cyrilzakka/clinical-trials huggingface dataset:
Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)

The main objective of this study is to develop and validate a visio-behavioral scale of visual abilities for subjects with profound multiple intellectual disabilities.

The secondary objectives of the study are:

* to validate the structure of the scale.
* to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
* to evaluate the feasibility of visio-behavioral scale.
* to evaluate the sensitivity to change.
* to study the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
* to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.

This study includes 3 phases:

* Elaboration of a list of behavioral items by a group of multi-disciplinary expertise (physicians, nurses, caregivers, ophthalmologies, orthoptists) based on their clinical experiences.
* Development of the scale based on the sample obtained by a prospective multicenter research trial.
* Validation of the sample obtained by a prospective transversal multicenter study.

This study will be performed in 5 centers in France. The enrollment of patients planned for 24 months targeting 310 patients. The duration of follow-up of the study for each patient will be varied according to the group of patients, il will be 1 day for group 1, 2 weeks for group 2, or 6 months for group 3.

Eligibility Criteria:
Inclusion Criteria:

* Causal brain injury occurred before the age of 3 years.
* Severe or deep mental retardation as defined by DSM IV.
* Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders.
* Score of Gross Motor Function Classification System \[Palisano 1997\] is III, IV or V.
* Score of Functional Independence Measure \< 55.
* Subject aged ≥3 years (because the visio-behavioral scale is not adapted for children younger than 3 years).
* Beneficiary of a social protection.
* Written consent signed by guardian or legal representative, or parents in case of a minor subject.

Exclusion Criteria:

* Acute intercurrent pathology precluding examinations.
* Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.
* Angle closure glaucoma suspect patient.
* Patient with severe hypertension.
* Short life expectancy.
MOMS Hubs- CT Dept of Social Services Block Grant

The MOMS Partnership aims to create "MOMS Zones" in New Haven neighborhoods where the hardest to reach families live. These "MOMS Zones" will have two unique features: (1) a MOMS "Hub" to deliver centralized mental health and family economic success services to the hardest to reach families living in New Haven's most impoverished neighborhoods, as measured by actual socio-economic status as well as by access to resources; (2) a neighborhood workforce of Community Mental Health Ambassadors (CMHAs--mothers who themselves live in New Haven). The MOMS Workforce Program and MOMS Mental Health Program will be offered at all three Hubs.

The MOMs workforce program will involve teaching, coaching, and supportive services for participants as they navigate their journeys to sustainable employment that pays a family-supporting wage. Participants will be guided through an individualized progression of services designed to increase their employability, to increase their ability to earn higher incomes in career-track employment, and to improve their chances of retaining jobs and advancing in them.

The MOMS Mental Health program centers around a manualized Stress Management Course 8-class group treatment, delivered once per week. The course was adapted from "The Mother and Child Course" by Munoz and Le (2011) for the population of New Haven mothers who are served by the MOMS Partnership.

Eligibility Criteria:
Inclusion criteria are as follows:

* Participant is a woman raising a child or adolescent under 18 years of age. The child/adolescent may be her biological offspring or in her custody due to adoption or foster care. Care arrangements may be legally sanctioned or informal, as is common in New Haven families. Thus, the eligible participant may be a sister, aunt, grandmother, or other female responsible for the daily care of children.
* Participant currently resides within the city limits of New Haven, CT.
* Participant resided within County of New Haven, CT on October 29, 2012.
* Participant's income is at or below 325% of the Federal poverty income.
* Participant is a U.S. citizen.
* Participant's score on CES-D \> 16.

Exclusion criteria are as follows:

* Signs or symptoms of active psychosis or active suicidality will be a basis for exclusion in the study.
* Lack of proficiency in English.
Autologous Human Schwann Cells in Peripheral Nerve Repair

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
* Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
* Between the ages of 18 and 65 years at last birthday;

Exclusion Criteria:

* Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
* Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
* Persons with severe peripheral nerve injury gap length \> 10 cm in length;
* Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
* Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
* Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
* History of active substance abuse;
* Persons allergic to gentamicin;
* Persons who test positive for HIV or Hepatitis B or C virus;
An Interview Study With Injured Workers Concerning Their Experiences With the Social Systems and Psychosocial Health Consequences

Objective: In addition to physical discomforts, work-related injuries and illnesses often result in various forms of hardships, including economic hardship, labor conflicts and legal disputes. The physical and psychological health conditions are likely to be worsen when the social supporting systems are not well functioning. In this study, the investigators aim to conduct in-depth interviews with injured workers to study their experiences with the social systems, including employment protection system, workers' compensation system, health care system and other social welfare systems, and to explore how the systems may affect workers' physical and psychological health.

Methods: Face-to-face interviews will be conducted with a semi-structured questionnaire. Subjects who had ever experienced work-related injuries or diseases (including muscular skeletal disorders and work-related cardiovascular or cerebrovascular diseases) over the past 3 years are invited. The investigators anticipate to recruit a total of 60\~100 cases, whom will be recruited through the assistance of occupational physicians, occupational health centers, labor groups and unions. Interview time will be limited to 1 hour.

Anticipated results and contribution: Findings of this study will help to advance our knowledge concerning the functions of current social systems and the hardships of workers who suffer from work-related injuries and diseases. Suggestions will be provided for the improvements of current systems.

Keywords: work-related injury, occupational disease, workers' compensation, psychological, policy.


Eligibility Criteria:
Cohort Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma

The purpose of this study is to determine if a simple blood test can help in disease management, particularly asthma. This will be researched by looking at certain features of the blood and to compare asthmatics without allergies to those that have allergy-induced asthma.

A total of 20 participants (men or women) between the ages of 18-50 years with asthma will be enrolled. Participants will remain on their usual asthma treatments as prescribed by their usual asthma care provider. Current asthma treatments and any changes will be recorded at baseline and each subsequent visit. The primary outcome measures are correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control. Secondary outcomes include correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18 and 50.
* have diagnosed asthma.
* must have less "one pack per day for 10 years" smoking history

Exclusion Criteria:

* You have had a fever of 100.4º within 24 hours of Visit 2.
* You are enrolled in another interventional research trial.
* Have other major chronic illnesses that would interfere with participation in the study.
* You are pregnant.
* You chronically use oral corticosteroids.
* You have taken anti-coagulants, insulin, and any investigative drugs within 2 months.
* You have the inability or unwillingness to provide consent.
* Inability to perform aerobic exercise.
* Inability to perform baseline measurements.
* Less than 80% completion of screening period diaries.
* Inability to be contacted by telephone.
* Intention to move out of the area within 6 months.
Market to MyPlate: Investigating the Impact of a Nutrition and Hands-On Cooking Intervention

Recent peer-reviewed research indicates that low-income families are at higher risk for unhealthy dietary intake and associated poor health outcomes. Interventions that teach individuals from low-income families about cooking and healthy eating are warranted to improve overall dietary behaviors. The purpose of this study is to evaluate the impact of the Market to MyPlate Program on participants' reported cooking, shopping, and dietary behaviors using a cluster randomized trial design, where class cohorts are randomly assigned to education with produce allocations, education only, or control conditions. A secondary aim is to collect program feedback and better understand facilitators and barriers to farmer's market use and food waste reduction.


Eligibility Criteria:
Inclusion Criteria:

* Recruited from SNAP-Ed eligible site (site where the majority of participants are eligible for US food assistance programs)
* Must be 18 years or older, or parent of any age with child(ren) to participate in data collection (all ages including children could participate in intervention)

Exclusion Criteria:

• Participated in an Extension nutrition education program in the last year
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study

This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* 18 years or older
* Meet specific requirements for diabetic retinopathy
* Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
* Hemoglobin A1c (HbA1C) ≤13.0%

Exclusion Criteria:

* History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
* Investigators, site personnel directly affiliated with the study and their families
* Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
* Presence of medical disorder, cancer, or elevated laboratory measurements that could represent a safety risk during the study
* Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control
Effect of Apples on cardioVascular Risk And Gut Health

There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Epidemiological studies have linked frequent apple consumption with several health benefits including a reduced risk of cardiovascular disease. Apples are an important source of polyphenols and fiber and their beneficial effects could be attributed to this content; however, their impact on our health is not clear. Although, there are some studies that have reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies have explored the impact on vascular function and gut microbiota. The objective of the current study is to assess whether a regular apple consumption, reduces total cholesterol levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic subjects compared with a control, sugar matched commercial clear apple juice squash.


Eligibility Criteria:
Inclusion Criteria:

* Mildly hypercholesterolemic: TC\>5.2 and \<7.9 mmol/L
* BMI: 20-35
* Age: 23-69
* Normal liver and kidney function

Exclusion Criteria:

* Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation.
* Vegetarians.
* Smoking.
* History of alcohol misuse.
* History of food allergy (e.g. apples, sulphites).
* Taking antibiotics for the previous 3 months.
* Taking phytochemical, antioxidant, fish oil supplements, or prebiotic/probiotic preparations unless willing to stop for the study period and after a 4 week wash out period (8 weeks for fish oil).
* Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence).
* Medical history of cardiovascular disease including coronary heart disease (angina and heart attack) and stroke (in the past 12 months).
* Family history of cardiovascular disease (their father or brother was under 55 or their mother or sister was under 65 when they were diagnosed with cardiovascular disease).
* Diabetes mellitus.
* Kidney, liver, pancreas or gastrointestinal diseases.
* Hematologic disorders (i.e. anaemia; men:haemoglobin\<13.8g/dl (8.56mmol/L) and women\<12.1 g/dl (5.51mmol/L)).
* Planning a weight reducing regime.
* Parallel participation in another dietary intervention study.
ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.

Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.

While PARP inhibitors have demonstrated consistent robust clinical activity in patients with relapsed ovarian cancer associated with HRD, prospective studies evaluating efficacy and safety of PARPi versus standard of care chemotherapy have been limited. The primary purpose of this Phase 3 study is to compare the efficacy and safety of rucaparib versus chemotherapy as treatment for relapsed ovarian cancer in patients with a deleterious BRCA1/2 mutation in their tumor.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age at the time the informed consent form is signed
* Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
* Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation
* Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses

Exclusion Criteria:

* History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed \>6 months prior and/or bone marrow transplant \>2 years prior to first dose of rucaparib).
* Prior treatment with any PARP inhibitor
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
* Women who are pregnant or breast feeding
* Hospitalization for bowel obstruction within 3 months prior to enrollment
Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation

The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses.

The project is designed inspired by The Complex Intervention Framework (MRC-Guidelines) combined with a patient and family participatory design. The project will consist of three sub-studies. The first study is a co-creation development of a model for the cardiac telerehabilitation intervention. The second study is a quasi-experimental study with a quantitative comparison of the group receiving the cardiac telerehabilitation intervention and control group. The third study will be a descriptive qualitative study which aim to investigate patient's experience with CTR using participant observation and individual interview or dyadic interview.

Eligibility Criteria:
Inclusion Criteria:

* Patients and their family members affiliated with the Department of Cardiology at Amager and Hvidovre Hospital and attending cardiac rehabilitation.
* Patients diagnosed with ischemic heart disease, heart failure, persistent atrial fibrillation, and cardiac valve surgery.

Exclusion Criteria:

* Patients with substantial language barriers and limited cognitive function.
* Patients who can't use a smart phone, tablet, or computer.
Clinical Evaluation of MyoCare in Europe (CEME)

A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism \< 1.50D, and anisometropia \< 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-13 years
* Caucasian ethnicity
* Monocular/binocular decimal visual acuity with correction ≥ 1.00
* Spherical equivalent between -0.75D and -5.00D
* Astigmatism \< 1.50D
* Anisometropia \< 1.00D
* Evolution of at least -0.50D in one year

Exclusion Criteria:

* Presence of ocular pathology or a history of ocular and systemic abnormalities
* Strabismus or binocular vision problems
* History of eye surgery
* Having previously used some method to control myopia.
* Having contraindications for the application of drugs for cycloplegia/corneal anesthesia
Impact of an Intervention Education Program on the Knowledge, Attitudes, and Practices of Dietitians

This study aims to develop, implement, and evaluate an educational program-based intervention on the knowledge, attitude, and practice toward renal nutrition among dietitians working with chronic kidney disease (CKD) patients in public hospitals in Saudi Arabia. The study hypothesizes that there will be a significant improvement in the knowledge, attitude, and practice of renal nutrition among the dietitians in the intervention group compared to the control group after the implementation of the educational program. The findings will contribute to enhancing the ability of dietitians to provide effective nutritional care and support for CKD patients in Saudi Arabia.

A cluster randomized controlled trial will be conducted to evaluate the effectiveness of the intervention on the level of knowledge, attitude, and practice in renal nutrition competencies among the dietitians. A total of 100 participants (50 participants for each group) will be select using simple random sampling.

The education intervention program will be developed based on the literature review of the guidelines for the nutritional management of CKD by looking into all evidence-based practice guidelines of renal medical nutrition therapy. The education intervention will include five weeks of in-person education sessions. The education intervention program will cover five lessons including nutrition assessment for CKD, malnutrition, macro- and micronutrients deficiencies in CKD, nutrition intervention and counselling skills. The education program will be delivered through lectures, workshops, brainstorming and case studies using materials such as PowerPoints, videos, cards, posters, booklets and activities. The program will be offered online via Zoom software, and the learners will have the materials to review at home. The program will be provided in close collaboration between the researcher and the hospital's nutrition department.

Data will be collected from four selected public hospitals in Jazan city, Saudi Arabia, by direct interview of the dietitians in the hospitals to determine the competency assessment on knowledge, attitude, and practice of renal nutrition. All respondents in the hospitals will be evaluated before the start of the program (baseline evaluation), after the final intervention session (post-intervention evaluation), and three months after intervention (three-month follow-up after intervention). Data will be analyzed by using the software Statistical Package for Social Sciences (SPSS) version 26.

Eligibility Criteria:
Inclusion Criteria:

* Dietitians who worked with chronic kidney disease patients.
* Dietitians who registered in Saudi Commission for Health Specialties.
* Completed at least one-year experience in their job.
* Dietitians who agree to participate in the study.
* Dietitians who are available at the time of data collection.

Exclusion Criteria:

* Medical doctor dietitians.
* Internship and student.
* Dietitians under one-year experience.