title: Efficacy and Safety of Bevacizumab for the Treatment Hemorrhagic Hereditary Telangiectasia (HHT) Associated With Severe Hepatic Vascular Malformations. Phase II Study.

acronym: METAFORE

summary:
The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered because of the molecular mechanisms implied in angiogenesis and HHT, as well as the mechanisms of action of this type of treatment. Two articles that have recently reported spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe liver involvement and cardiac effects support us in this sense.

Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver transplant, the disadvantages of which are both multiple and well known: long waiting lists, surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore, treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a subsequent liver transplant if necessary.

ReferenceCitation: Dupuis-Girod S, Ginon I, Saurin JC, Marion D, Guillot E, Decullier E, Roux A, Carette MF, Gilbert-Dussardier B, Hatron PY, Lacombe P, Lorcerie B, Rivière S, Corre R, Giraud S, Bailly S, Paintaud G, Ternant D, Valette PJ, Plauchu H, Faure F. Bevacizumab in patients with hereditary hemorrhagic telangiectasia and severe hepatic vascular malformations and high cardiac output. JAMA. 2012 Mar 7;307(9):948-55. doi: 10.1001/jama.2012.250.

family: Dupuis-Girod

full_name: Sophie Dupuis-Girod

given: Sophie

family: Ginon

full_name: Isabelle Ginon

given: Isabelle

family: Saurin

full_name: Jean-Christophe Saurin

given: Jean-Christophe

family: Marion

full_name: Denis Marion

given: Denis

family: Guillot

full_name: Elsa Guillot

given: Elsa

family: Decullier

full_name: Evelyne Decullier

given: Evelyne

family: Roux

full_name: Adeline Roux

given: Adeline

family: Carette

full_name: Marie-France Carette

given: Marie-France

family: Gilbert-Dussardier

full_name: Brigitte Gilbert-Dussardier

given: Brigitte

family: Hatron

full_name: Pierre-Yves Hatron

given: Pierre-Yves

family: Lacombe

full_name: Pascal Lacombe

given: Pascal

family: Lorcerie

full_name: Bernard Lorcerie

given: Bernard

family: Rivière

full_name: Sophie Rivière

family: Corre

full_name: Romain Corre

family: Giraud

full_name: Sophie Giraud

family: Bailly

full_name: Sabine Bailly

given: Sabine

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Ternant

full_name: David Ternant

given: David

family: Valette

full_name: Pierre-Jean Valette

given: Pierre-Jean

family: Plauchu

full_name: Henri Plauchu

given: Henri

family: Faure

full_name: Frédéric Faure

given: Frédéric

journal_name: JAMA

title: Bevacizumab in Patients With Hereditary Hemorrhagic Telangiectasia and Severe Hepatic Vascular Malformations and High Cardiac Output


title: Medical and Economical Impact of Predicting the Response to Anti-angiogenic Treatment in Metastatic Renal Cell Carcinoma Using Functional CT and MRI

acronym: REMISCAN

summary:
The goal is to study the impact of functional MRI and CT evaluation of changes in tumor vessels induced by anti-angiogenic treatment in patients with metastatic RCC.

The hypothesis is that good responders and poor responders will have different responses induced by anti-angiogenic treatment, and that the detection of theses changes by functional imaging can improve the therapeutic management.

Functional CT and MRI will be performed in 200 patients before the beginning of antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined by the RECIST criteria). Perfusion and diffusion parameters will be measured using a dedicated software.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique

status_simplified: Completed


title: Phase II Study of Treatment of Relapsed Agressive Lymphomas

summary: The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

study_type: Interventional

primary_purpose: Treatment

lead_sponsor: French Innovative Leukemia Organisation

intervention_type: Drug

lead_sponsor_type: industriel


title: ERP Study of Brain Electrophysiological Patterns in Obesity

summary: There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.

ReferenceType: background

ReferenceCitation: Bauer LO, Hesselbrock VM. P300 decrements in teenagers with conduct problems: implications for substance abuse risk and brain development. Biol Psychiatry. 1999 Jul 15;46(2):263-72.

ReferenceCitation: Patrick CJ, Bernat EM, Malone SM, Iacono WG, Krueger RF, McGue M. P300 amplitude as an indicator of externalizing in adolescent males. Psychophysiology. 2006 Jan;43(1):84-92.

ReferenceCitation: Yoon HH, Iacono WG, Malone SM, McGue M. Using the brain P300 response to identify novel phenotypes reflecting genetic vulnerability for adolescent substance misuse. Addict Behav. 2006 Jun;31(6):1067-87. Epub 2006 Apr 27.

lead_sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_facility: Centre de Recherche en Nutrition Humaine Rhone Alpes


title: Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases

acronym: Prolacsein

summary:
Prolactin is known to play an important role in breast development and differentiation. Thus proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative processes.

The aim of this project is to identify and to characterize new mutants of the prolactin receptor gene within cohorts of benign or malign breast diseases with low or high occurrence frequency in human populations

time_perspective: Cross-Sectional

intervention_type: Other


title: What Part Does the Premotor Cortex Play in Subjective Visual Perception and in the Perception of Others' Actions?

summary: This project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. It includes a test where we ask subjects to detect visual information in front of a computer screen, and another test where we ask them to imitate finger movements.

status: Terminated

status_simplified: Unknown


title: Evaluation of in Vitro NMR Spectroscopy to Identify Inborn Errors of Metabolism in Patients With Complex Neurological Diseases

acronym: SPECMET

summary:
The search for metabolic abnormalities in patients with neurological disorders represents an important challenge 1) to identify new potentially treatable inherited metabolic diseases, and 2) to identify biomarkers or new treatments in more common neurodegenerative or neurogenetic disorders.

This approach is currently limited by the fact that techniques aiming at identifying abnormal metabolites in human fluids (metabolomics) only detect subsets of molecules and that no general assays is available to detect abnormalities in the metabolism of complex molecules that takes place within cell organelles. As a consequence, only limited parts of the metabolism can be studied simultaneously.

The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines, cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with complex neurological diseases.

location_facility: Neurology department, Pitié-Salpêtrière Hospital


title: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma

summary: Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Béné MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.

name: Hematology Department, Rennes University Hospital, INSERM Research Unit 1236, Rennes, France;

family: Lamy

full_name: Thierry Lamy

given: Thierry

sequence: first

name: Hematology Department, Centre Hospitalier Universitaire (CHU) d’Amiens, INSERM U1245, Amiens, France;

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

sequence: additional

name: Bergonié Bordeaux Institute and Bordeaux University, Bordeaux, France;

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

name: Hematology and Cell Therapy Department, Clinical Investigation Center (CIC) INSERM U1415, CHU de Tours, Université François Rabelais, Tours, France;

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

name: Hematology Department, CHU Montpellier, Centre National de la Recherche Scientifique (CNRS) Unité Mixte de Recherche (UMR) 5235, Montpellier, France;

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

name: Hematology and Cell Therapy Department, University Hospital of Bordeaux, Bordeaux, France;

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

name: Onco Hematology Department, Hospital University Grenoble, INSERM U1209, CNRS UMR 5309, Université Grenoble Alpes, Site Santé, La Tronche, Grenoble, France;

family: Gressin

full_name: Rémy Gressin

given: Rémy

name: Hematology Department, Cancer Institute Lucien Neuwirth, Saint-Priest-en-Jarez, France;

family: Cornillon

full_name: Jérôme Cornillon

given: Jérôme

name: Hematology Department, Centre Hospitalier de la Côte Basque, Bayonne, France;

family: Banos

full_name: Anne Banos

given: Anne

name: Hematology Department, Clinique Victor Hugo, Le Mans, France;

family: Le Du

full_name: Katell Le Du

given: Katell

name: Radiotherapy Department, Centre Eugène Marquis, Rennes, France;

family: Benchalal

full_name: Mohamed Benchalal

given: Mohamed

name: Hematology Department, CHU d’Angers, Angers, France;

family: Moles

full_name: Marie-Pierre Moles

given: Marie-Pierre

name: Hematology Department, CHU de Nantes, University of Nantes, INSERM team 10 UMR 892, Institut de Recherche en Santé de l’Université de Nantes, CIC Hospital Hôtel Dieu, Nantes, France;

