ReferenceCitation: Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.

family: Alten

full_name: Rieke Alten

given: Rieke

family: Bingham

full_name: Clifton O. Bingham

given: Clifton O.

suffix: III

family: Cohen

full_name: Stanley B. Cohen

given: Stanley B.

family: Curtis

full_name: Jeffrey R. Curtis

given: Jeffrey R.

family: Kelly

full_name: Sheila Kelly

given: Sheila

family: Wong

full_name: Dennis Wong

given: Dennis

family: Genovese

full_name: Mark C. Genovese

given: Mark C.

currency_apc_doaj: GBP

journal_name: BMC Musculoskeletal Disorders

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

ReferenceCitation: Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1.

family: Tena

full_name: César Pacheco Tena

given: César Pacheco

family: Covarrubias

full_name: Arturo Covarrubias

given: Arturo

family: Leon

full_name: Gustavo Leon

given: Gustavo

family: Mysler

full_name: Eduardo Mysler

given: Eduardo

family: Keiserman

full_name: Mauro Keiserman

given: Mauro

family: Valente

full_name: Robert Valente

given: Robert

family: Nash

full_name: Peter Nash

given: Peter

family: Simon-Campos

full_name: J. Abraham Simon-Campos

given: J. Abraham

title: Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

ReferenceCitation: Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.

name: Stanford University, Palo Alto, California

name: Centro Medico De Las Americas, Merida, Mexico

name: Instituto De Ginecologia Y Reproduccion, Lima, Peru

name: Organización Médica de Investigación, Buenos Aires, Argentina

name: Pontificial Catholic University School of Medicine, Porto Alegre, Brazil

name: Physician Research Collaboration, Lincoln, Nebraska

name: University of Queensland, Brisbane, Queensland, Australia

name: Centro De Especialidades Médicas/HRAEPY, Merida, Mexico

name: Poznanski Osrodek Medyczny Novamed, Poznań, Poland

name: Box Arthritis and Rheumatology of the Carolinas, Charlotte, North Carolina

name: Low Country Rheumatology, Charleston, South Carolina

name: Institute of Rheumatology, Moscow, Russia

name: Cliniques Universitaires Saint‐Luc and Université Catholique de Louvain, Brussels, Belgium

name: Bristol‐Myers Squibb, Princeton, New Jersey

name: Schlosspark‐Klinik, Teaching Hospital of the Charité University Medicine Berlin, Berlin, Germany

title: Subcutaneous abatacept versus intravenous abatacept: A phase IIIb noninferiority study in patients with an inadequate response to methotrexate

location_country:
Peru
Greece
Belgium
Australia
Russian Federation
Taiwan
India
France
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Turkey

location_facility: Arthritis & Osteoporosis Treatment Center, Pa

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Albuquerque Rehabilitation & Rheumatology Pc

location_facility: Center For Arthritis & Rheumatic Diseases, Pc

location_facility: Arthritis And Rheumatic Disease Specialties

location_facility: South Puget Sound Clinincal Research Center

location_facility: Oklahoma Center For Arthritis Therapy And Research

location_facility: Rheumatic Disease Clinical Research Center, Llc

location_facility: Rheumatology Associates Of Central Florida

location_facility: Allergy & Rheumatology Medical Clinic, Inc.

location_facility: The Arthritis Clinic & Carolina Bone & Joint

location_facility: Valerius Medical Group &Research Ctr. Of Greater Long Beach

location_facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs

location_facility: Boise Rheumatology/ Intermountain Research Center, Inc

location_facility: Asheville Rheumatology & Osteoporosis Research Asso P. A.

location_facility: Arthritis Clinic Of Northern Virginia, P.C.

title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

summary: The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.


title: An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy

summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ciuleanu T, Stelmakh L, Cicenas S, Miliauskas S, Grigorescu AC, Hillenbach C, Johannsdottir HK, Klughammer B, Gonzalez EE. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012 Mar;13(3):300-8. doi: 10.1016/S1470-2045(11)70385-0. Epub 2012 Jan 24.

family: Ciuleanu

full_name: Tudor Ciuleanu

given: Tudor

sequence: first

family: Stelmakh

full_name: Lilia Stelmakh

given: Lilia

sequence: additional

family: Cicenas

full_name: Saulius Cicenas

given: Saulius

family: Miliauskas

full_name: Skaidrius Miliauskas

given: Skaidrius

family: Grigorescu

full_name: Alexandru Calin Grigorescu

given: Alexandru Calin

family: Hillenbach

full_name: Carina Hillenbach

given: Carina

family: Johannsdottir

full_name: Hrefna Kristin Johannsdottir

given: Hrefna Kristin

family: Klughammer

full_name: Barbara Klughammer

given: Barbara

family: Gonzalez

full_name: Emilio Esteban Gonzalez

given: Emilio Esteban

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hoffmann-La Roche

location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Lithuania
Slovakia
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Hungary
China
Germany
United Kingdom
Italy
Austria
Venezuela
New Zealand
Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: result

ReferenceCitation: Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):47-56. doi: 10.1111/epi.12432. Epub 2013 Oct 28.

name: Hospices Civils de Lyon and TIGER CRNL INSERM U1028 CNRS 5292 Lyon France

family: Ryvlin

full_name: Philippe Ryvlin

given: Philippe

family: Werhahn

full_name: Konrad J. Werhahn

given: Konrad J.

family: Blaszczyk

full_name: Barbara Blaszczyk

family: Johnson

full_name: Martin E. Johnson

given: Martin E.

family: Lu

full_name: Sarah Lu

given: Sarah

journal_name: Epilepsia

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: Results from a double‐blind, randomized, placebo‐controlled trial

ReferenceCitation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

name: Vall d'Hebron University Hospital Independent University of Barcelona Barcelona Spain

family: Toledo

full_name: Manuel Toledo

given: Manuel

name: UCB Pharma Raleigh North Carolina U.S.A.

