cyrilzakka/clinical-trials huggingface dataset:
Protein Supplementation for Chronic Stroke Treatment

Stroke patients usually have difficulties with moving and are venerable to secondary problems such as sarcopenia and strength loss. These problems may accelerate the disability process during aging. It is well known that exercise helps to maintain or promote human fitness. This study is conducted to explore the beneficial effects of exercise and protein supplement on fitness and body composition among patients with chronic stroke.

This is a multicenter randomized control trial. Participants will be recruited from 4 teaching hospitals in Taipei. Participants are randomly assigned to 2 groups:

1. protein supplementation + exercise (PRO group);
2. carbohydrate supplementation + exercise (CHO group);

The 1-hour exercise intervention includes aerobic cycling exercise followed by progressive resisted exercise with TheraBand. PRO group receives PS immediately before and after the exercise while the CHO group receive sham product (the same calories with no protein). The Interventions are arranged 3 sessions a week for 10 weeks. The outcome measurements are performed at 0-week, 10-week, and 20-week.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic stroke\>6months
2. Age : 20-75 y
3. Able to walk independently over 10 mins (with or without orthosis)
4. Able to use stationary bike

Exclusion Criteria:

1. Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
2. Not able to exercise due to severe cardiopulmonary dysfunction
3. Malnutrition (MNA\<11)
4. Severe obesity (BMI\>35)
5. Renal insufficiency
6. Unable to tolerate our cardiopulmonary exercise test (CPET) (eg, too short stature to fit the machine, leg spasticity is too strong to peddle the cycling, unable to maintain 50 rpm at the beginning of CPET, indications for early termination of CPET based on the American College of Sport Medicine suggestions)
Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence

The aim of our study is to compare the effects of hypopressive exercises with routine pelvic floor exercises in improving the frequency and severity of urinary incontinence in women and also to enhance their quality of life as it worsens after childbirth, pregnancy, and in older age.

A randomized control trial study will be conducted in which patients with urinary incontinence will be assigned to group 1 that will receive hypopressive exercises with electrical muscle stimulation (EMS) and patients in group 2 will receive pelvic floor exercises with EMS.

The intervention will be applied (3 days/week) for 8 weeks. Four sets of 10 repetitions with a 3-minute interval between each set will be performed for group 1 in an upright position while four sets of 10 repetitions with a 2-minute interval between each set will be performed for group 2 in the sitting position.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 20 to 65 years
* Gynecologist and urologist diagnosed patients
* Participants not engaged systematically in sports or physical activities(≤ sessions per week, ≤ weeks per week)

Exclusion Criteria:

* If participants had hypertension or any serious mental disease
* Pregnancy or up to 2 months postpartum
* Urge fecal incontinence or vaginal pain
* Underwent any physiotherapy for urinary incontinence before
* Any kidney disease
Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF

This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.

Participants in this study will have an overnight sleep study done while wearing a 24 hour pH monitor in the esophagus. If the participant has sleep apnea, he or she will be randomly assigned to receive either CPAP treatment or no CPAP treatment. After 4-8 weeks, the participant will have another overnight sleep study with 24 hour pH monitoring. Blood will also be collected at both time points and again after 6 months to measure biomarkers that are related to lung inflammation.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of IPF based on the 2018 IPF guidelines
* high likelihood of OSA based on the STOP-BANG measure, with a score of 3 or greater
* patients on nintedanib, or in whom nintedanib will be initiated prior to enrollment in the study
* able to participated in 24hr pH monitoring
* able to comply with CPAP treatment
* able to provide written informed consent prior to any study procedures
* willing to complete all study measurements and assessments in compliance with the protocol

Exclusion Criteria:

* interstitial lung disease caused by conditions other than IPF
* severe concomitant illness limiting life expectancy (\< 1 year)
* residual lung volume \> or equal to 120% of predicted
* obstructive lung disease: FEV1/FVC ratio \< 0.70
* current drug or alcohol dependence
* patients who are unable to tolerate nintedanib
* patients who are unable to use CPAP or are unwilling to participate in the 24 hr pH probe placement
* patients who were diagnosed with recent IPF exacerbation within 4 weeks of enrollment (may be rescheduled for enrollment once recovered)
* patients who have had prior nasal surgery or trauma that would make pH probe placement difficult
* patients on anticoagulation (aspirin is not an exclusion)
Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.

Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract

Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis.

Total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function.

