ReferenceCitation: Huber K, Ducrocq G, Hamm CW, van 't Hof A, Lapostolle F, Coste P, Gordini G, Steinmetz J, Verheugt FWA, Adgey J, Nibbe L, Kaniĉ V, Clemmensen P, Zeymer U, Bernstein D, Prats J, Deliargyris EN, Gabriel Steg P. Early clinical outcomes as a function of use of newer oral P2Y(12) inhibitors versus clopidogrel in the EUROMAX trial. Open Heart. 2017 Nov 28;4(2):e000677. doi: 10.1136/openhrt-2017-000677. eCollection 2017.

family: Huber

full_name: Kurt Huber

given: Kurt

family: Ducrocq

full_name: Gregory Ducrocq

given: Gregory

family: Hamm

full_name: Christian W Hamm

given: Christian W

family: van ’t Hof

full_name: Arnoud van ’t Hof

given: Arnoud

family: Lapostolle

full_name: Frédéric Lapostolle

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family: Coste

full_name: Pierre Coste

given: Pierre

family: Gordini

full_name: Giovanni Gordini

family: Steinmetz

full_name: Jacob Steinmetz

given: Jacob

family: Verheugt

full_name: Freek W A Verheugt

given: Freek W A

family: Adgey

full_name: Jennifer Adgey

given: Jennifer

family: Nibbe

full_name: Lutz Nibbe

given: Lutz

family: Kaniĉ

full_name: Vojko Kaniĉ

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family: Clemmensen

full_name: Peter Clemmensen

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

family: Bernstein

full_name: Debra Bernstein

given: Debra

family: Prats

full_name: Jayne Prats

given: Jayne

family: Deliargyris

full_name: Efthymios N Deliargyris

given: Efthymios N

family: Gabriel Steg

full_name: Ph Gabriel Steg

given: Ph

journal_name: Open Heart

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

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

repositories:
PubMed Central
Pure (Denmark)
repository.ubn.ru.nl

title: Early clinical outcomes as a function of use of newer oral P2Y 12 inhibitors versus clopidogrel in the EUROMAX trial

ReferenceCitation: Fabris E, Kilic S, Van't Hof AWJ, Ten Berg J, Ayesta A, Zeymer U, Hamon M, Soulat L, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. One-Year Mortality for Bivalirudin vs Heparins Plus Optional Glycoprotein IIb/IIIa Inhibitor Treatment Started in the Ambulance for ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the EUROMAX Randomized Clinical Trial. JAMA Cardiol. 2017 Jul 1;2(7):791-796. doi: 10.1001/jamacardio.2016.5975.

name: Department of Cardiology, Isala Hospital, Zwolle, the Netherlands2Cardiovascular Department, Azienda Sanitaria Universitaria Integrata, University of Trieste, Trieste, Italy

name: Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands

name: Department of Cardiology, Hospital General Universitario Gregorio Marañon, Madrid, Spain

name: Department of Cardiology, Klinikum Ludwigshafen, Ludwigshafen, Germany

name: Services d’Aide Médicale Urgente, Service Mobile d’Urgence et de Réanimation Urgences, Centre Hospitalier, Chateauroux, France

name: The Medicines Company, Parsippany, New Jersey

name: Institut National de la Santé et de la Recherche Medicale U-1148, Département Hospitalo-Universitaire FIRE (Fibrosis Inflammation Remodeling), Université Paris-Diderot, Paris, France 10Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, Paris, France11National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, England

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Ducrocq G, Steg PG, Van't Hof A, Zeymer U, Mehran R, Hamm CW, Bernstein D, Prats J, Deliargyris EN, Stone GW. Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):659-665. doi: 10.1177/2048872616650869. Epub 2016 Jun 10.

name: Hôpital Bichat, Université Paris-Diderot, France

name: NHLI, Imperial College, Royal Brompton Hospital, UK

name: Isala Klinieken, Department of Cardiology, the Netherlands

name: Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Germany

name: Mount Sinai School of Medicine and the Cardiovascular Research Foundation, USA

name: Kerckhoff Heart and Thoraxcenter, Germany

name: Columbia University Medical Center and the Cardiovascular Research Foundation, USA

journal_name: European Heart Journal: Acute Cardiovascular Care

ReferenceCitation: Dangas GD, Schoos MM, Steg PG, Mehran R, Clemmensen P, van 't Hof A, Prats J, Bernstein D, Deliargyris EN, Stone GW. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials. Circ Cardiovasc Interv. 2016 May;9(5):e003272. doi: 10.1161/CIRCINTERVENTIONS.115.003272.

name: From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology,...

title: Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment–Elevation Myocardial Infarction

ReferenceCitation: Kilic S, Van't Hof AW, Ten Berg J, Lopez AA, Zeymer U, Hamon M, Soulat L, Bernstein D, Deliargyris EN, Steg PG. Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial. Int J Cardiol. 2016 May 15;211:119-23. doi: 10.1016/j.ijcard.2016.02.131. Epub 2016 Mar 3.

ReferenceCitation: Hamon M, Coste P, Van't Hof A, Ten Berg J, Clemmensen P, Tabone X, Benamer H, Kristensen SD, Cavallini C, Marzocchi A, Hamm C, Kanic V, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002049. doi: 10.1161/CIRCINTERVENTIONS.114.002049.

name: From the Department of Clinical Research, University of Caen, Caen, France (M.H.); Department of Cardiology, Hôpital Cardiologique–Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, Pessac, France (P. Coste); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands (J.T.B.); Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (P. Clemmensen); Department...

title: Impact of Arterial Access Site on Outcomes After Primary Percutaneous Coronary Intervention

ReferenceCitation: Stone GW, Mehran R, Goldstein P, Witzenbichler B, Van't Hof A, Guagliumi G, Hamm CW, Généreux P, Clemmensen P, Pocock SJ, Gersh BJ, Bernstein D, Deliargyris EN, Steg PG. Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: pooled patient-level analysis from the HORIZONS-AMI and EUROMAX trials. J Am Coll Cardiol. 2015 Jan 6;65(1):27-38. doi: 10.1016/j.jacc.2014.10.029.

title: Bivalirudin Versus Heparin With or Without Glycoprotein IIb/IIIa Inhibitors in Patients With STEMI Undergoing Primary Percutaneous Coronary Intervention

ReferenceCitation: Steg PG, van 't Hof A, Clemmensen P, Lapostolle F, Dudek D, Hamon M, Cavallini C, Gordini G, Huber K, Coste P, Thicoipe M, Nibbe L, Steinmetz J, Ten Berg J, Eggink GJ, Zeymer U, Campo dell' Orto M, Kanic V, Deliargyris EN, Day J, Schuette D, Hamm CW, Goldstein P. Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX): an international randomized open-label ambulance trial of bivalirudin versus standard-of-care anticoagulation in patients with acute ST-segment-elevation myocardial infarction transferred for primary percutaneous coronary intervention. Am Heart J. 2013 Dec;166(6):960-967.e6. doi: 10.1016/j.ahj.2013.08.025. Epub 2013 Nov 7.

title: Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX): An international randomized open-label ambulance trial of bivalirudin versus standard-of-care anticoagulation in patients with acute ST-segment-elevation myocardial infarction transferred for primary percutaneous coronary intervention

ReferenceCitation: Steg PG, van 't Hof A, Hamm CW, Clemmensen P, Lapostolle F, Coste P, Ten Berg J, Van Grunsven P, Eggink GJ, Nibbe L, Zeymer U, Campo dell' Orto M, Nef H, Steinmetz J, Soulat L, Huber K, Deliargyris EN, Bernstein D, Schuette D, Prats J, Clayton T, Pocock S, Hamon M, Goldstein P; EUROMAX Investigators. Bivalirudin started during emergency transport for primary PCI. N Engl J Med. 2013 Dec 5;369(23):2207-17. doi: 10.1056/NEJMoa1311096. Epub 2013 Oct 30.

