent", "value": "The review ed studies conclude that there is not a clear relationship between IFNβ and depression .\nA history of depression is a risk factor for developing depression during the first 6 months of treatment , nevertheless , it is not sufficient to contraindicate it .\nIt is suggested that these patients would have fewer functional reserve remaining to deal with stressful life events , which could precipitate a depressive disorder" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS : To compare the efficacy of and tolerance to oral fluconazole and intraconazole in preventing fungal infection in neutropenic patients with haematological malignancies . PATIENTS : 213 consecutive , afebrile adult patients treated with or without autologous stem cell transplantation for haematological malignancies . METHODS : A r and omised , double blind , single centre study . Patients were r and omly assigned to receive fluconazole 50 mg or itraconazole 100 mg , both twice daily in identical capsules . An intention to treat analysis was performed on 202 patients , 101 in each group . RESULTS : Microbiologically documented systemic fungal infections occurred in four patients in each group . Clinical fungal infection was thought to be present in seven recipients of fluconazole and four of itraconazole . In all 202 patients , 29 proceeded to intravenous amphotericin ( amphotericin B ) , 16 in the fluconazole group and 13 in the itraconazole group . Superficial fungal infection was seen only in three non-compliant patients in the fluconazole group . All these infections were oral . No major differences were noted in the isolates of fungi in mouth washes and fecal sample s. Overall mortality was 8.9 % ( 18 deaths ; seven in the fluconazole group , 11 in the itraconazole group ) . Mortality from microbiologically and clinical ly documented fungal infection was 4.5 % ( nine deaths ; three in the fluconazole group , six in the itraconazole group ) . Median time to suspected or proven fungal infection was 16 days in both groups . None of these comparisons reached statistical significance ( p < 0.05 ) . No major clinical toxicity was noted and compliance was excellent . CONCLUSIONS : In neutropenic patients treated for haematological malignancies with or without autologous stem cell transplantation , fluconazole and itraconazole in low doses result in a similar low frequency of fungal disease . Fluconazole may be the preferable drug because of the smaller number of capsules and lack of need for timing relative to meals Goal of workThe aim of the study is to evaluate the effect of fluconazole antifungal prophylaxis on the severity of mucositis in head and neck cancer patients receiving radiotherapy . Patients and methods Sixty-three patients , with malignant head and neck tumor , eligible to receive radiotherapy , entered the study . Thirty-four patients ( group A ) received 100 mg/day of fluconazole prophylaxis during radiotherapy and were compared with 29 patients , who received radiotherapy alone ( group B ) . The two groups were similar in terms of patients and radiotherapy characteristics . Smear to test for C and ida carriage was taken before and after radiotherapy . Oral c and idiasis was diagnosed using the criteria described before . Oral mucositis was recorded according to EORTC/RTOG criteria .Main results A significant reduction of severe mucositis at the end of radiotherapy ( 14.7 vs 44.8 % , p=0.018 ) and of interruptions ( 0 vs 17.2 % , p=0.017 ) was observed in group A. C and idiasis was prevented ( 0 vs 34.5 % , p=0.001 ) , with a significant reduction of C and ida carriage of 40.7 % ( p=0.001 ) . Conclusion Fluconazole prophylaxis showed a significant beneficial impact on the severity of mucositis and on radiotherapy interruptions in this group of patients . The current study provides data on the build of a r and omized controlled trial on the effect of fluconazole prophylaxis on treatment schedule and quality of life of the patients during head and neck radiotherapy The aim of this study was to investigate oral yeast colonization and oral yeast strain diversity in irradiated ( head and neck ) , dentate , xerostomic individuals . Subjects were recruited from a nasopharyngeal carcinoma clinic and were segregated into group A ( age , < 60 years [ n = 25 ; average age + /- st and ard deviation ( SD ) , 48 + /- 6 years ; average postirradiation time + /- SD , 5 + /- 5 years ] ) and group B ( age , > /=60 years [ n = 8 ; average age + /- SD , 67 + /- 4 years ; average postirradiation time + /- SD , 2 + /- 2 years ] ) and were compared with age- and sex-matched healthy individuals in group C ( age , < 60 years [ n = 20 ; average age + /- SD , 44 + /- 12 years ] and group D ( age , > /=60 years [ n = 10 ; average age , 70 + /- 3 years ] ) . Selective culture of oral rinse sample s was carried out to isolate , quantify , and speciate yeast recovery . All test subjects underwent a 3-month comprehensive oral and preventive care regimen plus topical antifungal therapy , if indicated . A total of 12 subjects from group A and 5 subjects from group B were recalled for re assessment of yeast colonization . Sequential ( pre- and posttherapy ) C and ida isolate pairs from patients were phenotypically ( all isolate pairs ; biotyping and resistotyping profiles ) and genotypically ( C and ida albicans isolate pairs only ; electrophoretic karyotyping by pulsed-field gel electrophoresis , restriction fragment length polymorphism [ RFLP ] , and r and omly amplified polymorphic DNA [ RAPD ] assays ) evaluated . All isolates were C and ida species . Irradiated individuals were found to have a significantly increased yeast carriage compared with the controls . The isolation rate of C and ida posttherapy remained unchanged . A total of 9 of the 12 subjects in group A and 3 of the 5 subjects in group B harbored the same C. albicans or C and ida tropicalis phenotype at recall . Varying degrees of congruence in the molecular profiles were observed when these sequential isolate pairs of C. albicans were analyzed by RFLP and RAPD assays . Variations in the genotype were complementary to those in the phenotypic characteristics for some isolates . In conclusion , irradiation-induced xerostomia seems to favor intraoral colonization of C and ida species , particularly C. albicans , which appeared to undergo temporal modifications in clonal profiles both phenotypically and genotypically following hygienic and preventive oral care which included topical antifungal therapy , if indicated . We postulate that the observed ability of C and ida species to undergo genetic and phenotypic adaptation could strategically enhance its survival in the human oral cavity , particularly when salivary defenses are impaired Guidelines for the management of patients with invasive c and idiasis and mucosal c and idiasis were prepared by an Expert Panel of the Infectious Diseases Society of America . These up date d guidelines replace the previous guidelines published in the 15 January 2004 issue of Clinical Infectious Diseases and are intended for use by health care providers who care for patients who either have or are at risk of these infections . Since 2004 , several new antifungal agents have become available , and several new studies have been published relating to the treatment of c and idemia , other forms of invasive c and idiasis , and mucosal disease , including oropharyngeal and esophageal c and idiasis . There are also recent prospect i ve data on the prevention of invasive c and idiasis in high-risk neonates and adults and on the empiric treatment of suspected invasive c and idiasis in adults . This new information is incorporated into this revised document To evaluate the efficacy of itraconazole capsules in prophylaxis for fungal infections in neutropenic patients , we conducted a prospect i ve , double-blind , placebo-controlled , r and omized trial . Patients with hematologic malignancies or those who received autologous bone marrow transplants were assigned either a regimen of itraconazole ( 100 mg orally twice daily ; n=104 ) or of placebo ( n=106 ) . Overall , fungal infections ( superficial or systemic ) occurred more frequently in the placebo group ( 15 % vs. 6 % ; P=.03 ) . There were no differences in the empirical use of amphotericin B or systemic fungal infections . Among patients with neutropenia that was profound ( < 100 neutrophils/mm3 ) and prolonged ( for at least 7 days ) , those receiving itraconazole used less empirical amphotericin B ( 22 % vs. 61 % ; P=.0001 ) and developed fewer systemic fungal infections ( 6 % vs. 19 % ; P=.04 ) . For patients with profound and prolonged neutropenia , itraconazole capsules at the dosage of 100 mg every 12 h reduce the frequency of systemic fungal infections and the use of empirical amphotericin Fungal infections are a major problem in patients with hematologic malignancy . Attempts to reduce their frequency with antifungal agents have not been successful . A double-blind , controlled , single-center trial was conducted with 96 consecutive patients undergoing 154 episodes of chemotherapy . Patients received 400 mg of fluconazole or placebo until bone marrow recovery or initiation of intravenous amphotericin B infusions . End points were amphotericin B use , fungal infection , stable neutrophil count > 0.5 x 10(9)/L , toxicity precluding further fluconazole use , and death . By Kaplan-Meier estimation , the time to initiation of amphotericin B therapy was shorter in 76 patients treated with placebo than in 75 treated with fluconazole ( P = .003 ) . Also , fluconazole reduced the number of febrile days by 20 % ( P = .002 ) and prevented oropharyngeal c and idiasis ( 1/75 vs. 9/76 , P = .018 ) . The frequency of deep mycoses ( 8/76 vs. 8/75 ) and outcome were unaffected . Fluconazole did not have a favorable effect on infection-related health care costs and was associated with prolonged severe neutropenia ( P = .01 ) In a prospect i ve r and omized study the efficacy of fluconazole ( 50 mg in one single daily dose ) was compared with oral amphotericin B in suspension and tablets ( each 200 mg four times daily ) for prevention of colonization and subsequent infection by yeasts in 50 patients undergoing remission induction treatment for acute leukaemia . All patients received ciprofloxacin for prevention of bacterial infections . Fluconazole was as effective as amphotericin B in preventing severe local and disseminated fungal disease ( one documented and one highly suspected infection in each group of patients ) . Fluconazole effectively prevented yeast colonization of the oropharynx but was less effective than amphotericin B in preventing colonization of the lower alimentary tract . Fifty-two percent of patients receiving fluconazole had persistent positive stool cultures as compared to 4 % in the amphotericin B group ( P less than 0.01 ) . Fluconazole was better tolerated than amphotericin B. One patient developed an extended rash leading to the termination of fluconazole PURPOSE To identify predictors of oral mucositis and gastrointestinal toxicity after high-dose therapy . PATIENTS AND METHODS Mucositis and gastrointestinal toxicity were prospect ively evaluated in 202 recipients of high-dose therapy and autologous or allogeneic stem-cell rescue . Of 10 outcome variables , three were selected as end points : the peak value for the University of Nebraska Oral Assessment Score ( MUCPEAK ) , the duration of parenteral nutritional support , and the peak daily output of diarrhea . Potential covariates included patient age , sex , diagnosis , treatment protocol , transplantation type , stem-cell source , and rate of neutrophil recovery . The three selected end points were also examined for correlation with blood infections and transplant-related mortality . RESULTS A diagnosis of leukemia , use of total body irradiation , allogeneic transplantation , and delayed neutrophil recovery were associated with increased oral mucositis and longer parenteral nutritional support . No factors were associated with diarrhea . Also , moderate to severe oral mucositis ( MUCPEAK > or = 18 on a scale of 8 to 24 ) was correlated with blood infections and transplant-related mortality : 60 % of patients with MUCPEAK > or = 18 had positive blood cultures versus 30 % of patients with MUCPEAK less than 18 ( P = .001 ) ; 24 % of patients with MUCPEAK > or = 8 died during the transplantation procedure versus 4 % of patients with MUCPEAK less than 18 ( P = .001 ) . CONCLUSION Gastrointestinal toxicity is a major cause of transplant-related morbidity and mortality , emphasizing the need for corrective strategies . The peak oral mucositis score and the duration of parenteral nutritional support are useful indices of gastrointestinal toxicity because these end points are correlated with clinical ly significant events , including blood infections and treatment-related mortality The goal of this prospect i ve r and omized single-center study was the comparison of safety and efficacy of high-dose oral/intravenous fluconazole ( 400 \n Output:\n " }, { "from": "agent", "value": "Conclusions There is an increased risk of clinical ly significant oral fungal infection during cancer therapy .\nSystemic antifungals are effective in the prevention of clinical oral fungal infection in patients receiving cancer therapy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Epidural analgesia initiated early in labor ( when the cervix is less than 4.0 cm dilated ) has been associated with an increased risk of cesarean delivery . It is unclear , however , whether this increase in risk is due to the analgesia or is attributable to other factors . METHODS We conducted a r and omized trial of 750 nulliparous women at term who were in spontaneous labor or had spontaneous rupture of the membranes and who had a cervical dilatation of less than 4.0 cm . Women were r and omly assigned to receive intrathecal fentanyl or systemic hydromorphone at the first request for analgesia . Epidural analgesia was initiated in the intrathecal group at the second request for analgesia and in the systemic group at a cervical dilatation of 4.0 cm or greater or at the third request for analgesia . The primary outcome was the rate of cesarean delivery . RESULTS The rate of cesarean delivery was not significantly different between the groups ( 17.8 percent after intrathecal analgesia vs. 20.7 percent after systemic analgesia ; 95 percent confidence interval for the difference , -9.0 to 3.0 percentage points ; P=0.31 ) . The median time from the initiation of analgesia to complete dilatation was significantly shorter after intrathecal analgesia than after systemic analgesia ( 295 minutes vs. 385 minutes , P<0.001 ) , as was the time to vaginal delivery ( 398 minutes vs. 479 minutes , P<0.001 ) . Pain scores after the first intervention were significantly lower after intrathecal analgesia than after systemic analgesia ( 2 vs. 6 on a 0-to-10 scale , P<0.001 ) . The incidence of one-minute Apgar scores below 7 was significantly higher after systemic analgesia ( 24.0 percent vs. 16.7 percent , P=0.01 ) . CONCLUSIONS Neuraxial analgesia in early labor did not increase the rate of cesarean delivery , and it provided better analgesia and result ed in a shorter duration of labor than systemic analgesia To compare the efficacy and side effects of 0.2 mg intrathecal ( IT ) morphine with 0.125 % epidural bupivacaine , 62 women in labor were studied . They were r and omly divided into three groups : group 1 ( n = 20 ) received IT morphine ; group 2 ( n = 22 ) received epidural bupivacaine ; and group 3 ( n = 20 ) received a combination of both using a combined spinal-epidural ( CSE ) technique . According to a visual analogue scale for assessing analgesia , neither IT 0.2 mg morphine nor 10 ml 0.125 % epidural bupivacaine was effective in producing adequate pain relief in labor , whereas the combination produced excellent analgesia . The use of IT morphine significantly reduced the dosage requirement of epidural bupivacaine . The incidence of nausea , vomiting , and pruritus was significantly higher when IT morphine had been administered , whereas that of urinary retention did not differ . No serious respiratory depression occurred in any of the patients . When the course of labor was studied , the prior use of IT morphine significantly prolonged the duration of the first stage of labor and the total duration of labor . We conclude that the administration of 0.2 mg IT morphine in combination with epidural administration of 0.125 % bupivacaine provides better analgesia than the administration of either drug alone Intrathecal opioids can provide labor analgesia . We attempted to prolong the duration of intrathecal sufentanil analgesia by adding epinephrine or morphine . Forty-one healthy , term nulliparae with cervical dilation < 5 cm participated in this double-blind , r and omized protocol . Using a combined spinal and epidural technique , we gave intrathecal injections of either sufentanil 10 micrograms , sufentanil 10 micrograms plus epinephrine 200 micrograms , or sufentanil 10 micrograms plus morphine 250 micrograms . At baseline and every 5 min for 30 min thereafter , we recorded arterial blood pressure and asked the patients to rate their pain , nausea , and pruritus on visual analog scales . The women continued to rate these variables every 30 min until they requested additional analgesia . They then received 10 mL of 0.25 % bupivacaine via the epidural catheter , and rated the above variables every 30 min until they requested additional epidural drug injection . Both morphine and epinephrine prolonged the duration of sufentanil analgesia . Only morphine prolonged analgesia after the first dose of epidural bupivacaine . However , because women in the morphine group experienced significantly more side effects throughout the study period , we do not recommend intrathecal morphine for labor analgesia Objective : To evaluate the use of intrapartum intrathecal narcotic analgesia in the obstetric population of our community-based hospital . Methods : A protocol to administer intrapartum intrathecal narcotic analgesia was established at our institution in December 1992 . All patients consenting to this procedure received a single lumbar intrathecal injection of 25 μg fentanyl and 0.25 mg morphine sulfate through a 25-gauge spinal needle . Only those patients with singleton pregnancies in the vertex presentation were included in this study . The study group was matched by gravidity and parity with singleton pregnancies delivered during the study period . Patients in the study group were asked to complete an analgesia satisfaction survey using a five-point Likert scale ranging from 0 for total dissatisfaction to 5 for total satisfaction . Results : A total of 75 patients were assigned to each group ; the control and study groups were similar with respect to age , race , estimated gestational age , infant birth weight , interval between rupture of membranes and delivery , and mode of delivery . The length of the first and second stages of labor and the incidence of fetal malposition were not significantly different between the two groups . Frequent side effects of this analgesia included complaints of pruritus ( 81.3 % ) , urinary retention ( 53.3 % ) , and nausea and vomiting ( 44.0 % ) . Headaches were less common ( 9.3 % ) , with two ( 2.7 % ) of seven patients requiring an epidural blood patch for relief . Infrequent side effects included respiratory depression ( 1.3 % ) and oversedation ( 1.3 % ) . Patients were generally satisfied with the degree of pain relief obtained , rating it highly during the first and second stages of labor and in comparison to their previous labor experience . Conclusion : The use of intrapartum intrathecal narcotic analgesia provides a satisfactory level of pain relief without disrupting the normal course of labor . ( Obstet Gynecol 1994;84:931 - 6 Early first-stage labor pain is primarily visceral in origin . Increasing pain intensity and transition to somatic nociceptive input characterizes late first- and second-stage labor pain . The effect of this change in nociceptive input on the duration of intrathecal labor analgesia has not been well studied . This prospect i ve cohort observational study compares the duration of intrathecal labor analgesia after intrathecal injections made in early labor ( 3- to 5-cm cervical dilation ) and those made in more advanced labor ( 7- to 10-cm cervical dilation ) . Forty-one parturients ( 18 in early labor and 23 in advanced labor ) received intrathecal sufentanil ( 10 micro g ) and bupivacaine ( 2.5 mg ) as part of a combined spinal-epidural technique . Patients rated their pain using a 0 - 10 verbal pain scale prior to intrathecal injection and every 20 min thereafter . Duration of analgesia was defined as the lesser of time until the pain score exceeded 5 or until a request for supplemental epidural analgesia was made . The duration of spinal analgesia was significantly less when intrathecal injection was made in advanced labor ( 120 + /- 26 min ) compared with early labor ( 163 + /- 57 min , P < 0.01 ) . We conclude that cervical dilation and stage of labor significantly impact the effective duration of intrathecal sufentanil/bupivacaine labor analgesia . ( Anesth Analg 1997;84:1108 - 12 We design ed a prospect i ve , r and omized , double-blind study to evaluate the efficacy of the combination of intrathecal sufentanil with a low dose of local anesthetic in an attempt to prolong analgesia in labor . Fifty-two patients received one of the following intrathecal study solutions : 2.5 mg of bupivacaine ; 10 micro gram of sufentanil ; or 2.5 mg of bupivacaine plus 10 micro gram of sufentanil . The mean duration of analgesia ( min + /- SD ) was significantly different among all three groups : 70 + /- 34 min for bupivacaine , 114 + /- 26 min for sufentanil , and 148 + /- 27 min for bupivacaine-sufentanil ( P < 0.001 ) . Visual analog scale ( VAS ) scores for pain were significantly higher in the bupivacaine group compared to both the sufentanil group and the bupivacaine-sufentanil group ( P < 0.02 ) , and were significantly higher in the sufentanil group compared to bupivacaine-sufentanil at 75 min postinjection and beyond ( P < 0.02 ) . Hypotension was not observed in the sufentanil group but occurred transiently in the other two groups ( P = 0.09 ) . There was no evidence of motor blockade , excessive somnolence , fetal heart rate ( FHR ) abnormalities , or postdural puncture headache ( PDPH ) in any of the patients . The addition of 2.5 mg of bupivacaine to 10 micro gram of intrathecal sufentanil significantly prolonged labor analgesia without adverse maternal or fetal effects . ( Anesth Analg 1995;81:305 - 9 Background Although intrathecal sufentanil has been reported to provide rapid-onset , complete analgesia lasting 1–3 h for the first stage of labor , no well-controlled double-blind study has compared this technique to the use of epidurally administered local anesthetics . Methods Fifty healthy parturient women requesting labor analgesia were studied . In a combined spinal-epldural technique , a spinal needle was inserted through the epidural needle before insertion of the epidural catheter . Patients were r and omly assigned to receive either intrathecal sufentanil ( 10 μg ) and epidural saline , or intrathecal saline and epidural bupivacaine ( 30 mg ) . Visual analog scores for pain , blood pressure , heart rate , sensory levels , and the incidence of nausea , pruritus , and motor blockade were recorded . Results Patients receiving intrathecal sufentanil had significantly lower visual analog pain scores at 5 , 15 , and 30 min after injection and a greater duration of analgesia before requesting additional medication ( mean 123 vs. 68 min for those receiving bupivacaine ; P < 0.05 ) . These patients also experienced pruritus more frequently but motor blockade less frequently than patients receiving epidural bupivacaine . The groups exhibited dermatomal sensory deficits to pin prick as well as bradycardia and hypotension with equal frequency . The length of labor and type of delivery were similar between the groups . No patient experienced a post-dural puncture headache . Conclusions The rapid onset of analgesia and lack of motor blockade from intrathecal sufentanil injection may be advantageous in certain clinical situations . With this technique , however , pruritus is common ; hypotension may occur ; and extensive dermatomal spread suggests that early-onset respiratory depression could occur . Therefore , blood pressure and respiratory adequacy should be monitored if intrathecal sufentanil is used The combination intrathecal fentanyl ( 25 & mgr;g ) and bupivacaine ( 2.5 mg ) provides effective labor analgesia for approximately 90 minutes . The purpose of this prospect i ve , r and omized , double-blinded investigation was to determine if the addition of morphine ( 150 & mgr;g ) to the intrathecal combination of fentanyl ( 25 & mgr;g ) and bupivacaine ( 2.5 mg ) would prolong labor analgesia . By using the combined spinal epidural technique , 95 healthy primiparous laboring women in early labor received 2 mL of one of the two intrathecal study solutions , either FB ( n = 48 ) : fentanyl ( 25 & mgr;g ) and bupivacaine ( 2.5 mg ) ; or FBM ( n = 47 ) : fentanyl ( 25 & mgr;g ) and bupivacaine ( 2.5 mg ) plus morphine ( 150 & mgr;g ) . The mean duration of labor analgesia was significantly longer in the FBM group than in the FB group ( 252 ± 63 min vs 148 ± 44 min , P < 0.01 ) . There were no significant differences between the two groups regarding the sensory levels , the incidence of nausea , vomiting , pruritus , hypotension , or operative delivery . In conclusion , the addition of 150 & mgr;g of morphine to the intr \n Output:\n " }, { "from": "agent", "value": "MAIN MESSAGE The literature supports use of ITN as a safe and effective alternative to epidural anesthesia .\nThe advantage of single-dose ITN is that fewer physicians and nurses are needed to administer it even though its safety and effectiveness are comparable with other analgesics .\nUse of ITN is associated with a shorter first stage of labour and more rapid cervical dilation .\nA combination of 2.5 mg of bupivacaine , 25 microg of fentanyl , and 250 microg of morphine intrathecally usually provides a 4-hour window of acceptable analgesia for patients without complications not anticipating protracted labour .\nPhysicians practising modern obstetrics in rural and small urban centres might find single-dose ITN a useful alternative to parenteral or epidural analgesia for appropriately selected patients" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Several open trials and case studies have reported beneficial effects following the addition of risperidone for partial responders to clozapine . The purpose of this study was to carry out a placebo-controlled , r and omized , double-blind trial of the efficacy , safety , and tolerability of adjunctive treatment with risperidone in patients with schizophrenia partially responsive to clozapine . METHOD In this 6-week double-blind study , 30 patients with DSM-IV schizophrenia who had partial response to clozapine despite being treated for a mean of 32 months were r and omly assigned to risperidone ( N = 16 ) up to 6 mg/day or placebo ( N = 14 ) . Efficacy assessment s included the Positive and Negative Syndrome Scale ( PANSS ) , the Calgary Depression Scale , the Clinical Global Impressions-Severity of Illness scale , the Global Assessment of Functioning scale , and the Quality of Life Scale . A variety of safety and tolerability measures were also obtained . Data were collected between November 2001 and July 2003 . RESULTS Significant improvement was noted in both groups on a variety of measures of psychopathology , but there was significantly greater improvement in the placebo-treated patients on the primary outcome measure , the PANSS positive symptom subscale . There were no significant differences between the treatment groups regarding extrapyramidal symptoms , weight gain , vital signs , serum clozapine levels , and QTc interval . The only side effect significantly more severe in risperidone-treated compared to placebo-treated patients was sedation . The patients treated with risperidone developed significant increases in plasma prolactin levels . CONCLUSION Adjunctive risperidone treatment in schizophrenia patients partially responsive to clozapine does not significantly improve psychopathology or quality of life compared to placebo in a 6-week period OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered \" mildly ill \" according to the CGI approximately corresponded to a PANSS total score of 58 , \" moderately ill \" to a PANSS of 75 , \" markedly ill \" to a PANSS of 95 and severely ill to a PANSS of 116 . To be \" minimally improved \" according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating \" much improved \" were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate INTRODUCTION Treatment resistance in schizophrenia often leads to add-on of atypical antipsychotics to clozapine . METHODS In a r and omized trial , we recently obtained evidence for comparable efficacy and differential side effects of clozapine in combination with ziprasidone ( CZ , N=12 ) versus risperidone ( CR , N=12 ) . Here , we present the open-label , long-term evaluations of these patients after 26 and 52 weeks . RESULTS Sustained improvements of psychopathology as assessed by PANSS ( positive and negative syndrome scale ) , SANS ( scale for the assessment of negative symptoms ) , and HAMD ( Hamilton depression scale ) were documented in both sub sample s being treated according to protocol , while dropouts reduced the study sample after 26 ( CZ : reduced by -4 ; CR : -2 ) and 52 weeks ( CZ : -0 ; CR : -5 ) . We observed a slight increase of akathisia in the CZ group whereas general clozapine-associated side effects improved . DISCUSSION The combinations of clozapine with ziprasidone or risperidone exhibit long-term efficacy , but the level of evidence is limited . Further head-to-head comparisons of atypical antipsychotics as add-on to clozapine are necessary Schizophrenia is a devastating psychiatric disorder . Clozapine has long been the gold st and ard for treatment of patients with treatment-resistant schizophrenia ; however , some patients are only partially responsive to clozapine treatment . Augmentation of clozapine treatment might enhance its effectiveness in partial responders , but only a few studies have investigated possible augmentation strategies . This study compared the effectiveness and tolerability of the combination of amisulpride and clozapine with the combination of quetiapine and clozapine in patients who were only partially responsive to clozapine monotherapy . Fifty-six treatment-resistant patients who were partially responsive to clozapine were r and omly assigned to receive amisulpride or quetiapine along with an ongoing stable dose of clozapine . Fifty patients completed the study . Patients were evaluated at baseline and at the first , third , sixth , and eighth weeks . Efficacy measures consisted of the Brief Psychiatric Rating Scale ( BPRS ) , the Scale for the Assessment of Negative Symptoms ( SANS ) , the Scale for the Assessment of Positive Symptoms ( SAPS ) , and the Clinical Global Impression ( CGI ) scale . Tolerability and adverse effects were assessed with the Udvalg for Kliniske Undersogelser ( UKU ) Side Effect Rating Scale and the Simpson Angus Scale ( SAS ) . A substantial improvement occurred in both groups by the end of the eighth week ; however , the improvement associated with amisulpride was significantly greater than that seen with quetiapine . This difference was noted as early as the third week of follow-up in terms of CGI scores , and by the sixth week with regard to BPRS , SANS , and SAPS scores . Both drugs were well tolerated , as measured by UKU and SAS . Improvement favoring clozapine+amisulpride could be attributed to the selective D2/D3 binding property of amisulpride , which had an additional effect in improving symptoms of schizophrenia . The authors concluded that amisulpride seems to be effective and well tolerated for augmentation purpose s in clozapine-resistant patients Background One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment . Under real-world circumstances , the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies . In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy , despite the lack of robust evidence of its efficacy , we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematic ally provided and evaluated within the context of a pragmatic , multicentre , independent r and omised study . Methods / Design The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time . This project is a prospect i ve , multicentre , r and omized , parallel-group , superiority trial that follow patients over a period of 12 months . Withdrawal from allocated treatment within 3 months is the primary outcome . Discussion The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce r and omised knowledge . The employed pragmatic attitude allowed to r and omly allocate more than 100 individuals , which means that this study is the largest antipsychotic combination trial conducted so far in Western countries . We expect that the current project , by generating evidence on whether it is clinical ly useful to combine clozapine with aripiprazole rather than with haloperidol , provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia . Trial Registration Clincaltrials.gov Identifier : The atypical antipsychotic zotepine was compared to haloperidol in 126 patients suffering from acute exacerbation of schizophrenia ( DSM-III-R ) in a r and omized , double-blind study . After 8-weeks , 150 to 300 mg zotepine improved scores on the Brief Psychiatric Rating Scale ( BPRS ) more than 10 to 20 mg haloperidol ( -17.03 versus -13.45 ; 95%CI for zotepine-haloperidol -9.34/2.04 ) . BPRS subscores and Clinical Global impressions ( CGI ) Severity and improvement subscales showed comparable gains , but scores on the Scale for the Assessment of Negative Symptoms ( SANS ) improved significantly more with zotepine ( -23.82 ) than haloperidol ( -15.15 ; P < .05 ; 95%CI for zotepine haloperidol -18.03/-0.18 ) . Adverse events were reported by 71 percent of zotepine and 78 percent of haloperidol patients . Extrapyramidal side effect ( EPMS ) scores decreased with zotepine ( -0.34 ) but increased with haloperidol ( + 2.32 ; P < .05 ) . Seven haloperidol patients reported akathisia but no zotepine patients did ( p < .05 ) . Uric acid reductions ( which appear to have no clinical consequence ) and transient raised liver enzymes were recorded with zotepine . Weight increased on zotepine ( 2.32 kg ; P < .001 ) and a small increase in pulse rate occurred ( P < .05 ) . Both drugs were effective in reducing positive symptoms of schizophrenia ; zotepine was significantly more effective against negative symptoms and reduced EPMS Background Long-term studies for patients with resistant schizophrenia are necessary to assess the effectiveness