cyrilzakka/clinical-trials huggingface dataset:
Peer Education, Exercising and Eating Right - Obesity Prevention in Freshmen Women

Project PEER utilizes a randomized controlled study design to investigate the combined effects of an exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year (N = 300). The control group will receive minimal interaction from the research team, paralleling the typical freshman experience on the UIUC campus. Recruitment will take place in two waves (consecutive fall terms with n = 150).

During the final year (Fall 2010) of the project, a General Education course will be offered that targets weight management. Importantly, the discussion groups for this course will be taught by peer educators trained using the peer resources further refined during the PEER project. In addition to conventional measures of content knowledge assessed in the college classroom when obtaining class credit, personal physical activity and nutrition behaviors along with behavioral determinants (self-efficacy, self-regulatory skills and outcome expectations) will also be assessed.

Primary Aim 1: To determine the effectiveness of a peer-delivered self efficacy-based behavioral intervention to enhance nutrition and physical activity behaviors and subsequently weight management success in female university freshman over one academic year. We hypothesize that freshmen randomized to the intervention group will be more successful in losing or maintaining weight than the control group through a combination of diet and physical activity strategies.

Primary Aim 2: To examine the role played by social cognitive factors in changing nutrition and physical activity behaviors across one academic year. We hypothesize that self-efficacy will have both a direct influence on behavior and an indirect effect through its influence on self-regulatory skills and outcome expectations.


Eligibility Criteria:
Inclusion Criteria:

* Female
* In first year on campus, enrolled full-time, and in residence on the UIUC campus
* Aged 17-19 yrs (minors will be required to obtain parental signature on the IRB form)
* Free from any chronic disease/condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension or pregnancy.
* Free from an eating disorder as assessed using the Eating Disorder Inventory
* Free from any medications that would alter adiposity or psychological outcomes
* Sedentary or participation in non-professional recreational activity
* Non-smoking
* Body mass index (BMI) between the 50th and 95th BMI-for-age percentile

Exclusion Criteria:

* Male
* Status other than freshman or enrolled for entire year
* Not living on campus
* Smoking
* Pregnant
* Competitive athlete
* Chronic condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension
* Eating disorder as assessed using the Eating Disorder Inventory
* Taking medications that would alter adiposity or psychological outcomes
* Participation in competitive athletics
* BMI outside parameters
Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal

This study is designed to assess the impact of the first introduction of microscope-based health education on people's attitude and practice towards disease prevention in Nepal, measured by vaccine acceptance rate. Such health education has an important role to play in communities where vaccine acceptance is low.


Eligibility Criteria:
Inclusion Criteria:

* People aged 18 years or older who are resident of the study target area
* People who stayed at least for 6 months on the area of study
* People who agrees with the procedure of study and follow ups visits
* People who provide consent for their participation will be recruited in the study.

Exclusion Criteria:

* People under 18 years of age will not be enrolled into study due to their limitation of understanding and implementation of the content of workshop given as intervention.
* People who do not wish to participate in the trial
* Those with currently ongoing court hearing and deprive of freedom will not be enrolled for the study.
Telehealth-Based Chronic Disease Management for Type 2 Diabetes

This study will be conducted from enrollment until the end of the six-month follow-up period.

This study aims to assess the impact of the Internet hospital online + offline integrated chronic disease management model on patients with type 2 diabetes mellitus. It will also evaluate the economic impact of the model and identify the characteristics of the appropriate population for the model. Finally, it will develop a toolkit to help manage chronic diseases.