title: Bivalirudin Started during Emergency Transport for Primary PCI

location_country:
Italy
Austria
Netherlands
France
Poland
Slovenia
Denmark
Germany
Czech Republic

location_facility: Szpital Powiatowy W Sedziszowie Malopolskim

location_facility: Universitatsklinikum Benjamin Franklin, Hindenburgdamm 30

location_facility: Jagiellonian University Medical College,

location_facility: Stadtisches Klinikum Luneburg, Bogelstr. 1

location_facility: Hopital Andre Mignot - Centre Hospitalier De Versailles

location_facility: Regional Ambulance Service Gelderland-Zuid Distributiecentrum

location_facility: Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie

location_facility: Cwz Klinisch Geneesmiddelonderzoek Klinische

location_facility: Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques

location_facility: Charite Universitatsmedizin Berlin Campus Virchow-Klinikum

location_facility: Medizinische Hochschule Hannover, Carl Neuberg Str. 1

location_facility: Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23

location_facility: Oddzial Kardiologii Al.Lotnikow Polskich 18

location_facility: Zdravstveni Dom Dr. Adolfa Drolca Maribor

location_facility: Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej

location_facility: Ch Sud Francilien - Site Corbeil, Pharmacie

location_facility: Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd

location_facility: Sana Klinikum Lichtenberg Oskar Ziethen Krankenhaus, Fanningerstrasse 32

location_facility: Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie

location_facility: Spzoz Szpital Im. J.Dietla W Krynicy Zdroj

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy

location_facility: Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23

location_facility: Helios Klinik Der Universitat Witten Herdecke

location_facility: Chu De Toulouse - Hopital Paule De Viguier

location_facility: Emergency Rescue & Mobile Als Unit, Lanciarini Pub

location_facility: Regional Ambulance Service Gelderland Zuid

location_facility: Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy

location_facility: Centre Hospitalier Universitaire De Caen

location_facility: Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel

location_facility: Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1

location_facility: Regional Ambulance Service Gelderland Midden

location_facility: Chi Le Raincy - Montfermeil Site De Montfermeil

location_facility: Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach

location_facility: Oddzial Polskiej-Amerikanskiej Kliniki Serca

location_facility: Cardiologic Hospital - Coronary Care Unit, University of Bordeaux

title: Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)

summary: To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.


title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.

summary: This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.

ReferenceCitation: Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.

name: Medical University of Vienna; Vienna Austria

family: Ferenci

full_name: Peter Ferenci

given: Peter

sequence: first

name: The Goiás Federal University Clinical Hospital; Gioânia Brazil

family: Aires

full_name: Rodrigo Aires

given: Rodrigo

sequence: additional

name: Hospital “Dr. I. Cantacuzino”; Bucharest Romania

family: Ancuta

full_name: Ioan Ancuta

given: Ioan

name: University of Chicago Medical Center; Chicago IL USA

family: Arohnson

full_name: Andrew Arohnson

given: Andrew

name: Hospital de Clínicas de Porto Alegre; Porto Alegre Brazil

family: Cheinquer

full_name: Hugo Cheinquer

given: Hugo

name: Clinic for Infectious Disease; Clinical Center Serbia; Belgrade Serbia

family: Delic

full_name: Dragan Delic

given: Dragan

name: 4th Department of Internal Medicine; Wilhelminenspital; Vienna Austria

family: Gschwantler

full_name: Michael Gschwantler

given: Michael

name: Liver Unit; Saint Eloi Hospital; Montpellier France

family: Larrey

full_name: Dominique Larrey

given: Dominique

name: Divisione di Medicina; Ospedale Elena D'Aosta; Naples Italy

family: Tallarico

full_name: Ludovico Tallarico

given: Ludovico

family: Schmitz

full_name: Manuela Schmitz

given: Manuela

name: F. Hoffmann-La Roche Ltd; Basel Switzerland

family: Tatsch

full_name: Fernando Tatsch

given: Fernando

name: Institut Arnault Tzanck; Saint-Laurent-du-Var France

family: Ouzan

full_name: Denis Ouzan

given: Denis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Liver International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)

acronym: WAVE bd

summary: This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

ReferenceCitation: Vieta E, Langosch JM, Figueira ML, Souery D, Blasco-Colmenares E, Medina E, Moreno-Manzanaro M, Gonzalez MA, Bellivier F. Clinical management and burden of bipolar disorder: results from a multinational longitudinal study (WAVE-bd). Int J Neuropsychopharmacol. 2013 Sep;16(8):1719-32. doi: 10.1017/S1461145713000278. Epub 2013 May 13.

name: Bipolar Disorders Program, Hospital Clínic, University of Barcelona, Barcelona, Spain

family: Vieta

full_name: Eduard Vieta

given: Eduard

name: Bethanien Hospital for Psychiatry, Psychosomatics, and Psychotherapy, Greifswald, Germany

family: Langosch

full_name: Jens M. Langosch

given: Jens M.

name: Psychiatric Department, Hospital Santa Maria, Faculty of Medicine, University of Lisbon, Portugal

family: Figueira

full_name: Maria Luisa Figueira

given: Maria Luisa

name: Centre Européen de Psychologie Médicale/Psy-Pluriel, Brussels, Belgium

family: Souery

full_name: Daniel Souery

given: Daniel

name: Johns Hopkins University Institution, SOM DOM Cardiology, MD, USA

family: Blasco-Colmenares

full_name: Elena Blasco-Colmenares

given: Elena

name: Medical Department, AstraZeneca Pharmaceuticals, Madrid, Spain

family: Medina

full_name: Esteban Medina

given: Esteban

family: Moreno-Manzanaro

full_name: Miriam Moreno-Manzanaro

given: Miriam

family: Gonzalez

full_name: Miguel Angel Gonzalez

given: Miguel Angel

name: AP-HP, GH Saint-Louis-Lariboisière-Fernand Widal, Paris, France

family: Bellivier

full_name: Frank Bellivier

given: Frank

currency_apc_doaj: GBP

journal_name: International Journal of Neuropsychopharmacology

oa_host_type: publisher

evidence: open (via page says Open Access)

host_type: publisher

license: implied-oa

license_normalized: implied-oa

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Vieta E, Blasco-Colmenares E, Figueira ML, Langosch JM, Moreno-Manzanaro M, Medina E; WAVE-bd Study Group. Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd study). BMC Psychiatry. 2011 Apr 11;11:58. doi: 10.1186/1471-244X-11-58.

full_name: Jens M Langosch

given: Jens M

journal_name: BMC Psychiatry

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

title: Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd Study)

location_country: Austria Brazil France Venezuela Romania Belgium Portugal Turkey Germany Ukraine


ReferenceCitation: Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28.

family: Pott

full_name: Christiane Pott

given: Christiane

family: Sehn

full_name: Laurie H. Sehn

given: Laurie H.

family: Belada

full_name: David Belada

given: David

family: Gribben

full_name: John Gribben

given: John

family: Hoster

full_name: Eva Hoster

given: Eva

family: Kahl

full_name: Brad Kahl

given: Brad

family: Kehden

full_name: Britta Kehden

given: Britta

family: Nicolas-Virelizier

full_name: Emmanuelle Nicolas-Virelizier

given: Emmanuelle

family: Spielewoy

full_name: Nathalie Spielewoy

given: Nathalie

family: Fingerle-Rowson

full_name: Guenter Fingerle-Rowson

given: Guenter

family: Harbron

full_name: Chris Harbron

given: Chris

family: Mundt

full_name: Kirsten Mundt

given: Kirsten

family: Wassner-Fritsch

full_name: Elisabeth Wassner-Fritsch

given: Elisabeth

family: Cheson

full_name: Bruce D. Cheson

given: Bruce D.

journal_name: Leukemia

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

family: Gibiansky

full_name: Ekaterina Gibiansky

given: Ekaterina

full_name: Leonid Gibiansky

given: Leonid

name: Pharma Research and Early DevelopmentRoche Innovation Center Basel Basel Switzerland

family: Buchheit

full_name: Vincent Buchheit

given: Vincent

family: Frey

full_name: Nicolas Frey

name: Clinical DevelopmentRoche Innovation Center Welwyn Welwyn Garden City UK

name: Pharma Development Clinical OncologyF. Hoffmann‐La Roche Ltd Basel Switzerland

journal_name: British Journal of Clinical Pharmacology

title: Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab‐refractory follicular lymphoma patients in the GADOLIN phase III study

ReferenceCitation: Cheson BD, Chua N, Mayer J, Dueck G, Trněný M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.

name: Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal...

