title: FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

acronym: FORWARD I

summary: This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

ReferenceCitation: Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.

family: Moore

full_name: K.N. Moore

family: Oza

full_name: A.M. Oza

family: Colombo

full_name: N. Colombo

given: N.

family: Oaknin

full_name: A. Oaknin

given: A.

family: Scambia

full_name: G. Scambia

given: G.

family: Lorusso

full_name: D. Lorusso

given: D.

family: Konecny

full_name: G.E. Konecny

family: Banerjee

full_name: S. Banerjee

given: S.

family: Murphy

full_name: C.G. Murphy

family: Tanyi

full_name: J.L. Tanyi

family: Hirte

full_name: H. Hirte

given: H.

family: Konner

full_name: J.A. Konner

family: Lim

full_name: P.C. Lim

family: Prasad-Hayes

full_name: M. Prasad-Hayes

given: M.

family: Monk

full_name: B.J. Monk

family: Pautier

full_name: P. Pautier

given: P.

family: Wang

full_name: J. Wang

given: J.

family: Berkenblit

full_name: A. Berkenblit

family: Vergote

full_name: I. Vergote

given: I.

family: Birrer

full_name: M.J. Birrer

journal_name: Annals of Oncology

lead_sponsor: ImmunoGen, Inc.

location_country:
Italy
United States
Bosnia and Herzegovina
Serbia
Switzerland
France
Czechia
Ireland
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center

location_facility: Florida State University College of Medicine

location_facility: Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga

location_facility: Kantonsspital Winterthur, Medizinische Onkologie

location_facility: McGill University Health Centre - Glen Site

location_facility: State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Mater Private Hospital and Mater Misericordiae University Hospital

location_facility: Institut Català d'Oncologia - Unitad de Investigación Clínica

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: University of Oklahoma Health Sciences Center

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

location_facility: Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)

location_facility: University of California San Diego Medical Center

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center

location_facility: Institut de Cancerologie de L'Ouest - site Paul Papin

location_facility: Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"

location_facility: Sunnybrook Research Institute - Odette Cancer Centre

location_facility: Fairview Hospital, Moll Pavilion Cancer Center

location_facility: Centre hospitalier de l'Université de Montréal

location_facility: Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

location_facility: Levine Cancer Institute - Carolinas Medical Center

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin

location_facility: Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University

location_facility: The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW

location_facility: Servicio de Oncología Médica Hospital Universitario La Paz

location_facility: UCLA Women's Health Clinical Research Unit - OBGYN

location_facility: Froedtert and Medical College of Wisconsin

location_facility: State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"

location_facility: University Clinical Center of Republic of Srpska

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: MD Anderson Cancer Center - Cooper Health

location_facility: Fondazione IRCCS National Cancer Institute

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol

location_facility: University of Texas Southwestern Medical Center


ReferenceType: derived

ReferenceCitation: Matasar MJ, Dreyling M, Leppä S, Santoro A, Pedersen M, Buvaylo V, Fletcher M, Childs BH, Zinzani PL. Feasibility of Combining the Phosphatidylinositol 3-Kinase Inhibitor Copanlisib With Rituximab-Based Immunochemotherapy in Patients With Relapsed Indolent B-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):e886-e894. doi: 10.1016/j.clml.2021.06.021. Epub 2021 Jul 2.

family: Matasar

full_name: Matthew J. Matasar

given: Matthew J.

sequence: first

family: Dreyling

full_name: Martin Dreyling

given: Martin

sequence: additional

family: Leppä

full_name: Sirpa Leppä

given: Sirpa

family: Santoro

full_name: Armando Santoro

given: Armando

family: Pedersen

full_name: Michael Pedersen

given: Michael

family: Buvaylo

full_name: Viktoriya Buvaylo

given: Viktoriya

family: Fletcher

full_name: Monique Fletcher

given: Monique

family: Childs

full_name: Barrett H. Childs

given: Barrett H.

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Lymphoma Myeloma and Leukemia

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Bayer

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Thailand
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Bulgaria
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Centre Hospitalier Universite de Grenoble

location_facility: University Multiprofile Hosp. for Active Treat. Sveti Ivan

location_facility: Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.

location_facility: Sociedad de Investigaciones Medicas Ltda

location_facility: Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: 1st Affiliated hospital of Soochow University

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Centre Universitaire de Sante de l'Estrie

location_facility: Hiroshima Red Cross & Atomic-bomb Survivors Hospital

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: University General Hospital of Athens "ATTIKON"

location_facility: Centro de Investigación Clínica Chapultepec S.A. de C.V.

location_facility: Centre Hospitalier Intercommunal de la Côte Basque-Bayonne

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Multiprofile Hospital for Active Treatment Hristo Botev AD

location_facility: Albert Alberts Stem Cell Transplant Research Centre

location_facility: FuJian Medical University Union Hospital

location_facility: Memorial Sloan Kettering Cancer Center- Bergen

location_facility: Fifth Medical Center, General Hospital of the Chinese People

location_facility: Tianjin Union Medicine Centre (People's Hospital of Tianjin)

location_facility: Saitama Medical University International Medical Center

location_facility: Klinikum der Universität München Grosshadern

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva

location_facility: Turun yliopistollinen keskussairaala, kantasairaala

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: SCL Health Research at St Joseph's Hospital Denver CO

location_facility: Hospital Universitario "José Eleuterio González"

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

location_facility: Faculdade de Ciencias Medicas-Universidade Estadual Campinas

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Centro Especializado en Investigación Clínica S.C.

location_facility: Multidisciplinary Clinical Hosp. 4 Dnipro

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Centre Hospitalier de la Durance - Avignon

location_facility: Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: Wojew. Szpital Specjalistyczny im. M. Kopernika

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Centro de Atencion e Investigacion Clinica en Oncologia SCP

location_facility: Institute of Blood Pathology and Transfusion medicine

location_facility: S.C. Policlinica de Diagnostic Rapid S.A.

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Institut Jules Bordet/Jules Bordet Instituut

location_facility: Centro de Investigaciones Clínicas Viña del Mar Ltda.

location_facility: Tianjin Medical University Cancer Institiute & Hospital

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

summary: The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceCitation: Steensma DP, Fenaux P, Van Eygen K, Raza A, Santini V, Germing U, Font P, Diez-Campelo M, Thepot S, Vellenga E, Patnaik MM, Jang JH, Varsos H, Bussolari J, Rose E, Sherman L, Sun L, Wan Y, Dougherty S, Huang F, Feller F, Rizo A, Platzbecker U. Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study. J Clin Oncol. 2021 Jan 1;39(1):48-56. doi: 10.1200/JCO.20.01895. Epub 2020 Oct 27.

name: Dana-Farber Cancer Institute, Boston, MA

family: Steensma

full_name: David P. Steensma

given: David P.

name: Hôpital Saint-Louis, Université Paris Diderot, Paris, France

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

name: Algemeen Ziekenhuis Groeninge, Kortrijk, Belgium

family: Van Eygen

full_name: Koen Van Eygen

given: Koen

name: Columbia University Medical Center, New York, NY

family: Raza

full_name: Azra Raza

given: Azra

name: MDS Unit, AOU Careggi-University of Florence, Florence, Italy

family: Santini

full_name: Valeria Santini

given: Valeria

name: Klinik für Hämatologie, Onkologie and Klinische lmmunologie, Universitätsklinik Düsseldorf, Heinrich-Heine-Universität, Düsseldorf, Germany

family: Germing

full_name: Ulrich Germing

given: Ulrich

name: Department of Hematology, Hospital General Universitario Gregorio Marañon, Madrid, Spain

family: Font

full_name: Patricia Font

given: Patricia

name: Hematology Department, The University Hospital of Salamanca, Salamanca, Spain

family: Diez-Campelo

full_name: Maria Diez-Campelo

given: Maria

family: Thepot

full_name: Sylvain Thepot

given: Sylvain

name: Department of Hematology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

family: Vellenga

full_name: Edo Vellenga

given: Edo

name: Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN

family: Patnaik

full_name: Mrinal M. Patnaik

given: Mrinal M.

name: Department of Hematology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

family: Jang

full_name: Jun Ho Jang

given: Jun Ho

name: Janssen Research & Development, Raritan, NJ

family: Varsos

full_name: Helen Varsos

given: Helen

family: Bussolari

full_name: Jacqueline Bussolari

given: Jacqueline

family: Rose

full_name: Esther Rose

given: Esther

family: Sherman

full_name: Laurie Sherman

given: Laurie

family: Sun

full_name: Libo Sun

given: Libo

family: Wan

full_name: Ying Wan

given: Ying

family: Dougherty

full_name: Souria Dougherty

given: Souria

family: Huang

full_name: Fei Huang

given: Fei

family: Feller

full_name: Faye Feller

given: Faye

family: Rizo

full_name: Aleksandra Rizo

given: Aleksandra

name: Department of Hematology and Cell Therapy, University Clinic Leipzig, Leipzig, Germany

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

journal_name: Journal of Clinical Oncology

oa_host_type: repository

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

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher: American Society of Clinical Oncology (ASCO)

title: Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion–Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Czechia
Poland
Israel
Belgium
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: Wojewódzki Szpital Specjalistyczny sp.z o.o.

location_facility: A.O. Ospedali Riuniti Marche Nord Presidio Ospedaliero S. Salvatore di Pesaro-Stabilim. di Muraglia

location_facility: Ege Universitesi Tip Fakultesi - Hematology

location_facility: Azienda Ospedaliera Universitaria Careggi di Firenze

location_facility: Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz

location_facility: Ankara University Medical Faculty - Hematology

location_facility: Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Fachärztliche Gemeinschaftspraxis mit Schwerpunkt

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: A.O. Universitaria Policlinico Tor Vergata

location_facility: Pusan National University Hospital - Hematology and Oncology

location_facility: KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi

location_facility: KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi

location_facility: SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

location_facility: Vanderbilt University Medical - Hematology-Oncology

location_facility: University of Alberta Hospital - Hematology Research

location_facility: Chonnam National University Hwasun Hospital

location_facility: Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Kantonsspital St. Gallen - Onkologie/Hämatologie

location_facility: Washington University School of Medicine

location_facility: Fred Hutchinson Cancer Research Center (FHCRC)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Klinikum rechts der Isar an der Technischen Universität München

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: AO S. Andrea, Università degli Studi di Roma La Sapienza

location_facility: Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

location_facility: Texas Oncology/Methodist Charlton Cancer Center

location_facility: The Ohio State Comprehensive Cancer Center

location_facility: Gachon University Gil Medical Center - oncology

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Nottingham University Hospitals NHS Trust

location_facility: CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

location_facility: Tennessee Oncology at Centennial Medical Center

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center

title: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

summary: The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study.


title: A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

acronym: IDHENTIFY

summary: This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.

lead_sponsor: Celgene

location_country:
Italy
Austria
Brazil
Spain
Germany
France
Czechia
Korea, Republic of
Australia
Belgium
Russian Federation
China
Turkey
Denmark
United States
United Kingdom
Canada
Taiwan

location_facility: Medizinische Hochschule HannoverZentrum Innere Medizin

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Montefiore Medical Center Albert Einstein Cancer Center

location_facility: Hematology Dept Azienda Ospedaliero Universitaria Careggi

location_facility: The Third Xiangya hospital of central south university

location_facility: John Radcliffe Hospital The Oxford Radcliffe Hospital Clinical Haematology

location_facility: Shands Cancer Center University of Florida

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: Hospital Universitario Central de Asturias

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Northshore University Healthsystem Research Institute

location_facility: University of Southern California Norris Cancer Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Queens Centre for Oncology & Haematology

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Peter MacCallum Cancer Centre - East Melbourne

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: University of Miami Sylvester Cancer Research Center

location_facility: Copenhagen University Hospital Rigshosptalet

location_facility: The First Hospital of China Medical University

location_facility: Hwasun Chonnam National University Hospital

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: University Hospitals Cleveland Medical Center

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Fujian Medical University Union Hospital

location_facility: Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences

location_facility: UCLA School of Medicine Hematology Oncology

intervention_type: Other


type: Other Identifier

title: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

summary: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. doi: 10.1200/JCO.20.03025. Epub 2021 Mar 1.

name: Medical University of Gdańsk, Gdańsk, Poland

family: Dziadziuszko

full_name: Rafal Dziadziuszko

given: Rafal

name: Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester and The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom

family: Krebs

full_name: Matthew G. Krebs

given: Matthew G.

name: Department of Oncology and Hematology-Oncology, Università degli Studi di Milano, Milan, Italy

name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

family: De Braud

full_name: Filippo De Braud

given: Filippo

name: Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy

family: Siena

full_name: Salvatore Siena

given: Salvatore

name: Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, New York, NY

family: Drilon

full_name: Alexander Drilon

given: Alexander

family: Doebele

full_name: Robert C. Doebele

given: Robert C.

name: University of Minnesota, Department of Medicine, Minneapolis, MN

family: Patel

full_name: Manish R. Patel

given: Manish R.

name: Yonsei Cancer Center, Seoul, Republic of Korea

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Liu

full_name: Stephen V. Liu

given: Stephen V.

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

name: Taipei Veterans General Hospital, Taipei, Taiwan

family: Chiu

full_name: Chao-Hua Chiu

given: Chao-Hua

name: Massachusetts General Hospital, Boston, MA

family: Farago

full_name: Anna F. Farago

given: Anna F.

name: National Taiwan University Hospital, Taipei, Taiwan

family: Lin

full_name: Chia-Chi Lin

given: Chia-Chi

name: Flinders Medical Centre and Flinders University, South Australia, Australia

family: Karapetis

full_name: Christos S. Karapetis

given: Christos S.

name: Hong Kong United Oncology Centre, Hong Kong SAR, China

family: Li

full_name: Yu-Chung Li

given: Yu-Chung

family: Day

full_name: Bann-mo Day

given: Bann-mo

family: Chen

full_name: David Chen

given: David

family: Wilson

full_name: Timothy R. Wilson

given: Timothy R.

name: Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France

name: Gustave Roussy Cancer Campus, Villejuif, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: repository

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

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion–Positive Non–Small-Cell Lung Cancer

ReferenceCitation: Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. doi: 10.1016/S1470-2045(19)30690-4. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341.

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

repository_institution: University College London - UCL Discovery

repository_institution: The University of Manchester - Research Explorer

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

repositories_institution: The University of Manchester - Research Explorer

repositories_institution: University College London - UCL Discovery

title: Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1–2 trials

ReferenceCitation: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

title: Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1–2 trials

ReferenceCitation: Sigal D, Tartar M, Xavier M, Bao F, Foley P, Luo D, Christiansen J, Hornby Z, Maneval EC, Multani P. Activity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. J Natl Compr Canc Netw. 2017 Nov;15(11):1317-1322. doi: 10.6004/jnccn.2017.7029.

journal_name: Journal of the National Comprehensive Cancer Network

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

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire

location_facility: Institut de Recherche en Cancérologie de Montpellier

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: NCT Uniklinikum Heidelberg; Medizinische Onkologie

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Università Campus Bio-Medico di Roma; Oncologia Medica

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Shizuoka Cancer Center; Respiratory Internal Medicine

location_facility: Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit

location_facility: Fondazione del Piemonte per l'Oncologia - IRCCS;Ematologia

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte ; Charite Comprehensive Cancer Center

location_facility: University of California San Diego Moores Cancer Center; Dept of Lung Cancer

location_facility: Hospital Universitario de La Princesa; Servicio de Oncologia

location_facility: Cancer Treatment Centers of America; Tulsa

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Cancer Treatment Centers of America - Eastern Regional Medical Center

location_facility: Universitaetsklinikum Koeln; Innere Medizin I, Haematologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Western Regional Medical Center at Cancer Treatment Centers of America

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology

location_facility: Kindai University Hospital; Medical Oncology

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; Unidad de Fase I-Oncologica

location_facility: Hospital Universitario Ramon y Cajal; Servicio de Farmacia

location_facility: Hôpital Européen Georges Pompidou; Hématologie Oncologie

location_facility: Azienda Ospedaliero Universitaria San Martino; Lung Cancer Unit

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria S.Luigi Gonzaga; SSD Oncologia Polmonare

location_facility: Hyogo Cancer Center, Dept of Respiratory Medicine

location_facility: University Hospital Medical Oncology Clinic; Harold C. Simmons Comprehensive Cancer Center

location_facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

location_facility: Advocate Medical Group - Park Ridge, Luther Lane - Oncology

location_facility: University of Southern California Medical Center

location_facility: A.O Città della Salute e della Scienza di Torino; Colorectal Cancer Unit (CRCU) - SSCVD

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitari Vall dHebron; Oncology

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Univ Of California Irvine College Of Medicine; 300194620

location_facility: Dignity Health St Joseph's Hospital and Medical Center

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Weinberg Cancer Institution at Franklin Square

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology

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

location_facility: National University Hospital; Haematology/Oncology

location_facility: Wheaton Franciscan Cancer Care-All Saints

location_facility: NHO Shikoku Cancer Center; Dept of Respiratory Medicine

location_facility: Niigata Cancer Center Hospital; Internal Medicine

location_facility: National Cancer Center Hospital; Dept of Respiratory Medicine

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology


title: A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

summary: The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Ackaert O, McDougall D, Pérez-Ruixo C, Pérez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.

family: Ackaert

full_name: Oliver Ackaert

given: Oliver

family: McDougall

full_name: David McDougall

family: Pérez-Ruixo

full_name: Carlos Pérez-Ruixo

given: Carlos

full_name: Juan Jose Pérez-Ruixo

given: Juan Jose

family: Jezorwski

full_name: John Jezorwski

given: John

family: Crauwels

full_name: Herta M. Crauwels

given: Herta M.

bso_classification: Chemistry

journal_name: The AAPS Journal

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Orkin C, Eron JJ, Rockstroh J, Podzamczer D, Esser S, Vandekerckhove L, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Opsomer M; AMBER study group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2020 Apr 1;34(5):707-718. doi: 10.1097/QAD.0000000000002463.

family: Orkin

full_name: Chloe Orkin

given: Chloe

family: Eron

full_name: Joseph J. Eron

given: Joseph J.

family: Rockstroh

full_name: Jürgen Rockstroh

given: Jürgen

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Esser

full_name: Stefan Esser

given: Stefan

family: Vandekerckhove

full_name: Linos Vandekerckhove

given: Linos

family: Van Landuyt

full_name: Erika Van Landuyt

given: Erika

family: Lathouwers

full_name: Erkki Lathouwers

given: Erkki

family: Hufkens

full_name: Veerle Hufkens

given: Veerle

family: Opsomer

full_name: Magda Opsomer

given: Magda

journal_name: AIDS

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.

name: Janssen Pharmaceutica NV, Beerse, Belgium.

name: Janssen Scientific Affairs, LLC, Titusville, New Jersey.

name: Janssen Research & Development LLC, Raritan, New Jersey.

name: Janssen Research & Development, Pennington, New Jersey.

name: on behalf of the AMBER and EMERALD Study Groups

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

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be

ReferenceCitation: Rashbaum B, Spinner CD, McDonald C, Mussini C, Jezorwski J, Luo D, Van Landuyt E, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study. HIV Res Clin Pract. 2019 Feb;20(1):24-33. doi: 10.1080/15284336.2019.1608714. Epub 2019 May 29.

name: Capital Medical Associates, Washington, DC, USA;

name: University Hospital Klinikum rechts der Isar, Technische Universität München, Munich, Germany;

name: Tarrant County Infectious Disease Associates, Fort Worth, TX, USA;

name: University of Modena and Reggio Emilia, Modena, Italy;

name: Janssen Research & Development, LLC, Pennington, NJ, USA;

name: Janssen Research & Development, LLC, Titusville, NJ, USA;

name: Janssen Research & Development, Beerse, Belgium;

name: Janssen Scientific Affairs, LLC, Titusville, NJ, USA

ReferenceCitation: Eron JJ, Orkin C, Gallant J, Molina JM, Negredo E, Antinori A, Mills A, Reynes J, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Vanveggel S, Opsomer M; AMBER study group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018 Jul 17;32(11):1431-1442. doi: 10.1097/QAD.0000000000001817.

location_country:
United States
Germany
France
Poland
Belgium
Puerto Rico
Russian Federation
Spain
Canada
United Kingdom


title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression

summary: The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

family: Doty

full_name: Richard L. Doty

given: Richard L.

family: Popova

full_name: Vanina Popova

given: Vanina

family: Wylie

full_name: Crystal Wylie

given: Crystal

family: Fedgchin

full_name: Maggie Fedgchin

given: Maggie

family: Daly

full_name: Ella Daly

given: Ella

family: Janik

full_name: Adam Janik

given: Adam

family: Ochs-Ross

full_name: Rachel Ochs-Ross

given: Rachel

family: Lane

full_name: Rosanne Lane

given: Rosanne

family: Lim

full_name: Pilar Lim

given: Pilar

family: Cooper

full_name: Kim Cooper

given: Kim

family: Melkote

full_name: Rama Melkote

given: Rama

family: Jamieson

full_name: Carol Jamieson

given: Carol

family: Singh

full_name: Jaskaran Singh

given: Jaskaran

family: Drevets

full_name: Wayne C. Drevets

given: Wayne C.

journal_name: CNS Drugs

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

ReferenceCitation: Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

family: Perez-Ruixo

full_name: Carlos Perez-Ruixo

family: Rossenu

full_name: Stefaan Rossenu

given: Stefaan

family: Zannikos

full_name: Peter Zannikos

given: Peter

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

name: Janssen Research & Development, LLC Raritan New Jersey USA

name: Janssen Research & Development, LLC Titusville New Jersey USA

name: Former employee of Janssen Research and Development, LLC Titusville New Jersey USA

name: Janssen Research & Development, LLC San Diego California USA

name: Neurocrine Biosciences San Diego California USA

title: Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression

location_country:
Brazil
South Africa
Sweden
Finland
France
Bulgaria
Lithuania
Poland
Belgium
Spain
United States
United Kingdom


title: A Randomized, Open-label, Phase 3 Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing

acronym: ARROW

summary: The purpose of the study is to compare the progression-free survival (PFS) of once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in adults with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

ReferenceType: background

ReferenceCitation: Moreau P, Mateos MV, Berenson JR, Weisel K, Lazzaro A, Song K, Dimopoulos MA, Huang M, Zahlten-Kumeli A, Stewart AK. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018 Jul;19(7):953-964. doi: 10.1016/S1470-2045(18)30354-1. Epub 2018 Jun 1. Erratum in: Lancet Oncol. 2018 Aug;19(8):e382.

ReferenceCitation: Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Iida

full_name: Shinsuke Iida

given: Shinsuke

family: Huang

full_name: Shang-Yi Huang

given: Shang-Yi

family: Takezako

full_name: Naoki Takezako

given: Naoki

family: Chng

full_name: Wee Joo Chng

given: Wee Joo

family: Zahlten-Kumeli

full_name: Anita Zahlten-Kumeli

given: Anita

family: Sersch

full_name: Martina A. Sersch

given: Martina A.

family: Li

full_name: Julia Li

given: Julia

full_name: Mei Huang

given: Mei

family: Lee

full_name: Jae Hoon Lee

given: Jae Hoon

journal_name: International Journal of Hematology

ReferenceCitation: Moreau P, Kumar S, Boccia R, Iida S, Goldschmidt H, Cocks K, Trigg A, Zahlten-Kumeli A, Yucel E, Panjabi SS, Dimopoulos M. Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m(2) vs. twice-weekly 27 mg/m(2) carfilzomib (randomized A.R.R.O.W. study). Leukemia. 2019 Dec;33(12):2934-2946. doi: 10.1038/s41375-019-0480-2. Epub 2019 May 15.

family: Kumar

full_name: Shaji Kumar

given: Shaji

family: Boccia

full_name: Ralph Boccia

given: Ralph

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

family: Cocks

full_name: Kim Cocks

family: Trigg

full_name: Andrew Trigg

given: Andrew

family: Yucel

full_name: Emre Yucel

title: Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m2 vs. twice-weekly 27 mg/m2 carfilzomib (randomized A.R.R.O.W. study)

location_country:
Italy
United States
Sweden
Spain
Germany
Finland
France
Czechia
Greece
Japan
Poland
Norway
Hungary
Belgium
Australia
New Zealand
Romania
Denmark
Canada
United Kingdom

location_facility: John Theurer Cancer Center at Hackensack University Medical Center


type: Registry Identifier

title: An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

summary: The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.

ReferenceCitation: Danese S, Sandborn WJ, Colombel JF, Vermeire S, Glover SC, Rimola J, Siegelman J, Jones S, Bornstein JD, Feagan BG. Endoscopic, Radiologic, and Histologic Healing With Vedolizumab in Patients With Active Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1007-1018.e7. doi: 10.1053/j.gastro.2019.06.038. Epub 2019 Jul 4.

family: Danese

full_name: Silvio Danese

given: Silvio

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Colombel

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Glover

full_name: Sarah C. Glover

given: Sarah C.

family: Rimola

full_name: Jordi Rimola

given: Jordi

family: Siegelman

full_name: Jenifer Siegelman

given: Jenifer

family: Jones

full_name: Stephen Jones

given: Stephen

family: Bornstein

full_name: Jeffrey D. Bornstein

given: Jeffrey D.

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

journal_name: Gastroenterology

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
LIRIAS (KU Leuven)
Zenodo

repositories_institution:
INFN Catania - INFM-OAR
KU Leuven - Lirias

title: Endoscopic, Radiologic, and Histologic Healing With Vedolizumab in Patients With Active Crohn’s Disease

lead_sponsor: Takeda

location_country:
Italy
United States
France
Czechia
Poland
Hungary
Belgium
Canada

status_simplified: Completed


ReferenceCitation: Raevens S, Fallon MB. PORTICO: First Randomized Controlled Trial of Vasomodulator Therapy in Portopulmonary Hypertension. Hepatology. 2020 May;71(5):1870-1872. doi: 10.1002/hep.31166.

name: Department of Gastroenterology and Hepatology – Hepatology Research Unit Ghent University – Ghent University Hospital Ghent Belgium

name: Department of Internal Medicine University of Arizona College of Medicine Phoenix AZ

family: Raevens

full_name: Sarah Raevens

given: Sarah

family: Fallon

full_name: Michael B. Fallon

given: Michael B.

journal_name: Hepatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Sitbon O, Bosch J, Cottreel E, Csonka D, de Groote P, Hoeper MM, Kim NH, Martin N, Savale L, Krowka M. Macitentan for the treatment of portopulmonary hypertension (PORTICO): a multicentre, randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2019 Jul;7(7):594-604. doi: 10.1016/S2213-2600(19)30091-8. Epub 2019 Jun 6.

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Bosch

full_name: Jaume Bosch

given: Jaume

family: Cottreel

full_name: Emmanuelle Cottreel

given: Emmanuelle

family: Csonka

full_name: Denes Csonka

given: Denes

family: de Groote

full_name: Pascal de Groote

given: Pascal

family: Hoeper

full_name: Marius M Hoeper

given: Marius M

family: Kim

full_name: Nick H Kim

given: Nick H

family: Martin

full_name: Nicolas Martin

given: Nicolas

family: Savale

full_name: Laurent Savale

given: Laurent

family: Krowka

full_name: Michael Krowka

given: Michael

journal_name: The Lancet Respiratory Medicine

lead_sponsor: Actelion

location_country:
Brazil
Germany
France
Czechia
Spain
United States
United Kingdom

acronym: PORTICO

location_facility: CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine

location_facility: Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: University of Florida College of Medicine

location_facility: Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"

location_facility: Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination

location_facility: Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie

location_facility: University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

location_facility: Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U

location_facility: Medizinische Hochschule Hannover, Abteilung Pneumologie

location_facility: Hôpital Kremlin Bicêtre Service de Pneumologie

location_facility: IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)

location_facility: University of Florida - Divison of Pulmonary Critical Care & Sleep

location_facility: University of New Mexico Health Science Center

location_facility: Cleveland Clinic - Department of Cardiovascular Medicine

location_facility: University of Colorado Health Sciences Center Aurora

location_facility: Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre

location_facility: Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"

location_facility: CHU Côte de Nacre, Service de Pneumologie

location_facility: CHRU de Grenoble, Hôpital Albert Michallon

location_facility: The Royal Free Hospital/ Cardiology Department

location_facility: Hospital Clinico i Provincial Servicio de Neumología

location_facility: Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"

title: A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

summary: 24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.


ReferenceCitation: Kozal M, Aberg J, Pialoux G, Cahn P, Thompson M, Molina JM, Grinsztejn B, Diaz R, Castagna A, Kumar P, Latiff G, DeJesus E, Gummel M, Gartland M, Pierce A, Ackerman P, Llamoso C, Lataillade M; BRIGHTE Trial Team. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020 Mar 26;382(13):1232-1243. doi: 10.1056/NEJMoa1902493.

ReferenceCitation: Anderson SJ, Murray M, Cella D, Grossberg R, Hagins D, Towner W, Wang M, Clark A, Pierce A, Llamoso C, Ackerman P, Lataillade M. Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals. Patient. 2021 Jun 28. doi: 10.1007/s40271-021-00534-y. [Epub ahead of print]

family: Anderson

full_name: Sarah-Jane Anderson

given: Sarah-Jane

family: Murray

full_name: Miranda Murray

given: Miranda

family: Cella

full_name: David Cella

given: David

family: Grossberg

full_name: Robert Grossberg

given: Robert

family: Hagins

full_name: Debbie Hagins

given: Debbie

family: Towner

full_name: William Towner

given: William

family: Wang

full_name: Marcia Wang

given: Marcia

family: Clark

full_name: Andrew Clark

given: Andrew

family: Pierce

full_name: Amy Pierce

given: Amy

family: Llamoso

full_name: Cyril Llamoso

given: Cyril

family: Ackerman

full_name: Peter Ackerman

given: Peter

family: Lataillade

full_name: Max Lataillade

given: Max

journal_name: The Patient - Patient-Centered Outcomes Research

ReferenceCitation: Lataillade M, Lalezari JP, Kozal M, Aberg JA, Pialoux G, Cahn P, Thompson M, Molina JM, Moreno S, Grinsztejn B, Diaz RS, Castagna A, Kumar PN, Latiff GH, De Jesus E, Wang M, Chabria S, Gartland M, Pierce A, Ackerman P, Llamoso C. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020 Nov;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X.

family: Lalezari

full_name: Jacob P Lalezari

given: Jacob P

family: Kozal

full_name: Michael Kozal

family: Aberg

full_name: Judith A Aberg

given: Judith A

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: Cahn

full_name: Pedro Cahn

given: Pedro

family: Thompson

full_name: Melanie Thompson

given: Melanie

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Moreno

full_name: Santiago Moreno

given: Santiago

ReferenceCitation: Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis. Clin Transl Sci. 2020 Jul;13(4):769-776. doi: 10.1111/cts.12763. Epub 2020 Mar 19.

name: GlaxoSmithKline Collegeville Pennsylvania USA

name: ViiV Healthcare Research Triangle Park North Carolina USA

name: ViiV Healthcare Branford Connecticut USA

title: Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure–Response Analysis

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Poland
Argentina
Canada
Colombia
South Africa
Chile
Netherlands
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain

title: A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)

summary: The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.


ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Italy
United States
Chile
Mexico
Spain
Germany
France
Czechia
Greece
Israel
Argentina
Australia
Portugal
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Colombia

acronym: ESTAIR

location_facility:
Investigational Site Number 376003
Investigational Site Number 250005
Investigational Site Number 792005
Investigational Site Number 410006
Investigational Site Number 376004
Investigational Site Number 410004
Investigational Site Number 724001
Investigational Site Number 840011
Investigational Site Number 840008
Investigational Site Number 380005
Investigational Site Number 792002
Investigational Site Number 620003
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 032002
Investigational Site Number 208002
Investigational Site Number 792003
Investigational Site Number 124003
Investigational Site Number 036002
Investigational Site Number 724007
Investigational Site Number 276003
Investigational Site Number 152006
Investigational Site Number 032004
Investigational Site Number 724002
Investigational Site Number 152002
Investigational Site Number 250002
Investigational Site Number 840014
Investigational Site Number 250009
Investigational Site Number 840009
Investigational Site Number 250001
Investigational Site Number 484003
Investigational Site Number 840020
Investigational Site Number 840023
Investigational Site Number 826003
Investigational Site Number 300001
Investigational Site Number 152001
Investigational Site Number 250003
Investigational Site Number 032009
Investigational Site Number 840001
Investigational Site Number 124002
Investigational Site Number 203001
Investigational Site Number 410003
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 036004
Investigational Site Number 152007
Investigational Site Number 170004
Investigational Site Number 724005
Investigational Site Number 826002
Investigational Site Number 840013
Investigational Site Number 826004
Investigational Site Number 276002
Investigational Site Number 410005
Investigational Site Number 484001
Investigational Site Number 792001
Investigational Site Number 380001
Investigational Site Number 032001
Investigational Site Number 380004
Investigational Site Number 840015
Investigational Site Number 276004
Investigational Site Number 032007
Investigational Site Number 036003
Investigational Site Number 724006
Investigational Site Number 032005
Investigational Site Number 250008
Investigational Site Number 792004
Investigational Site Number 840002
Investigational Site Number 203004
Investigational Site Number 380006
Investigational Site Number 380002
Investigational Site Number 484005
Investigational Site Number 840024
Investigational Site Number 203003
Investigational Site Number 840022
Investigational Site Number 203002
Investigational Site Number 620004
Investigational Site Number 276001
Investigational Site Number 250004
Investigational Site Number 376001
Investigational Site Number 826001
Investigational Site Number 376005
Investigational Site Number 036001
Investigational Site Number 840026
Investigational Site Number 840003
Investigational Site Number 484002
Investigational Site Number 250006
Investigational Site Number 376002
Investigational Site Number 840017
Investigational Site Number 840006
Investigational Site Number 410002
Investigational Site Number 724004
Investigational Site Number 152003
Investigational Site Number 152004
Investigational Site Number 036005
Investigational Site Number 170005
Investigational Site Number 276005
Investigational Site Number 208001
Investigational Site Number 170001
Investigational Site Number 840012
Investigational Site Number 250007
Investigational Site Number 792006

ipd_sharing: Yes

title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

summary:
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.


ReferenceCitation: West H, McCleod M, Hussein M, Morabito A, Rittmeyer A, Conter HJ, Kopp HG, Daniel D, McCune S, Mekhail T, Zer A, Reinmuth N, Sadiq A, Sandler A, Lin W, Ochi Lohmann T, Archer V, Wang L, Kowanetz M, Cappuzzo F. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20.

family: West

full_name: Howard West

given: Howard

family: McCleod

full_name: Michael McCleod

given: Michael

family: Hussein

full_name: Maen Hussein

given: Maen

family: Morabito

full_name: Alessandro Morabito

given: Alessandro

family: Rittmeyer

full_name: Achim Rittmeyer

given: Achim

family: Conter

full_name: Henry J Conter

given: Henry J

family: Kopp

full_name: Hans-Georg Kopp

given: Hans-Georg

family: Daniel

full_name: Davey Daniel

given: Davey

family: McCune

full_name: Steven McCune

given: Steven

family: Mekhail

full_name: Tarek Mekhail

given: Tarek

family: Zer

full_name: Alona Zer

given: Alona

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

family: Sadiq

full_name: Ahad Sadiq

given: Ahad

family: Sandler

full_name: Alan Sandler

given: Alan

family: Lin

full_name: Wei Lin

given: Wei

family: Ochi Lohmann

full_name: Tania Ochi Lohmann

given: Tania

family: Archer

full_name: Venice Archer

given: Venice

full_name: Lijia Wang

given: Lijia

family: Kowanetz

full_name: Marcin Kowanetz

given: Marcin

family: Cappuzzo

full_name: Federico Cappuzzo

given: Federico

journal_name: The Lancet Oncology

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Germany
France
Israel
Belgium
Spain
Canada

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Cancer Care Network of South Texas - SAT & BC

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Hospital General Universitario de Guadalajara

location_facility: University of Iowa Hospitals and Clinics

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Walter Reed National Military Medical Center

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie

location_facility: Duke University Medical Center; Department of Medicine

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Kaiser Permanente - San Jose Medical Center

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Praxis fur Haematologie und Internistische Onkologie

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: University of Miami School of Medicine - Sylvester at Deerfield

location_facility: Southern Illinois University, Simmons Cancer Institute

location_facility: Suburban Hematology / Oncology Associates

location_facility: Kaiser Permanente Medical Center - Roseville

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Hopital American de Paris (American Hospital of Paris)

location_facility: Fort Wayne Med Oncology & Hematology Inc

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

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Centre D'oncologie de Gentilly; Service Oncologie Medicale

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

location_facility: HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Fondation Hopital Saint Joseph;Cardiologie Clinique

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

summary: This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).


ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
France
Czechia
Greece
Poland
Norway
Belgium
Russian Federation
Spain
Turkey
Germany
United Kingdom

acronym: PRESIDE

location_facility:
Site BE32004
Site ES34006
Site GB44004
Site DE49018
Site IT39010
Site BE32002
Site RU70005
Site FR33014
Site CZ42003
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Site GB44003
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Site PL48002
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Site TR90002
Site DE49001
Site NO47005
Site AT43004

title: A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone

summary: The purpose of the study is to understand if there is benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when treated with enzalutamide alone.


title: A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

family: Zhang

full_name: Qu Zhang

given: Qu

family: Luo

full_name: Jia Luo

given: Jia

family: Wu

full_name: Song Wu

given: Song

family: Si

full_name: Han Si

given: Han

family: Gao

full_name: Chen Gao

given: Chen

family: Xu

full_name: Wenjing Xu

given: Wenjing

family: Abdullah

full_name: Shaad E. Abdullah

given: Shaad E.

family: Higgs

full_name: Brandon W. Higgs

given: Brandon W.

family: Dennis

full_name: Phillip A. Dennis

given: Phillip A.

family: van der Heijden

full_name: Michiel S. van der Heijden

given: Michiel S.

family: Segal

full_name: Neil H. Segal

given: Neil H.

family: Chaft

full_name: Jamie E. Chaft

given: Jamie E.

family: Hembrough

full_name: Todd Hembrough

given: Todd

family: Barrett

full_name: J. Carl Barrett

given: J. Carl

family: Hellmann

full_name: Matthew D. Hellmann

given: Matthew D.

journal_name: Cancer Discovery

oa_colors: green other

evidence: open (via free pdf)

version: acceptedVersion

publisher: American Association for Cancer Research (AACR)

lead_sponsor: MedImmune LLC

location_country:
United States
Netherlands
France
Korea, Republic of
Israel
Spain
Germany
United Kingdom
Canada

intervention_type: Biological


title: A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population

acronym: EXTEND

summary: The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

ReferenceCitation: Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.

family: Cornely

full_name: Oliver A. Cornely

given: Oliver A.

family: Vehreschild

full_name: Maria J. G. T. Vehreschild

given: Maria J. G. T.

family: Adomakoh

full_name: Nicholas Adomakoh

given: Nicholas

family: Georgopali

full_name: Areti Georgopali

given: Areti

family: Karas

full_name: Andreas Karas

given: Andreas

family: Kazeem

full_name: Gbenga Kazeem

given: Gbenga

family: Guery

full_name: Benoit Guery

given: Benoit

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: Université de Lausanne - SERVAL

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

ReferenceCitation: Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.

family: Menichetti

full_name: Francesco Menichetti

given: Francesco

family: Anttila

full_name: Veli-Jukka Anttila

given: Veli-Jukka

family: Aguado

full_name: Jose Maria Aguado

given: Jose Maria

family: Bisnauthsing

full_name: Karen Bisnauthsing

given: Karen

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Finland
Greece
Romania
Belgium
Russian Federation
Denmark
Croatia
France
Poland
Slovenia
Sweden
Switzerland
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Spain
Turkey

location_facility:
Site PT35102
Site ES34006
Site IT39009
Site DK45001
Site PL48008
Site HR38501
Site FR33007
Site IT39010
Site PL48012
Site IT39007
Site CZ42003
Site RO40001
Site ES34005
Site IT39006
Site PL48011
Site SI38605
Site DE49012
Site SI38601
Site FR33004
Site IT39005
Site TR90005
Site AT43002
Site GR30004
Site PT35107
Site SI38602
Site CZ42002
Site AT43003
Site TR90003
Site BE32001
Site TR90001
Site BE32005
Site TR90006
Site FR33008
Site TR90004
Site DK45004
Site HU36010
Site CZ42004
Site IE35302
Site DE49006
Site FI35801
Site HR38503
Site CZ42001
Site GR30008
Site IT39001
Site PT35104
Site DE49011
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Site GR30005
Site HU36007
Site FR33006
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Site IT39002
Site PT35106
Site ES34004
Site SE46005
Site RU70001
Site GB44008
Site FR33009
Site GB44006
Site GR30007
Site BE32006
Site FR33002
Site CH41001
Site FR33001
Site TR90007
Site GB44010
Site RO40002
Site HR38505
Site DE49016
Site HU36004
Site ES34003
Site HU36008
Site IT39003
Site HR38506
Site FI35802
Site HU36009
Site GR30006
Site DK45005
Site CZ42005
Site SI38603
Site FR33003
Site RU70003
Site SE46004
Site PL48003
Site HU36006
Site GR30010
Site BE32008
Site SE46001
Site HU36005
Site CH41002
Site PL48004
Site AT43001
Site IT39004
Site CH41004
Site GR30009
Site PT35101
Site GB44003
Site FR33005
Site GB44005
Site PL48002
Site IE35304
Site TR90002
Site HU36001
Site DE49001
Site BE32007
Site GB44009
Site DE49008


title: A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).

acronym: ARCTIC

summary: This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®).

ReferenceCitation: Martin ML, Correll J, Walding A, Rydén A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2021 May 31. doi: 10.1007/s11136-021-02882-6. [Epub ahead of print]

family: Martin

full_name: Mona L. Martin

given: Mona L.

family: Correll

full_name: Julia Correll

given: Julia

family: Walding

full_name: Andrew Walding

given: Andrew

family: Rydén

full_name: Anna Rydén

given: Anna

journal_name: Quality of Life Research

ReferenceCitation: Planchard D, Reinmuth N, Orlov S, Fischer JR, Sugawara S, Mandziuk S, Marquez-Medina D, Novello S, Takeda Y, Soo R, Park K, McCleod M, Geater SL, Powell M, May R, Scheuring U, Stockman P, Kowalski D. ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer. Ann Oncol. 2020 May;31(5):609-618. doi: 10.1016/j.annonc.2020.02.006. Epub 2020 Feb 20.

family: Planchard

full_name: D. Planchard

given: D.

family: Reinmuth

full_name: N. Reinmuth

given: N.

family: Orlov

full_name: S. Orlov

given: S.

family: Fischer

full_name: J.R. Fischer

family: Sugawara

full_name: S. Sugawara

family: Mandziuk

full_name: S. Mandziuk

family: Marquez-Medina

full_name: D. Marquez-Medina

family: Novello

full_name: S. Novello

family: Takeda

full_name: Y. Takeda

given: Y.

family: Soo

full_name: R. Soo

given: R.

family: Park

full_name: K. Park

given: K.

family: McCleod

full_name: M. McCleod

given: M.

family: Geater

full_name: S.L. Geater

family: Powell

full_name: M. Powell

family: May

full_name: R. May

family: Scheuring

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

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Serbia
Czechia
Israel
Spain


title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

acronym: TOPAZ-I

summary: The purpose of this study is to evaluate Long-term outcomes following treatment with ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Norway
Canada
Sweden
Saudi Arabia
Switzerland
Netherlands
Bulgaria
Ireland
Algeria
Portugal
Germany
United Kingdom
Italy
Austria
Mexico
Israel
Spain
Turkey

location_facility: King's College Hospital NHS Foundation Trust /ID# 131157

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 132179

location_facility: St. James University Hospital /ID# 132305

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106

location_facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143

location_facility: Hospital General Universitario Santa Lucia /ID# 131139

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 132292

location_facility: Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie "Dr. Victor Babes" /Id# 131126

location_facility: Tolyatti City Clinical Hospital #1 /ID# 132273

location_facility: General University Hospital of Alexandroupolis /ID# 131056

location_facility: Policlinico Agostino Gemelli /ID# 131098

location_facility: General Hospital of Athens Laiko /ID# 131088

location_facility: Azienda Sanitaria Universitaria Friuli Centrale /ID# 132196

location_facility: St Vincent's University Hosp /ID# 132181

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031

location_facility: Hospital Universitari Son Espases /ID# 131140

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 131137

location_facility: Medizinische Universität Graz /ID# 131018

location_facility: Vancouver Infectious Diseases Centre /ID# 134369

location_facility: Hospital Universitario La Paz /ID# 131132

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 134370

location_facility: South-Ural State Med. Academy /ID# 132274

location_facility: Istanbul University Istanbul Medical Faculty /ID# 131153

location_facility: AOU Citta della Salute Scienza /ID# 131100

location_facility: KH der Elisabethinen Linz GmbH /ID# 131017

location_facility: Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051

location_facility: Moscow Clinical Scientific Center /ID# 132266

location_facility: Azienda Ospedaliera - Polo Uni /ID# 132198

location_facility: Greenslopes Private Hospital /ID# 131003

location_facility: Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107

location_facility: Diagnostic Consultative Center /ID# 131027

location_facility: Universitair Ziekenhuis Leuven /ID# 131021

location_facility: Universita di Napoli Federico II /ID# 132191

location_facility: Institutul Nat. de Boli Infectioase /ID# 131124

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120

location_facility: A.O.U. Policlinico G. Martino /ID# 132193

location_facility: Samara State Medical University /ID# 136913

location_facility: Saint John Regional Hospital /ID# 131210

location_facility: Clinical Infectious Diseases Hospital #1 /ID# 132272

location_facility: Montreal General Hospital - McGill University Health Center /ID# 132166

location_facility: ITESM campus Ciudad de Mexico /ID# 132383

location_facility: Aarhus Univ Hospital, Skejby /ID# 131030

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118

location_facility: Hospital Universitario Virgen de la Victoria /ID# 131136

location_facility: Tel Aviv Sourasky Medical Center /ID# 132182

location_facility: Medizinisches Versorgungszentrum Düsseldorf /ID# 131052

location_facility: Policlinico Univ Tor Vergata /ID# 132185

location_facility: Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278

location_facility: Uludag University Medical Faculty /ID# 132297

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 131041

location_facility: St. Vincent's Hospital, Darlinghurst /ID# 131001

location_facility: Helsinki Univ Central Hospital /ID# 131034

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 131141

location_facility: Centro Hospitalar do Porto EPE /ID# 131117

location_facility: I. M. Sechenov First Moscow State Medical University /ID# 132275

location_facility: Leids Universitair Medisch Centrum /ID# 132204

location_facility: Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288

location_facility: Instituto Metropolitano de Inv /ID# 132201

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 131053

location_facility: Toronto Digestive Disease Asso /ID# 130968

location_facility: Izmir Tepecik Egitim ve Arastirma Hastanesi /ID# 134968

location_facility: Hacettepe University Faculty of Medicine /ID# 131150

location_facility: Group Practice Gastroenterolog /ID# 131050

location_facility: Azienda Ospedaliero Uni Parma /ID# 132183

location_facility: Hospital Universitario 12 de Octubre /ID# 131133

location_facility: Universita di Napoli Federico II /ID# 131096

location_facility: Medizinische Universitat Wien /ID# 131015

location_facility: Medizinische Hochschule Hannover /ID# 131054

location_facility: St Vincent's Hospital Melbourne /ID# 131000

location_facility: Stavanger University Hospital /ID# 132211

location_facility: Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270

location_facility: Stavropol State Medical Univ /ID# 132279

location_facility: Hospital Universitario Virgen del Rocio /ID# 131134

location_facility: Royal Brisbane and Women's Hospital /ID# 131004

location_facility: Univ Hospitals Birmingham NHS Foundation trust /ID# 131154

location_facility: Universitaetsklinikum Freiburg /ID# 131044

location_facility: Odense Universitets Hospital /ID# 131029

location_facility: Multidisciplinary Consultative and Diagnostic Center /ID# 131130

location_facility: Universitatsklinikum Frankfurt /ID# 131055

location_facility: Centrum für interdisziplinaere Medizin /ID# 131046

location_facility: Inselspital, Universitaetsklinik /ID# 132294

location_facility: Universitaetsklinik Heidelberg /ID# 134371

location_facility: Ministry Nat Guard Hosp Health /ID# 145126

location_facility: Ege University Medical Faculty /ID# 132298

location_facility: The Royal Bournemouth Hospital /ID# 132306

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 134372

location_facility: LMU Klinikum Campus Grosshadern /ID# 131049

location_facility: Central Cliniсal Hospital of teh Russian Academy of Sciences /ID# 132289

location_facility: Hospital Universitario de la Princesa /ID# 131131

location_facility: Centro Hosp de Lisboa Central /ID# 131116

location_facility: GIRI Gastrointestinal Research Institute /ID# 132171

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 131161

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115

location_facility: Hospital Universitario Central de Asturias /ID# 131138

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 131104

location_facility: Hospital Universitario Reina Sofia /ID# 131135

location_facility: Universitaetsklinikum Tuebingen /ID# 131045

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona /ID# 132192

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108

location_facility: Hippokration General Hospital /ID# 131057

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 132293

location_facility: King Khalid University Hospita /ID# 132291

location_facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190

location_facility: Sverdlovsk Regional Clinical Hospital #1 /ID# 132267

location_facility: Akershus Universitetssykehus_MAIN /ID# 132212