title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

acronym: AMBITION

summary: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

ReferenceCitation: Kuwana M, Blair C, Takahashi T, Langley J, Coghlan JG. Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis. Ann Rheum Dis. 2020 May;79(5):626-634. doi: 10.1136/annrheumdis-2019-216274. Epub 2020 Mar 11. Erratum in: Ann Rheum Dis. 2020 Sep;79(9):e118.

family: Kuwana

full_name: Masataka Kuwana

given: Masataka

family: Blair

full_name: Christiana Blair

given: Christiana

family: Takahashi

full_name: Tomohiko Takahashi

given: Tomohiko

family: Langley

full_name: Jonathan Langley

given: Jonathan

family: Coghlan

full_name: John G Coghlan

given: John G

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: White RJ, Vonk-Noordegraaf A, Rosenkranz S, Oudiz RJ, McLaughlin VV, Hoeper MM, Grünig E, Ghofrani HA, Chakinala MM, Barberà JA, Blair C, Langley J, Frost AE. Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension. Respir Res. 2019 Sep 12;20(1):208. doi: 10.1186/s12931-019-1180-1.

family: White

full_name: R. James White

given: R. James

family: Vonk-Noordegraaf

full_name: Anton Vonk-Noordegraaf

given: Anton

family: Rosenkranz

full_name: Stephan Rosenkranz

given: Stephan

family: Oudiz

full_name: Ronald J. Oudiz

given: Ronald J.

family: McLaughlin

full_name: Vallerie V. McLaughlin

given: Vallerie V.

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Chakinala

full_name: Murali M. Chakinala

given: Murali M.

family: Barberà

full_name: Joan A. Barberà

given: Joan A.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC
University of Michigan - Deep Blue

ReferenceCitation: Coghlan JG, Galiè N, Barberà JA, Frost AE, Ghofrani HA, Hoeper MM, Kuwana M, McLaughlin VV, Peacock AJ, Simonneau G, Vachiéry JL, Blair C, Gillies H, Miller KL, Harris JHN, Langley J, Rubin LJ; AMBITION investigators. Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial. Ann Rheum Dis. 2017 Jul;76(7):1219-1227. doi: 10.1136/annrheumdis-2016-210236. Epub 2016 Dec 30.

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

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

ReferenceCitation: Galiè N, Barberà JA, Frost AE, Ghofrani HA, Hoeper MM, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Grünig E, Oudiz RJ, Vonk-Noordegraaf A, White RJ, Blair C, Gillies H, Miller KL, Harris JH, Langley J, Rubin LJ; AMBITION Investigators. Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension. N Engl J Med. 2015 Aug 27;373(9):834-44. doi: 10.1056/NEJMoa1413687.

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

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Peacock AJ, Zamboni W, Vizza CD. Ambrisentan for the treatment of adults with pulmonary arterial hypertension: a review. Curr Med Res Opin. 2015;31(9):1793-807. doi: 10.1185/03007995.2015.1074890. Epub 2015 Aug 27. Review.

name: aScottish Pulmonary Vascular Unit, Regional Heart and Lung Centre, Glasgow, UK

name: bEuropean Immunology and Rare Diseases Unit, GlaxoSmithKline SpA, Verona, Italy

name: cPulmonary Hypertension Unit, Department of Cardiovascular and Respiratory Disease, Sapienza University of Rome, Rome, Italy

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Japan
Greece
Australia
Belgium
Spain
Canada
United Kingdom


ReferenceType: result

ReferenceCitation: Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arastéh K, Moyle G, Rizzardini G, Fehr J, Liu Y, Zhong L, Callebaut C, Szwarcberg J, Rhee MS, Cheng AK. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013 Jul;208(1):32-9. doi: 10.1093/infdis/jit122. Epub 2013 Mar 26.

family: Gallant

full_name: Joel E. Gallant

given: Joel E.

sequence: first

family: Koenig

full_name: Ellen Koenig

given: Ellen

sequence: additional

family: Andrade-Villanueva

full_name: Jaime Andrade-Villanueva

given: Jaime

family: Chetchotisakd

full_name: Ploenchan Chetchotisakd

given: Ploenchan

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Antunes

full_name: Francisco Antunes

given: Francisco

family: Arastéh

full_name: Keikawus Arastéh

given: Keikawus

family: Moyle

full_name: Graeme Moyle

given: Graeme

family: Rizzardini

full_name: Giuliano Rizzardini

given: Giuliano

family: Fehr

full_name: Jan Fehr

given: Jan

family: Liu

full_name: Yapei Liu

given: Yapei

family: Zhong

full_name: Lijie Zhong

given: Lijie

family: Callebaut

full_name: Christian Callebaut

given: Christian

family: Szwarcberg

full_name: Javier Szwarcberg

given: Javier

family: Rhee

full_name: Martin S. Rhee

given: Martin S.

family: Cheng

full_name: Andrew K. Cheng

given: Andrew K.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Infectious Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: reroDoc Digital Library

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Cobicistat Versus Ritonavir as a Pharmacoenhancer of Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naive HIV Type 1–Infected Patients: Week 48 Results

ReferenceCitation: Gallant JE, Koenig E, Andrade-Villanueva JF, Chetchotisakd P, DeJesus E, Antunes F, Arastéh K, Rizzardini G, Fehr J, Liu HC, Abram ME, Cao H, Szwarcberg J. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598.