Based on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients more than 18 years old.
2. Patients with staghorn stone (partial, complete).
3. Patients with multiple calyceal calculi which are inaccessible by single tract.

Exclusion Criteria:

1. Patients under 18 years old.
2. Patients with renal anomalies.
3. Patients with only function kidney.
4. Patients with distal ureteric obstruction.
5. Patients with radiolucent stone.
6. Patients with febrile urinary tract infection.
7. Patients with abnormal coagulopathy state.
8. Patients refused to participate in this study.
9. pregnancy.
10. Musculoskeletal deformity.
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.

The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months).


Eligibility Criteria:
Inclusion Criteria:

* Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic,
* Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology equation),
* Women of childbearing potential are eligible only if the following applies:

  * Negative pregnancy test at the screening visit and at baseline (i.e., end of run-in period).
  * Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation.
  * Agree to use highly-effective methods of contraception up to at least 30 days after study treatment discontinuation.

Exclusion Criteria:

* Mean sitting systolic blood pressure above 170 mmHg measured by "automated office blood pressure measurement" (AOBPM),
* Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
* Change in renal function requiring hospitalization, documented eGFR decline of greater than 20% in the 3 months prior to the screening visit, dialysis in the 3 months before the screening visit,
* Planned dialysis or kidney transplant during the course of this study,
* Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g,
* Known and documented chronic heart failure.
Support Via Technology: Living and Learning With Advancing FTD

Much effort over the last several decades has been devoted to developing and implementing psychoeducational interventions for family caregiving partners for those with Alzheimer's and relatedm dementias (ADRD). However, few interventions address the specific needs of care partners for those with frontotemporal degeneration (FTD).

This study tests an intervention to support family caregivers for those with FTD.

Much effort over the last several decades has been devoted to developing and implementing psychoeducational interventions for family caregiving partners for those with Alzheimer's and related dementias (ADRD). However, few interventions address the specific needs of care partners for those with frontotemporal degeneration (FTD), the most common form of dementia in adults under age 60.

Caring for a family member with FTD can affect the psychological, social, and relational health of families. Care partners for those with the disease have higher levels of burden and depression, as well as more sleep disturbances and worse financial strain than care partners for those with ADRD. Psychoeducational interventions can alleviate some of the psychological symptoms associated with dementia caregiving, but few programs have been designed for care partners for persons with FTD. Further, many of the existing programs are inaccessible for families due to distance and cost. The STELLA (Support via TEchnology: Living and Learning with Advancing dementia) intervention is designed to teach ADRD care partners strategies for managing behavioral symptoms associated with dementia. STELLA uses videoconferencing to connect care partners, in their own homes, with experienced Guides (e.g., nurses). The Guides use cognitive behavioral techniques to assist care partners in identifying and implementing strategies to reduce distressing behavioral symptoms in the person with dementia.

Our pilot work found that early versions of STELLA reduced the frequency of behavioral symptoms and care partner reactivity to them. In this study, the investigators will adapt STELLA to specifically address the needs of family care partners for persons with frontotemporal degeneration. Aim 1. Adapt STELLA to the needs of care partners for those with FTD

1. Gather FTD care partner feedback on STELLA and suggestions for tailoring STELLA for FTD
2. Adapt STELLA for FTD care partners based on end-user feedback Aim 2. Assess the feasibility, acceptability and STELLA-FTD with FTD care partners Aim 3. Assess the preliminary efficacy of STELLA-FTD on the primary outcomes: reducing the frequency of behavioral symptoms and care partner reactivity to the symptoms as measured on the Revised Memory and Behavior Problems Checklist (RMBPC).

Eligibility Criteria:
Inclusion Criteria:

* Care Partner for family member, close friend or kin with FTD, primary progressive aphasia, progressive supranuclear palsy or other frontotemporal degenerative dementia
* Must speak English
* Must be able to see and hear the videoconference-based interactions.

Exclusion Criteria:

- Family member does not care for someone with FTD conditions.
Overweight and Obesity in Preschoolers

Obesity interventions in early childhood are recommended as they have been proven to be more effective than interventions later in life. The overall aim of this study is to assess the effectiveness, feasibility, and acceptance of an overweight and obesity intervention in socially disadvantaged families. Participants will be families with children aged 2-6 years (n = 300) with overweight or obesity and will be recruited from three sites: Stockholm, Sweden (n = 100); Timisoara, Romania (n = 100); and Mallorca, Spain (n = 100).

