acronym: Extension study

lead_sponsor: Genentech, Inc.

summary: This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

sponsor_collaborators:
Genentech, Inc.
Hoffmann-La Roche

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)

location_facility: Saitama Medical University International Medical Center; Breast Oncology

location_facility: Anne Arundel Medical Center; Anne Arundel Health System

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Ospedale San Carlo; Day Hospital Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Memorial Cancer Institute at Memorial West

location_facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

location_facility: Univ of Calif, San Francisco; Breast Cancer Center

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: ?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Ottawa Regional Cancer Centre; Civic Hospital Division

location_facility: Centro de Investigacion; Clinica Del Pacifico

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Centre Hospitalier de l?Université de Montréal (CHUM)

location_facility: Western General Hospital; Clinical Oncology

location_facility: BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Midwestern Regional Medical Center; Office of Research

location_facility: Dana Farber Cancer Institute; Breast Oncology

location_facility: Kyungpook National University Medical Center; Oncology

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Oncology Assoc of Cedar Rapids; Iowa Cancer Care

location_facility: Florida Cancer Specialists - Tampa (Dr. MLK Blvd)

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Klinik Favoriten; 1 Medizinische Abteilung

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: RCCS - Centro di Riferimento; Oncologia Medica B

location_facility: CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: St. John's Mercy Medical Ctr; David C. Pratt Cancer Center

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Millennium Research & Clinical Development

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Christina Care Institutional Review Board

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Northwest Cancer Specialists - Portland (N Broadway)

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Can Care Assoc Med Group Inc; Beach Cities Offices

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Uni of Washington Medical Center; Dept of Oncology

location_facility: Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Humanitas Istituto Clinico Catanese S.p.A

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Bashkirian Republican Clinical Oncology Dispensary

status: Recruiting

title: An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study

study_completion_date_type: Anticipated

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Thailand
Croatia
Chile
Czechia
Canada
France
Slovenia
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
North Macedonia
Belgium
China
Peru
Philippines
Italy
Guatemala
Norway
Singapore
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Panama
Taiwan
Bulgaria
Russian Federation
Israel

status_simplified: Ongoing


title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

summary: The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BE, Laties AM, Lewis M, Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, Reynolds RF. Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors. J Sex Med. 2015 Jan;12(1):139-51. doi: 10.1111/jsm.12726. Epub 2014 Oct 31.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Oxford University Press

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

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy

acronym: PALETTE

summary: A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.

ReferenceCitation: Cesne AL, Bauer S, Demetri GD, Han G, Dezzani L, Ahmad Q, Blay JY, Judson I, Schoffski P, Aglietta M, Hohenberger P, Gelderblom H. Safety and efficacy of Pazopanib in advanced soft tissue sarcoma: PALETTE (EORTC 62072) subgroup analyses. BMC Cancer. 2019 Aug 13;19(1):794. doi: 10.1186/s12885-019-5988-3.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
LIRIAS (KU Leuven)
PubMed Central
iris.unito.it

repositories_concat: LIRIAS (KU Leuven);PubMed Central;iris.unito.it

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. doi: 10.1093/jjco/hyv184. Epub 2016 Feb 10.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: hybrid

ReferenceCitation: Kasper B, Sleijfer S, Litiere S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Japan
Netherlands
Sweden
Belgium
United States
Korea, Republic of
Spain
France


study_start_date_type: Actual

acronym: INFORMS

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population

ReferenceCitation: Leppert D, Kropshofer H, Haring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15.

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

ReferenceCitation: Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli O, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Haring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: California Digital Library - eScholarship

publisher_dissemination: Wiley

ReferenceCitation: Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Haring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28. Erratum In: Lancet. 2017 Jan 21;389(10066):254.

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories:
UCL Discovery
univOAK

repositories_concat: UCL Discovery;univOAK

ReferenceCitation: Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880. No abstract available.

title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

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

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

location_country:
Finland
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Turkey
Czechia
Canada
France


lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

Week 27-52 after randomisation

- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.

Week 53-78 after randomisation

Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

ReferenceType: result

ReferenceCitation: Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8. Erratum In: Lancet. 2010 Jul 24;376(9737):234.

ReferenceCitation: Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x.

ReferenceCitation: Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1.

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.

ReferenceCitation: Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30.

ReferenceCitation: Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.

ReferenceCitation: Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013 Apr;19(3):237-46. doi: 10.18553/jmcp.2013.19.3.237.

publisher_dissemination: Academy of Managed Care Pharmacy

title: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension

type: EudraCT Number

source: euctr

location_country:
Former Serbia and Montenegro
Germany
Ireland
Italy
Slovenia
Slovakia
United Kingdom
Romania
Netherlands
United States
Spain
Croatia
Canada
Puerto Rico
France


title: Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations

acronym: ICE

summary: To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

design_allocation: Non-Randomized

ReferenceCitation: De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.

evidence: open (via crossref license)

repositories_concat: PubMed Central;iris.unito.it

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

ReferenceCitation: Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.

ReferenceCitation: Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.

