title: Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

summary:
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

primary_purpose: Other

lead_sponsor: Celgene

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Japan
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: University of Rochester James P. Wilmot Cancer Center

location_facility: Virginia Commonwealth University (VCU) Medical Center

location_facility: Hematology and Oncology Associates of SC, LLC

location_facility: University of California, San Francisco- California

location_facility: Sidney Kimmel Comp Cancer Center at Johns Hopkins

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

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

location_facility: Winship Cancer Institute of Emory University

location_facility: Norton Cancer Institute Louisville Oncology

location_facility: Karmanos Cancer Center Wayne State University

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: Lombardi Cancer Center - Georgetown University Hospital

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: Thomas Jefferson University - Clinical Research Institute

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: NYU Langone Laura and Isaac Perlmutter Cancer Center

location_facility: University of Pennsylvania Perelman Center for Advanced Medicine

intervention_type: Genetic


type: EudraCT Number

title: A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kaseb AO, Guan Y, Gok Yavuz B, Abbas AR, Lu S, Hasanov E, Toh HC, Verret W, Wang Y. Serum IGF-1 Scores and Clinical Outcomes in the Phase III IMbrave150 Study of Atezolizumab Plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2022 Oct 11;9:1065-1079. doi: 10.2147/JHC.S369951. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Informa

ReferenceCitation: Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.

oa_host_type: repository

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

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: green

ReferenceCitation: Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.

ReferenceCitation: Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.

ReferenceCitation: Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

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

lead_sponsor: Hoffmann-La Roche

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of California Irvine Medical Center

location_facility: Institut Gustave Roussy; Gastro-Enterologie

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

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: General Hospital of Jinan Military Command of PLA

location_facility: The 900th Hospital of PLA joint service support force

location_facility: Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Veterans General Hospital; Cancer Center

location_facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

location_facility: The First People's Hospital of Foshan; Local Ethic Committee

location_facility: Hopital Timone Adultes; Gastro Enterologie

location_facility: Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie

location_facility: Hospital Universitario Miguel Servet; Servicio de Oncologia Medica

location_facility: Hôpital d'Adultes; Service hépato-gastro-entérologie

location_facility: Uni of California - San Diego; Cancer Center & Dept of Medicine

location_facility: M.D Anderson Cancer Center; Uni of Texas At Houston

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Hopital Charles Nicolle; Gastroenterologie

location_facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies

location_facility: SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

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

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Chonnam National University Hwasun Hospital

location_facility: CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Harbin Medical University Cancer Hospital

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

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: McGill University Health Centre - Glen Site

location_facility: Med. Hochschule Hannover; Gastroenterologie

location_facility: Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Centre hospitalier de l'Universite de Montreal (CHUM)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.

ReferenceCitation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.

publisher_dissemination: Springer-Nature

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

oa_colors: green hybrid

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

location_facility: Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Hospital da Clinicas da Faculdade de Medicina da USP

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd

location_facility: Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

location_facility: Queen's Square Dermatology and Allergology

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Fondazione IRCCS Osp.Maggiore Policlinico - Dermatologia

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

type: Other Identifier

source: euctr

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
Italy
Poland
United Kingdom
Japan
Brazil
Netherlands
Austria
Belgium
Switzerland
Spain
Russian Federation
France


title: A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)

summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Zhang P, Gumuscu B, Swaby RF, Hughes BGM. Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629). J Clin Oncol. 2020 Sep 1;38(25):2916-2925. doi: 10.1200/JCO.19.03054. Epub 2020 Jul 16.

evidence: open (via page says license)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hughes BGM, Mendoza RG, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Chirovsky D, Zhang P, Gumuscu B, Swaby RF, Grob JJ. Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629. Dermatol Ther (Heidelb). 2021 Oct;11(5):1777-1790. doi: 10.1007/s13555-021-00598-6. Epub 2021 Sep 23.

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

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Israel
Norway
United Kingdom
Australia
Mexico
United States
Spain
Canada
France

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8001)

location_facility: Sunnybrook Research Institute ( Site 0105)

location_facility: Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0605)

location_facility: University of Kansas Cancer Center ( Site 0361)

location_facility: Medizinische Hochschule Hannover ( Site 0652)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)

location_facility: Universitaets-Hautklinik Kiel ( Site 0656)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0364)

location_facility: Hospital General de Valencia ( Site 0752)

location_facility: Institut Gustave Roussy (IGR) ( Site 0602)

location_facility: Universitatsklinikum Tübingen ( Site 0651)

location_facility: Princess Alexandra Hospital ( Site 0405)

location_facility: Southern Medical Day Care Centre ( Site 0408)

location_facility: Royal Brisbane and Women s Hospital ( Site 0407)

location_facility: Haukeland Universitetssykehus ( Site 0902)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)

location_facility: Dr. Leon Richard Oncology Centre ( Site 0100)

location_facility: Universitaetsklinikum Mannheim GmbH ( Site 0654)

location_facility: Massachusetts General Hospital ( Site 0362)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0308)

location_facility: Universitaetsklinikum Essen ( Site 0650)

location_facility: Princess Margaret Cancer Centre ( Site 0102)

location_facility: CHU Reims - Hopital Robert Debre ( Site 0610)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 0754)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0901)

location_facility: Lombardi Comprehensive Cancer Center ( Site 0360)

location_facility: The Ottawa Hospital Cancer Centre ( Site 0101)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0753)

location_facility: St. Joseph Heritage Healthcare ( Site 0350)

location_facility: University College Hospital NHS Foundation Trust ( Site 0801)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 0600)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)

location_facility: Moores UC San Diego Cancer Center ( Site 0352)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0800)

location_facility: Hospital Duran i Reinals ICO de Hospitalet ( Site 0751)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 0804)

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0356)

location_facility: Stanford University Medical Center ( Site 0366)

intervention_type: Biological


title: A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Incyte Corporation

sponsor_collaborators:
Incyte Corporation
Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
New Zealand
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Hungary
United States
Ukraine
Italy
Norway
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.

location_facility: Instituto do Cancer de Sao Paulo - ICESP

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Severance Hospital Yonsei University Health System

location_facility: Universitaetsklinikum Magdeburg. Klinik fuer Urologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council

location_facility: Niigata University Medical & Dental Hospital

location_facility: Centro Avancado de Tratamento Oncologico - CENANTRON -

location_facility: Chang Gung Med Foundation. Kaohsiung Branch

location_facility: Hopital Prive Toulon Hyeres Sainte Marguerite

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Istanbul Medeniyet Universitesi Goztepe EAH

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden

location_facility: Saitama Medical University International Medical Center

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec

location_facility: Pontificia Universidad Catolica de Chile

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Ankara Numune Education and Research Hospital

location_facility: Universitetssykehuset i Nord Norge. Kreftavdelingen

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Chonnam National University Hwasun Hospital

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: MI Precarpathian Clinical Oncology Center

location_facility: Central Clinical Hospital with outpatient Clinic

location_facility: University of Tennessee Erlanger Oncology & Hematology

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Sunnybrook Health Sciences, Odette Cancer Centre

location_facility: RMI Sumy Regional Clinical Oncology Dispensary

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC

location_facility: National Medical Research Radiology Centre

location_facility: Kingston Health Sciences Centre - KGH Site

location_facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov

status_simplified: Ongoing


title: A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

summary:
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene [ESR1] Y537S mutation).

ReferenceCitation: Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERalpha Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Eisai Inc.

location_country:
United States
United Kingdom
France

location_facility: Florida Cancer Specialists and Research Institute

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago

location_facility: Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix

location_facility: Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta


title: An International, Multicentre, Prospective, Non-interventional Observational Registry for Patients With X-Linked Hypophosphatemia (XLH)

summary: This is an international, multicentre, prospective, non-interventional, observational Registry of patients with X-Linked hypophosphatemia (XLH). The main objective of this XLH Registry is to collect data to characterise the treatment, progression and long-term outcomes of XLH in both adult and paediatric settings.

study_type: Observational

time_perspective: Other

ReferenceCitation: Brandi ML, Ariceta G, Beck-Nielsen SS, Boot AM, Briot K, de Lucas Collantes C, Emma F, Giannini S, Haffner D, Keen R, Levtchenko E, Mӓkitie O, Nilsson O, Schnabel D, Tripto-Shkolnik L, Zillikens MC, Liu J, Tudor A, Mughal MZ. Post-authorisation safety study of burosumab use in paediatric, adolescent and adult patients with X-linked hypophosphataemia: rationale and description. Ther Adv Chronic Dis. 2022 Sep 5;13:20406223221117471. doi: 10.1177/20406223221117471. eCollection 2022.

repository_institution: University of Helsinki - Helda

repository_institution: Erasmus University Rotterdam - EUR Research Repository

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

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

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

repositories_concat: HELDA - Digital Repository of the University of Helsinki;PubMed Central;pure.eur.nl;pure.rug.nl;repositorio.uam.es

publisher_dissemination: SAGE Publications

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Germany
Ireland
Czechia
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Spain
Bulgaria
Israel

location_facility: Royal Hospital for Sick Children and Young People

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital Dona Estefânia

location_facility: Presidio Ospedaliero Di Summa Antonio Perrino

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Presidio Sant'Anna)

location_facility: Klinikum Ernst-von-Bergmann Potsdam und Bad Belzig

location_facility: National Institute of Childrenś Health NUDCH

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Århus Universitetshospital - Aarhus sygehus

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

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario Central de Asturias

location_facility: Great Ormond Street Hospital for Children

location_facility: Istituto Auxologico Italiano -I.R.C.C.S.

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: "Hopital Pierre-Paul Riquet Centre de Rhumatologie"

location_facility: Hospital General Universitario Santa Lucía

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Complejo Hospitalario Universitario Insular Materno-Infantil


title: A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide

acronym: OCEAN

summary: This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients with RRMM following 2-4 lines of prior therapy and who are refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients will receive either melflufen+dex or pomalidomide+dex.

ReferenceCitation: Schjesvold FH, Dimopoulos MA, Delimpasi S, Robak P, Coriu D, Legiec W, Pour L, Spicka I, Masszi T, Doronin V, Minarik J, Salogub G, Alekseeva Y, Lazzaro A, Maisnar V, Mikala G, Rosinol L, Liberati AM, Symeonidis A, Moody V, Thuresson M, Byrne C, Harmenberg J, Bakker NA, Hajek R, Mateos MV, Richardson PG, Sonneveld P; OCEAN (OP-103) Investigators. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study. Lancet Haematol. 2022 Feb;9(2):e98-e110. doi: 10.1016/S2352-3026(21)00381-1. Epub 2022 Jan 12.

evidence: open (via free pdf)

ipd_sharing: Undecided

lead_sponsor: Oncopeptides AB

location_country:
Poland
Czechia
France
Lithuania
Hungary
Denmark
United States
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


acronym: PARALLAX

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

ReferenceCitation: Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

oa_colors: green other

publisher_dissemination: American Medical Association

title: A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

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

location_country:
Germany
Argentina
Brazil
Thailand
Turkey
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
India
Romania
Belgium
Peru
Estonia
Italy
Guatemala
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation
Israel


lead_sponsor: Boehringer Ingelheim

summary: The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

ReferenceCitation: Ferreira JP, Zannad F, Butler J, Filippatos G, Pocock SJ, Brueckmann M, Steubl D, Schueler E, Anker SD, Packer M. Association of Empagliflozin Treatment With Albuminuria Levels in Patients With Heart Failure: A Secondary Analysis of EMPEROR-Pooled. JAMA Cardiol. 2022 Nov 1;7(11):1148-1159. doi: 10.1001/jamacardio.2022.2924. Erratum In: JAMA Cardiol. 2022 Nov 1;7(11):1177.

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

repository_normalized: HAL

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repositories:
HAL
PubMed Central
researchonline.lshtm.ac.uk

ReferenceCitation: Ferreira JP, Zannad F, Butler J, Filipattos G, Ritter I, Schuler E, Kraus BJ, Pocock SJ, Anker SD, Packer M. Empagliflozin and serum potassium in heart failure: an analysis from EMPEROR-Pooled. Eur Heart J. 2022 Aug 14;43(31):2984-2993. doi: 10.1093/eurheartj/ehac306. Erratum In: Eur Heart J. 2022 Jul 22;:

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: Oxford University Press

ReferenceCitation: Ferreira JP, Butler J, Zannad F, Filippatos G, Schueler E, Steubl D, Zeller C, Januzzi JL, Pocock S, Packer M, Anker SD. Mineralocorticoid Receptor Antagonists and Empagliflozin in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Mar 29;79(12):1129-1137. doi: 10.1016/j.jacc.2022.01.029.

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

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

ReferenceCitation: Ferreira JP, Anker SD, Butler J, Filippatos G, Iwata T, Salsali A, Zeller C, Pocock SJ, Zannad F, Packer M. Impact of anaemia and the effect of empagliflozin in heart failure with reduced ejection fraction: findings from EMPEROR-Reduced. Eur J Heart Fail. 2022 Apr;24(4):708-715. doi: 10.1002/ejhf.2409. Epub 2022 Jan 9.

ReferenceCitation: Verma S, Dhingra NK, Butler J, Anker SD, Ferreira JP, Filippatos G, Januzzi JL, Lam CSP, Sattar N, Peil B, Nordaby M, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Reduced trial committees and investigators. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial. Lancet Diabetes Endocrinol. 2022 Jan;10(1):35-45. doi: 10.1016/S2213-8587(21)00292-8. Epub 2021 Nov 30.

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

ReferenceCitation: Ryden L, Ferrannini G. Is the impact of add on heart failure therapy influenced by background therapy? Lancet Diabetes Endocrinol. 2022 Jan;10(1):3-5. doi: 10.1016/S2213-8587(21)00311-9. Epub 2021 Nov 30. No abstract available.

ReferenceCitation: Bohm M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Mahfoud F, Brueckmann M, Jamal W, Ofstad AP, Schuler E, Ponikowski P, Wanner C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol. 2021 Sep 28;78(13):1337-1348. doi: 10.1016/j.jacc.2021.07.049.

ReferenceCitation: Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046.

ReferenceCitation: Packer M, Butler J, Zannad F, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Schnaidt S, Zeller C, Schnee JM, Anker SD. Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial. Circulation. 2021 Oct 19;144(16):1284-1294. doi: 10.1161/CIRCULATIONAHA.121.056824. Epub 2021 Aug 29.

ReferenceCitation: Pocock SJ, Ferreira JP, Gregson J, Anker SD, Butler J, Filippatos G, Gollop ND, Iwata T, Brueckmann M, Januzzi JL, Voors AA, Zannad F, Packer M. Novel biomarker-driven prognostic models to predict morbidity and mortality in chronic heart failure: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4455-4464. doi: 10.1093/eurheartj/ehab579.

repository_institution: University of East Anglia - UEA Digital Repository

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

repositories_institution: University of East Anglia - UEA Digital Repository

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

ReferenceCitation: Lam CSP, Ferreira JP, Pfarr E, Sim D, Tsutsui H, Anker SD, Butler J, Filippatos G, Pocock SJ, Sattar N, Verma S, Brueckmann M, Schnee J, Cotton D, Zannad F, Packer M. Regional and ethnic influences on the response to empagliflozin in patients with heart failure and a reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4442-4451. doi: 10.1093/eurheartj/ehab360.

ReferenceCitation: Ferreira JP, Zannad F, Pocock SJ, Anker SD, Butler J, Filippatos G, Brueckmann M, Jamal W, Steubl D, Schueler E, Packer M. Interplay of Mineralocorticoid Receptor Antagonists and Empagliflozin in Heart Failure: EMPEROR-Reduced. J Am Coll Cardiol. 2021 Mar 23;77(11):1397-1407. doi: 10.1016/j.jacc.2021.01.044.

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Brueckmann M, Jamal W, Cotton D, Iwata T, Zannad F; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload: EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Mar 23;77(11):1381-1392. doi: 10.1016/j.jacc.2021.01.033.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Butler J, Anker SD, Filippatos G, Khan MS, Ferreira JP, Pocock SJ, Giannetti N, Januzzi JL, Pina IL, Lam CSP, Ponikowski P, Sattar N, Verma S, Brueckmann M, Jamal W, Vedin O, Peil B, Zeller C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Mar 31;42(13):1203-1212. doi: 10.1093/eurheartj/ehaa1007.

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

ReferenceCitation: Anker SD, Butler J, Filippatos G, Khan MS, Marx N, Lam CSP, Schnaidt S, Ofstad AP, Brueckmann M, Jamal W, Bocchi EA, Ponikowski P, Perrone SV, Januzzi JL, Verma S, Bohm M, Ferreira JP, Pocock SJ, Zannad F, Packer M. Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):337-349. doi: 10.1161/CIRCULATIONAHA.120.051824. Epub 2020 Nov 11.

ReferenceCitation: Zannad F, Ferreira JP, Pocock SJ, Zeller C, Anker SD, Butler J, Filippatos G, Hauske SJ, Brueckmann M, Pfarr E, Schnee J, Wanner C, Packer M. Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights From EMPEROR-Reduced. Circulation. 2021 Jan 26;143(4):310-321. doi: 10.1161/CIRCULATIONAHA.120.051685. Epub 2020 Oct 23. Erratum In: Circulation. 2021 Jan 26;143(4):e29.

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Brueckmann M, Jamal W, Zeller C, Schnaidt S, Zannad F. Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):326-336. doi: 10.1161/CIRCULATIONAHA.120.051783. Epub 2020 Oct 21. Erratum In: Circulation. 2021 Jan 26;143(4):e30.

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.

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

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_facility: General Hospital of Shenyang Military Region

location_facility: Poradnia Kardiologiczna Jaroslaw Jurowiecki

location_facility: Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice

location_facility: Leszek Bryniarski Specialized Medical Cabinet

location_facility: INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: Instituto Medico Fundación Grupo Colaborativo Rosario

location_facility: National Hospital Organization Kobe Medical Center

location_facility: Instituto Cardiovascular de Monclova, S de RL de CV

location_facility: Nanchang University Affiliated 3rd Hospital

location_facility: SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

location_facility: Dr. Nagy Laszlo Kardiologiai Maganrendeles

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: IPECC - Instituto de Pesquisa Clínica de Campinas

location_facility: National Hospital Organization Hakodate Hospital

location_facility: Fukuokaken Saiseikai Futsukaichi Hospital

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Diseño y Planeación en Investigación Médica SC

location_facility: The First Affiliated Hospital of Lanzhou University

location_facility: CEMEDIC - Centro de Especialidades Medicas

location_facility: 2nd Xiangya Hospital of Central South University

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Cardiovascular Research Center of South Florida

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: Corporacion Medica de Gral. San Martin S.A.

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: First Hospital Affiliated with Nanjing Medical University

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Captain James A. Lovell Federal Health Care Center

location_facility: William Jennings Bryan Dorn VA Medical Center

location_facility: Asklepios Klinik Langen-Seligenstadt GmbH

location_facility: Novant Health Heart and Vascular Institute

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Centre de sante et de services sociaux de Beauce

location_facility: Hospital Universitário Pedro Ernesto UERJ

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas

location_facility: Centro de Investigación Clinica Acelerada, S.C.

location_facility: Centro Especializado em Cardiol Loema Instituto de Pesq Clin

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Specialistic Cardiology&Hypertension Out-patient Clin,Kielce

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Shengjing Hospital of China Medical University

location_facility: CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

location_facility: Centro de Investigacion Cardiovascular y Metabolica

location_facility: The First Afiliated Hospital, Sun Yet-sen University

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie West

location_facility: Specialist Hospital J. Dietla NZOZ Specialized Clinic "Gemini"

location_facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

location_facility: St. Francis Medical Group-Indiana Heart Physicians, Inc

location_facility: Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

location_facility: The Affiliated Hospital of Southwest Medical University

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: The Second Affiliated Hospital of Lanzhou Medical University

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Ospedale della Val di Chiana Santa Margherita

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Centro de Investigacion Biomedica y Farmaceutica, S.C.

location_facility: First Affiliated Hospital of Xi'an JiaoTong University

location_facility: ICDF - Instituto de Cardiologia do Distrito Federal

location_facility: The University of North Carolina at Chapel Hill

location_facility: University of Texas Southwestern Medical Center

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: Hospital de Messejana Dr. Carlos Alberto Studart Gomes

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Instituto de Investigaciones Clínicas de Quilmes

location_facility: North York Diagnostic and Cardiac Centre

location_facility: Belgyogyaszati es Kardiologiai Maganrendelo

location_facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ

location_facility: CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: Cardiovascular Institute and Fu Wai Hospital

location_facility: Johns Hopkins University Hospital School of Medicine

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Curnew Medicine Professional Corporation

location_facility: FGM - Clínica Paulista de Doenças Cardiovasculares

location_facility: National Hospital Organization Kanazawa Medical Center

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

location_facility: The Provincial Polyclinical Hospital in Torun

location_facility: Krakow Specialistic Hospital of John Paul II

location_facility: VA Greater Los Angeles Healthcare System

location_facility: MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: Cardiac Care and Vascular Medicine, PLLC

location_facility: Doctor Jivraj Mehta Smarak Health Foundation

location_facility: Jacksonville Center for Clinical Research

location_facility: Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos - Universidade de Caxias do Sul

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

location_facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Fundacao Faculdade Regional de Medicina, Sao Jose

location_facility: Fejer County Saint George University Teaching Hospital

location_facility: Mohan Babapulle Medicine Professional Medicine

location_facility: University of North Texas Health Science Center

location_facility: Tianjin Union Medical Center Nankai University Affiliated Hospital

location_facility: Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.

location_facility: Seoul National University Bundang Hospital

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Hospital Interzonal General de Agudos Dr Jose Penna

location_facility: Cardresearch Cardiologia Assistencial e de Pesquisas Ltda

location_facility: Centro de Investigaciones Clínicas del Litoral

location_facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

location_facility: Nemocnice ve Frydku-Mistku, prispevkova organizace

location_facility: Irmandade da Santa Casa de Misericórdia de Curitiba

location_facility: Hospital Italiano Regional del Sur, Bahia Blanca

location_facility: Batra Hospital and Medical Research Centre

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: CEPIC - Centro Paulista de Investigacao Clinica

title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Hungary
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain


title: BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments

acronym: BYLieve

summary: Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), harboring PIK3CA mutations, who have progressed on or after prior treatments.

ReferenceCitation: Rugo HS, Lerebours F, Ciruelos E, Drullinsky P, Ruiz-Borrego M, Neven P, Park YH, Prat A, Bachelot T, Juric D, Turner N, Sophos N, Zarate JP, Arce C, Shen YM, Turner S, Kanakamedala H, Hsu WC, Chia S. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021 Apr;22(4):489-498. doi: 10.1016/S1470-2045(21)00034-6. Erratum In: Lancet Oncol. 2021 May;22(5):e184.

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

location_country:
Germany
Argentina
Japan
Chile
Canada
France
Denmark
United States
India
Belgium
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Greater Baltimore Medical Center Cancer Center

location_facility: Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2)

location_facility: Josephine Ford Cancer Center Main Centre

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

location_facility: University of California San Francisco Main Centre

location_facility: University Hospitals of Cleveland Seidman Cancer Center

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: University of Louisville / James Graham Brown Cancer Center SC


lead_sponsor: Acerta Pharma BV

summary: This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

ReferenceCitation: Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021 Mar 11;5(1):27. doi: 10.1186/s41687-021-00294-1.

ReferenceCitation: Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.

title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

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.

location_country:
Germany
Poland
New Zealand
Australia
Croatia
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
United States
Ukraine
Belgium
Italy
United Kingdom
Singapore
Sweden
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an Acute Myocardial Infarction (AMI)

acronym: PARADISE-MI

summary: The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.

ReferenceCitation: Mehran R, Steg PG, Pfeffer MA, Jering K, Claggett B, Lewis EF, Granger C, Kober L, Maggioni A, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Ducrocq G, Berwanger O, De Pasquale CG, Landmesser U, Petrie M, Leng DSK, van der Meer P, Lefkowitz M, Zhou Y, Braunwald E. The Effects of Angiotensin Receptor-Neprilysin Inhibition on Major Coronary Events in Patients With Acute Myocardial Infarction: Insights From the PARADISE-MI Trial. Circulation. 2022 Dec 6;146(23):1749-1757. doi: 10.1161/CIRCULATIONAHA.122.060841. Epub 2022 Nov 2.

version: acceptedVersion

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Shah AM, Claggett B, Prasad N, Li G, Volquez M, Jering K, Cikes M, Kovacs A, Mullens W, Nicolau JC, Kober L, van der Meer P, Jhund PS, Ibram G, Lefkowitz M, Zhou Y, Solomon SD, Pfeffer MA. Impact of Sacubitril/Valsartan Compared With Ramipril on Cardiac Structure and Function After Acute Myocardial Infarction: The PARADISE-MI Echocardiographic Substudy. Circulation. 2022 Oct 4;146(14):1067-1081. doi: 10.1161/CIRCULATIONAHA.122.059210. Epub 2022 Sep 9.

repository_institution: UHasselt - Document Server@UHasselt

ReferenceCitation: Pfeffer MA, Claggett B, Lewis EF, Granger CB, Kober L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, Fernandez A, Filippatos G, Jering K, Landmesser U, Menon V, Merkely B, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Wang Y, Braunwald E. Impact of Sacubitril/Valsartan Versus Ramipril on Total Heart Failure Events in the PARADISE-MI Trial. Circulation. 2022 Jan 4;145(1):87-89. doi: 10.1161/CIRCULATIONAHA.121.057429. Epub 2021 Nov 19. No abstract available.

repositories_concat: PubMed Central;pure.rug.nl

ReferenceCitation: Pfeffer MA, Claggett B, Lewis EF, Granger CB, Kober L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, East C, Fernandez A, Jering K, Landmesser U, Mehran R, Merkely B, Vaghaiwalla Mody F, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Gong J, Braunwald E; PARADISE-MI Investigators and Committees. Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction. N Engl J Med. 2021 Nov 11;385(20):1845-1855. doi: 10.1056/NEJMoa2104508. Erratum In: N Engl J Med. 2021 Dec 30;385(27):2592.

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

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Croatia
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
India
Romania
Belgium
China
Peru
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

ReferenceCitation: Robert C, Lewis KD, Gutzmer R, Stroyakovskiy D, Gogas H, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Caro I, Forbes H, Shah K, Yan Y, Li H, McArthur GA, Ascierto PA. Biomarkers of treatment benefit with atezolizumab plus vemurafenib plus cobimetinib in BRAFV600 mutation-positive melanoma. Ann Oncol. 2022 May;33(5):544-555. doi: 10.1016/j.annonc.2022.01.076. Epub 2022 Feb 4.

ReferenceCitation: de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAFV600 wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

ReferenceCitation: Gutzmer R, Stroyakovskiy D, Gogas H, Robert C, Lewis K, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Manikhas GM, Yan Y, Huang KC, Uyei A, McNally V, McArthur GA, Ascierto PA. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAFV600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Jun 13;395(10240):1835-1844. doi: 10.1016/S0140-6736(20)30934-X. Erratum In: Lancet. 2020 Aug 15;396(10249):466.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Wellington Hospital; Wellington Blood and Cancer Centre

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

location_facility: LKH Innsbruck; Universitätsklinik für Dermatologie

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

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

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

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

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

location_facility: Universitätsklinikum Würzburg; Med. Klinik 1, Pneumologie

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Elbekliniken Buxtehude; Klinik für Dermatologie

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

location_facility: LHSC - Victoria Hospital; London Regional Cancer Program

location_facility: UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Sharett Institute - Hadassah Hebrew University Medical Center

location_facility: Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

location_facility: Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: Medical University of Graz, Department of Dermatology

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Istituto Tumori ?Giovanni Paolo II?, Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Universitatsklinikum Essen; Klinik für Dermatologie

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie

location_facility: IPO de Lisboa; Servico de Oncologia Medica

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

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

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

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

title: A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Canada
France
Portugal
Hungary
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

ReferenceCitation: Scherpereel A, Antonia S, Bautista Y, Grossi F, Kowalski D, Zalcman G, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Sun X, Lawrance R, Zhang X, Daumont MJ, Bennett B, McKenna M, Baas P. First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743. Lung Cancer. 2022 May;167:8-16. doi: 10.1016/j.lungcan.2022.03.012. Epub 2022 Mar 21.

repository_institution: Leiden University - Leiden Repository

ReferenceCitation: Peters S, Scherpereel A, Cornelissen R, Oulkhouir Y, Greillier L, Kaplan MA, Talbot T, Monnet I, Hiret S, Baas P, Nowak AK, Fujimoto N, Tsao AS, Mansfield AS, Popat S, Zhang X, Hu N, Balli D, Spires T, Zalcman G. First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743. Ann Oncol. 2022 May;33(5):488-499. doi: 10.1016/j.annonc.2022.01.074. Epub 2022 Feb 3.

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodriguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21. Erratum In: Lancet. 2021 Feb 20;397(10275):670.

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repository_institution: University of Western Australia - UWA Profiles and Research Repository

repositories_concat: LillOA (Lille Open Archive);Pure (Denmark);scholarlypublications.universiteitleiden.nl

ReferenceCitation: Wright K. FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. Oncology (Williston Park). 2020 Nov 12;34(11):502-503. doi: 10.46883/ONC.2020.3411.0502.

publisher_dissemination: MJH Life Sciences

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility: Univ Of Maryland Greenbaum Cancer Center

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

location_facility: Cancer & Hematology Centers Of Western Michigan

title: A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Chile
France
Colombia
Switzerland
United States
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Greece
South Africa
Russian Federation


title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)

summary: The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

location_country:
Germany
Italy
Israel
United Kingdom
Denmark
Japan
Netherlands
Belgium
United States
Spain
France

location_facility: ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: TRIO - Comprehensive Cancer Centers of Nevada

location_facility: University of North Carolina at Chapel Hill

location_facility: Texas Oncology - Baylor Charles A. Sammons

location_facility: UCSF Helen Diller Family Comprehensive Care Center

location_facility: Saitama Medical University International Medical Center

location_facility: University of Maryland, Greenebaum Cancer Center

location_facility: University of Wisconsic Hospital and Clinic

location_facility: Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Compass Oncology the Northwest Cancer Specialists

location_facility: Nottingham University Hospitals City Campus

location_facility: Calaway-Young Cancer Center at Valley View Hospital

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza


acronym: ENTRUST-AF-PCI

lead_sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

summary: There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

ReferenceCitation: Goette A, Eckardt L, Valgimigli M, Lewalter T, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Tijssen JG, Vranckx P. Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis. Clin Res Cardiol. 2021 Jun;110(6):831-840. doi: 10.1007/s00392-020-01760-4. Epub 2020 Oct 24.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.

ReferenceCitation: Vranckx P, Lewalter T, Valgimigli M, Tijssen JG, Reimitz PE, Eckardt L, Lanz HJ, Zierhut W, Smolnik R, Goette A. Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial. Am Heart J. 2018 Feb;196:105-112. doi: 10.1016/j.ahj.2017.10.009. Epub 2017 Oct 23.

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

location_facility: Communal Institution of Kyiv Regional Rada

location_facility: Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta

location_facility: Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco

location_facility: Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie

location_facility: X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca

location_facility: Chernivtsi Regional Clinical Cardiology Dispensary

location_facility: S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: AOU Materdomini, Magna Graecia University

location_facility: Vinnytsya Regional Clinical Hospital n.a. Pyrogov

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin

location_facility: III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"

location_facility: Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: Zaporizhzhia Regional cardiology dispensary

location_facility: Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center

location_facility: Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)

location_facility: Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica

location_facility: St. Josefs-Hospital - Medizinische Klinik I, Kardiologie

location_facility: Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)

location_facility: Odessa Regional Hospital, Cardiosurgery Center

location_facility: Vilnius University Hospital "Santariskiu Clinic"

location_facility: Institute of Cardiovascular Diseases of Vojvodina

location_facility: Complejo Hospitalario Universitario de Granada

location_facility: Transcarpathian Regional Clinical Cardiology Clinic

location_facility: St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II

location_facility: Communal Institution Dnepropetrovsk Regional Diagnostic Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca

location_facility: "Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases

location_facility: Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin

location_facility: HFR Freiburg - Kantonsspital Kardiologie

location_facility: Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I

location_facility: Communal Institution of Sumy Regional Rada

location_facility: Lithuanian University of Health Sciences hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões

location_facility: Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum

location_facility: CI "Dnipropetrovsk Joint Emergency Hospital"

location_facility: Oradea Emergency County Clinical Hospital

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Seoul National University Bundang Hospital

location_facility: Oleksandrivska Kiyv City Clinical Hospital

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen

location_facility: Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie

location_facility: Institute of CV Diseases Clinical Center of Serbia

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

location_facility: L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine

location_facility: State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'

location_facility: China Medical University Hospital (CMUH)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin

location_facility: Communal Institution Rivne Regional Clinical Hospital

location_facility: Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca

location_facility: Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie

location_facility: Universitätsklinikum Münster - Department für Kardiologie und Angiologie

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Institutul de Boli Cardiovasculare Timisoara

location_facility: Emergency Institute of Cardiovascular Diseases and Transplantation

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca

location_facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)

location_facility: "Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"

location_facility: Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"

location_facility: Complejo Asistencial Universitario de León

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

title: Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Germany
Italy
Lithuania
Poland
Portugal
Hungary
United Kingdom
Romania
Netherlands
Austria
Belgium
Switzerland
Korea, Republic of
Spain
Taiwan
Ukraine
Serbia
France


title: A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)

summary: The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Switzerland
Austria
Belgium
United States
Canada
France

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust

location_facility: Methodist Healthcare Dallas - The Liver Institute

location_facility: University of Arkansas for Medical Sciences

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Nottingham University Hospitals NHS Trust


acronym: Onset® 5

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

ReferenceCitation: Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.

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

repository_institution: University of Cambridge - Apollo

repositories:
HAL
PubMed Central
www.repository.cam.ac.uk

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

ReferenceCitation: Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.

publisher_dissemination: Mary Ann Liebert Inc

title: Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

location_country:
Germany
Slovenia
United Kingdom
Netherlands
Belgium
United States
Canada
Russian Federation
France


title: Phase IIIb Randomized Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer. A Joint Study of the EORTC ROG and GUCG

acronym: PEGASUS

summary:
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.

Secondary objectives include:

documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline;
documentation of side effects and quality of life, I-PSS and urinary tract infections;
assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.

enrollment_type: Anticipated

ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

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

location_country:
Germany
Italy
United Kingdom
Denmark
Switzerland
Belgium
Spain
France

location_facility: Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque

location_facility: Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

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

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik

location_facility: Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Hospital General Universitario Santa Lucia

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

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

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: University Hospitals Copenhagen - Rigshospitalet

location_facility: Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli


acronym: DAYBREAK-ALZ

lead_sponsor: AstraZeneca

summary: The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

ReferenceCitation: Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum In: JAMA Neurol. 2020 Sep 1;77(9):1179.

repository_institution: The University of Arizona - UA Campus Repository

repositories_concat: PubMed Central;repository.arizona.edu

ReferenceCitation: Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjall S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053. doi: 10.3233/JAD-160701.

publisher_dissemination: IOS Press

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: SDN - Istituto di Ricerca Diagnostica e Nucleare

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Jacksonville Center for Clinical Research

location_facility: Shanghai Huashan Hospital Affil to Fu Dan University

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Research Center for Clinical Studies, Inc

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Instituto de Informacion en Salud Mental (INFOSAM)

location_facility: True North Clinical Research Halifax, LLC

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Praxis für Neurologie und Psychiatrie Dr. med. Roth

location_facility: Allied Biomedical Research Institute, Inc.

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

location_facility: Regional State Institution of Healthcare Tomsk Clinica Psych

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Neurology Specialists of Monmouth County

location_facility: Univ of North Texas Health Science Center

location_facility: LLC City Neurological Centre Sibneuromed

location_facility: The Research Center of Southern California

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: RSBIH Smolensk Regional Clinical Hospital

location_facility: Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

location_facility: Mexico Centre for Clinical Research SA de CV

location_facility: Xuanwu Hospital-Capital Medical University

location_facility: ISPG - Institut für Studien zur psychischen Gesundheit

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Seoul National University Bundang Hospital

location_facility: Institute for Neurodegenerative Disorders

location_facility: Center for Clinical and Basic Research -CCBR

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centro de Estudios Clinicos y Esp Medicas SC

location_facility: SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst

location_facility: Toronto Sunnybrook Regional Cancer Center

location_facility: Azienda Ospedaliera Citta della Salute della Scienza Torino

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED

location_facility: Texas Medical Research Associates, L.L.C.

location_facility: West China Hospital of Sichuan University

location_facility: CSSS-Institut Universitaire Gériatric de Sherbrooke

location_facility: The First Affiliated Hospital of Wenzhou Medical College

status: Terminated

title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Denmark
Japan
Netherlands
Mexico
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Russian Federation
France

status_simplified: Unknown


title: Stellarex Vascular E-Registry

acronym: SAVER

summary: Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

time_perspective: Prospective

ReferenceCitation: Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

lead_sponsor: Spectranetics Corporation

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
France

location_facility: Âzienda Ospedaliera Per L'emergenza Cannizzaro

location_facility: Ev. Krankenhaus Königin Elisabeth Herzberge

location_facility: Krankenhaus der Barmherzigen Schwesterrn Reid

location_facility: Grand Hôpital de l'Est Francilien - Site de Marne la Vallée

location_facility: Krankenhäuser Landkreis Freudenstadt GmbH

intervention_type: Device


title: A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors

acronym: MEDIOLA

summary: The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

ReferenceCitation: Staniszewska AD, Armenia J, King M, Michaloglou C, Reddy A, Singh M, San Martin M, Prickett L, Wilson Z, Proia T, Russell D, Thomas M, Delpuech O, O'Connor MJ, Leo E, Angell H, Valge-Archer V. PARP inhibition is a modulator of anti-tumor immune response in BRCA-deficient tumors. Oncoimmunology. 2022 Jun 18;11(1):2083755. doi: 10.1080/2162402X.2022.2083755. eCollection 2022.

ReferenceCitation: Domchek SM, Postel-Vinay S, Im SA, Park YH, Delord JP, Italiano A, Alexandre J, You B, Bastian S, Krebs MG, Wang D, Waqar SN, Lanasa M, Rhee J, Gao H, Rocher-Ros V, Jones EV, Gulati S, Coenen-Stass A, Kozarewa I, Lai Z, Angell HK, Opincar L, Herbolsheimer P, Kaufman B. Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Lancet Oncol. 2020 Sep;21(9):1155-1164. doi: 10.1016/S1470-2045(20)30324-7. Epub 2020 Aug 6.

repository_institution: The University of Manchester - Research Explorer

repositories_concat: Pure (Denmark)

sponsor_collaborators:
AstraZeneca
Iqvia Pty Ltd

location_country:
France
United Kingdom
Netherlands
Switzerland
United States
Korea, Republic of
Israel