title: Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method With Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.

acronym: PROLISA

summary: The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.

ReferenceType: result

ReferenceCitation: Dekker J, Lopriore E, Rijken M, Rijntjes-Jacobs E, Smits-Wintjens V, Te Pas A. Sedation during Minimal Invasive Surfactant Therapy in Preterm Infants. Neonatology. 2016;109(4):308-13. doi: 10.1159/000443823. Epub 2016 Feb 24.

family: Dekker

full_name: Janneke Dekker

given: Janneke

family: Lopriore

full_name: Enrico Lopriore

given: Enrico

family: Rijken

full_name: Monique Rijken

given: Monique

family: Rijntjes-Jacobs

full_name: Esther Rijntjes-Jacobs

given: Esther

family: Smits-Wintjens

full_name: Vivianne Smits-Wintjens

given: Vivianne

family: te Pas

full_name: Arjan te Pas

given: Arjan

journal_name: Neonatology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

ReferenceCitation: Dargaville PA, Kamlin CO, De Paoli AG, Carlin JB, Orsini F, Soll RF, Davis PG. The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation. BMC Pediatr. 2014 Aug 27;14:213. doi: 10.1186/1471-2431-14-213.

family: Dargaville

full_name: Peter A Dargaville

given: Peter A

family: Kamlin

full_name: Camille Omar F Kamlin

given: Camille Omar F

family: De Paoli

full_name: Antonio G De Paoli

given: Antonio G

family: Carlin

full_name: John B Carlin

given: John B

family: Orsini

full_name: Francesca Orsini

given: Francesca

family: Soll

full_name: Roger F Soll

given: Roger F

family: Davis

full_name: Peter G Davis

given: Peter G

journal_name: BMC Pediatrics

title: The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25–28 weeks gestation

ReferenceCitation: Göpel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, Siegel J, Avenarius S, von der Wense A, Vochem M, Groneck P, Weller U, Möller J, Härtel C, Haller S, Roth B, Herting E; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011 Nov 5;378(9803):1627-34. doi: 10.1016/S0140-6736(11)60986-0. Epub 2011 Sep 29.

ReferenceCitation: Dekker J, Lopriore E, van Zanten HA, Tan RNGB, Hooper SB, Te Pas AB. Sedation during minimal invasive surfactant therapy: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F378-F383. doi: 10.1136/archdischild-2018-315015. Epub 2018 Aug 1.

journal_name: Archives of Disease in Childhood - Fetal and Neonatal Edition

ReferenceCitation: Berde CB, Walco GA, Krane EJ, Anand KJ, Aranda JV, Craig KD, Dampier CD, Finkel JC, Grabois M, Johnston C, Lantos J, Lebel A, Maxwell LG, McGrath P, Oberlander TF, Schanberg LE, Stevens B, Taddio A, von Baeyer CL, Yaster M, Zempsky WT. Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop. Pediatrics. 2012 Feb;129(2):354-64. doi: 10.1542/peds.2010-3591. Epub 2012 Jan 16.

title: Pediatric Analgesic Clinical Trial Designs, Measures, and Extrapolation: Report of an FDA Scientific Workshop

ReferenceCitation: Bourgoin L, Caeymaex L, Decobert F, Jung C, Danan C, Durrmeyer X. Administering atropine and ketamine before less invasive surfactant administration resulted in low pain scores in a prospective study of premature neonates. Acta Paediatr. 2018 Jul;107(7):1184-1190. doi: 10.1111/apa.14317. Epub 2018 Apr 16.

name: Neonatal Intensive Care Unit; Centre Hospitalier Intercommunal de Créteil; Créteil France

name: Inserm U955, Team 13; Université Paris Est (UPEC); Créteil France

name: Clinical Research Center; Centre Hospitalier Intercommunal de Créteil; Créteil France

ReferenceCitation: Ghanta S, Abdel-Latif ME, Lui K, Ravindranathan H, Awad J, Oei J. Propofol compared with the morphine, atropine, and suxamethonium regimen as induction agents for neonatal endotracheal intubation: a randomized, controlled trial. Pediatrics. 2007 Jun;119(6):e1248-55. Epub 2007 May 7.

ReferenceCitation: Owen LS, Manley BJ. Nasal intermittent positive pressure ventilation in preterm infants: Equipment, evidence, and synchronization. Semin Fetal Neonatal Med. 2016 Jun;21(3):146-53. doi: 10.1016/j.siny.2016.01.003. Epub 2016 Feb 26. Review.

ReferenceCitation: Durrmeyer X, Daoud P, Decobert F, Boileau P, Renolleau S, Zana-Taieb E, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Nicloux M, de Saint Blanquat L, Shankland R, Boëlle PY, Carbajal R. Premedication for neonatal endotracheal intubation: results from the epidemiology of procedural pain in neonates study. Pediatr Crit Care Med. 2013 May;14(4):e169-75. doi: 10.1097/PCC.0b013e3182720616.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

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

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Premedication for Neonatal Endotracheal Intubation

ReferenceCitation: Kanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013 Feb;131(2):e502-9. doi: 10.1542/peds.2012-0603. Epub 2013 Jan 28.

title: Surfactant Administration via Thin Catheter During Spontaneous Breathing: Randomized Controlled Trial

ReferenceCitation: Descamps CS, Chevallier M, Ego A, Pin I, Epiard C, Debillon T. Propofol for sedation during less invasive surfactant administration in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F465. doi: 10.1136/archdischild-2017-312791. Epub 2017 May 8.

ReferenceCitation: Klotz D, Porcaro U, Fleck T, Fuchs H. European perspective on less invasive surfactant administration-a survey. Eur J Pediatr. 2017 Feb;176(2):147-154. doi: 10.1007/s00431-016-2812-9. Epub 2016 Dec 9.

title: European perspective on less invasive surfactant administration—a survey

ReferenceCitation: Chevallier M, Durrmeyer X, Ego A, Debillon T; PROLISA Study Group. Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA). BMC Pediatr. 2020 May 8;20(1):199. doi: 10.1186/s12887-020-02112-x.

location_facility:
Ap-H Marseille
Chu Chambery
Chi Creteil
Chu Brest
CHU Grenoble Alpes
Chu Angers
Chu Limoges
Ch Rennes
Chu Amiens
centre hospitalier deTroyes
Chu Nantes
Chu Nimes
Chi Poissy St Germain


title: Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I

acronym: THYGRET

summary:
This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

lead_sponsor: University Hospital, Brest

location_facility: Hopitaux Universitaires de Strasbourg - Hopital civil

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Grillot N, Garot M, Lasocki S, Huet O, Bouzat P, Le Moal C, Oudot M, Chatel-Josse N, El Amine Y, Danguy des Déserts M, Bruneau N, Cinotti R, David JS, Langeron O, Minville V, Tching-Sin M, Faurel-Paul E, Lerebourg C, Flattres-Duchaussoy D, Jobert A, Asehnoune K, Feuillet F, Roquilly A. Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study). Trials. 2021 Mar 30;22(1):237. doi: 10.1186/s13063-021-05192-x.

family: Grillot

full_name: Nicolas Grillot

given: Nicolas

sequence: first

family: Garot

full_name: Matthias Garot

given: Matthias

sequence: additional

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Huet

full_name: Olivier Huet

given: Olivier

family: Bouzat

full_name: Pierre Bouzat

given: Pierre

family: Le Moal

full_name: Charlène Le Moal

given: Charlène

family: Oudot

full_name: Mathieu Oudot

given: Mathieu

family: Chatel-Josse

full_name: Nolwenn Chatel-Josse

given: Nolwenn

family: El Amine

full_name: Younes El Amine

given: Younes

family: Danguy des Déserts

full_name: Marc Danguy des Déserts

given: Marc

family: Bruneau

full_name: Nathalie Bruneau

given: Nathalie

family: Cinotti

full_name: Raphael Cinotti

given: Raphael

family: David

full_name: Jean-Stéphane David

given: Jean-Stéphane

family: Langeron

full_name: Olivier Langeron

family: Minville

full_name: Vincent Minville

given: Vincent

family: Tching-Sin

full_name: Martine Tching-Sin

given: Martine

family: Faurel-Paul

full_name: Elodie Faurel-Paul

given: Elodie

family: Lerebourg

full_name: Céline Lerebourg

given: Céline

family: Flattres-Duchaussoy

full_name: Delphine Flattres-Duchaussoy

given: Delphine

family: Jobert

full_name: Alexandra Jobert

given: Alexandra

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

oa_colors: green gold

location_facility:
University hospital (SALENGRO hospital)
Military Hospital
Le Confluent
Hospital
University Hospital Lyon Sud
University Hospital
CHD Vendée
Toulouse University Hospital

title: Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial

summary: REMICrush is a French multicentric non inferiority simple blind randomized clinical trial that will compare the use of Remifentanil to muscle relaxant (reference treatment) for anesthetic rapid sequence intubation in terms of major complications (difficult intubation, gastric liquid aspiration, desaturation, hemodynamics reaction, ventricular arrhythmia, anaphylactic reaction).


type: Other Identifier

title: Evaluation of the Feasibility of an E-health Tool in the Follow-up and Characterization of Chronic Pain Patients.

acronym: e-DOL

summary:
Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, Investigator has created e-DOL, a smartphone application for patients and a web platform for physicians. The purpose of this study is to evaluate the feasibility and clinical interest of an e-Health smartphone application for the characterization and follow-up of chronic pain patients..

