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NCT06296329

Recruiting

Rubber Hand Illusion in Anorexia Nervosa

The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group.

- EligibilityCriteria: Inclusion criteria: Right-handed diagnosis of Anorexia Nervosa according to the APA criteria Exclusion criteria: • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Participants with anorexia nervosa will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital. - SamplingMethod: Non-Probability Sample

NCT06296316

Recruiting

Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.

- EligibilityCriteria: Inclusion Criteria: Female patient of at least 18 years old Patient presenting apical pelvic organ prolapse and being eligible to surgical treatment Surgeon having decided to treat the patient with a Restorelle mesh as per its CE mark indication and IFU, before patient inclusion Patient having received appropriate information and counselling before mesh implantation Patient has been provided written informed consent Exclusion Criteria: Patient currently pregnant or breastfeeding Patient being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult female patients presenting with apical pelvic organ prolapse which is clinically indicated for a surgical treatment with Restorelle mesh - SamplingMethod: Non-Probability Sample

NCT06296303

Not yet recruiting

Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients

Purposes of the study To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

- EligibilityCriteria: Inclusion Criteria: Patient age ranges from 20 -45 Unilateral chronic lumbosacral radiculopathy Intervertebral disc herniation confirmed by MRI one of the following : H- reflex amplitude side to side difference 0.67 in absence of latency difference. H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference. 3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec. Exclusion Criteria: Systematic disease Lumbar canal stenosis Pervious surgeries Scoliosis Kyphosis Spinal fracture Bilateral symptoms Steroid injection - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06296277

Not yet recruiting

Mechanical Ventilation in Surgical Patients

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation. Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

- EligibilityCriteria: Inclusion Criteria: Adults; and Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery Exclusion Criteria: Receiving intraoperative IMV outside of an operating room; and Receiving intraoperative IMV during extracorporeal life support - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner - SamplingMethod: Probability Sample

NCT06296264

Not yet recruiting

Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture

The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain. The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.

- EligibilityCriteria: Inclusion Criteria: Patient aged at least 18 years old Patient with an A-DIVA (Adult Difficult Intravenous Access) score > 1 Supported by a nurse trained in all the techniques used in the protocol Patient having given free, informed and oral consent - Exclusion Criteria: Patient who has already been included in the study Patient whose inclusion in the study would lead to a delay in treatment Adult patient protected by law Pregnant woman Patient not benefiting from French Social Security system - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296251

Not yet recruiting

Dietary Supplementation on Body Fat Composition

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

- EligibilityCriteria: Inclusion Criteria: Male or female, ≥18 years of age at visit 1 (week -1). Body mass index (BMI) of ≥28.0 kg/m2 to <35.0 kg/m2 at visit 1 (week -1). At least one of the following comorbidities based on blood draws at visit 1: Dyslipidemia (any of the following) Total-C ≥200 mg/dL LDL-C ≥130 mg/dL HDL-C ≤40 mg/dL Triglycerides ≥150 mg/dL Pre-diabetes o HbA1c ≥5.7 to ≤6.4% Stable use of medications allowed, where stable use is defined as the same dose for at least 90 d prior to visit1. Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period. Willing to maintain a stable intake of current dietary supplements and medications not specifically listed as exclusionary or deemed to interfere with study outcomes throughout study duration. Willing to adhere to all study procedures and signs forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator. Exclusion Criteria: Weight loss or gain ≥4.5 kg within 90 days of visit 1. Use of weight loss medications within 90 days of visit 1 History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. Current medical diagnosis of type 1 or type 2 diabetes mellitus. HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable). History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD). Unstable use of medications for mental or emotional disorders, where stable use is defined as the same dose for ≥90 days prior to visit 1. Uncontrolled stage 2 hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1. Participants with hypertension on a stable dose of medication may be allowed in the study per Investigator's discretion. Stable dose is defined as same dose for >90 days. Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1. History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer. Unstable use of thyroid hormone replacement medication, where stable use is defined as the same dose for ≥90 days prior to visit 1. Known intolerance or sensitivity to any ingredients in the study products. Exposure to any non-registered drug product within 4 weeks prior to visit 1. Signs or symptoms of an active infection of clinical relevance* within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits). Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk. *If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06296225

Not yet recruiting

Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase

It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase. The investigations will be carried out by a specialized physiotherapist from the neurology department. The experiment consists of three successive phases: First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration. Second : Rest period Third: control phase with measurement of the maximum grip force every ten minutes without vibration.

- EligibilityCriteria: Inclusion Criteria: Age:18 to 85 Acute stroke (less than 7 days) Paretic upper limb: 3 or 4 to the MRC score and able to obtain a value of at least 10 kilograms on the handgrip strength Able to sign a consent form Affiliated to a social insurance Exclusion Criteria: Person under tutorship or curatorship, Sleepiness Pregnancy or breastfeeding woman - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06296212

Not yet recruiting

Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia.

The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia. The main question it aims to answer is: • could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia? Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment. Eligible patients who meet the study inclusion criteria and complete the required Screening & Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI & Patient blinded. TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered: intravenously (with an infusion rate of 10 mL/min) 2 times a day (with a dosing interval of 8 hours ± 30 minutes) for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5) patients will then be required to undergo five Follow-up Visits.

- EligibilityCriteria: Inclusion Criteria Patients with an age of ≥ 18 and ≤ 80 years Diagnosis of CAP or HAP requiring hospitalization Patients with one of the following : - At least one cardiovascular comorbidity: Chronic atrial fibrillation History of ischemic heart disease (≥ 3 months) Heart failure Cardiac Valvular Disease Previous (≥ 6 months) episode of myocarditis or pericarditis. - Very high risk of developing cardiovascular diseases according to the SCORE2 and SCORE2-OP risk models for moderate risk European regions (score ≥ 7.5% for patients < 50 years old, score ≥ 10% for patients 50-69 years old, and score ≥ 15% for patients ≥ 70 years old). Provision of written informed consent as approved by the Ethics Committee (EC). Exclusion Criteria Medical Conditions: Active malignancy Severe heart failure (NYHA class III and IV) End-stage renal failure (eGFR < 30 mL/min) Severe liver disease History of hypersensitivity to glutathione or any excipients Use of drugs containing sacubitril Use of drugs with antioxidant activity in the last 3 months Use of narcotics Use of invasive mechanical ventilation Recent (< 3 months) ACS (STEMI, NSTEMI, UA), myocardial revascularization, myocarditis, acute pericarditis episodes. General Conditions: Pregnant or breastfeeding women Women of child-bearing potential not using at least one effective contraceptive method for the entire trial Participation in other investigational drug or device clinical trials within 30 days prior to study screening Patients legally or mentally incapacitated unable to give informed consent for the participation in this trial Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06296199

Not yet recruiting

Music, Virtual Reality for Inpatients in IUGM

Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR. Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.

- EligibilityCriteria: Inclusion Criteria: be hospitalized at the URFI of the IUGM, be 60 years of age or older, not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure, have no psycho-behavioural disorders, no major neurocognitive disorder at a severe stage, no severe visual or hearing impairment, no vestibular balance disorders, give written consent to participate in the study. Exclusion Criteria: Participate in another concurrent experimental clinical study, to avoid interference with our study. Do not understand written or spoken French or English. The participants are French and/or English speakers, and the questionnaires are only available in these 2 languages. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult

NCT06296186

Not yet recruiting

Massed Prolonged Exposure for PTSD in Substance Use Treatment

The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are: Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms? Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.

- EligibilityCriteria: Inclusion Criteria: Veterans age 18+ who have served since September 2001 who are enrolled in a SUD IOP at a participating VA meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone not sufficient for inclusion) meet DSM-5 criteria for PTSD report substance use at least 20 of the last 90 days are able to give informed consent. Exclusion Criteria: severe cognitive impairment current suicidal or homicidal intent requiring immediate treatment current unstable psychotic or manic symptoms not attributable to SUD - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296173

Not yet recruiting

Open Lung Protective Extubation Following General Anesthesia

Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation. Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.

- EligibilityCriteria: Inclusion Criteria: Adult patients (18 years of age or over) Elective intra-abdominal surgery under general anesthesia. Moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more) Planned postoperative hospitalization Exclusion Criteria: Expected or known difficult intubation according to the treating anesthesiologist Postoperative mechanical ventilation (planned or unplanned) General anesthesia performed outside the main operating room - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296160

Recruiting

A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis

Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches.

- EligibilityCriteria: Inclusion Criteria: Chronic in-center hemodialysis patients for at least three months Exclusion Criteria: Active Cancer. Active infection. Patients with pulmonary fibrosis. Patients with diffuse pneumonia. Patients with frequent hypotension episodes in HD Extreme weight gain between dialysis sessions demanding more than 13 ml/kg/h UF rate. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult

NCT06296147

Recruiting

Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.

- EligibilityCriteria: Inclusion Criteria: Patient is 18 years or older Patient is male Patient is due for a transperineal prostate biopsy Patient signed and dated informed consent form on Redcap agreeing to participate in the study Exclusion Criteria: Patient has a known psychiatric or mental illness that would impede use of the VR device or aromatherapy patch Patient has severe hearing or vision problems that would impair use of the VR headset (under the physician's discretion) Patient has a history of seizures or epilepsy or is on a medication that would lower the threshold for a seizure Patient has a history of reactions to noxious odors - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296134

Not yet recruiting

Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation

The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation.

- EligibilityCriteria: Inclusion Criteria: pregnant women with the following characteristics: nulliparous single pregnancy cephalic presentation of the fetus Italian language fluency Exclusion Criteria: multiparous age < 18 y, age > 40 y previous urinary or fecal incontinence contraindications to vaginal delivery (such as placenta previa, vasa previa, etc) twin pregnancy language barrier BMI at or > 30 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06296121

Recruiting

A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

- EligibilityCriteria: Inclusion Criteria: Signed informed consent form. Age ≥ 18 years at the time of signing of the informed consent form. Documented diagnosis of multiple myeloma according to IMWG criteria Measurable disease at screening: M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio . At least a partial response according to IMWG criteria to at least 1 prior line of therapy. Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy ECOG score 0-2. Not pregnant and willing to use contraception. Consent to bone marrow biopsy in the study. Exclusion Criteria: Prior treatment with daratumumab or other anti-CD38 therapy. Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization. Allogeneic hematopoietic stem cell transplantation, regardless of timing. Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study. Plasma cell leukemia, POEMS syndrome or amyloidosis. Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement. A history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the Investigator's opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years. Plasmapheresis within 28 days prior to randomization. Clinical signs of meningeal involvement of multiple myeloma. Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06296082

Not yet recruiting

Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial

Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeks Trial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion; 7) being able to walk independently with or without aids. Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up. The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities.

- EligibilityCriteria: Inclusion Criteria: aged 18-85 years old, having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); having had a first stroke; having no more than 12 months of evolution since stroke; having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion; being able to walk independently with or without aids. Exclusion Criteria: medical conditions interfering with data interpretation; any contraindication to receiving BTX A or PS treatment; If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06296069

Not yet recruiting

Exergames on an Unstable Surface in Stroke Inpatients

Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients. This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.

- EligibilityCriteria: Inclusion Criteria: Prescription for inpatient rehabilitation due to a stroke Ability to provide a signed informed consent Mini-Mental State Examination (MMSE) score ≥ 20 Physically able to stand for at least 3 minutes without external support (self-report) Exclusion Criteria: Insufficient knowledge of the German language to understand the instructions and the games Conservatively treated osteoporotic fractures in the last 16 weeks Depending on assistance for ambulation (Functional Ambulation Categories <2), Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities which impair the ability to play the exergames and/or conduct the pre-/post assessments - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult

NCT06296056

Not yet recruiting

Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care

To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions.

