cyrilzakka/clinical-trials huggingface dataset:
Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair

The goal of this randomized controlled trial is to teach patients to safely and effectively self-remove drains at home in adults (aged 18 and older) following a ventral hernia repair (VHR). Researchers will compare the group of subjects self-removing the drain at home to a control group of standard of care drain removal during a clinic visit by a provider to see if subjects are able to safely self-remove the drain at home.

Annually, in the United States, it is estimated that 500,000 ventral hernia repairs (VHRs) are performed with a cost in excess of $3.2 billion. Drains are frequently used in an effort to prevent seroma formation. Seromas are defined as a buildup of bodily fluid in a potential space post-surgery, usually at the surgical site. Rate of seroma has been estimated to be between 9-11% following abdominal wall reconstruction (AWR). The timing of the removal is usually after discharge but before patient's scheduled postoperative visit, thus most patients must call and speak to a health provider and come in for an additional clinic visit specifically for drain removal. The goal of this study is to teach patients to safely and effectively self-remove drains at home. This will allow patients to forgo the cost associated with commuting to the clinic, the clinic cost associated with nursing time and scheduling, the clinic visit, physician or nurse time to remove the drain and possibly lost wages for the patient from time off work. It is important to note that self-drain removal will not compromise or deviate from typical patient follow up. Instead, this will eliminate an extra patient visit when inevitably the timing of drain removal does not align with the typical follow-up period. Additionally, this will allow providers to see additional patient consultations or perform other duties, as they will not have the time constraints associated with in-office drain removal. This study will show that patient self-drain removal benefits the patients, the providers, and healthcare system without compromising patient safety, satisfaction, and postoperative care.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years.
* Undergoing elective ventral hernia repair (VHR).
* Sub-cutaneous drain placement.
* Anticipated Centers for Disease Control and Preventions (CDC) 1\&2 wound class.

Exclusion Criteria:

* Patients who do not have access to the online training video.
* The surgeon does not believe the patient can self-remove the drain.
* Planned concomitant procedures.
* Current mesh infection.
Neuromuscular Training and Strengthening CORE in Volleyball Amateur Players 18 to 25 Years

Introduction. The most popular injuries in volleyball are the ones who occur in knee joints, due the jumps and landings that happen through the game. For this reason there is a high index of loss of stability because of the dynamic valgus during the landing, a loss of balance and a decrease of power during the jumps.

Objective. Evaluate the effectiveness of neuromuscular training in combination with strengthening of CORE in the improvement of knee joint stability, balance and power in vertical jump in volleyball players from 18 to 25 years old.

Study design. Randomized, multicenter, single-blind clinical study with follow-up period.

Methods. The study will be realized with an initial sample of 30 players, which in a random way, will be divided into two groups: experimental and control. It will be realized an initial evaluation where sociodemographic, anthropometric and clinical measures will be taken, and the study variables: knee joint stability (single leg squat test), balance (star excursion balance test) and vertical jump (sargent jump test). The intervention will last six weeks, with two sessions per week of approximately twenty minutes each.

Expected results. The investigators expected to observe improvement in the stability in the knee joint, balance and power in the vertical jump in 18-25 years volleyball players that have received a neuromuscular training with strengthening of CORE.


Eligibility Criteria:
Inclusion Criteria:

* Volleyball players
* Female
* From 18 to 25 years
* With more than one year of sports practice
* Currently participate in amateur industry competitions

Exclusion Criteria:

* Present a medical diagnosis of musculoskeletal injury at the time of beginning the study
* Receive a physiotherapy treatment unrelated to the study
* Have suffered neurological pathology in the last 6 months
* Have some type of auditory or vestibular disorder
* Not signed the informed consent.
Lycopene in Preventing Prostate Cancer in Healthy Participants

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.

OBJECTIVES:

* Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants.
* Determine the pharmacokinetics of this agent in these participants.
* Determine the dose range of this agent in these participants.

OUTLINE: This is a dose-escalation study.

Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.

Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 participants experience dose-limiting toxicity.

Participants are evaluated periodically for 28 days.

PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy participants in good medical condition

  * No chronic medical conditions
  * No regular use of prescription medications
  * No evidence of psychiatric disorder
  * Non-smoker

    * Former smokers allowed provided they have not smoked within the past 3 months
  * No history of alcohol abuse
* Serum lycopene concentration \< 700 nM

PATIENT CHARACTERISTICS:

Age

* 18 to 45

Performance status

* Karnofsky 100%

Life expectancy

* Not specified

Hematopoietic

* Hemoglobin ≥ 13.0 g/dL
* WBC ≥ 4,000/mm\^3
* Platelet count 150,000-400,000/mm\^3

