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NCT ID: NCT02571062 Completed - Clinical trials for Trypanosomiasis, African

Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation

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

Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition. The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate crossover study under fed condition. The 4-period sequences for the replicate design will be TRTR and RTRT, where R designates the reference formulation and T the test formulation. Subject will be allocated randomly to one of the two sequences of treatments according to the randomization list.

NCT ID: NCT02571010 Completed - Allodynia Clinical Trials

Evaluation of the Efficacy of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia

RESISTAL
Start date: October 2015
Phase: N/A
Study type: Interventional

This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

NCT ID: NCT02570724 Completed - Clinical trials for Intracranial Hypotension

HES Patch Versus Blood Patch

Start date: June 2013
Phase: N/A
Study type: Interventional

The injection of autologous blood Blood Patch (BP) into the epidural space is the standard treatment for headache associated with intracranial hypotension. It provokes cerebral vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever, sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood patch. This alternative technique is simple to implement and does not have some of the specific blood pressure contra-indications. The study aims at comparing the "Blood Patch" group versus the "HES Patch" in terms of clinical efficacy , tolerance, satisfaction of the anesthetist, ease of implementation and effect of the injection of epidural anesthesia on cerebral blood flow within 24 hours.

NCT ID: NCT02570620 Completed - Delivery Uterine Clinical Trials

Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time

ECOLDIA
Start date: September 2010
Phase: N/A
Study type: Interventional

Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.

NCT ID: NCT02570594 Completed - Schizophrenia Clinical Trials

Autobiographical Memory Organization in Schizophrenia

AMOrSchiz
Start date: January 2014
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the temporal organization of autobiographical memory in patients with schizophrenia. Patients and control participants will be invited separately to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an automatic camera around their neck, which is called SenseCam®. Pictures obtained with SenseCam® will be later presented to the participants during the session of test. They will be asked to determine the chronological order of 12 pictures corresponding to 12 particular events of the tour. Then they will be asked to watch the complete sequence of photos from the tour and to determine the beginning and ending of the events that have occurred during the tour. According to the investigators hypotheses, patients should have difficulty to find out the correct chronological order of the photos and to determine the appropriate beginnings and endings of the events

NCT ID: NCT02570581 Completed - Healthy Clinical Trials

MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers

MELA
Start date: June 2014
Phase: Phase 1
Study type: Interventional

Elderly people often suffer from chronic pathologies and they are given polypharmacy. In case of swallowing problems, the drugs are crushed and mixed in food, which alters the taste of food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs have nether been investigated. The MELA study is a one session hedonic test involving 16 healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8 food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they will have a unique opportunity to communicate and propose solutions to this neglected aspect of malnutrition in elderly populations.

NCT ID: NCT02570555 Completed - Strabismus Clinical Trials

Strabismus Surgery and Driving Ability

Start date: November 2013
Phase:
Study type: Observational

The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of patients with strabismus may be reduced. The goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; Patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.

NCT ID: NCT02570516 Completed - Lynch Syndrome Clinical Trials

NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

LYNCH-CHROMO
Start date: November 2015
Phase: N/A
Study type: Interventional

This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome

NCT ID: NCT02569970 Completed - Epilepsy Clinical Trials

Efficacy of Fluoxetine Against Seizure-induced Central Apneas

FLUOXETINE
Start date: November 2010
Phase: Phase 3
Study type: Interventional

Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood, it appears that the majority of such death occurs in the immediate aftermath of a general tonic-clonic seizure. There is currently no validated preventive treatment for SUDEP. Some evidence suggest that modulation of the serotoninergic tone, and more specifically selective serotonin recapture inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the control of breathing, especially during sleep and in response to repeated hypoxia. In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs. The investigators project aimed at testing whether fluoxetine can reduce the risk of ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled trial in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of their focal drug-resistant epilepsy.

NCT ID: NCT02569736 Completed - Clinical trials for Arthritis, Rheumatoid

Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation

Tocihelper
Start date: September 2014
Phase:
Study type: Observational

Naïve CD4+ helper T (Th) cells, upon encountering their cognate antigens presented on professional antigen-presenting cells, differentiate into different effector cells: - Th1 cells produce Interferon-γ and regulate antigen presentation and immunity against intracellular pathogens; - Th2 cells produce IL-4 (Interleukin-4), IL-5 and IL-13, and mediate humoral responses and immunity against parasites; - Th17 cells produce IL-17, IL-17F and IL-22 and regulate inflammatory responses by tissue cells. An additional TH subset called follicular helper T (Tfh) cells has recently been identified in germinal centers and also in whole blood (circulating Tfh cells). These cells regulate B-cell maturation and immunoglobulin production during normal immune responses. They produce factors essential for B cell selection and maturation into memory B-cells or long-lived antibody-secreting plasma cells. Furthermore, they also seem to favor pathogenic autoantibody production in systemic autoimmunity, and therefore could potentially represent a novel therapeutic target in autoimmune diseases. Indeed, rheumatoid arthritis synovium is characterized by the presence of ectopic lymphoid structures, resembling germinal centers. Potentially, Tfh cells from these nonlymphoid tissues could promote B-cell maturation and synthesis of pathogenic autoantibody production, thus potentiating tissue injury. Interestingly, production of IL-21 by Tfh cells is implicated in B cell activation, and the same cytokine have been associated with rheumatoid arthritis (RA) pathogenesis. IL-6 blocking therapy significantly reduces signs and symptoms as well as radiological progression in RA. However, so far, it has not been determined which of the pleiotropic IL-6 effects impact the observed clinical response. Recently, Samson et al have demonstrated that Tocilizumab (TCZ) corrects the imbalance between Th17 cells and Treg cells in patients with RA. More interestingly, the group of Hans-Peter Tony has reported the impact of TCZ on B cell compartment. They showed a significant reduction in the frequency of peripheral pre-switch and post-switch memory B cells but also a reduction of serum immunoglobulin levels, that could be the reflect of TCZ on Tfh cells development, circulation and/or function. Most of the work studying the role of IL-6 on Tfh cells development has been performed in mice. They showed that optimal Tfh cells formation requires IL-21 and IL-6, and that cytokines alone are insufficient to drive Tfh cells differentiation. To better understand the impact of IL-6 on human Tfh cells, the investigators would like to conduct a prospective study in patients with active RA and investigated the effects of blocking IL-6 with TCZ on circulating Tfh cells levels and Tfh cells subsets over a 12-week study period. Furthermore, the impact of TCZ treatment on Tfh cells generation will be explored in vitro.