of combination strategies on persisting positive symptoms . Aims and Methods This multicenter , naturalistic , r and omized , superiority study ( Clinical Trials.gov identifier : NCT00395915 ) aim ed to compare clinical efficacy and tolerability of haloperidol versus aripiprazole as combination treatment with clozapine in patients with resistant schizophrenia . Results One hundred six patients were followed up for 12 months . After 12 months , the proportion of patients who discontinued treatment was not significantly different between aripiprazole and haloperidol ( 37 % vs 28 % , respectively ; P = 0.431 ) . The change in the Brief Psychiatric Rating Scale score was similar in the aripiprazole and haloperidol groups ( −7.0 vs −7.9 , respectively ; P = 0.389 ) , whereas the tolerability total score decreased significantly more in the aripiprazole group ( −7.2 vs −2.3 ; P = 0.008 ) . Conclusions While the effectiveness of clozapine augmentation with a second antipsychotic agent is not clearly demonstrated yet , results from this study suggest that augmentation with aripiprazole offers no substantial benefit over haloperidol in efficacy . Aripiprazole was perceived more tolerable than haloperidol , but it is uncertain how this finding may translate into the real world of clinical practice Background The proportion of clinical research sponsored by industry will likely continue to exp and as federal funds for academic research decreases , particularly in the fields of HIV/AIDS and hepatitis C ( HCV ) . While HIV and HCV continue to burden the US population , insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases . Debate exists about whether pharmaceutical companies undertake more market-driven research practice s to promote therapeutics , or instead conduct more rigorous trials than their non-industry counterparts because of increased re sources and scrutiny . The Clinical Trials.gov registry , which allows investigators to fulfill a federal m and ate for public trial registration , provides an opportunity for critical evaluation of study design s for industry-sponsored trials , independent of publication status . As part of a large public policy effort , the Clinical Trials Transformation Initiative ( CTTI ) recently transformed the Clinical Trials.gov registry into a search able data set to facilitate research on clinical trials themselves . Methods We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials , registered with Clinical Trials.gov from 1 October 2007 to 27 September 2010 , to study the relationship of study sponsorship with r and omized study design . The likelihood of using r and omization given industry ( versus non-industry ) sponsorship was reported with prevalence ratios ( PR ) . PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee , enrollment size , study phase , number of \n Output:\n " }, { "from": "agent", "value": "We found some significant differences between clozapine combination strategies for global and mental state ( clinical ly significant response and change ) , and there were data for leaving the study early and weight gain .\nWe found no data for service utilisation and quality of life ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In 1973 the observation was published that in patients who had received non specific blood transfusions before kidney transplantation graft survival was improved . An immunosuppressive effect of blood transfusion was suggested . Indeed , modulation on the cellular and humoral immunologic system has been demonstrated during the last decade . But this immunomodulation effect might worsen the prognosis after cancer surgery . Whereas in several experimental studies in animals the negative influence was confirmed , clinical investigations on the other h and are contradictive . In our retrospective study we analysed the follow-up of 273 patients ( 158 men , 115 women ; average age 66 years ) on which we had performed a curative resection of their colorectal carcinoma . 182 patients had received nonspecific r and om blood transfusions . The survival rate for patients with blood transfusions was significantly worse in comparison to the non-transfused group ( 43 % versus 73 % , respectively ) . Even when we subdivided our patients into tumor stage , differentiation and localisation , the negative influence of transfused blood was confirmed . We conclude that beside the risk of transmitting hepatitis or HIV the immunosuppressive effect is a strong argument to restrict the indication for blood transfusion After curative resection of colorectal cancer , immediate short-term postoperative intraportal adjuvant chemotherapy reduces the relative risk of recurrence and death in the non-transfused patient significantly , when compared to transfused patients without chemotherapy . This is demonstrated in a multivariate analysis using the Cox model on a group of 469 patients who have been intraoperatively r and omized to receive either intraportal chemotherapy for 7 days or no further treatment . The transfused patients with chemotherapy and those receiving neither transfusions nor chemotherapy had a relative risk of recurrence and death situated in between the two groups mentioned above , not statistically different from either of them . In the setting of this study , 7 days postoperative intraportal chemotherapy seems particularly effective in the non-transfused patients BACKGROUND Benchmarking transfusion activity may help to eliminate inappropriate use of blood products . The goal of this study was to measure and to compare the current transfusion practice and to identify predictors of transfusion in public hospitals to develop strategies to optimize transfusion practice s. STUDY DESIGN AND METHODS This was a prospect i ve observational study in 18 r and omly selected public hospitals from April 2004 to February 2005 . Primary outcome measures were the amount of intra- and postoperative blood components transfused and intercenter variability of transfusion rate . Secondary outcome measures were prevalence of preoperative anemia , calculated perioperative blood loss , and lowest measured perioperative hemoglobin ( Hb ) level . RESULTS Adult patients undergoing primary unilateral total hip replacement ( THR , n = 1401 ) , primary unilateral knee replacement ( TKR , n = 1296 ) , hemicolectomy ( HECOC , n = 148 ) , and coronary artery bypass graft ( CABG ) surgery ( n = 777 ) were enrolled . Due to the small number , data of HECOC patients were not fully analyzed . In the remaining procedures , there was a large intercenter variability in the percentage of patients who received transfusions : THR 16 to 85 percent , TKR 12 to 87 percent , and CABG 37 to 63 percent . In the patients who received transfusions , the number of red blood cells ( RBC ) units transfused varied significantly . There was also a considerable intercenter variability in RBC loss . The prevalence of preoperative anemia was 19 percent and identical in both sexes . The incidence of preoperative anemia was three times higher in patients who received transfusions compared to those who did not . CONCLUSION This study demonstrates a high intercenter variability in RBC transfusions and RBC loss in st and ard surgical procedures . Whereas the variability in blood loss remains largely unexplained , the main predictors for allogeneic RBC transfusions are preoperative and nadir Hb and surgical RBC loss The aim of this prospect i ve study was to evaluate if there was a statistical correlation between allogeneic blood transfusion and postoperative infections , and if this could have a dose-dependent pattern . The evaluation was based on multiple logistic and receiver operating characteristics ( ROC ) curve analyses . On hospital admission the following parameters were determined in 267 consecutive patients with colorectal cancer : hemoglobin , serum albumin , serum cholinesterase activity , total iron binding capacity and weight loss . Duration of operation , operative blood loss , amount of transfused blood , Dukes ' cancer stage and occurrence of postoperative infections were also recorded . One hundred and thirty-two patients ( 49.4 % ) were given perioperatively allogeneic blood . Postoperative infections developed in 47 ( 17.6 % ) patients . Multivariate analysis identified allogeneic blood transfusion as the only variable related to the occurrence of postoperative infections ( p < 0.05 ) . ROC curve analysis showed that the risk for the occurrence of infection was significantly higher in patients transfused one unit of blood ( p < 0.01 ) . Moreover , a significant trend between increasing number of transfused blood units and susceptibility to infection was found ( p < 0.00019 ) R and om‐donor blood transfusions are deliberately given before cadaver renal allografting to improve allograft survival . Since host modifications that improve the outcome of an allograft might be associated with a decreased ability of the host to control cancer growth , the relationship between blood transfusions and the outcome of 146 Dukes ' stages A , B , and C colon cancers treated by resection during the years 1974 to 1979 was studied . It was found that 65 patients ( 45 % ) had been transfused and that at 5 years , overall survival was significantly better in the nontransfused patients compared to the transfused patients ( 0.68 and 0.51 5‐year product limit survival fractions respectively ; P = 0.03 for unadjusted log‐rank comparison of entire survival curves ) . Relative risk of death due to cancer in transfused patients versus nontransfused patients was 2.3 ( P = 0.05 ) when controlled for sex , age , stage , histologic differentiation , cancer location , and preresection hemoglobin level using Cox regression analysis . Thus , blood transfusion appears to be an additional important prognostic variable . The hypothesis suggested but not proven by these data that the outcome for some malignancies may be related to the immunomodulating effects of blood transfusions needs further study . Cancer 55:1195‐1201 , 1985 Clinical studies report reduced recurrence-free survival and increased cancer-related death after surgical treatment for cancer , when peri-operative blood transfusions were given . In this study we collected transfusion data of 212 patients who participated in a prospect i ve study of two different resection techniques for colorectal cancer . One hundred and fifty-eight patients were transfused and 54 were not . The follow-up period for almost all patients was 5 years . The 5-year survival rate was 52 % both for the transfused patients and the nontransfused patients . For subgroups of patients with Dukes ' B and Dukes ' C tumours no statistically significant differences were found . In the group of patients that were transfused the number of transfusions did not affect survival . In this study we could not confirm the deleterious effect of peri-operative blood transfusions on survival PURPOSE Allogeneic blood transfusions have reportedly been associated with a poor prognosis in patients with curatively resected cancer . To control for immunosuppression induced by a speculatively causal allogeneic blood transfusion , we design ed a r and omized study in which the control group received autologous blood transfusions not related to any condition of immunosuppression . PATIENTS AND METHODS One hundred twenty patients with potentially curative resectable colorectal cancer and the capability to predeposit autologous blood were r and omly selected to receive either st and ard allogeneic blood transfusion or predeposited autologous blood . RESULTS In curatively resected cancer patients , the number who needed allogeneic blood transfusions was reduced from 60 % in the allogeneic blood group to 33 % in the autologous blood group ( P = .009 ) . After a median follow-up duration of 22 months ( range , 8 to 48 ) tumor recurrence was observed in 28.9 % of the allogeneic blood group and 16.7 % of the autologous blood group . Life-table analysis established a tendency toward a shorter tumor-free survival for the allogeneic blood group ( log-rank P = .11 ) . The problem with this analysis was the strong association of allogeneic blood transfusions with tumor recurrence , which interfered in 33 % of patients in the autologous blood group who required additional allogeneic blood transfusions . Multivariate analysis of established risk factors for tumor recurrence and surgery-related variables reflecting potential immunosuppressive conditions showed that only pT stage ( relative risk , 6.61 ; 95 % confidence interval [ CI ] , 1.82 to 23.99 ; P = .004 ) , pN stage ( relative risk , 8.39 ; 95 % CI , 3.15 to 22.33 ; P < .001 ) , and the need for allogeneic blood ( relative risk , 6.18 ; 95 % CI , 2.20 to 17.37 ; P < .001 ) were independent predictors of tumor recurrence . Subgroup analysis of patients who received a transfusion of < or = 2 U blood found a significantly higher risk of tumor recurrence in the allogeneic blood group ( relative risk , 5.16 ; 95 % CI , 1.13 to 23.62 ; P = .034 ) , which was reduced to borderline significance ( relative risk , 3.54 ; 95 % CI , 0.76 to 16.51 ; P = .107 ) by adjustment for tumor ( T ) and node ( N ) stage . CONCLUSION As indicated by these first results , the blood transfusion modality has a significant effect on tumor recurrence after surgical treatment of colorectal cancer . A change in the practice of blood transfusion might thus potentially surpass the impact of any recent adjuvant treatment strategies The relationship between blood transfusion , disease-free survival , and other potential prognostic factors was prospect ively studied in 339 consecutive patients with colorectal cancer . Admission and discharge hematocrit , Dukes ' stage , and blood loss were significantly related to both blood transfusion and disease-free survival . Using Cox proportional hazards model , however , the association of transfusion with disease-free survival was significant ( p = 0.0196 ) after controlling for age , sex , blood loss , procedure , tumor differentiation , stage , admission hematocrit , duration of surgery , length of the specimen , and tumor size . Dukes ' stage ( p < 0.0001 ) and blood transfusion ( p < 0.0001 ) were the only variables independently related to disease-free survival . Forty per cent ( 44 ) of the 110 patients who received transfusions developed cancer recurrence , compared with 22 % ( 50 ) of the 229 patients who did not receive blood ( p < 0.0001 ) . Five-year disease-free survival of the transfused patients was 57 % , compared with 77 % for nontransfuscd patients . Patients who developed recurrence received an average of twice as much blood as patients without recurrence ( 1.26 versus 0.61 units , p = 0.0128 ) . Peri-operative blood transfusion is a significant independent prognostic factor for colorectal cancer BACKGROUND Previous studies on patients with hip fractures and in patients with colorectal cancer have documented that perioperative transfusion is associated with a significant increase in postoperative infection rate . Therefore , we sought to investigate the incidence of preoperative and postoperative anemia in noncardiac surgical patients and to determine if transfusion is an independent risk factor for infection and adverse outcome postoperatively . METHODS Prospect i ve data from the National Veterans Administration Surgical Quality Improvement Program ( NSQIP ) was collected on 6301 noncardiac surgical patients at the Veterans Affairs Maryl and Healthcare System from 1995 to 2000 . RESULTS The mean age of the study cohort was 61 + /- 13 . Descriptive data revealed 95 % were male , 44 % used tobacco , 19 % were diabetic , 9 % had COPD , 9 % used alcohol , 3 % used steroids , 1.7 % had a diagnosis of cancer , and 1.2 % had ascites . Preoperative anemia ( hematocrit less than 36 ) was found in 33.9 % and postoperative anemia was found in 84.1 % of the study cohort . In the postoperative period , 32.5 % of patients had a hematocrit of 26 - 30 , and 26.5 % had a hematocrit of 21 - 25 . Mean units of blood transfused in the perioperative period ranged from 0.1 + /- 0.9 in patients without anemia to 2.7 + /- 2.9 in those with anemia . Incidence of pneumonia increased from 2.6 to 5 % with increasing degree of anemia . Multiple logistic regression analysis documented that low preoperative hematocrit , low postoperative hematocrit , and increased blood transfusion rates were associated with increased mortality ( P < 0.01 ) , increased postoperative \n Output:\n " }, { "from": "agent", "value": "In patients with colorectal cancer ( CRC ) undergoing surgery , ABTs are associated with adverse clinical outcomes , including increased mortality ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Cognitive and affective complaints are common in patients with primary hyperparathyroidism ( PHPT ) , but few studies have used psychometric testing to document these symptoms and their response to parathyroidectomy . The current study sought to clarify the nature of cognitive and affective impairments in PHPT and changes postparathyroidectomy . One hundred eleven patients with PHPT underwent neuropsychological evaluation prior to parathyroidectomy with 68 returning for an early postsurgical evaluation . Changes in cognition were assessed using practice effect corrected reliable change indices . Biochemical and anesthesia variables were compared between groups who improved and declined . In a subset of patients , assessment revealed a significant pattern of cognitive slowing , reductions in psychomotor speed , memory impairment , and depression prior to