cyrilzakka/clinical-trials huggingface dataset:
The French Multiple Sclerosis Registry

OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc.

In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are

* To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
* To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
* To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
* To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
* To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
* To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
* To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* RIS
* CIS
* MS according to McDonald 2010 criteria
* NMOSD and others as per NOMADMUS criteria
* No age limt
* All clinical courses
* Domiciliated in France
* Signed OFSEP informed consent

Exclusion Criteria:

NONE

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Postpartum Screening of Type 2 Diabetes

Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).

However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking... A mother-friendly solution is direly needed.

The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.

The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 45 years;
* Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
* Treated with diet or insulin;
* Have given birth to a child at term; gestational age \> 37 weeks;
* Have been followed during her pregnancy by a physician who delivers in CHUS;
* Have signed the consent form.

Exclusion Criteria:

* History of glucose intolerance or diabetes before the pregnancy;
* Have presented another obstetrical pathology during the pregnancy;

  * Severe gestational high blood pressure with proteinuria;
  * Delayed intrauterine development syndrome;
  * Pregnancy with more than a foetus;
  * Drug addiction;
  * Had complications during the delivery such as:
* Moderate to severe postpartum bleeding;
* Surgery in postpartum (curettage, hysterectomy, etc.).
Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients

The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.

Studies have previously shown the positive impact of music on the autonomic nervous system, neurohormonal and cardiovascular system. In addition, a previously published study found a positive impact of music resulting in an improvement of quality of life (QOL) in heart failure patients. Proposed mechanisms of benefit of music in heart failure include a reduction in sympathetic activity, and modulation of parasympathetic activity. Further, reduction in anxiety and arterial relaxation are thought to be beneficial effects of music. It is hypothesized that heart failure patients listening to music would have better exercise stress test performance and increased exercise time.

Adult patients with systolic heart failure scheduled to undergo Cardiopulmonary Exercise (CPX) testing at the Gill Heart and Vascular Institute will be recruited.

While the patients are undergoing Cardiopulmonary exercise testing, patients randomized to the 'music arm' will listen to pre-selected upbeat music during their duration of the exercise testing via headphones that will be provided to patients by the study personnel. The patients who are randomized to 'non-music arm' in which their headphones will not play music and the patients will perform the cardiopulmonary exercise testing as usual.

Standard clinical care is performing cardiopulmonary exercise testing without any music.

The investigators will then compare the results of CPX study of the two arms to assess the impact of music on exercise performance.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \>18 years)
* Able to consent
* English speaking

Exclusion Criteria:

* Severe hearing deficiency
* Unable to exercise.
Testing a Meditation App With Justice-Involved Youth on Probation

This study is a randomized controlled trial (RCT) testing the effects of a mindfulness-based intervention delivered to justice-involved youth on probation via smartphone app on youths' emotion regulation and HIV/sexually transmitted infection (STI) risk-taking behaviors (i.e., alcohol use, cannabis use, sexual behaviors, and aggressive behaviors).

The investigators will enroll 200 justice-involved youth on probation 13-18 years old of all genders who report regular access to an Apple or Android smartphone. Following completion of a baseline questionnaire, participants will be individually randomized at a 1:1 ratio to 1 of 2 smartphone app conditions: (1) Bodhi AIM (Action In Mindfulness), a 30-day mindfulness-based intervention, or (2) HIB (Health In Balance), a health promotion control app matched to Bodhi AIM for time and structure. Follow-up assessments will occur at 1 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 13-18 years old
* On probation in the Chicago Cook County Juvenile Justice System

Exclusion Criteria:

* Unable to understand the permission/consent/assent process
* Do not speak English, due to norming of instruments
* Do not assent/consent
* Legal guardian does not give permission for youth's participation if under 18 years old
* Do not have an Apple or Android phone
* Are detained
* Are in care of DCFS
Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose

Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test)

Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test) Study: Testing of reliability and applicability of the Ascensia Contour Glucometer, Bayer. Comparison of 100 fasting glucose values measured in venous plasma by the hexokinase method in the Laboratory with 100 fasting glucose values measured in capillary whole blood on the Ascensia Contour Glucometer Outcome: If Ascensia Contour Glucometer shows applicable accuracy (narrow scatter of values), the two-step procedure should be replaced by one-step procedure: 1 only one appointment for the measurement of the fasting glucose value in capillary whole blood on Ascensia Contour Glucometer and if above 4.8 mmol/l Glucose Tolerance Test on the same day

Eligibility Criteria:
Inclusion criteria:

* Healthy pregnant women in 2nd Trimester of pregnancy scheduled for the measurement of fasting glucose value

Exclusion criteria:

* Pregnant women with pre-existent (Type 1 or 2) diabetes or already diagnosed diabetes of pregnancy
CP009 SYNERGOSS PXX Observational

The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.

