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NCT ID: NCT02908308 Completed - Clinical trials for Out-of-hospital Cardiac Arrest

Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest

TTM-2
Start date: November 18, 2017
Phase: N/A
Study type: Interventional

ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.

NCT ID: NCT02908217 Completed - Clinical trials for Polymyalgia Rheumatica

Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

Start date: February 15, 2017
Phase: Phase 3
Study type: Interventional

Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS. The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale). All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.

NCT ID: NCT02907970 Completed - Clinical trials for Uterine Cervical Neoplasms

Perceived Barriers of Cervical Cancer Screening in Reunion Island and Key Levers for Improvment

FOSFORE
Start date: February 20, 2017
Phase:
Study type: Observational

FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.

NCT ID: NCT02907905 Completed - Social Insecurity Clinical Trials

Epidemiology of Viral Hepatitis Among Subjects in Precarious

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water. We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.

NCT ID: NCT02907463 Completed - Aortic Stenosis Clinical Trials

EDWARDS INTUITY Elite Valve System

MISSION
Start date: February 2016
Phase:
Study type: Observational

The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

NCT ID: NCT02907450 Completed - Clinical trials for Dentofacial Functional Disorder

TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis

TolTwiCare
Start date: October 2012
Phase: N/A
Study type: Interventional

The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention. The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study. The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.

NCT ID: NCT02907372 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer (CRPCa)

Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer

COG-PRO
Start date: November 2016
Phase: N/A
Study type: Interventional

This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.

NCT ID: NCT02907359 Completed - Clinical trials for Myelodysplastic Syndromes

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

Start date: January 13, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

NCT ID: NCT02907151 Completed - Clinical trials for Under Oral Anticoagulation Patients

Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education

EDUCONSULT
Start date: September 2016
Phase:
Study type: Observational

To assess the value of a dedicated knowledge questionnaire, filled by the patient prior consultation. Indeed, it could allow to target specific shortcomings of patients first, and help the cardiologist to prioritize the other therapeutic education, targeting specifically the information provided.

NCT ID: NCT02907060 Completed - Prolonged Pregnancy Clinical Trials

Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

Start date: January 27, 2017
Phase: Phase 3
Study type: Interventional

A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged. A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical. Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening. At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.