parathyroidectomy . Postsurgical evaluations revealed a trend for improvements on timed tests and depression but a decline in memory . Older patients responded less well to surgical intervention , as did patients who experienced more dramatic changes in biochemical status following surgery . Cognitive changes early postparathyroidectomy are characterized by improved information processing speed and decline in verbal memory , with younger patients more likely to recover during this acute phase . The need for longer-term follow-up studies and increasing utilization of neuropsychological assessment s in this population are discussed BACKGROUND A role for vitamin D deficiency in Parkinson disease ( PD ) has recently been proposed . OBJECTIVE To compare the prevalence of vitamin D deficiency in a research data base cohort of patients with PD with the prevalence in age-matched healthy controls and patients with Alzheimer disease ( AD ) . DESIGN Survey study and blinded comparison of plasma 25-hydroxyvitamin D ( 25[OH]D ) concentrations of stored sample s in a clinical research data base at Emory University School of Medicine . SETTING Referral center ( PD and AD patients ) , primary care clinics , and community setting ( controls ) . PARTICIPANTS Participants were recruited into the study between May 1992 and March 2007 . Every fifth consecutively enrolled PD patient was selected from the clinical research data base . Unrelated AD ( n = 97 ) and control ( n = 99 ) participants were r and omly selected from the data base after matching for age , sex , race , APOE genotype , and geographic location . MAIN OUTCOME MEASURES Prevalence of suboptimal vitamin D and mean 25(OH)D concentrations . RESULTS Significantly more patients with PD ( 55 % ) had insufficient vitamin D than did controls ( 36 % ) or patients with AD ( 41 % ; P = .02 , chi(2)test ) . The mean ( SD ) 25(OH)D concentration in the PD cohort was significantly lower than in the AD and control cohorts ( 31.9 [ 13.6 ] ng/mL vs 34.8 [ 15.4 ] ng/mL and 37.0 [ 14.5 ] ng/mL , respectively ; P = .03 ) . CONCLUSIONS This report of 25(OH)D concentrations in a predominantly white PD cohort demonstrates a significantly higher prevalence of hypovitaminosis in PD vs both healthy controls and patients with AD . These data support a possible role of vitamin D insufficiency in PD . Further studies are needed to determine the factors contributing to these differences and eluci date the potential role of vitamin D in pathogenesis and clinical course of PD BACKGROUND Reductions in iodine and zinc deficiencies and improvements in hemoglobin were achieved from a micronutrient-fortified seasoning powder consumed in school lunches by children in northeast Thail and . OBJECTIVE The objective was to determine whether fortification with 4 micronutrients in a school lunch results in changes in children 's growth , morbidity , and cognitive function compared with no fortification . DESIGN In a r and omized controlled trial of 569 children aged 5.5 - 13.4 y from 10 schools , we compared the efficacy of a seasoning powder fortified with or without 5 mg Fe , 5 mg Zn , 50 mug I , and 270 mug vitamin A per serving consumed with a school lunch 5 d/wk . Here we report on results of the secondary functional outcomes . RESULTS The groups were comparable concerning compliance and loss to follow-up . The intervention had no statistically significant effect on anthropometric measures over 31 wk , but reduced the incidence of respiratory-related illnesses [ rate ratio ( RR ) : 0.83 ; 95 % CI : 0.73 , 0.94 ] , symptoms of runny nose ( RR : 0.80 ; 95 % CI : 0.70 , 0.92 ) , cough ( RR : 0.80 ; 95 % CI : 0.66 , 0.96 ) , and diarrhea ( RR : 0.38 ; 95 % CI : 0.16 , 0.90 ) . For the visual recall test , those in the fortified group recalled 0.5 more items ( 95 % CI : 0.1 , 0.9 ) than did the controls . There were no statistically significant differences between groups in the results of the digits forward and backward tests or in school grade s at the conclusion of the 2 semesters . CONCLUSION The beneficial effects on morbidity and visual recall over a short period , in addition to some biochemical improvements , highlight the potential of this micronutrient-fortified seasoning powder supplied in a school lunch . This trial was registered at clinical trials.gov as ACTRN12605000341628 BACKGROUND To our knowledge , no prospect i ve study has examined the association between vitamin D and cognitive decline or dementia . METHODS We determined whether low levels of serum 25-hydroxyvitamin D ( 25[OH]D ) were associated with an increased risk of substantial cognitive decline in the InCHIANTI population -based study conducted in Italy between 1998 and 2006 with follow-up assessment s every 3 years . A total of 858 adults 65 years or older completed interviews , cognitive assessment s , and medical examinations and provided blood sample s. Cognitive decline was assessed using the Mini-Mental State Examination ( MMSE ) , and substantial decline was defined as 3 or more points . The Trail-Making Tests A and B were also used , and substantial decline was defined as the worst 10 % of the distribution of decline or as discontinued testing . RESULTS The multivariate adjusted relative risk ( 95 % confidence interval [ CI ] ) of substantial cognitive decline on the MMSE in participants who were severely serum 25(OH)D deficient ( levels < 25 nmol/L ) in comparison with those with sufficient levels of 25(OH)D ( > /=75 nmol/L ) was 1.60 ( 95 % CI , 1.19 - 2.00 ) . Multivariate adjusted r and om-effects models demonstrated that the scores of participants who were severely 25(OH)D deficient declined by an additional 0.3 MMSE points per year more than those with sufficient levels of 25(OH)D. The relative risk for substantial decline on Trail-Making Test B was 1.31 ( 95 % CI , 1.03 - 1.51 ) among those who were severely 25(OH)D deficient compared with those with sufficient levels of 25(OH)D. No significant association was observed for Trail-Making Test A. CONCLUSION Low levels of vitamin D were associated with substantial cognitive decline in the elderly population studied over a 6-year period , which raises important new possibilities for treatment and prevention OBJECTIVE To determine whether supplementation with vitamins and trace elements in modest amounts influences cognitive function in apparently healthy , elderly subjects . METHODS The study was design ed as a r and omized , double-blind , placebo-controlled trial . Ninety-six , apparently healthy , independent men and women older than 65 y of age were recruited and r and omized to receive a supplement of trace elements and vitamins or a placebo daily for 12 mo . Blood-nutrient levels were estimated at baseline and at the end of the study . The major outcome measure assessed was cognitive function consisting of immediate and long-term memory , abstract thinking , problem-solving ability , and attention . RESULTS Eighty-six subjects completed the 1-y trial . The supplemented group showed a significant improvement in all cognitive tests ( P < 0.001 to 0.05 ) except long-term memory recall ( P > 0.1 ) . Those whose blood-nutrient levels were below the reference st and ard showed lower responses on cognitive tests . There was no significant correlation between individual nutrient levels and performance on various cognitive function tests . CONCLUSIONS Cognitive functions improved after oral supplementation with modest amounts of vitamins and trace elements . This has considerable clinical and public health significance . We recommend that such a supplement be provided to all elderly subjects because it should significantly improve cognition and thus quality of life and the ability to perform activities of daily living . Such a nutritional approach may delay the onset of Alzheimer 's disease Summary This prospect i ve study finds that ergocalciferol 50,000 IU three times weekly for four weeks effectively and safely corrects vitamin D inadequacy in nursing home residents . Introduction Low vitamin D status is common among nursing home residents and contributes to bone loss , falls and fractures . The objective of this study was to evaluate the efficacy and safety of short course , high dose , oral vitamin D2 ( ergocalciferol ) treatment . Methods This prospect i ve study included 63 nursing home residents . The 25 with low vitamin D status ( serum 25(OH)D ≤ 25 ng/ml ) received oral ergocalciferol 50,000 IU three times weekly for four weeks ; the others received no change to their routine care . Serum total 25(OH)D , 25(OH)D2 , 25(OH)D3 , calcium , parathyroid hormone ( PTH ) , bone turnover markers and neuro-cognitive assessment s were obtained at baseline and four weeks . Results Mean total 25(OH)D concentration increased ( p < 0.0001 ) from 17.3 to 63.8 ng/ml in the treated group and remained unchanged in the comparison group . Serum 25(OH)D3 remained stable in the comparison group , but declined ( p < 0.0001 ) with D2 treatment from 15.4 to 9.1 ng/ml . Serum PTH trended down in the treatment group ( p = 0.06 ) . No treatment-induced improvement in ambulation , cognition or behavior was observed . No hypercalcemia or other adverse effects were observed with ergocalciferol treatment . Conclusion Four weeks of oral vitamin D2 supplementation effectively and safely normalizes serum 25(OH)D in nursing home residents Background / Aims : Recent studies suggest that vitamin D metabolites may be important for preserving cognitive function via specific neuroprotective effects . No large studies have examined the association between vitamin D status and cognition . Methods : In this cross-sectional study , we analyzed the serum 25-hydroxyvitamin D3 levels and Mini-Mental State Examination ( MMSE ) test scores of 225 older out patients who were diagnosed as having probable Alzheimer ’s disease ( AD ) . In addition to the 25-hydroxyvitamin D3 levels , we analyzed the serum vitamin B1 , B6 and B12 levels . Results : An association was found between MMSE test scores and serum 25-hydroxyvitamin D3 levels , with a β-coefficient of 0.05 ( p = 0.01 ) . Vitamin-D-sufficient patients had significantly higher MMSE scores as compared to vitamin-D-insufficient ones . No association was found with the other serum vitamin levels . Conclusions : These data support the idea that a relationship exists between vitamin D status and cognition in patients with probable AD . However , given the cross-sectional design of this study , no causality can be concluded . Further prospect i ve studies are needed to specify the contribution of vitamin D status to the onset and course of cognitive decline and AD CONTEXT Data regarding the presence , extent , and reversibility of psychological and cognitive features of primary hyperparathyroidism ( PHPT ) are conflicting . OBJECTIVE This study evaluated psychological symptoms and cognitive function in PHPT . DESIGN This is a case-control study in which symptoms and their improvement 6 months after surgical cure of PHPT were assessed . SETTING S The study was conducted in a university hospital metabolic bone disease unit and endocrine surgery practice . PARTICIPANTS Thirty-nine postmenopausal women with PHPT and 89 postmenopausal controls without PHPT participated in the study . INTERVENTION Participants with PHPT underwent parathyroidectomy . OUTCOME MEASURES Measurements used in the study were : Beck Depression Inventory ( BDI ) ; State-Trait Anxiety Inventory , Form Y ( STAI-Y ) ; North American Adult Reading Test ( NAART ) ; Wechsler Memory Scale Logical Memory Test , Russell revision ( LM ) ; Buschke Selective Reminding Test ( SRT ) ; Rey Visual Design Learning Test ( RVDLT ) ; Booklet Category Test , Victoria revision ( BCT ) ; Rosen Target Detection Test ( RTD ) ; Wechsler Adult Intelligence Scale-Revised Digit Symbol Subtest ( DSy ) ; Wechsler Adult Intelligence Scale Digit Span Subtest ( DSpan ) . RESULTS At baseline , women with PHPT had significantly higher symptom scores for depression and anxiety than controls and worse performance on tests of verbal memory ( LM and SRT \n Output:\n " }, { "from": "agent", "value": "Conclusion : These results suggest that lower vitamin D concentrations are associated with poorer cognitive function and a higher risk of AD ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE The objective of this systematic review is to identify educational content and techniques that lead to successful patient self-management and improved outcomes in congestive heart failure education programs . METHODS MEDLINE , CINAHL and the Cochrane Central Register of Controlled Trials , as well as reference lists of included studies and relevant review s , were search ed . Eligible studies were r and omised controlled trials evaluating congestive heart failure self-management education programs with outcome measures . Two of the investigators independently abstract ed descriptive information , education content topics and outcomes data . RESULTS A total of 7413 patients participated in the 35 eligible congestive heart failure self-management education studies . The congestive heart failure self-management programs incorporated 20 education topics in four categories : ( i ) knowledge and self-management ( diagnosis and prognosis , pathophysiology of how congestive heart failure affects the body , aims of treatment , management and symptoms , medication review and discussion of side-effects , knowing when to access/call the general practitioner , communication with the physician , follow up for assessment or reinforcement ) ; ( ii ) social interaction and support ( social interaction and support , stress , depression ) ; ( iii ) fluids management ( sodium restriction , fluid balance , daily measurement of weight , ankle circumference , self-monitoring and compliance relative to fluids ) ; and ( iv ) diet and activity ( dietary assessment and instructions , physical activity and exercise , alcohol intake , smoking cessation ) . A total of 113 unique outcomes in nine categories ( satisfaction , learning , behaviour , medications , clinical status , social functioning , mortality , medical re source utilisation and cost ) were measured in the studies . Sixty ( 53 % ) of the outcomes showed significant improvement in at least one study . CONCLUSION Educational interventions should be based on scientifically sound research evidence . The education topic list developed in this review can be used by patients and clinicians to prioritise and personalise education AIM This paper is a report of a study to explore the views , concerns and experiences of doctors ' assistants of case management for patients with chronic heart failure , while experiencing the new role of being a case manager within the Heidelberg Integrated Case Management trial . BACKGROUND Case management is being investigated as part of a r and omised controlled trial aim ing to improve care for patients with chronic systolic heart failure . In a complex , multifaceted intervention , trained doctors ' assistants ( equivalent to a nursing role ) adopted new tasks using st and ardised case management involving telephone monitoring , home visits and diagnostic screening . METHOD In April 2007 , 3 months after implementation of the intervention programme , 27 doctors ' assistants participated in four focus group interviews discussing their views on , and experiences of , case management . Thematic analysis of the data was undertaken . FINDINGS Participants believed that the most positive factors in case management were about interaction with patients , including opportunities for identifying disease and psychosocial problems . However , barriers included lack of time allocated to perform case management in addition to their normal role and poor cooperation within the practice team . According to the doctors ' assistants , the routine implementation of case management was acceptable , feasible and effective in improving the management of patients with chronic systolic heart failure . CONCLUSION Case management enhanced the role of doctors ' assistants , leading to increased awareness of the perspective of patients with chronic disease . In the wider international primary care practice nursing context , the orchestrated delegation of tasks using specific case management may be a promising strategy for improving the quality of care of chronically ill patients and enabling patient self-management \n Output:\n " }, { "from": "agent", "value": "This synthesis showed that case management provides positive quality of care for patients , increases perceived access to services and creates more time to ask questions and develop trusted relationships .\nFor health professionals , case management enhanced care by improved relationships with both patients and colleagues although concerns remained around re sources , training and inter-professional conflict .\nThis synthesis emphasizes the importance of the quality of being cared for as a patient and caring as a health professional .