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Brief Report

ReferenceCitation: Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP, Myers J, Rosenblatt L, Yang L, Szwarcberg J. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. doi: 10.2174/1570162X14666161021102728.

name: Southwest CARE Center, 649 Harkle Road, Ste. E, Santa Fe, NM, United States

name: Chelsea and Westminster Hospital, London, United Kingdom

name: Hospital General Universitario Gregorio Maranon, Madrid, Spain

name: Gilead Sciences, Inc., Foster City, CA, United States

name: Bristol-Myers Squibb, Plainsboro, NJ, United States

name: Bristol-Myers Squibb, Hopewell, NJ, United States

location_country:
Italy
Austria
Brazil
Switzerland
Mexico
Netherlands
Germany
Spain
Dominican Republic
France
Thailand
Australia
Belgium
Puerto Rico
Portugal
Denmark
United States
United Kingdom
Canada

location_facility: Instituto de Investigacion Clentifica del Sur

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: University Health Network, Toronto General Hospital

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Service des Maladies Infectieuses, CHU de Caen

location_facility: Johns Hopkins University School of Medicine

location_facility: Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Instituto De Pesquisa Clinica Evandro Chagas

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: George Washington University Medical Faculty Associates

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: Brasilmed Assistencia Medica E Pesquisas

location_facility: Hopital Saint Antoine, Service De Maladies Infectieuses

location_facility: Instituto Dominicano de Estudios Virologicos - IDEV

location_facility: HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

location_facility: Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH

location_facility: Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

location_facility: Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich

location_facility: Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Tarrant County Infectious Disease Associates

location_facility: Division of Infectious Diseases, Thomas Jefferson University

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: La Playa Medical Group and Clinical Research

location_facility: Community Research Initiative of New England

location_facility: Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic

location_facility: East Carolina University, The Brody School of Medicine

location_facility: Universitätsklinik für Infektiologie, Universitätsspital Bern

location_facility: Broward Health/Comprehensive Care Center

location_facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

location_facility: University of California, Davis Medical Center

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

location_facility: Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

location_facility: Infektio Research GmbH / Infektiologikum Frankfurt

location_facility: University of Cologne, Department of Internal Medicine

location_facility: Serviço de Doenças Infecciosas, Hospital de São João

location_facility: Infectious Disease Research Institute Inc.

location_facility: Centre François Magendie, Hôpital du Haut Lévêque

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

summary:
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.


ReferenceCitation: DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

family: Rockstroh

full_name: Jürgen K Rockstroh

given: Jürgen K

family: Henry

full_name: Keith Henry

given: Keith

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Gathe

full_name: Joseph Gathe

given: Joseph

family: Ramanathan

full_name: Srinivasan Ramanathan

given: Srinivasan

family: Wei

full_name: Xuelian Wei

given: Xuelian

family: Yale

full_name: Kitty Yale

given: Kitty

family: White

full_name: Kirsten White

given: Kirsten

full_name: Andrew K Cheng

given: Andrew K

family: Kearney

full_name: Brian P Kearney

given: Brian P

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Rockstroh JK, DeJesus E, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.

full_name: Jürgen K. Rockstroh

given: Jürgen K.

family: Plummer

full_name: Andrew Plummer

given: Andrew

family: Abram

full_name: Michael Abram

given: Michael

family: Fordyce

title: A Randomized, Double-Blind Comparison of Coformulated Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF vs Ritonavir-Boosted Atazanavir Plus Coformulated Emtricitabine and Tenofovir DF for Initial Treatment of HIV-1 Infection

ReferenceCitation: Clumeck N, Molina JM, Henry K, Gathe J, Rockstroh JK, DeJesus E, Wei X, White K, Fordyce MW, Rhee MS, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e121-4. doi: 10.1097/QAI.0000000000000089.

title: A Randomized, Double-blind Comparison of Single-Tablet Regimen Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF vs Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir DF for Initial Treatment of HIV-1 Infection

location_country:
Italy
Austria
United States
Sweden
Switzerland
Mexico
Netherlands
Germany
France
Thailand
Australia
Belgium
Puerto Rico
Portugal
Denmark
Canada
United Kingdom

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: University Health Network, Toronto General Hospital

location_facility: Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)

location_facility: Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Service des Maladies Infectieuses, CHU de Caen

location_facility: Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Erasmus MC, Internal Medicine, Section of Infectious Diseases

location_facility: St. Mary's Hospital, London (Imperial College, London)

location_facility: STAR Health Care Center (SUNY Downstate)

location_facility: Yale University HIV Clinical Trials Program

location_facility: National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: George Washington University Medical Faculty Associates

location_facility: University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: Garden State Infectious Diseases Associates, PA

location_facility: Hopital Saint Antoine, Service De Maladies Infectieuses

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Tarrant County Infectious Disease Associates

location_facility: CHU Gui de Chauliac, Maladies Infectieuses Dpt

location_facility: Division of Infectious Diseases, Thomas Jefferson University

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: La Playa Medical Group and Clinical Research

location_facility: Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic

location_facility: Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68

location_facility: Division of Infectious Diseases, St. Louis University Medical Center

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

summary: To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.


title: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

acronym: SCOT

summary:
The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.

Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.

Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Austria
Netherlands
France
Poland
Greece
Lithuania
Slovenia
Hungary
Spain
Estonia
Germany
Czech Republic
Korea, Republic of

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Chinot OL, Nishikawa R, Mason W, Henriksson R, Saran F, Cloughesy T, Garcia J, Revil C, Abrey L, Wick W. Upfront bevacizumab may extend survival for glioblastoma patients who do not receive second-line therapy: an exploratory analysis of AVAglio. Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22.

family: Chinot

full_name: Olivier L. Chinot

given: Olivier L.

family: Nishikawa

full_name: Ryo Nishikawa

given: Ryo

family: Mason

full_name: Warren Mason

given: Warren

family: Henriksson

full_name: Roger Henriksson

given: Roger

family: Saran

full_name: Frank Saran

given: Frank

family: Cloughesy

full_name: Timothy Cloughesy

given: Timothy

family: Garcia

full_name: Josep Garcia

given: Josep

family: Revil

full_name: Cedric Revil

given: Cedric

family: Abrey

full_name: Lauren Abrey

given: Lauren

family: Wick

full_name: Wolfgang Wick

given: Wolfgang

journal_name: Neuro-Oncology

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

ReferenceCitation: Saran F, Chinot OL, Henriksson R, Mason W, Wick W, Cloughesy T, Dhar S, Pozzi E, Garcia J, Nishikawa R. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy. Neuro Oncol. 2016 Jul;18(7):991-1001. doi: 10.1093/neuonc/nov300. Epub 2016 Jan 24.

family: Dhar

full_name: Sunita Dhar

given: Sunita

family: Pozzi

full_name: Emanuela Pozzi

given: Emanuela

ReferenceCitation: Taphoorn MJ, Henriksson R, Bottomley A, Cloughesy T, Wick W, Mason WP, Saran F, Nishikawa R, Hilton M, Theodore-Oklota C, Ravelo A, Chinot OL. Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. J Clin Oncol. 2015 Jul 1;33(19):2166-75. doi: 10.1200/JCO.2014.60.3217. Epub 2015 May 26.

name: Martin J.B. Taphoorn, Medical Center Haaglanden, the Hague, and VU University Medical Center, Amsterdam, the Netherlands; Roger Henriksson, Cancer Center Stockholm Gotland, Karolinska, Stockholm, and Umeå University, Umeå, Sweden; Andrew Bottomley, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Timothy Cloughesy, University of California, Los Angeles, Los Angeles; Christina Theodore-Oklota and Arliene Ravelo, Genentech, South San Francisco, CA; Wolfgang Wick, University...

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.

title: Bevacizumab plus Radiotherapy–Temozolomide for Newly Diagnosed Glioblastoma

ReferenceCitation: Chinot OL, Macdonald DR, Abrey LE, Zahlmann G, Kerloëguen Y, Cloughesy TF. Response assessment criteria for glioblastoma: practical adaptation and implementation in clinical trials of antiangiogenic therapy. Curr Neurol Neurosci Rep. 2013 May;13(5):347. doi: 10.1007/s11910-013-0347-2. Review.

journal_name: Current Neurology and Neuroscience Reports

title: Response Assessment Criteria for Glioblastoma: Practical Adaptation and Implementation in Clinical Trials of Antiangiogenic Therapy

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Israel
New Zealand
Spain

location_facility: Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Waikato Hospital; Regional Cancer Center

location_facility: Chaim Sheba MC; Pediatric Hematology Oncology

location_facility: Kyungpook National University Hosital; Neuro Sugery

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Pusan National University Hospital; Neuro Sugery

location_facility: BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology

location_facility: Institut Bergonie; Gastro Enterologie Oncologie

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: University of Alabama At Birmingham; Neuro-Oncology

location_facility: Justus-Liebig-Universität Giessen; Neurochirurgische Klinik

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Samsung Medical Center; Neurosurgery Department

location_facility: Norrlands Universitetssjukhus; Cancer Centrum

location_facility: Prince of Wales Hospital; Department of Medical Oncology

location_facility: National Cancer Center Hospital; Neurosurgery

location_facility: Calvary North Adelaide; North Adeliade Oncology Centre

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Scientific Research Neurosurgery Institute; Dept. of Neurooncology

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: University Hospital of Larissa; Oncology

location_facility: Northern Centre for Cancer Care;Oncology

location_facility: Ottawa Hospital Regional Cancer Centre; Neuro-Oncology

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica

location_facility: National Cancer Centre; Neurosurgery Dept

location_facility: Chonnam National University Hwasun Hospital

location_facility: Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

location_facility: Kumamoto University Hospital; Neurosurgery

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre

location_facility: Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

location_facility: Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Catharina Ziekenhuis; Dept of Internal Medicin

location_facility: Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Queen Elizabeth Medical Centre; Neurosurgery

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Institution of Higher Professional Learning Military; Neurooncology

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: Centre Val Aurelle Paul Lamarque; Medecine B3

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: The Royal Marsden NHS Foundation Trust; Oncology

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie

location_facility: North Shore Private Hospital; Northern Specialist Centre

location_facility: Hiroshima University Hospital; Neurosurgery

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

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Papageorgiou General Hospital; Medical Oncology

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

location_facility: Kyorin University Hospital; Neurosurgery

location_facility: Ospedale di Treviso, Universita di Padova; Neurosurgery Dept

location_facility: Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Universitatsklinikum Heidelberg; Abteilung Neuroonkologie

location_facility: Utrecht University Medical Centre; Dept of Medical Oncology and UPC

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Saitama Medical University International Medical Center; Clinical and Medical Oncology

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma

summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.


design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Bayer

primary_purpose: Treatment

location_country:
Peru
Greece
Australia
Belgium
Russian Federation
Taiwan
France
Poland
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Bulgaria
Singapore
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
New Zealand
Spain

acronym: SEARCH

type: EudraCT Number

source: euctr

title: A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

summary: This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.


title: Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome

summary: The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

status: Terminated

primary_purpose: Prevention

ReferenceCitation: Sharma A, Hagström E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.

family: Sharma

full_name: Abhinav Sharma

given: Abhinav

family: Hagström

full_name: Emil Hagström

given: Emil

family: Wojdyla

full_name: Daniel M. Wojdyla

given: Daniel M.

family: Neely

full_name: Megan L. Neely

given: Megan L.

family: Harrington

full_name: Robert A. Harrington

given: Robert A.

