ReferenceCitation: Emery P, Rigby W, Tak PP, Dörner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.

family: Emery

full_name: Paul Emery

family: Rigby

full_name: William Rigby

given: William

family: Tak

full_name: Paul P. Tak

given: Paul P.

family: Dörner

full_name: Thomas Dörner

given: Thomas

family: Olech

full_name: Ewa Olech

given: Ewa

family: Martin

full_name: Carmen Martin

given: Carmen

family: Millar

full_name: Laurie Millar

given: Laurie

family: Travers

full_name: Helen Travers

given: Helen

family: Fisheleva

full_name: Elena Fisheleva

given: Elena

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Safety with Ocrelizumab in Rheumatoid Arthritis: Results from the Ocrelizumab Phase III Program

ReferenceCitation: Tak PP, Mease PJ, Genovese MC, Kremer J, Haraoui B, Tanaka Y, Bingham CO 3rd, Ashrafzadeh A, Travers H, Safa-Leathers S, Kumar S, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):360-70.

lead_sponsor: Genentech, Inc.

location_country:
Peru
Belgium
Australia
Taiwan
France
Japan
Panama
Poland
Slovakia
Argentina
Canada
Slovenia
Sweden
Switzerland
Netherlands
Hungary
Germany
United States
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

acronym: SCRIPT

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Tampa General Hospital; Rheumatology Research Dept

location_facility: Osaka Minami Medical Center; Rheumatoid Arthritis

location_facility: Centro Internacional de Pesquisa; Reumatologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Uni of Texas Southwestern Medical Center; Internal Medicine

location_facility: Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

location_facility: Inst. de Rehabilitacion Psicofisica; Reumathology

location_facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia

location_facility: Seirei Hamamatsu General Hospital; Rheumatology

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Saitama Medical University Hospital ; Rheumatology and Applied Immunology

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: Saitama Medical Center/School; Rheumatology, Clinical immunology

location_facility: Evangelisches Krankenhaus Hagen-Haspe Rheumaklinik

location_facility: Sasebo Chuo Hospital ; Internal Medicine

location_facility: Vas Megye Es Szombathely M.J.V. Markusovszky Korhaza

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Reumatologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Reumatologia

location_facility: Seacoast Arthritis and Osteoporosis Center

location_facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia

location_facility: Hospital Abreu Sodre - AACD;Pesquisa Clinica

location_facility: St. Alexius Medical Center; Arthritis Clinic

location_facility: Sourasky / Ichilov Hospital; Rheumatology

location_facility: Physicians Group, LC DBA Rheumatology & Internal Medicine Associates

location_facility: Advanced Rheumatology & Arthritis Research Center

location_facility: National Hospital Organization Kyushu Medical Center; Rheumatology and Internal Medicine

location_facility: Universitätsspital Zürich; Klinik für Rheumatologie

location_facility: Higashihiroshima Memorial Hospital; Rheumatology, Internal Medicine

location_facility: Hospital Univ. Central de Asturias; Servicio de Reumatologia

location_facility: Clinica San Felipe; Consultorio de Reumatología

location_facility: Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology

location_facility: Internistisches Praxiszentrum Am Krankenhaus Balserische Stiftung; Innere Medizin / Rheumatologie

location_facility: Uni Hospital Linkoeping; Dept. of Rheumatology

location_facility: Orszagos Reumatologiai Es Fizioterapias Intezet

location_facility: Complejo Asistencial Universitario de Burgos; Servicio de Reumatología

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Hospital Alberto Sabogal Sologuren; Remautology

location_facility: Hopital Louis Pasteur; Service De Medecine Interne et de Rhumatologie

location_facility: The Ottawa Hospital - Riverside Campus; the Arthritis Centre

location_facility: Bolnica dr. Petra Drzaja, Klinicni center Ljubljana; Klinicni oddelek za revmatologijo

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Univ. of Occupational and Environmental Health; Rheumatology, Clinical Immunology and Medicine

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Matsubara Mayflower Hospital; Rheumatology

location_facility: Arthritis Rheumatic & Back Disease Associates

location_facility: St. Joseph'S Health Care Centre; Rheumatology

location_facility: Arizona Arthritis & Rheumatology Research, Pllc

location_facility: Universitätsklinikum Freiburg; Medizinische UNI-Klinik; Abt. Innere Medizin - VI Rheumatologie

location_facility: Sarasota Arthritis Center; Research Dept

location_facility: Academisch Medisch Centrum; Division of Clinical Immunology & Rheumatology

location_facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii

location_facility: Klinik Duisburg; Klinik Für Rheumatologie

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Nashua Rheumatology - Foundation Medical Partners

location_facility: Hopital Maisonneuve- Rosemont; Rheumatology

location_facility: University Hospitals Case Medical Center

location_facility: Fachärzte für Innere Medizin - Rheumatologie - Dr. med. Ino Gao und Dr. med. Maria Anna Meier

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Uni of Southern California School of Medicine

location_facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214

location_facility: Hospital Sierrallana; Servicio de Reumatologia

location_facility: Centro de Estudos em Terapias Inovadoras - CETI

location_facility: Iu Outpatient Clinical Research Facility

location_facility: Sunshine Coast Rheumatology Research Unit

location_facility: Arthritis & Rheumatism; Disease Specialities

location_facility: Deaconess Arthritis Center; Rheumatic Disease Study Group

location_facility: Medical Specialists Clinical Research Center

location_facility: Narodny Ustav Reumatickych Chorob - 34479; Rheumatology

location_facility: Chang Gung Medical Foundation - Kaohsiung; Rheumatology

location_facility: University Health Network; Toronto Western Hospital

location_facility: Oklahoma Center For Arthritis Therapy & Research

location_facility: Arthrocare, Arthritis Care and Research, P.C.

location_facility: Valerius Medical Group & Research Ctr of Greater Long Beach

location_facility: The Governors of the Uni of Alberta; Heritage Medical Research Centre

location_facility: Tokyo Medical & Dental University; Medicine & Rheumatology

location_facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

location_facility: St. John'S Health System Inc.; St. John'S Medical Research

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Reumatologia

location_facility: Endokrinologikum Frankfurt; Rheumatologie & Gynäkologie

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Reumatologia

location_facility: Johns Hopkins University; Department of Rheumatology

location_facility: North Mississippi Medical Ctr; Internal Medicine Associates

location_facility: Princess Alexandra Hospital; Rheumatology

location_facility: Jacksonville Center For Clinical Research

location_facility: Jichi Medical School Hospital; Rheumatology and Clinical Immunology

location_facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia

location_facility: Hospital Clinic i Provincial; Servicio de Reumatologia

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

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

location_facility: Hospital Universitario Infanta Cristina; Servicio de Reumatologia

location_facility: Irccs Policlinico San Matteo; Reumatologia Adulti

location_facility: Rheumatology, P.C.; Medical Arts Building

location_facility: Evanston Northwestern Healthcare; Rheumatology

location_facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia

location_facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

location_facility: Rheumatology Associates of North Alabama

location_facility: Arthritis & Osteoporosis Associates, LLP

location_facility: St. Mary'S Duluth Clinic Health System; Rheumatology Dept

location_facility: Seihoku Chuoh Hospital; Department Of Rheumatology

location_facility: Stanford Uni Medical Center; Divison of Rheumatology

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

location_facility: Hokkaido Uni Hospital; Second Department of Internal Medicine

location_facility: Kentuckiana Center For Better Bone & Joint Healthx

location_facility: CHUV; Hôpital orthopédique, Rhumatologie

location_facility: Clinsite;Research Division of Integrated Health Associates

location_facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy

summary: This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.


ReferenceType: result

ReferenceCitation: Mathiesen ER, Damm P, Jovanovic L, McCance DR, Thyregod C, Jensen AB, Hod M. Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. Diabetes Metab Res Rev. 2011 Sep;27(6):543-51. doi: 10.1002/dmrr.1213. Review.

family: Mathiesen

full_name: Elisabeth R. Mathiesen

given: Elisabeth R.

sequence: first

family: Damm

full_name: Peter Damm

given: Peter

sequence: additional

family: Jovanovic

full_name: Lois Jovanovic

given: Lois

family: McCance

full_name: David R. McCance

given: David R.

family: Thyregod

full_name: Camilla Thyregod

given: Camilla

family: Jensen

full_name: Anders Boisen Jensen

given: Anders Boisen

family: Hod

full_name: Moshe Hod

given: Moshe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes/Metabolism Research and Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brøndsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. Epub 2012 Jul 30.

ReferenceCitation: Hod M, Mathiesen ER, Jovanovič L, McCance DR, Ivanisevic M, Durán-Garcia S, Brøndsted L, Nazeri A, Damm P. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med. 2014 Jan;27(1):7-13. doi: 10.3109/14767058.2013.799650. Epub 2013 Jun 5.

family: Jovanovič

full_name: Lois Jovanovič

family: Ivanisevic

full_name: Marina Ivanisevic

given: Marina

family: Durán-Garcia

full_name: Santiago Durán-Garcia

given: Santiago

family: Brøndsted

full_name: Lise Brøndsted

given: Lise

family: Nazeri

full_name: Avideh Nazeri

given: Avideh

journal_name: The Journal of Maternal-Fetal & Neonatal Medicine

oa_host_type: repository

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
PubMed Central
Pure (Denmark)

publisher: Informa UK Limited

location_country:
Austria
Brazil
South Africa
Finland
Croatia
France
Poland
Israel
Norway
Ireland
Argentina
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom

title: A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Women With Type 1 Diabetes

summary: This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).


ReferenceType: derived

ReferenceCitation: Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.

name: University of California at San Francisco, USA.

family: Goodin

full_name: Douglas S Goodin

given: Douglas S

name: Heinrich-Heine Universität, Düsseldorf, Germany.

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

name: St. Michael’s Hospital, Toronto, Canada.

family: O’Connor

full_name: Paul O’Connor

given: Paul

name: Neuroimaging Research Unit, Scientific Institute and University, Ospedale San Raffaele, Milan, Italy.

family: Filippi

full_name: Massimo Filippi

given: Massimo

name: Surgery Brain Research Institutes, Chicago, USA.

family: Arnason

full_name: Barry Arnason

given: Barry

name: Department of Neurology and Clinical Neurophysiology, Vita-Salute University, Milan, Italy.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

name: UMD New Jersey Medical School, Newark, USA.

family: Cook

full_name: Stuart Cook

given: Stuart

family: Jeffery

full_name: Douglas Jeffery

given: Douglas

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Bayer HealthCare Pharmaceuticals, Montville, USA.

family: Bogumil

full_name: Timon Bogumil

given: Timon

family: Knappertz

full_name: Volker Knappertz

given: Volker

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

family: Beckmann

full_name: Karola Beckmann

given: Karola

name: University of British Columbia, Vancouver, Canada.

family: White

full_name: Rick White

given: Rick

family: Petkau

full_name: John Petkau

given: John

family: Pohl

full_name: Christoph Pohl

given: Christoph

journal_name: Multiple Sclerosis Journal

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

design_allocation: Non-Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Bayer

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Ukraine
France
Poland
Norway
Argentina
Canada
Slovenia
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
Italy
Austria
Brazil
Israel
Spain
Latvia

acronym: Beyond

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg

summary: The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

summary: This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naïve patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. Epub 2006 May 30.

ReferenceCitation: Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. Epub 2006 Jan 30.

ReferenceCitation: S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006

ReferenceCitation: Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006

ReferenceCitation: Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45.

ReferenceCitation: Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-2/3 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.

family: Nelson

full_name: David R. Nelson

given: David R.

family: Benhamou

full_name: Yves Benhamou

given: Yves

family: Chuang

full_name: Wan–Long Chuang

given: Wan–Long

family: Lawitz

full_name: Eric J. Lawitz

given: Eric J.

family: Rodriguez–Torres

full_name: Maribel Rodriguez–Torres

given: Maribel

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: Rasenack

full_name: Jens W.F. Rasenack

given: Jens W.F.

family: Kryczka

full_name: Wiesław Kryczka

given: Wiesław

family: Lee

full_name: Chuan–Mo Lee

given: Chuan–Mo

family: Bain

full_name: Vincent G. Bain

given: Vincent G.

family: Pianko

full_name: Stephen Pianko

given: Stephen

family: Patel

full_name: Keyur Patel

given: Keyur

family: Cronin

full_name: Patrick W. Cronin

given: Patrick W.

family: Pulkstenis

full_name: Erik Pulkstenis

given: Erik

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: McHutchison

full_name: John G. McHutchison

given: John G.

journal_name: Gastroenterology

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Albinterferon Alfa-2b Was Not Inferior to Pegylated Interferon-α in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 2 or 3

lead_sponsor: Human Genome Sciences Inc.

location_country:
Malaysia
Belgium
Australia
Taiwan
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Singapore
Puerto Rico
Germany
United States
United Kingdom
Brazil
Mexico
Israel
Spain

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Maulana Azad Medical College and Associated Lok Nayak Hospital

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Seoul National University Hospital(Bundang)

location_facility: Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Complejo Hospitalario Nuestra Señora de Valme

location_facility: St George Hospital Clinical School of Medicine

location_facility: Universidade Federal de São Paulo - UNIFESP

location_facility: NY Presbyterian Medical Center - Columbia Univ. Med Center

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Instituto Nac. de Cs Médicas y Nutrición "Salvador Zubirán"

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: P. D. Hinduja National Hospital and Medical Research Centre

location_facility: Gallipoli Research Foundation and Greenslopes Private Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Jaslok Hospital and Research Centre and Breach Candy Hospital,

location_facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

location_facility: University of Manitoba Health Sciences Centre


title: Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1

summary: This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.

ReferenceCitation: Zeuzem S, Sulkowski MS, Lawitz EJ, Rustgi VK, Rodriguez-Torres M, Bacon BR, Grigorescu M, Tice AD, Lurie Y, Cianciara J, Muir AJ, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-1 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 1. Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Sulkowski

full_name: Mark S. Sulkowski

given: Mark S.

family: Rustgi

full_name: Vinod K. Rustgi

given: Vinod K.

family: Bacon

full_name: Bruce R. Bacon

given: Bruce R.

family: Grigorescu

full_name: Mircea Grigorescu

given: Mircea

family: Tice

full_name: Alan D. Tice

given: Alan D.

family: Lurie

full_name: Yoav Lurie

given: Yoav

family: Cianciara

full_name: Janusz Cianciara

given: Janusz

family: Muir

full_name: Andrew J. Muir

given: Andrew J.

title: Albinterferon Alfa-2b Was Not Inferior to Pegylated Interferon-α in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 1

location_country:
Italy
Austria
United States
India
United Kingdom
Germany
France
Poland
Israel
Romania
Australia
Puerto Rico
Spain
Canada
Czech Republic

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University of Iowa Hospitals and Clinics

location_facility: Seconda Università di Napoli c/o Secondo Policlinico

location_facility: Imperial College London St Mary's Hospital Campus

location_facility: Wojewódzki Szpital Specjalistyczny im.K. Dłuskiego

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: St George Hospital Clinical School of Medicine University of New South Wales

location_facility: San Diego Digestive Diseases Consultants, Inc

location_facility: Northwest Georgia Gastroenterology Associates

location_facility: I.R.C.C.S. Policlinico S. Matteo Università degli Studi di Pavia

location_facility: Nottingham University Hospitals NHS Trust Queens Medical Centre Campus

location_facility: Azienda Ospedaliera S. Giovanni Battista Molinette

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: IRCCS Ospedale Maggiore, Fondazione Policlinico Mangiagalli e Regina Elena, Università di Milano

location_facility: University of Colorado Health Sciences Ctr

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

location_facility: Virginia Commonwealth University Medical Ctr

location_facility: University of California at San Francisco

location_facility: Tulane University Health Sciences Center


title: A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)

acronym: Darusentan

summary: This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.

ReferenceCitation: Bakris GL, Lindholm LH, Black HR, Krum H, Linas S, Linseman JV, Arterburn S, Sager P, Weber M. Divergent results using clinic and ambulatory blood pressures: report of a darusentan-resistant hypertension trial. Hypertension. 2010 Nov;56(5):824-30. doi: 10.1161/HYPERTENSIONAHA.110.156976. Epub 2010 Oct 4.

name: From the University of Chicago (G.L.B.), Department of Medicine, Hypertensive Disease Unit, Chicago, Ill; Umea University Hospital (L.H.L.), Umea University, Department of Medicine, Umea, Sweden; New York University (H.R.B.), Department of Medicine, New York, NY; Monash University (H.K.), Department of Medicine, Melbourne, Victoria, Australia; Denver Health Medical Center (S.L.), Department of Medicine, Nephrology Division, Denver, Colo; Gilead Sciences, Inc (J.V.L., S.A., P.S.), Foster City, Calif;...

family: Bakris

full_name: George L. Bakris

given: George L.

family: Lindholm

full_name: Lars H. Lindholm

given: Lars H.

family: Black

full_name: Henry R. Black

given: Henry R.

family: Krum

full_name: Henry Krum

given: Henry

family: Linas

full_name: Stuart Linas

given: Stuart

family: Linseman

full_name: Jennifer V. Linseman

given: Jennifer V.

family: Arterburn

full_name: Sarah Arterburn

given: Sarah

family: Sager

full_name: Philip Sager

given: Philip

family: Weber

full_name: Michael Weber

given: Michael

journal_name: Hypertension

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Divergent Results Using Clinic and Ambulatory Blood Pressures

lead_sponsor: Gilead Sciences

location_country:
Brazil
Spain
Germany
France
Belgium
Argentina
Australia
New Zealand
Denmark
United States

location_facility: Diabaid (Instituto de Asistencia Integral en Diabetes)

location_facility: HealthFirst Physician of AR, PA dba Convenient Care Clinic

location_facility: Private Practice of Dr. Jean Boulet-Gercourt

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: Private Practice of Dr. Francis Vrancken

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Methodist Medical Center-Heart, Lung & Vascular Institute

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Castlerock Clinical Research Counsultants, LLC

location_facility: Central Minnesota Heart Center at St. Cloud Hospital

location_facility: Southeast Texas Clinical Research Center

location_facility: Charite Campus Mitte, Universitatsmedizin Berlin

location_facility: Private Practice for Internal Medicine & Cardiology

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Hospital General de Agudos "Dr. Abel Zubizarreta"

location_facility: Ormond Medical Arts Pharmaceutical Research center

location_facility: Private Practice of Dr. Gildas Ganuchaud

location_facility: Northwest Florida Heart Group, PA - Research Dept

location_facility: Private Practice of Dr. Herwig Van Aerde

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Executive Health and Research Associates

location_facility: Internal Medicine Associates of South Florida

location_facility: Private Practice of Dr. Bridget Bellingar

location_facility: Centre for Clinical Research and Effective Practice (CCRep)

location_facility: Fletcher Allen Health Care/University of Vermont

location_facility: Region Sjaelland, Storstrommens Sygenhus, Naestved

location_facility: IFG-Institut fur Gesundheitsforderung GmbH

location_facility: Private Practice of Dr. Josef Junggeburth

location_facility: Private Practice of Dr. Isabelle Schenkenberger

location_facility: Private Practice of Dr. Geert Hollanders

location_facility: Instituto de Investigaciones Clinicas de Quilmes


title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine) (CGX-635) in the Treatment of Patients With Chronic Myeloid Leukemia. (CML) With the T315I BCR-ABL Gene Mutation

summary: To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

study_start_date_type: Actual

ReferenceCitation: Cortes J, Lipton JH, Rea D, Digumarti R, Chuah C, Nanda N, Benichou AC, Craig AR, Michallet M, Nicolini FE, Kantarjian H; Omacetaxine 202 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation. Blood. 2012 Sep 27;120(13):2573-80. Epub 2012 Aug 15.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
United States
India
France
Poland
Singapore
Hungary
Germany
United Kingdom
Canada

location_facility:
Teva Investigational Site 004
Teva Investigational Site 028
Teva Investigational Site 002
Teva Investigational Site 007
Teva Investigational Site 009
Teva Investigational Site 031
Teva Investigational Site 005
Teva Investigational Site 029
Teva Investigational Site 008
Teva Investigational Site 024
Teva Investigational Site 025
Teva Investigational Site 060
Teva Investigational Site 006
Teva Investigational Site 003
Teva Investigational Site 030
Teva Investigational Site 013
Teva Investigational Site 040
Teva Investigational Site 011
Teva Investigational Site 026
Teva Investigational Site 071
Teva Investigational Site 061
Teva Investigational Site 010
Teva Investigational Site 050
Teva Investigational Site 023
Teva Investigational Site 001
Teva Investigational Site 027
Teva Investigational Site 080
Teva Investigational Site 070
Teva Investigational Site 022
Teva Investigational Site 090
Teva Investigational Site 020
Teva Investigational Site 021


title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

summary: To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

status: Terminated

study_completion_date_type: Anticipated

lead_sponsor: Pharmexa A/S

location_country:
Italy
Sweden
Netherlands
France
Poland
Norway
Ireland
Belgium
Australia
Spain
Denmark
United States

location_facility: Ghent University Hospital, Digestive Oncology

location_facility: Oncology Research Team, Mater Private University Hospital

location_facility: The Townsville Hospital, Townsville Cancer Centre

location_facility: Cancer Clinical Trials Unit, Beaumont Hospital

location_facility: Toledo Community Hospital Oncology Program

location_facility: Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas

location_facility: Royal Hobart Hospital, Centre for Clinical Research

location_facility: Oncology Trials Unit, Cork University Hospital

location_facility: Odense Universitetshospital, Onkologisk afd. R

location_facility: Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita

location_facility: Tampa General Hospital Usf Digestive Disorders Centre

location_facility: Oncologie Médicale, Centre Cathrine de Siennes

location_facility: Oncology Department, Clinic Universitary Hospital

location_facility: Ullevål Universitetssykehus, Gastrokirurgisk afd.

location_facility: Cancer Research Unit, Mater Misericordlae University Hospital

location_facility: Service de Medicine Interne, CHRU de Lille

location_facility: Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii

location_facility: Westmead Hospital, Dept. of Medical Oncology and Palliative Care

location_facility: Hospital Universitario Gregorio Marañón, Departamento de Oncología

location_facility: Service de Cancerologie, Hospital Europeen Georges Pompidou

location_facility: St George Hospital, Department of Medical Oncology

location_facility: Policlinico Universitario "Mater Domini", Unita Oncologia

location_facility: Centrum Onkologii, Wosewodzki Osrodek Onkologii

location_facility: Medical Oncology Dpt, Armoricaine Private Hospital of Radiology

location_facility: Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology

location_facility: Royal Perth Hospital, Department of Medical Oncology

location_facility: Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma

location_facility: Medical Oncology Department, General Hospital of Baza

location_facility: Karolinska Institute / Hospital Solna, Department of Oncology

location_facility: Azienda Ospedaliera, Arcispedale S. Maria Nuova

location_facility: Hepatogastroenterology Dpt, University Hospital Center of Grenoble

location_facility: Fremantle Hospital, Haemtology Department

location_facility: Sorlandet Hospital, Senter for Kreftbehandling

location_facility: Department of Oncology, Malmö University Hospital

location_facility: Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych

location_facility: Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii

location_facility: Department of Oncology, University Hospital of Northern-Norway

location_facility: Fundaciόn Hospital de Alcorcόn, Unidad de Oncología

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale

location_facility: Hospital Clinic I Provincial De Barcelona

location_facility: Hematology Oncology Specialists, Covington

location_facility: Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Medical Oncology Department, Virgen de Las Nieves Hospital

location_facility: The Alfred Hospital, Medical Oncology Unit

location_facility: Digestive Unit, Universitary Hospital Virgen de La Macarena

location_facility: Flinders Medical Centre, Medical Oncology - Clinical Trials

location_facility: Department of Oncology, Karolinska Universitetssjukhuset

location_facility: University Hospital, Department Of surgery and Gasterenterology

location_facility: Mary Crowley Medical Research Center, Worth St.

location_facility: Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University

location_facility: Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital

location_facility: Sahlgrenska Hospital, Head Division for Upper GI Surgery

location_facility: Hospital Universitario La Paz, Departamento de Oncología

location_facility: Carolinas Hematology Oncology Associates

location_facility: Clínica Puerta de Hierro, Departamento de Oncología

location_facility: University of South Alabama Mitchell Cancer Institute

status_simplified: Unknown


title: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

acronym: ONYX

summary:
To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

ReferenceCitation: McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.

family: McIntyre

full_name: Roger S. McIntyre

given: Roger S.

family: Gorwood

full_name: Philip Gorwood

family: Thase

full_name: Michael E. Thase

given: Michael E.

family: Liss

full_name: Charlie Liss

given: Charlie

family: Desai

full_name: Dhaval Desai

given: Dhaval

family: Chen

full_name: Ji Chen

given: Ji

family: Bauer

full_name: Michael Bauer

journal_name: Journal of Clinical Psychopharmacology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.

family: Weisler

full_name: Richard Weisler

given: Richard

family: Montgomery

full_name: Stuart A. Montgomery

given: Stuart A.

family: Earley

full_name: Willie R. Earley

given: Willie R.

family: Szamosi

full_name: Johan Szamosi

given: Johan

family: Eriksson

full_name: Hans Eriksson

given: Hans

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

title: Extended Release Quetiapine Fumarate in Patients With Major Depressive Disorder

ReferenceCitation: Weisler R, McIntyre RS, Bauer M. Extended-release quetiapine fumarate in the treatment of patients with major depressive disorder: adjunct therapy. Expert Rev Neurother. 2013 Nov;13(11):1183-200. doi: 10.1586/14737175.2013.846519. Review.

full_name: Roger S McIntyre

given: Roger S

ReferenceCitation: Bauer M, Demyttenaere K, El-Khalili N, Thase ME, Papakostas GI, Szamosi J, Earley WR, Eriksson H. Pooled analysis of adjunct extended-release quetiapine fumarate in patients with major depressive disorder according to ongoing SSRI or SNRI treatment. Int Clin Psychopharmacol. 2014 Jan;29(1):16-25. doi: 10.1097/YIC.0000000000000011.

ReferenceCitation: Clayton AH, Locklear JC, Svedsäter H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.

ReferenceCitation: Bauer M, McIntyre RS, Szamosi J, Eriksson H. Evaluation of adjunct extended-release quetiapine fumarate on sleep disturbance and quality in patients with major depressive disorder and an inadequate response to on-going antidepressant therapy. Int J Neuropsychopharmacol. 2013 Sep;16(8):1755-65. doi: 10.1017/S146114571300031X. Epub 2013 May 14.

name: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany

name: Department of Psychiatry, University Health Network, University of Toronto, Canada

journal_name: International Journal of Neuropsychopharmacology

ReferenceCitation: Vieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14.

ReferenceCitation: Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. Epub 2009 Apr 7.

location_country:
South Africa
Sweden
Germany
Finland
France
Poland
Norway
Romania
Belgium
Australia
Canada
Czech Republic


title: A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

summary: The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

ReferenceCitation: Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, Baccarani M, Deininger MW, Cervantes F, Fujihara S, Ortmann CE, Menssen HD, Kantarjian H, O'Brien SG, Druker BJ; IRIS Investigators. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017 Mar 9;376(10):917-927. doi: 10.1056/NEJMoa1609324.

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

family: Larson

full_name: Richard A. Larson

given: Richard A.

family: Guilhot

full_name: François Guilhot

given: François

family: Radich

full_name: Jerald P. Radich

given: Jerald P.

family: Branford

full_name: Susan Branford

given: Susan

family: Hughes

full_name: Timothy P. Hughes

given: Timothy P.

family: Baccarani

full_name: Michele Baccarani

given: Michele

family: Deininger

full_name: Michael W. Deininger

given: Michael W.

family: Cervantes

full_name: Francisco Cervantes

given: Francisco

family: Fujihara

full_name: Satoko Fujihara

given: Satoko

family: Ortmann

full_name: Christine-Elke Ortmann

given: Christine-Elke

family: Menssen

full_name: Hans D. Menssen

given: Hans D.

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: O’Brien

full_name: Stephen G. O’Brien

given: Stephen G.

family: Druker

full_name: Brian J. Druker

given: Brian J.

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

endpoint_id: fhisxppmrqpajgzqkvft

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

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintás-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25.

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

ReferenceCitation: Larson RA, Druker BJ, Guilhot F, O'Brien SG, Riviere GJ, Krahnke T, Gathmann I, Wang Y; IRIS (International Randomized Interferon vs STI571) Study Group. Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood. 2008 Apr 15;111(8):4022-8. doi: 10.1182/blood-2007-10-116475. Epub 2008 Feb 6.

name: Oregon Health and Science University Cancer Institute, Portland;

name: Clinical Investigational Center Inserm, Centre Hospitalier Universitaire (CHU), Poitiers, France;

name: University of Newcastle, Newcastle, United Kingdom;

name: Novartis Pharma, Rueil-Malmaison, France;

name: Novartis Pharma, Basel, Switzerland; and

name: Novartis Pharmaceuticals, East Hanover, NJ

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Norway
Australia
Belgium
New Zealand
Spain
Denmark
Canada
United Kingdom


title: A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

summary:
This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.

This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.

primary_purpose: Prevention

ReferenceCitation: Crump M, Leppä S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23.

name: Michael Crump, Princess Margaret Cancer Centre, Toronto, Ontario; Kerry J. Savage, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Sirpa Leppä, Helsinki University Hospital Cancer Center, Helsinki, Finland; Luis Fayad, The University of Texas MD Anderson Cancer Center, Houston, TX; Frederick Schnell, Central Georgia Cancer Care, Macon, GA; Robert Rifkin, US Oncology Research Network and Rocky Mountain Cancer Centers, Denver, CO; Lauren Pinter-Brown, University of California at Los...

family: Crump

full_name: Michael Crump

given: Michael

family: Leppä

full_name: Sirpa Leppä

given: Sirpa

family: Fayad

full_name: Luis Fayad

given: Luis

family: Lee

full_name: Je Jung Lee

given: Je Jung

family: Di Rocco

full_name: Alice Di Rocco

given: Alice

family: Ogura

full_name: Michinori Ogura

given: Michinori

family: Hagberg

full_name: Hans Hagberg

given: Hans

family: Schnell

full_name: Frederick Schnell

given: Frederick

family: Rifkin

full_name: Robert Rifkin

given: Robert

family: Mackensen

full_name: Andreas Mackensen

family: Offner

full_name: Fritz Offner

given: Fritz

family: Pinter-Brown

full_name: Lauren Pinter-Brown

given: Lauren

family: Smith

full_name: Sonali Smith

given: Sonali

family: Tobinai

full_name: Kensei Tobinai

given: Kensei

family: Yeh

full_name: Su-Peng Yeh

given: Su-Peng

family: Hsi

full_name: Eric D. Hsi

given: Eric D.

family: Nguyen

full_name: Tuan Nguyen

given: Tuan

family: Shi

full_name: Peipei Shi

given: Peipei

family: Hahka-Kemppinen

full_name: Marjo Hahka-Kemppinen

given: Marjo

family: Thornton

full_name: Don Thornton

given: Don

family: Lin

full_name: Boris Lin

given: Boris

family: Kahl

full_name: Brad Kahl

given: Brad

family: Schmitz

full_name: Norbert Schmitz

given: Norbert

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Finland
Greece
Belgium
Australia
Denmark
Taiwan
India
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Hungary
Puerto Rico
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain

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


title: Phase 3 Multinational, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type

summary: This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.

lead_sponsor: Myrexis Inc.

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


title: Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

summary: To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

ReferenceCitation: Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24.

ReferenceCitation: Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Abreu

full_name: Maria T. Abreu

given: Maria T.

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

family: Vermeire

full_name: Severine Vermeire

given: Severine

family: Mitchev

full_name: Krassimir Mitchev

given: Krassimir

family: Jamoul

full_name: Corinne Jamoul

given: Corinne

family: Fedorak

full_name: Richard N. Fedorak

given: Richard N.

family: Spehlmann

full_name: Martina E. Spehlmann

given: Martina E.

family: Wolf

full_name: Douglas C. Wolf

given: Douglas C.

family: Lee

full_name: Scott Lee

given: Scott

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

journal_name: Clinical Gastroenterology and Hepatology

title: Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease and Secondary Failure to Infliximab

ReferenceCitation: Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.

family: Feagan

full_name: B. G. Feagan

given: B. G.

full_name: W. J. Sandborn

given: W. J.

full_name: D. C. Wolf

given: D. C.

family: Coteur

full_name: G. Coteur

given: G.

family: Purcaru

full_name: O. Purcaru

given: O.

family: Brabant

full_name: Y. Brabant

given: Y.

full_name: P. J. Rutgeerts

given: P. J.

journal_name: Alimentary Pharmacology & Therapeutics

title: Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Norway
Belgium
Spain
Denmark
Canada
United Kingdom


title: Long-term Safety Follow-up of REMICADE (RESULTS)

summary: This is a study evaluating the long-term safety of infliximab (Remicade)

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centocor, Inc.

location_country:
Austria
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Poland
Israel
Norway
Hungary
Argentina
Belgium
Ireland
Spain
Denmark
Canada
United Kingdom


title: Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

summary: The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

ReferenceCitation: Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.

ReferenceCitation: Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.

name: Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain

family: Vieta

full_name: Eduard Vieta

given: Eduard

name: Bristol-Myers Squibb, Wallingford, CT, USA

family: Owen

full_name: Randall Owen

given: Randall

name: Bristol-Myers Squibb, Braine-l’Alleud, Belgium

family: Baudelet

full_name: Christine Baudelet

given: Christine

name: Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA

family: McQuade

full_name: Robert D. McQuade

given: Robert D.

family: Sanchez

full_name: Raymond Sanchez

given: Raymond

family: Marcus

full_name: Ronald N. Marcus

given: Ronald N.

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
South Africa
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Bulgaria
Poland
Hungary
Australia
Russian Federation
Portugal
Estonia
United States
Czech Republic


title: International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

summary: To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

lead_sponsor: Pfizer

location_country:
Greece
Belgium
Australia
Czech Republic
Taiwan
India
France
Poland
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Cyprus
Israel
Spain


title: Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.

summary: The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

ReferenceCitation: van Zanten SV, Wahlqvist P, Talley NJ, Halling K, Vakil N, Lauritsen K, Flook N, Persson T, Bolling-Sternevald E; STARS II Investigators. Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study. Aliment Pharmacol Ther. 2011 Oct;34(7):714-23. doi: 10.1111/j.1365-2036.2011.04789.x. Epub 2011 Aug 17.

family: Veldhuyzen van Zanten

full_name: S. Veldhuyzen van Zanten

given: S.

family: Wahlqvist

full_name: P. Wahlqvist

given: P.

family: Talley

full_name: N. J. Talley

given: N. J.

family: Halling

full_name: K. Halling

given: K.

family: Vakil

full_name: N. Vakil

given: N.

family: Lauritsen

full_name: K. Lauritsen

family: Flook

full_name: N. Flook

family: Persson

full_name: T. Persson

given: T.

family: Bolling-Sternevald

full_name: E. Bolling-Sternevald

given: E.

title: Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole - results from the STARS II study

ReferenceCitation: van Zanten SV, Flook N, Talley NJ, Vakil N, Lauritsen K, Bolling-Sternevald E, Persson T, Björck E, Svedberg LE; STARS II Study Group. One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study. Aliment Pharmacol Ther. 2007 Sep 1;26(5):665-72.

lead_sponsor: AstraZeneca

location_country:
Austria
South Africa
Sweden
Switzerland
Mexico
Germany
Finland
France
Norway
Hungary
Belgium
Canada
United Kingdom


title: A Multicentre, Two-part, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic Treatment of Migraine.

summary: Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the prevention of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the prophylactic treatment of migraine headache.

lead_sponsor: GlaxoSmithKline

location_country: Italy Netherlands Finland France Norway Belgium Spain Denmark Germany

intervention_type: Other


title: A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Breast Cancer.

summary: The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.

ReferenceCitation: Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103.

ReferenceCitation: Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13.

family: Fujiwara

full_name: Yasuhiro Fujiwara

given: Yasuhiro

family: Takatsuka

full_name: Yuichi Takatsuka

given: Yuichi

family: Imoto

full_name: Shigeru Imoto

given: Shigeru

family: Inaji

full_name: Hideo Inaji

given: Hideo

family: Ikeda

full_name: Tadashi Ikeda

given: Tadashi

family: Akiyama

full_name: Futoshi Akiyama

given: Futoshi

family: Tamura

full_name: Motoshi Tamura

given: Motoshi

family: Miyoshi

full_name: Kazuya Miyoshi

given: Kazuya

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

family: Mitsuyama

full_name: Shoshu Mitsuyama

given: Shoshu

family: Noguchi

full_name: Shinzaburo Noguchi

given: Shinzaburo

journal_name: Cancer Science

location_country:
Italy
Brazil
United States
Netherlands
France
Japan
Hungary
Belgium
Canada
Czech Republic


title: CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness

summary: The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.

lead_sponsor: Janssen-Cilag International NV

location_country:
Greece
Romania
Denmark
Czech Republic
Croatia
France
Lithuania
Poland
Slovakia
Slovenia
Turkey
Sweden
Saudi Arabia
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Austria
Israel
Spain
Estonia
Latvia


title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

summary: The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

ReferenceCitation: Krämer BK, Albano L, Banas B, Charpentier B, Bäckman L, Tedesco-Silva H Jr, Lehner F, Mondragón-Ramírez GA, Glyda M, Cassuto-Viguier E, Viklický O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

family: Krämer

full_name: B.K. Krämer

family: Albano

full_name: L. Albano

given: L.

family: Banas

full_name: B. Banas

given: B.

family: Charpentier

full_name: B. Charpentier

family: Bäckman

full_name: L. Bäckman

family: Tedesco-Silva

full_name: H. Tedesco-Silva

given: H.

suffix: Jr.

family: Lehner

full_name: F. Lehner

given: F.

family: Mondragón-Ramírez

full_name: G.A. Mondragón-Ramírez

family: Glyda

full_name: M. Glyda

given: M.

family: Cassuto-Viguier

full_name: E. Cassuto-Viguier

family: Viklický

full_name: O. Viklický

given: O.

family: Mourad

full_name: G. Mourad

given: G.

family: Rigotti

full_name: P. Rigotti

given: P.

family: Schleibner

full_name: S. Schleibner

given: S.

family: Kamar

full_name: N. Kamar

journal_name: Transplantation Proceedings

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

version: submittedVersion

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
Greece
Australia
Belgium
Czech Republic
France
Poland
Norway
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Spain


title: Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.

ReferenceCitation: Musat E, Roelofs E, Bar-Deroma R, Fenton P, Gulyban A, Collette L, Stupp R, Weber DC, Bernard Davis J, Aird E, Baumert BG. Dummy run and conformity indices in the ongoing EORTC low-grade glioma trial 22033-26033: First evaluation of quality of radiotherapy planning. Radiother Oncol. 2010 May;95(2):218-24. doi: 10.1016/j.radonc.2010.03.005. Epub 2010 Apr 6.

ReferenceCitation: Fairchild A, Weber DC, Bar-Deroma R, Gulyban A, Fenton PA, Stupp R, Baumert BG. Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review. Radiother Oncol. 2012 Jun;103(3):287-92. doi: 10.1016/j.radonc.2012.04.002. Epub 2012 May 3.

ReferenceCitation: Gao Y, Weenink B, van den Bent MJ, Erdem-Eraslan L, Kros JM, Sillevis Smitt P, Hoang-Xuan K, Brandes AA, Vos M, Dhermain F, Enting R, Ryan GF, Chinot O, Ben Hassel M, van Linde ME, Mason WP, Gijtenbeek JMM, Balana C, von Deimling A, Gorlia T, Stupp R, Hegi ME, Baumert BG, French PJ. Expression-based intrinsic glioma subtypes are prognostic in low-grade gliomas of the EORTC22033-26033 clinical trial. Eur J Cancer. 2018 May;94:168-178. doi: 10.1016/j.ejca.2018.02.023. Epub 2018 Mar 20.

family: Gao

full_name: Y. Gao

given: Y.

family: Weenink

full_name: B. Weenink

family: van den Bent

full_name: M.J. van den Bent

family: Erdem-Eraslan

full_name: L. Erdem-Eraslan

family: Kros

full_name: J.M. Kros

family: Sillevis Smitt

full_name: PAE Sillevis Smitt

given: PAE

family: Hoang-Xuan

full_name: K. Hoang-Xuan

given: K.

family: Brandes

full_name: A.A. Brandes

family: Vos

full_name: M. Vos

family: Dhermain

full_name: F. Dhermain

family: Enting

full_name: R. Enting

given: R.

family: Ryan

full_name: G.F. Ryan

family: Chinot

full_name: O. Chinot

family: Ben Hassel

full_name: M. Ben Hassel

family: van Linde

full_name: M.E. van Linde

family: Mason

full_name: W.P. Mason

family: Gijtenbeek

full_name: J.M.M. Gijtenbeek

family: Balana

full_name: C. Balana

given: C.

family: von Deimling

full_name: A. von Deimling

given: A.

family: Gorlia

full_name: Th Gorlia

given: Th

family: Stupp

full_name: R. Stupp

family: Hegi

full_name: M.E. Hegi

family: Baumert

full_name: B.G. Baumert

family: French

full_name: P.J. French

ReferenceCitation: Baumert BG, Hegi ME, van den Bent MJ, von Deimling A, Gorlia T, Hoang-Xuan K, Brandes AA, Kantor G, Taphoorn MJB, Hassel MB, Hartmann C, Ryan G, Capper D, Kros JM, Kurscheid S, Wick W, Enting R, Reni M, Thiessen B, Dhermain F, Bromberg JE, Feuvret L, Reijneveld JC, Chinot O, Gijtenbeek JMM, Rossiter JP, Dif N, Balana C, Bravo-Marques J, Clement PM, Marosi C, Tzuk-Shina T, Nordal RA, Rees J, Lacombe D, Mason WP, Stupp R. Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1521-1532. doi: 10.1016/S1470-2045(16)30313-8. Epub 2016 Sep 27.

