title: Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.

acronym: REPERE

summary:
The main objective is to assess the role of antenatal detection of fetal growth restriction (FGR) on stillbirth, by a case-control study in a population-based sample of small for gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of French customised birth weight curves.

Our secondary objectives are

to identify determinants of antenatal detection of FGR among a representative sample of SGA births, with a special interest in the definition of FGR. Our hypothesis is that births who are SGA by customised birthweight curves and non-SGA by population birthweight curves, are not detected antenatally, despite the current strategy including the use of umbilical Doppler.
to analyse prenatal care of a subsample of SGA stillbirths with and without detection of FGR by a confidential enquiry.

ReferenceCitation: Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32.

ReferenceCitation: Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. Review.

ReferenceCitation: Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.

ReferenceCitation: Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. Review.

ReferenceCitation: Hecher K, Snijders R, Campbell S, Nicolaides K. Fetal venous, intracardiac, and arterial blood flow measurements in intrauterine growth retardation: relationship with fetal blood gases. Am J Obstet Gynecol. 1995 Jul;173(1):10-5.

ReferenceCitation: Severi FM, Bocchi C, Visentin A, Falco P, Cobellis L, Florio P, Zagonari S, Pilu G. Uterine and fetal cerebral Doppler predict the outcome of third-trimester small-for-gestational age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2002 Mar;19(3):225-8.

ReferenceCitation: Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009 May 7;9 Suppl 1:S5. doi: 10.1186/1471-2393-9-S1-S5. Review.

ReferenceCitation: Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health. 2011 Apr 13;11 Suppl 3:S1. doi: 10.1186/1471-2458-11-S3-S1. Review.

ReferenceCitation: Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87.

ReferenceCitation: Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. Review. Update in: Cochrane Database Syst Rev. 2007;(2):CD001451. Cochrane Database Syst Rev. 2008;(4):CD001451.

ReferenceCitation: Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD001451.

ReferenceCitation: Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.

ReferenceCitation: GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. BJOG. 2003 Jan;110(1):27-32.

ReferenceCitation: Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20.

ReferenceCitation: Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Effectiveness of detection of intrauterine growth retardation by abdominal palpation as screening test in a low risk population: an observational study. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):164-9.

ReferenceCitation: Jahn A, Razum O, Berle P. Routine screening for intrauterine growth retardation in Germany: low sensitivity and questionable benefit for diagnosed cases. Acta Obstet Gynecol Scand. 1998 Jul;77(6):643-8.

ReferenceCitation: Mattioli KP, Sanderson M, Chauhan SP. Inadequate identification of small-for-gestational-age fetuses at an urban teaching hospital. Int J Gynaecol Obstet. 2010 May;109(2):140-3. doi: 10.1016/j.ijgo.2009.11.023. Epub 2010 Feb 2.

ReferenceCitation: Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64.

ReferenceCitation: Ogundipe EM, Wolfe CD, Seed P, Gamsu HR. Does the antenatal detection of small-for-gestational-age babies influence their two-year outcomes? Am J Perinatol. 2000;17(2):73-81.

ReferenceCitation: Fretts RC, Boyd ME, Usher RH, Usher HA. The changing pattern of fetal death, 1961-1988. Obstet Gynecol. 1992 Jan;79(1):35-9.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinique Saint Vincent de Paul Bourgoin Jallieu


title: European Surgical Outcomes Study: A Multi-centre, International Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Non-cardiac Surgery

acronym: EuSOS

summary:
The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.

Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ahmad T, Beilstein CM, Aldecoa C, Moreno RP, Molnár Z, Novak-Jankovic V, Hofer CK, Sander M, Rhodes A, Pearse RM. Variation in haemodynamic monitoring for major surgery in European nations: secondary analysis of the EuSOS dataset. Perioper Med (Lond). 2015 Sep 23;4:8. doi: 10.1186/s13741-015-0018-8. eCollection 2015.

family: Ahmad

full_name: Tahania Ahmad

given: Tahania

sequence: first

family: Beilstein

full_name: Christian M. Beilstein

given: Christian M.

sequence: additional

family: Aldecoa

full_name: Cesar Aldecoa

given: Cesar

family: Moreno

full_name: Rui P. Moreno

given: Rui P.

family: Molnár

full_name: Zsolt Molnár

given: Zsolt

family: Novak-Jankovic

full_name: Vesna Novak-Jankovic

given: Vesna

family: Hofer

full_name: Christoph K. Hofer

given: Christoph K.

family: Sander

full_name: Michael Sander

given: Michael

family: Rhodes

full_name: Andrew Rhodes

given: Andrew

family: Pearse

full_name: Rupert M. Pearse

given: Rupert M.

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Perioperative Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

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

repository_institution: Queen Mary University of London - Queen Mary Research Online

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: St George's University of London - St George's Online Research Archive

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: van Zaane B, van Klei WA, Buhre WF, Bauer P, Boerma EC, Hoeft A, Metnitz P, Moreno RP, Pearse R, Pelosi P, Sander M, Vallet B, Pettilä V, Vincent JL, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Nonelective surgery at night and in-hospital mortality: Prospective observational data from the European Surgical Outcomes Study. Eur J Anaesthesiol. 2015 Jul;32(7):477-85. doi: 10.1097/EJA.0000000000000256.

family: van Zaane

full_name: Bas van Zaane

given: Bas

family: van Klei

full_name: Wilton A. van Klei

given: Wilton A.

family: Buhre

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Jammer I, Ahmad T, Aldecoa C, Koulenti D, Goranović T, Grigoras I, Mazul-Sunko B, Matos R, Moreno R, Sigurdsson GH, Toft P, Walder B, Rhodes A, Pearse RM; European Surgical Outcomes Study (EuSOS) group. Point prevalence of surgical checklist use in Europe: relationship with hospital mortality. Br J Anaesth. 2015 May;114(5):801-7. doi: 10.1093/bja/aeu460. Epub 2015 Jan 13.

repository_institution: Landspítali University Hospital - Hirsla

ReferenceCitation: Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, Pearse RM, Metnitz P; European Surgical Outcomes Study (EuSOS) group for Trials Groups of European Society of Intensive Care Medicine; European Society of Anaesthesiology. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014 Sep;113(3):416-23. doi: 10.1093/bja/aeu098. Epub 2014 May 14.

location_country:
Finland
Greece
Romania
Belgium
Denmark
Czech Republic
Iceland
Croatia
France
Lithuania
Poland
Slovakia
Norway
Slovenia
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Serbia
Cyprus
Spain
Estonia
Latvia


type: U.S. NIH Grant/Contract

title: Myocardial Ischemia and Transfusion

acronym: MINT

summary: The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.

ReferenceCitation: Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.

ipd_sharing: Yes

ipd_sharing_description: Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.

lead_sponsor: Rutgers, The State University of New Jersey

location_country:
Brazil
United States
France
Australia
New Zealand
Canada

location_facility: Hospital Universitário Professor Edgard Santos

location_facility: Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil

location_facility: University of Minnesota Medical Center Fairview

location_facility: Instituto de Ensino e Pesquisa do Hospital da Bahia

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Hospital Maternidade e Pronto Socorro Santa Lúcia

location_facility: NYU Langone Medical Center, Bellevue Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hôpital Universitaire Carémeau (CHU Carémeau)

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Minneapolis Heart Institute (Foundation)

location_facility: University of Arkansas Medical Sciences (UAMS) Hospital

location_facility: The University of North Carolina at Chapel Hill

location_facility: Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A

summary: This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.

lead_sponsor: Hoffmann-La Roche

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Drug

lead_sponsor: PharmaMar

location_country:
Brazil
Peru
South Africa
Mexico
Spain
France
Bulgaria
Greece
Romania
Argentina
Portugal
Turkey
Colombia

acronym: Neptuno

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) - Hopital Bretonneau

location_facility: Ege University Medical School, Department of Infectious Diseases and Clinical Microbiology

location_facility: Tzaneio Hospital General Hospital of Piraeus Tzaneio

location_facility: Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi - Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

location_facility: "Specialised Hospital for Active Treatment for Pneumophthisiatric Diseases Dr. Dimitar Gramatikov - Ruse" Ltd Department of Pneumology and Phthisiatry

