cyrilzakka/clinical-trials huggingface dataset:
Gut Microbial Metabolites of Apple Polyphenols

The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate how differences in gut bacteria across individuals influence metabolism of polyphenols from foods, which may influence health benefits that people receive from different foods.

This is a randomized, cross-over controlled feeding trial. Thirty healthy adult volunteers will be selected to participate on the basis of urinary screening results measuring a gut bacterial metabolite that is produced following consumption of a soy food: 15 O-desmethylangolensin (ODMA) producers and 15 age and gender-matched ODMA non-producers will be included. Participants will be assigned to consume two diets in random order: an apple catechin diet that provides a controlled amount of catechins in apple juice, and a nutritionally-matched low catechin diet. Both diet phases will last 3 days, with a 10 day washout period in between the two diet phases.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of informed consent.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Any gender identification, aged 18 - 45.
4. BMI 18.5 - 40 kg/m\^2
5. Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
6. Agreement to provide urine and fecal samples according to the study protocol.
7. Agreement to adhere to avoid high catechin foods (tea, chocolate) for 4 weeks.
8. Able to come to the study location for 8 visits according to the study schedule.
9. As assessed through an initial urine screening phase, a person is eligible either on the basis of (1) the presence of a urinary marker for soy isoflavone metabolism (ODMA), or (2) as a control matched for age and gender.

Exclusion Criteria:

1. Current, regular use of antacids or acid reducers.
2. Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
3. Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
4. Known allergic reactions to components of the foods or beverages of the study diet (soy, wheat, dairy, peanut, tree nuts, apples, eggs) or any history of anaphylactic food allergy.
5. Current diagnosis of renal, hepatic, or gastrointestinal conditions.
6. History of stroke.
7. Underweight (BMI \<18.5 kg/m\^2) or severe obesity (BMI \>40 kg/m\^2).
8. Under 18 years or above 45 years of age.
9. Unwilling or unable to participate in the controlled dietary intervention or provide urine or fecal samples.
10. Has a pacemaker, implanted defibrillator, or other implanted electronic device.
11. Change of body weight \>10% between screening and dietary intervention.
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE

The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.

This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Men aged 50 years old and older
2. ≥5 years either of

   * GERD symptoms,
   * GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
   * any combination of treated and untreated periods, as long the cumulative total is at least 5 years
3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
4. One or more of the following risk factors:

   1. Caucasian race
   2. Current or past history of cigarette smoking
   3. BMI of at least 30 kg/m2
   4. First-degree relative with BE or EAC

      -

Exclusion Criteria:

1. History of prior EGD procedure
2. Inability to provide written informed consent
3. On anti-coagulant drug(s) that cannot be temporarily discontinued
4. Known history of esophageal varices or esophageal stricture
5. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
6. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
7. Oropharyngeal tumor
8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
9. History of myocardial infarction or cerebrovascular accident within past 6 months
10. History of esophageal motility disorder
11. Currently implanted Linx device
Therapeutic Potential of Kappa-Opioids Against Cocaine - 1

The purpose of this study is to characterize the effects of enadoline compared to hydromorphone and butorphanol.


Eligibility Criteria:
Inclusion Criteria:

opiate experienced, healthy

Exclusion Criteria:

physical dependence on opioids, barbiturates or alcohol
Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery

The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary.

The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy.

Methods:

Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B:

Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed.

Objective: The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients

Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy.

Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG.

Eligibility Criteria:
Inclusion Criteria:

* Undergo primary bariatric surgery (RYGB or SG)
* Speak and read the Dutch language

Exclusion Criteria:

* Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
* Same-day discharge after bariatric surgery
* Diagnosed OSA with treatment (CPAP, oral appliances)
* Professional drivers
* Use of alpha blockers
* Unable to speak or read the Dutch language
Dietary Lutein and the Retinopathy of Prematurity

The clinical trial aspect of this study is the provision of a lutein supplement to lactating women and compare the amount of lutein in the milk and blood with lactating women who do not receive the lutein supplement.

