summary: The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

status: Terminated

ReferenceCitation: ACTIVE Writing Group of the ACTIVE Investigators, Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Pfeffer M, Hohnloser S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006 Jun 10;367(9526):1903-12.

ReferenceCitation: Flaker GC, Pogue J, Yusuf S, Pfeffer MA, Goldhaber SZ, Granger CB, Anand IS, Hart R, Connolly SJ; Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE) Investigators. Cognitive function and anticoagulation control in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):277-83. doi: 10.1161/CIRCOUTCOMES.109.884171. Epub 2010 Mar 16.

name: From the University of Missouri-Columbia (G.C.F.), Columbia, Mo; McMaster University (J.P., S.Y., S.J.C.), Hamilton, Ontario, Canada; Brigham and Women’s Hospital (M.A.P., S.Z.G.), Harvard Medical School, Boston, Mass; Duke University (C.B.G.), Durham, NC; VA Medical Center and University of Minnesota (I.S.A), Minneapolis, Minn; University of Texas (R.H.), San Antonio, Tex.

family: Flaker

full_name: Greg C. Flaker

given: Greg C.

family: Pogue

full_name: Janice Pogue

given: Janice

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Pfeffer

full_name: Marc A. Pfeffer

given: Marc A.

family: Goldhaber

full_name: Samuel Z. Goldhaber

given: Samuel Z.

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Anand

full_name: Inderjit S. Anand

given: Inderjit S.

family: Hart

full_name: Robert Hart

given: Robert

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Cognitive Function and Anticoagulation Control in Patients With Atrial Fibrillation

ReferenceCitation: Cairns JA, Wittes J, Wyse DG, Pogue J, Gent M, Hirsh J, Marler J, Pritchett EL. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J. 2008 Jan;155(1):33-41. Epub 2007 Nov 26. Review.

ReferenceCitation: Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ; ACTIVE W Investigators. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. 2007 Nov 27;50(22):2156-61. Epub 2007 Nov 13.

location_country:
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Poland
Norway
Canada
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey


title: A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)

summary: The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country: Netherlands France Belgium Spain Portugal

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Placebo Controlled Double Blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200, or 300 mg OD, With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

acronym: MAIA

summary: Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Khitri AR, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Kowey PR. Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter. J Cardiovasc Electrophysiol. 2012 May;23(5):462-72. doi: 10.1111/j.1540-8167.2011.02234.x. Epub 2011 Dec 15.

family: KHITRI

full_name: AVINASH R. KHITRI

given: AVINASH R.

sequence: first

family: ALIOT

full_name: ETIENNE M. ALIOT

given: ETIENNE M.

sequence: additional

family: CAPUCCI

full_name: ALESSANDRO CAPUCCI

given: ALESSANDRO

family: CONNOLLY

full_name: STUART J. CONNOLLY

given: STUART J.

family: CRIJNS

full_name: HARRY CRIJNS

given: HARRY

family: HOHNLOSER

full_name: STEFAN H. HOHNLOSER

given: STEFAN H.

family: KULAKOWSKI

full_name: PIOTR KULAKOWSKI

given: PIOTR

family: ROY

full_name: DENIS ROY

given: DENIS

family: RADZIK

full_name: DAVID RADZIK

given: DAVID

family: KOWEY

full_name: PETER R. KOWEY

given: PETER R.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Cardiovascular Electrophysiology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Celivarone for Maintenance of Sinus Rhythm and Conversion of Atrial Fibrillation/Flutter

lead_sponsor: Sanofi

location_country:
Italy
United States
Chile
Sweden
Switzerland
Netherlands
Germany
France
Japan
Poland
Hungary
Argentina
Australia
Russian Federation
Spain
Denmark
Canada

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-Bä, a Mixture of Two Monoclonal Antibodies, as Compared to Hepatitis B Immune Globulin in Patients Who Have Received Hepatic Allografts for Treatment of End-Stage Liver Disease Due to Hepatitis B Virus Infection

summary: The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether or not the drugs prevent the Hepatitis B virus from infecting the new liver.

primary_purpose: Prevention

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
United States
France
Israel
New Zealand
Spain
Germany
United Kingdom

location_facility: Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery

location_facility: Virginia Commonwealth University Health System

location_facility: Metropolitan Liver Diseases/Gastroenterology Center

location_facility: University of Pennsylvania Health System

location_facility: Centre Hepato-Biliaire Hospital Paul Brousse

location_facility: Hospital La Fe Servicio de Medicina Degestiva

status_simplified: Unknown


title: A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

summary: To determine whether UK-390,957 is a safe treatment for premature ejaculation.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Italy
Austria
United States
Sweden
United Kingdom
Germany
France
Poland
Israel
Norway
Australia
Turkey
Canada
Czech Republic


type: EudraCT Number

title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

summary: An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).

ReferenceType: background

ReferenceCitation: Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

name: Department of Immunology CIC1408 GIMAP EA3064 Université Jean Monnet Saint Étienne France

family: Paul

full_name: Stéphane Paul

given: Stéphane

name: Department of Rheumatology SAINBOISE AINBIOSE INSERM 1059 University of Lyon Saint‐Étienne France

family: Marotte

full_name: Hubert Marotte

given: Hubert

name: Division of Rheumatology, Allergy & Immunology University of California San Diego School of Medicine La Jolla California USA

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

name: Department of Rheumatology University Hospital of ToursEA 7501 Tours France

family: Goupille

full_name: Philippe Goupille

given: Philippe

name: Department of Rheumatology Diakonhjemmet Hospital Oslo Norway

family: Kvien

full_name: Tore K. Kvien

given: Tore K.

family: Longueville

full_name: Marc Longueville

given: Marc

family: Mulleman

full_name: Denis Mulleman

given: Denis

name: Department of Medicine University of California San Diego La Jolla California USA

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Vande Casteele

full_name: Niels Vande Casteele

given: Niels

journal_name: Clinical and Translational Science

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

title: Exposure–Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis

ReferenceCitation: Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewé R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16.

family: Keystone

full_name: E. C. Keystone

given: E. C.

family: Combe

full_name: B. Combe

given: B.

family: Smolen

full_name: J. Smolen

given: J.

family: Strand

full_name: V. Strand

given: V.

family: Goel

full_name: N. Goel

given: N.

family: van Vollenhoven

full_name: R. van Vollenhoven

given: R.

family: Mease

full_name: P. Mease

given: P.

ReferenceCitation: van der Heijde D, Keystone EC, Curtis JR, Landewé RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15.

title: Timing and Magnitude of Initial Change in Disease Activity Score 28 Predicts the Likelihood of Achieving Low Disease Activity at 1 Year in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol: A Post-hoc Analysis of the RAPID 1 Trial

ReferenceCitation: Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387.

title: Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: An analysis of individual patient-level data

ReferenceCitation: Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.

ReferenceCitation: Smolen J, Landewé RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Finland
Belgium
Australia
Russian Federation
Ukraine
Croatia
France
Lithuania
Slovakia
Argentina
Canada
Chile
Bulgaria
Hungary
United States
Serbia
Mexico
Czechia
Israel
New Zealand
Estonia
Latvia


type: Registry Identifier

title: PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy

acronym: PROactive

summary: The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.