Hepatic

* AST and ALT ≤ 75 U/L
* Bilirubin ≤ 2.0 mg/dL
* No liver disease

Renal

* Creatinine ≤ 1.5 mg/dL
* No renal disease

Cardiovascular

* No cardiovascular disease
* No abnormal EKG

Other

* Within 15% of ideal body weight
* No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
* No alcohol consumption within the past 72 hours
* No allergy to tomato-based products
* No history of cancer
* No diabetes mellitus
* No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 4 weeks since prior experimental drugs
* More than 14 days since prior prescription drugs
* No concurrent participation in another experimental trial
* No concurrent prescription drugs
A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects

The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive).
* Fasting glucose (FG) \< - 240 mg/dL, while on metformin or antidiabetic diet alone.
* HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%

Exclusion Criteria:

* Women of childbearing potential
Kinesia HomeView - Home Diary Comparison

The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks
* Experiencing dyskinesia more than 25% of the waking day (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 32)
* With dyskinesias at least moderately disabling (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 33)
* Capable of accurately completing diaries
* Capable of accurately using Kinesia HomeView

Exclusion Criteria:

* Significant medical or psychiatric illness
* Subjects not capable of following the required clinical instructions
* Serious medical conditions that would compromise safety
Intervention Program for Patients With Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.

Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.

Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.

Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.

To conduct a small scale pilot randomized control trial (total N = 60; 30 in each group) to pilot test the intervention program. The intervention group will receive the caregiver training program, and the control group received printed sheets with general information on MCI and dementia such as the causes, courses and symptoms. At 1 month, 3 months, and 6 months after the intervention group will complete the two-session training program, both groups will receive a follow-up assessment for preparedness, HRQoL and depressive symptoms. To minimize attrition, caregivers in both groups will receive monthly follow-up phone calls from the first to the sixth month. Changes in outcome variables will be analyzed using hierarchical linear models, in order to provide a reference for further formal clinical trial.

Eligibility Criteria:
Patients' Inclusion Criteria:

* Age 65 years or older
* Being diagnosed as having MCI by a neurologist or a psychiatris
* Being cared for in a home setting

Patients' Exclusion Criteria:

* Terminally ill

Caregivers' Inclusion Criteria:

* Age 20 years or older
* Assuming primary responsibility for the care of the frail elderly person

Caregivers' Exclusion Criteria:

* Terminally ill
Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product (eli-cel) in a parent clinical study (Study ALD-102 or Study ALD-104).

After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent for this study by the participant or participant's parent(s)/ legal guardian(s) and written informed assent by participant, if applicable
* Have received eli-cel in a parent clinical study

Exclusion Criteria:

* There are no exclusion criteria for this study
Comparison of Coronary CT With IVUS in Heart Transplant Population

To compare results of Intravascular Ultrasound (which occurs during cardiac catheterization) with Computed Tomography (CT) scan to detect blockages or narrowing of the arteries that feed the heart. These will be studied in the cardiac transplant population.


Eligibility Criteria:
Inclusion Criteria:

* Heart transplant patients coming to the Cardiac Cath Lab for their yearly angiogram which includes intravascular ultrasound (IVUS)

Exclusion Criteria:

* Patients with a history of allergic reactions to contrast material Creatine \>1.5 Clinical or hemodynamic instability Those who are unable to consent for enrollment into the study
A Mobile Health Solution for Homework During CBT

The purpose of this study is to preliminarily evaluate a web-based app to improve provider implementation and patient engagement in homework (i.e., between-session practice of skills learned during therapy) during child mental health treatment by conducting a small-scale feasibility trial in community practice settings comparing Cognitive Behavioral Therapy (CBT) to CBT enhanced with the app.


Eligibility Criteria:
Inclusion Criteria:

Providers:

* English-speaking
* Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
* Carry active child mental health treatment caseloads
* Have a laptop, tablet, or smartphone with internet access

Youth:

* English-speaking
* Youth Ages 7-17 years
* Clinically elevated anxiety and depression as indicated by a T-score ≥ 65 on the Revised Children's Anxiety and Depression Scale-25 Child Version (RCADS-25-Y) and/or Revised Children's Anxiety and Depression Scale-25 Parent Version (RCADS-25-P) or total score ≥ 15 on the Child and Adolescent Trauma Screen - Youth Report (CATS-Y) and/or Child and Adolescent Trauma Screen - Caregiver Report (CATS-P)
* Have a laptop, tablet, or smartphone with internet access

Caregivers:

* English-speaking
* Adult (≥18 years old)
* Caregivers of a youth who meets eligibility criteria
* Have internet and smartphone access.

Exclusion Criteria:

Youth with self- or caregiver-reported:

* Active psychotic symptoms (e.g., hallucinations, delusions)
* Significant cognitive disability, developmental delays, or pervasive developmental disorder.
Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult patients with ALS, FTD, or mixed ALS/FTD phenotype with a documented mutation in the C9orf72 gene. To participate in the study, patients must have successfully completed Phase 1b/2a WVE-004-001 study.


Eligibility Criteria:
Inclusion Criteria:

* Patient successfully completed the Phase 1b/2a study with WVE-004, WVE-004-001.