family: Whitesides

full_name: John Whitesides

given: John

family: Schiemann

full_name: Jimmy Schiemann

given: Jimmy

family: Eckhardt

full_name: Klaus Eckhardt

given: Klaus

family: McDonough

full_name: Belinda McDonough

given: Belinda

family: Borghs

full_name: Simon Borghs

given: Simon

name: University of Melbourne and Royal Melbourne Hospital Parkville Victoria Australia

name: Department of Medicine and Therapeutics The Chinese University of Hong Kong Hong Kong China

family: Kwan

full_name: Patrick Kwan

given: Patrick

title: Safety, tolerability, and seizure control during long‐term treatment with adjunctive brivaracetam for partial‐onset seizures

ReferenceCitation: Ben-Menachem E, Mameniškienė R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Mameniškienė

full_name: Rūta Mameniškienė

given: Rūta

family: Quarato

full_name: Pier Paolo Quarato

given: Pier Paolo

family: Klein

full_name: Pavel Klein

given: Pavel

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.

ReferenceCitation: Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

ReferenceCitation: Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

ReferenceCitation: Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained ≥50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

name: Mid-Atlantic Epilepsy and Sleep Center; Bethesda Maryland U.S.A

name: UCB Pharma; Raleigh North Carolina U.S.A

ReferenceCitation: Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum in: Epilepsy Res. 2017 Nov;137:165-166.

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

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

ReferenceCitation: Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

ReferenceCitation: Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

name: Mid‐Atlantic Epilepsy and Sleep Center Bethesda MD USA

title: Time course of 75%–100% efficacy response of adjunctive brivaracetam

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

title: Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht–Lundborg disease: An open-label, long-term follow-up trial

location_country:
Italy
India
Switzerland
Netherlands
Finland
France
Poland
Hungary
Belgium
Spain
Germany
United Kingdom

title: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.

summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


title: A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia

summary: To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

lead_sponsor: Sunovion

location_country:
Austria
Serbia
Poland
Croatia
France
Romania
Hungary
Russian Federation
United Kingdom
Ukraine


title: A Multinational, Prospective, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Sequential Intravenous/Oral Moxifloxacin in Comparison to Intravenous Levofloxacin Plus Intravenous Ceftriaxone Followed by Oral Levofloxacin, in the Treatment of Patients With Severe Community-acquired Pneumonia

summary: Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.

ReferenceCitation: Torres A, Garau J, Arvis P, Carlet J, Choudhri S, Kureishi A, Le Berre MA, Lode H, Winter J, Read RC; MOTIV (MOxifloxacin Treatment IV) Study Group. Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study--a randomized clinical trial. Clin Infect Dis. 2008 May 15;46(10):1499-509. doi: 10.1086/587519.

family: Torres

full_name: Antoni Torres

given: Antoni

family: Garau

full_name: Javier Garau

given: Javier

family: Arvis

full_name: Pierre Arvis

given: Pierre

family: Carlet

full_name: Jean Carlet

given: Jean

family: Choudhri

full_name: Shurjeel Choudhri

given: Shurjeel

family: Kureishi

full_name: Amar Kureishi

given: Amar

family: Le Berre

full_name: Marie‐Aude Le Berre

given: Marie‐Aude

family: Lode

full_name: Hartmut Lode

given: Hartmut

family: Winter

full_name: John Winter

family: Read

full_name: Robert C. Read

given: Robert C.

journal_name: Clinical Infectious Diseases

evidence: open (via free pdf)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Moxifloxacin Monotherapy Is Effective in Hospitalized Patients with Community‐Acquired Pneumonia: The MOTIV Study—A Randomized Clinical Trial

lead_sponsor: Bayer

location_country:
South Africa
Chile
Peru
Sweden
Mexico
Netherlands
Spain
France
Poland
Greece
Israel
Lithuania
Belgium
Argentina
Portugal
Germany
United Kingdom
Colombia


title: A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia

acronym: LUCID

summary: This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.

status: Terminated

ReferenceType: background

ReferenceCitation: Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20.

ReferenceCitation: Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. Epub 2007 Nov 21.

ReferenceCitation: Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55.

ReferenceCitation: Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.

name: The Ohio State University Comprehensive Cancer Center; Columbus OH USA

family: Awan

full_name: Farrukh T. Awan

given: Farrukh T.

name: St James's Institute of Clinical Oncology; Leeds UK

family: Hillmen

full_name: Peter Hillmen

given: Peter

name: Department of Haematology; Medical University of Gdańsk; Gdansk Poland

family: Hellmann

full_name: Andrzej Hellmann

given: Andrzej

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

family: Hughes

full_name: Steven G. Hughes

given: Steven G.

family: Trone

full_name: Denise Trone

given: Denise

family: Shannon

full_name: Megan Shannon

given: Megan

name: The Sarah Cannon Research Institute; Nashville TN USA

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

family: Byrd

full_name: John C. Byrd

given: John C.

journal_name: British Journal of Haematology

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

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

version: submittedVersion

lead_sponsor: Biogen

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
India
France
Poland
Lithuania
Slovakia
Argentina
Canada
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
New Zealand
Spain

status_simplified: Unknown


ReferenceCitation: Patel A, Ravaud A, Motzer RJ, Pantuck AJ, Staehler M, Escudier B, Martini JF, Lechuga M, Lin X, George DJ. Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting. Future Oncol. 2021 Feb;17(4):403-409. doi: 10.2217/fon-2020-0652. Epub 2020 Oct 8.

family: Patel

full_name: Anup Patel

given: Anup

name: Bordeaux University Hospital, 33000 Bordeaux, France

family: Ravaud

full_name: Alain Ravaud

given: Alain

name: Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

family: Motzer

full_name: Robert J Motzer

given: Robert J

name: UCLA David Geffen School of Medicine, Los Angeles, CA 90094, USA

family: Pantuck

full_name: Allan J Pantuck

given: Allan J

name: University Hospital of Munich, 80336 Munich, Germany

family: Staehler

full_name: Michael Staehler

given: Michael

name: Institut Gustave Roussy, 94800 Villejuif, France

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Martini

full_name: Jean-François Martini

given: Jean-François

name: Pfizer S.r.L, Via Anna Maria Mozzoni, 12, 20152 Milan, Italy

family: Lechuga

full_name: Mariajose Lechuga

given: Mariajose

family: Lin

full_name: Xun Lin

given: Xun

name: Duke Cancer Institute, Durham, NC 27710, USA

family: George

full_name: Daniel J George

given: Daniel J

journal_name: Future Oncology

oa_colors: green other

evidence: open (via page says license)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Ouzaid I, Kammerer-Jacquet SF, Khene Z, Ravaud A, Patard JJ, Bensalah K, Rioux-Leclercq N. Exploring Biological Predictive Factors of Progression After Surgery in High-Risk Renal Cell Carcinoma: Results From the French Cohort of the Randomized S-TRAC Trial Patients. Front Surg. 2020 Jun 5;7:26. doi: 10.3389/fsurg.2020.00026. eCollection 2020.

family: Ouzaid

full_name: Idir Ouzaid

given: Idir

family: Kammerer-Jacquet

full_name: Solène Florence Kammerer-Jacquet

given: Solène Florence

family: Khene

full_name: Zineddine Khene

given: Zineddine

family: Patard

full_name: Jean-Jacques Patard

given: Jean-Jacques

family: Bensalah

full_name: Karim Bensalah

given: Karim

family: Rioux-Leclercq

full_name: Nathalie Rioux-Leclercq

given: Nathalie

currency_apc_doaj: USD

journal_name: Frontiers in Surgery

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ReferenceCitation: Staehler M, Motzer RJ, George DJ, Pandha HS, Donskov F, Escudier B, Pantuck AJ, Patel A, DeAnnuntis L, Bhattacharyya H, Ramaswamy K, Zanotti G, Lin X, Lechuga M, Serfass L, Paty J, Ravaud A. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial. Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.

repositories_institution:
Elsevier - Scopus
PubMed Central - Europe PMC

ReferenceCitation: Rini BI, Escudier B, Martini JF, Magheli A, Svedman C, Lopatin M, Knezevic D, Goddard AD, Febbo PG, Li R, Lin X, Valota O, Staehler M, Motzer RJ, Ravaud A. Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib. Clin Cancer Res. 2018 Sep 15;24(18):4407-4415. doi: 10.1158/1078-0432.CCR-18-0323. Epub 2018 May 17.

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

ReferenceCitation: George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Escudier B, Gerletti P, Li S, Casey M, Laguerre B, Pandha HS, Pantuck AJ, Patel A, Lechuga MJ, Ravaud A. Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study. Clin Cancer Res. 2018 Apr 1;24(7):1554-1561. doi: 10.1158/1078-0432.CCR-17-2822. Epub 2018 Jan 26.

ReferenceCitation: Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results. Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.

ReferenceCitation: Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9.

location_country:
Malaysia
Greece
Australia
Denmark
Taiwan
France
Poland
Slovakia
Korea, Republic of
Colombia
Sweden
Switzerland
Ireland
China
Germany
United States
United Kingdom
Italy
Mexico
Czechia
Israel
Spain

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Chinese PLA General Hospital/Urology Department

location_facility: IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro

location_facility: Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services

location_facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

location_facility: Department of Urology, Shanghai Changhai Hospital

location_facility: Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni

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

location_facility: Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny

location_facility: Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck

location_facility: Fakultni nemocnice v Motole, Klinika zobrazovacich metod

location_facility: Fakultni nemocnice v Motole, Ustav nuklearni mediciny

location_facility: The first affiliated hospital of Soochow university/Department of Urology

location_facility: Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

location_facility: Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Fudan University Cancer Hospital, Department of Urology

location_facility: Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow

location_facility: Onkologisches Institut, Inselspital Bern

location_facility: Krajska zdravotni a. s., Masarykova nemocnice v Usti nad Labem, o. z.

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Klinika Onkologii, Wojskowy Instytut Medyczny

location_facility: Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

location_facility: Universitaetsklinikum Ulm, Urologische Universitaetsklinik

location_facility: Institut Claudius Regaud - Centre de Lutte Contre le Cancer

location_facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

location_facility: Eberhardt-Karls-Universität Tübingen, Klinik für Urologie

location_facility: Charite Universitaetsmedizin Berlin, Campus Charite Mitte

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A

location_facility: Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

location_facility: Institut Gustave Roussy / Service d'Immunotherapie

location_facility: Tianjin Oncology Hospital, urology department

location_facility: Department of Internal Medicine, Seoul National University Bundang Hospital

location_facility: Department of Urology,Peking University First Hospital

location_facility: Medical Oncology, Patterson institute for Cancer Research

location_facility: Instituto Nacional de Cancerologia - ESE

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie

location_facility: Urology Department, Sun Yet-Sen University Cancer Center

location_facility: P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica

location_facility: Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie

location_facility: Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona

location_facility: St. Mary's Hospital, Imperial College, Health care NHS Trust

location_facility: Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi

location_facility: Norrlands universitetssjukhus, Urologiska kliniken

location_facility: Post Graduate Medical School, University of Surrey

location_facility: Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie

location_facility: Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau

location_facility: Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II

location_facility: Urology Department, South-Western Hospital, 3rd Military Medical University.

location_facility: The University of North Carolina at Chapel Hill

location_facility: "Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie

title: Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc

summary: To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.


study_start_date_type: Actual

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
Switzerland
Netherlands
Finland
France
Ireland
Spain
Germany
United Kingdom

type: EudraCT Number

source: euctr

title: Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

summary:
This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).


title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.

summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

ReferenceCitation: Locatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drüeke TB; Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta investigators and coordinators. Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study. Curr Med Res Opin. 2010 Nov;26(11):2543-52. doi: 10.1185/03007995.2010.516237. Epub 2010 Sep 17.

name: Dialysis and Renal Transplantation, Ospedale A. Manzoni, Lecco, Italy

family: Locatelli

full_name: Francesco Locatelli

given: Francesco

name: University of Erlangen-Nürnberg, Erlangen, Germany

family: Eckardt

full_name: Kai-Uwe Eckardt

given: Kai-Uwe

family: Macdougall

full_name: Iain C. Macdougall

given: Iain C.

name: General Hospital of Veria, Veria, Greece

family: Tsakiris

full_name: Dimitrios Tsakiris

given: Dimitrios

name: University Hospital of Lund, Lund, Sweden

family: Clyne

full_name: Naomi Clyne

given: Naomi

family: Burger

full_name: Hans-Ulrich Burger

given: Hans-Ulrich

name: Mannheim University Hospital, University of Heidelberg, Heidelberg, 1. Medical Clinic, Germany; and Pharmaceutical Division, F. Hoffmann-La Roche, Basel, Switzerland

family: Scherhag

full_name: Armin Scherhag

given: Armin

name: INSERM Research Unit 507 and Division of Nephrology, Necker Hospital, Paris, France

family: Drüeke

full_name: Tilman B. Drüeke

given: Tilman B.

name: on behalf of the Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta (CREATE) investigators and coordinators

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Drüeke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84.

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Poland
Thailand
Norway
Sweden
Hong Kong
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Mexico
Spain
Turkey


title: A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects

summary: The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

lead_sponsor: Abbott

location_country:
Italy
United States
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Poland
Greece
Singapore
Ireland
Belgium
Australia
Puerto Rico
Russian Federation
Canada
Czech Republic
Taiwan

location_facility:
Site Reference ID/Investigator# 792
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title: Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)

summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

primary_purpose: Prevention

ReferenceCitation: Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.

family: Boxus

full_name: Mathieu Boxus

given: Mathieu

family: Lockman

full_name: Laurence Lockman

given: Laurence

family: Fochesato

full_name: Michel Fochesato

given: Michel

family: Lorin

full_name: Clarisse Lorin

given: Clarisse

family: Thomas

full_name: Florence Thomas

given: Florence

family: Giannini

full_name: Sandra L. Giannini

given: Sandra L.

bso_classification: Biology (fond.)

journal_name: Vaccine

title: Antibody avidity measurements in recipients of Cervarix® vaccine following a two-dose schedule or a three-dose schedule

ReferenceCitation: Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004.

family: Schwarz

full_name: Tino F. Schwarz

given: Tino F.

family: Huang

full_name: Li-Min Huang

given: Li-Min

family: Medina

full_name: Doris Maribel Rivera Medina

given: Doris Maribel Rivera

family: Valencia

full_name: Alejandra Valencia

given: Alejandra

full_name: Tzou-Yien Lin

given: Tzou-Yien

family: Behre

full_name: Ulrich Behre

given: Ulrich

family: Catteau

full_name: Grégory Catteau

given: Grégory

family: Descamps

full_name: Dominique Descamps

given: Dominique

bso_classification: Social sciences

journal_name: Journal of Adolescent Health

oa_host_type: repository

repository_institution: 臺灣機構典藏 - NTUR - NTUR

title: Four-Year Follow-up of the Immunogenicity and Safety of the HPV-16/18 AS04-Adjuvanted Vaccine When Administered to Adolescent Girls Aged 10–14 Years

ReferenceCitation: Medina DM, Valencia A, de Velasquez A, Huang LM, Prymula R, García-Sicilia J, Rombo L, David MP, Descamps D, Hardt K, Dubin G; HPV-013 Study Group. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls. J Adolesc Health. 2010 May;46(5):414-21. doi: 10.1016/j.jadohealth.2010.02.006.

family: Rivera Medina

full_name: Doris M. Rivera Medina

title: Safety and Immunogenicity of the HPV-16/18 AS04-Adjuvanted Vaccine: A Randomized, Controlled Trial in Adolescent Girls

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

location_country:
Sweden
Honduras
France
Panama
Norway
Australia
Spain
Germany
Czech Republic
Korea, Republic of
Taiwan
Colombia


title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).

summary: This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

ReferenceCitation: Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. Review.

ReferenceCitation: Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, López de la Torre M, Liebl A. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):700-8. doi: 10.1111/j.1463-1326.2009.01035.x. Epub 2009 May 19.

family: Cucinotta

full_name: D. Cucinotta

given: D.

family: Smirnova

full_name: O. Smirnova

given: O.

family: Christiansen

full_name: J. S. Christiansen

given: J. S.

family: Kanc

full_name: K. Kanc

given: K.

family: le Devehat

full_name: C. le Devehat

given: C.

family: Wojciechowska

full_name: M. Wojciechowska

given: M.

family: López de la Torre

full_name: M. López de la Torre

family: Liebl

full_name: A. Liebl

given: A.

journal_name: Diabetes, Obesity and Metabolism

location_country:
Italy
Austria
Switzerland
Netherlands
United Kingdom
France
Bulgaria
Poland
Slovenia
Romania
Hungary
Belgium
Russian Federation
Spain
Turkey
Denmark
Germany
Czech Republic


title: A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial

summary: The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

ReferenceCitation: Böttiger BW, Arntz HR, Chamberlain DA, Bluhmki E, Belmans A, Danays T, Carli PA, Adgey JA, Bode C, Wenzel V; TROICA Trial Investigators; European Resuscitation Council Study Group. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62. doi: 10.1056/NEJMoa070570.

family: Böttiger

full_name: Bernd W. Böttiger

given: Bernd W.

family: Arntz

full_name: Hans-Richard Arntz

given: Hans-Richard

family: Chamberlain

full_name: Douglas A. Chamberlain

given: Douglas A.

family: Bluhmki

full_name: Erich Bluhmki

given: Erich

family: Belmans

full_name: Ann Belmans

given: Ann

family: Danays

full_name: Thierry Danays

given: Thierry

family: Carli

full_name: Pierre A. Carli

given: Pierre A.

family: Adgey

full_name: Jennifer A. Adgey

given: Jennifer A.

family: Bode

full_name: Christoph Bode

given: Christoph

family: Wenzel

full_name: Volker Wenzel

given: Volker

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Thrombolysis during Resuscitation for Out-of-Hospital Cardiac Arrest

lead_sponsor: Boehringer Ingelheim

location_country: Italy Austria Sweden Switzerland France Norway Belgium Spain Germany

location_facility: Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg

location_facility: Akuttklinikken / NLA, Sentralsjukehuset i Rogaland

location_facility: Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429

location_facility: Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg

location_facility: Hospital Clínico Provincial de BCN / Cardiology Service

location_facility: Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Complejo Hospitalario Universitario de Vigo / Cardiology

location_facility: Vírgen de las Nieves. Critical Care-Emergency Room

location_facility: Hospital Universitario Reina Sofía / ICU

location_facility: Hospital Clínico Universitario Vírgen de la Victoria / ICU

location_facility: Univ.-Klinik f. Anaesthesie u. Intensivmedizin

location_facility: Hospital Clínico San Carlos / Hemodynamics


title: A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study

summary:
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.

The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.

location_country:
Italy
Spain
France
Malaysia
Slovakia
Russian Federation
Portugal
Denmark
Germany
Czech Republic
Korea, Republic of
Taiwan
Ukraine

location_facility: Associac?o Protectora dos Diabeticos de Portugal

location_facility: Azienda Ospedaliera S. Maria degli Angeli

location_facility: Russian Academy for Advanced Medical Studies

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: National Endocrinology Research Center of Russia

location_facility: Azienda Ospedaliera Policlinico S. Orsola Malpighi

location_facility: V.P. Komisarenko Institute of Endocrinology and Metabolism

location_facility: Keimyung University Dongsan Medical Center

location_facility: Institute of Diabetic pathology problems

location_facility: Regional Clinical Scientific Research Institute


title: An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients

summary: The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

ReferenceCitation: Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96.

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

location_country: Italy Sweden Netherlands France Ireland Belgium Spain Canada


title: A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

summary: This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

ReferenceCitation: Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4.

ReferenceCitation: Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Müller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70. doi: 10.1002/ajh.21615.

family: Lilly

full_name: Michael B. Lilly

given: Michael B.

family: Ottmann

full_name: Oliver G. Ottmann

given: Oliver G.

family: Shah

full_name: Neil P. Shah

given: Neil P.

family: Larson

full_name: Richard A. Larson

given: Richard A.

family: Reiffers

full_name: Josy J. Reiffers

given: Josy J.

family: Ehninger

full_name: Gerhard Ehninger

given: Gerhard

family: Müller

full_name: Martin C. Müller

given: Martin C.

family: Charbonnier

full_name: Aude Charbonnier

given: Aude

family: Bullorsky

full_name: Eduardo Bullorsky

given: Eduardo

family: Dombret

full_name: Herve Dombret

given: Herve

family: Brigid Bradley-Garelik

full_name: Mary Brigid Bradley-Garelik

given: Mary

family: Zhu

full_name: Chao Zhu

given: Chao

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

journal_name: American Journal of Hematology

ReferenceCitation: Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J, Müller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman MS. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009 Jun 18;113(25):6322-9. doi: 10.1182/blood-2008-11-186817. Epub 2009 Apr 15.

name: M. D. Anderson Cancer Center, Houston, TX;

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Kim

full_name: Dong-Wook Kim

given: Dong-Wook

name: Hospital das Clinicas, Sao Paulo, Brazil;

family: Dorlhiac-Llacer

full_name: Pedro Dorlhiac-Llacer

given: Pedro

name: Hospital De Clinicas De Curitiba, Curitiba, Brazil;

family: Pasquini

full_name: Ricardo Pasquini

given: Ricardo

name: Washington University School of Medicine, St Louis, MO;

family: DiPersio

full_name: John DiPersio

given: John

name: Medizinische Fakultaet Mannheim, University of Heidelberg, Heidelberg, Germany;

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

name: Emory University School of Medicine, Atlanta, GA;

name: National Research Hematology Center, Moscow, Russian Federation;

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

name: Northwestern University Feinberg School of Medicine, Chicago, IL

location_country:
Peru
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Philippines
Singapore
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: The University Of North Carolina At Chapel Hill

location_facility: Washington Cancer Institute At Washington Hospital Center

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Washington University School Of Medicine


title: A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

summary: This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

ReferenceCitation: Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86. doi: 10.1002/cncr.24734.

ReferenceCitation: Müller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.

ReferenceCitation: Shah NP, Kantarjian HM, Kim DW, Réa D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.

ReferenceCitation: Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423. Epub 2016 Jun 20.

name: UCSF School of Medicine; San Francisco; California

family: Shah

full_name: Neil P. Shah

given: Neil P.

name: Hôpital André Mignot and Université Versailles Saint-Quentin-en-Yvelines; Versailles France

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

name: Wayne State University School of Medicine; Detroit Michigan

family: Schiffer

full_name: Charles Schiffer

given: Charles

family: Rea

full_name: Delphine Rea

given: Delphine

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

full_name: Jorge E. Cortes

given: Jorge E.

name: Hospital Italiano De La Plata; La Plata Argentina

family: Milone

full_name: Jorge Milone

name: Bristol-Myers Squibb; Princeton New Jersey

family: Mohamed

full_name: Hesham Mohamed

given: Hesham

family: Healey

full_name: Diane Healey

given: Diane

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

family: Saglio

full_name: Giuseppe Saglio

given: Giuseppe

repository_institution: PubMed Central - Europe PMC

repository_institution: California Digital Library - eScholarship

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

ReferenceCitation: Shah NP, Guilhot F, Cortes JE, Schiffer CA, le Coutre P, Brümmendorf TH, Kantarjian HM, Hochhaus A, Rousselot P, Mohamed H, Healey D, Cunningham M, Saglio G. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014 Apr 10;123(15):2317-24. doi: 10.1182/blood-2013-10-532341. Epub 2014 Feb 25.