- EligibilityCriteria: Inclusion Criteria: Those who have been histologically or cytologically confirmed as adenocarcinoma among colorectal cancers Those with at least one measurable or evaliable lesion by RECIST v1.1 Those who fail standard treatment for metastatic colorectal cancer (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process) ECOG performance status 0 or 1 person A person who can draw about 100 cc of whole blood for the manufacture of immune cells Weight: More than 50 kg for men and more than 45 kg for women Hb: 9.0 g/dL or higher (registerable if hemoglobin levels recover to 10.0 g/dL or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed) Appropriate contraceptive regimen up to 2 months after clinical research drug administration A person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing Exclusion Criteria: Brain Metastasis patients who have symptoms or need treatment [However, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register] A person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment Those with the following cardio-cerebrovascular diseases as of the time of screening a person who is HIV-positive Those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (HBV, HCV) test a person with acute or severe infection Those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases Those with a history of organ transplants a hematopoietic stem cell transplant patient - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult

NCT06296043

Not yet recruiting

The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome

The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.

- EligibilityCriteria: Inclusion Criteria: Getting over 104 points from the PMS scale, Having regular menstruation, Not having any chronic disease, Not using any method to cope with PMS. Exclusion Criteria: Having irregular menstruation, Having musculoskeletal system and respiratory diseases, Having a diagnosed psychiatric disease, Having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Since it is a study conducted on premenstrual symptoms with women, it concerns the female gender. - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06296017

Recruiting

Investigation of the Effectiveness of Different Physiotherapy Applications in Trigger Finger Treatment

There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF.

- EligibilityCriteria: Inclusion Criteria: Volunteering Being between the ages of 18-65 Being diagnosed with stage 1 or stage 2 (according to the Froimson classification) trigger finger Having the language and cognitive skills to answer the questionnaires used in the evaluation Exclusion Criteria: Being pregnant Having an inflammatory disorder Having had surgery on the hand/wrist Having a neurological disease NSAIDs, painkillers, etc. being on medication De Quervain's tenosynovitis, carpal tunnel syndrome - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06296004

Not yet recruiting

Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

- EligibilityCriteria: Inclusion Criteria: Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease . Accept to participate in the current study - Exclusion Criteria: Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease). Patients with high myopia or media opacities preventing high-quality imaging like cataract and cornea guttata, vitreoretinal disease, previous retinal surgery, macular edema, glaucoma or neurological disease. Patients with other comorbidities as diabetes, hypertension were excluded from the study. Refused to participate in the current study. - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: The study will include 80 participants: Group 1: 40 patients with who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease (Disease et al., 2014). . Group 2: 40 healthy matched controls. - SamplingMethod: Probability Sample

NCT06295991

Not yet recruiting

The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis

The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals.

- EligibilityCriteria: Inclusion Criteria: Being diagnosed with spastic diplegic CP Being diagnosed with scoliosis, To be between the ages of ten and eighteen, Being at I-II-III level according to GMFCS classification (18), Not having undergone scoliosis surgery, Cobb angle to be between 10-40 degrees, To be receiving physiotherapy appropriate to the functional status for at least 6 months. Exclusion Criteria: Psychiatric disorders, Having a communication problem at a level that cannot adapt to the physiotherapist's instructions, To have undergone scoliosis surgery, Uncontrolled epilepsy. - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06295978

Recruiting

Multimarker Approach in Acute Chest Pain

Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem. The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years; Patients who came to the emergency department with chest pain of presumable cardiac origin and uncertain etiologic diagnosis ECG not diagnostic for ischemia cTnI ultra within limits Exclusion Criteria: STEMI Sepsis and viral infections Patients with ECG abnormalities that make it uninterpretable for ischemic purposes Patients with previous coronary events History of heart failure Known diagnosis of cardiovascular disease, acute or chronic, including pericarditis, myocarditis Conditions involving increases in sST2 and suPAR unrelated to cardiac causes, especially acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, neoplasms, moderate-to-severe pulmonary fibrosis, chronic hepatopathy; autoimmune diseases) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients entering the emergency department with chest pain or other typical symptoms suspected of ACS will be included in the study if they are adults, not pregnant, and meet the predetermined inclusion criteria. Furthermore, patients who sign written informed consent to participate in the study and to the processing of personal data - SamplingMethod: Non-Probability Sample

NCT06295965

Recruiting

Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers

This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.

- EligibilityCriteria: Inclusion Criteria: * Subjects will have or had ovarian cancer and are on or have completed PARPi maintenance therapy Or have been diagnosed with ovarian cancer as well as clonal hematopoiesis of indeterminate potential Have a life expectancy of greater than 6 months Exclusion Criteria: * Individuals with a life expectancy of less than 6 months - HealthyVolunteers: No - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Subjects will have or had ovarian cancer and are on or have completed PARPi maintenance therapy or have been diagnosed with ovarian cancer as well as clonal hematopoiesis of indeterminate potential - SamplingMethod: Non-Probability Sample

NCT06295952

Recruiting

A Study of Pasireotide in People With Prolactinoma

The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma.

- EligibilityCriteria: Inclusion Criteria: Age 18 or older Male and female patients with prolactinomas and hyperprolactinemia with at least one of the following criteria: Clinical intolerance due to adverse events on DA treatment, preventing continued treatment. Contraindication to DA treatment (e.g., patients requiring dopamine antagonist therapy or other therapy that is contraindicated). Tumor resistance to DA, defined as <50% decrease in longest diameter, or progression in tumor size and/or lack of prolactin normalization with at least 2 mg per week, or maximally tolerated dose, of cabergoline or bromocriptine. Patients with a partial response to DA, including a prolactin reduction but not normalization on treatment, will be included, and will continue DA during the study. Patients are not considered candidates for surgery (e.g., poor surgical candidates, inoperable tumors, patients who refuse surgical treatment, or for whom surgery is deemed not appropriate treatment). For patients with a history of pituitary radiation, the following criteria must be present: At least 6 months must have elapsed from the time of the most recent radiation treatment to the time of enrollment, and Stable or up trending serum prolactin levels and/or evidence of tumor growth since completion of radiation. At least 8 weeks washout of prior first-generation somatostatin receptor ligand therapy (octreotide or lanreotide). Patients on temozolomide will need a washout period of at least 3 weeks. Patients on carboplatin, cisplatin or etoposide will need a washout period of at least 4 weeks. Patients on protein kinase inhibitors (e.g., everolimus, lapatinib) will need a washout period of at least 5 half-lives or 2 weeks, whichever in longer. In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g., bevacizumab). Stable or lower dose of DA (cabergoline or bromocriptine) for at least one month for those patients continuing DA treatment, i.e. DA dose may not be escalated during trial enrollment. Screening laboratory values must meet the following criteria: WBC ≥ 2000/μL Neutrophils ≥ 1500/μL Platelets ≥ 100 x103/μL Hemoglobin > 9.0 g/dL AST/ALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min using the Cockcroft-Gault formula Karnofsky Performance Status (KPS) 70 or above Measurable tumor by RECIST V1.1 criteria, ≥ 10 mm. Women of childbearing potential (WOCBP) must use appropriate methods of contraception while participating in the trial until 30 days after the follow-up period. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women who are not of childbearing potential are not required to use contraception. Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry. Men who are sexually active with women of childbearing potential must use adequate contraception while participating in the trial. Men who are surgically sterile or azoospermia do not require contraception. Exclusion Criteria: Additional pituitary tumor directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy Concurrent malignancy except non-melanoma skin cancer Any pituitary surgery within 14 days of enrollment. Patients with poorly controlled diabetes as defined by HBA1c >9% or not optimally treated for diabetes mellitus as judged by the investigator Patients who are not euthyroid as judged by the investigator Patient with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with serum ALT and/or AST >3x ULN, or total bilirubin >1.5 x ULN Patients with QTc > 500 ms History of intolerance or resistance to pasireotide Women who are pregnant or breast-feeding Inability to undergo radiographic surveillance Inability to provide informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295926

Not yet recruiting

Serplulimab Combined With CCRT for LS-SCLC.

Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.

- EligibilityCriteria: Inclusion Criteria: Aged 18 years or older Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging) Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment Measurable lesions based on RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention Baseline hematologic, blood biochemistry, and urine biochemistry tests confirming sufficient bone marrow and organ function Life expectancy of at least 6 months Male participants: Male participants must agree to use effective contraception during the study treatment and for at least 180 days after the last dose, and must not donate sperm during this period Female participants must not be pregnant or lactating, and must meet at least one of the following conditions: Women who are not capable of reproduction or Agree to use effective contraception during the treatment and for at least 180 days after the last dose Women capable of reproduction must undergo a serum or urine pregnancy test within 72 hours before starting the medication, and the result must be negative (minimum sensitivity 25 IU/L or equivalent units of HCG) (11) Signed informed consent form Exclusion Criteria: Patients with extensive-stage small cell lung cancer Cancer patients who have undergone surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer LS-SCLC patients with stage I disease amenable to surgical resection Patients with active autoimmune diseases requiring systemic treatment (with disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed History of (non-infectious) pneumonia/interstitial lung disease requiring steroids or current active pneumonia/interstitial lung disease requiring steroids Previously diagnosed with immunodeficiency diseases such as immunoglobulin deficiency, aplastic anemia, etc. Known history of human immunodeficiency virus (HIV) infection Concurrent active hepatitis B (defined as HBV DNA > 500 copies) and hepatitis C virus (defined as HCV RNA (+)) infection Known active tuberculosis history (tuberculin bacillus) Receipt of live vaccine or attenuated live vaccine within 30 days prior to the first study intervention. Use of inactivated vaccines is allowed. Live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines. Injectable seasonal influenza vaccine is generally an inactivated virus vaccine and is allowed; however, intranasal influenza vaccine (e.g., FluMist®) is an attenuated live vaccine and is not allowed Known other malignancy within the past 1 year that is progressing or requires active treatment. Note: Excludes adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma (excluding in situ bladder carcinoma) Symptomatic central nervous system metastases and/or carcinomatous meningitis Severe hypersensitivity reaction (≥3 grade) to nivolumab/platinum/etoposide and/or any of their excipients Active infection requiring systemic therapy Any medical condition the investigator believes would pose excessive risk to the patient. For example, poorly controlled diabetes, active infection requiring parenteral anti-infective therapy, hepatic failure, any psychiatric condition that would interfere with understanding the informed consent form (ICF). Any past or present disease, treatment, laboratory abnormality, or other condition that, in the opinion of the investigator, would confound the study results or interfere with participation throughout the study Known psychiatric illness or substance abuse that would interfere with compliance with trial requirements Pregnancy, lactation, planned pregnancy, or intent to become pregnant or father children during the expected duration of the study (from screening visit through 180 days after the last dose of investigational drug) Prior allogeneic tissue/organ transplantation Patients unable to comply with study visits Currently participating in or has used other investigational drugs or devices - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295913

Recruiting

Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases

The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging.

- EligibilityCriteria: Inclusion Criteria: Prediabetes (defined as fasting glucose levels according to the American Diabetes Association guideline, with fasting blood glucose ≥100 and <126 mg/dL, or hemoglobin A1c levels ranging from 5.7% to 6.4%) Overweight (body mass index BMI 24-29.9 kg/m2) Exclusion Criteria: Any prior diagnosis of diabetes, hypertension, hyperlipidemia, other cardiovascular diseases, thyroid gland disorders, asthma, arthritis, or inflammatory conditions, cirrhosis, or other liver diseases Weight loss > 2.5 kg in the last 6 months Being on pharmacological treatment of any kind Taking dietary supplements containing antioxidants other than vitamins Being a smoker or habitual alcohol consumer; being HIV positive Being pregnant or breastfeeding Blood pressure ≥ 140 mmHg (systolic) and ≥ 90 mmHg (diastolic) Total cholesterol ≥ 240 mg/dL, LDL cholesterol ≥ 160 mg/dL, or TG ≥ 200 mg/dl - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295900

Recruiting

The Effect of Aromatherapy Massage on Sleep Quality

Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality.

- EligibilityCriteria: Inclusion Criteria: 18 years of age and over, Conscious patients, Staying in intensive care for 24 hours or more, Those with stable hemodynamic status, Receiving O2 therapy, Intubated patients, patients who have passed 24 hours after being extubated, Those whose saturation level is 85 and above Exclusion Criteria: Patients with peripheral neuropathy or quadriplegia, Patients with open wounds on their body, Patients receiving analgesia and sedation infusion, Patients who are sedated, Patients in delirium, Patients with allergies detected before starting the application - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295887

Not yet recruiting

Educational Efficacy of VR vs. Simulator in Emergency Medical Training

It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man. In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training. After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish.