ReferenceCitation: Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.

repository_institution: Radboud University - Radboud Repository

repositories_concat: PubMed Central;repository.ubn.ru.nl

repositories_institution:
PubMed Central - Europe PMC
Radboud University - Radboud Repository

lead_sponsor: Pfizer

location_country:
Germany
Poland
Turkey
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Denmark
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Greece
Russian Federation


title: A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.

summary: This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

lead_sponsor: Bayer

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


title: LENS - Long-term Eltrombopag Observational Study - A Long Term Observational Ocular Safety Follow-up Study in Adults Who Have Received Study Medication (SB-497115-GR / Eltrombopag Olamine or Placebo) in a Phase II or III Clinical Study Evaluating Eltrombopag

acronym: LENS

summary: A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.

time_perspective: Prospective

location_country:
Germany
Poland
Australia
Pakistan
Canada
France
Czech Republic
Hungary
Hong Kong
United States
Ukraine
India
Tunisia
Peru
Puerto Rico
Italy
United Kingdom
Spain
Bulgaria
Russian Federation
Sweden


acronym: EORTC protocol 18071

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma

ReferenceCitation: Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.

ReferenceCitation: Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Bottomley A, Kotapati S, de Pril V, Testori A, Eggermont AMM. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017 Mar;18(3):393-403. doi: 10.1016/S1470-2045(17)30015-3. Epub 2017 Feb 3.

version: acceptedVersion

ReferenceCitation: Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Bastholt L, Mortier L, Thomas L, Tahir S, Hauschild A, Hassel JC, Hodi FS, Taitt C, de Pril V, de Schaetzen G, Suciu S, Testori A. Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy. N Engl J Med. 2016 Nov 10;375(19):1845-1855. doi: 10.1056/NEJMoa1611299. Epub 2016 Oct 7. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

oa_colors: green other

evidence: open (via free article)

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: PubMed Central;sdu.dk

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Konto C, Hoos A, de Pril V, Gurunath RK, de Schaetzen G, Suciu S, Testori A. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 May;16(5):522-30. doi: 10.1016/S1470-2045(15)70122-1. Epub 2015 Mar 31. Erratum In: Lancet Oncol. 2015 Jun;16(6):e262. Lancet Oncol. 2016 Jun;17 (6):e223.

location_facility: North. Cal. Melanoma Center-St. Mary's Medical Center

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: Huntsman Cancer Institute At The Univ. Of Utah

location_facility: Washington University School Of Medicine

title: Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Russian Federation
Sweden


title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

ReferenceCitation: Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.

lead_sponsor: Vertex Pharmaceuticals Incorporated

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited

location_country:
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Australia
Austria
United States
Spain
Canada
Puerto Rico
France


type: Other Identifier

title: An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

summary: This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.

ReferenceCitation: Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. Epub 2013 Feb 13.

lead_sponsor: NantCell, Inc.

location_country:
Germany
Ireland
United Kingdom
Australia
Switzerland
United States
Spain
Canada
France


title: ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

acronym: ADVANCEIII

summary: To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.

ReferenceCitation: Landolina M, Boriani G, Biffi M, Cattafi G, Capucci A, Dello Russo A, Facchin D, Rordorf R, Sagone A, Del Greco M, Morani G, Nicolis D, Meloni S, Grammatico A, Gasparini M. Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor? J Cardiovasc Med (Hagerstown). 2022 Jan 1;23(1):42-48. doi: 10.2459/JCM.0000000000001236.

ReferenceCitation: Gasparini M, Kloppe A, Lunati M, Varma N, Martinez-Ferrer JB, Hersi A, Gulaj M, Wijffels MCEF, Arenal A, Mangoni di Santo Stefano L, Proclemer A. Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times. Heart. 2020 Apr;106(7):520-526. doi: 10.1136/heartjnl-2019-315650. Epub 2019 Dec 11.

publisher_dissemination: British Medical Journal

ReferenceCitation: Gasparini M, Lunati MG, Proclemer A, Arenal A, Kloppe A, Martinez Ferrer JB, Hersi AS, Gulaj M, Wijffels MCE, Santi E, Manotta L, Varma N. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol. 2017 Nov;3(11):1275-1282. doi: 10.1016/j.jacep.2017.05.001. Epub 2017 May 31.

ReferenceCitation: Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18.

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Kloppe A, Proclemer A, Arenal A, Lunati M, Martinez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention population: data from the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) trial. Circulation. 2014 Jul 22;130(4):308-14. doi: 10.1161/CIRCULATIONAHA.114.009468. Epub 2014 May 16.

ReferenceCitation: Gasparini M, Proclemer A, Klersy C, Kloppe A, Lunati M, Ferrer JB, Hersi A, Gulaj M, Wijfels MC, Santi E, Manotta L, Arenal A. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA. 2013 May 8;309(18):1903-11. doi: 10.1001/jama.2013.4598. Erratum In: JAMA. 2013 Jun 26;309(24):2552.

publisher_dissemination: American Medical Association

ReferenceCitation: Schwab JO, Gasparini M, Lunati M, Proclemer A, Kaup B, Santi E, Ligorio G, Klersy C, DE Sousa J, Okreglicki A, Arenal A, Wijffels M, Lemke B. Avoid delivering therapies for nonsustained fast ventricular tachyarrhythmia in patients with implantable cardioverter/defibrillator: the ADVANCE III Trial. J Cardiovasc Electrophysiol. 2009 Jun;20(6):663-6. doi: 10.1111/j.1540-8167.2008.01415.x. Epub 2009 Jan 9.

lead_sponsor: Medtronic Bakken Research Center

location_country:
Finland
Germany
Italy
Poland
Portugal
Hungary
Denmark
Netherlands
Belgium
Saudi Arabia
Spain
South Africa
Russian Federation
France

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Stab. Ospedaliero Di Summa-Perrino - Brindisi

location_facility: Ente Ospedaliero Ospedali Galliera - Genova

location_facility: University of Cape Town - Groote Schuur Hospital

location_facility: Kardiologisches Zentrum an der Klinik Rotes Kreuz

location_facility: Universität Rostock- Medizinische Fakultät

location_facility: Hospital Clinico de Malaga - Virgen de la Victoria

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Osp. S. Giovanni di Dio e Ruggi dAragona

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: King Khalid Univ. Hospital - King Saud University

intervention_type: Device


title: A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.

summary: The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

ReferenceCitation: Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.

location_country:
Germany
Italy
Colombia
India
Portugal
United Kingdom
Denmark
Australia
Brazil
Netherlands
Austria
Switzerland
United States
Greece
South Africa
Czechia
Canada
France


acronym: CLEOPATRA

summary:
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.

Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.

ReferenceCitation: Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.

ReferenceCitation: Swain SM, Miles D, Kim SB, Im YH, Im SA, Semiglazov V, Ciruelos E, Schneeweiss A, Loi S, Monturus E, Clark E, Knott A, Restuccia E, Benyunes MC, Cortes J; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Apr;21(4):519-530. doi: 10.1016/S1470-2045(19)30863-0. Epub 2020 Mar 12.

ReferenceCitation: Miles D, Im YH, Fung A, Yoo B, Knott A, Heeson S, Beattie MS, Swain SM. Effect of docetaxel duration on clinical outcomes: exploratory analysis of CLEOPATRA, a phase III randomized controlled trial. Ann Oncol. 2017 Nov 1;28(11):2761-2767. doi: 10.1093/annonc/mdx406.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Swain SM, Schneeweiss A, Gianni L, Gao JJ, Stein A, Waldron-Lynch M, Heeson S, Beattie MS, Yoo B, Cortes J, Baselga J. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. Ann Oncol. 2017 Apr 1;28(4):761-768. doi: 10.1093/annonc/mdw695. Erratum In: Ann Oncol. 2018 Apr 1;29(4):1075. Ann Oncol. 2018 Jul 1;29(7):1607. Ann Oncol. 2019 Aug 1;30(8):1404.

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

ReferenceCitation: Luen SJ, Salgado R, Fox S, Savas P, Eng-Wong J, Clark E, Kiermaier A, Swain SM, Baselga J, Michiels S, Loi S. Tumour-infiltrating lymphocytes in advanced HER2-positive breast cancer treated with pertuzumab or placebo in addition to trastuzumab and docetaxel: a retrospective analysis of the CLEOPATRA study. Lancet Oncol. 2017 Jan;18(1):52-62. doi: 10.1016/S1470-2045(16)30631-3. Epub 2016 Dec 7. Erratum In: Lancet Oncol. 2018 Dec;19(12):e667.

ReferenceCitation: Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Heeson S, Clark E, Ross G, Benyunes MC, Cortes J; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. doi: 10.1056/NEJMoa1413513.

repository_institution: Tampere University - Tampere University Institutional Repository

repositories_concat: PubMed Central;trepo.tuni.fi

ReferenceCitation: Baselga J, Cortes J, Im SA, Clark E, Ross G, Kiermaier A, Swain SM. Biomarker analyses in CLEOPATRA: a phase III, placebo-controlled study of pertuzumab in human epidermal growth factor receptor 2-positive, first-line metastatic breast cancer. J Clin Oncol. 2014 Nov 20;32(33):3753-61. doi: 10.1200/JCO.2013.54.5384. Epub 2014 Oct 20.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Swain SM, Baselga J, Miles D, Im YH, Quah C, Lee LF, Cortes J. Incidence of central nervous system metastases in patients with HER2-positive metastatic breast cancer treated with pertuzumab, trastuzumab, and docetaxel: results from the randomized phase III study CLEOPATRA. Ann Oncol. 2014 Jun;25(6):1116-21. doi: 10.1093/annonc/mdu133. Epub 2014 Mar 31.

ReferenceCitation: Miles D, Baselga J, Amadori D, Sunpaweravong P, Semiglazov V, Knott A, Clark E, Ross G, Swain SM. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013 Nov;142(1):89-99. doi: 10.1007/s10549-013-2710-z. Epub 2013 Oct 16.

ReferenceCitation: Cortes J, Baselga J, Im YH, Im SA, Pivot X, Ross G, Clark E, Knott A, Swain SM. Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer. Ann Oncol. 2013 Oct;24(10):2630-2635. doi: 10.1093/annonc/mdt274. Epub 2013 Jul 17.

ReferenceCitation: Swain SM, Kim SB, Cortes J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013 May;14(6):461-71. doi: 10.1016/S1470-2045(13)70130-X. Epub 2013 Apr 18.