The proposed randomized controlled trial has five specific aims:

Specific Aim 1: To determine the effectiveness of a 10 week parent-only group support program focusing on evidence-based parenting practices followed by a mobile health (mHealth) component for 6-months (n = 150) compared to standard care (n = 150) for overweight and obesity in pre-school children (change in BMI z-scores after 9 months primary outcome).

Specific Aim 2: To determine if the intervention can improve body composition (waist circumference), child eating behaviour, physical activity, and parental feeding practices in comparison to the control group.

Specific Aim 3: To assess reversibility of the molecular signatures of obesity following the intervention through epigenetic markers in white blood cells (methylation) and analyzing the role of the gut hormones.

Specific Aim 4: To assess and validate child food intake with metabolic markers in urine.

Specific Aim 5: To evaluate the feasibility of recruitment (facilitators and barriers), attrition and acceptability, as well as patient and caregiver satisfaction to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 2 to 6 year old children with overweight or obesity according to international cut-offs.
* Children who have no other underlying medical condition(s).
* Parent(s) who have the ability to communicate in Swedish (for the Swedish part), Romanian (for the Romanian part), and Spanish (for the Spanish part).

Exclusion Criteria:

* Parent(s) not owning a smartphone compatible with the MINISTOP app.
Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features

The purpose of this study is to determine a dose of the investigational drug betahistine dihydrochloride that is both well tolerated and potentially effective in treating the symptoms of atypical depression. Atypical depression is characterized by the ability of the person's mood to improve temporarily in response to positive events, as well as features such as increased appetite, increased sleep and severe fatigue.

All patients will start taking 50 mg of betahistine dihydrochloride on treatment day 1 (after baseline visit). Starting on day 4, the daily dose will be increased by adding a 50 mg dose. If tolerated, the daily dose will be titrated to 200 mg. At the end of week 3, the dose will be titrated to 300 mg.

Eligibility Criteria:
Inclusion Criteria:

1. Have signed written informed consent
2. Be male and/or female outpatients 18 65 years of age, inclusive
3. For women: must be surgically sterile, 2 years postmenopausal, or, if they have childbearing potential, using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e., barrier method with spermicide, steroidal contraceptive or intrauterine device \[IUD\])
4. Meet DSM IV1 criteria for major depressive episode (unipolar), with atypical features
5. Have a score of 20 or greater on the Hamilton Depression Rating, 28-item version (HAM-D-28)
6. Have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ECG before study entry.
7. Have baseline laboratory values and ECG that are normal, or abnormalities that are clinically insignificant

Exclusion Criteria:

1. Have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination
2. Have a history of peptic ulcer disease
3. Have a history of severe asthma
4. Have a current diagnosis of pheochromocytoma
5. Are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit)
6. Meet criteria for DSM IV1 psychoactive substance abuse or dependence in the past month
7. Have a history of a psychotic disorder
8. Use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
9. Have a history of hypersensitivity to betahistine dihydrochloride
10. Exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
11. Are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the HAM-D 28
12. Have received any investigational product within 28 days of Screening
13. Have used any antidepressant within 7 days of Screening (14 days for MAOIs; 21 days for fluoxetine)
Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD

Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4) for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment. With its mode of action Daxas can reduce exacerbations rates and improve lung function parameters which may result in a better health-related quality of life and an improved long-term management of COPD.

The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting. Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.


Eligibility Criteria:
Main Inclusion Criteria:

* severe COPD

Main Exclusion Criteria:

* Child pugh (classified B and C)
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively.
* in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery.

Exclusion Criteria:

* receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents.
* have significant concurrent pulmonary conditions.

Other protocol-specific exclusion/inclusion criteria may apply.
A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form (ICF) prior to any study-mandated procedure.
* Male or female subjects ≥ 55 years old at the time of signing the ICF.
* Insomnia complaints for at least 3 months prior to Visit 1.
* Insomnia Severity Index© (ISI©) score ≥ 13 at Visit 1.
* Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.
* Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.

Exclusion Criteria:

* Woman of childbearing potential, pregnant or plans to become pregnant.
* Planned travel across ≥ 3 time zones during study.
* Life time history of suicidality assessed via Columbia Suicide Severity Rating Scale© (C-SSRS©).
* Regular caffeine consumption after 4 pm.
* Unable to refrain from smoking during the night.
* Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or rapid eye movement (REM) sleep behavior disorder.
* Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondary polydipsia.
* Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1.
* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.