ReferenceCitation: Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Søndergaard 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.

family: Pratley

full_name: Richard E Pratley

given: Richard E

family: Nauck

full_name: Michael Nauck

given: Michael

family: Bailey

full_name: Timothy Bailey

given: Timothy

family: Montanya

full_name: Eduard Montanya

given: Eduard

family: Cuddihy

full_name: Robert Cuddihy

given: Robert

family: Filetti

full_name: Sebastiano Filetti

given: Sebastiano

family: Thomsen

full_name: Anne Bloch Thomsen

given: Anne Bloch

family: Søndergaard

full_name: Rie Elvang Søndergaard

given: Rie Elvang

family: Davies

full_name: Melanie Davies

given: Melanie

journal_name: The Lancet

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.

full_name: M. Davies

given: M.

full_name: R. Pratley

given: R.

family: Hammer

full_name: M. Hammer

full_name: A. B. Thomsen

given: A. B.

full_name: R. Cuddihy

journal_name: Diabetic Medicine

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.

full_name: M. Nauck

full_name: T. Bailey

given: T.

full_name: E. Montanya

given: E.

full_name: S. Filetti

given: S.

journal_name: International Journal of Clinical Practice

repository_institution: University of Leicester - Leicester Research Archive

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.

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.

name: Department of Cardiovascular Sciences, University of Leicester, Leicester

name: Novo Nordisk Ltd, Crawley, West Sussex, UK

name: Ossian Health Economics and Communications, Basel, Switzerland

title: Cost–utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add‐on to metformin monotherapy in Type 2 diabetes mellitus

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. 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.

name: Division of Diabetes, Endocrinology and Metabolism, Department of Medicine; Vanderbilt University School of Medicine; Nashville; TN; USA

name: Division of Endocrinology Diabetes and Nutrition, St Luke's-Roosevelt Hospital, Columbia University; New York; NY; USA

name: Diabetes Care Center; University of North Carolina School of Medicine; Chapel Hill; NC; USA

name: Novo Nordisk Pharma Ltd; Crawley; West Sussex; UK

name: Department of Diabetes and Endocrinology, Royal Surrey County Hospital, University of Surrey; Guildford; Surrey; UK

name: Samuel Lunenfeld Research Institute; Mount Sinai Hospital, University of Toronto; Toronto; ON; Canada

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.

title: A meta-analysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer

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.

title: 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%

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. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

title: 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

ReferenceCitation: Davidson JA, Ørsted 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.

name: Touchstone Diabetes Center Dallas University of Texas Southwestern Medical Center  Dallas TX USA

name: UT Health Science Center  San Antonio TX USA

title: Efficacy and safety of liraglutide, a once‐daily human glucagon‐like peptide‐1 analogue, in L atino/ H ispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials

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.

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

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

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.


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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

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.

family: De Rosa

full_name: Francesco Giuseppe De Rosa

given: Francesco Giuseppe

sequence: first

family: Busca

full_name: Alessandro Busca

given: Alessandro

sequence: additional

family: Capparella

full_name: Maria Rita Capparella

given: Maria Rita

family: Yan

full_name: Jean Li Yan

given: Jean Li

family: Aram

full_name: Jalal A. Aram

given: Jalal A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Drug Investigation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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.

family: Sganga

full_name: Gabriele Sganga

given: Gabriele

family: Wang

full_name: Minggui Wang

given: Minggui

full_name: M. Rita Capparella

given: M. Rita

family: Tawadrous

full_name: Margaret Tawadrous

given: Margaret

full_name: Jean L. Yan

given: Jean L.

family: Montravers

full_name: Philippe Montravers

given: Philippe

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

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.

