ReferenceCitation: Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

family: Ferrannini

full_name: E. Ferrannini

given: E.

family: Berk

full_name: A. Berk

given: A.

family: Hantel

full_name: S. Hantel

family: Pinnetti

full_name: S. Pinnetti

family: Hach

full_name: T. Hach

given: T.

family: Woerle

full_name: H. J. Woerle

given: H. J.

family: Broedl

full_name: U. C. Broedl

given: U. C.

journal_name: Diabetes Care

oa_colors: green other

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Long-Term Safety and Efficacy of Empagliflozin, Sitagliptin, and Metformin: An active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes

location_country:
Finland
Romania
Russian Federation
Czech Republic
Taiwan
Ukraine
Croatia
France
Lithuania
Slovakia
Norway
Korea, Republic of
Sweden
Hungary
Germany
United States
Italy
Austria
Spain
Estonia
Latvia

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location_facility: 1245.24.381006 Boehringer Ingelheim Investigational Site

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location_facility: 1245.24.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701014 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421108 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3310C Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886104 Boehringer Ingelheim Investigational Site

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location_facility: 1245.24.3303B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421106 Boehringer Ingelheim Investigational Site

title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

summary: The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.


ReferenceType: background

ReferenceCitation: Hersh EM, Del Vecchio M, Brown MP, Kefford R, Loquai C, Testori A, Bhatia S, Gutzmer R, Conry R, Haydon A, Robert C, Ernst S, Homsi J, Grob JJ, Kendra K, Agarwala SS, Li M, Clawson A, Brachmann C, Karnoub M, Elias I, Renschler MF, Hauschild A. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Celgene

enrollment_type: Actual

primary_purpose: Treatment

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

location_facility: IST-Istituto Nazionale per la Ricera sul Cancro

location_facility: OH State University Arthur G. James Cancer Hospital

location_facility: Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc

location_facility: Groupe hospitalier Cochin-St. Vincent de Paul

location_facility: Centre Hospitaller Universitaire de Grenoble

location_facility: Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: Centre Regional Val d' Aurelle Paul Lamarque

location_facility: Singleton Hospital, Sothwest Wales Inst.

location_facility: Sydney West Cancer Trials Centre/Westmead Hospital

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: University of Southern California/Norris Cancer Center

location_facility: San Diego Pacific Oncology and Hematology Associates

location_facility: Ist. Naz. per lo studio e la cura dei tumori G. Pascale

location_facility: University of Arkansa for Medical Sciences

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei T

location_facility: Univ. of Washington Medical Center/Seattle Cancer Care Alliance

location_facility: University of Miami Hospital and Clincs/SCCC

location_facility: McGill University Dept. of Oncology Clinical Research Program

location_facility: Nottingham University Hospitals NHS Trust

study_completion_date_type: Actual

source: euctr

title: An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

summary: The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.

family: Kolamunnage-Dona

full_name: Ruwanthi Kolamunnage-Dona

given: Ruwanthi

sequence: first

family: Berhane

full_name: Sarah Berhane

given: Sarah

sequence: additional

family: Potts

full_name: Harry Potts

given: Harry

family: Williams

full_name: Edward H. Williams

given: Edward H.

family: Tanner

full_name: James Tanner

given: James

family: Janowitz

full_name: Tobias Janowitz

given: Tobias

family: Hoare

full_name: Matthew Hoare

given: Matthew

family: Johnson

full_name: Philip Johnson

given: Philip

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Aviña J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26.

name: Philip J. Johnson, University of Birmingham, Birmingham, United Kingdom; Shukui Qin, Nanjing Bayi Hospital, Nanjing; Jianming Xu, 307 Hospital of PLA, Beijing; Ligong Lu, Guangdong Provincial People's Hospital, Guangdong; Lunan Yan, West China Hospital of Sichuan University, Chengdu; Ronnie T.P. Poon, University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China; Joong Won Park, Center for Liver Cancer, National Cancer Center, Goyang; Jeong Heo, Pusan National University...

full_name: Philip J. Johnson

given: Philip J.

family: Qin

full_name: Shukui Qin

given: Shukui

family: Park

full_name: Joong-Won Park

given: Joong-Won

family: Poon

full_name: Ronnie T.P. Poon

given: Ronnie T.P.

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Philip

full_name: Philip A. Philip

given: Philip A.

family: Hsu

full_name: Chih-Hung Hsu

given: Chih-Hung

family: Hu

full_name: Tsung-Hui Hu

given: Tsung-Hui

family: Heo

full_name: Jeong Heo

given: Jeong

family: Xu

full_name: Jianming Xu

given: Jianming

family: Lu

full_name: Ligong Lu

given: Ligong

family: Chao

full_name: Yee Chao

given: Yee

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Han

full_name: Kwang-Hyub Han

given: Kwang-Hyub

family: Paik

publisher: American Society of Clinical Oncology (ASCO)

title: Brivanib Versus Sorafenib As First-Line Therapy in Patients With Unresectable, Advanced Hepatocellular Carcinoma: Results From the Randomized Phase III BRISK-FL Study

location_country:
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility: Agajanian Institute Of Hematology And Oncology

title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

summary: The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.