- EligibilityCriteria: Inclusion Criteria: the medical interns who participate in the education program for medical interns, who will work as interns at Seoul National University Hospital from March 2024 participants who agree to the purpose of the study and consent to participation Exclusion Criteria: who do not consent to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06295874

Recruiting

The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort

Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients.

- EligibilityCriteria: Inclusion Criteria: 18 years of age and over, Conscious patients, Staying in intensive care for 24 hours or more, Those with stable hemodynamic status, Receiving O2 therapy, Intubated patients, patients who have passed 24 hours after being extubated, Those whose saturation level is 85 and above Exclusion Criteria: Patients with peripheral neuropathy or quadriplegia, Patients with open wounds on their body, Patients receiving analgesia and sedation infusion, Patients who are sedated, Patients in delirium, Patients with an allergy detected before starting the application, Patients with a GKS (Glasgow Coma Scale) score of 3 and below - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295848

Recruiting

The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients

The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment. Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.

- EligibilityCriteria: Inclusion Criteria: Patients diagnosed with RA according to ACR/EULAR 2010 criteria Taking regular treatment for at least 1 month according to ACR/EULAR guidelines Patients diagnosed with HT according to the 2018 European Society of Hypertension and European Society of Cardiology (ESH/ESC) guideline Exclusion Criteria: Refusing to participate in the program Severe mental disorder Neurological disease or deformity in the lower extremity that would prevent the patient from using the treadmill. High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis) Uncontrolled HT, Diabetes, cardiac arrhythmia and heart failure Symptomatic severe aortic stenosis Acute pulmonary embolism or pulmonary infarction and severe pulmonary hypertension - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06295835

Not yet recruiting

Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood

Method comparison study for Potassium (K) and ionized calcium (iCa).

- EligibilityCriteria: Inclusion Criteria: Signed and dated consent form (if required by the IRB) ≥ 18 years of age Exclusion Criteria: • Prior enrollment in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295822

Not yet recruiting

The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea

Primary dysmenorrhea is a common under-diagnosed complaint, with a prevalence of about 45-95% in women of childbearing age and about 10-25% in severe cases. Menstrual pain can be classified as primary or secondary. Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology, which usually occurs 6 to 12 months after the first menstruation. Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours. The cause is still unknown, but studies suggest that it may be related to increased prostaglandins, which cause painful contractions of the uterus. The pain is often accompanied by other menstrual discomfort symptoms, including headache, breast tenderness, drowsiness, nausea, vomiting, constipation or diarrhea, and psychological anxiety, depression or irritability. In the case of secondary menstrual pain, there are clear pelvic pathologies, such as endometriosis, uterine fibroids, and pelvic inflammatory disease.

- EligibilityCriteria: Inclusion Criteria: 20-40 year-old women Regular menstrual cycle of 21-35 days, with menstruation lasting 3-7 days Dysmenorrhea started before the age of 20, and have menstrual pain every month No organic lesions on ultrasound within one year (either abdomen or vagina) VAS score above 4 Agree to participate in the study and sign the consent form Exclusion Criteria: Has used the same formula of Nuan-gong-ye before. Allergic to Nuan-gong-ye. Has abdominal wounds, infections, or skin diseases. Pregnant or planning to become pregnant within the next five months. Has taken traditional Chinese medicine or prescribed medication for menstrual pain by a Chinese medicine doctor in the past month. Has major illnesses defined by the Taiwan National Health Insurance Administration, such as cancer, heart disease, etc. Has mental illness or cognitive impairment and cannot independently fill out the questionnaire. Has a history of epilepsy or pelvic disorders. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06295809

Not yet recruiting

A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)

This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.

- EligibilityCriteria: Inclusion Criteria: Has a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted) Has LA Stage II-IV (M0) cSCC without distant metastases cSCC must be amenable to surgery (resectable) with curative intent Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available or is able to provide one that is suitable for the Next-generation Sequencing (NGS) required for this study For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving adjuvant radiation therapy (RT), and for ≥3 months after the last dose of study intervention Is female and not pregnant/breastfeeding and at least one of the following applies during the study : is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) at least during use of V940: 15 days, Pembrolizumab: 120 days, Adjuvant RT, if performed: 90 days after last exposure or is a WOCBP who is abstinent from heterosexual intercourse Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology Has a life expectancy of >3 months per investigator assessment Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization Has adequate organ function If hepatitis B surface antigen (HBsAg) positive must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization If there is a history of hepatitis C virus (HCV) infection, HCV viral load must be undetectable at screening If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), or melanoma Has distant metastatic disease (M1), visceral and/or distant nodal Has received prior therapy with an anti-programmed cell death receptor 1 (anti-PD-1), anti-programmed cell death receptor ligand 1 (anti-PD-L1), or anti-programmed cell death receptor ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte associated protein 4 (CTLA-4), OX-40, CD137) Has received prior systemic anticancer therapy including investigational agents for cSCC before randomization Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the screening blood sample (including the NGS blood sample) Has received prior treatment with another cancer vaccine Has received prior radiotherapy to the index lesion (in-field lesion). Must have recovered from all radiation-related toxicities prior to randomization and not have had radiation pneumonitis Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication Has a known additional malignancy that is progressing or has required active treatment within the past 2 years History of chronic lymphocytic leukemia (CLL) History of central nervous system (CNS) metastases and/or carcinomatous meningitis Has severe hypersensitivity (≥Grade 3) to either V940 or pembrolizumab and/or any of its excipients Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease Has an active infection requiring systemic therapy Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection Has had a myocardial infarction within 6 months of randomization Has a history of allogeneic tissue/solid organ transplant Has not adequately recovered from major surgery or have ongoing surgical complications - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295796

Not yet recruiting

A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.

- EligibilityCriteria: Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Moderate and Severe RI With the exception of RI, is in sufficient health for study participation. Has stable renal function. Healthy Matches mean age to participants with moderate and severe RI. Has normal renal function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants History of cancer (malignancy). Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV). Had a major surgery or lost significant volume of blood within 56 days prior to dosing. Donated plasma within 7 days prior to dosing. Moderate and Severe RI Failed renal transplant or had a nephrectomy. End stage renal disease requiring dialysis. Any significant arrhythmia or conduction abnormality. Has non-sustained or sustained ventricular tachycardia. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295783

Not yet recruiting

Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect

To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years English as a primary language Participants with a diagnosis of HNC undergoing active curative RT or having received curative RT within the past 5 years at MD Anderson Ability to complete the survey(s) of their own volition Exclusion Criteria: Age < 18 years Non-English speaking participants Participants who are receiving or have received RT in a non-HN site. Participants in follow up and over 5 years from post-treatment Neurocognitive deficits that render patients unable to complete the survey(s) on their own. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Head and Neck Cancer (HNC) participants undergoing active radiation therapy. - SamplingMethod: Non-Probability Sample

NCT06295770

Not yet recruiting

Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).

- EligibilityCriteria: Inclusion Criteria: ≥18 years of age Biopsy proven fibrillary glomerulonephritis Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy eGFR ≥ 20 ml/min/BSA Exclusion Criteria: Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy) Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy) Hepatitis B, C or HIV positive Pregnant or breast-feeding Active infection Kidney transplant Anemia with Hgb < 8.0 g/dL Thrombocytopenia with platelet count < 100'000 Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication Patients who have received cyclophosphamide in the last 6 months Patients who have received ACTH and/or mycophenolate mofetil in the last 30 days Patient who are on prednisone therapy at a dose > 10 mg/day in the last 15 days Patients who received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295757

Not yet recruiting

Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.

- EligibilityCriteria: Inclusion Criteria: Smoking at least 10 cigarettes/day for at least 1 year (confirmed by CO > 8 ppm or NicAlert test of 6) Engaging in relighting for at least half of their CPD No smoking quit attempts in the past month nor intentions to quit in the next month Stable medical or psychiatric conditions with systolic blood pressure < 160, diastolic blood pressure < 100 and heart rate < 105 bpm Exclusion Criteria: Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month Currently trying or planning to quit smoking in the next month Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult

NCT06295744

Not yet recruiting

Outcomes and Cosmesis With Whole Breast Irradiation and Boost

This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.

- EligibilityCriteria: Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques Treatment plan includes breast tumor bed boost Willingness to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Mastectomy of ipsilateral breast Lack of histologic diagnosis Histologic involvement of the axillary or regional nodes or metastatic disease Accelerated partial breast irradiation treatment plan Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin Previous history of chest radiation therapy Previous history of ipsilateral breast cancer Concurrent cytotoxic chemotherapy Active connective tissue disease including scleroderma Inability or unwillingness to return for required follow up visit - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295731

Not yet recruiting

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.

- EligibilityCriteria: Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies. Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis. Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing. Has measurable disease per RECIST 1.1 guidelines. Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding. Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception. Exclusion Criteria: Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site. Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC. Prior systemic therapy completed >6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion. Has clinically active central nervous system metastases and/or carcinomatous meningitis. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain. Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295705

Not yet recruiting

Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD)

This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD.

- EligibilityCriteria: Inclusion Criteria for Youth Participants Elementary school children ages 7-11. Parent/caregiver/guardian must provide proof of an Individualized Education Plan (IEP) with a Primary Eligibility of Autism. o Parent/caregiver/guardian must provide proof of IEP and eligibility. Will speak and understand English. Able to physically participate in the dance program without the use of adaptive equipment. Answer yes to the following Skillset Checklist (Per parent/caregiver/guardian report): Follow 1- and 2-step instructions. Follow structured activities with supervision (e.g., visual schedule, routine). Previous participation in extracurricular group activities over the last 6 months - 1 year (e.g., structured sports). Minimum 5-minutes of attention to task. Exclusion Criteria: No IEP Primary Eligibility of Autism. No children participants younger than 7. No children participants older than 11. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 11 Years - StdAgeList: Child

NCT06295692

Recruiting

A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

- EligibilityCriteria: Inclusion Criteria: The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment) A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention Exclusion Criteria: The study participant has a total score of JDA severity index for GPP >=14 at baseline if participants have a diagnosis of GPP The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP The study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances The study participant has a history of amyloidosis Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult

NCT06295679

Recruiting

A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease

The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.

- EligibilityCriteria: Inclusion Criteria: Adult participants ≥ 18 years of age. Participants or participant's legally authorized representative has provided informed consent to participate in this study. Participants who meet one of the following: Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label. OR Already received SOC treatment prior to enrollment. Participants with ANY of the following. Diagnosis of MI OR stroke within 2 years before enrollment. 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment. Diagnosis of (MI OR stroke) AND diabetes. Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as > 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography). Diagnosis of symptomatic peripheral arterial disease. Most recent fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (≥ 2.6 mmol/L) within 6 months prior to enrollment. Most recent fasting triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) within 6 months prior to enrollment. Exclusion Criteria: Stroke within past 1 month. Known hemorrhagic stroke at any time. Stroke due to thromboembolic event. Any prior use of Repatha® or other proprotein convertase subtilisin/kexin type 9 inhibition treatments within past 6 months prior to enrollment. Participants currently enrolled in another study involving any investigational procedure, device or drug. Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 150 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population comprises Chinese participants with established ASCVD treated with Repatha® in combination with SOC or with SOC alone in a clinical setting which includes any primary through tertiary healthcare setting where Repatha® is prescribed. - SamplingMethod: Non-Probability Sample

NCT06295653

Not yet recruiting

Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement

The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.

