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30
24751304
results
There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .
6
24751304
results
There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .
7
24751304
conclusions
This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use .
8
24751304
conclusions
Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium - or quetiapine-treated patients with bipolar I or II disorder over @ months , after controlling for potential confounding factors .
9
25531162
background
Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .
0
25531162
background
Oxidative stress is associated with DKD severity and risk of progression , but currently approved therapies do not directly attenuate the pathologic consequences of oxidative stress .
1
25531162
background
GS-@ is a once daily , oral molecule that inhibits Apoptosis Signal-regulating Kinase @ ( ASK@ ) , which is a key mediator of the deleterious effects of oxidative stress .
2
25531162
methods
We describe the rationale and design of a Phase @ placebo-controlled clinical trial investigating the effects of GS-@ in patients with T@DM and stage @/@ DKD receiving standard of care therapy .
3
25531162
methods
Approximately , @ subjects will be randomized in a stratified manner , based on the estimated glomerular filtration rate ( eGFR ) and urine albumin to creatinine ratio , to one of four arms in this dose-ranging study .
4
25531162
methods
The primary endpoint is change in eGFR at @ weeks , and the key secondary endpoint is change in albuminuria .
5
25531162
conclusions
Guided by the biology of oxidative stress signaling through ASK@ , the biology of DKD pathogenesis , and solid statistical methods , the decisions made for this Phase @ study regarding delineating study population , efficacy outcomes , treatment period and statistical methods represent innovative attempts to resolve challenges specific to DKD study design .
6
24885317
background
Adherence to medication is often low .
0
24885317
background
Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs .
1
24885317
background
Goal of the current study is to assess the effectiveness of a patient-tailored , telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence , satisfaction with information and counselling and the beliefs about medicines .
2
24885317
methods
A cluster randomized controlled intervention trial in @ Dutch pharmacies , randomly assigned to @ of @ intervention groups .
3
24885317
methods
Each group consists of an intervention arm and an usual care arm .
4
24885317
methods
The intervention arm in the first group is the usual care arm in the second group and vice versa .
5
24885317
methods
One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors .
6
24885317
methods
The intervention consists of a telephone call by a pharmacist @ or @ weeks after a new prescription .
7
24885317
methods
A random sample of pharmacies will send questionnaires @ months after the first prescription .
8
24885317
methods
This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) .
9
24885317
methods
The primary outcome measure will be medication adherence calculated from dispensing records retrieved @ months after the intervention .
10
24885317
methods
Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes .
11
24885317
conclusions
The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment .
12
24885317
conclusions
By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence .
13
24885317
conclusions
Finally the study will provide information on which patients are most likely to benefit from this intervention .
14
25141094
objective
The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on female spectators ( i.e. , do female spectators who view heavier athletes respond differently than those who view less heavy athletes ? )
0
25141094
methods
We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = @ ) who served as athletic event spectators .
1
25141094
results
Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs .
2
25141094
conclusions
The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level .
3
24484541
background
Approximately @ % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly .
0
24484541
background
Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown .
1
24484541
background
Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year .
2
24484541
background
No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes .
3
24484541
background
We are also investigating whether the structure of the physiotherapy provision itself influences outcomes .
4
24484541
methods
The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it .
5
24484541
methods
Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit @ patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy .
6
24484541
methods
The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises .
7
24484541
methods
Patients will be randomised to either group using a web-based system .
8
24484541
methods
Both groups will receive pre and post-intervention physiotherapy review .
9
24484541
methods
Patients will be followed-up to one year post-operation .
10
24484541
methods
The primary outcome measure is the Oxford Knee Score .
11
24484541
methods
Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness .
12
26296950
background
In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care .
0
26296950
background
We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies .
1
26296950
methods
This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh .
2
26296950
methods
We randomly assigned children younger than @ years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( @ L/min starting at a CPAP level of @ cm H@O ) , standard low-flow nasal cannula ( @ L/min ) , or high-flow nasal cannula ( @ L/kg per min up to the maximum of @ L/min ) .
3
26296950
methods
Randomisation was done with use of the permuted block methods ( block size of @ patients ) and Fisher and Yates tables of random permutations .
4
26296950
methods
The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than @ h of treatment .
5
26296950
methods
Primary and safety analyses were by intention to treat .
6
26296950
methods
We did two interim analyses and stopped the trial after the second interim analysis on Aug @ , @ , as directed by the data safety and monitoring board .
7
26296950
methods
This trial is registered at ClinicalTrials.gov , number NCT@ .