ReferenceCitation: Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Køber LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

family: Shen

full_name: Li Shen

given: Li

family: Claggett

full_name: Brian L. Claggett

given: Brian L.

family: Jhund

full_name: Pardeep S. Jhund

given: Pardeep S.

family: Abraham

full_name: William T. Abraham

given: William T.

family: Desai

full_name: Akshay Suvas Desai

given: Akshay Suvas

family: Dickstein

full_name: Kenneth Dickstein

given: Kenneth

family: Gong

full_name: Jianjian Gong

given: Jianjian

family: Køber

full_name: Lars V. Køber

given: Lars V.

family: Lefkowitz

full_name: Marty P. Lefkowitz

given: Marty P.

family: Rouleau

full_name: Jean L. Rouleau

given: Jean L.

family: Shi

full_name: Victor C. Shi

given: Victor C.

family: Swedberg

full_name: Karl Swedberg

given: Karl

family: Zile

full_name: Michael R. Zile

given: Michael R.

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: McMurray

full_name: John J. V. McMurray

given: John J. V.

journal_name: Clinical Research in Cardiology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_institution: The University of Glasgow - Enlighten: Publications

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10:CD012569. doi: 10.1002/14651858.CD012569.pub2.

name: Department of Pharmacology; School of Pharmacy, Fudan University; Shanghai China

family: Wang

full_name: Gan Mi Wang

given: Gan Mi

family: Li

full_name: Liang Jin Li

given: Liang Jin

family: Tang

full_name: Wen Lu Tang

given: Wen Lu

name: Department of Anesthesiology, Pharmacology and Therapeutics; University of British Columbia; Vancouver Canada

ReferenceCitation: Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rørth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.

name: BHF Cardiovascular Research Centre University of Glasgow  Glasgow UK

name: Department of Cardiology Rigshospitalet University Hospital  Copenhagen Denmark

name: Division of Cardiology, Department of Medical Sciences University of Turin  Turin Italy

name: Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute Ohio State University  Columbus OH USA

name: Cardiovascular Medicine, Brigham and Women's Hospital  Boston MA USA

name: Stavanger University Hospital, Stavanger, and the Institute of Internal Medicine University of Bergen  Bergen Norway

name: Institut de Cardiologie Université de Montréal  Montréal Canada

name: Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center  Charleston SC USA

name: Department of Molecular and Clinical Medicine University of Gothenburg  Gothenburg Sweden

name: Baylor Heart and Vascular Institute Baylor University Medical Center, Dallas, TX, USA and National Heart and Lung Institute, Imperial College  London

name: PARADIGM‐HF and ATMOSPHERE Committees and Investigators.

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

title: Prevalence and incidence of intra‐ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM‐HF and ATMOSPHERE

ReferenceCitation: Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Böhm M, Desai AS, Dickstein K, Køber LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.

name: BHF Cardiovascular Research CentreUniversity of Glasgow Glasgow UK

name: Division of Cardiology, Città della Salute e della Scienza Hospital, Department of Medical SciencesUniversity of Turin Torino Italy

name: Division of Cardiovascular Medicine, Davis Heart and Lung Research InstituteThe Ohio State University Columbus OH USA

name: Department of Internal Medicine III, University Hospital of SaarlandSaarland University Homburg/Saar Germany

name: Cardiovascular MedicineBrigham and Women's Hospital Boston MA USA

name: Department of CardiologyUniversity of Bergen, Stavanger University Hospital Stavanger Norway

name: Department of Cardiology, The Heart CentreRigshospitalet Copenhagen University Hospital Copenhagen Denmark

name: Baylor Heart and Vascular InstituteBaylor University Medical Center Dallas TX USA

name: Institut de Cardiologie de MontréalUniversité de Montréal Montréal Canada

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; National Heart and Lung InstituteImperial College London London UK

name: Department of Cardiology, Royal Brompton Hospital, National Heart and Lung InstituteImperial College London London UK

name: Department of MedicineMedical University of South Carolina Charleston SC USA

ReferenceCitation: Dewan P, Rørth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Køber L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum in: Circ Heart Fail. 2020 Jan;13(1):e000036.

name: BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (P.D., R.R., R.T.C., L.S., P.S.J., M.C.P., J.J.V.M.).

name: Rigshospitalet Copenhagen University Hospital, Denmark (R.R., L.K.).

name: Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada (V.R.).

name: Department of Experimental Medicine, Sapienza University of Rome, Italy (V.R.).

name: VA Medical Center, University of Minnesota, MN (I.S.A.).

name: Georgetown University, Washington DC Veterans Affairs Medical Center (P.E.C.).

name: Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (A.S.D., M.A.P., S.D.S.).

name: Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.).

name: Department of Cardiology, Hospital Saint Joseph, France (M.K.).

name: St. Joseph’s Healthcare Centre, Western University, London, ON, Canada (R.S.M.).

name: Montreal Heart Institute and Université de Montreal, Quebec, Canada (E.O.).

name: Department of Internal Medicine-Cardiology, University of Michigan School of Medicine, Ann Arbor (B.P.).