- EligibilityCriteria: Inclusion Criteria: Patients with good systemic health with no contraindication for periodontal surgery. No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing. Ability to maintain good oral hygiene as evidenced in recall visits. Aged 30 to 55 years. Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness). Exclusion Criteria: Medically compromised patients and systemic conditions precluding periodontal surgery. Smokers. Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure. Patients subjected to irradiation in the head and neck area. Patients treated or under treatment with intravenous amino bisphosphonates. Patient affected by active periodontitis or has poor oral hygiene and motivation. Uncontrolled diabetes mellitus. Pregnant women or planning become pregnant, and nursing mothers. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06295640

Recruiting

Relative Contribution of Brain Insulin Action for Postprandial Metabolism

The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women. Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

- EligibilityCriteria: Inclusion Criteria: BMI < 24 kg/m2 no known primary diseases no hormonal contraception Exclusion Criteria: Alcohol or drug abuse Smoking At screening: Hb < 12 g/dl for women and Hb < 14 g/dl for men Any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06295614

Recruiting

Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease

The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease.

- EligibilityCriteria: Inclusion Criteria: Typical form of Parkinson's Disease with III-V Hoehn-Yahr stage with standard therapy, Suffering from debilitating locomotor deficits, including gait impairments of either postural instability and/or freezing of gait, despite optimal medical management, 18 years of age or older, Able to understand and interact with the study team in French or English, Must use safe contraception for women of childbearing capacity, Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits. Must provide and sign the study's Informed Consent prior to any study-related procedures. Exclusion Criteria: Atypical forms of Parkinson's Disease (such as Multiple System Atrophy or Progressive Supranuclear Palsy), Secondary causes of gait problems independent of Parkinson's Disease, Inability to follow study procedures, Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator, History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist, Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation), Diseases and conditions that would increase the morbidity and mortality of the implantation surgery, Spinal anatomical abnormalities precluding surgery, History of drug or alcohol abuse in the past 5 years, Life expectancy of less than 12 months, Pregnant or breast feeding, Intention to get pregnant during the course of the study, Indication requiring frequent Magnetic Resonance Imaging (MRI), Experimental treatment taken in the past 5 years, Participation in another interventional study, Enrolment of the investigator, his/her family members, employees, and other dependent persons. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295601

Not yet recruiting

Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis

This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

- EligibilityCriteria: Inclusion Criteria: Being diagnosed with mulltiple sclerosis according to the McDonald criteria Expanded Disability Status Scale<5.5, Being between the ages of 18-65, Mini mental test score>24, Have a phone that can adapt to participating in a video call Exclusion Criteria: Having another additional neurological disease that may cause balance and coordination disorders, Receiving physical therapy in the last 6 months, Having an attack in the last 3 months Refusal to participate in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06295588

Not yet recruiting

Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.

- EligibilityCriteria: Inclusion Criteria: Survivors of cancer Age 18 or older Speak and understand English Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment. Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?" Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits. Completed Informed Consent Exclusion Criteria: Current warfarin or other anti-coagulation medication use. Current use of supplements that contain fucoidan Any allergy to fucoidan Be diagnosed with a major psychiatric illness requiring hospitalization within the last year. Be diagnosed with dementia. Be pregnant or nursing - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295562

Not yet recruiting

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.

- EligibilityCriteria: Inclusion Criteria: apnea-hypopnea index ≥ 15 hr-¹ Exclusion Criteria: the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases current use of continuous positive airway pressure therapy use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study known allergy to the investigational medication current smoking heavy alcohol drinking (male > 14 drinks and women >7 drinks per week) pregnant or lactating periodic limb movement index ≤ 15hr-1 the presence of sleep-related hypoventilation - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult

NCT06295549

Recruiting

Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

- EligibilityCriteria: Inclusion Criteria: Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. Aged 18-75 years (inclusive). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20. At least one evaluable tumor lesion according to Lugano 2014 criteria. Response to prior therapy is consistent with one of the following: Primary refractory. Relapsed or refractory after 2 or more lines of therapy. For LBCL, 3B FL. t-iNHL: Relapse within 12 months after first-line chemoimmunotherapy to achieve CR; Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation; 7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria Exclusion Criteria: Subject eligible for this study must not meet any of the following criteria: Prior antitumor therapy with insufficient washout period ; Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab). 6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO. 7. Pregnant or lactating women; - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295536

Not yet recruiting

Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children

The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

- EligibilityCriteria: Inclusion Criteria: Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old) At least 6 years old and up to 12 years old at time of informed consent and assent Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval [-10.00, +0.75] Cylindrical refractive error between 0 and 4.00 D on both eyes Corrected binocular visual acuity in distance vision at least 6/9 Exclusion Criteria: Incapable of expressing consent All categories of persons particularly protected by law Subject in another study which might have an influence on vision or interfere with study assessment Less than 6 years old, or 13 years old or above at time of informed consent and assent Amblyopia, Cataract, Strabismus. Aphakic or pseudophakic (intraocular implant) Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye. Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus) Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…), Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 13 Years - StdAgeList: Child

NCT06295523

Recruiting

Heat Waves and the Elderly With COPD

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

- EligibilityCriteria: Inclusion Criteria: 65 years old or older Diagnosis of COPD Exclusion Criteria: Known heart disease Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram Current smokers Participant with a body mass index ≥31 kg/m2 - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06295510

Not yet recruiting

Observational Study of the Association Between Food Intake and Endometrial Polyps

There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps.

- EligibilityCriteria: Inclusion Criteria: Consistent with the international clinical diagnosis of endometrial polyps.Can complete content recall alone. Exclusion Criteria: No other mental diseases. Not associated with other major diseases, including tumors, immune system diseases - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study period will include all patients who attended gynecological outpatient clinics between March 1, 2024 and May 1, 2024 - SamplingMethod: Non-Probability Sample

NCT06295497

Not yet recruiting

Lung Cancer Screening by Artificial Intelligence Device

Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population.

- EligibilityCriteria: Inclusion Criteria: Patients are eligible to be included in the study only if all of the following criteria apply: Age 50-75 years old Non-smoker (defined as less than 100 cigarettes in lifetime) Having a first-degree family history of lung cancer Physically fit for curative treatment if early-staged lung cancer is found Able to provide written informed consent Consent to follow up visits and follow up CT scan if indicated Consent to blood taking for translational research Exclusion Criteria: Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study: History of malignancy Smoking history (defined as more than 100 cigarettes in lifetime) Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss Medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder Pregnant ladies or ladies planning for conception History of tuberculosis or interstitial lung disease Pneumonia requiring antibiotic treatment within the last 12 weeks CT thorax or chest performed within 2 years (including LDCT or CT coronary angiogram) Unable or unwilling to provide written informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295484

Recruiting

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support. The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs. Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (>9 cmH2O) to what the investigators use in the NIPPV in preterm babies. One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.

- EligibilityCriteria: Inclusion Criteria: Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist) Birth weight less than 1500 grams Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen Exclusion Criteria: Congenital anomalies of the gastrointestinal tract Phrenic nerve damage Diaphragmatic paralysis Esophageal perforation Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure Significant congenital heart disease (including symptomatic PDA) Congenital anomalies of the diaphragm Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM') Ongoing treatment for sepsis Ongoing treatment for necrotizing enterocolitis (NEC) Ongoing treatment for lung infections Narcotic analgesics Gastric motility agents Infants on nasal CPAP and requiring more than 35% oxygen Infants with significant gastric residuals and vomiting Infants with facial anomalies Infants with pneumothorax or pneumomediastinum Infants in the immediate postoperative period - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 8 Months - StdAgeList: Child

NCT06295471

Not yet recruiting

A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser

This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.

- EligibilityCriteria: Inclusion Criteria: Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol; Subjects must be in good general health, based on answers provided during the screening visit; Subjects must be able to read and understand English. Subjects must be above the age of 18. Subjects must have no history of skin conditions that affect the integrity of the skin barrier. Exclusion Criteria: Are pregnant or lactating; Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks]; Are smoking or have a history of smoking; Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the forearms; Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest; Presence of sunburn or tan in the treatment area; Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months; Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months; History of blood-clotting abnormality; History of keloid formation or hypertrophic scarring; History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol; Investigator, interfere with study evaluations or pose a risk to subject safety during the study; Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study; Is not able to follow study protocol. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295458

Not yet recruiting

Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait

The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid. Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG. Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence. FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD.

- EligibilityCriteria: Inclusion Criteria: PD Diagnosis by UK Brain Bank Criteria Hoehn & Yahr stage I-IV in the off-state FOG noted in medical history FOG confirmed visually by the examiner in the office PD that is levodopa-treated and responsive Able to manage 12 hours of "OFF" dopaminergic medication state Age 50-75 years Able to sign a consent document and willing to participate in all aspects of the study Exclusion Criteria: A diagnosis of atypical parkinsonism including vascular parkinsonism Prior treatment with medications that cause Parkinsonism Stage V PD -unable to walk independently when OFF Absence of levodopa response Neurological or orthopedic disorders interfering with gait Dementia precluding completing study protocol including those meeting criteria for dementia with Lewy bodies Major depression based on the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria Any medical problems that would preclude participation, including individuals with a history of migraines, tinnitus, or seizures because sensory stimuli can potentially exacerbate these conditions. Profound sensory loss as determined by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295432

Recruiting

A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)

DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy.

- EligibilityCriteria: Inclusion Criteria: Patients must be able to understand the nature of the trial and provide a signed and dated informed consent form prior to screening. Aged at least 18 years old when sign ICF. Histological or cytological confirmed locally advanced or metastatic NSCLC. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the previous 2 weeks. Predicted life expectancy ≥ 12 weeks. Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable e.g. no evidence of progression for at least 2 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance image [MRI] or computed tomography [CT] scan) during the screening period), neurologically asymptomatic and not require corticosteroid treatment. Adequate organ system functions, as outlined below Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Absolute lymphocyte count ≥ 0.8 x 109/L Platelets ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver involvement or ≤ 5 x ULN with liver involvement Creatinine ≤ 1.5 x ULN, or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN; Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN Male subjects with a female partner who intend to have children should use barrier contraception (e.g. condom) during their participation in the clinical study until 6 months after the last dose. Male subjects should not donate sperm during the clinical study until 6 months after the last dose. If the male subject has fertility requirements, it is recommended that sperm be frozen prior to the start of the clinical study. Female subjects should use contraception at screening until 6 weeks after the last dose of DZD9008 or 3 months after the last dose of AZD4205, whichever is later, should not be breastfeeding and should have a negative pregnancy test (blood or urine β-HCG) at the time of screening. Part A specific inclusion criteria: Subjects should harbour any type of EGFR mutation. Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic/locally advanced disease. Part B specific inclusion criteria: Subjects must have documented EGFR sensitizing mutation from a local certified laboratory. Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic/locally advanced disease. Patient must have measurable disease according to RECIST 1.1: At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for repeated measurement. Agree and be willing to provide an adequate amount of the required tumor tissue for exploratory studies. Exclusion Criteria: Treatment with any of the followings: Prior treatment with any onco-immunotherapy (e.g. PD-1) within 4 weeks before the first administration of IP. Any cytotoxic chemotherapy, or other anticancer drugs from a previous treatment regimen within 2 weeks before the first administration of IP. Radiotherapy within 2 weeks of the first dose or have not recovered from radiotherapy-related toxicity May receive palliative radiotherapy other than chest and brain, stereotactic radiosurgery and stereotactic body radiation therapy within 1 week prior to first dose a limited field of radiation for palliation within 1 week of the first administration of IP. Patients currently receiving (or unable to stop using) medications known to be potent inhibitors or inducers of CYP3A or herbal supplements within 2 weeks before the first administration of IP. Patients should avoid eating food known to be inhibitors of CYP3A such as grapefruit and Seville oranges (and other products containing these fruits, e.g., grapefruit juice or marmalade) within 2 weeks before the first administration of IP and 2 weeks after the therapy. Drugs that prolong the QT interval need to be discontinued before the start of IP Major surgery (excluding biopsy) within 4 weeks before the first administration of IP, or expect to have major surgery during study. Treatment with any investigational drug (or unable to stop using) within 4 weeks before the first administration of IP Spinal cord compression or leptomeningeal metastasis. Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer type which has been disease free for > 2 years with life expectancy >2 years Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting IP with the exception of alopecia. History of stroke or intracranial haemorrhage within 6 months before the first administration of IP. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (e.g., hemophilia, Von Willebrand disease). Presence of persistent or active infection, including but not limited to: Active or latent tuberculosis Active herpes simplex, herpes zoster infection COVID-19 active HBV, HCV, HIV infection Any of the following cardiac abnormal and disease: resting corrected QT interval (QTc) > 470 msec Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec Any factors that increase the risk of QTc prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval Prior history of atrial fibrillation except prior drug treatment related and recovered Prior history of myocardial infarction, congestive heart failure, arrhythmias that are poorly controlled by medication LVEF < 55% accessed by ECHO Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, immunotherapy-induced immune pneumonitis. Significant pulmonary function impairment (i.e. pulmonary function test showing FEV1 and DLCO < 60% of expected values). Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of IP. Receiving live vaccines within 2 weeks before the first administration of IP. Women who are pregnant or breast feeding. Involvement in the planning and conduct of the study (applies to Dizal staff or staff at the study site). Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295419

Not yet recruiting

The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy

The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers. Evaluations to be made in the study (children with CP) and control (typically developing peers) groups: Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire. Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person. Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10. In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph. Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph. In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds. The Body Control Measurement Scale will be applied for body evaluation purposes. As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children.

- EligibilityCriteria: Inclusion Criteria: Participants must be between the ages of 7-15, Not having a chronic disease. Exclusion Criteria: Participants must have had Botulinum Toxin applied to the upper extremity in the last 6 months Participants must have had a health problem or had an operation that would affect the musculoskeletal system or dexterity performance in the last year (EX: Distal radius fracture). Having concentration problems such as attention deficit hyperactivity disorder (ADHD). Not volunteering to participate in the study and not signing a consent form. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 15 Years - StdAgeList: Child

NCT06295406

Recruiting

Reading Ability in Childhood Obesity

There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success. In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.

- EligibilityCriteria: Inclusion criteria • diagnosis of overweight or obesity Exclusion criteria: • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 11 Years - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). - SamplingMethod: Non-Probability Sample

NCT06295393

Recruiting

Renin Angiotensin Aldosterone System In Septic Kids

Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI. Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients. Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.

- EligibilityCriteria: Inclusion Criteria: pediatric patients age 1 days - 18 years old with sepsis or age 1 day - 18 years and healthy. Exclusion Criteria: -pre-existing end stage renal disease (ESRD), chronic renal failure (CRF), home use of angiotensin converting enzyme inhibitor(ACE) or angiotensin receptor blocker(ARB) medications, pre-existing congestive heart failure (CHF), and unrepaired congenital heart disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Day - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Pediatric subjects, age 1 day to 18 years. Septic cohort will meet criteria for sepsis (pSOFA >/= 2 or Phoenix criteria) and healthy cohort. - SamplingMethod: Non-Probability Sample

NCT06295380

Not yet recruiting

Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase).

- EligibilityCriteria: Inclusion Criteria: unilateral lower limb amputation ability to walk independently age between 18 and 75 years absence of severe comorbidities that may interfere with treatment Exclusion Criteria: presence of severe neurological and psychiatric disorders walking with aids - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295367

Not yet recruiting

Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer.

- EligibilityCriteria: Inclusion Criteria: NON-PATIENTS PARTICIPANTS: Participant must speak English NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to participate in this study NON-PATIENTS PARTICIPANTS: Participant must be one of the following: A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform A practice oncology provider (i.e., physician or mid-level), or A practice financial counselor, social workers, financial navigators, or pharmacist who have provided care or been in contact (in the last 3 months) to a patient who was assigned to the CostCOM arm, and who completed the at least 6 month study follow-up PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be ≥ 18 years of age PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be within 120 days of a new diagnosis of any solid cancer of any stage at the time of Step 0 PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of Step 0 PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not have indolent cancer undergoing observation alone (i.e., active surveillance) PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy), unless they are receiving systemic therapy PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3, OR Patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice) PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials. NOTE: If S1912CD is activated in a participating practice, S1912CD should be offered first to patients with metastatic cancer meeting eligibility criteria for S1912CD. Only if a patient is not eligible or not interested in participating in S1912CD, the EAQ222CD can be offered. For early stage cancer, EAQ222CD can be offered first given S1912CD does not enroll patients with early stage cancer PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in other clinical trials where OOPC communication or financial navigation (i.e., professional guidance to identify financial assistance programs to alleviate cost of care) is being offered as part of the trial NOTE: If a trial is offering financial counseling alone without financial navigation patients are allowed to co-enroll NOTE: Gift cards for survey completion, or parking passes are not considered financial navigation PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0 PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have a completed baseline survey in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0) PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy) either before or within 30 days of the date of OPEN registration and consent (step 0) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06295354

Not yet recruiting

Early Variations in Immune Aging

Background: Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes. Study design: A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between.

- EligibilityCriteria: Inclusion Criteria: Aged between 20 and 60 years; Able to communicate orally in Dutch or English; Able to give informed consent. Exclusion Criteria: Any systemic disease or condition, or the use of systemic medication, with the exception of the following: Cardiovascular disease and related medication Metabolic syndrome, including diabetes, hypertension, and hyperuricemia Pregnancy at inclusion (will be recorded during study); Acute illness or fever <1 month before inclusion; Received vaccines or antibiotics 3 months before inclusion; Participation in an intervention trial; Legally incapacitated or unwilling to provide informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Participants for each age group will be recruited via invitation. Former participants from the HFGP cohorts will be invited only if they had originally given permission to be approached for future studies. In case insufficient inclusions result from previous cohorts, we will proceed to recruit new healthy volunteers from the Nijmegen region. In that case, we will promote the study via local newspaper(s), social media, and flyers (will be added to the CMO file should this arise). This way, the recruitment is performed as an open invitation, and any willing participants may reach out to the research team via email or telephone. This is an observational study to explore natural aging. Participants are not subjected to any intervention. - SamplingMethod: Non-Probability Sample

NCT06295341

Recruiting

Short Stature and Psychological Well-being

The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA.

- EligibilityCriteria: Inclusion Criteria: age between 6 and 14 years, of both sexes 35 with familiar short stature (height < 3rd centile according to the Italian reference standards) and their caregivers of reference. Children with familial short stature are characterized by: short stature in other members of the family group, not necessarily the parents, harmonious appearance, without particular clinical signs and normal pubertal development, parallel growth curve below the 3rd centile, bone age corresponding to chronological age. 35 with normal height (height > 25th centile), aged between 6 and 14 years, of normal weight, and their caregivers of reference 10 children, aged between 6 and 14 years, of both sexes, affected by isolated GH deficiency according to the criteria established by AIFA note 39 for this pathology (short stature: ≤ -3 SD or ≤ -2 SD and growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests < 8 ng/ml) and their caregivers of reference Exclusion Criteria: children and teenagers with obesity (BMI > 97th centile) are excluded (for the subgroups with familiar short stature or normal height children and teenagers with the presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI) (for the subgroup with growth hormone deficiency) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 14 Years - StdAgeList: Child - StudyPopulation: 35 children with familiar short stature, 35 with normal height (height > 25th centile), and 10 with growth hormone deficiency and their caregivers of reference (see above the description of the diagnostic criteria). - SamplingMethod: Probability Sample

NCT06295328

Recruiting

From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients

Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB). Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group. Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial. Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir > 6 months (group B, n=16). Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B). Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg >0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA >0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage.

- EligibilityCriteria: Inclusion Criteria: Age 18 - 60 years Proven CHB for more than 6 months, based on serology (HBsAg positivity) and at screening a viral load of: i) Group A: HBV DNA ≥200 IU/mL and <20,000 IU/mL ii) Group B: HBV DNA < 20 IU/mL HBeAg-positive or HBeAg-negative No current use of any antiviral medication (group A) or currently treated with tenofovir only, for > 6 months (group B). Normal liver function tests, assessed as follows: i) Liver stiffness measurement using Fibroscan® of ≤ 7.0 kiloPascal (kPa) ii) Alanine aminotransferase (ALT) and/or aspirate aminotransferase (AST) at screening ≤ 1.25 x upper limit of normal (ULN) iii) Thrombocytes 150-400 10E9/L iv) Total bilirubin 0-17 µmol/L (elevated levels may be accepted if unconjugated portion is elevated in patients with Gilbert syndrome) v) Albumin within normal value (35 - 50 g/L) vi) Prothrombin Time (PT) within normal value (9,5 - 12.5 sec) vii) Alkaline phosphatase (ALP) and Gamma-glutamyltransferase (GGT) within normal values (40-120 U/L and 0-40 U/L respectively) Body mass index (BMI): 17.0-35.0 kg/m2 Clinical chemistry, hematologic and coagulation tests at screening must be within normal limits or clinically non-significant, as by the investigator's assessment. At screening, women of child bearing potential must be non-pregnant and non-lactating; a urine or serum pregnancy test will be performed at screening. Female patients of child-bearing potential (with a fertile male sexual partner) and male patients (if not surgically sterilized) must be willing to use adequate contraception from screening until last study visit. No recent (<3 months) history of any clinically significant conditions, which, in the opinion of the investigator, would jeopardize the safety of the patient or impact the validity of the study results. Written informed consent must be obtained before any study related interventions (including screening and enrollment) can be conducted. Exclusion Criteria: Currently active, or a history of liver cirrhosis determined by one or more of the following: i) Liver biopsy; ii) Elastography (e.g. Fibroscan); iii) Combination of usual radiological and biochemical criteria Currently active liver disease other than CHB Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and/or human immunodeficiency virus (HIV) Acute hepatitis A virus (HAV) infection at screening Renal impairment (estimated glomerular filtration rate (eGRF) < 60ml/min) Currently active, or a history of, psoriasis or lupus erythematodes Use of oral medication that interacts with the liver metabolism enzyme CYP2D6, or which is known to be hepatotoxic or otherwise known to interact with terbinafine (such as rifampicin). The use of a L-type calcium (LTCC) blocker (such as lomerizine of nifedipine), since these may interact with the HBV transcription according to the article by Klundert et al. Usage or plans to receive systemic immunosuppressive or immunomodulating medication (e.g. IFN) during the study or ≤4 months prior to the first investigational product administration. Clinical diagnosis of substance abuse ≤12 months prior to screening with narcotics or cocaine or with alcohol (regular consumption >14 units/week [men] and >7 units/week [women]) Inability to understand the patient information and make an informed decision to participate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06295315

Recruiting

Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome

The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated.

- EligibilityCriteria: Inclusion Criteria: subjects with a genetic diagnosis of PWS capable of understanding the questionnaires Exclusion Criteria: subjects with a genetic diagnosis of PWS with cognitive problems (evaluated throughout the Mini-Mental State Examination) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: Subjects with a genetic diagnosis of PWS, hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo-Verbania (Italy) for a 3-week body weight reduction program - SamplingMethod: Non-Probability Sample

NCT06295302

Recruiting

A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria

This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated.