Exclusion Criteria:

* Patient has a clinically significant medical finding on the physical examination other than C9orf72-associated ALS or FTD that, in the judgment of the Investigator or Sponsor, will make the patient unsuitable for participation in and/or completion of the trial procedures.
* Patient received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Patient received an investigational oligonucleotide within the past 6 months or 5 half-lives of the drug, whichever is longer.
Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease

The goal of this interventional study is to evaluate the impact of a specific diet (low salt, limited caffeine, high potassium, low phosphate, limited protein, limited carbohydrate intake, adequate water intake) on changes in serum and urinary biomarkers, total kidney volume (TKV), and cyst progression in subjects with autosomal dominant polycystic kidney disease (ADPKD).

Researchers will compare the results of subjects in the study diet (interventional) arm to the results of subjects in the regular diet (control) arm.

15 subjects will be enrolled in each dietary arm for a total of 30 subjects. All subjects will follow the study diet for one week, after which serum and urinary biomarkers will be measured. A baseline evaluation, including genetic testing, MRI, Mayo Clinic Imaging Classification and 10-question survey will also be conducted. After Week 1 of the study, subjects will be assigned to the intervention or control arm. Subjects will have six follow-up visits at months 1, 2, 3, 6, 9 and 12 to assess adherence to diet. Serum and urinary biomarkers will be repeated at each visit. MRI will be repeated at Month 12.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ADPKD
* Genetic testing confirmation of PKD1 or PKD2
* eGFR \>30mL/1.73m2
* Willingness to adhere to a preconditioning diet for 1 week and ability to complete the study
* Mayo Clinic Imaging Classification (MCIC): 1C, 1D, 1E

Exclusion Criteria:

* History of dietary non-adherence
* Subjects on Tolvaptan
* Comorbidities that could interfere with participation (Diabetes, Heart Failure (EF\<30%) Advanced Chronic Kidney Disease (CKD) Stage 4 and higher)
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation

This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.

We wish to test the following hypotheses:

1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.
2. Vipassana meditation improves the psychological profile in patients with CHF. In this study, subjects meeting the inclusion and exclusion criteria will be recruited into the study after obtaining informed consent. The subjects will then be randomized into either an experimental group ( Meditation) or into a control group (usual care).

This is a single center, investigator-initiated, randomized, controlled trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators and cardiac resynchronization devices. The former are used to protect patients against cardiac fibrillation and the latter for synchronizing the contractions of the two ventricles.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 85
* All patients with NYHA class II to III congestive heart failure symptoms from ischemic and non-ischemic etiology who received a defibrillator at least 3 months prior to enrollment.
* All patients with NYHA class III and IV symptoms, QRS complex of the ECG more than 120 ms, who received device for cardiac resynchronization at least 3 months prior to enrollment. These devices are placed when the two ventricles beat at slightly different times. These devices also have the capacity to record arrhythmias as the defibrillators.

Exclusion Criteria:

* Patients with life expectancy less than 6 months from non-cardiac causes
* Pregnant women
* Smokers
* History of major psychosis.
* Significant chronic liver, renal and pulmonary disease
* Active alcohol and drug abuse
Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years

Main objective :

Evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16

Hypothesis :

Practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer

Medical process are leading to an increase in the survival of children/adolescents undergoing treatment for blood cancer. Caregivers need to focus on optimizing these patients' quality of life during and after the disease. Sleep is essential to their development. Sleep disorders are symptoms reported by patients. They have a negative impact on their quality of life. Adapted physical activity sessions are offered in pediatric oncology departments, but sedentary behavior persists. The hypothesis is that the daily practice of adapted physical activity will improve sleep in patients treated for blood cancer.

This is a randomized, cross-over, open-label, two-armed parallel, unique center therapeutic trial comparing the effect of practice adapted physical activity only once during four days (conventional strategy) versus practice adapted physical activity each day during four days (experimental strategy) on the sleep of the children with blood cancer from 5 to 16 at the hospital in Clermont-Ferrand and at home.

The study will last four weeks with a wash-out week after 2 weeks. The outcomes are described later. The nurse informs and obtains the consent of the child and his parents. After statistical analysis of these two arms, it will be possible to determine the value of practice daily adapted physical activity on the sleep of children with blood cancer from 5 to 16 at the hospital and at home.

Eligibility Criteria:
Inclusion Criteria:

* Children from 5 to 16 with haematological cancer undergoing treatment
* Subjects and their parents who were informed about the study and gave informed consent.
* Enrollment in the Social Security system

Exclusion Criteria:

* Children on high-dose corticosteroids
* Children under anxiolytic treatment
* Children with sleep disorders (sleep apnea)
* Children taking melatonin or sleeping pills
* Contraindication to adapted physical activity
* Refusal to participate on the part of the participant or his/her parents
* Holders of parental authority under curatorship, guardianship, safeguard of justice
* Pregnant or breast-feeding teenagers