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).

name: National Heart and Lung Institute, Imperial College, London (K.S.).

name: Ralph H. Johnson Veterans Administration Medical Center, Medical University of South Carolina, Charleston, SC (M.R.Z.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Shen L, Ramires F, Martinez F, Bodanese LC, Echeverría LE, Gómez EA, Abraham WT, Dickstein K, Køber L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11). pii: e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.

name: From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (L.S., P.S.J., J.J.V.M.); Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil (F.R.); Instituto DAMIC/Fundacion Rusculleda, Cordoba, Argentina (F.M.); Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (L.C.B.); Grupo de Ciencias Cardiovasculares, Fundación Cardiovascular de Colombia, Santander (L.E.E.); Clinica Shaio, Bogota,...

name: on behalf of the PARADIGM-HF and ATMOSPHERE Investigators and Committees

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

repository_institution: Australian Catholic University - Research Bank

repositories_institution: Australian Catholic University - Research Bank

ReferenceCitation: Kristensen SL, Jhund PS, Mogensen UM, Rørth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10). pii: e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.

name: From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.L.K., P.S.J., U.M.M., R.R., J.J.V.M.); Department of Cardiology, Rigshospitalet University Hospital, Copenhagen, Denmark (S.L.K., U.M.M., R.R., L.K.); The Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.TA.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (A.D., S.D.S.); Stavanger University Hospital, Stavanger, and Department of...

ReferenceCitation: Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Køber L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.

name: Department of Cardiology, Rigshospitalet; University of Copenhagen; Copenhagen Denmark

name: Institute of Cardiovascular and Medical sciences; University of Glasgow; Glasgow UK

name: Division of Cardiovascular Medicine; Davis Heart and Lung Research Institute, Ohio State University; Columbus OH USA

name: University of Bergen; Stavanger University Hospital; Stavanger Norway

ReferenceCitation: McMurray JJ, Krum H, Abraham WT, Dickstein K, Køber LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: University of Zurich - Zurich Open Repository and Archive

title: Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
India
Costa Rica
France
Japan
Lithuania
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Switzerland
Netherlands
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Dominican Republic
Venezuela
Spain
Estonia
Latvia

title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).

summary: The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.


ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.

name: Department of Neurology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany

family: Gold

full_name: Ralf Gold

given: Ralf

name: Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, QC, Canada

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

name: Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

name: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA

family: Fox

full_name: Robert J. Fox

given: Robert J.

name: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Chen

full_name: Chongshu Chen

given: Chongshu

family: Parks

full_name: Becky Parks

given: Becky

name: Biogen, 225 Binney Street, Cambridge, MA 02142, USA

family: Miller

full_name: Catherine Miller

given: Catherine

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Neurological Disorders

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

family: Mehta

full_name: Devangi Mehta

given: Devangi

family: Bame

full_name: Eris Bame

given: Eris

family: Hanna

full_name: Jerome Hanna

given: Jerome

family: Liu

full_name: Shifang Liu

given: Shifang

family: Matta

full_name: André Matta

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

title: Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing–Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies

location_country:
North Macedonia
Greece
Romania
Australia
Belgium
Ukraine
India
Spain
Croatia
France
Poland
Slovakia
Moldova, Republic of
Canada
South Africa
Switzerland
Netherlands
Bulgaria
Ireland
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Israel
New Zealand
Belarus
Estonia
Latvia

title: A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.


ReferenceType: result

ReferenceCitation: Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684.

family: Archer

full_name: Stephen L. Archer

given: Stephen L.

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: Riociguat for Pulmonary Hypertension — A Glass Half Full

ReferenceCitation: Ghofrani HA, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Grimminger

full_name: Friedrich Grimminger

given: Friedrich

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

family: Humbert

full_name: Marc Humbert

given: Marc

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

family: Keogh

full_name: Anne M. Keogh

given: Anne M.

family: Langleben

full_name: David Langleben

given: David

family: Kilama

full_name: Michael Ochan Kilama

given: Michael Ochan

family: Fritsch

full_name: Arno Fritsch

given: Arno

family: Neuser

full_name: Dieter Neuser

given: Dieter

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

title: Riociguat for the Treatment of Pulmonary Arterial Hypertension

ReferenceCitation: Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

family: Rosenkranz

full_name: Stephan Rosenkranz

given: Stephan

family: Beghetti

full_name: Maurice Beghetti

given: Maurice

family: Ivy

full_name: Dunbar Ivy

given: Dunbar

family: Frey

full_name: Reiner Frey

given: Reiner

family: Weimann

full_name: Gerrit Weimann

given: Gerrit

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2. Review.

ReferenceCitation: Benza RL, Ghofrani HA, Grünig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

journal_name: The Journal of Heart and Lung Transplantation

ReferenceCitation: Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: University College London - UCL Discovery

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

name: Clinical Pharmacology, Pharma Research Center, Bayer Pharma, Wuppertal, Germany

title: Population Pharmacokinetics and the Pharmacokinetic/Pharmacodynamic Relationship of Riociguat in Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Singapore
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).


title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

summary: This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

family: Leighl

full_name: N B Leighl

given: N B

family: Bennouna

full_name: J Bennouna

given: J

family: Yi

full_name: J Yi

family: Moore

full_name: N Moore

given: N

family: Hambleton

full_name: J Hambleton

family: Hurwitz

full_name: H Hurwitz

given: H

journal_name: British Journal of Cancer

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

license: implied-oa

license_normalized: implied-oa

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.

full_name: Natasha B. Leighl

given: Natasha B.

family: Zatloukal

full_name: Petr Zatloukal

given: Petr

family: Mezger

full_name: Jörg Mezger

given: Jörg

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

full_name: Nicola Moore

given: Nicola

family: Reck

full_name: Martin Reck

given: Martin

family: Manegold

full_name: Christian Manegold

given: Christian

journal_name: Journal of Thoracic Oncology

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Efficacy and Safety of Bevacizumab-Based Therapy in Elderly Patients with Advanced or Recurrent Nonsquamous Non-small Cell Lung Cancer in the Phase III BO17704 Study (AVAiL)

ReferenceCitation: Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.

title: Overall survival with cisplatin–gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL)

location_country:
Italy
Brazil
Hong Kong
Spain
United Kingdom
Germany
France
Bulgaria
Greece
Israel
Poland
Thailand
Hungary
Belgium
Argentina
Australia
Russian Federation
Canada
Czech Republic
Taiwan


ReferenceCitation: Macìas G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol. 2013 Aug;33(6):591-6. doi: 10.3109/01443615.2013.800851.

family: Macìas

full_name: G. Macìas

given: G.

family: Merki-Feld

full_name: G. S. Merki-Feld

given: G. S.

family: Parke

full_name: S. Parke

given: S.

family: Mellinger

full_name: U. Mellinger

given: U.

family: Serrani

full_name: M. Serrani

given: M.

journal_name: Journal of Obstetrics and Gynaecology

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: Results from the multicentre, randomised, double-blind, active-controlled HARMONY II study

lead_sponsor: Bayer

primary_purpose: Prevention

location_country:
Switzerland
Mexico
Finland
France
Thailand
Australia
Spain
Germany
United Kingdom

type: Other Identifier

type: EudraCT Number

title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment

summary: The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).


ReferenceCitation: Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.

family: Pope

full_name: Janet Pope

given: Janet

family: Bingham

full_name: Clifton O. Bingham

given: Clifton O.

suffix: III

family: Fleischmann

full_name: Roy M. Fleischmann

given: Roy M.

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Massarotti

full_name: Elena M. Massarotti

given: Elena M.

family: Wollenhaupt

full_name: Jürgen Wollenhaupt

given: Jürgen

family: Duncan

full_name: Benjamin Duncan

given: Benjamin

family: Coteur

full_name: Geoffroy Coteur

given: Geoffroy

family: Weinblatt

full_name: Michael E. Weinblatt

given: Michael E.

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

ReferenceCitation: Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.

full_name: Roy Fleischmann

given: Roy

family: van Vollenhoven

full_name: Ronald F. van Vollenhoven

given: Ronald F.

family: Emery

full_name: Paul Emery

given: Paul

family: Huizinga

full_name: Tom WJ Huizinga

given: Tom WJ

family: Cutolo

full_name: Maurizio Cutolo

given: Maurizio

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

ReferenceCitation: Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.

location_country:
Italy
United States
Netherlands
France
Spain
Germany
Canada

title: A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.

summary: This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.


title: A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

summary: The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

status: Terminated

ReferenceCitation: Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.

name: Ann-Lii Cheng, National Taiwan University Hospital, Taipei; Deng-Yn Lin, Chang Gung Memorial Hospital, Chang Gung University, Guishan Township, Taiwan, Republic of China; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Hyun-Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul; Joong-Won Park, National Cancer Center, Goyang, Republic of Korea; Masatoshi Kudo, Kinki University Hospital, Osaka; Masao Omata, Yamanashi Prefecture Central Hospital, Kofu,...

family: Cheng

full_name: Ann-Lii Cheng

given: Ann-Lii

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Lin

full_name: Deng-Yn Lin

given: Deng-Yn

family: Park

full_name: Joong-Won Park

given: Joong-Won

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Qin

full_name: Shukui Qin

given: Shukui

family: Chung

full_name: Hyun-Cheol Chung

given: Hyun-Cheol

family: Song

full_name: Xiangqun Song

given: Xiangqun

family: Xu

full_name: Jianming Xu

given: Jianming

family: Poggi

full_name: Guido Poggi

given: Guido

family: Omata

full_name: Masao Omata

given: Masao

family: Pitman Lowenthal

full_name: Susan Pitman Lowenthal

given: Susan

family: Lanzalone

full_name: Silvana Lanzalone

given: Silvana

family: Yang

full_name: Liqiang Yang

given: Liqiang

family: Lechuga

full_name: Maria Jose Lechuga

given: Maria Jose

family: Raymond

full_name: Eric Raymond

given: Eric

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Sunitinib Versus Sorafenib in Advanced Hepatocellular Cancer: Results of a Randomized Phase III Trial

ReferenceCitation: Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovàcs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.

name: aKantonsspital, St. Gallen, Switzerland;

family: Koeberle

full_name: Dieter Koeberle

given: Dieter

name: bUniversity Hospital CHUV, Lausanne, Switzerland;

family: Montemurro

full_name: Michael Montemurro

given: Michael

name: cUniversity Hospital, Zurich, Switzerland;

family: Samaras

full_name: Panagiotis Samaras

given: Panagiotis

name: dUniversity Hospital, Geneva, Switzerland;

family: Majno

full_name: Pietro Majno

given: Pietro

name: fSAKK Coordinating Center, Bern, Switzerland;

family: Simcock

full_name: Mathew Simcock

given: Mathew

family: Limacher

full_name: Andreas Limacher

given: Andreas

name: gSt. László Teaching Hospital, Budapest, Hungary;

name: hUniversity Hospital, Basel, Switzerland;

name: iOncology Institute of Southern Switzerland, Bellinzona, Switzerland;

title: Continuous Sunitinib Treatment in Patients with Advanced Hepatocellular Carcinoma: A Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) Multicenter Phase II Trial (SAKK 77/06)

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Philippines
Singapore
China
United States
Germany
United Kingdom
Italy
Spain
Turkey


title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry

acronym: IHMR

summary: This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Ethicon, Inc.

