cyrilzakka/clinical-trials huggingface dataset:
PLANTS Pilot Trial

This pilot cluster-randomized controlled trial will evaluate the PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety) course among high school staff. The primary hypotheses are that the PLANTS course will have high acceptability, usability, appropriateness, and feasibility as reported by high school staff.

The intervention being studied, PLANTS, is an online-delivered training program, including asynchronous and synchronous activities targeting high school staff. This intervention is informed by the Information-Motivation-Behavior theory to target high school staffs' skills, self-efficacy, knowledge, and outcome expectations. Members of the study population as well as collaborators invested in Sexual and Gender Minority Youth (SGMY) well-being provided valuable feedback on PLANTS throughout its development. Comparison schools will receive the email-based control intervention, E-learning to Maximize Academic Inclusion of LGBTQ+ Students (EMAILS). Staff will receive periodic emails with publicly available resources on similar topics to those of PLANTS.

Regarding the intervention's targeted behavioral outcomes, upon completion of the PLANTS program, high school staff will: provide interpersonal support and affirmation to SGMY; provide educational resources that are inclusive of SGMY; provide safe spaces for SGMY; promote acceptance of SGMY among cisgender heterosexual youth; prevent and reduce bullying, cyberbullying, and harassment of SGMY; evaluate and advocate for SGMY inclusivity and protections in school policies; and maintain the confidentiality of SGMY. By having high school staff achieve these behavioral outcomes, the investigators hypothesize that SGMY will experience less risk factors (e.g., bullying victimization) and more protective factors (e.g., school-based adult support), which will in turn reduce SGMY's substance use and mental health problems.

The primary aim of this clinical trial is to rigorously test the acceptability, usability, appropriateness, and feasibility of the PLANTS intervention using a 2-armed cluster-randomized controlled trial. The investigators will also examine the efficacy of intervention in improving high school staff outcomes as well as implementation and safety outcomes related to the intervention and trial. Results from this pilot trial will provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the ultimate health outcome of SGMY alcohol use.

Eligibility Criteria:
Inclusion Criteria:

* Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts
* Age 18 years old or older
* Consents to participate

Exclusion Criteria:

• Does not interact with high school students at work
Oral Immunotherapy in Young Children With Food Allergy

The goal of this clinical trial is to learn about oral immunotherapy in food allergic children \< 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.

Primary objective: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care? Secondary objective: What is the effect of early low-dose oral immunotherapy in children under the age of 30 months with an established food allergy on (allergy specific) quality of life of parents and children compared to routine care? Study design: randomized controlled superiority trial Study population: Children between 9 and 30 months old with an IgE-mediated food allergy to peanut, tree nuts, cow's milk and/or hen's egg as proven by an oral food challenge. Intervention: 1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared to strict avoidance in the control group.

Main study parameters/endpoints: Long-term tolerance as assessed by an exit oral food challenge at 4 weeks after discontinuation of the oral immunotherapy, combined with uncomplicated consumption of a full dose of the specific food at 6 months after discontinuation of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* An IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/or hen's egg as proven by sensitization to the specific allergen (sIgE \> 0.35kU/l) and a positive oral food challenge.
* The fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s).

Exclusion Criteria:

* (Suspected) eosinophilic oesophagitis
* Uncontrolled asthma/ viral wheeze.
* The inability of parents to follow instructions, recognize allergic reactions or administer emergency medication.
* Participation in any other intervention study at the time of the OIT study, with the exception of studies on guided early introduction of highly allergenic foods.
Selfcare Management Intervention in Heart Failure

A novel tool for self-care enhancement for heart failure (HF) patients has been developed. In this randomized controlled trial, patients will be randomized 1:1 to either receive the home-based tool (OPTILOGG) or standard care. The intervention will go on for 8 months, and outcomes are self-care, cardiovascular events (including emergency visits, admissions, number of in-hospital days).

Patients will be recruited using continuous sampling, and will be approached either in connection with being discharged after a heart failure (HF) related event or upon visiting an out-patient HF clinic if the patient has been admitted for HF at least once the last year.

After written consent has been given, demographical data will be noted, and the patient will complete forms: the European Heart Failure Self-care Behaviour scale 9-item questionnaire (EHFScB-9) and self-assessment of symtoms (NYHAclass). Expected time for this is 20 minutes. The baseline demographical data will include age, gender, ejection-fraction, New York Heart Association (NYHA)-class, blood pressure, heart rate, HF aetiology, and other routine tests for HF visits as outlined in the European guidelines for HF treatment.

After the patient has filled out the forms, the patient will be randomized to the control group (CG) meaning standard care, or the intervention group (IG). Patients allocated to the IG will be equipped with the home based self-care enhancement tool OPTILOGG. OPTILOGG assists the patient with symptom monitoring and flexible diuretics regimen, as well as education about living with HF. It consists of a specialized tablet computer wirelessly connected to a weight scale. OPTILOGG is CE-marked. The intervention will be deployed for eight months. After the eight months, the patients will be called to a follow-up visit. During the visit all data that was collected at baseline/recruitment will be collected again. All cardiovascular events for each patient will be retrieved, for the eight months during which the intervention was deployed, but also for the following 12 months. These events include hospital admissions, ER-visits and number of in-hospital days.

Based off of previous findings in the literature, target for enrollment was set at 70 + 70 patients, to achieve statistical significance with 80% power.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed heart failure, International classification of diseases (ICD): I50, existing or de-novo, in NYHA-class II-IV
* Admission for HF within the last 12 months
* Filled out consent form
* Expected to be able to use the tool, if allocated to the intervention group

Exclusion Criteria:

* Decline to participate
* More than mild cognitive impairment
* Expectancy of life \< 8 months
* For other reasons deemed inappropriate to be enrolled, e.g. participating in another study affecting standard care
The Role of After-school Exercise Services in Promoting Myopia and Physical and Mental Health in Children

This project is a prospective cohort study to evaluate the impact of after-school extended physical education services on the visual health, physical health indicators, and mental health of children and adolescents participating in these services over a one-year period. The study collected data on the participation rate, duration, activity content, and organisational form of the after-school extended hours service through a questionnaire; the demographic characteristics, sleeping habits, and dietary habits of the participants through a self-administered questionnaire on the multidisease behaviour of children and adolescents; the intensity of the activities of the students who participated in the after-school extended hours service was investigated through an accelerometer and a physical activity questionnaire; and data on students\&#39; visual acuity, body mass index, and mental health status were collected through a medical check-up. Students' visual acuity data, body mass index, maximum oxygen uptake, and other indicators of physical health and mental health were collected through physical examination, and data on changes in one year were collected through half-yearly/follow-up visits to establish a cohort to evaluate the effects of after-school extended hours services on students' myopia rates, physical health and mental health levels by different types, intensity and duration of exercise.

Students in grades 1-6 of several primary schools were selected as the study subjects. According to the baseline survey, the study subjects were divided into after-school extended physical education service group and non-after-school extended physical education service group, and their behavioural habits as well as the contents of the after-school extended physical education service, visual acuity, BMI, cardiorespiratory fitness, spinal curvature abnormality, and mental health were investigated by means of questionnaires and other tools, so as to analyse the relationship between after-school extended physical education service and the physical and mental health of the students.

Eligibility Criteria:
Inclusion Criteria:

* ① Those who voluntarily participate in the after-school extended hours service;

  * Those who voluntarily participate in this study and sign the informed consent; ③ Basic reading, writing and comprehension skills to understand the questionnaire and be able to answer it;

Exclusion Criteria:

* ① Unfit to participate in sports activities for health or physical reasons; ② Suffering from glaucoma, glaucoma and other diseases.

  * Those who suffer from glaucoma, strabismus, refractive error and other eye diseases that affect vision;
Oral Therapies in Oncology: Cognitive Function and Compliance

The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis "Living during and after cancer" highlighted in the Cancer Plan


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years,
* Patients treated with a first prescription of exclusive oral therapy (chemotherapy and/or targeted therapy) as part of a cancer,
* Patients who begin treatment with ZYTIGA ® (abiraterone acetate) are incluables,
* Patients with asymptomatic brain metastases are incluables,
* Lack of personality disorders and psychiatric illness scalable,
* Knowledge of spoken and written French,
* Having signed the informed consent of study participation.

Exclusion Criteria:

* Pathology psychiatric
* Refusal to participate,
* Patient unable to respond to cognitive tests, - Documented use of drugs,
* Heavy drinking, - Cancer primitive central nervous system, - Participation in a clinical trial.
The Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation

Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery.