The study will include 1,636 patients with type 2 diabetes who did not reach the standard of control target of glucose, blood pressure or LDL at the endocrine outpatient clinic and inpatient wards of the Third Hospital of Peking University. We will collect information from participants before the study starts. And the patients will be followed up for 6 months from enrollment. The study management mode included online and offline integrated management in the Internet hospital, and routine offline management mode. After completing the enrollment and assessment, we will arrange outpatient follow-up and management according to the current status, doctor's requirements, and study subjects' needs.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old;
* Confirmed diagnosis of type 2 diabetes mellitus;
* Ability to use smartphones to participate in online diagnosis and treatment;
* Ability of the patient or relatives to assist the patient in self-monitoring of blood glucose;
* Failure to meet control targets: glycated hemoglobin ≥7. 0%, or LDL-C ≥ 2.6 mmol/L (and ASCVD or definite atherosclerosis with stenosis ≥ 1.8 mmol/L), or blood pressure \> 130% and ≥ 1.8 mmol/kg. L), or blood pressure over 130/80 mmHg.

Exclusion Criteria:

* Mental illness, cognitive dysfunction;
* Other diseases and complex conditions (untreated tumors, heart disease within 3 months);
* Acute complications of diabetes, severe hyperglycemia, fasting glucose greater than 16.9 mmol / L, random glucose greater than 20 mmol / L. Diabetic ketoacidosis and hypoglycemic coma that are not suitable for online management of diabetes emergencies;
* Patients with severe chronic complications of diabetes in critical condition (blindness, vision deterioration, new onset of ASCVD symptoms);
* Those who are unsuitable for the study: infection, fracture, trauma, foot ulceration, edema, blindness, cardiovascular emergencies, coma, etc;
* Those who have not signed the informed consent form.
Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit

Patient care who requires fast and intensive care by a mobile intensive care unit in a rescue helicopter is a common practice in Auvergne since more than 3 years. Indeed, a complete team (nurse and emergency physician) is on Dragon 63 and HeliSMUR 63 (SMUR = emergency medical services ). There are multiple fields of action, with a primary rescue activity (patient care directly at the site of the operation) but also secondary transport (transfer of patients from one hospital to another). This allows a reduction in transport time and therefore unavailability of the MICU team in general hospitals, which are in short supply of attending physicians. In addition, this allows patients to be repatriated to the Clermont-Ferrand University Hospital Center, which is the reference center for many pathologies and has the Level 3 adult and pediatric Trauma Center.

This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (institution mailing lists via a referent, flash codes distributed to physicians, etc.).

The questionnaire will assess the type of medicalisation, the type of activity, the different hours of intervention, the age, the type and the severity of the patient's disease, the type of care practiced and the stress of the physician.

Eligibility Criteria:
Inclusion Criteria:

* Every Emergency Physician that participate to the Helicopter rescue

Exclusion Criteria:

* Every Emergency Physician non-voluntary to participate
Postoperative Catheterization After Anterior Colporrhaphy

Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis.


Eligibility Criteria:
Inclusion Criteria:

* all patients planned for a cystocele repair

Exclusion Criteria:

* patients who already have voiding problems before the operation not related to the cystocele
* patients that are not capable of understanding our patient information form because of mental status or language
Effect of AN-PEP Enzyme on Gluten Digestion

The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in the stomach and how much gluten enters the small intestine. A second question is whether the caloric density of a meal can influence the efficacy of AN-PEP breakdown.

In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be investigated in healthy subjects. In addition, it will be assessed if meal calories can affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo, with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled, cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.

Eligibility Criteria:
Inclusion Criteria:

* Male/female
* Age ≥ 18 years but \< 45 years
* Hormonal contraceptive treatment
* Subject has read and understood the information provided on the study and given written informed consent

Exclusion Criteria:

* Any medical condition or laboratory test result that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
* pregnancy or lactation
* women not treated with hormonal contraceptive treatment
A Long-term Study of NPC-12G Gel in Neurofibromatosis Type I

The purpose of this tria is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel to patients with neurofibromatosis type I.