- EligibilityCriteria: Inclusion Criteria: Age ≥18, ≤70 years old; Participants with chronic spontaneous urticaria (CSU) at the time of randomization as defined by the following: presence of itch and hives for ≥ 6 consecutive weeks prior to screening, despite second generation H1-antihistamine during this period; Urticaria Activity Score (UAS7) (range 0-42) ≥16, Hives Severity Score (HSS7) (range 0-21) ≥ 6 and Itch Severity Score (ISS7) (range 0-21) ≥ 6 during 7 consecutive days prior to randomization; CSU duration ≥6 months prior to screening (defined as the onset of CSU as determined by the investigator based on all available supporting documentation). Willing and able to complete the Urticaria Participant Daily eDiary (UPDD) for the duration of the study; Willing to take background medication and emergency medication according to the study protocol. 6) Written informed consent signed voluntarily by the patient or their legal representatives. Exclusion Criteria: Previous use of HWH486 or other Bruton's tyrosine kinase(BTK) inhibitors; Participants having a predominant or sole trigger of their chronic urticaria (chronic inducible urticaria); Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis With symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain disease, or with a history of gastrointestinal bleeding that is associated with a significant risk of bleeding or coagulopathy, or is clinically significant (such as requiring hospitalization or blood transfusion), or with other chronic medical conditions that are not eligible for participation in this clinical trial, or having a history of malignancy, other than non-metastatic basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of the cervix with appropriate treatment and no signs of recurrence; Clinically important laboratory test indicators are abnormal, including: abnormal blood routine: hemoglobin (Hb) < 100g/L, or white blood cell count (WBC) < 3.5×10^9/L; Abnormal liver function: aspartate aminotransferase (AST) ≥1.5×ULN, or alanyl aminotransferase (ALT) ≥1.5×ULN, or total bilirubin (TBIL) ≥1.5×ULN; Abnormal renal function: creatinine (Cr) ≥1×ULN; any other laboratory test indicators that researchers think may affect the evaluation of test results; Active and uncontrolled viral and bacterial infections at the time of screening, such as human immunodeficiency virus(HIV), hepatitis B virus(HBV), hepatitis C virus (HCV), syphilis, tuberculosis test results, or if there are any clinical symptoms of bacterial, viral, parasitic or fungal infection requiring treatment; Pregnant or breastfeeding women; having pregnancy plans during the clinical trial and within 1 month after the last dose, and do not want to take medically accepted reliable contraceptive methods; History of allergy to any investigational therapeutic drug or its excipients; History or evidence of alcohol or drug abuse within the six months prior to randomization; Use of other immunosuppressive drugs, including but not limited to hydroxychloroquine, methotrexate, cyclosporin A, cyclophosphamide, tacrolimus, mycophenolate, tripterygium, and compound glycyrrhizin, within 30 days or 5 half-lives (whichever is older) prior to screening; The investigator determines that the subjects have any conditions that make them unfit to participate in the experiment (such as weak health, poor compliance, etc.). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06295289

Recruiting

Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial

Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period.

- EligibilityCriteria: Inclusion Criteria: 1）18~75 years old (including 18 years old and 75 years old), 2）Perioperative patients with need diabetes including type 2 diabetes mellitus and other special types of diabetes mellitus and need insulin therapy; 3）Fasting blood glucose ≥7.0mmol/L or random blood glucose 11.1≥mmol/L; 4）Patients signed the informed consent form and volunteered to participate in the clinical trial. Exclusion Criteria: The patients were complicated with diabetic emergencies, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma, etc. Type 1 diabetes mellitus Patients with severe cardiac and renal organ dysfunction: cardiac function above grade III; Serum creatinine over 442μmol/L; Hemoglobin less than 90g/L; White blood cell count <4.0×109/L or platelet count <90×109/L; Patients had used glucocorticoids for more than 1 week or were currently using glucocorticoids within 1 month before screening Patients who are allergic to drugs specified in clinical protocols Patients who are not suitable for conventional insulin pump therapy. Patients who are allergic constitution and allergic to tape Patients with skin diseases such as rash and prurigo, or abnormal coagulation function; Patients who suffer from mental illness, have no self-control, and cannot express themselves clearly. Other circumstances that investigator considered to be inappropriate for clinical trial participation; 11) Patients with severe complications during or after surgery. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295276

Recruiting

Effect of Teletherapy-supported Training on Nursing Students

Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group. The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week. The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale

- EligibilityCriteria: Inclusion Criteria: Nursing students between 18 and 60 years of any gender Self-reported chronic neck and back pain in the last six months (more than three months as described by the International Association for the Study of Pain (IASP)). Speak and understand German Exclusion Criteria: Surgery in the last year on the spine, cervical, thoracic, or lumbar spine Currently on sick leave Acute back pain Severe neurological injuries or symptoms Acute trauma to the musculoskeletal system Renal insufficiency, dialysis Severe impairment of the ability to grip with the hand, e.g., rheumatoid arthritis. Severe cardiovascular diseases, e.g. heart failure Severe respiratory diseases, e.g., Chronic Obstructive Pulmonary Disease-COPD Nystagmus Falling tendency/balance disorders Latex allergy, as rubber band may be made of latex Lack of ability to stand, inability to stand safely without the help of a person or object. A spine-specific pain therapy drug treatment within the last three months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06295263

Not yet recruiting

Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases

1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease. (2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease. (3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders. (4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients.

- EligibilityCriteria: Inclusion Criteria 1.1 A total of 100 patients with primary Parkinson's disease were enrolled. The inclusion criteria were as follows: patients with primary Parkinson's disease, based on the 2015 MDS diagnostic criteria for Parkinson's disease. Disorder (MMSE score < 24); (3) those with severe mental illness who are difficult to cooperate. 1.2 A total of 100 patients with Alzheimer's disease were enrolled. The inclusion criteria were as follows: patients with Alzheimer's disease, based on the IWG-2 clinical diagnostic criteria. 1.3 Neurodegenerative diseases (non-PD and non-AD) group (n = 100) : meeting the diagnostic criteria of the corresponding diseases. 1.4 Eighty healthy elderly controls were included. The inclusion criteria were as follows: ① voluntarily participated in this study and signed the informed consent; ② Age and gender were matched with the case group. 1.5 80 young healthy controls, inclusion criteria: ① voluntarily participated in this study and signed the informed consent; ② Gender was matched with the case group, and the age was less than 60 years old. Exclusion Criteria 2.1 A total of 100 patients with PD were enrolled. Exclusion criteria: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and after neurosurgery; ② patients with various types of cognitive impairment (MMSE score < 24); (3) those with severe mental illness who are difficult to cooperate. 2.2 A total of 100 patients with Alzheimer's disease were enrolled. The exclusion criteria were: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, central system inflammatory diseases, intracranial tumors and after neurosurgery; ② patients with severe mental illness who are difficult to cooperate. 2.3 Neurodegenerative diseases (non-PD non-AD) group (n = 100), exclusion criteria: ① patients with other central nervous system diseases, such as cerebrovascular diseases, brain trauma, central system inflammatory diseases, intracranial tumors and after neurosurgery; ② patients with severe mental illness who are difficult to cooperate. 2.4 Eighty healthy elderly controls were included. The exclusion criteria were as follows: ① History of chronic diseases related to the study subjects, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and neurosurgery; ② patients with various types of cognitive impairment (MMSE score < 24); ③ Poor compliance. 2.5 80 young healthy controls, exclusion criteria: ① history of chronic diseases related to the study subjects, such as cerebrovascular diseases, brain trauma, inflammatory diseases of the central system, intracranial tumors and neurosurgical surgery; ② patients with various types of cognitive impairment (MMSE score < 24); ③ Poor compliance. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 8 Years - MaximumAge: 100 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: 100 patients with primary Parkinson's disease were included, mainly from the outpatient clinics and wards of the Parkinson's Disease and Movement Disorders Center. Inclusion criteria: patients with primary Parkinson's disease, based on the 2015 MDS Parkinson's disease diagnostic criteria. 100 patients with Alzheimer's disease were included, mainly from geriatric neurology outpatient clinics and wards (F5A&F6A). Inclusion criteria: patients with Alzheimer's disease, meeting the IWG-2 clinical diagnostic criteria as the basis. Neurodegenerative diseases (non-PD and non-AD) group 100 people: the source of neurology outpatient clinic 80 healthy elderly controls, from peer attendees and health check centers. 80 young healthy controls, from peer clinic attendees and health screening centers. - SamplingMethod: Probability Sample

NCT06295250

Not yet recruiting

ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question[s] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months.

- EligibilityCriteria: Inclusion Criteria: married women; age 18-75; fluent in Bengali); Meets criteria on an Economic Vulnerability Index >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale at baseline Exclusion Criteria: Inability to provide informed consent; Plans to travel for > 1 month during 24 M period. Inability to participate in the study for any other reason - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06295237

Recruiting

Automatic Adjustment for Asynchronies During Mechanical Ventilation

Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software.

- EligibilityCriteria: Inclusion Criteria: Age >17 years Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp <0.6); obstructive (RCExp >0.9); normal (RCExp 0.6 - 0.9). Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation. Presence of asyncronies in pressure and volume curves tracings of the ventilator. Signed informed content. Exclusion Criteria: Pregnant On extracorporeal respiratory support (ECMO or ECCO2R) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295224

Recruiting

Retrospective Evaluation of Effect of Anterior Iliac Block

In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure.

- EligibilityCriteria: Inclusion Criteria: ASA-1, ASA-2 and ASA-3 patients Female/male Exclusion Criteria: Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who underwent anterior iliac graft harvesting and were performed anterior iliac block at Kocaeli University Faculty of Medicine between January 2021 and December 2023 will be included in the study. - SamplingMethod: Non-Probability Sample

NCT06295198

Recruiting

The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain

Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players.

- EligibilityCriteria: Inclusion Criteria: 18-35 years old Being a professional basketball player Clinical diagnosis of lateral ankle sprain in the last 12 months Having a Cumberland Ankle Instability Test score <24 >2.5 cm symmetry between the two extremities in the lunge test Not to participate in any ankle treatment program in the last three months, Being Volunteer Exclusion Criteria: History of lower extremity surgery History of disease that may affect sensorimotor function in the lower extremity Musculoskeletal disorders that may affect balance Having any musculoskeletal and orthopedic problems Having a history of previous ankle fracture or ankle surgery Presence of any visual impairment, metabolic, neurological or rheumatological disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06295185

Not yet recruiting

Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care

The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'.

- EligibilityCriteria: Inclusion Criteria: HISBEANS store employees Age: 18 years old or older possessing a smartphone with internet connection subjects agree to participate in the study Exclusion Criteria: Those who have symptoms of psychotic disorder are acutely active or advanced, making clinical intervention difficult Those who has been started or changed their antidepressant medication within the last 1 month or cannot be maintained stably during the intervention period Those who are non-literate Those who have used the Maro app previously Those who couldn't use Maro app in their own smartphone Those who participate in another intervention study Those who have a serious medical condition that prevents them from participating in the intervention and efficacy evaluation Those who is unable to participate fully and cooperatively by the judgment of the researcher - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295172

Not yet recruiting

A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds

- EligibilityCriteria: Inclusion Criteria: Men and women between the ages of 19 and 70 Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study A person who voluntarily decided to participate in this clinical trial and gave written consent to the subject consent form Exclusion Criteria: Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study History of bleeding disorder in past or present Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening Administered an hyaluronic acid filler within 24 weeks of the date of the screening Those who have received CaHA (Calcium Hydroxypatite), PLLA (Poly L-Lactide), or PMMA (Para-Methoxymethamphetamine), Polycaprolactone filler, etc. on the site where the clinical trial medical device is applied within 2 years from the screening date Those who have used topical application agents (steroids, retinoids: applicable to pharmaceuticals and cosmetics), functional cosmetics for wrinkle improvement on the face within 4 weeks from the screening date, or are planning to use them during the clinical trial period (However, for therapeutic purposes, steroid ointment should be used for 14 consecutive days) available for a short period of time) Those who have used immunosuppressants, chemotherapeutic agents, or systemic corticosteroids within 12 weeks of screening Those who insert permanent skin extension implants such as hardening gel (Softform) in the face Those who have facial skin disease or wound infection that may affect this clinical trial Those who have autoimmune disease or a history of autoimmune disease that may affect this clinical trial, or have reduced immunity Those with a history of hypertrophic scars or keloids on the face Those with a history of anaphylaxis or severe combined allergy symptoms Those who currently have streptococcal disease Those currently receiving cortisol treatment A person who has undergone skin augmentation at the treatment site or its adjacent area Those who have skin hypersensitivity to this clinical trial medical device in the results of the intradermal reaction test Those who have had side effects with amide-based local anesthetics, EMLA Cream, or equivalent lidocaine preparations Those with confirmed sarcoid granulomatous pathology or Oslers endodontitis Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or have had or currently have a psychiatric disorder that significantly affects this clinical trial Pregnant and lactating women Among female subjects of childbearing potential, those who do not agree to contraception* by a medically accepted method up to 12 weeks after application of the investigational medical device in this clinical trial * Medically accepted methods of contraception: condoms, oral contraceptives lasting for at least 6 months, use of injectable or implantable contraceptives, and intrauterine contraceptives installed, etc. Those who have participated in other clinical trials within 4 weeks from the screening date and have been administered/applied clinical investigational drugs/clinical investigational devices Others who are deemed difficult to conduct this clinical trial when judged by the person in charge of the clinical trial - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06295159

Recruiting

Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma

The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system.

