title: Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in an Unselected Group of Young Stroke Patients: an International, Multicentre Prevalence Study

summary: More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry Disease.

ReferenceCitation: Rolfs A, Böttcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Löhr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. Erratum in: Lancet. 2006 Dec 23;368(9554):2210.

ReferenceCitation: Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Böttcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21.

ReferenceCitation: Thijs V, Grittner U, Fazekas F, McCabe DJH, Giese AK, Kessler C, Martus P, Norrving B, Ringelstein EB, Schmidt R, Tanislav C, Putaala J, Tatlisumak T, von Sarnowski B, Rolfs A, Enzinger C; Stroke in Fabry (SIFAP1) Investigators. Dolichoectasia and Small Vessel Disease in Young Patients With Transient Ischemic Attack and Stroke. Stroke. 2017 Sep;48(9):2361-2367. doi: 10.1161/STROKEAHA.117.017406. Epub 2017 Jul 28.

name: From the Stroke Division, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia (V.T.); Department of Neurology, Austin Health, Heidelberg, Victoria, Australia (V.T.); Center for Stroke Research and Department of Biostatistics and Clinical Epidemiology, Charité – University Medical Centre Berlin, Germany (U.G.); Department of Neurology (F.F., R.S., C.E.) and Division of Neuroradiology, Department of Radiology (C.E.), Medical University of Graz,...

family: Thijs

full_name: Vincent Thijs

family: Grittner

full_name: Ulrike Grittner

given: Ulrike

family: Fazekas

full_name: Franz Fazekas

given: Franz

family: McCabe

full_name: Dominick J.H. McCabe

given: Dominick J.H.

family: Giese

full_name: Anne-Katrin Giese

given: Anne-Katrin

family: Kessler

full_name: Christof Kessler

given: Christof

family: Martus

full_name: Peter Martus

given: Peter

family: Norrving

full_name: Bo Norrving

given: Bo

family: Ringelstein

full_name: Erich Bernd Ringelstein

given: Erich Bernd

family: Schmidt

full_name: Reinhold Schmidt

given: Reinhold

family: Tanislav

full_name: Christian Tanislav

family: Putaala

full_name: Jukka Putaala

given: Jukka

family: Tatlisumak

full_name: Turgut Tatlisumak

given: Turgut

family: von Sarnowski

full_name: Bettina von Sarnowski

given: Bettina

family: Rolfs

full_name: Arndt Rolfs

given: Arndt

family: Enzinger

full_name: Christian Enzinger

journal_name: Stroke

ReferenceCitation: Aigner A, Grittner U, Rolfs A, Norrving B, Siegerink B, Busch MA. Contribution of Established Stroke Risk Factors to the Burden of Stroke in Young Adults. Stroke. 2017 Jul;48(7):1744-1751. doi: 10.1161/STROKEAHA.117.016599. Epub 2017 Jun 15.

name: From the Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany (A.A.); Center for Stroke Research (U.G., B.S.) and Department of Biostatistics and Clinical Epidemiology (U.G.), Charité–Universitätsmedizin Berlin, Germany; Medical Faculty, Albrecht Kossel Institute for Neuroregeneration, University of Rostock, Germany (A.R.); Department of Clinical Sciences, Neurology, Skane University Hospital, Lund University, Sweden (B.N.); and Department of...

family: Aigner

full_name: Annette Aigner

given: Annette

ReferenceCitation: von Sarnowski B, Schminke U, Grittner U, Tanislav C, Böttcher T, Hennerici MG, Tatlisumak T, Putaala J, Kaps M, Fazekas F, Enzinger C, Rolfs A, Kessler C; sifap1 Investigators. Posterior versus Anterior Circulation Stroke in Young Adults: A Comparative Study of Stroke Aetiologies and Risk Factors in Stroke among Young Fabry Patients (sifap1). Cerebrovasc Dis. 2017;43(3-4):152-160. doi: 10.1159/000454840. Epub 2017 Jan 14.

ReferenceCitation: Huber R, Grittner U, Weidemann F, Thijs V, Tanislav C, Enzinger C, Fazekas F, Wolf M, Hennerici MG, McCabe DJ, Putaala J, Tatlisumak T, Kessler C, von Sarnowski B, Martus P, Kolodny E, Norrving B, Rolfs A; Stroke in Young Fabry Patients (SIFAP) Investigators. Patent Foramen Ovale and Cryptogenic Strokes in the Stroke in Young Fabry Patients Study. Stroke. 2017 Jan;48(1):30-35. doi: 10.1161/STROKEAHA.116.013620. Epub 2016 Nov 29.

name: From the Department of Neurology, Medical Campus Lake Constance, Klinikum Friedrichshafen, Germany (R.H.); Department of Neurology, University of Ulm, Ulm, Germany (R.H.); Department for Biostatistics and Clinical Epidemiology (U.G.) and Center for Stroke Research (U.G.), Charité-Universitätsmedizin Berlin, Germany; Department of Internal Medicine II, Katharinen Hospital, Unna, Germany (F.W.); Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Heidelberg,...

ReferenceCitation: Tatlisumak T, Putaala J, Innilä M, Enzinger C, Metso TM, Curtze S, von Sarnowski B, Amaral-Silva A, Jungehulsing GJ, Tanislav C, Thijs V, Rolfs A, Norrving B, Fazekas F, Suomalainen A, Kolodny EH. Frequency of MELAS main mutation in a phenotype-targeted young ischemic stroke patient population. J Neurol. 2016 Feb;263(2):257-262. doi: 10.1007/s00415-015-7969-z. Epub 2015 Nov 14.

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

ReferenceCitation: Wolf ME, Grittner U, Böttcher T, Norrving B, Rolfs A, Hennerici MG; sifap1 TM investigators. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study. Cerebrovasc Dis. 2015;40(3-4):129-35. doi: 10.1159/000434760. Epub 2015 Jul 25.

name: on behalf of the sifap1 TM investigators

ReferenceCitation: Thijs V, Grittner U, Dichgans M, Enzinger C, Fazekas F, Giese AK, Kessler C, Kolodny E, Kropp P, Martus P, Norrving B, Ringelstein EB, Rothwell PM, Schmidt R, Tanislav C, Tatlisumak T, von Sarnowski B, Rolfs A; Stroke in Fabry Investigators. Family History in Young Patients With Stroke. Stroke. 2015 Jul;46(7):1975-8. doi: 10.1161/STROKEAHA.115.009341. Epub 2015 Jun 2.

title: Family History in Young Patients With Stroke

ReferenceCitation: Fazekas F, Enzinger C, Schmidt R, Grittner U, Giese AK, Hennerici MG, Huber R, Jungehulsing GJ, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Thijs V, von Sarnowski B, Norrving B, Rolfs A; SIFAP 1 Investigators. Brain magnetic resonance imaging findings fail to suspect Fabry disease in young patients with an acute cerebrovascular event. Stroke. 2015 Jun;46(6):1548-53. doi: 10.1161/STROKEAHA.114.008548. Epub 2015 Apr 21.

name: From the Department of Neurology (F.F., C.E., R.S., S.R.) and Division of Neuroradiology, Department of Radiology (C.E.), Medical University of Graz, Graz, Austria; Department of Biostatistics and Clinical Epidemiology, Charité-Universitätsmedizin, Berlin, Germany (U.G.); Albrecht-Kossel-Institute for Neuroregeneration, University of Rostock, Rostock, Germany (A.-K.G., A.R.); Department of Neurology, Universitätsmedizin Mannheim, University of Heidelberg, Mannheim, Germany (M.G.H.); Department of...

title: Brain Magnetic Resonance Imaging Findings Fail to Suspect Fabry Disease in Young Patients With an Acute Cerebrovascular Event

ReferenceCitation: Tanislav C, Kropp P, Grittner U, Holzhausen M, Fazekas F, Jungehülsing GJ, Tatlisumak T, von Sarnowski B, Putaala J, Huber R, Thijs V, Schmidt R, Kaps M, Enzinger C, Dichgans M, Norrving B, Rolfs A. Clinically relevant depressive symptoms in young stroke patients - results of the sifap1 study. Neuroepidemiology. 2015;44(1):30-8. doi: 10.1159/000371389. Epub 2015 Jan 31.

title: Clinically Relevant Depressive Symptoms in Young Stroke Patients - Results of the sifap1 Study

ReferenceCitation: Kaps M, Grittner U, Jungehülsing G, Tatlisumak T, Kessler C, Schmidt R, Jukka P, Norrving B, Rolfs A, Tanislav C; sifap1 Investigators. Clinical signs in young patients with stroke related to FAST: results of the sifap1 study. BMJ Open. 2014 Nov 7;4(11):e005276. doi: 10.1136/bmjopen-2014-005276.

