ReferenceCitation: Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Perl

full_name: Alexander E Perl

given: Alexander E

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Kovacsovics

full_name: Tibor Kovacsovics

given: Tibor

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Steffen

full_name: Björn Steffen

given: Björn

family: Dombret

full_name: Hervé Dombret

given: Hervé

family: Estey

full_name: Elihu Estey

given: Elihu

family: Strickland

full_name: Stephen Strickland

given: Stephen

family: Altman

full_name: Jessica K Altman

given: Jessica K

family: Baldus

full_name: Claudia D Baldus

given: Claudia D

family: Burnett

full_name: Alan Burnett

given: Alan

family: Krämer

full_name: Alwin Krämer

given: Alwin

family: Russell

full_name: Nigel Russell

given: Nigel

family: Shah

full_name: Neil P Shah

given: Neil P

family: Smith

full_name: Catherine C Smith

given: Catherine C

family: Wang

full_name: Eunice S Wang

given: Eunice S

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

family: Gammon

full_name: Guy Gammon

given: Guy

family: Trone

full_name: Denise Trone

given: Denise

family: Lazzaretto

full_name: Deborah Lazzaretto

given: Deborah

family: Levis

full_name: Mark Levis

given: Mark

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Italy
United States
Netherlands
France
Poland
Spain
Germany
United Kingdom
Canada

location_facility: Instituto Di Ematologia "L.Ea. Seragnoli"

location_facility: Universitatsklinikum Leipzig Selbstandige Abteilung fur Hamatologie

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Centre Hospitalier Universitaire Brabois

location_facility: Institut Paoli Calmettes Centre Regional de Lutte Contre le Cancer

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Centre Hospitalier Regional Universitaire, Hopital de Hautepierre

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Clinica Ematologica

location_facility: Hospital Universitario de Salamanca, Hospital Clinico, Servicio de Hematologia

location_facility: Utrecht University Medical Centre, Dept. of Hematology

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Presidio Ospedaliero "A. Businco" - Centro di Riferimento Oncologico Regionale

location_facility: Uniklinik Essen, Westdeutsches Tumorzentrum

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Universita Degli Studi di Roma Tor Vergata

location_facility: Universitatsklinikum Regensburg Abteilung fur Hamatologie

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Saint James University Hospital, Institute of Oncology

location_facility: Hanmmersmith Hospital, Dept. of Hematology

location_facility: Klinikum rechts der Isar, Technische Universitat Munchen

location_facility: Unita Trapianti di Midollo Osseo per Adulti

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Centre Henry Becquerel, Service d'Hematologie

location_facility: Hospital de la Princesa, Servicio de Hematologia

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Institut Catala d'Oncologia del Hospital Universitari Germans

location_facility: Instituto Catalan de Oncologia-Hospital Universitari de Girona

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z

title: Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations

summary: AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).


ReferenceType: background

ReferenceCitation: Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.

ReferenceCitation: Hulin C, Belch A, Shustik C, Petrucci MT, Dührsen U, Lu J, Song K, Rodon P, Pégourié B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.

ReferenceCitation: Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.

ReferenceCitation: Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.

ReferenceCitation: Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.

ReferenceCitation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathé Y, Facon T. A predictive model for risk of early grade ≥ 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

ReferenceCitation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

ReferenceCitation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

ReferenceCitation: Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.

ReferenceCitation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

ReferenceCitation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

ReferenceType: result

ReferenceCitation: Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.

family: Bahlis

full_name: N J Bahlis

given: N J

sequence: first

family: Corso

full_name: A Corso

given: A

sequence: additional

family: Mugge

full_name: L-O Mugge

given: L-O

family: Shen

full_name: Z-X Shen

given: Z-X

family: Desjardins

full_name: P Desjardins

given: P

family: Stoppa

full_name: A-M Stoppa

given: A-M

family: Decaux

full_name: O Decaux

given: O

family: de Revel

full_name: T de Revel

given: T

family: Granell

full_name: M Granell

given: M

family: Marit

full_name: G Marit

given: G

family: Nahi

full_name: H Nahi

given: H

family: Demuynck

full_name: H Demuynck

family: Huang

full_name: S-Y Huang

given: S-Y

family: Basu

full_name: S Basu

given: S

family: Guthrie

full_name: T H Guthrie

given: T H

family: Ervin-Haynes

full_name: A Ervin-Haynes

family: Marek

full_name: J Marek

given: J

family: Chen

full_name: G Chen

family: Facon

full_name: T Facon

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Leukemia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

ReferenceCitation: Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.

name: Peking University People's Hospital; Beijing China

name: Gachon University Gil Hospital; Incheon Korea

name: National Taiwan University Hospital; Taipei Taiwan

name: Institute of Haematology and Blood Diseases Hospital; Chinese Academy of Medical Sciences and Peking Union Medical College; Tianjin China

name: Chonnam National University Hwasun Hospital; Hwasun-gun Jeonnam Korea

name: West China Hospital of Sichuan University; Chengdu China

name: Seoul National University Hospital; Seoul Korea

name: Sungkyunkwan University; Samsung Medical Centre; Seoul Korea

name: Ruijin Hospital; Shanghai Jiaotong University; Shanghai China

name: National Cancer Centre; Gyeonggi-do Korea

name: Beijing Chao-Yang Hospital; Beijing China

name: The Catholic University of Korea; Seoul Korea

name: Hallym University Sacred Heart Hospital; Anyang Korea

name: Seoul National University Bundang Hospital; Seongnam Korea

name: Chonbuk National University Hospital; Jeonju Korea

name: Hospital University Centre (CHU); Bordeaux France

name: Service des Maladies du Sang; Hôpital Claude Huriez; Lille France

location_country:
Italy
Austria
United States
Sweden
Switzerland
Spain
Germany
France
Greece
Ireland
Australia
Belgium
New Zealand
China
Canada
United Kingdom
Korea, Republic of
Taiwan
Portugal

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH

location_facility: Oncologia Medica, Università della Magna Grecia

location_facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie

location_facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

location_facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital of the Barmherzigen Bruder Vienna

location_facility: University of Tennessee Cancer Institute

location_facility: Clinique Pont de chaume Oncologie et Radiotherapie

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Belfast City Hospital Haematology Department

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Cedar Sinai Medical Center Dept of Medicine

location_facility: Casa di Cura La Maddalena, Divisione di Ematologia

location_facility: Abteilung Onkologie Haematologie des Kantonsspitals Aarau

location_facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia

location_facility: Maine Center for Cancer Medicine Blood Disorders

location_facility: CHUQ - Hotel-Dieu de QuebecHematology - Oncology

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Daegu Catholic University Medical Center 3056-6

location_facility: Medizinische Fakultat der Universitat Rostock

location_facility: Seoul National University Bundang Hospital

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Dept of Haematology St Bartholomews Hospital

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: Unità Operativa di Oncoematologia, Ospedale di Matera

location_facility: Hwasun Chonnam National University Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Staedtische Kliniken Frankfurt am Main Hochst

location_facility: U.O. di Ematologia e Trapianto di Midollo Osseo

location_facility: Alexandra Hospital, University of Athens

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: West China Hospital of Sichuan University

location_facility: Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College

location_facility: Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: University of California, San Francisco- California

title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.

summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.


title: Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus

acronym: PANDORA

summary: Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Sanna G, Alesso D, Mediati M, Cimminiello C, Borghi C, Fazzari AL, Mangrella M; PANDORA study investigators. Prevalence of peripheral arterial disease in subjects with moderate cardiovascular risk: Italian results from the PANDORA study Data from PANDORA (Prevalence of peripheral Arterial disease in subjects with moderate CVD risk, with No overt vascular Diseases nor Diabetes mellitus). BMC Cardiovasc Disord. 2011 Oct 7;11:59. doi: 10.1186/1471-2261-11-59.

