cyrilzakka/clinical-trials huggingface dataset:
Co-creation of Nutrition Interventions in Higher Education Settings (DACCORD Study)

The DACCORD study is a participatory research project which aims to provide insights on how to involve higher education students and diverse partners in the co-creation of campus nutrition interventions through a deliberative mini-public.

The DACCORD study takes place at the University Sorbonne Paris Nord (USPN), located in the Seine Saint Denis department, in the Northern area of the Paris region (France). The intervention consists in a deliberative mini-public, a student citizen's assembly on diet and physical activity. The mandate of this student citizen's assembly is to co-create a list of concrete proposals that would improve the access of USPN students to sustainable diets and physical activity. The mini-public includes 30 students enrolled at USPN at the time of the study and a team of academic and non-academic partners involved in student life, nutrition, physical activity, or public policies.

The specific aims of the DACCORD study are 1) to design and implement a student citizens' assembly using participatory approaches, 2) to describe its process and evaluate its transferability, 3) to evaluate changes in nutritional habits, knowledge and citizen practices among students participating in the student citizen's assembly, using quantitative and qualitative methods.

Transferability will be evaluated continuously throughout the study, up to one year after completion of the student citizens' assembly. Nutritional habits, knowledge and citizen practices will be evaluated before and 1 months after the student citizens' assembly.

Eligibility Criteria:
Inclusion Criteria:

* being an adult (18 years of age or older)
* being enrolled at USPN at the time of the study
* being enrolled in initial training with in-person classes

Exclusion Criteria:

* being enrolled in continuing education or work-study programs
Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis

A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates

: the study included patients with COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest, patients with normal CT chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease and patients with rheumatoid arthritis or systemic lupus erythematosus were excluded from the study.

Study patients were randomly assigned to either steroid group or control group and were followed up for 14 days, and CT chest was done at end of 14 days and was evaluated by a radiologist how was blinded for study arm, Ct chest was graded either very minimal infiltrates including reticular shadows, hallow sign, and ground glass s (GGO), infiltrates \<25%, and infiltrates \>25%.

The steroid group received 20 mg/day prednisolone for 14 days in addition to symptomatic treatment; the control group received symptomatic treatment without steroids Data collected included patient demographics, symptoms, and its duration at baseline, CBC, Ferritin and D-dime, CT chest at discharge, and after 14 days of inclusions in the study.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest

Exclusion Criteria:

* patients with normal CT chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus
PRP in 2ry Spontaneous Pneumothorax

secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules


Eligibility Criteria:
Inclusion Criteria:

* COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion

Exclusion Criteria:

* refusal of participation
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers

The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.

This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or subject knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. Placebo (containing inactive substances only) or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a single IV infusion (directly into a vein) or a single dose of up to 3 injections under the skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a screening period of up to 4 weeks. All participants will be in the study for 17 weeks after dose administration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy man or woman with no clinically significant abnormalities
* Body weight in the range of 50 to 100 kg inclusive
* Body mass index (BMI) of 18.5 to 30 kg/m2 inclusive
* For healthy atopic patients: history of atopic allergy

Exclusion Criteria:

* Known or suspected intolerance or hypersensitivity to any biologic medication or to any components of the formulation used in this study
* Received an experimental antibody or biologic therapy within the previous 6 months
Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery

Background:

The glycocalyx is a fundamental component of the endothelial barrier and alterations at this level have been shown to exacerbate the inflammatory response in the microcirculation. Its degradation in the surgical patient, has been tested in interventions that involve regional or general ischemia, for example in cardiac surgery, major vascular surgery or transplantation. On interventions that do not involve ischemic events the literature is limited, such is the case of those patients undergoing major abdominal and thoracic surgery.

Objective:

Assess whether there is a glycocalyx degradation in major elective abdominal and thoracic surgery, measured as an increase in plasma syndecane-1 levels during the first 24 hours of postoperative care.

Methodology:

Prospective observational study in patients undergoing major elective thoracic and abdominal surgery at the University Hospital Vall d´Hebrón. Measurement of the syndecane-1 plasma levels are going to be done during the first 24 hours after the intervention. It is intended to evaluate whether its elevation is related to anesthetic perioperative factors, and if it has an impact con morbildity and mortality in the following 6 months after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Patients that are scheduled to major abdominal and thoracic elective surgery in Universtity Hospital Vall d´ Hebrón.
* Patients ASA I, II and III.
* Patients that after the intervention have their recovering in the Surgical ICU

Exclusion Criteria:

* Patients ASA IV and V.
* Patients that are hospitilized previous to the surgery.
* Patients that undergo emergent surgery.
* Patients with Chronic or Acute Renal Failure previous to the surgery.
* Patients with past medical history of autoinmune disseases.
* Patients with an active infection previous to the surgery.
* Patients in treatment with steroids previous to the surgery
Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

This is an observational research study whose purposes are to see the effects of repeated hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than air at sea level. In this research, the concentration of oxygen will be twice the level of oxygen at sea level.