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

name: Oncology Department, Médicale-Pôle Santé République, Clermont-Ferrand, France;

family: Fleury

full_name: Joel Fleury

given: Joel

name: Hematology Department, Centre Hospitalier de Vannes, Vannes, France;

family: Godmer

full_name: Pascal Godmer

name: Hematology Department, Centre Hospitalier Départemental de Vendée, La Roche-Sur-Yon, France;

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

name: Hematology Department, Centre Hospitalier Regional Universitaire Besançon, INSERM UMR 1098, Université de Franche-Comté, Besançon, France;

family: Deconinck

full_name: Eric Deconinck

given: Eric

name: Hematology Department, Rennes University Hospital, INSERM UMR 1236, Rennes, France;

family: Houot

full_name: Roch Houot

given: Roch

name: Hematology Department, Centre Hospitalier du Mans, Le Mans, France;

family: Laribi

full_name: Kamel Laribi

given: Kamel

name: Hematology and Cell Therapy Department, CIC U1415, Department EA4666, CHU Amiens, Amiens, France;

family: Marolleau

full_name: Jean Pierre Marolleau

given: Jean Pierre

name: Hematology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France;

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

name: Health Network of Pays de Loire, Nantes, France;

family: Branger

full_name: Bernard Branger

name: Nuclear Medicine Department, Centre Eugène Marquis, Rennes, France;

family: Devillers

full_name: Anne Devillers

name: Imaging Nuclear Medicine Department and Radiopharmaceutical and Bioclinical Department, CHU de Grenoble, INSERM U1039, Grenoble University, Grenoble, France;

family: Vuillez

name: INSERM UMR 1236, Rennes University, Etablissement Français du Sang and Laboratoire d’Hématologie, CHU de Rennes, Rennes, France;

name: Hematology and Cell Therapy Department, CIC INSERM U1415, CHU de Tours, Université François Rabelais, Tours, France;

name: Pathology Department, CHU Montpellier, Montpellier, France;

name: Hematology Biology, Nantes University Hospital, Nantes, France; and

name: Hematology and Cell Therapy Department, CIC INSERM U1415, CHU de Poitiers, and CIC INSERM 1402, Université de Poitiers, Poitiers, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.

name: Université François-Rabelais de Tours, National Center for Scientific Research (CNRS), Genetics, Immunotherapy, Chemistry, and Cancer (GICC), UMR 7292, Tours, France;

name: Department of Clinical Hematology, Centre Hospitalier Universitaire (CHU) Dijon, INSERM Lipids, Nutrition, Cancer (LNC) UMR 866, Dijon, France;

name: Lymphoma Study Association (LYSA) Imaging, Henri Mondor University Hospital, Créteil, France;

name: Department of Clinical Hematology, CHU Rennes, U917, Rennes 1 University, Rennes, France;

name: Department of Clinical Hematology, CHU Lille, Groupe de Recherches sur les formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;

name: Department of Hematology, Hospices Civils de Lyon, Université Claude Bernard Lyon-1, France;

name: Department of Hematology and Cell Therapy, Clinical Investigations Center INSERM U1415, CHU Tours, Tours, France;

name: Lymphoid Malignancies Unit, Henri Mondor University Hospital, Assistance Publique – Hôpitaux de Paris and Universités Paris-Est Créteil (UPEC), Créteil, France;

name: Department of Hematology, CHU Angers, Angers, France;

name: Department of Hematology, CHU Nancy, Nancy, France;

name: Lymphoma Academic Research Organization, CHU Lyon-Sud, Lyon, France;

name: Laboratory of Pharmacology-Toxicology, CHU Tours, Tours, France;

name: Department of Hematology, CHU Montpellier, Montpellier, France; and

name: University of Montpellier, CNRS UMR 5235, Montpellier, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - uB


title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

summary:
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.

family: Kassai

full_name: B. Kassai

given: B.

family: Rabilloud

full_name: M. Rabilloud

given: M.

family: Dantony

full_name: E. Dantony

given: E.

family: Grousson

full_name: S. Grousson

given: S.

family: Revol

full_name: O. Revol

given: O.

family: Malik

full_name: S. Malik

family: Ginhoux

full_name: T. Ginhoux

given: T.

family: Touil

full_name: N. Touil

given: N.

family: Chassard

full_name: D. Chassard

given: D.

family: Pereira de Souza Neto

full_name: E. Pereira de Souza Neto

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Anaesthesia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon


title: A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS

summary:
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Institut Paoli-Calmettes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

intervention_type: Procedure


title: Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

acronym: EFU

summary: The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.


title: Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

acronym: LICITE

summary: The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

location_facility: Service de Médecine Physique et de Réadaptation - Hôpital BICHAT


title: Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

summary: The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

lead_sponsor: Bayer


title: Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.

summary: The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations


title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy

acronym: NEURODIAB

summary: The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.

ReferenceCitation: Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Saïd S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.

family: Lecleire-Collet

full_name: Amélie Lecleire-Collet

given: Amélie

name: the Center for Clinical Investigation 503 INSERM, Centre Hospitalier National d'Ophtalmologie des XV–XX, Pierre et Marie Curie, Paris 6 University, Paris, France.

family: Audo

full_name: Isabelle Audo

given: Isabelle

name: the Clinical Research Unit, Hôpital Fernand Widal, Assistance Publique-Hôpitaux de Paris, Paris 7 University, Paris, France; and

family: Aout

full_name: Mounir Aout

given: Mounir

family: Girmens

full_name: Jean-François Girmens

given: Jean-François

family: Sofroni

full_name: Rénata Sofroni

given: Rénata

family: Erginay

full_name: Ali Erginay

given: Ali

family: Le Gargasson

full_name: Jean-François Le Gargasson

family: Mohand-Saïd

full_name: Saddek Mohand-Saïd

given: Saddek

name: Internal Medicine B, Hôpital Lariboisière, and

family: Meas

full_name: Taly Meas

given: Taly

family: Guillausseau

full_name: Pierre-Jean Guillausseau

given: Pierre-Jean

family: Vicaut

full_name: Eric Vicaut

family: Paques

full_name: Michel Paques

given: Michel

name: From the Departments of Ophthalmology and the 2Center for Clinical Investigation 503 INSERM, Centre Hospitalier National d'Ophtalmologie des XV–XX, Pierre et Marie Curie, Paris 6 University, Paris, France.

family: Massin

full_name: Pascale Massin

given: Pascale

journal_name: Investigative Opthalmology & Visual Science

oa_host_type: repository

evidence: oa repository (via OAI-PMH title match)

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: Evaluation of Retinal Function and Flicker Light-Induced Retinal Vascular Response in Normotensive Patients with Diabetes without Retinopathy


title: Evaluation of a Mechanical Insufflation-exsufflation Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders: a Prospective, Randomized, Controlled, Multicenter Study

acronym: Nemucough

summary: The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a decrease in the number of intubations and more rapid clinical improvement in children and adults with neuromuscular disease who are admitted for an acute respiratory exacerbation.In this prospective, randomised, multicenter study, 55 patients will be treated with standard treatment and a MI-E, and 55 patients with standard treatment and standard respiratory physiotherapy. The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group). The main secondary objectives are a reduction in hospital stay and an improvement in clinical condition, dyspnea and respiratory muscle function.

location_facility: Hospital Armand Trousseau, Pediatric Pulmonology Department and INSERM UMR S-893

intervention_type: Device


title: Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.

acronym: VIVA

summary: The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of superior functions, with loss of autonomy, behaviour and mood degradation, associated with physical disabilities. The work hypothesis is that a loss of sensorial functions, particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of communication with outside circle. The protocol consists in investigating superior functions, autonomy, and behaviour troubles of the participating patients, with the help of a series of neuropsychological tests used one month before and three months after cataract operation on the eye with the worst vision. Independently of the study, patients must have given an informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim of the study is to evaluate whether the cataract surgery improves patients' behaviour, autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main objective targets to cataract surgery benefice on patients suffering from both Alzheimer's disease and impeding cataract, aiming to improve behaviour troubles. The specific objective is to measure this benefice in correlation with visual acuity improvement.

intervention_type: Behavioral


title: A Double Blind Randomized, Placebo-controlled, Cross-over Trial to Evaluate the Efficiency of a Mouthrinse, Containing Red Grape Seed Extract and nicométhanol Fluorhydrate, in the Control of Dental Plaque Deposit in a 4-days Plaque Regrowth Model

acronym: Bain de bouche

summary:
The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits.