ReferenceCitation: Baselga J, Swain SM. CLEOPATRA: a phase III evaluation of pertuzumab and trastuzumab for HER2-positive metastatic breast cancer. Clin Breast Cancer. 2010 Dec 1;10(6):489-91. doi: 10.3816/CBC.2010.n.065.

location_facility: Erlanger Health System; Oncology Research

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Oncologia

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Florida Cancer Specialists - Goodlette, Naples

location_facility: Chiba Cancer Center; Breast Surgical Oncology

location_facility: Clinica Amo - Assistencia Medica Em Oncologia

location_facility: UCLA / Santa Clarita Valley Cancer Center

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica

location_facility: Robert-Bosch-Krankenhaus; Hämatologie, Onkologie und Palliativmedizin

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: National Cancer Center Hospital East; Breast and Medical Oncology

location_facility: Consultants in Medical Oncology/Hematology

location_facility: National Cancer Center Hospital; Breast and Medical Oncology

location_facility: Medical College of Ohio; Cancer Institute

location_facility: Groupe Hospitalier Sud; Oncologie Radiotherapie

location_facility: Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Sansum Santa Barbara Medical Foundation Clinic

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Center Instituto Médico Privado I.M.P.; Oncology

location_facility: St. Bartholomew'S Hospital; Dept of Medical Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Regional Oncology Hospital Of Kursk; Chemotherapy

location_facility: National Cancer Centre; Medical Oncology

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: St George'S Hospital; Oncology Research Office /Oncology Opd

location_facility: Jichi Medical University; Dept of Clinical Oncology

location_facility: Private Practice Robert R. Carroll, Md, Pa

location_facility: Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery

location_facility: SBI of Healthcare Leningrad Regional Oncology Dispensary

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Azienda Sanitaria S. Maria Annunziata; S. C. Oncologia Medica

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Veterans Memorial Medical Center; Oncology

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: CA Care Associates-OK Oncology and Hematology

location_facility: Innovative clinical research institute/American institute of research

location_facility: Central Georgia Hematology Oncology Associates

location_facility: Southern Nevada Cancer Research Foundation

location_facility: Therapeutic Research Inst. & Lab S.A. (Trial)

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Conslts in Med Onc (Newtown); Bryn Mawr Health Canc Ctr

location_facility: P.Stradins Clinical University Hospital, Oncology Centre

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Saitama Medical University International Medical Center; Medical Oncology

location_facility: Uni of Iowa Hospital&Clinic; Holden Comprehens. Cancer Ctr

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Florida Cancer Specialists - Port Charlotte

location_facility: US Oncology Research at Minnesota Oncology

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Kaiser Permanente San Diego; Hepatology Research

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Cancer Center of Acadiana at Lafayette General

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Pacific Coast Hematology/Oncology Medical Group

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Sutter Gould Medical Foundation; Clinical Research

location_facility: UM Sylvester Deerfield Beach; Sylvester Cancer Ctr

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Cancer & Hematology Center of West Michigan

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Midwestern Regional Medical Center; Office of Research

location_facility: Florida Cancer Specialists - Sunset Lake, Venice

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Upstate Ny Cancer Research & Education Foundation

location_facility: Hosp Provincial D. Centenarios; Oncology Dept

location_facility: Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology

location_facility: Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

location_facility: Ospedale Provinciale Santa Maria delle Croci

location_facility: Shizuoka Cancer Center; Female Internal Medicine

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Florida Cancer Specialists - Venice (S. Tamiami Tr)

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: University Hospital Centre Zagreb; Clinic For Oncology

location_facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

location_facility: Hospital Angeles Metropolitano; Room 220

location_facility: Beth Israel Comprehensive Cancer Center Pharmacy

location_facility: Uni of Pittsburgh; Magee-Women'S Hospital

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho - ICAVC; Pesquisa Clinica

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

location_facility: University of Tennessee Cancer Institute;Hem-Onc Consultants

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: Florida Cancer Specialists -Cape Coral (Cape Coral Pkwy)

location_facility: Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Osaka University Hospital; Breast and Endocrine Surgery

location_facility: Community Cancer Center Rutland Regional Medical Center

location_facility: Policlinica Privada Site la Plata SA; Oncology

location_facility: Kumamoto Shinto General Hospital; Breast Cancer Center

location_facility: Kitakyushu Municipal Medical Center, Surgery

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Centro de Oncologia e Investigacion Buenos Aires (COIBA)

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Fuzhou General Hospital, PLA Nanjing Military Area Command

location_facility: Southdale Cancer Clinic U of M Medical Center, Fairview- Edina

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Ronald Reagan UCLA Medical Center Clin Lab

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Florida Cancer Specialists - Cape Coral (Del Prado Blvd)

location_facility: Hospital Carlos Andrade Marin; Servicio de Oncología

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Florida Cancer Specialists - Pine Ridge, Naples

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Instituto Medico Especializado (IME); Oncologia

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Tokyo Metropolitan; Komagome Hospital, Surgery

location_facility: Tokai University Hospital, Breast and Endocrine Surgery

location_facility: Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.

location_facility: National Cancer Center; Medical Oncology

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: Breast Cancer Centre at Memorial Hospital West

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Costa Rica
Thailand
Croatia
Canada
France
Hong Kong
United States
Latvia
North Macedonia
China
Philippines
Italy
Guatemala
Ecuador
Singapore
United Kingdom
Mexico
Korea, Republic of
Spain
Russian Federation


title: A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

acronym: PRESERVE

summary: To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

ReferenceCitation: Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Smolen JS, Pedersen R, Jones H, Mahgoub E, Marshall L. Impact of flare on radiographic progression after etanercept continuation, tapering or withdrawal in patients with rheumatoid arthritis. Rheumatology (Oxford). 2020 Jan 1;59(1):153-164. doi: 10.1093/rheumatology/kez224.

ReferenceCitation: Smolen JS, Szumski A, Koenig AS, Jones TV, Marshall L. Predictors of remission with etanercept-methotrexate induction therapy and loss of remission with etanercept maintenance, reduction, or withdrawal in moderately active rheumatoid arthritis: results of the PRESERVE trial. Arthritis Res Ther. 2018 Jan 16;20(1):8. doi: 10.1186/s13075-017-1484-9.

ReferenceCitation: Smolen JS, Strand V, Koenig AS, Szumski A, Kotak S, Jones TV. Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity. Arthritis Res Ther. 2016 May 21;18(1):114. doi: 10.1186/s13075-016-1004-3.

ReferenceCitation: Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, Irazoque-Palazuelos F, Miranda P, Park MC, Pavelka K, Pedersen R, Szumski A, Hammond C, Koenig AS, Vlahos B. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet. 2013 Mar 16;381(9870):918-29. doi: 10.1016/S0140-6736(12)61811-X. Epub 2013 Jan 17.

location_country:
Germany
Poland
Australia
Chile
France
Czech Republic
Colombia
Hungary
Former Serbia and Montenegro
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


title: A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension

summary: This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

ReferenceCitation: Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.

ReferenceCitation: Ruilope LM, Dukat A, Bohm M, Lacourciere Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16.

location_country:
Finland
Germany
Italy
Lithuania
Poland
Slovakia
Hungary
Argentina
Denmark
Sweden
Netherlands
United States
Latvia
Spain
Taiwan
Canada
Russian Federation
France


title: A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis

summary: This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

ReferenceCitation: Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508. Erratum In: Ann Intern Med. 2015 Mar 17;162(6):463. Ann Intern Med. 2019 Feb 5;170(3):220.

publisher_dissemination: American College of Physicians

ReferenceCitation: Liu P, Mould DR. Population pharmacokinetic-pharmacodynamic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4727-36. doi: 10.1128/AAC.02809-13. Epub 2014 Jun 9.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Liu P, Mould DR. Population pharmacokinetic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4718-26. doi: 10.1128/AAC.02808-13. Epub 2014 Jun 9.

location_country:
Germany
Poland
Australia
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Portugal
Switzerland
United States
India
Belgium
Peru
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation


lead_sponsor: Tibotec BVBA

summary: The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

ReferenceCitation: Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2.

title: A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection

location_country: Germany Netherlands Austria Belgium Spain France


acronym: LCS Pearl Index Study

summary: This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

ReferenceCitation: Nahum GG, Kaunitz AM, Rosen K, Schmelter T, Lynen R. Ovarian cysts: presence and persistence with use of a 13.5mg levonorgestrel-releasing intrauterine system. Contraception. 2015 May;91(5):412-7. doi: 10.1016/j.contraception.2015.01.021. Epub 2015 Feb 7.

ReferenceCitation: Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14.

ReferenceCitation: Nelson A, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Gemzell-Danielsson K. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol. 2013 Dec;122(6):1205-13. doi: 10.1097/AOG.0000000000000019. Erratum In: Obstet Gynecol. 2014 May;123(5):1109.

ReferenceCitation: Gemzell-Danielsson K, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Nelson A. The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial. PLoS One. 2015 Sep 17;10(9):e0135309. doi: 10.1371/journal.pone.0135309. eCollection 2015.

publisher_dissemination: Public Library of Science

title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years

primary_purpose: Prevention

location_country:
Finland
Hungary
Argentina
Norway
Sweden
Netherlands
Mexico
United States
Chile
Canada
France


lead_sponsor: Amgen

summary:
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

ReferenceCitation: Dieras V, Wildiers H, Jassem J, Dirix LY, Guastalla JP, Bono P, Hurvitz SA, Goncalves A, Romieu G, Limentani SA, Jerusalem G, Lakshmaiah KC, Roche H, Sanchez-Rovira P, Pienkowski T, Segui Palmer MA, Li A, Sun YN, Pickett CA, Slamon DJ. Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study. Breast. 2015 Jun;24(3):182-90. doi: 10.1016/j.breast.2014.11.003. Epub 2015 Mar 5.

repositories_concat: LIRIAS (KU Leuven)

title: A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination With Bevacizumab and Paclitaxel or AMG 386 Plus Paclitaxel as First-Line Therapy in Subjects With Her2-Negative, Metastatic or Locally Recurrent Breast Cancer

location_country:
Finland
Poland
India
Hungary
United Kingdom
Denmark
Australia
Netherlands
Austria
Belgium
United States
Spain
France


title: A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

summary: 258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

status: Terminated

sponsor_collaborators:
Bristol-Myers Squibb
Otsuka America Pharmaceutical

location_country:
Germany
Hungary
Switzerland
Belgium
Spain
Greece
Turkey
Czech Republic
France

status_simplified: Unknown


title: Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

acronym: AVERROES

summary: The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

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

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repositories_concat: PubMed Central;ses.library.usyd.edu.au

ReferenceCitation: Bhagirath VC, Eikelboom JW, Hirsh J, Coppens M, Ginsberg J, Vanassche T, Yuan F, Chan N, Yusuf S, Connolly SJ. Apixaban-Calibrated Anti-FXa Activity in Relation to Outcome Events and Clinical Characteristics in Patients with Atrial Fibrillation: Results from the AVERROES Trial. TH Open. 2017 Dec 12;1(2):e139-e145. doi: 10.1055/s-0037-1613679. eCollection 2017 Jul.

publisher_dissemination: Georg Thieme

ReferenceCitation: Ng KH, Shestakovska O, Connolly SJ, Eikelboom JW, Avezum A, Diaz R, Lanas F, Yusuf S, Hart RG. Efficacy and safety of apixaban compared with aspirin in the elderly: a subgroup analysis from the AVERROES trial. Age Ageing. 2016 Jan;45(1):77-83. doi: 10.1093/ageing/afv156. Epub 2015 Nov 19.