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: Lund University - Lund University Publications

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories: HELDA - Digital Repository of the University of Helsinki

repositories_institution: Lund University - Lund University Publications

ReferenceCitation: Tanislav C, Grittner U, Misselwitz B, Jungehuelsing GJ, Enzinger C, von Sarnowski B, Putaala J, Kaps M, Kropp P, Rolfs A, Tatlisumak T, Fazekas F, Kolodny E, Norrving B. Lessons from everyday stroke care for clinical research and vice versa: comparison of a comprehensive and a research population of young stroke patients. BMC Neurol. 2014 Mar 7;14:45. doi: 10.1186/1471-2377-14-45.

repositories_institution:
PubMed Central - Europe PMC
University of Helsinki - Helda

ReferenceCitation: Fazekas F, Enzinger C, Schmidt R, Dichgans M, Gaertner B, Jungehulsing GJ, Hennerici MG, Heuschmann P, Holzhausen M, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Norrving B, Rolfs A; sifap1 Investigators. MRI in acute cerebral ischemia of the young: the Stroke in Young Fabry Patients (sifap1) Study. Neurology. 2013 Nov 26;81(22):1914-21. doi: 10.1212/01.wnl.0000436611.28210.ec. Epub 2013 Nov 1.

title: MRI in acute cerebral ischemia of the young: The Stroke in Young Fabry Patients (sifap1) Study

ReferenceCitation: Kropp P, Holzhausen M, Kolodny E, Becker U, Dichgans M, Diez-Tejedor E, Enzinger C, Fazekas F, Fuentes B, Karpinska A, Meyer W, Tanislav C, Böttcher T, Rolfs A; Stroke in Young Fabry Patients (sifap) Investigators. Headache as a symptom at stroke onset in 4,431 young ischaemic stroke patients. Results from the "Stroke in Young Fabry Patients (SIFAP1) study". J Neural Transm (Vienna). 2013 Oct;120(10):1433-40. doi: 10.1007/s00702-013-1014-0. Epub 2013 Jun 9.

name: Stroke in Young Fabry Patients (sifap) Investigators

title: Headache as a symptom at stroke onset in 4,431 young ischaemic stroke patients. Results from the “stroke in young fabry patients (SIFAP1) study”

ReferenceCitation: von Sarnowski B, Schminke U, Tatlisumak T, Putaala J, Grittner U, Kaps M, Tobin WO, Kinsella JA, McCabe DJ, Hennerici MG, Fazekas F, Norrving B, Kessler C, Rolfs A; sifap1 investigators. Prevalence of stenoses and occlusions of brain-supplying arteries in young stroke patients. Neurology. 2013 Apr 2;80(14):1287-94. doi: 10.1212/WNL.0b013e31828ab2ed. Epub 2013 Mar 6.

ReferenceCitation: Rolfs A, Fazekas F, Grittner U, Dichgans M, Martus P, Holzhausen M, Böttcher T, Heuschmann PU, Tatlisumak T, Tanislav C, Jungehulsing GJ, Giese AK, Putaala J, Huber R, Bodechtel U, Lichy C, Enzinger C, Schmidt R, Hennerici MG, Kaps M, Kessler C, Lackner K, Paschke E, Meyer W, Mascher H, Riess O, Kolodny E, Norrving B; Stroke in Young Fabry Patients (sifap) Investigators. Acute cerebrovascular disease in the young: the Stroke in Young Fabry Patients study. Stroke. 2013 Feb;44(2):340-9. doi: 10.1161/STROKEAHA.112.663708. Epub 2013 Jan 10.

name: From the Albrecht-Kossel-Institute for Neuroregeneration, University of Rostock, Rostock, Germany (A.R., T.B., A.K.G.); Department of Neurology, University of Graz, Graz, Austria (F.F., C.E., R.S.); Institute for Biostatistics and Clinical Epidemiology, Charite-University Medicine, Berlin, Germany (U.G., P.M., M.H.); Institute for Stroke and Dementia Research and Department of Neurology, Ludwig-Maximillians University, Munich, Germany (M.D.); Center for Stroke Research Berlin,...

name: Department of Biostatistics and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Germany

name: Dept of Neurology, Medical University of Graz, Graz, Austria

name: (London) epidemiology and neuropsychiatry

title: Acute Cerebrovascular Disease in the Young

ReferenceCitation: von Sarnowski B, Putaala J, Grittner U, Gaertner B, Schminke U, Curtze S, Huber R, Tanislav C, Lichy C, Demarin V, Basic-Kes V, Ringelstein EB, Neumann-Haefelin T, Enzinger C, Fazekas F, Rothwell PM, Dichgans M, Jungehulsing GJ, Heuschmann PU, Kaps M, Norrving B, Rolfs A, Kessler C, Tatlisumak T; sifap1 Investigators. Lifestyle risk factors for ischemic stroke and transient ischemic attack in young adults in the Stroke in Young Fabry Patients study. Stroke. 2013 Jan;44(1):119-25. doi: 10.1161/STROKEAHA.112.665190. Epub 2012 Nov 13.

title: Lifestyle Risk Factors for Ischemic Stroke and Transient Ischemic Attack in Young Adults in the Stroke in Young Fabry Patients Study

ReferenceCitation: Steinicke R, Gaertner B, Grittner U, Schmidt W, Dichgans M, Heuschmann PU, Tanislav C, Putaala J, Kaps M, Endres M, Schmidt R, Fazekas F, Norrving B, Rolfs A, Martus P, Tatlisumak T, Enzinger C, Jungehulsing GJ. Kidney function and white matter disease in young stroke patients: analysis of the stroke in young fabry patients study population. Stroke. 2012 Sep;43(9):2382-8. doi: 10.1161/STROKEAHA.111.645713. Epub 2012 Jun 21.

name: From the Center for Stroke Research Berlin (R.S., W.S., P.U.H., M.E., G.J.J.) and Department of Biostatistics and Clinical Epidemiology (B.G., U.G., P.M.), Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, Justus Liebig University, Giessen, Germany (C.T., M.K.); Helsinki University Central Hospital, Helsinki, Finland (J.P., T.T.); Medical University of Graz, Graz, Austria (R.Sc., F.F., C.E.); Institute for Stroke and Dementia Research, Klinikum Großhadern, LMU, München,...

title: Kidney Function and White Matter Disease in Young Stroke Patients

ReferenceCitation: Fellgiebel A, Keller I, Martus P, Ropele S, Yakushev I, Böttcher T, Fazekas F, Rolfs A. Basilar artery diameter is a potential screening tool for Fabry disease in young stroke patients. Cerebrovasc Dis. 2011;31(3):294-9. doi: 10.1159/000322558. Epub 2010 Dec 22.

title: Basilar Artery Diameter Is a Potential Screening Tool for Fabry Disease in Young Stroke Patients

location_country:
Italy
Austria
Spain
Finland
Croatia
France
Poland
Georgia
Malta
Ireland
Belgium
Portugal
Germany
United Kingdom

location_facility: Helsinki University Central Hospital, Department of Neurology

location_facility: Dept. of Neurology, Johann-Wolfgang-Goethe-Universität

location_facility: Department of Neurology, Klinikum Chemnitz gGmbH

location_facility: Christian-Doppler-Klinik, Department für medizin. Studien

location_facility: Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital

location_facility: University Schleswig-Holstein, Dept. of Neurology

location_facility: University of Giessen-Marburg Dept. of Neurology

location_facility: Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

location_facility: Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

location_facility: Centro Hospitalar de Lisboa Central, Servico de Neurologia

location_facility: Department of Neurology, Universitaetsklinikum Jena

location_facility: Department of Neurology, Kreiskrankenhaus Altenburg

location_facility: Ludwig-Maximilians-University of Munich, Dept. of Neurology

location_facility: Heinrich-Heine University Duesseldorf, Dept. of Neurology

location_facility: Department of Neurology, Allgemeines Krankenhaus Celle

location_facility: University of Ulm, Department of Neurology

location_facility: Klinikum Bremen Mitte gGmbH, Neurologische Klinik

location_facility: Wagner-Jauregg Linz, Department of Neurology

location_facility: Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

location_facility: Department of Neurology, Ernst-Moritz-Arndt-University

location_facility: Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck

location_facility: Department of Neurology, Universitaetsklinikum Carl Gustav Carus

location_facility: Department of Neurology, Klinik und Poliklinik fuer Neurologie

location_facility: Dept. of Neurology, Ospoedale Maggiore Policlinico

location_facility: Charite Campus Benjamin Franklin, Dept. of Neurology

location_facility: University of Muenster, Dept. of Neurology

location_facility: Department of Neurology, Hospital Universitario La Paz

location_facility: Department of Neurology, Universitaetsklinikum Leipzig

location_facility: Department of Neurology, Klinikum Hohe Warte

location_facility: Department of Neurology, University Tuebingen

location_facility: Department of Neurology, University Hospital Sestre Milosrdnice

location_facility: Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie

location_facility: Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie

location_facility: The Adelaide and Meath Hospital, Department of Neurology

location_facility: Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf

location_facility: Middelheim General Hospital, Dept. of Neurology/Memory Clinic

location_facility: University of Heidelberg, Department of Neurology

location_facility: Institute of Psychiatry and Neurology, Dept. of Neurology

location_facility: Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Stroke Prevention Research Unit, John Radcliffe Hospital

location_facility: University of Rostock, Department of Neurology

location_facility: Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln


title: Evaluation de la réponse Immunitaire contre la souche de Neisseria meningitidis B:14,P1-7,16 chez les sujets amenés à être vaccinés par MenBVac®

acronym: EFFIVAC

source: euctr

lead_sponsor: CHu - Hôpitaux de Rouen

study_type: Interventional

status: Ongoing

lead_sponsor_type: academique

status_simplified: Ongoing


title: Traitement par forte dose d'érythropoïétine après arrêt cardiaque : essai multicentrique contrôlé randomisé EPO-ACR 02