The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.

ReferenceCitation: Addy M. Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures. Int Dent J. 1995 Jun;45(3):185-96. Review.

ReferenceCitation: Guidelines for acceptance of chemotherapeutic products for the control of supragingival dental plaque and gingivitis. Council on Dental Therapeutics. J Am Dent Assoc. 1986 Apr;112(4):529-32.

ReferenceCitation: Yates RJ, Shearer BH, Morgan R, Addy M. A modification to the experimental gingivitis protocol to compare the antiplaque properties of two toothpastes. J Clin Periodontol. 2003 Feb;30(2):119-24.

ReferenceCitation: Furiga A, Lonvaud-Funel A, Dorignac G, Badet C. In vitro anti-bacterial and anti-adherence effects of natural polyphenolic compounds on oral bacteria. J Appl Microbiol. 2008 Nov;105(5):1470-6. doi: 10.1111/j.1365-2672.2008.03882.x. Epub 2008 Sep 13.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet


type: Registry Identifier

title: Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.

acronym: EXAOS

summary:
The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.

The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.

Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.

Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.

Methodology: Test physiopathological parallel group, controlled, randomized.

lead_sponsor: University Hospital, Grenoble


title: MESenchymal Stem Cells: Alterations in GEnome

acronym: MESSAGE

summary: The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.

lead_sponsor: Nantes University Hospital


title: Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact

acronym: SNA&Sepsis

summary: Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.


title: Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic

acronym: BIO-IRA

summary:
Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.

We propose to determine the more relevant marker combination in this case.


title: Chronic Pain After Thoracotomy, an Incidence Study in a Single Surgical Center

summary: Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for development of chronic pain are investigated. Questionnaire survey.

time_perspective: Retrospective

lead_sponsor: Hopital Foch


title: Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients

acronym: PICCO-LungT

summary: Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation


title: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

summary:
Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it lacks objective evaluation methods.

The aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effectiveness of Routine Fetal RhD Genotyping for RhD- Pregnant Women

acronym: GENIFERH

summary: The study is divided in two sub-studies. The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women: the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management, i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13 maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support; it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies.

ReferenceCitation: Branger B, Winer N. [Epidemiology of anti-D allo-immunization during pregnancy]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S87-1S92. Review. French.

ReferenceCitation: Parant O. [Comparison of the efficacy of different methods for the prevention of anti-D allo-immunization during pregnancy: targeted strategy limited to risk situations or associated with systematic prevention in the 3rd trimester]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S93-1S103. Review. French.

ReferenceCitation: Bennett PR, Le Van Kim C, Colin Y, Warwick RM, Chérif-Zahar B, Fisk NM, Cartron JP. Prenatal determination of fetal RhD type by DNA amplification. N Engl J Med. 1993 Aug 26;329(9):607-10.

ReferenceCitation: Aubin JT, Le Van Kim C, Mouro I, Colin Y, Bignozzi C, Brossard Y, Cartron JP. Specificity and sensitivity of RHD genotyping methods by PCR-based DNA amplification. Br J Haematol. 1997 Aug;98(2):356-64.

ReferenceCitation: Lo YM, Corbetta N, Chamberlain PF, Rai V, Sargent IL, Redman CW, Wainscoat JS. Presence of fetal DNA in maternal plasma and serum. Lancet. 1997 Aug 16;350(9076):485-7.

ReferenceCitation: Lo YM, Tein MS, Lau TK, Haines CJ, Leung TN, Poon PM, Wainscoat JS, Johnson PJ, Chang AM, Hjelm NM. Quantitative analysis of fetal DNA in maternal plasma and serum: implications for noninvasive prenatal diagnosis. Am J Hum Genet. 1998 Apr;62(4):768-75.

ReferenceCitation: Brossard Y, Sender A, Cartron JP, Huchet J, Pinon F, Blot P, David G. [Value of RHD fetal genotyping in the prevention of anti-D immunization]. Bull Acad Natl Med. 2001;185(2):329-36. French.

ReferenceCitation: Faas BH, Beuling EA, Christiaens GC, von dem Borne AE, van der Schoot CE. Detection of fetal RHD-specific sequences in maternal plasma. Lancet. 1998 Oct 10;352(9135):1196.

ReferenceCitation: Rouillac-Le Sciellour C, Puillandre P, Gillot R, Baulard C, Métral S, Le Van Kim C, Cartron JP, Colin Y, Brossard Y. Large-scale pre-diagnosis study of fetal RHD genotyping by PCR on plasma DNA from RhD-negative pregnant women. Mol Diagn. 2004;8(1):23-31.

ReferenceCitation: Colin Y, Chérif-Zahar B, Le Van Kim C, Raynal V, Van Huffel V, Cartron JP. Genetic basis of the RhD-positive and RhD-negative blood group polymorphism as determined by Southern analysis. Blood. 1991 Nov 15;78(10):2747-52.

ReferenceCitation: Singleton BK, Green CA, Avent ND, Martin PG, Smart E, Daka A, Narter-Olaga EG, Hawthorne LM, Daniels G. The presence of an RHD pseudogene containing a 37 base pair duplication and a nonsense mutation in africans with the Rh D-negative blood group phenotype. Blood. 2000 Jan 1;95(1):12-8.

ReferenceCitation: Geifman-Holtzman O, Grotegut CA, Gaughan JP. Diagnostic accuracy of noninvasive fetal Rh genotyping from maternal blood--a meta-analysis. Am J Obstet Gynecol. 2006 Oct;195(4):1163-73.

ReferenceCitation: Lo YM, Hjelm NM, Fidler C, Sargent IL, Murphy MF, Chamberlain PF, Poon PM, Redman CW, Wainscoat JS. Prenatal diagnosis of fetal RhD status by molecular analysis of maternal plasma. N Engl J Med. 1998 Dec 10;339(24):1734-8.

ReferenceCitation: Finning K, Martin P, Daniels G. A clinical service in the UK to predict fetal Rh (Rhesus) D blood group using free fetal DNA in maternal plasma. Ann N Y Acad Sci. 2004 Jun;1022:119-23.

ReferenceCitation: van der Schoot CE. Molecular diagnostics in immunohaematology. Vox Sang. 2004 Jul;87 Suppl 2:189-92. Review.

ReferenceCitation: Cortey A, Brossard Y, Beliard R, Bourel D. [Prevention of fetomaternal rhesus-D allo-immunization. Perspectives]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S119-1S122. Review. French.

ReferenceCitation: Zimmermann B, El-Sheikhah A, Nicolaides K, Holzgreve W, Hahn S. Optimized real-time quantitative PCR measurement of male fetal DNA in maternal plasma. Clin Chem. 2005 Sep;51(9):1598-604. Epub 2005 Jul 14.

ReferenceCitation: Chan KC, Ding C, Gerovassili A, Yeung SW, Chiu RW, Leung TN, Lau TK, Chim SS, Chung GT, Nicolaides KH, Lo YM. Hypermethylated RASSF1A in maternal plasma: A universal fetal DNA marker that improves the reliability of noninvasive prenatal diagnosis. Clin Chem. 2006 Dec;52(12):2211-8. Epub 2006 Oct 26.

ReferenceCitation: Daniels G, van der Schoot CE, Olsson ML. Report of the Second International Workshop on molecular blood group genotyping. Vox Sang. 2007 Jul;93(1):83-8.

ReferenceCitation: Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review.