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Chu Grenoble
Hospices Civils de Lyon
Ch Voiron
Chu Limoges
Ap-Hp Lariboisiere
Chu Rouen
Chu Amiens
Chu Nimes
Chu Toulouse
Ch Bayeux
AP-HP Ambroise Paré
Chu Clermont-Ferrand
Ap-Hp Cochin

intervention_type: Device

status_simplified: Completed


title: Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia

acronym: POETRY

summary:
Interventional, prospective, multicenter, post-marketing clinical follow-up study.

After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health.

As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Medtronic - MITG

location_facility:
CHU de Nîmes
CHU Strasbourg - Nouvel Hôpital Civil
CHU de Bordeaux - Hôpital Haut-Lévêque
CHU de Rennes - Hôpital Pontchaillou
CHU Hopitaux de Rouen
CHU de Nantes
CHU de Bordeaux
HCL Louis Pradel
Centre Hospitalier Lyon Sud
CHU Montpellier
CHU Besançon
CHU Lille
Centre Hospitalier Valenciennes

lead_sponsor_type: industriel


title: A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)

acronym: AScalate

summary: This is a randomized, parallel-group, open-label, multicenter study of patients with active axSpA. The aim is to demonstrate that the efficacy of a Treat-to-Target (T2T) approach (with secukinumab as first-line biologic) is superior to a Standard-Of-Care (SOC) approach in terms of achieving strong clinical efficacy in patients with active axial Spondyloarthritis (axSpA) who are naïve to biological therapy and who have had an inadequate response to non-steroidal anti-inflammatory drugs. The study will include an 8-week Screening period, a 36-week treatment period according to previous randomization, and a safety follow-up period of 20 weeks. The primary endpoint is the percentage of patients achieving an Assessment in SpondyloArthritis international Society response 40 (ASAS40) at Week 24.

status: Active, not recruiting

design_allocation: Randomized

ReferenceCitation: Poddubnyy D, Hammel L, Heyne M, Veit J, Jentzsch C, Baraliakos X. Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate. BMJ Open. 2020 Sep 30;10(9):e039059. doi: 10.1136/bmjopen-2020-039059.

family: Poddubnyy

full_name: Denis Poddubnyy

given: Denis

family: Hammel

full_name: Ludwig Hammel

given: Ludwig

family: Heyne

full_name: Marvin Heyne

given: Marvin

family: Veit

full_name: Justyna Veit

given: Justyna

family: Jentzsch

full_name: Claudia Jentzsch

given: Claudia

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

journal_name: BMJ Open

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany France


title: Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients

acronym: PAPASéPA

summary: The link between post-stroke pathways and patient sequelae have not yet been clearly defined. The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode.

status: Unknown status

ReferenceCitation: Broussy S, Rouanet F, Lesaine E, Domecq S, Kret M, Maugeais M, Aly F, Dehail P, Bénard A, Wittwer J, Salamon R, Sibon I, Saillour-Glenisson F. Post-stroke pathway analysis and link with one year sequelae in a French cohort of stroke patients: the PAPASePA protocol study. BMC Health Serv Res. 2019 Oct 29;19(1):770. doi: 10.1186/s12913-019-4522-2.

apc_source: openAPC

family: Broussy

full_name: S. Broussy

given: S.

family: Rouanet

full_name: F. Rouanet

given: F.

family: Lesaine

full_name: E. Lesaine

given: E.

family: Domecq

full_name: S. Domecq

family: Kret

full_name: M. Kret

given: M.

family: Maugeais

full_name: M. Maugeais

family: Aly

full_name: F. Aly

family: Dehail

full_name: P. Dehail

given: P.

family: Bénard

full_name: A. Bénard

given: A.

family: Wittwer

full_name: J. Wittwer

given: J.

family: Salamon

full_name: R. Salamon

given: R.

family: Sibon

full_name: I. Sibon

given: I.

family: Saillour-Glenisson

full_name: F. Saillour-Glenisson

journal_name: BMC Health Services Research

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

repository_normalized: HAL

location_facility:
Pôle de Santé du Villeneuvois
CH Pau
CH Oloron
CH Blaye
CH Agen
CH Mont de Marsan - site Layné
CH Arcachon
CHIC Marmande-Tonneins
CHU Bordeaux
CH Libourne
CH Sud Gironde - Langon
Clinique Mutualiste Lesparre Médoc
CH Orthez


title: Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

acronym: VinMetAtezo

summary:
The majority of patients diagnosed with advanced NSCLC are treated with platinum-doublet chemotherapy regimens, except those harboring specific oncogenic drivers such as epidermal growth-factor-receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In the second-line setting, response rates remain low and median survival rarely exceeds 10 months.

Over the past few years, several checkpoint inhibitors targeting programmed cell death protein-1 (PD1) or its ligand (PDL1) used as second-line therapies generated evidence of improving survival and, more recently, as first-line NSCLC treatment.

Although pembrolizumab (anti-PD1) was recently approved as first-line treatment for patients with at least 50% of their NSCLC cells expressing PDL1, many patients are still not benefiting from this first-line agent.

For patients with relapsed NSCLC, atezolizumab (anti-PDL1) prolonged survival compared to docetaxel in the phase II POPLAR and phase III OAK trials. Novel concepts of synergic action between immunotherapy and chemotherapy have emerged recently. However, those types of treatments are given for different durations: chemotherapy is allowed for only a short period (rarely exceeding 6 cycles), while anti-PDL1 can be continued for several months until loss of its clinical benefit.

Metronomic chemotherapy is defined as low-dose and frequent chemotherapy administration, without prolonged drug-free breaks. Metronomic administration of oral vinorelbine has been tested against breast cancer and advanced refractory NSCLC. The combination could have immunostimulatory effects: induction of immunogenic cancer-cell death, enhancement of antigen presentation through dendritic cell modulation, increased cancer-cell immunogenicity, preferential depletion of regulatory T cells, modulation of myeloid-derived suppressor cells, enhancement of the cytotoxic activity of immune-effector cells.

ReferenceCitation: Vergnenegre A, Monnet I, Bizieux A, Bernardi M, Chiapa AM, Léna H, Chouaïd C, Robinet G. Open-label Phase II trial to evaluate safety and efficacy of second-line metronomic oral vinorelbine-atezolizumab combination for stage-IV non-small-cell lung cancer - VinMetAtezo trial, (GFPC(‡) 04-2017). Future Oncol. 2020 Feb;16(4):5-10. doi: 10.2217/fon-2019-0730. Epub 2020 Jan 2.

name: UOTC, Centre Hospitalier Universitaire Dupuytren, Limoges, France

family: Vergnenegre

full_name: Alain Vergnenegre

given: Alain

name: Department of Pneumology, Centre Hospitalier Intercommunal Créteil, Créteil, France

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

name: Department of Pneumology, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France

family: Bizieux

full_name: Acya Bizieux

given: Acya

name: Department of Pneumology, Centre Hospitalier Aix-en-Provence, Aix-en-Provence, France

family: Bernardi

full_name: Marie Bernardi

given: Marie

name: Department of Pneumology, Centre Hospitalier Quimper, Quimper, France

family: Chiapa

full_name: Anne Marie Chiapa

given: Anne Marie

family: Léna

full_name: Hervé Léna

given: Hervé

family: Chouaïd

full_name: Christos Chouaïd

given: Christos

name: Department of Pneumology, Centre Hospitalier Universitaire Brest, Brest France

family: Robinet

full_name: Gilles Robinet

given: Gilles

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

title: Open-label Phase II trial to evaluate safety and efficacy of second-line metronomic oral vinorelbine–atezolizumab combination for stage-IV non-small-cell lung cancer – VinMetAtezo trial, (GFPC‡ 04-2017)

