ReferenceCitation: Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.

name: Department of Medical Oncology, Washington University School of Medicine, Saint Louis, MO, USA;

family: Govindan

full_name: Ramaswamy Govindan

given: Ramaswamy

name: Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands;

family: Senan

full_name: Suresh Senan

given: Suresh

name: Department of Pulmonology, Mathias – Spital Rheine, Rheine, Germany;

family: Dickgreber

full_name: Nicolas Dickgreber

given: Nicolas

name: Department of Medical Oncology, Hospital Puerta de Hierro, Madrid, Spain;

family: Provencio

full_name: Mariano Provencio

given: Mariano

name: Department of Lung Cancer, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China;

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

name: Department of Medicine, National and Kapodistrian University of Athens, Athens, Greece;

family: Syrigos

full_name: Konstantinos Syrigos

given: Konstantinos

name: Department of Pulmonology, Hospital CUF Porto, Porto, Portugal;

family: Parente

full_name: Barbara Parente

given: Barbara

name: Department of Health Economics, RTI Health Solutions, Research Triangle Park, NC, USA;

family: Wilson

full_name: Michele Wilson

given: Michele

name: Department of Biostatistics, RTI Health Solutions, Research Triangle Park, NC, USA;

family: Ziemiecki

full_name: Ryan Ziemiecki

given: Ryan

name: Eli Lilly and Company, Neuilly-sur-Seine, France;

family: Chouaki

full_name: Nadia Chouaki

given: Nadia

name: Eli Lilly and Company, Indianapolis, IN, USA;

family: Hossain

full_name: Anwar Hossain

given: Anwar

family: San Antonio

full_name: Belén San Antonio

given: Belén

family: Winfree

full_name: Katherine Winfree

given: Katherine

name: Department of Medicine, University of Chicago, Chicago, IL, USA

family: Vokes

full_name: Everett E. Vokes

given: Everett E.

ReferenceCitation: Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.

family: Brade

full_name: Anthony M. Brade

given: Anthony M.

family: Wenz

full_name: Frederik Wenz

given: Frederik

family: Koppe

full_name: Friederike Koppe

given: Friederike

family: Lievens

full_name: Yolande Lievens

given: Yolande

full_name: Belen San Antonio

given: Belen

family: Iscoe

full_name: Neill A. Iscoe

given: Neill A.

journal_name: International Journal of Radiation Oncology*Biology*Physics

location_country:
Brazil
India
Netherlands
Spain
Germany
France
Korea, Republic of
Greece
Ireland
Belgium
Argentina
Australia
China
Turkey
United States
United Kingdom
Canada
Taiwan
Portugal

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

title: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

summary: This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.


ReferenceType: derived

ReferenceCitation: Kuemmerle-Deschner JB, Hachulla E, Cartwright R, Hawkins PN, Tran TA, Bader-Meunier B, Hoyer J, Gattorno M, Gul A, Smith J, Leslie KS, Jiménez S, Morell-Dubois S, Davis N, Patel N, Widmer A, Preiss R, Lachmann HJ. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011 Dec;70(12):2095-102. doi: 10.1136/ard.2011.152728. Epub 2011 Aug 21.

family: Kuemmerle-Deschner

full_name: J. B. Kuemmerle-Deschner

given: J. B.

sequence: first

family: Hachulla

full_name: E. Hachulla

given: E.

sequence: additional

family: Cartwright

full_name: R. Cartwright

given: R.

family: Hawkins

full_name: P. N. Hawkins

given: P. N.

family: Tran

full_name: T. A. Tran

given: T. A.

family: Bader-Meunier

full_name: B. Bader-Meunier

given: B.

family: Hoyer

full_name: J. Hoyer

given: J.

family: Gattorno

full_name: M. Gattorno

given: M.

family: Gul

full_name: A. Gul

given: A.

family: Smith

full_name: J. Smith

family: Leslie

full_name: K. S. Leslie

given: K. S.

family: Jimenez

full_name: S. Jimenez

given: S.

family: Morell-Dubois

full_name: S. Morell-Dubois

family: Davis

full_name: N. Davis

given: N.

family: Patel

full_name: N. Patel

family: Widmer

full_name: A. Widmer

family: Preiss

full_name: R. Preiss

family: Lachmann

full_name: H. J. Lachmann

given: H. J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Novartis

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
United States
India
France
Belgium
Spain
Turkey
Germany
United Kingdom

location_facility: Rush-Presbyterian St. Lukes Medical Center

study_completion_date_type: Actual

source: euctr

title: An Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1β Monoclonal Antibody) Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

summary:
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease.

The duration of this study was 6 months with a maximum duration of 2 years

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243.

family: Inzinger

full_name: M Inzinger

given: M

family: Weger

full_name: W Weger

given: W

family: Salmhofer

full_name: W Salmhofer

family: Wolf

full_name: P Wolf

given: P

currency_apc_doaj: EUR

journal_name: Acta Dermato Venereologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (semantic scholar lookup)

host_type: repository

license_normalized: no license

version: submittedVersion

publisher: Acta Dermato-Venereologica

publisher_dissemination: Acta Dermato-Venereologica

publisher_group: Acta Dermato-Venereologica

publisher_normalized: Acta Dermato-Venereologica

title: Differential Response of Chronic Plaque Psoriasis to Briakinumab vs. Ustekinumab

ReferenceCitation: Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.

family: Reich

full_name: Kristian Reich

given: Kristian

family: Langley

full_name: Richard G. Langley

given: Richard G.

family: Papp

full_name: Kim A. Papp

given: Kim A.

family: Ortonne

full_name: Jean-Paul Ortonne

given: Jean-Paul

family: Unnebrink

full_name: Kristina Unnebrink

given: Kristina

family: Kaul

full_name: Martin Kaul

given: Martin

family: Valdes

full_name: Joaquin M. Valdes

given: Joaquin M.

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: A 52-Week Trial Comparing Briakinumab with Methotrexate in Patients with Psoriasis

design_allocation: Randomized

lead_sponsor: AbbVie (prior sponsor, Abbott)

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

location_facility:
Site Reference ID/Investigator# 13104
Site Reference ID/Investigator# 11864
Site Reference ID/Investigator# 9583
Site Reference ID/Investigator# 11701
Site Reference ID/Investigator# 8033
Site Reference ID/Investigator# 8026
Site Reference ID/Investigator# 12401
Site Reference ID/Investigator# 10963
Site Reference ID/Investigator# 12763
Site Reference ID/Investigator# 13221
Site Reference ID/Investigator# 8027
Site Reference ID/Investigator# 8034
Site Reference ID/Investigator# 13163
Site Reference ID/Investigator# 11381
Site Reference ID/Investigator# 8022
Site Reference ID/Investigator# 10702
Site Reference ID/Investigator# 11001
Site Reference ID/Investigator# 12381
Site Reference ID/Investigator# 8362
Site Reference ID/Investigator# 13481
Site Reference ID/Investigator# 11661
Site Reference ID/Investigator# 8363
Site Reference ID/Investigator# 13422
Site Reference ID/Investigator# 8030
Site Reference ID/Investigator# 8023
Site Reference ID/Investigator# 8019
Site Reference ID/Investigator# 8032
Site Reference ID/Investigator# 8020
Site Reference ID/Investigator# 10203
Site Reference ID/Investigator# 11504
Site Reference ID/Investigator# 8025
Site Reference ID/Investigator# 8024
Site Reference ID/Investigator# 8185
Site Reference ID/Investigator# 13462
Site Reference ID/Investigator# 8021
Site Reference ID/Investigator# 13223
Site Reference ID/Investigator# 13161
Site Reference ID/Investigator# 11161
Site Reference ID/Investigator# 13461
Site Reference ID/Investigator# 9904
Site Reference ID/Investigator# 11841
Site Reference ID/Investigator# 8035
Site Reference ID/Investigator# 8551

type: EudraCT Number

title: A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

summary: This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.