ReferenceCitation: Darlington M, Carbonne B, Mailloux A, Brossard Y, Levy-Mozziconacci A, Cortey A, Maoulida H, Simon T, Rousseau A, Durand-Zaleski I; GENIFERH1 Study Group. Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women. BMC Pregnancy Childbirth. 2018 Dec 14;18(1):496. doi: 10.1186/s12884-018-2114-5.

family: Darlington

full_name: Meryl Darlington

given: Meryl

family: Carbonne

full_name: Bruno Carbonne

given: Bruno

family: Mailloux

full_name: Agnès Mailloux

given: Agnès

family: Brossard

full_name: Yves Brossard

given: Yves

family: Levy-Mozziconacci

full_name: Annie Levy-Mozziconacci

given: Annie

family: Cortey

full_name: Anne Cortey

given: Anne

family: Maoulida

full_name: Hassani Maoulida

given: Hassani

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

currency_apc_doaj: GBP

journal_name: BMC Pregnancy and Childbirth

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot


title: Identification of Large-Scale Mutations of POLG Gene by QMPSF in Patients With Mitochondrial DNA Instability.

summary:
Mitochondrial diseases are a heterogeneous group caused by genetic defects in mitochondrial DNA or in nuclear genes. POLG is the most frequently involved gene in mtDNA instability diseases resulting in mtDNA multiple deletion and/or depletion. It encodes the DNA polymerase gamma (POLγ), the only known DNA polymerase found in mammalian mitochondria. Mutations in POLG could explain 45% of familial progressive external ophtalmoplegia associated with multiple mtDNA deletions. However, in more than 70%, the analysis of the genes involved in mtDNA instability remains unsuccessful.

To date, these genes are screened by sequencing methods that are not able to detect large-scale rearrangements. In order to detect possible large-scale rearrangements, the investigators propose to develop a new assay based on QMPSF (Quantitative Multiplex PCR of Short fluorescent Fragments) able to detect exon deletions and duplications. the investigators propose to screen the POLG gene by QMPSF in at least twenty patients with either no mutation or only one mutation detected in POLG and no mutation in other genes such as TWINKLE and ANT1.

This study would allow the investigators to know if large-scale rearrangements occur in the POLG gene and to estimate their frequency in patients with mtDNA instability. These data are important to know if the sequencing analysis of POLG should be completed by the screening for partial deletions and duplications to ensure an accurate molecular diagnosis of these syndromes. Moreover, this method could be extended to ANT1 and TWINKLE genes.

status: Unknown status

location_facility: Centre Hospitalier Universitaire de Nice- Hôpital ARCHET 2 -Laboratoire de Génétique Médicale

intervention_type: Genetic


title: Impact of a Geriatric Mobile Unit on the Screening of Psycho-cognitive Troubles in Internal Medicine Departments and Circumstances of Calling in This Unit.

acronym: EMG

summary: The main objective of the study is to assess the rate of patients with psycho-cognitive troubles among hospitalised elderly patients.

location_facility: Hopital Louis Mourier, Assistance Publique Hopitaux de Paris


title: Assessment of Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation

summary:
Goals of the study :

To study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine
To establish reference values of thyroid function at different stages of pregnancy (3 trimesters)
To precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

primary_purpose: Prevention

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

intervention_type: Dietary Supplement


title: Assessment of Sleep Disturbance in Alzheimer Disease

summary:
The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.

This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings

primary_purpose: Basic Science

location_facility: Centre Mémoire de Ressources et de Recherche, CHU de Nice


title: Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.

acronym: ICEP

summary: Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.

lead_sponsor: University Hospital, Caen


title: Pompe Prevalence Study in Patients With Muscle Weakness Without Diagnosis

acronym: POPS

summary:
An international consensual group recommends confirming the diagnosis of the Pompe disease after a dried blood spot (DBS) with a dosage of the enzymatic activity in other tissue. This strategy is currently used in the usual practice.

The aim is evaluate the prevalence of the Pompe disease among patients with progressive limb girdle muscular weakness and/or axial deficiency, and/or respiratory insufficiency. The diagnosis will be confirmed using DBS.


title: Efficacy and Safety of Combination Therapies With Oseltamivir & Zanamivir or Oseltamivir & Amantadine Versus Oseltamivir Monotherapy in the Treatment of Seasonal Influenza A Infection

acronym: Combina

summary:
Neuraminidase inhibitors (NAI) are effective anti-influenza antiviral treatment. During their use in experimentally infected patients, it has been shown that the viral load detected in the nasal fluid is decreasing significantly faster than in non treated patients. During clinical practice, the emergence of NAI-resistant strains has been observed. These strains remain rare, but their emergence seemed to be related to the mis-use of the NAI products (insufficient duration or dosage). This observation as well as the detection of NAI-resistant viruses in the community raises concerns about putative emergence of resistant clones in the specific context of a pandemic, when the use of NAI will be very large in the aim of reducing transmission, and subsequently the impact of the emerging virus.

In this context, it is important to determine the putative interest of alternative strategies.

Although zanamivir and oseltamivir are both issued from the same class , this combination may lead to a more rapid viral clearance in the infected cases, and to a reduction in the emergence of resistant sub-clones, and alternatively, might lead to a competitive inhibition. The evaluation of these combinations needs to be conducted in vivo.

Among available anti influenza antivirals, M2 blockers have been previously used. Although their efficacy against A H5N1 remains to be ascertained, their use in combination with NAI should also be evaluated in the context of a preparation for a possible pandemic and determination of the stockpile.

Therefore, the evaluation of combination therapies in the treatment of a virologically suspected influenza will be investigated in primary care during the winter season 2008-2009.

study_completion_date_type: Anticipated


title: Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT

acronym: CT-Nav

summary: The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.

ReferenceCitation: Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.

family: Robert

full_name: Adeline L.G. Robert

given: Adeline L.G.

family: Chagnon

full_name: Grégory Chagnon

given: Grégory

family: Bricault

full_name: Ivan Bricault

given: Ivan

family: Cinquin

full_name: Philippe Cinquin

given: Philippe

family: Moreau-Gaudry

full_name: Alexandre Moreau-Gaudry

given: Alexandre

journal_name: Journal of the Mechanical Behavior of Biomedical Materials

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

version: submittedVersion

evidence: oa repository (via OAI-PMH title and first author match)

lead_sponsor: AdministrateurCIC


title: Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)

acronym: PRIOD

summary: The purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.


title: The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

acronym: anémie

summary: Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

lead_sponsor: University Hospital, Limoges

intervention_type: Biological


title: Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients

summary: Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.


title: Assessment of Efficacy and Safety of Continuous Wound Infiltration With Local Anesthesics Through a Parietal Paravertebral Catheter for Postoperative Analgesia After Posterior Lumbar Arthrodesis

acronym: ICALP

summary:
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. The application of opioids are the most frequently used therapies for postoperative pain relief but it very often results side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. In the setting of spine surgery, a single bolus administration of a local anesthetic is a useful method (with a reduction in parenteral morphine consumption during the 48 first hours) but has a limited effect because of its short duration of action. Prolonged administration through a multi-holed catheter positioned by the surgeon at the end of the procedure could increase the duration of action and may thereby improve the efficacy of local wound infiltration. Easy and effective, this new modality of administration has expanded the indications for parietal infiltrations toward major painful procedures.

We designed this study to determine whether local anesthetic (compared with saline solution) continuous wound infiltration during the first two days after posterior lumbar arthrodesis on degenerative spine, could improve postoperative analgesia at short-term but particularly at mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar pains (resulting in best life quality, opioid consumption limited and rehabilitation hastened) and postoperative hyperalgesia areas. The postoperative analgesic and antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and the safety of opioid administration and multi-holed parietal catheter will be compared in the two groups (control and study).


title: Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD

summary:
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.


title: Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

summary: Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy

lead_sponsor: University Hospital, Clermont-Ferrand


title: Exploratory Study of Natural Killer Cells in Human Skin

summary: Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de Dermatologie- Hopital Sainte Marguerite


lead_sponsor: Ipsen

acronym: EGB 761 in FRIEDREICH ATAXIA

type: EudraCT Number

source: euctr

title: Efficacy of EGb761 120mg Bid Versus Placebo in Patients Suffering From Friedreich Ataxia. A 3 Month, Phase II, Randomised, Double Blind, Placebo Controlled, Parallel Group Clinical Study.

summary: The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia


title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position

summary: The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.

lead_sponsor: Datascope Corp.


title: Immune Status of Elderly Population Admitted in an Acute Geriatric Unit

summary:
Ageing is associated with vulnerability against infections leading to increased morbidity with risk of death. Innate and adaptive immunities are altered with ageing responsible of deficits in immune response against pathogens and after vaccination, and favouring the elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal infections.