Eligibility Criteria:
Inclusion Criteria:

Patients recruited will be healthy volunteers with no current, ongoing infection or chronic disease.

Exclusion Criteria:

We will exclude or delay the treatment if our patients have an active lung infection, develops cancer, if the patient cannot undergo pressurization/ depressurization because of eustachian-tube dysfunction and confinement anxiety. Any patient that cannot breathe without a respirator will be excluded.
Hepatitis C Elimination in the Netherlands

The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Ever diagnosed with (possible) chronic HCV in the 15-year period prior to initiation of the study, defined as having had a positive anti-HCV or HCV RNA test
* Lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive HCV test result

Exclusion Criteria:

* Younger than 18
* Deceased
* Not residing in the Netherlands
* Unknown current address
* Severe comorbidity or short life expectancy that limits patients from benefiting from retrieval
Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

The purpose of this research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin.

Diabetes is a common, morbid and expensive disease among veterans. Achieving and maintaining adequate glycemic control can reduce the devastating complications of diabetes. Unfortunately a large percentage of veterans with type 2 diabetes continue to have poorly controlled blood sugars. Insulin is the most potent medication for reducing glycemia, but is not used often enough due to barriers that are both patient and provider driven.

We propose to conduct a pilot study to evaluate the feasibility of establishing an insulin education group that would serve to educate patients about insulin, to initiate insulin in a group setting, and to provide appropriate follow-up of those who start insulin. If the intervention is successful, we plan to develop a multicenter study to test rigorously the effect of this approach.

Specific Aims:

To determine if psychological barriers to insulin initiation in patients with uncontrolled type 2 diabetes are favorably affected by a group insulin education and insulin initiation visit, as measured by the Barriers to Insulin Treatment (BIT) Questionaire before and after the intervention.

To evaluate the feasibility of the intervention as measured by the percent of patients who are referred to the class, but either cancel without rescheduling or fail to report and the percent of patients who begin insulin.

To evaluate the safety of the intervention as measured by the proportion of patients experiencing hypoglycemic symptoms; proportion of patients requiring sugar intake to manage hypoglycemia; and the proportion of patients requiring assistance to manage hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Primary care patient at McGuire Veterans Affairs Medical Center in Richmond, Virginia
* Age \> 18 years
* Inadequately controlled diabetes (HbA1c \> 8.0%) and not on insulin (using most recent HbA1c, within 1 month of the first visit)
* Primary Care Provider referral to insulin initiation/education group
* Patient brings home glucose readings to first visit

Exclusion Criteria:

* Patient is reluctant to participate in a group visit for any reason
* Patient unwilling to sign consent form
Hyperbaric Oxygen Post Established Stroke

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.

Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. Some of these effects have been postulated to be beneficial in the context of ischemic stroke.

Most of the recovery after stroke occurs in the first 30 to 90 days after the acute event. Recovery is largely based on recovery of brain that is injured, but viable. Physiological imaging studies (PET, EEG) have demonstrated that brain tissue may remain alive but not functional for months or years after ischemic insult.

Subjects will be selected from the stroke population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will have suffered an ischemic stroke involving the cerebral cortex within the last 6 to 36 months. The study will be enrolling 140 subjects and will be randomized to two different treatment arms: experimental group and a waitlist group.

Each subject will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, 3 weeks and 6 weeks into treatment and then again at the end of treatment. After treatment ends, the investigators will conduct these assessments again at 3 months, 6 months, 9 months and 1 year from the date of the participants last treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 19 and 85.
2. Able to speak English and give informed consent or have a substitute decision maker and able to assent.
3. One or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months
4. Able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes.

Exclusion Criteria:

1. Contraindication to HBOT (Appendix C) including:

   1. Untreated collapsed lung (pneumothorax)
   2. Have taken the chemotherapy drug Doxorubicin within 72 hours
   3. Have taken the chemotherapy drug Bleomycin within 4 months
   4. Bowel obstruction
   5. Heart pacemaker of unknown make and model
   6. Pregnancy
   7. Cigarette Smoking
   8. Chronic Obstructive Pulmonary Disease (COPD)
2. Participation in other stroke related studies.
3. Previous history stroke \> 36 months prior to study baseline
The Relationship of Aerobic Capacity With Agility, Core Muscle Endurance and Peripheral Muscle Strength in Adolescent Basketball Players

The aim of this study is to investigate the relationship of aerobic capacity with agility, core muscle endurance and peripheral muscle strength in adolescent basketball players.

