ReferenceCitation: Cung TT, Morel O, Cayla G, Rioufol G, Garcia-Dorado D, Angoulvant D, Bonnefoy-Cudraz E, Guérin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Claeys MJ, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, De Poli F, Morice MC, Ider O, Dubois-Randé JL, Unterseeh T, Le Breton H, Béard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Elmer E, Hansson MJ, Bergerot C, Boussaha I, Jossan C, Derumeaux G, Mewton N, Ovize M. Cyclosporine before PCI in Patients with Acute Myocardial Infarction. N Engl J Med. 2015 Sep 10;373(11):1021-31. doi: 10.1056/NEJMoa1505489. Epub 2015 Aug 30.

ReferenceCitation: Bochaton T, Claeys MJ, Garcia-Dorado D, Mewton N, Bergerot C, Jossan C, Amaz C, Boussaha I, Thibault H, Ovize M. Importance of infarct size versus other variables for clinical outcomes after PPCI in STEMI patients. Basic Res Cardiol. 2019 Dec 12;115(1):4. doi: 10.1007/s00395-019-0764-8.

family: Bochaton

full_name: Thomas Bochaton

given: Thomas

family: Claeys

full_name: Marc J. Claeys

given: Marc J.

family: Garcia-Dorado

full_name: David Garcia-Dorado

given: David

family: Mewton

full_name: Nathan Mewton

given: Nathan

family: Bergerot

full_name: Cyrille Bergerot

given: Cyrille

family: Jossan

full_name: Claire Jossan

given: Claire

family: Amaz

full_name: Camille Amaz

given: Camille

family: Boussaha

full_name: Inesse Boussaha

given: Inesse

family: Thibault

full_name: Hélène Thibault

given: Hélène

family: Ovize

full_name: Michel Ovize

given: Michel

journal_name: Basic Research in Cardiology

ReferenceCitation: Mewton N, Cung TT, Morel O, Cayla G, Bonnefoy-Cudraz E, Rioufol G, Angoulvant D, Guerin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, Morice MC, Monassier JP, Ider O, Dubois-Randé JL, Unterseeh T, Lebreton H, Beard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Hansson MJ, Elmer E, Boussaha I, Jossan C, Torner A, Claeys M, Garcia-Dorado D, Ovize M; CIRCUS Study Investigators. Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial). Am Heart J. 2015 Jun;169(6):758-766.e6. doi: 10.1016/j.ahj.2015.02.020. Epub 2015 Mar 13.

family: Cung

full_name: Thien T. Cung

given: Thien T.

full_name: Olivier Morel

given: Olivier

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Bonnefoy-Cudraz

full_name: Eric Bonnefoy-Cudraz

family: Rioufol

full_name: Gilles Rioufol

given: Gilles

family: Angoulvant

full_name: Denis Angoulvant

given: Denis

family: Guerin

full_name: Patrice Guerin

given: Patrice

family: Elbaz

full_name: Meyer Elbaz

given: Meyer

family: Delarche

full_name: Nicolas Delarche

given: Nicolas

family: Coste

full_name: Pierre Coste

given: Pierre

family: Vanzetto

full_name: Gerald Vanzetto

given: Gerald

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

location_facility: Hôpitaux Universitaires, Nouvel Hôpital Civil

location_facility: Hopital Louis Pradel, Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire d'Angers

title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

summary: Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.


type: Registry Identifier

title: A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

acronym: INIS

summary: The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Takeda

location_country:
Sweden
France
Greece
Norway
Ireland
Denmark
United Kingdom

lead_sponsor_type: industriel

status_simplified: Completed


title: Kuvan® Adult Maternal Pediatric European Registry

acronym: KAMPER

summary:
Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.

Kuvan® received marketed authorisation in Europe in December 2008 and is now available in several European countries for the treatment of Hyperphenylalaninemia (HPA).

The primary objective is to assess the long-term safety in subjects treated with Kuvan®.

Secondary objectives are to provide additional information regarding:

Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with renal or hepatic insufficiency).
Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are receiving treatment with Kuvan®.
Progress and outcome of pregnancy for women with HPA who become pregnant while receiving treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry).
Assessment of adherence to diet and to Kuvan®.
Assessment of long-term sensitivity to Kuvan®treatment.

lead_sponsor: BioMarin Pharmaceutical

location_country: Italy Austria Sweden Netherlands Spain France Slovakia Portugal Germany

location_facility:
Research Site
Research Site - Ospedale Annunziata
Research Site - Necker
Research Site - Armand Trousseau
Research Site - Policlinico Federico


design_allocation: Randomized

intervention_type: Drug

study_type: Interventional

lead_sponsor: Boehringer Ingelheim

primary_purpose: Treatment

location_country: Italy France Belgium Spain Germany

acronym: BIBF 1120 vs Bevacizumab in  CRC

location_facility: 1199.51.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34007 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3302B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3307C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.32005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.34006 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3301A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308B Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308D Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305E Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305A Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3308C Boehringer Ingelheim Investigational Site

location_facility: 1199.51.39005 Boehringer Ingelheim Investigational Site

location_facility: 1199.51.3305D Boehringer Ingelheim Investigational Site

type: EudraCT Number

source: euctr

title: A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients

summary: The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.


type: Other Identifier

title: Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

acronym: PHYSICOSMICI

summary: This study is an observational study. The purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD. Physical activity is an important determinant of health throughout the whole lifespan. Engaging in regular moderate-to-vigorous physical activity has important health benefits. Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with IBD.

study_start_date_type: Actual

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Lille

location_facility:
Chu Amiens-Picardie - Site Sud
Centre Hospitalier
Centre Hospitalier St Vincent
Clinical Investigation Center
Centre hospitalier

intervention_type: Device

lead_sponsor_type: academique


ReferenceType: derived

ReferenceCitation: Fouquet G, Guidez S, Petillon MO, Louni C, Ohyba B, Dib M, Poulain S, Herbaux C, Martin A, Thielemans B, Brice P, Choquet S, Bakala J, Bories C, Demarquette H, Nudel M, Tournilhac O, Arnulf B, LeGouill S, Morel P, Banos A, Karlin L, Salles G, Leblond V, Leleu X. Lenalidomide is safe and active in Waldenström macroglobulinemia. Am J Hematol. 2015 Nov;90(11):1055-9. doi: 10.1002/ajh.24175. Epub 2015 Oct 6.

name: Maladies Du Sang, Hôpital Huriez, CHRU; Lille France

family: Fouquet

full_name: Guillemette Fouquet

given: Guillemette

sequence: first

family: Guidez

full_name: Stéphanie Guidez

given: Stéphanie

sequence: additional

family: Petillon

full_name: Marie-Odile Petillon

given: Marie-Odile

name: Département De Recherche Clinique, CHRU; Lille France

family: Louni

full_name: Chanaz Louni

given: Chanaz

family: Ohyba

full_name: Bella Ohyba

given: Bella

family: Dib

full_name: Malek Dib

given: Malek

family: Poulain

full_name: Stéphanie Poulain

family: Herbaux

full_name: Charles Herbaux

given: Charles

name: Hématologie, Hôpital Côte De Nacre, CHU Caen; France

family: Martin

full_name: Audrey Martin

given: Audrey

family: Thielemans

full_name: Béatrice Thielemans

given: Béatrice

name: Hématologie, Hôpital Pitié-Salpêtrière, APHP; Paris France

family: Brice

full_name: Pauline Brice

given: Pauline

name: Institut Universitaire D'hématologie, APHP Saint Louis; Paris EA3963 France

family: Choquet

full_name: Sylvain Choquet

given: Sylvain

family: Bakala

full_name: Jana Bakala

given: Jana

family: Bories

full_name: Claire Bories

family: Demarquette

full_name: Hélène Demarquette

family: Nudel

full_name: Morgane Nudel

given: Morgane

name: Hématologie Clinique Hôpital Estaing; CHU Clermont-Ferrand France

family: Tournilhac

full_name: Olivier Tournilhac

family: Arnulf

full_name: Bertrand Arnulf

given: Bertrand

name: Hématologie Clinique, Hôtel-Dieu, CHU; France Nantes

family: LeGouill

full_name: Steven LeGouill

given: Steven

family: Morel

full_name: Pierre Morel

family: Banos

full_name: Anne Banos

given: Anne

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Salles

full_name: Gilles Salles

family: Leblond

full_name: Véronique Leblond

given: Véronique

family: Leleu

full_name: Xavier Leleu

given: Xavier

location_facility:
Centre Hospitalier de la côte basque
Ch Nantes
Centre Hospitalier Lyon Sud
Groupe hospitalier Pitié Salpétrière
Chru Lille
Ch Clermond Ferrand
CH LENS

title: A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia

summary: The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.


title: Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.

summary: The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

ReferenceCitation: Mariani P, Blumberg J, Landau A, Lebrun-Jezekova D, Botton E, Beatrix O, Mayeur D, Herve R, Maisonobe P, Chauvenet L. Symptomatic treatment with lanreotide microparticles in inoperable bowel obstruction resulting from peritoneal carcinomatosis: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol. 2012 Dec 10;30(35):4337-43. doi: 10.1200/JCO.2011.40.5712. Epub 2012 Oct 29.

name: Pascale Mariani, Institut Curie; Laure Chauvenet, Hôpital Hôtel-Dieu, Paris; Joëlle Blumberg, Ipsen, Les Ulis; Alain Landau, Hôpital Victor Jousselin, Dreux; Daniela Lebrun-Jezekova, Institut Jean Godinot, Reims; Estelle Botton, Centre Eugène Marquis, Rennes; Olivier Beatrix, Centre Hospitalier Lyon Sud, Pierre Benite; Didier Mayeur, Hôpital André Mignot, Le Chesnay; Robert Herve, Hôpital Prive Clairval, Marseille; and Pascal Maisonobe, Ipsen, Boulogne, France.

family: Mariani

full_name: Pascale Mariani

given: Pascale

family: Blumberg

full_name: Joëlle Blumberg

given: Joëlle

family: Landau

full_name: Alain Landau

given: Alain

family: Lebrun-Jezekova

full_name: Daniela Lebrun-Jezekova

given: Daniela

family: Botton

full_name: Estelle Botton

given: Estelle

family: Beatrix

full_name: Olivier Beatrix

given: Olivier

family: Mayeur

full_name: Didier Mayeur

given: Didier

family: Herve

full_name: Robert Herve

given: Robert

family: Maisonobe

full_name: Pascal Maisonobe

given: Pascal

family: Chauvenet

full_name: Laure Chauvenet

given: Laure

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Symptomatic Treatment With Lanreotide Microparticles in Inoperable Bowel Obstruction Resulting From Peritoneal Carcinomatosis: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

lead_sponsor: Ipsen

location_country: Belgium France Netherlands

location_facility: Centre de Radiothérapie et Oncologie Médicale

intervention_type: Other


title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients With Septic Shock and Elevated Adrenomedullin

summary: This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

ReferenceCitation: Laterre PF, Pickkers P, Marx G, Wittebole X, Meziani F, Dugernier T, Huberlant V, Schuerholz T, François B, Lascarrou JB, Beishuizen A, Oueslati H, Contou D, Hoiting O, Lacherade JC, Chousterman B, Pottecher J, Bauer M, Godet T, Karakas M, Helms J, Bergmann A, Zimmermann J, Richter K, Hartmann O, Pars M, Mebazaa A; AdrenOSS-2 study participants. Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. Intensive Care Med. 2021 Nov;47(11):1284-1294. doi: 10.1007/s00134-021-06537-5. Epub 2021 Oct 4.

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

family: Pickkers

full_name: Peter Pickkers

given: Peter

family: Marx

full_name: Gernot Marx

given: Gernot

family: Wittebole

full_name: Xavier Wittebole

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Dugernier

full_name: Thierry Dugernier

given: Thierry

family: Huberlant

full_name: Vincent Huberlant

given: Vincent

family: Schuerholz

full_name: Tobias Schuerholz

given: Tobias

family: François

full_name: Bruno François

given: Bruno

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Beishuizen

full_name: Albertus Beishuizen

given: Albertus

family: Oueslati

full_name: Haikel Oueslati

given: Haikel

family: Contou

full_name: Damien Contou

given: Damien

family: Hoiting

full_name: Oscar Hoiting

given: Oscar

family: Lacherade

full_name: Jean-Claude Lacherade

given: Jean-Claude

family: Chousterman

full_name: Benjamin Chousterman

given: Benjamin

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Bauer

full_name: Michael Bauer

given: Michael

family: Godet

full_name: Thomas Godet

given: Thomas

family: Karakas

full_name: Mahir Karakas

given: Mahir

family: Helms

full_name: Julie Helms

given: Julie

family: Bergmann

full_name: Andreas Bergmann

given: Andreas

family: Zimmermann

full_name: Jens Zimmermann

given: Jens

ReferenceCitation: Geven C, Blet A, Kox M, Hartmann O, Scigalla P, Zimmermann J, Marx G, Laterre PF, Mebazaa A, Pickkers P. A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2). BMJ Open. 2019 Feb 19;9(2):e024475. doi: 10.1136/bmjopen-2018-024475.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_facility: University Hospital of Clermont-Ferrand, Dept. of Perioperative Medicine

location_facility: Hôpital de Bicêtre, Service d'anesthésie-réanimation chirurgicale

location_facility: Universitätsklinikum Aachen, Klinik für Operative Intensivmedizin

location_facility: Clinique Universitaire Saint-Luc (UCL Bruxelles)

location_facility: Hôpital Saint-Louis, Service d'Anesthésie-Réanimation

location_facility: Medical Intensive Care Medicine, Centre hospital - universitaire

location_facility: AP-HP, Hopital Louis Mourier, Réanimation Médicale

location_facility: Medisch Spectrum Twente, Department of Intensive Care

location_facility: Zuyderland Medical Center, Department of Intensive Care

location_facility: CHU de Nantes; Medicine Intensive Reanimation

location_facility: Groupe Jolimont, Hospitalier de Jolimont

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Intensivmedizin

location_facility: Hôpital de Hautepierre , Hôpitaux Universitaires de Strasbourg, Unité de Réanimation Chirurgicale, Service d'Anesthésie-Réanimation Chirurgicale

location_facility: Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie

location_facility: Gelderse Vallei Hospital, Department of Intensive Care

location_facility: Antwerp University Hospital (UZA), Critical Care Medicine

location_facility: Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin

location_facility: Universitätsmedizin Rostock Klinik und Poliklinik für Anästhesiologie und Intensivtherapie

location_facility: Hôpital Lariboisière, Réanimation Médicale et Traumatologique

location_facility: CHRU Bretonneau, Medecine Intensive Réanimation

location_facility: Hôpital Lariboisière, Dept. d'Anesthesie

location_facility: Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation Chirurgicale, Université Paris Descartes

location_facility: Canisius-Wilhelmina-Ziekenhuis (CWZ), Intensive Care


title: A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients.

acronym: RACE

summary: The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Italy
Switzerland
Netherlands
France
Spain
United Kingdom

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

location_facility: AOU Città della Salute e della Scienza di Torino


ReferenceCitation: Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.

name: Eric Pujade-Lauraine, Centre des Cancers de la Femme et Recherche Clinique, Paris; Frédéric Selle, Hôpitaux Universitaires de l’Est Parisien-site Tenon and Alliance Pour la Recherche En Cancérologie, Paris; Béatrice Weber, Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Isabelle-Laure Ray-Coquard, Centre Léon Bérard and Université Claude Bernard-Lyon I, Lyon; Alain Lortholary, Centre Catherine de Sienne, Nantes; Anne Lesoin, Centre Oscar Lambret, Lille; Philippe Follana, Centre Antoine-Lacassagne, Nice;...

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

family: Selle

full_name: Frédéric Selle

given: Frédéric

family: Weber

full_name: Béatrice Weber

given: Béatrice

family: Ray-Coquard

full_name: Isabelle-Laure Ray-Coquard

given: Isabelle-Laure

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Sufliarsky

full_name: Jozef Sufliarsky

given: Jozef

family: Del Campo

full_name: Josep Maria Del Campo

given: Josep Maria

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Lesoin

full_name: Anne Lesoin

given: Anne

family: Follana

full_name: Philippe Follana

given: Philippe

family: Freyer

full_name: Gilles Freyer

given: Gilles

family: Pardo

full_name: Beatriz Pardo

given: Beatriz

family: Vidal

full_name: Laura Vidal

given: Laura

family: Tholander

full_name: Bengt Tholander

given: Bengt

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

family: Sassi

full_name: Mouna Sassi

given: Mouna

family: Garin-Chesa

full_name: Pilar Garin-Chesa

given: Pilar

family: Nazabadioko

full_name: Serge Nazabadioko

given: Serge

family: Marzin

full_name: Kristell Marzin

given: Kristell

family: Pilz

full_name: Korinna Pilz

given: Korinna

family: Joly

full_name: Florence Joly

given: Florence

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country: Sweden France Slovakia Belgium Spain

acronym: BI 6727 randomised phase II trial in ovarian cancer

location_facility: 1230.18.34001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3314A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3313A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3321A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3305A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3322A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3301A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34002 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34007 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3310A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34004 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46005 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3309A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3315A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3311A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34006 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.46001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32002 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3308A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.42103 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3302A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32003 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.34005 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32004 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.32001 Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3307A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3312A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.3320A Boehringer Ingelheim Investigational Site

location_facility: 1230.18.42101 Boehringer Ingelheim Investigational Site

title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy

summary:
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)


title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)

acronym: TRacKING

summary:
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion.

This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Leon Berard

location_country:
Italy
Austria
United Kingdom
Netherlands
France
Czechia
Poland
Spain
Denmark
Germany
Slovenia

location_facility: "Klinik für Gastroenterologie, Hepatologie und Infekt Universitätsklinikum Magdeburg"

location_facility: Azienda Ospedaliera - Universitaria - Policlinico S Orsola-Malpighi Univertsita di Bologna

location_facility: University Hospital Würzburg (UniversitätsKlinikum Würzburg)

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

location_facility: Maria Sklodowska Curie National Research Institute of Oncology

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Südharzklinikum"

location_facility: "Hämatologisch-onkologische Ambulanz Universitätsklinikum Halle"

location_facility: Universitätsklinikum Tübingen Medizinische Universitätsklinik;

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM)

location_facility: "Klinik für Innere Medizin III, Hämatologie, Onkologie Klinikum Chemnitz"

location_facility: "Hämato-Onkologischer Studienkreis MVZ am Klinikum Aschaffenburg / Onkologie"

location_facility: Mannheim University Medical Center (UniversitatsMedizin Mannheim)

location_facility: Azienda Ospedaliero - Universitaria Cita della Salute e della Scienza di Torino

location_facility: University College London NHS Foundation Trust

location_facility: Complejo Hospitalario regional Virgen del Rocio

location_facility: Masaryk Memorial Cancer Institute (Masarykuv Onkologicky Ustav)

location_facility: "Medizinische Klinik 1- Gastroenterologie, Hepatologie, Pneumologie Universitätsklinikum Frankfurt"

location_facility: "Medizinische Klinik und Poliklinik III LMU - Klinikum der Universität München"

status_simplified: Ongoing


ReferenceType: background

ReferenceCitation: Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20;27(15):2466-73. doi: 10.1200/JCO.2008.19.8424. Epub 2009 Apr 6.

ReferenceCitation: Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer. 2008 Jun;8(3):287-92. doi: 10.3816/CBC.2008.n.035.

ReferenceCitation: Borner M, Bacchi M, Goldhirsch A, Greiner R, Harder F, Castiglione M, Jungi WF, Thürlimann B, Cavalli F, Obrecht JP, et al. First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research. J Clin Oncol. 1994 Oct;12(10):2071-7.

ReferenceCitation: Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Martín M, Nortier JW, Paterson AH, Rimawi MF, Cañada JM, Thürlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.

ReferenceCitation: Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martín M, Nortier JWR, Paterson AHG, Rimawi MF, Láng I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. doi: 10.1200/JCO.2017.76.5719. Epub 2018 Feb 14.

ReferenceCitation: Migliaccio I, Di Leo A, Malorni L. Cyclin-dependent kinase 4/6 inhibitors in breast cancer therapy. Curr Opin Oncol. 2014 Nov;26(6):568-75. doi: 10.1097/CCO.0000000000000129. Review.

ReferenceCitation: Wardell SE, Ellis MJ, Alley HM, Eisele K, VanArsdale T, Dann SG, Arndt KT, Primeau T, Griffin E, Shao J, Crowder R, Lai JP, Norris JD, McDonnell DP, Li S. Efficacy of SERD/SERM Hybrid-CDK4/6 Inhibitor Combinations in Models of Endocrine Therapy-Resistant Breast Cancer. Clin Cancer Res. 2015 Nov 15;21(22):5121-5130. doi: 10.1158/1078-0432.CCR-15-0360. Epub 2015 May 19.

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

family: Finn

full_name: Richard S Finn

given: Richard S

family: Crown

full_name: John P Crown

given: John P

family: Lang

full_name: Istvan Lang

given: Istvan

family: Boer

full_name: Katalin Boer

given: Katalin

family: Bondarenko

full_name: Igor M Bondarenko

given: Igor M

family: Kulyk

full_name: Sergey O Kulyk

given: Sergey O

family: Ettl

full_name: Johannes Ettl

given: Johannes

family: Patel

full_name: Ravindranath Patel

given: Ravindranath

family: Pinter

full_name: Tamas Pinter

given: Tamas

family: Schmidt

full_name: Marcus Schmidt

given: Marcus

family: Shparyk

full_name: Yaroslav Shparyk

given: Yaroslav

family: Thummala

full_name: Anu R Thummala

given: Anu R

family: Voytko

full_name: Nataliya L Voytko

given: Nataliya L

family: Fowst

full_name: Camilla Fowst

given: Camilla

family: Huang

full_name: Xin Huang

given: Xin

family: Kim

full_name: Sindy T Kim

given: Sindy T

family: Randolph

full_name: Sophia Randolph

given: Sophia

family: Slamon

full_name: Dennis J Slamon

given: Dennis J

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Turner NC, Huang Bartlett C, Cristofanilli M. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Oct 22;373(17):1672-3. doi: 10.1056/NEJMc1510345.

lead_sponsor: International Breast Cancer Study Group

location_country: Italy Austria Switzerland France Hungary Spain

acronym: POLAR

location_facility: MUW - Universitätsklinik für Innere Medizin

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: AOU Maggiore Della Carita, University of Eastern Piedmont

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Groupe hospitalier de Bretagne Sud, Hôpital du Scorff

location_facility: Hospital General Universitario de Alicante

location_facility: Istituto scientifico Romagnolo per lo studio e la cura

location_facility: Instituto Catalan de Oncologia L´Hospitalet

location_facility: Medizinische Universität Innsbruck - Univ.-Klinik f. Frauenheilkunde

title: A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer

summary:
POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is assessed together with standard anti-hormone therapy in this study. Palbociclib is used to treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread beyond the original tumor and/or to other organs.

During this study, anti-hormone therapy will consist of either a selective estrogen receptor modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an LHRH (luteinizing hormone-releasing hormone) agonist by injection.

It is standard of care for people with hormone receptor positive breast cancer to take anti-hormone therapy. The study doctor will determine the type of standard anti-hormone therapy that will be given during this trial.

The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in combination with standard anti-hormone therapy with standard anti-hormone therapy alone and to evaluate the time until the breast cancer returns, if it does return.


title: Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel

acronym: PSO-TOP

summary: A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.

ReferenceCitation: Reich K, Zschocke I, Bachelez H, de Jong EM, Gisondi P, Puig L, Warren RB, Mrowietz U; TTOP study group. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1156-63. doi: 10.1111/jdv.12774. Epub 2014 Oct 26.

ReferenceCitation: Reich K, Mrowietz U, Karakasili E, Zschocke I. Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). Arch Dermatol Res. 2014 Sep;306(7):667-76. doi: 10.1007/s00403-014-1475-5. Epub 2014 Jun 4.

ReferenceCitation: Zschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014 Apr;306(3):287-97. doi: 10.1007/s00403-014-1446-x. Epub 2014 Feb 8.

ReferenceCitation: Reich K, Zschocke I, Bachelez H, de Jong EMGJ, Gisondi P, Puig L, Warren RB, Ortland C, Mrowietz U; PSO-TOP study group. A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP). Br J Dermatol. 2017 Jul;177(1):197-205. doi: 10.1111/bjd.15466. Epub 2017 Jun 6.

family: Reich

full_name: K. Reich

given: K.

family: Zschocke

full_name: I. Zschocke

given: I.

name: Sorbonne Paris Cité Université Paris-Diderot; AP-HP Hôpital Saint-Louis; Paris France

family: Bachelez

full_name: H. Bachelez

given: H.

name: Radboud University Medical Centre and Radboud University; Nijmegen the Netherlands

family: de Jong

full_name: E.M.G.J. de Jong

name: Dermatology and Venerology Section; University of Verona; Verona Italy

family: Gisondi

full_name: P. Gisondi

given: P.

name: Department of Dermatology; Hospital de la Santa Creu i Sant Pau; Universitat Autònoma de Barcelona; Barcelona Spain

family: Puig

full_name: L. Puig

given: L.

name: The Dermatology Centre; Salford Royal NHS Foundation Trust; The University of Manchester; Manchester Academic Health Science Centre; Manchester U.K.

family: Warren

full_name: R.B. Warren

name: Das Forschungsdock Service for Clinical Development; Schenefeld Germany

family: Ortland

full_name: C. Ortland

given: C.

name: Psoriasis Center; Department of Dermatology; University Medical Center Schleswig-Holstein; Campus Kiel; Kiel Germany

family: Mrowietz

full_name: U. Mrowietz

given: U.

journal_name: British Journal of Dermatology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

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

repository_institution: Radboud University - Radboud Repository

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Kristian Reich, MD

location_country:
Italy
Sweden
Netherlands
France
Spain
Denmark
Germany
United Kingdom


title: Exploratory Evaluation of Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients Treated With HAART (CD4+ ≥ 200 Cells mm3): An Open Labeled, Non-comparative Study

summary: Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients

ReferenceCitation: Saiag P, Bauhofer A, Bouscarat F, Aquilina C, Ortonne JP, Dupin N, Mougin C. Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study. Br J Dermatol. 2009 Oct;161(4):904-9. doi: 10.1111/j.1365-2133.2009.09210.x. Epub 2009 May 15.

family: Saiag

full_name: P. Saiag

family: Bauhofer

full_name: A. Bauhofer

given: A.

family: Bouscarat

full_name: F. Bouscarat

given: F.

family: Aquilina

full_name: C. Aquilina

family: Ortonne

full_name: J.P. Ortonne

family: Dupin

full_name: N. Dupin

given: N.

family: Mougin

full_name: C. Mougin

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_country: Belgium France

location_facility: Service de Dermatologie Centre Hospitalier de Valence

location_facility: Service de Dermatologie CHU Saint-Pierre

location_facility: Service de Dermatologie, Hôpital Ambroise Paré

location_facility: Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard

location_facility: Service Dermatologie Hopital COCHIN - Pavillon Tarnier

location_facility: Départment de Gynécologie-Obstétrique CHU Saint-Pierre

location_facility: Service de Dermatologie et Vénéréologie Hôpital Saint Jacques

location_facility: Service Dermatologie C.H. François Rabelais (César de Paepe)

location_facility: Service de Dermatologie Hôpital de l'Archet II

location_facility: Service de Dermatologie Groupe Hospitalier La Grave

location_facility: Service de Maladies Infectieuses Hôpital de la Conception


ReferenceCitation: Bennouna J, André T, Campion L, Hiret S, Miglianico L, Mineur L, Touchefeu Y, Artru P, Asmis T, Bouché O, Borde F, Kavan P, Lam YH, Rajpar LS, Emile JF, Jouffroy C, Gill S, Taïeb J. Rationale and Design of the IROCAS Study: Multicenter, International, Randomized Phase 3 Trial Comparing Adjuvant Modified (m) FOLFIRINOX to mFOLFOX6 in Patients With High-Risk Stage III (pT4 and/or N2) Colon Cancer-A UNICANCER GI-PRODIGE Trial. Clin Colorectal Cancer. 2019 Mar;18(1):e69-e73. doi: 10.1016/j.clcc.2018.09.011. Epub 2018 Oct 19.

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: André

full_name: Thierry André

given: Thierry

family: Campion

full_name: Loïc Campion

given: Loïc

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Miglianico

full_name: Laurent Miglianico

given: Laurent

family: Mineur

full_name: Laurent Mineur

family: Touchefeu

full_name: Yann Touchefeu

given: Yann

family: Artru

full_name: Pascal Artru

given: Pascal

family: Asmis

full_name: Timothy Asmis

given: Timothy

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Borde

full_name: Florence Borde

given: Florence

family: Kavan

full_name: Petr Kavan

given: Petr

family: Lam

full_name: You-Heng Lam

given: You-Heng

family: Rajpar

full_name: Laetitia-Shana Rajpar

given: Laetitia-Shana

family: Emile

full_name: Jean-François Emile

given: Jean-François

family: Jouffroy

full_name: Claire Jouffroy

given: Claire

family: Gill

full_name: Sharlene Gill

given: Sharlene

family: Taïeb

full_name: Julien Taïeb

given: Julien

journal_name: Clinical Colorectal Cancer

title: Rationale and Design of the IROCAS Study: Multicenter, International, Randomized Phase 3 Trial Comparing Adjuvant Modified (m) FOLFIRINOX to mFOLFOX6 in Patients With High-Risk Stage III (pT4 and/or N2) Colon Cancer—A UNICANCER GI-PRODIGE Trial

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.

lead_sponsor: UNICANCER

location_country: Canada France

acronym: IROCAS

location_facility: Hospices civils de Lyon - Hôpital Edouard Herriot

location_facility: The PEI Cancer Treatment Centre Queen Elizabeth Hospital

location_facility: Institut de Cancérologie de l'Ouest -site René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest -site Paul Papin

location_facility: Centre hospitalier de l'Université de Montréal

ipd_sharing: Yes

title: A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting

summary: The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil (5-FU), folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.


title: A Prospective Observational Study Cohort to Assess the Rate of Castration Resistance, Disease Progression and Overall Survival Over a 3-year Period Post-androgen Deprivation Therapy Induction in Patients With Advanced Prostate Cancer Who Have Previously Participated in the Triptocare Study (Http://Clinicaltrials.Gov/ct2/Show/Study/NCT01020448)

acronym: TRIPTOCARE LT

summary: The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

location_country:
United Kingdom
Netherlands
France
Lithuania
Romania
Denmark
Latvia

location_facility:
Hôpital Nord
Institut Mutualiste Monsouris
Clinique Rhône Durance
Hôpital Val de Grâce
Sc E-Uro Srl
Leicester General Hospital
Odense Universitets Hospital
CHU Pasteur
University Hospital Coventry
P.Stradins Clinical University Hospital
CHU Nantes
Chru Lille
Nottingham City Hospital
Lister Hospital
Diaconessenhuis
Oncomed
Hôpital Foch
CHU Henri Mondor
Center of Oncology
Clinique Beau Soleil
Frederiksbergs Hospital
Addenbrookes Hospital
Ulster hospital
University Hospital
University Oncological Institute
Fredericia Sygehus
Academisch Medisch Centrum
Medical Center
Hôpital Henry Gabrielle
University Hospital Wales
Herlev University Hospital
Private practice
Hôpital Pellegrin
Medical University Clinics
Bristol Royal Infirmary


title: A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

acronym: MUSIC

summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

ReferenceCitation: Colombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hébuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1.

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Dupas

full_name: Jean–Louis Dupas

given: Jean–Louis

family: Dewit

full_name: Olivier Dewit

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Parker

full_name: Gerald Parker

given: Gerald

family: Pierre–Louis

full_name: Bosny Pierre–Louis

given: Bosny

family: Hébuterne

full_name: Xavier Hébuterne

given: Xavier

journal_name: Clinical Gastroenterology and Hepatology

title: Association Between Plasma Concentrations of Certolizumab Pegol and Endoscopic Outcomes of Patients With Crohn's Disease

ReferenceCitation: Hébuterne X, Lémann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault É, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23.

family: Lémann

full_name: Marc Lémann

given: Marc

full_name: Jean-Louis Dupas

given: Jean-Louis

family: Mross

full_name: Michael Mross

given: Michael

family: Mitchev

full_name: Krassimir Mitchev

given: Krassimir

family: Ernault

full_name: Étienne Ernault

given: Étienne

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Brixi-Benmansour

full_name: Hedia Brixi-Benmansour

given: Hedia

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories:
PubMed Central
irua
open-archive.highwire.org


title: A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

status: Unknown status

lead_sponsor: Bellus Health Inc

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Poland
Belgium
Spain
Germany
United Kingdom

location_facility: Hôpital Sainte Marguerite Service de neuro-geriatrie

location_facility: Memory Clinic UMC St Radboud - Alzheimer Centre

location_facility: Glasgow Memory Clinic - Golden Jubilee National Hospital

location_facility: Memory Assessment Centre - Moorgreen Hospital

location_facility: Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge

location_facility: Hospital del Mar- Servicio de Neurologia

location_facility: CHU Reims- Hôpital Sébastopol-Service de médecine interne et Gérontologie Clinique

location_facility: Fundaciò ACE- Institut Català de Neurociències Aplicades

location_facility: Johann-Wolfgang Goethe-Universität - Klinik für Psychiatrie und Psychotherapie

location_facility: Unitat de Valoració de la Memòria i les Demències - Hospital Santa Caterina - Institut d'Assistència Sanitària

location_facility: Memory Clinic - Neuropsychology Center - University Hospital

location_facility: Kingshill Research Centre - Victoria Hospital

location_facility: Memory Clinic University Hospital Gasthuisberg, Neurology Department

location_facility: Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg

location_facility: IRCCS Centro San Giovanni di Dio- Fatebenefratelli

location_facility: Dept. of Neurosciences TCR - University of Modena and Reggio Emilia

location_facility: Research Institute for Care of Elderly - St Martin's Hospital

location_facility: Klinik für Psychiatrie und Psychotherapie - University Hospital Hamburg-Eppendorf - Dept. of Psychiatry and Psychotherapy

location_facility: Hospital Universitario Ramón y Cajal - Unidad de Geriatria

location_facility: Hôpital Gui de Chauliac - Service de Neurologie du Pr J. Touchon

location_facility: Hôpital Hôtel Dieu - Consultation de Gérontologie

location_facility: University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Memory Clinic -Geriatric Centre - Academic Hospital

location_facility: Neuropsychiatric Clinic - University Hospital MAS

location_facility: Hospital Santa Creu i Sant Pau, Servicio de Neurología, Unitad de Memoria

location_facility: Wales College of Medicine - Llandough Hospital

location_facility: Department of Neuroscience - Section of Neurology - University of Pisa

location_facility: Memory Centre, Polycliniques Brull, CHU de Liège

location_facility: Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie

location_facility: Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center

location_facility: San Martino Hospital - Padiglione Specialita' Fondi

location_facility: Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz

location_facility: Centre Mémoire de Ressources et de Recherche Hôpital Pasteur

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of the Efficacy and Safety of 2 Doses of Lenalidomide Versus Placebo in Red Blood Cell (RBC) Transfusion-Dependent Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated With a Deletion (Del) 5q[31] Cytogenetic Abnormality

summary: The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q[31] cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).

ReferenceType: result

ReferenceCitation: Fenaux, Pierre, Giagounidis, Aristotle, Selleslag, Dominik, Beyne-Rauzy, Odile, Mufti, Ghulam J, Mittelman, Moshe, Muus, Petra, te Boekhorst, Peter, Sanz, Guillermo, del Canizo, Consuelo, Guerci-Bresler, Agnes, Schlegelberger, Brigitte, Aul, Carlo, Kreipe, Hans, Goehring, Gudrun, Knight, Robert, Francis, John, Fu, Tommy, Hellstrom-Lindberg, Eva. RBC Transfusion Independence and Safety Profile of Lenalidomide 5 or 10 mg in Pts with Low- or Int-1-Risk MDS with Del5q: Results From a Randomized Phase III Trial (MDS-004). ASH Annual Meeting Abstracts 2009 114: 944.

ReferenceCitation: Fenaux, P., Giagounidis, A., Selleslag, D. L., Beyne-Rauzy, O., Mittelman, M., Muus, P., Knight, R. D., Fu, T., Hellstrom-Lindberg, E., The MDS-004 Len del(5q) Study Group. Safety of lenalidomide (LEN) from a randomized phase III trial (MDS-004) in low-/int-1-risk myelodysplastic syndromes (MDS) with a del(5q) abnormality. J Clin Oncol (Meeting Abstracts) 2010 28: 6598

ReferenceCitation: Fenaux, P., Giagounidis, A., Selleslag, D., Knight, R., Fu, T., Hellström-Lindberg, E. Effect of baseline EPO and prior erythropoiesis stimulating agents on RBC transfusion independence in Low-/Int-1-Risk MDS with del 5q treated with lenalidomide: A randomized phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:125, abs. 0311.

ReferenceCitation: Brandenburg, N., Fu, T., Revicki, D., Knight, R., Muus, P., Fenaux, P. Impact of lenalidomide on health-related quality of life in patients with RBC transfusion-dependent low- or int-1-risk myelodysplastic syndromes with del 5q: a randomized Phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:127, abs. 0316

ReferenceCitation: Fenaux, P., Giagounidis, A., Beyne-Rauzy, O., Mufti, G., Mittelman, M., Muus, P., te Boekhorst, P., Sanz, G., Cazzola, M., Backstrom, J., Fu, T., Hellström-Lindberg, E. Prognostic Factors of Long-Term Outcomes In Low- or Int-1-Risk MDS with del5q Treated with Lenalidomide (LEN): Results From a Randomized Phase 3 Trial (MDS-004). Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 4027.

ReferenceCitation: Brandenburg, N., Yu, R., Revicki, D. Reliability and Validity of the FACT-AN In Patients with Low or Int-1-Risk Myelodysplastic Syndromes with Deletion 5q. Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 3827.

ReferenceCitation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mittelman M, Muus P, Nimer SD, Hellström-Lindberg E, Powell BL, Guerci-Bresler A, Sekeres MA, Deeg HJ, Del Cañizo C, Greenberg PL, Shammo JM, Skikne B, Yu X, List AF. Clinical characteristics and outcomes according to age in lenalidomide-treated patients with RBC transfusion-dependent lower-risk MDS and del(5q). J Hematol Oncol. 2017 Jun 26;10(1):131. doi: 10.1186/s13045-017-0491-2.

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Giagounidis

full_name: Aristoteles Giagounidis

given: Aristoteles

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Beyne-Rauzy

full_name: Odile Beyne-Rauzy

given: Odile

family: Mittelman

full_name: Moshe Mittelman

given: Moshe

family: Muus

full_name: Petra Muus

given: Petra

family: Nimer

full_name: Stephen D. Nimer

given: Stephen D.

family: Hellström-Lindberg

full_name: Eva Hellström-Lindberg

given: Eva

family: Powell

full_name: Bayard L. Powell

given: Bayard L.

family: Guerci-Bresler

full_name: Agnes Guerci-Bresler

given: Agnes

family: Sekeres

full_name: Mikkael A. Sekeres

given: Mikkael A.

family: Deeg

full_name: H. Joachim Deeg

given: H. Joachim

family: del Cañizo

full_name: Consuelo del Cañizo

given: Consuelo

family: Greenberg

full_name: Peter L. Greenberg

given: Peter L.

family: Shammo

full_name: Jamile M. Shammo

given: Jamile M.

family: Skikne

full_name: Barry Skikne

given: Barry

family: Yu

full_name: Xujie Yu

given: Xujie

family: List

full_name: Alan F. List

given: Alan F.

currency_apc_doaj: GBP

journal_name: Journal of Hematology & Oncology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

ReferenceCitation: Saft L, Karimi M, Ghaderi M, Matolcsy A, Mufti GJ, Kulasekararaj A, Göhring G, Giagounidis A, Selleslag D, Muus P, Sanz G, Mittelman M, Bowen D, Porwit A, Fu T, Backstrom J, Fenaux P, MacBeth KJ, Hellström-Lindberg E. p53 protein expression independently predicts outcome in patients with lower-risk myelodysplastic syndromes with del(5q). Haematologica. 2014 Jun;99(6):1041-9. doi: 10.3324/haematol.2013.098103. Epub 2014 Mar 28.

repository_institution: Semmelweis University - Semmelweis University Repository

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Cañizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lübbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellström-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. doi: 10.1182/blood-2011-01-330126. Epub 2011 Jul 13.

name: Hopital Avicenne, Assistance Publique–Hôpitaux de Paris, Université Paris XIII, Bobigny, France;

name: St Johannes Hospital, Duisburg, Germany;

name: Centre Hospitalier Universitaire Purpan Pavillion de Médecines, Toulouse, France;

name: King's College Hospital, London, United Kingdom;

name: Tel Aviv Sourasky Medical Center, Tel Aviv, Israel;

name: Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;

name: Erasmus Medical Center, Rotterdam, The Netherlands;

name: Hospital Universitario La Fe, Valencia, Spain;

name: Hospital Universitario de Salamanca, Salamanca, Spain;

name: Centre Hospitalier Universitaire Nancy Hématologie et Médecine Interne, Vandoeuvre, France;

name: Skåne University Hospital, Lund, Sweden;

name: Universitätsklinikum Carl Gustav Carus, Dresden, Germany;

name: University of Freiburg Medical Center, Freiburg, Germany;

name: Centre Hospitalier Régional Universitaire Claude Huriez Service des Maladies du Sang, Lille, France;

name: Department of Hematology Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, University of Pavia, Pavia, Italy;

name: Hannover Medical School, Hannover, Germany;

name: St James's Institute of Oncology, Leeds, United Kingdom;

name: Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden

name: for the MDS-004 Lenalidomide del5q Study Group

ReferenceCitation: Göhring G, Giagounidis A, Büsche G, Hofmann W, Kreipe HH, Fenaux P, Hellström-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.

location_country:
Italy
Sweden
Netherlands
France
Israel
Belgium
Spain
Germany
United Kingdom

location_facility: Centre Jean Bernhard Service Onco-Hematologie

location_facility: John Radcliffe Hospital and the Weatherall Institute of Molecular Medicine

location_facility: CHU Purpan, Place du Dr Baylac, Pavillon des Médecines

location_facility: SU/Sahlgrenska Section of Hematology & Coagulation

location_facility: Korolinska Institutet Department of Hematology

location_facility: CHU Nancy Hematologie et Medecine interne

location_facility: Central Manchester and Manchester Children's University Hospitals NHS Trust

location_facility: CHU Nantes Hematologie et Medicine interne

location_facility: University Hospital of Wales, Dept of Haematology

location_facility: CHU d'Angers Service des Maladies du Sang

location_facility: Department of Medicine University Hospital

location_facility: University of Pavia Division of Hematology

location_facility: CHU Purpan, Place du Dr. Baylac, Pavillion des Medecines

location_facility: Centre Henri Becquerel Service d'Hematologie Clinique


title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure

summary: Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.

status: Terminated

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Switzerland
France
Belgium
Germany
United Kingdom


title: Safety and Performance Evaluation of the AccuCinch® Ventricular Repair System for the Treatment of Heart Failure With or Without Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - The CorCinch-EU Study

summary: This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

lead_sponsor: Ancora Heart, Inc.

location_country:
Italy
Netherlands
France
Czechia
Lithuania
Poland
Belgium
Belarus
United Kingdom

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Republican Scientific and Practical Centre of Cardiology


title: Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

acronym: SIRCCA

summary: The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

status: Active, not recruiting

lead_sponsor: Sirtex Medical

location_country:
Italy
Netherlands
France
Belgium
Australia
Spain
United States
United Kingdom

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Hammersmith Hospital Imperial College Healthcare NHS Trust


title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias

summary: This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.

ReferenceCitation: Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15.

name: Paracelsus-Elena Hospital; Kassel Germany

name: Department of Neurosurgery; University Medical Center; Goettingen Germany

name: German Parkinson Study Group; Marburg Germany

family: Trenkwalder

full_name: Claudia Trenkwalder

given: Claudia

name: Department of Neurodegeneration; Hertie-Institute for Clinical Brain Research and German Center for Neurodegenerative Diseases; Tübingen Germany

family: Berg

full_name: Daniela Berg

given: Daniela

name: Department of Clinical Pharmacology and Neurosciences; NeuroToul Excellence Center for Neurodegenerative Disorders, University UPS of Toulouse III; CIC-9302/INSERM UMR825, Hôpital Purpan - Pavillon Riser Toulouse France

family: Rascol

full_name: Olivier Rascol

given: Olivier

name: Department of Neurology; Philipps-University of Marburg; Marburg Germany

family: Eggert

full_name: Karla Eggert

given: Karla

name: Schön Klinik München-Schwabing; München Germany

family: Ceballos-Baumann

full_name: Andres Ceballos-Baumann

given: Andres

name: Sorbonne Universités, UPMC Univ Paris 06, and INSERM UMRS 1127 /CIC-1422, and CNRS UMR 7225, and AP-HP, and ICM, Hôpital Pitié-Salpêtrière, Département des maladies du système nerveux; Paris France

family: Corvol

full_name: Jean-Christophe Corvol

given: Jean-Christophe

name: Division of Neurodegenerative Diseases; Department of Neurology; Dresden University of Technology; Dresden Germany

family: Storch

full_name: Alexander Storch

given: Alexander

name: Department of Neurology; UC Davis MIND Institute; Sacramento California USA

family: Zhang

full_name: Lin Zhang

given: Lin

name: Service de Neurologie et pathologie du Mouvement; Hôpital de la Timone; Marseille Cedex France

family: Azulay

full_name: Jean-Philippe Azulay

given: Jean-Philippe

name: Univisité Lyon 1, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, Service de Neurologie C; Lyon France

name: CNRS UMR 5229, Centre de Neurosciences Cognitives, Team Basal Ganglia; Bron France

family: Broussolle

full_name: Emmanuel Broussolle

given: Emmanuel

name: Service de Neurologie et Pathologie du movement, EA 1046, CHU de Lille; Hôpital Roger Salengro; Lille France

family: Defebvre

full_name: Luc Defebvre

given: Luc

name: Movement to Health (M2H) laboratory, Euromov, University Montpellier 1, Hôpital gui de Chauliac; Montpellier France

family: Geny

full_name: Christian Geny

given: Christian

name: Center for Neurological Restoration, Cleveland Clinic; Cleveland Ohio USA

family: Gostkowski

full_name: Michal Gostkowski

given: Michal

name: Department of Neurology; Institute for Research and Medical Care; IROCS Rome Italy

family: Stocchi

full_name: Fabrizio Stocchi

given: Fabrizio

name: Service de Neurologie; Hôpital de Hautepierre; Strasbourg France

family: Tranchant

full_name: Christine Tranchant

given: Christine

name: Centre Investigation Clinique Neurologie, CHU Nantes, Hôpital G&R Laennec; Nantes France

family: Derkinderen

full_name: Pascal Derkinderen

given: Pascal

name: Service de Neurologie, Hôpital Gabriel Montpied; Clermont-Ferrand France

family: Durif

full_name: Franck Durif

given: Franck

name: Department of Neurology; James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati Academic Health Center; Cincinnati Ohio USA

family: Espay

full_name: Alberto J. Espay

given: Alberto J.

name: Feinstein Institute for Medical Research; North Shore - LIJ Health System; Manhasset New York USA

family: Feigin

full_name: Andrew Feigin

given: Andrew

name: Service de Neurologie, CIC-INSERM 1402, CHU de Poitiers, Université de Poitiers; Poitiers France

family: Houeto

full_name: Jean-Luc Houeto

given: Jean-Luc

family: Schwarz

full_name: Johannes Schwarz

given: Johannes

name: Neuroscience Research Unit, Centre de recherche du CHU de Québec; Québec Canada

name: Faculty of Pharmacy, Laval University; Québec Canada

family: Di Paolo

full_name: Thérèse Di Paolo

given: Thérèse

name: Novartis Institutes for BioMedical Research; Basel Switzerland

family: Feuerbach

full_name: Dominik Feuerbach

name: Biometrics Matters Ltd; Hamilton New Zealand

name: Albert Einstein College of Medicine, New York, NY, USA, and CognitionMetrics, LLC; Wilmington Delaware USA

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey USA

name: CogState, Inc; New Haven Connecticut USA

name: Department of Neurology and Neurosurgery; McGill University; Montreal Québec Canada

repository_normalized: University of Melbourne - Minerva Access


title: A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

summary: The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

ReferenceCitation: Hézode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourlière M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. [Epub ahead of print]

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Alric

full_name: Laurent Alric

given: Laurent

family: Brown

full_name: Ashley Brown

given: Ashley

family: Hassanein

full_name: Tarek Hassanein

given: Tarek

family: Rizzetto

full_name: Mario Rizzetto

given: Mario

family: Buti

full_name: Maria Buti

given: Maria

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Thabut

full_name: Dominique Thabut

given: Dominique

family: Molina

full_name: Esther Molina

given: Esther

family: Rustgi

full_name: Vinod Rustgi

given: Vinod

family: Samuel

full_name: Didier Samuel

given: Didier

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Liu

full_name: Zhaohui Liu

given: Zhaohui

family: Yin

full_name: Philip D Yin

given: Philip D

family: Hughes

full_name: Eric Hughes

given: Eric

family: Treitel

full_name: Michelle Treitel

given: Michelle

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Randomized controlled trial of the NS5A inhibitor daclatasvir plus peginterferon and ribavirin for HCV genotype-4 (COMMAND-4)

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
France
Greece
Puerto Rico
Spain
United States
United Kingdom

location_facility:
University Gastroenterology
Umass Memorial Medical Center
Scti Research Foundation
Metropolitan Research
Local Institution


title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

acronym: REFINE

summary: The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

lead_sponsor: Biogen


title: Is the Endoscopic Remission Evaluation, Using the CREDO 1 Index / Score in CD Patients in Clinical Remission at Baseline, Predictive of Sustained Clinical Remission Using a 2-year Follow up: a Multicenter Prospective Cohort Study

summary:
The CREDO 2 study follows CREDO 1 study, which aims to construct an objective evaluation of endoscopic remission in Crohn's Disease (CD). In addition to reproducibility and validation, the predictive value of this remission evaluation needs to be tested in different settings to valorise its usefulness in clinical practice and in clinical trials.

CREDO 2 aims to investigate whether the evaluation of endoscopic remission, as defined in CREDO 1, in patients in clinical remission is predictive of sustained clinical remission at 2 years.

The design of CREDO2 is a multicentre longitudinal prospective cohort study. The screening period to include a patient is two weeks. Patients will be followed up to week 104.

primary_purpose: Other

ipd_sharing: Undecided

ipd_sharing_description: ND

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
UZ Leuven
Hôpital Saint Antoine
CHU Estaing - Clermont Ferrand
AZ Sint Lucas Gent
Leuven University Hospital
CHU Nancy - Hôpital Barbois
CHRU de Lille - Hôpital C. Huriez
CHU Montpellier - Hôpital Saint Eloi
CHU de Nice - Hôpital de l'Archet 2
CHU Bordeaux - Hôpital Haut Lévêque
CHU Liège
CHU Nantes - Hôtel Dieu
CHU Besançon - Hôpital Jean Minjoz
APHP- Hopital BEAUJON

intervention_type: Diagnostic Test


title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)

acronym: TICOSPA

summary: This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e. usual care) in patients with axial spondyloarthritis.

ReferenceCitation: Molto A, López-Medina C, Van den Bosch FE, Boonen A, Webers C, Dernis E, van Gaalen FA, Soubrier M, Claudepierre P, Baillet A, Starmans-Kool M, Spoorenberg A, Jacques P, Carron P, Joos R, Lenaerts J, Gossec L, Pouplin S, Ruyssen-Witrand A, Sparsa L, van Tubergen A, van der Heijde D, Dougados M. Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Ann Rheum Dis. 2021 Nov;80(11):1436-1444. doi: 10.1136/annrheumdis-2020-219585. Epub 2021 May 6.

family: Molto

full_name: Anna Molto

given: Anna

family: López-Medina

full_name: Clementina López-Medina

given: Clementina

family: Van den Bosch

full_name: Filip E Van den Bosch

given: Filip E

family: Boonen

full_name: Annelies Boonen

given: Annelies

family: Webers

full_name: Casper Webers

given: Casper

family: Dernis

full_name: Emanuelle Dernis

given: Emanuelle

family: van Gaalen

full_name: Floris A van Gaalen

given: Floris A

family: Soubrier

full_name: Martin Soubrier

given: Martin

family: Claudepierre

full_name: Pascal Claudepierre

given: Pascal

family: Baillet

full_name: Athan Baillet

given: Athan

family: Starmans-Kool

full_name: Mirian Starmans-Kool

given: Mirian

family: Spoorenberg

full_name: Anneke Spoorenberg

given: Anneke

family: Jacques

full_name: Peggy Jacques

given: Peggy

family: Carron

full_name: Philippe Carron

given: Philippe

family: Joos

full_name: Rik Joos

given: Rik

family: Lenaerts

full_name: Jan Lenaerts

given: Jan

family: Gossec

full_name: Laure Gossec

given: Laure

family: Pouplin

full_name: Sophie Pouplin

given: Sophie

family: Ruyssen-Witrand

full_name: Adeline Ruyssen-Witrand

given: Adeline

family: Sparsa

full_name: Laetitia Sparsa

given: Laetitia

family: van Tubergen

full_name: Astrid van Tubergen

given: Astrid

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Dougados

full_name: Maxime Dougados

given: Maxime

repository_institution: Ghent University - Ghent University Academic Bibliography

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_facility:
Hopital Lapeyronnie
Chu Grenoble
UMCG
LUMC
Maastricht UMC
Hopital Cochin
Hopital Henri Mondor
Chu Rouen
Chu Gabriel Montpied
UZ GENT
Hopital de La Pitie Salpetriere
AZ Alma
Reumatologie Medizorg
Chu Toulouse
Chu Le Mans
Zuyderland MC
Jessa Ziekenhuis
Ch Mulhouse


title: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care

acronym: Bakri

summary:
This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.

primary_purpose: Prevention

ReferenceCitation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7:CD013663. doi: 10.1002/14651858.CD013663.

name: Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health; The University of Liverpool; Liverpool UK

family: Kellie

full_name: Frances J Kellie

given: Frances J

name: Department of Obstetrics and Gynaecology; Busitema University; Mbale Uganda

family: Wandabwa

full_name: Julius N Wandabwa

given: Julius N

name: University Department of Obstetrics and Gynaecology, Fetal and Maternal Medicine Unit; Leicester Royal Infirmary; Leicester UK

family: Mousa

full_name: Hatem A Mousa

given: Hatem A

family: Weeks

full_name: Andrew D Weeks

given: Andrew D

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Comparative Analysis of Two Therapeutic Strategies: "Early Switch" Versus "Therapeutic Intensification" in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.

acronym: STRADA

summary:
The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.

Patients and Methods:

Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24).

Expected results:

On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.

lead_sponsor: University Hospital, Rouen

location_facility:
Dieppe Hospital
UH Rouen
Le Havre Hospital
UH Lille
Elbeuf Hospital
UH Amiens
UH Caen

intervention_type: Biological


title: An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.

acronym: MispheC

summary: The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.

lead_sponsor: Center Eugene Marquis

location_facility:
Hôpital Henri Mondor
Centre Eugene Marquis
CHU- Hotel Dieu
Hôpital Beaujon - Service de Chirurgie
CHU Poitiers
Hôpital saint-Eloi
CHU Nancy - Hôpital Brabois

intervention_type: Radiation


title: A Multicenter Study Assessing the Prevalence of Co-addictions in Subjects Receiving Maintenance Treatment for Opiate Dependence. Determination of Clinical and Pharmacological Profil.

acronym: OPAL

summary:
The aim of this study is to determine the current prevalence of co-addictions, including problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST), and to then compare patients receiving OST with or without a co-addiction (excluding tobacco dependence) in order to determine their clinical profile.

In addition, an ancillary study to be carried out only among those patients receiving methadone, will aim to etablish whether a low plasma concentration of methadone, on the one hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics most commonly associated with the presence of co-addictions. This will allow us to complete patient's pharmacological characterization.

ReferenceCitation: Bouju G, Hardouin JB, Boutin C, Gorwood P, Le Bourvellec JD, Feuillet F, Venisse JL, Grall-Bronnec M. A shorter and multidimensional version of the Gambling Attitudes and Beliefs Survey (GABS-23). J Gambl Stud. 2014 Jun;30(2):349-67. doi: 10.1007/s10899-012-9356-3.

ReferenceCitation: Grall-Bronnec M, Wainstein L, Feuillet F, Bouju G, Rocher B, Vénisse JL, Sébille-Rivain V. Clinical profiles as a function of level and type of impulsivity in a sample group of at-risk and pathological gamblers seeking treatment. J Gambl Stud. 2012 Jun;28(2):239-52. doi: 10.1007/s10899-011-9258-9.

ReferenceCitation: Grall-Bronnec M, Wainstein L, Augy J, Bouju G, Feuillet F, Vénisse JL, Sébille-Rivain V. Attention deficit hyperactivity disorder among pathological and at-risk gamblers seeking treatment: a hidden disorder. Eur Addict Res. 2011;17(5):231-40. doi: 10.1159/000328628. Epub 2011 Jun 7.

ReferenceCitation: Guillou-Landreat M, Dany A, Challet-Bouju G, Laforgue E, Leboucher J, Benoit Hardouin J, Victorri-Vigneau C, Grall-Bronnec M. What Differs between Patients under Methadone and under Buprenorphine for Opioid Use Disorder (OUD) in Daily Clinical Practice in France? A Short Report. Int J Environ Res Public Health. 2021 Feb 3;18(4). pii: 1425. doi: 10.3390/ijerph18041425.

family: Guillou-Landreat

full_name: Morgane Guillou-Landreat

given: Morgane

family: Dany

full_name: Antoine Dany

given: Antoine

family: Challet-Bouju

full_name: Gaëlle Challet-Bouju

given: Gaëlle

family: Laforgue

full_name: Edouard Laforgue

given: Edouard

family: Leboucher

full_name: Juliette Leboucher

given: Juliette

family: Benoit Hardouin

full_name: Jean Benoit Hardouin

given: Jean

family: Victorri-Vigneau

full_name: Caroline Victorri-Vigneau

given: Caroline

family: Grall-Bronnec

full_name: Marie Grall-Bronnec

given: Marie

currency_apc_doaj: CHF

journal_name: International Journal of Environmental Research and Public Health

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

lead_sponsor: Nantes University Hospital

location_facility: Réseau toxicomanie de la région nantaise


title: Endomysial Fibrosis, Muscular Inflammatory Response and Calcium Homeostasis Dysfunction : Potential Links and Targeted Pharmacotherapy in Duchenne Muscular Dystrophy (DMD).

summary:
Duchenne muscular dystrophy (DMD) is the most common and devastating form of muscular dystrophy, caused by an X-chromosome gene mutation resulting in the absence of the protein dystrophin. Gene therapy by exon skipping or stop codon read-through and cell therapy are at the stage of clinical assays with very promising results. Nevertheless, they will not allow a complete cure of DMD patients and they will concern only specific types of mutations. It is therefore crucial to develop other therapeutic strategies related to the natural history of the disease and targeted not on the dystrophin itself, but on the consequences of its absence.

Another crucial pathophysiological pathway in DMD is muscle cell calcium homeostasis, particularly via the ryanodine recepteur (RyR1).

Our study focus on the relationship between endomysial fibrosis, abnormal inflammation response and calcium homeostasis dysfunction which are not entirely established in DMD.

The identification of the biological mechanisms that play a role in the severity of the phenotype, particularly endomysial fibrosis, should allow the development of targeted pharmacotherapy as a complementary strategy for the future treatment of DMD.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier

location_facility:
Montpellier University Hospital
UH Saint Etienne
UH Bordeaux
Necker Hospital
UH Lille
UH Reims
UH Toulouse


summary:
Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow transplantation, organ transplantation or patient immunodeficient.

They will receive one to three injections of allogenic CTL specific EBV.

The purpose of this study is to ensure that these injections can not cause a GVH and to study what the side effects are and to see whether this therapy might help patients with Lymphoma.

Immunological monitoring will also be studied.

ReferenceCitation: Gallot G, Vollant S, Saïagh S, Clémenceau B, Vivien R, Cerato E, Bignon JD, Ferrand C, Jaccard A, Vigouroux S, Choquet S, Dalle JH, Frachon I, Bruno B, Mothy M, Mechinaud F, Leblond V, Milpied N, Vié H. T-cell therapy using a bank of EBV-specific cytotoxic T cells: lessons from a phase I/II feasibility and safety study. J Immunother. 2014 Apr;37(3):170-9. doi: 10.1097/CJI.0000000000000031.

family: Gallot

full_name: Géraldine Gallot

given: Géraldine

family: Vollant

full_name: Solène Vollant

given: Solène

family: Saïagh

full_name: Soraya Saïagh

given: Soraya

family: Clémenceau

full_name: Béatrice Clémenceau

given: Béatrice

family: Vivien

full_name: Régine Vivien

given: Régine

family: Cerato

full_name: Evelyne Cerato

given: Evelyne

family: Bignon

full_name: Jean-D. Bignon

given: Jean-D.

family: Ferrand

full_name: Christophe Ferrand

given: Christophe

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

family: Vigouroux

full_name: Stéphane Vigouroux

given: Stéphane

family: Choquet

full_name: Sylvain Choquet

given: Sylvain

family: Dalle

full_name: Jean-Hugues Dalle

given: Jean-Hugues

family: Frachon

full_name: Irène Frachon

given: Irène

family: Bruno

full_name: Bénédicte Bruno

given: Bénédicte

family: Mothy

full_name: Mohamad Mothy

given: Mohamad

family: Mechinaud

full_name: Françoise Mechinaud

given: Françoise

family: Leblond

full_name: Véronique Leblond

given: Véronique

family: Milpied

full_name: Noël Milpied

given: Noël

family: Vié

full_name: Henri Vié

given: Henri

journal_name: Journal of Immunotherapy

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: T-cell Therapy Using a Bank of EBV-specific Cytotoxic T Cells

location_facility:
Hôpital Necker
CHU de Nantes
CHU de Limoges
CHU de Bordeaux
CHU de Lille
CHU de Brest
Hopital Pitié Salpétrière


title: Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer

acronym: APAPI

summary: The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Pierre Curie
Centre Oscar Lambret
Centre Hospitalier
Hôpital Privé de Villeneuve d'Ascq
Centre Marie Curie
Centre Léonard de Vinci
Nouvelle Clinique des Dentellières

intervention_type: Behavioral


title: Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.

summary: The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.

primary_purpose: Health Services Research

ReferenceCitation: Grégoire M, Dailly E, Le Turnier P, Garot D, Guimard T, Bernard L, Tattevin P, Vandamme YM, Hoff J, Lemaitre F, Verdier MC, Deslandes G, Bellouard R, Sébille V, Chiffoleau A, Boutoille D, Navas D, Asseray N. High-Dose Ceftriaxone for Bacterial Meningitis and Optimization of Administration Scheme Based on Nomogram. Antimicrob Agents Chemother. 2019 Aug 23;63(9). pii: e00634-19. doi: 10.1128/AAC.00634-19. Print 2019 Sep.

name: Clinical Pharmacology Department, CHU Nantes, Nantes, France

name: UMR INSERM 1235, Enteric Nervous System in Gut and Brain Disorders, University of Nantes, Nantes, France

family: Grégoire

full_name: Matthieu Grégoire

given: Matthieu

name: EE 1701 MiHAR, University of Nantes, Nantes, France

family: Dailly

full_name: Eric Dailly

given: Eric

name: Infectious Diseases Department, CHU Nantes and CIC 1413, INSERM, Nantes, France

family: Le Turnier

full_name: Paul Le Turnier

given: Paul

name: Intensive Care Unit, CHU Tours, Tours, France

family: Garot

full_name: Denis Garot

given: Denis

name: Infectious Diseases and Emergency Department, Centre Hospitalier de La Roche sur Yon, La Roche sur Yon, France

family: Guimard

full_name: Thomas Guimard

given: Thomas

name: Infectious Diseases Department, CHU Tours, Tours, France

family: Bernard

full_name: Louis Bernard

given: Louis

name: Infectious Diseases Department, CHU Rennes, Rennes, France

family: Tattevin

full_name: Pierre Tattevin

given: Pierre

name: Infectious Diseases Department, CHU Angers, Angers, France

family: Vandamme

full_name: Yves-Marie Vandamme

given: Yves-Marie

name: Intensive Care Unit, Anaesthesia and Critical Care Department, Centre Hospitalier de Saint Nazaire, Saint Nazaire, France

family: Hoff

full_name: Jérôme Hoff

given: Jérôme

name: Clinical Pharmacology Department, CHU Rennes, Rennes, France

name: INSERM, CIC-P 1414 Clinical Investigation Center, Rennes, France

family: Lemaitre

full_name: Florian Lemaitre

given: Florian

family: Verdier

full_name: Marie-Clémence Verdier

given: Marie-Clémence

family: Deslandes

full_name: Guillaume Deslandes

given: Guillaume

family: Bellouard

full_name: Ronan Bellouard

given: Ronan

name: Biostatistics Unit, Research Board, University Hospital of Nantes, Nantes, France

family: Sébille

full_name: Véronique Sébille

name: Pharmacovigilance, Research Board, University Hospital of Nantes, Nantes, France

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

name: EA 3826 Thérapeutiques Cliniques et Expérimentales des Infections, University of Nantes, Nantes, France

family: Boutoille

full_name: David Boutoille

given: David

name: Pharmacy Department, CHU Nantes, Nantes, France

family: Navas

full_name: Dominique Navas

given: Dominique

family: Asseray

full_name: Nathalie Asseray

given: Nathalie

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

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

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

location_facility:
Nantes Universitary Hospital
La Roche/Yon hospital
Poitiers Universitary hospital
Rennes Universitary hospital
St Nazaire hospital
Tours universitary hospital
Angers Universitary Hospital


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

acronym: SYNERGY

summary: Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

lead_sponsor: Maquet Cardiovascular

location_country: Germany France

location_facility:
Hôpital Edouard Herriot
Hôpital G. et R. Laennec
CHU La Milétrie
CHU Dupuytren
Krankenhaus Nordwest
CHU Jean Minjoz
Hôpital Pompidou
CHRU


title: Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)

acronym: Douleur-PR

summary:
Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .

Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.

So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.

On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.

The aim of this study is:

to assess the multidimensional origin of the pain in RA patients by means of questionnaires
to look for a possible correlation between the serum level of cytokines and pain.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU Hautepierre
CHU Hôpital R. Salengro
CHU Gabriel Montpied
CHU Bois-Guillaume
CHU Hôtel-Dieu
Service de Rhumatologie
CHU Bordeaux- Pellegrin