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NCT ID: NCT02882425 Completed - Healthy Subjects Clinical Trials

Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

NCT ID: NCT02882399 Completed - Clinical trials for Pubic and Abdominal Pathology

Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes

Shortystrap
Start date: April 12, 2013
Phase: Phase 2
Study type: Interventional

The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.

NCT ID: NCT02881983 Completed - Clinical trials for Alcohol Use Disorder

Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients

REAL
Start date: April 2014
Phase: N/A
Study type: Observational

Background: Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol. Main aim: Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD. Secondary objectives: Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).

NCT ID: NCT02881580 Completed - Spinal Deformity Clinical Trials

Risk Factors for Proximal Junctional Kyphosis Assessment After Spinal Instrumentation

CYPHORACHI
Start date: June 2015
Phase:
Study type: Observational

The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of material used or the type of correction maneuver used. All these variables affect the surgical outcome and may be involved as a modifiable risk factor for possible postoperative complications. The study proposes to focus on the junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK). Their prevalence in adults ranges from 20% to 43% depending on the series. The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra proximal not instrumented; this measure is being compared to the pre operative data. Either the CJP are asymptomatic and do not require revision surgery either they are and thereby generate a revision surgery. Several factors may potentially influence the development of the CJP. Among them, age, preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid instrumentation, correction forces applied during surgery, sagittal balance pre and post operative degeneration joint capsules, etc. There are few studies on the identification and analysis of these risk factors; literature gives only single-center studies on small samples with a single surgical procedure. Review articles describe the incidence and risk factors of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to this day. The aim of this study is to determine the incidence of occurrence of postoperative kyphosis proximal junctional and identify risk factors for developing this major complication of a multicenter population of scoliosis operated an extensive fusion.

NCT ID: NCT02881437 Completed - Clinical trials for Primary Immunodeficiency

IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia

Start date: November 11, 2016
Phase: Phase 4
Study type: Interventional

Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks

NCT ID: NCT02881268 Completed - Clinical trials for Patient Hospitalized in Intensive Care Unit

Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

IMPRIM
Start date: January 19, 2016
Phase:
Study type: Observational

Open-label, non-randomized, prospective, single center, observational, translational study

NCT ID: NCT02881034 Completed - Hepatitis C Clinical Trials

Ribavirin Bioavailability After Telaprevir Exposure

Start date: February 2014
Phase: N/A
Study type: Observational

Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.

NCT ID: NCT02880644 Completed - Clinical trials for Retinal Vein Occlusion

Ultra-wide Fluorescein Angiography in Patients With Central Retinal Vein Occlusion Treated by Afilbercept

HERMES
Start date: January 26, 2017
Phase:
Study type: Observational [Patient Registry]

In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific. With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.

NCT ID: NCT02880527 Completed - Dermatomyositis Clinical Trials

Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

EPIDEMYOSITIS
Start date: July 2014
Phase: N/A
Study type: Observational

Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population. Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.

NCT ID: NCT02880488 Completed - Amblyopia Clinical Trials

Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus

ASTEQ
Start date: n/a
Phase: N/A
Study type: Observational

The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.