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava, Sectia de Boli Infectioase

location_facility: Hacettepe University, School of Medicine

location_facility: Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Instituto de Investigación Sanitaria Valdecilla (IDIVAL)

location_facility: University First MHAT "St.Yoan Krastitel"-Sofia EAD

location_facility: Organización Clinica Bonnadona Prevenir S.A.S

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes - Bucharest

location_facility: Evangelismos Hospital General Hospital of Athens Evangelismos, Intensive Care Unit

location_facility: Sotiria Hospital General Hospital of Chest Diseases of Athens "Sotiria" 3rd Department of Internal Medicine of University of Athens

location_facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo

location_facility: University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD

location_facility: Centre Hospitalier Universitaire (CHU) Dijon Bourgogne - Hopital Francois Mitterand

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM CITY CLINIC TOKUDA HOSPIAL

location_facility: Centro de Investigación Clínica Chapultepec

location_facility: Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

location_facility: Spitalul Clinic De Boli Infectioase Cluj-Napoca, Sectia HIV/SIDA

location_facility: Hospital Nacional Hipolito Unanue (HNHU)

location_facility: AHEPA Hospital University General Hospital AHEPA

location_facility: Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Universidad de Cadiz (UCA) - Hospital Universitario Puerta del Mar (HUPM)

location_facility: Sociedad de Cirugía de Bogotá; Hospital de San José

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: Universidad Peruana Cayetano Heredia (UPCH) - Hospital Cayetano Heredia (HCH)

location_facility: Hospital General Universitario de Alicante

location_facility: Spitalul Clinic De Boli Infectioase "Sfanta Parascheva" IASI, Sectia Boli Infectioase III

location_facility: Democritus University Hospital University General Hospital of Alexandroupolis

location_facility: CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

location_facility: Nouvel Hôpital Civil Service des maladies infectieuses

location_facility: General Hospital of Athens "Laiko", University of Athens Agiou

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Spitalul Clinic de Boli Infectioase Constanta

location_facility: Hospital Universitario Virgen de las Nieves (HUVN)

location_facility: T.C. Saglik Bakanligi Tepecik Egitim ve Arastirma Hastanesi - Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Klinigi

location_facility: Hospital de Emergencias Enfermera Isabel Zendal

location_facility: CliniSalud del Sur S.A.S - Centro de Investigación

type: EudraCT Number

source: euctr

title: A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patient Requiring Hospitalisation for Management of Moderate COVID-19 Infection

summary: Treatment of patients hospitalised for management of moderate COVID-19 infection


ReferenceCitation: Bourlière M, Bronowicki JP, de Ledinghen V, Hézode C, Zoulim F, Mathurin P, Tran A, Larrey DG, Ratziu V, Alric L, Hyland RH, Jiang D, Doehle B, Pang PS, Symonds WT, Subramanian GM, McHutchison JG, Marcellin P, Habersetzer F, Guyader D, Grangé JD, Loustaud-Ratti V, Serfaty L, Metivier S, Leroy V, Abergel A, Pol S. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015 Apr;15(4):397-404. doi: 10.1016/S1473-3099(15)70050-2. Epub 2015 Mar 13. Erratum in: Lancet Infect Dis. 2015 Jul;15(7):761.

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: de Ledinghen

full_name: Victor de Ledinghen

given: Victor

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Zoulim

full_name: Fabien Zoulim

given: Fabien

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Tran

full_name: Albert Tran

given: Albert

family: Larrey

full_name: Dominique G Larrey

given: Dominique G

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Alric

full_name: Laurent Alric

given: Laurent

family: Hyland

full_name: Robert H Hyland

given: Robert H

family: Jiang

full_name: Deyuan Jiang

given: Deyuan

family: Doehle

full_name: Brian Doehle

given: Brian

family: Pang

full_name: Phillip S Pang

given: Phillip S

family: Symonds

full_name: William T Symonds

given: William T

family: Subramanian

full_name: G Mani Subramanian

given: G Mani

family: McHutchison

full_name: John G McHutchison

given: John G

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Habersetzer

full_name: François Habersetzer

given: François

family: Guyader

full_name: Dominique Guyader

given: Dominique

family: Grangé

full_name: Jean-Didier Grangé

given: Jean-Didier

family: Loustaud-Ratti

full_name: Véronique Loustaud-Ratti

given: Véronique

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

family: Metivier

full_name: Sophie Metivier

given: Sophie

family: Leroy

full_name: Vincent Leroy

given: Vincent

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

summary:
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or achieved HCV RNA < LLOQ).


title: A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP)

acronym: PTC

summary: To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).

status: Unknown status

ReferenceCitation: Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pépin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarère J, Bedos JP, Aegerter P, Crémieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5. Erratum in: Lancet. 2021 Jun 5;397(10290):2150.

family: Dinh

full_name: Aurélien Dinh

given: Aurélien

family: Ropers

full_name: Jacques Ropers

given: Jacques

family: Duran

full_name: Clara Duran

given: Clara

family: Davido

full_name: Benjamin Davido

given: Benjamin

family: Deconinck

full_name: Laurène Deconinck

given: Laurène

family: Matt

full_name: Morgan Matt

given: Morgan

family: Senard

full_name: Olivia Senard

given: Olivia

family: Lagrange

full_name: Aurore Lagrange

given: Aurore

family: Makhloufi

full_name: Sabrina Makhloufi

given: Sabrina

family: Mellon

full_name: Guillaume Mellon

given: Guillaume

family: de Lastours

full_name: Victoire de Lastours

given: Victoire

family: Bouchand

full_name: Frédérique Bouchand

given: Frédérique

family: Mathieu

full_name: Emmanuel Mathieu

given: Emmanuel

family: Kahn

full_name: Jean-Emmanuel Kahn

given: Jean-Emmanuel

family: Rouveix

full_name: Elisabeth Rouveix

given: Elisabeth

family: Grenet

full_name: Julie Grenet

given: Julie

family: Dumoulin

full_name: Jennifer Dumoulin

given: Jennifer

family: Chinet

full_name: Thierry Chinet

given: Thierry

family: Pépin

full_name: Marion Pépin

given: Marion

family: Delcey

full_name: Véronique Delcey

family: Diamantis

full_name: Sylvain Diamantis

given: Sylvain

family: Benhamou

full_name: Daniel Benhamou

given: Daniel

family: Vitrat

full_name: Virginie Vitrat

given: Virginie

location_facility:
CHU Cochin
CHU Ambroise Paré
CH Pontoise
CHU Bichat
CHU Rennes Pontchaillou
CHU Rouen
CH d'Annecy Genevois
CH Tenon
CHI Creteil
CH Argenteuil
CH Lariboisière
Central Hospital Raymon Poincaré
CHU de Grenoble
CH Versailles
CH Beaujon
CH Saint Denis
Foch Hospital
CH Bicêtre
CHU Saint Antoine
Melun Hospital


title: Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment

acronym: PREVACT

summary:
The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding.

Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K.

However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad.

The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy.

PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.

status: Terminated

lead_sponsor: University Hospital, Angers

location_facility:
CH Agen
CHU Clermont Ferrand
Ch Longjumeau
Chu Poitiers
Ch Annecy
Chu Nantes
Chg Montauban
Ch Les Sables D'Olonne
Chu Saint Brieuc
HCL Edouard Herriot
Chu Tenon
CHU METZ
Ch Saint Malo
Chu Tours
CHU Pitié Salpétrière
CHU Chateauroux
CHU Angers
CHG du Mans
Chu Toulouse
CHU Nice
Ch Versailles

status_simplified: Unknown


title: Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer

acronym: OPERAGE

summary: schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 32
Site 07
Site 11
Centre Hospitalier D Argenteuil
Site 30
Site 41
Centre Hospitalier Régional
Centre Hospitalier du Morvan
Site 12
Centre Hospitalier Universitaire
Centre Hospitalier René Dubos
Site 06
Site 20
Site 33
Hôpital Yves Le Foll
Site 14
Site 42
Centre Hospitalier Les Oudairies
Site 19
Hospital du Cluzeau
Centre François Baclesse
Hospital Saint Antoine
Site 18
Site 17
Site 04


title: Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

acronym: ESPOIR 1-5

summary:
Inclusion visit (D0):

verification of inclusion and non-inclusion criteria
information and collection of consent
standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)

intervention_type: Device


title: e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial

acronym: E-SEP

summary: The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Lille Catholic University

location_facility:
Saint-Philibert hospital
CHU Amiens-Picardie
CHRU
CH d'Arras
Saint Vincent hospital
Charles Nicolle Hospital

intervention_type: Diagnostic Test


title: Acceptability Assessment of an "Organization of Care Integrating Artificial Intelligence and a Solution of Telemedicine" on Care of the Nursing Home Residents Located in a Medical Desert: Pilot Study INTEL@MED-POC

summary: While depend elderly people needs are important in Nursing Home, the medical resources are weak from both inside and outside residences located in a medical desert. The goal of this project is to measure the acceptability of Artificial Intelligence and Telemedicine in Nursing Home located in medical desert for patients, nurses, and medical doctor

primary_purpose: Prevention

lead_sponsor: University Hospital, Limoges

location_facility:
EHPAD Ernest Coulaud
Ehpad Le Chavanon
EHPAD La Porte d'Aquitaine
EHPAD Le Chant des Rivières
EHPAD J et M Colaud
EHPAD Le Bois Joli

intervention_type: Other


title: Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment

acronym: ARETA

summary:
Endovascular treatment is now the first line treatment for the management of intracranial aneurysms. However aneurysm recanalization is an important limitation to this treatment. Several factors seems to be associated with aneurysm recanalization including medical history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location, modalities of treatment, immediate post-operative occlusion of the aneurysm.

A precise knowledge of factors increasing the risk of aneurysm recanalization is quite important to optimize strategy of treatment and reduce the recanalization rate. No large, prospective, multicenter trial dealing with this question has been published in the literature.

ReferenceCitation: Pierot L, Barbe C, Thierry A, Bala F, Eugene F, Cognard C, Herbreteau D, Velasco S, Chabert E, Desal H, Aggour M, Rodriguez-Regent C, Gallas S, Sedat J, Marnat G, Sourour N, Consoli A, Papagiannaki C, Spelle L, White P. Patient and aneurysm factors associated with aneurysm recanalization after coiling. J Neurointerv Surg. 2021 Nov 5. pii: neurintsurg-2021-017972. doi: 10.1136/neurintsurg-2021-017972. [Epub ahead of print]

family: Pierot

full_name: Laurent Pierot

given: Laurent

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Thierry

full_name: Aurore Thierry

family: Bala

full_name: Fouzi Bala

given: Fouzi

family: Eugene

full_name: Francois Eugene

given: Francois

family: Cognard

full_name: Christophe Cognard

given: Christophe

family: Herbreteau

full_name: Denis Herbreteau

given: Denis

family: Velasco

full_name: Stéphane Velasco

given: Stéphane

family: Chabert

full_name: Emmanuel Chabert

family: Desal

full_name: Hubert Desal

given: Hubert

family: Aggour

full_name: Mohamed Aggour

given: Mohamed

family: Rodriguez-Regent

full_name: Christine Rodriguez-Regent

given: Christine

family: Gallas

full_name: Sophie Gallas

given: Sophie

family: Sedat

full_name: Jacques Sedat

given: Jacques

family: Marnat

full_name: Gaultier Marnat

given: Gaultier

family: Sourour

full_name: Nader Sourour

given: Nader

family: Consoli

full_name: Arturo Consoli

given: Arturo

family: Papagiannaki

full_name: Chrysanthi Papagiannaki

given: Chrysanthi

family: Spelle

full_name: Laurent Spelle

family: White

full_name: Phil White

given: Phil

journal_name: Journal of NeuroInterventional Surgery

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

ReferenceCitation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarençon F, Papagiannaki C, White P, Spelle L; From the Departments of Neuroradiology, Research, and Public Health. Immediate post-operative aneurysm occlusion after endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1189 patients: Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2021 Oct;13(10):918-923. doi: 10.1136/neurintsurg-2020-017012. Epub 2020 Dec 21.

ReferenceCitation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarençon F, Papagiannaki C, White P, Spelle L. Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients. J Neurointerv Surg. 2021 Jun;13(6):534-540. doi: 10.1136/neurintsurg-2020-016654. Epub 2020 Sep 7.

ReferenceCitation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarençon F, Papagiannaki C, White P, Spelle L. Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients-Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2020 Dec;12(12):1219-1225. doi: 10.1136/neurintsurg-2020-015971. Epub 2020 Jun 16.

title: Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients—Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study

ReferenceCitation: Pierot L, Barbe C, Ferré JC, Cognard C, Soize S, White P, Spelle L. Patient and aneurysm factors associated with aneurysm rupture in the population of the ARETA study. J Neuroradiol. 2020 Jun;47(4):292-300. doi: 10.1016/j.neurad.2019.07.007. Epub 2019 Sep 17.

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Universitaire de Besançon


title: A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER

acronym: ESMERALDA

summary:
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.

It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre Hospitalier Privé de Saint-Grégoire

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: Institut Curie - Hopital Claudius Régaud


title: A Cohort of Outpatients From French Research Memory Centers in Order to Improve Knowledge on Alzheimer's Disease and Related Disorders

acronym: MEMENTO

summary: A Multicenter national prospective cohort study including at least 2300 individuals consecutively recruited from French Research Memory Centers and followed-up over 5 years.

ReferenceCitation: Dufouil C, Dubois B, Vellas B, Pasquier F, Blanc F, Hugon J, Hanon O, Dartigues JF, Harston S, Gabelle A, Ceccaldi M, Beauchet O, Krolak-Salmon P, David R, Rouaud O, Godefroy O, Belin C, Rouch I, Auguste N, Wallon D, Benetos A, Pariente J, Paccalin M, Moreaud O, Hommet C, Sellal F, Boutoleau-Bretonniére C, Jalenques I, Gentric A, Vandel P, Azouani C, Fillon L, Fischer C, Savarieau H, Operto G, Bertin H, Chupin M, Bouteloup V, Habert MO, Mangin JF, Chêne G; MEMENTO cohort Study Group. Cognitive and imaging markers in non-demented subjects attending a memory clinic: study design and baseline findings of the MEMENTO cohort. Alzheimers Res Ther. 2017 Aug 29;9(1):67. doi: 10.1186/s13195-017-0288-0.

apc_source: openAPC

family: Dufouil

full_name: Carole Dufouil

given: Carole

name: on behalf of the MEMENTO cohort Study Group

family: Dubois

full_name: Bruno Dubois

given: Bruno

family: Vellas

full_name: Bruno Vellas

family: Pasquier

full_name: Florence Pasquier

given: Florence

family: Blanc

full_name: Frédéric Blanc

given: Frédéric

family: Hugon

full_name: Jacques Hugon

family: Hanon

full_name: Olivier Hanon

given: Olivier

family: Dartigues

full_name: Jean-François Dartigues

given: Jean-François

family: Harston

full_name: Sandrine Harston

given: Sandrine

family: Gabelle

full_name: Audrey Gabelle

given: Audrey

family: Ceccaldi

full_name: Mathieu Ceccaldi

given: Mathieu

family: Beauchet

full_name: Olivier Beauchet

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

family: David

full_name: Renaud David

given: Renaud

family: Rouaud

full_name: Olivier Rouaud

family: Godefroy

full_name: Olivier Godefroy

family: Belin

full_name: Catherine Belin

given: Catherine

family: Rouch

full_name: Isabelle Rouch

given: Isabelle

family: Auguste

full_name: Nicolas Auguste

given: Nicolas

family: Wallon

full_name: David Wallon

given: David

family: Benetos

full_name: Athanase Benetos

given: Athanase

family: Pariente

full_name: Jérémie Pariente

given: Jérémie

family: Paccalin

full_name: Marc Paccalin

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

location_facility: CHU de Bordeaux - Hôpital Xavier-Arnozan

location_facility: CHU de Saint-Etienne - Hôpital de la charité


type: Other Identifier

title: Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.

acronym: MITRA-FR

summary:
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.

This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).

ReferenceCitation: Iung B, Messika-Zeitoun D, Boutitie F, Trochu JN, Armoiry X, Maucort-Boulch D, Obadia JF, Vahanian A. Characteristics and Outcome of COAPT-Eligible Patients in the MITRA-FR Trial. Circulation. 2020 Dec 22;142(25):2482-2484. doi: 10.1161/CIRCULATIONAHA.120.049743. Epub 2020 Dec 21.

name: APHP, Hôpital Bichat, Paris, France (B.I.).

name: Université de Paris and Institut National de la Santé et de la Recherche Scientifique 1148, Paris, France (B.I., A.V.).

family: Iung

full_name: Bernard Iung

given: Bernard

name: Division of Cardiology, University of Ottawa Heart Institute, Canada (D.M.-Z.).

family: Messika-Zeitoun

full_name: David Messika-Zeitoun

name: Université Lyon 1, Villeurbanne, France (F.B., D.M.-B.).

name: Centre national de la Recherche Scientifique, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France (F.B., D.M.-B.).

family: Boutitie

full_name: Florent Boutitie

given: Florent

name: Centre Hospitalo-UniversitaireNantes, Institut National de la Santé et de la Recherche Scientifique, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, Centre d’Investigations Cliniques 1413, Institut du Thorax, Nantes, France (J.-N.T.).

family: Trochu

full_name: Jean-Noël Trochu

given: Jean-Noël

name: Hôpital Edouard Herriot, Pharmacy Department/Laboratoire MATEIS, Claude Bernard University, Lyon, France (X.A.).

family: Armoiry

full_name: Xavier Armoiry

given: Xavier

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

name: Hôpital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France (J.-F.O.).

family: Obadia

full_name: Jean-Francois Obadia

given: Jean-Francois

family: Vahanian

full_name: Alec Vahanian

given: Alec

journal_name: Circulation

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Messika-Zeitoun D, Iung B, Armoiry X, Trochu JN, Donal E, Habib G, Brochet E, Thibault H, Piriou N, Cormier B, Tribouilloy C, Guerin P, Lefèvre T, Maucort-Boulch D, Vahanian A, Boutitie F, Obadia JF. Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial. JACC Cardiovasc Imaging. 2021 Apr;14(4):742-752. doi: 10.1016/j.jcmg.2020.07.021. Epub 2020 Sep 16.

family: Donal

full_name: Erwan Donal

given: Erwan

family: Habib

full_name: Gilbert Habib

given: Gilbert

family: Brochet

full_name: Eric Brochet

given: Eric

family: Thibault

full_name: Hélène Thibault

given: Hélène

family: Piriou

full_name: Nicolas Piriou

family: Cormier

full_name: Bertrand Cormier

given: Bertrand

family: Tribouilloy

full_name: Christophe Tribouilloy

given: Christophe

ReferenceCitation: Iung B, Armoiry X, Vahanian A, Boutitie F, Mewton N, Trochu JN, Lefèvre T, Messika-Zeitoun D, Guerin P, Cormier B, Brochet E, Thibault H, Himbert D, Thivolet S, Leurent G, Bonnet G, Donal E, Piriou N, Piot C, Habib G, Rouleau F, Carrié D, Nejjari M, Ohlmann P, Saint Etienne C, Leroux L, Gilard M, Samson G, Rioufol G, Maucort-Boulch D, Obadia JF; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail. 2019 Dec;21(12):1619-1627. doi: 10.1002/ejhf.1616. Epub 2019 Nov 18.

name: Université de Paris and INSERM 1148 Paris France

name: APHP, Hôpital Bichat, DHU FIRE Paris France

name: Pharmacy Department and Laboratoire MATEISHospices Civils de Lyon and Claude Bernard University Lyon France

name: Lyon, France; Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique‐SantéService de Biostatistique ‐ Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon Villeurbanne France

name: Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center & Heart Failure DepartmentINSERM 1407, Hospices Civils de Lyon and Claude Bernard University Lyon France

name: CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax Nantes France

name: Division of CardiologyUniversity of Ottawa Heart Institute Ottawa Canada

name: Hôpital Cardiovasculaire Louis Pradel, Service des Explorations Fonctionnelles Cardiovasculaires, Hospices Civils de Lyon and Claude Bernard University Lyon France

name: CHU Rennes, Hôpital Pontchaillou Rennes France

name: APHM, Hôpital de la Timone Marseille France

name: Clinique du Millénaire Montpellier France

name: CHU Toulouse, Hôpital Rangueil Toulouse France

name: Centre Cardiologique du Nord Saint‐Denis France

name: Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil Strasbourg France

name: CHRU de Tours, Hôpital Trousseau Tours France

name: CHU Bordeaux, Hôpital Haut‐Lévêque Pessac France

name: CHRU Brest, Hôpital de La Cavale Blanche Brest France

name: Hopital Cardiovasculaire Louis Pradel, Service d'Hémodynamique et Cardiologie Interventionnelle, Hospices Civils de Lyon and Claude Bernard University Lyon France

name: Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio‐Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University Lyon France

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

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

ReferenceCitation: Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefèvre T, Piot C, Rouleau F, Carrié D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.

name: From Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque (J.-F.O.), Pharmacy Department and Laboratoire Mateis (X.A.), and Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center and Heart Failure Department, INSERM 1407 (C.B., G.S., N. Mewton), Hospices Civils de Lyon and Claude Bernard University, Lyon, Assistance Publique–Hôpitaux de Paris (APHP), Hôpital Bichat (D.M.-Z., B.I., A.V.), and APHP, Hôpital Européen Georges Pompidou (N.K.), Paris,...

location_facility:
Hôpital Nord
Chu de Bordeaux
Groupe Hospitalier La Salpétrière
Clinique du Tonkin
Hôpital privé le Bois
Institut Arnault Tzanck
CHU d'Angers
Chu de Toulouse
Hôpital Saint-Joseph
Hopital de La Timone
Hôpital privé Clairval
Chu de Montpellier
CHRU de Tours
CHRU La Milétrie
Centre Cardiologique du Nord
CH Annecy Genevois
Institut Hospitalier Jacques Cartier
Hôpital Pasteur
Groupement Hospitalier Est
CHU de Grenoble
Clinique Pasteur
Aphp Hopital Bichat
Chu de Besancon
Hôpital Gabriel Montpied
APHP Hôpital Henri Mondor
Chu de Lille
Centre Chirurgical Marie Lannelongue
Chu de Nancy
Chu de Rennes
Chu de Strasbourg
Chu de Nantes
Institut Mutualiste Montsouris
Clinique Du Millenaire
Clinique Cardiologique Saint Gatien
Centre chirurgicale Ambroise Paré
CHU Caen
CHRU La Cavale Blanche
Hôpital privé de Parly 2
Hôpital Européen Georges Pompidou
CHU Rouen


ReferenceCitation: Chibaudel B, Bonnetain F, Tournigand C, de Larauze MH, de Gramont A, Laurent-Puig P, Paget J, Hadengue A, Notelet D, Benetkiewicz M, André T, de Gramont A. STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer. BMC Cancer. 2015 Jul 4;15:496. doi: 10.1186/s12885-015-1503-7.