8
26296950
results
Between Aug @ , @ , and July @ , @ , @ eligible children were recruited .
9
26296950
results
We randomly allocated @ ( @ % ) children to receive oxygen therapy by bubble CPAP , @ ( @ % ) to low-flow oxygen therapy , and @ ( @ % ) to high-flow oxygen therapy .
10
26296950
results
Treatment failed for @ ( @ % ) children , of whom five ( @ % ) had received bubble CPAP , @ ( @ % ) had received low-flow oxygen therapy , and ten ( @ % ) had received high-flow oxygen therapy .
11
26296950
results
Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk -LSB- RR -RSB- @ , @ % CI @-@ ; p = @ ) .
12
26296950
results
No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR @ , @ % @-@ ; p = @ ) .
13
26296950
results
@ ( @ % ) children died .
14
26296950
results
Three ( @ % ) children died in the bubble CPAP group , ten ( @ % ) children died in the low-flow oxygen therapy group , and ten ( @ % ) children died in the high-flow oxygen therapy group .
15
26296950
results
Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR @ , @ % CI @-@ ; p = @ ) .
16
26296950
conclusions
Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy .
17
26296950
conclusions
Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy .
18
26296950
conclusions
The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings .
19
26296950
conclusions
Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology .
20
24274431
background
Blood Pressure related disease affected @ million people in India in the year @ ; this figure will double by @ .
0
24274431
background
Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care .
1
24274431
background
Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed .
2
24274431
methods
We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare .
3
24274431
methods
This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in @ primary health centres and @ villages in rural Andhra Pradesh involving adults aged @ years at high cardiovascular disease event risk ( approximately @,@ people ) .
4
24274431
methods
Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts .
5
24274431
methods
Cluster randomisation will occur at the level of the primary health centres .
6
24274431
methods
Outcome analyses will be conducted blinded to intervention allocation .
7
24274431
objective
The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period .
8
24274431
objective
Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-@D ) ; and cardiovascular disease events ( using hospitalisation data ) .
9
24274431
objective
Trial outcomes will be accompanied by detailed process and economic evaluations .
10
24274431
conclusions
The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings .
11
25137845
objective
To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) .
0
25137845
methods
Totally @ CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , @ in each group .
1
25137845
methods
All patients received WM therapy .
2
25137845
methods
Those in the treatment group were applied with ZR at Xinshu ( BL@ ) and Shenshu ( BL@ ) , while those in the control group were applied with placebos at Xinshu ( BL@ ) and Shenshu ( BL@ ) .
3
25137845
methods
The therapeutic course for all was @ weeks .
4
25137845
methods
The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and @ min walking distance were observed before and after treatment .
5
25137845
results
After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < @ ) .
6
25137845
results
There was no statistical difference in @ min walking distance between the two groups ( P > @ ) .
7
25137845
conclusions
External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS .
8
24885942
background
High levels of circulating fibroblast growth factor @ ( FGF@ ) are associated with chronic kidney disease ( CKD ) progression and high mortality .
0
24885942
background
In the Phosphate Reduction Evaluation of FGF@ in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF@ levels in normophosphatemic patients with CKD stage @ .
1
24885942
methods
Thirty-five individuals were randomized to lanthanum carbonate @ mg/day ( n = @ ) or placebo ( n = @ ) for @ weeks .
2
24885942
methods
Levels of intact FGF@ ( iFGF@ ) , C-terminal FGF@ , serum and urinary phosphate and calcium , intact parathyroid hormone and @,@-dihydroxyvitamin D were assessed .
3
24885942
results
The median age was @ years in the lanthanum group and @ years in the placebo group ; @ % and @ % were men , respectively .
4
24885942
results
No significant difference was seen in mean iFGF@ between groups at week @ .
5
24885942
results
There was , however , a transient reduction from baseline in iFGF@ in the lanthanum group at week @ , from @ pg/ml to @ pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = @ ) .
6
24885942
results
Urinary phosphate decreased after @ week of lanthanum treatment and remained low at week @ .
7
24885942
conclusions
Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF@ in patients with CKD stage @ , although phosphaturia decreased .
8
24885942
conclusions
This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF@ in patients with CKD .
9
24412457
objective
This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .
0
24412457
background
Treatment of patients with ISR remains a challenge .
1
24412457
methods
This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .
2
24412457
methods
The primary endpoint was the minimal lumen diameter at @ months ' follow-up .
3
24412457
results
A total of @ patients with BMS-ISR from @ Spanish sites were included ( @ were allocated to DEB and @ to EES ) .
4