cyrilzakka/clinical-trials huggingface dataset:
A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease

The study is designed to see if stress echocardiography can be used as a screening exam in peri-, or post-menopausal women with a risk of developing of coronary artery disease and experiencing future cardiac events.

The clinical trial is designed to determine the prognostic value of stress echocardiography as a screening examination in peri-, or post-menopausal female patients with an intermediate likelihood of coronary artery disease (CAD) based on risk factors to identify patients at higher risk of experiencing future cardiac events.Female patients who are able to adequately exercise will undergo a symptom-limited exercise echocardiogram. Patients who are unable to adequately exercise or are predicted to be unable to exercise adequately (because of orthopedic/neurologic limitations, lung disease or debility), will perform dobutamine stress echocardiography. All patients will receive DEFINITY at rest and stress to enhance wall motion assessment.

Eligibility Criteria:
Inclusion Criteria:

* Peri or Post menopausal women either:

  * without symptoms but with risk factors for heart disease OR
  * experiencing atypical chest pain, OR
  * experiencing exertional dyspnea AND 2 or more risk factors for CAD
* Must be able to perform an exercise stress test

Peri-or post-menopausal (including surgical menopause) based on history.

* Post-menopausal is defined as females age 40-65 who self-report the absence of menstrual periods for at least 12 months.
* Peri-menopausal is defined as females age 40-65 who self-report the absence or irregularity of menstrual periods for 6-12 months.
* Surgical menopause is defined as females who have had a bilateral salpingo-oophorectomy with or without hysterectomy.

Exclusion Criteria:

* Previous confirmed heart disease
Health Effects of Reducing Sedentary Behavior

A recent review indicated that sedentary behavior has been associated with increased morbidity and mortality but the intervention studies frequently focus only on changing sedentary behavior (reducing sedentary time) without measuring health-associated outcomes. Elevated cortisol (related to stress) has been linked with health risks. Improved physical fitness has been linked with improved cortisol responses to psychosocial stressors. In addition, increased physical activity induced favorable effects upon low density lipoprotein, high density lipoprotein, and total cholesterol. Previous study also indicated that increasing daily steps have positive effect on blood glucose in people with impaired glucose tolerance. Ultimately, the investigators think that sedentary intervention and stress management may have benefits on these health indicators. As such the investigators will examine whether sedentary intervention or stress management can have positive effect on human health by measuring salivary cortisol, blood lipid profile, fasting blood glucose, blood pressure, resting energy expenditure, and body composition.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years.

Exclusion Criteria:

* Unable/unwilling to provide informed consent.
* Having mobility impairment.
* Current severe untreated depression (i.e., score in the severe depression range on the Hospital Anxiety and Depression Scale; HADS).
* Women who are pregnant or nursing.
* Currently smoking (within last 12 months).
* Currently use medications that affect salivary cortisol level (i.e. prednisone, dexamethasone).
* Have been diagnosed Addison's disease.
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.

Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.

All procedures will be performed under CARTO-3 guidance for the treatment of atrial fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. Additionally, D700 system safety, feasibility, usability and clinical applicability will be documented.

The entire procedure will be conducted as customary, using standard and approved off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the EPD D700 system. The physician will neither use nor rely on any of the D700 system output for clinical decision making and will be blinded to the D700 lesion assessment forecasts. After 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the D700 predictions.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Paroxysmal atrial fibrillation (PAF)
3. Able to provide written informed consent form to participate in the study, prior to any study related procedures.
4. Able and willing to comply with the study protocol requirements.
5. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedures.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Previous AF ablation therapy.
4. Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality.
5. Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances.
6. Patient has a pacemaker.
7. Thrombi detected in the heart.
8. Life expectancy less than 12 months.
9. Known severe renal insufficiency.
10. Known allergy to Iodine.
Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).

This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).

Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.

Hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious, vascular and metabolic complications. We hypothesize that a control of glycemia by insulin will improve the vital outcome and the rate of complications in a heterogeneous population of critically ill patients. This hypothesis is supported by the findings of a recent trial performed in one surgical intensive care unit, which demonstrated a significant improvement in vital outcome and in several indices of morbidity in patients randomized to a tight control of glycemia. However, these findings can hardly be extrapolated to other conditions, including different types of pathologies and management. The present prospective, randomized, controlled and multicentric study, will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively) and will be powered to detect a 4% decrease in absolute intensive care unit (ICU) mortality. Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in ICU and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, number of red-cell transfusions.

Eligibility Criteria:
Inclusion Criteria:

* All adult (older than 18 years old at admission) patients admitted in Intensive Care Unit whatever the reason

Exclusion Criteria:

* Absence of the informed consent (as approved by the local ethical committee).
* Life expectancy lower than 24 hours, as estimated upon admission.
* Therapeutic limitation upon admission in ICU
* Pregnancy
Efficacy and Safety of Aspirin in Patients with Chronic Coronary Syndromes Without Revascularization

The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.

Aspirin for secondary prevention in the acute phase of acute coronary syndromes has been established. Although it is still disputable about the duration, there is also a consensus for antiplatelet therapy in patients after percutaneous coronary revascularization. On the other hand, several large randomized clinical trials (RCTs) have shown that aspirin treatment for primary prevention of cardiovascular events increases bleeding events and does not provide net clinical benefit.Patient with chronic coronary syndromes (CCS) but not eligible for revascularization do not belong to any of these categories and there is no evidence on the efficacy of aspirin in this population. Therefore, we designed a multicenter, randomized, open-label study to evaluate the efficacy and safety of aspirin in patients with CCS who are not eligible for revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic coronary syndromes with ≧50% diameter stenosis in one or more major coronary vessels/major branches on coronary CT or coronary angiography but not eligible for coronary revascularization
* Patients for whom consent can be obtained

Exclusion Criteria:

* Patients with history of acute coronary syndromes (ACS)
* Patients with history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
* Patients with left main trunk stenosis (≥50%)
* Patients for whom aspirin administration is mandatory
* Patients undergoing antithrombotic therapy other than aspirin
* Patients with atrial fibrillation
* Patients with history of stroke within six months
* Patients scheduled for major surgical procedures that will require aspirin discontinuation
* Patients with contraindication of aspirin
* Patients expected to have a prognosis of 1 year or less due to comorbidities
* Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
* Patients who are judged by attending physicians to be inappropriate to participate in this study
Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure

The number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. While studies have suggested that physical activity, in particular, high-intensity interval training (HIIT), could be as efficient as the commonly used antihypertensive medications, no studies have actually compared their effects in the same population. This protocol will determine if HIIT is at least as efficient as hydrochlorothiazide in order to lower 24h-ambulatory blood pressure (BP) in prehypertensive older adults.


Eligibility Criteria:
Inclusion Criteria:

1. Age at consent ≥ 60 years;
2. Systolic Blood pressure measured through BPtru™ between SBP ≥ 120 mmHg and \< 140 and or DBP ≥ 80 mmHg
3. Being able to sign the informed consent form

Exclusion Criteria:

1. Considered "highly active" according to the International Physical Activity Questionnaire
2. Practicing more than 20 min per week of High-Intensity Interval Training
3. Use of antihypertensive medication
4. Contraindication for the practice of intense physical activity
5. Functional limitations related to the exercise test and to intensive training
6. Cardiovascular pathology
7. Atrial fibrillation
8. Psychiatric or neurological disorder
9. Renal failure
10. MMSE score \< 26
11. Persons benefiting of enhanced protection: persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and patients in emergency situations.
12. Diabetes
Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects;
2. Ages 45 years and older;
3. Are to receive a liver transplant.

Exclusion Criteria:

1. Recipients of a multi-organ transplant;
2. known hypersensitivity to daclizumab, CellCept®, or prednisone;
3. therapy with an investigational medication within 4 weeks of study entry;
4. history of malignancies within the past 5 years and/or lymphoma, excluding adequately treated skin carcinoma (basal or squamous cell), or other than exclusion #9;
5. history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
6. history of HIV infection;
7. females who are pregnant or nursing;
8. subject is receiving systemic corticosteroids for other medical conditions for which the physician feels that discontinuation of corticosteroids is contraindicated;
9. T2 or higher hepatocellular carcinoma
Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study

Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time.

The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics.

In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same.

Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth.

It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure.

The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.


Eligibility Criteria:
Inclusion Criteria:

* Newborns of mothers treated with known doses of psychoactive drugs during pregnancy or exposed to cannabinoids during pregnancy
* Full-term newborns (≥37 weeks)
* Informed consent signed by the child's legal representatives
* Affiliation to Social Security

Exclusion Criteria:

* Newborns of mothers exposed to unknown doses of psychoactive substances (excluding cannabis) during pregnancy
* One of the child's legal representatives hasn't signed the informed consent
* Premature delivery \<37 weeks of amenorrhea
* Newborns who can't be followed at T 4-6 months.
A Comparative Study of Kinesiology Taping Versus Taping in the Treatment of Plantar Fasciitis

Plantar fasciitis is a very studied pathology and treated with taping. There are studies that assess the effectiveness of Kinesio taping, as well as taping or low-dye taping, few studies that compare the two treatments and assess which is more effective.