family: Sanna

full_name: Guido Sanna

given: Guido

family: Alesso

full_name: Donatella Alesso

given: Donatella

family: Mediati

full_name: Malek Mediati

given: Malek

family: Cimminiello

full_name: Claudio Cimminiello

given: Claudio

family: Borghi

full_name: Claudio Borghi

family: Fazzari

full_name: Amalia Lucia Fazzari

given: Amalia Lucia

family: Mangrella

full_name: Mario Mangrella

given: Mario

currency_apc_doaj: GBP

journal_name: BMC Cardiovascular Disorders

oa_colors: green gold

evidence: oa journal (via doaj)

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Cimminiello C, Borghi C, Kownator S, Wautrecht JC, Carvounis CP, Kranendonk SE, Kindler B, Mangrella M; PANDORA Study Investigators. Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study. BMC Cardiovasc Disord. 2010 Aug 5;10:35. doi: 10.1186/1471-2261-10-35.

family: Kownator

full_name: Serge Kownator

given: Serge

family: Wautrecht

full_name: Jean Claude Wautrecht

given: Jean Claude

family: Carvounis

full_name: Christos P Carvounis

given: Christos P

family: Kranendonk

full_name: Stefanus E Kranendonk

given: Stefanus E

family: Kindler

full_name: Beat Kindler

given: Beat

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

location_country: Italy Switzerland Netherlands France Greece Belgium


title: An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman

acronym: CARIATIDE

summary: This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
Chile
Peru
Sweden
Switzerland
United Kingdom
Finland
Croatia
France
Greece
Venezuela
Romania
Australia
Belgium
Turkey
Czech Republic
Colombia

lead_sponsor_type: industriel

status_simplified: Completed


title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

acronym: VOLT

summary: The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Sweden
United Kingdom
Netherlands
Germany
France
Greece
Slovakia
Norway
Belgium
Australia
Spain
Denmark
Canada
Czech Republic

intervention_type: Drug


title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, Schett G, Amital H, Navarro-Sarabia F, Hou A, Bernasconi C, Huizinga TW. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013 Jan;72(1):43-50. doi: 10.1136/annrheumdis-2011-201282. Epub 2012 May 5.

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Kissel

full_name: Karsten Kissel

given: Karsten

family: Sheeran

full_name: Tom Sheeran

given: Tom

family: Tak

full_name: Paul P Tak

given: Paul P

family: Conaghan

full_name: Philip G Conaghan

given: Philip G

family: Mola

full_name: Emilio Martín Mola

given: Emilio Martín

family: Schett

full_name: Georg Schett

given: Georg

family: Amital

full_name: Howard Amital

given: Howard

family: Navarro-Sarabia

full_name: Federico Navarro-Sarabia

given: Federico

family: Hou

full_name: Antony Hou

given: Antony

family: Bernasconi

full_name: Corrado Bernasconi

given: Corrado

family: Huizinga

full_name: TWJ Huizinga

given: TWJ

journal_name: Annals of the Rheumatic Diseases

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Dougados M, Kissel K, Conaghan PG, Mola EM, Schett G, Gerli R, Hansen MS, Amital H, Xavier RM, Troum O, Bernasconi C, Huizinga TW. Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study. Ann Rheum Dis. 2014 May;73(5):803-9. doi: 10.1136/annrheumdis-2013-204761. Epub 2014 Jan 28.

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

ReferenceCitation: Dougados M, Huizinga TW, Choy EH, Bingham CO 3rd, Aassi M, Bernasconi C. Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1762-6. doi: 10.1002/acr.22633.

name: Leiden University Medical CentreLeiden The Netherlands

name: Cardiff University School of MedicineCardiff UK

name: Johns Hopkins UniversityBaltimore Maryland

name: F. Hoffmann‐La Roche Ltd.Basel Switzerland

title: Evaluation of the Disease Activity Score in Twenty‐Eight Joints–Based Flare Definitions in Rheumatoid Arthritis: Data From a Three‐Year Clinical Trial

ReferenceCitation: Huizinga TW, Conaghan PG, Martin-Mola E, Schett G, Amital H, Xavier RM, Troum O, Aassi M, Bernasconi C, Dougados M. Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study. Ann Rheum Dis. 2015 Jan;74(1):35-43. doi: 10.1136/annrheumdis-2014-205752. Epub 2014 Aug 28.

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

location_country:
Italy
Brazil
Sweden
Serbia
United Kingdom
Netherlands
Germany
Croatia
France
Greece
Israel
Thailand
Norway
Romania
Russian Federation
Spain
Estonia
Denmark
United States
Latvia


title: A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

ReferenceCitation: Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.

family: Nauck

full_name: M. Nauck

given: M.

family: Horton

full_name: E. Horton

given: E.

family: Andjelkovic

full_name: M. Andjelkovic

family: Ampudia-Blasco

full_name: F. J. Ampudia-Blasco

given: F. J.

family: Parusel

full_name: C. T. Parusel

given: C. T.

family: Boldrin

full_name: M. Boldrin

family: Balena

full_name: R. Balena

given: R.

journal_name: Diabetic Medicine

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Guatemala
Finland
Greece
Australia
Belgium
Russian Federation
Czech Republic
France
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
New Zealand
Spain


title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

summary: The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

ReferenceCitation: Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.

ReferenceCitation: Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.

ReferenceCitation: Malavera A, You S, Zheng D, Delcourt C, Anderson CS; INTERACT2 Investigators. Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study. J Neurol Sci. 2021 Apr 15;423:117364. doi: 10.1016/j.jns.2021.117364. Epub 2021 Feb 26.

family: Malavera

full_name: Alejandra Malavera

given: Alejandra

family: You

full_name: Shoujiang You

given: Shoujiang

family: Zheng

full_name: Danni Zheng

given: Danni

family: Delcourt

full_name: Candice Delcourt

given: Candice

family: Anderson

full_name: Craig S. Anderson

given: Craig S.

journal_name: Journal of the Neurological Sciences

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study

ReferenceCitation: Sandset EC, Wang X, Carcel C, Sato S, Delcourt C, Arima H, Stapf C, Robinson T, Lavados P, Chalmers J, Woodward M, Anderson CS. Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2. Eur Stroke J. 2020 Dec;5(4):345-350. doi: 10.1177/2396987320957513. Epub 2020 Sep 20.

name: Department of Neurology, Oslo University Hospital, Oslo, Norway

family: Sandset

full_name: Else Charlotte Sandset

given: Else Charlotte

name: The George Institute for Global Health, University of New South Wales, Sydney, Australia

name: Central Clinical School, University of Sydney, Sydney, Australia

family: Wang

full_name: Xia Wang

given: Xia

name: Neurology Department, Royal Prince Alfred Hospital, Sydney, Australia

family: Carcel

full_name: Cheryl Carcel

given: Cheryl

name: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan

family: Sato

full_name: Shoichiro Sato

given: Shoichiro

name: Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan

family: Arima

full_name: Hisatomi Arima

given: Hisatomi

name: Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CRCHUM), Département de Neurosciences, Université de Montréal, Montréal, Canada

family: Stapf

full_name: Christian Stapf

given: Christian

name: Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK

family: Robinson

full_name: Thompson Robinson

given: Thompson

name: Unidad de Neurología vascular, Servicio de Neurología, Departamento de Medicina, Clínica Alemana; Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile

family: Lavados

full_name: Pablo Lavados

given: Pablo

family: Chalmers

full_name: John Chalmers

given: John

name: The George Institute for Global Health, Imperial College London, UK

name: Department of Epidemiology, Johns Hopkins University, Baltimore, USA

family: Woodward

full_name: Mark Woodward

given: Mark

name: The George Institute China at Peking University Health Science Center, Beijing, China

full_name: Craig S Anderson

given: Craig S

journal_name: European Stroke Journal

evidence: open (via free pdf)