\nCase management enhances communication between patients and health professionals , supports patient self-care and self-management and can be an important contributing factor in reducing unplanned admissions for patients with heart failure" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Purpose — Determining cognitive dysfunctioning ( CDF ) after stroke is an important issue because it influences choices for management in terms of return to previous activities . Because previous research in subacute stroke has shown important variations in CDF rates , we aim ed to describe the frequency and neuropsychological profile of CDF in subacute stroke outside dementia . We used a large battery of tests to screen any potentially hidden CDF . Methods — Patients with Mini-Mental State Examination scores ≥23 were prospect ively and consecutively included 2 weeks after a first-ever ischemic brain infa rct . Stroke features were based on MRI . Four domains were evaluated : instrumental and executive functions , episodic memory , and working memory ( WM ) . Patients were scored using means and compared with education- and age-matched control subjects . Then we attributed Z-scores for each test and each domain . The most relevant cognitive tests characterizing CDF were determined using logistic regression . Results — Among 177 patients ( mean age , 50.6 years ) , 91.5 % failed in at least one cognitive domain . WM was the most impaired domain ( 87.6 % ) with executive functions ( 64.4 % ) , episodic memory ( 64.4 % ) , and instrumental functions ( 24.9 % ) being relatively preserved . CDF was associated with age , education , depression , neurological deficit , and leukoaraiosis in bivariate analysis . Using logistic regression , WM tests and age predicted CDF ( Modified Paced Auditorial Serial Addition Test : OR=0.96 CI=0.93 to 0.98 ; Owen-spatial-WM : OR=1.07 CI=1.02 to 1.12 ; age : OR=0.96 CI=0.93 to 0.98 ) . Conclusion — CDF appears to be almost constant , although underestimated , in subacute stroke . WM could reflect some hidden dysfunctioning , which may interfere with rehabilitation and return to work . Clinical routine may include WM tests in young patients with mild stroke Objectives To investigate the prognostic value of the neurocognitive status measured by screening instruments , the Montreal Cognitive Assessment ( MoCA ) and Mini-Mental State Examination ( MMSE ) , individually and in combination with the stroke severity scale , the National Institute of Health Stroke Scale ( NIHSS ) , obtained at the subacute stroke phase or the baseline ( ≤2 weeks ) , for functional outcome 3–6 months later . Design Prospect i ve observational study . Setting Tertiary stroke neurology service . Participants 400 patients with a recent ischaemic stroke or transient ischaemic attack ( TIA ) received NIHSS , MoCA and MMSE at baseline and were followed up 3–6 months later . Primary outcome measures At 3–6 months following the index event , functional outcome was measured by the modified Rankin Scale ( mRS ) scores . Results Most patients ( 79.8 % ) had a mild ischaemic stroke and less disability ( median NIHSS=2 , median mRS=2 and median premorbid mRS=0 ) , while a minority of patients had TIA ( 20.3 % ) . Baseline NIHSS , MMSE and MoCA scores individually predicted mRS scores at 3–6 months , with NIHSS being the strongest predictor ( NIHSS : R2 change=0.043 , p<0.001 ) . Moreover , baseline MMSE scores had a small but statistically significant incremental predictive value to the baseline NIHSS for mRS scores at 3–6 months , while baseline MoCA scores did not ( MMSE : R2 changes=0.006 , p=0.03 ; MoCA : R2 changes=0.004 , p=0.083 ) . However , in patients with more severe stroke at baseline ( defined as NIHSS>2 ) , baseline MoCA and MMSE had a significant and moderately large incremental predictive value to the baseline NIHSS for mRS scores at 3–6 months ( MMSE : R2 changes=0.021 , p=0.010 ; MoCA : R2 changes=0.017 , p=0.021 ) . Conclusions Cognitive screening at the subacute stroke phase can predict functional outcome independently and improve the predictive value of stroke severity scores for functional outcome 3–6 months later , particularly in patients with more severe stroke Objective : To evaluate the prognostic value of domain-specific cognitive abilities in acute stroke with respect to long-term cognitive and functional outcome in addition to neurologic and demographic predictors . Methods : The authors evaluated 168 patients within the first 3 weeks after first-ever stroke . The prevalence of neuropsychological impairment was calculated vs 75 matched healthy controls . The authors also recorded demographic data , vascular risk factors , lesion characteristics , and clinical factors at admission . Independent predictor variables associated with long-term cognitive impairment ( assessed with a follow-up neuropsychological examination ) and functional impairment ( assessed with the modified Barthel Index and the Frenchay Activities Index ) were identified with stepwise multiple logistic regression . Areas under receiver operator characteristic curves were used to compare the predictive value of three models , i.e. , a st and ard medical model , a purely cognitive model , and a model consisting of both medical and cognitive predictors . Results : Thirty-one percent of patients showed long-term cognitive impairment . Basic and instrumental ADL disturbances remained present in 19 % and 24 % of patients . Domain-specific cognitive functioning predicted cognitive and functional outcome better than any other variable . Moreover , the prediction of instrumental ADL functioning improved when cognitive predictors were added to the st and ard medical model ( p < 0.05 ) . Impairments in abstract reasoning and executive functioning were independent predictors of long-term cognitive impairment . Inattention and perceptual disorders were more important in predicting long-term functional impairment . Conclusion : Domain-specific cognitive abilities in the early phase of stroke are excellent independent predictors of long-term cognitive and functional outcome While the Mini-Mental State Examination ( MMSE ) was originally developed to screen for dementia and delirium , many neurologists use this measure as a screening instrument for ' cognitive impairment ' in hospitalized stroke patients . However , the validity of the MMSE as such has never been evaluated in acute stroke . We administered the MMSE in addition to a neuropsychological examination covering six cognitive domains to 34 stroke patients ( mean interval between stroke and examination , 6.5+/-2.9 days ) and 34 healthy controls . The area under the receiver operating characteristic curve ( AUC ) was calculated in addition to the sensitivity and specificity for various cut-off points on the MMSE . Seventy percent of the patients were impaired in at least one cognitive domain . The accuracy of the MMSE in detecting cognitive impairment was no better than chance ( AUC = 0.67 ; p = 0.13 ) . No optimum MMSE cut-off value could be identified . The MMSE is particularly insensitive to impairments in abstract reasoning , executive functioning , and visual perception/construction Objectives To determine the prognostic value of brief cognitive screening tests administered in the subacute stroke phase ( initial 2 weeks ) for the detection of significant cognitive impairment 3–6 months after stroke , the authors compared the Montreal Cognitive Assessment ( MoCA ) and the Mini-Mental State Examination ( MMSE ) . Methods Patients with ischaemic stroke and transient ischaemic attack were assessed with both MoCA and MMSE within 14 days after index stroke , followed by a formal neuropsychological evaluation of seven cognitive domains 3–6 months later . Cognitive outcomes were dichotomised as either no – mild ( impairment in ≤2 cognitive domains ) or moderate – severe ( impairment in ≥3 cognitive domains ) vascular cognitive impairment . Area under the receiver operating characteristic ( ROC ) curve analysis was used to compare discriminatory ability . Results 300 patients were recruited , of whom 239 received formal neuropsychological assessment 3–6 months after the stroke . 60 ( 25 % ) patients had moderate – severe VCI . The overall discriminant validity for detection of moderate – severe cognitive impairment was similar for MoCA ( ROC 0.85 ( 95 % CI 0.79 to 0.90 ) and MMSE ( ROC 0.83 ( 95 % CI 0.77 to 0.89 ) ) , p=0.96 ) . Both MoCA ( 21/22 ) and MMSE ( 25/26 ) had similar discriminant indices at their optimal cutoff points ; sensitivity 0.88 versus 0.88 ; specificity 0.64 versus 0.67 ; 70 % versus 72 % correctly classified . Moreover , both tests had similar discriminant indices in detecting impaired cognitive domains . Conclusions Brief screening tests during acute admission in patients with mild stroke are predictive of significant vascular cognitive impairment 3–6 months after stroke OBJECTIVE To assess whether , and to what extent , cognitive outcome relates to overall functional outcome among elderly stroke patients . DESIGN Nonconcurrent prospect i ve study . SETTING Geriatric rehabilitation division at a large , urban , academic , freest and ing hospital in Israel . PARTICIPANTS Three hundred thirty-six patients aged 60 years and older admitted consecutively for rehabilitation after first acute stroke . Inclusion criteria were met by 315 patients , who were included in the final analysis . Average age was 75.3 years . The stroke was right sided in 44.1 % . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The motor subscale of the FIM instrument assessed functional status . Absolute functional gain was determined by the FIM motor gain . Relative functional gain was calculated according to the Montebello Rehabilitation Factor Score . Cognitive status was assessed with the Mini-Mental State Examination ( MMSE ) and the FIM cognitive subscale . RESULTS FIM scores increased significantly during rehabilitation , mainly due to improvement in motor functioning . A strong association was found between the cognitive scales ( r=.853 , P<.001 ) . Better rehabilitation outcomes were observed in patients with higher admission cognitive status , adjusting for the effect of age , sex , onset to admission interval , length of stay , and severity of stroke ( odds ratio = 2.0 ; 95 % confidence interval , 1.5 - 2.5 ) . CONCLUSIONS Impaired cognitive status at admission negatively affects the rehabilitation outcome of elderly stroke patients . The utility of routinely using a cognitive test for all patients before admission to rehabilitation , preferably the MMSE , is emphasized . The time , cost , and effort involved in performing such a test are negligible , and the potential benefits are considerable Background and aim : Social functioning is impaired in approximately two-thirds of stroke patients of vocational age , even several months after a first ever mild to moderate stroke . The known predictors of social functioning are initial stroke severity , anxiety and depression , and the Mini-Mental State Evaluation , suggesting that cognitive deficits contribute to post-stroke social dysfunctioning . The aim of this study was to evaluate whether cognitive domains correlated with social functioning and to determine the cognitive predictors of social dysfunctioning . Methods : 74 patients were prospect ively included 6 months after a first ever stroke . National Institutes of Health Stroke Scale ( NIHSS ) , modified Rankin scale , depression and anxiety were recorded . Social functioning was recorded using the Work and Social Adjustment Scale ( WSAS ) . An extensive neuropsychological test battery explored general cognitive functioning , episodic memory , instrumental functions , executive functions and working memory . Univariate comparisons assessed the relationships between the neuropsychological tests and scores on the WSAS . Predicting factors for WSAS were determined using ordinal logistic regression . Results : 52 patients ( 70 % ; 95 % confidence interval 58 % to 80 % ) complained of significant perturbations in work and social functioning . In univariate comparisons , general cognitive functioning , memory , instrumental functions , executive functions and working memory significantly correlated with social functioning . Working memory was the most affected domain . With multivariate modelling , the NIHSS at admission , Hospital Anxiety Depression scale and Owen ’s Spatial Working Memory test were independent predictors of WSAS . Conclusions : All cognitive domains were associated with social functioning , working memory being the main cognitive determinant . Our results suggest that cognitive impairment impacts on social dysfunctioning , which is known to be a component of quality of life OBJECTIVES To assess the sensitivity and specificity of a screening battery for detecting cognitive impairment after stroke . DESIGN A r and omized controlled trial . METHODS Stroke patients were recruited from hospitals in three centres . Patients were screened for cognitive impairment on the Mini-Mental State Examination , the Sheffield Screening Test for Acquired Language Disorders and Raven 's Coloured Progressive Matrices and received a further battery of assessment s of cognitive function . Sensitivity and specificity values were calculated for the three screening measures for overall conclusions regarding cognitive impairment reached from a comprehensive assessment . Receiver Operating Characteristic Curves were plotted . CONCLUSION The Mini-Mental State Examination was not a useful screen for memory problems or overall cognitive impairment after stroke . The Sheffield Screening Test for Acquired Language Disorders was an appropriate screen for language problems . The Raven 's Coloured Progressive Matrices was appropriate as a screen for perceptual problems and visual inattention but not for executive deficits OBJECTIVES To determine whether cognitive impairment affects access to , or quality of , rehabilitation services , and to examine the effects of functional outcomes in stroke patients . DESIGN Secondary analysis of prospect i ve cohort of stroke patients followed for 6 months after stroke . SETTING S Eleven large-volume US Department of Veterans Affairs hospitals nationwide . PARTICIPANTS Stroke patients ( N \n Output:\n " }, { "from": "agent", "value": "Conclusion : None of the existing instruments fulfils all criteria ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The long‐term effects of abdominal aortic aneurysm ( AAA ) screening were investigated in extended follow‐up from the UK Multicentre Aneurysm Screening Study ( MASS ) r and omized trial Context Is it cost-effective to screen older adults for abdominal aortic aneurysm ( AAA ) ? Contribution This 7-year follow-up report of a large r and omized trial in the United Kingdom found that men age 65 to 74 years who were invited to have ultrasonography and surveillance for AAA had lower mortality rates than did those who were not invited ( hazard ratio , 0.53 [ CI , 0.42 to 0.68 ] ) . Cost-effectiveness for AAA-related deaths , based on costs applied to the events experienced by the men , was estimated at $ 19500 ( CI , $ 12400 to $ 39800 ) per life-year gained . Caution s Only men were studied . Actual costs of screening and surveillance may vary substantially in different setting s. The Editors A fast-growing body of literature is providing evidence in favor of screening men for abdominal aortic aneurysm ( AAA ) . Several large , r and omized trials published in the past few years ( 14 ) have consistently shown that screening reduces AAA-related mortality . A few observational studies of programs under way in localized areas have established the feasibility of systematic screening and have explored its practical implementation ( 57 ) . In addition to the mortality benefit , evidence indicating that screening is highly cost-effective is increasing ( 811 ) . In light of this evidence , national screening programs are now being considered in many countries ( 1214 ) . However , there is little evidence regarding long-term outcomes after AAA screening ; almost all of the evidence from r and omized trials is limited to the first 4 years after screening ( 14 ) . Moreover , long-term cost-effectiveness has been estimated only through health economic modeling ( 10 ) . We describe cost-effectiveness based on 7-year follow-up from the largest of the 4 trials of AAA screeningthe Multicentre Aneurysm Screening Study ( MASS ) ( 2 ) . The trial r and omly assigned approximately 67800 men age 65 to 74 years to receive an invitation to screening or to not receive an invitation . At 4-year follow-up , the trial reported a substantial relative reduction of 42 % ( 95 % CI , 22 % to 58 % ) in AAA-related mortality and an incremental cost-effectiveness ratio of $ 44900 ( CI , $ 24000 to $ 231000 ) per life-year gained ( 9 ) , which is at the borderline of the commonly accepted threshold for interventions . All values are reported in U.S. dollars ( U.K. 1 = U.S. $ 1.58 ) ( 15 ) . The costs of AAA screening are primarily incurred at the start of the program , but benefits continue to accrue in terms of life-years gained in patients in whom AAA rupture is avoided through elective surgery . It is therefore expected that cost-effectiveness of screening will improve over time . The mid-term results of MASS provide reliable , trial-based information regarding clinical outcomes and cost-effectiveness over a longer period . Methods The details of the MASS protocol were described previously ( 2 ) , but a brief summary is provided ( Figure 1 ) . Between 1997 and 1999 , a population -based sample of 70495 men age 65 to 74 years from 4 centers in the United Kingdom was identified by obtaining records for every man in this age range who was registered with a family physician ( registered persons account for approximately 98 % of the population ) . Persons who were ineligible for the trial ( incorrect details , known AAA , previous AAA surgery , or terminal illness ) were excluded before r and omization . The remaining 67770 men were r and omly assigned to receive an invitation to ultrasonography for AAA or to not receive an invitation to ultrasonography . At screening , men with an aortic diameter of 3.0 cm or greater were defined as having an AAA and were subsequently invited for recall scans to monitor growth of the aneurysm . Men with an aortic diameter of 3.0 to 4.4 cm were rescreened every year , and those with an aortic diameter of 4.5 to 5.4 cm were rescreened every 3 months . Participants were considered for elective surgery when the aortic diameter reached 5.5 cm , aortic expansion was 1.0 cm or more in 1 year , or they experienced symptoms attributable to the aneurysm . Men with an aortic diameter less than 3.0 cm on the initial scan were not rescreened . Blood pressure was also measured ; although family physicians were informed of these measurements , no further intervention was provided through the screening program . We obtained approval from local ethics committees at each center , and all patients who had screening provided signed informed consent . Figure 1 . Study flow diagram . Additional data on follow-up scans and AAA surgeries were collected from hospital records . Deaths up to 31 March 2005 were confirmed by the U.K. Office of National Statistics after matching of the unique National Health Service number for each person . Follow-up ranged from 5.9 to 8.2 years ( mean , 7.1 years ) . The primary outcome of interest , AAA-related mortality , is defined as all deaths within 30 days of any AAA surgery ( elective or emergency ) plus all deaths with International Classification of Diseases , Ninth Revision , codes 441.3 ( ruptured abdominal aortic aneurysm ) , 441.4 ( abdominal aortic aneurysm without mention of rupture ) , 441.5 ( ruptured aortic aneurysm at unspecified site ) , or 441.6 ( aortic aneurysm at unspecified site without mention of rupture ) . The use of codes 441.5 and 441.6 may result in inclusion of some thoracic aortic aneurysm deaths . Investigation of the accuracy of cause-of-death coding on the death certificates was done by an independent mortality working party that was blinded to group allocation . The results of this analysis showed that inaccuracies in coding did not have an important impact on study outcomes ( 2 ) . Statistical Analysis All analyses were done by using Stata , version 9 ( Stata Corp. , College Station , Texas ) . Deaths related to AAA ( primary analysis ) and all-cause mortality ( secondary analysis ) were compared between the 2 r and omized groups by using unadjusted Cox regression by intention-to-treat analysis . Adjustment for age at baseline did not influence the results . The proportional hazards assumption was tested by using Schoenfeld residuals . An unbiased r and omization-based estimate of the benefit of screening was also obtained ( 16 ) . This estimate is calculated by subtracting from the control group a subgroup that is equivalent in terms of survival to the nonadherent subgroup in the invited group . Thus , the remaining controls are comparable to the group of invited patients who attended screening . Life-years gained are estimated as the area between the KaplanMeier curves for both groups ( 17 ) . The cost-effectiveness of screening is estimated from a health service perspective for follow-up truncated at 7 years , with adjustment for censoring ( 18 ) . Details of the costing exercise in the trial at 20002001 prices were reported previously ( 9 ) . The unit costs obtained ( U.K. 1 = U.S. $ 1.58 for the year 2000 [ 15 ] ) are inflated to the 20042005 financial-year level by using annual hospital and community health services pay and price inflation indices ( 19 ) . Costs are applied to the following events on the basis of individual re source use : invitation to screening ( $ 2.46 ) , reinvitation after nonresponse ( $ 2.42 ) , initial scan ( $ 35.95 ) , recall scan ( $ 86.74 ; done in the hospital rather than in the community and including costs for periodic routine meetings with a consultant ) , consultation for elective surgery ( $ 583.79 ) , elective AAA surgery ( $ 13015.74 ) , and emergency AAA surgery ( $ 21054.32 ) . Costs relating to scans of incidentally detected AAAs in the control group are not included ( data not available ) , but costs relating from result ant AAA repair surgery are included . Sensitivity analyses were done by using 1 ) costs retained at the 20002001 financial-year level for comparison with previous publications , 2 ) quality -adjusted life-years based on age-related reductions , 3 ) U.S.-based unit cost estimates for scans and surgeries , 4 ) an increase of 50 % in the cost of a consultation ( a U.S.-based estimate was not available , but this analysis reflects possible additional assessment s ) , 5 ) 3 and 4 combined . Quality -of-life adjustments are made only on the basis of age , with an adjustment of 0.78 for life-years gained between the ages 65 and 74 years and an adjustment of 0.75 for life-years gained at ages older than 75 years ( 20 ) . The U.S.-specific estimates for scans ( initial and recall ) are based on Medicare reimbursement for AAA screening at $ 90.95 ( Current Procedural Terminology code G0389 ) ( 21 ) , and U.S.-specific costs for surgeries are based on previously published estimates ( 22 , 23 ) that were inflated to 2004 prices ( 24 ) : $ 18160 for elective procedures and $ 31106 for emergency procedures . Discounting is applied at the current recommended values of 3 % per annum for costs and effects ( 25 ) . Estimates of AAA-related costs and effects take into account the rate of nonAAA-related deaths across both groups over time . The Fieller method is used to calculate bounds for the CI for cost-effectiveness ( 26 , 27 ) . Role of the Funding Source This study was funded by the Medical Research Council . The funding source had no role in the design , implementation , or analysis of the study . Results Figure 1 shows the flow of participants through the trial . Numbers differ slightly from earlier publications because of identification of a few duplicate records in the data base . Of 67770 r and omly assigned men , 33883 were invited to be screened : 27204 ( 80 % ) attended and 1334 ( 4.9 % ) AAAs were identified . The mean age at r and omization was 69.2 years in both groups . Loss to follow-up because of death was 2.1 % overall ( 2.2 % in the control group and 2.1 % in the invited group ) . Loss to clinical follow-up ( nonattendance at recall scans ) was 19 % at 4 years and 24 % at 7 years . The Appendix Table shows surgeries and deaths within 30 days in each of the r and omly assigned groups . A few endovascular operations are included in these figures6 in the control group and 14 in the invited group . As expected , the total number of elective procedures is greater in the invited group than in the control group The natural history of the ectatic infrarenal aorta remains undetermined . While surveillance protocol s have been proposed for true aneurysms , no recommendations are currently available for ectatic aortas . The purpose of this study is to define the natural history and recommend surveillance protocol s for the infrarenal aorta 2.5 - 2.9 cm in diameter . Screening of 12,500 yielded 223 patients with an infrarenal abdominal aorta 2.5 - 2.9 cm in diameter at a university-affiliated VA medical center . All patients were prospect ively followed by ultrasound from August 1993 through October 2000 and expansion rates were calculated by comparing the first and last study . Multivariate analysis of risk factors classically associated with abdominal aortic aneurysm was performed . Current data suggest that ectatic infrarenal aortas exp and slowly , do not rupture , and rarely meet criteria for operative repair . No risk factors linked to the development of aneurysms were identified . On the basis of this study we recommend that patients with ectatic aortas have a repeat ultrasound 5 years after the initial study BACKGROUND At present , several regions and countries are considering screening for abdominal aortic aneurysm ( AAA ) . However , The Chichester Aneurysms Screening Trial has reported poor long term benefit of screening for AAA . We therefore supplement previously published data with a preliminary analysis of the ten-year mortality from AAA , based upon population -based data until 2002 ( 7 years ) and incomplete hospital-based information on deaths until 2005 ( 10 years ) . METHODS AND MATERIAL In 1994 we started a r and omised screening trial of 12,639 64 - 73 year-old males ; 6,306 were controls , and 6,333 were invited to an abdominal ultrasound scan at their district hospital . Information on all deaths until 15.3.2005 was obtained from the Office of Civil Registration . Information on AAA related deaths was obtained from the national registry of Causes of Deaths from 1.4.1994 to 31.12.2001 , and supplemented with AAA deaths known to the Danish National Patient Registry until 15.3.2005 . Operations were obtained from the Danish National Vascular Registry from 1.4.1994 to 15.3.2005 . Death certificates and medical records were review ed by two independent assessors . The analyses were based on \" intention to treat \" from the date of r and omisation \n Output:\n " }, { "from": "agent", "value": "Ultrasonography is noninvasive , can be conducted at a low cost , and does not involve radiation exposure .\nWhen we pooled AAA-related mortality and screening harms , the summary effects showed high statistical heterogeneity at the longest follow-up ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients , but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer . Methods : In a r and omized , controlled , parallel-group , double-blind ( patients and outcome assessors ) superiority trial in the intensive care unit of a tertiary oncology hospital , the authors evaluated whether a restrictive strategy of erythrocyte transfusion ( transfusion when hemoglobin concentration < 7 g/dl ) was superior to a liberal one ( transfusion when hemoglobin concentration < 9 g/dl ) for reducing mortality and severe clinical complications among patients having major cancer surgery . All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and r and omly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy . The primary outcome was a composite endpoint of mortality and morbidity . Results : A total of 198 patients were included as follows : 101 in the restrictive group and 97 in the liberal group . The primary composite endpoint occurred in 19.6 % ( 95 % CI , 12.9 to 28.6 % ) of patients in the liberal- strategy group and in 35.6 % ( 27.0 to 45.4 % ) of patients in the restrictive- strategy group ( P = 0.012 ) . Compared with the restrictive strategy , the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16 % ( 3.8 to 28.2 % ) and a number needed to treat of 6.2 ( 3.5 to 26.5 ) . Conclusion : A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy Objectives : To assess the transfusion practice in the intensive care unit ( ICU ) in a general hospital in Kuwait relative to indications , pretransfusion hemoglobin , red blood cell ( RBC ) use and outcome . Subjects and Methods : 475 patients were admitted to the ICU during the study period ( January 2009 to February 2010 ) . Ninety-nine received RBC transfusion . Demographic , clinical and transfusion data were prospect ively collected for the 99 patients who were followed up for 30 days , until hospital discharge , or death , whichever occurred first . Indications for RBC transfusion included hemorrhage in 39 patients , improving oxygen-carrying capacity in 55 , and hemolysis in 5 . Results : Of the 99 transfused patients , 22 ( 22.22 % ) were also transfused after discharge from the ICU . Transfusions were more frequent in patients admitted with respiratory failure ( 30 , 30.3 % ) , hemorrhagic shock ( 24 , 24.2 % ) , and septic shock ( 18 , 18.4 % ) . The mean pretransfusion hemoglobin in ICU transfusions was statistically different ( 70.9 ± 12.7 g/l ) from transfusions after discharge ( 79.7 ± 9.4 g/l ) ( p < 0.001 ) . Longer ICU stay was associated with more RBC units transfused per transfusion episode per patient ( p < 0.001 ) . The Sequential Organ Failure Assessment ( SOFA ) score was significantly associated with the number of RBC units transfused per patient ( p = 0.006 ) . Mortality was significantly associated with Acute Physiology and Chronic Health Evaluation II and SOFA scores , the need and duration for mechanical ventilation , and the length of stay in hospital . Conclusion : Intensivists in our center followed a restrictive transfusion practice , by adopting a low pretransfusion hemoglobin threshold . Decisions on RBC transfusions seemed in most cases to be based on a ‘ transfusion trigger ’ rather than a physiologic need Background Although the optimum hemoglobin ( H ) concentration for patients with septic shock ( SS ) has not been specifically investigated , current guidelines suggest that H of 7 - 9 g/dL , compared with 10 - 12 g/dL , was not associated with increased mortality in critically ill adults . This contrasts with early goal -directed resuscitation protocol s that use a target hematocrit of 30 % in patients with low central venous oxygen saturation ( ScvO2 ) during the first 6 hours of resuscitation of SS . Methods Data elements were prospect ively collected on all patients with SS patients ( lactic acid ( LA ) > 4 mmol/L , or hypotension ) . Out of a total of 396 SS patients , 46 patients received red blood cell ( RBC ) transfusion for ScvO2 < 70 % ( RBC group ) . We then matched 71 SS patients that did not receive RBC transfusion ( NRBC group ) on the following goals ( G ) : LA obtained within 6 hours ( G1 ) , antibiotics given within 3 hours ( G2 ) , 20 mL/kg fluid bolus followed by vasopressors ( VP ) if needed to keep mean arterial pressure > 65 mm Hg ( G3 ) , central venous pressure > 8 mm Hg within 6 hours ( G4 ) and ScvO2 > 70 % within 6 hours ( G5 ) . Results In the RBC group , after one unit of RBC transfusion , ScvO2 improved from average of 63 % ( ± 12 % ) to 68 % ( ± 10 % ) ( P = 0.02 ) . Sixteen patients required another unit of RBC , and this result ed in increase of ScvO2 to 78 % ( ± 11 % ) ( P < 0.01 ) . The RBC and NRBC groups were matched on sequential organ failure assessment ( SOFA ) scores and all five goals . There was no difference in mortality between the two groups : 41 % vs. 39.4 % ( OR : 0.8 , 95 % CI : 0.4 - 1.7 , P = 0.6 ) . Conclusions In our study , transfusion of RBC was not associated with decreased mortality in SS patients CONTEXT Anemia is a common problem in critically ill patients admitted to intensive care units ( ICUs ) , but the consequences of anemia on morbidity and mortality in the critically ill is poorly defined . OBJECTIVES To prospect ively define the incidence of anemia and use of red blood cell ( RBC ) transfusions in critically ill patients and to explore the potential benefits and risks associated with transfusion in the ICU . DESIGN Prospect i ve observational study conducted November 1999 , with 2 components : a blood sampling study and an anemia and blood transfusion study . SETTING AND PATIENTS The blood sampling study included 1136 patients from 145 western European ICUs , and the anemia and blood transfusion study included 3534 patients from 146 western European ICUs . Patients were followed up for 28 days or until hospital discharge , interinstitutional transfer , or death . MAIN OUTCOME MEASURES Frequency of blood drawing and associated volume of blood drawn , collected over a 24-hour period ; hemoglobin levels , transfusion rate , organ dysfunction ( assessed using the Sequential Organ Failure Assessment score ) , and mortality , collected throughout a 2-week period . RESULTS The mean ( SD ) volume per blood draw was 10.3 ( 6.6 ) mL , with an average total volume of 41.1 ( 39.7 ) mL during the 24-hour period . There was a positive correlation between organ dysfunction and the number of blood draws ( r = 0.34 ; P<.001 ) and total volume drawn ( r = 0.28 ; P<.001 ) . The mean hemoglobin concentration at ICU admission was 11.3 ( 2.3 ) g/dL , with 29 % ( 963/3295 ) having a concentration of less than 10 g/dL. The transfusion rate during the ICU period was 37.0 % ( 1307/3534 ) . Older patients and those with a longer ICU length of stay were more commonly transfused . Both ICU and overall mortality rates were significantly higher in patients who had vs had not received a transfusion ( ICU rates : 18.5 % vs 10.1 % , respectively ; chi(2 ) = 50.1 ; P<.001 ; overall rates : 29.0 % vs 14.9 % , respectively ; chi(2 ) = 88.1 ; P<.001 ) . For similar degrees of organ dysfunction , patients who had a transfusion had a higher mortality rate . For matched patients in the propensity analysis , the 28-day mortality was 22.7 % among patients with transfusions and 17.1 % among those without ( P = .02 ) ; the Kaplan-Meier log-rank test confirmed this difference . CONCLUSIONS This multicenter observational study reveals the common occurrence of anemia and the large use of blood transfusion in critically ill patients . Additionally , this epidemiologic study provides evidence of an association between transfusions and diminished organ function as well as between transfusions and mortality BACKGROUND In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock , mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal -directed therapy ( EGDT ) , in which intravenous fluids , vasopressors , inotropes , and blood transfusions were adjusted to reach central hemodynamic targets , than among those receiving usual care . We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary . METHODS In 31 emergency departments in the United States , we r and omly assigned patients with septic shock to one of three groups for 6 hours of resuscitation : protocol -based EGDT ; protocol -based st and ard therapy that did not require the placement of a central venous catheter , administration of inotropes , or blood transfusions ; or usual care . The primary end point was 60-day in-hospital mortality . We tested sequentially whether protocol -based care ( EGDT and st and ard-therapy groups combined ) was superior to usual care and whether protocol -based EGDT was superior to protocol -based st and ard therapy . Secondary outcomes included longer-term mortality and the need for organ support . RESULTS We enrolled 1341 patients , of whom 439 were r and omly assigned to protocol -based EGDT , 446 to protocol -based st and ard therapy , and 456 to usual care . Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids , vasopressors , inotropes , and blood transfusions . By 60 days , there were 92 deaths in the protocol -based EGDT group ( 21.0 % ) , 81 in the protocol -based st and ard-therapy group ( 18.2 % ) , and 86 in the usual-care group ( 18.9 % ) ( relative risk with protocol -based therapy vs. usual care , 1.04 ; 95 % confidence interval [ CI ] , 0.82 to 1.31 ; P=0.83 ; relative risk with protocol -based EGDT vs. protocol -based st and ard therapy , 1.15 ; 95 % CI , 0.88 to 1.51 ; P=0.31 ) . There were no significant differences in 90-day mortality , 1-year mortality , or the need for organ support . CONCLUSIONS In a multicenter trial conducted in the tertiary care setting , protocol -based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes . ( Funded by the National Institute of General Medical Sciences ; ProCESS Clinical Trials.gov number , NCT00510835 . ) Background Treating anaemia with red blood cell ( RBC ) transfusion is frequent , but controversial , in patients with septic shock . Therefore we assessed characteristics and outcome associated with RBC transfusion in this group of high risk patients . Methods We did a prospect i ve cohort study at 7 general intensive care units ( ICUs ) including all adult patients with septic shock in a 5-month period . Results Ninety-five of the 213 included patients ( 45 % ) received median 3 ( interquartile range 2–5 ) RBC units during shock . The median pre-transfusion haemoglobin level was 8.1 ( 7.4–8.9 ) g/dl and independent of shock day and bleeding . Patients with cardiovascular disease were transfused at higher haemoglobin levels . Transfused patients had higher Simplified Acute Physiology Score ( SAPS ) II ( 56 ( 45 - 69 ) vs. 48 ( 37 - 61 ) , p = 0.0005 ) , more bleeding episodes , lower haemoglobin levels days 1 to 5 , higher Sepsis-related Organ Failure Assessment ( SOFA ) scores ( days 1 and 5 ) , more days in shock ( 5 ( 3 - 10 ) vs. 2 ( 2 - 4 ) , p = 0.0001 ) , more days in ICU ( 10 ( 4 - 19 ) vs. 4 ( 2 - 8 ) , p = 0.0001 ) and higher 90-day mortality ( 66 vs. 43 % , p = 0.001 ) . The latter association was lost after adjustment for admission category and SAPS II and SOFA-score on day 1 . Conclusions The decision to transfuse patients with septic \n Output:\n " }, { "from": "agent", "value": "The restrictive RBCT strategy was not associated with harm or benefit compared to liberal strategy .\nAs a result , the safety of a RBCT restrictive strategy was confirmed , although only one study specifically focused on ICU patients with sepsis .\nThen , RBCT was not associated with increased mortality rate , but was associated with increased in occurrence of NI , ALI and AKI ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The presence of group-B streptococci in the urine of pregnant women seems to be associated with preterm labour . Urine sample s from 4122 women at 27 - 31 weeks ' gestation were examined for bacteria . Group-B streptococci were found in the urine of 69 women . In a double-blind , controlled study these patients were given either penicillin ( 10(6 ) IU three times daily for 6 days ; 37 patients ) or placebo ( 32 patients ) . The rates of primary rupture of the membranes ( 11 % v 53 % ; p less than 0.001 ) and preterm labour ( 5.4 % v 38 % ; p less than 0.002 ) were significantly lower in the penicillin group than in the placebo group . These results suggest that treatment and follow-up to prevent recolonisation in pregnant women with group-B streptococci in the urine may reduce the frequency of preterm labour in these patients A total of 1,661 pregnant women aged between 13 and 45 years were screened for bacteriuria by urine culture . Of the 1,661 culture results , 615 ( 37 % ) yielded no growth ; 728 ( 43.8 % ) yielded no significant growth ( presence of < 10(5 ) organisms/ml urine of one or more types of bacteria ) ; 286 ( 17.2 % ) yielded mixed growth ( presence of > 10(5 ) organisms/ml urine of more than one type of bacteria ) and only 32 ( 1.9 % ) showed significant growth ( presence of > 10(5 ) organisms/ml urine of a single bacterium ) . Urine microscopy was also conducted . Two hundred and twenty-four ( 13.5 % ) specimens had > 10 white blood cells/ml urine , of which 66 had > 100 white blood cells ; 13 were from the significant growth group . Three hundred and seventy-four ( 22.5 % ) specimens showed the presence of bacteria , 42 ( 2.5 % ) had red blood cells , 370 ( 22.3 % ) had epithelial cells , 58 ( 3.5 % ) had crystals , and 14 ( 0.8 % ) had yeasts . The most common bacterium isolated was Escherichia coli ( 12 ; 40 % ) ; the others included group B Streptococcus ( 5 ; 15 % ) , Klebsiella spp ( 5 ; 15 % ) , Diphtheroids ( 2 ) , and C and ida albicans ( 2 ) . Fifty-two percent of tested strains were sensitive to ampicillin ; 24 of 28 strains ( 85.7 % ) were sensitive to ciprofloxacin ; all 7 strains tested were sensitive to nitrofurantoin and all 20 strains tested were sensitive to cotrimoxazole ; 14/20 ( 70 % ) and 16/17 ( 94.1 % ) were sensitive to cephalexin and cefuroxime respectively . This study shows that asymptomatic bacteriuria does occur in pregnant women , albeit at a very low rate in an urban setting like Cheras . Urine microscopy is not specific and only serves as a guide to bacteriuria . The commonest causative organisms are those from the gastrointestinal tract and vagina . The antibiogram showed that cefuroxime and cephalexin are likely to be effective in treating bacteriuria : ampicillin must be reserved for Gram-negative organisms . For Gram-positive organisms , of which Group B Streptococcus is important , ampicillin is still effective in vitro . Nitrofurantion and cotrimoxazole have excellent activity in vitro and should be considered for therapy . 17.2 % of the urine culture yielded mixed growth : likely to indicate that contamination of urine specimens still happens despite the strict instructions given to patients about the collection of a midstream urine specimen . Proper collection , appropriate transport , and the early processing of urine specimens remain essential Abstract Objective : To evaluate the performance of reagent test strips in screening pregnant women for asymptomatic bacteriuria at their first visit to an antenatal clinic . Design : Prospect i ve case series . Setting : Antenatal clinic of a large inner city maternity hospital . Subjects : All women attending for their first antenatal clinic . Patients taking antibiotics for any reason and those with urinary tract symptoms were excluded . Intervention : A midstream urine specimen was divided ; half was sent for microscopy and formal bacteriological culture and the other half was tested with a commercial reagent strip test for the presence of blood , protein , nitrite , and leucocyte esterase . Main outcome measures : Sensitivity , specificity , and positive and negative predictive values of the reagent strips in diagnosing asymptomatic bacteriuria ( defined as 105 colony forming units/ml urine ) . Results : Sensitivity was low , with a maximum of 33 % when all four tests were used in combination . Specificity was high , with typical values of 99 % or more . Positive predictive value reached a maximum of 69 % and negative predictive value was typically 95 % or more . Conclusion : Urine reagent strips are not sufficiently sensitive to be of use in the screening for asymptomatic bacteriuria and therefore many patients would be missed . In view of the potentially serious sequelae of this condition in pregnant women we recommend that formal bacteriological investigation remain the investigation of choice in this group of patients . Key messages Asymptomatic bacteriuria is a potentially serious clinical condition Early antenatal urine screening should identify all cases to ensure adequate treatment Commercially available reagent strips for testing urine do perform to a sufficient st and ard The cost savings associated with reagent strips can not be justified in this group of women All patients should have at least one urine specimen formally cultured in early pregnancy to exclude Pivmecillinam was given to 44 women with bacteriuria in pregnancy . Treatment was successful in 33 ( 87 % ) out of the 38 patients assessed . Thirty women subsequently received at r and om either a low-dose of pivmecillinam for up to three months or acted as a control group . Further bacteriuric episodes during pregnancy were recorded only in three patients in the control group . Thirty-nine out of the 41 women followed to term delivered healthy babies . One infant was stillborn and another child had a cleft palate . Neither was considered to be related to treatment with pivmecillinam The incidence of impaired renal concentrating ability in pregnant women with asymptomatic significant bacteriuria is significantly less than previously reported when osmolality readings are performed on every urine specimen obtained during the 24 hours ' deprivation of fluids . The concentrating defect is more considerable as pregnancy progresses . The lower the maximum urinary osmolality the more difficult is the treatment of the patient , and the higher the incidence of acute pyelonephritis Although it has been shown that bacteriuria of pregnancy can be eradicated by keeping patients on antibacterial agents throughout pregnancy [ 1 ] , this regimen of treatment would be unacceptable to most individuals , particularly when asymptomatic ; and there are many who would question the ethical justification for such prolonged antibacterial therapy in pregnancy . This paper presents the results of a study design ed to determine whether antibacterial therapy of limited duration would eradicate \n Output:\n " }, { "from": "agent", "value": "REVIEW ER 'S CONCLUSIONS Antibiotic treatment is effective in reducing the risk of pyelonephritis in pregnancy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The use of warfarin sodium for treating venous thromboembolism in patients with cancer is associated with a significant risk of recurrence and bleeding . The use of low-molecular-weight heparin sodium for secondary prevention of venous thromboembolism in cancer patients may reduce the complication rate . OBJECTIVE To determine whether a fixed dose of subcutaneous low-molecular-weight heparin is superior to oral warfarin for the secondary prophylaxis of venous thromboembolism in patients with cancer and venous thromboembolism . METHODS In a r and omized , open-label multicenter trial performed between April 1995 and March 1999 , we compared subcutaneous enoxaparin sodium ( 1.5 mg/kg once a day ) with warfarin given for 3 months in 146 patients with venous thromboembolism and cancer . MAIN OUTCOME MEASURE A combined outcome event defined as major bleeding or recurrent venous thromboembolism within 3 months . RESULTS Of the 71 evaluable patients assigned to receive warfarin , 15 ( 21.1 % ; 95 % confidence interval [ CI ] , 12.3%-32.4 % ) experienced one major outcome event compared with 7 ( 10.5 % ) of the 67 evaluable patients assigned to receive enoxaparin ( 95 % CI , 4.3%-20.3 % ; P = .09 ) . There were 6 deaths owing to hemorrhage in the warfarin group compared with none in the enoxaparin group . In the warfarin group , 17 patients ( 22.7 % ) died ( 95 % CI , 13.8%-33.8 % ) compared with 8 ( 11.3 % ) in the enoxaparin group ( 95 % CI , 5.0%-21.0 % ; P = .07 ) . No difference was observed regarding the progression of the underlying cancer or cancer-related death . CONCLUSIONS These results confirm that warfarin is associated with a high bleeding rate in patients with venous thromboembolism and cancer . Prolonged treatment with low-molecular-weight heparin may be as effective as oral anticoagulants and may be safer in these cancer patients Background Patients with cancer are at increased risk of venous thromboembolism ( VTE ) and the risk is further elevated after a primary VTE . To reduce the risk of recurrent events , extended prophylaxis with vitamin K antagonists ( VKA ) is available for use . However , in a large r and omized trial ( Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer [ CLOT ] ; Lee et al ) , extended duration dalteparin reduced the relative risk of recurrent VTE by 52 % compared to VKA ( p=0.002 ) . A recent subgroup analysis of patients with moderate-to-severe renal impairment also revealed lower absolute VTE rates with dalteparin ( 3 % vs. 17 % ; p=0.011 ) . To measure the economic value of dalteparin as an alternative to VKA , a patient-level cost utility analysis was conducted from a Canadian perspective . Methods Re source use data captured during the CLOT trial were extracted and linked to 2015 Canadian unit cost estimates . Health state utilities were then measured using the Time-Trade-Off technique in 24 r and omly selected members of the general Canadian public to estimate the gains in quality -adjusted life years ( QALYs ) . Results For the entire CLOT trial population ( n=676 ) , the dalteparin group had significantly higher mean costs compared to the VKA group ( $ Can5,771 vs. $ Can2,569 ; p<0.001 ) . However , the utility assessment revealed that 21 of 24 respondents ( 88 % ) selected dalteparin over VKA , with an associated gain of 0.14 ( 95 % confidence interval [ CI ] : 0.10–0.18 ) QALYs . When the incremental cost of dalteparin was combined with the QALY gain , dalteparin had a cost of $ Can23,100 ( 95 % CI : $ Can19,200–$Can25,800 ) per QALY gained . The analysis in patients with renal impairment suggested even better economic value with the cost per QALY gained being < $ 14,000 . Conclusion Extended duration dalteparin is a cost-effective alternative to VKA for the prevention of recurrent VTE in patients with cancer , especially in those with renal impairment This study evaluated enoxaparin alone versus initial enoxaparin followed by warfarin in secondary prevention of venous thromboembolic events in adults with active malignancy . Cancer patients ( n = 122 ) with acute symptomatic venous thromboembolic events were r and omly allocated to receive subcutaneous enoxaparin 1.0 mg/kg every 12 hours for 5 days , followed by 1.0 mg/kg daily ( group 1a ) or 1.5 mg/kg daily ( group 1b ) for 175 days , or subcutaneous enoxaparin 1.0 mg/kg every 12 hours for at least 5 days and until a stable international normalized ratio of 2 to 3 was achieved on oral warfarin begun on day 2 and continued to day 180 ( group 2 ) . There were no significant differences in major and minor bleeding rates between treatment groups . No bleeding events were intracranial or fatal . Enoxaparin treatment was feasible , generally well tolerated , and effective for a 180-day period in the secondary prevention of venous thromboembolic events in patients with active malignancy OBJECTIVE To determine the cost and cost effectiveness of adding venous thromboembolism ( VTE ) prophylaxis with enoxaparin , a low-molecular-weight heparin , to st and ard care for acutely ill , hospitalized medical patients . METHODS A pharmacoeconomic model was developed to simulate the 6- to 14-day course of enoxaparin prophylaxis evaluated in the MEDENOX trial in a US healthcare setting . Clinical results as reported for the trial were applied to re source use and treatment costs in a US healthcare environment . The model projects hospital length of stay and cost for an acute medical admission from a third-party payer perspective , as well as costs for the course of enoxaparin . RESULTS VTE prophylaxis with enoxaparin would account for 1.2 % to 2.4 % of the cost of a hospital admission , with an additional $ 23 + /- $ 28 to $ 99 + /- $ 122 to complete the course of prophylaxis out of hospital . Incremental cost effectiveness of VTE prophylaxis relative to no prophylaxis ranges from $ 1249 to $ 3088 per VTE avoided . Venous thromboembolism prophylaxis appears to be a break-even intervention , with the cost recouped through avoided treatment , if the rate of treated VTE without prophylaxis is at least 3 - 4 % . DISCUSSION AND CONCLUSIONS The MEDENOX trial demonstrated that prophylaxis with enoxaparin substantially decreases the risk of VTE among acutely ill , hospitalized medical patients . Economic analysis indicates that this protection represents a small increase in current treatment costs . Prophylaxis is cost effective in terms of incremental cost per VTE avoided . Furthermore , there is a reasonable likelihood that the cost of prophylaxis will be offset by avoided future VTE treatment Background : In a r and omized trial ( ie , Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer [ CLOT ] ) that evaluated secondary prophylaxis of recurrent venous thromboembolism ( VTE ) in patients with cancer , dalteparin reduced the relative risk by 52 % compared to oral vitamin K antagonists ( VKAs ; hazard ratio = 0.48 , P = .002 ) . A recent subgroup analysis in patients with moderate to severe renal impairment also revealed lower absolute VTE rates with dalteparin ( 3 % vs 17 % ; P = .011 ) . To measure the economic value of dalteparin in these population s , a pharmacoeconomic analysis was conducted from the Dutch health-care system perspective . Methods : Re source utilization data contained within the CLOT trial data base were extracted and converted into direct cost estimates . Univariate analysis was then conducted to compare the total cost of therapy between patients r and omized to dalteparin or VKA therapy . Health state utilities were then measured in 24 members of the general public using the time trade-off technique . Results : When all of the cost components were combined for the entire population ( n = 676 ) , the dalteparin group had significantly higher overall costs than the VKA control group ( dalteparin = € 2375 vs VKA = € 1724 ; P < .001 ) . However , dalteparin was associated with a gain of 0.14 ( 95 % confidence interval [ CI ] : 0.10 - 0.18 ) quality -adjusted life years ( QALYs ) over VKA . When the incremental cost was combined with the utility gain , dalteparin had a cost of € 4,697 ( 95 % CI : € 3824-€4951 ) per QALY gained . Conclusion : Secondary prophylaxis with dalteparin is a cost-effective alternative to VKA for the prevention of recurrent VTE in patients with cancer OBJECTIVE To evaluate whether low-molecular-weight heparin ( LMWH ) could be equally ( or more ) effective than oral anti-vitamin-K agents ( AVK ) in the long-term treatment of deep venous thrombosis ( DVT ) . DESIGN A r and omised , open-label trial . MATERIAL AND METHODS In this trial , 241 patients with symptomatic proximal DVT of the lower limbs confirmed by duplex ultrasound scan were included . After initial LMWH , patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol . The primary outcome was the 12-month incidence of symptomatic recurrent venous thrombo-embolism ( VTE ) . Duplex scans were performed at 6 and 12 months . RESULTS During the 12-month period , six patients ( 5 % ) of 119 who received LMWH and 13 ( 10.7 % ) of 122 who received AVK had recurrent VTE ( p=0.11 ) . In patients with cancer , recurrent VTE tended to be lower in the LMWH group ( two of 36 [ 5.5 % ] ) vs. seven of 33 [ 21.2 % ] ; p=0.06 ) . One major bleeding occurred in the LMWH group and three in the AVK group . Venous re-canalisation increased significantly at 6 months ( 73.1 % vs. 47.5 % ) and at 12 months ( 91.5 % vs. 69.2 % ) in the LMWH group . CONCLUSIONS Tinzaparin was more effective than AVK in achieving re-canalisation of leg thrombi . Long-term tinzaparin was at least as efficacious and safe as AVK for preventing recurrent VTE , especially in patients with cancer Direct oral anticoagulants may be effective and safe for treatment of venous thromboembolism ( VTE ) in cancer patients , but they have not been compared with low-molecular-weight heparin ( LMWH ) , the current recommended treatment for these patients . The Hokusai VTE-cancer study is a r and omised , open-label , clinical trial to evaluate whether edoxaban , an oral factor Xa inhibitor , is non-inferior to LMWH for treatment of VTE in patients with cancer . We present the rationale and some design features of the study . One such feature is the composite primary outcome of recurrent VTE and major bleeding during a 12-month study period . These two complications occur frequently in cancer patients receiving anticoagulant treatment and have a significant impact . The evaluation beyond six months will fill the current gap in the evidence base for the long-term treatment of these patients . Based on the observation that the risk of recurrent VTE in patients with active cancer is similar to that in those with a history of cancer , the Hokusai VTE-cancer study will enrol patients if whose cancer was diagnosed within the past two years . In addition , patients with incidental VTE are eligible because their risk of recurrent VTE is similar to that in patients with symptomatic disease . The unique design features of the Hokusai VTE-cancer study should lead to enrolment of a broad spectrum of cancer patients with VTE who could benefit from oral anticoagulant treatment \n Output:\n " }, { "from": "agent", "value": "Conclusions The totality of high- quality clinical and cost-effectiveness data supports the use of dalteparin over other low-molecular-weight heparins for preventing recurrent venous thromboembolism in patients with cancer" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Ventilator-associated pneumonia ( VAP ) , an infection of the lower respiratory tract which occurs in association with mechanical ventilation , is one of the most common causes of nosocomial infection in the intensive care unit ( ICU ) . VAP causes significant morbidity and mortality in critically ill patients including increased duration of mechanical ventilation , ICU stay and hospitalization . Current knowledge for its prevention , diagnosis and management is therefore important clinical ly and is the basis for this review . We discuss recent changes in VAP surveillance nomenclature incorporating ventilator-associated conditions and ventilator-associated events , terms recently proposed by the Centers for Disease Control . To the extent possible , we rely predominantly on data from r and omized control trials ( RCTs ) and meta-analyses BACKGROUND A study was undertaken to assess the diagnostic value of different clinical criteria and the impact of microbiological testing on the accuracy of clinical diagnosis of suspected ventilator associated pneumonia ( VAP ) . METHODS Twenty five deceased mechanically ventilated patients were studied prospect ively . Immediately after death , multiple bilateral lung biopsy specimens ( 16 specimens/patient ) were obtained for histological examination and quantitative lung cultures . The presence of both histological pneumonia and positive lung cultures was used as a reference test . RESULTS The presence of infiltrates on the chest radiograph and two of three clinical criteria ( leucocytosis , purulent secretions , fever ) had a sensitivity of 69 % and a specificity of 75 % ; the corresponding numbers for the clinical pulmonary infection score ( CPIS ) were 77 % and 42 % . Non-invasive as well as invasive sampling techniques had comparable values . The combination of all techniques achieved a sensitivity of 85 % and a specificity of 50 % , and these values remained virtually unchanged despite the presence of previous treatment with antibiotics . When microbiological results were added to clinical criteria , adequate diagnoses originating from microbiological results which might have corrected false positive and false negative clinical judgements ( n = 5 ) were countered by a similar proportion of inadequate diagnoses ( n = 6 ) . CONCLUSIONS Clinical criteria had reasonable diagnostic values . CPIS was not superior to conventional clinical criteria . Non-invasive and invasive sampling techniques had diagnostic values comparable to clinical criteria . An algorithm guiding antibiotic treatment exclusively by microbiological results does not increase the overall diagnostic accuracy and carries the risk of undertreatment BACKGROUND The Centers for Disease Control and Prevention has shifted policy away from using ventilator-associated pneumonia ( VAP ) and toward using ventilator-associated conditions ( VACs ) as a marker of ICU quality . To date , limited prospect i ve data regarding the incidence of VAC among medical and surgical ICU patients , the ability of VAC criteria to capture patients with VAP , and the potential clinical preventability of VACs are available . METHODS This study was a prospect i ve 12-month cohort study ( January 2013 to December 2013 ) . RESULTS We prospect ively surveyed 1,209 patients ventilated for ≥ 2 calendar days . Sixty-seven VACs were identified ( 5.5 % ) , of which 34 ( 50.7 % ) were classified as an infection-related VAC ( IVAC ) with corresponding rates of 7.0 and 3.6 per 1,000 ventilator days , respectively . The mortality rate of patients having a VAC was significantly greater than that of patients without a VAC ( 65.7 % vs 14.4 % , P < .001 ) . The most common causes of VACs included IVACs ( 50.7 % ) , ARDS ( 16.4 % ) , pulmonary edema ( 14.9 % ) , and atelectasis ( 9.0 % ) . Among IVACs , 44.1 % were probable VAP and 17.6 % were possible VAP . Twenty-five VACs ( 37.3 % ) were adjudicated to represent potentially preventable events . Eighty-six episodes of VAP occurred in 84 patients ( 10.0 of 1,000 ventilator days ) during the study period . The sensitivity of the VAC criteria for the detection of VAP was 25.9 % ( 95 % CI , 16.7%-34.5 % ) . CONCLUSIONS Although relatively uncommon , VACs are associated with greater mortality and morbidity when they occur . Most VACs represent nonpreventable events , and the VAC criteria capture a minority of VAP episodes Background Ventilator-associated pneumonia ( VAP ) surveillance is time consuming , subjective , inaccurate , and inconsistently predicts outcomes . Shifting surveillance from pneumonia in particular to complications in general might circumvent the VAP definition 's subjectivity and inaccuracy , facilitate electronic assessment , make interfacility comparisons more meaningful , and encourage broader prevention strategies . We therefore evaluated a novel surveillance paradigm for ventilator-associated complications ( VAC ) defined by sustained increases in patients ' ventilator setting s after a period of stable or decreasing support . Methods We assessed 600 mechanically ventilated medical and surgical patients from three hospitals . Each hospital contributed 100 r and omly selected patients ventilated 2–7 days and 100 patients ventilated > 7 days . All patients were independently assessed for VAP and for VAC . We compared incidence-density , duration of mechanical ventilation , intensive care and hospital lengths of stay , hospital mortality , and time required for surveillance for VAP and for VAC . A subset of patients with VAP and VAC were independently review ed by a physician to determine possible etiology . Results Of 597 evaluable patients , 9.3 % had VAP ( 8.8 per 1,000 ventilator days ) and 23 % had VAC ( 21.2 per 1,000 ventilator days ) . Compared to matched controls , both VAP and VAC prolonged days to extubation ( 5.8 , 95 % CI 4.2–8.0 and 6.0 , 95 % CI 5.1–7.1 respectively ) , days to intensive care discharge ( 5.7 , 95 % CI 4.2–7.7 and 5.0 , 95 % CI 4.1–5.9 ) , and days to hospital discharge ( 4.7 , 95 % CI 2.6–7.5 and 3.0 , 95 % CI 2.1–4.0 ) . VAC was associated with increased mortality ( OR 2.0 , 95 % CI 1.3–3.2 ) but VAP was not ( OR 1.1 , 95 % CI 0.5–2.4 ) . VAC assessment was faster ( mean 1.8 versus 39 minutes per patient ) . Both VAP and VAC events were predominantly attributable to pneumonia , pulmonary edema , ARDS , and atelectasis . Conclusions Screening ventilator setting s for VAC captures a similar set of complications to traditional VAP surveillance but is faster , more objective , and a superior predictor of outcomes Objectives : Correct classification of the source of infection is important in observational and interventional studies of sepsis . Centers for Disease Control and Prevention criteria are most commonly used for this purpose , but the robustness of these definitions in critically ill patients is not known . We hypothesized that in a mixed ICU population , the performance of these criteria would be generally reduced and would vary among diagnostic subgroups . Design : Prospect i ve cohort . Setting : Data were collected as part of a cohort of 1,214 critically ill patients admitted to two hospitals in The Netherl and s between January 2011 and June 2011 . Patients : Eight observers assessed a r and om sample of 168 of 554 patients who had experienced at least one infectious episode in the ICU . Each patient was assessed by two r and omly selected observers who independently scored the source of infection ( by affected organ system or site ) , the plausibility of infection ( rated as none , possible , probable , or definite ) , and the most likely causative pathogen . Assessment s were based on a post hoc review of all available clinical , radiological , and microbiological evidence . The observed diagnostic agreement for source of infection was classified as partial ( i.e. , matching on organ system or site ) or complete ( i.e. , matching on specific diagnostic terms ) , for plausibility as partial ( 2-point scale ) or complete ( 4-point scale ) , and for causative pathogens as an approximate or exact pathogen match . Interobserver agreement was expressed as a concordant percentage and as a kappa statistic . Interventions : None . Measurements and Main Results : A total of 206 infectious episodes were observed . Agreement regarding the source of infection was 89 % ( 183/206 ) and 69 % ( 142/206 ) for a partial and complete diagnostic match , respectively . This result ed in a kappa of 0.85 ( 95 % CI , 0.79–0.90 ) . Agreement varied from 63 % to 91 % within major diagnostic categories and from 35 % to 97 % within specific diagnostic subgroups , with the lowest concordance observed in cases of ventilator-associated pneumonia . In the 142 episodes for which a complete match on source of infection was obtained , the interobserver agreement for plausibility of infection was 83 % and 65 % on a 2- and 4-point scale , respectively . For causative pathogen , agreement was 78 % and 70 % for an approximate and exact pathogen match , respectively . Conclusions : Interobserver agreement for classifying sources of infection using Centers for Disease Control and Prevention criteria was excellent overall . However , full concordance on all aspects of the diagnosis between independent observers was rare for some types of infection , in particular for ventilator-associated pneumonia Purpose Early hyperoxia may be an independent risk factor for mortality in mechanically ventilated intensive care unit ( ICU ) patients . We examined the relationship between early arterial oxygen tension ( PaO2 ) and in-hospital mortality . Method We retrospectively assessed arterial blood gases ( ABG ) with ‘ worst ’ alveolar-arterial ( A-a ) gradient during the first 24 h of ICU admission for all ventilated adult patients from 150 participating ICUs between 2000 and 2009 . We used multivariate analysis in all patients and defined subgroups to determine the relationship between PaO2 and mortality . We also studied the relationship between worst PaO2 , admission PaO2 and peak PaO2 in a r and om cohort of patients . Results We studied 152,680 patients . Their mean PaO2 was 20.3 kPa ( SD 14.6 ) and mean inspired fraction of oxygen ( FiO2 ) was 62 % ( SD 26 ) . Worst A-a gradient ABG identified that 49.8 % ( 76,110 ) had hyperoxia ( PaO2 > 16 kPa ) . Nineteen per cent of patients died in ICU and 26 % in hospital . After adjusting for site , Simplified Acute Physiology Score II ( SAPS II ) , age , FiO2 , surgical type , Glasgow Coma Scale ( GCS ) below 15 and year of ICU admission , there was an association between progressively lower PaO2 and increasing in-hospital mortality , but not with increasing levels of hyperoxia . Similar findings were observed with a sensitivity analysis of PaO2 derived from high FiO2 ( ≥50 % ) versus low FiO2 ( < 50 % ) and in defined subgroups . Worst PaO2 showed a strong correlation with admission PaO2 ( r = 0.98 ) and peak PaO2 within 24 h of admission ( r = 0.86 ) . Conclusion We found there was an association between hypoxia and increased in-hospital mortality , but not with hyperoxia in the first 24 h in ICU and mortality in ventilated patients . Our findings differ from previous studies and suggest that the impact of early hyperoxia on mortality remains uncertain Objectives : Centers for Disease Control and Prevention built up new surveillance paradigms for the patients on mechanical ventilation and the ventilator-associated events , comprising ventilator-associated conditions and infection-related ventilator-associated complications . We assess 1 ) the current epidemiology of ventilator-associated event , 2 ) the relationship between ventilator-associated event and ventilator-associated pneumonia , and 3 ) the impact of ventilator-associated event on antimicrobials consumption and mechanical ventilation duration . Design : Inception cohort study from the longitudinal prospect i ve French multicenter OUTCOME REA data base ( 1996 - 2012 ) . Patients : Patients on mechanical ventilation for greater than or equal to 5 consecutive days were classified as to the presence of a ventilator-associated event episode , using slightly modified Centers for Disease Control and Prevention definitions . Intervention : None . Measurements and Main Results : Among the 3,028 patients , 2,331 patients ( 77 % ) had at least one ventilator-associated condition , and 869 patients ( 29 % ) had one infection-related ventilator-associated complication episode . Multiple causes , or the lack of identified cause , were frequent . The leading causes associated with ventilator-associated condition and infection-related ventilator-associated complication were nosocomial infections ( 27.3 % and 43.8 % ) , including ventilator-associated pneumonia ( 14.5 % and 27.6 % ) . Sensitivity and specificity of diagnosing ventilator-associated pneumonia were 0.92 and 0.28 for ventilator-associated condition and 0.67 and 0 \n Output:\n " }, { "from": "agent", "value": "Conclusions VAE surveillance missed many cases of VAP , and the population characteristics identified by the two surveillance paradigms differed .\nVAE surveillance does not accurately detect cases of traditional VAP in ICUs" } ]