ReferenceCitation: Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Li

full_name: David Li

given: David

family: Calabresi

full_name: Peter A Calabresi

given: Peter A

family: O'Connor

full_name: Paul O'Connor

given: Paul

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Yin

full_name: Ming Yin

given: Ming

family: Leppert

full_name: David Leppert

family: Glanzman

full_name: Robert Glanzman

given: Robert

family: Tinbergen

full_name: Jeroen Tinbergen

given: Jeroen

family: Hauser

full_name: Stephen L Hauser

given: Stephen L

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

status: Active, not recruiting

study_start_date_type: Actual

lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
Serbia
Switzerland
Mexico
Germany
France
Czechia
Bulgaria
Slovakia
Romania
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom
Ukraine

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: University of Virginia - Fontain Research Park

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

location_facility: Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie

location_facility: Shepherd Center; Multiple Sclerosis Center

location_facility: Ohio State University Med Ctr; MS Center

location_facility: Walton Center For Neurology & Neurosurgery; Clinical Trials Unit

location_facility: Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology

location_facility: MRC for Oncology and Neurology; Neurology

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Shat of Cardiovascular Diseases; Clinic of Neurology

location_facility: Nemocnica s Poliklinikou Spisska Nova Ves, a.s.

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Michigan Institute for Neurological Disorders

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY

location_facility: Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

location_facility: Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu

location_facility: Clinical Center of Serbia; Institute of Neurology

location_facility: Clinical Center Nis; Clinic for Mental Health

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Uni Hospital Queens Medical Centre; Neurology

location_facility: UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY

location_facility: Uni of British Columbia Hospital; Ms Clinical Research Group

location_facility: Fakultna Nemocnica Nitra; Neurologicka Klinika

location_facility: CHU De Caen; Service De Neurologie Dejerine

location_facility: Hospital Universitario La Fe; Unidad de Esclerosis Multiple

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Suny At Stony Brook; Department Of Neurology

location_facility: Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states

location_facility: Legacy Health System; Clinical Research & Tech Ctr

location_facility: Asklepios Klinik Nord-Heidberg; Neurologie

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: Dartmouth-Hitchcock Medical Center; Dept of Neurology

location_facility: McGill University; Montreal Neurological Institute; Neurological and Psychiatric

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: East Bay Physicians Med Group;Sutter East Bay Med Foundation

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU

location_facility: LLC Research Medical Complex Vashe Zdorovie

location_facility: Spitalul Clinic Colentina; Clinica de Neurologie

location_facility: Fletcher Allen Health Care/University of Vermont

study_completion_date_type: Anticipated

type: Other Identifier

title: Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

summary: This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

status_simplified: Ongoing


title: Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

summary: This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

ReferenceCitation: Guja C, Frías JP, Suchower L, Hardy E, Marr G, Sjöström CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum in: Diabetes Ther. 2020 Dec;11(12):3011-3013.

family: Guja

full_name: Cristian Guja

given: Cristian

family: Frías

full_name: Juan P. Frías

given: Juan P.

family: Suchower

full_name: Lisa Suchower

given: Lisa

family: Hardy

full_name: Elise Hardy

given: Elise

family: Marr

full_name: Galina Marr

given: Galina

family: Sjöström

full_name: C. David Sjöström

given: C. David

family: Jabbour

full_name: Serge A. Jabbour

given: Serge A.

journal_name: Diabetes Therapy

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.

family: Malloy

full_name: Jaret Malloy

given: Jaret

family: Meloni

full_name: Alison Meloni

given: Alison

family: Han

full_name: Jenny Han

given: Jenny

journal_name: Postgraduate Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Efficacy and Tolerability of Exenatide Once Weekly Versus Sitagliptin in Patients With Type 2 Diabetes Mellitus: A Retrospective Analysis of Pooled Clinical Trial Data

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

family: Grimm

full_name: Michael Grimm

given: Michael

family: Weaver

full_name: Carole Weaver

given: Carole

family: Griffin

full_name: Pete Griffin

title: Efficacy, Safety, and Tolerability of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus: An Integrated Analysis of the DURATION Trials

ReferenceCitation: Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.

ReferenceCitation: Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, González JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Efficacy and Safety of Exenatide Once Weekly Versus Metformin, Pioglitazone, and Sitagliptin Used as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4): A 26-week double-blind study

location_country:
Romania
Belgium
Russian Federation
India
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Turkey


title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

acronym: REFINE-ICD

summary: This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Perkiömäki J, Exner DV, Piira OP, Kavanagh K, Lepojärvi S, Talajic M, Karvonen J, Philippon F, Junttila J, Coutu B, Huikuri H. Heart Rate Turbulence and T-Wave Alternans in Patients with Coronary Artery Disease: The Influence of Diabetes. Ann Noninvasive Electrocardiol. 2015 Sep;20(5):481-7. doi: 10.1111/anec.12244. Epub 2015 Jan 15.

name: Division of Cardiology, Institute of Clinical Medicine; University of Oulu, and University Hospital of Oulu; Finland

family: Perkiömäki

full_name: Juha Perkiömäki

given: Juha

name: Libin Cardiovascular Institute of Alberta; Calgary Alberta Canada

family: Exner

full_name: Derek V. Exner

given: Derek V.

family: Piira

full_name: Olli-Pekka Piira

given: Olli-Pekka

family: Kavanagh

full_name: Katherine Kavanagh

given: Katherine

family: Lepojärvi

full_name: Samuli Lepojärvi

given: Samuli

name: Cardiology; Montreal Heart Institute; Montreal Quebec Canada

family: Talajic

full_name: Mario Talajic

given: Mario

family: Karvonen

full_name: Jarkko Karvonen

given: Jarkko

name: Quebec Heart Institute; Quebec City Quebec Canada

family: Philippon

full_name: Francois Philippon

given: Francois

family: Junttila

full_name: Juhani Junttila

given: Juhani

name: Centre Hopital University of Montreal; Montreal Quebec Canada

family: Coutu

full_name: Benoit Coutu

given: Benoit

family: Huikuri

full_name: Heikki Huikuri

given: Heikki

journal_name: Annals of Noninvasive Electrocardiology

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing: Undecided

ipd_sharing_description: uncertain

lead_sponsor: University of Calgary

location_country:
Italy
United States
South Africa
Sweden
Saudi Arabia
Germany
Finland
France
Slovakia
Norway
Hungary
Belgium
Spain
Canada
United Kingdom

location_facility: HUCH Helsinki University Central Hospital

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Hospital General Universitario de Alicante (HGUA)