ReferenceCitation: Song L, Wang X, Ouyang M, Sun L, Chen X, Arima H, Sandset EC, Delcourt C, Wang J, Chen G, Robinson T, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Associations of an Abnormal Physiological Score With Outcomes in Acute Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2021 Jan;52(2):722-725. doi: 10.1161/STROKEAHA.120.030435. Epub 2021 Jan 11.

name: The George Institute China, Peking University Health Science Center, Beijing (L. Song, L. Sun, C.S.A.).

name: George Institute for Global Health, Sydney, Australia (L. Song, X.W., M.O., X.C., H.A., C.D., R.I.L, J.C., C.S.A.).

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (L. Song, X.W., M.O., X.C., C.D., J.C., C.S.A.).

name: Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Japan (H.A.).

name: Stroke Unit, Department of Neurology, Oslo University Hospital, Norway (E.C.S.).

name: Department of Neurology, Royal Prince Alfred Hospital, Sydney, Australia (C.D., C.S.A.).

name: University of Sydney, Australia (C.D., R.I.L, J.C., C.S.A.).

name: Shanghai Institute of Hypertension, Ruijin Hospital, China (J.W.).

name: Department of Neurology, Xuzhou Central Hospital, Jiangsu, China (G.C.).

name: Department of Cardiovascular Sciences and National Institute of Health Research Leicester Biomedical Research Centre, University of Leicester, United Kingdom (T.R.).

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Associations of an Abnormal Physiological Score With Outcomes in Acute Intracerebral Hemorrhage

ReferenceCitation: Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.

name: The George Institute for Global Health, University of New South Wales, Australia (X.W., Q.L., R.L., D.Z., C.D., X.C., J.C., C.S.A.).

name: University of Leicester, Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, United Kingdom (T.G.R.).

name: Department of Cardiology, Oslo University Hospital, Norway (E.B.).

name: Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom (T.J.M.).

name: Westmead Hospital, University of Sydney, NSW, Australia (R.L.).

name: Sydney Medical School, The University of Sydney, Australia (C.D.).

name: Neurology Department, Royal Prince Alfred Hospital, Sydney, NSW, Australia (C.D., C.S.A.).

name: Department of Public Health, Fukuoka University, Japan (H.A.).

name: The George Institute China at Peking University Health Science Centre, Beijing, PR China (L.S., C.S.A.).

name: Department of Neurology, the First Affiliated Hospital of Chengdu Medical College, China (J.Y.).

name: Department of Neurology, Oslo University Hospital, Norway (E.C.S.).

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

title: Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome

ReferenceCitation: You S, Zheng D, Delcourt C, Sato S, Cao Y, Zhang S, Yang J, Wang X, Lindley RI, Robinson T, Anderson CS, Chalmers J. Determinants of Early Versus Delayed Neurological Deterioration in Intracerebral Hemorrhage. Stroke. 2019 Jun;50(6):1409-1414. doi: 10.1161/STROKEAHA.118.024403. Epub 2019 Apr 18.

name: From the Department of Neurology, the Second Affiliated Hospital of Soochow University, Suzhou, China (S.Y., Y.C.)

name: Centre for Big Data Research in Health, University of New South Wales, Sydney, Australia (D.Z.)

name: The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (D.Z., C.D., X.W., C.S.A., J.C.)

name: Department of Neurology, Royal Prince Alfred Hospital, Sydney, NSW, Australia (C.D., C.S.A.)

name: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (S.S.)

name: Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (S.Z.)

name: Department of Neurology, the First Affiliated Hospital of Chengdu Medical College, China (J.Y.)

name: Western Clinical School, University of Sydney, NSW, Australia (R.I.L.)

name: Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Centre, University of Leicester, United Kingdom (T.R.)

name: The George Institute China at Peking University Health Science Center, Beijing, PR China (C.S.A.).

title: Determinants of Early Versus Delayed Neurological Deterioration in Intracerebral Hemorrhage

ReferenceCitation: Wang X, Sandset EC, Moullaali TJ, Chen G, Song L, Carcel C, Delcourt C, Woodward M, Robinson T, Chalmers J, Arima H, Anderson CS; INTERACT2 Investigators. Determinants of the high admission blood pressure in mild-to-moderate acute intracerebral hemorrhage. J Hypertens. 2019 Jul;37(7):1463-1466. doi: 10.1097/HJH.0000000000002056.

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

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

title: Determinants of the high admission blood pressure in mild-to-moderate acute intracerebral hemorrhage

ReferenceCitation: Chen R, Wang X, Anderson CS, Robinson T, Lavados PM, Lindley RI, Chalmers J, Delcourt C. Infratentorial Intracerebral Hemorrhage. Stroke. 2019 May;50(5):1257-1259. doi: 10.1161/STROKEAHA.118.023766.

name: From the Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu (R.C.)

name: George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.W., C.S.A., R.I.L., J.C., C.D.)

name: George Institute China at Peking University Medical Science Center, Beijing (C.S.A.)

name: Department of Cardiovascular Sciences and National Institute for Health Research Biomedical Research Unit in Cardiovascular Disease, University of Leicester, United Kingdom (T.R.)

name: Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago (P.M.L.)

name: Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina, Universidad del Desarrollo, Santiago, Chile (P.M.L.)

title: Infratentorial Intracerebral Hemorrhage

ReferenceCitation: Moullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12.

name: The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia

name: Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK

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

name: Department of Neurology, University of Missouri, Columbia, MO, USA

name: Neurology Department, Royal Prince Alfred Hospital, Sydney, NSW, Australia

ReferenceCitation: Delcourt C, Sato S, Zhang S, Sandset EC, Zheng D, Chen X, Hackett ML, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Robinson T, Davies L, Lavados PM, Lindley RI, Stapf C, Chalmers J, Anderson CS; INTERACT2 Investigators. Intracerebral hemorrhage location and outcome among INTERACT2 participants. Neurology. 2017 Apr 11;88(15):1408-1414. doi: 10.1212/WNL.0000000000003771. Epub 2017 Feb 24.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_normalized: HELDA - Digital Repository of the University of Helsinki

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

repository_institution: University of Leicester - Leicester Research Archive

repository_institution: University of Central Lancashire - CLOK - Central Lancashire Online Knowledge

repositories: HELDA - Digital Repository of the University of Helsinki

repositories: University of Melbourne - Minerva Access

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

repositories_institution: University of Central Lancashire - CLOK - Central Lancashire Online Knowledge

repositories_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Melbourne - Minerva Access

title: Intracerebral hemorrhage location and outcome among INTERACT2 participants

ReferenceCitation: Delcourt C, Zheng D, Chen X, Hackett M, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Woodward M, Huang Y, Robinson T, Lavados PM, Lindley RI, Stapf C, Davies L, Chalmers J, Anderson CS, Sato S; INTERACT Investigators. Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):70-75. doi: 10.1136/jnnp-2016-314414. Epub 2016 Oct 21.

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

title: Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies

ReferenceCitation: Muñoz Venturelli P, Wang X, Zahuranec DB, Lavados PM, Stapf C, Lindley R, Delcourt C, Chalmers J, Anderson CS, Robinson TG, Robinson TG; INTERACT2 Investigators. Withdrawal of active treatment after intracerebral haemorrhage in the INTERACT2 study. Age Ageing. 2017 Mar 1;46(2):329-332. doi: 10.1093/ageing/afw187.

name: Neurological and Mental Health division, The George Institute for Global Health, Sydney, New South Wales, Australia

name: School of Public Health, University of Sydney, Sydney, NSW, Australia

name: Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Medicina Interna, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile

name: Stroke Program, Department of Neurology, University of Michigan, Ann Arbor, USA

name: Departamento de Ciencias Neurológicas, Universidad de Chile, Santiago, Chile

name: Department of Neurology and Department of Neuroscience, CRCHUM, University of Montreal, Quebec, Canada

name: Department of Cardiovascular Sciences and NIHR Biomedical Research Unit in Cardiovascular Disease, University of Leicester, Leicester, UK

title: Withdrawal of active treatment after intracerebral haemorrhage in the INTERACT2 study

ReferenceCitation: Song L, Sandset EC, Arima H, Heeley E, Delcourt C, Chen G, Yang J, Wu G, Wang X, Lavados PM, Huang Y, Stapf C, Wang J, Robinson TG, Chalmers J, Lindley RI, Anderson CS; INTERACT2 Investigators. Early blood pressure lowering in patients with intracerebral haemorrhage and prior use of antithrombotic agents: pooled analysis of the INTERACT studies. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1330-1335. doi: 10.1136/jnnp-2016-313246. Epub 2016 May 13.

title: Early blood pressure lowering in patients with intracerebral haemorrhage and prior use of antithrombotic agents: pooled analysis of the INTERACT studies

ReferenceCitation: Qiu M, Sato S, Zheng D, Wang X, Carcel C, Hirakawa Y, Sandset EC, Delcourt C, Arima H, Wang J, Chalmers J, Anderson CS; INTERACT Investigators*. Admission Heart Rate Predicts Poor Outcomes in Acute Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial Studies. Stroke. 2016 Jun;47(6):1479-85. doi: 10.1161/STROKEAHA.115.012382. Epub 2016 May 10.

name: From the Neurological and Mental Health Division, The George Institute for Global Health, The University of Sydney, Sydney, New South Wales, Australia (M.Q., S.S., D.Z., X.W., C.C., Y.H., E.C.S., C.D., J.C., C.S.A.); The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China (M.Q., J.W.); Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan (S.S.); Neurology Department, Royal Prince Alfred Hospital, Sydney, New...

title: Admission Heart Rate Predicts Poor Outcomes in Acute Intracerebral Hemorrhage

ReferenceCitation: Carcel C, Wang X, Sato S, Stapf C, Sandset EC, Delcourt C, Arima H, Robinson T, Lavados P, Chalmers J, Anderson CS; INTERACT2 Investigators*. Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage: Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial-2 Results. Stroke. 2016 Jun;47(6):1651-3. doi: 10.1161/STROKEAHA.116.013326. Epub 2016 May 3.

name: From the Neurological and Mental Health Division, The George Institute for Global Health, Sydney, New South Wales, Australia (C.C., X.W., S.S., E.C.S., C.D., H.A., J.C., C.S.A.); Sydney Medical School, the University of Sydney, Sydney, New South Wales, Australia (C.C., X.W., C.D., J.C., C.S.A.); Department of Neurology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (C.C, C.D, J.C., C.S.A.); Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita,...

title: Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage

ReferenceCitation: Delcourt C, Zhang S, Arima H, Sato S, Al-Shahi Salman R, Wang X, Davies L, Stapf C, Robinson T, Lavados PM, Chalmers J, Heeley E, Liu M, Lindley RI, Anderson CS; INTERACT2 investigators. Significance of Hematoma Shape and Density in Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial Study. Stroke. 2016 May;47(5):1227-32. doi: 10.1161/STROKEAHA.116.012921. Epub 2016 Apr 12.

name: From the Neurology Department, Royal Prince Alfred Hospital, Sydney, Australia (C.D., L.D., C.S.A.); Neurological and Mental Health Division, The George Institute for Global Health, Sydney, New South Wales, Australia (H.A., S.S., X.W., J.C., E.H., R.I.L.); Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (S.Z., M.L.); Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom (R.A.-S.S.); Division of Clinical Neurosciences, Centre de...

title: Significance of Hematoma Shape and Density in Intracerebral Hemorrhage

ReferenceCitation: Muñoz-Venturelli P, Wang X, Lavados PM, Stapf C, Robinson T, Lindley R, Heeley E, Delcourt C, Chalmers J, Anderson CS; INTERACT2 Investigators. Prophylactic heparin in acute intracerebral hemorrhage: a propensity score-matched analysis of the INTERACT2 study. Int J Stroke. 2016 Jul;11(5):549-56. doi: 10.1177/1747493016641113. Epub 2016 Mar 23.

name: The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia

name: Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Medicina, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile

name: Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago, Chile

name: Department of Neuroscience, CRCHUM, University of Montreal, Montreal, Quebec, Canada

name: on behalf of the INTERACT2 Investigators

title: Prophylactic heparin in acute intracerebral hemorrhage: a propensity score-matched analysis of the INTERACT2 study

ReferenceCitation: Zheng D, Arima H, Sato S, Gasparrini A, Heeley E, Delcourt C, Lo S, Huang Y, Wang J, Stapf C, Robinson T, Lavados P, Chalmers J, Anderson CS; INTERACT2 investigators. Low Ambient Temperature and Intracerebral Hemorrhage: The INTERACT2 Study. PLoS One. 2016 Feb 9;11(2):e0149040. doi: 10.1371/journal.pone.0149040. eCollection 2016.

title: Low Ambient Temperature and Intracerebral Hemorrhage: The INTERACT2 Study

ReferenceCitation: Sato S, Delcourt C, Heeley E, Arima H, Zhang S, Al-Shahi Salman R, Stapf C, Woo D, Flaherty ML, Vagal A, Levi C, Davies L, Wang J, Robinson T, Lavados PM, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Significance of Cerebral Small-Vessel Disease in Acute Intracerebral Hemorrhage. Stroke. 2016 Mar;47(3):701-7. doi: 10.1161/STROKEAHA.115.012147. Epub 2016 Feb 4.

name: From the Neurological and Mental Health Division, George Institute for Global Health, Sydney, New South Wales, Australia (S.S., C.D., E.H., H.A., R.I.L., J.C., C.S.A.); Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (S.S.); Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia (C.D., E.H., H.A., L.D., R.I.L., J.C., C.S.A.); Neurology Department, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia...

title: Significance of Cerebral Small-Vessel Disease in Acute Intracerebral Hemorrhage

ReferenceCitation: Saxena A, Anderson CS, Wang X, Sato S, Arima H, Chan E, Muñoz-Venturelli P, Delcourt C, Robinson T, Stapf C, Lavados PM, Wang J, Neal B, Chalmers J, Heeley E; INTERACT2 Investigators. Prognostic Significance of Hyperglycemia in Acute Intracerebral Hemorrhage: The INTERACT2 Study. Stroke. 2016 Mar;47(3):682-8. doi: 10.1161/STROKEAHA.115.011627. Epub 2016 Jan 26.