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Sehn LH, Chua N, Mayer J, Dueck G, Trněný M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Czechia
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: I Interni klinika; Vseobecna fakultni nemocnice

location_facility: University of Florida; Division of Hematology/Oncology

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Republican Clinical Hospital n.a. Baranov; Haematology

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Toronto East General Hospital; Main Pharmacy G Wing Basement

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

title: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).


title: A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

summary: Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Molnlycke Health Care AB

location_country:
Germany
Czech Republic
France
Netherlands

location_facility: Dermatovenerologická klinika, University Hospital Bohunice,

location_facility: Hopital Robert Debré Service de Dermatologie

location_facility: Hôpital privé d'Antony Service de Dermatologie

location_facility: Cabinet d'Angiologie, 1 bis rue de Salgareda

location_facility: Universität klinikum Jena, Klinik für dermatologie und dermatologische

location_facility: Service de Dermatologie, Centre Hospitalier Regional Universitaire

location_facility: Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -

location_facility: Dermatology Department, University Hospital, Hopital Sud

location_facility: chirugické oddělení, Fakultní nemocnice Královské Vinohrady

location_facility: Fakultní nemocnice U svate Anny, St. Anne´s University Hospital

location_facility: CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies

location_facility: Centre Hospitalier le Mans Service de Dermatologie

location_facility: Hopital Beauregard / Secrétariat de Dermatologie

location_facility: Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Dermatovenerologická klinike, Univerzita Karlova

location_facility: Maison de Santé Protestante de Bordeaux-Bagatelle

location_facility: Polyclinique de Picardie Service d'Angiologie Phlébologie

location_facility: Hôpital Albert Michallon Service de médecine vasculaire

intervention_type: Device


ReferenceCitation: Toenges G, Mütze T, Jahn-Eimermacher A. A comparison of semiparametric approaches to evaluate composite endpoints in heart failure trials. Stat Med. 2021 Nov 20;40(26):5702-5724. doi: 10.1002/sim.9149. Epub 2021 Jul 30.

ReferenceCitation: Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Køber LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

family: Shen

full_name: Li Shen

given: Li

family: Claggett

full_name: Brian L. Claggett

given: Brian L.

family: Jhund

full_name: Pardeep S. Jhund

given: Pardeep S.

family: Abraham

full_name: William T. Abraham

given: William T.

family: Desai

full_name: Akshay Suvas Desai

given: Akshay Suvas

family: Dickstein

full_name: Kenneth Dickstein

given: Kenneth

family: Gong

full_name: Jianjian Gong

given: Jianjian

family: Køber

full_name: Lars V. Køber

given: Lars V.

family: Lefkowitz

full_name: Marty P. Lefkowitz

given: Marty P.

family: Rouleau

full_name: Jean L. Rouleau

given: Jean L.

family: Shi

full_name: Victor C. Shi

given: Victor C.

family: Swedberg

full_name: Karl Swedberg

given: Karl

family: Zile

full_name: Michael R. Zile

given: Michael R.

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: McMurray

full_name: John J. V. McMurray

given: John J. V.

journal_name: Clinical Research in Cardiology

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.

family: Anand

full_name: Inder S. Anand

given: Inder S.

journal_name: Journal of the American College of Cardiology

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

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

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

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

title: Incidence and Outcomes of Pneumonia in Patients With Heart Failure

ReferenceCitation: Ehteshami-Afshar S, Mooney L, Dewan P, Desai AS, Lang NN, Lefkowitz MP, Petrie MC, Rizkala AR, Rouleau JL, Solomon SD, Swedberg K, Shi VC, Zile MR, Packer M, McMurray JJV, Jhund PS, Hawkins NM. Clinical Characteristics and Outcomes of Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease: Insights From PARADIGM-HF. J Am Heart Assoc. 2021 Feb 16;10(4):e019238. doi: 10.1161/JAHA.120.019238. Epub 2021 Jan 30.

name: Department of Medicine Yale University School of Medicine New Haven CT

name: BHF Glasgow Cardiovascular Research Centre University of Glasgow Glasgow UK

name: Division of Cardiovascular Medicine Brigham and Women’s Hospital Boston MA

name: Novartis Pharmaceutical Corporation East Hanover NJ

name: Institut de Cardiologie Université de Montréal Montréal Québec Canada

name: University of Gothenburg Gothenburg Sweden

name: Department of Medicine Medical University of South Carolina Charleston SC

name: Baylor Heart and Vascular InstituteBaylor University Medical CenterImperial College Dallas TX USA

name: Division of Cardiology University of British Columbia Vancouver Canada

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Clinical Characteristics and Outcomes of Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease: Insights From PARADIGM‐HF

ReferenceCitation: Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rørth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.

name: BHF Cardiovascular Research Centre University of Glasgow  Glasgow UK

name: Department of Cardiology Rigshospitalet University Hospital  Copenhagen Denmark

name: Division of Cardiology, Department of Medical Sciences University of Turin  Turin Italy

name: Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute Ohio State University  Columbus OH USA

name: Cardiovascular Medicine, Brigham and Women's Hospital  Boston MA USA

name: Stavanger University Hospital, Stavanger, and the Institute of Internal Medicine University of Bergen  Bergen Norway

name: Institut de Cardiologie Université de Montréal  Montréal Canada

name: Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center  Charleston SC USA

name: Department of Molecular and Clinical Medicine University of Gothenburg  Gothenburg Sweden

name: Baylor Heart and Vascular Institute Baylor University Medical Center, Dallas, TX, USA and National Heart and Lung Institute, Imperial College  London

name: PARADIGM‐HF and ATMOSPHERE Committees and Investigators.

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories_institution: University of Turin - Institutional Research Information System University of Turin

title: Prevalence and incidence of intra‐ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM‐HF and ATMOSPHERE

ReferenceCitation: Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Böhm M, Desai AS, Dickstein K, Køber LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.

name: BHF Cardiovascular Research CentreUniversity of Glasgow Glasgow UK

name: Division of Cardiology, Città della Salute e della Scienza Hospital, Department of Medical SciencesUniversity of Turin Torino Italy

name: Division of Cardiovascular Medicine, Davis Heart and Lung Research InstituteThe Ohio State University Columbus OH USA

name: Department of Internal Medicine III, University Hospital of SaarlandSaarland University Homburg/Saar Germany

name: Cardiovascular MedicineBrigham and Women's Hospital Boston MA USA

name: Department of CardiologyUniversity of Bergen, Stavanger University Hospital Stavanger Norway

name: Department of Cardiology, The Heart CentreRigshospitalet Copenhagen University Hospital Copenhagen Denmark

name: Baylor Heart and Vascular InstituteBaylor University Medical Center Dallas TX USA

name: Institut de Cardiologie de MontréalUniversité de Montréal Montréal Canada

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; National Heart and Lung InstituteImperial College London London UK

name: Department of Cardiology, Royal Brompton Hospital, National Heart and Lung InstituteImperial College London London UK

name: Department of MedicineMedical University of South Carolina Charleston SC USA

ReferenceCitation: Dewan P, Rørth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Køber L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum in: Circ Heart Fail. 2020 Jan;13(1):e000036.

name: BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (P.D., R.R., R.T.C., L.S., P.S.J., M.C.P., J.J.V.M.).

name: Rigshospitalet Copenhagen University Hospital, Denmark (R.R., L.K.).

name: Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada (V.R.).

name: Department of Experimental Medicine, Sapienza University of Rome, Italy (V.R.).

name: VA Medical Center, University of Minnesota, MN (I.S.A.).

name: Georgetown University, Washington DC Veterans Affairs Medical Center (P.E.C.).

name: Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (A.S.D., M.A.P., S.D.S.).

name: Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.).

name: Department of Cardiology, Hospital Saint Joseph, France (M.K.).

name: St. Joseph’s Healthcare Centre, Western University, London, ON, Canada (R.S.M.).

name: Montreal Heart Institute and Université de Montreal, Quebec, Canada (E.O.).

name: Department of Internal Medicine-Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.).

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).

name: National Heart and Lung Institute, Imperial College, London (K.S.).

name: Ralph H. Johnson Veterans Administration Medical Center, Medical University of South Carolina, Charleston, SC (M.R.Z.).

title: Sex-Related Differences in Heart Failure With Preserved Ejection Fraction

ReferenceCitation: Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.

name: Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).

name: Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).

name: Imperial College, London, United Kingdom (M.P.).

name: Medical University of South Carolina, Charleston (M.Z.).

name: Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC (M.Z.).

name: National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.).

name: Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.R.).

name: Department of Medicine, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden (L.H.L.).

name: Department of Cardiology, Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (L.K.).

name: Department of Medicine, VA Medical Center and University of Minnesota, Minneapolis (I.A.).

name: Sarver Heart Center, University of Arizona College of Medicine, Tucson (N.S.).

name: Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, The Netherlands (G.L.).

name: Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).

name: University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).

name: Department of Medicine, National Yang-Ming University, Taipei, Taiwan, Republic of China (C.-H.C.).

name: Cardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy (M.S.).

name: St Luke’s Heart Institute, St. Luke’s Medical Center, Taguig, Philippines (A.S.).

name: National Research Center for Cardiology of the Ministry of Health of the Russian Federation, Moscow (S.B.).

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).

title: Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure

ReferenceCitation: Selvaraj S, Claggett B, Pozzi A, McMurray JJV, Jhund PS, Packer M, Desai AS, Lewis EF, Vaduganathan M, Lefkowitz MP, Rouleau JL, Shi VC, Zile MR, Swedberg K, Solomon SD. Prognostic Implications of Congestion on Physical Examination Among Contemporary Patients With Heart Failure and Reduced Ejection Fraction: PARADIGM-HF. Circulation. 2019 Oct 22;140(17):1369-1379. doi: 10.1161/CIRCULATIONAHA.119.039920. Epub 2019 Sep 12.

name: Division of Cardiology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia (S.S.).

name: Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Boston, MA (B.C., A.S.D., E.F.L, M.V., S.D.S.).

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (A.P., J.J.V.M., P.S.J.).

name: Institut de Cardiologie de Montreal, Université de Montreal, Canada (J.L.R.).

name: Medical University of South Carolina and Ralph H. Johnson Department of Veterans Administration Medical Center, Charleston (M.R.Z.).

title: Prognostic Implications of Congestion on Physical Examination Among Contemporary Patients With Heart Failure and Reduced Ejection Fraction

ReferenceCitation: Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.

title: Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction

ReferenceCitation: Balmforth C, Simpson J, Shen L, Jhund PS, Lefkowitz M, Rizkala AR, Rouleau JL, Shi V, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJV. Outcomes and Effect of Treatment According to Etiology in HFrEF: An Analysis of PARADIGM-HF. JACC Heart Fail. 2019 Jun;7(6):457-465. doi: 10.1016/j.jchf.2019.02.015. Epub 2019 May 8.

title: Outcomes and Effect of Treatment According to Etiology in HFrEF

ReferenceCitation: Myhre PL, Vaduganathan M, Claggett B, Packer M, Desai AS, Rouleau JL, Zile MR, Swedberg K, Lefkowitz M, Shi V, McMurray JJV, Solomon SD. B-Type Natriuretic Peptide During Treatment With Sacubitril/Valsartan: The PARADIGM-HF Trial. J Am Coll Cardiol. 2019 Mar 26;73(11):1264-1272. doi: 10.1016/j.jacc.2019.01.018. Epub 2019 Mar 4.

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

title: B-Type Natriuretic Peptide During Treatment With Sacubitril/Valsartan

ReferenceCitation: Zile MR, O'Meara E, Claggett B, Prescott MF, Solomon SD, Swedberg K, Packer M, McMurray JJV, Shi V, Lefkowitz M, Rouleau J. Effects of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFrEF. J Am Coll Cardiol. 2019 Feb 26;73(7):795-806. doi: 10.1016/j.jacc.2018.11.042.

title: Effects of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFrEF

ReferenceCitation: Bouabdallaoui N, Claggett B, Zile MR, McMurray JJV, O'Meara E, Packer M, Prescott MF, Swedberg K, Solomon SD, Rouleau JL; PARADIGM-HF Investigators and Committees. Growth differentiation factor-15 is not modified by sacubitril/valsartan and is an independent marker of risk in patients with heart failure and reduced ejection fraction: the PARADIGM-HF trial. Eur J Heart Fail. 2018 Dec;20(12):1701-1709. doi: 10.1002/ejhf.1301. Epub 2018 Sep 11.

name: Montreal Heart Institute and University of Montreal Montreal, Quebec Canada

name: Brigham and Women's Hospital Boston MA USA

name: Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center Charleston SC USA

name: Baylor University Medical Center Dallas TX USA

name: Novartis Pharmaceuticals Corporation East Hanover NJ USA

name: for the PARADIGM‐HF Investigators and Committees

title: Growth differentiation factor‐15 is not modified by sacubitril/valsartan and is an independent marker of risk in patients with heart failure and reduced ejection fraction: the PARADIGM‐HF trial

ReferenceCitation: O'Meara E, Prescott MF, Claggett B, Rouleau JL, Chiang LM, Solomon SD, Packer M, McMurray JJV, Zile MR. Independent Prognostic Value of Serum Soluble ST2 Measurements in Patients With Heart Failure and a Reduced Ejection Fraction in the PARADIGM-HF Trial (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). Circ Heart Fail. 2018 May;11(5):e004446. doi: 10.1161/CIRCHEARTFAILURE.117.004446.

name: Montreal Heart Institute Department of Medicine (Cardiology) and Research Centre, and Université de Montréal, QC, Canada (E.O., J.L.R.).

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ (M.F.P., L.-M.C.).

name: Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (B.C., S.D.S.).

name: Baylor Heart and Vascular Hospital, Baylor University Medical Center, Dallas, TX (M.P.).

name: Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).

name: Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston (M.R.Z.).

ReferenceCitation: Packer M, Claggett B, Lefkowitz MP, McMurray JJV, Rouleau JL, Solomon SD, Zile MR. Effect of neprilysin inhibition on renal function in patients with type 2 diabetes and chronic heart failure who are receiving target doses of inhibitors of the renin-angiotensin system: a secondary analysis of the PARADIGM-HF trial. Lancet Diabetes Endocrinol. 2018 Jul;6(7):547-554. doi: 10.1016/S2213-8587(18)30100-1. Epub 2018 Apr 13.

ReferenceCitation: Chandra A, Lewis EF, Claggett BL, Desai AS, Packer M, Zile MR, Swedberg K, Rouleau JL, Shi VC, Lefkowitz MP, Katova T, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2018 Jun 1;3(6):498-505. doi: 10.1001/jamacardio.2018.0398.

name: Brigham and Women’s Hospital, Boston, Massachusetts

name: Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas

name: Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center, Charleston

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden

name: National Heart and Lung Institute, Imperial College, London, England

name: Institut Cardiologie de Montreal, Université de Montreal, Montreal, Quebec, Canada

name: National Hospital of Cardiology, Sofia, Bulgaria

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland

title: Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure

ReferenceCitation: Shen L, Ramires F, Martinez F, Bodanese LC, Echeverría LE, Gómez EA, Abraham WT, Dickstein K, Køber L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11). pii: e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.

name: From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (L.S., P.S.J., J.J.V.M.); Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil (F.R.); Instituto DAMIC/Fundacion Rusculleda, Cordoba, Argentina (F.M.); Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (L.C.B.); Grupo de Ciencias Cardiovasculares, Fundación Cardiovascular de Colombia, Santander (L.E.E.); Clinica Shaio, Bogota,...

name: on behalf of the PARADIGM-HF and ATMOSPHERE Investigators and Committees

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

repository_institution: Australian Catholic University - Research Bank

repositories_institution: Australian Catholic University - Research Bank

title: Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy

ReferenceCitation: Kristensen SL, Jhund PS, Mogensen UM, Rørth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10). pii: e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.

name: From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.L.K., P.S.J., U.M.M., R.R., J.J.V.M.); Department of Cardiology, Rigshospitalet University Hospital, Copenhagen, Denmark (S.L.K., U.M.M., R.R., L.K.); The Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.TA.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (A.D., S.D.S.); Stavanger University Hospital, Stavanger, and Department of...

title: Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation

ReferenceCitation: Lewis EF, Claggett BL, McMurray JJV, Packer M, Lefkowitz MP, Rouleau JL, Liu J, Shi VC, Zile MR, Desai AS, Solomon SD, Swedberg K. Health-Related Quality of Life Outcomes in PARADIGM-HF. Circ Heart Fail. 2017 Aug;10(8). pii: e003430. doi: 10.1161/CIRCHEARTFAILURE.116.003430.

name: From the Brigham and Women’s Hospital, Boston, MA (E.F.L., B.L.C., J.L., A.S.D., S.D.S.); BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.); Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.); Novartis, East Hanover, NJ (M.P.L., V.C.S.); Institut de Cardiologie de Montreal, Université de Montreal, Canada (J.L.R.); Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston, SC ...

title: Health-Related Quality of Life Outcomes in PARADIGM-HF

ReferenceCitation: Zile MR, Claggett BL, Prescott MF, McMurray JJ, Packer M, Rouleau JL, Swedberg K, Desai AS, Gong J, Shi VC, Solomon SD. Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol. 2016 Dec 6;68(22):2425-2436. doi: 10.1016/j.jacc.2016.09.931.

title: Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure

ReferenceCitation: Nadruz W Jr, Claggett BL, McMurray JJ, Packer M, Zile MR, Rouleau JL, Desai AS, Swedberg K, Lefkowitz M, Shi VC, Prescott MF, Solomon SD. Impact of Body Mass Index on the Accuracy of N-Terminal Pro-Brain Natriuretic Peptide and Brain Natriuretic Peptide for Predicting Outcomes in Patients With Chronic Heart Failure and Reduced Ejection Fraction: Insights From the PARADIGM-HF Study (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial). Circulation. 2016 Nov 29;134(22):1785-1787.