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Reijneveld JC, Taphoorn MJB, Coens C, Bromberg JEC, Mason WP, Hoang-Xuan K, Ryan G, Hassel MB, Enting RH, Brandes AA, Wick A, Chinot O, Reni M, Kantor G, Thiessen B, Klein M, Verger E, Borchers C, Hau P, Back M, Smits A, Golfinopoulos V, Gorlia T, Bottomley A, Stupp R, Baumert BG. Health-related quality of life in patients with high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1533-1542. doi: 10.1016/S1470-2045(16)30305-9. Epub 2016 Sep 27.

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

location_country:
Italy
Austria
Luxembourg
Sweden
Switzerland
Netherlands
Spain
Germany
France
Israel
Singapore
Hungary
Australia
Belgium
Egypt
New Zealand
Canada
United Kingdom
Portugal

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Sir Charles Gairdner Hospital - Nedlands

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Edmond Odette Cancer Centre at Sunnybrook

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Hospital Clinico Universitario de Barcelona

location_facility: Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

location_facility: ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli

location_facility: Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

location_facility: Radboud University Medical Center Nijmegen

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne


title: A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

summary: To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.

location_country:
Italy
Sweden
Netherlands
France
Greece
Ireland
Belgium
Australia
Spain
Denmark
Germany
United Kingdom


title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

summary: The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

ReferenceCitation: Schiff M, Pritchard C, Huffstutter JE, Rodriguez-Valverde V, Durez P, Zhou X, Li T, Bahrt K, Kelly S, Le Bars M, Genovese MC. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. doi: 10.1136/ard.2008.099218. Epub 2008 Dec 15.

ReferenceCitation: Alten R, Burkhardt H, Feist E, Krüger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.

family: Alten

full_name: Rieke Alten

given: Rieke

family: Burkhardt

full_name: Harald Burkhardt

given: Harald

family: Feist

full_name: Eugen Feist

given: Eugen

family: Krüger

full_name: Klaus Krüger

given: Klaus

family: Rech

full_name: Juergen Rech

given: Juergen

family: Rubbert-Roth

full_name: Andrea Rubbert-Roth

given: Andrea

family: Voll

full_name: Reinhard E. Voll

given: Reinhard E.

family: Elbez

full_name: Yedid Elbez

given: Yedid

family: Rauch

full_name: Christiane Rauch

given: Christiane

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

family: Vieira

full_name: Maria-Cecilia Vieira

given: Maria-Cecilia

family: Zwillich

full_name: Samuel H. Zwillich

given: Samuel H.

family: Jansen

full_name: Jeroen P. Jansen

given: Jeroen P.

family: Smiechowski

full_name: Brielan Smiechowski

given: Brielan

family: Spurden

full_name: Dean Spurden

given: Dean

family: Wallenstein

full_name: Gene V. Wallenstein

ReferenceCitation: Hassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. doi: 10.1185/030079908X297376 . Epub 2008 Apr 9.

name:
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
New Brunswick, NJUSA

name:
Health Care and Outcomes Research, University of Toronto
Toronto, OntarioCanada

ReferenceCitation: Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis. 2008 Apr;67(4):547-54. Epub 2007 Oct 5.

location_country:
Italy
United States
United Kingdom
Mexico
France
Ireland
Belgium
Spain
Germany
Czech Republic


title: A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.

summary:
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions:

Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)

Group A - Imatinib failure only (arms 2, 3 and 4)

imatinib-resistant or intolerant CML - Chronic Phase (CP)
imatinib-resistant or intolerant CML - Accelerated Phase (AP)
imatinib-resistant or intolerant CML - Blast Crisis (BC)

Group B - Imatinib and other TKI failure (arms 2, 3 and 4)

imatinib-resistant or intolerant CML - Chronic Phase (CP)
imatinib-resistant or intolerant CML - Accelerated Phase (AP)
imatinib-resistant or intolerant CML - Blast Crisis (BC)

Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)

Systemic mastocytosis (Sm) (arm 6)

ReferenceCitation: Hochhaus A, Baccarani M, Giles FJ, le Coutre PD, Müller MC, Reiter A, Santanastasio H, Leung M, Novick S, Kantarjian HM. Nilotinib in patients with systemic mastocytosis: analysis of the phase 2, open-label, single-arm nilotinib registration study. J Cancer Res Clin Oncol. 2015 Nov;141(11):2047-60. doi: 10.1007/s00432-015-1988-0. Epub 2015 May 23.

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

family: Baccarani

full_name: Michele Baccarani

given: Michele

family: Giles

full_name: Francis J. Giles

given: Francis J.

family: le Coutre

full_name: Philipp D. le Coutre

given: Philipp D.

family: Müller

full_name: Martin C. Müller

given: Martin C.

family: Reiter

full_name: Andreas Reiter

family: Santanastasio

full_name: Helene Santanastasio

given: Helene

family: Leung

full_name: Mimi Leung

given: Mimi

family: Novick

full_name: Steven Novick

given: Steven

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

journal_name: Journal of Cancer Research and Clinical Oncology

evidence: open (via page says license)

ReferenceCitation: Hochhaus A, le Coutre PD, Kantarjian HM, Baccarani M, Erben P, Reiter A, McCulloch T, Fan X, Novick S, Giles FJ. Effect of the tyrosine kinase inhibitor nilotinib in patients with hypereosinophilic syndrome/chronic eosinophilic leukemia: analysis of the phase 2, open-label, single-arm A2101 study. J Cancer Res Clin Oncol. 2013 Dec;139(12):1985-93. doi: 10.1007/s00432-013-1529-7. Epub 2013 Sep 22.

family: Erben

full_name: Philipp Erben

given: Philipp

ReferenceCitation: Stein AM, Martinelli G, Hughes TP, Müller MC, Beppu L, Gottardi E, Branford S, Soverini S, Woodman RC, Hochhaus A, Kim DW, Saglio G, Radich JP. Rapid initial decline in BCR-ABL1 is associated with superior responses to second-line nilotinib in patients with chronic-phase chronic myeloid leukemia. BMC Cancer. 2013 Apr 2;13:173. doi: 10.1186/1471-2407-13-173.

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

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

ReferenceCitation: Kantarjian HM, Giles FJ, Bhalla KN, Pinilla-Ibarz J, Larson RA, Gattermann N, Ottmann OG, Hochhaus A, Radich JP, Saglio G, Hughes TP, Martinelli G, Kim DW, Shou Y, Gallagher NJ, Blakesley R, Baccarani M, Cortes J, le Coutre PD. Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results. Blood. 2011 Jan 27;117(4):1141-5. doi: 10.1182/blood-2010-03-277152. Epub 2010 Nov 22.

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

name: CTRC at The UT Health Science Center, The Institute for Drug Development, San Antonio, TX;

name: Medical College of Georgia Cancer Center, Augusta, GA;

name: H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL;

name: Johann Wolfgang Goethe Universität, Frankfurt, Germany;

name: Universitätsklinikum Jena, Jena, Germany;

name: Fred Hutchinson Cancer Research Center, Seattle, WA;

name: SA Pathology, Royal Adelaide Hospital, Adelaide, Australia;

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

name: Novartis Institutes for BioMedical Research, Cambridge, MA;

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ; and

name: Charité, Campus Virchow, Universitätsmedizin Berlin, Berlin, Germany

ReferenceCitation: Kantarjian HM, Giles F, Gattermann N, Bhalla K, Alimena G, Palandri F, Ossenkoppele GJ, Nicolini FE, O'Brien SG, Litzow M, Bhatia R, Cervantes F, Haque A, Shou Y, Resta DJ, Weitzman A, Hochhaus A, le Coutre P. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007 Nov 15;110(10):3540-6. Epub 2007 Aug 22.

ReferenceCitation: Kantarjian H, Giles F, Wunderle L, Bhalla K, O'Brien S, Wassmann B, Tanaka C, Manley P, Rae P, Mietlowski W, Bochinski K, Hochhaus A, Griffin JD, Hoelzer D, Albitar M, Dugan M, Cortes J, Alland L, Ottmann OG. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. N Engl J Med. 2006 Jun 15;354(24):2542-51.

location_country:
Finland
Australia
Belgium
Denmark
Taiwan
France
Poland
Norway
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
United States
Germany
United Kingdom
Italy
Austria
New Zealand
Spain

location_facility: Wake Forest University Baptist Medical Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt

location_facility: Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2)

location_facility: University of Illinois at Chicago Divisionof Hematology/Oncology

location_facility: Roswell Park Cancer Institute Rosewell SC

location_facility: University of Michigan Health System Clinical Trials Office

location_facility: Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie


title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

family: Vieira

full_name: Maria-Cecilia Vieira

given: Gene V.

journal_name: Clinical Therapeutics

title: Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

family: Keystone

full_name: Edward C. Keystone

given: Edward C.

family: Anisfeld

full_name: Andrew Anisfeld

given: Andrew

family: Ogale

full_name: Sarika Ogale

given: Sarika

family: Devenport

full_name: Jenny N. Devenport

given: Jenny N.

family: Curtis

full_name: Jeffrey R. Curtis

given: Jeffrey R.

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

title: Continued Benefit of Tocilizumab Plus Disease-modifying Antirheumatic Drug Therapy in Patients with Rheumatoid Arthritis and Inadequate Clinical Responses by Week 8 of Treatment

ReferenceCitation: Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. Epub 2012 Jun 28.

ReferenceCitation: Karsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6.

family: Karsdal

full_name: Morten A. Karsdal

given: Morten A.

family: Schett

full_name: Georg Schett

given: Georg

family: Emery

full_name: Paul Emery

given: Paul

family: Harari

full_name: Olivier Harari

given: Olivier

family: Byrjalsen

title: IL-6 Receptor Inhibition Positively Modulates Bone Balance in Rheumatoid Arthritis Patients with an Inadequate Response to Anti-Tumor Necrosis Factor Therapy: Biochemical Marker Analysis of Bone Metabolism in the Tocilizumab RADIATE Study (NCT00106522)

ReferenceCitation: Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14. Erratum in: Ann Rheum Dis. 2009 Feb;68(2):296.

location_country:
Italy
United States
Sweden
Switzerland
Mexico
Netherlands
Germany
France
Belgium
Australia
Puerto Rico
Canada
United Kingdom
Iceland


title: A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

acronym: SHARP

summary: The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

ReferenceCitation: Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

family: Llovet

full_name: Josep M. Llovet

given: Josep M.

family: Ricci

full_name: Sergio Ricci

given: Sergio

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: Hilgard

full_name: Philip Hilgard

given: Philip

family: Gane

full_name: Edward Gane

given: Edward

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: de Oliveira

full_name: Andre Cosme de Oliveira

given: Andre Cosme

family: Santoro

full_name: Armando Santoro

given: Armando

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Forner

full_name: Alejandro Forner

given: Alejandro

family: Schwartz

full_name: Myron Schwartz

given: Myron

family: Porta

full_name: Camillo Porta

given: Camillo

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Bolondi

full_name: Luigi Bolondi

given: Luigi

family: Greten

full_name: Tim F. Greten

given: Tim F.

family: Galle

full_name: Peter R. Galle

given: Peter R.

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Borbath

full_name: Ivan Borbath

given: Ivan

family: Häussinger

full_name: Dieter Häussinger

given: Dieter

family: Giannaris

full_name: Tom Giannaris

given: Tom

family: Shan

full_name: Minghua Shan

given: Minghua

family: Moscovici

full_name: Marius Moscovici

given: Marius

family: Voliotis

full_name: Dimitris Voliotis

given: Dimitris

title: Sorafenib in Advanced Hepatocellular Carcinoma

ReferenceCitation: Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4. Erratum in: J Hepatol. 2018 Oct;69(4):990-991.

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Croatia
France
Poland
Argentina
Canada
Chile
Switzerland
Bulgaria
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Spain


title: Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

ReferenceCitation: Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. Erratum in: Clin Ther. 2006 Nov;28(11):1967.

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Netherlands
France
Norway
Spain
Denmark
United States


title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo

summary: The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.

ReferenceCitation: Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.

family: Houston

full_name: John P. Houston

given: John P.

family: Kohler

full_name: Jared Kohler

given: Jared

family: Bishop

full_name: Jeffrey R. Bishop

given: Jeffrey R.

family: Ellingrod

full_name: Vicki L. Ellingrod

given: Vicki L.

family: Ostbye

full_name: Katherine M. Ostbye

given: Katherine M.

family: Zhao

full_name: Fangyi Zhao

given: Fangyi

family: Conley

full_name: Robert R. Conley

given: Robert R.

family: Hoffmann

full_name: Vicki Poole Hoffmann

given: Vicki Poole

family: Fijal

full_name: Bonnie A. Fijal

given: Bonnie A.

title: Pharmacogenomic Associations With Weight Gain in Olanzapine Treatment of Patients Without Schizophrenia

ReferenceCitation: Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.

full_name: John Houston

given: John

family: Dharia

full_name: Sweta Dharia

given: Sweta

full_name: Bonnie Fijal

given: Bonnie

family: Jacobson

full_name: Jennie G. Jacobson

given: Jennie G.

full_name: Vicki P. Hoffmann

given: Vicki P.

journal_name: Psychiatry Research

ReferenceCitation: Schulz SC, Zanarini MC, Bateman A, Bohus M, Detke HC, Trzaskoma Q, Tanaka Y, Lin D, Deberdt W, Corya S. Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study. Br J Psychiatry. 2008 Dec;193(6):485-92. doi: 10.1192/bjp.bp.107.037903.

family: Schulz

full_name: S. Charles Schulz

given: S. Charles

family: Zanarini

full_name: Mary C. Zanarini

given: Mary C.

family: Bateman

full_name: Anthony Bateman

given: Anthony

location_country:
United States
Sweden
Spain
France
Norway
Belgium
Portugal
Germany
United Kingdom

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