name: From the The George Institute for Global Health, Royal Prince Alfred Hospital, Sydney, NSW, Australia (A.S., C.S.A., X.W., S.S., H.A., E.C., P.M.-V., C.D., B.N., J.C., E.H.); Central Clinical School, University of Sydney, Sydney, Australia (A.S., C.S.A., X.W., E.C., P.M.-V., C.D., B.N., J.C., E.H.); Center for Epidemiologic Research in Asia, Shiga University of Medical Science, Japan (H.A.); Clínica Alemana de Santiago, Universidad del Desarrollo, Chile (P.M.-V., P.M.L.); Department of...

title: Prognostic Significance of Hyperglycemia in Acute Intracerebral Hemorrhage

ReferenceCitation: Yu S, Arima H, Heeley E, Delcourt C, Krause M, Peng B, Yang J, Wu G, Chen X, Chalmers J, Anderson CS; INTERACT2 Investigators. White blood cell count and clinical outcomes after intracerebral hemorrhage: The INTERACT2 trial. J Neurol Sci. 2016 Feb 15;361:112-6. doi: 10.1016/j.jns.2015.12.033. Epub 2015 Dec 22.

title: White blood cell count and clinical outcomes after intracerebral hemorrhage: The INTERACT2 trial

ReferenceCitation: Moullaali TJ, Sato S, Wang X, Rabinstein AA, Arima H, Carcel C, Chen G, Robinson T, Heeley E, Chan E, Delcourt C, Stapf C, Cordonnier C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of delayed intraventricular haemorrhage in the INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):19-24. doi: 10.1136/jnnp-2015-311562. Epub 2016 Jan 8.

title: Prognostic significance of delayed intraventricular haemorrhage in the INTERACT studies

ReferenceCitation: Wang X, Arima H, Yang J, Zhang S, Wu G, Woodward M, Muñoz-Venturelli P, Lavados PM, Stapf C, Robinson T, Heeley E, Delcourt C, Lindley RI, Parsons M, Chalmers J, Anderson CS; INTERACT2 Investigators. Mannitol and Outcome in Intracerebral Hemorrhage: Propensity Score and Multivariable Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial 2 Results. Stroke. 2015 Oct;46(10):2762-7. doi: 10.1161/STROKEAHA.115.009357. Epub 2015 Aug 11.

name: From The George Institute for Global Health, School of Public Health, the University of Sydney, Sydney, Australia (X.W., H.A., M.W., P.M.-V., E.H., C.D., R.I.L., J.C., C.S.A.); Neurology Department, Royal Prince Alfred Hospital, Sydney, Australia (C.D., C.S.A.); Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (J.Y.); Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (S.Z.); Department of Neurology, Hebei Yutian Hospital,...

title: Mannitol and Outcome in Intracerebral Hemorrhage

ReferenceCitation: Sato S, Arima H, Heeley E, Hirakawa Y, Delcourt C, Lindley RI, Robinson T, Huang Y, Morgenstern L, Stapf C, Wang J, Chalmers J, Anderson CS; INTERACT2 Investigators. Off-Hour Admission and Outcomes in Patients with Acute Intracerebral Hemorrhage in the INTERACT2 Trial. Cerebrovasc Dis. 2015;40(3-4):114-20. doi: 10.1159/000434690. Epub 2015 Jul 18.

title: Off-Hour Admission and Outcomes in Patients with Acute Intracerebral Hemorrhage in the INTERACT2 Trial

ReferenceCitation: Heeley E, Anderson CS, Woodward M, Arima H, Robinson T, Stapf C, Parsons M, Lavados PM, Huang Y, Wang Y, Crozier S, Parry-Jones A, Wang J, Chalmers J; INTERACT2 Investigators. Poor utility of grading scales in acute intracerebral hemorrhage: results from the INTERACT2 trial. Int J Stroke. 2015 Oct;10(7):1101-7. doi: 10.1111/ijs.12518. Epub 2015 Jun 4.

name: Royal Prince Alfred Hospital, Sydney, NSW, Australia

name: The George Institute for Global Health, University of Oxford, Oxford, UK

name: Seta University of Medical Science, Tsukinowa-cho, Otsu, Shiga, Japan

name: Department of Neurology, APHP – Hôpital Lariboisière and DHU NeuroVasc Paris – Sorbonne, Univ Paris Diderot – Sorbonne Paris Cité, Paris, France

name: Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia

name: Servicio de Neurología, Departamento de Medicina, Clínica Alemana, Centro de Neurociencias, Universidad del Desarrollo, Santiago, Chile

name: Department of Neurology, Peking University First Hospital, Beijing, China

name: Hejian City People's Hospital, Hebei, China

name: Stroke unit, Pitié-Salpêtriere Hospital, Paris, AP-HP, France

name: Salford Royal NHS Foundation Trust, Salford, UK

name: The Shanghai Institute of Hypertension, Rui Jin Hospital, Shanghai Jiaotong University, Shanghai, China

title: Poor Utility of Grading Scales in Acute Intracerebral Hemorrhage: Results from the Interact2 Trial

ReferenceCitation: Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS. Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies. Cerebrovasc Dis. 2015;39(3-4):242-8. doi: 10.1159/000381107. Epub 2015 Mar 25.

ReferenceCitation: Wang X, Arima H, Heeley E, Delcourt C, Huang Y, Wang J, Stapf C, Robinson T, Woodward M, Chalmers J, Anderson CS; INTERACT2 Investigators. Magnitude of blood pressure reduction and clinical outcomes in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial study. Hypertension. 2015 May;65(5):1026-32. doi: 10.1161/HYPERTENSIONAHA.114.05044. Epub 2015 Mar 23.

name: From the George Institute for Global Health, Neurological and Mental Health Division, University of Sydney, Royal Prince Alfred Hospital, Sydney, Australia (X.W., H.A., E.H., C.D., M.W., J.C., C.S.A.); Department of Neurology, Peking University First Hospital, Beijing, China (Y.H.); Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China (J.W.); Department of Neurology,...

title: Magnitude of Blood Pressure Reduction and Clinical Outcomes in Acute Intracerebral Hemorrhage

ReferenceCitation: Yang J, Arima H, Wu G, Heeley E, Delcourt C, Zhou J, Chen G, Wang X, Zhang S, Yu S, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of perihematomal edema in acute intracerebral hemorrhage: pooled analysis from the intensive blood pressure reduction in acute cerebral hemorrhage trial studies. Stroke. 2015 Apr;46(4):1009-13. doi: 10.1161/STROKEAHA.114.007154. Epub 2015 Feb 24.

name: From the Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (J.Y., J.Z.); The George Institute for Global Health, Central Clinical School, University of Sydney and Department of Neurology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (J.Y., H.A., G.W., E.H., C.D., G.C., X.W., S.Z., S.Y., J.C., C.S.A.); Department of Neurology, Hebei Yutian Hospital, Tangshan, China (G.W.); Department of Neurology, Xuzhou Central Hospital, Xuzhou, China (G...

title: Prognostic Significance of Perihematomal Edema in Acute Intracerebral Hemorrhage

ReferenceCitation: Chan E, Anderson CS, Wang X, Arima H, Saxena A, Moullaali TJ, Heeley E, Delcourt C, Wu G, Wang J, Chen G, Lavados PM, Stapf C, Robinson T, Chalmers J, Huang Y; INTERACT2 Investigators. Significance of intraventricular hemorrhage in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial results. Stroke. 2015 Mar;46(3):653-8. doi: 10.1161/STROKEAHA.114.008470. Epub 2015 Feb 12.

name: From the George Institute for Global Health, Neurological and Mental Health Division, Royal Prince Alfred Hospital, Sydney, Australia (E.C., C.S.A., X.W., H.A., A.S., T.J.M., E.H., C.D., J.C.); Central Clinical School, University of Sydney, Sydney, Australia (E.C., C.S.A., X.W., H.A., A.S., E.H., C.D., J.C.); Department of Neurology, Hebei Yutian Hospital, Tangshan, China (G.W., J.W.); Department of Neurology, Xuzhou Central Hospital, Jiangsu, China (G.C.); Servicio de Neurología, Departamento de...

title: Significance of Intraventricular Hemorrhage in Acute Intracerebral Hemorrhage

ReferenceCitation: Priglinger M, Arima H, Anderson C, Krause M; INTERACT Investigators. No relationship of lipid-lowering agents to hematoma growth: pooled analysis of the intensive blood pressure reduction in acute cerebral hemorrhage trials studies. Stroke. 2015 Mar;46(3):857-9. doi: 10.1161/STROKEAHA.114.007664. Epub 2015 Feb 5.

name: From the Department of Neurology, Stroke Network, Royal North Shore Hospital, Sydney, Australia (M.P., M.K.); Department of Neurology, George Institute for Global Health, Royal Prince Alfred Hospital, Sydney, Australia (H.A., C.A.); and Sydney Medical School,University of Sydney, Sydney, Australia (M.K., H.A., C.A.).

title: No Relationship of Lipid-Lowering Agents to Hematoma Growth

ReferenceCitation: Sato S, Heeley E, Arima H, Delcourt C, Hirakawa Y, Pamidimukkala V, Li Z, Tao Q, Xu Y, Hennerici MG, Robinson T, Tzourio C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators, Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang LJ, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J. Higher mortality in patients with right hemispheric intracerebral haemorrhage: INTERACT1 and 2. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1319-23. doi: 10.1136/jnnp-2014-309870. Epub 2015 Jan 14.

title: Higher mortality in patients with right hemispheric intracerebral haemorrhage: INTERACT1 and 2

ReferenceCitation: Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS; INTERACT Investigators. Clinical prediction algorithm (BRAIN) to determine risk of hematoma growth in acute intracerebral hemorrhage. Stroke. 2015 Feb;46(2):376-81. doi: 10.1161/STROKEAHA.114.006910. Epub 2014 Dec 11.

name: From the The George Institute for Global Health, University of Sydney, Sydney, Australia (X.W., H.A., M.W., E.H., C.D., C.S.A.); Royal Prince Alfred Hospital, Sydney, Australia (X.W., H.A., M.W., E.H., C.D., C.S.A.); Division of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK (R.A.-S.S.); Department of Neurology, APHP—HôpitalLariboisière and DHU NeuroVasc Paris—Sorbonne, Univ Paris Diderot—Sorbonne Paris Cité, Paris, France (C.S.); Servicio de...

title: Clinical Prediction Algorithm (BRAIN) to Determine Risk of Hematoma Growth in Acute Intracerebral Hemorrhage

ReferenceCitation: Rådholm K, Arima H, Lindley RI, Wang J, Tzourio C, Robinson T, Heeley E, Anderson CS, Chalmers J; INTERACT2 Investigators. Older age is a strong predictor for poor outcome in intracerebral haemorrhage: the INTERACT2 study. Age Ageing. 2015 May;44(3):422-7. doi: 10.1093/ageing/afu198. Epub 2014 Dec 13.

title: Older age is a strong predictor for poor outcome in intracerebral haemorrhage: the INTERACT2 study

ReferenceCitation: Manning L, Hirakawa Y, Arima H, Wang X, Chalmers J, Wang J, Lindley R, Heeley E, Delcourt C, Neal B, Lavados P, Davis SM, Tzourio C, Huang Y, Stapf C, Woodward M, Rothwell PM, Robinson TG, Anderson CS; INTERACT2 investigators. Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial. Lancet Neurol. 2014 Apr;13(4):364-73. doi: 10.1016/S1474-4422(14)70018-3. Epub 2014 Feb 13.

title: Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial

ReferenceCitation: Chen G, Arima H, Wu G, Heeley E, Delcourt C, Zhang P, Rabinstein AA, Robinson T, Stapf C, Huang Y, Song L, Yang J, Wang X, Li Q, Chen X, Chalmers J, Anderson C; INTERACT2 Investigators. Subarachnoid extension of intracerebral hemorrhage and 90-day outcomes in INTERACT2. Stroke. 2014 Jan;45(1):258-60. doi: 10.1161/STROKEAHA.113.003524. Epub 2013 Oct 22.

name: From the Department of Neurology (G.C.) and Department of Cardiology (P.Z.), Xuzhou Central Hospital, Jiangsu, China; The George Institute for Global Health, University of Sydney, Sydney, Australia (G.C., H.A., G.W., E.H., C.D., L.S., J.Y., X.W., Q.L., X.C., J.C., C.A.); Department of Neurology, Hebei Yutian Hospital, Tang Shan, China (G.W.); Department of Neurology, Mayo Clinic, Rochester, MN (A.A.R.); Department of Cardiovascular Sciences and NIHR Biomedical Research Unit for Cardiovascular...

title: Subarachnoid Extension of Intracerebral Hemorrhage and 90-Day Outcomes in INTERACT2

ReferenceCitation: Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repository_institution: University of Newcastle, Australia - NOVA

repositories_institution: The University of Sydney - The Sydney eScholarship Repository

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

repositories_institution: University of Newcastle, Australia - NOVA

title: Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage

ReferenceCitation: Delcourt C, Stapf C, Tzourio C, Héritier S, Anderson C. [The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): protocol and baseline characteristics of patients included in France]. Rev Neurol (Paris). 2012 Apr;168(4):321-7. doi: 10.1016/j.neurol.2011.08.010. Epub 2011 Nov 29. French.

title: La seconde phase d’une étude randomisée, multicentrique évaluant en ouvert l’effet de la réduction intensive de la pression artérielle dans l’hémorragie cérébrale (INTERACT2) : protocole et caractéristiques des patients inclus en France

location_country:
Italy
Austria
Brazil
Chile
India
Hong Kong
Spain
Switzerland
Germany
Pakistan
Finland
France
Argentina
Australia
Belgium
China
United States
United Kingdom
Portugal

location_facility: Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere

location_facility: Universitatsklinikum Ulm, Oberer Eselsberg

location_facility: Regional Coordinating Centre United Kingdom

location_facility: Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University

location_facility: Hospital General Universitario de Albacete

location_facility: Regional Coordinating Centre China: The George Institute China

location_facility: Regional Coordinating Centre India: The George Institute India

location_facility: Royal Brisbane and Women's Hospital Health Service District


ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos A, Tapson V. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis. 2011 May;31(4):407-16. doi: 10.1007/s11239-011-0549-x.

family: Cohen

full_name: Alexander Thomas Cohen

given: Alexander Thomas

family: Spiro

full_name: Theodore Erich Spiro

given: Theodore Erich

family: Büller

full_name: Harry Roger Büller

given: Harry Roger

family: Haskell

full_name: Lloyd Haskell

given: Lloyd

family: Hu

full_name: Dayi Hu

given: Dayi

family: Hull

full_name: Russell Hull

given: Russell

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Merli

full_name: Geno Merli

given: Geno

family: Schellong

full_name: Sebastian Schellong

given: Sebastian

family: Spyropoulos

full_name: Alex Spyropoulos

given: Alex

family: Tapson

full_name: Victor Tapson

given: Victor

journal_name: Journal of Thrombosis and Thrombolysis

ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

full_name: Alexander T. Cohen

given: Alexander T.

full_name: Theodore E. Spiro

given: Theodore E.

full_name: Harry R. Büller

given: Harry R.

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

title: Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x. Review.