A Phase 3, open-label, uncontrolled, multicenter study to evaluate the safety and efficacy of long-term treatment with NPC-12G gel for patients with neurofibromatosis type I. Patients who meet all entry criteria for this trial apply NPC-12G gel twice a day for 52 weeks or more. Approximately 100 eligible patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as neurofibromatosis type 1 based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association
2. Patients participated in a Phase II/III investigator-initiated clinical trial for neurofibromatosis type I (OSD-001-004) who wish to continue treatment of the investigational drug
3. At the time of enrollment, patients who are able to choose ten evaluable target lesions for efficacy (at least 5)..
4. Patients who have evaluable skin neurofibromas at baseline.
5. Males and females who are 3 years old or elder at the time of informed consent.
6. Patients who (or whose guardian) give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation.
7. Patients whose use or continued use of the investigational drug is judged to be reasonable by the principal investigator or sub-investigator.

Exclusion Criteria:

1. Patients who occurred serious adverse effects, who discontinued the sudy due to adverse effects, or who discontinued the trial due to withdrew of their consent in the Phase II/III investigator-initiated study of neurofibromatosis type I (OSD-001-004)
2. Patients with abnormal findings (e.g., pneumonia) in the results of chest x-ray at the time of screening
3. Patients with creatinine clearance of less than 50 mL/min
4. Patients with poorly controlled dyslipidemia (serum triglycerides \>500 mg/dL or LDL cholesterol \>190 mg/dL even with treatment)
5. Patients who have complications such as infection, cardiac, hepatic, pulmonary, renal, or hematological diseases and malignant tumors that are considered unsuitable for participation in this trial.
6. Patients with alcohol sensitivity or allergy to an ingredient of the study drug (Sirolimus)
7. Female patients who are pregnant, may be pregnant, or are lactating
8. Patients (including male patients with a fertile partner) who cannot consent to use adequate contraception from the date of consent to 12 weeks after the end of treatment
9. Patients who participated in any other clinical trial or clinical study, other than the OSD-001-004 study, and have taken an investigational or investigational drug within 6 months prior to the date of the consent
10. Patients who are participating in an observational study during this trial
11. Patients who are considered by the investigator as unsuitable for participation in this trial
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease

This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.

There is growing evidence that metformin, a drug widely used for the treatment of type 2 diabetes and polycystic ovary syndrome, may serve as a novel therapy for individuals in the early stages of Autosomal Dominant Polycystic Kidney Disease ADPKD by activating the metabolic sensor AMP-activated protein kinase (AMPK). AMPK is activated under conditions of metabolic and other cellular stresses. Through its actions on downstream mediators, AMPK activation during low energy states decreases cellular energy consumption while stimulating energy generating pathways. It has been shown that AMPK phosphorylates and inhibits cystic fibrosis transmembrane conductance regulator (CFTR), thus suppressing epithelial fluid and electrolyte secretion. Similarly, AMPK phosphorylates the tuberin protein, leading to indirect inhibition of the mTOR pathway. Thus, AMPK inhibits both CFTR and mTOR, suggesting that targeted activation of this kinase by metformin may provide a therapeutic benefit in ADPKD. It has been shown that metformin treatment of kidney epithelial cells leads to stimulation of AMPK and subsequent inhibition of both mTOR and CFTR activity. It has also been shown that metformin slows cystogenesis in animal models of PKD, supporting the potential of this drug in ADPKD treatment.

Eligibility Criteria:
Inclusion Criteria:

Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English

Exclusion Criteria:

Subject is not on active military duty; Subject is not currently participating in another clinical trial; Subject's current GFR is not \<50 cc/min/1.73m2; Subject does not have diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject does not have a solitary kidney; Subject does not have an allergy or intolerance to metformin; Subject is not pregnant or lactating or intending to become pregnant within the next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject does not have active coronary artery disease; Subject does not have an MRI incompatible device/implant; Subject does not have severe claustrophobia; Subject has not had any solid organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (Jynarque or Samsca)
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders

To evaluate, over a period of six months, the links between physiological data collected such as electrodermal activity (or Galvanic Skin Response), motor activity measured by accelerometer, heartbeat measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patient able to give written informed consent, - Presenting a major depressive episode defined according to DSM V criteria, - Presenting a MADRS score ≥ 20 - Able to understand all study procedures and follow-up

Exclusion Criteria:

* - Inability to wear the wearable monitor for the duration of the study (6 months)
* Patient with a severe medical condition at the discretion of the investigator (neurological, rheumatological, etc.)
* Resistant depression
* Chronic depression, dysthymia
* Depression with psychotic features not congruent with mood, schizophrenia disorder
* Depression with catatonic features
* Substance use disorder in the last 6 months
* Extreme sports during the conduct of the study
* Pre-existing skin infection at the wearable monitor site
* Pregnant or lactating woman
* Participation in another drug or medical device study
* Inability to give informed consent
Critical Shoulder Angle and Acromial Index on 3D Models

Objective: The relationship between rotator cuff tears and morphological features of the shoulder joint has not been fully explained. The earlier studies are usually done with two-dimensional radiography images, but joint positions and bone formations could not be fully evaluated in two-dimensional images. This study aims to evaluate the relationship between rotator cuff tears and critical shoulder angle (CSA) and acromial index (AI) values in three dimensions.

Methods: This study examined computerized tomography of 24 rotator cuff tears (rotator cuff tear group) and 20 Bankart lesions, and no rotator cuff tears (control group). CSA and AI were measured on three-dimensional glenohumeral joint models obtained by three-dimensional reconstructions of computed tomography examinations.

The investigators anticipate results of this study will guide clinicians in revealing the etiology of rotator cuff degeneration and determining the surgical method to be used for treatment.


Eligibility Criteria:
Inclusion Criteria:

* A total of 44 patients, including 24 patients with proven rotator cuff tear by arthroscopic surgery (rotator cuff tear group) and 20 patients with proven Bankart lesion and no rotator cuff tear by arthroscopic surgery (control group), were included in the study.

Exclusion Criteria:

* Those with an inflammatory disease and trauma history were not included in the study.
Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism

This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
Auditory MMN EEG in TRD in Response to Ketamine

To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.

The investigators propose applying a previously validated computational model of the MMN and the ensuing effects of NMDAR antagonism to predict treatment response following ketamine infusions in TRD patients and distinguish ketamine's antisuicidal effects from those related to mood improvements. The study has two subgoals: first, the computational mechanisms underlying MMN reductions that predict ketamine treatment response in TRD patients will be examined. Second, the computational mechanisms will be linked to their underlying neural causes using neural circuit models. Beyond understanding ketamine's short- and long-term mechanisms of action in TRD, the parameters obtained from fitting these models to noninvasive EEG recordings may facilitate single-patient treatment predictions. If successful, this approach may provide clinically useful prognostic statements in individual patients.

Eligibility Criteria:
Inclusion Criteria:

1.18 to 65 years of age 2. Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for MDD and in a Major Depressive Episode and ≥10 on the Montgomery-Asberg Depression Rating Scale (MADRS).

3. Competent to consent-based on their ability to provide a spontaneous narrative description of the key elements of the study.

4. Failure of at least two trials of antidepressant therapy during the current episode (treatment-resistant depression) and receiving ketamine treatment clinically as administered by their clinician 5. Staying on stable dosages of any concomitant psychotropic medications.

Exclusion Criteria:

1. History of bipolar disorder or psychosis
2. Current substance use or history of substance use during the past year (excluding nicotine and caffeine use disorder)
3. Concomitant major and unstable medical or neurologic illness or a history of seizures.
4. Non-English-speaking individuals.
Intracranial Pressure During Migraine

An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.

Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 non menopausal women
* Menstrual migraine
* Using a triptan as usual treatment to relieve attacks
* Usual triptan efficacy although recurrence is possible

Exclusion Criteria:

* Disease of the ear
* Intracranial hypertension
* Chronic daily headache
* Use of topiramate or acetazolamide
* Triptans used more than 10 days/month
* Analgesic drug used more than 15 days/month
* Uncontrolled high blood pressure
* BMI \>30
* Ongoing allergic rhinitis or flu