In the present work the effectiveness of Kinesio taping and taping will be assessed, as well as whether possible differences among intervention effects exist in terms of pain improvement, comfort and durability of the bandage.


Eligibility Criteria:
Inclusion Criteria:

* People with plantar fasciitis.
* People of legal age.

Exclusion Criteria:

* Healthy people
* Minors.
* People with pathologies other than plantar fasciitis in the foot.
* People who have treatment for fasciitis at the time of starting the study
Retrospective Study of Bone Infection Due to Campylobacter Spp

Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? For answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter species.

Methods: By browsing the microbiological database of 6 BJI French reference centers, we collected all cases due to Campylobacter species between 2002 and 2012, including first and relapse cases. Clinical, microbiological and treatment features were analyzed using descriptive statistics.

Results: 14 episodes of BJI due to Campylobacter spp were identified in 10 patients. Mean age was 76.8 y.o. (63-96). Sex ratio M/F was 1.5. Nine patient had hip (n=6), knee (n=2), and shoulder (n=2) implants. Immunosuppression was observed in 6 patients (3 cancers, 1 cirrhosis, 1 rheumatoid arthritis, 1 corticosteroid treatment). During the 10 primary cases: all patients had fever and 2 presented digestive symptoms. Campylobacter spp were isolated on per operative samples in 5 patients. One of them presented positive blood culture. 5 patients had joint punctures: all of them were positives. Campylobacter species were C. fetus (n=7), C. coli (n=2) and C. spp (1). Strains were resistant to nalidixic acid (=10), ciprofloxacin (n=4), erythromycin (n=3) or cefotaxime (n=2). Only one C. fetus was susceptible to all antibiotics tested. Surgical treatment was performed in 8 patients (2 two-stage procedure, 6 irrigation). The mean duration of adapted antibiotherapy was 77 days (26-237). 3 out of 4 relapse cases were due to C. fetus. All were resistant to more than one antibiotic classes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with peroperative bone samples positive to Campylobacter spp. between Jan 2002 and Dec. 2012
* Adults over 18 yo
* No opposition to the study expressed by the patient

Exclusion Criteria:

* Adults below 18 yo
* Spine infection to Campylobacter spp.
* Outside of the timeframe of the study
* No microbiologic data available
* Opposition to the study expressed by the patient
Development of a Platform for the Clinical Implementation of Precision Oncology in the Central-Southern Regions of Italy (COESIT)

COESIT aims to establish a network of reference laboratories in the central-southern regions of Italy for the genetic and molecular characterization of tumors, with the goal of implementing precision and personalized oncology in clinical practice.

The project will begin with a technological upgrade of the laboratories and the standardization of sequencing procedures and bioinformatics analyses, involving all institutions participating in the initiative. Subsequently, a shared database will be created, integrating sequencing data and clinicopathological information. This will enable research projects aimed at expanding knowledge on the genetic alterations of tumors in patients from central-southern Italy and identifying prognostic and predictive biomarkers that support the implementation of precision and personalized medicine.

The enhancement of genomic laboratories, the sharing of analytical procedures and bioinformatics protocols, and the development of a common database of sequencing and clinicopathological data will serve as essential tools to deepen specific knowledge on the genomic characteristics of tumors in patients from southern Italy. This will facilitate the clinical implementation of precision and personalized medicine based on genomic analysis.

The study is multicentric and observational. The nature of the data included will be both retrospective and prospective, as described below:

1. Prospective collection of clinicopathological information, including lifestyle factors and exposure to environmental and occupational carcinogens, as well as CGP (Comprehensive Genomic Profiling) data obtained through targeted sequencing techniques. These data will be generated within clinical practice or local genomic screening programs, with the patient's informed consent.
2. Analysis of the correlation between tumor heterogeneity-specifically genomic biomarkers-and therapy response in all enrolled patients who did not respond to targeted therapy administered according to current clinical guidelines.
3. Retrospective collection of clinicopathological information and CGP data from case series available in COESIT center biobanks for the identification of new biomarkers. Specific sub-studies will be proposed with amendments to the main study described here.
4. Collection of information on germline alterations in individuals at risk for breast and gastric cancer, already analyzed within approved protocols , with the subject's informed consent for data inclusion in the COESIT platform.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Patients from the central-southern regions

Exclusion Criteria:

-