ReferenceCitation: Desai AS, Vardeny O, Claggett B, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Zile MR, Lefkowitz M, Shi V, Solomon SD. Reduced Risk of Hyperkalemia During Treatment of Heart Failure With Mineralocorticoid Receptor Antagonists by Use of Sacubitril/Valsartan Compared With Enalapril: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2017 Jan 1;2(1):79-85. doi: 10.1001/jamacardio.2016.4733.

name: Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts

name: Pharmacy Practice Division, University of Wisconsin School of Pharmacy, Madison

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden6National Heart and Lung Institute, Imperial College, London, England

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

name: Medical University of South Carolina, Charleston9Ralph H. Johnston Veterans Administration Medical Center, Charleston, South Carolina

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

ReferenceCitation: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ; PARADIGM-HF Investigators and Committees*. Effects of Sacubitril/Valsartan in the PARADIGM-HF Trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) According to Background Therapy. Circ Heart Fail. 2016 Sep;9(9). pii: e003212. doi: 10.1161/CIRCHEARTFAILURE.116.003212.

name: From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (N.O., P.S.J., J.J.V.M.); Novartis Pharmaceutical Corporation, East Hanover, NJ (J.G., M.P.L., A.R.R., V.C.S.); Institut de Cardiologie de Montréal, Université de Montréal, Quebec, Canada (J.L.R.); Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.); National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.); Medical University of South Carolina and RHJ...

ReferenceCitation: Solomon SD, Claggett B, Packer M, Desai A, Zile MR, Swedberg K, Rouleau J, Shi V, Lefkowitz M, McMurray JJV. Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Oct;4(10):816-822. doi: 10.1016/j.jchf.2016.05.002. Epub 2016 Jul 6.

title: Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation

ReferenceCitation: Kristensen SL, Martinez F, Jhund PS, Arango JL, Bĕlohlávek J, Boytsov S, Cabrera W, Gomez E, Hagège AA, Huang J, Kiatchoosakun S, Kim KS, Mendoza I, Senni M, Squire IB, Vinereanu D, Wong RC, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJ. Geographic variations in the PARADIGM-HF heart failure trial. Eur Heart J. 2016 Nov 1;37(41):3167-3174. Epub 2016 Jun 28.

ReferenceCitation: Desai AS, Solomon S, Claggett B, McMurray JJ, Rouleau J, Swedberg K, Zile M, Lefkowitz M, Shi V, Packer M. Factors Associated With Noncompletion During the Run-In Period Before Randomization and Influence on the Estimated Benefit of LCZ696 in the PARADIGM-HF Trial. Circ Heart Fail. 2016 Jun;9(6). pii: e002735. doi: 10.1161/CIRCHEARTFAILURE.115.002735.

name: From the Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (A.S.D., S.S., B.C.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.M.); Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.R.); Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.); National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.); Division of Cardiology, Medical University of...

ReferenceCitation: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ; PARADIGM-HF Investigators and Committees*. Importance of Clinical Worsening of Heart Failure Treated in the Outpatient Setting: Evidence From the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial (PARADIGM-HF). Circulation. 2016 Jun 7;133(23):2254-62. doi: 10.1161/CIRCULATIONAHA.115.020729. Epub 2016 Apr 20.

name: From BHF Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (N.O., P.S.J., J.J.V.M.); Novartis Pharmaceutical Corporation, East Hanover, NJ (J.G., M.P.L., A.R.R., V.C.S.); Institut de Cardiologie, Université de Montréal, Canada (J.L.R.); Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden and National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.); Medical University of South...

title: Importance of Clinical Worsening of Heart Failure Treated in the Outpatient Setting

ReferenceCitation: Solomon SD, Claggett B, Desai AS, Packer M, Zile M, Swedberg K, Rouleau JL, Shi VC, Starling RC, Kozan Ö, Dukat A, Lefkowitz MP, McMurray JJ. Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Trial. Circ Heart Fail. 2016 Mar;9(3):e002744. doi: 10.1161/CIRCHEARTFAILURE.115.002744.

name: From the Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (S.D.S., B.C., A.S.D.); Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.); Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston (M.Z.); Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden (K.S.); National Hearth and Lung Institute, Imperial College, London, UK (K.S.); Institut de Cardiologie...

title: Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction

ReferenceCitation: Kristensen SL, Preiss D, Jhund PS, Squire I, Cardoso JS, Merkely B, Martinez F, Starling RC, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial. Circ Heart Fail. 2016 Jan;9(1). pii: e002560. doi: 10.1161/CIRCHEARTFAILURE.115.002560.

name: From the British Heart Foundation, Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (S.L.K., D.P., P.J., J.J.V.M.); Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark (S.L.K.); Department of Cardiovascular Sciences, University of Leicester, Leicester, UK (I.S.); NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK (I.S.); Department of Cardiology, Porto Medical School, Porto, Portugal (J.S.C.); Heart and Vascular...

repository_institution: Keele University - Keele Research Repository

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

repositories_institution: Keele University - Keele Research Repository

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

title: Risk Related to Pre–Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction

ReferenceCitation: Simpson J, Jhund PS, Silva Cardoso J, Martinez F, Mosterd A, Ramires F, Rizkala AR, Senni M, Squire I, Gong J, Lefkowitz MP, Shi VC, Desai AS, Rouleau JL, Swedberg K, Zile MR, McMurray JJV, Packer M, Solomon SD; PARADIGM-HF Investigators and Committees. Comparing LCZ696 with enalapril according to baseline risk using the MAGGIC and EMPHASIS-HF risk scores: an analysis of mortality and morbidity in PARADIGM-HF. J Am Coll Cardiol. 2015 Nov 10;66(19):2059-2071. doi: 10.1016/j.jacc.2015.08.878.

title: Comparing LCZ696 With Enalapril According to Baseline Risk Using the MAGGIC and EMPHASIS-HF Risk Scores

ReferenceCitation: Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4. Review.

name: Department of Biomedicine, Pharmacology; Aarhus University; Aarhus Denmark

name: Clinic for Plastic, Aesthetic and Hand Surgery; Otto-von-Guericke-University Magdeburg; Magdeburg Germany

journal_name: Basic & Clinical Pharmacology & Toxicology

title: LCZ696 (Valsartan/Sacubitril) - A Possible New Treatment for Hypertension and Heart Failure

ReferenceCitation: Jhund PS, Fu M, Bayram E, Chen CH, Negrusz-Kawecka M, Rosenthal A, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur Heart J. 2015 Oct 7;36(38):2576-84. doi: 10.1093/eurheartj/ehv330. Epub 2015 Jul 31.

title: Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF

ReferenceCitation: Desai AS, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Chen F, Gong J, Rizkala AR, Brahimi A, Claggett B, Finn PV, Hartley LH, Liu J, Lefkowitz M, Shi V, Zile MR, Solomon SD. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J. 2015 Aug 7;36(30):1990-7. doi: 10.1093/eurheartj/ehv186. Epub 2015 May 28.

title: Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients

ReferenceCitation: McMurray J, Packer M, Desai A, Gong J, Greenlaw N, Lefkowitz M, Rizkala A, Shi V, Rouleau J, Solomon S, Swedberg K, Zile MR, Andersen K, Arango JL, Arnold M, Bĕlohlávek J, Böhm M, Boytsov S, Burgess L, Cabrera W, Chen CH, Erglis A, Fu M, Gomez E, Gonzalez A, Hagege AA, Katova T, Kiatchoosakun S, Kim KS, Bayram E, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires F, Refsgaard J, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire I, Starling RC, Vinereanu D, Teerlink JR, Wong R; PARADIGM-HF Committees and Investigators. A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure. Eur Heart J. 2015 Feb 14;36(7):434-9.