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

name: INSERM Clinical Investigation Center 1402, Centre Hospitalier et Universitaire de Poitiers, Université de Poitiers, Poitiers, France;

family: Guilhot

full_name: François Guilhot

given: François

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

name: Karmanos Cancer Institute, Wayne State University, Detroit, MI;

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

name: Universitätsklinikum der Rheinisch-Westfälische Technische Hochschule Aachen, Klinik für Hämatologie und Onkologie, Aachen, Germany, and Universitätsklinikum Hamburg-Eppendorf, Klinik für Onkologie und Hämatologie, Hamburg, Germany;

name: Universitätsklinikum Jena, Jena, Germany;

name: Hôpital André Mignot and Université Versailles Saint-Quentin-en-Yvelines, Versailles, France;

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

location_country:
Peru
Finland
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Philippines
Singapore
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: University Of North Carolina At Chapel Hill

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Oncology Hematology Associates Of Central Illinois, Pc


type: Other Identifier

title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

ReferenceCitation: Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015.

family: Larkin

full_name: James Larkin

given: James

family: Hatswell

full_name: Anthony J. Hatswell

given: Anthony J.

family: Nathan

full_name: Paul Nathan

given: Paul

family: Lebmeier

full_name: Maximilian Lebmeier

given: Maximilian

family: Lee

full_name: Dawn Lee

given: Dawn

journal_name: PLOS ONE

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

ReferenceCitation: Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.

family: Koguchi

full_name: Yoshinobu Koguchi

given: Yoshinobu

family: Hoen

full_name: Helena M. Hoen

given: Helena M.

family: Bambina

full_name: Shelly A. Bambina

given: Shelly A.

family: Rynning

full_name: Michael D. Rynning

given: Michael D.

family: Fuerstenberg

full_name: Richard K. Fuerstenberg

given: Richard K.

family: Curti

full_name: Brendan D. Curti

given: Brendan D.

family: Urba

full_name: Walter J. Urba

given: Walter J.

family: Milburn

full_name: Christina Milburn

given: Christina

family: Bahjat

full_name: Frances Rena Bahjat

given: Frances Rena

family: Korman

full_name: Alan J. Korman

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

name: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman,...

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.

ReferenceCitation: Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1.

ReferenceCitation: McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-2698. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13.

ReferenceCitation: Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26.

title: Efficacy and Safety of Retreatment with Ipilimumab in Patients with Pretreated Advanced Melanoma Who Progressed after Initially Achieving Disease Control

ReferenceCitation: Weber JS, Dummer R, de Pril V, Lebbé C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7.

ReferenceCitation: Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Southampton - ePrints Soton

ReferenceCitation: Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbé C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. Erratum in: N Engl J Med. 2010 Sep 23;363(13):1290.

repository_institution: The University of Manchester - Research Explorer

title: Improved Survival with Ipilimumab in Patients with Metastatic Melanoma

location_country:
United States
Brazil
Chile
South Africa
Switzerland
Netherlands
Germany
France
Hungary
Belgium
Argentina
Canada
United Kingdom

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: La Jolla Hematology and Oncology Medical Group

location_facility: Klinikum der Friedrich-Schiller-Universitaet Jena

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Municipal de Oncoligia Maria Curie

location_facility: Indiana Oncology Hematology Consutants of Noblesville

location_facility: Columbia University Medical Center, Irving Center for Clinical Research

location_facility: Santo Andre Diagnosticos e Tratamentos Ltda.

location_facility: Sociedade Beneficante de Sennores - Hospital Sino Libante

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: University of Florida/Jacksonville Faculty Clinic

location_facility: Dermatologische Klinik Universitatsspital Zurich

location_facility: University of Pittsburgh Cancer Institute

location_facility: Hospital de Cancer de Barretos - Fundacao Pio XII

location_facility: Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie

location_facility: Indiana Oncology Hematology Consultants North

location_facility: Biocor - Hosp. de Doencas Cardiovasculares Ltda.

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center

location_facility: Erasme Hospital, Free Universtiy of Brussels

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: Sir Mortimer B. Davis - Jewish General Hospital

location_facility: Yale University School of Medicine - Oncology Outpatient Clinic

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: University of Colorado Health Sciences Center

location_facility: Emory University Hospital-Winship Cancer Institute

location_facility: University of North Carolina at Chapel Hill

location_facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Centre-Hospitalier Universitaire de Saint-Etienne

location_facility: Cancer Centre of Southeastern Ontario at KGH

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Debrecen, Medical and Health Sciences Center

location_facility: Centre Hospitalier Universitaire Vaudois - CHUV

location_facility: Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: St. Mary's Medical Center - Northern California Melanoma Center

location_facility: Hospital General de Agudos Carlos G. Durand

location_facility: Henry Ford Medical Center- West Bloomfield

location_facility: Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias

location_facility: Washington Unv. School of Med./ Siteman Cancer Center

location_facility: Hospital Municipal de Oncologia Maria Curie

location_facility: North County Oncology Medical Clinical, Inc.

location_facility: The Angeles Clinic and Research Institute

location_facility: Center for Oncology Research and Treatment

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Center for Cancer Care at Goshen Health System

location_facility: St. Luke's Cancer Center, The Royal Surrey County Hospital


title: A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy

summary: The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

ReferenceCitation: Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.

name: Centre for Applied Pharmacokinetic Research University of Manchester  UK

name: Division of Pharmacy and Optometry University of Manchester  UK

family: Lombard

full_name: Aurélie Lombard

given: Aurélie

name: Division of Cancer Sciences University of Manchester  UK

family: Mistry

full_name: Hitesh Mistry

given: Hitesh

family: Aarons

full_name: Leon Aarons

given: Leon

family: Ogungbenro

full_name: Kayode Ogungbenro

given: Kayode

journal_name: British Journal of Clinical Pharmacology

title: Dose individualisation in oncology using chemotherapy‐induced neutropenia: Example of docetaxel in non‐small cell lung cancer patients

ReferenceCitation: Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.

name: From the Centre René Gauducheau, Nantes, France; Princess Margaret Hospital, University of Toronto, Toronto, Canada; McGill University Health Centre, Montreal, Canada; State Key Laboratory in Oncology in South China, Sir YK Pao Centre for Cancer, Department of Clinical Oncology, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong; Shanghai Chest Hospital, Shanghai, China; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC; Centre Regional de...

family: Douillard

full_name: Jean-Yves Douillard

given: Jean-Yves

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

family: Hirsh

full_name: Vera Hirsh

given: Vera

family: Mok

full_name: Tony Mok

given: Tony

family: Socinski

full_name: Mark A. Socinski

given: Mark A.

family: Gervais

full_name: Radj Gervais

given: Radj

family: Liao

full_name: Mei-Lin Liao

given: Mei-Lin

family: Bischoff

full_name: Helge Bischoff

given: Helge

family: Reck

full_name: Martin Reck

given: Martin

family: Sellers

full_name: Mark V. Sellers

given: Mark V.

family: Watkins

full_name: Claire L. Watkins

given: Claire L.

family: Speake

full_name: Georgina Speake

given: Georgina

family: Armour

full_name: Alison A. Armour

given: Alison A.

family: Kim

full_name: Edward S. Kim

given: Edward S.

journal_name: Journal of Clinical Oncology

title: Molecular Predictors of Outcome With Gefitinib and Docetaxel in Previously Treated Non–Small-Cell Lung Cancer: Data From the Randomized Phase III INTEREST Trial

ReferenceCitation: Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.

full_name: Edward S Kim

given: Edward S

location_country:
Malaysia
Belgium
Denmark
Croatia
France
Thailand
Argentina
Indonesia
Canada
Slovenia
Turkey
Sweden
Hong Kong
Switzerland
Philippines
Singapore
China
United States
Germany
Italy
Brazil
Mexico
Spain
Estonia
Latvia


title: A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.

location_country:
Italy
Austria
United States
South Africa
Sweden
Netherlands
Germany
France
Poland
Greece
Ireland
Australia
Belgium
New Zealand
Spain
Canada
United Kingdom

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: The University Of North Carolina At Chapel Hill

location_facility: South Orange County Medical Research Center

location_facility: University Of Washington School Of Medicine

location_facility: Klinik Und Poliklinik für Urologie und Kinder

location_facility: Clinica Urologica I - Università di Bari

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Drs. Werner, Murdock, & Francis, Pa Urology Assoc.

location_facility: Istituto Nazionale per la Ricerca sul Cancro -IST

location_facility: Dept of Veteran's Affairs North Texas Healthcare System

location_facility: The Institute Of Cancer Research - Royal Marsden Hospital

location_facility: Clinical Research Centre - St Georges Hospital

location_facility: Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

location_facility: Mississippi Center For Clinical Research, LLC

location_facility: Clinica Urologica - Università Di Milano

location_facility: Klinik fur Urologie der Universitat Wien

location_facility: Albany Medical Center South Clinical Campus

location_facility: Urologische Klinik Und Poliklinik Grosshadern

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: The University Of TX SW Medical Center At Dallas

location_facility: University Of Natal - Nelson R Mandela School of Medicine

location_facility: Hillcrest Urological Medical Group, Inc.


title: PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER

summary:
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925). Acta Oncol. 2010;49(1):24-34. doi: 10.3109/02841860903352959.

family: Matzinger

full_name: Oscar Matzinger

given: Oscar

family: Heimsoth

full_name: Irma Heimsoth

given: Irma

family: Poortmans

full_name: Philip Poortmans

given: Philip

family: Collette

full_name: Laurence Collette

given: Laurence

family: Struikmans

full_name: Henk Struikmans

given: Henk

family: Bogaert

full_name: Walter Van Den Bogaert

given: Walter Van Den

family: Fourquet

full_name: Alain Fourquet

given: Alain

family: Bartelink

full_name: Harry Bartelink

given: Harry

family: Ataman

full_name: Fatma Ataman

given: Fatma

family: Gulyban

full_name: Akos Gulyban

given: Akos

family: Pierart

full_name: Marianne Pierart

given: Marianne

family: Tienhoven

full_name: Geertjan Van Tienhoven

given: Geertjan Van

journal_name: Acta Oncologica

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher: Informa UK Limited

ReferenceCitation: Musat E, Poortmans P, Van den Bogaert W, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer. 2007 Mar;43(4):718-24. Epub 2007 Jan 19.

ReferenceCitation: Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the role of irradiation of the internal mammary and medial supraclavicular lymph node chain works. Strahlenther Onkol. 2006 Oct;182(10):576-82.

ReferenceCitation: Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irradiation in stage I-III breast cancer: the individual case review. Eur J Cancer. 2003 Sep;39(14):2035-42.

ReferenceCitation: Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiotherapy of the internal mammary lymph node chain: a quality-assurance report on the dummy run of EORTC Phase III randomized trial 22922/10925 in Stage I--III breast cancer(1). Int J Radiat Oncol Biol Phys. 2001 Apr 1;49(5):1399-408.

ReferenceCitation: Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.

ReferenceCitation: Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34(suppl 5): A257, s58, 1998.