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)

location_facility: Aurora St. Luke's Medical Center/Aurora Cardiovascular Services

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Hôpital Guillaume et René Laënnec - CHU de Nantes

location_facility: Associated Cardiovascular Consultants/Lourdes Cardiology Services

location_facility: St. Paul's Hospital/Providence Health Care

location_facility: Hospital Universitario Clinic de Barcelona

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation

acronym: AVRO

summary: The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

ReferenceCitation: Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046.

family: Camm

full_name: A. John Camm

given: A. John

family: Capucci

full_name: Alessandro Capucci

given: Alessandro

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

family: Torp-Pedersen

full_name: Christian Torp-Pedersen

given: Christian

family: Van Gelder

full_name: Isabelle C. Van Gelder

given: Isabelle C.

family: Mangal

full_name: Brian Mangal

given: Brian

family: Beatch

full_name: Gregory Beatch

given: Gregory

journal_name: Journal of the American College of Cardiology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: A Randomized Active-Controlled Study Comparing the Efficacy and Safety of Vernakalant to Amiodarone in Recent-Onset Atrial Fibrillation

lead_sponsor: Correvio International Sarl

location_country:
Sweden
Serbia
Netherlands
Germany
Finland
France
Poland
Lithuania
Slovakia
Latvia
Australia
Estonia
Denmark
Canada
Czech Republic
Ukraine

location_facility: Klinikum Pirna GmbH, Innere Medizin II, Kardiologie

location_facility: McGill University Health Center The Montreal General Hospital

location_facility: Middle Slovak Institute of Cardiovascular Diseases (SUSCCH)

location_facility: Klinika Kardiologii Zachowawczej Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

location_facility: Medizinische Klinik, Klinikum Hannover Nordstadt

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Robert-Bosch-Krankenhaus, Abt. Kardiologie / Pulmologie

location_facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

location_facility: Slovensky ustav srdcovych a cevnych chorob

location_facility: Okregowy Szpital Kolejowy w Lublinie Samodzielny

location_facility: Vilnius University Hospital Santariskiu Clinic - Center of Cardiology and Angiology

location_facility: Ustredni vojenska nemocnice Koronarni jednotka

location_facility: Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Szpital Wojewódzki im. Jana Bożego w Lublinie

location_facility: Hopital Trousseau - Service de Cardiologie

location_facility: N.D. Strazhesko Institute of Cardiology Intensive Care Unit

location_facility: III Klinika Chorob Wewnetrznych i Kardiologii

location_facility: Klinikum der Universität Köln, Medizinische Klinik III

location_facility: Lugansk First Clinical Multiprofile Hospital #1, Cardiology

location_facility: Clinical Center Zemun, Dept. of Cardiology

location_facility: Herzzentrum Brandenburg in Bernau Innere Medizin

location_facility: Martin-Luther Universitat Halle, Med. Klinik und Poliklinik III- Fachrichtung Kardiologie

location_facility: Institute of Treatment and Reahabilitation 'Niska Banja'

location_facility: East Tallinn Central Hospital-Clinic of Cardiology

location_facility: WCN - Department of Cardiology Rijnstate Ziekenhuls

location_facility: Launceston General Hospital Cardiac Research Unit

location_facility: Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction

location_facility: Oblastni nemocnice Pribram Interni Oddeleni

location_facility: Campus Virchow-Klinikum, Charite - Universitaetsmedizin Berlin

location_facility: Nemocnice Kutna Hora s.r.o. Interni Oddeleni

location_facility: Oddzial Kardiologiczny Wielospecjalityczny Szpital Miejski im.

location_facility: City Clinical Hospital #9 Dept of Arrhythmia

location_facility: CHU de Strasbourg - Hopital Hautepierre - Service de Cardiologie

location_facility: Clinical Center of Serbia, Institute of CV Diseases

location_facility: Oulu University Hospital - Dept of Internal Medicine

location_facility: Kaunas Medical University Hospital - Department of Cardiology

location_facility: CHU de Nancy - Hopital Brabois - Service de Cardiologie

location_facility: Latvian Center of Cardiology, P. Stradins Clinical University Hospital

location_facility: Klinika Chorob Wewnetrznych z Oddzialem Farmakologii Klinicznej i Terapii Monitorowanej

location_facility: Ambulantes Herzzentrum Kassel Innere Medizin

location_facility: Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur

location_facility: Kiev City Clinical Hospital No 5, Coronary Care Unit

location_facility: Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie

location_facility: Szpital Miejski im. J. Brudzinskiego Oddzial Kardiologii

location_facility: Charite Campus Mitte, Med. Klinik und Poliklinik mit Schwerpunkt Kardiologie und Angiologie

location_facility: Osrodek Chorob Serca, Klinika Kardiologii, 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny

location_facility: City Clinical Hospital #1 Intensive Care Unit

location_facility: Universitätsklinikum Bonn, Med. Klinik und Poliklinik II

location_facility: Royal Hobart Hospital Cardiology Research

location_facility: Centre Hopitalier de L'Universite de Montreal - Hotel Dieu

location_facility: Interna klinika FN Trnava, Fakultna nemocnica Trnava

location_facility: Gentofte Amtssygehus Kardiologisk afdeling

location_facility: Oddział Kardiologiczno-Internistyczny Specjalistyczny Szpital Miejski im. Mikołaja Kopernika

location_facility: Oddzial Kardiologii Inwazyjnej Szpital Specjalistyczny im. E.Szczeklika w Tarnowie


ReferenceCitation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

family: Asmane

full_name: Irène Asmane

given: Irène

family: Watkin

full_name: Emmanuel Watkin

given: Emmanuel

family: Alberti

full_name: Laurent Alberti

given: Laurent

family: Duc

full_name: Adeline Duc

given: Adeline

family: Marec-Berard

full_name: Perrine Marec-Berard

given: Perrine

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Decouvelaere

full_name: Anne-Valérie Decouvelaere

given: Anne-Valérie

family: Ranchère

full_name: Dominique Ranchère

given: Dominique

family: Kurtz

full_name: Jean-Emmanuel Kurtz

given: Jean-Emmanuel

family: Bergerat

full_name: Jean-Pierre Bergerat

given: Jean-Pierre

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

journal_name: European Journal of Cancer

title: Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: A predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas

intervention_type: Biological

lead_sponsor: Eli Lilly and Company

location_country:
United States
Netherlands
France
Poland
Belgium
Spain
Germany

title: A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET

summary:
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis:

Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
rhabdomyosarcoma
leiomyosarcoma
adipocytic sarcoma
synovial sarcoma.

A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.