ReferenceCitation: Packer M, McMurray JJ, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile M, Andersen K, Arango JL, Arnold JM, Bělohlávek J, Böhm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzàlez-Medina A, Hagège AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan Ö, Llamas EB, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires FJ, Refsgaard J, Rosenthal A, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire IB, Starling RC, Teerlink JR, Vanhaecke J, Vinereanu D, Wong RC; PARADIGM-HF Investigators and Coordinators. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015 Jan 6;131(1):54-61. doi: 10.1161/CIRCULATIONAHA.114.013748. Epub 2014 Nov 17.

name: From the Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX (M.P.); BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, UK (J.J.V.M.); Brigham and Women’s Hospital, Cardiovascular Medicine, MA (A.S.D., S.D.S.); Novartis Pharmaceutical Corporation, East Hanover, NJ (J.G., M.P.L., A.R.R., V.C.S.); Université de Montréal, Institut de Cardiologie, Montréal, Canada (J.L.R.); Department of Molecular and Clinical Medicine, Gothenburg,...

repository_institution: Landspítali University Hospital - Hirsla

repository_institution: University of Luxembourg - Open Repository and Bibliography

repositories_institution: Landspítali University Hospital - Hirsla

repositories_institution: University of Luxembourg - Open Repository and Bibliography

title: Angiotensin Receptor Neprilysin Inhibition Compared With Enalapril on the Risk of Clinical Progression in Surviving Patients With Heart Failure

ReferenceCitation: McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

title: Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure

ReferenceCitation: McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau J, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Committees and Investigators. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail. 2013 Sep;15(9):1062-73. doi: 10.1093/eurjhf/hft052. Epub 2013 Apr 5.

name: BHF Cardiovascular Research Centre; University of Glasgow; Glasgow UK

name: University of Texas Southwestern Medical Center; Dallas TX USA

name: Brigham and Women's Hospital; Cardiovascular Medicine; MA USA

name: Novartis Pharmaceutical Corporation; East Hanover NJ USA

name: Université de Montréal; Institut de Cardiologie; Montréal Canada

name: University of Gothenburg; Cardiovascular Medicine Department; Gothenburg Sweden

name: The Medical University of South Carolina and RHJ Department of Veterans Administration Medical center; Charleston SC USA

name: on behalf of the PARADIGM-HF Committees and Investigators

location_country:
Peru
Guatemala
Finland
Malaysia
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Iceland
Ecuador
India
France
Panama
Lithuania
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Dominican Republic
Venezuela
Israel
Spain
Estonia
Latvia

title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

summary: The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).


ReferenceCitation: Zhu AX, Chen D, He W, Kanai M, Voi M, Chen LT, Daniele B, Furuse J, Kang YK, Poon RT, Vogel A, Chiang DY. Integrative biomarker analyses indicate etiological variations in hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):296-304. doi: 10.1016/j.jhep.2016.04.015. Epub 2016 Apr 27.

family: Zhu

full_name: Andrew X. Zhu

given: Andrew X.

family: Chen

full_name: David Chen

given: David

family: He

full_name: Wei He

given: Wei

family: Kanai

full_name: Masayuki Kanai

given: Masayuki

family: Voi

full_name: Maurizio Voi

given: Maurizio

full_name: Li-Tzong Chen

given: Li-Tzong

family: Daniele

full_name: Bruno Daniele

given: Bruno

family: Furuse

full_name: Junji Furuse

given: Junji

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Poon

full_name: Ronnie T.P. Poon

given: Ronnie T.P.

family: Vogel

full_name: Arndt Vogel

given: Arndt

family: Chiang

full_name: Derek Y. Chiang

given: Derek Y.

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Zhu AX, Kudo M, Assenat E, Cattan S, Kang YK, Lim HY, Poon RT, Blanc JF, Vogel A, Chen CL, Dorval E, Peck-Radosavljevic M, Santoro A, Daniele B, Furuse J, Jappe A, Perraud K, Anak O, Sellami DB, Chen LT. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA. 2014 Jul 2;312(1):57-67. doi: 10.1001/jama.2014.7189.

name: Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston

name: Kinki University School of Medicine, Osaka, Japan

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Assenat

full_name: Eric Assenat

given: Eric

name: University Nord De France, Lille, France

family: Cattan

full_name: Stéphane Cattan

given: Stéphane

name: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

family: Lim

full_name: Ho Yeong Lim

given: Ho Yeong

name: University of Hong Kong, Queen Mary Hospital, Hong Kong, China

full_name: Ronnie T. P. Poon

given: Ronnie T. P.

family: Blanc

full_name: Jean-Frederic Blanc

given: Jean-Frederic

name: Medical School Hannover, Hannover, Germany

name: Kaohsiung Chang Gung Memorial Hospital, Taiwan

full_name: Chao-Long Chen

given: Chao-Long

family: Dorval

name: Medical University of Vienna, Vienna, Austria

name: Humanitas Cancer Center, Istituto Clinico Humanitas, Rozzano, Italy

name: Kyorin University School of Medicine, Tokyo, Japan

name: Novartis Pharmaceuticals, East Hanover, New Jersey

name: National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan19National Cheng Kung University Hospital, Tainan, Taiwan20Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan

title: Effect of Everolimus on Survival in Advanced Hepatocellular Carcinoma After Failure of Sorafenib

location_country:
Italy
Austria
United States
Hong Kong
Spain
Germany
France
Japan
Greece
Israel
Thailand
Hungary
Australia
Belgium
China
Canada
Korea, Republic of
Taiwan

location_facility: California Pacific Medical Center California Pacific Med

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS

location_facility: Methodist Charlton Cancer Center Methodist

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

location_facility: Massachusetts General Hospital Dept. of Mass General Hospital

location_facility: Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4)

location_facility: Queen's Medical Center Queens Cancer Center

location_facility: University of Rochester Medical Center Rochester

location_facility: Compassionate Cancer Care Medical Group CCCMG

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)

location_facility: Northwest Cancer Specialists Rose Quarter Cancer Center

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

location_facility: University of California San Diego - Moores Cancer Center SC - 3

location_facility: Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care

location_facility: Midwest Cancer Care Physicians Research Medical Center

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU

title: A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study

summary: The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.


title: Icatibant Outcome Survey (IOS) Registry

summary: The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Longhurst HJ, Dempster J, Lorenzo L, Buckland M, Grigoriadou S, Symons C, Bethune C, Fabien V, Bangs C, Garcez T. Real-world outcomes in hereditary angioedema: first experience from the Icatibant Outcome Survey in the United Kingdom. Allergy Asthma Clin Immunol. 2018 Aug 6;14:28. doi: 10.1186/s13223-018-0253-x. eCollection 2018.

family: Longhurst

full_name: Hilary J. Longhurst

given: Hilary J.

family: Dempster

full_name: John Dempster

given: John

family: Lorenzo

full_name: Lorena Lorenzo

given: Lorena

family: Buckland

full_name: Matthew Buckland

given: Matthew

family: Grigoriadou

full_name: Sofia Grigoriadou

given: Sofia

family: Symons

full_name: Christine Symons

given: Christine

family: Bethune

full_name: Claire Bethune

given: Claire

family: Fabien

full_name: Vincent Fabien

given: Vincent

family: Bangs

full_name: Catherine Bangs

given: Catherine

family: Garcez

full_name: Tomaz Garcez

given: Tomaz

journal_name: Allergy, Asthma & Clinical Immunology

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

ReferenceCitation: Caballero T, Zanichelli A, Aberer W, Maurer M, Longhurst HJ, Bouillet L, Andresen I; IOS Study Group. Effectiveness of icatibant for treatment of hereditary angioedema attacks is not affected by body weight: findings from the Icatibant Outcome Survey, a cohort observational study. Clin Transl Allergy. 2018 Mar 23;8:11. doi: 10.1186/s13601-018-0195-x. eCollection 2018.

family: Caballero

full_name: Teresa Caballero

given: Teresa

family: Zanichelli

full_name: Andrea Zanichelli

given: Andrea

family: Aberer

full_name: Werner Aberer

given: Werner

family: Maurer

full_name: Marcus Maurer

given: Marcus

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Aberer W, Maurer M, Bouillet L, Zanichelli A, Caballero T, Longhurst HJ, Perrin A, Andresen I; IOS Study Group. Breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis are responsive to icatibant: findings from the Icatibant Outcome Survey. Allergy Asthma Clin Immunol. 2017 Jul 5;13:31. doi: 10.1186/s13223-017-0203-z. eCollection 2017.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories:
PubMed Central
dnet
refubium.fu-berlin.de

ReferenceCitation: Zanichelli A, Longhurst HJ, Maurer M, Bouillet L, Aberer W, Fabien V, Andresen I, Caballero T; IOS Study Group. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting. Ann Allergy Asthma Immunol. 2016 Oct;117(4):394-398. doi: 10.1016/j.anai.2016.08.014.