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Alexander

full_name: John H. Alexander

given: John H.

family: Goodman

full_name: Shaun G. Goodman

given: Shaun G.

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

journal_name: American Heart Journal

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

family: Inohara

full_name: Taku Inohara

given: Taku

family: Pieper

full_name: Karen Pieper

given: Karen

family: Patel

full_name: Manesh R. Patel

given: Manesh R.

family: Jones

full_name: William Schuyler Jones

given: William Schuyler

family: Tricoci

full_name: Pierluigi Tricoci

given: Pierluigi

family: Mahaffey

full_name: Kenneth W. Mahaffey

given: Kenneth W.

family: James

full_name: Stefan K. James

given: Stefan K.

family: Ohman

full_name: Erik Magnus Ohman

given: Erik Magnus

ReferenceCitation: Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.

ReferenceCitation: Guimarães PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4). pii: e005490. doi: 10.1161/JAHA.117.005490.

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC

name: Instituto do Coração (InCor), Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

journal_name: Journal of the American Heart Association

ReferenceCitation: Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

name: Department of Medicine, Stanford University, Stanford, CA

name: Duke Clinical Research Institute, Durham, NC

name: Green Lane Cardiovascular Service, Auckland, New Zealand

name: Division of Cardiology, University of Alberta, Edmonton, Canada

name: Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

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

repository_institution: The Pennsylvania State University - CiteSeer X

title: Meta‐Analysis of Intracranial Hemorrhage in Acute Coronary Syndromes: Incidence, Predictors, and Clinical Outcomes

ReferenceCitation: Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.

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

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

repositories_institution: University of Zurich - Zurich Open Repository and Archive

title: Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

location_country:
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

location_facility: Sendara Cardiovasular Research Institute

location_facility: The University Of North Carolina At Chapel Hill

location_facility: Cardiovascular Research Institute Of Dallas

location_facility: Wheaton Franciscan Healthcare St. Joseph

location_facility: Alegent Health Clinic Heart & Vascular Specialists

location_facility: Centex Research, Pineloch Medical Clinic

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Dr Kiran C Patel Research Institute At Pepin Heart Hospital

location_facility: Cardiology Associates Of Southeastern Ohio

location_facility: Cardiology Assoicates, Pc/Black Hills Clinical Research Ctr

location_facility: The Heart And Vascular Institute Of Florida

location_facility: Consultants In Cardiovascular Diseases, Inc.

location_facility: Texas Health Research & Education Institute

location_facility: Washington University School Of Medicine

location_facility: Miami Cardiology Clinical Research, L.L.C.

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Central Cardiovascular Institute Of San Antonio

location_facility: Methodist Debakey Heart & Vascular Center

location_facility: Cincinnati Veterans Affairs Medical Center

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Virgina Commonwealth Universitymedical Center

location_facility: Thoracic And Cardiovascular Healthcare Foundation

location_facility: University Of Mississippi Medical Center

location_facility: Richard M. Kastelic M.D. & Associates, P.C.

location_facility: Jacksonville Center For Clinical Research

location_facility: Bermisa Family Practice & Research Center

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Cardiovascular Specialist Of South Florida

location_facility: East Carolina Heart Institute At East Carolina University

location_facility: Great Lakes Heart & Vascular Institute, Pc

location_facility: Louisiana State University Health Sciences Center-Shreveport

location_facility: Cardiovascular Physicians Of North Atlanta

location_facility: Melbourne Internal Medicine Associates (Mima)

location_facility: Alta Pharmaceutical Research Center, Inc.

location_facility: Indian River Cardiovascular Associates, Inc


ReferenceCitation: Diéras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16. Erratum in: Lancet Oncol. 2017 Aug;18(8):e433. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Miles

full_name: David Miles

given: David

family: Verma

full_name: Sunil Verma

given: Sunil

family: Pegram

full_name: Mark Pegram

given: Mark

family: Welslau

full_name: Manfred Welslau

given: Manfred

family: Baselga

full_name: José Baselga

given: José

family: Krop

full_name: Ian E Krop

given: Ian E

family: Blackwell

full_name: Kim Blackwell

given: Kim

family: Hoersch

full_name: Silke Hoersch

given: Silke

family: Xu

full_name: Jin Xu

given: Jin

family: Green

full_name: Marjorie Green

given: Marjorie

family: Gianni

full_name: Luca Gianni

given: Luca

journal_name: The Lancet Oncology

oa_host_type: repository

ReferenceCitation: Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1. Erratum in: N Engl J Med. 2013 Jun 20;368(25):2442.

full_name: Ian E. Krop

given: Ian E.

family: Oh

title: Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer

ReferenceCitation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. Review.

title: Antibody therapy of cancer

location_country:
Finland
Russian Federation
Denmark
Taiwan
India
France
Poland
Canada
Slovenia
Korea, Republic of
Colombia
Sweden
Hong Kong
Switzerland
Philippines
Bulgaria
Singapore
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Mexico
New Zealand
Spain

title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

summary: This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.