ReferenceCitation: Mebazaa A, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

name: From Université Paris Diderot, PRES Sorbonne Paris Cité and Department of Anesthesiology and Critical Care Medicine, Saint Louis Lariboisière University Hospitals, U942 Inserm, Paris, France (A.M.); Bayer HealthCare Pharmaceuticals Inc, Montville, NJ (T.E.S., Y.D.S.); Academic Medical Center, Amsterdam, The Netherlands (H.R.B.); Janssen Research & Development LLC, Raritan, NJ (L.H.); People’s Hospital of Peking University, Beijing, China (D.H.); Foothills Hospital, Calgary, Alberta, Canada (R.H....

title: Predicting the Risk of Venous Thromboembolism in Patients Hospitalized With Heart Failure

ReferenceCitation: Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.

name: Hofstra North Shore-LIJ School of Medicine; Hempstead NY USA

name: Academic Medical Center; Amsterdam the Netherlands

name: Janssen Research Development; LLC; Raritan NJ USA

name: People's Hospital of Peking University; Beijing China

name: Saint Louis Lariboisière Hospitals; Paris France

name: Thomas Jefferson Hospitals; Philadelphia PA USA

name: Dresden-Friedrichstadt Hospital; Dresden Germany

name: Duke University Medical Center; Durham NC USA

ReferenceCitation: Raskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 10:e021579. doi: 10.1161/JAHA.121.021579. [Epub ahead of print]

name: Hudson College of Public HealthUniversity of Oklahoma Health Sciences Center Oklahoma City OK

name: Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill HospitalThe Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Feinstein Institute for Medical Research New York NY

name: Department of Obstetrics and Gynecology I.M. Sechenov First Moscow State Medical University Moscow Russia

name: Thrombosis and Hematology Therapeutic Area Clinical Development Pharmaceuticals Bayer U.S. LLC Whippany NJ

name: Janssen Research and Development LLC Raritan NJ

name: Janssen Research and Development LLC Titusville NJ

journal_name: Journal of the American Heart Association

title: Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER

ReferenceCitation: Raskob GE, Spyropoulos AC, Cohen AT, Weitz JI, Ageno W, De Sanctis Y, Lu W, Xu J, Albanese J, Sugarmann C, Weber T, Lipardi C, Spiro TE, Barnathan ES. Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients. J Am Heart Assoc. 2021 Feb;10(5):e019459. doi: 10.1161/JAHA.120.019459. Epub 2021 Feb 15.

name: The Feinstein Institutes for Medical Research and Zucker School of Medicine at Hofstra/Northwell Anticoagulation and Clinical Thrombosis Services Department of Medicine Northwell Health at Lenox Hill Hospital New York NY

name: Department of Hematological Medicine Guys and St Thomas/NHS Foundation Trust, King's College London London United Kingdom

name: McMaster University, and the Thrombosis and Atherosclerosis Research Institute Hamilton Ontario Canada

name: Department of Medicine and Surgery University of Insubria Varese Italy

name: Statistics and Data Insights Bayer US LLC Whippany NJ

name: Biostatistics Department Janssen Research and Development LLC Raritan NJ

name: Cardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJ

ReferenceCitation: Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.

journal_name: Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine

ReferenceCitation: Weitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.

name: The Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada

name: College of Public Health, University of Oklahoma, Oklahoma City, Oklahoma, United States

name: The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, New York, United States

name: The Feinstein Institute for Medical Research, New York, New York, United States

name: Department of Medicine, Anticoagulation and Clinical Thrombosis Services, Northwell Health at Lenox Hill Hospital, New York, New York, United States

name: Thrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey, United States

name: Statistics and Data Insights, Bayer U.S. LLC, Whippany, New Jersey, United States

name: Janssen Research and Development LLC, Raritan, New Jersey, United States

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

name: Cardiovascular Division; Departments of Medicine; Beth Israel Deaconess Medical Center; Harvard Medical School; Boston MA USA

name: Cardiovascular Division; Brigham and Women's Hospital; Harvard Medical School; Boston MA USA

name: Department of Biostatistics and Informatics; Colorado School of Public Health; University of Colorado Anschutz Medical Campus; Aurora CO USA

name: Department of Medicine; Hamilton Health Sciences; General Division; Hamilton Ontario Canada

name: Duke University and Duke Clinical Research Institute; Durham NC USA

name: Division of Cardiology; R. A. H. Faculty of Medicine; University of Calgary; Calgary Alberta Canada

name: Portola Pharmaceuticals Inc.; South San Francisco CA USA

name: Department of Haematological Medicine; Guy's and St Thomas' Hospitals; King's College; London UK

name: Division of Cardiovascular Medicine; Department of Medicine; Stanford University; Stanford CA USA

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

name: Department of Neurology, University of Arkansas for Medical Sciences, Little Rock, AR, USA

name: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA

name: Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

location_country:
Luxembourg
Peru
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
India
Pakistan
Croatia
France
Japan
Lithuania
Poland
Norway
Slovakia
Argentina
Thailand
Indonesia
Canada
Slovenia
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: 1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.

location_facility: The 1st Affiliated Hosp of the 4th Military Med Uni

location_facility: Hospital de Agudos "Dr. Carlos Bocalandro"

location_facility: National Hospital Organization Ibaraki Higashi Hospital

title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study

summary: This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.


type: EudraCT Number

type: Other Identifier

title: AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS

acronym: POEM

summary: The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

study_start_date_type: Actual

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: ViiV Healthcare

location_country:
Italy
Brazil
United States
Germany
France
Greece
Belgium
Puerto Rico
Spain
Canada
United Kingdom

location_facility: Yale University School of Medicine Aids Program

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS

location_facility: Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia

location_facility: Hospital General Universitário de Alicante

location_facility: Klinik I fuer Innere Medizin der Uni-Klinik Koeln

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Louisiana State University Health Sciences Center

location_facility: University of Toledo: Health Sciences Campus

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: ID Consultants Inc & Infectious Disease Research Corp.

location_facility: University of Iowa Hospitals and Clinics

location_facility: Michigan State University College of Osteopathic Medicine

location_facility: University of South Carolina School of Medicine

location_facility: Infectomed GbR Zentrum für medizinische Studien

location_facility: University of Oklahoma Health Sciences Center

location_facility: Alta Bates Summit Medical Center East Bay AIDS Center

location_facility: Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria

location_facility: Ambulatorio Day Hospital Malattie Infettive

location_facility: Hospital of the J.W. Goethe University, Medical Clinic II

location_facility: Infectious Disease Research Institute, Inc

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Hôpital Haut - Leveque - Centre Francois Magendie

location_facility: ifi-Institut am Allgemeines Krankenhaus St.Georg

location_facility: Marshall University Joan C. Edwards School of Medicine

location_facility: Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S.

location_facility: A Professional Corporation, Research Department

location_facility: Division of Infectious Diseases, George Washington University Medical Center

location_facility: Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive

location_facility: The Ohio State University Medical Center

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Dipartimento di Medicina Clinica Specialistica e Sperimentale

location_facility: 1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco

location_facility: Royal Free Hospital, Ian Charleson Day Centre

location_facility: SOD Malattie Infettive, La Piastra dei Servizi

location_facility: Montgomery Infectious Disease Associates, P.A. (Private Practice)

location_facility: Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,

location_facility: George Washington University Medical Faculty Assoc

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: AOUP Paolo Giaccone, UOC Malattie Infettive

location_facility: Hospital Universitario Germans Tias I Pujol

location_facility: Tarrant County Infectious Disease Associates

location_facility: Kaiser Permanente Northwest Region, Immune Deficiency Clinic

location_facility: Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik

location_facility: Arztpraxis fuer Innere Medizin Dr. Knechten

location_facility: Michael E. DeBakey Veterans Affairs Medical Center

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

location_facility: Erie County Medical Center, HIV Services

location_facility: UT Southwestern Medical Center HIV/AIDS Research Unit

location_facility: University of California Irvine Medical Center

location_facility: University of British Columbia/ Downtown Infectious Diseases Clinic

location_facility: Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

location_facility: Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt

location_facility: Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Kaiser Permanete of Colorado Rock Creek Medical Offices

location_facility: Centro de Referencia e Treinamento DST/AIDS

location_facility: Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero

location_facility: South Florida Infectious Deisease and Tropical Medicine Center

location_facility: Hopital Jean Verdier, Unite de maladies infectieuses

location_facility: Tarrant County Infectious Disease Assocciates

location_facility: Southern Illinois University School of Medicine

location_facility: Universita'Cattolica del Sacro Cuore Policlinico Gemelli

location_facility: Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital

location_facility: Mount Sinai Downtown Comprehensive Health Program

location_facility: Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali

location_facility: Hull & East Yorkshire Hospitals NHS Trust

location_facility: Infectious Diseases Associates of Central Virginia

location_facility: Centrum fuer interdisziplinaere Medizin Muenster GmbH


title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

summary: The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
Austria
South Africa
France
Poland
Greece
Romania
Hungary
Russian Federation
Spain
Turkey
Germany
Czech Republic


title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

ReferenceCitation: Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.

family: Liu

full_name: Xianchen Liu

given: Xianchen

family: Thompson

full_name: John Thompson

given: John

family: Phatak

full_name: Hemant Phatak

given: Hemant

family: Mardekian

full_name: Jack Mardekian

given: Jack

family: Porcari

full_name: Anthony Porcari

given: Anthony

family: Johnson

full_name: Margot Johnson

given: Margot

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

family: Buller

full_name: Harry R. Buller

full_name: Alexander Cohen

given: Alexander

family: Curto

full_name: Madelyn Curto

given: Madelyn

family: Gallus

full_name: Alexander S. Gallus

given: Alexander S.

family: Raskob

full_name: Gary E. Raskob

given: Gary E.

family: Weitz

full_name: Jeffrey I. Weitz

given: Jeffrey I.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

evidence: oa repository (semantic scholar lookup)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Apixaban for Extended Treatment of Venous Thromboembolism

lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Philippines
Singapore
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Internal Medical Associates Of Grand Island, P.C

location_facility: Anne Arundel Health System Research Institute, Inc.

location_facility: Jobst Vascular Center At The Toledo Hospital

location_facility: Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

location_facility: Primary Care Of The Treasure Coast, Inc.

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: St. Francis Sleep Allergy & Lung Institute

location_facility: Scripps Clinic/Scripps Health And Green Hospital

location_facility: Charleston Hematology Oncology Associates, Pa


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects With Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

ReferenceCitation: Harrington K, Temam S, Mehanna H, D'Cruz A, Jain M, D'Onofrio I, Manikhas G, Horvath Z, Sun Y, Dietzsch S, Dubinsky P, Holeckova P, El-Hariry I, Franklin N, Biswas-Baldwin N, Legenne P, Wissel P, Netherway T, Farrell J, Ellis C, Wang-Silvanto J, Amonkar M, Ahmed N, Santillana S, Bourhis J. Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Oncol. 2015 Dec 10;33(35):4202-9. doi: 10.1200/JCO.2015.61.4370. Epub 2015 Nov 2.

name: Kevin Harrington, Institute of Cancer Research and Royal Marsden Hospital, London; Hisham Mehanna, Institute of Head and Neck Studies and Education, University of Birmingham, Birmingham; Natalie Franklin and John Farrell, GlaxoSmithKline, Uxbridge, United Kingdom; Stephane Temam and Jean Bourhis, Institut Gustave- Roussy, Villejuif; Ida D'Onofrio, Hôpital Forcilles, Paris, France; Anil D'Cruz, Tata Memorial Hospital, Mumbai; Minish Jain, Ruby Hall Clinic–Cancer Centre, Pune, India; Georgy Manikhas, St...

family: Harrington

full_name: Kevin Harrington

given: Kevin

family: Temam

full_name: Stephane Temam

given: Stephane

family: Mehanna

full_name: Hisham Mehanna

given: Hisham

family: D'Cruz

full_name: Anil D'Cruz

given: Anil

family: Jain

full_name: Minish Jain

given: Minish

family: D'Onofrio

full_name: Ida D'Onofrio

given: Ida

family: Manikhas

full_name: Georgy Manikhas

given: Georgy

family: Horvath

full_name: Zsuzsanna Horvath

given: Zsuzsanna

family: Sun

full_name: Yan Sun

given: Yan

family: Dietzsch

full_name: Stefan Dietzsch

given: Stefan

family: Dubinsky

full_name: Pavol Dubinsky

given: Pavol

family: Holeckova

full_name: Petra Holeckova

given: Petra

family: El-Hariry

full_name: Iman El-Hariry

given: Iman

family: Franklin

full_name: Natalie Franklin

given: Natalie

family: Biswas-Baldwin

full_name: Nigel Biswas-Baldwin

given: Nigel

family: Legenne

full_name: Philippe Legenne

given: Philippe

family: Wissel

full_name: Paul Wissel

given: Paul

family: Netherway

full_name: Thelma Netherway

given: Thelma

family: Farrell

full_name: John Farrell

family: Ellis

full_name: Catherine Ellis

given: Catherine

family: Wang-Silvanto

full_name: Jing Wang-Silvanto

given: Jing

family: Amonkar

full_name: Mayur Amonkar

given: Mayur

family: Ahmed

full_name: Nazma Ahmed

given: Nazma

family: Santillana

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Greece
Russian Federation
Czech Republic
India
Croatia
France
Thailand
Slovakia
Argentina
Canada
Hong Kong
Philippines
Hungary
Ireland
China
United States
Germany
United Kingdom
Italy
Austria
Spain
Estonia


title: A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

summary: This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

location_country:
Italy
Switzerland
Mexico
Netherlands
France
Lithuania
Ireland
Belgium
Spain
Germany
United Kingdom


title: An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

summary: This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

family: Moseley

full_name: Brian D. Moseley

given: Brian D.

family: Dimova

full_name: Svetlana Dimova

given: Svetlana

family: Elmoufti

full_name: Sami Elmoufti

given: Sami

family: Laloyaux

full_name: Cédric Laloyaux

given: Cédric

family: Asadi-Pooya

full_name: Ali A. Asadi-Pooya

given: Ali A.

journal_name: Epilepsy Research

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Oxford - Oxford Academix

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Baulac

full_name: Michel Baulac

given: Michel

family: Hong

full_name: Seung Bong Hong

given: Seung Bong

family: Cleveland

full_name: Jody M. Cleveland

given: Jody M.

family: Reichel

full_name: Christoph Reichel

given: Christoph

family: Schulz

full_name: Anne-Liv Schulz

given: Anne-Liv

family: Wagener

full_name: Gilbert Wagener

given: Gilbert

family: Brandt

full_name: Christian Brandt

given: Christian

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

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

title: Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht–Lundborg disease: An open-label, long-term follow-up trial

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

title: Brivaracetam: First Global Approval

location_country:
Finland
Belgium
Russian Federation
Taiwan
Ukraine
France
Poland
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
United States
Germany
Italy
Austria
Serbia
Czechia
Israel
Tunisia
Spain