ReferenceCitation: Longhurst HJ, Aberer W, Bouillet L, Caballero T, Maurer M, Fabien V, Zanichelli A; IOS Study Group. The Icatibant Outcome Survey: treatment of laryngeal angioedema attacks. Eur J Emerg Med. 2016 Jun;23(3):224-7. doi: 10.1097/MEJ.0000000000000292.

title: The Icatibant Outcome Survey

ReferenceCitation: Longhurst HJ, Aberer W, Bouillet L, Caballero T, Fabien V, Zanichelli A, Maurer M; IOS Investigators. Analysis of characteristics associated with reinjection of icatibant: Results from the icatibant outcome survey. Allergy Asthma Proc. 2015 Sep-Oct;36(5):399-406. doi: 10.2500/aap.2015.36.3892. Erratum in: Allergy Asthma Proc. 2015 Nov-Dec;36(6):511.

title: Analysis of characteristics associated with reinjection of icatibant: Results from the Icatibant Outcome Survey

ReferenceCitation: Hernández Fernandez de Rojas D, Ibañez E, Longhurst H, Maurer M, Fabien V, Aberer W, Bouillet L, Zanichelli A, Caballero T; IOS Study Group. Treatment of HAE Attacks in the Icatibant Outcome Survey: An Analysis of Icatibant Self-Administration versus Administration by Health Care Professionals. Int Arch Allergy Immunol. 2015;167(1):21-8. doi: 10.1159/000430864. Epub 2015 Jun 25.

journal_name: International Archives of Allergy and Immunology

ReferenceCitation: Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.

name: Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany

title: Treatment of hereditary angioedema with icatibant: Efficacy in clinical trials versus effectiveness in the real-world setting

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.

location_country:
Italy
Austria
Brazil
Sweden
France
Czechia
Greece
Israel
Ireland
Australia
Spain
Denmark
Germany
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat


type: Other Identifier

title: Observational, Non-interventional Registry to Assess Medication Usage Patterns in Clinical Routine Practice, in Subjects Receiving Antipsychotic Treatment With Risperidone Long Acting Injectable (Gluteal or Deltoid) or Oral Antipsychotics

summary: International Observational Registry on Schizophrenia

lead_sponsor: Janssen-Cilag International NV

location_country:
South Africa
France
Greece
Russian Federation
Spain
Turkey
Germany
Czech Republic


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

acronym: RENEW

summary:
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).

This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

status: Terminated

ReferenceCitation: Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.

name: University of Nebraska Medical Center; Omaha; NE; USA

family: Vose

full_name: Julie M. Vose

given: Julie M.

family: Habermann

full_name: Thomas M. Habermann

given: Thomas M.

name: Roswell Park Cancer Institute; Buffalo; NY; USA

family: Czuczman

full_name: Myron S. Czuczman

given: Myron S.

name: Institute of Haematology and Oncology Seragnoli; University of Bologna; Bologna; Italy

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

name: Mayo Clinic Arizona; Scottsdale; AZ; USA

family: Reeder

full_name: Craig B. Reeder

given: Craig B.

name: UC Davis Comprehensive Cancer Center; Sacramento; CA; USA

family: Tuscano

full_name: Joseph M. Tuscano

given: Joseph M.

name: University of Miami School of Medicine; Miami; FL; USA

family: Lossos

full_name: Izidore S. Lossos

given: Izidore S.

family: Li

full_name: Ju Li

given: Ju

family: Pietronigro

full_name: Dennis Pietronigro

given: Dennis

family: Witzig

full_name: Thomas E. Witzig

given: Thomas E.

journal_name: British Journal of Haematology

evidence: open (via free pdf)

lead_sponsor: Celgene

location_country:
Italy
United States
Spain
France
Czechia
Poland
Israel
Puerto Rico
Russian Federation
Portugal
Germany
United Kingdom

location_facility: CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire

location_facility: Republican Clinical Oncological Dispensary

location_facility: Clinica Universitaria de Navarra, Hematology

location_facility: CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie

location_facility: CHD Les Oudairies, Service d'Oncologie Hématologie

location_facility: Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie

location_facility: CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique

location_facility: Clinic of Oncology Faculty Hospital Motol

location_facility: Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe

location_facility: Az. Osp. SS.Antonio e Biagio SC Ematologia

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies

location_facility: Fondazione San Raffaele del Monte Tabor I.R.C.C.S.

location_facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli

location_facility: UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Ospedale Regionale di Bolzano - Divisione di Ematologia

location_facility: A,O Ospedale Niguarda Ca Granda Dept Hematology

location_facility: Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

location_facility: Barts & The London NHS Trust Medical Oncology

location_facility: CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale

location_facility: Instituto Português de Oncologia (IPO) do Porto

location_facility: Klinikum der Universität München - Großhadern, Medizinische Klinik III

location_facility: Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria

location_facility: Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia

location_facility: Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia

location_facility: CHU de Reims, Hôpital Robert Debré, Hématologie Clinique

location_facility: Policlinico San Matteo - Dip. Di Ematologia

location_facility: Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika

location_facility: Hôpital Pontchaillou Hématologie Clinique

location_facility: CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne

location_facility: Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation

location_facility: Sverdlovsk Regional Clinical Hospital - Volgogradskaya

location_facility: Università del Piemonte Orientale "Amedeo Avogadro"

location_facility: Hematology Dept, Azienda Ospedaliero Universitaria Careggi

location_facility: Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency

location_facility: Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia

location_facility: Hospital Universitario Vall d´Hebrón Hematology Department

location_facility: Weill Cornell Medical College/New York Presbyterian Hospital

location_facility: Azienda Ospedaliera Universitaria "San Martino"

location_facility: Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico

location_facility: Ospedale Cardinale G. Panico - Ematologia e Immunoematologia

location_facility: Dolnoslaskie Centrum Transplantacji Komórkowych

location_facility: State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1

location_facility: Davidoff Cancer Center The Institute of Hematology

location_facility: State Educational Institution of High Professional Education

location_facility: Soroka Medical Center The Institute of Hematology

location_facility: Salisbury NHS Foundation Trust, Haematology

location_facility: Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)

location_facility: IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Hôpital Henri Mondor Unité Hémopathies Lymphoides

location_facility: Instituto Português de Oncologia (IPO) de Lisboa

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Universitätsklinikum Essen Zentrum für Innere Medizin

location_facility: Sharp Healthcare Oncology Associates of San Diego

intervention_type: Other

status_simplified: Unknown


title: Nephroblastoma Clinical Trial and Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for stage I Wilms' tumor.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms' tumor.

status: Unknown status

ReferenceType: background

ReferenceCitation: Sudour H, Audry G, Schleimacher G, Patte C, Dussart S, Bergeron C. Bilateral Wilms tumors (WT) treated with the SIOP 93 protocol in France: epidemiological survey and patient outcome. Pediatr Blood Cancer. 2012 Jul 15;59(1):57-61. doi: 10.1002/pbc.24059. Epub 2012 Jan 11.

ReferenceCitation: Warmann SW, Nourkami N, Frühwald M, Leuschner I, Schenk JP, Fuchs J, Graf N. Primary lung metastases in pediatric malignant non-Wilms renal tumors: data from SIOP 93-01/GPOH and SIOP 2001/GPOH. Klin Padiatr. 2012 Apr;224(3):148-52. doi: 10.1055/s-0032-1304600. Epub 2012 Apr 18.

ReferenceCitation: Furtwängler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rübe C, Siemer S, Leuschner I, Graf N. Update on relapses in unilateral nephroblastoma registered in 3 consecutive SIOP/GPOH studies - a report from the GPOH-nephroblastoma study group. Klin Padiatr. 2011 May;223(3):113-9. doi: 10.1055/s-0031-1275293. Epub 2011 Apr 20.

ReferenceCitation: van den Heuvel-Eibrink MM, van Tinteren H, Rehorst H, Coulombe A, Patte C, de Camargo B, de Kraker J, Leuschner I, Lugtenberg R, Pritchard-Jones K, Sandstedt B, Spreafico F, Graf N, Vujanic GM. Malignant rhabdoid tumours of the kidney (MRTKs), registered on recent SIOP protocols from 1993 to 2005: a report of the SIOP renal tumour study group. Pediatr Blood Cancer. 2011 May;56(5):733-7. doi: 10.1002/pbc.22922. Epub 2010 Dec 22.

ReferenceCitation: Warmann SW, Furtwängler R, Blumenstock G, Armeanu S, Nourkami N, Leuschner I, Schenk JP, Graf N, Fuchs J. Tumor biology influences the prognosis of nephroblastoma patients with primary pulmonary metastases: results from SIOP 93-01/GPOH and SIOP 2001/GPOH. Ann Surg. 2011 Jul;254(1):155-62. doi: 10.1097/SLA.0b013e318222015e.

ReferenceCitation: van den Heuvel-Eibrink MM, Grundy P, Graf N, Pritchard-Jones K, Bergeron C, Patte C, van Tinteren H, Rey A, Langford C, Anderson JR, de Kraker J. Characteristics and survival of 750 children diagnosed with a renal tumor in the first seven months of life: A collaborative study by the SIOP/GPOH/SFOP, NWTSG, and UKCCSG Wilms tumor study groups. Pediatr Blood Cancer. 2008 Jun;50(6):1130-4.

ReferenceCitation: Luithle T, Szavay P, Furtwängler R, Graf N, Fuchs J; SIOP/GPOH Study Group. Treatment of cystic nephroma and cystic partially differentiated nephroblastoma--a report from the SIOP/GPOH study group. J Urol. 2007 Jan;177(1):294-6.

ReferenceCitation: Szavay P, Luithle T, Graf N, Furtwängler R, Fuchs J. Primary hepatic metastases in nephroblastoma--a report of the SIOP/GPOH Study. J Pediatr Surg. 2006 Jan;41(1):168-72; discussion 168-72.

ReferenceType: result

ReferenceCitation: Boccon-Gibod LA. Pathological evaluation of renal tumors in children: international society of pediatric oncology approach. Pediatr Dev Pathol. 1998 May-Jun;1(3):243-8.

ReferenceCitation: Fuchs J, Kienecker K, Furtwängler R, Warmann SW, Bürger D, Thürhoff JW, Hager J, Graf N. Surgical aspects in the treatment of patients with unilateral wilms tumor: a report from the SIOP 93-01/German Society of Pediatric Oncology and Hematology. Ann Surg. 2009 Apr;249(4):666-71. doi: 10.1097/SLA.0b013e31819ed92b.

family: Fuchs

full_name: Joerg Fuchs

given: Joerg

family: Kienecker

full_name: Katarina Kienecker

given: Katarina

family: Furtwängler

full_name: Rhoikos Furtwängler

given: Rhoikos

family: Warmann

full_name: Steven W. Warmann

given: Steven W.

family: Bürger

full_name: Dietrich Bürger

given: Dietrich

family: Thürhoff

full_name: Joachim W. Thürhoff

given: Joachim W.

family: Hager

full_name: Josef Hager

given: Josef

family: Graf

full_name: Norbert Graf

given: Norbert

journal_name: Annals of Surgery

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Surgical Aspects in the Treatment of Patients With Unilateral Wilms Tumor

ReferenceCitation: Furtwangler R, Reinhard H, Beier R, et al.: Clear-cell sarcoma (CCSK) of the kidney - results of the SIOP 93-01/GPOH trial. [Abstract] Pediatr Blood Cancer 45 (4 Suppl 1): A-0.155, 423, 2005.

ReferenceCitation: Ora I, van Tinteren H, Bergeron C, de Kraker J; SIOP Nephroblastoma Study Committee. Progression of localised Wilms' tumour during preoperative chemotherapy is an independent prognostic factor: a report from the SIOP 93-01 nephroblastoma trial and study. Eur J Cancer. 2007 Jan;43(1):131-6. Epub 2006 Nov 2.

ReferenceCitation: Reinhard H, Aliani S, Ruebe C, Stöckle M, Leuschner I, Graf N. Wilms' tumor in adults: results of the Society of Pediatric Oncology (SIOP) 93-01/Society for Pediatric Oncology and Hematology (GPOH) Study. J Clin Oncol. 2004 Nov 15;22(22):4500-6.

ReferenceCitation: Reinhard H, Semler O, Bürger D, Bode U, Flentje M, Göbel U, Gutjahr P, Leuschner I, Maass E, Niggli F, Scheel-Walter HG, Stöckle M, Thüroff JW, Tröger J, Weirich A, von Schweinitz D, Zoubek A, Graf N. Results of the SIOP 93-01/GPOH trial and study for the treatment of patients with unilateral nonmetastatic Wilms Tumor. Klin Padiatr. 2004 May-Jun;216(3):132-40.

ReferenceCitation: Verschuur AC, Vujanic GM, Van Tinteren H, Jones KP, de Kraker J, Sandstedt B. Stromal and epithelial predominant Wilms tumours have an excellent outcome: the SIOP 93 01 experience. Pediatr Blood Cancer. 2010 Aug;55(2):233-8. doi: 10.1002/pbc.22496.

family: Verschuur

full_name: Arnauld C. Verschuur

given: Arnauld C.

family: Vujanic

full_name: Gordan M. Vujanic

given: Gordan M.

family: Van Tinteren

full_name: Harm Van Tinteren

given: Harm

family: Jones

full_name: Kathy Pritchard Jones

given: Kathy Pritchard

family: de Kraker

full_name: Jan de Kraker

given: Jan

family: Sandstedt

full_name: Bengt Sandstedt

given: Bengt

journal_name: Pediatric Blood & Cancer

title: Stromal and epithelial predominant Wilms tumours have an excellent outcome: The SIOP 93 01 experience

ReferenceCitation: Vujanić GM, Harms D, Bohoslavsky R, Leuschner I, de Kraker J, Sandstedt B. Nonviable tumor tissue should not upstage Wilms' tumor from stage I to stage II: a report from the SIOP 93-01 nephroblastoma trial and study. Pediatr Dev Pathol. 2009 Mar-Apr;12(2):111-5. doi: 10.2350/08-03-0432.1. Epub 2008 Sep 23.

name: Department of Histopathology, School of Medicine, Cardiff University, Cardiff, United Kingdom

family: Vujanić

full_name: Gordan M. Vujanić

name: Department of Paediatric Pathology, University of Kiel, Kiel, Germany

family: Harms

full_name: Dieter Harms

name: Comprehensive Cancer Centre, Amsterdam, The Netherlands

name: Department of Paediatric Haematology and Oncology, Emma Kinderziekenhuis, Academic Medical Centre, Amsterdam, The Netherlands

name: Childhood Cancer Research Unit, Astrid Lindgren's Children's Hospital, Karolinska Institutet, Stockholm, Sweden

title: Nonviable Tumor Tissue Should Not Upstage Wilms' Tumor from Stage I to Stage II: A Report from the SIOP 93–01 Nephroblastoma Trial and Study

location_country:
Italy
Sweden
United Arab Emirates
Netherlands
Spain
Croatia
France
Greece
Poland
Slovenia
Norway
Belgium
Portugal
Denmark
Czech Republic

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Haukeland Hospital - University of Bergen

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Hospital General Universitari Vall d'Hebron


title: Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.

status: Active, not recruiting

ReferenceCitation: Aleman BM, Raemaekers JM, Tomiŝiĉ R, Baaijens MH, Bortolus R, Lybeert ML, van der Maazen RW, Girinsky T, Demeestere G, Lugtenburg P, Lievens Y, de Jong D, Pinna A, Henry-Amar M; European Organization for Research and Treatment of Cancer (EORTC) Lymphoma Group. Involved-field radiotherapy for patients in partial remission after chemotherapy for advanced Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):19-30. Epub 2006 Nov 9.

ReferenceCitation: Aleman BM, Girinsky T, van der Maazen RW, Strijk S, Meijnders P, Bortolus R, Olofsen-van Acht MJ, Lybeert ML, Lievens Y, Eghbali H, Noordijk EM, Tomsic R, Meerwaldt JH, Poortmans PM, Smit WG, Pinna A, Henry-Amar M, Raemaekers JM; European Organization for Research; Treatment of Cancer (EORTC) Lymphoma Group. Quality control of involved-field radiotherapy in patients with advanced Hodgkin's lymphoma (EORTC 20884). Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1184-90. Epub 2005 Jun 2.

ReferenceCitation: Aleman BMP, Girinsky T, Strijk S, et al.: Quality control of involved-field radiotherapy in patients with advanced stage Hodgkin's lymphoma (HL) enrolled on the EORTC trial 20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A02, 42, 2004.

ReferenceCitation: Aleman BMP, Raemaekers JMM, Tomsic R, et al.: Radiotherapy in advanced Hodgkin lymphoma (HL) patients in partial remission (PR) after chemotherapy: detailed results from the EORTC lymphoma group trial no.20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A01, 42, 2004.

ReferenceCitation: Aleman BM, Raemaekers JM, Henry-Amar M, et al.: Involved-field radiotherapy in patients with stage III/IV Hodgkin's lymphoma: first results of the randomised EORTC trial # 20884. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-3, 2, 2001.

ReferenceCitation: Raemaekers J, Burgers M, Henry-Amar M, Pinna A, Mandard A, Monfardini S, Hagenbeek A, Breed W, Carde P, Vovk M, van Hoof A, Thomas J, Noordijk E. Patients with stage III/IV Hodgkin's disease in partial remission after MOPP/ABV chemotherapy have excellent prognosis after additional involved-field radiotherapy: interim results from the ongoing EORTC-LCG and GPMC phase III trial. The EORTC Lymphoma Cooperative Group and Groupe Pierre-et-Marie-Curie. Ann Oncol. 1997;8 Suppl 1:111-4.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Italy Netherlands France Poland Belgium Egypt Portugal Germany Slovenia

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Centro di Riferimento Oncologico - Aviano

intervention_type: Radiation

status_simplified: Ongoing