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Polymorphismes du gène codant pour le cytochrome 2C19 et réponse au clopidogrel chez le sujet sain

acronym: CLOVIS


title: Traitement de la nephropathie à cylindres myelomateux. MYRE

acronym: MYRE


title: Comparaison de l’anesthésie par bloc axillaire sous échographie avec 40 ou 25 ml de xylocaine 1,5% adrénalinée dans la prise en charge de la chirurgie de l’avant-bras et de la main.

acronym: COMBAX

lead_sponsor: CHU de BREST


title: Efficacy and tolerance of V0071 GM 01A in inflammatory seborrhoeic dermatitis of the scalp.

lead_sponsor: Pierre Fabre Dermatologie

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: Effects of OMACOR in patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome. A proof of concept study.

lead_sponsor: Pierre Fabre Médicament


title: Effets de l’injection per-opératoire d’anesthésiques locaux et d’adrénaline au cours d’une Arthroplastie Totale de Hanche sur les pertes sanguines per et post opératoires.

acronym: EDIPO

lead_sponsor: CHU Clermont-Ferrand


title: Etude de phase II du sunitinib ( SUTENT®)  pour le traitement de patients atteints de cancer de la prostate hormono-résistant après progression sous docétaxel.

acronym: PROSUT


title: Place de la Kétamine à dose anti-hyperalgésique dans l'épargne morphinique en réanimation.

acronym: KETAREA

lead_sponsor: CHU de Clermont-Ferrand


title: Essai randomisé multicentrique de phase III comparant la poursuite du traitement d’entretien par l’association bevacizumab + taxane versus remplacement par bevacizumab + exemestane chez des patientes atteintes de cancer du sein métastatique ou localement avancé,  avec des récepteurs aux estrogènes positifs et ayant au moins une stabilisation de la maladie après 16-18 semaines de traitement par bevacizumab + taxane.

acronym: AROBASE

lead_sponsor: ARCAGY


title: Etude de phase II randomisée multicentrique évaluant l'efficacité d’estramustine phosphate (Estracyt ®) chez des patientes présentant un cancer du sein métastatique HER2- / RH+ ayant déjà reçu un traitement par inhibiteur d’aromatase

acronym: EFESE

lead_sponsor: CRLCC Alexis Vautrin


title: Analgésie post-opératoire en chirurgie cardiaque:effet de l'administration continue de ropivacaine par cathéter multiperforé bi-latérosternal après sternotomie.

acronym: Ropi-BLS-Sternotomie


title: Essai de phase I-II évaluant l’association de Cetuximab et de Trastuzumab chez des patients atteints de cancer pancréatique métastatique ayant progressé sous chimiothérapie à base de gemcitabine (Essai THERAPY)

acronym: THERAPY

lead_sponsor: Centre Régional de Lutte contre le Cancer Val d'Aurelle- Paul Lamarque


title: Etude de phase II randomisée chez des patients porteurs d’un cancer épidermoïde métastatique de l’œsophage évaluant l’intérêt de la poursuite ou non d’un traitement cytotoxique chez des patients non progressifs après 6 semaines de chimiothérapie

acronym: E-DIS

lead_sponsor: Centre Oscar Lambret


title: Adalimumab dans l’Arthrite Juvénile Idiopathique pour le traitement de l’UVéITE (étude ADJUVITE)

acronym: ADJUVITE

status_simplified: Unknown


title: Etude de phase II monocentrique associant Bevacizumab et Temozolomide chez des patients atteints de mélanome uvéal en première ligne métastatique.

acronym: BEVATEM

lead_sponsor: INSTITUT CURIE


title: Recherche de la DE90 d'un bolus de sufentanil pour l'analgésie des soins douloureux de nursing des malades intubés de réanimation

acronym: Reanursuf

lead_sponsor: Centre Hospitalier de Toulouse


title: Essai randomisé multicentrique de phase III évaluant chez des patients en primo-infection VIH-1 l’impact sur les réservoirs (par quantification de l’ADN-VIH-1 dans les PBMC) d’une combinaison comprenant soit raltégravir, maraviroc, darunavir/r associée au Truvada® (emtricitabine / ténofovir), soit darunavir/r associé au Truvada®.

acronym: OPTIPRIM

lead_sponsor: Agence nationale de recherches sur le sida et les hépatites virales ANRS


title: Multicenter, open, pragmatic, randomized trial comparing the efficacy of 3 different lifestyle interventions after addition of sitagliptin to patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin therapy

acronym: ADdition of Januvia Improves Glycemic control in patients inadequately controlled by Metformin

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


type: U.S. NIH Grant/Contract

type: Other Identifier

title: A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)

summary: The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.

name: Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;

family: Cutler

full_name: Corey Cutler

given: Corey

sequence: first

name: Medical College of Wisconsin, Milwaukee, WI;

family: Logan

full_name: Brent Logan

given: Brent

sequence: additional

name: City of Hope Medical Center, Duarte, CA;

family: Nakamura

full_name: Ryotaro Nakamura

given: Ryotaro

family: Johnston

full_name: Laura Johnston

given: Laura

family: Choi

full_name: Sung Choi

given: Sung

name: University of Pennsylvania, Philadelphia, PA;

family: Porter

full_name: David Porter

given: David

family: Hogan

full_name: William J. Hogan

given: William J.

family: Pasquini

full_name: Marcelo Pasquini

given: Marcelo

name: University of Minnesota Medical School, Minneapolis, MN;

family: MacMillan

full_name: Margaret L. MacMillan

given: Margaret L.

family: Hsu

full_name: Jack W. Hsu

given: Jack W.

name: Winship Cancer Institute, Emory University, Atlanta, GA;

family: Waller

full_name: Edmund K. Waller

given: Edmund K.

name: The Children’s Hospital of Philadelphia, Philadelphia, PA;

family: Grupp

full_name: Stephan Grupp

given: Stephan

name: Roswell Park Cancer Institute, Buffalo, NY; and

family: McCarthy

full_name: Philip McCarthy

given: Philip

family: Wu

full_name: Juan Wu

given: Juan

family: Hu

full_name: Zhen-Huan Hu

given: Zhen-Huan

family: Carter

full_name: Shelly L. Carter

given: Shelly L.

family: Horowitz

full_name: Mary M. Horowitz

given: Mary M.

family: Antin

full_name: Joseph H. Antin

given: Joseph H.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

ipd_sharing_description: Findings will be published in a manuscript.

location_facility: University of Pittsburgh Cancer Institute

location_facility: Washington University/Barnes Jewish Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Ohio State, Arthur G. James Cancer Hospital

location_facility: University Hospitals of Cleveland/Case Western

location_facility: University of Florida College of Medicine (Shands)

location_facility: Virginia Commonwealth University/MCV Hospital

location_facility: University of Wisconsin Hospital & Clinics

location_facility: University of Pennsylvania Cancer Center


title:
TRAnexamic Acid for Preventing postpartum hemorrhage following a Cesarean Delivery :a multicenter randomised, double blind placebo controlled trial (TRAAP2)

 L'acide tranéxamique en prévention de l'hémorragie du post-partum après césarienne. Etude contrôlée, en double aveugle, contre placebo, randomisée, multicentrique (TRAAP2)

lead_sponsor: CHU de Bordeaux


title: A Pan-European Randomized, Parallel Group, Two-arm Placebo-controlled, Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Impaired Fasting Blood Glucose With or Without Other Comorbidities

acronym: PRADO

summary:
Primary objective:

To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.

Main Secondary objectives:

To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters.

To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.

status: Terminated

lead_sponsor: Sanofi

location_country:
Luxembourg
Finland
Greece
Belgium
Denmark
Czech Republic
France
Lithuania
Slovakia
Norway
Canada
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Portugal
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Egypt
Spain
Turkey

intervention_type: Drug


title: Efficacité d’une Supplémentation anténatale maternelle en N-acétylcystéine dans les contextes de MAP (Menace d’Accouchement Prématuré) modérées ou sévères, sur la correction du déficit en glutathion du nouveau-né à la naissance

acronym: GSH MAP

lead_sponsor: CHU de Nantes


title:
Preoperative window-of-opportunity (WoO) study of Debio 1143 with or without cisplatin (CDDP) in patients with resectable squamous cell carcinoma of the head and neck.

 Etude pré-opératoire exploratoire du Debio 1143 avec ou sans cisplatine chez des patients atteints d’un carcinome épidermoïde opérable de la tête et du cou

acronym: Debio 1143-SCCHN-202

lead_sponsor: Debiopharm International S.A.


title: Etude diagnostique comparative multicentrique et prospective de la TEP/TDM au 68Ga-HBED-CC-PSMA et des procédures d’imagerie conventionnelle  dans le bilan des cancers de prostate en rechute biologique occulte

acronym: TEP PSMA REBIOLOC

lead_sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST


title:
A multicentric Phase II, open-label study evaluating the efficacy of the combination of hypofractionated stereotactic radiation therapy with the anti-PDL1 immune checkpoint inhibitor Durvalumab in NSCLC patients with 1 to 4 Brain Metastases.

 Etude de phase II multicentrique en ouvert évaluant l’efficacité de l’association d’une radiothérapie hypofractionnée en conditions stéréotaxiques et de l’inhibiteur de checkpoint immunitaire anti-PDL1 durvalumab chez des patients porteurs de 1 à 4 métastases cérébrales de CBNPC.

lead_sponsor: INSTITUT CLAUDIUS REGAUD


title: An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors

acronym: NIRADO

lead_sponsor: Gustave Roussy


title: Urea treatment of hyponatremia during subarachnoid hemorrhage

acronym: NAT-URE

lead_sponsor: CHU Grenoble-Alpes


title:
«Efficacy of Fluticasone Propionate associated with Salmeterol using inhalation chamber versus placebo to improve the respiratory function in children over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥10% from pre transplantation»

 Efficacité de l'association du Fluticasone Salméterol versus Placebo chez les enfants de 6 ans ou plus, allogreffés de moelle présentant un déclin du VEMS de 10% ou plus par rapport à la greffe.

acronym:
RESPPEDOPS

 RESPPEDOPS

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Pilot study of aprepitant effect on aldosterone secretion in diabetic patient (diabetes mellitus) with hypertension associated with low renin

lead_sponsor: Rouen University Hospital


title:
Essai randomisé, contrôlé, en double aveugle, de l'anakinra contre placebo, en adjonction à la corticothérapie dans l'artérite à cellules géantes.

 Essai randomisé, contrôlé, en double aveugle, de l'anakinra contre placebo, en adjonction à la corticothérapie dans l'artérite à cellules géantes.

acronym:
GiAnT

 GiAnT

lead_sponsor: CHU CAEN


title:
Dexamethasone in Herpes Simplex Virus Encephalitis  Open label Randomized Controlled Trial with an Observer-blinded evaluation at 6 months

 Etude multicentrique, randomisée, contrôlée, en ouvert avec évaluation en aveugle à 6 mois, visant à évaluer l’intérêt de dexaméthasone en traitement complémentaire des encéphalites à Herpès Simplex Virus.

acronym: DexEnceph

lead_sponsor: University Hospital Grenoble


title:
Evaluation de l'efficacité d’une solution de chlorhydrate de lidocaïne 1% et de phénazone 4% en gouttes auriculaires (Otipax®) dans l’otite moyenne aiguë congestive de l’enfant
 Etude clinique ouverte, prospective, monocentrique

 Evaluation de l'efficacité d’une solution de chlorhydrate de lidocaïne 1% et de phénazone 4% en gouttes auriculaires (Otipax®) dans l’otite moyenne aiguë congestive de l’enfant
 Etude clinique ouverte, prospective, monocentrique

acronym: OTIKID

lead_sponsor: BIOCODEX


title:
Subcutaneous route and pharmacology of metoclopramide  - SOPHA-Méto

 SOus-cutanée et PHArmacologie du Métoclopramide - SOPHA-Méto

acronym:
SOPHA-Meto

 SOPHA-Meto


ReferenceType: derived

ReferenceCitation: Wessel DL, Berger F, Li JS, Dähnert I, Rakhit A, Fontecave S, Newburger JW; CLARINET Investigators. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.

family: Wessel

full_name: David L. Wessel

given: David L.

family: Berger

full_name: Felix Berger

given: Felix

family: Li

full_name: Jennifer S. Li

given: Jennifer S.

family: Dähnert

full_name: Ingo Dähnert

given: Ingo

family: Rakhit

full_name: Amit Rakhit

given: Amit

family: Fontecave

full_name: Sylvie Fontecave

given: Sylvie

family: Newburger

full_name: Jane W. Newburger

given: Jane W.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Clopidogrel in Infants with Systemic-to-Pulmonary-Artery Shunts

location_country:
Finland
Malaysia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Singapore
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Egypt
Spain

acronym: CLARINET

location_facility:
Sanofi-Aventis Admnistrative Office
Sanofi-Aventis Administraive Office
Sanofi-Aventis Administrative Office

type: EudraCT Number

title: International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

summary:
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.

The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).

The secondary objective was to assess the safety of Clopidogrel in the study population.


type: Registry Identifier

title: A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.

summary: Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Germany
France
Australia
Canada

location_facility:
St. Louis University
Mayo Clinic
Three Medical Park
Rochester General Hospital
University of Connecticut Health Center
UC Irvine/Long Beach
Henry Ford Health System
Carolinas Medical Center
Novartis Investigative Site
Ohio State University Medical Center


title: Essai Bayésien de phase I/II évaluant l’efficacité et la tolérance du danazol chez les patients ayant une atteinte hématologique ou pulmonaire sévère liée à une téloméropathie

acronym: ANDROTELO


title:
Effect of intra-venous ocytocine injection after fetal expulsion in management of third-stage of labor after second trimester medical pregnancy termination

 Analyse de la Délivrance Dirigée par Ocytocine dans les Interruptions Médicales de Grossesses au Deuxième trimestre

acronym:
ANDDROID

 ANDDROID


title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

summary:
Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

ReferenceCitation: Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Ginès P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

family: Wong

full_name: Florence Wong

given: Florence

family: Watson

full_name: Hugh Watson

given: Hugh

family: Gerbes

full_name: Alexander Gerbes

given: Alexander

family: Vilstrup

full_name: Hendrik Vilstrup

given: Hendrik

family: Badalamenti

full_name: Salvatore Badalamenti

given: Salvatore

family: Bernardi

full_name: Mauro Bernardi

given: Mauro

family: Ginès

full_name: Pere Ginès

given: Pere

journal_name: Gut

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_country:
Malaysia
Romania
Belgium
Australia
Russian Federation
Czech Republic
France
Poland
Argentina
Canada
Chile
Bulgaria
Singapore
Germany
United States
Brazil
Bosnia and Herzegovina
Serbia
Mexico
Spain
Turkey


title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

summary:
Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

title: Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity

location_country:
Malaysia
Romania
Belgium
Australia
Czech Republic
Taiwan
Croatia
France
Argentina
Canada
Korea, Republic of
South Africa
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Israel
Spain


title:
Prostate cancer with OligometaSTatic relapse: Combining stereotactic Ablative Radiotherapy and Durvalumab (MEDI4736), a randomized phase II trial

 Cancer prostatique en rechute oligométastatique: association de la radiothérapie stéréotaxique hypofractionnée et Durvalumab (MEDI4736), essai randomisé de phase II

acronym: POSTCARD - GETUG-P13


title:
Efficacy of dalbavancin during osteo-articular infections associated with hip and knee prostheses

 Efficacité de la dalbavancine au cours des infections ostéo-articulaires associées aux prothèses (IOAP) de hanche et de genou

acronym:
PRO-DALBA

 PRO-DALBA

lead_sponsor: CHU de Nice


title: Phase 2 multicentric open-label study of switch from abacavir/lamivudine fixed dose combination plus nevirapine to abacavir/lamivudine/dolutegravir in virologically suppressed HIV-1 infected adults

acronym: SWAD


title: PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF EARLY OXYBUTININ TREATMENT FOR BOYS WITH POSTERIOR URETHRAL VALVES

acronym: PRETIPUV


title: Comparaison de trois biomédicaments en termes d’évolution des sous-populations lymphocytaires régulatrices et pro-inflammatoires chez des patients atteints de polyarthrite rhumatoïde.

