cyrilzakka/clinical-trials huggingface dataset:
Impact of a Physical Activity Program on the Mental Health of Medical Students.

University students frequently adopt a sedentary lifestyle with low levels of physical activity, leading to a deterioration in their health. A significant number of them also suffer from social isolation. Moreover, numerous studies have highlighted the vulnerability of university students (particularly those in medical programs) to mental health issues. Medical students, with their demanding academic curriculum, are no exception to this trend.

A student association at the Lyon Est Faculty of Medicine reported that students' mental health is very low (2022): at least 1 in 2 students has experienced a depressive episode, and 1 in 3 has had suicidal thoughts during their studies. Other recent studies indicate that medical students at Lyon Est exhibit high levels of stress, low self-confidence, and excessive sedentary behavior (ECOSTRESS and ECOSPERF studies, 2021, 2022, and 2023). Unfortunately, in 2024, new mental health surveys among medical students from the second year through the end of their internship continue to confirm these findings.

The SANTE project aims to offer solution to student to a highly effective means of improving both their mental health and their level of physical activity throught an intervention program. More precisely, the goal of this interventional study is to evaluate the impact of a physical activity program on the mental health in second-cycle medical students at the University of Lyon 1. The development of the SANTÉ program was based on (i) data from the literature, (ii) results from a previous local study (IRB No. 2024-07-02-03) that identified student needs through individual interviews and focus groups, and (iii) local findings from a co-construction workshop with students.


Eligibility Criteria:
Inclusion Criteria:

* Being a 2th-year or a 3th-year medical student at the Faculty of Medicine Lyon East and Lyon South during the academic years 2024-2025.
* Having read the information note.
* Having signed the written consent.

Exclusion Criteria:

* No exclusion criteria will be applied.
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).


Eligibility Criteria:
Inclusion Criteria:

1. Chronic HCV infection at Screening.
2. Screening laboratory result indicating HCV genotype 1b infection.
3. Treatment-naïve and non-cirrhotic.

Exclusion Criteria:

1. HCV genotype or subtype other than GT1b.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
3. Any current or past clinical evidence of cirrhosis.
4. Screening laboratory analyses that shows abnormal results.
5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.
A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer

The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of inoperable/recurrent rectal cancer
* Age \> 18 years
* At least 1 measurable lesion should be present
* WHO performance score \< 2
* Life expentancy of at least 12 weeks
* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
* Documented informed consent to participate in the trial

Exclusion Criteria:

* Previous systemic chemotherapy
* Previous radiotherapy to the planned exposure area
* Subjects with distant metastases
* (a)white blood cell \< 4.0x109/L (unless absolute neutrophil count is \>2.0x109/L or (b) Platelet count \< 100x109/L
* Serum creatinine above the upper limit of the normal range
* (a) Serum bilirubin \> 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) \>2.5 times the upper limit of the normal range
* Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
* Pregnancy or breast feeding. Women of childbearing age must use effective contraception
* Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
* Patient participation in other studies
Red Blood Cell Precursor Formulation to Determine Increased Production

The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.

Medical foods are a distinct FDA regulatory category different from single molecule chemical pharmaceuticals, and from dietary supplements. The FDA has regulated amino acid preparations as drugs since the 1940s as they can elicit pharmacologic effects similar to conventional single molecule pharmaceuticals. The best known amino acid preparations are used to treat conditions such as maple syrup disease and phenylketonuria (PKU). An official definition and categorization of medical foods was made in 1988 as part of the Orphan Drug Act. Medical foods are regulated similarly to drugs except they do not require pre-approval because all ingredients are found on the FDA's generally recognized as safe (GRAS) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act) list and claims are confined to the nutritional management of a specific disease. Medical food claims must be supported by recognized scientific data as determined by medical evaluation. A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Eligibility Criteria:
Inclusion Criteria:

1. M/F patients 18 to 75 years old, non-pregnant/lactating
2. Male patients with \< Hemoglobin of 12.5
3. Female Patients with \< Hemoglobin of 11
4. Diagnosis of mild to moderate anemia by study physician

Exclusion Criteria:

1. Pregnant or unwilling to use adequate birth control for the duration of the study.
2. Unwilling or unable to sign informed consent.
3. Myocardial infarction within the last 6 months.
4. Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study.
5. GI bleed in the last 6 months.
6. Inflammatory bowel disease.
7. Chronic liver disease.
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System

This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000 for active treatment of chronic low back pain.

Currently, there are no prospective safety and/or outcomes studies utilizing the DRX9000™ in the peer-reviewed medical literature. There are published trials utilizing similar machines which provided evidence in support of the FDA granted indications for use spinal decompression and of the DRX9000™. Axiom Worldwide has determined it will be of benefit to the continuing medical care of patients and a furthering of the scientific knowledge of the treatment of LBP to complete such a prospective evaluation using a standardized treatment protocol. This study will therefore attempt to establish and validate the safety and efficacy of this computerized spinal decompression system in the treatment of LBP and sciatica.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, greater than 18 years of age
* Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
* LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
* Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
* Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up

Exclusion Criteria:

* Pregnancy
* Evidence of neurological motor deficits on clinical examination
* Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
* Evidence of severe central stenosis with neurological deficits or nerve root entrapment
* Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
* Previous spine fusion surgery, insertion of hardware or artificial disc
* Hemiplegia or paraplegia
* History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
* Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
* Known alcohol abuse or drug abuse
* Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
* Body weight greater than 300 pounds (136 kg)
Peer-Led Self-Management Support in "Real World" Clinical and Community Settings

This study will systematically evaluate a training program in state-of-the-art behavioral change approaches and facilitation skills for peer leaders and a peer-led diabetes self-management support program designed to be conducted in community and clinic-based settings on an ongoing basis.

In phase one we will develop and evaluate a theoretically-driven program to train peer leaders to facilitate longer-term empowerment-based interventions that, when led by health care professionals, have been associated with improved diabetes-related health and psychosocial outcomes.1-8 In phase two we will examine the impact of a sustained peer-led, empowerment-based self-management intervention on improving and maintaining diabetes-related health outcomes. We propose to develop and test the training and program simultaneously in two distinct cultural and linguistic communities with which the team already has strong working relationships and a track record of prior work: African-American (AA) adults in a community-based setting (Ypsilanti, Michigan) and Latino adults (Spanish- and English-speaking) in a clinic-based setting (Southwest Detroit). This will allow us to compare and contrast the translations of the training and program in these two different contexts and to better refine and understand effective methods and develop culturally tailored training and program materials in both English and Spanish.

Eligibility Criteria:
Inclusion Criteria:

* the study will recruit African Americans and Latinos with type 2 diabetes, - at least 21 years old, and
* who have a regular health care provider, and
* will commit to attend the 12 session DSME program.

Exclusion Criteria:

* having physical limitations preventing participation, and
* other serious health conditions (e.g., terminal cancer),
* serious psychiatric illness, self-reported excessive alcohol or illicit drug use, and
* serious diabetes complications (e.g., blindness) that would impede meaningful participation in the program
A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.

This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.


Eligibility Criteria:
Inclusion criteria:

1. Patient has established hypertension (diagnosed ≥12 months prior to screening) and is on a guideline based stable drug regimen (≥ 4 weeks), consisting of ≥3 anti-hypertensive medications of different classes including a diuretic;
2. Office systolic blood pressure \>150 mmHg;
3. Patient has (under directly observed therapy) average daytime systolic blood pressure values \> 140 mmHg by 24h ambulatory blood pressure monitoring;
4. Patient is ≥ 18 and ≤ 75 years of age at time of consent;
5. Patient must be able and willing to comply with the required follow-up schedule;
6. Patient must be able and willing to provide written informed consent;

Exclusion criteria:

1. Patient has known significant reno-vascular abnormalities such as renal artery stenosis \> 30%;
2. Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure \< 90 mmHg;
3. Evidence or history of secondary hypertension, other than sleep apnea syndrome;
4. Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
5. Patient has significant valvular heart disease;
6. Patient has known coagulation abnormalities;
7. Patient life expectancy is \< 12 months, as estimated by the study Investigator;
8. Patient is participating in another clinical study, which is before its primary endpoint and/or has the potential to impact his/her hypertension management (pharmaceutical / device);
9. Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods;
10. Patient has active systemic infection;
11. Patient has small \<4.0 mm in diameter, large \>6.5 mm in diameter or short \<20.0 mm in length, multiple main, or highly tortuous renal arteries;
12. Patient has impaired renal function with an estimated GFR \<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula;
13. Patient had a renal transplant or is awaiting a renal transplant;
14. Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication;
15. Any medical condition as estimated by the Study Investigator that may harm patient or jeopardize study participation, the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition);
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome

The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type.
* Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut.
* Previous positive Octreoscan.
* World Health Organization (WHO) performance score lower than 2.

At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment:

* Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days).
* Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days).
* WHO performance score lower than 2.

Exclusion Criteria:

* VIPoma or other non-carcinoid tumor.
* Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study.
* Radionuclide treatment within three months prior to inclusion, or planned during the study.
* Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus).
* Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study.
* Life expectancy of less than 6 months.
* Any investigational drug given within 30 days prior to inclusion or expected to be given during the study.
* No access to a telephone for completion of the daily telephone diary.
Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial

Double-blind randomized controlled clinical trial (RCT) of low-dose lenalidomide in the treatment of elderly patients (\> 60 years of age) with mild to moderate clinical signs of COVID-19 disease from the Hospital Universitario of Getafe.

The study will include patients of both sexes (\> 60 years of age) with mild to moderate clinical presentation of COVID-19 (ROX index \> 10). Subjects will be randomly assigned to the experimental arm with lenalidomide (5 mg/24h, day 1, 3 and 5) or to the controlled arm. Other concomitant medication for the treatment of COVID-19 will be also considered.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 60 years of age
* Diagnosed case (PCR test for COVID-19 if available) or COVID-19 clinical symptoms (defined as fever, dry cough, dyspnea, chest radiography with compatible findings with COVID-19)
* Lymphocyte count ≥ 0.2 x 103/µL and ≤1.0 x 103/µL.
* Neutrophil count ≥ 1.8 x 103/µL, platelets ≥ 150 x 103/µL.
* ROX ≥ 10 index
* Signed informed consent document
* Willing to comply with the lenalidomide Risk Minimization Program (Pregnancy Prevention Program approved)

Exclusion Criteria:

* Absolute contraindication of lenalidomide use or hypersensitivity to the active ingredient or any of the excipients.
* Active neoplasia
* Previous autoimmune disease
* Concurrent infection of HBV, HCV or tuberculosis.
* Aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal (ULN).
* Bilirubin levels \> 1.5 times the ULN
* Renal impairment with an estimated GF \< 30ml/min
* Venous thromboembolism events within the previous 3 years
* Significant active heart disease within the previous 6 months, including congestive heart failure (class II-IV NYHA), unstable angina or myocardial infarctions
* Sexually active subjects who refuse the lenalidomide Risk Minimization Program
* Inability to comply with the working protocol under the responsible health professional opinion.
Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies

The purpose of the study is to determine the safety and tolerability of RGB-286638, a novel, multi-targeted kinase inhibitor, administered to patients with selected, relapsed or refractory hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed diagnosis of:

  * Multiple myeloma (MM)
  * Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
  * Mantle Cell Lymphoma (MCL)
  * Chronic Myelogenous Leukemia (CML)
* Refractory to/relapsed after and/or intolerant of one or more standard therapies or for which no standard therapy exists.
* ECOG performance status 0-2.
* Adequate bone marrow, cardiovascular, renal and hepatic function
* Recovery from all adverse events due to prior therapies
* Contraception

Exclusion Criteria:

* Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy (involving ≥ 30% of the active bone marrow) within 14 days prior to the first dose (note nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose of RGB-286638).
* CNS involvement of the hematological malignancy.
* Active or unstable cardiac disease and/or history of myocardial infarction within 6 months and/or history of clinically significant ventricular arrhythmias.
* Concomitant therapies that are known to prolong the QT interval and are associated with a risk of Torsades de Pointes (TdP) are not permitted within 7 days before the first dose; however, amiodarone is not permitted within 90 days before the first dose.
* Patients with uncontrolled and unstable intercurrent illness.
* Concomitant therapy with inhibitors and/or inducers of CYP450 3A4 within 1 week of the first dose.
* Bleeding disorder unrelated to hematological malignant disease.
* HIV or HIV-related malignancy.
* History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 2 years.
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Effect of Exercise on Metabolic Health

One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \[BMI\] = 30-45 kg/m2, fasting blood glucose concentration must be \< or = to125 mg/dl, Hematocrit \> or = to 34%, all women must be pre-menopausal

Exclusion Criteria:

* pregnancy or actively breastfeeding, weight instability (\> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.
Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis

The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.

- Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.

Eligibility Criteria:
Inclusion Criteria:

Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included.

Exclusion Criteria: Patients who do not give written consent will not be included.