About one-fourth of preterm infants who weight less than 2 3/4 pounds at birth develop an eye problem. This problem occurs in the retina (back of the eye) and may result in blindness. This eye problem is called the retinopathy of prematurity(ROP). There are two yellow pigments in the retina called lutein and zeaxanthin. These pigments may protect the retina from being damaged by light. They may also protect the retina from being damaged by oxygen. These pigments are transferred from the mother to the baby. Most of this takes place during the last trimester of pregnancy. The situation could be worse if the baby receives formula. Most baby formulas do not contain lutein and zeaxanthin; breast milk does. Another worry is that breast milk may not have enough lutein and zeaxanthin if the mother does not eat enough vegetables and fruits. The purpose of this study is to measure the transfer of lutein and zeaxanthin from the mother to the baby, to measure the amount of lutein and zeaxanthin in breast milk, to find out if taking a lutein supplement will increase the amount of lutein in breast milk and to find out if dietary lutein and zeaxanthin are involved in the development of the retinopathy of prematurity (ROP).

Eligibility Criteria:
Inclusion Criteria:

* Planning to breast feed for at least 12 weeks
* Willing to be randomized to take the lutein supplement

Exclusion Criteria:

* Insufficient quantity of breast milk
Outcomes After PCI of the Aneurysmatic Right Coronary Artery

This study aims to evaluate procedural and clinical outcomes of acute coronay syndrome (ACS) patients with aneurysmatic culprit right coronary artery (RCA).

The investigators sought differences in procedural (slow-flow, no-reflow, distal embolisation,Thrombolysis in Myocardial Infarction final flow (TIMI) etc.) and in immediate and long-term clinical outcomes between several subgroups such as index vs staged percutaneous coronary intervention (PCI), premedication vs none, use of IIb/IIIa inhibitors vs none, bare metal stent (BMS) vs drug eluting stent (DES), ultrathin DES vs thick DES, durable polymer vs bioresorbable or free polymer etc.

The investigators also want to investigate the efficacy of different technical manoeuvres involved in resolving high thrombotic burden before stent deployment, such as thrombus aspiration, dilatation, intracoronary infusion of adenosine or thrombolytic agents, direct stenting etc.). Long-term follow-up includes target vessel failure (Cardiac Death, target vessel MI, clinically-driven target vessel revascularisation), define or probable stent thrombosis, target vessel revascularisation for ACS, clinically driven target vessel revascularisation and intrastent restenosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ACS of the aneurysmatic or ectasic RCA
* Patient with at least 6 months clinical or angiographic follow-up
* Patients with accurate procedural and clinical records (particularly use of drugs before, during and after procedure, according to RCA PCI procedure (index or staged).

Exclusion Criteria:

* Elective aneurysmatic or ectasic RCA PCI
* Patient with lack of accurate procedural and clinical data
* Patient with lack of clinical or angiographic follow up
Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives

The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.


Eligibility Criteria:
Inclusion Criteria:

* For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.
* For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.

Exclusion Criteria:

* NONE
Tele-Coaching Community-Based Exercise (CBE) Study

The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV.

Investigators will use the RE-AIM (Reach-Effectiveness-Adoption-Implementation-Maintenance) Framework to evaluate the tele-coaching CBE intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational levels in order to promote uptake, transferability and ultimate enhance the impact of health promotion interventions.

Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults living with HIV participate in the intervention (Reach); 2) To assess the impact of the intervention on physical activity, health, and engagement in the care cascade (Effectiveness); 3) To assess engagement in exercise for adults living with HIV over time (physical activity, adherence) (Maintenance); and 4) To evaluate the a) process (strengths, challenges, accessibility, cost, fidelity) and b) feasibility of sustainability of the implementation, from the perspective of adults living with HIV, representatives of community-based organizations (CBOs), health and fitness centres, health providers, and policy stakeholders to build capacity, products, and considerations for broader implementation (Implementation and Adoption).

Investigators will conduct a prospective longitudinal mixed methods intervention study to evaluate the implementation of an innovative online tele-coaching CBE intervention with adults living with HIV. They will use a combination of quantitative (self-reported questionnaires, fitness assessments) to assess outcomes bimonthly during the tele-coaching CBE intervention (6 months) and during a follow-up monitoring phase (6 months) to evaluate the short and long term impact of online CBE. Investigators will use a qualitative longitudinal design using interviews to assess processes and outcomes at baseline (0 months), post-intervention (6 months) and post-follow-up (12 months).