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
CH Pringy
Hia Saint Anne
CH Quimper
CH MEAUX
CH Aix en Provence
CLCC Caen
CH Saint-Brieuc
CH de Créteil
Ch La Roche Sur Yon
CHRU de Brest - Hôpital Morvan
CHU de Limoges - Hôpital DUPUYTREN
CHU de Rennes
CHU Rouen

intervention_type: Drug


title: Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children

summary: The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

lead_sponsor: University Hospital, Tours

location_facility: Pediatric Surgery Service, University Hospital, Nantes

location_facility: Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP

location_facility: Pediatric Surgery Service, Robert-Debré Hospital, AP-HP

location_facility: Pediatric Surgery Service, University Hospital, Grenoble

location_facility: Pediatric Surgery Service, University Hospital, Rennes

location_facility: Pediatric Surgery Service, University Hospital, Bordeaux

location_facility: Pediatric Surgery Service, University Hospital, Marseille

location_facility: Pediatric Surgery Service, University Hospital, Toulouse

location_facility: Pediatric Surgery Service, University Hospital, Tours

location_facility: Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP

location_facility: Pediatric Surgery Service, University Hospital, Nice

location_facility: Pediatric Surgery Service, University Hospital, Lyon

location_facility: Pediatric Surgery Service, University Hospital, Saint-Etienne

intervention_type: Procedure


title: Impact of Meteorological Conditions on the Onset of First Episod of Spontaneous Pneumothorax : a French Multicenter Case-crosserover Study About 945 Subjects in 14 Centers

acronym: EXPPO

summary: The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Angers
Clinique de HENIN BEAUMONT
Centre Hospitalier de Vesoul
CHU Toulouse
CHU Nimes
Centre Hospitalier de Belfort
CHU Clermont Ferrand
CHU Poitiers
CH Mulhouse
CH Lomme
CHU Dijon
Polyclinique de DIVION
CH Boulogne sur Mer


type: Registry Identifier

title: Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy

acronym: STEREO-RE-PRO

summary:
Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy.

The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment.

The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.

ReferenceCitation: Pasquier D, Le Deley MC, Tresch E, Cormier L, Duterque M, Nenan S, Lartigau E. GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy-study protocol. BMJ Open. 2019 Aug 2;9(8):e026666. doi: 10.1136/bmjopen-2018-026666.

family: Pasquier

full_name: David Pasquier

given: David

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

family: Tresch

full_name: Emmanuelle Tresch

given: Emmanuelle

family: Cormier

full_name: Luc Cormier

given: Luc

family: Duterque

full_name: Martine Duterque

given: Martine

family: Nenan

full_name: Soazig Nenan

given: Soazig

family: Lartigau

full_name: Eric Lartigau

given: Eric

title: GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy—study protocol

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut régional du Cancer de Montpellier

intervention_type: Radiation


title: Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life

acronym: GEVOL

summary: The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

status: Terminated

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_facility:
HOPITAL NORD-CHU de SAINT-ETIENNE
Gh mutualiste les portes du sud
Clinique Ambroise Pare
Ghef Ch Marne La Vallee
Ch Lyon Sud
Hopital Saint Eloi-Chru Montpellier
Hopital Edouard Herriot
Ch de Blois
HOPITAUX DE BRABOIS-CHRU de NANCY
Clinique du palais
Centre Hospitalier Cote Basque
Ctre Hosp St Joseph Et St Luc
Polyclinique Cote Basque Sud

status_simplified: Unknown


title: Gemcitabine-cisplatin Plus Avelumab or Gemcitabine-cisplatin as First-line Treatment of Patients With Locally Advanced or Metastatic Urothelial Bladder Carcinoma (GCISAVE)

acronym: GCISAVE

summary: This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started).

ReferenceCitation: Gross-Goupil M, Domblides C, Lefort F, Ravaud A. Open-label randomized multi-center phase 2 study: gemcitabine cisplatin plus avelumab or gemcitabine cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma: GCisAve. Bull Cancer. 2020 Jun;107(5S):eS1-eS7. doi: 10.1016/S0007-4551(20)30280-0.

family: Gross-Goupil

full_name: Marine Gross-Goupil

given: Marine

family: Domblides

full_name: Charlotte Domblides

given: Charlotte

family: Lefort

full_name: Felix Lefort

given: Felix

family: Ravaud

full_name: Alain Ravaud

journal_name: Bulletin du Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Européen Georges-Pompidou, AP-HP

location_facility: Institut de cancérologie de l'Ouest - René Gauducheau

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

acronym: NAVIGATOR

summary: The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector

lead_sponsor: MicroPort CRM

location_country: Italy Netherlands Spain France Portugal Germany

location_facility: Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra

location_facility: Centro H. Lisboa Norte - Hospital de Santa Maria

location_facility: Centro Hospitalar e Universitário de Coimbra - Hospital Geral

location_facility: Az. Osp. Univ. S. Maria della Misericordia

location_facility: Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)

location_facility: Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi

location_facility: Centro Hospitalar do Porto CHP Hospital de Santo Antonio

location_facility: Hospital General Universitario de Alicante

location_facility: Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel


ReferenceCitation: Asselah T, Pol S, Hezode C, Loustaud-Ratti V, Leroy V, Ahmed SNS, Ozenne V, Bronowicki JP, Larrey D, Tran A, Alric L, Nguyen-Khac E, Robertson MN, Hanna GJ, Brown D, Asante-Appiah E, Su FH, Hwang P, Hall JD, Guidoum A, Hagen K, Haber BA, Talwani R, Serfaty L. Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. Liver Int. 2020 May;40(5):1042-1051. doi: 10.1111/liv.14313. Epub 2020 Mar 22.

name: Department of Hepatology and Gastroenterology University Paris Diderot, Sorbonne Paris Cité, CRI, UMR 1149 INSERM Paris France

name: Department of Hepatology AP‐HP Hôpital Beaujon Clichy France

family: Asselah

full_name: Tarik Asselah

given: Tarik

name: Department of Hepatology APHP Hôpital Cochin/Université Paris Descartes/INSERM U1223Institut Pasteur Paris France

family: Pol

full_name: Stanislas Pol

given: Stanislas

name: Department of Hepatology Henri Mondor Hospital APHP, University of Paris‐Est, INSERM U955 Créteil France

family: Hezode

full_name: Christophe Hezode

given: Christophe

name: Department of Hepatology and Gastroenterology CHU de Limoges U850 INSERM Université Limoges Limoges France

family: Loustaud‐Ratti

full_name: Veronique Loustaud‐Ratti

given: Veronique

family: Leroy

full_name: Vincent Leroy

given: Vincent

name: Department of Hepatology and Gastroenterology Pȏle de Recherche Clinique Hôpital Saint Joseph Marseille France

family: Ahmed

full_name: Si Nafa Si Ahmed

given: Si Nafa Si

name: Department of Hepatology and Gastroenterology Hôpital Saint Antoine Paris France

family: Ozenne

full_name: Violaine Ozenne

given: Violaine

name: Department of Hepatology and Gastroenterology CHU de Nancy Nancy France

family: Bronowicki

full_name: Jean‐Pierre Bronowicki

given: Jean‐Pierre

name: Department of Hepatology Hôpital Saint Eloi Ecole de Médecine de Montpellier Montpellier France

family: Larrey

full_name: Dominique Larrey

given: Dominique

name: Department of Gastroenterology Université Côte d'Azur Nice France

family: Tran

full_name: Albert Tran

given: Albert

name: Department of Internal Medicine/Gastroenterology CHU de Toulouse Toulouse France

family: Alric

full_name: Laurent Alric

given: Laurent

name: Department of Hepatology and Gastroenterology CHU de Amiens Amiens France

family: Nguyen‐Khac

full_name: Eric Nguyen‐Khac

name: Department of Infectious Diseases Merck & Co., Inc. Kenilworth NJ USA

family: Robertson

full_name: Michael N. Robertson

given: Michael N.