If immunity has been widely studied in immunosenescence, there are few prospective, comparative studies with elderly ill patients. Moreover among these studies, pathologies are not well defined.

The main objective of our project is to compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected with strict criteria, in order to precise the impact of polypathology and of various pathologies on immunity state.

location_facility: HOPITAL DE SAINTE MARGUERITE Service de Gériatrie Sud


title: Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery

summary:
Because local anesthetic infiltration has not been comparated to continuous infusion after spine fusion surgery, the investigators designed this study to determine whether this technique could enhance analgesia and improve patient outcome after posterior lumbar arthrodesis.

The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours.

In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL, and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.

The secondary outcomes are the consumption of morphine,the rate of the nausea and the postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration of hospital stay and the persistence of residual pain.


title: Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

summary: The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality at 30 days in case of subarachnoid hemorrhage.

ReferenceCitation: Litrico S, Almairac F, Gaberel T, Ramakrishna R, Fontaine D, Sedat J, Lonjon M, Paquis P. Intraventricular fibrinolysis for severe aneurysmal intraventricular hemorrhage: a randomized controlled trial and meta-analysis. Neurosurg Rev. 2013 Oct;36(4):523-30; discussion 530-1. doi: 10.1007/s10143-013-0469-7. Epub 2013 May 2.

family: Litrico

full_name: Stephane Litrico

given: Stephane

family: Almairac

full_name: Fabien Almairac

given: Fabien

family: Gaberel

full_name: Thomas Gaberel

given: Thomas

family: Ramakrishna

full_name: Rohan Ramakrishna

given: Rohan

family: Fontaine

full_name: Denys Fontaine

given: Denys

family: Sedat

full_name: Jacques Sedat

given: Jacques

family: Lonjon

full_name: Michel Lonjon

family: Paquis

full_name: Philippe Paquis

journal_name: Neurosurgical Review

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_facility: Neurosurgery department , Nice University Hospital


title: A Controlled Study of rTMS Over Supplementary Motor Area (SMA) in Obsessive Compulsive Disorder

acronym: TMS-TOC

summary: Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non invasive method of cerebral modulation) in patients suffering from chronic obsessive compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5 sessions each week), and its effects on OCD symptoms will be compared to those of a "sham" (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned to the comparison group. The maintenance of the therapeutic effects will be explored during 8 weeks following the end of the treatment. In addition to classical scales used to measure the treatment effects, all patients will be examined using a functional magnetic resonance imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of the Pharmacokinetic, Pharmacodynamic, Pharmacogenetic Relationships of Morphine and Metabolites After Severe Postoperative Pain in Adults

summary: The main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs sub acute).

ReferenceCitation: Aubrun F, Zahr N, Langeron O, Boccheciampe N, Cozic N, Belin L, Hulot JS, Khiami F, Riou B. Opioid-related genetic polymorphisms do not influence postoperative opioid requirement: A prospective observational study. Eur J Anaesthesiol. 2018 Jul;35(7):496-504. doi: 10.1097/EJA.0000000000000793.

family: Aubrun

full_name: Frédéric Aubrun

given: Frédéric

family: Zahr

full_name: Noël Zahr

given: Noël

family: Langeron

full_name: Olivier Langeron

given: Olivier

family: Boccheciampe

full_name: Nicolas Boccheciampe

given: Nicolas

family: Cozic

full_name: Nathalie Cozic

given: Nathalie

family: Belin

full_name: Lisa Belin

given: Lisa

family: Hulot

full_name: Jean-Sebastien Hulot

given: Jean-Sebastien

family: Khiami

full_name: Frederic Khiami

given: Frederic

family: Riou

full_name: Bruno Riou

given: Bruno

bso_classification: Chemistry

journal_name: European Journal of Anaesthesiology

oa_host_type: publisher

evidence: open (via free article)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation

acronym: OPTIDUAL

summary: To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.

ReferenceCitation: Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E; OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J. 2016 Jan 21;37(4):365-74. doi: 10.1093/eurheartj/ehv481. Epub 2015 Sep 12.

family: Helft

full_name: Gérard Helft

given: Gérard

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Le Feuvre

full_name: Claude Le Feuvre

given: Claude

family: Georges

full_name: Jean-Louis Georges

given: Jean-Louis

family: Carrie

full_name: Didier Carrie

given: Didier

family: Dreyfus

full_name: Xavier Dreyfus

given: Xavier

family: Furber

full_name: Alain Furber

given: Alain

family: Leclercq

full_name: Florence Leclercq

given: Florence

family: Eltchaninoff

full_name: Hélène Eltchaninoff

given: Hélène

family: Falquier

full_name: Jean-François Falquier

given: Jean-François

family: Henry

full_name: Patrick Henry

given: Patrick

family: Cattan

full_name: Simon Cattan

given: Simon

family: Sebagh

full_name: Laurent Sebagh

given: Laurent

family: Michel

full_name: Pierre-Louis Michel

given: Pierre-Louis

family: Tuambilangana

full_name: Albert Tuambilangana

given: Albert

family: Hammoudi

full_name: Nadjib Hammoudi

given: Nadjib

family: Boccara

full_name: Franck Boccara

given: Franck

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Douard

full_name: Hervé Douard

given: Hervé

family: Diallo

full_name: Abdourahmane Diallo

given: Abdourahmane

family: Berman

full_name: Emmanuel Berman

given: Emmanuel

family: Komajda

full_name: Michel Komajda

given: Michel

family: Metzger

full_name: Jean-Philippe Metzger

given: Jean-Philippe

ReferenceCitation: Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.

location_facility: Hopital la Pitié Salpêtrière Institut de Cardiologie


title: Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis

summary: The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.

location_facility: department of dermatology, Nice University Hospital


title: Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy

acronym: ADIPOKINES

summary:
Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels

Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients who developed LD versus those who did not developed LD during the first 3 months of a systemic therapy with corticosteroids

Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and PPARg in fat samples of patients before and after treatment with systemic corticosteroids and between LD+ and LD-patients To compare the fat morphology before and after treatment with glucosteroids


title: Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy

summary: It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo).

lead_sponsor: Department of Clinical Research and Innovation


title: Markers of Glomerular Filtration Rate in the HIV Infected Patient - Role of Body Composition

acronym: HIVERS

summary:
Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease. Patients survival has dramatically improved but complications may occur that need to be prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney disease, an affection that is not symptomatic until a very late stage secondary to HIV infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal function should be regularly assessed in HIV patients to perform early diagnosis for chronic kidney disease and allow initiation of preventive measures aimed at preserving renal function.

Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of renal function. Other markers like cystatin C may be used. None of these markers has been validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the gold standard measurement of glomerular renal function.


title: Study of Deep Brain Stimulation of the Pedunculo-pontin Nucleus (PPN) for the Treatment of Gait and Balance Disturbances in Patients With Parkinson's Disease (PPN-GAB-PARK Study)

summary: Disturbance of posture, gait and balance usually appear several years after Parkinson's disease (PD) onset. These axial signs, generally resistant to conventional drug and non-drug treatment, can generate a loss of autonomy and traumatic complications. Improvement of these axial signs by deep brain stimulation (DBS) of the pedunculo-pontin nucleus (PPN) has been described for a small number of patients. The objectives of the present prospective monocentric pilot study are to determine the optimal stimulation parameters of PPN-DBS, to evaluate the long term tolerance and the effect of PPN-DBS on axial signs and quality of life in five patients with severe PD. The use of detailed clinical rating scales and quantitative computer-based gait analysis will allow to identify the optimal stimulation parameters and relevant clinical efficacy parameters, mandatory for the design of further comparative large-scale studies.

location_facility: Neurology, Neurosugery of Nice University Hospital


summary: The investigators evaluated clinical tolerance, biological tolerance, feasibility and efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10 patients with facioscapulohumeral muscular dystrophy, the third most common inherited myopathy.