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) living with HIV who consider themselves medically stable and safe to engage in exercise.
* Access to technology (computer/tablet, Wi-Fi, web-cam).
* Willing to take part in a 12 month study involving thrice weekly exercise.

Exclusion Criteria:

• Not applicable.
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)

The proposed research has the following objectives:

Based off findings from the "Development of a Resiliency Program for Siblings of Children with Autism Spectrum Disorder" qualitative focus group study (protocol 2019P002284), the aim is to determine the feasibility and acceptability, of an 8-session Relaxation Response Resiliency (SibChat) program for siblings of children with ASD.

We primarily aim to test the preliminary effectiveness of a pilot waitlist controlled trial on improving resiliency and stress coping, This will be assessed by comparing Baseline-3 mo. scores on primary and secondary outcome measures between the Immediate and Waitlist control groups.

Among participants randomized to both conditions, we secondarily aim to investigate the extent of pre-post changes in primary and secondary outcomes. Among immediate condition group only, we also aim to assess whether end-of-treatment (3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment.

This intervention will be a modified version of Dr. Elyse Park's evidence-based 8-week multimodal treatment which is designed to promote adaptation to stress and promotion of resiliency. The program is an 8 session, 1 hour a week multi modal intervention that incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for coping with stress. This study will refine an 8-session group virtual-delivered resiliency treatment program consisting of 8 virtual group 1-1 ½ hour sessions. The goal of this study would be to advance our ultimate objective to implement a national sibling resiliency program.

Eligibility Criteria:
Inclusion Criteria:

1. Age 14-17 years (inclusive of ages 14 and 17)
2. Being the sibling of at least one individual with ASD
3. Access to internet or smart phone
4. English speaking

Exclusion Criteria:

1. Diagnosis of ASD
2. Past year psychiatric hospitalization

There are no exclusion criteria with respect to ethnicity or socioeconomic status.
Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery

Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.

Up to 300 patients who underwent sleeve, bypass or revisional bariatric surgery with the use of Altus Powered Stapler will be included in the study. The stapler should be used according to the Instructions for Use and according to the local practice.

The Altus Powered Stapler is used in open or laparoscopic surgeries and simultaneously cuts and staples soft tissues. In order to avoid great physical efforts by the physician and ensure excellent tissue suturing, the cutting and stapling mechanism is driven by the 12-volt battery that comes with the stapler.

Patients will be followed by 7, 30 and 90 days and 12 months after the procedure, as per the research center's standard routine.

Eligibility Criteria:
Inclusion Criteria:

* Patients with grade II obesity (BMI ≥ 35 kg/m\^2) with one or more associated comorbidities;
* Patients with grade III obesity (BMI ≥ 40 kg/m\^2) regardless of associated diseases;
* Patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the Altus Powered Stapler;
* The patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up.

Exclusion Criteria:

* Impossibility of collecting data related to the surgical procedure
* Impossibility of contact with the patient to obtain the informed consent form
Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine

Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.

The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.

200 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines.

Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants

Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.

Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years old or 55 years and older
* Be eligible to receive one of the study vaccines as part of the trial
* Understand and agree to comply with study procedures (visits, telephone calls)
* Agree not to participate in any other vaccine study during the time of the study
* Give written informed consent prior to any examination performed as part of the trial

Exclusion Criteria:

* Positive SARS-CoV-2 antigenic test
* Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
* History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
* Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)
* Pregnant or breastfeeding woman
* Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
* Anti-coagulant treatment
* Immunosuppressive treatment
* Contraindication to the proposed vaccine (according to RCP)
* Previously received at least one injection of a SARS-CoV-2 vaccine
* Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
* A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
* Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study
A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Histologically confirmed Hodgkin's lymphoma
* Relapsed or refractory to at least two prior treatment lines
* Relapsed after nivolumab treatment or refractory to nivolumab treatment
* Age 18-70 years old
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.