ReferenceCitation: Hohnloser SH, Shestakovska O, Eikelboom J, Franzosi MG, Tan RS, Zhu J, Yusuf S, Connolly SJ. The effects of apixaban on hospitalizations in patients with different types of atrial fibrillation: insights from the AVERROES trial. Eur Heart J. 2013 Sep;34(35):2752-9. doi: 10.1093/eurheartj/eht292. Epub 2013 Jul 25.

ReferenceCitation: Lip GY, Connolly S, Yusuf S, Shestakovska O, Flaker G, Hart R, Lanas F, Xavier D, Eikelboom J; ERROES Investigators. Modification of outcomes with aspirin or apixaban in relation to CHADS(2) and CHA(2)DS(2)-VASc scores in patients with atrial fibrillation: a secondary analysis of the AVERROES study. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):31-8. doi: 10.1161/CIRCEP.112.975847. Epub 2013 Feb 6.

ReferenceCitation: Flaker GC, Eikelboom JW, Shestakovska O, Connolly SJ, Kaatz S, Budaj A, Husted S, Yusuf S, Lip GY, Hart RG. Bleeding during treatment with aspirin versus apixaban in patients with atrial fibrillation unsuitable for warfarin: the apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment (AVERROES) trial. Stroke. 2012 Dec;43(12):3291-7. doi: 10.1161/STROKEAHA.112.664144. Epub 2012 Oct 2.

ReferenceCitation: Diener HC, Eikelboom J, Connolly SJ, Joyner CD, Hart RG, Lip GY, O'Donnell M, Hohnloser SH, Hankey GJ, Shestakovska O, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial. Lancet Neurol. 2012 Mar;11(3):225-31. doi: 10.1016/S1474-4422(12)70017-0. Epub 2012 Feb 1.

ReferenceCitation: Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.

sponsor_collaborators:
Bristol-Myers Squibb
Pfizer

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Colombia
Hong Kong
Denmark
United States
Ukraine
Indonesia
India
Belgium
China
Malaysia
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility: Salem Veterans Administration Medical Center

location_facility: Grand View - Lehigh Valley Health Services

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

location_facility: Michael F. Lesser, Md, Facc Osler Medical Inc.

location_facility: Cardiology Consultants Of Orange County Med. Group Inc

location_facility: Kaiser Permanente Medical Center, West Los Angeles

location_facility: Fox Valley Clinical Research Center, Llc

location_facility: Oregon Medical Group - Clinical Research

location_facility: The Heart & Vascular Institute Of Florida


intervention_type: Biological

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

ReferenceCitation: Perrig K, Krupka N, Jordi SBU, Rossel JB, Biedermann L, Greuter T, Schreiner P, Vavricka SR, Juillerat P, Burri E, Zimmermann D, Maillard MH, Sulz MC, Brand S, Rogler G, Misselwitz B. Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland. Therap Adv Gastroenterol. 2022 Feb 9;15:17562848221074188. doi: 10.1177/17562848221074188. eCollection 2022.

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: SAGE Publications

ReferenceCitation: Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.

ReferenceCitation: Philip G, Cornillie F, Adedokun JO, Melsheimer R, Rutgeerts P, Colombel JF, Marano C. Early Dose Optimisation of Golimumab in Nonresponders to Induction Treatment for Ulcerative Colitis Is Effective and Supported by Pharmacokinetic Data. J Crohns Colitis. 2019 Sep 27;13(10):1257-1264. doi: 10.1093/ecco-jcc/jjz052.

ReferenceCitation: Reinisch W, Gibson PR, Sandborn WJ, Feagan BG, Strauss R, Johanns J, Padgett L, Adedokun OJ, Colombel JF, Collins J, Rutgeerts P, Tarabar D, Marano C. Long-Term Benefit of Golimumab for Patients with Moderately to Severely Active Ulcerative Colitis: Results from the PURSUIT-Maintenance Extension. J Crohns Colitis. 2018 Aug 29;12(9):1053-1066. doi: 10.1093/ecco-jcc/jjy079.

repository_institution: Monash University - Monash University Research Portal

ReferenceCitation: Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14.

sponsor_collaborators:
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC

title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

location_country:
Germany
Poland
New Zealand
Australia
Japan
Canada
Serbia
France
Czech Republic
Lithuania
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Belgium
Sweden
Netherlands
Austria
South Africa
Bulgaria
Russian Federation
Israel


title: A Multicenter, Single-arm, Open, Conversion Study From a Cyclosporine (CyA) Based Immunosuppressive Regimen to a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Kidney Transplant Subjects (CONCERTO: Converting Cyclosporine to FK506E (MR4) in Renal Transplantation)

acronym: CONCERTO

summary: Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

ReferenceCitation: Rostaing L, Sanchez-Fructuoso A, Franco A, Glyda M, Kuypers DR, Jaray J. Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: a multicenter study. Transpl Int. 2012 Apr;25(4):391-400. doi: 10.1111/j.1432-2277.2011.01409.x. Epub 2011 Dec 27.

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
France
Germany
Italy
Poland
Hungary
Denmark
Sweden
Switzerland
Austria
Belgium
Spain
Czech Republic


title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)

summary: The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

ReferenceCitation: Cosiano MF, Vista A, Sun JL, Alhanti B, Harrington J, Butler J, Starling RC, Mentz RJ, Greene SJ. Comparing New York Heart Association Class and Patient-Reported Outcomes Among Patients Hospitalized for Heart Failure. Circ Heart Fail. 2023 Jan;16(1):e010107. doi: 10.1161/CIRCHEARTFAILURE.122.010107. Epub 2022 Oct 31.