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

location_facility: Laparoscopic Surgical Center of New York

location_facility: Owen Drive Surgical Clinic of Fayetteville

location_facility: Huadong Hospital- Affilated to Fudan University

location_facility: Washington University School of Medicine

location_facility: Clinque de l' Orangerie / Cabinet de Chirurgie

location_facility: Service de Chirurgie Generale et Cancerologie Digestiv

location_facility: CH Avignon - Service de Chirurgie Digestive

location_facility: Centre for the Advancement of Minimally Invasive Surgery (CAMIS)

location_facility: South East Area Health Education Center (SEAHEC)

status_simplified: Ongoing


title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

acronym: BELIEVE

summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

ReferenceCitation: Paul C, van de Kerkhof P, Puig L, Unnebrink K, Goldblum O, Thaçi D. Influence of psoriatic arthritis on the efficacy of adalimumab and on the treatment response of other markers of psoriasis burden: subanalysis of the BELIEVE study. Eur J Dermatol. 2012 Nov-Dec;22(6):762-9. doi: 10.1684/ejd.2012.1863.

family: Paul

full_name: Carle Paul

given: Carle

family: van de Kerkhof

full_name: Peter van de Kerkhof

given: Peter

family: Puig

full_name: Lluis Puig

given: Lluis

family: Unnebrink

full_name: Kristina Unnebrink

given: Kristina

family: Goldblum

full_name: Orin Goldblum

given: Orin

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

journal_name: European Journal of Dermatology

publisher: John Libbey Eurotext

publisher_dissemination: John Libbey Eurotext

publisher_group: John Libbey Eurotext

publisher_normalized: John Libbey Eurotext

lead_sponsor: Abbott

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
United Kingdom
Finland
France
Greece
Belgium
Spain
Turkey
Denmark
Germany
Czech Republic


title: A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib Versus Lapatinib Monotherapy in Patients With ErbB2 Over-expressing Inflammatory Breast Cancer

summary: The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

lead_sponsor: GlaxoSmithKline

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
Morocco
Pakistan
France
Thailand
Canada
Korea, Republic of
Chile
Hong Kong
Philippines
Singapore
China
United States
Germany
United Kingdom
Italy
Israel
Tunisia
Egypt
Spain
Turkey


ReferenceCitation: Chan DL, Yao JC, Carnaghi C, Buzzoni R, Herbst F, Ridolfi A, Strosberg J, Kulke MH, Pavel M, Singh S. Markers of Systemic Inflammation in Neuroendocrine Tumors: A Pooled Analysis of the RADIANT-3 and RADIANT-4 Studies. Pancreas. 2021 Feb 1;50(2):130-137. doi: 10.1097/MPA.0000000000001745.

family: Chan

full_name: David L. Chan

given: David L.

family: Yao

full_name: James C. Yao

given: James C.

family: Carnaghi

full_name: Carlo Carnaghi

given: Carlo

family: Buzzoni

full_name: Roberto Buzzoni

given: Roberto

family: Herbst

full_name: Fabian Herbst

given: Fabian

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Strosberg

full_name: Jonathan Strosberg

given: Jonathan

family: Kulke

full_name: Matthew H. Kulke

given: Matthew H.

family: Pavel

full_name: Marianne Pavel

given: Marianne

family: Singh

full_name: Simron Singh

given: Simron

journal_name: Pancreas

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Yao JC, Voi M, Lincy J, Pavel M. Reply to V. Amoroso et al. J Clin Oncol. 2017 May 1;35(13):1488-1489. doi: 10.1200/JCO.2017.71.3875. Epub 2017 Jan 23.

name: James C. Yao, University of Texas/MD Anderson Cancer Center, Houston, TX; Maurizio Voi, Novartis Pharmaceuticals Corporation, East Hanover, NJ; Jeremie Lincy, Novartis Pharmaceuticals AG, Basel, Switzerland; and Marianne Pavel, Charité Universitätsmedizin Berlin, Berlin, Germany

family: Voi

full_name: Maurizio Voi

given: Maurizio

family: Lincy

full_name: Jeremie Lincy

given: Jeremie

publisher_group: American Society of Clinical Oncology (ASCO)

title: Reply to V. Amoroso et al

ReferenceCitation: Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Öberg K. Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. doi: 10.1200/JCO.2016.68.0702. Epub 2016 Sep 30.

name: James C. Yao, University of Texas MD Anderson Cancer Center, Houston, TX; Maurizio Voi, Wei He, and David Chen, Novartis, East Hanover, NJ; Timothy Hobday, Mayo Clinic College of Medicine, Rochester, MN; Rodney Pommier, Oregon Health & Science University, Portland, OR; Marianne Pavel, Charité Universitätsmedizin, Berlin, Germany; Catherine Lombard-Bohas, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; Eric Van Cutsem, University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven,...