ReferenceCitation: Colson SS, Benchortane M, Tanant V, Faghan JP, Fournier-Mehouas M, Benaïm C, Desnuelle C, Sacconi S. Neuromuscular electrical stimulation training: a safe and effective treatment for facioscapulohumeral muscular dystrophy patients. Arch Phys Med Rehabil. 2010 May;91(5):697-702. doi: 10.1016/j.apmr.2010.01.019.

family: Colson

full_name: Serge S. Colson

given: Serge S.

family: Benchortane

full_name: Michaël Benchortane

given: Michaël

family: Tanant

full_name: Véronique Tanant

given: Véronique

family: Faghan

full_name: Jean-Paul Faghan

given: Jean-Paul

family: Fournier-Mehouas

full_name: Manuela Fournier-Mehouas

given: Manuela

family: Benaïm

full_name: Charles Benaïm

given: Charles

family: Desnuelle

full_name: Claude Desnuelle

given: Claude

family: Sacconi

full_name: Sabrina Sacconi

given: Sabrina

journal_name: Archives of Physical Medicine and Rehabilitation

title: Neuromuscular Electrical Stimulation Training: A Safe and Effective Treatment for Facioscapulohumeral Muscular Dystrophy Patients


title: Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.

lead_sponsor: Centre Leon Berard

intervention_type: Radiation


title: Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.

acronym: PK-rituximab

summary:
Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.

The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.

The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.

primary_purpose: Other

ReferenceCitation: Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease. Br J Clin Pharmacol. 2013 Nov;76(5):734-40. doi: 10.1111/bcp.12098.

name: Pharmacie; Centre Hospitalier Universitaire; Toulouse France

name: EA4553; Université Paul Sabatier and Institut Claudius-Regaud; Toulouse France

family: Puisset

full_name: Florent Puisset

given: Florent

family: White-Koning

full_name: Mélanie White-Koning

given: Mélanie

name: Département de néphrologie et transplantation d'organe CHU Rangueil; Toulouse France

name: INSERM U1043; IFR-BMT; CHU Purpan; Toulouse France

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Huart

full_name: Antoine Huart

given: Antoine

family: Haberer

full_name: Frédérique Haberer

given: Frédérique

name: Laboratoire de Biochimie et Biologie Moléculaire; CHU de Tours; INSERM U930; Université François Rabelais; Tours France

family: Blasco

full_name: Hélène Blasco

given: Hélène

name: EA4245 ‘Cellules dendritiques, immunomodulation et greffes’; Université François Rabelais; de Tours France

family: Le Guellec

full_name: Chantal Le Guellec

given: Chantal

family: Lafont

full_name: Thierry Lafont

given: Thierry

family: Grand

full_name: Anaïs Grand

given: Anaïs

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Chatelut

full_name: Etienne Chatelut

given: Etienne

family: Pourrat

full_name: Jacques Pourrat

given: Jacques

journal_name: British Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Toulouse


title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia

acronym: Dolastron

summary:
This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).

Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.

This treatment will be renewed after one month, after 2 months and after 3 months.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.


title: Functional Exploration of the Immune Response Using the B-Subunit of Cholera Toxin Administered by Mucosal Way in Healthy Adult Volunteer: Potential Role in Development of Vaccine Processes

summary: It is a biomedical research without direct individual benefit, exploring and comparing the mucosal immune response after oral, nasal and sublingual administration of B-subunit of non-toxic cholera toxin (CTB) in healthy adult volunteers.

location_facility: Laboratoire d'anatomo-pathologie, hôpital Pasteur


title: Evaluation of the Value Forecasts of the Identification of the Circulating Tumoral Cells (CTC) in the Broncho-lung Carcinomas Not in Small Cells of Stages I and II by the Method ISET (Insulation by Size of Epithelial Tumor Cells)

summary: The aim of this study is, i) to assess the presence and the frequency of CTC in NSCLC patients undergoing surgery by using cytopathological analysis after their isolation by size (ISET method), and, ii) to correlate the presence of CNHC with pTNM stage, histological subtype, and percentage of tumor cells present into the primary tumors.


title: Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

summary:
The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface between the body and its outside environment. Its strategic position confers it a crucial role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is slower in elderly comparatively to young subjects.

The purpose of this study is to investigate, by characterizing molecular events, the effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier function after acute disruption of stratum corneum in ederly subjects.

10 male volunteers aged from 60 to 75 years are randomized to receive topical application of ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential selloptape strips, epidermal samples of treated and control skin are removed under local anesthesia, using a dermatome. Differential gene expression analysis is performed using micro array techniques and quantitative RT-PCR.

treatment, randomized on the location, double blind, placebo control, internal control subject, prospective study.

lead_sponsor: L'Oreal

location_facility: Centre de recherche bioclinique -Hopital st louis


title: A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome

summary: Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.

ReferenceCitation: Bruckert E, Duchêne E, Bonnefont-Rousselot D, Hansel B, Ansquer JC, Dubois A, Gaymard B. Proof of concept study: does fenofibrate have a role in sleep apnoea syndrome? Curr Med Res Opin. 2010 May;26(5):1185-92. doi: 10.1185/03007991003693581.

name: Service d’Endocrinologie et Métabolisme, Assistance Publique – Hôpitaux de Paris, Hôpital de la Pitié-Salpétrière, 75013 Paris, France

family: Bruckert

full_name: Eric Bruckert

given: Eric

family: Duchêne

full_name: Emilie Duchêne

given: Emilie

family: Bonnefont-Rousselot

full_name: Dominique Bonnefont-Rousselot

given: Dominique

family: Hansel

full_name: Boris Hansel

given: Boris

name: Fournier SA, 50 rue de Dijon 21121, Daix, France

family: Ansquer

full_name: Jean-Claude Ansquer

given: Jean-Claude

family: Dubois

full_name: André Dubois

given: André

name: UMRS 975 Institut National de la Santé et de la Recherche Médicale – CNRS – Université Pierre et Marie Curie, Paris, France

family: Gaymard

full_name: Bertrand Gaymard

given: Bertrand

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Solvay Pharmaceuticals


title: Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

acronym: Neu I

summary: The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

lead_sponsor: Neurim Pharmaceuticals Ltd.


title: Comparaison de la Chromo Endoscopie Virtuelle FICE (Fujinon Intelligent Chromoendoscopy) Avec la Coloscopie Conventionnelle Dans la détection de la Dysplasie Chez Patients Porteurs de Recto Colite ulcéro hémorragique (RCH).

summary: The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy with recommended targeted and random biopsies) in the endoscopic surveillance of patient with long-standing UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using each technique. The combined histological outcome following the two procedures will represent the gold-standard diagnosis for each patient. Secondary outcomes will be the number of patients with false-positive findings, the number of neoplastic lesions detected, the number of false-positive lesions per patient for each technique and the total time required for each procedure.

location_facility: Departement d'Endoscopie digestive - Hopital Archet 2, CHU de Nice


title: Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.

acronym: FcrèchMV

summary:
Direct DNA amplification, viral isolation and specific antibody measurement in saliva

From children in day care centers (samples collection will take place during a single week)
From children coming at the emergency department of our hospital during a three months period.

Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.


title: PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial

acronym: PRALIMAP

summary: The aim of this study is to compare the effectiveness of three public health intervention strategies to reduce weight excess and obesity prevalence among teenagers within the frame of a public health program aiming at promoting healthy eating and physical activity behaviors.

ReferenceCitation: Langlois J, Omorou AY, Vuillemin A, Briançon S, Lecomte E; PRALIMAP Trial Group. Association of socioeconomic, school-related and family factors and physical activity and sedentary behaviour among adolescents: multilevel analysis of the PRALIMAP trial inclusion data. BMC Public Health. 2017 Feb 8;17(1):175. doi: 10.1186/s12889-017-4070-9.

family: Langlois

full_name: Johanne Langlois

given: Johanne

family: Omorou

full_name: Abdou Y Omorou

given: Abdou Y

family: Vuillemin

full_name: Anne Vuillemin

given: Anne

family: Briançon

full_name: Serge Briançon

given: Serge

family: Lecomte

full_name: Edith Lecomte

given: Edith

journal_name: BMC Public Health

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ParisTech

repositories:
HAL
PubMed Central

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Omorou AY, Langlois J, Lecomte E, Vuillemin A, Briançon S; PRALIMAP Trial Group. Adolescents' Physical Activity and Sedentary Behavior: A Pathway in Reducing Overweight and Obesity. The PRALIMAP 2-Year Cluster Randomized Controlled Trial. J Phys Act Health. 2015 May;12(5):628-35. doi: 10.1123/jpah.2014-0035. Epub 2014 Nov 13.

full_name: Abdou Y. Omorou

given: Abdou Y.

journal_name: Journal of Physical Activity and Health

publisher: Human Kinetics

publisher_dissemination: Human Kinetics

title: Adolescents’ Physical Activity and Sedentary Behavior: A Pathway in Reducing Overweight and Obesity: The PRALIMAP 2-Year Cluster Randomized Controlled Trial

ReferenceCitation: Bonsergent E, Agrinier N, Thilly N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF, Briançon S; PRALIMAP Trial Group. Overweight and obesity prevention for adolescents: a cluster randomized controlled trial in a school setting. Am J Prev Med. 2013 Jan;44(1):30-9. doi: 10.1016/j.amepre.2012.09.055.

title: Overweight and Obesity Prevention for Adolescents

ReferenceCitation: Legrand K, Bonsergent E, Latarche C, Empereur F, Collin JF, Lecomte E, Aptel E, Thilly N, Briançon S. Intervention dose estimation in health promotion programmes: a framework and a tool. Application to the diet and physical activity promotion PRALIMAP trial. BMC Med Res Methodol. 2012 Sep 19;12:146. doi: 10.1186/1471-2288-12-146.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

ReferenceCitation: Briançon S, Bonsergent E, Agrinier N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF; PRALIMAP Trial Group. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies. Trials. 2010 Dec 6;11:119. doi: 10.1186/1745-6215-11-119.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - uB


title: Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer

summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with kidney cancer that has spread to the brain.

lead_sponsor: Institut Claudius Regaud


title: Effects of Growth Hormone on Corticoid Myopathy in Children With Chronic Disease: Effects on Muscle Mass and Strength

summary:
Children suffering from chronic disease and receiving long-term glucocorticoid therapy suffer over years from severe growth retardation and profoundly altered body composition. They consist in a marked increase in fat mass and a decrease in lean body mass. Published studies have shown that Growth Hormone (GH) treatment in children with Juvenile Idiopathic Arthritis can improve body composition by increasing lean mass and by preventing increase in fat mass. The aim of the present protocol is to evaluate whether the increase in lean body mass observed during GH treatment is associated with changes in muscle strength and mass.

In order to be able to evaluate the effect of GH on the muscle a comparative group is needed. Therefore it will be proposed to delay in a group of patients the start of Growth Hormone(GH) treatment by 6 months. As most publications have shown a maximum effect of GH within the first year of treatment, six months should be enough to evaluate short-term effect of GH on the muscle. Therefore, this study will be a randomized trial: immediate start of Growth Hormone (GH) treatment versus start of Growth Hormone treatment 6 months later. After 6 months all children will be treated with GH. Therefore, the follow-up will be one year after baseline.

lead_sponsor: Association REMEDE


title: Etude épidémiologique Multicentrique Des Douleurs Neuropathiques Post-opératoires

acronym: EDONIS

summary: This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent pain, as well as to describe the neuropathic features of this pain. It includes more than 3000 patients scheduled for different types of surgery, some of them already known to induce persistent pain, some being frequent procedures with no additional data. Clinical and genetical risk factors will be searched.

time_perspective: Other

ReferenceCitation: Niccolaï P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchêne P, Chirat C, Soule-Sonneville S, Dualé C, Dubray C, Schoeffler P. Persistent neuropathic pain after inguinal herniorrhaphy depending on the procedure (open mesh v. laparoscopy): a propensity-matched analysis. Can J Surg. 2015 Apr;58(2):114-20.

ReferenceCitation: Blanc P, Génin E, Jesson B, Dubray C, Dualé C; EDONIS-gene Investigating group. Genetics and postsurgical neuropathic pain: An ancillary study of a multicentre survey. Eur J Anaesthesiol. 2019 May;36(5):342-350. doi: 10.1097/EJA.0000000000000986.

family: Blanc

full_name: Pierre Blanc

given: Pierre

family: Génin

full_name: Emmanuelle Génin

given: Emmanuelle

family: Jesson

full_name: Béline Jesson

given: Béline

family: Dubray

full_name: Claude Dubray

given: Claude

family: Dualé

full_name: Christian Dualé

given: Christian

ReferenceCitation: Richez B, Ouchchane L, Guttmann A, Mirault F, Bonnin M, Noudem Y, Cognet V, Dalmas AF, Brisebrat L, Andant N, Soule-Sonneville S, Dubray C, Dualé C, Schoeffler P. The Role of Psychological Factors in Persistent Pain After Cesarean Delivery. J Pain. 2015 Nov;16(11):1136-46. doi: 10.1016/j.jpain.2015.08.001. Epub 2015 Aug 20.

family: Richez

full_name: Brice Richez

given: Brice

family: Ouchchane

full_name: Lemlih Ouchchane

given: Lemlih

family: Guttmann

full_name: Aline Guttmann

given: Aline

family: Mirault

full_name: François Mirault

given: François

family: Bonnin

full_name: Martine Bonnin

given: Martine

family: Noudem

full_name: Yves Noudem

given: Yves

family: Cognet

full_name: Virginie Cognet

given: Virginie

family: Dalmas

full_name: Anne-Frédérique Dalmas

given: Anne-Frédérique

family: Brisebrat

full_name: Lise Brisebrat

given: Lise

family: Andant

full_name: Nicolas Andant

given: Nicolas

family: Soule-Sonneville

full_name: Sylvie Soule-Sonneville

given: Sylvie

family: Schoeffler

full_name: Pierre Schoeffler

ReferenceCitation: Lefebvre-Kuntz D, Dualé C, Albi-Feldzer A, Nougarède B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.

ReferenceCitation: Dualé C, Ouchchane L, Schoeffler P; EDONIS Investigating Group, Dubray C. Neuropathic aspects of persistent postsurgical pain: a French multicenter survey with a 6-month prospective follow-up. J Pain. 2014 Jan;15(1):24.e1-24.e20. doi: 10.1016/j.jpain.2013.08.014. Epub 2013 Oct 25.

title: Neuropathic Aspects of Persistent Postsurgical Pain: A French Multicenter Survey With a 6-Month Prospective Follow-Up


title: Open-label, Single Center, Uncontrolled Phase I/II Study Evaluating the Safety and Maximum Tolerated Dose of Daily Sorafenib Administered in Combination With Prolonged Temozolomide in Patients With Metastatic Melanoma

summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effect of Pioglitazone Administered to Patients With Friedreich's ATAXIA:Proof of Concept

acronym: ACTFRIE

summary:
Friedreich's ataxia (FA) is a rare progressive neurological disorder affecting approximately 1/30, 000 individuals. No treatment is presently available to counteract the neurodegeneration of this extremely severe disease.

Pioglitazone, a well known PPAR gamma (peroxysome proliferators-activated receptor gamma) ligand induces the expression of many enzymes involved in the mitochondrial metabolism, including the superoxide dismutases. This agent may be therapeutic by counteracting the disabled recruitment of antioxidant enzymes in FA patients. This potential neuroprotective agent crosses the brain blood barrier in human.