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

name: Department of Medicine; University of Udine; Udine Italy

name: Universidade Federal do Rio de Janeiro; Rio de Janeiro Brazil

title: Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis : Analysis of pooled data from six prospective clinical studies

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.

name: Department of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, PO Box 9101, Geert Grooteplein 8, 6525 GA Nijmegen, The Netherlands

name: Division of Infectious Diseases, Medical College of Georgia/Augusta University, 1120 15th Street, Augusta, GA 30912, USA

name: Department of Medicine, Srinagarind Hospital, Mueang Khon Kaen 40000, Thailand

name: Department of Internal Medicine, University Hospital, Universidade Federal do Rio de Janeiro, Avenida Pedro Calmon 550, Rio de Janeiro 21941-901, Brazil

name: Department of Emergency and Intensive Care, Centro Hospitalar São João, Faculty of Medicine, University of Porto, Praça Gomes Teixeira, Porto 4099-002, Portugal

name: University Hospitals of Geneva, 4 rue Gabrille-Perret-Gentil, CH 1211 Geneva, Switzerland

name: Pfizer Inc., 235 E 42nd Street, New York, NY, USA

name: Pfizer PFE, 23-25 avenue du Docteur Lannelongue, 75668 Paris cedex 14, France

name: Department of Oncology and Hematology, Hôpital de Hautepierre and Université de Strasbourg, 1 place de l’Hôpital, BP 426, 67091 Strasbourg cedex, France

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

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

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


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.

design_allocation: Randomized

lead_sponsor: Bayer

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


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.

study_type: Observational

time_perspective: Prospective

lead_sponsor: GlaxoSmithKline

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


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.

family: Weber

full_name: Jeffrey S. Weber

given: Jeffrey S.

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Middleton

full_name: Mark R. Middleton

given: Mark R.

family: Hennicken

full_name: Delphine Hennicken

given: Delphine

family: Zoffoli

full_name: Roberto Zoffoli

given: Roberto

family: Pieters

full_name: Anne Pieters

given: Anne

family: Amadi

full_name: Adenike Amadi

given: Adenike

family: Kupas

full_name: Katrin Kupas

given: Katrin

family: Kotapati

full_name: Srividya Kotapati

given: Srividya

family: Moshyk

full_name: Andriy Moshyk

given: Andriy

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

journal_name: European Journal of Cancer

oa_host_type: publisher

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé 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.

family: Coens

full_name: Corneel Coens

given: Corneel

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: Chiarion-Sileni

full_name: Vanna Chiarion-Sileni

given: Vanna

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Wolchok

full_name: Jedd D Wolchok

given: Jedd D

family: Schmidt

full_name: Henrik Schmidt

given: Henrik

family: Hamid

full_name: Omid Hamid

given: Omid

family: Robert

full_name: Caroline Robert

given: Caroline

full_name: Paolo A Ascierto

given: Paolo A

ReferenceCitation: Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé 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. Epub 2016 Oct 7. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé 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_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Czechia
Poland
Norway
Australia
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: Huntsman Cancer Institute At The Univ. Of Utah

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

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

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

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


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.

family: Jacobson

full_name: Ira M. Jacobson

given: Ira M.

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Dusheiko

full_name: Geoffrey Dusheiko

given: Geoffrey

family: Di Bisceglie

full_name: Adrian M. Di Bisceglie

given: Adrian M.

family: Reddy

full_name: K. Rajender Reddy

given: K. Rajender

family: Bzowej

full_name: Natalie H. Bzowej

given: Natalie H.

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Muir

full_name: Andrew J. Muir

given: Andrew J.

family: Ferenci

full_name: Peter Ferenci

given: Peter

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: George

full_name: Jacob George

given: Jacob

family: Rizzetto

full_name: Mario Rizzetto

given: Mario

family: Shouval

full_name: Daniel Shouval

given: Daniel

family: Sola

full_name: Ricard Sola

given: Ricard

family: Terg

full_name: Ruben A. Terg

given: Ruben A.

family: Yoshida

full_name: Eric M. Yoshida

given: Eric M.

family: Adda

full_name: Nathalie Adda

given: Nathalie

family: Bengtsson

full_name: Leif Bengtsson

given: Leif

family: Sankoh

full_name: Abdul J. Sankoh

given: Abdul J.

family: Kieffer

full_name: Tara L. Kieffer

given: Tara L.

full_name: Shelley George

given: Shelley

family: Kauffman

full_name: Robert S. Kauffman

given: Robert S.

family: Zeuzem

full_name: Stefan Zeuzem

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

title: Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection

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


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.

ReferenceType: background

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


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). 2021 Aug 13. doi: 10.2459/JCM.0000000000001236. [Epub ahead of print]

family: Landolina

full_name: Maurizio Landolina

given: Maurizio

family: Boriani

full_name: Giuseppe Boriani

given: Giuseppe

family: Biffi

full_name: Mauro Biffi

given: Mauro

family: Cattafi

full_name: Giuseppe Cattafi

family: Capucci

full_name: Alessandro Capucci

given: Alessandro

family: Dello Russo

full_name: Antonio Dello Russo

given: Antonio

family: Facchin

full_name: Domenico Facchin

given: Domenico

family: Rordorf

full_name: Roberto Rordorf

given: Roberto

family: Sagone

full_name: Antonio Sagone

family: Del Greco

full_name: Maurizio Del Greco

family: Morani

full_name: Giovanni Morani

given: Giovanni

family: Nicolis

full_name: Daniele Nicolis

given: Daniele

family: Meloni

full_name: Sarah Meloni

given: Sarah

family: Grammatico

full_name: Andrea Grammatico

given: Andrea

family: Gasparini

full_name: Maurizio Gasparini

journal_name: Journal of Cardiovascular Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

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.

family: Kloppe

full_name: Axel Kloppe

given: Axel

family: Lunati

full_name: Maurizio Lunati

family: Varma

full_name: Niraj Varma

given: Niraj

family: Martinez-Ferrer

full_name: Jose B Martinez-Ferrer

given: Jose B

family: Hersi

full_name: Ahmed Hersi

given: Ahmed

ReferenceCitation: Gasparini M, Lunati MG, Proclemer A, Arenal A, Kloppe A, Martínez 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.

name: Electrophysiology and Pacing Unit; IRCCS Humanitas Research Hospital; Rozzano Italy

name: Department of Cardiology; Ruhr-Universität-Bochum; Bochum Germany

name: Cardiology Department; Niguarda Hospital; Milan Italy

name: Cardiology Department; University Hospital C. Nicolle; Rouen France

name: Institute of Cardiology; Maggiore Hospital; Crema Italy

name: Department of Cardiology; Hospital de Txagorritxu C/José Achotegui; Vitoria (Álava) Spain

name: Department of Cardiology; S. Maria della Misericordia Hospital; Udine Italy

name: Cardiology Department; Azienda Ospedaliera Universitaria Integrata; Verona Italy

name: Institute of Cardiology; University of Bologna and Azienda Ospedaliera S. Orsola-Malpighi; Bologna Italy

name: Department of Cardiology; San Filippo Neri Hospital; Rome Italy

name: Department of Cardiology; Fondazione IRCCS Policlinico S. Matteo; Pavia Italy

name: Medtronic Regional Clinical Center; Rome Italy

name: Aston Medical Research Institute, Aston Medical School; Aston University; Birmingham UK

name: Cardiology Department, Policlinico di Modena; University of Modena and Reggio Emilia; Modena Italy

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Kloppe A, Proclemer A, Arenal A, Lunati M, Martìnez 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.

name: From Medizinische Klinik II, Kardiologie und Angiologie, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Ruhr Universität Bochum, Bochum, Germany (A.K.); Azienda Ospedaliero Universitaria S. Maria della Misericordia, Udine, Italy (A.P.); Hospital General Universitario Gregorio Marañón, Madrid, Spain (A.A.); Azienda Ospedaliera Niguarda Ca’ Granda, Milano, Italy (M.L.); Hospital de Txagorritxu, Vitoria (Álava), Spain (J.B.M.F.); College of Medicine, King Saud University, Riyadh, Saudi...

title: Efficacy of Long Detection Interval Implantable Cardioverter-Defibrillator Settings in Secondary Prevention Population

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.

title: Effect of Long-Detection Interval vs Standard-Detection Interval for Implantable Cardioverter-Defibrillators on Antitachycardia Pacing and Shock Delivery

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.

journal_name: Journal of Cardiovascular Electrophysiology

title: Avoid Delivering Therapies for Nonsustained Fast Ventricular Tachyarrhythmia in Patients with Implantable Cardioverter/Defibrillator: The ADVANCE III Trial

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

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg

location_facility: University of Cape Town - Groote Schuur Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec

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

location_facility: Ente Ospedaliero Ospedali Galliera - Genova

location_facility: Universität Rostock- Medizinische Fakultät

location_facility: Stab. Ospedaliero Di Summa-Perrino - Brindisi

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: King Khalid Univ. Hospital - King Saud University

location_facility: Hospital General Universitario de Alicante

location_facility: Kardiologisches Zentrum an der Klinik Rotes Kreuz

location_facility: Hospital Clinico de Malaga - Virgen de la Victoria

location_facility: Hospital Universitario Virgen de las Nieves


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.

name: From Pfizer Ltd., Walton Oaks, United Kingdom;

family: Loftus

full_name: Jane V. Loftus

given: Jane V.

family: Sultan

full_name: Marla B. Sultan

given: Marla B.

family: Pleil

full_name: Andreas M. Pleil

given: Andreas M.

journal_name: Investigative Opthalmology & Visual Science

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: Changes in Vision- and Health-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Pegaptanib Sodium or Sham

lead_sponsor: Pfizer

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


ReferenceType: result

ReferenceCitation: Baselga J, Cortés 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.

family: Baselga

full_name: José Baselga

given: José

family: Cortés

full_name: Javier Cortés

given: Javier

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Hegg

full_name: Roberto Hegg

full_name: Young-Hyuck Im

given: Young-Hyuck

family: Roman

full_name: Laslo Roman

given: Laslo

family: Pedrini

full_name: José Luiz Pedrini

given: José Luiz

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Knott

full_name: Adam Knott

given: Adam

family: Clark

full_name: Emma Clark

given: Emma

family: Benyunes

full_name: Mark C. Benyunes

given: Mark C.

family: Ross

full_name: Graham Ross

given: Graham

family: Swain

full_name: Sandra M. Swain

given: Sandra M.

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free pdf)

repository_institution: São Paulo Research Foundation, Latin American and Caribbean Center on Health Sciences Information, Conselho Nacional de Desenvolvimento Científico e Tecnológico - Scientific Electronic Library Online

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer

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, Cortés 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.

full_name: Sandra M Swain

given: Sandra M

family: Miles

full_name: David Miles

given: David

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.

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.

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, Cortés 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_institution: Tampere University - Tampere University Institutional Repository

title: Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

ReferenceCitation: Baselga J, Cortés 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.

name: José Baselga, Memorial Sloan Kettering Cancer Center, New York, NY; Javier Cortés, Vall d'Hebron University Hospital, Barcelona, Spain; Seock-Ah Im, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea; Emma Clark and Graham Ross, Roche Products, Welwyn Garden City, United Kingdom; Astrid Kiermaier, F. Hoffmann-La Roche, Basel, Switzerland; and Sandra M. Swain, Washington Cancer Institute, MedStar Washington Hospital Center, Washington, DC.

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: 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

ReferenceCitation: Swain SM, Baselga J, Miles D, Im YH, Quah C, Lee LF, Cortés 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: Cortés 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, Cortés 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.

title: CLEOPATRA: A Phase III Evaluation of Pertuzumab and Trastuzumab for HER2-Positive Metastatic Breast Cancer

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

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

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

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

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: National Cancer Center Hospital; Breast and Medical Oncology

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Fuzhou General Hospital, PLA Nanjing Military Area Command

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto

location_facility: Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

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

location_facility: University of Kansas; Medical Center & Medical pavilion

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

location_facility: Consultants in Medical Oncology/Hematology

location_facility: UM Sylvester Deerfield Beach; Sylvester Cancer Ctr

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Hospital Angeles Metropolitano; Room 220

location_facility: Innovative clinical research institute/American institute of research

location_facility: Sansum Santa Barbara Medical Foundation Clinic

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

location_facility: Pacific Coast Hematology/Oncology Medical Group

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

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

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

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

location_facility: Tokyo Metropolitan; Komagome Hospital, Surgery

location_facility: Erlanger Health System; Oncology Research

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

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

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

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Florida Cancer Specialists - Port Charlotte

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

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

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

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

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Veterans Memorial Medical Center; Oncology

location_facility: P.Stradins Clinical University Hospital, Oncology Centre

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

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

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

location_facility: Kumamoto Shinto General Hospital; Breast Cancer Center

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Kitakyushu Municipal Medical Center, Surgery

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

location_facility: National Cancer Center; Medical Oncology

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Cancer Center of Acadiana at Lafayette General

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

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Hospital Carlos Andrade Marin; Servicio de Oncología

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Osaka University Hospital; Breast and Endocrine Surgery

location_facility: Florida Cancer Specialists - Sunset Lake, Venice

location_facility: Cancer & Hematology Center of West Michigan

location_facility: Southern Nevada Cancer Research Foundation

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

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

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

location_facility: Shizuoka General Hospital; Breast Surgery

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

location_facility: National Cancer Centre; Medical Oncology

location_facility: CA Care Associates-OK Oncology and Hematology

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

location_facility: Charing Cross Hospital; Medical Oncology.

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

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

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

location_facility: Tokai University Hospital, Breast and Endocrine Surgery

location_facility: UCLA / Santa Clarita Valley Cancer Center

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Jichi Medical University; Dept of Clinical Oncology

location_facility: US Oncology Research at Minnesota Oncology

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

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

location_facility: Blokhin Cancer Research Center; Combined Treatment

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

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

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

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

location_facility: Central Georgia Hematology Oncology Associates

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

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

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

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: Chulalongkorn Hospital; Medical Oncology

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

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

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

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

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

location_facility: Kaiser Permanente San Diego; Hepatology Research

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Shizuoka Cancer Center; Female Internal Medicine

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

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Regional Oncology Hospital Of Kursk; Chemotherapy

location_facility: Medical College of Ohio; Cancer Institute

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Ospedale Provinciale Santa Maria delle Croci

location_facility: Sutter Gould Medical Foundation; Clinical Research

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

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

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

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Florida Cancer Specialists - Pine Ridge, Naples

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

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Policlinica Privada Site la Plata SA; Oncology

location_facility: Florida Cancer Specialists - Goodlette, Naples

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

location_facility: Breast Cancer Centre at Memorial Hospital West

location_facility: Upstate Ny Cancer Research & Education Foundation

location_facility: Community Cancer Center Rutland Regional Medical Center

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

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

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Midwestern Regional Medical Center; Office of Research

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

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Ronald Reagan UCLA Medical Center Clin Lab

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

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

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

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

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

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

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Instituto Medico Especializado (IME); Oncologia

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Oncologia

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Chiba Cancer Center; Breast Surgical Oncology

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

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

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

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

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

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

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

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

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

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

location_facility: University Hospital Centre Zagreb; Clinic For Oncology

location_facility: SBI of Healthcare Leningrad Regional Oncology Dispensary

location_facility: Clinica Amo - Assistencia Medica Em Oncologia

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

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

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Saitama Medical University International Medical Center; Medical Oncology

location_facility: Hosp Provincial D. Centenarios; Oncology Dept

location_facility: Beth Israel Comprehensive Cancer Center Pharmacy

location_facility: Groupe Hospitalier Sud; Oncologie Radiotherapie

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

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

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

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.


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.

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Smolen

full_name: Josef S. Smolen

given: Josef S.

family: Jones

full_name: Heather Jones

given: Heather

family: Szumski

full_name: Annette Szumski

given: Annette

family: Marshall

full_name: Lisa Marshall

given: Lisa

family: Emery

full_name: Paul Emery

given: Paul

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

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.

name: Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria

full_name: Josef S Smolen

given: Josef S

name: Global Medical Affairs, Pfizer, Collegeville, PA, USA

family: Pedersen

full_name: Ronald Pedersen

given: Ronald

family: Mahgoub

full_name: Ehab Mahgoub

given: Ehab

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

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


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. Review.

name: Department of Biomedicine, Pharmacology; Aarhus University; Aarhus Denmark

family: Andersen

full_name: Mathilde Borring Andersen

given: Mathilde Borring

family: Simonsen

full_name: Ulf Simonsen

given: Ulf

name: Clinic for Plastic, Aesthetic and Hand Surgery; Otto-von-Guericke-University Magdeburg; Magdeburg Germany

family: Wehland

full_name: Markus Wehland

given: Markus

family: Pietsch

full_name: Jessica Pietsch

given: Jessica

family: Grimm

full_name: Daniela Grimm

given: Daniela

journal_name: Basic & Clinical Pharmacology & Toxicology

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: LCZ696 (Valsartan/Sacubitril) - A Possible New Treatment for Hypertension and Heart Failure