acronym: CELyPoR

lead_sponsor: CHU Amiens-Picardie


title: Antagonistes NMDA en relais de la kétamine dans la douleur neuropathique.

acronym: Etude Antagonistes NMDA et douleur neuropathique

lead_sponsor: CHU de Clermont-Ferrand


title:
Effect of Liraglutide on fatty liver content evaluated by 1H-spectroscopy and lipoprotein kinetic, in patients with type 2 diabetes

 Effet du Liraglutide sur le contenu en graisse hépatique (évalué par spectroscopie protonique) et sur la cinétique des lipoprotéines chez des patients diabétiques de type 2

lead_sponsor: CHU Dijon

status: Prematurely Ended


title:
A phase II study to assess the efficacy and safety of frontline combination of dasatinib (SPRYCEL®) and pegylated-interferon alpha 2b (Peg-IFNα2b) therapy in patients newly diagnosed with chronic phase chronic myeloid leukaemia (CP-CML)

 Etude de phase II évaluant l’efficacité et la tolérance de l’association dasatinib (Sprycel®) et Peg-Interféron alpha 2b (PegIFN-α2b) comme première ligne de traitement des patients atteints de Leucémie Myéloïde Chronique en phase chronique (LMC-PC) nouvellement diagnostiquée

acronym: DASA-PEGIFN

lead_sponsor: CHU DE POITIERS


title: Immunogenicity and Safety of the Trivalent Influenza Vaccine (Split-Virion, Inactivated), Northern Hemisphere 2013-2014 Formulation (Intradermal Route)

lead_sponsor: Sanofi Pasteur


title:
Assessment of incidence of adverse events in a naive pediatric population treated with an antipsychotic drug over 12 months follow-up

 EVALUATION DE L’INCIDENCE DES EVENEMENTS INDESIRABLES EN POPULATION PEDIATRIQUE NAIVE TRAITEE PAR ANTIPSYCHOTIQUE AU COURS D’UN SUIVI DE 12 MOIS

acronym:
Unwanted events in naive pediatric population treated by antipsychotic

 Evénements indésirables en population pédiatrique naïve traitée par antipsychotique


title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone

acronym: IMSIII

summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.

ReferenceCitation: Chalos V, van der Ende NAM, Lingsma HF, Mulder MJHL, Venema E, Dijkland SA, Berkhemer OA, Yoo AJ, Broderick JP, Palesch YY, Yeatts SD, Roos YBWEM, van Oostenbrugge RJ, van Zwam WH, Majoie CBLM, van der Lugt A, Roozenbeek B, Dippel DWJ; MR CLEAN Investigators. National Institutes of Health Stroke Scale: An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke. Stroke. 2020 Jan;51(1):282-290. doi: 10.1161/STROKEAHA.119.026791. Epub 2019 Dec 4.

name: From the Departments of Neurology (V.C., N.A.M.v.d.E., M.J.H.L.M., E.V., O.A.B., B.R., D.W.J.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands

name: Public Health (V.C., H.F.L., E.V., S.A.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands

name: Radiology and Nuclear Medicine (V.C., N.A.M.v.d.E., O.A.B., A.v.d.L., B.R.), Erasmus MC University Medical Center, Rotterdam, the Netherlands

family: Chalos

full_name: Vicky Chalos

given: Vicky

family: van der Ende

full_name: Nadinda A.M. van der Ende

given: Nadinda A.M.

family: Lingsma

full_name: Hester F. Lingsma

given: Hester F.

family: Mulder

full_name: Maxim J.H.L. Mulder

given: Maxim J.H.L.

family: Venema

full_name: Esmee Venema

given: Esmee

family: Dijkland

full_name: Simone A. Dijkland

given: Simone A.

name: Departments of Radiology and Nuclear Medicine (O.A.B., C.B.L.M.M.), Amsterdam UMC, Location AMC, University of Amsterdam, the Netherlands

name: Radiology (O.A.B., W.H.v.Z.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.

family: Berkhemer

full_name: Olvert A. Berkhemer

given: Olvert A.

name: Department of Interventional Neuroradiology, Texas Stroke Institute, Dallas-Fort Worth (A.J.Y.)

family: Yoo

full_name: Albert J. Yoo

given: Albert J.

name: Department of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B.)

family: Broderick

full_name: Joseph P. Broderick

given: Joseph P.

name: Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., S.D.Y.)

family: Palesch

full_name: Yuko Y. Palesch

given: Yuko Y.

family: Yeatts

full_name: Sharon D. Yeatts

given: Sharon D.

name: Neurology (Y.B.W.E.M.R.), Amsterdam UMC, Location AMC, University of Amsterdam, the Netherlands

family: Roos

full_name: Yvo B.W.E.M. Roos

given: Yvo B.W.E.M.

name: Departments of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.

family: van Oostenbrugge

full_name: Robert J. van Oostenbrugge

given: Robert J.

family: van Zwam

full_name: Wim H. van Zwam

given: Wim H.

family: Majoie

full_name: Charles B.L.M. Majoie

given: Charles B.L.M.

family: van der Lugt

full_name: Aad van der Lugt

given: Aad

family: Roozenbeek

full_name: Bob Roozenbeek

given: Bob

family: Dippel

full_name: Diederik W.J. Dippel

given: Diederik W.J.

family: Fransen

full_name: Puck S.S. Fransen

given: Puck S.S.

family: Beumer

full_name: Debbie Beumer

given: Debbie

family: van den Berg

full_name: Lucie A. van den Berg

given: Lucie A.

name: on behalf of the MR CLEAN Investigators*

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

publisher: Ovid Technologies (Wolters Kluwer Health)

title: National Institutes of Health Stroke Scale

ReferenceCitation: Simpson KN, Simpson AN, Mauldin PD, Palesch YY, Yeatts SD, Kleindorfer D, Tomsick TA, Foster LD, Demchuk AM, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Broderick JP; Interventional Management of Stroke (IMS) III Investigators. Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III. J Am Heart Assoc. 2017 May 8;6(5). pii: e004513. doi: 10.1161/JAHA.116.004513.

name: Department of Healthcare Leadership and Management, Medical University of South Carolina, Charleston, SC

name: Department of General Internal Medicine and Geriatrics, Medical University of South Carolina, Charleston, SC

name: Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC

name: Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Gardner Neuroscience Institute University of Cincinnati Academic Health Center, Cincinnati, OH

name: Calgary Stroke Program, Departments of Clinical Neurosciences and Radiology, Seaman Family MR Research Centre, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada

name: Division of Emergency Medicine, Medical University of South Carolina, Charleston, SC

name: Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh, PA

name: Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia

name: Institute of Diagnostic and Interventional Neuroradiology, University Hospital Dresden, Dresden, Germany

name: Neurovascular Unit, Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona, Spain

name: Department of Neurology, University Medical Center Utrecht and the Rudolph Magnus Institute of Neurosciences, Utrecht, The Netherlands

name: St. Antonius Hospital, Nieuwegein, The Netherlands

name: Department of Neurology and Stroke Center, Lariboisière Hospital, DHU NeuroVasc, Paris, France

name: Neurorehabilitation Unit, Department of Neurology, Basel University Hospital, University of Basel, Basel, Switzerland

name: University Center for Medicine of Aging, Felix Platter Hospital, Basel, Switzerland

name: George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia

name: National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD

name: the Interventional Management of Stroke (IMS) III Investigators

journal_name: Journal of the American Heart Association

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

title: Observed Cost and Variations in Short Term Cost‐Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III

ReferenceCitation: Venema E, Mulder MJHL, Roozenbeek B, Broderick JP, Yeatts SD, Khatri P, Berkhemer OA, Emmer BJ, Roos YBWEM, Majoie CBLM, van Oostenbrugge RJ, van Zwam WH, van der Lugt A, Steyerberg EW, Dippel DWJ, Lingsma HF. Selection of patients for intra-arterial treatment for acute ischaemic stroke: development and validation of a clinical decision tool in two randomised trials. BMJ. 2017 May 3;357:j1710. doi: 10.1136/bmj.j1710.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Mulder MJ, Venema E, Roozenbeek B, Broderick JP, Yeatts SD, Khatri P, Berkhemer OA, Roos YB, Majoie CB, van Oostenbrugge RJ, van Zwam WH, van der Lugt A, Steyerberg EW, Dippel DW, Lingsma HF. Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid. BMJ Open. 2017 Mar 22;7(3):e013699. doi: 10.1136/bmjopen-2016-013699.

