cyrilzakka/clinical-trials huggingface dataset:
Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old

Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.

Qualitative observational study of human and social sciences (SHS), multicenter, conducted with schoolchildren.

The qualitative methodology used combines the use of photographs, open questionnaires and focus groups, over very large panels, aiming at both diversity and representativeness.

* Photo expression: to identify the determinants perceived as having a positive or negative influence on one's health;
* CQR : Certainty/Question/Rumour on how to take care of one's health (health promotion input following on from school policies, i.e. PES: Politique d'Etablissements Scolaires);
* Photo narration: to identify argumentative frameworks in health and alternatives perceived as being positive or negative for one's health,
* Focus groups: to improve understanding of the rationalities built by adolescents in relation to that which determines their health.

This choice is justified by the need to explore and understand the actions from the participants' point of view.

The diversity of schools and pupils (5 classes in 4 schools in the AURA region, i.e. 320 pupils) will make it possible to obtain the data saturation required in qualitative research.

This makes it possible to consider a mixed analysis strategy, both qualitative and quantitative.

This project aims to better understand the rationalities elaborated by children and the way in which their concepts on the determinants of cancer interlink, as well as to describe the declared impact these concepts have on the decision-making regarding their health.

Eligibility Criteria:
Inclusion Criteria:

* School volunteering to participate in the project Primary school
* children aged 6 to 11
* Girls and boys
* All school levels Private and public primary school
* Rural and urban primary school

Exclusion Criteria:

* Class ULIS
* Students who benefit from a personalized support plan
* Individual refusal of participation (child and / or family)
Limb Cooling in Essential Tremor

Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with ET at three different temperatures; and will measure changes in tremor amplitude after cooling of the upper limb.

Once the subject has agreed to participate in the study the following assessments will be performed.

Three non-pharmacological assessments will be performed at different temperature to the upper limbs. The first will be a baseline assessment with upper limbs maintaining a normal body temperature (96-98°F). The second assessment will be performed with upper limbs at a temperature of 59°F and the third will be performed at a temperature of 80°F for a period of 10 minutes. At the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes.

1. Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT).
2. The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and accelerometer readings.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18 to 95 years,
* Clinical diagnosis of essential tremor for at least a year,
* A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand

Exclusion Criteria:

* Dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash),
* Sensory loss in the upper limbs,
* Known history of sensitivity to cold (i.e., cold urticaria),
* Known peripheral vascular disease,
* Raynaud's phenomenon,
* Scleroderma

Healthy normal controls will be enrolled through advertisements. All controls will be examined to ensure that they are neurologically healthy.

The exclusion criteria for controls will remain same as those for patient subjects.
Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection

DETECT'CHUTE CLINIBED is a smart carpet equipped with several sensors. Positioned at the foot of the bed, this system allows detecting i) patient fall out of the bed and ii) when patient is not back to bed after a certain time. When one of these two events is detected, the system then sends a short message syteme (SMS) and/or an email to the medical staff. The aim of this clinical study is to test the system ability to detect and transmit alarms for both those events.

In this clinical trial, the investigators will therefore test the alarms positive and negative predictive values for both the events.


Eligibility Criteria:
Inclusion Criteria:

* residents of the facility free to get up at night (without a barrier)
* residents may or may not be suffering from Alzheimer's disease or related illness.
* having fallen several times in the last 12 months and / or at risk of falling (time up and go test ≥ 20 seconds).

Exclusion Criteria:

* Subject under tutelage
* use of night barriers or other forms of physical restraint deemed necessary by the physician in charge of the unit care or the patient
* Refusal of the resident's relatives.
Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients

The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients.

Specific Aim: The purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Hypotheses: Clinical efforts to through a multimodal educational intervention will:

1. Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation \[SpO2\] 90-96% and/or arterial oxygen \[PaO2\] 60-100 mmHg \[when applicable\]
2. Limit use of excessive supplemental oxygen
3. Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Eligibility Criteria:
Inclusion Criteria:

* Acutely injured patients who meet the criteria for entry into the state or national trauma registry
* Admission to surgical/trauma ICU within 24 hours of hospital arrival

Exclusion Criteria:

* Age \<18 years
* Prisoners
* Known pregnancy
* Transferred patients not admitted through the emergency department
Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation

Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and AF itself. This results in complex electrical conduction disorders, which is defined as electropathology. The aim of our study is to evaluate whether an artificial intelligence (AI)-enabled ECG algorithm (on an ECG in Sinus Rhythm) can predict electropathology in patients with AF who undergo a first PVI.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent.
* First PVI-procedure
* Age is 18 years or higher.
* 12-lead ECG available in SR during the last 14 days.

Exclusion Criteria:

* Mitral insufficiency of grade 3 or 4.
* Participating in another study that may interfere with participation in this study
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Prior to the first randomization, participants entered a screening period to determine eligibility. During screening, all participants received subcutaneous placebo corresponding to the once monthly dose volume. Participants who completed the screening period and met eligibility criteria were randomized to 1 of 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg) for a 4 week lipid stabilization period based on statin therapy at the time of study entry (no statin use vs non-intensive statin use vs intensive statin use).