ReferenceCitation: Tambuyzer L, Thys K, Hoogstoel A, Nijs S, Tomaka F, Opsomer M, De Meyer S, Vingerhoets J. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21(4):317-27. doi: 10.3851/IMP3011. Epub 2015 Nov 13.

family: Tambuyzer

full_name: Lotke Tambuyzer

given: Lotke

family: Thys

full_name: Kim Thys

given: Kim

family: Hoogstoel

full_name: Annemie Hoogstoel

given: Annemie

family: Nijs

full_name: Steven Nijs

given: Steven

family: Tomaka

full_name: Frank Tomaka

given: Frank

family: Opsomer

full_name: Magda Opsomer

given: Magda

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

family: Vingerhoets

full_name: Johan Vingerhoets

given: Johan

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Brazil
United States
South Africa
Netherlands
Spain
France
Thailand
Romania
Argentina
Puerto Rico
Portugal
Canada
United Kingdom

acronym: Pediatric trial with Intelence as an Active NNRTI Option (PIANO)

title: A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents

summary: The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.


title: MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

summary: A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

ReferenceType: result

ReferenceCitation: Wilson R, Anzueto A, Miravitlles M, Arvis P, Faragó G, Haverstock D, Trajanovic M, Sethi S. A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology. Int J Chron Obstruct Pulmon Dis. 2011;6:373-83. doi: 10.2147/COPD.S21071. Epub 2011 Jun 29.

family: Wilson

full_name: Robert Wilson

given: Robert

family: Anzueto

full_name: Antonio Anzueto

given: Antonio

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Arvis

full_name: Arvis

family: Farago

full_name: Farago

family: Haverstock

full_name: Haverstock

family: Trajanovic

full_name: Trajanovic

family: Sethi

full_name: Sanjay Sethi

given: Sanjay

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

license: implied-oa

license_normalized: implied-oa

ReferenceCitation: Wilson R, Anzueto A, Miravitlles M, Arvis P, Haverstock D, Trajanovic M, Sethi S. Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 2;10:985-93. doi: 10.2147/COPD.S80926. eCollection 2015.

full_name: Pierre Arvis

given: Pierre

full_name: Daniel Haverstock

given: Daniel

full_name: Mila Trajanovic

given: Mila

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

location_country:
Peru
Greece
Belgium
Australia
Czech Republic
Pakistan
Andorra
Croatia
France
Lithuania
Thailand
Argentina
Indonesia
Canada
Colombia
South Africa
Chile
Hong Kong
Netherlands
Philippines
Switzerland
Ireland
China
Portugal
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Latvia


title: A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity

acronym: SONIC

summary: A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis

ipd_sharing: Yes

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Netherlands
France
Czechia
Hungary
Belgium
Australia
Russian Federation
Spain
Germany
United Kingdom


status: Terminated

lead_sponsor: H. Lundbeck A/S

location_country:
Austria
Sweden
Philippines
Germany
France
Bulgaria
Lithuania
Malaysia
Poland
Romania
Slovakia
Australia
Belgium
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

title: Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder

summary: This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.


title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients

acronym: DIA-AID

summary: The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

ReferenceCitation: Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Procházka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391. Retraction in: Diabetes Care. 2015 Jan;38(1):178.

RetractionSource: Diabetes Care. 2015 Jan;38(1):178

family: Raz

full_name: Itamar Raz

given: Itamar

family: Ziegler

full_name: Anette G. Ziegler

given: Anette G.

family: Linn

full_name: Thomas Linn

given: Thomas

family: Schernthaner

full_name: Guntram Schernthaner

given: Guntram

family: Bonnici

full_name: Francois Bonnici

given: Francois

family: Distiller

full_name: Larry A. Distiller

given: Larry A.

family: Giordano

full_name: Carla Giordano

given: Carla

family: Giorgino

full_name: Francesco Giorgino

given: Francesco

family: de Vries

full_name: Liat de Vries

given: Liat

family: Mauricio

full_name: Didac Mauricio

given: Didac

family: Procházka

full_name: Vlastimil Procházka

given: Vlastimil

family: Wainstein

full_name: Julio Wainstein

given: Julio

family: Elias

full_name: Dana Elias

given: Dana

family: Avron

full_name: Ann Avron

given: Ann

family: Tamir

full_name: Merana Tamir

given: Merana

family: Eren

full_name: Rachel Eren

given: Rachel

family: Peled

full_name: Dana Peled

family: Dagan

full_name: Shlomo Dagan

given: Shlomo

family: Cohen

full_name: Irun R. Cohen

given: Irun R.

family: Pozzilli

full_name: Paolo Pozzilli

given: Paolo

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

title: Treatment of Recent-Onset Type 1 Diabetic Patients With DiaPep277: Results of a Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial

ReferenceCitation: Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9. Retraction in: Diabetes Care. 2015 Jan;38(1):179.

title: Evaluation of Long-Term Treatment Effect in a Type 1 Diabetes Intervention Trial: Differences After Stimulation With Glucagon or a Mixed Meal

location_country:
Italy
Austria
South Africa
United Kingdom
Finland
France
Greece
Israel
Spain
Germany
Czech Republic

location_facility: Hospital Nuestra Señora de La Candelaria

location_facility: Diabetes Centre for Children and Adolescents

location_facility: Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin


title: A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen

summary: The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.

lead_sponsor: Pfizer

location_country:
Italy
France
Japan
Korea, Republic of
Poland
Spain
United States
Canada


title: A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Subjects With Excess Abdominal Fat Accumulation

summary: HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.

ReferenceCitation: Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.

family: Fourman

full_name: Lindsay T. Fourman

given: Lindsay T.

family: Czerwonka

full_name: Natalia Czerwonka

given: Natalia

family: Feldpausch

full_name: Meghan N. Feldpausch

given: Meghan N.

family: Weiss

full_name: Julian Weiss

given: Julian

family: Mamputu

full_name: Jean-Claude Mamputu

given: Jean-Claude

family: Falutz

full_name: Julian Falutz

family: Morin

full_name: Josée Morin

given: Josée

family: Marsolais

full_name: Christian Marsolais

given: Christian

family: Stanley

full_name: Takara L. Stanley

given: Takara L.

family: Grinspoon

full_name: Steven K. Grinspoon

given: Steven K.

journal_name: AIDS

version: acceptedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.

full_name: T. L. Stanley

given: T. L.

full_name: J. Falutz

given: J.

full_name: C. Marsolais

given: C.

full_name: J. Morin

family: Soulban

full_name: G. Soulban

given: G.

full_name: J.-C. Mamputu

family: Assaad

full_name: H. Assaad

given: H.

family: Turner

full_name: R. Turner

given: R.

title: Reduction in Visceral Adiposity Is Associated With an Improved Metabolic Profile in HIV-Infected Patients Receiving Tesamorelin

ReferenceCitation: Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Effects of Tesamorelin (TH9507), a Growth Hormone-Releasing Factor Analog, in Human Immunodeficiency Virus-Infected Patients with Excess Abdominal Fat: A Pooled Analysis of Two Multicenter, Double-Blind Placebo-Controlled Phase 3 Trials with Safety Extension Data

ReferenceCitation: Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

title: Effects of Tesamorelin, a Growth Hormone–Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety Extension

location_country:
United States
France
Belgium
Spain
Canada
United Kingdom

location_facility: AIDS Community Research Initiative of America

location_facility: Centre Hospitalier Universitaire de Santé de l'Estrie

location_facility: University of North Carolina at Chapel Hill

location_facility: Indiana University Department of Medicine

location_facility: McMaster University Health Sciences Centre

location_facility: Infectious Disease Research Institute Inc.