ReferenceCitation: Broderick JP, Berkhemer OA, Palesch YY, Dippel DW, Foster LD, Roos YB, van der Lugt A, Tomsick TA, Majoie CB, van Zwam WH, Demchuk AM, van Oostenbrugge RJ, Khatri P, Lingsma HF, Hill MD, Roozenbeek B, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson CS, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Simpson KN; IMS III Investigators; MR CLEAN Investigators. Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data. Stroke. 2015 Dec;46(12):3416-22. doi: 10.1161/STROKEAHA.115.011397. Epub 2015 Oct 20. Erratum in: Stroke. 2016 Jan;47(1):e21. IMS II [corrected to IMS III Investigators].

name: From the Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH (J.P.B., P.K., J.S., J.C., T.A.T.); Division of Emergency Medicine (E.C.J.), Department of Public Health Sciences (Y.Y.P., L.D.F.), and Department of Healthcare Management and Leadership (K.N.S.), Medical University of South Carolina, Charleston; Calgary Stroke Program, Seaman Family MR Research Centre,...

name: for the IMS III and MR CLEAN Investigators

title: Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke

ReferenceCitation: Abou-Chebl A, Yeatts SD, Yan B, Cockroft K, Goyal M, Jovin T, Khatri P, Meyers P, Spilker J, Sugg R, Wartenberg KE, Tomsick T, Broderick J, Hill MD. Impact of General Anesthesia on Safety and Outcomes in the Endovascular Arm of Interventional Management of Stroke (IMS) III Trial. Stroke. 2015 Aug;46(8):2142-8. doi: 10.1161/STROKEAHA.115.008761. Epub 2015 Jul 2.

name: From Baptist Neuroscience Associates, Baptist Health, Louisville, KY (A.A.-C.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (S.D.Y.); Department of Neurology, Royal Melbourne Hospital, Parkville, Australia (B.Y.); Departments of Neurosurgery, Radiology, and Public Health Sciences, Penn State Hershey, PA (K.C.); Departments of Radiology and Clinical Neurosciences, Foothills Medical Centre, Calgary, AB, Canada (M.G.); Department of Neurology, University of...

ReferenceCitation: Al-Ali F, Elias JJ, Tomsick TA, Liebeskind DS, Broderick JP; IMS Study Groups. Relative Influence of Capillary Index Score, Revascularization, and Time on Stroke Outcomes From the Interventional Management of Stroke III Trial. Stroke. 2015 Jun;46(6):1590-4. doi: 10.1161/STROKEAHA.115.009066. Epub 2015 May 7.

name: From the Departments of Neuro-Interventional Surgery (F.A.-A.) and Research (J.J.E.), Akron General Medical Center, OH; Department of Radiology, University of Cincinnati Academic Health Center, OH (T.A.T.); Neurovascular Imaging Research Core & UCLA Department of Neurology, Los Angeles, CA (D.S.L.); and Department of Neurology, University of Cincinnati Academic Health Center, OH (J.P.B.).

ReferenceCitation: Palesch YY, Yeatts SD, Tomsick TA, Foster LD, Demchuk AM, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Simpson A, Simpson KN, Broderick JP; Interventional Management of Stroke III Investigators. Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial. Stroke. 2015 May;46(5):1321-7. doi: 10.1161/STROKEAHA.115.009180. Epub 2015 Apr 9.

name: From the Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati (J.P.B., P.K., J.S., J.C., T.A.T.); Department of Public Health Sciences (Y.Y.P., S.D.Y., L.D.F., A.S., K.N.S.) and Division of Emergency Medicine (E.C.J.), Medical University of South Carolina, Charleston; Calgary Stroke Program, Seaman Family MR Research Centre, Departments of Clinical Neurosciences and Radiology,...

ReferenceCitation: Menon BK, Qazi E, Nambiar V, Foster LD, Yeatts SD, Liebeskind D, Jovin TG, Goyal M, Hill MD, Tomsick TA, Broderick JP, Demchuk AM; Interventional Management of Stroke III Investigators. Differential Effect of Baseline Computed Tomographic Angiography Collaterals on Clinical Outcome in Patients Enrolled in the Interventional Management of Stroke III Trial. Stroke. 2015 May;46(5):1239-44. doi: 10.1161/STROKEAHA.115.009009. Epub 2015 Mar 19.

name: From the Calgary Stroke Program and the Department of Clinical Neurosciences (B.K.M., E.Q., V.N., M.G., M.D.H., A.M.D.), Department of Radiology (B.K.M., M.G., M.D.H., A.M.D.), University of Calgary, Calgary, Canada; Department of Public Health Sciences, Medical University of South Carolina, Charleston (L.D.F., S.D.Y.); Department of Neurosciences, University of California, Los Angeles (D.L.); Department of Neurosciences, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Community...

ReferenceCitation: Tomsick TA, Yeatts SD, Liebeskind DS, Carrozzella J, Foster L, Goyal M, von Kummer R, Hill MD, Demchuk AM, Jovin T, Yan B, Zaidat OO, Schonewille W, Engelter S, Martin R, Khatri P, Spilker J, Palesch YY, Broderick JP; IMS III Investigators. Endovascular revascularization results in IMS III: intracranial ICA and M1 occlusions. J Neurointerv Surg. 2015 Nov;7(11):795-802. doi: 10.1136/neurintsurg-2014-011318. Epub 2014 Oct 23.

title: Endovascular revascularization results in IMS III: intracranial ICA and M1 occlusions

ReferenceCitation: Simpson KN, Simpson AN, Mauldin PD, Hill MD, Yeatts SD, Spilker JA, Foster LD, Khatri P, Martin R, Jauch EC, Kleindorfer D, Palesch YY, Broderick JP; IMS III Investigators. Drivers of costs associated with reperfusion therapy in acute stroke: the Interventional Management of Stroke III Trial. Stroke. 2014 Jun;45(6):1791-8. doi: 10.1161/STROKEAHA.113.003874. Epub 2014 May 13.

name: From the Department of Neurology and Rehabilitation Medicine, University of Cincinnati Academic Health Center, OH (J.P.B., D.K., P.K., J.A.S.); Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada (M.D.H.); and Department of Healthcare Leadership and Management (K.N.S., A.N.S.), Department of General Internal Medicine (P.D.M.), Department of Public Health Sciences (S.D.Y., L.D.F., R.M., Y.Y.P.), Department of Emergency Medicine (E.C.J.), Medical University of South Carolina,...

title: Drivers of Costs Associated With Reperfusion Therapy in Acute Stroke

ReferenceCitation: Goyal M, Almekhlafi MA, Fan L, Menon BK, Demchuk AM, Yeatts SD, Hill MD, Tomsick T, Khatri P, Zaidat OO, Jauch EC, Eesa M, Jovin TG, Broderick JP. Evaluation of interval times from onset to reperfusion in patients undergoing endovascular therapy in the Interventional Management of Stroke III trial. Circulation. 2014 Jul 15;130(3):265-72. doi: 10.1161/CIRCULATIONAHA.113.007826. Epub 2014 May 9.

name: Departments of Radiology and Clinical Neurosciences, Calgary Stroke Program, University of Calgary, Calgary, Alberta, Canada (M.G., M.A.A., B.K.M., A.M.D., M.D.H., M.E.); Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia (M.A.A.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (L.F., S.D.Y.); Departments of Neurology and Radiology, University of Cincinnati, Cincinnati, OH (T.T., P.K., J.P.B.); Department of Radiology, Medical College of...

title: Evaluation of Interval Times From Onset to Reperfusion in Patients Undergoing Endovascular Therapy in the Interventional Management of Stroke III Trial

ReferenceCitation: Yeatts SD, Martin RH, Coffey CS, Lyden PD, Foster LD, Woolson RF, Broderick JP, Di Tullio MR, Jungreis CA, Palesch YY; IMS III Investigators. Challenges of decision making regarding futility in a randomized trial: the Interventional Management of Stroke III experience. Stroke. 2014 May;45(5):1408-14. doi: 10.1161/STROKEAHA.113.003925. Epub 2014 Apr 3.

name: From the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC (S.D.Y., R.H.M., L.D.F., R.F.W., Y.Y.P.); Department of Biostatistics, University of Iowa, Iowa City, IA (C.S.C.); Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.D.L.); Department of Neurology, University of Cincinnati Academic Health Center, Cincinnati, OH (J.P.B.); Department of Medicine, Division of Cardiology, Columbia University Medical Center,...

title: Challenges of Decision Making Regarding Futility in a Randomized Trial

ReferenceCitation: Liebeskind DS, Tomsick TA, Foster LD, Yeatts SD, Carrozzella J, Demchuk AM, Jovin TG, Khatri P, von Kummer R, Sugg RM, Zaidat OO, Hussain SI, Goyal M, Menon BK, Al Ali F, Yan B, Palesch YY, Broderick JP; IMS III Investigators. Collaterals at angiography and outcomes in the Interventional Management of Stroke (IMS) III trial. Stroke. 2014 Mar;45(3):759-64. doi: 10.1161/STROKEAHA.113.004072. Epub 2014 Jan 28.

name: From UCLA Stroke Center, Los Angeles, CA (D.S.L.); University of Cincinnati, Cincinnati, OH (T.A.T., J.C., P.K., J.P.B.); Medical University of South Carolina, Charleston, SC (L.D.F., S.D.Y., Y.Y.P.); Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada (A.M.D., M.G., B.K.M.); UPMC Stroke Institute, Pittsburgh, PA (T.G.J.); Department of Neuroradiology, University of Dresden, Dresden, Germany (R.v.K.); University of...

title: Collaterals at Angiography and Outcomes in the Interventional Management of Stroke (IMS) III Trial

ReferenceCitation: Hill MD, Demchuk AM, Goyal M, Jovin TG, Foster LD, Tomsick TA, von Kummer R, Yeatts SD, Palesch YY, Broderick JP; IMS3 Investigators. Alberta Stroke Program early computed tomography score to select patients for endovascular treatment: Interventional Management of Stroke (IMS)-III Trial. Stroke. 2014 Feb;45(2):444-9. doi: 10.1161/STROKEAHA.113.003580. Epub 2013 Dec 12.

title: Alberta Stroke Program Early Computed Tomography Score to Select Patients for Endovascular Treatment

ReferenceCitation: Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA; Interventional Management of Stroke (IMS) III Investigators. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013 Mar 7;368(10):893-903. doi: 10.1056/NEJMoa1214300. Epub 2013 Feb 7. Erratum in: N Engl J Med. 2013 Mar 28;368(13):1265.

title: Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke

location_country:
United States
Switzerland
Netherlands
Germany
France
Australia
Spain
Canada

location_facility: Bethesda North Hospital, 10500 Montgomery Rd.

location_facility: Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave.

location_facility: Henry Ford Hospital, 2799 W Grand Blvd, CFP-260

location_facility: Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404

location_facility: Massachusetts General Hospital, 55 Fruit Street

location_facility: University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520

location_facility: Good Samaritan Hospital, 375 Dixmyth Ave.

location_facility: Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206

location_facility: University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400

location_facility: Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville

location_facility: Santa Monica-UCLA Medical Center, 1250 16th Street

location_facility: The University Hospital, 234 Goodman Ave.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Miami Miller School of Medicine

location_facility: St. Elizabeth Medical Center South, One Medical Village Drive

location_facility: University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor

location_facility: Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton

location_facility: University of Mississippi Medical Center

location_facility: St Luke's West Hospital, 7380 Turfway Rd.

location_facility: Riverside Methodist Hospital, 3535 Olentangy River Road

location_facility: University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044

location_facility: The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue

location_facility: UCLA Medical Center, 924 Westwood Blvd., Suite 300

location_facility: University Medical Center at Brackenridge Hospital

location_facility: University of British Columbia, Vancouver General Hospital, VGH Stroke Program, Gordon & Leslie Diamond Healthcare Centre, 2775 Laurel St., 8th Fl., Ste. 8295

location_facility: University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW

location_facility: St. Luke's Hospital East, 85 N. Grand Ave.

location_facility: Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd.

location_facility: Stroke Center at Hartford, 80 Seymour St. Rm JB603

location_facility: Morton Plant Mease Health Care, 300 Pinellas Street MS 49

location_facility: Johns Hopkins University, 1500 Orleans St. 3M South

location_facility: Michigan State University, Sparrow Hospital, B 401 Clinical Center

location_facility: OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital

location_facility: The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd

location_facility: PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212

location_facility: St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst

location_facility: Alexian Brothers Medical Center, 800 Biesterfield Rd.

location_facility: Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue

location_facility: Mercy Hospital, Western Hills, 3131 Queen City Ave.

location_facility: Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400

location_facility: Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue

location_facility: University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508

location_facility: Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St.

location_facility: Mercy Hospital, Mt Airy, 2446 Kipling Ave.

location_facility: Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd


title: Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver

acronym: CATS

summary:
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

ReferenceCitation: Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Ginès P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

family: Wong

full_name: Florence Wong

given: Florence

family: Watson

full_name: Hugh Watson

given: Hugh

family: Gerbes

full_name: Alexander Gerbes

given: Alexander

family: Vilstrup

full_name: Hendrik Vilstrup

given: Hendrik

family: Badalamenti

full_name: Salvatore Badalamenti

given: Salvatore

family: Bernardi

full_name: Mauro Bernardi

given: Mauro

family: Ginès

full_name: Pere Ginès

given: Pere

lead_sponsor: Sanofi

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
Croatia
France
Poland
Argentina
Canada
Chile
Sweden
Netherlands
Hungary
Portugal
United States
United Kingdom
Italy
Brazil
Israel
Spain


title: Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 3/4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous Infusion (CI) Versus Intermittent Bolus Infusion (BI) in Subjects With Severe or Moderately Severe Hemophilia A Undergoing Major Orthopedic Surgery

summary: The purpose of this study is to compare the hemostatic efficacy and safety of continuous infusion versus intermittent bolus infusion in the peri- and post-operative setting, employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or animal proteins, in previously treated patients with severe or moderately severe hemophilia A (baseline factor VIII level <= 2% of normal) who are undergoing unilateral major orthopedic surgery that requires drain placement. The total study period per subject (from consent to study completion) will vary from approximately 9 to 26 weeks and will involve clinical and laboratory assessments.

study_start_date_type: Actual

ipd_sharing: Yes

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

lead_sponsor: Baxalta now part of Shire

location_country:
Italy
Austria
Sweden
Netherlands
Spain
France
Poland
Norway
Hungary
Belgium
Romania
Russian Federation
Portugal
United States

location_facility: Fundeni Clinical Institute, Clinical Laboratory "St. Berceanu" Hematology and Bone Marrow Transplantation Department

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University Hospital MAS, Department for Coagulation Disorders

location_facility: University Hospital for Internal Medicine I (Hematology/Hemostaseology)

location_facility: University of Debrecen, 2nd Dept of Internal Medicine

location_facility: The University of Texas Health Science Center at Houston Medical School

location_facility: AMC Medical Research BV, Department of Vascular Medicine

location_facility: Hospital Vall d´Hebron, Servei d´Hemofilia

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: Centro Emofilia e Trombosi "Angelo Bianchi Bonomi"

location_facility: Hematology Research Center under Russian Academy of Medical Sciences, Department of Reconstructive Orthopedic Surgery for Hemophilia Patients

location_facility: Russian Research Institute of Hematology and Transfusiology, Department of Surgical Hematology and Angiology

location_facility: PTE ÁOK I. Internal Medical Clinic, Dept of Hematology

location_facility: State Health Centre, National Hemophilia Centre

location_facility: "Louis Turcanu" Emergency Clinical Children´s Hospital, 3rd Pediatrics Department, Hemophilia Center

location_facility: Cliniques Universitaires St. Luc, Haematology Department

location_facility: Department of Clinical & Experimental Medecine, AOU Federico II


title: A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents

summary: The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.

ReferenceCitation: Blanche S, Bologna R, Cahn P, Rugina S, Flynn P, Fortuny C, Vis P, Sekar V, van Baelen B, Dierynck I, Spinosa-Guzman S. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009 Sep 24;23(15):2005-13. doi: 10.1097/QAD.0b013e328330abaa.

family: Blanche

full_name: Stéphane Blanche

given: Stéphane

family: Bologna

full_name: Rosa Bologna

given: Rosa

family: Cahn

full_name: Pedro Cahn

given: Pedro

family: Rugina

full_name: Sorin Rugina

given: Sorin

family: Flynn

full_name: Patricia Flynn

given: Patricia

family: Fortuny

full_name: Claudia Fortuny

given: Claudia

family: Vis

full_name: Peter Vis

given: Peter

family: Sekar

full_name: Vanitha Sekar

given: Vanitha

family: van Baelen

full_name: Ben van Baelen

given: Ben

family: Dierynck

full_name: Inge Dierynck

given: Inge

family: Spinosa-Guzman

full_name: Sabrina Spinosa-Guzman

given: Sabrina

journal_name: AIDS

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Brazil
United States
South Africa
France
Romania
Argentina
Spain
Canada


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

summary: The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.

ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

family: Ryan

full_name: Caitriona Ryan

given: Caitriona

family: Sobell

full_name: Jeffrey M. Sobell

given: Jeffrey M.

family: Leonardi

full_name: Craig L. Leonardi

given: Craig L.

family: Lynde

full_name: Charles W. Lynde

given: Charles W.

family: Karunaratne

full_name: Mahinda Karunaratne

given: Mahinda

family: Valdecantos

full_name: Wendell C. Valdecantos

given: Wendell C.

family: Hendrickson

full_name: Barbara A. Hendrickson

given: Barbara A.

journal_name: American Journal of Clinical Dermatology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Rutgeerts P, Reinisch W, Colombel JF, Sandborn WJ, D'Haens G, Petersson J, Zhou Q, Iezzi A, Thakkar RB. Agreement of site and central readings of ileocolonoscopic scores in Crohn's disease: comparison using data from the EXTEND trial. Gastrointest Endosc. 2016 Jan;83(1):188-97.e1-3. doi: 10.1016/j.gie.2015.06.018. Epub 2015 Jul 30.

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Colombel

full_name: Jean-Frederic Colombel

given: Jean-Frederic

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: D’Haens

full_name: Geert D’Haens

given: Geert

family: Petersson

full_name: Joel Petersson

given: Joel

family: Zhou

full_name: Qian Zhou

given: Qian

family: Iezzi

full_name: Annalisa Iezzi

given: Annalisa

family: Thakkar

full_name: Roopal B. Thakkar

ReferenceCitation: Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.

journal_name: Clinical Gastroenterology and Hepatology

title: Adalimumab Induces Deep Remission in Patients With Crohn's Disease

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Belgium
Canada


title: An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis

acronym: CASSIOPEA

summary: Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

ReferenceCitation: Büller HR, Gallus AS, Pillion G, Prins MH, Raskob GE; Cassiopea Investigators. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial. Lancet. 2012 Jan 14;379(9811):123-9. doi: 10.1016/S0140-6736(11)61505-5. Epub 2011 Nov 28.

family: Büller

full_name: Harry R Büller

given: Harry R

family: Gallus

full_name: Alex S Gallus

given: Alex S

family: Pillion

full_name: Gerard Pillion

given: Gerard

family: Prins

full_name: Martin H Prins

given: Martin H

family: Raskob

full_name: Gary E Raskob

given: Gary E

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
Peru
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
India
Spain
Croatia
France
Poland
Slovakia
Norway
Argentina
Canada
Turkey
Colombia
South Africa
Chile
Sweden
Netherlands
Philippines
Bulgaria
Puerto Rico
China
Portugal
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Egypt
Belarus
Estonia

location_facility: sanofi-aventis Australia & New Zealand administrative office


summary: The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.

study_type: Observational

ReferenceType: background

ReferenceCitation: Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17. Review.

ReferenceCitation: Kroner BL, Rosenberg PS, Aledort LM, Alvord WG, Goedert JJ. HIV-1 infection incidence among persons with hemophilia in the United States and western Europe, 1978-1990. Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1994 Mar;7(3):279-86.

ReferenceCitation: Eyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. The Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1993 Jun;6(6):602-10.

lead_sponsor: National Cancer Institute (NCI)

location_country:
Italy
Brazil
Sweden
Germany
France
Greece
United States
Canada

location_facility: North Shore Long Island Jewish Health System

location_facility: Karolinska Institute St. Gorans Hospital


title: Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.

summary: The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

ReferenceCitation: CURRENT-OASIS 7 Investigators, Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475. Erratum in: N Engl J Med. 2010 Oct 14;363(16):1585.

title: Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes

ReferenceCitation: Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):976-7. doi: 10.1056/NEJMe1008891.

family: Fuster

full_name: Valentin Fuster

given: Valentin

title: Fine-Tuning Therapy for Acute Coronary Syndromes

ReferenceCitation: Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.

family: Mehta

full_name: Shamir R Mehta

given: Shamir R

family: Tanguay

full_name: Jean-Francois Tanguay

given: Jean-Francois

family: Eikelboom

full_name: John W Eikelboom

given: John W

family: Jolly

full_name: Sanjit S Jolly

given: Sanjit S

family: Joyner

full_name: Campbell D Joyner

given: Campbell D

family: Granger

full_name: Christopher B Granger

given: Christopher B

family: Faxon

full_name: David P Faxon

given: David P

family: Rupprecht

full_name: Hans-Jurgen Rupprecht

given: Hans-Jurgen

family: Budaj

full_name: Andrzej Budaj

given: Andrzej

family: Avezum

full_name: Alvaro Avezum

given: Alvaro

family: Widimsky

full_name: Petr Widimsky

given: Petr

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Bassand

full_name: Jean-Pierre Bassand

given: Jean-Pierre

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Macaya

full_name: Carlos Macaya

given: Carlos

family: Di Pasquale

full_name: Giuseppe Di Pasquale

given: Giuseppe

family: Niemela

full_name: Kari Niemela

given: Kari

family: Ajani

ReferenceCitation: Stone GW. Acute coronary syndromes: finding meaning in OASIS 7. Lancet. 2010 Oct 9;376(9748):1203-5. doi: 10.1016/S0140-6736(10)61262-7.

ReferenceCitation: Bossard M, Gao P, Boden W, Steg G, Tanguay JF, Joyner C, Granger CB, Kastrati A, Faxon D, Budaj A, Pais P, Di Pasquale G, Valentin V, Flather M, Moccetti T, Yusuf S, Mehta SR. Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease. Heart. 2021 Nov;107(21):1739-1747. doi: 10.1136/heartjnl-2020-318045. Epub 2021 Jan 27.

ReferenceCitation: Bossard M, Granger CB, Tanguay JF, Montalescot G, Faxon DP, Jolly SS, Widimsky P, Niemela K, Steg PG, Natarajan MK, Gao P, Fox KAA, Yusuf S, Mehta SR. Double-Dose Versus Standard-Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Nov 3;6(11). pii: e006577. doi: 10.1161/JAHA.117.006577.

name: Population Health Research Institute, McMaster University Hamilton Health Sciences, East Hamilton, Ontario, Canada

name: Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland

name: Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC

name: Montreal Heart Institute, Université de Montréal, Montréal, Quebec, Canada

name: Université Sorbonne‐Paris 6, ACTION group, Institute of Cardiology, Centre Hospitalier Universitaire Pitié‐Salpêtrière (AP‐HP), Paris, France

name: Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard University, Boston, MA

name: Cardiocenter, Third Faculty of Medicine, Charles University in Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic

name: Heart Center, Tampere University Hospital, Tampere, Finland

name: Cardiology Department, Hôpital Bichat‐Claude Bernard, Paris, France

name: Centre for Cardiovascular Science, Royal Infirmary, University of Edinburgh, United Kingdom

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

title: Double‐Dose Versus Standard‐Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention

ReferenceCitation: Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Fox KA, Granger CB, Jolly S, Rupprecht HJ, Widimsky P, Yusuf S; CURRENT-OASIS 7 Steering Committee. Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. Am Heart J. 2008 Dec;156(6):1080-1088.e1. doi: 10.1016/j.ahj.2008.07.026. Epub 2008 Nov 1.

title: Design and rationale of CURRENT-OASIS 7: A randomized, 2 × 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non–ST-elevation acute coronary syndromes managed with an early invasive strategy

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
India
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Estonia
Latvia


summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

ReferenceCitation: Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.

name: UCL Institute of Ophthalmology and Moorfields Eye Hospital, London, United Kingdom

family: Lightman

full_name: Susan Lightman

given: Susan

name: Department of Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil

family: Belfort

full_name: Rubens Belfort

given: Rubens

suffix: Jr.

family: Naik

full_name: Rupali K. Naik

given: Rupali K.

name: Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio

family: Lowder

full_name: Careen Lowder

given: Careen

name: Ophthalmology, Ocular Immunology and Uveitis Foundation, Cambridge, Massachusetts

family: Foster

full_name: C. Stephen Foster

given: C. Stephen

name: United BioSource Corporation, Bethesda, Maryland

family: Rentz

full_name: Anne M. Rentz

given: Anne M.

family: Cui

full_name: Harry Cui

given: Harry

family: Whitcup

full_name: Scott M. Whitcup

given: Scott M.

family: Kowalski

full_name: Jonathan W. Kowalski

given: Jonathan W.

family: Revicki

full_name: Dennis A. Revicki

given: Dennis A.

journal_name: Investigative Opthalmology & Visual Science

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

title: Vision-Related Functioning Outcomes of Dexamethasone Intravitreal Implant in Noninfectious Intermediate or Posterior Uveitis

ReferenceCitation: Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.

journal_name: JAMA Ophthalmology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

title: Normative Comparison of Patient-Reported Outcomes in Patients With Noninfectious Uveitis

ReferenceCitation: Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.

title: Dexamethasone Intravitreal Implant for Noninfectious Intermediate or Posterior Uveitis

location_country:
Austria
United States
Brazil
India
South Africa
Switzerland
Spain
United Kingdom
Germany
France
Poland
Greece
Israel
Australia
Portugal
Canada
Czech Republic
Korea, Republic of