acronym: monarchE

lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

ReferenceCitation: Toi M, Boyle F, Im YH, Reinisch M, Molthrop D, Jiang Z, Wei R, Sapunar F, Grimes BR, Nabinger SC, Johnston SRD. Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1. Oncologist. 2023 Jan 18;28(1):e77-e81. doi: 10.1093/oncolo/oyac234.

publisher_dissemination: Oxford University Press

ReferenceCitation: Martin M, Hegg R, Kim SB, Schenker M, Grecea D, Garcia-Saenz JA, Papazisis K, Ouyang Q, Lacko A, Oksuzoglu B, Reeves J, Okera M, Testa L, Shimizu C, Denduluri N, Adamchuk H, Dakhil S, Wei R, Forrester T, Fernandez MM, Zimmermann A, Headley D, Johnston SRD. Treatment With Adjuvant Abemaciclib Plus Endocrine Therapy in Patients With High-risk Early Breast Cancer Who Received Neoadjuvant Chemotherapy: A Prespecified Analysis of the monarchE Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1190-1194. doi: 10.1001/jamaoncol.2022.1488.

ReferenceCitation: Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Polewski MD, Nielsen GB, Gu Y, Weaver AT, Gegg G, Tabuena-Frolli S, Cajaiba M, Hanks D, Method M, Press MF, Gottstein C, Gruver AM. A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone. Appl Immunohistochem Mol Morphol. 2022 Apr 1;30(4):237-245. doi: 10.1097/PAI.0000000000001009.

ReferenceCitation: Rugo HS, O'Shaughnessy J, Boyle F, Toi M, Broom R, Blancas I, Gumus M, Yamashita T, Im YH, Rastogi P, Zagouri F, Song C, Campone M, San Antonio B, Shahir A, Hulstijn M, Brown J, Zimmermann A, Wei R, Johnston SRD, Reinisch M, Tolaney SM; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 Jun;33(6):616-627. doi: 10.1016/j.annonc.2022.03.006. Epub 2022 Mar 23.

ReferenceCitation: Royce M, Osgood C, Mulkey F, Bloomquist E, Pierce WF, Roy A, Kalavar S, Ghosh S, Philip R, Rizvi F, Mixter BD, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. J Clin Oncol. 2022 Apr 10;40(11):1155-1162. doi: 10.1200/JCO.21.02742. Epub 2022 Jan 27.

ReferenceCitation: Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.

sponsor_collaborators:
Eli Lilly and Company
NSABP Foundation Inc

location_facility: WellSpan Health/York Cancer Center Oncology Research

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: King Abdulaziz Medical City - National Guard Hospital

location_facility: Unidad de Investigacion en Salud de Chihuahua S.C.

location_facility: New England Cancer Specialists - Scarborough

location_facility: Poltava Regional Clinical Oncological Dispensary

location_facility: Hematology Oncology Associates of Fredericksburg Inc.

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Ankara Gulhane Training ve Research Hospital

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Texas Oncology-Deke Slayton Cancer Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: St. Elisabeth Gruppe - Marien Hospital Witten

location_facility: Yaroslavl region regional clinical oncology hospital

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Consultorio Centro Hemato Oncologico Privado

location_facility: Loma Linda University School of Medicine

location_facility: Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli

location_facility: Columbus Community Clinical Oncology Program

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Joaquin Gabriel Reinoso Toledo (Consultorios de Medicina Especializada)

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: St-Petersburg scientifical practical cente spec medical care

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Hospital Universitario Central de Asturias

location_facility: The Fifth Medical Center of PLA General Hospital

location_facility: Instituto de Investigaciones Metabolicas

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: California Cancer Associates Research and Excellence (cCARE)

location_facility: CHU de Quebec-Hopital de Saint-Sacrement

location_facility: Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem

location_facility: Hospital Clinico Universitario San Cecilio

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

location_facility: Deenanth Mangeshkar Hospital and Research Centre

location_facility: University Hospitals Case Medical Center

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Wake Forest University School of Medicine

location_facility: Hospital Araujo Jorge da Assoc. Combate ao Cancer em Goias

location_facility: Communal Enterprise "Volyn Regional Medical Oncology Center"

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University

location_facility: Centre Hospitalier de Vendee Les Oudairies

location_facility: ASST Monza - Presidio Ospedaliero di Monza

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Fovarosi Onkormanyzat Szent Margit Korhaza

location_facility: S.C. R.T.C. Radiology Therapeutic Center S.R.L.

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Fundacion CENIT para la Investigacion en Neurociencias

location_facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: Centre Hospitalier Universitaire de Sherbrooke - CHUS

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: Centro de Estudios y Prevencion del Cancer A.C.

location_facility: Providence Cancer Center Oncology Hematology Care

location_facility: KH Hietzing mit neurologischem Zentrum Rosenhügel

location_facility: The First Affiliated Hospital, Sun-Yat Sen University

location_facility: Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: Volgograd regional clinical oncology dispensary

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaz

location_facility: Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga

location_facility: Hospital de Base Fac de Medicina de Sao Jose do Rio Preto

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: University of Southern Florida School of Medicine

location_facility: Brig Center For Cancer Care and Survivorship

location_facility: Instituto de Assistência Médica ao Servidor Público Estadual

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: Orenburg Regional Clinical Oncology Dispensary

location_facility: Soonchunhyang University Hospital Cheonan

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Instituto COI de Pesquisa Educação e Gestão

location_facility: Principal Military Clinical Hospital n.a. N. N. Burdenko

location_facility: Texas Oncology-El Paso Cancer Treatment Center

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: Dongnam Institute of Radiological and Medical Sciences

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: COI Centro Oncológico Internacional S.A.P.I de C.V.

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: University of California, Davis - Health Systems

location_facility: Willamette Valley Cancer Institute & research Ctr.

location_facility: Institutul Oncologic Dr Trestioreanu Bucuresti

location_facility: Centro para la Atencion Integral del Paciente Oncologico

location_facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau

location_facility: Semmelweis Egyetem III. sz Belgyogyaszati Klinika

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centros de Investigaciones Cli-nicas. Clinica Viedma

location_facility: Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: MVZ Onkologie Barmbek - Asklepios Klinik Barmbek

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Gynäkologisch-onkologische Schwerpunktpraxis am Pelikanplatz

location_facility: Fujian Medical University Union Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut

location_facility: California Cancer Associates in Research and Excellence

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Saitama Medical University International Medical Center

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: Post Graduate Institute of Medical Education & Research

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: St. Petersburg City Clinical Oncological Dispensary

location_facility: National Center for Global Health and Medicine

location_facility: Instituto Português de Oncologia Dr. Francisco Gentil

location_facility: Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Azienda Ospedaliero-Universitaria S.Giovanni Battista

location_facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung

location_facility: Istituto Tumori Fondazione G. Pascale IRCCS

location_facility: Ordination Dr. Hubalek - Brustzentrum Schwaz

location_facility: University of Texas Health Science Center - San Antonio

location_facility: Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Health Pharma Professional Research, S.A. de C.V.

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: St Marianna University School of Medicine Toyoko Hospital

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: Seoul National University Bundang Hospital

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Ibcc-Instituto Brasileiro de Controle Do Câncer

location_facility: The Hospital of Hyogo College of Medecine

location_facility: Centre de Lutte Contre le Cancer Leon Berard

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária

location_facility: University General Hospital of Heraklion

location_facility: Commu Instit "Krivorizhskiy oncology dispensary" Dnip reg Co

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hacettepe University Faculty of Medicine

title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Ukraine
India
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


title: Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study

acronym: POSE

summary: The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kowark A, Berger M, Rossaint R, Schmid M, Coburn M; POSE-Study group. Association between benzodiazepine premedication and 30-day mortality rate: A propensity-score weighted analysis of the Peri-interventional Outcome Study in the Elderly (POSE). Eur J Anaesthesiol. 2022 Mar 1;39(3):210-218. doi: 10.1097/EJA.0000000000001638.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Universidad de Las Palmas de Gran Canaria - Acceda

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
LIRIAS (KU Leuven)
PubMed Central
accedacris.ulpgc.es

repositories_concat: LIRIAS (KU Leuven);PubMed Central;accedacris.ulpgc.es

unpaywall_oa_status: hybrid

ReferenceCitation: POSE-Study group. Peri-interventional outcome study in the elderly in Europe: A 30-day prospective cohort study. Eur J Anaesthesiol. 2022 Mar 1;39(3):198-209. doi: 10.1097/EJA.0000000000001639.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ipd_sharing: No

lead_sponsor: Mark Coburn

location_country:
Germany
Ireland
Poland
Turkey
Serbia
France
Portugal
Denmark
Switzerland
Ukraine
North Macedonia
Romania
Belgium
Netherlands
Austria
Spain
Greece
Georgia
Russian Federation
Israel

location_facility: Medical Corporation Evex, Tbilisi Referral Hospital

location_facility: Baskent University Konya Research Center

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Marien Hospital Herne, UK der Ruhr-Universität Bochum

location_facility: University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Medical Corporation Evex - Zugdidi Referral Hospital

location_facility: Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Universitätsklinikum Schleswig-Holstein Campus Luebeck

location_facility: Centro Hospitalar Lisboa Norte - Hospital Santa Maria

location_facility: Universitary General Hospital of Ciudad Real

location_facility: Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia

location_facility: University Clinic for Gyn & Ob / Clinical Center Mother Teresa

location_facility: GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital

location_facility: Huriez Hospital, University Hospital of Lille

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: University Hospital Knappschaftskrankenhaus Bochum

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital

location_facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

location_facility: Saglik Bilimleri University Tepecik Education and Research Hospital

location_facility: Medical School, Aristotle University of Thessaloniki

location_facility: Clinical Emergency Hospital of Bucharest

location_facility: Kliniverbund St. Antonius und St. Josef GmbH

location_facility: Clinic for orthopedics surgery and traumatology Clinical center of Serbia

location_facility: Klinikum der Ludwigs-Maximilians-Universität München (LMU)

location_facility: TR Ministry of Health Erzurum Palandoken State Hospital

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: P.A. Herzen Moscow Cancer Research Institute

location_facility: Federal State Autonomous Institution N.N. Burdenko National medical research center of neurosurgery of the ministry of health of the Russian federation (N.N. Burdenko NMRCN)

location_facility: Republic of Turkey Ministry of Health Tunceli State Hospital

location_facility: Neurologic Hospital-Hospices Civils de Lyon

location_facility: Emergency Center, Clinical Center of Serbia

location_facility: Department of Anesthesiology, University Hospital Aachen

location_facility: Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral

location_facility: Istanbul University, Istanbul Faculty of Medicine

location_facility: Urology Hospital, Clinical center of Serbia

location_facility: University Emergency Central Military Hospital

location_facility: Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"

location_facility: Acad. N. Kipshidze Central University Clinic

location_facility: Ankara University Faculty of Medicine-Ibni Sina Hospital

location_facility: NN Blokhin National Medical Cancer Research Center

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: General Hospital of Volos "Achillopouleio"

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

ReferenceCitation: Miles D, Gligorov J, Andre F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1.

evidence: open (via crossref license)

publisher_dissemination: Elsevier

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU

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

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: West China Hospital, Sichuan University; Department of Breast

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Dr. B L Kapur Memorial Hospital; BLK Cancer Centre

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: King Fahad Medical City; Gastroentrology

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

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

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)

location_facility: The Second Affiliated Hospital of Xi'an Jiao Tong University

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: Manipal Hospital; Department of Oncology

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Klinikum Ernst von Bergmann; Frauenklinik

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: ARETAIEION UNIVERSITY HOSPITAL; oncology unit

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Uludag University Medical Faculty; Internal Medicine

location_facility: Izmir Ataturk Training and Research Hospital

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

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

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Universita Campus Bio-Medico di Roma (UCBM)

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: King Fahad Specialist Hospital; Oncology

location_facility: Max Super Speciality Hospital; Medical Oncology

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Rambam Health Corporation; Oncology Institute

title: A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

primary_purpose: Treatment

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_country:
Germany
Argentina
Japan
Brazil
Vietnam
Turkey
Croatia
Czechia
Canada
France
Slovakia
United States
Morocco
India
Romania
China
Italy
United Kingdom
Saudi Arabia
Spain
Greece
South Africa
Russian Federation
Israel

study_type: Interventional


acronym: REACH 3

lead_sponsor: Incyte Corporation

summary: The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).

ReferenceCitation: Le RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

publisher_dissemination: Future Science Ltd

location_facility:
Novartis Investigational Site
Incyte Investigative Site
Novartis Investigative Site

title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)

type: Other Identifier

location_country:
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
India
Romania
Belgium
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Greece
Jordan
Bulgaria
Russian Federation
Israel


acronym: OReO

lead_sponsor: AstraZeneca

summary: The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)

sponsor_collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

title: A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy

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

location_country:
Germany
Italy
Poland
Israel
Norway
Denmark
United Kingdom
Belgium
Spain
Canada
France

ipd_sharing: Yes


lead_sponsor: Acerta Pharma BV

summary: This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

sponsor_collaborators:
Acerta Pharma BV
AstraZeneca

status: Active, not recruiting

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

study_completion_date_type: Anticipated

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Vietnam
Czechia
Canada
France
Hungary
Hong Kong
United States
Ukraine
Romania
Belgium
China
Peru
Italy
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

status_simplified: Ongoing


title: Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)

acronym: CheckMate 744

summary: The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Seagen Inc.

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: Smilow Cancer Hospital At Yale New Haven Hospital

location_facility: Childrens Hospital Of Pittsburgh Of Upmc

location_facility: Nemours / A. I. duPont Hospital for Children

location_facility: Cincinnati Children'S Hospital Medical Center

location_facility: The Montreal Children's Hospital of the MUHC

location_facility: Lucile Packard Children'S Research Hospital/Stanford Univ

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Children'S Hospital & Research Center At Oakland

location_facility: Washington University School Of Medicine

intervention_type: Biological


title: A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome (Cohort 2)

summary: The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet syndrome.

ReferenceType: result

ReferenceCitation: Nabbout R, Mistry A, Zuberi S, Villeneuve N, Gil-Nagel A, Sanchez-Carpintero R, Stephani U, Laux L, Wirrell E, Knupp K, Chiron C, Farfel G, Galer BS, Morrison G, Lock M, Agarwal A, Auvin S; FAiRE, DS Study Group. Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens: A Randomized Clinical Trial. JAMA Neurol. 2020 Mar 1;77(3):300-308. doi: 10.1001/jamaneurol.2019.4113.

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Medical Association

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.

license: cc-by

license_normalized: cc-by

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
LIRIAS (KU Leuven)
UCL Discovery

repositories_concat: LIRIAS (KU Leuven);UCL Discovery

ReferenceCitation: Sullivan J, Perry MS, Wheless JW, Galer B, Gammaitoni A. Fenfluramine responder analyses and numbers needed to treat: Translating epilepsy trial data into clinical practice. Eur J Paediatr Neurol. 2021 Mar;31:10-14. doi: 10.1016/j.ejpn.2021.01.005. Epub 2021 Jan 22.

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_country:
Germany
United Kingdom
Netherlands
United States
Spain
Canada
France

location_facility: Cliníca Universidad de Navarra Nidad de Neuropediatría

location_facility: Hôpital de La Timone, Service de Neuro-Métabolisme Pédiatrique

location_facility: Alder Hey Children'S Nhs Foundation Trust, Littlewood'S Neurosciences Unit

location_facility: Ann & Robert H. Lurie Children'S Hospital of Chicago

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Krankenhaus Mara, Epilepsie-Zentrum Bethel

location_facility: Evelina London Children'S Hospital, Paediatric Neurosciences

location_facility: HÔPITAL FEMME-MÈRE-ENFANT Hôpital Service de Neurologie Pédiatrique

location_facility: Chu Amiens Picardie Service de Neurologie Pédiatrique

location_facility: Universitätsklinikum Schleswig-Holstein, Klinik Für Neuropädiatrie

location_facility: Great Ormond Street Hospital For Children Nhs Foundation Trust

location_facility: Kleinwachau Sächsisches Epilepsiezentrum Radeberg

location_facility: Chu Sainte-Justine Hospital Neurology Clinic

location_facility: Royal Hospital For Children, Queen Elizabeth University, Institute of Neurosciences Hospital

location_facility: Hospital Ruber Internacional-Servicio de Neurología

location_facility: Bc Children'S Hospital Division of Neurology


lead_sponsor: Astex Pharmaceuticals, Inc.

summary:
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone:

High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide, and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).
Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).
BSC.

location_facility: University of New Mexico School of Medicine

location_facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Kobe City Medical Center General Hospital

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia

location_facility: East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital

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

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hospital Universitario Central de Asturias

location_facility: The University of Chicago Medical Center

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Hospital of the University of Pennsylvania

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

location_facility: West Virginia University Hospitals, Inc.

location_facility: Heart of England NHS Foundation Trust - Heartlands Hospital

title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Japan
Sweden
Belgium
United States
Korea, Republic of
Spain
Canada
Ukraine
France


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

lead_sponsor: GlaxoSmithKline

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

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.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Singh AK, Carroll K, Perkovic V, 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, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2325-2335. doi: 10.1056/NEJMoa2113379. Epub 2021 Nov 5.

oa_colors: green other

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

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

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.

repositories:
PubMed Central
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 Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

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


title: Randomized Efficacy and Safety Trial With Oral S 44819 After Recent Ischemic Cerebral Event. International, Multi-centre, Randomized, Doubleblind Placebo-controlled Phase II Study. (RESTORE BRAIN Study)

summary: The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

ReferenceType: background

ReferenceCitation: Chabriat H, Bassetti CL, Marx U, Picarel-Blanchot F, Sors A, Gruget C, Saba B, Wattez M, Audoli ML, Hermann DM. Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study. Trials. 2020 Feb 3;21(1):136. doi: 10.1186/s13063-020-4072-2.

ReferenceCitation: Chabriat H, Bassetti CL, Marx U, Audoli-Inthavong ML, Sors A, Lambert E, Wattez M, Hermann DM; RESTORE BRAIN study investigators. Safety and efficacy of GABAA alpha5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2020 Mar;19(3):226-233. doi: 10.1016/S1474-4422(20)30004-1.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

sponsor_collaborators: Institut de Recherches Internationales Servier

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Brazil
Netherlands
Sweden
Belgium
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo

location_facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Royal Stoke University Hospital Stroke Team Office

location_facility: Kanizsai Dorottya Korhaz Neurologiai Osztaly

location_facility: Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku

location_facility: Canisius Wilhelmina Ziekenhuis Afdeling Neurologie

location_facility: CHU-Hôpital de la Milétrie Service de Neurologie

location_facility: Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung

location_facility: Chonnam National University Hospital Department of Neurology

location_facility: UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia

location_facility: Universitätsklinikum Erlangen Neurologische Klinik

location_facility: IMV Pesquisa Neurológica Setor de Pesquisa Clinica

location_facility: Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy

location_facility: Royal Adelaide Hospital Department of Neurology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont

location_facility: Sint Andries Ziekenhuis Dienst Neurologie

location_facility: Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit

location_facility: Dong-A University Medical Center Department of Neurology

location_facility: H. Germans Trias I Pujol Servicio de Neurología

location_facility: Lyell McEwin Hospital Neurology Department

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii

location_facility: Kreisklinikum Siegen Klinik fuer Neurologie

location_facility: H. Valle de Hebrón Servicio de Neurología

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia

location_facility: Fakultni nemocnice u sv. Anny Neurologicka klinika

location_facility: Hospital Carlos Fernando Malzone Departamento de Neurologia

location_facility: Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii

location_facility: Royal Brisbane & Women's Hospital Department of Neurology

location_facility: Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly

location_facility: Hospital Universitario La Fe Servicio de Neurología

location_facility: University Hospital Department of Neurology

location_facility: Ospedale San Giuseppe UOC di Neurologia e Stroke Unit

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: CHRU-Hôpital Roger Salengro Service de Neurologie

location_facility: Leicester Royal Infirmary Dpt of Neurology

location_facility: Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera

location_facility: Hôpital Sud-Francilien Unité Neurovasculaire

location_facility: Hospital Quinta D'or Departamento de Neurologia

location_facility: Gosford Hospital Neurosciences Department

location_facility: CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie

location_facility: Monash Medical Centre Department of Neurology

location_facility: Fakultni nemocnice Brno Neurologicka klinika

location_facility: Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym

location_facility: H. Clinic de Barcelona Comprehensive Stroke Center

location_facility: ASAN Medical Center Department of Neurology

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für

location_facility: Royal United Hospital Older People's Unit

location_facility: Hôpital Lariboisière, Fernand-Vidal Service de Neurologie

location_facility: Policlinico Umberto I Emergency Department Stroke Unit

location_facility: H. Universitario de Donosti Servicio de Neurología

location_facility: Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia

location_facility: Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9

location_facility: Universitätsklinikum Ulm Neurologische Klinik (RKU)

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Johannes Wesling Klinik Minden Klinik für Neurologie

location_facility: Zuyderland Medisch Centrum Afdeling Neurologie

location_facility: St George's University Hospitals Stroke Research office

location_facility: Akademiska Sjukhuset Strokeavdelningen 85B

location_facility: Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK

location_facility: Hôpital Sainte-Anne Service de Neurologie

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly

location_facility: Kyungpook National University Hospital Department of Neurology

location_facility: Universitaetsklinikum Essen Neurologische Universitätsklinik Essen

location_facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

location_facility: Istituto Neurologico mediterraneo NEUROMED Dipartimento di Medicina Riabilitativa e Specialistica Repar

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly

location_facility: B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica

location_facility: Seoul National University Bundang Hospital Department of Orthopaedic

location_facility: Ospedale Sacro Cuore Don Calabria Negrar NEUROLOGY DEPT

location_facility: H. Virgen del Rocío Servicio de Neurología

location_facility: CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique

location_facility: Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy

location_facility: H. Universitario La Princesa Servicio de Neurología

location_facility: Royal Melbourne Hospital Department of Neurology

location_facility: H. General de Albacete Servicio de Neurología

location_facility: M. Kopernika Provincial Specialist Hospital Dpt of Neurology

location_facility: Klinikum Altenburger Land GmbH Neurologische Klinik

location_facility: Josa Andras Oktatokorhaz Neurologiai Osztaly

location_facility: Clínica Neurológica e Neurocirúrgica de Joinville

location_facility: Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9

location_facility: Charles LeMoyne Hospital-CISSS de la Monteregie-Centre


title: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER

summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population

ReferenceCitation: Solomon BJ, Bauer TM, Ignatius Ou SH, Liu G, Hayashi H, Bearz A, Penkov K, Wu YL, Arrieta O, Jassem J, Calella AM, Peltz G, Polli A, Thurm H, Mok T. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non-Small-Cell Lung Cancer From the Phase III CROWN Study. J Clin Oncol. 2022 Nov 1;40(31):3593-3602. doi: 10.1200/JCO.21.02278. Epub 2022 May 23.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Solomon BJ, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Shaw AT. Plain language summary of the CROWN study comparing lorlatinib with crizotinib for people with untreated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(34):4649-4656. doi: 10.2217/fon-2021-0904. Epub 2021 Sep 29.

license: cc-by-nd

license_normalized: cc-by-nd

ReferenceCitation: Shaw AT, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Solomon BJ; CROWN Trial Investigators. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020 Nov 19;383(21):2018-2029. doi: 10.1056/NEJMoa2027187.

ReferenceCitation: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23.

version: submittedVersion

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.

oa_host_type: closed

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Hong Kong
United States
India
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Grand Hopital de Charleroi - Site Notre Dame

location_facility: Bendigo Day Surgery Collection Centre and Laboratory

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: The University of Hong Kong, Department of Medicine

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Technische Universitat Dresden , Medizinische Fakultat Carl Gustav Carus

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas

location_facility: Universitatsklinikum Regensburg, Institut fur Rontgendiagnostik

location_facility: Institut Catala d'Oncologia L'Hospitalet

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II

location_facility: The William P. Beetham Eye Institute, Joslin Diabetes Center

location_facility: AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Budgetary Healthcare Institution Omsk Region "Clinical Oncological Dispensary"

location_facility: Médicos Especialistas en Cancer S.C. / San Peregrino.

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Universitätsklinikum des Saarlandes, Innere Medizin V

location_facility: LEC at SBIH "Saint-Petersburg Clinical Research Practical Center of specialized types of

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Bendigo Medical Imaging, Bendigo Hospital

location_facility: The Catholic University of Korea, St. Vincents Hospital

location_facility: Marmara Univ Pendik Training and Research Hospital

location_facility: Fakultni nemocnice Olomouc, Klinika plicnich nemoci a tuberkulozy

location_facility: Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne

location_facility: FSBI "N.N.Blokhin Medical Research Center of Oncology"

location_facility: Private Medical Institution "Euromedservice"

location_facility: The University of Hong Kong, Department of Clinical Oncology

location_facility: Azienda Ospedaliera Dei Colli Ospedale Monaldi

location_facility: Department of Respiratory,the First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: The Affiliated Hospital of Military Medical Sciences

location_facility: Uberortliche Radiologische Gemeinschaftspraxis Dr. med. Marc Amler

location_facility: Azienda Ospedaliera di Perugia - Ospedale S. M. Misericordia

location_facility: Sahyadri Clinical Research and Development Centre

location_facility: Hopital Haut-Léveque-Centre François Magendie

location_facility: RBHI Kursk Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: Groupe Hospitalier Bichat Claude Bernard, AP-HP

location_facility: Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd

location_facility: University of Rochester Cancer Center Pharmacy

location_facility: Wakayama Medical University Department of Pulmonary Medicine and Oncology

location_facility: Division of Medical Oncology, Severance Hospital, Yonsei University Health System


title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

acronym: CARAVAGGIO

summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

status: Unknown status

ReferenceCitation: Becattini C, Bauersachs R, Maraziti G, Bertoletti L, Cohen A, Connors JM, Manfellotto D, Sanchez A, Brenner B, Agnelli G. Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial. Haematologica. 2022 Jul 1;107(7):1567-1576. doi: 10.3324/haematol.2021.279072.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Giustozzi M, Connors JM, Ruperez Blanco AB, Szmit S, Falvo N, Cohen AT, Huisman M, Bauersachs R, Dentali F, Becattini C, Agnelli G. Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study. J Thromb Haemost. 2021 Nov;19(11):2751-2759. doi: 10.1111/jth.15461. Epub 2021 Jul 29.

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

ReferenceCitation: Agnelli G, Becattini C, Meyer G, Munoz A, Huisman MV, Connors JM, Cohen A, Bauersachs R, Brenner B, Torbicki A, Sueiro MR, Lambert C, Gussoni G, Campanini M, Fontanella A, Vescovo G, Verso M; Caravaggio Investigators. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. 2020 Apr 23;382(17):1599-1607. doi: 10.1056/NEJMoa1915103. Epub 2020 Mar 29.

lead_sponsor: Fadoi Foundation, Italy

sponsor_collaborators:
Fadoi Foundation, Italy
University Of Perugia

location_country:
Germany
France
Italy
Poland
Portugal
United Kingdom
Netherlands
Belgium
United States
Spain
Israel

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Ospedale Sacro Cuore-Don Calabria di Negrar-Verona.

location_facility: Hôpital des armées HIA Clermont Tonnerre

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Jacksonville Center for Clinical Research

location_facility: CH de Vendée Centre Hospitalier Départemental

location_facility: AO di Rilievo Nazione Antonio Cardarelli

location_facility: AO Ospedale di Circolo e Fondazione Macchi

location_facility: Ospedale Buon Consiglio Fatebenefratelli

location_facility: University of North Carolina at Chapel Hill

location_facility: Staten Island University Hospital/Northwell Health

location_facility: Centre Hospitalier Emile Roux Le Puy-en-Velay

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ospedale Sacro Cuore di Gesù Fatebenefratelli

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne

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

location_facility: Istituto Nazionale Tumori - IRCCS Fondazione Pascale

location_facility: Medical Centre for Postgraduate Education - ECZ-Otwock

location_facility: Department of Internal Medicine - University of Perugia

location_facility: Centre Hospitalier Universitaire Lyon-Sud

status_simplified: Unknown


title: Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

summary: Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
Belarus
Poland
Hungary
Australia
Mexico
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Czechia
Ukraine
Georgia
Peru
Russian Federation
France

location_facility:
Research Site 6
Research Site
Research Site 8
Research Site 1
Research Site 3
Research Site 5
Research Site 4
Research Site 10
Research Site 9
Research Site 2
Research Site 7


acronym: Galahad

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

ReferenceCitation: Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.

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

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repository_institution: Yonsei University Medical Library - YUHSpace

title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

location_country:
Israel
United Kingdom
Denmark
Australia
Brazil
Netherlands
Sweden
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France


title: NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug

acronym: NIMES-ROC

summary: Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug

lead_sponsor: PharmaMar

location_country: Germany Italy Belgium Spain France

location_facility: Institut d'Oncologie Hauts-de-Seine Nord

location_facility: Policlinico Universitario Agostino Gemelli Università Cattolica di Roma

location_facility: Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin

location_facility: Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH

location_facility: Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Strasbourg Oncologie Libérale Centre de radiothérapie

location_facility: Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie

location_facility: Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Centre d'Oncologie et de Radiothérapie du Parc


title: A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: CheckMate 714

summary: A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

location_country:
Finland
Ireland
Argentina
Brazil
Turkey
Chile
Czechia
Canada
France
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Mexico
Spain
South Africa
Russian Federation
Sweden

location_facility:
Local Institution - 0075
Local Institution - 0102
Local Institution - 0021
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0072
Local Institution - 0103
Local Institution - 0101
Local Institution - 0039
Local Institution - 0124
Local Institution - 0005
Local Institution - 0014
Local Institution - 0034
Local Institution - 0063
Local Institution - 0016
Local Institution - 0076
Local Institution - 0008
Local Institution
Local Institution - 0107
Local Institution - 0120
Local Institution - 0026
Local Institution - 0115
Local Institution - 0074
Local Institution - 0097
Mission Hospital, Inc
Local Institution - 0087
Donald Guthrie Foundation
Local Institution - 0046
University of Arizona Cancer Center
Local Institution - 0110
Local Institution - 0116
Local Institution - 0042
Local Institution - 0031
Local Institution - 0054
Local Institution - 0090
Local Institution - 0070
Ucla Department Of Medicine
Local Institution - 0069
Local Institution - 0037
Local Institution - 0033
Local Institution - 0023
Local Institution - 0053
Local Institution - 0079
Local Institution - 0066
Local Institution - 0060
Local Institution - 0051
Local Institution - 0121
Local Institution - 0006
Local Institution - 0111
Local Institution - 0119
Local Institution - 0082
Local Institution - 0083
Local Institution - 0067
Local Institution - 0059
Local Institution - 0081
Ft. Wayne Med Onco-Hema Inc
Local Institution - 0040
Local Institution - 0038
Local Institution - 0028
Local Institution - 0064
Local Institution - 0052
Local Institution - 0108
Local Institution - 0065
Local Institution - 0047
Local Institution - 0114
Local Institution - 0049
Local Institution - 0004
Local Institution - 0050
Oncology Associated Of Western Kentucky
Local Institution - 0048
Local Institution - 0010
Local Institution - 0089
Local Institution - 0017
Local Institution - 0029
Local Institution - 0030
Local Institution - 0084
Central Coast Med Oncology
Local Institution - 0041
Local Institution - 0092
Los Angeles Cancer Network
Local Institution - 0015
Local Institution - 0027
Local Institution - 0007
Local Institution - 0055
Local Institution - 0032
Local Institution - 0125
Local Institution - 0073
Local Institution - 0012
Local Institution - 0068
Local Institution - 0020
Local Institution - 0062
Local Institution - 0001
Local Institution - 0022
Local Institution - 0086
Local Institution - 0013
Local Institution - 0045
Local Institution - 0056
Local Institution - 0123
Local Institution - 0098
Local Institution - 0088

intervention_type: Other


title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)

acronym: CLEAR

summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review [IIR] using Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

ReferenceCitation: Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study. Lancet Oncol. 2022 Jun;23(6):768-780. doi: 10.1016/S1470-2045(22)00212-1. Epub 2022 Apr 27.

ReferenceCitation: Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, Grunwald V, Hutson TE, Kopyltsov E, Mendez-Vidal MJ, Kozlov V, Alyasova A, Hong SH, Kapoor A, Alonso Gordoa T, Merchan JR, Winquist E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer A, Procopio G, Takagi T, Melichar B, Rolland F, De Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Apr 8;384(14):1289-1300. doi: 10.1056/NEJMoa2035716. Epub 2021 Feb 13.

ReferenceCitation: Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.

repository_institution: Aberdeen University - Aberdeen University Research Archive

repositories_concat: PubMed Central;aura.abdn.ac.uk

lead_sponsor: Eisai Inc.

sponsor_collaborators:
Eisai Inc.
Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
Poland
Australia
Japan
Czechia
Canada
France
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Sunnybrook Research Institute - University of Toronto

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

location_facility: ICO l'Hospitalet - Hospital Duran I Reynals

location_facility: Weill Cornell Medical College New York Presbyterian Hospital

location_facility: Institut Regional du Cancer de Montpellier

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Asan Medical Center: Medical Oncology Department

location_facility: Department of Internal Medicine Division of Hematology/Oncology Cancer center 11F

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Urology

location_facility: SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie

location_facility: Adelaide and Meath Hospital Incorp The National Children's Hospital

location_facility: Hospital Universitario HM Madrid Sanchinarro

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

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

location_facility: Florida Cancer Specialists ( North Region)

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Fakultni nemocnice Olomouc, Neurologicka klinika

location_facility: Mission Hospital_ Cancer Care of Western North Carolina

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

location_facility: Krankenhaus der barmherzigen Schwestern Linz

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Oncology

location_facility: Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi

location_facility: Azienda Ospedaliera Santa Maria Degli Angeli

location_facility: FBHI Privolzhskiy District Medical Centre FMBA of Russia

location_facility: FSBI "National Medical Research Radiological Center" of the MoH of the RF

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: FSBI "Moscow scientific research oncology institute n.a. P.A. Gertsen" of MoH of RF

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Kyungpook National University Chilgok Hospital


title: Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

acronym: OPAL

summary: The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.

lead_sponsor: Janssen Biotech, Inc.

location_country:
Germany
Austria
United States
Korea, Republic of
Spain
Greece
Czechia
Canada
France


lead_sponsor: Boehringer Ingelheim

summary: The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

location_facility: National Center Neurology and Psychiatry

location_facility: Hospital Universitari General de Catalunya

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: CHU La Grave-Casselardit - Cité de la Santé

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University of Eastern Finland, Brain Research Unit

location_facility: Northeastern Pennsylvania Memory and Alzheimer Center

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: True North Clinical Research Kentville, Inc.

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Oslo Universitetssykehus HF, Hukommelsesklinikken

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: Private Practice for Psychiatry and Neurology

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o

location_facility: Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun

location_facility: Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center

title: A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy and Safety of Orally Administered BI 425809 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease.

location_country:
Finland
Germany
Italy
Poland
Hungary
Norway
United Kingdom
Japan
Austria
United States
Spain
Greece
Canada
France


acronym: Phase 3 Study of Epacadostat and Pembrolizumab in Melanoma

summary: The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma

ReferenceCitation: Long GV, Dummer R, Hamid O, Gajewski TF, Caglevic C, Dalle S, Arance A, Carlino MS, Grob JJ, Kim TM, Demidov L, Robert C, Larkin J, Anderson JR, Maleski J, Jones M, Diede SJ, Mitchell TC. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study. Lancet Oncol. 2019 Aug;20(8):1083-1097. doi: 10.1016/S1470-2045(19)30274-8. Epub 2019 Jun 17.

sponsor_collaborators:
Incyte Corporation
Merck Sharp & Dohme LLC

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Japan
Chile
Canada
France
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel


type: U.S. NIH Grant/Contract

title: Myocardial Ischemia and Transfusion

acronym: MINT

summary: The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

ReferenceCitation: Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.

ReferenceCitation: Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.

ReferenceCitation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ipd_sharing_description: Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.

lead_sponsor: Rutgers, The State University of New Jersey

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

location_country:
New Zealand
Australia
Brazil
United States
Canada
France

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Minneapolis Heart Institute (Foundation)

location_facility: The University of North Carolina at Chapel Hill

location_facility: Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil

location_facility: University of Minnesota Medical Center Fairview

location_facility: Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hôpital Universitaire Carémeau (CHU Carémeau)

location_facility: Instituto de Ensino e Pesquisa do Hospital da Bahia

location_facility: Hospital Universitário Professor Edgard Santos

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: NYU Langone Medical Center, Bellevue Hospital

location_facility: Hospital Maternidade e Pronto Socorro Santa Lúcia

location_facility: University of Arkansas Medical Sciences (UAMS) Hospital

lead_sponsor_type: academique


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

acronym: COMBI-i

summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma

ReferenceCitation: Tawbi HA, Robert C, Brase JC, Gusenleitner D, Gasal E, Garrett J, Savchenko A, Gorgun G, Flaherty KT, Ribas A, Dummer R, Schadendorf D, Long GV, Nathan PD, Ascierto PA. Spartalizumab or placebo in combination with dabrafenib and trametinib in patients with BRAF V600-mutant melanoma: exploratory biomarker analyses from a randomized phase 3 trial (COMBI-i). J Immunother Cancer. 2022 Jun;10(6):e004226. doi: 10.1136/jitc-2021-004226.

repositories_institution: California Digital Library - eScholarship

publisher_dissemination: British Medical Journal

ReferenceCitation: Dummer R, Long GV, Robert C, Tawbi HA, Flaherty KT, Ascierto PA, Nathan PD, Rutkowski P, Leonov O, Dutriaux C, Mandala M, Lorigan P, Ferrucci PF, Grob JJ, Meyer N, Gogas H, Stroyakovskiy D, Arance A, Brase JC, Green S, Haas T, Masood A, Gasal E, Ribas A, Schadendorf D. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma. J Clin Oncol. 2022 May 1;40(13):1428-1438. doi: 10.1200/JCO.21.01601. Epub 2022 Jan 14.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_concat: PubMed Central;www.zora.uzh.ch

ReferenceCitation: Dummer R, Lebbe C, Atkinson V, Mandala M, Nathan PD, Arance A, Richtig E, Yamazaki N, Robert C, Schadendorf D, Tawbi HA, Ascierto PA, Ribas A, Flaherty KT, Pakhle N, Campbell CD, Gusenleitner D, Masood A, Brase JC, Gasal E, Long GV. Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i. Nat Med. 2020 Oct;26(10):1557-1563. doi: 10.1038/s41591-020-1082-2. Epub 2020 Oct 5.

publisher_dissemination: Springer-Nature

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: California Cancer Associates for Research and Excellence SC-2

location_facility: University of Pittsburgh Medical Center SC

location_facility: University of TX MD Anderson Cancer Center SC-2

location_facility: NYU Laura and Isaac Perlmutter Cancer Center SC

location_facility: University of Tennessee Medical Center SC


acronym: Reach-Control

lead_sponsor: Sanofi

summary:
Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Secondary Objectives:

To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia).
Change in fasting plasma glucose (FPG).
Change in body weight.
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
Change in hypoglycemic control subscale (HCS)
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

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

ReferenceCitation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyen-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

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

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

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

repository_normalized: HAL

repository_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: Informa

location_facility:
Investigational Site Number 276005
Investigational Site Number 826021
Investigational Site Number 724017
Investigational Site Number 250055
Investigational Site Number 250046
Investigational Site Number 250008
Investigational Site Number 724016
Investigational Site Number 276006
Investigational Site Number 724008
Investigational Site Number 076008
Investigational Site Number 724021
Investigational Site Number 826027
Investigational Site Number 250028
Investigational Site Number 724001
Investigational Site Number 826038
Investigational Site Number 250009
Investigational Site Number 250051
Investigational Site Number 642006
Investigational Site Number 250045
Investigational Site Number 276013
Investigational Site Number 642009
Investigational Site Number 250026
Investigational Site Number 250063
Investigational Site Number 250059
Investigational Site Number 724005
Investigational Site Number 826011
Investigational Site Number 076003
Investigational Site Number 250031
Investigational Site Number 250007
Investigational Site Number 327002
Investigational Site Number 250002
Investigational Site Number 250029
Investigational Site Number 076007
Investigational Site Number 724030
Investigational Site Number 724028
Investigational Site Number 276010
Investigational Site Number 250013
Investigational Site Number 826028
Investigational Site Number 724007
Investigational Site Number 826004
Investigational Site Number 724012
Investigational Site Number 076010
Investigational Site Number 250033
Investigational Site Number 826016
Investigational Site Number 826035
Investigational Site Number 076009
Investigational Site Number 276008
Investigational Site Number 724018
Investigational Site Number 724026
Investigational Site Number 250022
Investigational Site Number 076011
Investigational Site Number 642007
Investigational Site Number 250052
Investigational Site Number 250011
Investigational Site Number 250025
Investigational Site Number 642002
Investigational Site Number 724025
Investigational Site Number 724022
Investigational Site Number 250027
Investigational Site Number 826013
Investigational Site Number 642001
Investigational Site Number 724013
Investigational Site Number 250023
Investigational Site Number 724010
Investigational Site Number 250054
Investigational Site Number 826018
Investigational Site Number 250030
Investigational Site Number 250035
Investigational Site Number 250004
Investigational Site Number 276014
Investigational Site Number 250032
Investigational Site Number 076004
Investigational Site Number 724006
Investigational Site Number 250034
Investigational Site Number 276002
Investigational Site Number 250014
Investigational Site Number 250024
Investigational Site Number 642005
Investigational Site Number 250005
Investigational Site Number 826009
Investigational Site Number 642004
Investigational Site Number 250064
Investigational Site Number 250016
Investigational Site Number 276007
Investigational Site Number 250020
Investigational Site Number 826033
Investigational Site Number 250012
Investigational Site Number 276001
Investigational Site Number 276011
Investigational Site Number 826020
Investigational Site Number 250058
Investigational Site Number 250003
Investigational Site Number 250021
Investigational Site Number 250060
Investigational Site Number 250050
Investigational Site Number 276009
Investigational Site Number 724024
Investigational Site Number 724014
Investigational Site Number 826008
Investigational Site Number 724002
Investigational Site Number 250039
Investigational Site Number 250053
Investigational Site Number 250057
Investigational Site Number 724019
Investigational Site Number 724020
Investigational Site Number 372003
Investigational Site Number 250006
Investigational Site Number 276017
Investigational Site Number 642008
Investigational Site Number 276012
Investigational Site Number 250041
Investigational Site Number 250001
Investigational Site Number 724027
Investigational Site Number 250044
Investigational Site Number 826006
Investigational Site Number 826002
Investigational Site Number 826003
Investigational Site Number 724011
Investigational Site Number 276016
Investigational Site Number 724009
Investigational Site Number 250056
Investigational Site Number 076-001
Investigational Site Number 826019
Investigational Site Number 250017
Investigational Site Number 826031
Investigational Site Number 826015
Investigational Site Number 076005
Investigational Site Number 250043

title: A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension

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
Ireland
United Kingdom
Romania
Brazil
Spain
France