A basketball player must have good physical condition to contribute to the team. In this physical condition, especially cardiorespiratory endurance (aerobic and anaerobic capacity), agility, muscle endurance and strength are important for basketball.

Revealing the interaction of aerobic capacity, which is critical for basketball, with other physical fitness components such as agility, core muscle endurance and peripheral muscle strength may shed light on the shaping of basketball players' exercise programs.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 10-19
* Male gender
* Interested in basketball sport for at least one year

Exclusion Criteria:

* Refusing to participate in the study
* Having any disability (orthopedic, cardiovascular, etc.) that would prevent participation in the study
Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®

The purpose of this study was the evaluation of inflammatory and healing profile after root coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root coverage surgery with subepithelial connective tissue graft, with and without enamel matrix derivative. The patient screening was based in the following inclusion criteria: bilateral recessions in maxillary anterior homologous teeth with aesthetical complaining ou hypersensitivity, non-smokers, healthy and no use of any medication that compromises periodontal health or healing. The split-mouth randomized model was followed in relation to test and control sites. The following clinical parameters were analyzed at baseline and 6-month post-surgery: recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness. In addition to the surgical analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These evaluations were performed at baseline, 7 and 14 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral gingival recessions in homologous teeth

Exclusion Criteria:

* Smokers;
* Systemic diseases;
* Drugs affecting periodontal health/healing.
Mindfulness Therapy in Inflammatory Bowel Disease

Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual control group in patients with bowel disease. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Background: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms.

Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-as usual control group in patients with bowel disease.

Outcome measures: quality of life, inflammatory and stress markers. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Eligibility Criteria:
Inclusion Criteria:

* patients with bowel disease diagnostic
* patients with non active disease symptoms in the last 3 month
* patients with access to internet and basic informatic knowledge

Exclusion Criteria:

* active disease symptoms
* planned surgery
* cognitive impairment
* previous experience with mindfulness
Epidemiological Survey on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

To investigate the prevalence of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) among adults in China

Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common chronic liver disease all over the world (1). In early 2020, a new definition of MAFLD has been proposed and is becoming increasingly widely accepted. The new diagnostic criteria are based on the histology or imaging of liver biopsies, or even blood biomarker tests indicative of the presence of fatty liver while satisfying any one of the following three conditions: overweight/obesity, type 2 diabetes, or metabolic dysfunction (2). The information on the prevalence of MAFLD is scarce. This study is designed to conduct MAFLD screening in adults with health check-ups at multiple health examination centers across China. The primary objective is to investigate the prevalence of MAFLD among adults in China.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75, both sex;
* Able to sign informed consent.

Exclusion Criteria:

* Pregnant women and those who are implanted with pacemakers, stents or any other metal devices.
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.

The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.

The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).

Heart centres in the Nordic region with experience (\>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.

Study hypothesis:

As compared to conventional aortic valve substitution in patients aged \>75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.

Primary clinical end-point:

Combined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.

Eligibility Criteria:
Inclusion Criteria:

* Significant aortic valve stenosis (valve area \< 1cm2)
* Age \> 75 (years Aarhus University Hospital, Skejby)
* Age \> 80 years (other participating centres)
* Operable by conventional surgery AND transapical stent valve implantation
* Expected survival \> 1 year following successful treatment
* Accept of participation and in follow-up investigations after adequate information
* Informed consent

Exclusion Criteria:

* Coronary artery disease requiring PCI or CABG
* Earlier cardiac surgery
* Myocardial infarction within 24 hours
* Kidney failure requiring any dialysis
* Ongoing infection
* Acute surgery
* Allergy to ASA or Clopidogrel
Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers

The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin.

The total length of time (from screening to follow-up) for each participant is approximately 7 weeks.

It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Is healthy and of non-child-bearing potential
* Has a body mass index of 18-30 kg/m\^2
* Has negative results for drugs of abuse, cotinine (smoking) and alcohol at screening
* Has signed informed consent and agreed to comply with all study requirements

Exclusion Criteria:

* Has history or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal , hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results, or 12-lead ECG
* Has any other condition detailed in the protocol, or that in the opinion of the Investigator, precludes participation in the study