cyrilzakka/clinical-trials huggingface dataset:
Impact of ILM Peeling in RRD/ I-Peel

Retinal detachment is associated with a substantial risk of re-detachment in 10-20% and to the formation of secondary epiretinal membranes in up to 15%. Relevant postoperative vision loss is encountered in many instances, primarily in consequence of macular involvement, but also secondarily due to postoperative complications, namely the formation of an epiretinal membrane and proliferative vitreoretinopathy. These mechanical reasons of influence can potentially be prevented by ILM peeling during reattachment surgery. This, however, is not a generally accepted standard of care during primary routine vitrectomy.

Two groups suffering from primary retinal detachment will be compared: the first group will receive standard re-attachment vitrectomy surgery, whereas the second group will receive an identical vitrectomy surgery, but with additional ILM peeling. In this study, the investigators wish to assess the influence of ILM peeling on visual outcomes and postoperative complications over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* primary rhegmatogenous retinal detachment
* of legal age (18 years or older)
* in case of bilateral retinal detachment, only the first-affected eye will be included

Exclusion Criteria:

* pre-existing functional and morphological changes to the macula, hindering visual recovery (amblyopia, trauma, macular degeneration)
* advanced retinal detachment with PVR stage C2 or more
* eyes pre-operated within six months prior to the development of RD
* state after any vitreoretinal surgery
* state after complicated cataract surgery, including aphakia and anterior chamber lens implantation
* patients with increased risk profiles
* myopia magna (≥7 diopters)
* advanced diabetic retinopathy
* any chronic ocular or systemic inflammatory disease
* any other proliferative systemic disease or condition associated with impaired wound healing
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention

The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.

This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.

The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.

This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.

The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.

The Specific Aims are:

Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.

Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.

Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.

Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.

Exclusion Criteria:

* Has an inability or unwillingness to give informed consent or assent
* Is a prisoner

Exclusion (child only)

* The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
Autonomic Assessment in Patients With Restless Legs Syndrome

Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. Although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. The objective of the study is to evaluate autonomic functions and determine possible associations between autonomic dysfunction with clinical factors in patients with RLS.

Restless legs syndrome (RLS) also known as Willis- Ekbom disease, is a common sensorimotor, sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs (or less commonly the arms) during inactivity or resting state.

Although, the clinical importance of autonomic involvement in patients with restless legs syndrome (RLS) remains incompletely understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction.

Previous reports have described autonomic impairment including changes in nocturnal blood pressure and heart rate variability (HRV), gastrointestinal, urinary and sexual dysfunction in patients with RLS. Despite many studies about electrophysiological autonomic changes in RLS, number of studies exploring autonomic functions by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) are limited.

In this study, the investigators plan to compare the presence of autonomic symptoms by using Scales for Outcomes in Parkinson's disease-Autonomic (SCOPA-AUT) questionnaire in drug- naive RLS patients to healthy controls. In addition, the investigators aim to evaluate possible associations between autonomic dysfunction with clinical factors in patients with RLS.

Eligibility Criteria:
Inclusion Criteria:

For the patient group:

* age \>18, \<65
* newly diagnosed, drug naive patients with primary restless legs syndrome

For the control group:

* age \>18, \<65
* participants without chronic systemic disorder

Exclusion Criteria:

* previous diagnosis of primary RLS
* subjects with secondary RLS
* concomitant use of drugs that could interfere with autonomic nervous system
* individuals with a known acute/chronic medical disease
* individuals with a minimental test score \< 25/30
* sleep disorders that could affect test performances
Metabolic Risk Following Gestational Diabetes Mellitus

Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.


Eligibility Criteria:
Inclusion Criteria:

* Women aged over 18years old
* Women with the criteria of GDM during pregnancy at 21-35 weeks of gestation (one situation):

  * After a 75g Oral Glucose Tolerance Test (OGTT - WHO criteria) with blood glucose (BG) values at T60≥180mg/dl and/or T120≥153mg/dl
  * An O. Sullivan test following a 100g oral glucose load with at least two pathological values (T60 ≥ 180mg/dl and/or T120 ≥ 155mg/dl and/or T180 ≥ 140mg/dl)
  * With a fasting BG value ≥92mg/dl
* Women with signed informed consent

Exclusion Criteria:

* Women aged less than 18years old
* Women with pregestational type 2 diabetes
* Women without signed informed consent
* Women who does not read and/or understand french language
* Women not affiliated to the health care system
* Women with recent infection (\<1month) and/or on steroids or anti-inflammatory drugs.
* Women with chronic diseases
* Women with a disable state
* Women with normal glucose tolerance
* Women already incorporated in another clinical study that could interfere with the present study
Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth

The primary aim of this study is to measure and explain the impact on long-term opioid use when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health system (A-CHESS).


Eligibility Criteria:
Inclusion Criteria:

1. are 18+ years old;
2. meet criteria for opioid use disorders of at least moderate severity (4 or 5 DSM-V criteria);
3. Are currently taking medication-assisted treatment (MAT) as part of their standard clinical care;
4. have no acute medical problem requiring immediate inpatient treatment;
5. have no history of psychotic disorders, though those with other co-morbid psychopathology (mood disorders, anxiety, other substance use disorders) will be eligible;
6. are willing to participate in a randomized clinical trial;
7. provide the name, verified telephone number, and address of at least 2 contacts willing to help locate the patient, if necessary, during follow-up;
8. are able to read and write in English;
9. are not pregnant;
10. are willing to share health-related data with primary care clinicians; and
11. are, at study intake, abstinent from opioids for at least 1 week and no longer than 2 months, except for medications used to treat the disorder (e.g., methadone).
Attenuated SOX as First-line Treatment in Elderly Patients With Relapsed or Metastatic Gastric Cancer

Stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the Korea. The elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. Systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. However, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. There is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. Therefore, this phase II trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of S-1 and oxaliplatin (attenuated SOX)in patients with elderly AGC

Treatment scheme

* S-1 60mg/m2/day (D1-14) Oxaliplatin: 85mg/m2 + 5DW 250mL MIV over 2-hours

Each cycle is repeated every 3 weeks

Response evaluation will be performed every 2 cycles

Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Age : more than 70 to 80 and ECOG PS 0-2
* Age : more than 65 to less than 70 and ECOG PS 2
* Histological or pathologically confirmed adenocarinoma
* Relapsed or metastatic adenocarcinoma of stomach
* No previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment
* At least more than one measurable lesion on RECIST criteria
* No radiation history for the target lesion
* An estimated life expectancy of more than 3 months
* Ability for adequate oral intake
* Adequate BM function: defined as WBC≥4000/μL, ANC ≥1500/μL, PLT≥100,000/μL.
* Adequate renal function: defined as Creatinine \<1.5mg/dL.
* Adequate hepatic function: defined as total bilirubin \< 2.0mg/dL, SGOT/SGPT \< normal x 3.
* Written informed consent

Exclusion Criteria:

* Symptomatic brain metastasis or meningeal metastasis.
* Double primary cancer
* Medical history of other cancer within 5 years
* G-I bleeding or intestinal obstruction (other condition that can't have the oral intake)
* Hypersensitivity to the 5-FU or oxaliplatin
* Active infectious disease that need to treat systemically
* Serious medical or psychologic condition: newly developed AMI ( within 6Ms)...
SmartMom: Teaching by Texting to Promote Health Behaviours in Pregnancy

The goal of this randomized clinical trial is to evaluate the effectiveness of SmartMom, a text messaging-based mobile health program for prenatal education. The main questions are to determine if healthy pregnant people receiving SmartMom messages that promote health behaviours in pregnancy versus messages that don't provoke behaviour change have improvement in:

1. knowledge about healthy pregnancy and birth
2. standardized measures of depression, anxiety, and fear of childbirth
3. adoption of positive health behaviours in pregnancy
4. maternal, fetal, and newborn outcomes

Participants in the intervention group will receive three evidence-based text messages per week, plus optional supplemental messages on topics relevant to them, throughout pregnancy.

The control group will receive general interest messages on pregnancy-related topics that are not promoting behaviour change.


Eligibility Criteria:
Inclusion Criteria:

* pregnant person
* at 15 weeks gestation or earlier
* singleton pregnancy
* can read and understand English at grade 8 level and comfortable completing online surveys
* live in Canada (excluding British Columbia where SmartMom has been piloted)

Exclusion Criteria:

* health conditions existing prior to pregnancy that require individualized care (e.g. hypertension, cardiac disease, diabetes)
* previously had a baby with the SmartMom program
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).

This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of BBB disruption using the ExAblate Model 4000 Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain. This study will be conducted at up to 8 sites in the United States and will enroll up to 30 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female between 50-85 years of age
2. Probable Alzheimer's Disease (AD)
3. If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
4. Able to communicate sensations during the ExAblate MRgFUS procedure
5. Ambulatory

Exclusion Criteria:

1. MRI Findings
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Significant cardiac disease or unstable hemodynamic status
4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer
5. History of a bleeding disorder
6. History of liver disease
7. Known cerebral or systemic vasculopathy
8. Significant depression and at potential risk of suicide
9. Any contraindications to MRI scanning
10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid
11. Untreated, uncontrolled sleep apnea
12. History of seizure disorder or epilepsy
13. Severely Impaired renal function
14. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
15. Chronic pulmonary disorders
16. Positive human immunodeficiency virus (HIV)
17. Known apolipoprotein E allele (ApoE4) homozygosity
The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men

Background: Protein intake is important for maintaining skeletal muscle mass. These proteins consist of a collection of small building blocks which are called amino acids. There are two types of amino acids that are needed to build muscle: essential amino acids (EAA) and non-essential amino acids (NEAA). EAAs cannot be made in the body and must be consumed through foods, while NEAAs can be made within the body. However, if NEAA are not consumed through foods, the process of making NEAA in the body costs the body energy. It is still unknown what the impact of a diet containing too few non-essential amino acids is for muscle building and the body's energy metabolism.

Objective: To determine if a diet lacking NEAA, with or without being replaced by additional EAA, influences muscle protein building and whole-body metabolism.

Study design: Randomized, parallel design, double-blind, 10-day dietary intervention study.

Study population: 45 healthy (BMI 22-30 kg/m2) young males (age: 18-35 y inclusive).

Hypothesis: It is hypothesized that a diet lacking NEAA, with or without being replaced by additional EAA, decreases muscle protein building in humans.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18 and 35 y inclusive
* BMI between 22 and 30 kg/m2
* Non-smoker
* Having given informed consent

Exclusion Criteria:

* Participating in a structured (progressive) exercise program
* Smoker
* Diagnosed GI tract disorders or diseases
* Diagnosed musculoskeletal disorders
* Diagnosed metabolic disorders (e.g. diabetes)
* Cardiovascular disease
* Hypertension (blood pressure above 140/90 mmHg)
* Donated blood 3 months prior to test day
* Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
* Chronic use of gastric acid suppressing medication
* Chronic use of anti-coagulants
* Any intolerance to foods included in the standardized diet intervention
* Any implants that would be a contra-indication for performing an MRI scan
Oncology Research Information Exchange Network in Improving Genetic Screening Rate in Patients With Cancer

This research trial studies how well Oncology Research Information Exchange Network (ORIEN) works in improving genetic screening rate in patients with cancer. Implementation of Progeny Genetic Pedigree and Family History Questionnaire software across all ORIEN member institutions may add value and utility for recognizing and caring for patients with an inherited susceptibility to cancer.

PRIMARY OBJECTIVES:

I. Measure the change in uptake of cancer genetic referrals and genetic testing in the ORIEN system of cancer centers implementing the Progeny Family History Questionnaire (FHQ).

SECONDARY OBJECTIVES:

I. Follow and estimate utilization of preventive health behaviors among Progeny FHQ users across all institutions.

II. Compare utilization of preventive health behavior between Progeny FHQ risk identification and genetic testing.

OUTLINE:

Patients take Progeny Genetic Pedigree and Family History Questionnaire. Results are reviewed by the site specific research coordinator and/or genetic counselor to assess whether a patient fulfills criteria for referral to the site specific cancer genetics clinic for further evaluation.

After completion of study, patients are followed up at 6 months after disclosure of genetic testing results.

Eligibility Criteria:
Inclusion Criteria:

* Limited to those patients who are consented to the Total Cancer Care Protocol (TCCP) protocol
* Able to understand and sign the TCCP informed consent, California subject?s bill of rights, Health Insurance Portability and Accountability Act (HIPAA), and research authorization form directly or through an authorized representative; the informed consent, subject?s bill of rights, HIPAA, and research authorization will be available in both English and Spanish languages

Exclusion Criteria:

* Individuals who are not registered as patients for outpatient or inpatient care to the TCCP protocol
* Individuals who are unable to understand or sign the TCCP informed consent, subject?s bill of rights, HIPAA, and research authorization in either English or Spanish
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3

Exclusion Criteria:

* Active or anticipated withdrawal of life support within 48 hours
* Open chest or open abdomen
* Current use of Extracorporeal Membrane Oxygenation (ECMO)