title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)

summary:
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.

ReferenceCitation: Boyer M, Sendur MAN, Rodriguez-Abreu D, Park K, Lee DH, Cicin I, Yumuk PF, Orlandi FJ, Leal TA, Molinier O, Soparattanapaisarn N, Langleben A, Califano R, Medgyasszay B, Hsia TC, Otterson GA, Xu L, Piperdi B, Samkari A, Reck M; KEYNOTE-598 Investigators. Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >/= 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study. J Clin Oncol. 2021 Jul 20;39(21):2327-2338. doi: 10.1200/JCO.20.03579. Epub 2021 Jan 29.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Chile
Canada
France
Colombia
Hungary
United States
Latvia
Ukraine
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan

location_facility: Medical Care and Research S.A. de C.V. ( Site 0602)

location_facility: Centro de Investigacion Clinica del Country ( Site 0500)

location_facility: Centro Oncologico Riojano Integral ( Site 0203)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1807)

location_facility: GVI Oncology Clinical Research Centre ( Site 1802)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1616)

location_facility: Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)

location_facility: National Cheng Kung University Hospital ( Site 2401)

location_facility: Texas Oncology-Flower Mound ( Site 8007)

location_facility: Karadeniz Teknik Universitesi ( Site 1910)

location_facility: Istituto Europeo di Oncologia ( Site 1007)

location_facility: CHU de Brest. Hopital Morvan ( Site 0800)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)

location_facility: Centre Hopitalier Intercommunal Creteil ( Site 0802)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0706)

location_facility: Hospital Germans Trias i Pujol ( Site 1207)

location_facility: Hospital Universitari Vall d Hebron ( Site 1211)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1321)

location_facility: Evangelische Lungenklinik Berlin ( Site 0903)

location_facility: Medical College of Wisconsin Clinical Cancer Center ( Site 0027)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 2404)

location_facility: MI Odessa Regional Oncological Centre ( Site 2004)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 0504)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)

location_facility: University Hospital Limerick ( Site 1403)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)

location_facility: Dr G.A. Landers Specialist Oncologist ( Site 1803)

location_facility: New England Cancer Specialists ( Site 0019)

location_facility: The Royal Marsden NHS Foundation Trust.. ( Site 1327)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1909)

location_facility: Lahey Hospital & Medical Center ( Site 0020)

location_facility: Universitaetsklinikum Heidelberg ( Site 0900)

location_facility: Texas Oncology-Arlington South ( Site 8006)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)

location_facility: The Christie NHS Foundation Trust ( Site 1301)

location_facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0404)

location_facility: Ospedale Santa Maria della Misericordia ( Site 1008)

location_facility: Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)

location_facility: CISSS-CA Hotel-Dieu de Levis ( Site 0108)

location_facility: MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)

location_facility: Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)

location_facility: Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)

location_facility: Ospedale San Gerardo ASST Monza ( Site 1002)

location_facility: Instituto de Oncologia de Rosario ( Site 0200)

location_facility: Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)

location_facility: St Vincents Hospital Melbourne ( Site 2101)

location_facility: Medical Park Izmir Hospital ( Site 1900)

location_facility: CEPON Centro de Pesquisa Oncológicas ( Site 0307)

location_facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)

location_facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1907)

location_facility: Hospital do Servidor Publico do Estado ( Site 0308)

location_facility: Texas Oncology-Longview Cancer Center ( Site 8009)

location_facility: Riga East Clinical University Hospital ( Site 1111)

location_facility: Universitaetsklinikum Leipzig ( Site 0919)

location_facility: Tennessee Cancer Specialists ( Site 0017)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 1203)

location_facility: Escola Paulista de Medicina - UNIFESP ( Site 0304)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0311)

location_facility: Royal Free NHS Foundation Trust ( Site 1324)

location_facility: China Medical University Hospital ( Site 2403)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)

location_facility: Clinica Universidad Catolica del Maule ( Site 0413)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 1503)

location_facility: Severance Hospital Yonsei University Health System ( Site 2300)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1511)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 1326)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0801)

location_facility: Universitas Annex National Hospital ( Site 1800)

location_facility: Oncologica de Puebla SA de CV ( Site 0606)

location_facility: Humanitas Research Hospital ( Site 1004)