ReferenceCitation: Ruilope LM, Dukat A, Böhm M, Lacourcière 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.

family: Ruilope

full_name: Luis Miguel Ruilope

given: Luis Miguel

family: Dukat

full_name: Andrej Dukat

given: Andrej

family: Böhm

full_name: Michael Böhm

given: Michael

family: Lacourcière

full_name: Yves Lacourcière

given: Yves

family: Gong

full_name: Jianjian Gong

given: Jianjian

family: Lefkowitz

full_name: Martin P Lefkowitz

given: Martin P

lead_sponsor: Novartis Pharmaceuticals

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


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.

name: From Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland; Pfizer and Weill Cornell Medical Center, Cornell University, New York, New York; Hôpital de Hautepierre, Strasbourg, France; CancerCare Manitoba and the University of Manitoba, Winnipeg, Manitoba, Canada; First Department of Internal Medicine, Clinical Trials Centre Cologne, ZKS Köln, BMBF 01KN1106, Köln, Germany; University of Würzburg Medical Centre, Würzburg, Germany; National...

family: Marr

full_name: Kieren A. Marr

given: Kieren A.

family: Schlamm

full_name: Haran T. Schlamm

given: Haran T.

family: Herbrecht

full_name: Raoul Herbrecht

given: Raoul

family: Rottinghaus

full_name: Scott T. Rottinghaus

given: Scott T.

family: Bow

full_name: Eric J. Bow

given: Eric J.

family: Cornely

full_name: Oliver A. Cornely

given: Oliver A.

family: Heinz

full_name: Werner J. Heinz

given: Werner J.

family: Jagannatha

full_name: Shyla Jagannatha

given: Shyla

family: Koh

full_name: Liang Piu Koh

given: Liang Piu

family: Kontoyiannis

full_name: Dimitrios P. Kontoyiannis

given: Dimitrios P.

family: Lee

full_name: Dong-Gun Lee

given: Dong-Gun

family: Nucci

full_name: Marcio Nucci

given: Marcio

family: Pappas

full_name: Peter G. Pappas

given: Peter G.

family: Slavin

full_name: Monica A. Slavin

given: Monica A.

family: Queiroz-Telles

full_name: Flavio Queiroz-Telles

given: Flavio

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Walsh

full_name: Thomas J. Walsh

given: Thomas J.

family: Wingard

full_name: John R. Wingard

given: John R.

family: Maertens

full_name: Johan A. Maertens

given: Johan A.

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

title: Combination Antifungal Therapy for Invasive Aspergillosis

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.

family: Liu

full_name: Ping Liu

given: Ping

family: Mould

full_name: Diane R. Mould

given: Diane R.

title: Population Pharmacokinetic-Pharmacodynamic Analysis of Voriconazole and Anidulafungin in Adult Patients with Invasive Aspergillosis

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.

title: Population Pharmacokinetic Analysis of Voriconazole and Anidulafungin in Adult Patients with Invasive Aspergillosis

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


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 α 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.

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

family: Forns

full_name: Xavier Forns

given: Xavier

family: Goeser

full_name: Tobias Goeser

given: Tobias

family: Ferenci

full_name: Peter Ferenci

given: Peter

family: Nevens

full_name: Frederik Nevens

given: Frederik

family: Carosi

full_name: Giampiero Carosi

given: Giampiero

family: Drenth

full_name: Joost P Drenth

given: Joost P

family: Lonjon-Domanec

full_name: Isabelle Lonjon-Domanec

given: Isabelle

family: DeMasi

full_name: Ralph DeMasi

given: Ralph

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: Beumont

full_name: Maria Beumont

given: Maria

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

journal_name: Gut

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Insulin resistance and response to telaprevir plus peginterferon α and ribavirin in treatment-naïve patients infected with HCV genotype 1

lead_sponsor: Tibotec BVBA

location_country: Austria Netherlands France Belgium Spain Germany

type: EudraCT Number

source: euctr

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

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: 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.

family: Nahum

full_name: Gerard G. Nahum

given: Gerard G.

family: Kaunitz

full_name: Andrew M. Kaunitz

given: Andrew M.

family: Rosen

full_name: Kimberly Rosen

given: Kimberly

family: Schmelter

full_name: Thomas Schmelter

given: Thomas

family: Lynen

full_name: Richard Lynen

given: Richard

journal_name: Contraception

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.

family: Apter

full_name: Dan Apter

given: Dan

family: Gemzell-Danielsson

full_name: Kristina Gemzell-Danielsson

given: Kristina

family: Hauck

full_name: Brian Hauck

given: Brian

family: Zurth

full_name: Christian Zurth

given: Christian

journal_name: Fertility and Sterility

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.

family: Nelson

full_name: Anita Nelson

given: Anita

family: Rybowski

full_name: Sarah Rybowski

given: Sarah

journal_name: Obstetrics & Gynecology

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.

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

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

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: Diéras V, Wildiers H, Jassem J, Dirix LY, Guastalla JP, Bono P, Hurvitz SA, Gonçalves A, Romieu G, Limentani SA, Jerusalem G, Lakshmaiah KC, Roché H, Sánchez-Rovira P, Pienkowski T, Seguí Palmer MÁ, 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.

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Wildiers

full_name: Hans Wildiers

given: Hans

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Dirix

full_name: Luc Y. Dirix

given: Luc Y.

family: Guastalla

full_name: Jean-Paul Guastalla

given: Jean-Paul

family: Bono

full_name: Petri Bono

given: Petri

family: Hurvitz

full_name: Sara A. Hurvitz

given: Sara A.

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Limentani

full_name: Steven A. Limentani

given: Steven A.

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Lakshmaiah

full_name: K.C. Lakshmaiah

family: Roché

full_name: Henri Roché

given: Henri

family: Sánchez-Rovira

full_name: Pedro Sánchez-Rovira

given: Pedro

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Seguí Palmer

full_name: Miguel Ángel Seguí Palmer

given: Miguel Ángel

family: Li

full_name: Ai Li

given: Ai

family: Sun

full_name: Yu-Nien Sun

given: Yu-Nien

family: Pickett

full_name: Cheryl A. Pickett

given: Cheryl A.

family: Slamon

full_name: Dennis J. Slamon

given: Dennis J.

journal_name: The Breast

lead_sponsor: Amgen

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

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

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.


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

lead_sponsor: Bristol-Myers Squibb

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

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.

study_start_date_type: Actual

primary_purpose: Prevention

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.

name: Department of Medicine, McMaster University, Hamilton, Ontario, Canada

name: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada

family: Bhagirath

full_name: Vinai Bhagirath

given: Vinai

family: Eikelboom

full_name: John Eikelboom

given: John

family: Hirsh

full_name: Jack Hirsh

given: Jack

name: Department of Vascular Medicine, Academic Medical Centre, Amsterdam, The Netherlands

family: Coppens

full_name: Michiel Coppens

given: Michiel

family: Ginsberg

full_name: Jeffrey Ginsberg

given: Jeffrey

name: Department of Cardiovascular Sciences, University Hospital, Leuven, Belgium

family: Vanassche

full_name: Thomas Vanassche

given: Thomas

family: Yuan

full_name: Fei Yuan

given: Fei

family: Chan

full_name: Noel Chan

given: Noel

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Connolly

full_name: Stuart Connolly

given: Stuart

journal_name: TH Open

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: 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.

family: Ng

full_name: Kuan H. Ng

given: Kuan H.

family: Shestakovska

full_name: Olga Shestakovska

given: Olga

full_name: Stuart J. Connolly

given: Stuart J.

full_name: John W. Eikelboom

given: John W.

family: Avezum

full_name: Alvaro Avezum

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.

