title: A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke

acronym: SPARCL

summary: To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.

ReferenceCitation: Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59. Erratum in: N Engl J Med. 2018 Jun 13;:null.

ReferenceCitation: Szarek M, Amarenco P, Callahan A, DeMicco D, Fayyad R, Goldstein LB, Laskey R, Sillesen H, Welch KM; SPARCL Committees and Investigators. Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial. J Am Coll Cardiol. 2020 May 5;75(17):2110-2118. doi: 10.1016/j.jacc.2020.03.015. Epub 2020 Mar 16.

family: Szarek

full_name: Michael Szarek

given: Michael

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

family: Callahan

full_name: Alfred Callahan

given: Alfred

family: DeMicco

full_name: David DeMicco

given: David

family: Fayyad

full_name: Rana Fayyad

given: Rana

family: Goldstein

full_name: Larry B. Goldstein

given: Larry B.

family: Laskey

full_name: Rachel Laskey

given: Rachel

family: Sillesen

full_name: Henrik Sillesen

given: Henrik

family: Welch

full_name: K. Michael Welch

given: K. Michael

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.

name: Department of Internal Medicine Amsterdam Cardiovascular Sciences Amsterdam University Medical Centre University of Amsterdam The Netherlands

family: Vogt

full_name: Liffert Vogt

given: Liffert

name: Division of Cardiology New York University School of Medicine New York NY

family: Bangalore

full_name: Sripal Bangalore

given: Sripal

family: Melamed

full_name: Shari Melamed

given: Shari

family: Hovingh

full_name: G. Kees Hovingh

given: G. Kees

full_name: David A. DeMicco

given: David A.

name: Division of Cardiology San Francisco General Hospital San Francisco CA

family: Waters

full_name: David D. Waters

given: David D.

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

repository_institution: California Digital Library - eScholarship

title: Atorvastatin Has a Dose‐Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double‐Blind Randomized Controlled Trials

ReferenceCitation: Ganz P, Amarenco P, Goldstein LB, Sillesen H, Bao W, Preston GM, Welch KMA; SPARCL Steering Committee. Association of Osteopontin, Neopterin, and Myeloperoxidase With Stroke Risk in Patients With Prior Stroke or Transient Ischemic Attacks: Results of an Analysis of 13 Biomarkers From the Stroke Prevention by Aggressive Reduction in Cholesterol Levels Trial. Stroke. 2017 Dec;48(12):3223-3231. doi: 10.1161/STROKEAHA.117.017965. Epub 2017 Nov 7.

name: From Division of Cardiology, San Francisco General Hospital and University of California (P.G.); Paris-Diderot, Sorbonne University, France (P.A.); Department of Neurology and Stroke Center, Bichat University Hospital, Paris, France (P.A.); Department of Neurology, University of Kentucky, Lexington (L.B.G.); Department of Vascular Surgery, University of Copenhagen, Denmark (H.S.); Pfizer Inc, New York, NY (W.B., G.M.P.); and Rosalind Franklin University of Medicine and Science, North Chicago, IL (K...

ReferenceCitation: Byun YS, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; SPARCL Trial Investigators. Oxidized Phospholipids on Apolipoprotein B-100 and Recurrent Ischemic Events Following Stroke or Transient Ischemic Attack. J Am Coll Cardiol. 2017 Jan 17;69(2):147-158. doi: 10.1016/j.jacc.2016.10.057.

ReferenceCitation: Amarenco P, Callahan A 3rd, Campese VM, Goldstein LB, Hennerici MG, Messig M, Sillesen H, Welch KM, Wilson DJ, Zivin JA. Effect of high-dose atorvastatin on renal function in subjects with stroke or transient ischemic attack in the SPARCL trial. Stroke. 2014 Oct;45(10):2974-82. doi: 10.1161/STROKEAHA.114.005832. Epub 2014 Aug 21.

name: Department of Neurology and Stroke Center, Paris-Diderot Sorbonne University, Paris, France (P.A.); Department of Neurology, Vanderbilt University, Nashville, TN (A.C.); Division of Nephrology and Hypertension Center, USC/Keck School of Medicine, Los Angeles, CA (V.M.C.); Department of Neurology, Duke University Medical Center, Durham, NC (L.B.G.); Department of Neurology, Universitat Heidelberg, Mannheim, Germany (M.G.H.); Pfizer Inc, New York, NY (M.M., D.J.W.); Department of Vascular Surgery,...

title: Effect of High-Dose Atorvastatin on Renal Function in Subjects With Stroke or Transient Ischemic Attack in the SPARCL Trial

ReferenceCitation: Ovbiagele B, Goldstein LB, Amarenco P, Messig M, Sillesen H, Callahan A 3rd, Hennerici MG, Zivin J, Welch KM; SPARCL Investigators. Prediction of major vascular events after stroke: the stroke prevention by aggressive reduction in cholesterol levels trial. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):778-84. doi: 10.1016/j.jstrokecerebrovasdis.2013.12.001. Epub 2014 Feb 24.

journal_name: Journal of Stroke and Cerebrovascular Diseases

title: Prediction of Major Vascular Events after Stroke: The Stroke Prevention by Aggressive Reduction in Cholesterol Levels Trial

ReferenceCitation: Callahan A, Amarenco P, Goldstein LB, Sillesen H, Messig M, Samsa GP, Altafullah I, Ledbetter LY, MacLeod MJ, Scott R, Hennerici M, Zivin JA, Welch KM; SPARCL Investigators. Risk of stroke and cardiovascular events after ischemic stroke or transient ischemic attack in patients with type 2 diabetes or metabolic syndrome: secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Arch Neurol. 2011 Oct;68(10):1245-51. doi: 10.1001/archneurol.2011.146. Epub 2011 Jun 13.

title: Risk of Stroke and Cardiovascular Events After Ischemic Stroke or Transient Ischemic Attack in Patients With Type 2 Diabetes or Metabolic Syndrome

ReferenceCitation: Schwartz GG, Chaitman BR, Goldberger JJ, Messig M. High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack: analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Am Heart J. 2011 May;161(5):993-9. doi: 10.1016/j.ahj.2011.02.002.

title: High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack: Analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

ReferenceCitation: Amarenco P, Goldstein LB, Sillesen H, Benavente O, Zweifler RM, Callahan A 3rd, Hennerici MG, Zivin JA, Welch KM; Stroke Prevention by Aggressive Reduction in Cholesterol Levels Investigators. Coronary heart disease risk in patients with stroke or transient ischemic attack and no known coronary heart disease: findings from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Stroke. 2010 Mar;41(3):426-30. doi: 10.1161/STROKEAHA.109.564781. Epub 2010 Jan 28.

name: From INSERM U-698 and Denis Diderot University (P.A.), Paris, France; Duke University (L.B.G.), Durham, NC; the University of Copenhagen (H.S.), Copenhagen, Denmark; the University of Texas Health Science Center (O.B.), San Antonio, Texas; Sentara Heart Hospital (R.M.Z.), Norfolk, Va; Vanderbilt University (A.C.), Nashville, Tenn; the University of Heidelberg (M.G.H.), Mannheim, Germany; the University of San Diego (J.A.Z.), San Diego, Calif; and Franklin University (K.M.A.W.), Chicago, Mich.

title: Coronary Heart Disease Risk in Patients With Stroke or Transient Ischemic Attack and No Known Coronary Heart Disease

ReferenceCitation: Amarenco P, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, O'Neill BJ, Rudolph AE, Simunovic L, Zivin JA, Welch KM; SPARCL Investigators. Baseline blood pressure, low- and high-density lipoproteins, and triglycerides and the risk of vascular events in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Atherosclerosis. 2009 Jun;204(2):515-20. doi: 10.1016/j.atherosclerosis.2008.09.008. Epub 2008 Sep 18.

location_country:
Finland
Greece
Australia
Belgium
Denmark
Czech Republic
France
Poland
Slovakia
South Africa
Chile
Sweden
Switzerland
Netherlands
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Venezuela
Israel
New Zealand
Spain


title: A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure

summary: For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Germany
France
Greece
Belgium
Australia
Spain
Canada
United Kingdom

location_facility:
GSK Clinical Trials Call Center
GSK Clinical Trials Call Centre
GSK Clinical Trials call Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation

summary: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

status: Completed

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

family: Aubin

full_name: H-J Aubin

given: H-J

sequence: first

family: Bobak

full_name: A Bobak

given: A

sequence: additional

family: Britton

full_name: J R Britton

given: J R

family: Oncken

full_name: C Oncken

given: C

family: Billing

full_name: C B Billing

given: C B

family: Gong

full_name: J Gong

given: J

family: Williams

full_name: K E Williams

given: K E

family: Reeves

full_name: K R Reeves

given: K R

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Thorax

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Pfizer

location_country:
Netherlands
France
Belgium
United States
United Kingdom

status_simplified: Completed


title: A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients

summary: Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country:
Austria
Germany
France
Australia
Spain
United States


type: EudraCT Number

title: A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of Presumed Pre-Core Mutant Chronic Hepatitis B

summary: This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.

ReferenceType: result

ReferenceCitation: Kitrinos KM, Corsa A, Liu Y, Flaherty J, Snow-Lampart A, Marcellin P, Borroto-Esoda K, Miller MD. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology. 2014 Feb;59(2):434-42.

ReferenceCitation: Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013 Feb 9;381(9865):468-75. doi: 10.1016/S0140-6736(12)61425-1. Epub 2012 Dec 10.

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Gane

full_name: Edward Gane

given: Edward

family: Buti

full_name: Maria Buti

given: Maria

family: Afdhal

full_name: Nezam Afdhal

given: Nezam

family: Sievert

full_name: William Sievert

given: William

family: Jacobson

full_name: Ira M Jacobson

given: Ira M

family: Washington

full_name: Mary Kay Washington

given: Mary Kay

family: Germanidis

full_name: George Germanidis

given: George

family: Flaherty

full_name: John F Flaherty

given: John F

family: Schall

full_name: Raul Aguilar Schall

given: Raul Aguilar

family: Bornstein

full_name: Jeffrey D Bornstein

given: Jeffrey D

family: Kitrinos

full_name: Kathryn M Kitrinos

given: Kathryn M

family: Subramanian

full_name: G Mani Subramanian

given: G Mani

family: McHutchison

full_name: John G McHutchison

given: John G

family: Heathcote

full_name: E Jenny Heathcote

given: E Jenny

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB, Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology. 2013 Aug;58(2):505-13. doi: 10.1002/hep.26277. Epub 2013 May 3.

family: Gordon

full_name: Stuart C. Gordon

given: Stuart C.

name: University HospitalSt. Ivan RilskySofiaBulgaria

family: Krastev

full_name: Zahary Krastev

given: Zahary

family: Horban

full_name: Andrzej Horban

given: Andrzej

name: Liver Unit Asklepios Klinik St. GeorgHamburgGermany

family: Petersen

full_name: Jörg Petersen

given: Jörg

name: Institute for Clinical and Experimental MedicinePragueCzech Republic

family: Sperl

full_name: Jan Sperl

given: Jan

family: Dinh

name: Hôpital BeaujonUniversity of ParisClichyFrance

ReferenceCitation: Tsai NC, Marcellin P, Buti M, Washington MK, Lee SS, Chan S, Trinh H, Flaherty JF, Kitrinos KM, Dinh P, Charuworn P, Subramanian GM, Gane E. Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in Asians with chronic hepatitis B. Dig Dis Sci. 2015 Jan;60(1):260-8. doi: 10.1007/s10620-014-3336-7. Epub 2014 Sep 2.

title: Viral Suppression and Cirrhosis Regression with Tenofovir Disoproxil Fumarate in Asians with Chronic Hepatitis B

ReferenceCitation: Fung S, Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Gane E, Jacobson IM, Yee LJ, Dinh P, Martins EB, Flaherty JF, Kitrinos KM, Dusheiko G, Trinh H, Flisiak R, Rustgi VK, Buti M, Marcellin P. Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (≥ 9 log10 copies/ml). Liver Int. 2015 Feb;35(2):422-8. doi: 10.1111/liv.12694. Epub 2014 Oct 28.

name: Henry Ford Health System; Detroit MI USA

name: University Hospital; St. Ivan Rilsky Sofia Bulgaria

name: Warsaw Medical University; Warsaw Poland

name: Liver Unit Asklepios Klinik St. Georg; Hamburg Germany

name: Institute for Clinical and Experimental Medicine; Prague Czech Republic

name: Auckland City Hospital; Aukland New Zealand

name: Weill Cornell Medical College; New York NY USA

name: Gilead Sciences Inc.; Foster City CA USA

name: San Jose Gastroenterology; San Jose CA USA

name: Medical University of Bialystok; Bialystok Poland

name: Metropolitan Liver Diseases; Fairfax VA USA

name: Hospital General Universitari Vall d'Hebron and Ciberehd del Instituto Carlos III; Barcelona Catalonia Spain

name: Hôpital Beaujon; University of Paris; Clichy France

ReferenceCitation: Buti M, Fung S, Gane E, Afdhal NH, Flisiak R, Gurel S, Flaherty JF, Martins EB, Yee LJ, Dinh P, Bornstein JD, Mani Subramanian G, Janssen HL, George J, Marcellin P. Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years. Hepatol Int. 2015 Apr;9(2):243-50. doi: 10.1007/s12072-015-9614-4. Epub 2015 Mar 13.

ReferenceCitation: Buti M, Tsai N, Petersen J, Flisiak R, Gurel S, Krastev Z, Aguilar Schall R, Flaherty JF, Martins EB, Charuworn P, Kitrinos KM, Subramanian GM, Gane E, Marcellin P. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci. 2015 May;60(5):1457-64. doi: 10.1007/s10620-014-3486-7. Epub 2014 Dec 23.

title: Seven-Year Efficacy and Safety of Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Virus Infection

ReferenceCitation: Corsa A, Liu Y, Flaherty JF, Marcellin P, Miller M, Kitrinos KM. No Detectable Resistance to Tenofovir Disoproxil Fumarate (TDF) in HBeAg+ and HBeAg- Patients With Chronic Hepatitis B (CHB) After Eight Years of Treatment [Abstract 1707]. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 08-10 November; Boston MA.

ReferenceCitation: Marcellin P, Gane EJ, Flisiak R, Trinh HN, Petersen J, Gurel S, et al. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials [Abstract]. 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston, MA.

ReferenceCitation: Gane EJ, Marcellin P, Sievert W, Trinh HN, Shiffman ML, Washington MK, et al. Five years of Treatment with Tenofovir DF for Chronic Hepatitis B Infection in Asian Patients is Associated with Sustained Viral Suppression and Significant Regression of Histological Fibrosis and Cirrhosis [Poster Number 1429]. 62nd Annual Meeting of the American Association for the Study of Liver Diseases; 2011 November 4-8; San Francisco, California.

ReferenceCitation: Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, Kitrinos KM, Marcellin P, Gane EJ. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat. 2017 Jan;24(1):68-74. doi: 10.1111/jvh.12613. Epub 2016 Sep 23.

name: Gilead Sciences, Inc; Foster City CA USA

name: Hospital General Universitari Vall d'Hebron; Barcelona Spain

name: Hôpital Beaujon; University Paris-Diderot; Clichy France

name: Auckland City Hospital; Auckland New Zealand

title: No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg− patients with chronic hepatitis B after 8 years of treatment

ReferenceCitation: Marcellin P, Wong DK, Sievert W, Buggisch P, Petersen J, Flisiak R, Manns M, Kaita K, Krastev Z, Lee SS, Cathcart AL, Crans G, Op den Brouw M, Jump B, Gaggar A, Flaherty J, Buti M. Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection. Liver Int. 2019 Oct;39(10):1868-1875. doi: 10.1111/liv.14155. Epub 2019 Jul 10.

name: Viral Hepatitis Research Unit Hôpital Beaujon Clichy France

name: Toronto Centre for Liver Disease University Health Network, University of Toronto Toronto Ontario Canada

name: Gastroenterology and Hepatology Unit Monash Health and Monash University Melbourne Australia

name: Liver Unit, IFI‐Institute for Interdisciplinary Medicine Asklepios Klinik St Georg Hamburg Germany

name: Department of Infectious Diseases and Hepatology Medical University Bialystok Bialystok Poland

name: Department of Gastroenterology, Hepatology, and Endocrinology Hannover Medical School Hannover Germany

name: Helmholtz Center for Infection Research (HZI) Hannover Germany

name: Viral Hepatitis Investigative Unit University of Manitoba Winnipeg Canada

name: Clinic of Gastroenterology St Ivan Rilsky University Hospital, Medical University Sofia Bulgaria

name: Liver Unit University of Calgary Calgary Alberta Canada

name: Gilead Sciences Inc Foster City California

name: Liver Unit Hospital Universitario Vall d’Hebron and CIBEREHD del Instituto Carlos III Barcelona Spain

repository_institution: Helmholtz-Zentrum für Infektionsforschung GmbH - HZI Open Repository

title: Ten‐year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection

ReferenceCitation: Buti M, Wong DK, Gane E, Flisiak R, Manns M, Kaita K, Janssen HLA, Op den Brouw M, Jump B, Kitrinos K, Crans G, Flaherty J, Gaggar A, Marcellin P. Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials. Lancet Gastroenterol Hepatol. 2019 Apr;4(4):296-304. doi: 10.1016/S2468-1253(19)30015-9. Epub 2019 Feb 20.

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Jacobson IM, Washington MK, Buti M, Thompson A, Afdhal N, Flisiak R, Akarca US, Tchernev KG, Flaherty JF, Aguilar Schall R, Myers RP, Subramanian GM, McHutchison JG, Younossi Z, Marcellin P, Patel K. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1087-1094.e2. doi: 10.1016/j.cgh.2017.01.032. Epub 2017 Feb 12.

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol. 2015 May 14;21(18):5524-31. doi: 10.3748/wjg.v21.i18.5524.

ReferenceCitation: Heathcote EJ, Marcellin P, Buti M, Gane E, De Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Gurel S, Snow-Lampart A, Borroto-Esoda K, Mondou E, Anderson J, Sorbel J, Rousseau F. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology. 2011 Jan;140(1):132-43. doi: 10.1053/j.gastro.2010.10.011. Epub 2010 Oct 16.

title: Three-Year Efficacy and Safety of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B

ReferenceCitation: Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.

title: Tenofovir Disoproxil Fumarate versus Adefovir Dipivoxil for Chronic Hepatitis B

location_country:
Italy
United States
United Kingdom
Netherlands
Germany
France
Bulgaria
Greece
Poland
Australia
New Zealand
Spain
Turkey
Canada
Czech Republic


title: A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.

summary:
The purpose of the study is to:

Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression
Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a
Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage
Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer
Find out the level of BAY43-9006 in the blood once per month and any changes in this level
Find out whether BAY43-9006 effects are associated with specific biomarkers

ReferenceCitation: Escudier B, Szczylik C, Hutson TE, Demkow T, Staehler M, Rolland F, Negrier S, Laferriere N, Scheuring UJ, Cella D, Shah S, Bukowski RM. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Mar 10;27(8):1280-9. doi: 10.1200/JCO.2008.19.3342. Epub 2009 Jan 26. Erratum in: J Clin Oncol. 2009 May 1; 27(13):2305.

name: From the Institut Gustave Roussy, Villejuif; Centre René Gauducheau, Nantes; and Centre Léon Bérard, Lyon, France; Department of Oncology, Military Medical Institute; and Klinika Nowotworów Ukladu Moczowego, Warsaw, Poland; Universitätsklinikum Großhadern, Munich; and Bayer Vital, Leverkusen, Germany; Baylor-Sammons/Texas Oncology, Dallas, TX; Evanston Northwestern Healthcare, Center on Outcomes Research and Education, Evanston, IL; Bayer HealthCare Pharmaceuticals, Montville, NJ; and Cleveland Clinic...

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Szczylik

full_name: Cezary Szczylik

given: Cezary

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

family: Demkow

full_name: Tomasz Demkow

given: Tomasz

family: Staehler

full_name: Michael Staehler

given: Michael

family: Rolland

full_name: Frédéric Rolland

given: Frédéric

family: Negrier

full_name: Sylvie Negrier

given: Sylvie

family: Laferriere

full_name: Nicole Laferriere

given: Nicole

family: Scheuring

full_name: Urban J. Scheuring

given: Urban J.

family: Cella

full_name: David Cella

given: David

family: Shah

full_name: Sonalee Shah

given: Sonalee

family: Bukowski

full_name: Ronald M. Bukowski

given: Ronald M.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma

lead_sponsor: Bayer

location_country:
United States
France
Poland
Russian Federation
Germany
United Kingdom
Ukraine


title: Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.

summary: The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

ReferenceCitation: Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. doi: 10.1200/JCO.2007.15.7636. Epub 2009 Apr 6.

name: From the University of Kiel, Kiel; Charité Berlin; University Hospital Benjamin Franklin, Berlin; Johannes Gutenberg Clinic-Mainz University, Mainz, Germany; Johann Wolfgang Goethe University, Frankfurt am Main; Klinikum rechts der Isar, Munich; University Hospital of Mannheim, Mannheim, Germany; University Hospital of Tuebingen, Tuebingen, Germany; St Luke's Hospital and Health Network, Bethlehem; University of Pittsburgh Cancer Institute, Pittsburgh, PA; University of Colorado Cancer Center, Aurora,...

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Agarwala

full_name: Sanjiv S. Agarwala

given: Sanjiv S.

family: Trefzer

full_name: Uwe Trefzer

given: Uwe

family: Hogg

full_name: David Hogg

family: Robert

full_name: Caroline Robert

given: Caroline

family: Hersey

full_name: Peter Hersey

given: Peter

family: Eggermont

full_name: Alexander Eggermont

given: Alexander

family: Grabbe

full_name: Stephan Grabbe

given: Stephan

family: Gonzalez

full_name: Rene Gonzalez

given: Rene

family: Gille

full_name: Jens Gille

given: Jens

family: Peschel

full_name: Christian Peschel

given: Christian

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Garbe

full_name: Claus Garbe

given: Claus

family: O'Day

full_name: Steven O'Day

given: Steven

family: Daud

full_name: Adil Daud

given: Adil

family: White

full_name: J. Michael White

given: J. Michael

family: Xia

full_name: Chenghua Xia

given: Chenghua

family: Patel

full_name: Kiran Patel

given: Kiran

family: Kirkwood

full_name: John M. Kirkwood

given: John M.

family: Keilholz

full_name: Ulrich Keilholz

given: Ulrich

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Results of a Phase III, Randomized, Placebo-Controlled Study of Sorafenib in Combination With Carboplatin and Paclitaxel As Second-Line Treatment in Patients With Unresectable Stage III or Stage IV Melanoma

location_country:
United States
Netherlands
Germany
France
Australia
Canada
United Kingdom


title: An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome

summary: This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).

location_country:
United States
South Africa
Sweden
Netherlands
Germany
France
Australia
Spain
Canada
United Kingdom


title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy

summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

family: Colombel

full_name: Jean Frédéric Colombel

given: Jean Frédéric

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Mantzaris

full_name: Gerassimos J. Mantzaris

given: Gerassimos J.

family: Kornbluth

full_name: Asher Kornbluth

given: Asher

family: Rachmilewitz

full_name: Daniel Rachmilewitz

given: Daniel

family: Lichtiger

full_name: Simon Lichtiger

given: Simon

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Diamond

full_name: Robert H. Diamond

given: Robert H.

family: Broussard

full_name: Delma L. Broussard

given: Delma L.

family: Tang

full_name: Kezhen L. Tang

given: Kezhen L.

family: van der Woude

full_name: C. Janneke van der Woude

given: C. Janneke

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease

ReferenceCitation: Colombel JF, Adedokun OJ, Gasink C, Gao LL, Cornillie FJ, D'Haens GR, Rutgeerts PJ, Reinisch W, Sandborn WJ, Hanauer SB. Combination Therapy With Infliximab and Azathioprine Improves Infliximab Pharmacokinetic Features and Efficacy: A Post Hoc Analysis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1525-1532.e1. doi: 10.1016/j.cgh.2018.09.033. Epub 2018 Sep 26.

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Adedokun

full_name: Omoniyi J. Adedokun

given: Omoniyi J.

family: Gasink

full_name: Christopher Gasink

given: Christopher

family: Gao

full_name: Long-Long Gao

given: Long-Long

family: Cornillie

full_name: Freddy J. Cornillie

given: Freddy J.

full_name: Geert R. D'Haens

given: Geert R.

full_name: Paul J. Rutgeerts

given: Paul J.

ReferenceCitation: Colombel JF, Reinisch W, Mantzaris GJ, Kornbluth A, Rutgeerts P, Tang KL, Oortwijn A, Bevelander GS, Cornillie FJ, Sandborn WJ. Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn's disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015 Apr;41(8):734-46. doi: 10.1111/apt.13139. Epub 2015 Mar 1.

name: The Dr. Henry D. Janowitz Division of Gastroenterology; Icahn School of Medicine at Mount Sinai; New York NY USA

name: Department of Internal Medicine; McMaster University; Hamilton ON Canada

name: Department of Internal Medicine III; Medical University Vienna; Vienna Austria

name: Department of Gastroenterology; Evangelismos Hospital; Athens Greece

name: Department of Gastroenterology; University Hospital Gasthuisberg; Leuven Belgium

name: Janssen Research & Development; LLC; Spring House PA USA

name: Janssen Biologics BV; Leiden The Netherlands

name: Division of Gastroenterology; University of California-San Diego; La Jolla CA USA

title: Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn's disease - a SONICpost hocanalysis

ReferenceCitation: Reinisch W, Colombel JF, Sandborn WJ, Mantzaris GJ, Kornbluth A, Adedokun OJ, Miller M, Tang KL, Rutgeerts P, Cornillie F. Factors associated with short- and long-term outcomes of therapy for Crohn's disease. Clin Gastroenterol Hepatol. 2015 Mar;13(3):539-547.e2. doi: 10.1016/j.cgh.2014.09.031. Epub 2014 Sep 19.

title: Factors Associated With Short- and Long-Term Outcomes of Therapy for Crohn’s Disease

ReferenceCitation: Peyrin-Biroulet L, Reinisch W, Colombel JF, Mantzaris GJ, Kornbluth A, Diamond R, Rutgeerts P, Tang LK, Cornillie FJ, Sandborn WJ. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial. Gut. 2014 Jan;63(1):88-95. doi: 10.1136/gutjnl-2013-304984. Epub 2013 Aug 23.

ReferenceCitation: Ferrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens GR, van der Woude CJ, Danese S, Diamond RH, Oortwijn AF, Tang KL, Miller M, Cornillie F, Rutgeerts PJ; International Organization for the Study of Inflammatory Bowel Diseases. Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013 Nov;145(5):978-986.e5. doi: 10.1053/j.gastro.2013.08.010. Epub 2013 Aug 14.

title: Validation of Endoscopic Activity Scores in Patients With Crohn's Disease Based on a Post Hoc Analysis of Data From SONIC

location_country:
Austria
United States
Sweden
Netherlands
Spain
Germany
France
Greece
Israel
Norway
Belgium
Portugal
Denmark
Canada
United Kingdom


title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

summary: The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

ReferenceCitation: Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.

name: Oregon Health and Science University, Portland, Oregon, USA;

family: Vuky

full_name: Jacqueline Vuky

given: Jacqueline

name: Virginia Mason Medical Center, Seattle, Washington, USA

family: Corman

full_name: John M. Corman

given: John M.

family: Porter

full_name: Christopher Porter

family: Olgac

full_name: Semra Olgac

given: Semra

family: Auerbach

full_name: Evan Auerbach

given: Evan

family: Dahl

full_name: Kathryn Dahl

given: Kathryn

journal_name: The Oncologist

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High‐Risk Clinically Localized Prostate Cancer

lead_sponsor: Cell Genesys

location_country:
United States
Sweden
Netherlands
Germany
France
Belgium
Canada
United Kingdom

location_facility: Oxford Cancer Centre, Churchill Hospital

location_facility: Presbyterian Hospital/ Center for Cancer Research

location_facility: Medcenter One Cancer Care / Odyssey Research

location_facility: The Don and Sybil Harrington Cancer Center

location_facility: William Beaumont Hospital, Cancer Clinical Trials Office

location_facility: Urology Specialists and Associates, P.A.

location_facility: Oncology-Hematology Group of South Florida/Advanced Medical Specialists

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital

location_facility: Center for Oncology Research and Treatment PA

location_facility: Fort Wayne Medical Oncology/Hematology Inc.

location_facility: Hematology/Oncology Centers of the Northern Rockies, P.C.

location_facility: Southwestern Oncology Research Department

location_facility: Centre Hopitalier Universitaire de Sherbrooke

location_facility: Centre Leon Berard Service de Cancerologie Medicale

location_facility: The Center for Cancer & Hematologic Disease

location_facility: Winship Cancer Institute, Emory University

location_facility: West Michigan Regional Cancer and Blood Center

location_facility: Northwestern Carolina Hematology Oncology, PA

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: Summit Medical Group/Overlook Oncology Center

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Cleveland Clinic Foundation, Taussig Cancer Center

location_facility: Hematology Oncology Associates of the Treasure Coast


type: Other Identifier

title: A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

ReferenceCitation: Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Lu

full_name: Shun Lu

given: Shun

family: Cheng

full_name: Ying Cheng

given: Ying

family: Zhou

full_name: Caicun Zhou

given: Caicun

family: Wang

full_name: Mengzhao Wang

given: Mengzhao

family: Qin

full_name: Shukui Qin

given: Shukui

full_name: You Lu

given: You

family: Zhang

full_name: Yang Zhang

given: Yang

family: Zhu

full_name: Yunzhong Zhu

given: Yunzhong

family: Song

full_name: Xiangqun Song

given: Xiangqun

full_name: Xin Wang

given: Xin

family: Barraclough

full_name: Helen Barraclough

given: Helen

full_name: Xiaoqing Zhang

given: Xiaoqing

family: Chi

full_name: Haidong Chi

given: Haidong

family: Orlando

full_name: Mauro Orlando

given: Mauro

journal_name: Lung Cancer

ReferenceCitation: Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

family: Brodowicz

full_name: Thomas Brodowicz

given: Thomas

family: Langer

full_name: Corey J. Langer

given: Corey J.

family: Peterson

full_name: Patrick Peterson

given: Patrick

family: Islam

full_name: Mominul Islam

given: Mominul

family: Guba

full_name: Susan C. Guba

title: Pemetrexed Therapy in Elderly Patients With Good Performance Status: Analysis of Two Phase III Trials of Patients With Nonsquamous Non–Small-Cell Lung Cancer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Finland
Greece
Australia
Belgium
Denmark
Taiwan
India
France
Poland
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician


title: A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy

summary: The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

lead_sponsor: Sanofi

location_country:
Finland
Romania
Australia
Czech Republic
Taiwan
France
Poland
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
South Africa
Chile
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain


title: An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

summary: The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

design_allocation: Non-Randomized

ReferenceCitation: Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Austria
Brazil
Spain
Germany
France
Hungary
Argentina
Australia
Belgium
Portugal
United States
United Kingdom
Canada


title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

summary: This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

location_country:
Italy
United States
South Africa
Serbia
United Kingdom
Germany
Finland
Croatia
France
Greece
Israel
Poland
Slovakia
Belgium
Puerto Rico
Spain
Canada
Slovenia
Korea, Republic of
Taiwan


title: A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.

summary: The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.

ReferenceCitation: Ellis SG, Armstrong P, Betriu A, Brodie B, Herrmann H, Montalescot G, Neumann FJ, Smith JJ, Topol E; Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events Investigators. Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial. Am Heart J. 2004 Apr;147(4):E16.

ReferenceCitation: Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17. doi: 10.1056/NEJMoa0706816.

family: Ellis

full_name: Stephen G. Ellis

given: Stephen G.

family: Tendera

full_name: Michal Tendera

given: Michal

family: de Belder

full_name: Mark A. de Belder

given: Mark A.

family: van Boven

full_name: Ad J. van Boven

given: Ad J.

family: Widimsky

full_name: Petr Widimsky

given: Petr

family: Janssens

full_name: Luc Janssens

given: Luc

family: Andersen

full_name: H.R. Andersen

family: Betriu

full_name: Amadeo Betriu

given: Amadeo

family: Savonitto

full_name: Stefano Savonitto

given: Stefano

family: Adamus

full_name: Jerzy Adamus

given: Jerzy

family: Peruga

full_name: Jan Z. Peruga

given: Jan Z.

family: Kosmider

full_name: Maciej Kosmider

given: Maciej

family: Katz

full_name: Olivier Katz

given: Olivier

family: Neunteufl

full_name: Thomas Neunteufl

family: Jorgova

full_name: Julia Jorgova

given: Julia

family: Dorobantu

full_name: Maria Dorobantu

given: Maria

family: Grinfeld

full_name: Liliana Grinfeld

given: Liliana

family: Armstrong

full_name: Paul Armstrong

given: Paul

family: Brodie

full_name: Bruce R. Brodie

given: Bruce R.

family: Herrmann

full_name: Howard C. Herrmann

given: Howard C.

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Neumann

full_name: Franz-Josef Neumann

given: Franz-Josef

family: Effron

full_name: Mark B. Effron

given: Mark B.

family: Barnathan

title: Facilitated PCI in Patients with ST-Elevation Myocardial Infarction

ReferenceCitation: Montalescot G, Ellis SG, de Belder MA, Janssens L, Katz O, Pluta W, Ecollan P, Tendera M, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Armstrong P, Brodie BR, Herrmann HC, Neumann FJ, Effron MB, Lu J, Barnathan ES, Topol EJ; Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events Investigators. Enoxaparin in primary and facilitated percutaneous coronary intervention A formal prospective nonrandomized substudy of the FINESSE trial (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events). JACC Cardiovasc Interv. 2010 Feb;3(2):203-12. doi: 10.1016/j.jcin.2009.11.012.

title: Enoxaparin in Primary and Facilitated Percutaneous Coronary Intervention

ReferenceCitation: Herrmann HC, Lu J, Brodie BR, Armstrong PW, Montalescot G, Betriu A, Neuman FJ, Effron MB, Barnathan ES, Topol EJ, Ellis SG; FINESSE Investigators. Benefit of facilitated percutaneous coronary intervention in high-risk ST-segment elevation myocardial infarction patients presenting to nonpercutaneous coronary intervention hospitals. JACC Cardiovasc Interv. 2009 Oct;2(10):917-24. doi: 10.1016/j.jcin.2009.06.018.

title: Benefit of Facilitated Percutaneous Coronary Intervention in High-Risk ST-Segment Elevation Myocardial Infarction Patients Presenting to Nonpercutaneous Coronary Intervention Hospitals

ReferenceCitation: Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Hamankiewicz M, Pluta W, Oldroyd K, Ecollan P, Janssens L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. 1-year survival in a randomized trial of facilitated reperfusion: results from the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. JACC Cardiovasc Interv. 2009 Oct;2(10):909-16. doi: 10.1016/j.jcin.2009.07.009.

title: 1-Year Survival in a Randomized Trial of Facilitated Reperfusion

location_country:
Austria
South Africa
Sweden
Switzerland
Netherlands
United Kingdom
Germany
France
Bulgaria
Poland
Israel
Romania
Argentina
Belgium
Spain
Denmark
United States
Czech Republic
Canada


title: A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

summary: Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
Peru
Sweden
Netherlands
Spain
Germany
France
Greece
Venezuela
Argentina
Australia
Belgium
Portugal
United States
United Kingdom
Taiwan
Colombia


title: A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

summary:
The purposes of this study are to determine:

If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.

LY900003 may not add any benefit to gemcitabine plus cisplatin.

location_country:
Romania
Belgium
Russian Federation
Taiwan
India
France
Poland
Norway
Argentina
South Africa
Chile
Sweden
Switzerland
Netherlands
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Spain


title: Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment (Standard of Care) in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission (CR)

summary:
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission.

PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy.

ReferenceCitation: Buyse M, Michiels S, Squifflet P, Lucchesi KJ, Hellstrand K, Brune ML, Castaigne S, Rowe JM. Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission. Haematologica. 2011 Aug;96(8):1106-12. doi: 10.3324/haematol.2010.039131. Epub 2011 May 5.

family: Buyse

full_name: M. Buyse

given: M.

family: Michiels

full_name: S. Michiels

given: S.

family: Squifflet

full_name: P. Squifflet

given: P.

family: Lucchesi

full_name: K. J. Lucchesi

given: K. J.

family: Hellstrand

full_name: K. Hellstrand

given: K.

family: Brune

full_name: M. L. Brune

given: M. L.

family: Castaigne

full_name: S. Castaigne

family: Rowe

full_name: J. M. Rowe

given: J. M.

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

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

repository_institution: University of Hasselt - Document Server@UHasselt

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Buyse M, Squifflet P, Lucchesi KJ, Brune ML, Castaigne S, Rowe JM. Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia. Trials. 2011 Mar 23;12:86. doi: 10.1186/1745-6215-12-86.

full_name: Marc Buyse

given: Marc

full_name: Pierre Squifflet

given: Pierre

full_name: Kathryn J Lucchesi

given: Kathryn J

full_name: Mats L Brune

given: Mats L

full_name: Sylvie Castaigne

given: Sylvie

full_name: Jacob M Rowe

given: Jacob M

currency_apc_doaj: GBP

journal_name: Trials

location_country:
United States
Sweden
Germany
Finland
France
Israel
Australia
New Zealand
Estonia
Denmark
Canada
United Kingdom

location_facility: University of Auckland School of Medicine

location_facility: Ottawa Regional Cancer Center - General Division

location_facility: University of Florida Health Science Center - Jacksonville

location_facility: Bethesda Bone Marrow Stem Cell Transplant Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Queen Elizabeth II Health Science Center

location_facility: Tel-Aviv Medical Center-Ichilov Hospital

location_facility: Washington University School of Medicine

location_facility: University of New Mexico Cancer Research & Treatment Center

location_facility: University of Alabama Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

location_facility: New York Presbyterian Hospital - Cornell Campus

location_facility: University of Pennsylvania Cancer Center

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Kaiser Permanente-Southern California Permanente Medical Group


title: RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS

summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.

ReferenceCitation: Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J, Therasse P. Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol. 2008 Oct 20;26(30):4883-90. doi: 10.1200/JCO.2007.14.4659. Epub 2008 Sep 15.

name: From the Universitair Ziekenhuis Gasthuisberg, Leuven; Algemeen Ziekenhuis Sint Augustinus, Antwerp; Institut Jules Bordet, Université Libre de Bruxelles; European Organisation for Research and Treatment of Cancer Data Centre, Brussels, Belgium; Radboud University Nijmegen Medical Centre, Nijmegen; Leiden University Medical Centre, Leiden, the Netherlands; University of Edinburgh & Western General Hospital, Edinburgh, United Kingdom; and The Institute of Oncology, Ljubljana, Slovenia

family: Paridaens

full_name: Robert J. Paridaens

given: Robert J.

family: Dirix

full_name: Luc Y. Dirix

given: Luc Y.

family: Beex

full_name: Louk V. Beex

given: Louk V.

family: Nooij

full_name: Marianne Nooij

given: Marianne

family: Cameron

full_name: David A. Cameron

given: David A.

family: Cufer

full_name: Tanja Cufer

given: Tanja

family: Piccart

full_name: Martine J. Piccart

given: Martine J.

family: Bogaerts

full_name: Jan Bogaerts

given: Jan

family: Therasse

full_name: Patrick Therasse

given: Patrick

repository_institution: University of Edinburgh - Edinburgh Research Explorer

publisher_group: American Society of Clinical Oncology (ASCO)

title: Phase III Study Comparing Exemestane With Tamoxifen As First-Line Hormonal Treatment of Metastatic Breast Cancer in Postmenopausal Women: The European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group

ReferenceCitation: Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, Lohrisch C, Cufer T, Lobelle JP, Mattiaci MR, Piccart M, Paridaens R. The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: a companion study to EORTC Trial 10951, 'Randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients'. Ann Oncol. 2004 Feb;15(2):211-7.

ReferenceCitation: Paridaens R, Therasse P, Dirix L, et al.: First line hormonal treatment (HT) for metastatic breast cancer (MBC) with exemestane (E) or tamoxifen (T) in postmenopausal patients (pts): A randomized phase III trial of the EORTC Breast group. [Abstract] J Clin Oncol 22 (Suppl 14): A-515, 6s, 2004.

ReferenceCitation: Paridaens R, Therasse P, Dirix L, et al.: First results of a randomized phase III trial comparing exemestane versus tamoxifen as first-line hormone therapy (HT) for postmenopausal women with metastatic breast cancer (MBC) : EORTC 10951 in collaboration with the exemestane working group and NCIC Clinical Trials Group. [Abstract] Eur J Cancer 2 (Suppl 3): A-241, 126, 2004.

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

location_country:
United Kingdom
Netherlands
Philippines
France
Malaysia
Poland
Thailand
Belgium
Australia
Russian Federation
Slovenia
Taiwan

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Medisch Centrum Haaglanden Locatle Antoniushove

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Centre Hospitalier Universitaire de Tivoli


title: A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

summary: The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.

lead_sponsor: Schering-Plough

location_country:
United States
Chile
Guatemala
Honduras
South Africa
Mexico
Germany
Dominican Republic
France
Panama
Israel
Thailand
Venezuela
Belgium
Argentina
Spain
Canada
Ethiopia

location_facility: Faculty of Medicine / Dept of Internal Medicine

location_facility: Hosp Roosevelt Chief Infectious Diseases Unit

location_facility: Universitaets Krankenhaus Eppendorf Medizinische Kernklinik

location_facility: Thomas Jefferson Univ / Division of Infectious Disease

location_facility: Rheinische Friedrich Wilhelms Universitaet Medizinische

location_facility: Universitat Munchen / Medizinische Poliklinik

location_facility: Service des Maladies Infectieuses Hopital de l Archet

location_facility: Univ of Stellenbosch Med School Depart Med Phys

location_facility: Rush Med College / Rush Presbyterian - St Luke's Med Cen

location_facility: Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler

location_facility: Hopital Guy de Chauliac Service des Maladies Infectieuses

location_facility: Program on AIDS / Thai Red Cross Society

location_facility: Hosp de Especialidades Centro Medico La Raza

location_facility: Centro de Micologia / Facultad de Medicina UBA


intervention_type: Biological

status: Not yet recruiting

study_start_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Chile
Sweden
Switzerland
Mexico
Germany
Finland
France
Greece
Israel
Norway
Romania
Argentina
Australia
Belgium
Spain
Denmark
United States
Canada

study_completion_date_type: Anticipated

source: euctr

title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

summary: The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

status_simplified: Ongoing


title: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

acronym: BRUIN CLL-322

summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

study_start_date_type: Actual

status: Recruiting

ipd_sharing: No

lead_sponsor: Loxo Oncology, Inc.

location_country:
United States
Belgium
France
Japan

location_facility: Cancer Specialists of North Florida -St Augustine


ReferenceCitation: Park K, Özgüroğlu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6.

family: Park

full_name: Keunchil Park

given: Keunchil

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

given: Mustafa

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

family: Spigel

full_name: David Spigel

given: David

family: Yang

full_name: James C.-H. Yang

given: James C.-H.

family: Bajars

full_name: Marcis Bajars

given: Marcis

family: Ruisi

full_name: Mary Ruisi

given: Mary

family: Manitz

full_name: Juliane Manitz

given: Juliane

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
HAL
LIRIAS (KU Leuven)

ReferenceCitation: Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Özgüroğlu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabrò L, Arén Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24. Erratum in: Lancet Oncol. 2018 Nov;19(11):e581.

family: Ishii

full_name: Hidenobu Ishii

given: Hidenobu

family: Garassino

full_name: Marina Garassino

given: Marina

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Peru
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Croatia
France
Japan
Poland
Slovakia
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Switzerland
Bulgaria
Hungary
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Oaxaca Site Management Organization S.C.

location_facility: University Clinic for Pulmonary Diseases

location_facility: Marmara University Pendik Research and Training Center

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 5 SUM

location_facility: University of Texas Health Science Center at Tyler

location_facility: Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: Seconda Università degli Studi di Napoli

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: Konya Necmettin Erbakan University Meram Faculty of Medicine

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Clínica Universitaria Privada Reina Fabiola

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Oncosinos - Clínica de Oncologia - Hospital Regina

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: Instituto de Terapias Oncologicas Providencia

location_facility: SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow

location_facility: Clinical Hospital Centar "Sestre Milosrdnice"

location_facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Complex Oncological Center - Plovdiv, EOOD

location_facility: SHI "Republican Clinical Oncological Dispensary of HM RT"

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hematology Oncology Associates of Rockland

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Penn State Univ. Milton S. Hershey Medical Center

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: CIEC - Centro Internacional de Estudios Clínicos

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Hospital General Universitario de Alicante

location_facility: Bezmi Alem Foundation University Medical Faculty Hospital

location_facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

location_facility: FSBHI Clinical research institute of phthisiopulmonology

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

location_facility: The Center for Cancer and Blood Disorders

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Fundacion Cardioinfantil Instituto de Cardiologia

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V.

location_facility: Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda

location_facility: University of Pretoria Oncology Department

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Hospital Universitario Materno-Infantil de Canarias

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

location_facility: Instituto Nacional de Cancerologia E.S.E.

title: A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet

summary: The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.


title: An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

ReferenceType: background

ReferenceCitation: Asselah T, Shafran S, Bourgeois S, Lai CL, Cramp M, Mathurin P, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in HCV Infected Patients Previously Treated With Placebo: Results of the Deferred Treatment Study (GS-US-342-1446 Study) [Abstract SAT-279]. J Hepatology 2016;64:S827-8.

ReferenceCitation: Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. J Viral Hepat. 2019 Oct;26(10):1229-1232. doi: 10.1111/jvh.13159. Epub 2019 Aug 4.

name: Hepatology Department, Head of Viral Hepatitis Team, INSERM UMR1149, Beaujon Hospital Université Paris Diderot Paris France

family: Asselah

full_name: Tarik Asselah

given: Tarik

family: Shafran

full_name: Stephen D. Shafran

given: Stephen D.

name: Ziekenhuis Netwerk Antwerpen STER Site Stuivenberg Antwerpen Belgium

family: Bourgeois

full_name: Stefan Bourgeois

given: Stefan

family: Lai

full_name: Ching‐Lung Lai

given: Ching‐Lung

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Willems

full_name: Bernard Willems

given: Bernard

name: Stanford University Medical Center Stanford California USA

family: Nguyen

full_name: Mindie H. Nguyen

given: Mindie H.

name: South Florida Center of Gastroenterology Wellington Florida USA

family: Davis

full_name: Mitchell N. Davis

given: Mitchell N.

name: Gilead Sciences, Inc Foster City California USA

family: Huang

full_name: K. C. Huang

given: K. C.

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Osinusi

full_name: Anu Osinusi

given: Anu

family: McNally

full_name: John McNally

given: John

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

name: VA Pittsburgh Healthcare System Pittsburgh Pennsylvania USA

family: Shaikh

full_name: Obaid S. Shaikh

given: Obaid S.

name: Cedars‐Sinai Medical Center Los Angeles California USA

family: Tran

full_name: Tram T. Tran

given: Tram T.

journal_name: Journal of Viral Hepatitis

title: Deferred treatment with a fixed‐dose combination of sofosbuvir‐velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
Hong Kong
Germany
France
Belgium
Puerto Rico
Canada
United Kingdom


title: A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease

summary:
The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of an autologous antigen-specific regulatory type 1 T lymphocyte expanded population administered via the intravenous route as an infusion.

The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection study; followed with a 16-week phase with either the possibility for an open-label treatment part or a safety follow-up part with no injection.

Then, the patients will be followed in an additional long-term safety follow-up, of maximum duration of 3 years from the first administration.

ReferenceCitation: Desreumaux P, Foussat A, Allez M, Beaugerie L, Hébuterne X, Bouhnik Y, Nachury M, Brun V, Bastian H, Belmonte N, Ticchioni M, Duchange A, Morel-Mandrino P, Neveu V, Clerget-Chossat N, Forte M, Colombel JF. Safety and efficacy of antigen-specific regulatory T-cell therapy for patients with refractory Crohn's disease. Gastroenterology. 2012 Nov;143(5):1207-1217.e2. doi: 10.1053/j.gastro.2012.07.116. Epub 2012 Aug 8.

lead_sponsor: TxCell

location_country:
Italy
Austria
France
Belgium
Germany
United Kingdom

location_facility: Guy's and St Thomas' NHS Foundation Trust


ReferenceCitation: Dimopoulos MA, Špička I, Quach H, Oriol A, Hájek R, Garg M, Beksac M, Bringhen S, Katodritou E, Chng WJ, Leleu X, Iida S, Mateos MV, Morgan G, Vorog A, Labotka R, Wang B, Palumbo A, Lonial S; TOURMALINE-MM4 study group. Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial. J Clin Oncol. 2020 Dec 1;38(34):4030-4041. doi: 10.1200/JCO.20.02060. Epub 2020 Oct 6.

name: Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

name: First Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic

family: Špička

full_name: Ivan Špička

given: Ivan

name: Department of Hematology, University of Melbourne, St Vincent’s Hospital, Melbourne, Victoria, Australia

family: Quach

full_name: Hang Quach

given: Hang

name: Institut d’Investigació contra la Leucèmia Josep Carreras and Institut Català d’Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain

family: Oriol

full_name: Albert Oriol

given: Albert

name: Department of Hemato-oncology, University Hospital Ostrava, University of Ostrava, and Faculty of Medicine, Ostrava, Czech Republic

family: Hájek

full_name: Roman Hájek

given: Roman

name: Hematology, Leicester Royal Infirmary/University Hospitals of Leicester NHS Trust, Leicester, United Kingdom

family: Garg

full_name: Mamta Garg

given: Mamta

name: Department of Hematology, Ankara University, Ankara, Turkey

family: Beksac

full_name: Meral Beksac

given: Meral

name: Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy

family: Bringhen

full_name: Sara Bringhen

given: Sara

name: Department of Hematology, Theagenion Cancer Hospital, Thessaloniki, Greece

family: Katodritou

full_name: Eirini Katodritou

given: Eirini

name: Department of Hematology-Oncology, National University Cancer Institute, National University Health System, and Yong Loo Lin School of Medicine and Cancer Science Institute of Singapore, National University of Singapore, Singapore

family: Chng

full_name: Wee-Joo Chng

given: Wee-Joo

name: Pôle Régional de Cancérologie, Department of Haematology, Centre Hospitalier Universitaire La Milétrie-Poitiers, Poitiers, France

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

family: Iida

full_name: Shinsuke Iida

given: Shinsuke

name: Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Celular del Cáncer, (Universitario de Salamanca Consejo Superior de Investigaciones Científicas), Salamanca, Spain

family: Mateos

full_name: María-Victoria Mateos

given: María-Victoria

name: Perlmutter Cancer Center, NYU Langone Health, New York, NY

family: Morgan

full_name: Gareth Morgan

given: Gareth

name: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA

family: Vorog

full_name: Alexander Vorog

given: Alexander

family: Labotka

full_name: Richard Labotka

given: Richard

family: Wang

full_name: Bingxia Wang

given: Bingxia

family: Palumbo

full_name: Antonio Palumbo

given: Antonio

name: Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA

family: Lonial

full_name: Sagar Lonial

given: Sagar

name: on behalf of the TOURMALINE-MM4 study group

evidence: open (via page says license)

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

publisher_normalized: American Society of Clinical Oncology (ASCO)

status: Active, not recruiting

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Croatia
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centro Internacional de Estudios Clinicos

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Medizinisches Versorgungszentrum Onkologischer Schwerpunkt

location_facility: Beijing Chaoyang Hospital Capital Medical University

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Siouxland Hematology - Oncology Associates LLP

location_facility: North County Oncology Medical Clinic Inc

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: National Hospital Organization Mito Medical Center

location_facility: Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

location_facility: W VA University Mary Babb Randolph Cancer Center

location_facility: Universidade Federal do Rio de Janeiro - UFRJ

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario HM Sanchinarro CIOCC

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Nara Hospital Kinki University Faculty of Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Winship Cancer Institute, Emory University

location_facility: Shanxi Medical University - Second Hospital

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Instituto Nacional de Cancerologia Colombia

location_facility: Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto

location_facility: Mae de Deus Center Hospital Giovanni Battista

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Internistisch Hamatologische und Internistische Praxis

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: CEHON - Centro de Hematologia e Oncologia da Bahia Ltda

location_facility: State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary

location_facility: Centro de Investigacion Farmaceutica Especializada de Occidente, SC

location_facility: Hospital Y Clinica OCA Sociedad Anonima de Capital Variable

location_facility: University Klinichki Bolnicki Centar Zagreb

location_facility: 1st Affiliated Hospital of Zhejiang University

location_facility: Oaxaca Site management Organization (OSMO)

location_facility: Renji Hospital Medical School of Shanghai Jiaotong University

location_facility: Praxis Pihusch Medizinisches Versorgungszentrum GbR

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter

location_facility: Clinical Hospital Center ''Bezanijska Kosa''

location_facility: Gemeinschaftspraxis fur Hamatologie und Onkologie

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Kobe City Medical Center General Hospital

location_facility: University of Athens Medical School - Regional General Hospital Alexandra

location_facility: Hospital Das Clinicas Da Universidade Federal de Goias

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: Arhus Universitetshospital Arhus Sygehus

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino Istituto Nazionale Per La Ricerca Sul Cancro

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Central Coast Medical Oncology Corporation

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

location_facility: Global Cancer Research Institute (GCRI), Inc.

location_facility: James Paget University Hospitals NHS Foundation Trust

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

summary: The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.


title: Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)

summary: This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Manetti L, Deutschbein T, Schopohl J, Yuen KCJ, Roughton M, Kriemler-Krahn U, Tauchmanova L, Maamari R, Giordano C. Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Pituitary. 2019 Oct;22(5):542-551. doi: 10.1007/s11102-019-00984-6.

family: Manetti

full_name: Luca Manetti

given: Luca

family: Deutschbein

full_name: Timo Deutschbein

given: Timo

family: Schopohl

full_name: Jochen Schopohl

given: Jochen

family: Yuen

full_name: Kevin C. J. Yuen

given: Kevin C. J.

family: Roughton

full_name: Michael Roughton

given: Michael

family: Kriemler-Krahn

full_name: Ulrike Kriemler-Krahn

given: Ulrike

family: Tauchmanova

full_name: Libuse Tauchmanova

given: Libuse

family: Maamari

full_name: Ricardo Maamari

given: Ricardo

family: Giordano

full_name: Carla Giordano

given: Carla

journal_name: Pituitary

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing’s disease: interim results from a long-term real-world evidence study

lead_sponsor: RECORDATI GROUP

location_country:
Italy
United States
Sweden
Lebanon
Netherlands
France
Israel
Romania
Germany
United Kingdom
Canada
Colombia

location_facility: LifeBridge Heath Cardiovascular Institute, Sinai Hospital SC - SOM230B2410

location_facility: R. I. Hospital Medical Oncology Clinical Research SC

location_facility: Massachusetts General Hospital SC - SOM230B2410

location_facility: University of Southern California CSOM230B2410 - SC

location_facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)


lead_sponsor: Biogen

location_country:
Italy
United States
Sweden
Serbia
Germany
France
Czechia
Bulgaria
Israel
Kuwait
Poland
Hungary
Belgium
Spain
Turkey
Denmark
Canada
United Kingdom

acronym: CONNECT

location_facility:
Resaerch Site
Resaeach Site
Research Site
Researh Site

title: Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

summary: The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.