ReferenceCitation: Baldwin DS, Loft H, Florea I. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):197-207. doi: 10.1097/YIC.0b013e3283530ad7.

family: Baldwin

full_name: David S. Baldwin

given: David S.

family: Loft

full_name: Henrik Loft

given: Henrik

family: Florea

full_name: Ioana Florea

given: Ioana

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30. Erratum in: CNS Spectr. 2019 Apr;24(2):275.

family: Christensen

full_name: Michael Cronquist Christensen

given: Michael Cronquist

family: McIntyre

full_name: Roger S. McIntyre

given: Roger S.

bso_classification: Social sciences

journal_name: CNS Spectrums

oa_host_type: publisher

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

lead_sponsor: H. Lundbeck A/S

location_country:
South Africa
Chile
Peru
Costa Rica
Finland
France
Hungary
Argentina
Russian Federation
Estonia
Colombia

acronym: Not applicable

title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

summary: The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.


title: A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.

acronym: LIP

summary: To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.

lead_sponsor: Onxeo

location_country:
United States
United Kingdom
France
Poland
Australia
Germany
Czech Republic

location_facility: University Hospital Bulovka 3rd Clinic of Inf. Diseases

location_facility: Hôpital L'Archet 2, Service de Dermatologie

location_facility: Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière

location_facility: Katedra i Klinika Dermatologii Collegium Medicum

location_facility: Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii

location_facility: Hôpital St Jacques Service de Dermatologie

location_facility: Hôpital Saint Louis Paris, Service de Dermatologie 1

location_facility: Clinvest, a Division of Banyan Group, Inc.,

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska

location_facility: NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn

location_facility: Specjalistyczne Gabinety Lekarskie Dermed

location_facility: University Hospital Bulovka Dept. of Dermatology

location_facility: Hopital Fournier, Service de dermatologie

location_facility: General Teaching Hospital, Dep. Of Dermatology

location_facility: Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Central military hospital Dept. of Dermatology


ReferenceCitation: Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.

family: Assael

full_name: Baroukh M. Assael

given: Baroukh M.

family: Pressler

full_name: Tacjana Pressler

given: Tacjana

family: Bilton

full_name: Diana Bilton

given: Diana

family: Fayon

full_name: Michael Fayon

given: Michael

family: Fischer

full_name: Rainald Fischer

given: Rainald

family: Chiron

full_name: Raphael Chiron

given: Raphael

family: LaRosa

full_name: Mario LaRosa

given: Mario

family: Knoop

full_name: Christiane Knoop

given: Christiane

family: McElvaney

full_name: Noel McElvaney

given: Noel

family: Lewis

full_name: Sandra A. Lewis

given: Sandra A.

family: Bresnik

full_name: Mark Bresnik

family: Montgomery

full_name: A. Bruce Montgomery

given: A. Bruce

family: Oermann

full_name: Christopher M. Oermann

given: Christopher M.

journal_name: Journal of Cystic Fibrosis

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: A comparative efficacy trial

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
France
Ireland
Belgium
Portugal
Denmark
United States
United Kingdom

title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)

summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.


title: An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

acronym: FUSE

summary: In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

ReferenceCitation: Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

family: Gatto

full_name: Nicolle M. Gatto

given: Nicolle M.

family: Koralek

full_name: Daniel O. Koralek

given: Daniel O.

family: Bracken

full_name: Michael B. Bracken

given: Michael B.

family: Duggan

full_name: William T. Duggan

given: William T.

family: Lem

full_name: Joanna Lem

given: Joanna

family: Klioze

full_name: Sol Klioze

given: Sol

family: Koch

full_name: Gary G. Koch

given: Gary G.

family: Wise

full_name: Robert A. Wise

given: Robert A.

family: Cohen

full_name: Roger B. Cohen

given: Roger B.

family: Jackson

full_name: Neville C. Jackson

given: Neville C.

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Lung Cancer–Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results

lead_sponsor: Pfizer

location_country:
Finland
Greece
Australia
Belgium
Denmark
Croatia
France
Poland
Slovakia
Norway
Argentina
Canada
South Africa
Sweden
Netherlands
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Estonia

intervention_type: Other


title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)

summary: The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

ReferenceCitation: Tavira B, Cheramy M, Axelsson S, Åkerman L, Ludvigsson J, Casas R. Effect of simultaneous vaccination with H1N1 and GAD-alum on GAD(65)-induced immune response. Diabetologia. 2017 Jul;60(7):1276-1283. doi: 10.1007/s00125-017-4263-x. Epub 2017 Mar 29.

family: Tavira

full_name: Beatriz Tavira

given: Beatriz

family: Cheramy

full_name: Mikael Cheramy

given: Mikael

family: Axelsson

full_name: Stina Axelsson

given: Stina

family: Åkerman

full_name: Linda Åkerman

given: Linda

family: Ludvigsson

full_name: Johnny Ludvigsson

given: Johnny

family: Casas

full_name: Rosaura Casas

given: Rosaura

journal_name: Diabetologia

license: cc-by

license_normalized: cc-by

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Effect of simultaneous vaccination with H1N1 and GAD-alum on GAD65-induced immune response

ReferenceCitation: Ludvigsson J, Chéramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.

name: Department of Clinical and Experimental Medicine; Linköping University; Linköping Sweden

name: Pediatric clinic; County Council of Östergötland; Linköping Sweden

family: Chéramy

full_name: Mikael Chéramy

family: Pihl

full_name: Mikael Pihl

name: for the clinical GAD-study group in Sweden

journal_name: Diabetes/Metabolism Research and Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Ludvigsson J, Krisky D, Casas R, Battelino T, Castaño L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Åman J, Kärdell G, Neiderud Helsingborg J, Lundström G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanås R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NÖ, Åkesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, López Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.