family: Hanna

full_name: George J. Hanna

given: George J.

family: Brown

full_name: Deborah Brown

given: Deborah

family: Asante‐Appiah

full_name: Ernest Asante‐Appiah

given: Ernest

family: Su

full_name: Feng‐Hsiu Su

given: Feng‐Hsiu

family: Hwang

full_name: Peggy Hwang

given: Peggy

family: Hall

full_name: Jessie Durrand Hall

given: Jessie Durrand

family: Guidoum

full_name: Amir Guidoum

given: Amir

family: Hagen

full_name: Karin Hagen

given: Karin

family: Haber

full_name: Barbara A. Haber

given: Barbara A.

family: Talwani

full_name: Rohit Talwani

given: Rohit

name: Department of Hepatology Hôpital de Hautepierre Universitaires de Strasbourg Strasbourg France

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

acronym: Efficacy/Safety of MK5172 in TN/TE GT4 HCV French Patients

location_facility: Centre Hospitalier Regional du Orleans ( Site 0212)

location_facility: CHU Amiens-Picardie - Hopital Sud ( Site 0217)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 0208)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 0204)

location_facility: CHU de Toulouse - Hopital Purpan ( Site 0216)

location_facility: C.H.U. de Nice Hopital de l Archet 2 ( Site 0215)

title: A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection

summary: The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid [RNA] < Lower Limit of Quantification [LLOQ]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.


title: A Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial Comparing Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites : Using or Not Using Rifaximin

acronym: ProPILARifax

summary: We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival.

location_facility:
CHU de Dijon
CHU de Reims
CHRU de Lille
CHU d'Angers
CHU de Nice
CHIC de Créteil
Hôpital Pitié Salpêtrière
Hôpital Jean Verdier
CHU de Toulouse
CHU de Besançon
Hôpital de la Roche sur Yon
CHU de Rennes
Hôpital Beaujon


acronym: BHL

summary: This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.

location_facility:
CHU Limoges
Chu Angers
CHU CAEN
CHU Poitiers
Hôpitaux Universitaires de Strasbourg
CHU Reims
Chu Clermont Ferrand
CHU Tours
APHP Hôpital Necker
CHU Rennes
CHU Rouen
CHU Brest
CHU Amiens


title: HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients

acronym: HiFIT

summary: Fractures of the upper end of the femur, called commonly "Hip fractures" are very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients.The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.

ReferenceCitation: Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27.

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Bruckert

full_name: Vincent Bruckert

given: Vincent

family: Campfort

full_name: Maeva Campfort

given: Maeva

family: Leger

full_name: Maxime Leger

given: Maxime

family: Rineau

full_name: Emmanuel Rineau

given: Emmanuel

journal_name: Anaesthesia Critical Care & Pain Medicine

ReferenceCitation: Lasocki S, Loupec T, Parot-Schinkel E, Vielle B, Danguy des Déserts M, Roquilly A, Lahlou-Casulli M, Collange V, Desebbe O, Duchalais A, Drugeon B, Bouzat P, Garrigue D, Mounet B, Hamard F, David JS, Leger M, Rineau E; HiFIT Study Group. Study protocol for a multicentre, 2×2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study). BMJ Open. 2021 Jan 17;11(1):e040273. doi: 10.1136/bmjopen-2020-040273.

family: Loupec

full_name: Thibault Loupec

given: Thibault

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Vielle

full_name: Bruno Vielle

given: Bruno

family: Danguy des Déserts

full_name: Marc Danguy des Déserts

given: Marc

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

family: Lahlou-Casulli

full_name: Maria Lahlou-Casulli

given: Maria

family: Collange

full_name: Vincent Collange

family: Desebbe

full_name: Olivier Desebbe

given: Olivier

family: Duchalais

full_name: Alexis Duchalais

given: Alexis

family: Drugeon

full_name: Bertrand Drugeon

given: Bertrand

family: Bouzat

full_name: Pierre Bouzat

given: Pierre

family: Garrigue

full_name: Delphine Garrigue

given: Delphine

family: Mounet

full_name: Benjamin Mounet

given: Benjamin

family: Hamard

full_name: Franck Hamard

given: Franck

family: David

full_name: Jean-Stéphane David

location_facility: Chu Poitiers - Service D'Anesthesie Reanimation

location_facility: Clinique de L'Anjou- Anesthesie Reanimation

location_facility: Chu Montpellier - Departement D'Anesthesie Reanimation

location_facility: CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION

location_facility: Chu Nantes- Service de Reanimation Chirurgicale

location_facility: Chu Grenoble - Departement D'Anesthesie Reanimation

location_facility: Chu Rennes - Service D'Anesthesie Reanimation


title: Epidemiologic Multicenter Prospective Study in Advanced NSCLC Patients With PDL1 Expression : Evaluation of Clinical and Pathological Characteristics of PDL1 High Expression Patients Compared to Patients With a Weak or no Expression of PDL1.

summary: Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression : evaluation of clinical and pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

primary_purpose: Other

ReferenceCitation: Fong L, Small EJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol. 2008 Nov 10;26(32):5275-83. doi: 10.1200/JCO.2008.17.8954. Epub 2008 Oct 6. Review.

name: From the Department of Medicine, Division of Hematology/Oncology, University of California, San Francisco, CA

family: Fong

full_name: Lawrence Fong

given: Lawrence

family: Small

full_name: Eric J. Small

given: Eric J.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Anti–Cytotoxic T-Lymphocyte Antigen-4 Antibody: The First in an Emerging Class of Immunomodulatory Antibodies for Cancer Treatment

ReferenceCitation: Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677-704. doi: 10.1146/annurev.immunol.26.021607.090331. Review.

name: Department of Pathology, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts 02115-5727;

family: Keir

full_name: Mary E. Keir

given: Mary E.

family: Butte

full_name: Manish J. Butte

given: Manish J.

name: Department of Medical Oncology, Dana Farber Cancer Institute, Department of Medicine, Harvard Medical School, Boston, Massachusetts 02115-6013

family: Freeman

full_name: Gordon J. Freeman

given: Gordon J.

family: Sharpe

full_name: Arlene H. Sharpe

given: Arlene H.

bso_classification: Biology (fond.)

journal_name: Annual Review of Immunology

publisher: Annual Reviews

publisher_dissemination: Annual Reviews

publisher_group: Annual Reviews

publisher_normalized: Annual Reviews

title: PD-1 and Its Ligands in Tolerance and Immunity

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility: Centre Hospitalier Universitaire DUPUYTREN


title: L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury: a Multicentre, Randomized, 2-parallel Group, Superiority Trial

acronym: CarniSave

summary: The primary objective of this study is to compare 28 day mortality rates between septic shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.

ReferenceType: background

ReferenceCitation: Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


acronym: AGATE

summary:
Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation.

Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005).

The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h.

Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.

primary_purpose: Prevention

ReferenceCitation: Marjanovic N, Boisson M, Asehnoune K, Foucrier A, Lasocki S, Ichai C, Leone M, Pottecher J, Lefrant JY, Falcon D, Veber B, Chabanne R, Drevet CM, Pili-Floury S, Dahyot-Fizelier C, Kerforne T, Seguin S, de Keizer J, Frasca D, Guenezan J, Mimoz O; AGATE Study Group. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study. Chest. 2021 Aug;160(2):499-508. doi: 10.1016/j.chest.2021.03.007. Epub 2021 Mar 13.

family: Marjanovic

full_name: Nicolas Marjanovic

given: Nicolas

family: Boisson

full_name: Matthieu Boisson

given: Matthieu

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Foucrier

full_name: Arnaud Foucrier

given: Arnaud

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Ichai

full_name: Carole Ichai

given: Carole

family: Leone

full_name: Marc Leone

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Falcon

full_name: Dominique Falcon

given: Dominique

family: Veber

full_name: Benoit Veber

given: Benoit

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Drevet

full_name: Claire-Marie Drevet

given: Claire-Marie

family: Pili-Floury

full_name: Sébastien Pili-Floury

given: Sébastien

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Kerforne

full_name: Thomas Kerforne

given: Thomas

family: Seguin

full_name: Sabrina Seguin

given: Sabrina

family: de Keizer

full_name: Joe de Keizer

given: Joe

family: Frasca

full_name: Denis Frasca

given: Denis

family: Guenezan

full_name: Jérémy Guenezan

given: Jérémy

family: Mimoz

full_name: Olivier Mimoz

family: Besch

full_name: Guillaume Besch

given: Guillaume

family: Bouhemad

full_name: Bélaid Bouhemad

given: Bélaid

ReferenceCitation: Marjanovic N, Frasca D, Asehnoune K, Paugam C, Lasocki S, Ichai C, Lefrant JY, Leone M, Dahyot-Fizelier C, Pottecher J, Falcon D, Veber B, Constantin JM, Seguin S, Guénézan J, Mimoz O; AGATE study group. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol. BMJ Open. 2017 Aug 7;7(8):e017003. doi: 10.1136/bmjopen-2017-017003.

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

location_facility:
Carole ICHAI
Julien POTTECHER
Catherine PAUGAM
Belaid BOUHEMAD
Karim ASEHNOUNE
Sigismond LASOCKI
Dominique FALCON
Jean Michel CONSTANTIN
Benoit VEBER
Jean Yves LEFRANT
Sébastien PILI FLOURY
Olivier MIMOZ
Marc LEONE


title: Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study

acronym: ReProLine

summary:
The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period.

Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Léon Berard
Centre Eugène Marquis
Centre Alexis Vautrin
CH
Centre Paul Strauss
CHU Jean Minjoz
Clinique Armoricaine de Radiologie
Centre Jean Godinot
Centre Henri Becquerel
CHU
Centre Jean Bernard
Institut de Cancerologie de l'Ouest


title: Study of Predictive Factors of Progression of Motor Neurone Disease Prognosis and Endophenotype Biomarkers French Database Set up

acronym: PULSE

summary:
Amyotrophic lateral sclerosis (ALS) is a complex polymorph and devastating neurodegenerative disease. Although the pathophysiological mechanisms underlying the development of ALS remain to be fully elucidated, there have been significant advances in the understanding of ALS pathogenesis, with evidence emerging of a complex interaction between genetic factors and dysfunction of vital molecular pathways. However, the numerous randomized clinical trials (RCT) for ALS have failed to generate improved drug treatments. Biomarkers able to bring prognostic value and to distinguish the different endophenotypes of this polymorphic disease could help to better select clusters of patients in order to improve the RCT outcomes. However, little progress has been made in the development of viable diagnostic, prognostic and monitoring markers. This could be explained by common shortcomings, such as relatively small sample sizes, statistically underpowered study designs, lack of disease controls and poorly characterized patient cohorts. It is yet crucial that the investigators further develop and validate ALS biomarkers and incorporate these biomarkers into the drug development pipeline for ALS.

The aim of the present study is therefore to determine the clinical, biological, imaging, and electrophysiological biomarkers of prognosis of survival without events (i.e. severe comorbidity, 24 hours of non invasive ventilation, tracheotomy). This is a prospective observational multicentric French study of a cohort of 1000 ALS patients.

This large multimodal database will be open for international fruitful scientific collaborations.

ReferenceCitation: Grolez G, Kyheng M, Lopes R, Moreau C, Timmerman K, Auger F, Kuchcinski G, Duhamel A, Jissendi-Tchofo P, Besson P, Laloux C, Petrault M, Devedjian JC, Pérez T, Pradat PF, Defebvre L, Bordet R, Danel-Brunaud V, Devos D. MRI of the cervical spinal cord predicts respiratory dysfunction in ALS. Sci Rep. 2018 Jan 29;8(1):1828. doi: 10.1038/s41598-018-19938-2.

family: Grolez

full_name: G. Grolez

given: G.

family: Kyheng

full_name: M. Kyheng

given: M.

family: Lopes

full_name: R. Lopes

given: R.

family: Moreau

full_name: C. Moreau

given: C.

family: Timmerman

full_name: K. Timmerman

given: K.

family: Auger

full_name: F. Auger

given: F.

family: Kuchcinski

full_name: G. Kuchcinski

family: Duhamel

full_name: A. Duhamel

given: A.

family: Jissendi-Tchofo

full_name: P. Jissendi-Tchofo

given: P.

family: Besson

full_name: P. Besson

family: Laloux

full_name: C. Laloux

family: Petrault

full_name: M. Petrault

family: Devedjian

full_name: J. C. Devedjian

given: J. C.

family: Pérez

full_name: Thierry Pérez

given: Thierry

family: Pradat

full_name: Pierre François Pradat

given: Pierre François

family: Defebvre

full_name: L. Defebvre

given: L.

family: Bordet

full_name: R. Bordet

family: Danel-Brunaud

full_name: V. Danel-Brunaud

given: V.

family: Devos

full_name: D. Devos

given: D.

currency_apc_doaj: USD

journal_name: Scientific Reports

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
dipot.ulb.ac.be

location_facility:
Hôpital Nord
Hôpital La Pitié (AP-HP)
Hôpital Dupuytren
CHU Gabriel Montpied
AP-HM,Hôpital de la Timone
Hôpital Gui de Chauliac
Centre Hospitalier
CHU Pontchaillou
Hôpital Neurologique Pierre Wertheimer
CHRU, Hôpital Salengro
CHU Bretonneau
Hôpital de l'Archet 1, CHU
CHU Cote de Nacre


title: Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria

acronym: XOLUS

summary: Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.

location_facility: Dermatology department, Centre Hospitalier Régional Universitaire

location_facility: Dermatology department, Hôpital Saint-Louis


title: Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility

acronym: DéProPAss

summary: The main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors.

location_facility: Cabinet Médical - 47 rue de la République

location_facility: Cabinet Médical - 7 bis avenue Rhin Danube

location_facility: Cabinet Médical - 36 place de l'Esplanade


title: EVALUATION OF THE IMPACT OF A THERAPY MANAGEMENT PLATFORM ON THE MANAGEMENT OF PATIENTS SUFFERING FROM ADVANCED/METASTATIC RENAL CELL CARCINOMA AND RECEIVING FIRST LINE TREATMENT WITH SUNITINIB, VERSUS STANDARD FOLLOW-UP

acronym: RENACALL

summary:
100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center

Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Polyclinique de Gentilly Service Oncologie Médicale

location_facility: Hopital Jean BERNARD - Tours - 7eme etage

location_facility: CHI de Cornouailles - Oncologie hospitalisation

location_facility: Clinique Claude Bernard Chimiotherapie Ambulatoire


title: Prospective, Multicenter, Randomized Controlled Study Evaluating the Efficacy of Parenteral Nutrition on the Quality of Life and Overall Survival in Patients in the Palliative Phase of Cancer.

acronym: ALIM-K

summary:
In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible.

Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives.

And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences.

We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer.

To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated.

The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care .

primary_purpose: Supportive Care

ReferenceCitation: Pazart L, Cretin E, Grodard G, Cornet C, Mathieu-Nicot F, Bonnetain F, Mercier M, Cuynet P, Bouleuc C, Aubry R; ALIM-K study investigational group. Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial. Trials. 2014 Sep 24;15:370. doi: 10.1186/1745-6215-15-370.

location_facility:
Centre de cancérologie de Lorraine
Palliative Care Unit - CHU Jean Minjoz
Centre Léon Bérard
Centre François Baclesse
Institut Paoli calmettes
Centre Oscar Lambret
Centre hospitalier Henri Mondor
Centre Georges François Leclerc
Hopital de la Timone
Centre Paul Strauss
Institut Curie
Institut Gustave Roussy
Insitut Jean Godinot


title: An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™

summary:
Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

lead_sponsor: Actelion

location_country: Italy France Spain

location_facility: Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare

location_facility: UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica

location_facility: Hospital Universitario Insular Gran Canarias


title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency

summary: The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_normalized: University of Melbourne - Minerva Access

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

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Berrouiguet S, Larsen ME, Mesmeur C, Gravey M, Billot R, Walter M; HUGOPSY Network, Lemey C, Lenca P. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 10;6(1):e8. doi: 10.2196/mhealth.7780.

family: Berrouiguet

full_name: Sofian Berrouiguet

given: Sofian

family: Larsen

full_name: Mark Erik Larsen

given: Mark Erik

family: Mesmeur

full_name: Catherine Mesmeur

given: Catherine

family: Gravey

full_name: Michel Gravey

given: Michel

family: Billot

full_name: Romain Billot

given: Romain

family: Walter

full_name: Michel Walter

family: Lemey

full_name: Christophe Lemey

given: Christophe

family: Lenca

full_name: Philippe Lenca

given: Philippe

journal_name: JMIR mHealth and uHealth

ReferenceCitation: Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-García E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.

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

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

location_facility:
CHU Angers
CHRU Lille
CH Quimperlé
CHU de Saint-Etienne, Hôpital Nord
CH St Malo
CHU Caen
CHU St Nazaire
CHU Tours
CH Vannes
CHU Nantes
CHRU de Brest
CHU de Lyon
CHU Rennes


type: EudraCT Number

title: Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State

acronym: Nebuadom

summary: Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).


type: Other Grant/Funding Number

title: Evaluate the Long-term (3 Months) Efficacy of L-threo DOPS (DroxiDopa) on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With Multiple System Atrophy (MSA). Comparative Study Versus Placebo

acronym: DOPS-AMS

summary: Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following randomization to continued therapy with droxidopa or placebo.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital G. & R. Laennec
CHU bordeaux
CHU de limoges
CHU de Dijon
Hôpital Pitié-Salpétrière
Hôpital La Timone
chu de Strasbourg
CHU de Clermont-Ferrand
CHU de Rouen
CHU Pontchaillou
CHU de Poitiers
CHRU de lille
Centre hospitalier d'Angers


title: Double Blind Randomized Study, Comparing Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

acronym: PRPET

summary: TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

ReferenceCitation: Bureau C, Thabut D, Jezequel C, Archambeaud I, D'Alteroche L, Dharancy S, Borentain P, Oberti F, Plessier A, De Ledinghen V, Ganne-Carrié N, Carbonell N, Rousseau V, Sommet A, Péron JM, Vinel JP. The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial. Ann Intern Med. 2021 May;174(5):633-640. doi: 10.7326/M20-0202. Epub 2021 Feb 2.

name: University Hospital of Toulouse and Toulouse III Paul Sabatier University, Toulouse, France (C.B., J.M.P., J.P.V.)

family: Bureau

full_name: Christophe Bureau

name: Groupe Hospitalier Pitié-Salpêtrière, Paris, France (D.T.)

family: Thabut

full_name: Dominique Thabut

given: Dominique

name: Centre d’Investigation Clinique de Rennes, Rennes, France (C.J.)

family: Jezequel

full_name: Caroline Jezequel

given: Caroline

name: Centre Hospitalier Universitaire de Nantes, Nantes, France (I.A.)

family: Archambeaud

full_name: Isabelle Archambeaud

given: Isabelle

name: Trousseau University Hospital of Tours, Tours, France (L.D.M.)

family: D’Alteroche

full_name: Louis D’Alteroche

given: Louis

name: Centre Hospitalier Universitaire de Lille, Lille, France (S.D.)

family: Dharancy

full_name: Sêbastien Dharancy

given: Sêbastien

name: Centre Hospitalo-Universitaire Timone, Marseille, France (P.B.)

family: Borentain

full_name: Patrick Borentain

given: Patrick

name: Centre Hospitalier Universitaire d’Angers, Angers, France (F.O.)

family: Oberti

full_name: Frédéric Oberti

given: Frédéric

family: Plessier

full_name: Aurélie Plessier

given: Aurélie

name: Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France (V.D.)

family: De Ledinghen

full_name: Victor De Ledinghen

given: Victor

name: Hôpitaux Universitaires Paris Seine-Saint-Denis, Bondy, and Université Paris 13, Sorbonne Paris Cité et INSERM UMR 1162, Paris, France (N.G.)

family: Ganne-Carrié

full_name: Nathalie Ganne-Carrié

given: Nathalie

name: Hôpital Saint-Antoine, Paris, France (N.C.)

family: Carbonell

full_name: Nicolas Carbonell

given: Nicolas

name: Toulouse University Hospital, Toulouse, France (V.R., A.S.).

family: Rousseau

full_name: Vanessa Rousseau

given: Vanessa

family: Sommet

full_name: Agnès Sommet

given: Agnès

family: Péron

full_name: Jean Marie Péron

given: Jean Marie

family: Vinel

full_name: Jean Pierre Vinel

given: Jean Pierre

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

location_facility:
CHU Angers
CHU Marseille
CHRU Lille
UHToulouse
Pitié Salpêtrière
CHU Poitiers
CHU Bordeaux
CHU Beaujon Clichy
CHU Tours
CHU Nantes
Hôpital Jean Verdier
CHU Rennes
CHU Saint-Antoine


title: Specific Cognitive Remediation for Schizophrenia (RECOS) and Sheltered Employment: a Multicentre Controlled Randomized Trial.

acronym: RemedRehab

summary:
This study, driven on schizophrenic patients, is aimed at :

Measuring the efficiency of the cognitive remediation program RECOS (COgnitive REmediation in Schizophrenia) on the capacity of the patients suffering from schizophrenia to improve the integration in sheltered employment (ESAT and EA).
Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on integration in sheltered employment of patients suffering from schizophrenia.

Realizing a comparative analysis, in both arms, of :

the number of working hours achieved in sheltered environment during the 6 months following the two programs (reported to the working time planned by the contract of employment)
the duration of such employments in sheltered areas.
Estimating the impact of RECOS on the neuropsychological variables, the symptomatology, the consciousness of the disorders(insight), the quality of life and the social autonomy before the treatment (month M0), at the end of the treatment (month M3), and 6 months later (month M9), and looking for a correlation between the improvement of these parameters and sheltered employment.
Estimating the impact of cognitive remediation on integration in sheltered employment.

ReferenceCitation: Deppen P, Sarrasin Bruchez P, Dukes R, Pellanda V, Vianin P. [Cognitive remediation program for individuals living with schizophrenia (Recos): preliminary results]. Encephale. 2011 Sep;37(4):314-21. doi: 10.1016/j.encep.2011.02.002. Epub 2011 Apr 9. French.

ReferenceCitation: Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network, Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.

lead_sponsor: Hôpital le Vinatier

location_facility: Centre de Santé Mentale Angevin (CESAME)

intervention_type: Behavioral


ReferenceCitation: Bible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM, Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. doi: 10.1016/S1470-2045(10)70203-5. Epub 2010 Sep 17.

ReferenceCitation: Altorki N, Lane ME, Bauer T, Lee PC, Guarino MJ, Pass H, Felip E, Peylan-Ramu N, Gurpide A, Grannis FW, Mitchell JD, Tachdjian S, Swann RS, Huff A, Roychowdhury DF, Reeves A, Ottesen LH, Yankelevitz DF. Phase II proof-of-concept study of pazopanib monotherapy in treatment-naive patients with stage I/II resectable non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3131-7. doi: 10.1200/JCO.2009.23.9749. Epub 2010 Jun 1.

ReferenceCitation: Billemont B, Medioni J, Taillade L, Helley D, Meric JB, Rixe O, Oudard S. Blood glucose levels in patients with metastatic renal cell carcinoma treated with sunitinib. Br J Cancer. 2008 Nov 4;99(9):1380-2. doi: 10.1038/sj.bjc.6604709. Epub 2008 Oct 7.

ReferenceCitation: Borson-Chazot F, Bardet S, Bournaud C, Conte-Devolx B, Corone C, D'Herbomez M, Henry JF, Leenhardt L, Peix JL, Schlumberger M, Wemeau JL; Expert Group for French Recommendations for the Management of Differentiated Thyroid Carcinomas of Vesicular Origin, Baudin E, Berger N, Bernard MH, Calzada-Nocaudie M, Caron P, Catargi B, Chabrier G, Charrie A, Franc B, Hartl D, Helal B, Kerlan V, Kraimps JL, Leboulleux S, Le Clech G, Menegaux F, Orgiazzi J, Perié S, Raingeard I, Rodien P, Rohmer V, Sadoul JL, Schwartz C, Tenenbaum F, Toubert ME, Tramalloni J, Travagli JP, Vaudrey C. Guidelines for the management of differentiated thyroid carcinomas of vesicular origin. Ann Endocrinol (Paris). 2008 Dec;69(6):472-86. Review.

ReferenceCitation: Brose M. S., et al. Effect of BRAFV600E on response to sorafenib in advanced thyroid cancer patients. J Clin Oncol (meeting Abstracts) 27.15S (2009) : 6002.

ReferenceCitation: Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. doi: 10.1158/1078-0432.CCR-10-0994. Epub 2010 Sep 16.

ReferenceCitation: de la Fouchardiere C, Droz JP. Targeted therapies and thyroid cancer: an update. Anticancer Drugs. 2011 Aug;22(7):688-99. doi: 10.1097/CAD.0b013e32834319c7. Review.

ReferenceCitation: Fagin JA, Tuttle RM, Pfister DG. Harvesting the low-hanging fruit: kinase inhibitors for therapy of advanced medullary and nonmedullary thyroid cancer. J Clin Endocrinol Metab. 2010 Jun;95(6):2621-4. doi: 10.1210/jc.2010-0800.

ReferenceCitation: GSK Laboratories. Investigator's Brochure of pazopanib, version 09 dated 25 Jan. 2012.Ref Type: Unpublished Work

ReferenceCitation: Gupta-Abramson V, Troxel AB, Nellore A, Puttaswamy K, Redlinger M, Ransone K, Mandel SJ, Flaherty KT, Loevner LA, O'Dwyer PJ, Brose MS. Phase II trial of sorafenib in advanced thyroid cancer. J Clin Oncol. 2008 Oct 10;26(29):4714-9. doi: 10.1200/JCO.2008.16.3279. Epub 2008 Jun 9.

ReferenceCitation: Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.

ReferenceCitation: Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9.

ReferenceCitation: Jebreel A, England J, Bedford K, Murphy J, Karsai L, Atkin S. Vascular endothelial growth factor (VEGF), VEGF receptors expression and microvascular density in benign and malignant thyroid diseases. Int J Exp Pathol. 2007 Aug;88(4):271-7.

ReferenceCitation: Iwamoto FM, Lamborn KR, Robins HI, Mehta MP, Chang SM, Butowski NA, Deangelis LM, Abrey LE, Zhang WT, Prados MD, Fine HA. Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02). Neuro Oncol. 2010 Aug;12(8):855-61. doi: 10.1093/neuonc/noq025. Epub 2010 Mar 3.

ReferenceCitation: Kaplan, E. L and P. Meier. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958): 457-81.

ReferenceCitation: Kumar R, Knick VB, Rudolph SK, Johnson JH, Crosby RM, Crouthamel MC, Hopper TM, Miller CG, Harrington LE, Onori JA, Mullin RJ, Gilmer TM, Truesdale AT, Epperly AH, Boloor A, Stafford JA, Luttrell DK, Cheung M. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007 Jul;6(7):2012-21.

ReferenceCitation: Lan, K. K. G. and D. L. De Mets. Discrete sequential boundaries for clinical trials. Biometrika 70 (1983): 659-63

ReferenceCitation: Leboulleux, S., Bastholt, L., and Krause TM. Vandetanib in locally advanced or metastatic differentiated thyroid cancer (papillary or follicular; DTC): a randomized, double-blind phase II trial. International Thyroid Conference;Paris, France; [ Sept 11.16, 2009. Abstr 0C.023.]. 2010. Ref Type: Abstract

ReferenceCitation: Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.

name: From the University of California Irvine Medical Center, Orange, CA; Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru; Centro Medico San Roque, Tucuman, Argentina; Vall d'Hebron University Hospital, Barcelona, Spain; Centre Regional de Lutte Contre le Cancer, Marseille, France; Chulalongkorn University, Bangkok, Thailand; and GlaxoSmithKline, Collegeville, PA.

family: Monk

full_name: Bradley J. Monk

given: Bradley J.

family: Mas Lopez

full_name: Luis Mas Lopez

given: Luis

family: Zarba

full_name: Juan J. Zarba

given: Juan J.

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Tarpin

full_name: Carole Tarpin

given: Carole

family: Termrungruanglert

full_name: Wichai Termrungruanglert

given: Wichai

family: Alber

full_name: Jacquelyn A. Alber

given: Jacquelyn A.

family: Ding

full_name: Jie Ding

given: Jie

family: Stutts

full_name: Melissa W. Stutts

given: Melissa W.

family: Pandite

full_name: Lini N. Pandite

given: Lini N.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Phase II, Open-Label Study of Pazopanib or Lapatinib Monotherapy Compared With Pazopanib Plus Lapatinib Combination Therapy in Patients With Advanced and Recurrent Cervical Cancer

ReferenceCitation: Nikiforov YE. Thyroid carcinoma: molecular pathways and therapeutic targets. Mod Pathol. 2008 May;21 Suppl 2:S37-43. doi: 10.1038/modpathol.2008.10. Review.

ReferenceCitation: Pacini F, Castagna MG, Brilli L, Pentheroudakis G; ESMO Guidelines Working Group. Differentiated thyroid cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2009 May;20 Suppl 4:143-6. doi: 10.1093/annonc/mdp156. Review.

ReferenceCitation: Prince HM, Hönemann D, Spencer A, Rizzieri DA, Stadtmauer EA, Roberts AW, Bahlis N, Tricot G, Bell B, Demarini DJ, Benjamin Suttle A, Baker KL, Pandite LN. Vascular endothelial growth factor inhibition is not an effective therapeutic strategy for relapsed or refractory multiple myeloma: a phase 2 study of pazopanib (GW786034). Blood. 2009 May 7;113(19):4819-20. doi: 10.1182/blood-2009-02-207209.

ReferenceCitation: Ravaud, A., et al. Sunitinib in patients with refractory advanced thyroid cancer: the THYSU phase II trial. J Clin Oncol (Meeting Abstracts) 26.15_suppl (2008): 6058.

ReferenceCitation: Ricarte-Filho JC, Ryder M, Chitale DA, Rivera M, Heguy A, Ladanyi M, Janakiraman M, Solit D, Knauf JA, Tuttle RM, Ghossein RA, Fagin JA. Mutational profile of advanced primary and metastatic radioactive iodine-refractory thyroid cancers reveals distinct pathogenetic roles for BRAF, PIK3CA, and AKT1. Cancer Res. 2009 Jun 1;69(11):4885-93. doi: 10.1158/0008-5472.CAN-09-0727.

ReferenceCitation: Schlumberger M. [Papillary and follicular thyroid carcinoma]. Ann Endocrinol (Paris). 2007 Jun;68(2-3):120-8. Epub 2007 Jun 19. Review. French.

ReferenceCitation: Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ; Motesanib Thyroid Cancer Study Group. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008 Jul 3;359(1):31-42. doi: 10.1056/NEJMoa075853.

ReferenceCitation: Slamon D,. et al. Pazopanib + Lapatinib is more active than Lapatinib alone : Updated results from a randomized study in patients with first-line ErbB2-positive advanced or metastatic breast cancer [ESMO abstract 139P]. Ann Oncol. 2008c ;19 (supp 8) : viii 64-65.

ReferenceCitation: Sleijfer, S., et al. Phase II study of pazopanib (GW786034) in patients (pts) with relapsed or refractory soft tissue sarcoma (STS): EORTC 62043. ASCO Meeting Abstracts 25.18_suppl (2007): 10031.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Soh EY, Duh QY, Sobhi SA, Young DM, Epstein HD, Wong MG, Garcia YK, Min YD, Grossman RF, Siperstein AE, Clark OH. Vascular endothelial growth factor expression is higher in differentiated thyroid cancer than in normal or benign thyroid. J Clin Endocrinol Metab. 1997 Nov;82(11):3741-7.

ReferenceCitation: Volante M, Rapa I, Gandhi M, Bussolati G, Giachino D, Papotti M, Nikiforov YE. RAS mutations are the predominant molecular alteration in poorly differentiated thyroid carcinomas and bear prognostic impact. J Clin Endocrinol Metab. 2009 Dec;94(12):4735-41. doi: 10.1210/jc.2009-1233. Epub 2009 Oct 16.

ReferenceCitation: de la Fouchardière C, Godbert Y, Dalban C, Illouz F, Wassermann J, Do Cao C, Bardet S, Zerdoud S, Chougnet CN, Zalzali M, Benisvy D, Niccoli P, Digue L, Lamartina L, Schwartz P, Borson Chazot F, Gautier J, Pérol D, Leboulleux S; PAZOTHYR investigators. Intermittent versus continuous administration of pazopanib in progressive radioiodine refractory thyroid carcinoma: Final results of the randomised, multicenter, open-label phase II trial PAZOTHYR. Eur J Cancer. 2021 Nov;157:153-164. doi: 10.1016/j.ejca.2021.07.029. Epub 2021 Sep 9.

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Godbert

full_name: Yann Godbert

given: Yann

family: Dalban

full_name: Cécile Dalban

given: Cécile

family: Illouz

full_name: Frédéric Illouz

family: Wassermann

full_name: Johanna Wassermann

given: Johanna

family: Do Cao

full_name: Christine Do Cao

given: Christine

location_facility:
CHU Angers
Hôpital de la Pitié Salpêtrière APHP
Centre Antoine Lacassagne
Centre François Baclesse
Hôpital Saint-Louis APHP
Institut Jean Godinot
Institut Claudius Régaud
CHU Bordeaux
Centre Leon Berard
Institut Bergonié
Institut Gustave Roussy
CHRU Lille Hôpital Claude Huriez
Hôpital de la Timone APHM

title: A Randomized, Multicenter, Open-label, Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma

summary: The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.


title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy

acronym: EDIEMHYPER

summary:
MAIN OBJECTIVE :

To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years

SECONDARY OBJECTIVES :

To assess the consequences of a maternal hyperthyroïd during pregnancy on the capacities of attention, learning process and the degree of hyperactivity of the child from 6 to 9 years.

To study if it exist differences of intellectual development, capacities of attention, learning process, and degree of hyperactivity in the child from 6 to 9 years, born to hyperthyroid mother during pregnancy, according to:

the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid versus disease of Basedow),
the use or not of a anti-thyroid treatment,
the rate of TSH néonatal (measured with the blotter by tracking with J3 at all the new born ones).

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Marseille
University Hospital of Nantes
University Hospital of Amiens
University Hospital of Lille
Hospital of Saint Antoine
University Hospital of Kremlin Bicetre
University Hospital of Cochin
Civil Hospices of Lyon
University Hospital of Poitiers
University Hospital of Reims
University Hospital of Toulouse
University Hospital of Angers
University Hospital of Strasbourg


title: Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65

acronym: FerHem

summary:
The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a common disorder in the elderly. Indeed, in 1996, in a French study, the median age of patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in the studies reported in English the median age was 71. If epidemiological data concerning lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic procedures and current resuscitation methods, gastrointestinal bleeding prognosis has greatly improved, whereas anaemia related to a bleeding episode remains a frequent complication of gastrointestinal bleeding in elderly patients.

Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on the criteria used and populations studied. The occurrence of a bleeding episode can either induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal bleeding are often unaware of anaemic consequences in the elderly patients which can often be serious. Various studies have shown that anaemia increases morbidity and mortality rates in the elderly. Life expectancy is independently significantly lower for anaemic patients over 65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of cardiovascular and neurological complications, impairment in cognitive function and increased risk of falling.

Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized for upper or lower gastrointestinal bleeding should be corrected rapidly and effectively. Currently, the cost and risks of infection or cardiovascular-related complications of transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL haemoglobin. It is also necessary to develop alternatives to massive transfusions. The correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.

In clinical practice, the effectiveness of iron intake by the oral route is limited by the frequent occurrence of significant gastrointestinal side effects that limit patient compliance and limited absorption necessitating prolonged treatment to correct iron deficiency.

The black colour of stools caused by taking oral iron supplements also makes it difficult to detect a possible recurrence of bleeding after hospitalization.

The prescription of intravenous iron seems more suitable for a rapid and complete correction of iron deficiency after gastrointestinal bleeding. The main objective of our study is to evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron supplementation, the rate of re-hospitalization within 6 months after discharge and patients quality of life. This is a prospective multicenter randomized study versus placebo. After obtaining informed consent, all patients aged over 65 admitted with upper or lower gastrointestinal bleeding, with successful outcome, not related to portal hypertension, responsible for persistent anaemia (definition: Hb < 11 g / dL) after hospitalization will be included in the study. Patients will be treated for their bleeding event in the usual manner of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of external bleeding and haematocrit and/or constant haemoglobin levels will be considered as the end of bleeding.

Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1 included: obtaining informed consent of the patient, determination of iron and ferritin blood levels and complete blood count. and randomization intravenous iron injection , (Ferinject) versus Placebo. Intravenous iron injection will be performed at Day 0. A complete blood count will be performed at week 6 and month 6. Patients will be reviewed in consultation at week 6 and at month 6 to obtain related intercurrent events and assess their quality of life.

The results of this study could lead to changes in the care of older patients hospitalized for gastrointestinal bleeding.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU de Caen
CHU de Pau
GH du havre
CH Le Mans
CH de Valenciennes
CHU d'Amiens
CH de Montélimar
CHU de Nice
CHU de Rouen
CH de Vendée
CHU de Rennes
CHI le Raincy Montfermeil
CH d'Orléans


summary: Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric, non randomized and with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter, randomized study.

lead_sponsor: Poitiers University Hospital

location_facility:
Saintes Hospital
Orléans Hospital
Rennes University Hospital
La Roche sur Yon Hospital
La Rochelle Hospital
Angoulême Hospital
Nice University Hospital
Limoges University Hospital
Tours University Hospital
Cochin University Hospital
Angers University Hospital
Poitiers University Hospital
Nantes University Hospital


title: Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

summary: The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.

ReferenceCitation: Allegre L, Debodinance P, Demattei C, Fabbro Peray P, Cayrac M, Fritel X, Courtieu C, Fatton B, de Tayrac R. Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial. Neurourol Urodyn. 2019 Nov;38(8):2242-2249. doi: 10.1002/nau.24125. Epub 2019 Jul 29.

name: Department of Obstetrics and GynaecologyNîmes University Hospital Nîmes France

family: Allegre

full_name: Lucie Allegre

given: Lucie

name: Department of Obstetrics and GynaecologyDunkerque Hospital Dunkerque France

family: Debodinance

full_name: Philippe Debodinance

given: Philippe

name: Department of BESPIM (Biostatistics, Epidemiology, Public Health and Innovation in Methodolgy)Nîmes University Hospital Nîmes France

family: Demattei

full_name: Christophe Demattei

given: Christophe

family: Fabbro Peray

full_name: Pascale Fabbro Peray

given: Pascale

name: Department of Obstetrics and GynaecologyMontpellier University Hospital Montpellier France

family: Cayrac

full_name: Mélanie Cayrac

given: Mélanie

name: Department of Obstetrics and GynaecologyPoitiers University Hospital Poitiers France

family: Fritel

full_name: Xavier Fritel

given: Xavier

name: Department of GynaecologyClinique Beau Soleil Montpellier France

family: Courtieu

full_name: Christophe Courtieu

family: Fatton

full_name: Brigitte Fatton

given: Brigitte

family: Tayrac

full_name: Renaud Tayrac

given: Renaud

journal_name: Neurourology and Urodynamics

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Lyon - Hôpital de la Croix Rousse

location_facility: CHU de Clermont Ferrand - Hôpital Estaing


title: Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)

acronym: ALS-TOX

summary: Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Explorations Fonctionelles Neuro-Musculaires, Hôpital Rangueil, CHU de Toulouse

location_facility: Service de Neurologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand

location_facility: Service de Neurologie, Hôpital de la Timone, CHU de Marseille

location_facility: Centre SLA, Service de Neurologie A et pathologies du mouvement, Hôpital Roger Salengro, CHU de Lille

location_facility: Centre de Référence maladies Neuromusculaires, Service de Médecine Physique et Réadaptation, Hôpital de l'Archet 1, CHU de Nice

location_facility: Département de Neurologie, Hôpital de l'Hôtel-Dieu, CHU d'Angers

location_facility: Service de Neurologie, CHU de Saint-Etienne

location_facility: Service de Neurologie, Hôpital Dupuytren, CHU de Limoges

location_facility: Département de Neurologie, Hôpital de Hautepierre, CHRU de Strasbourg

location_facility: Service de Neurologie Vastel, Hôpital Côte de Nacre, CHU de Caen

location_facility: Fédération des Maladies du Système Nerveux, Groupement Hospitalier Pitié Salpêtrière, AP-HP

location_facility: Centre SLA, Groupement Hospitalier Est, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

location_facility: Service de Neurologie, Hôpital Central, CHU de Nancy


title: Antibiotic Concentrations Among Critically Ill Patients

acronym: DALI

summary: The primary objective of the DALI study is to compare antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams and glycopeptides.

time_perspective: Cross-Sectional

intervention_type: Biological