After the 4-week lipid-stabilization period, eligible patients taking rosuvastatin or simvastatin during the lipid-stabilization phase were then randomized to 1 of 4 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) or matching placebo (subcutaneous, every 2 weeks), or evolocumab (420 mg, subcutaneous, monthly) or matching placebo (subcutaneous, monthly). Patients taking atorvastatin during the lipid-stabilization phase were then randomized to 1 of 6 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) and placebo (oral, daily), evolocumab (420 mg, subcutaneous, monthly) and placebo (oral, daily), placebo (subcutaneous, every 2 weeks) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily), or placebo (subcutaneous, monthly) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily).

A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria, and undergoing both randomization procedures.

Participants randomized to simvastatin who were taking verapamil or diltiazem prior to randomization received simvastatin 10 mg once daily (QD) while participants who were taking amlodipine, amiodarone or ranolazine prior to randomization received simvastatin 20 mg QD. All other participants randomized to simvastatin received simvastatin 40 mg QD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 to ≤ 80 years of age
* Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
* Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
* Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

* Statin intolerance
* New York Heart association (NYHA) III or IV heart failure
* Uncontrolled hypertension
* Uncontrolled cardiac arrhythmia
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Effect of Subcutaneous Tissue Closure on Wound Complications

Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth \>2 cm.

Postoperative wound complications are one of the great issues in cesarean section (CS) with an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections.

Evaluating the various techniques for closure of the subcutaneous layer.

Eligibility Criteria:
Inclusion Criteria:

* All patients included in this research BMI ≥ 30, First cesarean section performed, no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation

Exclusion Criteria:

* The following patients were excluded BMI \<30, Previous CS, DM with pregnancy, HTN with pregnancy
Use of Mellitor Sensor for Continuous Glucose Monitoring - An Ex-Vivo Study

Most patients with diabetes mellitus have to measure their blood glucose levels quite often, in order to maintain a proper glycemic control. Current methods of self-monitoring of blood glucose are invasive, painful, uncomfortable, and only allow occasional, from time-to-time, measurements. Real-time continuous monitoring would provide a helpful tool for improvement of glycemic control, thus decreasing the incidence of hypoglycemia and improving glucose control. The Mellitor sensor is a new concept of continue glucose monitoring device. The Mellitor device is an implantable continuous glucose monitoring sensor that is intended for detection episodes of hyperglycemia and hypoglycemia in diabetic patients, and facilitates both acute and long-term therapy adjustments. This study was design in order to evaluate glucose measurement capabilities by the Mellitor sensor that is being developed. Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.

Study Design

This study is an ex-vivo comparative study. 20 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria.

Study Goal

Study objective is to evaluate the feasibility of the Mellitor Sensor technology for glucose level measurement.

Study Endpoint

Mellitor technology feasibility will be established by comparing Mellitor glucose measurements results, based on transudate/exudates liquid withdrawal for other medical reasons, to "gold standard, Yellow Springs" glucose analyzer, or a comparable, calibrated and approved device using the same transudate/exudates liquid. Interdevice variability should be within 10%.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female aged 18 and up.
* Subject was scheduled for transudate/exudate liquid withdrawal.
* Subject able to comprehend and give informed consent for participation in this study.
* Signed Informed Consent Form

Exclusion Criteria:

* Known cognitive or psychiatric disorder.
* Subjects with HIV.
* Subject refuses to sign inform consent form.
Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy, as determined by medical history.
* Subject is between the ages of 15 and 23 years (not yet 24 years).
* For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
* Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study)
* Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
* Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications
* A negative urine pregnancy test is required for menstruating female subjects.

Exclusion Criteria:

* History of documented invasive meningococcal disease.
* Received any other meningococcal vaccine
* Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment
* Scheduled to receive any vaccination in the 28-day period after enrollment
* Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample
* Actively enrolled or scheduled to be enrolled in another clinical study
* Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
* Administration of immune globulin, other blood products, or corticosteroid within 3 months of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
* Personal or family history of Guillain-Barre Syndrome
* Suspected or known hypersensitivity to any of the vaccine components
* Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
* Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)

The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. ≥50 years of age (women) or ≥45 years of age (men)
2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
3. Waist circumference ≥88 cm (women) or ≥102 cm (men)
4. At increased risk of adverse cardiovascular outcomes:

   * Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:

     * History of documented myocardial infarction \>3 months prior to screening
     * History of coronary revascularization
     * History of carotid or peripheral revascularization
     * Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
     * Ankle brachial index \<0.9 (by simple palpation) within prior 2 years
     * ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years

AND/OR

* Type 2 diabetes mellitus with at least 2 of the following:

  * Hypertension (controlled with or without pharmacotherapy at \<145/95 mm Hg)
  * Dyslipidemia requiring pharmacotherapy
  * Documented low HDL cholesterol (\<50 mg/dL in women or \<40 mg/dL in men) within prior 12 months
  * Current tobacco smoker

Exclusion Criteria:

1. Myocardial infarction within 3 months prior to screening
2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
3. Clinical history of cerebrovascular disease (stroke)
4. History of tachyarrhythmia other than sinus tachycardia
5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty
6. History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures
7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)
8. Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection

Proton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme activities. The most essential role of a PPI in H. pylori eradication therapy is to make antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral levels.

Most patients who have failed in the eradication of H. pylori infection by triple therapy with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H. pylori.

Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19.

Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also achieved high eradication rates and has been recommended as the second line therapy in Japan. But carcinogenic actions of MNZ have been unclear.

The purpose of this study is to compare the re-eradication rates of H. pylori infection by the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the efficacies of these re-eradication regimens as second line eradication therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with H. pylori infection

Exclusion Criteria:

* Patients without H. pylori infection