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Groupe de Recherche en Rhumatologie et maladies osseuses


title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

ReferenceType: background

ReferenceCitation: Busse WW, Bleecker ER, Bateman ED, Lötvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012 Jan;67(1):35-41. doi: 10.1136/thoraxjnl-2011-200308. Epub 2011 Aug 9.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157.

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.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Chile
Peru
South Africa
Mexico
Netherlands
Germany
France
Bulgaria
Czechia
Poland
Thailand
Australia
Russian Federation
Estonia
Canada


ReferenceCitation: Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307-19. doi: 10.1056/NEJMoa1203165.

family: Fishbane

full_name: Steven Fishbane

given: Steven

family: Schiller

full_name: Brigitte Schiller

given: Brigitte

family: Locatelli

full_name: Francesco Locatelli

given: Francesco

family: Covic

full_name: Adrian C. Covic

given: Adrian C.

family: Provenzano

full_name: Robert Provenzano

given: Robert

family: Wiecek

full_name: Andrzej Wiecek

given: Andrzej

family: Levin

full_name: Nathan W. Levin

given: Nathan W.

family: Kaplan

full_name: Mark Kaplan

given: Mark

family: Macdougall

full_name: Iain C. Macdougall

given: Iain C.

family: Francisco

full_name: Carol Francisco

given: Carol

family: Mayo

full_name: Martha R. Mayo

given: Martha R.

family: Polu

full_name: Krishna R. Polu

given: Krishna R.

family: Duliege

full_name: Anne-Marie Duliege

given: Anne-Marie

family: Besarab

full_name: Anatole Besarab

given: Anatole

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

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

title: Peginesatide in Patients with Anemia Undergoing Hemodialysis

ReferenceCitation: Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S; PEARL Study Groups. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med. 2013 Jan 24;368(4):320-32. doi: 10.1056/NEJMoa1203166.

family: Sharma

full_name: Amit Sharma

given: Amit

family: Spinowitz

full_name: Bruce S. Spinowitz

given: Bruce S.

family: Schmidt

full_name: Rebecca J. Schmidt

given: Rebecca J.

family: Pergola

full_name: Pablo E. Pergola

given: Pablo E.

family: Zabaneh

full_name: Raja I. Zabaneh

given: Raja I.

family: Tong-Starksen

title: Peginesatide for Anemia in Patients with Chronic Kidney Disease Not Receiving Dialysis

location_country:
Italy
United States
France
Bulgaria
Poland
Romania
Spain
Germany
United Kingdom

location_facility:
Research Facility
Research Facilities (2)

title: AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin

summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.


title: A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

acronym: SCORE

summary: This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.

ReferenceCitation: Peterfy C, Emery P, Tak PP, Østergaard M, DiCarlo J, Otsa K, Navarro Sarabia F, Pavelka K, Bagnard MA, Gylvin LH, Bernasconi C, Gabriele A. MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study. Ann Rheum Dis. 2016 Jan;75(1):170-7. doi: 10.1136/annrheumdis-2014-206015. Epub 2014 Oct 29.

family: Peterfy

full_name: Charles Peterfy

given: Charles

family: Emery

full_name: Paul Emery

given: Paul

family: Tak

full_name: Paul P Tak

given: Paul P

family: Østergaard

full_name: Mikkel Østergaard

given: Mikkel

family: DiCarlo

full_name: Julie DiCarlo

given: Julie

family: Otsa

full_name: Kati Otsa

given: Kati

family: Navarro Sarabia

full_name: Federico Navarro Sarabia

given: Federico

family: Pavelka

full_name: Karel Pavelka

given: Karel

family: Bagnard

full_name: Marie-Agnes Bagnard

given: Marie-Agnes

family: Gylvin

full_name: Lykke Hinsch Gylvin

given: Lykke Hinsch

family: Bernasconi

full_name: Corrado Bernasconi

given: Corrado

family: Gabriele

full_name: Annarita Gabriele

given: Annarita

oa_colors: green hybrid

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

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

repository_normalized: Pure (Denmark)

location_country:
Brazil
Serbia
Switzerland
Netherlands
Germany
France
Greece
Lithuania
Norway
Latvia
Argentina
Romania
Russian Federation
Spain
Estonia
Denmark
Canada
Czech Republic
Turkey


title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

ReferenceCitation: Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.

family: Yelensky

full_name: R Yelensky

given: R

family: Li

full_name: Y Li

given: Y

family: Lewitzky

full_name: S Lewitzky

given: S

family: Leroy

full_name: E Leroy

given: E

family: Hurwitz

full_name: C Hurwitz

given: C

family: Rodman

full_name: D Rodman

given: D

family: Trifilieff

full_name: A Trifilieff

given: A

family: Paulding

full_name: C A Paulding

given: C A

journal_name: The Pharmacogenomics Journal

evidence: open (via free pdf)

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

family: Jones

full_name: Paul W. Jones

given: Paul W.

family: Mahler

full_name: Donald A. Mahler

given: Donald A.

family: Gale

full_name: Rupert Gale

given: Rupert

family: Owen

full_name: Roger Owen

given: Roger

family: Kramer

full_name: Benjamin Kramer

given: Benjamin

journal_name: Respiratory Medicine

ReferenceCitation: Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

family: Worth

full_name: Heinrich Worth

given: Heinrich

family: Chung

full_name: Kian Fan Chung

given: Kian Fan

family: Felser

full_name: James M. Felser

given: James M.

location_country:
Italy
Peru
India
Germany
Finland
France
Slovakia
Hungary
Russian Federation
Denmark
Canada
Czech Republic
Taiwan
Colombia
Iceland

location_facility:
novartis Investigator site
Novartis investigator site
Novartis Investigator site
Novartis Investgative Site
Novartis Investigator Site
Novartis Investigative Site


ReferenceCitation: Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.

name: Heribert Juergens, Uta Dirksen, University Children's Hospital, Muenster, Germany; Najat C. Daw, St Jude Children's Research Hospital, Memphis, TN; Najat C. Daw, MD Anderson Cancer Center, Houston, TX; Birgit Geoerger, Centre National de Recherche Scientifique UMR 8203, Institute Gustave Roussy, University Paris-Sud, Villejuif; Isabelle Aerts, Institute Curie, Paris, France; Stefano Ferrari, Istituto Ortopedico Rizzoli, Bologna, Italy; Milena Villarroel, Hospital Luis Calvo Mackenna, Santiago, Chile;...

family: Juergens

full_name: Heribert Juergens

given: Heribert

family: Daw

full_name: Najat C. Daw

given: Najat C.

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Ferrari

full_name: Stefano Ferrari

given: Stefano

family: Villarroel

full_name: Milena Villarroel

given: Milena

family: Aerts

full_name: Isabelle Aerts

given: Isabelle

family: Whelan

full_name: Jeremy Whelan

given: Jeremy

family: Dirksen

full_name: Uta Dirksen

given: Uta

family: Hixon

full_name: Mary L. Hixon

given: Mary L.

family: Yin

full_name: Donghua Yin

given: Donghua

family: Wang

full_name: Tao Wang

given: Tao

family: Green

full_name: Stephanie Green

given: Stephanie

family: Paccagnella

full_name: Luisa Paccagnella

given: Luisa

family: Gualberto

full_name: Antonio Gualberto

given: Antonio

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Preliminary Efficacy of the Anti-Insulin–Like Growth Factor Type 1 Receptor Antibody Figitumumab in Patients With Refractory Ewing Sarcoma

design_allocation: Non-Randomized

location_country:
Italy
Brazil
United States
Chile
Germany
France
Israel
Australia
Spain
Canada
United Kingdom

title: A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

summary: Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

summary: PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

ReferenceCitation: MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.

family: MacNee

full_name: William MacNee

given: William

family: Allan

full_name: Richard J Allan

given: Richard J

family: Jones

full_name: Ieuan Jones

given: Ieuan

family: De Salvo

full_name: Maria Cristina De Salvo

given: Maria Cristina

family: Tan

full_name: Lisa F Tan

given: Lisa F

journal_name: Thorax

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
South Africa
Chile
Netherlands
France
Czechia
Greece
Hungary
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of


title: AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

ReferenceCitation: von Pawel J, Jotte R, Spigel DR, O'Brien ME, Socinski MA, Mezger J, Steins M, Bosquée L, Bubis J, Nackaerts K, Trigo JM, Clingan P, Schütte W, Lorigan P, Reck M, Domine M, Shepherd FA, Li S, Renschler MF. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014 Dec 10;32(35):4012-9. doi: 10.1200/JCO.2013.54.5392. Epub 2014 Nov 10.

lead_sponsor: Celgene

location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Bulgaria
Czechia
Poland
Hungary
Australia
Belgium
Spain
Denmark
United States
United Kingdom
Canada

location_facility: University of Minnesota Medical Center, Cancer Center

location_facility: Fairfax Northern Virginia Hematology/Oncology

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)

location_facility: CHU Montpellier - Unité de Cancérologie Thoracique

location_facility: Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

location_facility: Fakultní Thomayerova nemocnice s poliklinikou

location_facility: St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie

location_facility: Zespol nr 1 Szpitala im. St. Leszczynskiego

location_facility: The Princess Alexandra Hospital, Dept of Respiratory Medicine

location_facility: Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: SUNY Upstate Medical University - Regional Oncology Center

location_facility: Fraser Valley Cancer Centre-Surrey Memorial Hospital

location_facility: Centre Hospitalier Notre-Dame et Reine Fabiola

location_facility: Cancer Care Associates of Fresno Medical Group, Inc.

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: UZ Brussel, Medical Oncology and Hematology

location_facility: Hospital Universitario Virgin de la Victoria

location_facility: Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten

location_facility: Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology

location_facility: Cancer & Hematology Specialists of Chicago (Main)

location_facility: The Sarah Cannon Research Institute/TN Oncology

location_facility: Comprehensive Care Centers of Nevada (Main)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

location_facility: Rocky Mountain Cancer Center - Midtown (Main)

location_facility: Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Texas Cancer Center at Medical City (Main)

location_facility: Hospital General Universitario de Valencia

location_facility: Universitätsklinikum Essen Innere Klinik und Poliklinik

location_facility: Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: Alliance Hematology Oncology, P.A. (Main)

location_facility: Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim

location_facility: Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Duran i Reynals Institut Catala d'Oncologia

location_facility: Little Rock Hematology Oncology Associates

location_facility: Northwest Cancer Specialists - Vancouver (Main)

location_facility: Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I

location_facility: Fundación Jiménez Díaz. Universidad Autónoma de Madrid

location_facility: New South Wales Southern Medical Day Care Centre

location_facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau

location_facility: Odense Universitetshospital,Onkologisk afdeling R

location_facility: Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus

location_facility: Országos Korányi Tbc és Pulmonológiai Intézet

location_facility: Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases

location_facility: Michigan Hematology & Oncology Institute

location_facility: Tulane University Health Sciences Center

location_facility: Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie

location_facility: University of Colorado Health Science Centre

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg AG


title: A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.

summary: The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

ReferenceCitation: Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

family: Rimsky

full_name: Laurence Rimsky

given: Laurence

family: Van Eygen

full_name: Veerle Van Eygen

given: Veerle

family: Hoogstoel

full_name: Annemie Hoogstoel

given: Annemie

family: Stevens

full_name: Marita Stevens

given: Marita

family: Boven

full_name: Katia Boven

given: Katia

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: Vingerhoets

full_name: Johan Vingerhoets

given: Johan

title: 96-week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials

ReferenceCitation: Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

family: Nelson

full_name: M. Nelson

given: M.

family: Amaya

full_name: G. Amaya

given: G.

family: Clumeck

full_name: N. Clumeck

given: N.

family: Arns da Cunha

full_name: C. Arns da Cunha

given: C.

family: Jayaweera

full_name: D. Jayaweera

given: D.

family: Junod

full_name: P. Junod

given: P.

family: Li

full_name: T. Li

given: T.

family: Tebas

full_name: P. Tebas

full_name: M. Stevens

family: Buelens

full_name: A. Buelens

given: A.

family: Vanveggel

full_name: S. Vanveggel

given: S.

full_name: K. Boven

given: K.

name: on behalf of the ECHO and THRIVE Study Groups

journal_name: Journal of Antimicrobial Chemotherapy

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011 Jul 16;378(9787):229-37. doi: 10.1016/S0140-6736(11)60983-5.

location_country:
United States
Brazil
Chile
India
Costa Rica
South Africa
Mexico
Spain
Germany
France
Panama
Thailand
Belgium
Australia
Puerto Rico
China
Russian Federation
Canada
United Kingdom
Portugal


title: A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

summary: The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

ReferenceCitation: McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.

family: McClung

full_name: M. R. McClung

given: M. R.

family: Miller

full_name: P. D. Miller

given: P. D.

family: Brown

full_name: J. P. Brown

given: J. P.

family: Zanchetta

full_name: J. Zanchetta

given: J.

family: Bolognese

full_name: M. A. Bolognese

given: M. A.

family: Benhamou

full_name: C. L. Benhamou

given: C. L.

family: Balske

full_name: A. Balske

family: Burgio

full_name: D. E. Burgio

given: D. E.

family: Sarley

full_name: J. Sarley

family: McCullough

full_name: L. K. McCullough

given: L. K.

family: Recker

full_name: R. R. Recker

given: R. R.

