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NCT ID: NCT03280537 Completed - Nasal Polyps Clinical Trials

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

POLYP 2
Start date: November 21, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

NCT ID: NCT03280290 Completed - Clinical trials for Acute Myeloblastic Leukemia

Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft

CCR7-CD4-DPL
Start date: March 20, 2012
Phase: N/A
Study type: Interventional

This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans. The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.

NCT ID: NCT03279913 Completed - Depression Clinical Trials

NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS

NEUROFEEDSTIM
Start date: December 18, 2017
Phase: N/A
Study type: Interventional

Neurofeedback is an increasingly researched technique for the treatment of many psychological disorders, such as attention deficit / hyperactivity disorder (AD / HD), depression, or substance abuse. This technique would allow patients to regulate their cortical electroencephalographic activity while receiving a visual or auditory feedback on the cortical electroencephalographic activity. Changes in the electroencephalogram (EEG) would thus be correlated with changes in cortical activity and thus with symptoms. On the electroencephalographic plane, the depression appears associated with relatively more alpha activity (in "resting state", 8-13 Hz) in left than in right frontal cortex. This difference in alpha activity between frontal regions is known as alpha asymmetry in depression. As a reminder, increased alpha activity indicates a decrease in cortical activation. This alpha asymmetry appears to be associated with a decrease in sensitivity to reward. It is on these bases that the modification of the alpha asymmetry has become one of the most frequent objectives of the studies on the use of neurofeedback in depression. Transcranial magnetic stimulation (TMS) also offers a non-invasive and painless method of effective cerebral stimulation in psychiatric disorders and especially depression. It received a favorable opinion from the Food & Drug Administration (FDA) in the United States for the treatment of this pathology. This treatment is still under evaluation in France. The results are promising but improvements must be done to increase its effectiveness. TMS offers stimulation of brain tissue in a localized and non-invasive manner. The principle consists of a brief electric current passing through a coil which generates a transient magnetic field inducing an electric field through conductive fabrics. TMS modifies neuronal activity in target superficial brain structures, but also modulates neuronal circuit activity. In recent years, the concept of "state dependency TMS" has been developed. It suggests that the activation state of neuronal circuits before and after stimulation alters the effect of stimulation. Thus, the efficacy of TMS could be amplified in depression by taking into account the cerebral activity during the stimulation sessions, in particular on the electroencephalographic plane. However, TMS may also help patients increase their EEG response during Neurofeedback sessions. The combination of stimulation techniques and brain-machine interfaces such as neurofeedback is still little studied at present. A study on the combined use of TMS and Neurofeedback by EEG in depression would therefore be an innovative approach and in line with the latest data from the literature. Design : Prospective, monocentric, non-randomized, non-comparative, unblinded study.

NCT ID: NCT03279835 Completed - HIV-1 Clinical Trials

Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients

NEURACog
Start date: March 16, 2017
Phase:
Study type: Observational

The objective of this prospective study is to evaluate the prevalence of neurocognitive impairments in HIV infected patients comparing patients with and without HAART. Recent studies have demonstrated a specific HIV infected patients neurocognitive disorders profile. These cognitive disorders concern primarily information processing speed, memory recall, attentional abilities, work related memory, executive functions, and psychometrical speed. This cognitive profile is similar to another highly documented one, described for another central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest and most severe disorder is the one related to the information processing speed. For the multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to identify cognitive disorders presence, but also in order to predict a long term disability worsening. A digital version of this test (CSCT), has recently been developed in order to make this early evaluation easier. We hypothesize that CSCT alteration would also predict HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and personal consuming. This short (approximatively 2 minutes) digital test would be highly helpful to identify patients, who will need a more extensive neuropsychological assessment.

NCT ID: NCT03279211 Completed - Amino Acid Clinical Trials

Amino Acid Digestibility of Whey and Zein Proteins

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.

NCT ID: NCT03279081 Completed - Crohn's Disease Clinical Trials

Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

ADMIRE-CD-II
Start date: September 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

NCT ID: NCT03279003 Completed - Sensitive Skin Clinical Trials

Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin

SENSILED
Start date: June 22, 2018
Phase: N/A
Study type: Interventional

Light-emitting diode (LED) light therapy is increasingly used successfully and without adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to perform a study in subjects with a sensitive skin without associated dermatosis.

NCT ID: NCT03278548 Completed - Clinical trials for Hypovolaemia Due to Acute Blood Loss

Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

PHOENICS
Start date: September 28, 2017
Phase: Phase 4
Study type: Interventional

The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

NCT ID: NCT03278171 Completed - Clinical trials for Post Traumatic Stress Disorder

Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit

STRESSREA
Start date: September 20, 2017
Phase:
Study type: Observational

Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in troubles due to a traumatism or a stress factor and appearing at least 1 month after confrontation with trauma. This trouble can become chronic, and be the source of psychiatric and somatic comorbidities, which themselves have personal, professional and economic consequences at the level of the individual and society. Some studies looked at the psychological effects induced by a stay in intensive care unit (ICU) since few years. The emergence of PTSD in these patients has been described, with an incidence varying from 4% to 60%. The literature is contradictory about identified risk factors for PTSD. It's not possible to design a screening of these patients actually, only focused on the risk factors. It has been shown that the presence of acute stress trouble (presence of symptoms during the first month after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care consultations have been done at 6 months, but not systematically. Only few symptoms are looked for and a sizable part of this population were not being followed probably due to a non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients will never be diagnosed and treated, favoring all complications linked to this trouble. Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would permit an exhaustive screening of patients at risk for PTSD and could permit to propose them an adapted care and then limit the emergence of PTSD and its consequences.. In this study, the investigators will screen acute stress symptoms within 8 days following the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD.

NCT ID: NCT03277963 Completed - Obesity Clinical Trials

Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient

Start date: February 4, 2010
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand, the SAOS could generate pain perception disorders in a population already affected by the mechanical weight constraints, generating potentially painful complications, and on the other hand, the improvement of sleep provided by continuous positive airway pressure (PPC) ventilation could "normalize" the pain perception thresholds. It was shown an early rebound effect after treatment on increasing pain threshold in the healthy subject. We want to check it among obese patients with OSA in early and mid-term.