location_facility: Mid Ohio Oncology/Hematology Inc. ( Site 0003)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2015)

location_facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0004)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0306)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0034)

location_facility: AORN dei Colli Plesso Monaldi ( Site 1003)

location_facility: Changhua Christian Hospital ( Site 2406)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)

location_facility: IRCCS Casa Sollievo della Sofferenza ( Site 1009)

location_facility: CISSS de la Monteregie-Centre ( Site 0100)

location_facility: St-Jerome Medical Research Inc ( Site 0113)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)

location_facility: John Wayne Cancer Institute ( Site 0021)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0908)

location_facility: University of Tennessee Erlanger Oncology & Hematology ( Site 0026)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)

location_facility: Pauls Stradins Clinical University Hospital ( Site 1100)

location_facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)

location_facility: Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)

location_facility: National Taiwan University Hospital ( Site 2400)

location_facility: Instituto Nacional del Cancer ( Site 0406)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)

location_facility: Disney Family Cancer Center ( Site 0035)

location_facility: Hospital San Pedro de Alcantara ( Site 1208)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)

location_facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)

location_facility: Hospital Clinico Vina del Mar ( Site 0400)

location_facility: Orszagos Onkologiai Intezet ( Site 1509)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1505)

location_facility: HELIOS Klinikum Emil von Behring ( Site 0905)

location_facility: Clinica Internacional Sede San Borja ( Site 0701)

location_facility: Seoul National University Hospital ( Site 2303)

location_facility: Florida Hospital Cancer Institute ( Site 0009)

location_facility: Hospital Privado Centro Medico Cordoba ( Site 0206)

location_facility: Universitaetsklinikum Schleswig Holstein. ( Site 0918)

location_facility: Avix Investigacion Clinica S.C. ( Site 0600)

location_facility: Uludag Universitesi Tip Fakultesi ( Site 1914)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1200)

location_facility: Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)

location_facility: Kyiv City Clinical Oncological Center ( Site 2014)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8001)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)

location_facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)

location_facility: Clinica Peruano Americana S.A. ( Site 0703)

location_facility: C.H.R.U de Lille - Hopital Calmette ( Site 0805)

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)

location_facility: University of Stellenbosch and Tygerberg Hospital ( Site 1810)

location_facility: The Ohio State University Wexner Medical Center ( Site 0016)

location_facility: Royal Wolverhampton Hospitals NHS Trust ( Site 1323)

intervention_type: Other


type: Other Identifier

title: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)

acronym: PACIFICA

summary:
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients)

Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis

Intervention/treatment: Drug-Pacritinib

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Gerds AT, Savona MR, Scott BL, Talpaz M, Egyed M, Harrison CN, Yacoub A, Vannucchi A, Mead AJ, Kiladjian JJ, O'Sullivan J, Garcia-Gutierrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Devineni S, Craig AR, Mascarenhas JO. Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis. Blood Adv. 2020 Nov 24;4(22):5825-5835. doi: 10.1182/bloodadvances.2020003314.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ipd_sharing: No

lead_sponsor: CTI BioPharma

sponsor_collaborators:
CTI BioPharma
PSI CRO

location_country:
Germany
Poland
Australia
Bosnia and Herzegovina
Czechia
Canada
Serbia
France
Belarus
Hungary
United States
Ukraine
Romania
Italy
United Kingdom
Korea, Republic of
Spain
Bulgaria
Georgia
Russian Federation
Israel

location_facility: The Tel Aviv Sourasky Medical Center, Department of Internal Medicine

location_facility: University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

location_facility: Volgograd Regional Clinical Oncology Center

location_facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

location_facility: LTD M.Zodelava's Hematology Center, Department of Hematology

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

location_facility: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

location_facility: Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology

location_facility: Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Lady Davis Carmel Medical Center, Department of Hematology,

location_facility: V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology

location_facility: Jewish General Hospital; Clinical Research Unit

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology

location_facility: Meir Medical Center, Hematology Institute and Blood Bank

location_facility: Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS

location_facility: University Polyclinic Foundation "Agostino Gemelli"

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service

location_facility: The Sarah Cannon Research Institute-Tennessee Oncology

location_facility: Tom Baker Cancer Center, Internal Medicine/Hematology

location_facility: University Hospital Ulm, Center for Internal Medicine,

location_facility: V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology

location_facility: Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy

location_facility: American Oncology Partners of Maryland, PA

location_facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"

location_facility: Kyiv City Clinical Hospital #9, Hematology Department #1

location_facility: University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology

location_facility: Memorial Sloan-Kettering Cancer Center- Commack

location_facility: Research Institute of Hematology and Transfusiology

location_facility: Centre Hospitalier de Toulouse- Hôpital Purpan

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: University Hospital Cologne, Department of Internal Medicine I,

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Regional Clinical Hospital, Department of Hematology,

location_facility: Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka

location_facility: Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

location_facility: Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

location_facility: Comprehensive Cancer Centers of Nevada- Twain Office

location_facility: Nova Scotia Health Authority, Centre for Clinical Research

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

location_facility: Cancer Institute "Giovanni Paolo II", IRCCS

location_facility: University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)

location_facility: Republican Research Center for Radiation Medicine and Human Ecology

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: University Hospital 12 de Octubre, Department of Hematology

location_facility: City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health

location_facility: Regional Cancer Care Associates LLC - CCBD Division

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: ASST Spedali Civili Brescia, Hematology Unit

location_facility: City Clinical Hospital #4" under Dnipro City Council

location_facility: JSC K. Eristavi National Center For Experimental and Clinical Surgery

location_facility: Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

location_facility: S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division

location_facility: Prof. Dr. Ion Chiricuta" Institute of Oncology

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Dana Farber Cancer Institute, Massachusetts General Hospital

location_facility: Kyiv Regional Oncology Center, Department of Hematology,

location_facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Michigan Medicine Hematology Clinic-Rogel Cancer Center

location_facility: Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology

location_facility: Bashkiria State Medical University, Department of Internal Medicine

location_facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow Transplantation

location_facility: Johannes Wesling Hospital Minden, Department of Oncology and Hematology

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology

location_facility: Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,

location_facility: Maryland Oncology Hematology, PA- Columbia

location_facility: Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Hadassah Medical Center, Department of Hematology,

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: The University of Chicago Medical Center

location_facility: LTD S.Khechinashvili University Hospital

location_facility: Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I

location_facility: Rabin Medical Center, Clinic for Myeloproliferative Disorders

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: University Hospital "Maggiore della Carita" of Novara

location_facility: Royal Hallamshire Hospital, Department of Hematology

location_facility: Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz

location_facility: Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine

location_facility: George Washington University-Medical Faculty Associates

location_facility: Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology

location_facility: Rocky Mountain Cancer Centers (US Oncology/McKesson)

location_facility: Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy

location_facility: Washington University School of Medicine-Siteman Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Pilot Study of Personalized Biomarker-based Treatment Strategy or Immunotherapy in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

acronym: UPSTREAM

summary: This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.

status: Active, not recruiting

design_allocation: Non-Randomized

ReferenceCitation: Galot R, Le Tourneau C, Guigay J, Licitra L, Tinhofer I, Kong A, Caballero C, Fortpied C, Bogaerts J, Govaerts AS, Staelens D, Raveloarivahy T, Rodegher L, Laes JF, Saada-Bouzid E, Machiels JP. Personalized biomarker-based treatment strategy for patients with squamous cell carcinoma of the head and neck: EORTC position and approach. Ann Oncol. 2018 Dec 1;29(12):2313-2327. doi: 10.1093/annonc/mdy452.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

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

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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

location_country:
Italy
United Kingdom
Belgium
Spain
France

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

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

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Institut de Cancerologie Strasbourg Europe

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

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

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

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre


lead_sponsor: Hoffmann-La Roche

summary: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.

ReferenceCitation: Powles T, Yuen KC, Gillessen S, Kadel EE 3rd, Rathkopf D, Matsubara N, Drake CG, Fizazi K, Piulats JM, Wysocki PJ, Buchschacher GL Jr, Alekseev B, Mellado B, Karaszewska B, Doss JF, Rasuo G, Datye A, Mariathasan S, Williams P, Sweeney CJ. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Nat Med. 2022 Jan;28(1):144-153. doi: 10.1038/s41591-021-01600-6. Epub 2022 Jan 10.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Friendship Hospital, Capital Medical University

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Concord Repatriation General Hospital; Concord Cancer Centre

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Kaiser Permanente San Diego - Los Angeles

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

location_facility: Medizinische Universität Wien; Universitätsklinik für Urologie

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Chang Gung Memorial Hospital-LinKou; Urology

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: IRCCS AOU San Martino - IST; Oncologia Medica 1

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Niigata University Medical & Dental Hospital

location_facility: Nebraska Cancer Specialists; Oncology Hematology West, PC

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Urology Cancer Center & GU Research Network

location_facility: University Hospital of Patras Medical Oncology

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

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

location_facility: Virginia Cancer Specialists - Alexandria

location_facility: Medical University of Bialystok; Oncology clinic

location_facility: Russian Scientific Center of Roentgenoradiology

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

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: University of Colorado; Division of Medical Oncology

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: University of Pittsburgh Cancer Institute; Division of Medical Oncology

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Woj. Wielospec. Centrum Onkologii i Traumatologii

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: James Cancer Hospital;Solove Research Institute

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: CHU de Québec - Université Laval - Hôtel-Dieu de Québec

location_facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

location_facility: Ospedale Area Aretina Nord; U.O.C. Oncologia

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Athens Medical Center; Dept. of Oncology

status: Completed

title: A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

status_simplified: Completed


title: TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

summary: The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

ReferenceType: result

ReferenceCitation: Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH; TRITON3 Investigators. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. doi: 10.1056/NEJMoa2214676. Epub 2023 Feb 16.

oa_colors: green other

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repositories_concat: PubMed Central;orca.cardiff.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

oa_host_type: closed

repositories_concat: closed

ipd_sharing: Yes

ipd_sharing_description:
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by zr pharma& Austria GmbH

lead_sponsor: pharmaand GmbH

sponsor_collaborators:
pharmaand GmbH
Foundation Medicine

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Denmark
Australia
Belgium
United States
Spain
Canada
France

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Northwest Cancer Specialist DBA Compass Oncology

location_facility: Alegent Health Bergan Mercy Hospital , GU Research Network

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: Centre Hospitalier Universitaire Dr-Georges-L.-Dumont

location_facility: Rambam Health Care Campus (RHCC), Rambam Medical Center

location_facility: Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

location_facility: Hospital General Universitario de Guadalajara

location_facility: Presidio Ospedaliero Santa Chiara di Trento

location_facility: University of Washington Fred Hutchinson Cancer Research Center

location_facility: Apotheke des Städtischen Klinikums Braunschweig

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Marques de Valdecilla University Hospital (HUMV)

location_facility: Walter Reed National Military Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Oxford Cancer Centre, Medical Oncology Unit

location_facility: Lakeridge Health Medical Specialty Medical Oncology

location_facility: Barwon Health, University Hospital Geelong

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Hospital Universitario Central de Asturias

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

location_facility: University of Florida Health Cancer Center

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

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

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO

location_facility: Adelaide & Meath Hospital, Incorporating the National Children's Hospital

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Medical Oncology Hematology Consultants - USOR

location_facility: VA Greater Los Angeles Healthcare System


summary:
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

ReferenceCitation: Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Wolters Kluwer Health

location_facility: Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie

location_facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: London Health Sciences Centre Uni Campus

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

location_facility: Box Hill Hospital; Department of Neurology

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Austin Hospital; Department of Neurology

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Hospital General Universitario de Alicante; Servicio de Neurología

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Spitalul Clinic Judetean de Urgenta Mures

location_facility: Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Hospital General Universitario Morales Meseguer; Servicio de Neurología

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: UBC Hospital; Div of Neurology, Dept of Medicine

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: MultipEL Studies - Institut für klinische Studien

location_facility: Montreal Neurological Institute and Hospital

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Palo Alto Medical Foundation Research Center

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

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

location_facility: Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: Mustafa Kemal Ataturk UTF; Department of norology

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Akershus universitetssykehus HF; Nevroklinikken S203

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Selcuk University Medical Faculty; Norology department

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

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB

location_facility: Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: University of Maryland Medical Center; Department of Neurology

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Istanbul University Istanbul Medical Faculty; Neurology

location_facility: Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología

location_facility: American University of Beirut - Medical Center

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Gazi University Medical Faculty; Departmant of Norology

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

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: Luzerner Kantonsspital Luzern Medizin Neurologie

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

location_facility: Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie

location_facility: Royal North Shore Hospital; Department of Neurology

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

title: An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Kuwait
Turkey
Croatia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Lebanon
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Sweden


acronym: STRONG

intervention_type: Biological

lead_sponsor: AstraZeneca

summary: To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

ReferenceCitation: Sonpavde GP, Sternberg CN, Loriot Y, Marabelle A, Lee JL, Flechon A, Roubaud G, Pouessel D, Zagonel V, Calabro F, Banna GL, Shin SJ, Vera-Badillo FE, Powles T, Hellmis E, Miranda PAP, Lima AR, Emeribe U, Oh SM, Hotte SJ. Primary results of STRONG: An open-label, multicenter, phase 3b study of fixed-dose durvalumab monotherapy in previously treated patients with urinary tract carcinoma. Eur J Cancer. 2022 Mar;163:55-65. doi: 10.1016/j.ejca.2021.12.012. Epub 2022 Jan 15.

repository_institution: Yonsei University Medical Library - YUHSpace

title: An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

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 requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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


title: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

acronym: SMART Registry

summary:
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Portugal
Slovakia
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Canada
France

location_facility: Voc Cardiologia Ospedaliera Polocino di Bari

location_facility: Azienda Ospedaliero - Universitaria di Ferrara

location_facility: Riverside Medical Center / Midwest Arrhythmia Consultants

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Barwon Health Myers House Ground Floor Geelong Hospital

location_facility: Basildon and Thurrock University Hospitals NHS Foundation Trust

location_facility: LHCH (Liverpool Heart and Chest Hospital)

location_facility: IKEM - Institut klinicke a experimentalni mediciny

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Columbia. University Medical Center/ NY Presbyterian Hospital

location_facility: The National Institute of Cardiovascular Diseases

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust'

location_facility: The University of Illinois Medical Center

location_facility: Ospedale Santa Maria della Misericordia di Rovigo

location_facility: Universität Mainz zentrum fur kardiologie

location_facility: Western Connecticut Health Network/ Danbury Hospital

location_facility: North Florida/South Georgia Veterans Health System

location_facility: Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)

location_facility: Azienda Socio-Sanitaria Territoriale dei Sette Laghi

location_facility: Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II

location_facility: Magna Graecia University AUO Mater Domini di Catanzaro

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf

location_facility: Landeskrankenhaus Salzburg Universitätsklinikum der PMU

location_facility: Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Klinikum Links der Weser-Elektrophysiologie Bremen

intervention_type: Device


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.

ReferenceCitation: Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.

oa_host_type: publisher

evidence: open (via free pdf)

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.

ReferenceCitation: Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3 and STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

ReferenceCitation: Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Rutgers New Jersey Medical School- Doctors Office Center

location_facility: Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center

location_facility: Tokyo Womens Medical University Hospital

location_facility: Tulane University Health Sciences Center

location_facility: Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

location_facility: Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)

location_facility: University of Colorado Denver and Hospital

location_facility: University of California, San Diego (Altman Clinical and Translational Research Center)

location_facility: Greenville Health System Gastroenterology and Liver Center

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: University of California, San Francisco-Liver Clinic

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: American Research Corporation, The Texas Liver Institute

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: NorthShore University HealthSystem - Glenbrook ACC

location_facility: Intermountain Liver Disease and Transplant Clinic

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Keimyung University Dongsan Medical Center

location_facility: Universitatsklinikum Frankfurt der Goethe-Universitat

location_facility: University of Massachusetts Medical School

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine

location_facility: Island View Gastroenterology Associates- Ventura

location_facility: Southern Therapy and Advanced Research LLC (STAR)

location_facility: University of Florida Hepatology Research at CTRB

location_facility: National Health Insurance Service- Ilsan Hospital

location_facility: Walter Reed National Military Medical Center

location_facility: University of Buffalo, Clinical and Translational Research Center

location_facility: Indiana University Health - University Hospital

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Medical University of South Carolina, University Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Department of Hepatology PGIMER Chandigarh

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Penn State University, The Milton S. Hershey Medical Center

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii

location_facility: Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease

location_facility: Toronto Center for Liver Diseases (TCLD), Toronto General Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Institute of Post Graduate Medical Education and Research (IPGMER)

location_facility: Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik III

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

location_facility: Northwell Health - Sandra Atlas Bass Center for Liver Diseases

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: Hospital Universitario Puerto de Hierro Majadahonda

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: CHOP_Complejo Hospitalario Universitario de Pntevedra

location_facility: University of California, Davis Medical Center

location_facility: Carolinas HealthCare System Center for Liver Disease

location_facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

location_facility: Kawasaki Medical School General Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

location_facility: The University of Chicago Medical Center

location_facility: Duke University Medical Center - Duke South Clinics

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute

location_facility: Groupe Hospitalier Universitaire La Pitie Salpetriere

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant

location_facility: The University of Vermont Medical Center

location_facility: Swedish Organ Transplant and Liver Center

location_facility: University of Louisville Clinical Trials Unit

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Manitoba, Health Sciences Centre, John Buhler Research Centre

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

location_facility: London Health Sciences Centre - University Hospital

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill

location_facility: Global Clinical Reseaech Services PVT LTD

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research

location_facility: Huntington Medical Research Institutes (HMRI) Liver Center

status: Terminated

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

location_country:
Germany
Poland
New Zealand
Australia
Japan
Canada
France
Hong Kong
Switzerland
United States
India
Belgium
Puerto Rico
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Israel

status_simplified: Unknown


acronym: Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non Dialysis (ASCEND-ND)

lead_sponsor: GlaxoSmithKline

summary: The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

ReferenceType: background

ReferenceCitation: Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196

doi: ajay

ReferenceCitation: Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

publisher_dissemination: Wiley

ReferenceCitation: Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: UCL Discovery;eprints.gla.ac.uk

title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Vietnam
Turkey
Czechia
Canada
France
Colombia
Portugal
Hungary
Hong Kong
Denmark
United States
Ukraine
India
Romania
Belgium
Malaysia
Estonia
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


lead_sponsor: Bristol-Myers Squibb

summary: A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Kentucky One Health St. Joseph East Cancer Center

location_facility: Gene Upshaw Memorial Tahoe Forest Cancer Center

title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Chile
Czechia
Canada
France
Hungary
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
Russian Federation


title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

acronym: CHARM

summary:
The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI.

The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

lead_sponsor: Biogen

location_country:
Finland
Germany
Australia
Brazil
Japan
Croatia
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Tianjin Medical University General Hospital

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Saint-Petersburg Scientific-Research Institute of Emergency Care

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: University of Tennessee Health Sciences Center

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: University of Pittsburgh School of Medicine

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: University of Pennsylvania Health System

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Xuanwu Hospital Capital Medical University

location_facility: University of Washington School of Medicine

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Showakai Brain Attack Center Ota Memorial Hospital

location_facility: SHI "Territorial Clinical Hospital #1 n.a. S.V. Ochapovsky"

location_facility: SBIH of Moscow 'City Clinical Hospital # 1 n. a. N. I. Pirogov'

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano

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

location_facility: Copenhagen University Hospital and Glostrup Hospital

location_facility: Rhode Island Hospital Warren Alpert Medical School Brown University

location_facility: Rutgers - Robert Wood Johnson Medical School

location_facility: Clinica Neurológica e Neurocirúrgica de Joinville

location_facility: Saitama Medical University International Medical Center

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: Army Specialty Medical Center of The Chinese People's Liberation Army

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Queen Elizabeth University Hospital Campus

location_facility: Republican Vilnius University Hospital, Public Institution

location_facility: Beth Israel Deaconess Medical Center, Inc.

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Affiliated Hospital of Nantong University

location_facility: Arizona Board of Regents, University of Arizona

location_facility: Seoul National University Bundang Hospital

location_facility: Newcastle University- Clinical Ageing Research Unit

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: St.David's HealthCare Office of Research

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: SBEI HPE 'Kazan State Medical University' of the MoH of the RF

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: University of California Davis Health System

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Nottingham University Hospitals City Campus

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra

location_facility: Columbia University Hervert Irving Comprehensive Cancer Center

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: University Hospital and UW Health Clinics

location_facility: Okayama City General Medical Center Okayama City Hospital

location_facility: National Cerebral and Cardiovascular Center


acronym: CheckMate 647

summary: The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility: Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus

location_facility: H. Lee Moffitt Cancer Center & Research Inst, Inc

location_facility: I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

title: A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)

location_country:
Germany
Italy
Hungary
Hong Kong
Israel
Japan
Brazil
Singapore
United States
Czechia
Canada
Russian Federation
France


title: Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

acronym: MASTER DAPT

summary:
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

ReferenceCitation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

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

publisher_dissemination: Oxford University Press

ReferenceCitation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

ReferenceCitation: Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016

ReferenceCitation: Smits PC, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Paradies V, Kala P, Kedev S, Al Mafragi A, Dewilde W, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk. J Am Coll Cardiol. 2022 Sep 27;80(13):1220-1237. doi: 10.1016/j.jacc.2022.07.016.

ReferenceCitation: Valgimigli M, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Delorme L, Kala P, Kedev S, Abhaichand RK, Velchev V, Dewilde W, Podolec J, Leibundgut G, Topic D, Schultz C, Stankovic G, Lee A, Johnson T, Tonino PAL, Klotzka A, Lesiak M, Lopes RD, Smits PC, Heg D; MASTER DAPT Investigators. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol. 2022 Aug 23;80(8):766-778. doi: 10.1016/j.jacc.2022.04.065.

ReferenceCitation: Valgimigli M, Smits PC, Frigoli E, Bongiovanni D, Tijssen J, Hovasse T, Mafragi A, Ruifrok WT, Karageorgiev D, Aminian A, Garducci S, Merkely B, Routledge H, Ando K, Diaz Fernandez JF, Cuisset T, Nesa Malik FT, Halabi M, Belle L, Din J, Beygui F, Abhyankar A, Reczuch K, Pedrazzini G, Heg D, Vranckx P; MASTER DAPT Investigators. Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis. Eur Heart J. 2022 Sep 1;43(33):3100-3114. doi: 10.1093/eurheartj/ehac284.

repository_institution: UHasselt - Document Server@UHasselt

ReferenceCitation: Smits PC, Frigoli E, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial. Circulation. 2021 Oct 12;144(15):1196-1211. doi: 10.1161/CIRCULATIONAHA.121.056680. Epub 2021 Aug 29.

evidence: open (via page says license)

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.

repository_institution: Keele University - Keele Research Repository

ReferenceCitation: Vlieger S, Danzi GB, Kauer F, Oemrawsingh RM, Stojkovic S, IJsselmuiden AJJ, Routledge H, Laanmets P, Roffi M, Frobert O, Baello P, Wlodarczak A, Puentes A, Polad J, Hildick-Smith D. One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries. Coron Artery Dis. 2021 Aug 1;32(5):391-396. doi: 10.1097/MCA.0000000000000958.

ReferenceCitation: Frigoli E, Smits P, Vranckx P, Ozaki Y, Tijssen J, Juni P, Morice MC, Onuma Y, Windecker S, Frenk A, Spaulding C, Chevalier B, Barbato E, Tonino P, Hildick-Smith D, Roffi M, Kornowski R, Schultz C, Lesiak M, Iniguez A, Colombo A, Alasnag M, Mullasari A, James S, Stankovic G, Ong PJL, Rodriguez AE, Mahfoud F, Bartunek J, Moschovitis A, Laanmets P, Leonardi S, Heg D, Sunnaker M, Valgimigli M. Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. Am Heart J. 2019 Mar;209:97-105. doi: 10.1016/j.ahj.2018.10.009. Epub 2018 Nov 22.

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

sponsor_collaborators:
ECRI bv
Cardialysis B.V.
European Cardiovascular Research Center
University of Bern
Terumo Medical Corporation

location_country:
Germany
Poland
Argentina
Australia
Japan
Vietnam
Czechia
Serbia
France
Slovenia
Hungary
Denmark
Switzerland
Bahrain
North Macedonia
India
Belgium
Estonia
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Bangladesh
Bulgaria
Israel

location_facility: St.Marianna University School of Medicine

location_facility: Japan Red Cross Nagoya Daini Hospital (2nd)

location_facility: Second university of Naples Monaldi Hospital

location_facility: Japan Red Cross Nagoya Daiichi Hospital (1st)


acronym: ICARIA-MM

lead_sponsor: Sanofi

summary:
Primary Objective:

To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM).

Secondary Objectives:

To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.
To compare the Overall Survival (OS) between the two arms.
To evaluate the Time To Progression (TTP) in each arm.
To evaluate the PFS in high risk cytogenetic population in each arm.
To evaluate the Duration of Response (DOR) in each arm.
To evaluate the safety in both treatment arms.
To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.
To evaluate the immunogenicity of isatuximab.
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

ReferenceCitation: Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Mace S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum In: Lancet. 2019 Dec 7;394(10214):2072.

ReferenceCitation: Richardson PG, Perrot A, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Malinge L, Dubin F, van de Velde H, Anderson KC. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10. Erratum In: Lancet Oncol. 2022 Apr;23(4):e161. Lancet Oncol. 2022 Sep;23(9):e404.

ReferenceCitation: Sunami K, Ikeda T, Huang SY, Wang MC, Koh Y, Min CK, Yeh SP, Matsumoto M, Uchiyama M, Iyama S, Shimazaki C, Lee JH, Kim K, Kaneko H, Kim JS, Lin TL, Campana F, Tada K, Iida S, Suzuki K; ICARIA-MM study group. Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e751-e761. doi: 10.1016/j.clml.2022.04.005. Epub 2022 Apr 8.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Wilmoth J, Colson K, Dubin F, Kellam C. Isatuximab: Nursing Considerations for Use in the Treatment of Multiple Myeloma. Clin J Oncol Nurs. 2021 Dec 1;25(6):706-712. doi: 10.1188/21.CJON.706-712.

publisher_dissemination: Oncology Nursing Society (ONS)

ReferenceCitation: Bringhen S, Pour L, Vorobyev V, Vural F, Warzocha K, Benboubker L, Koh Y, Maisnar V, Karlin L, Pavic M, Campana F, Le Guennec S, Menas F, van de Velde H, Richardson PG. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis. Leuk Res. 2021 May;104:106576. doi: 10.1016/j.leukres.2021.106576. Epub 2021 Mar 29.

ReferenceCitation: Schjesvold FH, Richardson PG, Facon T, Alegre A, Spencer A, Jurczyszyn A, Sunami K, Frenzel L, Min CK, Guillonneau S, Lin PL, Le-Guennec S, Campana F, van de Velde H, Bensfia S, Bringhen S. Isatuximab plus pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis. Haematologica. 2021 Apr 1;106(4):1182-1187. doi: 10.3324/haematol.2020.253450. No abstract available.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility: BRCR Medical Center Inc. Site Number : 8400002

title: A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

type: Registry Identifier

ipd_sharing_description: Qualified researchers may request access to patient 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. Patient 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://vivli.org

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
United States
Belgium
Italy
Norway
United Kingdom
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


title: NeuroVascular Product Surveillance Registry (PSR) Platform

acronym: INSPIRE

summary: Post market surveillance registry

ipd_sharing_description: Only multi center data will be available

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Finland
Germany
Poland
Argentina
Australia
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
Belgium
China
Italy
United Kingdom
Austria
United Arab Emirates
Spain
Greece
South Africa
Russian Federation
Israel

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Charité Universitätsmedizin Berlin -Campus Charite

location_facility: The First Affiliated Hospital Of Xi'an Jiaotong University

location_facility: Ziekenhuis Oost Limburg - Campus Sint-Jan

location_facility: Xuanwu Hospital Capital Medical University

location_facility: First Affiliated Hospital of Jiamusi University

location_facility: Chongqing University Three Gorges Hospital

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: CHU Toulouse - Hôpital Pierre-Paul Riquet

location_facility: The Affiliated Hospital of Jinggangshan University

location_facility: Almazov National Medical Research Centre

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: Universitätsklinikum Christian Doppler Klinik Salzburg

location_facility: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

location_facility: Hospital Universitario Central de Asturias

location_facility: Centre Hospitalier Bretagne Atlantique Vannes - Auray

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Siberian Federal Biomedical Research Center

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: Barking, Havering and Redbridge University Hospitals - Queen's Hospital

location_facility: Military Medical Institute-Wojskowy Instytut Medyczny

location_facility: Klinikum Nürnberg - Klinikum Nürnberg Süd