ReferenceCitation: Bottomley JM, Palmer AJ, Williams R, Dormandy JA, Massi-Benedetti M. PROactive 03: Pioglitazone, type 2 diabetes and reducing macrovascular events - economic implications?. Br J Diabetes Vasc Dis 2006;6(Pt 2):64-69

ReferenceCitation: Kirby,M, Heart Disease Prevention - What Place for the Glitazones. Br J Cardiol 2006;13:(1):66-70.

ReferenceCitation: Brändle M, Goodall G, Erny-Albrecht KM, Erdmann E, Valentine WJ. Cost-effectiveness of pioglitazone in patients with type 2 diabetes and a history of macrovascular disease in a Swiss setting. Swiss Med Wkly. 2009 Mar 21;139(11-12):173-84. doi: smw-12381.

ReferenceCitation: Betteridge DJ, DeFronzo RA, Chilton RJ. PROactive: time for a critical appraisal. Eur Heart J. 2008 Apr;29(8):969-83. doi: 10.1093/eurheartj/ehn114. Epub 2008 Mar 28. Review.

ReferenceCitation: Scherbaum WA, Goodall G, Erny-Albrecht KM, Massi-Benedetti M, Erdmann E, Valentine WJ. Cost-effectiveness of pioglitazone in type 2 diabetes patients with a history of macrovascular disease: a German perspective. Cost Eff Resour Alloc. 2009 May 5;7:9. doi: 10.1186/1478-7547-7-9.

ReferenceCitation: van Troostenburg de Bruyn AR, Dormandy J. Risk of thiazolidinedione-associated fracture should be appropriately assessed. Arch Intern Med. 2010 Jan 25;170(2):209-10. doi: 10.1001/archinternmed.2009.487.

ReferenceCitation: Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK, Skene AM, Tan MH, Lefèbvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Betteridge J, Birkeland K, Golay A, Heine RJ, Korányi L, Laakso M, Mokán M, Norkus A, Pirags V, Podar T, Scheen A, Scherbaum W, Schernthaner G, Schmitz O, Skrha J, Smith U, Taton J; PROactive Investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005 Oct 8;366(9493):1279-89.

ReferenceCitation: Schneider CA, Ferrannini E, Defronzo R, Schernthaner G, Yates J, Erdmann E. Effect of pioglitazone on cardiovascular outcome in diabetes and chronic kidney disease. J Am Soc Nephrol. 2008 Jan;19(1):182-7. Epub 2007 Dec 5. Erratum in: J Am Soc Nephrol. 2016 Sep;27(9):2918.

ReferenceCitation: Rydén L, Thráinsdóttir I, Swedberg K. Adjudication of serious heart failure in patients from PROactive. Lancet. 2007 Jan 20;369(9557):189-90.

ReferenceCitation: Erdmann E, Dormandy J, Wilcox R, Massi-Benedetti M, Charbonnel B. PROactive 07: pioglitazone in the treatment of type 2 diabetes: results of the PROactive study. Vasc Health Risk Manag. 2007;3(4):355-70. Review.

ReferenceCitation: Erdmann E, Dormandy JA. The Effect of Pioglitazone on Recurrent Myocardial Infarction in 2445 Patients with Type 2 Diabetes and Preexisting Myocardial Infarction - Data from the PROactive Study. Circulation 2005;112:(21):3364-3364

ReferenceCitation: Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM; PROactive Investigators. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol. 2007 May 1;49(17):1772-80. Epub 2007 Apr 16.

ReferenceCitation: Valentine WJ, Bottomley JM, Palmer AJ, Brändle M, Foos V, Williams R, Dormandy JA, Yates J, Tan MH, Massi-Benedetti M; PROactive Study Group. PROactive 06: cost-effectiveness of pioglitazone in Type 2 diabetes in the UK. Diabet Med. 2007 Sep;24(9):982-1002. Epub 2007 Jun 25.

ReferenceCitation: Wilcox R, Bousser MG, Betteridge DJ, Schernthaner G, Pirags V, Kupfer S, Dormandy J; PROactive Investigators. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events 04). Stroke. 2007 Mar;38(3):865-73. Epub 2007 Feb 8.

ReferenceCitation: Erdmann E, Charbonnel B, Wilcox RG, Skene AM, Massi-Benedetti M, Yates J, Tan M, Spanheimer R, Standl E, Dormandy JA; PROactive Investigators. Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care. 2007 Nov;30(11):2773-8. Epub 2007 Jul 31.

ReferenceCitation: Valentine WJ, Tucker D, Palmer AJ, Minshall ME, Foos V, Silberman C; PROactive Study Group. Long-term cost-effectiveness of pioglitazone versus placebo in addition to existing diabetes treatment: a US analysis based on PROactive. Value Health. 2009 Jan-Feb;12(1):1-9. doi: 10.1111/j.1524-4733.2008.00403.x. Epub 2008 Jul 24.

family: Valentine

full_name: William J. Valentine

family: Tucker

full_name: Daniel Tucker

given: Daniel

family: Silberman

full_name: Cheryl Silberman

given: Cheryl

family: Minshall

full_name: Michael E. Minshall

given: Michael E.

family: Palmer

full_name: Andrew J. Palmer

given: Andrew J.

family: Foos

full_name: Volker Foos

given: Volker

journal_name: Value in Health

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Long-Term Cost-Effectiveness of Pioglitazone versus Placebo in Addition to Existing Diabetes Treatment: A US Analysis Based on PROactive

ReferenceCitation: Wilcox R, Kupfer S, Erdmann E; PROactive Study investigators. Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10). Am Heart J. 2008 Apr;155(4):712-7. doi: 10.1016/j.ahj.2007.11.029. Epub 2008 Feb 21. Erratum in: Am Heart J. 2008 Aug;156(2):255.

family: Wilcox

full_name: Robert Wilcox

given: Robert

family: Kupfer

full_name: Stuart Kupfer

given: Stuart

family: Erdmann

full_name: Erland Erdmann

given: Erland

journal_name: American Heart Journal

title: Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: Results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10)

ReferenceCitation: Charbonnel B, Dormandy J, Erdmann E, Massi-Benedetti M, Skene A; PROactive Study Group. The prospective pioglitazone clinical trial in macrovascular events (PROactive): can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients. Diabetes Care. 2004 Jul;27(7):1647-53.

ReferenceCitation: Spanheimer R, Betteridge DJ, Tan MH, Ferrannini E, Charbonnel B; PROactive Investigators. Long-term lipid effects of pioglitazone by baseline anti-hyperglycemia medication therapy and statin use from the PROactive experience (PROactive 14). Am J Cardiol. 2009 Jul 15;104(2):234-9. doi: 10.1016/j.amjcard.2009.03.023. Epub 2009 Jun 3.

family: Spanheimer

full_name: Robert Spanheimer

family: Betteridge

full_name: D. John Betteridge

given: D. John

family: Tan

full_name: Meng H. Tan

given: Meng H.

family: Ferrannini

title: Long-Term Lipid Effects of Pioglitazone by Baseline Anti-Hyperglycemia Medication Therapy and Statin Use from the PROactive Experience (PROactive 14)

ReferenceCitation: Scheen AJ, Tan MH, Betteridge DJ, Birkeland K, Schmitz O, Charbonnel B; PROactive investigators. Long-term glycaemic control with metformin-sulphonylurea-pioglitazone triple therapy in PROactive (PROactive 17). Diabet Med. 2009 Oct;26(10):1033-9. doi: 10.1111/j.1464-5491.2009.02816.x.

name: on behalf of the PROactive investigators

ReferenceCitation: Scheen AJ, Tan MH, Betteridge DJ, Birkeland K, Schmitz O, Charbonnel B; PROactive investigators. Long-term glycaemic effects of pioglitazone compared with placebo as add-on treatment to metformin or sulphonylurea monotherapy in PROactive (PROactive 18). Diabet Med. 2009 Dec;26(12):1242-9. doi: 10.1111/j.1464-5491.2009.02857.x.