name: From the University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK (G.Y.H.L.); Population Health Research Institute, McMaster University, Hamilton, Canada (S.C., S.Y., O.S., R.H., J.E.); University of Missouri, Columbia, MO (G.F.); Universidad de La Frontera, Temuco, Chile (F.L.); and Department of Pharmacology, St. John’s Medical College, Bangalore, India (D.X.).

journal_name: Circulation: Arrhythmia and Electrophysiology

title: Modification of Outcomes With Aspirin or Apixaban in Relation to CHADS 2 and CHA 2 DS 2 -VASc Scores in Patients With Atrial Fibrillation

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.

name: From the University of Missouri–Columbia, Columbia, MO (G.C.F.); the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada (J.W.E., O.S., S.J.C., S.Y., R.G.H.); Henry Ford Hospital, Detroit MI (S.K.); Postgraduate Medical School, Warsaw, Poland (A.B.); Aarhus University Hospital, Skejby, Aarhus, Denmark (S.H.); and the University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK (G.Y.H.L.).

title: Bleeding During Treatment With Aspirin Versus Apixaban in Patients With Atrial Fibrillation Unsuitable for Warfarin

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.

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

title: Apixaban in Patients with Atrial Fibrillation

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

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

location_facility: The Heart & Vascular Institute Of Florida

location_facility: Oregon Medical Group - Clinical Research

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

location_facility: Kaiser Permanente Medical Center, West Los Angeles

location_facility: Cardiology Consultants Of Orange County Med. Group Inc

location_facility: Fox Valley Clinical Research Center, Llc

location_facility: Salem Veterans Administration Medical Center

location_facility: Grand View - Lehigh Valley Health Services


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.

family: Adedokun

full_name: Omoniyi J. Adedokun

given: Omoniyi J.

family: Xu

full_name: Zhenhua Xu

given: Zhenhua

family: Liao

full_name: Sam Liao

given: Sam

family: Strauss

full_name: Richard Strauss

given: Richard

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

family: Sandborn

full_name: William J. Sandborn

given: William J.

journal_name: Clinical Therapeutics

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Population Pharmacokinetics and Exposure–Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis

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.

name: Global Clinical Development, Merck & Co., Inc., Kenilworth, NJ, USA

family: Philip

full_name: George Philip

given: George

name: Global Medical Affairs, MSD International, Kriens-Luzern, Switzerland

family: Cornillie

full_name: Freddy Cornillie

given: Freddy

name: Immunology, Janssen Research & Development, LLC, Spring House, PA, USA

full_name: J Omoniyi Adedokun

given: J Omoniyi

name: Medical Affairs, Janssen Biologics BV, Leiden, The Netherlands

family: Melsheimer

full_name: Richard Melsheimer

name: Department of Endoscopy, University Hospital Gasthuisberg, Leuven, Belgium

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

name: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Colombel

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Marano

full_name: Colleen Marano

given: Colleen

journal_name: Journal of Crohn's and Colitis

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.

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

name: Monash University and Alfred Hospital, Melbourne, VIC, Australia

family: Gibson

full_name: Peter R Gibson

given: Peter R

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

full_name: William J Sandborn

given: William J

name: Robarts Research Institute, University of Western Ontario, London, ON, Canada

full_name: Brian G Feagan

given: Brian G

name: Immunology, Janssen Research & Development, LLC., Spring House, PA, USA

name: Oregon Health & Science University and Portland VA Medical Center, Portland, OR, USA

name: Division of Gastroenterology and Hepatology, University of Leuven, Gasthuisberg, Leuven, Belgium

name: Department of Gastroenterology, Military Medical Academy, Belgrade, Serbia

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, Järnerot 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.

title: Subcutaneous Golimumab Maintains Clinical Response in Patients With Moderate-to-Severe Ulcerative Colitis

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

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

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


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, Sánchez-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.

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Sánchez-Fructuoso

full_name: Ana Sánchez-Fructuoso

given: Ana

family: Franco

full_name: Antonio Franco

given: Antonio

family: Glyda

full_name: Maciej Glyda

given: Maciej

family: Kuypers

full_name: Dirk R. Kuypers

given: Dirk R.

family: Jaray

full_name: Jenö Jaray

given: Jenö

journal_name: Transplant International

lead_sponsor: Astellas Pharma Inc

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