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Tournigand

full_name: Christophe Tournigand

family: de Larauze

full_name: Marine Hug de Larauze

given: Marine Hug

family: de Gramont

full_name: Armand de Gramont

given: Armand

family: Laurent-Puig

full_name: Pierre Laurent-Puig

given: Pierre

family: Paget

full_name: Jérôme Paget

given: Jérôme

family: Hadengue

full_name: Alexandra Hadengue

given: Alexandra

family: Notelet

full_name: Dominique Notelet

given: Dominique

family: Benetkiewicz

full_name: Magdalena Benetkiewicz

given: Magdalena

family: André

full_name: Thierry André

given: Thierry

full_name: Aimery de Gramont

given: Aimery

journal_name: BMC Cancer

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

repository_institution: Université de Lausanne - SERVAL

repositories:
HAL
PubMed Central
serval.unil.ch

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Adelaide & Meath Hospital Dublin ( AMNCH)

location_facility: Centre d'oncologie et de radiothérapie du Parc

title: Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.

summary: STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.


lead_sponsor: Novartis Pharmaceuticals

acronym: ECLIPSE

title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

summary: The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.


title: Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock

acronym: CLOTILDE

summary: The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.

status: Withdrawn

lead_sponsor: Hospices Civils de Lyon

location_facility:
Chu de Bordeaux
CH Pays d'Aix
Chu de Nancy Brabois
Clinique de La Fourcade
Nouvel Hôpital Civil
Chru de Tours
Aphp Hopital Bichat
Chu Arnaud de Villeneuve
Hôpital Gabriel Montpied
Hopital Charles Nicolle
Chu de Rangueil
Hopital St Luc St Joseph
Chu Hopital A Michallon
Chu Hopital Du Bocage
Hopital Guillaume Et Rene Laennec
Chu de Nimes
Centre Hospitalier de Pau
CHU Hopital Cardiologique Louis Pradel


title: Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.

summary: This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Ch De Rambouillet; Pneumologie Cardiologie

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Chi Emile Durkheim Site Epinal; Pneumologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Hopital Calmette; Pneumologie Oncologie Ouest

location_facility: Groupe Oncorad Garonne; Unite Onco Hematologie

location_facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Centre Medical National Mgen; Pneumologie

location_facility: Hopital Du Cluzeau; Service de Pathologie Respiratoire

location_facility: Clinique sainte marie; chimiotherapie ambulatoire

location_facility: Gh Mutualiste Les Portes Du Sud; Pneumologie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Centre Hospitalier Lyon Sud; Pneumologie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Centre Hospitalier Alpes Leman CHAL;Pneumologie

location_facility: Chi Alpes Du Sud Site De Gap; Pneumologie

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: Centre Cardiologique Du Nord; Pneumologie

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Hopital Saint Vincent; Consult et Explorations

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Hopitaux Du Leman Site Thonon; Pneumologie

location_facility: Centre Hospitalier François Quesnay; Pneumologie-Neurologie

location_facility: Hopital Louis Pasteur; Pneumologie Tabacologie

location_facility: Hopital Bel Air; Pneumologie Allergologie

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie


title: Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project

acronym: BI-VILI

summary:
Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.

We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.

ReferenceCitation: Asehnoune K, Mrozek S, Perrigault PF, Seguin P, Dahyot-Fizelier C, Lasocki S, Pujol A, Martin M, Chabanne R, Muller L, Hanouz JL, Hammad E, Rozec B, Kerforne T, Ichai C, Cinotti R, Geeraerts T, Elaroussi D, Pelosi P, Jaber S, Dalichampt M, Feuillet F, Sebille V, Roquilly A; BI-VILI study group. A multi-faceted strategy to reduce ventilation-associated mortality in brain-injured patients. The BI-VILI project: a nationwide quality improvement project. Intensive Care Med. 2017 Jul;43(7):957-970. doi: 10.1007/s00134-017-4764-6. Epub 2017 Mar 18.

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Mrozek

full_name: Ségolène Mrozek

given: Ségolène

family: Perrigault

full_name: Pierre François Perrigault

given: Pierre François

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Pujol

full_name: Anne Pujol

given: Anne

family: Martin

full_name: Mathieu Martin

given: Mathieu

family: Chabanne

full_name: Russel Chabanne

given: Russel

family: Muller

full_name: Laurent Muller

given: Laurent

family: Hanouz

full_name: Jean Luc Hanouz

given: Jean Luc

family: Hammad

full_name: Emmanuelle Hammad

given: Emmanuelle

family: Rozec

full_name: Bertrand Rozec

family: Kerforne

full_name: Thomas Kerforne

given: Thomas

family: Ichai

full_name: Carole Ichai

given: Carole

family: Cinotti

full_name: Raphael Cinotti

given: Raphael

family: Geeraerts

full_name: Thomas Geeraerts

family: Elaroussi

full_name: Djillali Elaroussi

given: Djillali

family: Pelosi

full_name: Paolo Pelosi

given: Paolo

family: Jaber

full_name: Samir Jaber

given: Samir

family: Dalichampt

full_name: Marie Dalichampt

given: Marie

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Sebille

full_name: Véronique Sebille

given: Véronique

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

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

location_facility: Tours University Hospital - Neurotrauma ICU

location_facility: Tours Univeristy Hospital - Neurosurgery ICU


title: GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.

acronym: GASTRICHIP

summary:
A prospective, opened, multicentric, randomised, phase III trial with two arms:

Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
Arm B: curative gastrectomy with D1-D2 lymph node dissection

Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.

status: Active, not recruiting

ReferenceCitation: Glehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183.

family: Glehen

full_name: Olivier Glehen

given: Olivier

family: Passot

full_name: Guillaume Passot

given: Guillaume

family: Villeneuve

full_name: Laurent Villeneuve

family: Vaudoyer

full_name: Delphine Vaudoyer

given: Delphine

family: Bin-Dorel

full_name: Sylvie Bin-Dorel

given: Sylvie

family: Boschetti

full_name: Gilles Boschetti

given: Gilles

family: Piaton

full_name: Eric Piaton

given: Eric

family: Garofalo

full_name: Alfredo Garofalo

given: Alfredo

publisher_dissemination: Springer

publisher_group: Springer

location_country: France Spain

location_facility: Service de Chirurgie Digestive, CRLC Val d'Aurelle

location_facility: Service de Chirurgie Digestive, CLCC Léon Bérard

location_facility: Service de Chirurgie Digestive, Hôpital Archet II

location_facility: Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre

location_facility: Service de Chirurgie Viscérale, CHU de Poitiers

location_facility: Service de Chirurgie Viscérale, CHU Estaing

location_facility: Service de Chirurgie Générale et Digestive, Hôpital Purpan

location_facility: Service de Chirurgie Digestive, CLCC René Gauducheau

location_facility: Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis

location_facility: Hospital Universitario Principe de Asturias

location_facility: Service de Chirurgie Digestive, Hôpital Lariboisière

location_facility: Service de Chirurgie Digestive, Hôpital Nord

location_facility: Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy

location_facility: Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon

location_facility: Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin

location_facility: Service de Chirurgie Digestive Oncologique, CLCC Paul Papin

location_facility: Service de Chirurgie Viscérale, CLCC François Baclesse

location_facility: Service de Chirurgie Digestive, Institut Curie

location_facility: Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré

location_facility: Service de Chirurgie Digestive, Hôpital du Bocage

location_facility: Service de Chirurgie Digestive et Générale, Hôpital Huriez

location_facility: Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP

location_facility: Département de Chirurgie Digestive - CHU d'Angers

location_facility: Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle

location_facility: Service d'Oncologie Digestive, Hôpital de la Timone

location_facility: Département de Chirurgie Digestive, CHU d'Amiens

location_facility: Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon

intervention_type: Procedure


title: Prospective, Controlled Versus Placebo, Randomized, Double-blind Study, Evaluating the Value of Non-opioid Analgesic Combination (Based on Paracetamol, Nefopam, Ketoprofen) for Postoperative Analgesia.

acronym: OCTOPUS

summary:
The combination of different analgesic drugs and/or analgesia techniques is part of the standard management of postoperative analgesia. The analysis of the literature reveals a lack of comparison of the associations of non-opioid analgesic (NOA) with morphine for postoperative analgesia.

The objectives of this study are :

comparing the morphine sparing effect of different combination of 3 NOA (paracetamol, nefopam, ketoprofen) for postoperative analgesia.
determining whether the morphine-sparing effect is associated with or without a reduction in the incidence of morphine side effects.
evaluating the effects of NOA on postoperative hyperalgesia.

ReferenceCitation: Beloeil H, Albaladejo P, Sion A, Durand M, Martinez V, Lasocki S, Futier E, Verzili D, Minville V, Fessenmeyer C, Belbachir A, Aubrun F, Renault A, Bellissant E; OCTOPUS group. Multicentre, prospective, double-blind, randomised controlled clinical trial comparing different non-opioid analgesic combinations with morphine for postoperative analgesia: the OCTOPUS study. Br J Anaesth. 2019 Jun;122(6):e98-e106. doi: 10.1016/j.bja.2018.10.058. Epub 2018 Dec 29.

family: Beloeil

full_name: H. Beloeil

given: H.

family: Albaladejo

full_name: P. Albaladejo

given: P.

family: Sion

full_name: A. Sion

given: A.

family: Durand

full_name: M. Durand

given: M.

family: Martinez

full_name: V. Martinez

given: V.

family: Lasocki

full_name: S. Lasocki

given: S.

family: Futier

full_name: E. Futier

given: E.

family: Verzili

full_name: D. Verzili

given: D.

family: Minville

full_name: V. Minville

family: Fessenmeyer

full_name: C. Fessenmeyer

given: C.

family: Belbachir

full_name: A. Belbachir

family: Aubrun

full_name: F. Aubrun

given: F.

family: Renault

full_name: A. Renault

family: Bellissant

full_name: E. Bellissant

family: Bedague

full_name: D. Bedague

family: Blanié

full_name: A. Blanié

family: Casez

full_name: M. Casez

family: Chanques

full_name: G. Chanques

given: G.

family: Chaize

full_name: C. Chaize

family: Dessertaine

full_name: G. Dessertaine

family: Ferré

full_name: F. Ferré

family: Gaide Chevronnay

full_name: L. Gaide Chevronnay

given: L.

family: Hébrard

full_name: A. Hébrard

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

location_facility:
Sébastien Bloc
Marcel Chauvin
Marc Raucoules
Emmanuel Marret
Jacques Ripart
Pierre Albaladejo
Hawa Keita-Meyer
Jean-Xavier Mazoit
Anissa Belbachir
Dominique Fletcher
Vincent Minville
Hervé Bouaziz
Marc Gentili
Karine Nouette-Gaulain
Jean-Marc Malinovsky
Frédéric Aubrun
Xavier Capdevila
Marc Beaussier
Karim Asehnoune


acronym: ADDONIS

title: Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU

summary: To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.


title: Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.

acronym: MODEL

summary:
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).

There is two types of maintenance :

continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.

Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.

The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducoloné A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Oster

full_name: Jean-Philippe Oster

given: Jean-Philippe

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Pichon

full_name: Eric Pichon

family: Lavolé

full_name: Armelle Lavolé

given: Armelle

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Bigay-Game

full_name: Laurence Bigay-Game

given: Laurence

family: Dansin

full_name: Eric Dansin

family: Poudenx

full_name: Michel Poudenx

given: Michel

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Vaylet

full_name: Fabien Vaylet

given: Fabien

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Herman

full_name: Dominique Herman

given: Dominique

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Tredaniel

full_name: Jean Tredaniel

given: Jean

family: Ducoloné

full_name: Alain Ducoloné

given: Alain

family: Lebitasy

full_name: Marie-Paule Lebitasy

given: Marie-Paule

family: Baudrin

full_name: Laurence Baudrin

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Milleron

full_name: Bernard Milleron

given: Bernard

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: APHP - CHU Avicenne - Oncologie Medicale

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire


ReferenceCitation: Bonnefoi H, Grellety T, Tredan O, Saghatchian M, Dalenc F, Mailliez A, L'Haridon T, Cottu P, Abadie-Lacourtoisie S, You B, Mousseau M, Dauba J, Del Piano F, Desmoulins I, Coussy F, Madranges N, Grenier J, Bidard FC, Proudhon C, MacGrogan G, Orsini C, Pulido M, Gonçalves A. A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1). Ann Oncol. 2016 May;27(5):812-8. doi: 10.1093/annonc/mdw067. Epub 2016 Feb 18.

family: Bonnefoi

full_name: H. Bonnefoi

given: H.

family: Grellety

full_name: T. Grellety

given: T.

family: Tredan

full_name: O. Tredan

given: O.

family: Saghatchian

full_name: M. Saghatchian

given: M.

family: Dalenc

full_name: F. Dalenc

given: F.

family: Mailliez

full_name: A. Mailliez

given: A.

family: L'Haridon

full_name: T. L'Haridon

family: Cottu

full_name: P. Cottu

given: P.

family: Abadie-Lacourtoisie

full_name: S. Abadie-Lacourtoisie

given: S.

family: You

full_name: B. You

given: B.

family: Mousseau

full_name: M. Mousseau

family: Dauba

full_name: J. Dauba

given: J.

family: Del Piano

full_name: F. Del Piano

family: Desmoulins

full_name: I. Desmoulins

given: I.

family: Coussy

full_name: F. Coussy

family: Madranges

full_name: N. Madranges

given: N.

family: Grenier

full_name: J. Grenier

family: Bidard

full_name: F.C. Bidard

family: Proudhon

full_name: C. Proudhon

given: C.

family: MacGrogan

full_name: G. MacGrogan

given: G.

family: Orsini

full_name: C. Orsini

family: Pulido

full_name: M. Pulido

family: Gonçalves

full_name: A. Gonçalves

journal_name: Annals of Oncology

evidence: open (via crossref license)

location_facility: Institut Curie - Hôpital Claudius Regaud

title: A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer

summary: The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.


title: Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study

summary: The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.

time_perspective: Retrospective

lead_sponsor: Pfizer


lead_sponsor: Swiss Group for Clinical Cancer Research

location_country: Germany France Switzerland Netherlands

acronym: PERNETTA

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Civil

location_facility: Centre Hospitalier de Perpignan - Hopital Saint Jean

location_facility: Fondation Hopital Ambroise Pare - Hopital Europeen

location_facility: Antoni van Leeuwenhoek / Slotervaart hospital

location_facility: Kantonsspital Frauenfeld / Brustzentrum Thurgau

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

location_facility: Zentrum fuer Tumordiagnostik und Praevention

location_facility: Centre Hospitalier - Site Hopital du Scorff

location_facility: Leiden_Leids Universitair Medisch Centrum (LUMC)

location_facility: Hopital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: Institut Regional du Cancer Montpellier Val d'Aurelle

title: A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer

summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.


title: Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment

acronym: FACE

summary: The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).

ReferenceCitation: Tamisier R, Damy T, Davy JM, Verbraecken JA, Bailly S, Lavergne F, Palot A, Goutorbe F, Pépin JL, d'Ortho MP. Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation. BMJ Open. 2020 Jul 19;10(7):e038403. doi: 10.1136/bmjopen-2020-038403.

lead_sponsor: ResMed

location_facility: Arnaud de Villeneuve University Hospital

location_facility: APHP - Pitié-Salpêtrière University Hospital


title: Etude Resume (Retraitement Sunitinib Rein Metastatique)

acronym: RESUME

summary: Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

location_facility: Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: Institut Paoli-Calmettes / Hôpital de jour

location_facility: Centre Leon Berard, Service d'Oncologie Medicale

location_facility: Centre Oscar Lambret - Cancérologie Urologie Digestive


acronym: CUSTOMBONE

summary:
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™

The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.

The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).

lead_sponsor: Integra LifeSciences Corporation

location_facility:
CHU Angers
CHU Lariboisière
CHU Hautepierre
CHU Beaujon
CH Saint Etienne
CHU Henri Mondor
CH Bretonneau
Clinique du Tonkin
CH Amiens
CH de la cote basque
CHU Hotel Dieu
CHU Lyon
CHU Pasteur
Hopital Maison Blanche
CHRU Roger Salengro
CHU la cavale blanche
CHU La¨Pitié Salpêtrière
Hôpital Ponchaillou


title: Interest of Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure

acronym: DESYRE

summary:
Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event).

Observation or Investigation Method Used :

The study is :

multicenter
prospective
open

randomized: patients are divided into two parallel groups:

study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, Maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after transplantectomy. Corticosteroids: 5mg per day until one month after transplantectomy then stop within one month.
control group: No systematic transplantectomy. Antiproliferatives stop at the start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months.

In the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.

primary_purpose: Supportive Care

location_facility: Transplantation Department, Hôpital Edourad Herriot

location_facility: Service de Néphrologie, Centre Hospitalier Lyon Sud

location_facility: Service de Néphrologie-Dialyse, Centre Hospitalier d'Annecy

location_facility: Institut de Transplantation, Urologie et Néphrologie - CHU Nantes

location_facility: Urgence Néphrologique et Transplantation Rénale - Hôpital Tenon

location_facility: Unité de Transplantation Rénale - Hôpital de l'Archet

location_facility: Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital Nord

location_facility: Département de Néphrologie et Transplantation d'Organes - Hôpîtal Rangueil

location_facility: Service de Néphrologie, Immunologie Clinique - CHU Bretonneau

location_facility: Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied

location_facility: Service de Néphrologie et Transplantation Rénale - Nouvel Hôpital Civil

location_facility: Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon

location_facility: Service de Néphrologie - Hôpital de La Cavale blanche

location_facility: Service de Néphrologie - Hôpital Claude Huriez

location_facility: Service de Néphrologie, Dialyse et Transplantation - Hôpital Jean Minjoz

location_facility: Centre Hospitalier départemental Vendée - Site de la Roche-sur-Yon

location_facility: Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie

location_facility: Service de Néphrologie, Médecine interne, Hémodialyse, Transplantation Rénale, Hôpital Sud


title: A Multicenter, Open, Randomized, Controlled Phase IIb Trial Evaluating Efficacy and Tolerability of GRASPA (L-asparaginase Encapsulated in Red Blood Cells, Eryaspase) Plus Low-dose Cytarabine vs Low-dose Cytarabine Alone, in Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Elderly Patients, Unfit for Intensive Chemotherapy

acronym: ENFORCE

summary: The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy.

ipd_sharing: Undecided

lead_sponsor: ERYtech Pharma

location_facility:
Hôtel Dieu - CHU de NANTES
Hôpital Claude-Huriez
Chu D'Angers
Hôpital Haut-Lévèque
Groupe Hospitalier Sud
Centre Henri Becquerel
CHU Estaing
CHRU de Nîmes
Hôpital l'Archet 1
Hôpital Saint Eloi
Institut Paoli Calmettes
Hopital de Brabois
Institut de Cancérologie de la Loire
Hopital De Purpan CHU Toulouse
Centre Léon Bérard
Hopital Morvan
Hopital de Hautepierre
Centre hospitalier Lyon Sud
Hôpital JEAN MINJOZ
Hopital Région d'Annecy
hopital de Perpignan


ReferenceCitation: Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.

family: Pivot

full_name: X. Pivot

given: X.

family: Spano

full_name: J.P. Spano

family: Espie

full_name: M. Espie

family: Jouannaud

full_name: C. Jouannaud

family: Pottier

full_name: V. Pottier

given: V.

family: Moreau

full_name: L. Moreau

given: L.

family: Extra

full_name: J.M. Extra

family: Lortholary

full_name: A. Lortholary

family: Rivera

full_name: P. Rivera

family: Spaeth

full_name: D. Spaeth

given: D.

family: Attar-Rabia

full_name: H. Attar-Rabia

family: Benkanoun

full_name: C. Benkanoun

family: Dima-Martinez

full_name: L. Dima-Martinez

family: Esposito

full_name: N. Esposito

family: Gligorov

full_name: J. Gligorov

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hopital Belle Isle; Oncologie Hematologie

location_facility: Hopital Prive Nord Parisien; Soins De Suite - Oncologie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Centre Eugene Marquis; Bureau D Etudes Cliniques

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Polyclinique de la Cote Basque Sud; Oncologie

location_facility: HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

location_facility: Centre Oscar Lambret; Unite de Recherche Clinique

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Centre Henri Becquerel; Oncologie Medicale

title: An Open-Label, Randomized, Multicenter Phase III Study in Patients With HER2-Positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab

summary: This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.


ReferenceType: result

ReferenceCitation: Conroy T, Bosset JF, Etienne PL, Rio E, François É, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouché O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardière C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.

family: Conroy

full_name: Thierry Conroy

given: Thierry

family: Bosset

full_name: Jean-François Bosset

given: Jean-François

family: Etienne

full_name: Pierre-Luc Etienne

given: Pierre-Luc

family: Rio

full_name: Emmanuel Rio

given: Emmanuel

family: François

full_name: Éric François

given: Éric

family: Mesgouez-Nebout

full_name: Nathalie Mesgouez-Nebout

given: Nathalie

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: Artignan

full_name: Xavier Artignan

given: Xavier

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Gargot

full_name: Dany Gargot

given: Dany

family: Boige

full_name: Valérie Boige

given: Valérie

family: Bonichon-Lamichhane

full_name: Nathalie Bonichon-Lamichhane

family: Louvet

full_name: Christophe Louvet

given: Christophe

family: Morand

full_name: Clotilde Morand

given: Clotilde

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Lamfichekh

full_name: Najib Lamfichekh

given: Najib

family: Juzyna

full_name: Béata Juzyna

given: Béata

family: Jouffroy-Zeller

full_name: Claire Jouffroy-Zeller

given: Claire

family: Rullier

full_name: Eric Rullier

given: Eric

family: Marchal

full_name: Frédéric Marchal

given: Frédéric

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Castan

full_name: Florence Castan

given: Florence

family: Borg

full_name: Christophe Borg

evidence: open (via crossref license, author manuscript)

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: Centre Hospitalier de la Réunion - Site du GHSR

location_facility: Institut de Cancérologie de Franche Comté

location_facility: Centre hospitalier Universitaire d'Amiens

title: Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer

summary: National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.


ReferenceCitation: Pignata S, Lorusso D, Joly F, Gallo C, Colombo N, Sessa C, Bamias A, Salutari V, Selle F, Frezzini S, De Giorgi U, Pautier P, Bologna A, Orditura M, Dubot C, Gadducci A, Mammoliti S, Ray-Coquard I, Zafarana E, Breda E, Favier L, Ardizzoia A, Cinieri S, Largillier R, Sambataro D, Guardiola E, Lauria R, Pisano C, Raspagliesi F, Scambia G, Daniele G, Perrone F; MITO16b/MANGO-OV2/ENGOT-ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):267-276. doi: 10.1016/S1470-2045(20)30637-9.

family: Pignata

full_name: Sandro Pignata

given: Sandro

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

family: Joly

full_name: Florence Joly

family: Gallo

full_name: Ciro Gallo

given: Ciro

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Sessa

full_name: Cristiana Sessa

given: Cristiana

family: Bamias

full_name: Aristotelis Bamias

given: Aristotelis

family: Salutari

full_name: Vanda Salutari

given: Vanda

family: Selle

full_name: Frédèric Selle

given: Frédèric

family: Frezzini

full_name: Simona Frezzini

given: Simona

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

family: Pautier

full_name: Patricia Pautier

given: Patricia

family: Bologna

full_name: Alessandra Bologna

given: Alessandra

family: Orditura

full_name: Michele Orditura

given: Michele

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Gadducci

full_name: Angiolo Gadducci

given: Angiolo

family: Mammoliti

full_name: Serafina Mammoliti

given: Serafina

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Zafarana

full_name: Elena Zafarana

given: Elena

family: Breda

full_name: Enrico Breda

given: Enrico

family: Favier

full_name: Laure Favier

given: Laure

family: Ardizzoia

full_name: Antonio Ardizzoia

given: Antonio

family: Cinieri

full_name: Saverio Cinieri

given: Saverio

family: Largillier

full_name: Rémy Largillier

given: Rémy

family: Sambataro

full_name: Daniela Sambataro

given: Daniela

ReferenceCitation: Arend R, Westin SN, Coleman RL. Decision analysis for secondline maintenance treatment of platinum sensitive recurrent ovarian cancer: a review. Int J Gynecol Cancer. 2020 May;30(5):684-694. doi: 10.1136/ijgc-2019-001041. Epub 2020 Feb 19. Review.

journal_name: International Journal of Gynecologic Cancer

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: A.O. di Udine S. Maria della Misericordia

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Istituto Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Fondazione del Piemonte per l'Oncologia IRCCS

location_facility: Centre de Radiothèrapie - Clinique Sainte-Anne

location_facility: Zentrum fùr Onkologie/ Hamat. und Transf

location_facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hôpital Inter Armées de Begin (HIA Begin),

location_facility: Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

location_facility: Ospedale S. Maria delle Croci AUSL di Ravenna

location_facility: Ospedale S. Giovanni Calibita Fatebenefratelli

title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

summary:
Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.


title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial

acronym: GUERANDE

summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).

ReferenceCitation: Angoulvant F, Bellêttre X, Milcent K, Teglas JP, Claudet I, Le Guen CG, de Pontual L, Minodier P, Dubos F, Brouard J, Soussan-Banini V, Degas-Bussiere V, Gatin A, Schweitzer C, Epaud R, Ryckewaert A, Cros P, Marot Y, Flahaut P, Saunier P, Babe P, Patteau G, Delebarre M, Titomanlio L, Vrignaud B, Trieu TV, Tahir A, Regnard D, Micheau P, Charara O, Henry S, Ploin D, Panjo H, Vabret A, Bouyer J, Gajdos V; Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) Study Group. Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171333. doi: 10.1001/jamapediatrics.2017.1333. Epub 2017 Aug 7.

name: Service d'accueil des urgences pédiatriques, Necker-Enfants Malades University Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France2Epidémiologie Clinique et Évaluation Économique Appliquées aux Populations Vulnérables, INSERM, Unité Mixte de Recherche 1123, Paris, France

family: Angoulvant

full_name: François Angoulvant

given: François

name: Service d'accueil des urgences pédiatriques, Robert Debré University Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Bellêttre

full_name: Xavier Bellêttre

given: Xavier

name: Service de Pédiatrie, Antoine Béclère University Hospital, Assistance Publique–Hôpitaux de Paris, Clamart, France5Centre for Research in Epidemiology and Population Health, INSERM U1018, Villejuif, France

family: Milcent

full_name: Karen Milcent

given: Karen

family: Teglas

full_name: Jean-Paul Teglas

given: Jean-Paul

name: Service d'accueil des urgences pédiatriques, Toulouse University Hospital, Toulouse, France

family: Claudet

full_name: Isabelle Claudet

name: Service d'accueil des urgences pédiatriques, Nantes University Hospital, Nantes, France

family: Le Guen

full_name: Christèle Gras Le Guen

given: Christèle Gras

name: Service de Pédiatrie, Jean Verdier University Hospital, Assistance Publique–Hôpitaux de Paris, Bondy, France

family: de Pontual

full_name: Loïc de Pontual

given: Loïc

name: Service d'accueil des urgences pédiatriques, Marseille Nord University Hospital, Assistance Publique–Hôpitaux de Marseille, Marseille, France

family: Minodier

full_name: Philippe Minodier

given: Philippe

name: Service d'accueil des urgences pédiatriques, Lille University Hospital, Lille, France

family: Dubos

full_name: François Dubos

name: Service de Pédiatrie, Caen University Hospital, Caen, France

family: Brouard

full_name: Jacques Brouard

given: Jacques

name: Service de Pédiatrie, Ambroise Paré University Hospital, Assistance Publique–Hôpitaux de Paris, Boulogne-Billancourt, France

family: Soussan-Banini

full_name: Valérie Soussan-Banini

given: Valérie

name: Service de Pédiatrie, Sud-Francilien Hospital, Corbeil-Essonnes, France

family: Degas-Bussiere

full_name: Vanessa Degas-Bussiere

given: Vanessa

name: Service de médecine infantile, Nancy University Hospital, Vandoeuvre-Lès-Nancy, France

family: Gatin

full_name: Amélie Gatin

given: Amélie

family: Schweitzer

full_name: Cyril Schweitzer

given: Cyril

name: Service d'accueil des urgences pédiatriques, Creteil Intercommunal Hospital, Creteil, France

family: Epaud

full_name: Ralph Epaud

given: Ralph

name: Service d'accueil des urgences pédiatriques, Rennes University Hospital, Rennes, France

family: Ryckewaert

full_name: Amélie Ryckewaert

name: Service de Pédiatrie, Brest University Hospital, Brest, France

family: Cros

full_name: Pierrick Cros

given: Pierrick

name: Service d'accueil des urgences pédiatriques, Tours University Hospital, Tours, France

family: Marot

full_name: Yves Marot

given: Yves

name: Service d'accueil des urgences pédiatriques, Rouen University Hospital, Rouen, France

family: Flahaut

full_name: Philippe Flahaut

name: Service de Pédiatrie, Fontainebleau Hospital, Fontainebleau, France

family: Saunier

full_name: Pascal Saunier

given: Pascal

name: Service d'accueil des urgences pédiatriques, Lenval University Hospital, Nice, France

family: Babe

full_name: Philippe Babe

family: Patteau

full_name: Géraldine Patteau

given: Géraldine

family: Delebarre

full_name: Mathilde Delebarre

name: Service d'accueil des urgences pédiatriques, Limoges University Hospital, Limoges, France

name: Service d'accueil des urgences pédiatriques, Bicêtre University Hospital, Assistance Publique–Hôpitaux de Paris, Kremlin-Bicêtre, France

name: Service de Pédiatrie, André Mignot Hospital, Le Chesnay, France

name: Service de Pédiatrie, Laennec Hospital, Quimper, France

name: Service d'accueil des urgences pédiatriques, Mother Child University Hospital, Bron, France27Epidémiologie, Pharmacologie, Investigation Clinique, Information médicale, Mère-Enfant (EPICIME), Clinical Investigation Center, INSERM Clinical Investigation Center 1407, Bron, France

name: for the Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) Study Group

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

location_facility: Centre Hospitalier intercommunal de Créteil


title: Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians

acronym: PRALINE

summary: The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first before reimbursement and after reimbursement.

time_perspective: Cross-Sectional

lead_sponsor: GlaxoSmithKline