journal_name: Osteoporosis International

lead_sponsor: Warner Chilcott

location_country:
United States
France
Poland
Hungary
Belgium
Argentina
Estonia
Canada

location_facility:
Research Facility
Research Site


title: A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

summary: The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
India
France
Poland
Russian Federation
Germany
Ukraine

location_facility: Birmingham Hematology & Oncology Assoc. Llc

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: The Angeles Clinic & Research Institute, Inc

location_facility: Cmc-Northeast/ Northeast Oncology Associates

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: Southwest Cancer Treatment And Research Center


title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.

acronym: VERITAS 1

summary: The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

ReferenceCitation: Cotter G, Davison BA, Milo O, Bourge RC, Cleland JG, Jondeau G, Krum H, O'Connor CM, Metra M, Parker JD, Torre-Amione G, van Veldhuisen DJ, Kobrin I, Rainisio M, Senger S, Edwards C, McMurray JJ, Teerlink JR; VERITAS Investigators. Predictors and Associations With Outcomes of Length of Hospital Stay in Patients With Acute Heart Failure: Results From VERITAS. J Card Fail. 2016 Oct;22(10):815-22. doi: 10.1016/j.cardfail.2015.12.017. Epub 2015 Dec 22.

family: Cotter

full_name: Gad Cotter

given: Gad

family: Davison

full_name: Beth A. Davison

given: Beth A.

family: Milo

full_name: Olga Milo

given: Olga

family: Bourge

full_name: Robert C. Bourge

given: Robert C.

family: Cleland

full_name: John G.F. Cleland

given: John G.F.

family: Jondeau

full_name: Guillaume Jondeau

given: Guillaume

family: Krum

full_name: Henry Krum

given: Henry

family: O'Connor

full_name: Christopher M. O'Connor

given: Christopher M.

family: Metra

full_name: Marco Metra

given: Marco

family: Parker

full_name: John D. Parker

given: John D.

family: Torre-Amione

full_name: Guillermo Torre-Amione

given: Guillermo

family: van Veldhuisen

full_name: Dirk J. van Veldhuisen

given: Dirk J.

family: Kobrin

full_name: Isaac Kobrin

given: Isaac

family: Rainisio

full_name: Maurizio Rainisio

given: Maurizio

family: Senger

full_name: Stefanie Senger

given: Stefanie

family: Edwards

full_name: Christopher Edwards

given: Christopher

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Teerlink

full_name: John R. Teerlink

given: John R.

journal_name: Journal of Cardiac Failure

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: McMurray JJ, Teerlink JR, Cotter G, Bourge RC, Cleland JG, Jondeau G, Krum H, Metra M, O'Connor CM, Parker JD, Torre-Amione G, van Veldhuisen DJ, Lewsey J, Frey A, Rainisio M, Kobrin I; VERITAS Investigators. Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. JAMA. 2007 Nov 7;298(17):2009-19.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Austria
Switzerland
Germany
France
Poland
Greece
Israel
Denmark
United States
United Kingdom

location_facility: I Klinika Kardiolgii, Collegium Medicum UJ

location_facility: Klinika Chorob Serca, Akademia Medyczna w Gdansku

location_facility: AKH University of Vienna, Abt. Medizinische Kardiologie

location_facility: Medizinische Klinik I, Universitatsklinikum Aachen

location_facility: Hopitaux Universitaires de Strasbourg, Hopital Hautepierre

location_facility: Dept. of Cardiology, University of Athens, Alexandra Hospital

location_facility: Institute of Cardiology College, College of Medicine of Jagellonian University

location_facility: Georg-August-Universitat Gottingen, Zentrum fur Innere Med

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Cardio Centro Ticino, Servizio Cardiovasculare

location_facility: Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital

location_facility: Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section

location_facility: Hopital Ambroise Pare, Service de Cardiologie

location_facility: Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie

location_facility: The Heart Hospital at Alledgheny General, Division of Cardiology


ReferenceCitation: Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. Epub 2013 Mar 26.

lead_sponsor: UCB Pharma SA

location_country:
United States
Mexico
France
Belgium
Turkey
Germany

acronym: Pediatric commitment 1month-4years

title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy

summary: Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease

summary: 1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Arita K, Kato A, Shimizu M. Randomized Placebo-Controlled EPPIC Trials of AST-120 in CKD. J Am Soc Nephrol. 2015 Jul;26(7):1732-46. doi: 10.1681/ASN.2014010042. Epub 2014 Oct 27.

family: Schulman

full_name: Gerald Schulman

given: Gerald

family: Berl

full_name: Tomas Berl

given: Tomas

family: Beck

full_name: Gerald J. Beck

given: Gerald J.

family: Remuzzi

full_name: Giuseppe Remuzzi

given: Giuseppe

family: Ritz

full_name: Eberhard Ritz

given: Eberhard

family: Arita

full_name: Kiyoshi Arita

given: Kiyoshi

family: Kato

full_name: Akira Kato

given: Akira

family: Shimizu

full_name: Miho Shimizu

given: Miho

journal_name: Journal of the American Society of Nephrology

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Kikuchi M, Shobu Y. Risk factors for progression of chronic kidney disease in the EPPIC trials and the effect of AST-120. Clin Exp Nephrol. 2018 Apr;22(2):299-308. doi: 10.1007/s10157-017-1447-0. Epub 2017 Jul 24.

family: Kikuchi

full_name: Mami Kikuchi

given: Mami

family: Shobu

full_name: Yuko Shobu

given: Yuko

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Shobu Y, Kikuchi M. The effects of AST-120 on chronic kidney disease progression in the United States of America: a post hoc subgroup analysis of randomized controlled trials. BMC Nephrol. 2016 Sep 30;17(1):141.

location_country:
Italy
Brazil
United States
Mexico
France
Poland
Argentina
Puerto Rico
Russian Federation
Canada
Czech Republic
Ukraine


title: A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients

summary: A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

primary_purpose: Prevention

location_country:
Italy
United States
Brazil
Netherlands
Spain
Germany
France
Poland
Norway
Belgium
Australia
Portugal
Canada
Czech Republic
Korea, Republic of


ReferenceCitation: Baulac M, Brodie MJ, Patten A, Segieth J, Giorgi L. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2012 Jul;11(7):579-88. doi: 10.1016/S1474-4422(12)70105-9. Epub 2012 Jun 8.

family: Baulac

full_name: Michel Baulac

given: Michel

family: Brodie

full_name: Martin J Brodie

given: Martin J

family: Patten

full_name: Anna Patten

given: Anna

family: Segieth

full_name: Joanna Segieth

given: Joanna

family: Giorgi

full_name: Luigi Giorgi

given: Luigi

journal_name: The Lancet Neurology

lead_sponsor: Eisai Inc.

location_country:
Italy
South Africa
Sweden
India
Serbia
France
Poland
Greece
Slovakia
Hungary
Australia
Russian Federation
Spain
Denmark
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: MAZE

title: A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

summary: This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.


ReferenceCitation: Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquée L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

family: Vansteenkiste

full_name: Johan F. Vansteenkiste

given: Johan F.

family: Pas

full_name: Tommaso Martino De Pas

given: Tommaso Martino De

family: Atanackovic

full_name: Djordje Atanackovic

given: Djordje

family: Reck

full_name: Martin Reck

given: Martin

family: Thomeer

full_name: Michiel Thomeer

given: Michiel

family: Douillard

full_name: Jean-Yves Douillard

given: Jean-Yves

family: Fasola

full_name: Gianpiero Fasola

given: Gianpiero

family: Potter

full_name: Vanessa Potter

given: Vanessa

family: Taylor

full_name: Paul Taylor

given: Paul

family: Bosquée

full_name: Lionel Bosquée

given: Lionel

family: Scheubel

full_name: Robert Scheubel

given: Robert

family: Jarnjak

full_name: Silvija Jarnjak

given: Silvija

family: Debois

full_name: Muriel Debois

given: Muriel

family: de Sousa Alves

full_name: Pedro de Sousa Alves

given: Pedro

family: Louahed

full_name: Jamila Louahed

given: Jamila

family: Brichard

full_name: Vincent G. Brichard

given: Vincent G.

family: Lehmann

full_name: Frédéric F. Lehmann

given: Frédéric F.

journal_name: Journal of Thoracic Oncology

license_normalized: cc-by-nc-nd

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

intervention_type: Procedure

location_country:
Italy
France
Belgium
Germany
United Kingdom
Canada

title: Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer

summary: The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


ReferenceCitation: Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

lead_sponsor: Amgen

location_country:
Austria
France
Czechia
Lithuania
Slovakia
Belgium
Puerto Rico
Spain
United States

title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

summary: This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.


ReferenceCitation: Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.

family: Thalange

full_name: Nandu Thalange

given: Nandu

family: Bereket

full_name: Abdullah Bereket

given: Abdullah

family: Larsen

full_name: Jens Larsen

given: Jens

family: Hiort

full_name: Line Conradsen Hiort

given: Line Conradsen

family: Peterkova

full_name: Valentina Peterkova

given: Valentina

journal_name: Pediatric Diabetes

ReferenceCitation: Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.

name: Jenny Lind Children's Department Norfolk and Norwich University Hospital Norwich UK

full_name: N. Thalange

given: N.

name: Division of Paediatric Endocrinology and Diabetes Marmara University School of Medicine Istanbul Turkey

full_name: A. Bereket

given: A.

name: Insulin Medical and Science Novo Nordisk A/S Bagsvaerd Denmark

full_name: J. Larsen

given: J.

name: Biostatistics Novo Nordisk A/S Bagsvaerd Denmark

full_name: L. C. Hiort

given: L. C.

name: Endocrinological Research Centre Institute of Paediatric Endocrinology Moscow Russia

full_name: V. Peterkova

given: V.

journal_name: Diabetic Medicine

license: cc-by

license_normalized: cc-by

title: Insulin analogues in children with Type 1 diabetes: a 52‐week randomized clinical trial

ReferenceCitation: Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. Epub 2016 Sep 6.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of

title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

summary:
This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin


title: A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)

summary: The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.

ReferenceCitation: Wolf BJ, Spainhour JC, Arthur JM, Janech MG, Petri M, Oates JC. Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol. 2016 Aug;68(8):1955-63. doi: 10.1002/art.39623.

family: Wolf

full_name: Bethany J. Wolf

given: Bethany J.

name: Medical University of South Carolina, Charleston (current address: Georgia Institute of Technology and Emory University; Atlanta Georgia)

family: Spainhour

full_name: John C. Spainhour

given: John C.

name: Ralph H. Johnson VA Medical Center and Medical University of South Carolina; Charleston

family: Arthur

full_name: John M. Arthur

given: John M.

family: Janech

full_name: Michael G. Janech

given: Michael G.

name: Johns Hopkins University School of Medicine; Baltimore Maryland

family: Petri

full_name: Michelle Petri

given: Michelle

family: Oates

full_name: Jim C. Oates

given: Jim C.

journal_name: Arthritis & Rheumatology

ReferenceCitation: Furie R, Nicholls K, Cheng TT, Houssiau F, Burgos-Vargas R, Chen SL, Hillson JL, Meadows-Shropshire S, Kinaszczuk M, Merrill JT. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol. 2014 Feb;66(2):379-89. doi: 10.1002/art.38260.

name: North Shore–LIJ Health SystemGreat NeckNew York

family: Furie

full_name: Richard Furie

given: Richard

name: Royal Melbourne Hospital and University of MelbourneParkville, VictoriaAustralia

family: Nicholls

full_name: Kathy Nicholls

given: Kathy

name: Chang Gung Memorial Hospital–Kaohsiung Medical Center and Chang Gung UniversityKaohsiungTaiwan

family: Cheng

full_name: Tien‐Tsai Cheng

given: Tien‐Tsai

name: Cliniques Universitaires Saint‐Luc, Université Catholique de LouvainBrusselsBelgium

family: Houssiau

full_name: Frederic Houssiau

given: Frederic

name: Hospital General de México and Universidad Nacional Autonoma de MéxicoMexico CityMexico

family: Burgos‐Vargas

full_name: Ruben Burgos‐Vargas

given: Ruben

name: Shanghai Jiao Tong University School of MedicineShanghaiChina

family: Chen

full_name: Shun‐Le Chen

given: Shun‐Le

family: Hillson

full_name: Jan L. Hillson

given: Jan L.

family: Meadows‐Shropshire

full_name: Stephanie Meadows‐Shropshire

given: Stephanie

family: Kinaszczuk

full_name: Michael Kinaszczuk

given: Michael

name: Oklahoma Medical Research FoundationOklahoma City

family: Merrill

full_name: Joan T. Merrill

given: Joan T.

title: Efficacy and Safety of Abatacept in Lupus Nephritis: A Twelve‐Month, Randomized, Double‐Blind Study

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Comparison of alternative primary outcome measures for use in lupus nephritis clinical trials. Arthritis Rheum. 2013 Jun;65(6):1586-91. doi: 10.1002/art.37940.

name: Bristol-Myers Squibb; Princeton; New Jersey

name: Feinstein Institute for Medical Research; Manhasset; New York

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Comparison of Alternative Primary Outcome Measures for Use in Lupus Nephritis Clinical Trials

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.

title: Abatacept for lupus nephritis: Alternative definitions of complete response support conflicting conclusions

location_country:
Brazil
South Africa
India
Hong Kong
Mexico
France
Korea, Republic of
Poland
Belgium
Argentina
Australia
China
Russian Federation
Turkey
United States
United Kingdom
Canada
Taiwan

location_facility: The Feinstein Institute For Medical Research

location_facility: University Of North Carolina At Chapel Hill


title: A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer

summary:
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Netherlands
France
Belgium
Spain
United States

location_facility: Loma Linda University Dept.ofLomaLindaCancerCent(3)

location_facility: Peninsula Regional Medical Center Deptof Oncology and Hematology

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101

location_facility: Compassionate Cancer Care Medical Group Dept.ofCCCMG

location_facility: Wilshire Oncology Medical Group La Verne

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: University of California at Los Angeles Dept.of UCLA Dept.ofMed.

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)