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: Van Cutsem

full_name: Eric Van Cutsem

family: Brandt

full_name: Ulrike Brandt

ReferenceCitation: Lombard-Bohas C, Yao JC, Hobday T, Van Cutsem E, Wolin EM, Panneerselvam A, Stergiopoulos S, Shah MH, Capdevila J, Pommier R. Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors: a subgroup analysis of the phase III RADIANT-3 trial. Pancreas. 2015 Mar;44(2):181-9. doi: 10.1097/MPA.0000000000000262.

title: Impact of Prior Chemotherapy Use on the Efficacy of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

ReferenceCitation: Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Öberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.

title: Everolimus for Advanced Pancreatic Neuroendocrine Tumors

location_country:
Italy
Brazil
United States
Sweden
Switzerland
Netherlands
Germany
France
Japan
Greece
Slovakia
Thailand
Belgium
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Dept. of Neuroendocrine Clinic

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept. of OHSU Medical Center

location_facility: University of Louisville / James Graham Brown Cancer Center SC

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson CancerCent

location_facility: University of California San Francisco Dept. of UCSF Comp. Cancer

location_facility: University of Pittsburgh Medical Center Hillman Cancer Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: Indiana University Health Goshen Center for Cancer Dept. of Indiana Univ. Cancer

location_facility: Kaiser Permanente Northwest Franklin Medical Offices

location_facility: Columbia University Medical Center- New York Presbyterian Dept. of Columbia Med. Center

location_facility: Oregon Health & Science University Dept. of OHSU (3)

location_facility: Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (4)

location_facility: Littleton Regional Hospital Dept. of Hematology/Oncology

location_facility: University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)

location_facility: University of Iowa Medical Center Dept. of Iowa Medical Center

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: H. Lee Moffitt Cancer Center & Research Institute Malignant Hematology Clinic

location_facility: University of California at Los Angeles UCLA (3)

title: A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)

summary: The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.


title: A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

summary:
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

lead_sponsor: Sprout Pharmaceuticals, Inc

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
Finland
France
Norway
Hungary
Belgium
Spain
Germany
Czech Republic

location_facility: 511.77.49002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3305A Boehringer Ingelheim Investigational Site

location_facility: 511.77.31006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3306A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44011 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35805 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3314A Boehringer Ingelheim Investigational Site

location_facility: 511.77.31005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35803 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3308A Boehringer Ingelheim Investigational Site

location_facility: 511.77.49004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3302A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35804 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3311A Boehringer Ingelheim Investigational Site

location_facility: 511.77.32005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3310A Boehringer Ingelheim Investigational Site

location_facility: 511.77.49008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44010 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3312A Boehringer Ingelheim Investigational Site

location_facility: 511.77.3303A Boehringer Ingelheim Investigational Site

location_facility: 511.77.32003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3301A Boehringer Ingelheim Investigational Site

location_facility: 511.77.46009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35802 Boehringer Ingelheim Investigational Site

location_facility: 511.77.39001 IRCCS S. Fondazione Maugeri

location_facility: 511.77.35801 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49001 Boehringer Ingelheim Investigational Site


ReferenceCitation: Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.

apc_source: openAPC

family: Glauche

full_name: Ingmar Glauche

given: Ingmar

family: Kuhn

full_name: Matthias Kuhn

given: Matthias

family: Baldow

full_name: Christoph Baldow

given: Christoph

family: Schulze

full_name: Philipp Schulze

given: Philipp

family: Rothe

full_name: Tino Rothe

given: Tino

family: Liebscher

full_name: Hendrik Liebscher

given: Hendrik

family: Roy

full_name: Amit Roy

given: Amit

family: Wang

full_name: Xiaoning Wang

given: Xiaoning

family: Roeder

full_name: Ingo Roeder

given: Ingo

journal_name: Scientific Reports

repository_normalized: qucosa

repositories:
PubMed Central
qucosa

title: Quantitative prediction of long-term molecular response in TKI-treated CML – Lessons from an imatinib versus dasatinib comparison

ReferenceCitation: Hughes TP, Saglio G, Quintás-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.

family: Hughes

full_name: T P Hughes

given: T P

family: Saglio

full_name: G Saglio

given: G

family: Quintás-Cardama

full_name: A Quintás-Cardama

given: A

family: Mauro

full_name: M J Mauro

given: M J

family: Kim

full_name: D-W Kim

given: D-W

family: Lipton

full_name: J H Lipton

given: J H

family: Bradley-Garelik

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

ReferenceCitation: Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.

ReferenceCitation: Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boqué C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

name: The University of Texas MD Anderson Cancer Center, Houston, TX;

name: University of Torino, Ospedale San Luigi Gonzaga, Orbassano-Torino, Italy;

name: University of California, San Francisco School of Medicine, San Francisco, CA;

name: Department of Clinical Hematology, Institut Català d’Oncologia, Hospitalet de Llobregat, Barcelona, Spain;

name: Singapore General Hospital and Duke-National University of Singapore Graduate Medical School, Singapore;

name: Fundación Para Combatir la Leucemia, Angelica Ocampo Hospitalization and Clinical Research Center, Buenos Aires, Argentina;

name: University Hospital Brno and Central European Institute of Technology Masaryk University, Brno, Czech Republic;

name: Bristol-Myers Squibb, Princeton, NJ; and

ReferenceCitation: Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipiña JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.

name: The University of Texas M. D. Anderson Cancer Center, Houston, TX;

name: University of California–San Francisco School of Medicine, San Francisco, CA;

name: Department of Hematology-Oncology “L. and A. Seràgnoli,” University of Bologna, Bologna, Italy;

name: Institute of Medical Sciences, Bombay Hospital, Mumbai, India;

name: Department of Hematology, Hospital del Salvador, Santiago, Chile;

name: Department of Clinical Hematology, Institute of Hematology and Blood Diseases Hospital, Tianjin, China;

name: Hospital General de Mexico, Mexico City, Mexico;

name: Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea;

name: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan;

name: FUNDALEU, Angélica Ocampo Hospitalization and Clinical Research Center, Buenos Aires, Argentina;

name: Department of Hematology/Oncology, University of Rostock, Rostock, Germany;

name: Department of Hematology, Hospital Italiano de La Plata, Buenos Aires, Argentina;

name: Hematology Department, Edouard Herriot Hospital, Lyon, France;

name: Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland;

name: Department of Haematology, AZ St Jan Hospital, Brugge, Belgium;

name: Department of Hematology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands;

name: Bristol-Myers Squibb, Wallingford, CT; and

name: Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Jena, Germany

ReferenceCitation: Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boqué C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.

title: Dasatinib versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia

location_country:
Peru
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
India
France
Japan
Poland
Argentina
Korea, Republic of
Colombia
Chile
Netherlands
Singapore
Hungary
China
Germany
United States
Italy
Austria
Brazil
Mexico
Spain
Turkey

title: An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

summary: The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.


ReferenceCitation: Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, Bennouna J, Zhang L, Liao M, Sun Y, Gans S, Syrigos K, Le Marie E, Gottfried M, Vansteenkiste J, Alberola V, Strauss UP, Montegriffo E, Ong TJ, Santoro A; NSCLC [non-small-cell lung cancer] Research Experience Utilizing Sorafenib (NExUS) Investigators Study Group. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer. J Clin Oncol. 2012 Sep 1;30(25):3084-92. doi: 10.1200/JCO.2011.39.7646. Epub 2012 Jul 30.

name: Author affiliations appear at the end of this article.

family: Paz-Ares

full_name: Luis G. Paz-Ares

given: Luis G.

family: Biesma

full_name: Bonne Biesma

given: Bonne

family: Heigener

full_name: David Heigener

given: David

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

family: Eisen

full_name: Timothy Eisen

given: Timothy

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Zhang

full_name: Li Zhang

given: Li

family: Liao

full_name: Meilin Liao

given: Meilin

family: Sun

full_name: Yan Sun

given: Yan

family: Gans

full_name: Steven Gans

given: Steven

family: Syrigos

full_name: Kostas Syrigos

given: Kostas

family: Le Marie

full_name: Etienne Le Marie

given: Etienne

family: Gottfried

full_name: Maya Gottfried

given: Maya

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

family: Alberola

full_name: Vincente Alberola

given: Vincente

family: Strauss

full_name: Uwe Phillip Strauss

given: Uwe Phillip

family: Montegriffo

full_name: Elaine Montegriffo

given: Elaine

family: Ong

full_name: Teng Jin Ong

given: Teng Jin

family: Santoro

full_name: Armando Santoro

given: Armando

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Gemcitabine/Cisplatin Alone or With Sorafenib for the First-Line Treatment of Advanced, Nonsquamous Non–Small-Cell Lung Cancer

location_country:
Italy
Austria
Brazil
Switzerland
Mexico
Netherlands
Germany
Spain
Cyprus
Finland
France
Greece
Israel
Hungary
Belgium
China
Canada
United Kingdom

acronym: NEXUS

title: A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

summary: Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)


ReferenceCitation: Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crinò L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.

name: Karen Kelly, University of California, Davis, Comprehensive Cancer Center, Sacramento, CA; Nasser K. Altorki, New York Presbyterian Hospital–Weill Cornell Medical Center, New York, NY; Wilfried E.E. Eberhardt, University Hospital Essen, Essen, Germany; Mary E.R. O'Brien, Royal Marsden Hospital, London, United Kingdom; David R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Lucio Crinò, Ospedale S. Maria della Misericordia, Perugia, Italy; Chun-Ming Tsai, Taipei General Hospital and National Yang...

family: Kelly

full_name: Karen Kelly

given: Karen

family: Altorki

full_name: Nasser K. Altorki

given: Nasser K.

family: Eberhardt

full_name: Wilfried E.E. Eberhardt

given: Wilfried E.E.

family: O'Brien

full_name: Mary E.R. O'Brien

given: Mary E.R.

family: Spigel

full_name: David R. Spigel

given: David R.

family: Crinò

full_name: Lucio Crinò

given: Lucio

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Kim

full_name: Joo-Hang Kim

given: Joo-Hang

family: Cho

full_name: Eun Kyung Cho

given: Eun Kyung

family: Hoffman

full_name: Philip C. Hoffman

given: Philip C.

family: Orlov

full_name: Sergey V. Orlov

given: Sergey V.

family: Serwatowski

full_name: Piotr Serwatowski

given: Piotr

family: Wang

full_name: Jiuzhou Wang

given: Jiuzhou

family: Foley

full_name: Margaret A. Foley

given: Margaret A.

family: Horan

full_name: Julie D. Horan

given: Julie D.