ReferenceCitation: Dormandy JA, Betteridge DJ, Schernthaner G, Pirags V, Norgren L; PROactive investigators. Impact of peripheral arterial disease in patients with diabetes--results from PROactive (PROactive 11). Atherosclerosis. 2009 Jan;202(1):272-81. doi: 10.1016/j.atherosclerosis.2008.03.002. Epub 2008 Mar 18.

title: Impact of peripheral arterial disease in patients with diabetes—Results from PROactive (PROactive 11)

ReferenceCitation: Spanheimer,RG, Ferrannini,E, Long term effects of pioglitazone on diabetic dyslipidemia independent of baseline statin use and antihyperglycemic medication: a review from PROactive. Asia Pac J Cardiol 2009;1:(1):75-81.

ReferenceCitation: Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR; PROactive investigators. Safety and tolerability of pioglitazone in high-risk patients with type 2 diabetes: an overview of data from PROactive. Drug Saf. 2009;32(3):187-202. doi: 10.2165/00002018-200932030-00002. Review.

title: Safety and Tolerability of Pioglitazone in High-Risk Patients with Type 2 Diabetes

ReferenceCitation: Betteridge DJ. CHICAGO, PERISCOPE and PROactive: CV risk modification in diabetes with pioglitazone. Fundam Clin Pharmacol. 2009 Dec;23(6):675-9. doi: 10.1111/j.1472-8206.2009.00741.x. Epub 2009 Sep 10. Review.

ReferenceCitation: Erdmann E, Spanheimer R, Charbonnel B; PROactive Study Investigators. Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20). J Diabetes. 2010 Sep;2(3):212-20. doi: 10.1111/j.1753-0407.2010.00082.x.

name: on behalf of the PROactive Study Investigators

ReferenceCitation: Ferrannini E, Betteridge DJ, Dormandy JA, Charbonnel B, Wilcox RG, Spanheimer R, Erdmann E, Defronzo RA, Laakso M. High-density lipoprotein-cholesterol and not HbA1c was directly related to cardiovascular outcome in PROactive. Diabetes Obes Metab. 2011 Aug;13(8):759-64. doi: 10.1111/j.1463-1326.2011.01404.x.

ReferenceCitation: Doehner W, Erdmann E, Cairns R, Clark AL, Dormandy JA, Ferrannini E, Anker SD. Inverse relation of body weight and weight change with mortality and morbidity in patients with type 2 diabetes and cardiovascular co-morbidity: an analysis of the PROactive study population. Int J Cardiol. 2012 Dec 15;162(1):20-6. doi: 10.1016/j.ijcard.2011.09.039. Epub 2011 Oct 29.

title: Inverse relation of body weight and weight change with mortality and morbidity in patients with type 2 diabetes and cardiovascular co-morbidity: An analysis of the PROactive study population

ReferenceCitation: Pfister R, Cairns R, Erdmann E, Schneider CA; PROactive investigators. Prognostic impact of electrocardiographic signs in patients with Type 2 diabetes and cardiovascular disease: results from the PROactive study. Diabet Med. 2011 Oct;28(10):1206-12. doi: 10.1111/j.1464-5491.2011.03281.x.

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ReferenceCitation: Charbonnel B, DeFronzo R, Davidson J, Schmitz O, Birkeland K, Pirags V, Scheen A; PROactive investigators. Pioglitazone use in combination with insulin in the prospective pioglitazone clinical trial in macrovascular events study (PROactive19). J Clin Endocrinol Metab. 2010 May;95(5):2163-71. doi: 10.1210/jc.2009-1974. Epub 2010 Mar 17.

name: Clinique d’Endocrinologie, Maladies Metaboliques, et Nutrition (B.C.), 44093 Nantes, France

name: Diabetes Division (R.D.), The University of Texas Health Science Center, San Antonio, Texas 78229

name: Medical City Hospital (J.D.), Dallas, Texas 75230

name: Department of Medicine M (Endocrinology and Diabetes) (O.S.), Århus Kommunehospitalet, DK-8000 Aarhus, Denmark

name: Department of Clinical Endocrinology (K.B.), Aker University Hospital, 0514 Oslo, Norway

name: Department of Internal Medicine (V.P.), Paula Stradina Kliniska Universitates Slimnica, 1002 Riga, Latvia

name: Division of Diabetes, Nutrition, and Metabolic Disorders (A.S.), Department of Medicine, University of Liège, 4000 Liège, Belgium

journal_name: The Journal of Clinical Endocrinology & Metabolism

repository_institution: University of Liège - Open Repository and Bibliography

title: Pioglitazone Use in Combination with Insulin in the Prospective Pioglitazone Clinical Trial in Macrovascular Events Study (PROactive19)

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
United Kingdom
Finland
France
Poland
Lithuania
Slovakia
Norway
Hungary
Belgium
Latvia
Estonia
Denmark
Germany
Czech Republic


title: A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

summary: Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

ReferenceType: derived

ReferenceCitation: Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

family: Wirostko

full_name: B. M. Wirostko

given: B. M.

family: Tressler

full_name: C. Tressler

given: C.

family: Hwang

full_name: L.-J. Hwang

family: Burgess

full_name: G. Burgess

given: G.

family: Laties

full_name: A. M. Laties

given: A. M.

journal_name: BMJ

oa_colors: green hybrid

evidence: open (via page says license)

version: submittedVersion

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Rubin LJ, Badesch DB, Fleming TR, Galiè N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

family: Badesch

full_name: David B. Badesch

given: David B.

family: Fleming

full_name: Thomas R. Fleming

given: Thomas R.

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Simonneau

full_name: Gerald Simonneau

given: Gerald

family: Ghofrani

full_name: Hossein A. Ghofrani

given: Hossein A.

family: Oakes

full_name: Michael Oakes

given: Michael

family: Layton

full_name: Gary Layton

given: Gary

family: Serdarevic-Pehar

full_name: Marjana Serdarevic-Pehar

given: Marjana

family: McLaughlin

full_name: Vallerie V. McLaughlin

given: Vallerie V.

title: Long-term Treatment With Sildenafil Citrate in Pulmonary Arterial Hypertension

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Malaysia
Belgium
Australia
Denmark
France
Poland
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain


title: Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study

summary: The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.

study_start_date_type: Actual

ReferenceCitation: Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392 .

family: Shapiro

full_name: Amy Shapiro

given: Amy

family: Gruppo

full_name: Ralph Gruppo

given: Ralph

family: Pabinger

full_name: Ingrid Pabinger

given: Ingrid

family: Collins

full_name: Peter W Collins

given: Peter W

family: Hay

full_name: Charles RM Hay

given: Charles RM

family: Schroth

full_name: Phillip Schroth

given: Phillip

family: Casey

full_name: Kathleen Casey

given: Kathleen

family: Patrone

full_name: Lisa Patrone

given: Lisa

family: Ehrlich

full_name: Hartmut Ehrlich

given: Hartmut

family: Ewenstein

full_name: Bruce M Ewenstein

given: Bruce M

journal_name: Expert Opinion on Biological Therapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Baxalta now part of Shire

location_country:
Italy
Austria
United States
Sweden
Germany
France
Belgium
Canada
United Kingdom

location_facility: Children's Hospital Medical Center Pharmacy

location_facility: Klinikum Innenstadt der Universität München

location_facility: Childrens Healthcare of Atlanta Blood Bank

location_facility: Hemophilia Center of Western Pennsylvania

location_facility: University of Medicine & Dentistry of New Jersey

location_facility: Mountain States Regional Hemophilia and Thrombosis Center


title: TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension

acronym: TRIUMPH

summary: This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

ReferenceCitation: McLaughlin VV, Benza RL, Rubin LJ, Channick RN, Voswinckel R, Tapson VF, Robbins IM, Olschewski H, Rubenfire M, Seeger W. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1915-22. doi: 10.1016/j.jacc.2010.01.027.

family: Benza

full_name: Raymond L. Benza

given: Raymond L.

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

family: Channick

full_name: Richard N. Channick

given: Richard N.

family: Voswinckel

full_name: Robert Voswinckel

given: Robert

family: Tapson

full_name: Victor F. Tapson

given: Victor F.

family: Robbins

full_name: Ivan M. Robbins

given: Ivan M.

family: Olschewski

full_name: Horst Olschewski

given: Horst

family: Rubenfire

full_name: Melvyn Rubenfire

given: Melvyn

family: Seeger

full_name: Werner Seeger

given: Werner

journal_name: Journal of the American College of Cardiology

title: Addition of Inhaled Treprostinil to Oral Therapy for Pulmonary Arterial Hypertension

lead_sponsor: United Therapeutics

location_country:
Italy
Austria
Germany
France
Israel
Ireland
Belgium
Spain
United States
United Kingdom

location_facility: Instituto Malattie dell'Apparato Vascolare

location_facility: Univesitatsklinikum Giessen und Marburg GmbH


type: Other Identifier

title: An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies

summary: This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

ReferenceCitation: Hsu CW, Chao YC, Lee CM, Chang TT, Chen YC. Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at week 24. BMC Gastroenterol. 2012 Dec 13;12:178. doi: 10.1186/1471-230X-12-178.

family: Hsu

full_name: Chao Wei Hsu

given: Chao Wei

family: Chao

full_name: You Chen Chao

given: You Chen

family: Lee

full_name: Chuan Mo Lee

given: Chuan Mo

family: Chang

full_name: Ting Tsung Chang

given: Ting Tsung

family: Chen

full_name: Yi Cheng Chen

given: Yi Cheng

currency_apc_doaj: GBP

journal_name: BMC Gastroenterology

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at Week 24

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Australia
Taiwan
India
France
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Singapore
Puerto Rico
China
United States
Germany
United Kingdom
Italy
Czechia
Israel
New Zealand
Spain
Turkey


title: A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)

summary: This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Belgium
France


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia

acronym: RADIANCE 2

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia

ReferenceCitation: Tajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.

name: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

name: Department of Epidemiology & Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.

family: Tajik

full_name: Parvin Tajik

given: Parvin

family: Meijer

full_name: Rudy Meijer

given: Rudy

name: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

family: Duivenvoorden

full_name: Raphaël Duivenvoorden

given: Raphaël

family: Peters

full_name: Sanne AE Peters

given: Sanne AE

family: Kastelein

full_name: John J Kastelein

given: John J

name: Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.

family: Visseren

full_name: Frank J Visseren

given: Frank J

name: Division of Public Health Sciences, Wake Forest University, Winston Salem, USA.

family: Crouse

full_name: John R Crouse

given: John R

suffix: III

family: Palmer

full_name: Mike K Palmer

given: Mike K

family: Raichlen

full_name: Joel S Raichlen

given: Joel S

family: Grobbee

full_name: Diederick E Grobbee

given: Diederick E

family: Bots

full_name: Michiel L Bots

given: Michiel L

journal_name: European Journal of Preventive Cardiology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum in: Circulation. 2009 Feb 10;119(5):e197.

name: From the Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands (M.V., S.I.v.L., E.S.S., J.J.P.K.); Julius Center for Health Sciences and Primary Care (M.L.B., D.E.G.) and Department of Vascular Medicine (F.L.V.), University Medical Center Utrecht, Utrecht, The Netherlands; Westfries Gasthuis, Hoorn, The Netherlands (D.C.B.); Department of Internal Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands (E.J.S.); Division of Public Health Sciences, Wake Forest...

family: Vergeer

full_name: Menno Vergeer

given: Menno

full_name: Michiel L. Bots

given: Michiel L.

family: van Leuven

full_name: Sander I. van Leuven

given: Sander I.

family: Basart

full_name: Dick C. Basart

given: Dick C.

family: Sijbrands

full_name: Eric J. Sijbrands

given: Eric J.

family: Evans

full_name: Gregory W. Evans

given: Gregory W.

full_name: Diederick E. Grobbee

given: Diederick E.

full_name: Frank L. Visseren

given: Frank L.

family: Stalenhoef

full_name: Anton F. Stalenhoef

given: Anton F.

family: Stroes

full_name: Erik S. Stroes

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Cholesteryl Ester Transfer Protein Inhibitor Torcetrapib and Off-Target Toxicity

ReferenceCitation: Bots ML, Visseren FL, Evans GW, Riley WA, Revkin JH, Tegeler CH, Shear CL, Duggan WT, Vicari RM, Grobbee DE, Kastelein JJ; RADIANCE 2 Investigators. Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial. Lancet. 2007 Jul 14;370(9582):153-160. doi: 10.1016/S0140-6736(07)61088-5.

ReferenceCitation: Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94.

location_country:
Netherlands
Finland
France
United States
Czech Republic
Canada


title: A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

summary: This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

lead_sponsor: Novartis

location_country:
United States
France
Thailand
Israel
Singapore
Australia
New Zealand
China
Canada
United Kingdom
Taiwan


title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

summary: The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

lead_sponsor: Abbott

location_country:
Netherlands
France
United States
United Kingdom
Canada

location_facility: CroMedia Prime/Prime Trials Vancouver Hospital

location_facility: University Hospital Rotterdam, Department of Urology

location_facility: McGill University Health Center Royal VIctoria Hosptial

location_facility: Oregon Urology Specialist, Division of Clinical Research

location_facility: Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter

location_facility: ViaHealth Rochester General Hospital Center for Urology

location_facility: University of Pittsburgh Department of Urology

location_facility: Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.


title: Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH

summary: The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

ReferenceCitation: Hillmen P, Muus P, Dührsen U, Risitano AM, Schubert J, Luzzatto L, Schrezenmeier H, Szer J, Brodsky RA, Hill A, Socié G, Bessler M, Rollins SA, Bell L, Rother RP, Young NS. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria. Blood. 2007 Dec 1;110(12):4123-8. Epub 2007 Aug 16.

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Hospital De La Paz, Servicio de Hematologia

location_facility: Stockholm South Hospital, Division of Hematology

location_facility: Hospital Clinic i Provincial, Servicio de Hematologia

location_facility: Universitatskliniken des Saarlandes, Innere Medizin 1

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: Ospedale San Martino, Department of Hematology

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Institut fur Klinische Transfusionmedizin und Immunogenetik, Abtlg. Transfusionmedizin des Univ. Ulm

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program

location_facility: St. George's Hospital, Department of Haematology

location_facility: The Queen Elizabeth Hospital, Haematology/Oncology Department

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Hopital Saint Louis, Centre d'investigation Clinique

location_facility: Cleveland Clinic Florida, Department of Clinical Research

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: The Royal Perth Hospital, Department of Haematology/Level 2

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: National Heart, Lung, and Blood Institute, National Institutes of Health

location_facility: London Regional Cancer Centre, Clinical Research Unit Room C3080

location_facility: Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: St. James's Hospital, Cancer Clinical Trial Office

location_facility: UMC St. Radboud, Department of Hematology

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Washington University, Department of Internal Medicine/Division of Hematology

location_facility: Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica


title: Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study

summary: The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Hospital De La Paz, Servicio de Hematologia

location_facility: Stockholm South Hospital, Division of Hematology

location_facility: University Hospital, Dept. of Haematology

location_facility: St. James Hospital, Haematology Dept., Cancer Clinical Trial Office

location_facility: Hospital Clinic i Provincial, Servicio de Hematologia

location_facility: Universitatskliniken des Saarlandes, Innere Medizin 1

location_facility: St. Georges Hospital, Department of Haematology

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: The Royal Perth Hospital, Dept. of Haematology/Level 2

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia

location_facility: OHSU Center for Hematologic Malignancies

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: The Queen Elizabeth Hospital, Haematology/Oncology Department

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Washington University Medical Center, Department of Internal Medicine/Division of Hematology

location_facility: Hopital Saint-Louis, Centre d'investigation Clinique

location_facility: Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology

location_facility: Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionmedizin des Univer. Ulm

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

location_facility: Cleveland Clinic Florida, Dept. of Clinical Research

location_facility: Cooper University Hospital, Cooper Cancer Institute

location_facility: University of Utah, Hematology-BMT Department

location_facility: Ospedale San Martino, Dept. of Hematology

location_facility: Kantonsspital Basel, Abteilung fuer Haematologie


title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

acronym: DeCIDE

summary: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

lead_sponsor: University of Chicago

location_country:
Croatia
France
Russian Federation
Spain
United States

location_facility: Clinic of Oncology, University Hospital Center Zagreb

location_facility: USC University of Southern California Keck School of Medicine

location_facility: UM Sylvester Comprehensive Cancer Center

location_facility: Fort Wayne Medical Oncology/Hematology Inc.

location_facility: NN Blokhin Russian Cancer Research Centre RAMS

location_facility: University of Tennessee Cancer Institute

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

summary: This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

ReferenceCitation: Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. Epub 2007 Oct 1.

location_country:
United States
France
Thailand
Singapore
Australia
China
Canada
Korea, Republic of
Taiwan


title: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin Alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis

summary: Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.

ReferenceCitation: DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

name: LAP&P Consultants BV, Leiden, the Netherlands

family: DeJongh

full_name: Joost DeJongh

given: Joost

family: Frieling

full_name: Johan Frieling

given: Johan

family: Lowry

full_name: Simon Lowry

given: Simon

family: Drenth

full_name: Henk-Jan Drenth

given: Henk-Jan

journal_name: Clinical and Applied Thrombosis/Hemostasis

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Pharmacokinetics of Recombinant Human Antithrombin in Delivery and Surgery Patients With Hereditary Antithrombin Deficiency

lead_sponsor: rEVO Biologics

location_country:
Italy
Austria
United States
Germany
France
Australia
Canada
United Kingdom

intervention_type: Biological


title: A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma

summary: GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.

ReferenceCitation: Duvic M, Bates SE, Piekarz R, Eisch R, Kim YH, Lerner A, Robak T, Samtsov A, Becker JC, McCulloch W, Waksman J, Whittaker S. Responses to romidepsin in patients with cutaneous T-cell lymphoma and prior treatment with systemic chemotherapy. Leuk Lymphoma. 2018 Apr;59(4):880-887. doi: 10.1080/10428194.2017.1361022. Epub 2017 Aug 30.

ReferenceCitation: Foss F, Duvic M, Lerner A, Waksman J, Whittaker S. Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides. Clin Lymphoma Myeloma Leuk. 2016 Nov;16(11):637-643. doi: 10.1016/j.clml.2016.08.009. Epub 2016 Aug 10.

ReferenceCitation: Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.

family: Foss

full_name: Francine Foss

given: Francine

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Horwitz

full_name: Steven Horwitz

given: Steven

family: Pro

full_name: Barbara Pro

given: Barbara

family: Prince

full_name: H Miles Prince

given: H Miles

family: Sokol

full_name: Lubomir Sokol

given: Lubomir

family: Greenwood

full_name: Matthew Greenwood

given: Matthew

family: Lerner

full_name: Adam Lerner

given: Adam

family: Caballero

full_name: Dolores Caballero

given: Dolores

family: Baran

full_name: Eugeniusz Baran

given: Eugeniusz

family: Kim

full_name: Ellen Kim

given: Ellen

family: Nichols

full_name: Jean Nichols

given: Jean

family: Balser

full_name: Barbara Balser

family: Wolfson

full_name: Julie Wolfson

given: Julie

family: Whittaker

full_name: Sean Whittaker

given: Sean

journal_name: Biomarker Research

repository_normalized: University of Melbourne - Minerva Access

ReferenceCitation: Demierre M, et al. Pooled analyses of two international, multicenter clinical studies of romidepsin in 167 patients with cutaneous T-cell lymphoma (CTCL). Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando, FL. Abstract No: 8546. J Clin Oncol 27:15s, 2009 (suppl)

ReferenceCitation: Cabell C, et al. Systematic Assessment of Potential Cardiac Effects of the Novel Histone Deacetylase (HDAC) Inhibitor Romidepsin. Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando, FL. Abstract No: e19533. C J Clin Oncol 2009;27(suppl)

ReferenceCitation: Kim YH, et al. Clinically Significant Responses Achieved with Romidepsin in 37 Patient with Cutaneous T-Cell Lymphoma (CTCL) with Blood Involvement. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 2683.