ReferenceCitation: Blumer V, Mentz RJ, Sun JL, Butler J, Metra M, Voors AA, Hernandez AF, O'Connor CM, Greene SJ. Prognostic Role of Prior Heart Failure Hospitalization Among Patients Hospitalized for Worsening Chronic Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e007871. doi: 10.1161/CIRCHEARTFAILURE.120.007871. Epub 2021 Mar 29.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

ReferenceCitation: Greene SJ, DeVore AD, Sheng S, Fonarow GC, Butler J, Califf RM, Hernandez AF, Matsouaka RA, Samman Tahhan A, Thomas KL, Vaduganathan M, Yancy CW, Peterson ED, O'Connor CM, Mentz RJ. Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF. JACC Heart Fail. 2019 Nov;7(11):980-992. doi: 10.1016/j.jchf.2019.07.011. Epub 2019 Oct 9.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Greene SJ, Hernandez AF, Sun JL, Butler J, Armstrong PW, Ezekowitz JA, Zannad F, Ferreira JP, Coles A, Metra M, Voors AA, Califf RM, O'Connor CM, Mentz RJ. Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004783. doi: 10.1161/CIRCOUTCOMES.118.004783.

ReferenceCitation: Verma AK, Sun JL, Hernandez A, Teerlink JR, Schulte PJ, Ezekowitz J, Voors A, Starling R, Armstrong P, O'Conner CM, Mentz RJ. Rate pressure product and the components of heart rate and systolic blood pressure in hospitalized heart failure patients with preserved ejection fraction: Insights from ASCEND-HF. Clin Cardiol. 2018 Jul;41(7):945-952. doi: 10.1002/clc.22981. Epub 2018 Jul 17.

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Bhatt AS, Cooper LB, Ambrosy AP, Clare RM, Coles A, Joyce E, Krishnamoorthy A, Butler J, Felker GM, Ezekowitz JA, Armstrong PW, Hernandez AF, O'Connor CM, Mentz RJ. Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). J Am Heart Assoc. 2018 Feb 3;7(3):e006740. doi: 10.1161/JAHA.117.006740.

ReferenceCitation: Greene SJ, Hernandez AF, Dunning A, Ambrosy AP, Armstrong PW, Butler J, Cerbin LP, Coles A, Ezekowitz JA, Metra M, Starling RC, Teerlink JR, Voors AA, O'Connor CM, Mentz RJ. Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure: From the ASCEND-HF Trial. J Am Coll Cardiol. 2017 Jun 27;69(25):3029-3039. doi: 10.1016/j.jacc.2017.04.043.

ReferenceCitation: Greene SJ, Hernandez AF, Sun JL, Metra M, Butler J, Ambrosy AP, Ezekowitz JA, Starling RC, Teerlink JR, Schulte PJ, Voors AA, Armstrong PW, O'Connor CM, Mentz RJ. Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). Circ Heart Fail. 2016 Sep;9(9):e002986. doi: 10.1161/CIRCHEARTFAILURE.116.002986.

ReferenceCitation: Ezekowitz JA, Podder M, Hernandez AF, Armstrong PW, Starling RC, O'Connor CM, Califf RM. Arrival by ambulance in acute heart failure: insights into the mode of presentation from Acute Studies of Nesiritide in Decompensated Heart Failure (ASCEND-HF). BMJ Open. 2016 Mar 17;6(3):e010201. doi: 10.1136/bmjopen-2015-010201.

ReferenceCitation: Abualnaja S, Podder M, Hernandez AF, McMurray JJ, Starling RC, O'Connor CM, Califf RM, Armstrong PW, Ezekowitz JA. Acute Heart Failure and Atrial Fibrillation: Insights From the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) Trial. J Am Heart Assoc. 2015 Aug 24;4(8):e002092. doi: 10.1161/JAHA.115.002092.

repository_institution: Australian Catholic University - Research Bank

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Patel PA, Heizer G, O'Connor CM, Schulte PJ, Dickstein K, Ezekowitz JA, Armstrong PW, Hasselblad V, Mills RM, McMurray JJ, Starling RC, Tang WH, Califf RM, Hernandez AF. Hypotension during hospitalization for acute heart failure is independently associated with 30-day mortality: findings from ASCEND-HF. Circ Heart Fail. 2014 Nov;7(6):918-25. doi: 10.1161/CIRCHEARTFAILURE.113.000872. Epub 2014 Oct 3.

ReferenceCitation: van Deursen VM, Hernandez AF, Stebbins A, Hasselblad V, Ezekowitz JA, Califf RM, Gottlieb SS, O'Connor CM, Starling RC, Tang WH, McMurray JJ, Dickstein K, Voors AA. Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: results from the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF). Circulation. 2014 Sep 16;130(12):958-65. doi: 10.1161/CIRCULATIONAHA.113.003046. Epub 2014 Jul 29.

ReferenceCitation: Kaul P, Reed SD, Hernandez AF, Howlett JG, Ezekowitz JA, Li Y, Zheng Y, Rouleau JL, Starling RC, O'Connor CM, Califf RM, Armstrong PW. Differences in treatment, outcomes, and quality of life among patients with heart failure in Canada and the United States. JACC Heart Fail. 2013 Dec;1(6):523-30. doi: 10.1016/j.jchf.2013.07.004. Epub 2013 Oct 23.

ReferenceCitation: Toma M, Ezekowitz JA, Bakal JA, O'Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM, Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection fraction and mortality in patients with acute heart failure: insights from the ASCEND-HF Trial. Eur J Heart Fail. 2014 Mar;16(3):334-41. doi: 10.1002/ejhf.19. Epub 2013 Dec 14.

ReferenceCitation: Reed SD, Kaul P, Li Y, Eapen ZJ, Davidson-Ray L, Schulman KA, Massie BM, Armstrong PW, Starling RC, O'Connor CM, Hernandez AF, Califf RM. Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF. J Card Fail. 2013 Sep;19(9):611-20. doi: 10.1016/j.cardfail.2013.07.003.

ReferenceCitation: Howlett JG, Ezekowitz JA, Podder M, Hernandez AF, Diaz R, Dickstein K, Dunlap ME, Corbalan R, Armstrong PW, Starling RC, O'Connor CM, Califf RM, Fonarow GC; ASCEND-HF Investigators. Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: findings from the acute study clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF). Circ Cardiovasc Qual Outcomes. 2013 Sep 1;6(5):534-42. doi: 10.1161/CIRCOUTCOMES.113.000119. Epub 2013 Jul 30.

ReferenceCitation: Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong PW, Starling RC, McMurray JJ, Massie BM, Swedberg K, Ezekowitz JA, Fonarow GC, Teerlink JR, Metra M, Whellan DJ, O'Connor CM, Califf RM, Hernandez AF. Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF. Circ Heart Fail. 2013 Jul;6(4):727-32. doi: 10.1161/CIRCHEARTFAILURE.112.000265. Epub 2013 Jun 14.

ReferenceCitation: Ezekowitz JA, Hu J, Delgado D, Hernandez AF, Kaul P, Leader R, Proulx G, Virani S, White M, Zieroth S, O'Connor C, Westerhout CM, Armstrong PW. Acute heart failure: perspectives from a randomized trial and a simultaneous registry. Circ Heart Fail. 2012 Nov;5(6):735-41. doi: 10.1161/CIRCHEARTFAILURE.112.968974. Epub 2012 Oct 2.

ReferenceCitation: Ezekowitz JA, Hernandez AF, O'Connor CM, Starling RC, Proulx G, Weiss MH, Bakal JA, Califf RM, McMurray JJ, Armstrong PW. Assessment of dyspnea in acute decompensated heart failure: insights from ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) on the contributions of peak expiratory flow. J Am Coll Cardiol. 2012 Apr 17;59(16):1441-8. doi: 10.1016/j.jacc.2011.11.061.

ReferenceCitation: O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalan R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Mendez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. Erratum In: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Chile
Canada
France
Lithuania
Colombia
United States
Ukraine
India
China
Malaysia
Norway
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.

acronym: FUTURE

summary: This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

ReferenceCitation: Douillard JY, Zemelka T, Fountzilas G, Barone C, Schlichting M, Heighway J, Eggleton SP, Srimuninnimit V. FOLFOX4 with cetuximab vs. UFOX with cetuximab as first-line therapy in metastatic colorectal cancer: The randomized phase II FUTURE study. Clin Colorectal Cancer. 2014 Mar;13(1):14-26.e1. doi: 10.1016/j.clcc.2013.11.009. Epub 2013 Nov 16.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Germany
Italy
Poland
Israel
Argentina
Hong Kong
Australia
Brazil
Austria
Belgium
Mexico
Thailand
Greece
France

location_facility:
Research site
Research Site


title: A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

ReferenceCitation: Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreno L, Armstrong G, Collinson N, Shaw TM; MIRROR Trial Investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford). 2010 Sep;49(9):1683-93. doi: 10.1093/rheumatology/keq116. Epub 2010 May 12.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Italy
New Zealand
Slovakia
Hungary
United Kingdom
Australia
Brazil
Netherlands
Belgium
China
Spain
Thailand
South Africa
Taiwan
Canada
France


title: A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

summary: Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

ReferenceCitation: Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

ReferenceCitation: Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-1627. doi: 10.1093/annonc/mdq626. Epub 2011 Jan 12.

lead_sponsor: Celgene

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Hematology Oncology Associates of Central Brevard

location_facility: Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina

location_facility: Hospital Clinicio San Carlos, Servivio de Hematologia Clinica

location_facility: Complexo Hospitalario de Pontevedra Oncology Department

location_facility: Hospital Clinic I Provincial, Servicio de Hematologia

location_facility: Medical Oncology, Christie Hospital NHS Trust

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale

location_facility: Hospital Clinico Universitario de Salamanca, Servicio de Hematologia

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),

location_facility: Hospital Universitario Virgen de la Victoria, Servicio de oncologia

location_facility: Hopital Saint Louis Service d'Hémato-Oncologie

location_facility: Institute Paoli-Calmettes Départmentd 'Hématologie

location_facility: Sylvester Cancer Center/ Univeristy of Miami

location_facility: Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"

location_facility: Centre Hospitalier Lyon Sud, Hematologie Clinique

location_facility: Department d'Hématologie Centre Henri Becquerel

location_facility: Center for Cancer and Hematologic Disease

location_facility: Michigan Hematology and Oncology Institute

location_facility: Royal Marsden Hospital NHS Foundation Trust London and Surrey