title: A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy

acronym: ICELAND

summary: Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.

ReferenceCitation: Tombal B, Cornel EB, Persad R, Stari A, Gómez Veiga F, Schulman C. Clinical Outcomes and Testosterone Levels Following Continuous Androgen Deprivation in Patients with Relapsing or Locally Advanced Prostate Cancer: A Post Hoc Analysis of the ICELAND Study. J Urol. 2017 Nov;198(5):1054-1060. doi: 10.1016/j.juro.2017.05.072. Epub 2017 May 25.

name: Cliniques Universitaires Saint-Luc, Brussels, Belgium

family: Tombal

full_name: Bertrand Tombal

given: Bertrand

name: Department of Urology, Ziekenhuisgroep Twente, Hengelo, the Netherlands

family: Cornel

full_name: Erik B. Cornel

given: Erik B.

name: Department of Urology, University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom

family: Persad

full_name: Raj Persad

given: Raj

name: Astellas Pharma Medical Affairs EMEA, Chertsey, United Kingdom

family: Stari

full_name: Anny Stari

given: Anny

name: Salamanca University Hospital and Translational Research Group of Urology GITUR-IBSAL, Salamanca, Spain

family: Gómez Veiga

full_name: Francisco Gómez Veiga

given: Francisco

name: Clinic E Cavell and University of Brussels, Brussels, Belgium

family: Schulman

full_name: Claude Schulman

given: Claude

journal_name: Journal of Urology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Schulman C, Cornel E, Matveev V, Tammela TL, Schraml J, Bensadoun H, Warnack W, Persad R, Salagierski M, Gómez Veiga F, Baskin-Bey E, López B, Tombal B. Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND). Eur Urol. 2016 Apr;69(4):720-727. doi: 10.1016/j.eururo.2015.10.007. Epub 2015 Oct 29.

full_name: Erik Cornel

given: Erik

family: Matveev

full_name: Vsevolod Matveev

given: Vsevolod

family: Tammela

full_name: Teuvo L. Tammela

given: Teuvo L.

family: Schraml

full_name: Jan Schraml

given: Jan

family: Bensadoun

full_name: Henri Bensadoun

given: Henri

family: Warnack

full_name: Wolfgang Warnack

given: Wolfgang

family: Salagierski

full_name: Marek Salagierski

given: Marek

family: Baskin-Bey

full_name: Edwina Baskin-Bey

given: Edwina

family: López

full_name: Beatriz López

given: Beatriz

journal_name: European Urology

oa_colors: green hybrid

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

repository_institution: Tampere University - Tampere University Institutional Repository

location_country:
Italy
Finland
France
Slovakia
Hungary
Belgium
Russian Federation
Spain
Germany
Czech Republic


title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

acronym: EMERALD

summary: The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: MicroPort CRM

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Japan
Belgium
Australia
Spain
Denmark
Canada

location_facility: Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel

location_facility: Baerenfaenger Dr. Petra Private Practice

location_facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

location_facility: Med. Martina Trummel Praxis Innere Medizin / Kardiologie

location_facility: Centre hospitalier de la Région d'Annecy

location_facility: FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung

location_facility: Ospedale OO.OO.San Giovanni e Ruggi d'Aragona

location_facility: Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme

location_facility: Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt

location_facility: Sohien und Hufeland Klinikum Weimar Gmbh

location_facility: National Hospital Organization Oita Medical Center

location_facility: Kardiologische - angiologische Praxis Dr. med. Jörg Walter

location_facility: Staedt. Linikum Medizinische Klinik Lueneburg

location_facility: Hospital General Universitario de Alicante

location_facility: Complete Cardiology Care Live Oak Street

location_facility: Clinique & Maternité Sainte-Elisabeth Namur

lead_sponsor_type: industriel

status_simplified: Completed


title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

acronym: EPICOR

summary: The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

ReferenceType: derived

ReferenceCitation: Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.

family: Huo

full_name: Yong Huo

given: Yong

sequence: first

family: Van de Werf

full_name: Frans Van de Werf

given: Frans

sequence: additional

family: Han

full_name: Yaling Han

given: Yaling

family: Rossello

full_name: Xavier Rossello

given: Xavier

family: Pocock

full_name: Stuart J. Pocock

given: Stuart J.

family: Chin

full_name: Chee Tang Chin

given: Chee Tang

family: Lee

full_name: Stephen W.-L. Lee

given: Stephen W.-L.

family: Li

full_name: Yi Li

given: Yi

family: Jiang

full_name: Jie Jiang

given: Jie

family: Vega

full_name: Ana Maria Vega

given: Ana Maria

family: Medina

full_name: Jesús Medina

given: Jesús

family: Bueno

full_name: Héctor Bueno

given: Héctor

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Cardiovascular Drugs

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Martín-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.

family: Martín-Asenjo

full_name: Roberto Martín-Asenjo

given: Roberto

family: Gregson

full_name: John Gregson

given: John

journal_name: Journal of Cardiovascular Translational Research

ReferenceCitation: Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.

name: Department of Intensive Cardiac Therapy, Institute of Cardiology, Warsaw, Poland

name: Department of Public Health, I-CHER Interuniversity Centre for Health Economics Research, UGent and VUB, Ghent, Belgium

name: Department of Cardiology Hopital Europeen Georges Pompidou, Université Paris Descartes, Paris, France

name: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom

name: Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium

name: Medical Evidence and Observational Research, Global Medical Affairs, AstraZeneca, Madrid, Spain

name: Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain

ReferenceCitation: Bardají A, Leal M, Arrarte V, Garcia-Moll X, Pérez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.

name: Servicio de Cardiología; Hospital Universitario de Tarragona Joan XXIII, IISPV; Universidad Rovira Virgili; Tarragona Spain

name: Servicio de Cardiología; Hospital General Universitario; Alicante Spain

name: Servicio de Cardiología; Hospital de la Santa Creu i Sant Pau; Barcelona Spain

name: Department of Cardiology; Clinical Hospital San Carlos; Health Research Institute; San Carlos Madrid Spain

name: Universidad Complutense de Madrid; Madrid Spain

name: Centro Nacional de Investigaciones Cardiovasculares (CNIC); Madrid Spain

name: Instituto de investigación i+12 and Cardiology Department; Hospital Universitario 12 de Octubre; Madrid Spain

ReferenceCitation: Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

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

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.

repositories:
PubMed Central
dnet
researchonline.lshtm.ac.uk

ReferenceCitation: Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.

ReferenceCitation: Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.

ReferenceCitation: Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.

name: London School of Hygiene and Tropical Medicine, UK

name: Hospital General Universitario Gregorio Marañón, Spain

name: Medical Department, AstraZeneca France, France

name: AstraZeneca Observational Research Center, Spain

name: AstraZeneca Medical Evidence Center, USA

name: Interuniversity Centre for Health Economics Research UGent, Vrije Universiteit Brussel, Belgium

name: Hôpital Européen Georges Pompidou, René Descartes University, France

journal_name: European Heart Journal: Acute Cardiovascular Care

ReferenceCitation: Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.

location_country:
Italy
Brazil
Luxembourg
United Kingdom
Mexico
Netherlands
Finland
France
Poland
Greece
Venezuela
Norway
Romania
Belgium
Argentina
Spain
Turkey
Denmark
Germany
Slovenia


title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

summary: This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: LivaNova

location_country:
Italy
United States
United Kingdom
France
Belgium
Spain
Germany
Monaco

location_facility: Passaic Beth Israel Regional Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Johannes Gutenberg-Universität - Mainz Klinikum

location_facility: CHRU du Morvan Hôpital la Cavale Blanche

location_facility: Complejo Hospitalario Universitario de Vigo (CHUVI)

intervention_type: Device