ReferenceCitation: Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. doi: 10.1200/JCO.2010.28.9066. Epub 2010 Aug 9.

name: From Guy's and St Thomas' National Health Service Foundation Trust; Kings College London, London, United Kingdom; Boston Medical Center, Boston; Gloucester Pharmaceuticals, Cambridge, MA; Hospital of the University of Pennsylvania, Philadelphia, PA; M. D. Anderson Cancer Center, Houston TX; Stanford Cancer Center, Stanford, CA; Medical University of Lodz, Lodz, Poland; Univeritätsklinikum, Würzburg, Germany; and Akademika Lebedeva, Saint-Petersburg, Russia.

publisher: American Society of Clinical Oncology (ASCO)

title: Final Results From a Multicenter, International, Pivotal Study of Romidepsin in Refractory Cutaneous T-Cell Lymphoma

location_country:
United States
France
Poland
Russian Federation
Germany
United Kingdom

location_facility: University of Pennsylvania Abrahamson Cancer Center


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

summary: The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

ReferenceCitation: Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. Epub 2007 Apr 30.

location_country:
Canada
United States
Belgium
France

location_facility: Long Island Clinical Research Assoc. LLP

location_facility: Capitol Gastroenterology Consultants Medical Group, Inc.

location_facility: Liver and Intestinal Disease Research Center

location_facility: Gastroenterology Center of the Mid South

location_facility: The Oregon Clinic, PC Gastroenterology Division

location_facility: Outpatient Clinical Research Facility University of Indianapolis

location_facility: University of Kentucky Medical Center Division of Digestive Diseases

location_facility: Gastroenterology Associates of Cleveland

location_facility: Mount Sinai School of Medicine IBD Research Center

location_facility: Regional Gastroenterologist Associates of Lancaster

location_facility: Atlantic Gastroenterology Associates, LLC

location_facility: Heritage Medical Research Clinic Health Sciences Centre University of Calgary

location_facility: Gastrointestinal and Liver Disease Consultants

location_facility: Queen Elizabeth II Health Sciences Centre


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

summary: The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

location_country:
Italy
South Africa
Hong Kong
Netherlands
France
Singapore
Australia
Spain
United States
Taiwan

location_facility: Neurological Physicians of Arizona, Inc.

location_facility: Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"

location_facility: Alzheimer's Research & Clinical Programs

location_facility: sanofi-aventis Australia & New Zealand administrative office

location_facility: University Medical Center, Dept. of Psychiatry Clinical Trials


title: A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months

acronym: ASSERT

summary: The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

ReferenceCitation: Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. Epub 2002 Nov 14.

lead_sponsor: Icagen

location_country:
Brazil
Trinidad and Tobago
Jamaica
France
United States
United Kingdom


title: A Multinational, Randomized, Double-blind, Placebo-controlled, Forced-titration, 2 x 2 Factorial Design Study of the Efficacy and Safety of Long-term Administration of Nateglinide and Valsartan in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects With Impaired Glucose Tolerance (IGT)

acronym: Navigator

summary: This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.

ReferenceCitation: Harumi Higuchi Dos Santos M, Sharma A, Sun JL, Pieper K, McMurray JJ, Holman RR, Lopes RD. International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial. J Am Heart Assoc. 2017 Jan 13;6(1). pii: e003892. doi: 10.1161/JAHA.116.003892.

name: Instituto do Coração do Hospital das Clínicas, FMUSP, São Paulo, Brazil

family: Harumi Higuchi dos Santos

full_name: Marilia Harumi Higuchi dos Santos

given: Marilia

name: Duke Clinical Research Institute, Duke University, Durham, NC

name: Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada

family: Sharma

full_name: Abhinav Sharma

given: Abhinav

family: Sun

full_name: Jie‐Lena Sun

given: Jie‐Lena

family: Pieper

full_name: Karen Pieper

given: Karen

name: University of Cardiology, Western Infirmary, Glasgow, United Kingdom

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

name: Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, United Kingdom

family: Holman

full_name: Rury R. Holman

given: Rury R.

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Australian Catholic University - Research Bank

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Preiss D, Thomas LE, Wojdyla DM, Haffner SM, Gill JM, Yates T, Davies MJ, Holman RR, McMurray JJ, Califf RM, Kraus WE; NAVIGATOR Investigators. Prospective relationships between body weight and physical activity: an observational analysis from the NAVIGATOR study. BMJ Open. 2015 Aug 14;5(8):e007901. doi: 10.1136/bmjopen-2015-007901.

family: Preiss

full_name: David Preiss

given: David

family: Thomas

full_name: Laine E Thomas

given: Laine E

family: Wojdyla

full_name: Daniel M Wojdyla

given: Daniel M

family: Haffner

full_name: Steven M Haffner

given: Steven M

family: Gill

full_name: Jason M R Gill

ReferenceCitation: Katz M, Califf RM, Sun JL, McMurray JJ, Thomas L, Lopes RD. Venous thromboembolism and cardiovascular risk: results from the NAVIGATOR trial. Am J Med. 2015 Mar;128(3):297-302. doi: 10.1016/j.amjmed.2014.08.022. Epub 2014 Nov 20.

title: Venous Thromboembolism and Cardiovascular Risk: Results from the NAVIGATOR Trial

ReferenceCitation: Preiss D, Haffner SM, Thomas LE, Sun JL, Sattar N, Yates T, J Davies M, McMurray JJ, Holman RR, Califf RM, Kraus WE. Change in levels of physical activity after diagnosis of type 2 diabetes: an observational analysis from the NAVIGATOR study. Diabetes Obes Metab. 2014 Dec;16(12):1265-8. doi: 10.1111/dom.12320. Epub 2014 Jun 19.

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

name: Department of Medicine; Baylor College of Medicine; Houston TX USA

name: Duke Clinical Research Institute; Duke University Medical Center; Durham NC USA

name: Diabetes Research Centre; University of Leicester; Leicester UK

name: Diabetes Trials Unit; University of Oxford; Oxford UK

name: Duke Translational Medicine Institute; Duke University Medical Center; Durham NC USA

name: Division of Cardiovascular Medicine; Duke University Medical Center; Durham NC USA

ReferenceCitation: Huffman KM, Sun JL, Thomas L, Bales CW, Califf RM, Yates T, Davies MJ, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Haffner SM, Kraus WE. Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: results from NAVIGATOR. Metabolism. 2014 Apr;63(4):554-61. doi: 10.1016/j.metabol.2014.01.002. Epub 2014 Jan 15.

title: Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: Results from NAVIGATOR

ReferenceCitation: Yates T, Haffner SM, Schulte PJ, Thomas L, Huffman KM, Bales CW, Califf RM, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Davies MJ, Kraus WE. Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis. Lancet. 2014 Mar 22;383(9922):1059-66. doi: 10.1016/S0140-6736(13)62061-9. Epub 2013 Dec 20.

ReferenceCitation: Shen L, Shah BR, Reyes EM, Thomas L, Wojdyla D, Diem P, Leiter LA, Charbonnel B, Mareev V, Horton ES, Haffner SM, Soska V, Holman R, Bethel MA, Schaper F, Sun JL, McMurray JJ, Califf RM, Krum H. Role of diuretics, β blockers, and statins in increasing the risk of diabetes in patients with impaired glucose tolerance: reanalysis of data from the NAVIGATOR study. BMJ. 2013 Dec 9;347:f6745. doi: 10.1136/bmj.f6745. Erratum in: BMJ. 2014;348:f1339.

title: Role of diuretics, blockers, and statins in increasing the risk of diabetes in patients with impaired glucose tolerance: reanalysis of data from the NAVIGATOR study

ReferenceCitation: NAVIGATOR Study Group, McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamás G, Tognoni G, Tuomilehto J, Villamil AS, Vozár J, Califf RM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1477-90. doi: 10.1056/NEJMoa1001121. Epub 2010 Mar 14. Erratum in: N Engl J Med. 2010 May 6;362(18):1748.

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

repository_institution: Utrecht University - Utrecht University Repository

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

title: Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events

ReferenceCitation: NAVIGATOR Study Group, Holman RR, Haffner SM, McMurray JJ, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamás G, Tognoni G, Tuomilehto J, Villamil AS, Vozár J, Califf RM. Effect of nateglinide on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1463-76. doi: 10.1056/NEJMoa1001122. Epub 2010 Mar 14. Erratum in: N Engl J Med. 2010 May 6;362(18):1748.

repositories_institution: University of Liège - Open Repository and Bibliography

title: Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

ReferenceCitation: Krum H, McMurray JJ, Horton E, Gerlock T, Holzhauer B, Zuurman L, Haffner SM, Bethel MA, Holman RR, Califf RM. Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials. Cardiovasc Ther. 2010 Apr;28(2):124-32. doi: 10.1111/j.1755-5922.2010.00146.x. Epub 2010 Feb 23.

title: Baseline Characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial Population: Comparison with Other Diabetes Prevention Trials

ReferenceCitation: Bethel MA, Deedwania P, Levitt NS, Schmitz O, Huntsman-Labed A, Califf RM, Haffner SM, Diem P; NAVIGATOR Study Group. Metabolic syndrome and alanine aminotransferase: a global perspective from the NAVIGATOR screening population. Diabet Med. 2009 Dec;26(12):1204-11. doi: 10.1111/j.1464-5491.2009.02864.x.

ReferenceCitation: Bethel MA, Holman R, Haffner SM, Califf RM, Huntsman-Labed A, Hua TA, McMurray J. Determining the most appropriate components for a composite clinical trial outcome. Am Heart J. 2008 Oct;156(4):633-40. doi: 10.1016/j.ahj.2008.05.018. Epub 2008 Jul 31.

location_country:
Peru
Guatemala
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ecuador
Uruguay
France
Poland
Slovakia
Norway
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Turkey


title: A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

summary:
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.

lead_sponsor: Eisai Inc.

location_country:
United States
France
Ireland
Australia
Canada
United Kingdom


title: An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis

acronym: BATT

summary: The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

lead_sponsor: AstraZeneca

location_country:
India
France
Russian Federation
United States
United Kingdom
Canada


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)

summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

ReferenceCitation: Galiè N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8.

family: Galiè

full_name: N Galiè

given: N

family: Rubin

full_name: LJ Rubin

given: LJ

family: Hoeper

full_name: MM Hoeper

given: MM

family: Jansa

full_name: P Jansa

given: P

family: Al-Hiti

full_name: H Al-Hiti

given: H

family: Meyer

full_name: GMB Meyer

given: GMB

family: Chiossi

full_name: E Chiossi

given: E

family: Kusic-Pajic

full_name: A Kusic-Pajic

given: A

family: Simonneau

full_name: G Simonneau

given: G

journal_name: The Lancet

lead_sponsor: Actelion

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Australia
Belgium
China
Canada
Czech Republic

location_facility: Centre de Pneumologie de L'Hospital Laval


title: Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine

summary: The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.

lead_sponsor: Sanofi

location_country:
Italy
United States
South Africa
Switzerland
Netherlands
Germany
France
Belgium
Argentina
Spain
Turkey
Denmark
Canada
Korea, Republic of
Colombia


title: A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia

summary: This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

ReferenceCitation: Engert A, et al. Overall Survival Advantage and Acceptable Safety Profile with Fludarabine in Combination with Alemtuzumab (FluCam) in Previously Treated Patients with Advanced Stage Chronic Lymphocytic Leukemia. Poster Presentation at American Society of Hematology 10 December 2010; Blood (ASH Annual Meeting Abstracts), Nov 2010;116:919. http://ash.confex.com/ash/2010/webprogram/Paper31687.html

ReferenceCitation: Engert A, et al. Improved Progression-free Survival (PFS) of Alemtuzumab (Campath®, MabCampath®) plus Fludarabine (Fludara®) versus Fludarabine Alone as Second-line Treatment of Patients with B-Cell Chronic Lymphocytic Leukemia: Preliminary Results from a Phase III Randomized Trial. 51st ASH Annual Meeting. Blood 2009;114. Abstract 537. http://ash.confex.com/ash/2009/webprogram/Paper21929.html

ReferenceCitation: Engert A, et al. Fludarabine (FLU) plus Alemtuzumab (FluCAM) Improves Progression Free Survival versus Fludarabine in Previously Treated Chronic Lymphocytic Leukemia and Demonstrates Activity in High Risk Patients. Poster Presentation at European Hematology Association 12 June 2010. Abstract 0768. http://www.eventure-online.com/eventure/publicAbstractView.do?id=136964&congressId=3446

ReferenceCitation: Elter T, Gercheva-Kyuchukova L, Pylylpenko H, Robak T, Jaksic B, Rekhtman G, Kyrcz-Krzemień S, Vatutin M, Wu J, Sirard C, Hallek M, Engert A. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol. 2011 Dec;12(13):1204-13. doi: 10.1016/S1470-2045(11)70242-X. Epub 2011 Oct 10.

family: Elter

full_name: Thomas Elter

given: Thomas

family: Gercheva-Kyuchukova

full_name: Liana Gercheva-Kyuchukova

given: Liana

family: Pylylpenko

full_name: Halyna Pylylpenko

given: Halyna

family: Robak

full_name: Tadesuz Robak

given: Tadesuz

family: Jaksic

full_name: Branimir Jaksic

given: Branimir

family: Rekhtman

full_name: Grigoriy Rekhtman

given: Grigoriy

family: Kyrcz-Krzemień

full_name: Sławomira Kyrcz-Krzemień

given: Sławomira

family: Vatutin

full_name: Mykola Vatutin

given: Mykola

family: Wu

full_name: Jingyang Wu

given: Jingyang

family: Sirard

full_name: Cynthia Sirard

given: Cynthia

family: Hallek

full_name: Michael Hallek

given: Michael

family: Engert

full_name: Andreas Engert

given: Andreas

journal_name: The Lancet Oncology

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Austria
Sweden
Germany
Croatia
Bulgaria
France
Greece
Poland
Romania
Russian Federation
Portugal
United States
Canada
Ukraine

location_facility: "Laikon" General Hospital, University of Athens

location_facility: State Healthcare Department "Sverdlovsk Regional Clinical Hospital #1",

location_facility: Khmelnitskiy Regional Hospital, Hematology Department

location_facility: Scientific Centre for Radiation Medicine AMS of Ukraine, Dept of Hematology and Transplantology

location_facility: Multiprofile Hospital for Active Treatment, St. Marina

location_facility: GU "Main Military Clinical Hospital named after acad. N.N.Burdenko of MO of Russia", Haematology Centre 3

location_facility: Katedra i Klinika Hamatologii, Onkologii I Chorob Wewnetrznych AM

location_facility: Saint-Petersburg GUZ "City Hospital #31" 3, Dynamo Prospect

location_facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

location_facility: Klinika Hematologii, Nowotworow Krwii 1 Transplantacji Szpiku

location_facility: Klinika Hematologii i Transplantacji Szpiku

location_facility: Charite-Universitatsmedizin Berlin Campus Benjamin-Franklin

location_facility: Kharkov Regional Clinical Oncology Center, Department of Hematology

location_facility: Klinika Hematologii Pomorskiej Akademii Medycznej w Szczecinie

location_facility: City Clinical Hospital #4, Regional Hematology Center

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

location_facility: Institute of Hematology and Transfusiology AMS of Ukraine, City Clinical Hospital #9

location_facility: GOUVPO "Saint-Petersburg State Medical University named after acad I.P.Pavlov of Roszdrav", Bone Marrow Transplantology Clinic

location_facility: U.O. Oncologia Medica Azienda Ospedaliera "Pugliese-Ciaccio"

location_facility: Multiprofile Hospital for Active Treatment "Alexandrovska"

location_facility: Orebro University Hospital, Dep. of Medicine

location_facility: Hospital de Santa Maria Servico de Hematologia Clinica/Hospital de dia de Hematologia

location_facility: University Hospital, Dept. of Hematology

location_facility: Unita Operativa di Medicina Generale Reumatologia e Oncoematologia

location_facility: Hospital de Sao Teotonio, Servico de Hematologia/Hosptial de Dia Oncologico

location_facility: Istituto di Ematologia Dipartmento di Biotechnologie Celluari ed Ematologia, Universita di Roma "La Sapienza"

location_facility: Clinical Hospital Center Rijeka, Department of Haematology

location_facility: Klinikum der Universitat zu Koln, Klinik 1 fur Innere Medizin

location_facility: Institutol Clinic Fundeni, Clinica Heamtologie

location_facility: National Center for Heamtology and Transfusiology

location_facility: Lviv National Medical University named Danilo Galytcky


title: Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.

ReferenceCitation: Sternberg CN, Dumez H, Van Poppel H, Skoneczna I, Sella A, Daugaard G, Gil T, Graham J, Carpentier P, Calabro F, Collette L, Lacombe D; EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Ann Oncol. 2009 Jul;20(7):1264-9. doi: 10.1093/annonc/mdn784. Epub 2009 Mar 17.

family: Sternberg

full_name: C.N. Sternberg

family: Dumez

full_name: H. Dumez

given: H.

family: Van Poppel

full_name: H. Van Poppel

family: Skoneczna

full_name: I. Skoneczna

given: I.

family: Sella

full_name: A. Sella

given: A.

family: Daugaard

full_name: G. Daugaard

given: G.

family: Gil

full_name: T. Gil

given: T.

family: Graham

full_name: J. Graham

given: J.

family: Carpentier

full_name: P. Carpentier

given: P.

family: Calabro

full_name: F. Calabro

given: F.

family: Collette

full_name: L. Collette

given: L.

family: Lacombe

full_name: D. Lacombe

given: D.

journal_name: Annals of Oncology

ReferenceCitation: Sternberg CN, Dumez H, Van Poppel H, et al.: Multicenter randomized EORTC trial 30021 of docetaxel + oblimersen and docetaxel in patients (pts) with hormone refractory prostate cancer (HRPC). [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-144, 2007.

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

location_country:
Italy
Austria
Netherlands
Spain
France
Poland
Israel
Belgium
Portugal
Denmark
United Kingdom

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

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Academisch Medisch Centrum at University of Amsterdam


title: Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

summary: This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
Mexico
Germany
France
Czechia
Poland
Norway
Hungary
Belgium
Spain
Denmark
United States
United Kingdom


title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

summary:
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

status: Withdrawn

lead_sponsor: Jonsson Comprehensive Cancer Center

location_country:
United States
France
Australia
Canada
United Kingdom

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Greenebaum Cancer Center at University of Maryland Medical Center

location_facility: Herbert Irving Comprehensive Cancer Center at Columbia University

location_facility: McMaster Children's Hospital at Hamilton Health Sciences

location_facility: Rocky Mountain Cancer Centers - Denver Midtown

location_facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University

location_facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

location_facility: Jonsson Comprehensive Cancer Center at UCLA


title: A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy

summary: The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

ReferenceCitation: Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, López-Sendón JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006 Apr 6;354(14):1477-88. Epub 2006 Mar 14.

ReferenceCitation: Morrow DA, Antman EM, Fox KA, White HD, Giugliano R, Murphy SA, McCabe CH, Braunwald E; ExTRACT-TIMI 25 Investigators. One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial. Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.

family: Morrow

full_name: D. A. Morrow

given: D. A.

family: Antman

full_name: E. M. Antman

given: E. M.

family: Fox

full_name: K. A. A. Fox

given: K. A. A.

family: White

full_name: H. D. White

given: H. D.

family: Giugliano

full_name: R. Giugliano

given: R.

family: Murphy

full_name: S. A. Murphy

given: S. A.

family: McCabe

full_name: C. H. McCabe

given: C. H.

family: Braunwald

full_name: E. Braunwald

given: E.

name: on behalf of the ExTRACT-TIMI 25 Investigators

journal_name: European Heart Journal

evidence: open (via free pdf)

title: One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 Trial

location_country:
Jordan
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Spain
Uruguay
Croatia
France
Lithuania
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Israel
Belarus
Estonia
Latvia

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization

summary:
Primary objective:

To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study

To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

Major and minor hemorrhage
Heparin induced thrombocytopenia
Serious adverse events
To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

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

family: Chi

full_name: G. Chi

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

family: Goldhaber

full_name: S. Z. Goldhaber

given: S. Z.

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

family: Kittelson

full_name: J. M. Kittelson

given: J. M.

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

family: Turpie

full_name: A. G. G. Turpie

given: A. G. G.

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

family: Hernandez

full_name: A. F. Hernandez

given: A. F.

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

family: Hull

full_name: R. D. Hull

given: R. D.

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

family: Gold

full_name: A. Gold

family: Curnutte

full_name: J. T. Curnutte

given: J. T.

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

family: Cohen

full_name: A. T. Cohen

given: A. T.

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

family: Harrington

full_name: R. A. Harrington

given: R. A.

family: Gibson

full_name: C. M. Gibson

given: C. M.

journal_name: Journal of Thrombosis and Haemostasis

evidence: open (via free article)

ReferenceCitation: Turpie AG, Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Chen M, Yusen RD; EXCLAIM Investigators. Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study. Stroke. 2013 Jan;44(1):249-51. doi: 10.1161/STROKEAHA.112.659797. Epub 2012 Nov 1.

full_name: Alexander G.G. Turpie

given: Alexander G.G.

full_name: Russell D. Hull

given: Russell D.

family: Schellong

full_name: Sebastian M. Schellong

given: Sebastian M.

family: Tapson

full_name: Victor F. Tapson

given: Victor F.

family: Monreal

full_name: Manuel Monreal

given: Manuel

family: Samama

full_name: Meyer-Michel Samama

given: Meyer-Michel

family: Chen

full_name: Min Chen

given: Min

family: Yusen

full_name: Roger D. Yusen

given: Roger D.

title: Venous Thromboembolism Risk in Ischemic Stroke Patients Receiving Extended-Duration Enoxaparin Prophylaxis: Results From the EXCLAIM Study

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: Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. doi: 10.7326/0003-4819-153-1-201007060-00004.

title: Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility

location_country:
Italy
Austria
Brazil
South Africa
India
Mexico
Spain
Germany
France
Poland
Israel
Tunisia
Argentina
Australia
Belgium
Russian Federation
United States
United Kingdom
Canada
Colombia


title: Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

summary: This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

ReferenceCitation: E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010

location_country:
Malaysia
Australia
Russian Federation
Taiwan
India
France
Poland
Thailand
Canada
Korea, Republic of
Vietnam
Singapore
China
United States
United Kingdom
Germany
Israel
New Zealand
Spain
Turkey
Latvia


title: Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

summary: The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

ReferenceCitation: Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. Epub 2007 Oct 23.

lead_sponsor: Pfizer

location_country:
Germany
United States
France