title: GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus

location_country:
Italy
Sweden
United Kingdom
Netherlands
Finland
France
Spain
Germany
Slovenia

location_facility: Hospital Materno-Infantil Clínico de Valencia

location_facility: Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården

location_facility: Hospital Materno-Infantil Vírgen del Camino

location_facility: Barn- och ungdomskliniken, Centralsjukhuset

location_facility: Azienda Ospedaliero, Universitaria di Parma, Pediatria

location_facility: Struttura Complessa di Diabetologia, Ospedale S. Michele

location_facility: Turun yliopistollinen keskussairaala, Lastentautien Klinikka

location_facility: Maternal & Child Health Sciences, University of Dundee

location_facility: Barn- och ungdomskliniken, NU-sjukvården/NÄL

location_facility: Reparto di Pediatria, Ospedale S. Raffaele

location_facility: CHU Timone Enfants, Service de pédiatrie multidisciplinaire

location_facility: Barn- och ungdomskliniken, Länssjukhuset Ryhov

location_facility: Barn- och ungdomscentrum, Universitetssjukhuset MAS

location_facility: Kuopion yliopistollinen sairaala, Lasten klinikka

location_facility: Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig

location_facility: Hopital Robert Debré, Service d'Endocrinologie

location_facility: Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala

location_facility: Barn- och ungdomskliniken, Centrallasarettet

location_facility: Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka

location_facility: Meander Medisch Centrum, Lokatie Elisabeth

location_facility: Barn- och ungdomskliniken, Universitetssjukhuset

location_facility: Barn- och ungdomskliniken, Vrinnevi sjukhus

location_facility: Seinäjoen keskussairaala, Lastentautien poliklinikka

location_facility: Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,

location_facility: Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique

location_facility: Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen

location_facility: Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis

location_facility: Hospital Materno-Infantil Vírgen del Rocío

location_facility: Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco

location_facility: Barn och ungdomsmedicinska kliniken, Centralsjukhuset

location_facility: Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1

location_facility: Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita

location_facility: University Medical Centre Ljubljana, Department of Pediatric Endocrinology

location_facility: Clinica Pediatrica, Università di Genova

location_facility: Barn- och ungdomskliniken, Uddevalla Sjukhus

location_facility: Charité Campus Virchow Childrens Hospital

location_facility: Tampereen yliopistollinen sairaala, Lasten klinikka

location_facility: Unità Operativa di Pediatria, Policlinico

location_facility: Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique


ReferenceCitation: Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: LaMarca

full_name: Anthony LaMarca

given: Anthony

family: Andrade-Villanueva

full_name: Jaime Andrade-Villanueva

given: Jaime

family: Clotet

full_name: Bonaventura Clotet

given: Bonaventura

family: Clumeck

full_name: Nathan Clumeck

given: Nathan

family: Liu

full_name: Ya-Pei Liu

given: Ya-Pei

family: Zhong

full_name: Lijie Zhong

given: Lijie

family: Margot

full_name: Nicolas Margot

given: Nicolas

family: Cheng

full_name: Andrew K Cheng

given: Andrew K

family: Chuck

full_name: Steven L Chuck

given: Steven L

journal_name: The Lancet Infectious Diseases

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

location_facility: The George Washington University Medical Center

location_facility: Southwest Infectious Disease Clinical Research

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: University Health Network, Toronto General Hospital

location_facility: North Texas Infectious Disease Consultants

location_facility: Hopital Saint Antoine - Infectious Desease Department

location_facility: Infectious Disease Specialists of Atlanta (IDSA)

location_facility: Royal Free and University College Medical School

location_facility: Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hopital Pitie Salpetriere - Infectious Deseases Department

location_facility: Complexo Hospitalario Xeral-Cies (Chuvi) Vigo

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: The Emory Clinic, Inc., Division of Infectious Diseases

location_facility: Imperial College Healthcare NHS Trust, St. Mary's Campus

location_facility: Henry Ford Hospital Div of Infectious Disease

location_facility: Hopital Purpan - Service of Infectious Diseases

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)

location_facility: University of Manitoba - Health Sciences Centre

location_facility: Hawaii AIDS Clinical Research Program HACRP

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Instituto de Investigacion Cientifica del Sur

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Tarrant County Infectious Disease Associates

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hospital General Universitario del Elche

location_facility: University of Maryland, Institute of Human Virology

location_facility: Thomas Jefferson University Jefferson Alumni Hall

location_facility: Hospital General Universitario de Alicante

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Community Research Initiative of New England

location_facility: University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit

location_facility: University of Kentucky Healthcare/Bluegrass Care Clinic

location_facility: University Hospital of Montpellier - Gui de Chauliac

location_facility: Immunodeficiency Service, McGill University Health Centre (MUHC)

location_facility: University of Southern California, AIDS Clinical Trials Unit

location_facility: University of Texas Health Science Center at Houston

location_facility: AIDS Healthcare Foundation-Research Center

location_facility: University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice

location_facility: Universita La Sapienza Policlinico Umberto I

location_facility: Brody School of Medicine at East Carolina University

location_facility: University of Puerto Rico, School of Medicine, Proyecto ACTU

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Hopital de Bicentre - Service de medecine Interne et Immunologie

title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

summary:
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents.

Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).


title: A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

summary:
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

To compare the overall survival in the 2 treatment arms
To compare the objective response rate in the 2 treatment arms
To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

ReferenceCitation: Blay JY, Pápai Z, Tolcher AW, Italiano A, Cupissol D, López-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saâda-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Pápai

full_name: Zsuzsanna Pápai

given: Zsuzsanna

family: Tolcher

full_name: Anthony W Tolcher

given: Anthony W

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: López-Pousa

full_name: Antonio López-Pousa

given: Antonio

family: Chawla

full_name: Sant P Chawla

given: Sant P

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Babovic

full_name: Nada Babovic

given: Nada

family: Penel

full_name: Nicolas Penel

family: Isambert

full_name: Nicolas Isambert

family: Staddon

full_name: Arthur P Staddon

given: Arthur P

family: Saâda-Bouzid

full_name: Esma Saâda-Bouzid

given: Esma

family: Santoro

full_name: Armando Santoro

given: Armando

family: Franke

full_name: Fabio A Franke

given: Fabio A

family: Cohen

full_name: Patrick Cohen

given: Patrick

family: Le-Guennec

full_name: Solenn Le-Guennec

given: Solenn

family: Demetri

full_name: George D Demetri

given: George D

lead_sponsor: Sanofi

location_country:
Italy
Brazil
India
Serbia
France
Hungary
Belgium
Spain
United States
United Kingdom

location_facility:
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 056005
Investigational Site Number 380001
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 250009
Investigational Site Number 826001
Investigational Site Number 250001
Investigational Site Number 380004
Investigational Site Number 891002
Investigational Site Number 840004
Investigational Site Number 076005
Investigational Site Number 356005
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 826003
Investigational Site Number 250006
Investigational Site Number 076008
Investigational Site Number 056004
Investigational Site Number 250012
Investigational Site Number 250003
Investigational Site Number 348001
Investigational Site Number 076003
Investigational Site Number 840001
Investigational Site Number 250008
Investigational Site Number 356004
Investigational Site Number 724004
Investigational Site Number 840002
Investigational Site Number 076004
Investigational Site Number 076006
Investigational Site Number 250010
Investigational Site Number 380003
Investigational Site Number 724003
Investigational Site Number 076002
Investigational Site Number 826002
Investigational Site Number 891001
Investigational Site Number 380002
Investigational Site Number 348002
Investigational Site Number 056001
Investigational Site Number 356003
Investigational Site Number 840007
Investigational Site Number 076007
Investigational Site Number 250007
Investigational Site Number 076009


title: A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen

summary: This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

ReferenceCitation: Michaelson MD, Oudard S, Ou YC, Sengeløv L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullèn A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.

name: M. Dror Michaelson, Massachusetts General Hospital Cancer Center, Boston, MA; Stephane Oudard, George Pompidou European Hospital, Rene Descartes University, Paris; Nadine Houede, Institut Bergonie, Bordeaux; Tristan Maurina, CHU de Besançon, Hôpital Jean Minjoz, Besançon, France; Yen-Chuan Ou, Taichung Veterans General Hospital, Taichung, Taiwan; Lisa Sengeløv, Herlev Hospital, Herlev; Gedske Daugaard, Rigshospitalet, Copenhagen, Denmark; Fred Saad, University of Montreal, Montreal, Canada; Peter Ostler,...

family: Michaelson

full_name: M. Dror Michaelson

given: M. Dror

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Ou

full_name: Yen-Chuan Ou

given: Yen-Chuan

family: Sengeløv

full_name: Lisa Sengeløv

given: Lisa

family: Saad

full_name: Fred Saad

given: Fred

family: Houede

full_name: Nadine Houede

given: Nadine

family: Ostler

full_name: Peter Ostler

given: Peter

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Daugaard

full_name: Gedske Daugaard

given: Gedske

family: Jones

full_name: Robert Jones

given: Robert

family: Laestadius

full_name: Fredrik Laestadius

given: Fredrik

family: Ullèn

full_name: Anders Ullèn

given: Anders

family: Bahl

full_name: Amit Bahl

given: Amit

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Gschwend

full_name: Juergen Gschwend

given: Juergen

family: Maurina

full_name: Tristan Maurina

given: Tristan

family: Chow Maneval

full_name: Edna Chow Maneval

given: Edna

family: Wang

full_name: Shaw-Ling Wang

given: Shaw-Ling

family: Lechuga

full_name: Maria Jose Lechuga

given: Maria Jose

family: Paolini

full_name: Jolanda Paolini

given: Jolanda

family: Chen

full_name: Isan Chen

given: Isan

journal_name: Journal of Clinical Oncology

title: Randomized, Placebo-Controlled, Phase III Trial of Sunitinib Plus Prednisone Versus Prednisone Alone in Progressive, Metastatic, Castration-Resistant Prostate Cancer

location_country:
Peru
Finland
Belgium
Australia
Denmark
Czech Republic
Taiwan
France
Poland
Slovakia
Canada
Korea, Republic of
Sweden
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain

status_simplified: Unknown


title: 18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone

summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

lead_sponsor: AstraZeneca

location_country:
Italy
South Africa
Sweden
Mexico
France
Norway
Belgium
Argentina
Denmark


ReferenceCitation: Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26. Erratum in: Lancet Oncol. 2012 May;13(5):e186.

family: Miller

full_name: Vincent A Miller

given: Vincent A

family: Hirsh

full_name: Vera Hirsh

given: Vera

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

full_name: Yuh-Min Chen

given: Yuh-Min

family: Park

full_name: Keunchil Park

given: Keunchil

family: Kim

full_name: Sang-We Kim

given: Sang-We

family: Zhou

full_name: Caicun Zhou

given: Caicun

family: Su

full_name: Wu-Chou Su

given: Wu-Chou

full_name: Mengzhao Wang

given: Mengzhao

family: Sun

full_name: Yan Sun

given: Yan

family: Heo

full_name: Dae Seog Heo

given: Dae Seog

family: Crino

full_name: Lucio Crino

given: Lucio

family: Tan

full_name: Eng-Huat Tan

given: Eng-Huat

family: Chao

full_name: Tsu-Yi Chao

given: Tsu-Yi

family: Shahidi

full_name: Mehdi Shahidi

given: Mehdi

family: Cong

full_name: Xiuyu Julie Cong

given: Xiuyu Julie

family: Lorence

full_name: Robert M Lorence

given: Robert M

family: Yang

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
Germany
France
Thailand
Singapore
Belgium
China
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Phase IIb/III NSCLC Iressa/Tarceva Failures

location_facility: 1200.23.4403 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49004 Johannes Gutenberg-Universität Mainz

location_facility: 1200.23.88603 Chang Gung Memorial Hosp-Linkou

location_facility: 1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)

location_facility: 1200.23.1002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.027 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.056 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH

location_facility: 1200.23.39007 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4405 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.045 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3307A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86008 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.013 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.038 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3305A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3304B Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3306C Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.050 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4406 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3402 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.028 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49003 Asklepios Fachkliniken München-Gauting

location_facility: 1200.23.3401 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3406 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.020 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4401 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.85202 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.046 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3303A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49010 Zentralklinik Bad Berka GmbH

location_facility: 1200.23.86003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3303C Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.024 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88605 China Medical University Hospital

location_facility: 1200.23.66001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88601 National Taiwan University Hospital

location_facility: 1200.23.3301A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88607 Tri-Service General Hospital

location_facility: 1200.23.3304A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3302A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4404 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.029 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86007 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.65001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3403 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.039 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3404 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39008 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3306A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3302B Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3405 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.026 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88604 Taichung Veterans General Hospital

location_facility: 1200.23.1001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88606 National Cheng Kung University Hospital

location_facility: 1200.23.82005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39003 Boehringer Ingelheim Investigational Site

title: Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)

summary:
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.


title: Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

summary:
This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

ReferenceCitation: Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. Erratum in: Diabetes Care. 2007 Apr;30(4):1035.

ReferenceCitation: Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282.

name: Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.

family: Davies

full_name: Melanie J. Davies

given: Melanie J.

name: Outpatient Clinic, Eskulap Gniewkowo, Gniewkowo, Poland.

family: Derezinski

full_name: Tadeusz Derezinski

given: Tadeusz

name: Clinical Research–Levemir, Novo Nordisk A/S, Bagsvaerd, Denmark.

family: Pedersen

full_name: Claus Bang Pedersen

given: Claus Bang

name: Medical & Science–Levemir/NovoRapid, Novo Nordisk A/S, Bagsvaerd, Denmark.

family: Clauson

full_name: Per Clauson

given: Per

journal_name: Diabetes Technology & Therapeutics

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Reduced Weight Gain with Insulin Detemir Compared to NPH Insulin Is Not Explained by a Reduction in Hypoglycemia

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

name: Institute of General Practice and Evidence-Based Health Services Research; Medical University of Graz; Graz Austria

family: Semlitsch

full_name: Thomas Semlitsch

given: Thomas

name: Institute for General Practice; Goethe University; Frankfurt am Main Germany

family: Engler

full_name: Jennifer Engler

given: Jennifer

name: Institute of General Practice and Evidence-Based Health Services Research, Medical University of Graz; Graz, Austria / Institute of General Practice, Goethe University; Frankfurt am Main Austria

family: Siebenhofer

full_name: Andrea Siebenhofer

given: Andrea

name: Institute of General Practice and Evidence-Based Health Services Research / Institute for Medical Informatics, Statistics and Documentation; Medical University of Graz; Graz Austria

family: Jeitler

full_name: Klaus Jeitler

given: Klaus

family: Berghold

full_name: Andrea Berghold

name: Institute of General Practice and Evidence-Based Health Services Research / Department of Internal Medicine, Division of Endocrinology and Metabolism; Medical University of Graz; Graz Austria

family: Horvath

full_name: Karl Horvath

given: Karl

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

summary: Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

lead_sponsor: Sprout Pharmaceuticals, Inc

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
Finland
France
Hungary
Belgium
Spain
Germany
Czech Republic

location_facility: 511.118.44003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3311A Boehringer Ingelheim Investigational Site

location_facility: 511.118.36001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3301A Boehringer Ingelheim Investigational Site

location_facility: 511.118.44007 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3308A Boehringer Ingelheim Investigational Site

location_facility: 511.118.36005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3312A Boehringer Ingelheim Investigational Site

location_facility: 511.118.49006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3310A Boehringer Ingelheim Investigational Site

location_facility: 511.118.31003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31007 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35804 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3303A Boehringer Ingelheim Investigational Site

location_facility: 511.118.31004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35803 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3305A Boehringer Ingelheim Investigational Site

location_facility: 511.118.35805 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3314A Boehringer Ingelheim Investigational Site

location_facility: 511.118.31005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35802 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44008 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46009 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49008 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44009 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44010 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35801 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3306A Boehringer Ingelheim Investigational Site