Synergoss is a granulated bone graft intended for use in dental applications. It is composed of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on the ceramic granule surface.

The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS, a synthetic dental graft coated with collagen. For this observational study, we will enroll patients that already received a surgical intervention for sinus augmentation/ socket preservation by means of SYNERGOSS to maintain and regenerate bone before installation of endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just before they receive the surgery for the installation of endosseous titanium implants, about 24 weeks after the first surgery for the implant of SYNERGOSS.

The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen clinical benefit as declared in the Technical File.

The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those declared in the Technical File.

The study design is a

* National
* Monocentric
* Prospective: the participants are identified and then followed forward in time.
* Observational: participants that have recently received the grafting with SYNERGIES as part of normal and foreseen clinical procedures are enrolled in the study when they receive surgery for titanium implant placement and observed over time, with no substantial intervention other than the foreseen clinical treatment


Eligibility Criteria:
Inclusion Criteria:

* • Received in the past 16-24 weeks a bone graft for sinus lift or socket preservation with the ID

  * Capable of giving a valid informed consent
  * ASA 1, ASA 2
  * agrees to return for follow-up visits up to 2 years

Exclusion Criteria:

* • Uncontrolled Diabetes

  * Patients with psychiatric diseases
  * Neoplasic, immunodepressive, renal or liver major illnesses
  * Local radiotherapy
  * Major bruxism or major differences in the maxilla or mandubilar area
  * Drug or alcohol abuse
  * Major bone metabolism disorders
  * Heavy smokers (more than 10/day)
  * bisphosphonate treatment of major ostheoporosys or bone neoplasia
  * Pregnant women
  * Sinus illnesses
  * Contraindications to implant supported prostheses
  * Patients ASA 3,ASA 4, ASA5
  * Surgical intervention contraindications
Salivary Fluoride Clearance

This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Subjects will provide saliva samples at baseline and at 2, 6, 12, and 30 minutes post-treatment. The F- concentrations in each saliva sample will be determined by ion chromatography


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to study participation and be given a signed copy of the Informed Consent form;
* Be in good general health as determined by the Investigator/Designee based on a review of their medical history;
* Have at least 16 natural teeth;
* Have normal salivary flow (0.3-0.6 ml/min) or deemed acceptable by the Investigator/Designee as determined in a previous screening outside of this protocol;
* Agree not to participate in any other oral care studies for the duration of this study;
* Agree not to change their current oral care routine except 1) to refrain from using mouth rinse and 2) to agree to use study washout product as designated (current floss users are permitted to continue to floss during this study); viii. Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
* Agree to refrain from eating, using breath mints, using medicated lozenges, chewing gum, brushing their teeth or drinking within 2 hours of the visit, other than small sips of water up to 30 minutes prior to the visit;
* Agree to refrain from drinking tea or mineral water, and/or eating sardines within the 12 hours prior to the study visit; and
* Agree to return for all scheduled visits and to follow all study procedures.

Exclusion Criteria:

* Active treatment for gingivitis, periodontitis, or caries;
* Self-reported pregnancy or nursing;
* Smoking or tobacco chewing;
* Sjögren syndrome or any other disease/condition causing severe xerostomia;
* Kidney disease or renal impairment;
* Undergoing chemotherapy or irradiation procedures;
* Fixed orthodontic appliances that may interfere with product use;
* Inability to undergo any study procedures; or
* Any condition or disease, as determined by the Investigator/Designee that could be expected to interfere with examination procedures or with the subject's safe completion of the study
Computer-Based Intervention in HIV-Positive Young Adults

The purpose of this study is to investigate how working with a computer program may affect mood, feelings, overall health, and markers in blood in young adults with HIV.