Eligibility Criteria:
Inclusion Criteria:

* to be the parent of a child aged 12 to 36 months old having undergone neonatal surgery following oesophageal Atresia, congenital diaphragmatic hernia or short bowel syndrome diagnosis.
* to have lived with the child during his first year of life
* to have social security coverage
* to speak french

Exclusion Criteria:

* to be a person not having the capacity to consent or enjoying social protection (tutorship or guardianship);
* to be a person deprived of liberty;
* to be a minor;
* to be pregnant.
A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers

This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety/tolerability and PK data from the Western and Japanese populations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India

According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic disease, is the second leading cause of disability worldwide. Across 81 countries, approximately 120 million people are infected with the disease, and of those infected, an estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis, elephantiasis and lymphedema, cause long-term suffering in patients who are then often embarrassed or even rejected from their communities. Because of the disease's debilitating physical and social effects on patients, this study will explore the intersection of disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group in India will be used to gauge HRQol. In addition, the demographic and disease-specific factors associated with HRQoL and disability in filarial lymphedema subjects will be identified.


Eligibility Criteria:
Case Inclusion Criteria

* Subjects with a clinical diagnosis of lymphatic filariasis
* Subjects over the age of 18 and able to give consent

Case Exclusion Criteria

* Subjects on active treatment for lymphatic filariasis
* Subjects who are under the age of 18 or unable to give informed consent

Control Inclusion Criteria

* Subjects without a clinical diagnosis of lymphatic filariasis
* Subjects over the age of 18 and able to give consent

Control Exclusion Criteria

* Subjects without a clinical diagnosis of lymphatic filariasis
* Subjects who are under the age of 18 or unable to give informed consent
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma

The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a nebulizer, the VR647 Inhalation System. Secondary objectives include the evaluation of the safety and tolerability of VR647 Inhalation Suspension administered using the VR647 Inhalation System.

The study consists of four visits; a screening visit (Visit 1), two dosing days (Visits 2 and 3) and a follow-up visit (Visit 4). On each dosing day a single dose of treatment will be administered. Treatment allocation at Visits 2 and 3 is determined by a balanced incomplete block design.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or pre-menarchal female subjects.
* Aged 4 to 8 years, inclusive.
* Diagnosis of wheezing, reactive airway disease or mild asthma confirmed by a physician at least 3 months prior to screening.
* Wheezing, reactive airway disease or mild asthma controlled by intermittent or regular non-steroidal medications commonly used for asthma, such as short-acting β2-agonists (SABAs) or leukotriene receptor antagonists (LTRAs), for a minimum of 28 days prior to the Screening Visit.
* Body weight ≥15 kg.
* Subject is able to demonstrate the ability to use the VR647 Inhalation System and the conventional jet nebulizer effectively during training.

Key Exclusion Criteria:

* Clinically relevant abnormality or medical condition (other than wheezing, reactive airway disease or mild asthma) identified at the screening assessment that, in the opinion of the investigator, could interfere with the objectives of the trial or the safety of the subject. The sponsor's medical officer should be consulted in case of any doubt.
* Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episodes.
* Subjects currently using long-acting β2-agonists.
* Use of the following prescription medications within 28 days prior to the first treatment day: corticosteroids by any route and drugs that inhibit cytochrome P450 3A4.
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)

This study will collect biospecimens (including blood, tissue, and stool samples) and health information to create a database-a type of collection of information-for better understanding young onset colorectal cancer (YOCRC). The study will include both people with YOCRC and healthy people.


Eligibility Criteria:
Inclusion Criteria:

CRC Cohort:

* 18-49 years old
* Histological or cytological diagnosis of colorectal adenocarcinoma
* Planned CRC resection biopsy, or colonoscopy ,including surveillance colonoscopies and/or have already undergone prior surgical resection, with tissue, including normal colonic mucosae distant from the malignant tumor (only patients providing tissue sample)
* Enrollment in IRB# 20-315, Young Onset Gastrointestinal Cancer Prospective Registry (Andrea Cercek, PI)

Healthy Control Cohort:

* 18-49 years old at time of diagnosis
* Scheduled for standard-of-care colonoscopy at MSK
* Underwent surgical resection of a traumatic injury to the colon at Shaare Zedek Medical Center (SZMC)

Exclusion Criteria:

* CRC Cohort:
* Antibiotic use within 6 months of collection of stool for gut microbiome analysis s (only patients providing stool sample)
* Known inherited cancer susceptibility gene
* History of inflammatory bowel disease

Healthy Control Cohort:

* Antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample)
* History of or prior treatment for cancer ≤ 5 years prior to registration. Exceptions include non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.
* Colonoscopy for indications of IBD, anemia and/or genetic predisposition (only patients providing tissue sample).
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
* Eighteen (18) years of age or older
* New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
* Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
* Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
* The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
* Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.

Exclusion Criteria:

* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
* Mitral valve area (MVA) \< 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Patient is under guardianship