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

oa_host_type: repository

repository_institution: California Digital Library - eScholarship

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

title: Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non–Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial

lead_sponsor: OSI Pharmaceuticals

location_country:
Italy
Austria
United Kingdom
Spain
Germany
France
Korea, Republic of
Greece
Poland
Romania
Hungary
Argentina
Australia
Belgium
Russian Federation
United States
Czech Republic
Canada
Taiwan

acronym: RADIANT

location_facility: Städtisches Krankenhaus Martha-Maria, Halle-Dölau

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika

location_facility: State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"

location_facility: "G. Papanikolaou" General Hospital of Thessaloniki

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4

location_facility: SMZ Baumgartner Hoehe - Otto Wagner Spital

location_facility: Christus St. Vincent Regional Cancer Center

location_facility: Országos Korányi TBC és Pulmonológiai Intézet

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Chicago, Section of Hematology/Oncology

location_facility: State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"

location_facility: Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II

location_facility: Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: Istituto Nazionale per la Ricerca e la Cura del Cancro

location_facility: Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"

location_facility: FN Bulovka Klinika plincni a hrrudni chirurgie

location_facility: Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

location_facility: Azienda Ospedaliero- Universitaria di Parma

location_facility: Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care

location_facility: Severance Hospital, Yonsei Univ. College of Medicine

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: "Papageorgiou" General Hospital of Thessaloniki

location_facility: The New York Presbyterian-Weill Medical College of Cornell University

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: University of California, San Francisco Comprehensive Cancer Center

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

location_facility: RS MacLaughlin Durham Regional Cancer Centre

location_facility: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej

location_facility: Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie

location_facility: Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie

location_facility: Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci

location_facility: University of Arkansas for Medical Science

location_facility: State Healthcare Institution "Regional Clinical Oncology Dispensary"

location_facility: Hopital De La Croix-Rousse Service de Pneumologie

location_facility: St. Joseph Medical Center's Cancer Institute

location_facility: Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta

location_facility: Hospital General Universitario de Valencia

location_facility: Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: CHU - Hopital Pontchaillou - Service de pneumologie

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: Centre d'Oncologie et de Radiothérapie du Pays Basque

location_facility: Thunder Bay Regional Health Science Centre

location_facility: Cancer Center of Southeastern Ontario at Kingston General Hospital

location_facility: State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"

location_facility: Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie

location_facility: University of New Mexico Health Science Center

location_facility: St James' Institute of Oncology, Bexley Wing, St James' University Hospital

location_facility: CHU Larrey Service de Pneumologie, Clinique des voies respiratoires

location_facility: Texas Oncology Texas Cancer Center at Medical City

location_facility: Stronach Regional cancer Centre at Southlake

location_facility: Heartland Regional Medical Center d/b/a Heartland Clinic

location_facility: Hospital de Rehabilitación Respiratoria María Ferrer

location_facility: Cancer Care Centers of South Texas-HOAST

location_facility: Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie

location_facility: State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: Univ. of Washington/ Seattle Cancer Care Alliance

location_facility: The Hospital of the University of Pennsylvania

location_facility: C.H.U. Morvan, Institut de Cancerologie et d'Hématologie

location_facility: Gachon Medical School Ghil Medical Center

location_facility: Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag

location_facility: Cancer Care Centers of South Texas - HOAST

location_facility: Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care

location_facility: Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"

location_facility: Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina

location_facility: State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: SMZ Baumgartner Höhe - Otto- Wagner-Spital

location_facility: Aultman Hospital/ North Canton Medical Foundation

location_facility: Cancer Care Associates - Medical Oncology

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: The Royal Surrey County Hospital NHS Trust

location_facility: Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

summary: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.


title: A Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose

summary: This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

ipd_sharing: Yes

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

location_country:
Italy
Sweden
Netherlands
France
Poland
Lithuania
Norway
Belgium
Russian Federation
Spain
Denmark
Latvia


title: A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

summary: Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

ReferenceCitation: Ansquer JC, Bekaert I, Guy M, Hanefeld M, Simon A; Study Investigators. Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Am J Cardiovasc Drugs. 2009;9(2):91-101. doi: 10.2165/00129784-200909020-00003.

lead_sponsor: Solvay Pharmaceuticals

location_country: Germany Belgium France

location_facility:
Site 303
Site 314
Site 211
Site 312
Site 311
Site 107
Site 301
Site 108
Site 210
Site 305
Site 110
Site 306
Site 101
Site 204
Site 105
Site 109
Site 208
Site 313
Site 115
Site 103
Site 205
Site 308
Site 116
Site 111
Site 309
Site 207
Site 302
Site 304
Site 114
Site 209
Site 102
Site 206
Site 113
Site 212
Site 310
Site 201
Site 307
Site 202
Site 106
Site 112
Site 104
Site 203
Site 213


title: A 54 Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE4-stratified Subjects With Mild to Moderate Alzheimer's Disease

summary:
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606.

location_country:
Finland
Malaysia
Belgium
Australia
France
Poland
Slovakia
Canada
Slovenia
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
United States
Germany
United Kingdom
Czechia
Spain

intervention_type: Other


title: RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

summary: The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

ReferenceCitation: Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.

family: Eriksson

full_name: Bengt I. Eriksson

given: Bengt I.

family: Borris

full_name: Lars C. Borris

given: Lars C.

family: Friedman

full_name: Richard J. Friedman

given: Richard J.

family: Haas

full_name: Sylvia Haas

given: Sylvia

family: Huisman

full_name: Menno V. Huisman

given: Menno V.

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

family: Bandel

full_name: Tiemo J. Bandel

given: Tiemo J.

family: Beckmann

full_name: Horst Beckmann

given: Horst

family: Muehlhofer

full_name: Eva Muehlhofer

given: Eva

family: Misselwitz

full_name: Frank Misselwitz

given: Frank

family: Geerts

full_name: William Geerts

given: William

title: Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthroplasty

location_country:
Finland
Greece
Australia
Belgium
Denmark
Czech Republic
France
Poland
Lithuania
Slovakia
Norway
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Netherlands
Hungary
Germany
United States
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey