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NCT ID: NCT02640222 Completed - Anticoagulation Clinical Trials

APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study

Start date: January 1, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).

NCT ID: NCT02640105 Completed - Cluster Headache Clinical Trials

Cluster Headache, Addictions and Vascular Function

CHAD
Start date: June 25, 2014
Phase:
Study type: Observational [Patient Registry]

Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.

NCT ID: NCT02639871 Completed - Clinical trials for Brain Neuroimaging Biomarkers in Huntington Disease

Dynamic Neuroimaging Biomarkers in Huntington's Disease

HDeNERGY
Start date: June 28, 2016
Phase:
Study type: Observational

There is no curative treatment available today in Huntington disease (HD) despite the identification of the mutated gene 20 years ago. Nonetheless, safe and promising therapeutic strategies targeting brain energy metabolism are now becoming available. In view of the small effect sizes of any clinical parameter in HD, robust neuroimaging biomarkers reflecting brain energy metabolism are therefore urgently needed to better assess the potential of therapeutics targeting the mitochondria, and especially the Krebs cycle. Identifying such biomarkers at the presymptomatic phase in HD also provides a unique window for therapeutic intervention, which can be used as a proof-of-concept for the real challenge of tomorrow's medicine: the prevention of neurodegeneration HDeNERGY is an observational study consisting of the transfer of methods from preclinical to clinical studies and their application in HD. HDeNERGY aim at optimizing MRI/MRS methods to study the dynamics of brain energy metabolism. At the CENIR (Centre de neuro-imagerie et de recherche, Paris) the determination of creatine kinase rate will be first validated in healthy volunteers (n=20) and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20) together with the methods previously validated in HD patients (Mochel et al., 2012b) to determine the ratio of inorganic phosphate (Pi)/ phosphocreatine (PCr) during visual stimulation in presymptomatic individuals. The Chemical Exchange Saturation Transfer (CEST) method on the 3T clinical scanner of CENIR will be first validated in healthy volunteers (n=20) and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20). The cerebral synthesis rate of creatine phosphate and of brain glutamate concentrations and pH values will be compared between controls, HD patients and HD presymptomatic individuals, and correlated with clinical parameters (age, BMI, UHDRS).

NCT ID: NCT02639546 Completed - Solid Tumors Clinical Trials

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

iMATRIXcobi
Start date: May 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

NCT ID: NCT02639338 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis

POLARIS-3
Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

NCT ID: NCT02639247 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

POLARIS-4
Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

NCT ID: NCT02638948 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Start date: February 16, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

NCT ID: NCT02638935 Completed - Breast Neoplasms Clinical Trials

Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions

Start date: February 2016
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).

NCT ID: NCT02638844 Completed - ARDS Clinical Trials

Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome

ARDStrain
Start date: December 2015
Phase: N/A
Study type: Observational

Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.

NCT ID: NCT02638779 Completed - Septic Shock Clinical Trials

REAnimation Low Immune Status Markers

REALISM
Start date: December 11, 2015
Phase: N/A
Study type: Interventional

The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine storm, that participates to occurrence of organ failures and early death, followed by a compensatory anti-inflammatory response leading to immunosuppression, is now well established. This immunomodulating response results in a higher risk of secondary infections and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune status with time is crucial to guide therapy management. Objective of REALISM project is to demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data for septic shock patients, but also by extension to other situations of inflammatory aggressions like severe severe trauma or burns, or major surgery. This project will provide tools to predict occurrence of secondary infections and guide patient management by comparing innovating immunomonitoring tools to reference tests non already adapted to a routine patient management. Targeted populations are adult patients hospitalized for septic shock, severe trauma (including severe burn) or major surgery and healthy volunteers, whom blood samples will serve to validate reference intervals of the two reference tests.