Primary objective: To explore the effects of Pioglitazone on neurological function in FA patients. We expect neurological benefits taking into account the natural course of the disease.

Population: Subjects for this study will be limited to patients not older than 25 years Methodology: Prospective, randomized double-blind trial of Pioglitazone versus placebo in FA patients. Patients will be treated two years and will undergo clinical exams and testing during three days each six months at the clinical investigation centre.

ReferenceCitation: Simon AL, Meyblum J, Roche B, Vidal C, Mazda K, Husson I, Ilharreborde B. Scoliosis in Patients With Friedreich Ataxia: Results of a Consecutive Prospective Series. Spine Deform. 2019 Sep;7(5):812-821. doi: 10.1016/j.jspd.2019.02.005.

family: Simon

full_name: Anne Laure Simon

given: Anne Laure

family: Meyblum

full_name: Jean Meyblum

given: Jean

family: Roche

full_name: Bastien Roche

given: Bastien

family: Vidal

full_name: Christophe Vidal

given: Christophe

family: Mazda

full_name: Keyvan Mazda

given: Keyvan

family: Husson

full_name: Isabelle Husson

given: Isabelle

family: Ilharreborde

full_name: Brice Ilharreborde

journal_name: Spine Deformity

evidence: open (author manuscript)

version: acceptedVersion


title: Soluble Form of the Receptor for Advanced Glycation End Products (sRAGE) Levels in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS and Severe Sepsis : an Observational Prospective Study.

summary: sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. The purpose of this observational prospective study is to determine whether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock.

ReferenceCitation: Jabaudon M, Blondonnet R, Roszyk L, Bouvier D, Audard J, Clairefond G, Fournier M, Marceau G, Déchelotte P, Pereira B, Sapin V, Constantin JM. Soluble Receptor for Advanced Glycation End-Products Predicts Impaired Alveolar Fluid Clearance in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Jul 15;192(2):191-9. doi: 10.1164/rccm.201501-0020OC.

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Blondonnet

full_name: Raiko Blondonnet

given: Raiko

family: Roszyk

full_name: Laurence Roszyk

given: Laurence

family: Bouvier

full_name: Damien Bouvier

given: Damien

family: Audard

full_name: Jules Audard

given: Jules

family: Clairefond

full_name: Gael Clairefond

given: Gael

family: Fournier

full_name: Mathilde Fournier

given: Mathilde

family: Marceau

full_name: Geoffroy Marceau

given: Geoffroy

family: Déchelotte

full_name: Pierre Déchelotte

given: Pierre

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

ReferenceCitation: Jabaudon M, Futier E, Roszyk L, Chalus E, Guerin R, Petit A, Mrozek S, Perbet S, Cayot-Constantin S, Chartier C, Sapin V, Bazin JE, Constantin JM. Soluble form of the receptor for advanced glycation end products is a marker of acute lung injury but not of severe sepsis in critically ill patients. Crit Care Med. 2011 Mar;39(3):480-8. doi: 10.1097/CCM.0b013e318206b3ca.

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Chalus

full_name: Elodie Chalus

given: Elodie

family: Guerin

full_name: Renaud Guerin

given: Renaud

family: Petit

full_name: Antoine Petit

given: Antoine

family: Mrozek

full_name: Segolene Mrozek

given: Segolene

family: Perbet

full_name: Sebastien Perbet

given: Sebastien

family: Cayot-Constantin

full_name: Sophie Cayot-Constantin

given: Sophie

family: Chartier

title: Soluble form of the receptor for advanced glycation end products is a marker of acute lung injury but not of severe sepsis in critically ill patients*


title: Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers

summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy.


type: Other Identifier

title: Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.

acronym: ETAT

summary:
Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some patients will develop tuberculosis and some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are now available.

The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy

ReferenceCitation: Freund R, Granger B, Francois C, Carcelain G, Ravaud P, Mariette X, Fautrel B. Cost-effectiveness analysis of strategies using new immunological diagnostic tests of latent tuberculosis infection before TNF-blockers therapy. Presse Med. 2018 Feb;47(2):e9-e13. doi: 10.1016/j.lpm.2017.09.029. Epub 2018 Feb 23.

family: Freund

full_name: Romain Freund

given: Romain

family: Granger

full_name: Benjamin Granger

given: Benjamin

family: Francois

full_name: Cécile Francois

given: Cécile

family: Carcelain

full_name: Guislaine Carcelain

given: Guislaine

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Fautrel

full_name: Bruno Fautrel

journal_name: La Presse Médicale

ReferenceCitation: Mariette X, Baron G, Tubach F, Lioté F, Combe B, Miceli-Richard C, Flipo RM, Goupille P, Allez M, Salmon D, Emilie D, Carcelain G, Ravaud P. Influence of replacing tuberculin skin test with ex vivo interferon γ release assays on decision to administer prophylactic antituberculosis antibiotics before anti-TNF therapy. Ann Rheum Dis. 2012 Nov;71(11):1783-90. doi: 10.1136/annrheumdis-2011-200408. Epub 2012 Jan 17.

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Tubach

full_name: Florence Tubach

given: Florence

family: Lioté

full_name: Frédéric Lioté

given: Frédéric

family: Combe

full_name: Bernard Combe

given: Bernard

family: Miceli-Richard

full_name: Corinne Miceli-Richard

given: Corinne

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: Goupille

full_name: Philippe Goupille

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Salmon

full_name: Dominique Salmon

given: Dominique

family: Emilie

full_name: Dominique Emilie

repository_institution: University of Oxford - Oxford Academic Notes & Queries


title: Non-inferiority Study of Bi-Profenid® 200 mg Versus Bi-Profenid® 300 mg in Patients Presenting With Pain Related to Closed, Benign, Acute Post-traumatic Conditions of the Motor System or Acute, Non-infectious Rheumatologic Conditions

summary:
Primary objective:

To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.

Secondary Objectives:

To describe concomitant analgesic treatments
To describe the time between baseline and use of a step I, II or III analgesic
To evaluate patients pain relief using a Likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at D5
To evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days
To evaluate the patients overall satisfaction at the end of treatment using a 4-point Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
To evaluate the patients overall satisfaction at the end of the study using a 4-point Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
To compare the safety of the two treatments

lead_sponsor: Sanofi


title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

acronym: METHODA

summary:
The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.

ReferenceCitation: Goujon C, Viguier M, Staumont-Sallé D, Bernier C, Guillet G, Lahfa M, Ferrier Le Bouedec MC, Cambazard F, Bottigioli D, Grande S, Dahel K, Bérard F, Rabilloud M, Mercier C, Nicolas JF. Methotrexate Versus Cyclosporine in Adults with Moderate-to-Severe Atopic Dermatitis: A Phase III Randomized Noninferiority Trial. J Allergy Clin Immunol Pract. 2018 Mar - Apr;6(2):562-569.e3. doi: 10.1016/j.jaip.2017.07.007. Epub 2017 Sep 28.

family: Goujon

full_name: Catherine Goujon

given: Catherine

family: Viguier

full_name: Manuelle Viguier

given: Manuelle

family: Staumont-Sallé

full_name: Delphine Staumont-Sallé

given: Delphine

family: Bernier

full_name: Claire Bernier

given: Claire

family: Guillet

full_name: Gérard Guillet

given: Gérard

family: Lahfa

full_name: Morad Lahfa

given: Morad

family: Ferrier Le Bouedec

full_name: Marie-Christine Ferrier Le Bouedec

given: Marie-Christine

family: Cambazard

full_name: Frédéric Cambazard

family: Bottigioli

full_name: David Bottigioli

given: David

family: Grande

full_name: Sophie Grande

family: Dahel

full_name: Karima Dahel

given: Karima

family: Bérard

full_name: Frédéric Bérard

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Mercier

full_name: Catherine Mercier

family: Nicolas

full_name: Jean-François Nicolas

given: Jean-François

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

lead_sponsor: Hospices Civils de Lyon