- EligibilityCriteria: Inclusion Criteria: Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures. 18 years of age or older Histologic diagnosis of melanoma belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages (Tx or T1-4) and (N1b, N1c, N2b, N2c, N3b or N3c) and/or (M1a). No prior systemic therapy for melanoma. Must be considered surgically operable and may present as any of the following groups: Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis. Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis. Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis. Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis. Participants with in-transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist. Participants with distant cutaneous/subcutaneous, soft tissue or nodal metastases with or without regional lymph node involvement are allowed if they are considered potentially surgically resectable and can be biopsied at Screening by the treating surgical oncologist. Elevated LDH is not an exclusion. Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and/or in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or distant recurrence. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1) Participants must provide a sufficient and adequate formalin-fixed paraffin-embedded (FFPE) tumor tissue sample from the most recent biopsy of a tumor lesion, obtained within 90 days from signing informed consent form (ICF). If recent tumor tissue is unavailable or inadequate, a fresh biopsy will be required, unless the principal investigator agrees that it is not safe/feasible. Participants must be evaluated by standard-of-care full body imaging studies, the choice of which is decided by the treating physician investigator. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) in accordance with the standard of care for WOCBP. WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 5 months after the last dose of study treatment. Highly effective contraception is as stipulated in national or local guidelines. Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 5 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Willing and able to comply with the requirements of the protocol. Exclusion Criteria: Pregnancy or lactation. Treatment with another investigational drug or other systemic intervention for melanoma within 4 weeks of initiation of study drugs. Patients must not have radiotherapy within the preceding 2 weeks. Patients must have recovered from adverse events due to agents administered more than 4 weeks earlier. Participants must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection. Ocular or uveal melanoma. Bowel obstruction or impending bowel obstruction within the past 3 months. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure or serious uncontrolled cardiac arrhythmia requiring medication. Active or history of brain metastases or leptomeningeal metastases. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, i.e., patients with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the patient has no evidence of disease. Participants with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible. Treatment with one of the following classes of drugs within the delineated time window prior to C1D1: Cytotoxic, targeted therapy or other investigational therapy within 3 weeks. mAbs, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster < 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered > 7 days from C1D1 or > 7 days from future cycle on study. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids. History of allogeneic organ transplant. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator. Pregnant or breastfeeding or WOCBP who are not willing to employ effective birth control from screening to 90 days after the last dose of study treatment (whichever is later). Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1. Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required. Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required. Dependence on total parenteral nutrition. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295146

Not yet recruiting

Virtual Peer Coaching in Manual Wheelchair Skills

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3).

- EligibilityCriteria: Inclusion Criteria: Coaches: At least 18 years old Non-progressive SCI Able to speak and read English Reside in the community Independently use a manual wheelchair for at least 50% of mobility Coaches with paraplegia: - Able to complete all skills targeted by the intervention, except stair ascent, (WST-Q item scores 2) independently. Coaches with tetraplegia: - Able to complete all skills targeted by the intervention with or without assistance Trainees: At least 18 years old Non-progressive SCI Able to speak and read English Reside in the community Independently use a manual wheelchair for 50% of mobility Access to an Internet-ready device with video capabilities. Access to a spotter for practicing wheelchair skills Desire training for at least 5 of the 16 skills targeted by the training program Exclusion Criteria: none - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295133

Recruiting

Preventive Remediation of Stress for Optimal MEdical StudentS

Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities. Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum. Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies. The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction.

- EligibilityCriteria: Inclusion Criteria: Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024. Having read the information note. Having signed the written consent. Exclusion Criteria: No exclusion criteria will be applied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06295120

Recruiting

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-aqcuired pneumonia diagnosed in general practice. Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics. Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.

- EligibilityCriteria: Inclusion Criteria: Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics. Exclusion Criteria: Need for immediate hospitalisation at the time of diagnosis. Known allergy to beta-lactam antibiotics. Any coinfection necessitating antibiotic treatment. Use of systemic antibiotics, antivirals or mycolytics within the last month. Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer). Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder). Pregnant or lactating. Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06295107

Recruiting

Reliability of Range of Movement Measurements in Cerebral Palsy

The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability.

- EligibilityCriteria: Inclusion Criteria: Children with hemiplegic spastic cerebral palsy - Exclusion Criteria: Other cerebral palsy diagnoses. Surgery or botulinum toxin treatment within 3 month prior to examination. - - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Children with with hemiplegic spastic cerebral palsy in the south of Sweden, Skane county. - SamplingMethod: Non-Probability Sample

NCT06295094

Not yet recruiting

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.

- EligibilityCriteria: Inclusion criteria Gastric or Gastroesophageal junction Siewert type III adenocarcinomas Clinical T3-4a-stages Any differentiation grade Any histological subtype Clinical T2-stage a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy. Any clinical nodal-stage clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted) Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 Age 18 - 80 years Undergoing robotic or laparoscopic D2 gastrectomy Able and willing to provide written informed consent and to comply with the clinical study protocol Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception. Exclusion criteria Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds. Renal impairment, defined as glomerular filtration rate (GFR) < 40 ml/min (Cockcroft-Gault Equation). Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4. An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL). An inadequate haematological function, defined as absolute neutrophil count (ANC) <1.5 x 109/l and platelets <100 x 109/l. Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06295081

Recruiting

TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance

The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes. The main questions it aims to answer are: Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types. Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations. Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up. This study consists of three phases: Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrations Phase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease. Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up. Participants will visit our study centre two, three or four times: Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn. Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer. Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease.

- EligibilityCriteria: Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Participant of an affiliated mass-participation exercise event with a: Walking distance ≥20 km Cycling distance ≥100 km Running distance ≥15 km Age: ≥ 40 and <70 years old Able to understand and perform study related procedures For Phase 2 of the study (i.e. assessment of (sub)clinical coronary artery disease), the following additional criteria are present: • Free from (known) cardiovascular diseases Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in Phase 2 of the study: Renal transplantation in the past Contrast nephropathy in the past estimated glomerular filtration rate (eGFR) < 30 ml/min Atrial fibrillation (heart rhythm disorder) Previous allergic reaction to iodine contrast Participation in other studies involving radiation Not willing to be informed about potential incidental findings from the CT-scan - Gender: All - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 1500 Athletes will be recruited at mass-participation long-distance exercise events and stratified for type of sport (e.g. walking, cycling, running). Recruitment will take place via official websites/newsletters of the associated exercise events and social media channels. Our research has extensive experience performing studies in mass-participation exercise events, such as the Four Days Marches, Seven Hills Run, Eindhoven Marathon, Amsterdam Marathon, Maastricht Marathon in which we successfully included hundreds of participants. Therefore, we expect no difficulty to reach our target number of included participants. - SamplingMethod: Non-Probability Sample

NCT06295068

Recruiting

Evaluation of ARi With OpSens SavvyWire

The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.

- EligibilityCriteria: Inclusion Criteria: Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE Age > 18 years Able and willing to give informed consent. Exclusion Criteria: Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely Subject is considered part of a vulnerable population. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention - SamplingMethod: Non-Probability Sample

NCT06295055

Recruiting

Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)

This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement.

- EligibilityCriteria: Inclusion Criteria: subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth Planned for dental implant and fixed prosthesis Aged 20 and above but under the age of 65 with good physical health and good oral hygiene Able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment. Available for follow-up after implant placement. Exclusion Criteria: (i) Heavy smokers (>10 cigarettes/day) (ii) receiving bisphosphonates (iii) undergoing radiotherapy (iv) uncontrolled medical conditions (v) Alcoholism (vi) Pregnancy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06295029

Not yet recruiting

Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics

Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years old, regardless of gender; Diagnosed as an AML patient according to the Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non Acute Promyelocytic Leukemia) in China (2021 Edition) and receiving treatment with venetoclax; Before receiving venetoclax treatment, absolute neutrophil count (ANC) ≥ 1.0 ×10 ^9/L, white blood cell count (WBC) ≥ 2.0 ×10 ^9/L, platelet count (PLT) ≥ 50 ×10 ^9/L, and hemoglobin (HB) ≥ 90g /L; Before receiving venetoclax treatment, liver and kidney function were normal (aspartate aminotransferase ≤ 3 times the upper limit of normal (ULN), alanine aminotransferase ≤ 3.0 x ULN, bilirubin ≤ 1.5 x ULN, urea nitrogen:3.2-7.1 mmol/L, glomerular filtration rate (eGFR) ≥ 60ml/min; Sign an informed consent form. Exclusion Criteria: Age<18 years old; Non AML patients; Patients who plan to use a treatment regimen without venetoclax; Patients with poor medication adherence; Liver and kidney function damage before medication; Before medication, ANC<1.0 x 10 ^9/L or WBC<2.0 x 10 ^9/L or PLT<50 x 10 ^9/L or HB<90g /L; Pregnant and lactating women; Cases deemed unsuitable for inclusion by researchers - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study aims to include 200 patients with AML who were treated with venetoclax. A database of venetoclax medication for AML patients will be constructed based on demographic information, medication information, laboratory test information, blood drug concentration, SNPs, and drug-related adverse reactions. Randomly divide the data into training and testing sets in a 7:3 ratio, and construct the model through machine learning. - SamplingMethod: Non-Probability Sample

NCT06295016

Recruiting

Stressors and Recovery Regulation on the Super-compensation Effect

Purpose: Investigating the effects of stressors and recovery regulation on the super-compensation effect of high-intensity intensive training (IT) in endurance athletes. Methods: This study will recruit 176 competitively trained endurance adult athletes. Participants will conduct a 7-week 3-stage experiment, including 3 weeks of regular training, 3 weeks of 130% progressive IT, and 1 week of 55% taper. Measurement will include training responses (performance and fatigue symptoms), stressors, recovery regulation, and mood state at baseline, during and after regular training, IT, and taper separately. According to the performance after taper, all participants will category into either the responder or non-responder of well-response to supercompensation effect. Statistic analysis: Independent t-test, Chi-squared test, and binary logistic regression will be used to compare the difference in training responses, stressors, recovery regulation, and mood state characteristics between responder and non-responder groups. P value sets at 0.15 for identifying the potential predictors. Logistic stepwise multiple regression will be used further to determine the significant predictors for the responders of well-response to the super-compensation among endurance athletes. P value sets at 0.05.

- EligibilityCriteria: Inclusion Criteria: Athletes aged 18 or above with endurance-type competitive sports experience. For instance, athletes who have participated in track events of 400 meters or longer, marathons, road cycling, swimming, rowing, race walking, triathlons, orienteering, and similar competitive events. A habitual training regimen of at least 6 hours per week. For instance, training three times a week for at least 2 hours each session. Minimum of 3 years of training experience, such as being part of a school team or a specialized athlete. No severe injuries within the past year. For instance, severe non-regenerative anemia, craniotomy due to cerebral aneurysm, acute myocardial infarction, severe hepatic cirrhosis, severe systemic lupus erythematosus nephritis, severe rheumatoid arthritis, severe head trauma, and similar conditions. Not taking substances affecting athletic, physiological, and psychological performance. For instance, unauthorized drugs, prohibited substances, growth hormones like somatotropin and related substances, β2 agonists, hormone and metabolic modulators, diuretics, masking agents, stimulants, anesthetics, cannabis, adrenal corticosteroids, and similar substances. Exclusion Criteria: Presence of an illness resembling symptoms of overtraining syndrome in the week before the start of the experiment. This includes primary viral illnesses, bacterial infections, associated inflammatory diseases, diabetes, or hyperthyroidism. Suspected symptoms of high-risk overtraining syndrome in the week preceding the experiment, such as persistent fatigue or exhaustion, unexplained significant decrease in athletic performance exceeding 10%. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06294990

Not yet recruiting

Klinefelter Syndrome and Testosterone Treatment in Puberty

The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY). The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties. Participants will be randomized to two years treatment with testosterone or placebo.

- EligibilityCriteria: Inclusion Criteria: 47,XXY Klinefelter syndrome Age 10-14 years at inclusion Luteinizing Hormone > +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay Free Testosterone<+2 standard deviations Signed consent from parents Exclusion Criteria: Previous or ongoing T treatment except for TRT because of micropenis Contraindications to testosterone treatment known hypersensitivity to testosterone or to any other constituent of the gel known or suspected prostatic cancer or breast carcinoma Participation in any other clinical trial - HealthyVolunteers: No - Gender: Male - MinimumAge: 10 Years - MaximumAge: 14 Years - StdAgeList: Child

NCT06294951

Recruiting

fMRI for BPS: A Descriptive Study of Findings and Symptoms

The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are: To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS. Participants will undergo fMRI as well as other routine laboratory tests and queries.

- EligibilityCriteria: Inclusion Criteria for BPS group: Be 18 years of age or older and female; Be diagnosed with BPS (persistent or recurrent pain in the bladder area accompanied by at least one other symptom, such as increased pain when the bladder is full, and frequent urination during the day and/or at night, according to the current diagnostic criteria and clinical guidelines, without any of the conditions listed in the "Exclusion Criteria" below); Persistence of symptoms for more than 6 months; Visual analogue scale (VAS) of pain ≥ 4; O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) score of 12 or more, with pain and nocturia domain scores >2; Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) >13; No history of cystoscopy within 2 years. Exclusion Criteria for BPS group: With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS; Pregnant or lactating women; Contraindications to MRI; Average urine output less than 40 ml or more than 400 ml; Haematuria (more than 1+ in urine dipstick test); Evidence of current urinary tract infection at the time of recruitment; Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer; Recurrent urinary tract infection; History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months; History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease; Reliance on catheterisation; including clean intermittent catheterisation or indwelling catheterisation; Planned rehabilitation therapy affecting bladder function. Inclusion Criteria for Control group: Be 18 years of age or older and female; With symptoms of bladder pain (defined as persistent or recurrent pain in the bladder area accompanied by at least one other symptom, such as increased pain when the bladder is full, and frequent urination during the day and/or at night) according to current diagnostic criteria and clinical guidelines; Have a pain visual analogue scale (VAS) ≥ 4; Evidence of a current urinary tract infection; Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) >13; No history of cystoscopy within 2 years. Exclusion Criteria for Control group: With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS; Pregnant or lactating women; Contraindications to MRI; Average urine output less than 40 ml or more than 400 ml; Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer; History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months; History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease; Dependence on catheterisation; including clean intermittent catheterisation or indwelling catheterisation; Planned rehabilitation that affects bladder function. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The groups or cohorts will be selected from Urology clinic of Renji Hospital, Shanghai Jiao Tong University School of Medicine - SamplingMethod: Non-Probability Sample

NCT06294925

Not yet recruiting

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past. All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device. The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer. The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

- EligibilityCriteria: Inclusion Criteria: Male and female patients ≥18 and <65 years of age at baseline Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. Exclusion Criteria: Presence of clinical findings suggestive of Crohn's disease. Planned surgical intervention Prior/Concomitant Therapy: any previous exposure to etrasimod including participation in the etrasimod clinical program. any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator. Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study. - SamplingMethod: Probability Sample

NCT06294912

Not yet recruiting

A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)

The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.

- EligibilityCriteria: The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Is in good health Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 90 days after the last dose of MK-7602: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom plus additional contraceptive method For participant assigned female sex at birth: EITHER be a person of nonchildbearing potential (PONCBP) OR must use a highly effective contraceptive method or be abstinent during the intervention period and for at least 10 days after the last dose of study intervention Must provide confirmation of not living alone (at any stage from inoculation day until the end of the study). A participant who lives alone may be included on a case-by-case basis. Agrees to refrain from eating food containing poppy seeds for 48 hours prior to screening, malaria inoculation, and MK-7602 administration Exclusion Criteria: History of clinically significant clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases Is mentally or legally incapacitated or has a history of clinically significant psychiatric disorder History of cancer (malignancy) History of malaria History of splenectomy History of ever receiving a blood transfusion History of recurrent headache (eg, tension-type, cluster or migraine) with a frequency of ≥2 episodes per month on average and severe enough to require medical therapy, during the 5 years preceding the screening visit History of convulsion (including intravenous drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not considered an exclusion criterion. Has presence of clinically significant infectious disease or fever (eg, sublingual temperature ≥38.5 degrees Celsius) within the 5 days prior to inoculation Has evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise participant safety Has clinically significant disease or any condition or disease that might affect drug absorption, distribution, or excretion (eg, gastrectomy, diarrhea) Has a medical requirement for intravenous immunoglobulin or blood transfusions Has had a major surgery with more than 470 mL of blood loss, lost 1 unit of blood (approximately 470 mL) or undergone blood donation of any volume to the Australian Red Cross Blood Service (Blood Service) or other blood blank within 4 weeks prior to the prestudy screening visit) or during the 8 weeks prior to inoculation Has used any corticosteroids, anti-inflammatory drugs (excluding commonly used over-the-counter anti-inflammatory drugs such as ibuprofen, acetylsalicylic acid, diclofenac), immunomodulators or anticoagulants within the past three months History of receiving immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone, or inhaled steroids) at a dose or duration potentially associated with hypothalamic-pituitary-adrenal axis suppression within the past year from the screening visit Has had any vaccination within the last 28 days Has participated in another investigational study within 12 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit History of participation in a previous malaria challenge study or malaria vaccine study. Must not have had malaria exposure that is considered by the principal investigator or their delegate to be significant - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06294899

Not yet recruiting

CRP and Lung Ultrasound in Respiratory Evaluation

Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists. This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years old Clinical suspicion of LRTI defined as acute illness lasting less than 21 days, with cough as the main symptom, accompanied by at least one other lower respiratory symptom (such as sputum production, dyspnoea, difficult breathing, or chest pain) without any other explanation for the clinical picture. Ability to read, understand and willingness to give written consent to participate in the study. Exclusion Criteria: Patients who have been treated with antibiotics during the last 14 days up to inclusion. Patients with hemodynamic instability or that need emergency medical care due to the current clinical condition. Previous diagnosis of lung or pleural cancer. Thoracic surgery within the past 60 days. Lung interstitial diseases. Patients who refuse to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with lower respiratory tract infections attending Primary Care centres in Lleida. - SamplingMethod: Non-Probability Sample

NCT06294886

Recruiting

Vaginal Fluid Collection for Detection of Endometrial Cancer

The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN). The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.

- EligibilityCriteria: Inclusion Criteria: Women ≥18 years of age. Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN. Women whose planned surgical intervention (if any) includes hysterectomy, D&C, or hysteroscopic resection. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. - Exclusion Criteria: Patient with recurrent and/or previously treated EC. Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment. Prior hysterectomy. Current known pregnancy diagnosis. Prior or current biopsy and histopathology-proven cervical cancer. The presence of concomitant biopsy and histopathology-proven cervical dysplasia. Any prior pelvic or vaginal radiotherapy. Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years. Chemotherapy within the past 5 years. Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will enroll women ≥18 years of age with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia, or endometrial intraepithelial neoplasia (EIN) presenting for management of their endometrial pathology. - SamplingMethod: Probability Sample

NCT06294873

Recruiting

Stool Sample Collection Study

The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract.

- EligibilityCriteria: Inclusion Criteria: Participant is a person ≥18 years of age. Participant has a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. Exclusion Criteria: Participant has actively bleeding hemorrhoids. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer). Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years. Participant has a history of any inflammatory bowel disease. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps. Individual has a condition the Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Men and women 18 years or greater with a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. - SamplingMethod: Probability Sample

NCT06294860

Recruiting

Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy

The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism.

- EligibilityCriteria: Inclusion Criteria: children of both sexes age 5-15 years affected by isolated GH deficiency according to the criteria provided by note 39 AIFA for this pathology (short stature: ≤ -3 DS or ≤ -2 DS; growth rate/year ≤ -1.0 DS per age and sex evaluated at a distance of at least six months; GH peak at two different pharmacological stimulation tests < 8 ng/ml). Exclusion Criteria: - presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic NMR). - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 15 Years - StdAgeList: Child - StudyPopulation: Children with isolated growth hormone deficiency - SamplingMethod: Probability Sample

NCT06294847

Not yet recruiting

Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery

This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study. The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD). 120 patients will be enrolled and randomized in two groups: the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®) the control group "Placebo Group," with oral administration of the placebo.

- EligibilityCriteria: Inclusion Criteria: Aged 18 years or older, Scheduled to undergo surgical intervention through vitrectomy, Aphakic or pseudophakic patients, Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more, Presenting with macula OFF (raised macula) for 7 days or less before the onset of symptoms, Has signed a consent form, Affiliated with a health insurance plan. Exclusion Criteria: Patients who have previously undergone vitrectomy for retinal detachment, Patients with vitreous hemorrhage or any other associated retinal pathologies, Monophthalmic patients, Women of childbearing age without effective contraceptive methods, Pregnant or lactating women, Hypersensitivity to the active substance, bile acids, or any of the excipients in Ursolvan® (see §6.1.1 of this protocol), Patients with peptic ulcers, acute or chronic liver disease, acute infection or inflammation of the gallbladder or bile ducts, recurrent gallstones, or obstruction of the bile ducts (common bile duct or cystic duct obstruction), Patients with radiopaque calcified gallstones, Patients with severe pancreatic disorders, Patients with Crohn's disease, ulcerative colitis, or other intestinal diseases that may alter the enterohepatic circulation of bile acids, Patients on oral treatment with cholestyramine, colestipol, antacids containing aluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine, ciprofloxacin, nitrendipine, or dapsone, Patients with galactose intolerance, Lapp lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases), Patients participating or in the exclusion period following an interventional research with the use of prohibited medications in this study, Patients under protective custody. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294834

Recruiting

Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently.

- EligibilityCriteria: Inclusion Criteria: Practicing rehabilitation professional whose client population includes wheelchair users. Willing and able to attempt practicing wheelchair skills Access to a spotter(s) Access to an Internet-ready device with video capabilities. Speaks English Exclusion Criteria: 1) Confident in teaching (Self-Efficacy on Assessing, Training, and Spotting [SEATS] item score = 5) and able to complete (WST-Q capacity item score = 2) >50% of skills targeted by the training intervention. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294821

Not yet recruiting

4AP to Delay Carpal Tunnel Release (CTR)

The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery.

- EligibilityCriteria: Inclusion Criteria: Patients diagnosed with non-traumatic carpal tunnel syndrome without any other confounding diagnosis (e.g. cubital tunnel syndrome, cervical nerve compression) Standard of care EDX testing within 6 months of study enrollment Cognitive ability to report sensory and motor deficit during examination. Able to complete twice daily dosing of 4-AP for the entire 6 week treatment period. Adults subject aged 18-90 Ability to give written informed consent. Capable of safely undergoing electrodiagnostic testing (EDX). Availability for all study visits. Exclusion Criteria: Inability to complete twice daily dosing during 6 week treatment period. History of multiple sclerosis, stroke or any other diagnosed neurological disorder History of hypersensitivity to AMPYRA® or 4-aminopyridine Current use of aminopyridine medications, including other compounded 4-AP Suspected renal impairment based on the Choyke questionnaire. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06294795

Recruiting

Toric Intraocular Lens Implantation in Pediatric Cataract

To evaluate the visual and refractive outcomes after a IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism

- EligibilityCriteria: Inclusion criteria: Visually significant cataract; Corneal astigmatism more than 1.25 diopters; Children aged ≥ 6 years and < 18 years. Exclusion criteria: Patients with a corneal diameter less than 9 mm; Presence of corneal scarring; Irregular astigmatism; Intraocular pressure more than 25 mm Hg; Active inflammatory process of the eyeball or signs of a previous episode of inflammation; Traumatic, subluxated, or complicated cataract; Persistent Fetal Vasculature; Diseases of the optic nerve or macula that may limit visual potential; History of previous intraocular surgeries; Performing posterior capsulorhexis intraoperatively. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult