title: The Parkinson's Progression Markers Initiative (PPMI)

acronym: PPMI

summary:
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

ReferenceCitation: Kim R, Park S, Yoo D, Jun JS, Jeon B. Association of Physical Activity and APOE Genotype With Longitudinal Cognitive Change in Early Parkinson Disease. Neurology. 2021 May 11;96(19):e2429-e2437. doi: 10.1212/WNL.0000000000011852. Epub 2021 Mar 31.

family: Kim

full_name: Ryul Kim

given: Ryul

family: Park

full_name: Sangmin Park

given: Sangmin

family: Yoo

full_name: Dallah Yoo

given: Dallah

family: Jun

full_name: Jin-Sun Jun

given: Jin-Sun

family: Jeon

full_name: Beomseok Jeon

given: Beomseok

journal_name: Neurology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Simuni T, Brumm MC, Uribe L, Caspell-Garcia C, Coffey CS, Siderowf A, Alcalay RN, Trojanowski JQ, Shaw LM, Seibyl J, Singleton A, Toga AW, Galasko D, Foroud T, Nudelman K, Tosun-Turgut D, Poston K, Weintraub D, Mollenhauer B, Tanner CM, Kieburtz K, Chahine LM, Reimer A, Hutten S, Bressman S, Marek K; Parkinson's Progression Markers Initiative Investigators. Clinical and Dopamine Transporter Imaging Characteristics of Leucine Rich Repeat Kinase 2 (LRRK2) and Glucosylceramidase Beta (GBA) Parkinson's Disease Participants in the Parkinson's Progression Markers Initiative: A Cross-Sectional Study. Mov Disord. 2020 May;35(5):833-844. doi: 10.1002/mds.27989. Epub 2020 Feb 19.

name: Department of NeurologyNorthwestern University Feinberg School of Medicine Chicago Illinois USA

family: Simuni

full_name: Tanya Simuni

given: Tanya

name: Department of Biostatistics, College of Public HealthUniversity of Iowa Iowa City Iowa USA

family: Brumm

full_name: Michael C. Brumm

given: Michael C.

family: Uribe

full_name: Liz Uribe

given: Liz

family: Caspell‐Garcia

full_name: Chelsea Caspell‐Garcia

given: Chelsea

family: Coffey

full_name: Christopher S. Coffey

given: Christopher S.

name: Departments of Neurology Perelman School of MedicineUniversity of Pennsylvania Philadelphia Pennsylvania USA

family: Siderowf

full_name: Andrew Siderowf

given: Andrew

name: Department of Neurology, The Taub Institite for Research on Alzheimer's Disease and the Aging BrainColumbia University New York New York USA

family: Alcalay

full_name: Roy N. Alcalay

given: Roy N.

name: Departments of Pathology and Laboratory Medicine Perelman School of MedicineUniversity of Pennsylvania Philadelphia Pennsylvania USA

family: Trojanowski

full_name: John Q. Trojanowski

given: John Q.

family: Shaw

full_name: Leslie M. Shaw

given: Leslie M.

name: Institute for Neurodegenerative Disorders New Haven Connecticut USA

family: Seibyl

full_name: John Seibyl

given: John

name: Laboratory of NeurogeneticsNational Institute on Aging, NIH Bethesda Maryland USA

family: Singleton

full_name: Andrew Singleton

name: Laboratory of Neuroimaging (LONI)University of Southern California Los Angeles California USA

family: Toga

full_name: Arthur W. Toga

given: Arthur W.

name: Department of NeurologyUniversity of California San Diego California USA

family: Galasko

full_name: Doug Galasko

given: Doug

name: Department of Medical and Molecular GeneticsIndiana University Indianapolis Indiana USA

family: Foroud

full_name: Tatiana Foroud

given: Tatiana

family: Nudelman

full_name: Kelly Nudelman

given: Kelly

name: Department of NeurologyUniversity of California San Francisco San Francisco California USA

family: Tosun‐Turgut

full_name: Duygu Tosun‐Turgut

given: Duygu

name: Department of Neurology and Neurological SciencesStanford University Stanford California USA

name: Departments of Psychiatry and Neurology Perelman School of MedicineUniversity of Pennsylvania Philadelphia Pennsylvania USA

name: Department of NeurologyUniversity Medical Center Goettingen Goettingen, Germany and Paracelsus‐Elena‐Klinik Kassel Germany

name: Department of NeurologyUniversity of Rochester Medical Center Rochester New York USA

name: Department of NeurologyUniversity of Pittsburgh Pittsburgh Pennsylvania USA

name: The Michael J. Fox Foundation for Parkinson’s Research New York New York USA

name: Icahn School of Medicine Mount Sinai New York New York USA

title: Clinical and Dopamine Transporter Imaging Characteristics of Leucine Rich Repeat Kinase 2 (LRRK2) and Glucosylceramidase Beta (GBA) Parkinson's Disease Participants in the Parkinson's Progression Markers Initiative: A Cross‐Sectional Study

ReferenceCitation: Simuni T, Uribe L, Cho HR, Caspell-Garcia C, Coffey CS, Siderowf A, Trojanowski JQ, Shaw LM, Seibyl J, Singleton A, Toga AW, Galasko D, Foroud T, Tosun D, Poston K, Weintraub D, Mollenhauer B, Tanner CM, Kieburtz K, Chahine LM, Reimer A, Hutten SJ, Bressman S, Marek K; PPMI Investigators. Clinical and dopamine transporter imaging characteristics of non-manifest LRRK2 and GBA mutation carriers in the Parkinson's Progression Markers Initiative (PPMI): a cross-sectional study. Lancet Neurol. 2020 Jan;19(1):71-80. doi: 10.1016/S1474-4422(19)30319-9. Epub 2019 Oct 31.

ReferenceCitation: Simuni T, Caspell-Garcia C, Coffey CS, Weintraub D, Mollenhauer B, Lasch S, Tanner CM, Jennings D, Kieburtz K, Chahine LM, Marek K. Baseline prevalence and longitudinal evolution of non-motor symptoms in early Parkinson's disease: the PPMI cohort. J Neurol Neurosurg Psychiatry. 2018 Jan;89(1):78-88. doi: 10.1136/jnnp-2017-316213. Epub 2017 Oct 6.

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Baseline prevalence and longitudinal evolution of non-motor symptoms in early Parkinson’s disease: the PPMI cohort

ReferenceCitation: Latourelle JC, Beste MT, Hadzi TC, Miller RE, Oppenheim JN, Valko MP, Wuest DM, Church BW, Khalil IG, Hayete B, Venuto CS. Large-scale identification of clinical and genetic predictors of motor progression in patients with newly diagnosed Parkinson's disease: a longitudinal cohort study and validation. Lancet Neurol. 2017 Nov;16(11):908-916. doi: 10.1016/S1474-4422(17)30328-9. Epub 2017 Sep 25.

ReferenceCitation: Smith KM, Xie SX, Weintraub D. Incident impulse control disorder symptoms and dopamine transporter imaging in Parkinson disease. J Neurol Neurosurg Psychiatry. 2016 Aug;87(8):864-70. doi: 10.1136/jnnp-2015-311827. Epub 2015 Nov 3.

ReferenceCitation: Oliveira FP, Castelo-Branco M. Computer-aided diagnosis of Parkinson's disease based on [(123)I]FP-CIT SPECT binding potential images, using the voxels-as-features approach and support vector machines. J Neural Eng. 2015 Apr;12(2):026008. doi: 10.1088/1741-2560/12/2/026008. Epub 2015 Feb 24.

title: Computer-aided diagnosis of Parkinson’s disease based on [123I]FP-CIT SPECT binding potential images, using the voxels-as-features approach and support vector machines

location_country:
Italy
Austria
Germany
France
Greece
Israel
Norway
Australia
Spain
United States
United Kingdom

location_facility: Institute For Neurodegenerative Disorders

location_facility: Parkinson's Disease& Movement Disorder Center of Boca Raton

location_facility: University of Cincinnati/Cincinnati Children's Hospital

location_facility: Foundation for Biomedical Research of the Academy of Athens

location_facility: Univ of Washington and VA Puget Sound Health Care System


title: Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

summary: The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nishi T, Piroth Z, De Bruyne B, Jagic N, Möbius-Winkler S, Kobayashi Y, Derimay F, Fournier S, Barbato E, Tonino P, Jüni P, Pijls NHJ, Fearon WF. Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1797-1804. doi: 10.1161/CIRCULATIONAHA.118.035263.

name: Division of Cardiovascular Medicine, Stanford University School of Medicine and Stanford Cardiovascular Institute, CA (T.N., Y.K., F.D., W.F.F.).

family: Nishi

full_name: Takeshi Nishi

given: Takeshi

sequence: first

name: Hungarian Institute of Cardiology, Budapest, Hungary (Z.P.).

family: Piroth

full_name: Zsolt Piroth

given: Zsolt

sequence: additional

name: Cardiovascular Center Aalst, Aalst, Belgium (B.D.B., S.F., E.B.).

family: De Bruyne

full_name: Bernard De Bruyne

given: Bernard

name: Clinical Center Kragujevac, Serbia (N.J.).

name: University of Kragujevac, Faculty of Medicine, Serbia (N.J.).

family: Jagic

full_name: Nikola Jagic

given: Nikola

name: Heart Center Leipzig, Germany (S.M.-W.).

name: University Hospital Jena, Germany (S.M.-W.).

family: Möbius-Winkler

full_name: Sven Möbius-Winkler

given: Sven

family: Kobayashi

full_name: Yuhei Kobayashi

given: Yuhei

family: Derimay

full_name: François Derimay

given: François

family: Fournier

full_name: Stephane Fournier

given: Stephane

name: Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.).

family: Barbato

full_name: Emanuele Barbato

given: Emanuele

name: Catharina Hospital, Eindhoven, the Netherlands (P.T., N.H.J.P.).

family: Tonino

full_name: Pim Tonino

given: Pim

name: Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, University of Toronto, Ontario, Canada (P.J.).

family: Jüni

full_name: Peter Jüni

given: Peter

family: Pijls

full_name: Nico H.J. Pijls

given: Nico H.J.

family: Fearon

full_name: William F. Fearon

given: William F.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrøm T, Kääb S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Fröbert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbühler M, Jüni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.

name: From the Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium (P.X., S.F., E.B., G.G.T., B.D.B.); the Department of Cardiology, Catharina Hospital, and the Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven (N.H.J.P., P.A.L.T.), and Isala Klinieken, Zwolle (J.-H.D.) — all in the Netherlands; Stanford University Medical Center and Palo Alto Veterans Affairs (VA) Health Care Systems, Stanford, CA (W.F.F.); Rigshospitalet University Hospital, Copenhagen (T.E....

family: Xaplanteris

full_name: Panagiotis Xaplanteris

given: Panagiotis

full_name: Pim A.L. Tonino

given: Pim A.L.

family: Engstrøm

full_name: Thomas Engstrøm

given: Thomas

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

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

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

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Ciccarelli G, Barbato E, Toth GG, Gahl B, Xaplanteris P, Fournier S, Milkas A, Bartunek J, Vanderheyden M, Pijls N, Tonino P, Fearon WF, Jüni P, De Bruyne B. Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy. Circulation. 2018 Apr 3;137(14):1475-1485. doi: 10.1161/CIRCULATIONAHA.117.028782. Epub 2017 Nov 21. Erratum in: Circulation. 2018 May 29;137(22):e820.

name: Cardiovascular Center, OLV Hospital, Aalst, Belgium (G.C., E.B., P.X., S.F., A.M., J.B., M.V., B.D.B.)

name: University Heart Centre Graz, Austria (G.G.T.)

name: Department of Clinical Research, CTU Bern, University of Bern, Switzerland (B.G.)

name: Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands (N.P., P.T.)

name: Stanford University Medical Center, CA (W.F.F.)

name: Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, Toronto, Ontario, Canada (P.J.)

name: Department of Medicine, University of Toronto, Ontario, Canada (P.J.)

repository_institution: University of Bern - Bern Open Repository and Information System

ReferenceCitation: Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Jüni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.

name: Division of Cardiovascular Medicine (W.F.F., T.N., M.A.H.)

name: Stanford University School of Medicine and Stanford Cardiovascular Institute, CA. Cardiovascular Center Aalst, Belgium (B.D.B., E.B.)

name: Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, University of Toronto, Ontario, Canada (P.J.)

name: Department of Health Research and Policy (M.A.H.)

title: Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve–Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease

ReferenceCitation: Barbato E, Toth GG, Johnson NP, Pijls NH, Fearon WF, Tonino PA, Curzen N, Piroth Z, Rioufol G, Jüni P, De Bruyne B. A Prospective Natural History Study of Coronary Atherosclerosis Using Fractional Flow Reserve. J Am Coll Cardiol. 2016 Nov 29;68(21):2247-2255. doi: 10.1016/j.jacc.2016.08.055.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nüesch E, Jüni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. Erratum in: N Engl J Med. 2014 Oct 9;371(15):1465.

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

title: Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease

ReferenceCitation: Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Jüni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14.

name: From the Division of Cardiovascular Medicine (W.F.F., M.A.H.) and the Department of Health Research and Policy (D.S., D.B.B., M.A.H.), Stanford University School of Medicine, Stanford, CA; Catharina Hospital, Eindhoven, The Netherlands (N.H.J.P., P.A.L.T.); Cardiovascular Center Aalst, Aalst, Belgium (E.B., B.D.B.); and Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland and CTU Bern, Department of Clinical Research, University of Bern, Switzerland (P.J.).

title: Cost-Effectiveness of Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease and Abnormal Fractional Flow Reserve

ReferenceCitation: De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Möbius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Jüni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum in: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Möbius-Winkler, Sven].

title: Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease

location_country:
Italy
United States
Sweden
Serbia
Netherlands
Germany
France
Czechia
Hungary
Belgium
Denmark
Canada
United Kingdom

location_facility: Masaryk University and University Hospital Brno

location_facility: Azienda Ospedaliero Universitaria de Ferrara

location_facility: Gottsegen Hungarian Institute of Cardiology

location_facility: Centre Hospitalier de l'Universite de Montreal


title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

acronym: KAST

summary: The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

primary_purpose: Treatment

ReferenceCitation: Beall DP, Coe JD, McIlduff M, Bloch D, Hornberger J, Warner C, Tutton S. Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty. Pain Physician. 2017 Sep;20(6):521-528.

lead_sponsor: Benvenue Medical, Inc.

location_country:
United States
Germany
France
Belgium
Canada

location_facility:
Adventist Hospital
Penn State Hershey Medical Center
Mayo Clinic Jacksonville
Toronto Western Hospital
El Camino Hospital
Spine Institute of Louisiana
St. Mary's Spine Center
Clinical Radiology of Oklahoma
Evanston Hospital
Universitatsklinikum Bonn
Radiological Associates of Sacramento
CORE Orthopaedic Medical Center
Radiology Imaging Associates
Sierra Regional Spine Institute
Medical University of South Carolina
Mayo Clinic-Rochester
Medical College of Wisconsin
CHC Saint Joseph
CHU Amiens Sud
Klinikum Ernst von Bergmann gGmbH
Montreal General Hospital

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset

summary: The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

enrollment_type: Anticipated

ReferenceCitation: Hacke W, Schellinger PD, Albers GW, Bornstein NM, Dahlof BL, Fulton R, Kasner SE, Shuaib A, Richieri SP, Dilly SG, Zivin J, Lees KR; NEST 3 Committees and Investigators. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.

name: From the Department of Neurology, Heidelberg University, Heidelberg, Germany (W.H.); Department of Neurology, Johannes Wesling Klinikum Minden, Minden, Germany (P.D.S.); Department of Neurology, Stanford Stroke Center, Palo Alto, CA (G.W.A.); Department of Neurology, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel (N.M.B.); Department of Internal Medicine, Sahlgrenski University Hospital Östra, Göteborg University, Göteborg, Sweden (B.L.D.); Institute of Cardiovascular and Medical...

family: Hacke

full_name: Werner Hacke

given: Werner

family: Schellinger

full_name: Peter D. Schellinger

given: Peter D.

family: Albers

full_name: Gregory W. Albers

given: Gregory W.

family: Bornstein

full_name: Natan M. Bornstein

given: Natan M.

family: Dahlof

full_name: Bjorn L. Dahlof

given: Bjorn L.

family: Fulton

full_name: Rachael Fulton

given: Rachael

family: Kasner

full_name: Scott E. Kasner

given: Scott E.

family: Shuaib

full_name: Ashfaq Shuaib

given: Ashfaq

family: Richieri

full_name: Steven P. Richieri

given: Steven P.

family: Dilly

full_name: Stephen G. Dilly

given: Stephen G.

family: Zivin

full_name: Justin Zivin

given: Justin

family: Lees

full_name: Kennedy R. Lees

given: Kennedy R.

family: Broderick

full_name: Joseph Broderick

given: Joseph

family: Ivanova

full_name: Anastasia Ivanova

given: Anastasia

family: Johnston

full_name: Karen Johnston

given: Karen

family: Norrving

full_name: Bo Norrving

given: Bo

family: Alexandrov

full_name: Andrei Alexandrov

given: Andrei

name: Hoag Memorial Hospital Presbyterian, Newport Beach, CA

family: Brown

full_name: David Brown

given: David

name: Winchester Medical Center, Winchester, VA

family: Capone

full_name: Patrick Capone

given: Patrick

family: Chiu

full_name: David Chiu

name: Oregon Health Sciences University, Portland, OR

family: Clark

full_name: Wayne Clark

given: Wayne

family: Cochran

full_name: Jack Cochran

given: Jack

name: University of Washington St. Louis, St. Louis, MO

family: Deredyn

full_name: Colin Deredyn

given: Colin

family: Devlin

full_name: Thomas Devlin

name: Guilford Neuro/The Moses H. Cone Memorial Hospital, Greensboro, NC

name: Munroe Regional Medical Center, Ocala FL

name: University of North Carolina Healthcare, Chapel Hill, NC

name: Carilion Roanoke Memorial Hospital, Roanoke, VA

name: UMass Memoriol Medical Center, Worcester, MA

name: Gewinnett Medical Center, Duluth & Lawrenceville, GA

name: Mission Hospital/Mission Neurology Services, Asheville, NC

name: Sparks Regional Medical Center, Fort Smith, AR

name: Grey Nunes Community Hospital, Edmonton, Alberta, Canada

name: Hospital Nacional Dos de Mayo, Lima, Peru

name: Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

name: Neurologische Klinik Bad Neustadt, Bad Neustadt, Germany

name: Kreisklinikum Siegen GmbH, Siegen, Germany

name: HSK Dr. Horst Schmidt Klinik GmbH, Wiesbaden, Germany

name: Neurologische Universitätsklinik Aachen, Aachen, Germany

name: Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany

name: Neurologische Universitätsklinik Erlangen, Erlangen, Germany

name: Universitätsklinikum Münster, Münster, Germany

name: Klinik und Poliklinik für Neurologie Leipzig, Leipzig, Germany

name: Charite Campus Berlin Mitte, Berlin, Germany

name: Klinikum Frankfurt-Hoechst, Frankfurt, Germany

name: Johann Wolfgang Goethe Universität, Frankfurt, Germany

name: Universitätsklinikum Heidelberg, Heidelberg, Germany

name: Universitätsklinikum Essen, Essen, Germany

name: Sahlgrenska University Hospital, Göteborg, Sweden

name: CHRU Lille-Hospital Salengro, Lille, France

name: Helsinki University Central Hospital, Helsinki, Finland

name: University Hospital Zürich, Zürich, Switzerland

name: Universitätsspital Basel, Basel, Switzerland

name: Center Hospitalier Universitaire Vaudois, Lausanne, Switzerland

name: University Hospital Vall D’Hebron, Barcelona, Spain

name: Complejo Hospitalario Universitario Albacete, Albacete, Spain

title: Transcranial Laser Therapy in Acute Stroke Treatment

location_country:
Austria
Peru
Sweden
Switzerland
Germany
Finland
France
Spain
United States
Canada

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: University of Alberta Hospital - Walter C Mackenzie Health Science Center

location_facility: Centre Hospitalier Universitaire Vaudois


intervention_type: Drug

lead_sponsor: LEO Pharma

location_country:
Canada
United Kingdom
France

location_facility: The Centre for Dermatology and Cosmetic Surgery

location_facility: The Guenther Dermatology Research Centre

location_facility: Royal University Hospital, Division of Dermatology

location_facility: CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie

type: EudraCT Number

source: euctr

title: Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

summary: The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years


status: Terminated

lead_sponsor: Sanofi

location_country:
Austria
United States
Netherlands
France
Czechia
Lithuania
Poland
Hungary
Australia
Belgium
Spain
Canada

acronym: SUSTAIN

title: A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)

summary:
Primary Objective:

To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS)

Secondary Objective:

To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

status_simplified: Unknown


design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Japan
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

acronym: IMPRES Extn

title: An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension

summary: This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.


ReferenceType: background

ReferenceCitation: Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.

ReferenceCitation: Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.

study_start_date_type: Actual

lead_sponsor: AMAG Pharmaceuticals, Inc.

location_country:
Italy
South Africa
United Kingdom
France
Poland
Lithuania
Romania
Hungary
Australia
Spain
Germany
Latvia
Korea, Republic of
Ukraine

location_facility: For additional this triinformation regarding investigative sites for al, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

summary: The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).


type: Other Identifier

title: A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer

summary: The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

ReferenceCitation: Morris MJ, Loriot Y, Sweeney CJ, Fizazi K, Ryan CJ, Shevrin DH, Antonarakis ES, Pandit-Taskar N, Deandreis D, Jacene HA, Vesselle H, Petrenciuc O, Lu C, Carrasquillo JA, Higano CS. Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial. Eur J Cancer. 2019 Jun;114:107-116. doi: 10.1016/j.ejca.2019.04.007. Epub 2019 May 11.

family: Morris

full_name: Michael J. Morris

given: Michael J.

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Sweeney

full_name: Christopher J. Sweeney

given: Christopher J.

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Ryan

full_name: Charles J. Ryan

given: Charles J.

family: Shevrin

full_name: Daniel H. Shevrin

given: Daniel H.

family: Antonarakis

full_name: Emmanuel S. Antonarakis

given: Emmanuel S.

family: Pandit-Taskar

full_name: Neeta Pandit-Taskar

given: Neeta

family: Deandreis

full_name: Désirée Deandreis

given: Désirée

family: Jacene

full_name: Heather A. Jacene

given: Heather A.

family: Vesselle

full_name: Hubert Vesselle

given: Hubert

family: Petrenciuc

full_name: Oana Petrenciuc

given: Oana

family: Lu

full_name: Cindy Lu

given: Cindy

family: Carrasquillo

full_name: Jorge A. Carrasquillo

given: Jorge A.

family: Higano

full_name: Celestia S. Higano

given: Celestia S.

journal_name: European Journal of Cancer

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gkialas IK, Fragkoulis C. Emerging therapies targeting castration-resistant prostate cancer. J BUON. 2015 Nov-Dec;20(6):1389-96. Review.

lead_sponsor: Bayer

location_country:
United States
France


title: NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)

summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

ReferenceCitation: Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.

family: Gregorc

full_name: Vanesa Gregorc

given: Vanesa

family: Gaafar

full_name: Rabab M Gaafar

given: Rabab M

family: Favaretto

full_name: Adolfo Favaretto

given: Adolfo

family: Grossi

full_name: Francesco Grossi

given: Francesco

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Polychronis

full_name: Andreas Polychronis

given: Andreas

family: Bidoli

full_name: Paolo Bidoli

given: Paolo

family: Tiseo

full_name: Marcello Tiseo

given: Marcello

family: Shah

full_name: Riyaz Shah

given: Riyaz

family: Taylor

full_name: Paul Taylor

given: Paul

family: Novello

full_name: Silvia Novello

given: Silvia

family: Muzio

full_name: Alberto Muzio

given: Alberto

family: Bearz

full_name: Alessandra Bearz

given: Alessandra

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Fontana

full_name: Floriana Fontana

given: Floriana

family: Salini

full_name: Giulia Salini

given: Giulia

family: Lambiase

full_name: Antonio Lambiase

given: Antonio

family: O'Brien

full_name: Mary O'Brien

given: Mary

journal_name: The Lancet Oncology

lead_sponsor: AGC Biologics S.p.A.

location_country:
Italy
United States
Sweden
Netherlands
France
Poland
Ireland
Belgium
Egypt
Spain
Canada
United Kingdom

location_facility: Azienda Ospedaliero-Universitaria Careggi di Firenze

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Unità Sanitaria locale di Ravenna

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: UAB - Alberta Cancer Board - Cross Cancer Institute

location_facility: H. Lee Moffitt ancer Center and Research Institute

location_facility: A.O. Salvini Garbagnate, Ospedale di Rho

location_facility: University Health Network, Princess Margaret Hospital

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

location_facility: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Maria Sklodowska Memorial Cancer Center and Institute of Oncology

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Edinburgh Cancer Centre, Western General Hospital


title: A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)

acronym: INSURE

summary: This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

ReferenceCitation: Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

family: Dick

full_name: Andrew D. Dick

given: Andrew D.

family: Tugal-Tutkun

full_name: Ilknur Tugal-Tutkun

given: Ilknur

family: Foster

full_name: Stephen Foster

given: Stephen

family: Zierhut

full_name: Manfred Zierhut

given: Manfred

family: Melissa Liew

full_name: S.H. Melissa Liew

family: Bezlyak

full_name: Vladimir Bezlyak

given: Vladimir

family: Androudi

full_name: Sofia Androudi

given: Sofia

journal_name: Ophthalmology

title: Secukinumab in the Treatment of Noninfectious Uveitis: Results of Three Randomized, Controlled Clinical Trials

location_country:
United States
India
Switzerland
France
Japan
Israel
Singapore
Hungary
Egypt
Spain
Germany
United Kingdom
Canada


title: Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

summary: This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

lead_sponsor: Actelion

location_country:
Austria
Sweden
Serbia
Switzerland
Netherlands
Germany
Finland
France
Czechia
Bulgaria
Israel
Poland
Romania
Hungary
Russian Federation
Spain
United States
United Kingdom
Canada
Ukraine

status_simplified: Ongoing


title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System

summary: The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.

lead_sponsor: Zimmer Biomet

location_country:
Austria
Sweden
Netherlands
France
Australia
Belgium
Portugal
Denmark
United States
United Kingdom

location_facility:
Medipole de Savoie
Danderyd Hospital
The Queen Elizabeth Hospital
Logan Hospital
Aalborg University Hospital
Addenbrooke's Hospital
Torres Verdras Hospital
Amphia Ziekenhuis Breda
The Orthopaedic Hospital Speising
General Hospital Kreuzschwestern
Insall Scott Kelly Institute
St Luc General Hospital

intervention_type: Procedure


title: Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.

acronym: GARFIELD-AF

summary: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20.

ReferenceCitation: Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31.

ReferenceCitation: Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528.

ReferenceType: result

ReferenceCitation: Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

family: Mueller

full_name: Iris Mueller

given: Iris

family: Bassand

full_name: Jean-Pierre Bassand

given: Jean-Pierre

family: Fitzmaurice

full_name: David A. Fitzmaurice

given: David A.

family: Goldhaber

full_name: Samuel Z. Goldhaber

given: Samuel Z.

family: Goto

full_name: Shinya Goto

given: Shinya

family: Haas

full_name: Sylvia Haas

given: Sylvia

family: Hacke

full_name: Werner Hacke

given: Werner

family: Lip

full_name: Gregory Y. H. Lip

given: Gregory Y. H.

family: Mantovani

full_name: Lorenzo G. Mantovani

given: Lorenzo G.

family: Turpie

full_name: Alexander G. G. Turpie

given: Alexander G. G.

family: van Eickels

full_name: Martin van Eickels

given: Martin

family: Misselwitz

full_name: Frank Misselwitz

given: Frank

family: Rushton-Smith

full_name: Sophie Rushton-Smith

given: Sophie

family: Kayani

full_name: Gloria Kayani

given: Gloria

family: Wilkinson

full_name: Peter Wilkinson

given: Peter

family: Verheugt

full_name: Freek W. A. Verheugt

given: Freek W. A.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Università degli Studi di Milano - Institutional Research Information System

repository_institution: University College London - UCL Discovery

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

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

repositories_institution: University College London - UCL Discovery

repositories_institution: Università degli Studi di Milano - Institutional Research Information System

title: Risk Profiles and Antithrombotic Treatment of Patients Newly Diagnosed with Atrial Fibrillation at Risk of Stroke: Perspectives from the International, Observational, Prospective GARFIELD Registry

ReferenceCitation: Pope MK, Hall TS, Schirripa V, Radic P, Virdone S, Pieper KS, Le Heuzey JY, Jansky P, Fitzmaurice DA, Cappato R, Atar D, Camm AJ, Kakkar AK; GARFIELD-AF investigators. Cardioversion in patients with newly diagnosed non-valvular atrial fibrillation: observational study using prospectively collected registry data. BMJ. 2021 Oct 27;375:e066450. doi: 10.1136/bmj-2021-066450.

repository_institution: University of Warwick - Warwick Research Archive Portal

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

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

repositories_institution: University of Warwick - Warwick Research Archive Portal

ReferenceCitation: Cools F, Johnson D, Camm AJ, Bassand JP, Verheugt FWA, Yang S, Tsiatis A, Fitzmaurice DA, Goldhaber SZ, Kayani G, Goto S, Haas S, Misselwitz F, Turpie AGG, Fox KAA, Pieper KS, Kakkar AK; GARFIELD-AF Investigators. Risks associated with discontinuation of oral anticoagulation in newly diagnosed patients with atrial fibrillation: Results from the GARFIELD-AF Registry. J Thromb Haemost. 2021 Sep;19(9):2322-2334. doi: 10.1111/jth.15415. Epub 2021 Jul 23.

name: Department of Statistics North Carolina State University Raleigh NC USA

name: Cardiology Clinical Academic Group Molecular & Clinical Sciences Research Institute St. George’s University of London London UK

name: Onze Lieve Vrouwe Gasthuis (OLVG) Amsterdam The Netherlands

name: North Carolina State University Raleigh NC USA

name: University of Warwick Medical School Coventry UK

name: Brigham and Women’s Hospital and Harvard Medical School Boston MA USA

name: Tokai University School of Medicine Kanagawa Japan

name: Formerly Department of Medicine Technical University of Munich Munich Germany

name: Centre for Cardiovascular Science University of Edinburgh Edinburgh UK

title: Risks associated with discontinuation of oral anticoagulation in newly diagnosed patients with atrial fibrillation: Results from the GARFIELD‐AF Registry

ReferenceCitation: Pope MK, Atar D, Svilaas A, Hole T, Nielsen JD, Hintze U, Crisby M, Raatikainen P, Airaksinen KEJ, Virdone S, Pieper K, Kayani G, Le Heuzey JY, Steffel J, Stepinska J, Bassand JP, Camm AJ; GARFIELD-AF Investigators. Risk profile, antithrombotic treatment and clinical outcomes of patients in Nordic countries with atrial fibrillation - results from the GARFIELD-AF registry. Ann Med. 2021 Dec;53(1):485-494. doi: 10.1080/07853890.2021.1893897.

name: Institute of Clinical Medicine, University of Oslo, Oslo, Norway

name: Hamar Hospital, Innlandet Hospital Trust, Hamar, Norway

name: Department of Cardiology, Oslo University Hospital, Ullevål, Oslo, Norway

name: Nymoen Medical Centre, Kongsberg, Norway

name: Lipid Clinic, Oslo University Hospital, Oslo, Norway

name: Clinic of Medicine and Rehabilitation, More and Romsdal Hospital Trust, Alesund, Norway

name: Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU – Norwegian University of Science and Technology, Trondheim, Norway

name: Department of Cardiology, Copenhagen University Hospital, Copenhagen University, Copenhagen, Denmark

name: Department of Cardiology, Hospital of South West Jutland, Esbjerg, University of Southern Denmark, Denmark

name: Department of Neurobiology, Care Science and Society, Karolinska University Hospital, Stockholm, Sweden

name: Department of Cardiology, Heart and Lung Center, Helsinki University Hospital, Tampere, Finland

name: Heart Centre, Turku University Hospital and University of Turku, Turku, Finland

name: Thrombosis Research Institute, London, UK

name: Georges Pompidou Hospital, René Descartes University, Paris, France

name: Division of Electrophysiology and Pacing, Department of Cardiology, University Heart Center Zurich, Zurich, Switzerland

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

name: University of Besançon, Besancon, France

name: Cardiology Clinical Academic Group Molecular & Clinical Sciences Research Institute, St. George’s University of London, London, UK

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: University of Oslo - Duo Research Archive

repositories: HELDA - Digital Repository of the University of Helsinki

repositories_institution: University of Oslo - Duo Research Archive

title: Risk profile, antithrombotic treatment and clinical outcomes of patients in Nordic countries with atrial fibrillation – results from the GARFIELD-AF registry

ReferenceCitation: Sayin BY, Al Mahmeed W, Ragy HI, Elbahry A, Virdone S, Kakkar AK, Ersanlı M, Oto A. Middle East Treatment Strategies and Clinical Outcomes in Patients with Atrial Fibrillation: One-Year Follow-up Data from Garfield-AF Study. Adv Ther. 2021 May;38(5):2391-2405. doi: 10.1007/s12325-021-01670-5. Epub 2021 Mar 27.

ReferenceCitation: Gibbs H, Freedman B, Rosenqvist M, Virdone S, Mahmeed WA, Ambrosio G, Camm AJ, Jacobson B, Jerjes-Sanchez C, Kayani G, Oto A, Panchenko E, Ragy H, Kakkar AK; GARFIELD-AF Investigators. Clinical Outcomes in Asymptomatic and Symptomatic Atrial Fibrillation Presentations in GARFIELD-AF: Implications for AF Screening. Am J Med. 2021 Jul;134(7):893-901.e11. doi: 10.1016/j.amjmed.2021.01.017. Epub 2021 Feb 16.

ReferenceCitation: Bassand JP, Virdone S, Badoz M, Verheugt FWA, Camm AJ, Cools F, Fox KAA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Misselwitz F, Pieper KS, Turpie AGG, van Eickels M, Kakkar AK. Bleeding and related mortality with NOACs and VKAs in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry. Blood Adv. 2021 Feb 23;5(4):1081-1091. doi: 10.1182/bloodadvances.2020003560.

name: Department of Cardiology, University of Besançon, Besançon, France;

name: Thrombosis Research Institute, London, United Kingdom;

name: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands;

name: Cardiology Clinical Academic Group, Molecular and Clinical Sciences Institute, St. George’s University of London, London, United Kingdom;

name: Department of Cardiology, AZ Klina, Brasschaat, Belgium;

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

name: Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA;

name: Department of Medicine (Cardiology), Tokai University School of Medicine, Kanagawa, Japan;

name: Department of Medicine, Technical University of Munich, Munich, Germany;

name: Department of Neurology, University of Heidelberg, Heidelberg, Germany;

name: Department of Medicine, McMaster University, Hamilton, ON, Canada; and

name: University College London, London, United Kingdom

ReferenceCitation: Camm AJ, Fox KAA, Virdone S, Bassand JP, Fitzmaurice DA, Berchuck SI, Gersh BJ, Goldhaber SZ, Goto S, Haas S, Misselwitz F, Pieper KS, Turpie AGG, Verheugt FWA, Cappato R, Kakkar AK; GARFIELD-AF investigators. Comparative effectiveness of oral anticoagulants in everyday practice. Heart. 2021 Feb 16. pii: heartjnl-2020-318420. doi: 10.1136/heartjnl-2020-318420. [Epub ahead of print]

repositories:
PubMed Central
UCL Discovery
openaccess.sgul.ac.uk

title: Comparative effectiveness of oral anticoagulants in everyday practice

ReferenceCitation: Camm AJ, Cools F, Virdone S, Bassand JP, Fitzmaurice DA, Arthur Fox KA, Goldhaber SZ, Goto S, Haas S, Mantovani LG, Kayani G, Grierson Turpie AG, Antoon Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Mortality in Patients With Atrial Fibrillation Receiving Nonrecommended Doses of Direct Oral Anticoagulants. J Am Coll Cardiol. 2020 Sep 22;76(12):1425-1436. doi: 10.1016/j.jacc.2020.07.045.

title: Mortality in Patients With Atrial Fibrillation Receiving Nonrecommended Doses of Direct Oral Anticoagulants

ReferenceCitation: Bassand JP, Apenteng PN, Atar D, Camm AJ, Cools F, Corbalan R, Fitzmaurice DA, Fox KA, Goto S, Haas S, Hacke W, Jerjes-Sanchez C, Koretsune Y, Heuzey JL, Sawhney JP, Oh S, Stępińska J, Cate VT, Verheugt FW, Kayani G, Pieper KS, Kakkar AK, Garfield-Af Investigators FT. GARFIELD-AF: a worldwide prospective registry of patients with atrial fibrillation at risk of stroke. Future Cardiol. 2021 Jan;17(1):19-38. doi: 10.2217/fca-2020-0014. Epub 2020 Jul 22.

name: Department of Cardiology, University of Besançon, Besançon 25000, France

name: Department of Clinical Research, Thrombosis Research Institute, London SW3 6LR, UK

name: Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

name: Department of Cardiology, Oslo University Hospital Ullevaal, Oslo PO Box 4956, Norway

name: Institute of Clinical Science, University of Oslo, Oslo PO Box 4956, Norway

name: Molecular & Clinical Sciences Research Institute, St George’s University of London, London SW17 0RE, UK

name: Department of Cardiology, AZ Klina, Brasschaat 100, 2930, Belgium

name: Department of Cardiology, Catholic University, Santiago 8330024, Chile

name: Centre for Cardiovascular Science, University of Edinburgh, Edinburgh EH16 4TJ, UK

name: Department of Medicine(Cardiology), Tokai University School of Medicine, Kanagawa 259-1143, Japan

name: Department of Medicine, Formerly Technical University of Munich, Munich 80333, Germany

name: Department of Neurology, University of Heidelberg, Heidelberg 69120, Germany

name: Instituto de Cardiologia y Medicina Vascular, Tec Salud, Garza Garcia 66278, Mexico

name: Institute for Clinical Research, Osaka National Hospital, Osaka 540-0006, Japan

name: Department of Arrhythmia, European Hospital Georges Pompidou, René Descartes University, Paris 75015, France

name: Department of Cardiology, Sir Ganga Ram Hospital, New Delhi 110060, India

name: Department of Internal Medicine, Seoul National University College of Medicine, Seoul 110-799, Republic of Korea

name: Intensive Cardiac Therapy Clinic, Institute of Cardiology, Warsaw 04-628, Poland

name: Cardiovascular Research Institute Maastricht, Maastricht 6200, The Netherlands

name: Depertment of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam NL-1091-AC, The Netherlands

name: Department of Surgery, University College London, London WC1E 6BT, UK

title: GARFIELD-AF: a worldwide prospective registry of patients with atrial fibrillation at risk of stroke

ReferenceCitation: Hacke W, Bassand JP, Virdone S, Camm AJ, Fitzmaurice DA, Fox KA, Goldhaber SZ, Goto S, Haas S, Kayani G, Mantovani LG, Misselwitz F, Pieper KS, Turpie AG, van Eickels M, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Prior stroke and transient ischemic attack as risk factors for subsequent stroke in atrial fibrillation patients: A report from the GARFIELD-AF registry. Int J Stroke. 2020 Apr;15(3):308-317. doi: 10.1177/1747493019891516. Epub 2019 Dec 17.

name: Department of Neurology, University of Heidelberg, Heidelberg, Germany

name: Department of Cardiology, University of Besançon, Besançon, France

name: Department of Clinical Research, Thrombosis Research Institute, London, UK

name: Molecular and Clinical Sciences Institute, St. George’s University of London, London, UK

name: Warwick Medical School, University of Warwick, Coventry, UK

name: Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK

name: Cardiovascular Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, USA

name: Department of Medicine (Cardiology), Tokai University School of Medicine, Kanagawa, Japan

name: Formerly Klinikum rechts der Isar, Technical University of Munich, Munich, Germany

name: Center for Public Health Research, University of Milan Bicocca, and IRCCS Multimedica Milan, Italy

name: Therapeutic areas Thrombosis & Hematology, Bayer AG Pharmaceuticals, Berlin, Germany

name: Department of Medicine, McMaster University, Hamilton, Canada

name: Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands

name: Department of Surgery, University College London, London, UK

ReferenceCitation: Atar D, Berge E, Le Heuzey JY, Virdone S, Camm AJ, Steffel J, Gibbs H, Goldhaber SZ, Goto S, Kayani G, Misselwitz F, Stepinska J, Turpie AGG, Bassand JP, Kakkar AK; GARFIELD-AF Investigators. The association between patterns of atrial fibrillation, anticoagulation, and cardiovascular events. Europace. 2020 Feb 1;22(2):195-204. doi: 10.1093/europace/euz292.

name: Department of Cardiology, Oslo University Hospital, Kirkeveien 166, NO-0407 Oslo, Norway

name: Department of Cardiology, Institute of Clinical Sciences, University of Oslo, Oslo, Norway

name: Department of Cardiology, Georges Pompidou Hospital, René Descartes University, Paris, France

name: Department of Clinical Cardiology, St. George’s University of London, London, UK

name: Department of Cardiology, University Hospital, Zurich, CH, Switzerland

name: Vascular Laboratory, The Alfred Hospital, Melbourne, Australia

name: Department of Medicine (Cardiology), Tokai University, Kanagawa, Japan

name: Therapeutic areas Thrombosis & Hematology, Bayer AG, Berlin, Germany

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

name: Department of Cardiology, University of Besançon, France

title: The association between patterns of atrial fibrillation, anticoagulation, and cardiovascular events

ReferenceCitation: Verheugt FWA, Ambrosio G, Atar D, Bassand JP, Camm AJ, Costabel JP, Fitzmaurice DA, Illingworth L, Goldhaber SZ, Goto S, Haas S, Jansky P, Kayani G, Stepinska J, Turpie AGG, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Outcomes in Newly Diagnosed Atrial Fibrillation and History of Acute Coronary Syndromes: Insights from GARFIELD-AF. Am J Med. 2019 Dec;132(12):1431-1440.e7. doi: 10.1016/j.amjmed.2019.06.008. Epub 2019 Jul 12.

title: Outcomes in Newly Diagnosed Atrial Fibrillation and History of Acute Coronary Syndromes: Insights from GARFIELD-AF

ReferenceCitation: Haas S, Camm AJ, Bassand JP, Angchaisuksiri P, Cools F, Corbalan R, Gibbs H, Jacobson B, Koretsune Y, Mantovani LG, Misselwitz F, Panchenko E, Ragy HI, Stepinska J, Turpie AG, Sawhney JP, Steffel J, Lim TW, Pieper KS, Virdone S, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Predictors of NOAC versus VKA use for stroke prevention in patients with newly diagnosed atrial fibrillation: Results from GARFIELD-AF. Am Heart J. 2019 Jul;213:35-46. doi: 10.1016/j.ahj.2019.03.013. Epub 2019 Apr 11.

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: Technische Universität München - mediaTUM Gesamtbestand

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Corbalan R, Bassand JP, Illingworth L, Ambrosio G, Camm AJ, Fitzmaurice DA, Fox KAA, Goldhaber SZ, Goto S, Haas S, Kayani G, Mantovani LG, Misselwitz F, Pieper KS, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation: A Report From the GARFIELD-AF Registry. JAMA Cardiol. 2019 Jun 1;4(6):526-548. doi: 10.1001/jamacardio.2018.4729.

name: Division of Cardiovascular Diseases, Catholic University School of Medicine, Santiago, Chile

name: University of Besançon, Besançon, France

name: Thrombosis Research Institute, London, England

name: University of Perugia School of Medicine, Perugia, Italy

name: St George’s University of London, London, England

name: Warwick Medical School, University of Warwick, Coventry, England

name: Edinburgh University, Edinburgh, Scotland

name: Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Tokai University School of Medicine, Kanagawa, Japan

name: Formerly at Klinikum rechts der Isar, Technical University of Munich, Munich, Germany

name: Center for Public Health Research, University of Milan Bicocca, Monza, Italy

name: Bayer AG Pharmaceuticals, Berlin, Germany

name: Duke Clinical Research Institute, Durham, North Carolina

name: McMaster University, Hamilton, Ontario, Canada

name: Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands

title: Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation

ReferenceCitation: Jerjes-Sanchez C, Corbalan R, Barretto ACP, Luciardi HL, Allu J, Illingworth L, Pieper KS, Kayani G; GARFIELD-AF Investigators. Stroke prevention in patients from Latin American countries with non-valvular atrial fibrillation: Insights from the GARFIELD-AF registry. Clin Cardiol. 2019 May;42(5):553-560. doi: 10.1002/clc.23176. Epub 2019 Apr 9.

name: Instituto de Cardiologia y Medicina VascularTEC Salud, Tecnológico de Monterrey Monterrey Mexico

name: Cardiovascular DivisionPontificia Universidad Catolica Santiago Chile

name: Hospital das Clínicas da Faculdad de Medicina da USP Sao Paulo Brazil

name: Universidad Nacional de Tucumán San Miguel de Tucuman Argentina

name: Duke Clinical Research Institute Durham North Carolina

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

title: Stroke prevention in patients from Latin American countries with non‐valvular atrial fibrillation: Insights from the GARFIELD‐AF registry

ReferenceCitation: Goto S, Angchaisuksiri P, Bassand JP, Camm AJ, Dominguez H, Illingworth L, Gibbs H, Goldhaber SZ, Goto S, Jing ZC, Haas S, Kayani G, Koretsune Y, Lim TW, Oh S, Sawhney JPS, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Management and 1-Year Outcomes of Patients With Newly Diagnosed Atrial Fibrillation and Chronic Kidney Disease: Results From the Prospective GARFIELD - AF Registry. J Am Heart Assoc. 2019 Feb 5;8(3):e010510. doi: 10.1161/JAHA.118.010510.

name: Ramathibodi Hospital Mahidol University Bangkok Thailand

name: Thrombosis Research Institute London United Kingdom

name: St. George's University of London London United Kingdom

name: Bispebjerg‐Frederiksberg Hospital Copenhagen Denmark

name: Faculty of Health Sciences University of Copenhagen Copenhagen Denmark

name: Brigham and Women's Hospital and Harvard Medical School Boston MA

name: Keio University School of Medicine Tokyo Japan

name: Fu Wai Hospital State Key Lab of Cardiovascular Disease National Center for Cardiovascular Disease PUMC & CAMS Beijing China

name: Formerly Klinikum rechts der Isar Technical University of Munich Germany

name: National Hospital Organization Osaka National Hospital Osaka Japan

name: Seoul National University Hospital Seoul Korea

name: University College London London United Kingdom

journal_name: Journal of the American Heart Association

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

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

title: Management and 1‐Year Outcomes of Patients With Newly Diagnosed Atrial Fibrillation and Chronic Kidney Disease: Results From the Prospective GARFIELD‐AF Registry

ReferenceCitation: Bassand JP, Virdone S, Goldhaber SZ, Camm AJ, Fitzmaurice DA, Fox KAA, Goto S, Haas S, Hacke W, Kayani G, Mantovani LG, Misselwitz F, Pieper KS, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK. Early Risks of Death, Stroke/Systemic Embolism, and Major Bleeding in Patients With Newly Diagnosed Atrial Fibrillation. Circulation. 2019 Feb 5;139(6):787-798. doi: 10.1161/CIRCULATIONAHA.118.035012.

name: University of Besançon, France (J.-P.B.).

name: Thrombosis Research Institute, London, UK (J.-P.B., S.V., G.K., K.S.P., A.K.K.).

name: Brigham and Women’s Hospital and Harvard Medical School, Boston, MA (S.Z.G.).

name: St George’s University of London, UK (A.J.C.).

name: Warwick Medical School, University of Warwick, Coventry, UK (D.A.F.).

name: Centre for Cardiovascular Science, University of Edinburgh, UK (K.A.A.F.).

name: Tokai University School of Medicine, Kanagawa, Japan (S.G.).

name: Formerly Klinikum rechts der Isar, Technical University of Munich, Germany (S.H.).

name: University of Heidelberg, Germany (W.H.).

name: Center for Public Health Research, University of Milan Bicocca, Monza, Italy (L.G.M.).

name: Bayer AG, Pharmaceuticals, Berlin, Germany (F.M., M.v.E.).

name: Duke Clinical Research Institute, Durham, NC (K.S.P.).

name: McMaster University, Hamilton, Canada (A.G.G.T.).

name: Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands (F.W.A.V.).

title: Early Risks of Death, Stroke/Systemic Embolism, and Major Bleeding in Patients With Newly Diagnosed Atrial Fibrillation

ReferenceCitation: Sawhney JP, Kothiwale VA, Bisne V, Durgaprasad R, Jadhav P, Chopda M, Vanajakshamma V, Meena R, Vijayaraghavan G, Chawla K, Allu J, Pieper KS, John Camm A, Kakkar AK; GARFIELD-AF Investigators. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry. Indian Heart J. 2018 Nov - Dec;70(6):828-835. doi: 10.1016/j.ihj.2018.09.001. Epub 2018 Sep 12.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Cools F, Wollaert B, Vervoort G, Verstraete S, Voet J, Hermans K, Heyse A, De Wolf A, Hollanders G, Boussy T, Anné W, Vercammen J, Faes D, Beutels M, Mairesse G, Purnode P, Blankoff I, Vandergoten P, Capiau L, Allu J, Bassand JP, Kayani G; GARFIELD-AF Investigators. Treatment patterns in anticoagulant therapy in patients with newly diagnosed atrial fibrillation in Belgium: results from the GARFIELD-AF registry. Acta Cardiol. 2019 Aug;74(4):309-318. doi: 10.1080/00015385.2018.1494089. Epub 2018 Oct 27.

name: Cliniques Sud Luxembourg Arlon, Belgium;

name: Thrombosis Research Institute, London, UK;

ReferenceCitation: Bassand JP, Accetta G, Al Mahmeed W, Corbalan R, Eikelboom J, Fitzmaurice DA, Fox KAA, Gao H, Goldhaber SZ, Goto S, Haas S, Kayani G, Pieper K, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PLoS One. 2018 Jan 25;13(1):e0191592. doi: 10.1371/journal.pone.0191592. eCollection 2018.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Apenteng PN, Gao H, Hobbs FR, Fitzmaurice DA; UK GARFIELD-AF Investigators and GARFIELD-AF Steering Committee. Temporal trends in antithrombotic treatment of real-world UK patients with newly diagnosed atrial fibrillation: findings from the GARFIELD-AF registry. BMJ Open. 2018 Jan 13;8(1):e018905. doi: 10.1136/bmjopen-2017-018905.

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

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

ReferenceCitation: Verheugt FWA, Gao H, Al Mahmeed W, Ambrosio G, Angchaisuksiri P, Atar D, Bassand JP, Camm AJ, Cools F, Eikelboom J, Kayani G, Lim TW, Misselwitz F, Pieper KS, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Characteristics of patients with atrial fibrillation prescribed antiplatelet monotherapy compared with those on anticoagulants: insights from the GARFIELD-AF registry. Eur Heart J. 2018 Feb 7;39(6):464-473. doi: 10.1093/eurheartj/ehx730.

ReferenceCitation: Fox KAA, Lucas JE, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Oto A, Mantovani LG, Misselwitz F, Piccini JP, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open. 2017 Dec 21;7(12):e017157. doi: 10.1136/bmjopen-2017-017157.

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repositories_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

ReferenceCitation: Fox KAA, Accetta G, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Kayani G, Kakkar AK; GARFIELD-AF Investigators. Why are outcomes different for registry patients enrolled prospectively and retrospectively? Insights from the global anticoagulant registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). Eur Heart J Qual Care Clin Outcomes. 2018 Jan 1;4(1):27-35. doi: 10.1093/ehjqcco/qcx030.

name: Centre for Cardiovascular Science, University of Edinburgh, Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK

name: Thrombosis Research Institute, Emmanuel Kaye Building, Manresa Road, London SW3 6LR, UK

name: Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705, USA

name: University of Besançon, 1 Rue Claude Goudimel, Besançon 25000, France

name: Molecular and Clinical Sciences Research Institute, Cardiology Clinical Academic Group, St George's, University of London, Cranmer Terrace, London SW17 0RE, UK

name: Imperial College London, Kensington, London SW7 2AZ, UK

name: Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

name: University of London, Gower St, Kings Cross, London WC1E 6BT, UK

journal_name: European Heart Journal - Quality of Care and Clinical Outcomes

ReferenceCitation: Camm AJ, Accetta G, Al Mahmeed W, Ambrosio G, Goldhaber SZ, Haas S, Jansky P, Kayani G, Misselwitz F, Oh S, Oto A, Raatikainen P, Steffel J, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Impact of gender on event rates at 1 year in patients with newly diagnosed non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF registry. BMJ Open. 2017 Mar 6;7(3):e014579. doi: 10.1136/bmjopen-2016-014579.

ReferenceCitation: Haas S, Ten Cate H, Accetta G, Angchaisuksiri P, Bassand JP, Camm AJ, Corbalan R, Darius H, Fitzmaurice DA, Goldhaber SZ, Goto S, Jacobson B, Kayani G, Mantovani LG, Misselwitz F, Pieper K, Schellong SM, Stepinska J, Turpie AG, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Quality of Vitamin K Antagonist Control and 1-Year Outcomes in Patients with Atrial Fibrillation: A Global Perspective from the GARFIELD-AF Registry. PLoS One. 2016 Oct 28;11(10):e0164076. doi: 10.1371/journal.pone.0164076. eCollection 2016.

ReferenceCitation: Camm AJ, Accetta G, Ambrosio G, Atar D, Bassand JP, Berge E, Cools F, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Koretsune Y, Mantovani LG, Misselwitz F, Oh S, Turpie AG, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation. Heart. 2017 Feb 15;103(4):307-314. doi: 10.1136/heartjnl-2016-309832. Epub 2016 Sep 19.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

title: Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation

ReferenceCitation: Oh S, Goto S, Accetta G, Angchaisuksiri P, Camm AJ, Cools F, Haas S, Kayani G, Koretsune Y, Lim TW, Misselwitz F, van Eickels M, Kakkar AK; GARFIELD-AF Investigators. Vitamin K antagonist control in patients with atrial fibrillation in Asia compared with other regions of the world: Real-world data from the GARFIELD-AF registry. Int J Cardiol. 2016 Nov 15;223:543-547. doi: 10.1016/j.ijcard.2016.08.236. Epub 2016 Aug 13.

ReferenceCitation: Bassand JP, Accetta G, Camm AJ, Cools F, Fitzmaurice DA, Fox KA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Mantovani LG, Misselwitz F, Ten Cate H, Turpie AG, Verheugt FW, Kakkar AK; GARFIELD-AF Investigators. Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF. Eur Heart J. 2016 Oct 7;37(38):2882-2889. Epub 2016 Jun 29.

ReferenceCitation: Lip GY, Rushton-Smith SK, Goldhaber SZ, Fitzmaurice DA, Mantovani LG, Goto S, Haas S, Bassand JP, Camm AJ, Ambrosio G, Janský P, Al Mahmeed W, Oh S, van Eickels M, Raatikainen P, Steffel J, Oto A, Kayani G, Accetta G, Kakkar AK; GARFIELD-AF Investigators. Does sex affect anticoagulant use for stroke prevention in nonvalvular atrial fibrillation? The prospective global anticoagulant registry in the FIELD-Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2 Suppl 1):S12-20. doi: 10.1161/CIRCOUTCOMES.114.001556. Epub 2015 Feb 24.

journal_name: Circulation: Cardiovascular Quality and Outcomes

repository_institution: Aalborg Universitet - VBN Forskningsportal

repositories_institution: Aalborg Universitet - VBN Forskningsportal

title: Does Sex Affect Anticoagulant Use for Stroke Prevention in Nonvalvular Atrial Fibrillation?

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
United Arab Emirates
Switzerland
Netherlands
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Egypt
Spain
Turkey

location_facility: Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology

location_facility: Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere

location_facility: Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman

location_facility: Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey

location_facility: Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital

location_facility: Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,

location_facility: Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology

location_facility: Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick

location_facility: Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital

location_facility: Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia

location_facility: Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital

location_facility: Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand

location_facility: Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center

location_facility: Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute

location_facility: Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital

location_facility: Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital

location_facility: Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital

location_facility: Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz

location_facility: Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile

location_facility: Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau

location_facility: Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital

location_facility: Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou

location_facility: Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University

location_facility: Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi

location_facility: Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University

location_facility: Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital

location_facility: Dr Frank Cools, National Co-ordinating Investigator, AZ Klina

location_facility: Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht

location_facility: Prof Janina Stępińska, National Coordinating Investigator, Institute of Cardiology, Warsaw

location_facility: Prof. Seil Oh, National Coordinating Investigator, National University Hospital

location_facility: Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences

location_facility: Dr Jan Steffel, National Coordinating Investigator, University Hospital

location_facility: Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals

location_facility: Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukölln


title: A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event

summary: Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.

primary_purpose: Prevention

ReferenceCitation: Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

family: Devereaux

full_name: P.J. Devereaux

family: Mrkobrada

full_name: Marko Mrkobrada

given: Marko

family: Sessler

full_name: Daniel I. Sessler

given: Daniel I.

family: Leslie

full_name: Kate Leslie

given: Kate

family: Alonso-Coello

full_name: Pablo Alonso-Coello

given: Pablo

family: Kurz

full_name: Andrea Kurz

given: Andrea

family: Villar

full_name: Juan Carlos Villar

given: Juan Carlos

family: Sigamani

full_name: Alben Sigamani

given: Alben

family: Biccard

full_name: Bruce M. Biccard

given: Bruce M.

family: Meyhoff

full_name: Christian S. Meyhoff

given: Christian S.

family: Parlow

full_name: Joel L. Parlow

given: Joel L.

family: Guyatt

full_name: Gordon Guyatt

given: Gordon

family: Robinson

full_name: Andrea Robinson

family: Garg

full_name: Amit X. Garg

given: Amit X.

family: Rodseth

full_name: Reitze N. Rodseth

given: Reitze N.

family: Botto

full_name: Fernando Botto

given: Fernando

family: Lurati Buse

full_name: Giovanna Lurati Buse

given: Giovanna

family: Xavier

full_name: Denis Xavier

given: Denis

family: Chan

full_name: Matthew T.V. Chan

given: Matthew T.V.

family: Tiboni

full_name: Maria Tiboni

given: Maria

family: Cook

full_name: Deborah Cook

given: Deborah

family: Kumar

full_name: Priya A. Kumar

given: Priya A.

family: Forget

full_name: Patrice Forget

given: Patrice

family: Malaga

title: Aspirin in Patients Undergoing Noncardiac Surgery

ReferenceCitation: Devereaux PJ, Sessler DI, Leslie K, Kurz A, Mrkobrada M, Alonso-Coello P, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, Vanhelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Clonidine in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1504-13. doi: 10.1056/NEJMoa1401106. Epub 2014 Mar 31.

title: Clonidine in Patients Undergoing Noncardiac Surgery

ReferenceCitation: Garg AX, Kurz A, Sessler DI, Cuerden M, Robinson A, Mrkobrada M, Parikh C, Mizera R, Jones PM, Tiboni M, Rodriguez RG, Popova E, Rojas Gomez MF, Meyhoff CS, Vanhelder T, Chan MT, Torres D, Parlow J, de Nadal Clanchet M, Amir M, Bidgoli SJ, Pasin L, Martinsen K, Malaga G, Myles P, Acedillo R, Roshanov P, Walsh M, Dresser G, Kumar P, Fleischmann E, Villar JC, Painter T, Biccard B, Bergese S, Srinathan S, Cata JP, Chan V, Mehra B, Leslie K, Whitlock R, Devereaux PJ; POISE-2 Investigators. Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial. BMJ Open. 2014 Feb 25;4(2):e004886. doi: 10.1136/bmjopen-2014-004886.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

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

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Biccard BM, Sigamani A, Chan MTV, Sessler DI, Kurz A, Tittley JG, Rapanos T, Harlock J, Szalay D, Tiboni ME, Popova E, Vásquez SM, Kabon B, Amir M, Mrkobrada M, Mehra BR, El Beheiry H, Mata E, Tena B, Sabaté S, Zainal Abidin MK, Shah VR, Balasubramanian K, Devereaux PJ. Effect of aspirin in vascular surgery in patients from a randomized clinical trial (POISE-2). Br J Surg. 2018 Nov;105(12):1591-1597. doi: 10.1002/bjs.10925. Epub 2018 Jul 18.

name: Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa

name: Narayana Hrudayalaya Limited, Bangalore, India

name: Department of Anaesthetics, Chinese University of Hong Kong, Hong Kong, China

name: Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA

name: Department of General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA

name: Division of Vascular Surgery, McMaster University, Hamilton, Ontario, Canada

name: Department of Medicine, McMaster University, Hamilton, Ontario, Canada

name: Biomedical Research Institute (IIB – Sant Pau), Barcelona, Spain

name: Grupo de Cardiología Preventiva Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia

name: Department of Anaesthesiology, Medical University of Vienna, Vienna, Austria

name: Department of Surgery, Shifa International Hospital/Shifa Tameer-e-Millat University, Islamabad, Pakistan

name: Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada

name: Mahatma Gandhi Institute of Medical Sciences, Sevagram, India

name: University of Toronto, Trillium Health Partners, Toronto, Ontario, Canada

name: Hospital Universitario La Princesa, Madrid, Spain

name: Department of Anaesthesiology, Hospital Clinic, Barcelona, Spain

name: Department of Anaesthesiology, Fundació Puigvert (IUNA), Barcelona, Spain

name: Department of Anaesthesiology and Intensive Care, Sarawak General Hospital, Kuching, Sarawak, Malaysia

name: Population Health Research Institute, Hamilton, Ontario, Canada

ReferenceCitation: Graham MM, Sessler DI, Parlow JL, Biccard BM, Guyatt G, Leslie K, Chan MTV, Meyhoff CS, Xavier D, Sigamani A, Kumar PA, Mrkobrada M, Cook DJ, Tandon V, Alvarez-Garcia J, Villar JC, Painter TW, Landoni G, Fleischmann E, Lamy A, Whitlock R, Le Manach Y, Aphang-Lam M, Cata JP, Gao P, Terblanche NCS, Ramana PV, Jamieson KA, Bessissow A, Mendoza GR, Ramirez S, Diemunsch PA, Yusuf S, Devereaux PJ. Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery. Ann Intern Med. 2018 Feb 20;168(4):237-244. doi: 10.7326/M17-2341. Epub 2017 Nov 14.

name: University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada (M.M.G.)

name: Cleveland Clinic, Cleveland, Ohio (D.I.S.)

name: Queen's University, Kingston, Ontario, Canada (J.L.P.)

name: Groote Schuur Hospital and University of Cape Town, Western Cape, South Africa (B.M.B.)

name: Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada (G.G., D.J.C., V.T., A.L., R.W., Y.L., P.G., S.Y., P.D.)

name: Royal Melbourne Hospital, Melbourne Medical School, University of Melbourne, and Monash University, Melbourne, Victoria, Australia (K.L.)

name: The Chinese University of Hong Kong, Hong Kong, China (M.T.C.)

name: Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark (C.S.M.)

name: St. John's Medical College and Research Institute, Bangalore, India (D.X.)

name: Narayana Hrudayalaya, Bangalore, India (A.S.)

name: University of North Carolina, Chapel Hill, North Carolina (P.A.K.)

name: Schulich School of Medicine & Dentistry at Western University, London, Ontario, Canada (M.M.)

name: Sant Pau Hospital and Biomedical Research Institute, Autonomous University of Barcelona, Research Center of Cardiovascular Diseases (CIBERCV), Barcelona, Spain (J.A.)

name: Fundación Cardioinfantil Instituto de Cardiología, Bogotá, Colombia, and Department of Medicine, Universidad Autónoma de Bucaramanga, Santander, Colombia (J.C.V.)

name: University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia (T.W.P.)

name: IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy (G.L.)

name: Medical University of Vienna, Vienna, Austria (E.F.)

name: Hospital Arzobispo Loayza, Universidad Peruana Cayetano Heredia, Lima, Peru (M.A.)

name: The University of Texas MD Anderson Cancer Center, Houston, Texas (J.P.C.)

name: Royal Hobart Hospital and University of Tasmania, Hobart, Tasmania, Australia (N.C.T.)

name: CARE Hospitals, Maharanipeta, Visakhapatnam, India (P.V.R.)

name: Auckland City Hospital, Auckland, New Zealand (K.A.J.)

name: McGill University Health Centre, Montréal, Québec, Canada (A.B.)

name: Hospital Italiano de Buenos Aires, Buenos Aires, Argentina (G.R.M.)

name: Hospital Universitario Fundación Hospital Alcorcon, Madrid, Spain (S.R.)

name: Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France (P.A.D.)

ReferenceCitation: Garg AX, Kurz A, Sessler DI, Cuerden M, Robinson A, Mrkobrada M, Parikh CR, Mizera R, Jones PM, Tiboni M, Font A, Cegarra V, Gomez MF, Meyhoff CS, VanHelder T, Chan MT, Torres D, Parlow J, Clanchet Mde N, Amir M, Bidgoli SJ, Pasin L, Martinsen K, Malaga G, Myles P, Acedillo R, Roshanov PS, Walsh M, Dresser G, Kumar P, Fleischmann E, Villar JC, Painter T, Biccard B, Bergese S, Srinathan S, Cata JP, Chan V, Mehra B, Wijeysundera DN, Leslie K, Forget P, Whitlock R, Yusuf S, Devereaux PJ; POISE-2 Investigators. Perioperative aspirin and clonidine and risk of acute kidney injury: a randomized clinical trial. JAMA. 2014 Dec 3;312(21):2254-64. doi: 10.1001/jama.2014.15284.

name: London Health Sciences Centre and Western University, London, Ontario, Canada

name: McMaster University, Hamilton Health Sciences Centre, St Joseph’s Healthcare and the Population Health Research Institute, Hamilton, Ontario, Canada

name: Yale University School of Medicine, New Haven, Connecticut

name: Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

name: Fundación Oftalmológica de Santander, Bucaramanga, Colombia

name: Herlev Hospital and the University of Copenhagen, Copenhagen, Denmark

name: Chinese University of Hong Kong, Hong Kong Special Administrative Region, China

name: Clinica Santa Maria, Universidad de los Andes, Santiago, Chile

name: Kingston General Hospital, Kingston, Ontario, Canada

name: Hospital Vall d'Hebron, Barcelona, Spain

name: Shifa International Hospitals Limited, Islamabad, Pakistan

name: San Raffaele Scientific Institute, Milan, Italy

name: Hospital Nacional Cayetano Heredia, Lima, Peru

name: University of North Carolina Medical School, Chapel Hill

name: Vienna General Hospital and the Medical University of Vienna, Vienna, Austria

name: Fundación Cardioinfantil and the Universidad Autónoma de Bucaramanga, Bogotá, Colombia

name: Royal Adelaide Hospital, Adelaide, Australia

name: Nelson R. Mandela School of Medicine, Durban, South Africa

name: Ohio State University Medical Center, Columbus

name: University of Manitoba, Winnipeg, Canada

name: University of Texas and MD Anderson Cancer Center, Houston

name: University Health Network and the University of Toronto, Toronto, Ontario, Canada

name: Mahatma Gandhi Institute of Medical Sciences, Wardha, India

name: Royal Melbourne Hospital, Melbourne, Australia

name: Cliniques Universitaires Saint-Luc and the Université Catholique de Louvain, Brussels, Belgium

title: Perioperative Aspirin and Clonidine and Risk of Acute Kidney Injury

ReferenceCitation: Devereaux PJ; POISE-2 Investigators. Rationale and design of the PeriOperative ISchemic Evaluation-2 (POISE-2) trial: an international 2 × 2 factorial randomized controlled trial of acetyl-salicylic acid vs. placebo and clonidine vs. placebo in patients undergoing noncardiac surgery. Am Heart J. 2014 Jun;167(6):804-9.e4. doi: 10.1016/j.ahj.2014.01.007. Epub 2014 Feb 22.

title: Rationale and design of the PeriOperative ISchemic Evaluation-2 (POISE-2) trial: An international 2 × 2 factorial randomized controlled trial of acetyl-salicylic acid vs placebo and clonidine vs placebo in patients undergoing noncardiac surgery

ReferenceCitation: Chludzinski A, Irani C, Mascha EJ, Kurz A, Devereaux PJ, Sessler DI. Protocol understanding and anxiety in perioperative clinical trial patients approached for consent on the day of surgery. Mayo Clin Proc. 2013 May;88(5):446-54. doi: 10.1016/j.mayocp.2012.12.014.

title: Protocol Understanding and Anxiety in Perioperative Clinical Trial Patients Approached for Consent on the Day of Surgery

location_country:
Peru
Malaysia
Australia
Belgium
Denmark
India
Pakistan
France
Argentina
Canada
Colombia
South Africa
Chile
Hong Kong
Switzerland
Germany
United States
United Kingdom
Italy
Austria
Brazil
New Zealand
Spain

location_facility: National Coordination Office Australia and New Zealand


title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

summary: The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

lead_sponsor: Medtronic

location_country:
Italy
Austria
United States
Sweden
Former Serbia and Montenegro
Switzerland
Netherlands
Germany
France
Australia
Belgium
Spain
Denmark
Canada


title: Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study

summary: Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

time_perspective: Other

location_country:
Italy
Austria
United States
Sweden
Serbia
Switzerland
Netherlands
Germany
France
Australia
Belgium
Spain
Denmark
Canada


lead_sponsor: AVEO Pharmaceuticals, Inc.

location_country:
Italy
Chile
India
Serbia
France
Czechia
Bulgaria
Poland
Romania
Hungary
Russian Federation
United States
United Kingdom
Canada
Ukraine

location_facility:
Site 421
Site 170
Site 191
Site 411
Site 482
Site 444
Site 431
Site 455
Site 402
Site 466
Site 491
Site 110
Site 403
Site 440
Site 494
Site 122
Site 156
Site 187
Site 434
Site 496
Site 454
Site 152
Site 498
Site 497
Site 161
Site 400
Site 467
Site 422
Site 185
Site 154
Site 451
Site 464
Site 172
Site 458
Site 432
Site 151
Site 433
Site 430
Site 436
Site 442
Site 484
Site 184
Site 158
Site 162
Site 460
Site 490
Site 443
Site 459
Site 150
Site 493
Site 463
Site 483
Site 153
Site 160
Site 453
Site 462
Site 401
Site 423
Site 123
Site 182
Site 452
Site 450
Site 481
Site 186
Site 457
Site 480
Site 456
Site 133
Site 435
Site 492
Site 495
Site 441
Site 465
Site 404
Site 461

title: An Extension Treatment Protocol for Subjects Who Have Participated in a Phase 3 Study of Tivozanib vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301).

summary: Open-label, multi-center extension treatment protocol to allow access to tivozanib and sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose and schedule as in AV-951-09-301.


title: Validation of Dyskinesia Rating Scales

summary:
This study will evaluate the responsiveness of a variety of available dyskinesia rating scales to treatment with amantadine or placebo in Parkinson's disease patients with dyskinesia. The study will be a parallel, double-blind, randomized trial of 68 patients treated with amantadine or placebo for 8 weeks. Pre-treatment evaluations will be performed and compared to end of study evaluations on the best treatment dose (200 or 300 mg amantadine or matching placebo) daily. Safety evaluations will be conducted.

The responsiveness of the different scales will be evaluated statistically with a mixed model in which changes in the outcome measures over time will include a fixed effect of treatment group assignment. The model will additionally account for random effects of intercepts (the scale scores at baseline) that will include both random variation (person-specific) and specific variation associated with rate of change in outcome. The investigators may include adjustments for possible confounding covariates, including baseline demographics and center. The goal of the program is to provide researchers with the best scale(s) to distinguish dyskinesia change in Parkinson's disease (PD) associated with amantadine in comparison to placebo and to establish the magnitude of effect achievable with amantadine as a comparator "gold standard" that must be met or surpassed by future anti-dyskinetic agents. Additionally, with the use of paper and pencil questionnaires, the study will investigate the impact of patient optimism and patient and rater expectation of positive effects on the dyskinesia rating outcomes.

lead_sponsor: Rush University Medical Center

location_country:
Austria
United States
Canada
France

location_facility: Oregon Health & Science University (OHSU)

location_facility: Toronto Western Hospital (Movement Disorder Center)

location_facility: Centre d'investigation Clinique, CHU de Toulouse

lead_sponsor_type: academique