Depression frequently occurs in young adults with HIV infection. When young adults with HIV experience depression, they are less likely to take their prescribed antiretroviral therapy (ART). When HIV occurs simultaneously with depression, individuals are more likely to have indicators in their blood that are linked risk for developing other illnesses in the future. The purpose of this project is to examine the ability of an avatar-based intervention, called eSMART-MH, to decrease depressive symptoms in HIV-positive depressed young adults.

Eligibility Criteria:
Inclusion Criteria:

* 23-53 years of age
* Fluent in English
* Be able to view images and text on a computer screen and hear audio using a headset
* Have a diagnosis of unipolar depression or have significant depressive symptoms noted in the electronic medical record (EMR) or referred to the study by a provider at the Grady Ponce de Leon Clinic because of their depressive symptoms
* Receive care at Ponce de Leon Center and at least 1 scheduled HIV medical appointment in the last 6 months
* Reside in the Atlanta, Georgia area
* Have a valid telephone number and email address
* Answer all items correctly on consent post-test

Exclusion Criteria:

* Diagnosis of bipolar depression
* Deaf, blind or unable to understand spoken English
* Currently pregnant, history of pregnancy within the last year or plan to become pregnant within the next 4 months
* Plan to move from the Atlanta, Georgia area within four months of study enrollment
* Taking corticosteroids or disease-modifying anti-rheumatic drugs
* If on antidepressant medication, taking it for less than 1 month
* Fail to pass post-consent test after three attempt
The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics

The loss of deep inhalation bronchoprotection in asthmatic individuals has been shown to be related to the degree of airway hyperresponsiveness, a hallmark of asthma. In several studies, asthmatic individuals with mild airway hyperresponsiveness (AHR) (methacholine PC20 \> 2 mg/mL) had a difference in methacholine PC20 with and without deep inhalations that averaged 1.8 doubling methacholine concentrations (p=0.0003). Conversely, asthmatic individuals with moderate to severe AHR (methacholine PC20 ≤ 2 mg/mL) had a non-significant difference in methacholine PC20 with and without deep inhalations (p=0.09). This loss of deep inhalation bronchoprotection is also now believed to play an important role in the pathogenesis of asthma. Airway inflammation is another of the key features of asthma and information on airway inflammation is increasingly being used in the diagnosis and treatment of asthma. The level of airway inflammation (as measured by fraction of exhaled nitric oxide and sputum eosinophilia) has also been shown to be correlated to the level of airway hyperresponsiveness (as measured by methacholine PC20). In addition, glucocorticoids have been shown to decrease airway hyperresponsiveness, further suggesting that these two phenomena, airway inflammation and airway hyperresponsiveness, are related. We therefore suggest that the degree of airway inflammation is related to the loss of deep inhalation bronchoprotection and expect there to be a negative correlation between the degree of deep inhalation bronchoprotection and airway inflammation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of asthma

Exclusion Criteria:

* other lung disease(s)
* smoking
A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.

This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject ≥ 18 years of age.
* Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c) HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg.
* The ability to understand and follow all study-related procedures including study drug administration.
* Sexually active female of childbearing potential (FOCBP)\* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.

Exclusion Criteria:

* In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s).
* Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
* Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
* Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.
* Use of any cholinergic drug (e.g. bethanechol) within 30 days.
* Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
* Subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion.
* Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
* Subject is pregnant, lactating or is planning to become pregnant during the study.
* History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.

The investigators postulate that erythropoietin reduces the risk of delayed graft function.

Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.

The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Receiving a kidney from a non-heart-beating donor category 3

Exclusion Criteria:

* Donor related factors: a prolonged warm ischaemic time (\> 45 min); a cold ischaemic time of \> 24 hours; serum creatinin of \> 150 umol/l
French Pediatric Helicobacter Pylori Observatory

Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.

No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.


Eligibility Criteria:
Inclusion Criteria:

* Child with confirmed H. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies
* Age \< 18
* No opposition of at least one of the 2 parents to the use of health data for research purposes

Exclusion Criteria:

* Child with confirmed H. pylori infection by indirect diagnostic methods