ReferenceCitation: Poortmans PM, Struikmans H, De Brouwer P, Weltens C, Fortpied C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, vanTienhoven G, Weidner N, Noel G, Guckenberger M, Koiter E, vanLimbergen E, Engelen A, Fourquet A, Bartelink H; EORTC Radiation Oncology and Breast Cancer Groups. Side Effects 15 Years After Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925. J Natl Cancer Inst. 2021 Oct 1;113(10):1360-1368. doi: 10.1093/jnci/djab113.

name: Department of Radiation Oncology, Iridium Netwerk, Wilrijk-Antwerp, Belgium

name: Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk-Antwerp, Belgium

full_name: Philip M Poortmans

given: Philip M

name: Department of Radiation Oncology, Leiden University Medical Centre, Leiden, the Netherlands

name: Department of Radiation Oncology, Institute Verbeeten, Tilburg, the Netherlands

family: De Brouwer

full_name: Peter De Brouwer

given: Peter

name: Department of Radiation Oncology, University Hospital Leuven, KU Leuven Faculty of Medicine, Leuven, Belgium

family: Weltens

full_name: Caroline Weltens

given: Caroline

name: European Organisation for Research and Treatment of Cancer (EORTC), Headquarters, Brussels, Belgium

family: Fortpied

full_name: Catherine Fortpied

given: Catherine

name: Department of Radiation Oncology, University Hospital Saint Luc, Université Catholique de Louvain, Brussels, Belgium

family: Kirkove

full_name: Carine Kirkove

given: Carine

name: Department of Radiation Oncology, Charité–Universitaetsmedizin Berlin, Free University Berlin, Humboldt-University Berlin, Berlin Institute of Health, Berlin, Germany

name: Department of Radiation Oncology, Centre Georges François Leclerc, Dijon, France

name: Department of Radiation Oncology, University Medical Centre Utrecht, Utrecht, the Netherlands

name: Institute for Radiation Oncology RISO, Deventer, the Netherlands

name: Department of Radiation Oncology, Sant Anna Hospital, Como, Italy

name: Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands

name: Department of Radiation Oncology, University Hospital, Tübingen, Germany

name: Department of Radiation Oncology, Centre Paul Strauss, Strasbourg, France

name: Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Zurich, Switzerland

name: Department of Radiation Oncology, Medisch Spectrum Twente, Enschede, the Netherlands

name: Department of Radiation Oncology, Institut Curie, Paris, France

name: Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands

name: for the EORTC Radiation Oncology and Breast Cancer Groups

journal_name: JNCI: Journal of the National Cancer Institute

ReferenceCitation: Poortmans PM, Weltens C, Fortpied C, Kirkove C, Peignaux-Casasnovas K, Budach V, van der Leij F, Vonk E, Weidner N, Rivera S, van Tienhoven G, Fourquet A, Noel G, Valli M, Guckenberger M, Koiter E, Racadot S, Abdah-Bortnyak R, Van Limbergen EF, Engelen A, De Brouwer P, Struikmans H, Bartelink H; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1602-1610. doi: 10.1016/S1470-2045(20)30472-1. Epub 2020 Nov 2. Erratum in: Lancet Oncol. 2021 Jan;22(1):e5.

title: Internal mammary and medial supraclavicular lymph node chain irradiation in stage I–III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial

ReferenceCitation: Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, Collette L, Fourquet A, Maingon P, Valli M, De Winter K, Marnitz S, Barillot I, Scandolaro L, Vonk E, Rodenhuis C, Marsiglia H, Weidner N, van Tienhoven G, Glanzmann C, Kuten A, Arriagada R, Bartelink H, Van den Bogaert W; EORTC Radiation Oncology and Breast Cancer Groups. Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

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

location_country:
Italy
Bosnia and Herzegovina
Chile
Switzerland
Netherlands
Spain
France
Poland
Israel
Belgium
Portugal
Turkey
Germany
United Kingdom

location_facility: Institute of Oncology - Clinical Center University of Sarajevo

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Istituto Nazionale per la Ricerca sul Cancro

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

location_facility: Istanbul University-Institute of Oncology

location_facility: Service Cancerologie Polyclinique Clairval

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

acronym: PADOVA

summary: This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
Austria
Germany
France
Poland
Spain
United States
United Kingdom
Canada

location_facility: Henry Ford Hospital; Henry Ford Medical Center

location_facility: CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

location_facility: Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica

location_facility: Institute for Neurodegenerative Disorders

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Neurology Associates, PA; Research Department

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hôpital Henri Mondor; Centre Expert Parkinson

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Indiana University Health University Hospital

location_facility: Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease

location_facility: IRCCS Ospedale San Raffaele; U.O. di Neurologia

location_facility: Rocky Mountain Movement Disorders Center

location_facility: IRCCS San Raffaele Pisana; Clinical Trial Center

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Policlinico Universitario Agostino Gemelli; UOC Neurologia

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

location_facility: Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital Universitario Fundación Alcorcón; Servicio de Neurología

location_facility: Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1

location_facility: Ninewells Hospital, Dundee- Scotland; Neurology

location_facility: Baylor College of Medicine Medical Center

location_facility: BAG Prof Dr G Hoheisel Dr A Bonitz; Praxis fur Pneumologie und Allergologie

location_facility: Aventura Neurologic Associates; Department of Research

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Hospital General Universitario de Ciudad Real; Servicio de Neurologia

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Southern Illinois University, School of Medicine

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

status_simplified: Ongoing


title: A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)

summary: The purpose of the study is the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This is the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

primary_purpose: Other

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

location_country: Italy Austria Netherlands France Czechia Poland Slovakia Hungary Spain Denmark

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

location_facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

location_facility: Instituto Nazionale Neurologico "Carlo Besta"

location_facility: M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

location_facility: Instytut Psychiatrii i Neurologii - Dept of Neurology II

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Policlinico Università della Campania L. Vanvitelli

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog

location_facility: Centre hospitalier de la Côte Basque - Saint Léon

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: Ospedale Sant'Andrea Neurologia - Università La Sapienza

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum