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journal_name: The Lancet Oncology

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

lead_sponsor: Pfizer

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Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Switzerland
Hungary
Ireland
China
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United States
Germany
United Kingdom
Italy
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location_facility: Memorial Sloan Kettering Cancer Center Westchester

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location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Cabinet de radiologie Privé - Dr Joseph Mocaer

location_facility: Illawarra Shoalhaven Local Health District

location_facility: University of Missouri- Ellis Fischel Cancer Center

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: University Of Colorado Hospital Cancer Center

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location_facility: Washington University School of Medicine Siteman Cancer Center

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location_facility: Memorial Cancer Institute at Memorial Regional Hospital

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location_facility: University Hospitals Cleveland Medical Center

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

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location_facility: West China Hospital of Sichuan University

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth

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location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

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location_facility: AULSS 9 - Scaligera Ospedale Mater Salutis

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title: A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.


title: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

acronym: PATINA

summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.

ReferenceCitation: Welch HG, Gorski DH, Albertsen PC. Trends in Metastatic Breast and Prostate Cancer--Lessons in Cancer Dynamics. N Engl J Med. 2015 Oct 29;373(18):1685-7. doi: 10.1056/NEJMp1510443.

ReferenceCitation: Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.

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genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

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oa_host_type: publisher;repository

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license_normalized: no license

version: publishedVersion

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repository_institution: São Paulo Research Foundation, Latin American and Caribbean Center on Health Sciences Information, Conselho Nacional de Desenvolvimento Científico e Tecnológico - Scientific Electronic Library Online

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repository_normalized: PubMed Central

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publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer

ReferenceCitation: Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Heeson S, Clark E, Ross G, Benyunes MC, Cortés J; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. doi: 10.1056/NEJMoa1413513.

repository_institution: Tampere University - Tampere University Institutional Repository

title: Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

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ReferenceCitation: Peddi PF, Slamon DJ. Frontiers in HER2-positive breast cancer in 2020. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):48-52. doi: 10.1097/GCO.0000000000000677. Review.

journal_name: Current Opinion in Obstetrics & Gynecology

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Italy
United States
France
Australia
New Zealand
Spain
Germany

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: The University of Chicago Medical Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Michigan Cancer Research Consortium (St. Joseph Mercy Hospital

location_facility: Vidia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG Frauenklinik

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: St. Vincent's Hospital, Sydney Kinghorn Cancer Centre

location_facility: Institut de Cancérologie de l'Ouest, site Paul Papin

location_facility: The Valley Hospital, Okonite Research Center

location_facility: Metro-Minnesota NCI Community Oncology Research Program

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Washington University School of Medicine

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: Univ. Klinikum Oldenburg AÖR Hämatologie/Onkologie

location_facility: UKSH, Klinik für Gynäkologie und Geburtshilfe

location_facility: Auckland City Hospital Cancer and Blood Research

location_facility: Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

location_facility: Hospital Regional Universitario de Málaga

location_facility: Praxis Prof. Nitz im Brustzentrum Niederrhein

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: First Health of the Carolinas Cancer Center

location_facility: Peter MacCallum Cancer Centre, Royal Melbourne Hospital

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center


title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

summary: The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer.

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: De Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, Dent S, Martin M, Ring A, Cottu P, Lu J, Ciruelos E, Azim HA, Chatterjee S, Zhou K, Wu J, Menon-Singh L, Zamagni C. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021 Oct;189(3):689-699. doi: 10.1007/s10549-021-06334-0. Epub 2021 Aug 19. Erratum in: Breast Cancer Res Treat. 2021 Oct 8;:.

family: De Laurentiis

full_name: Michelino De Laurentiis

given: Michelino

family: Borstnar

full_name: Simona Borstnar

given: Simona

family: Campone

full_name: Mario Campone

given: Mario

family: Warner

full_name: Ellen Warner

given: Ellen

family: Bofill

full_name: Javier Salvador Bofill

given: Javier Salvador

family: Jacot

full_name: William Jacot

given: William

family: Dent

full_name: Susan Dent

given: Susan

family: Martin

full_name: Miguel Martin

given: Miguel

family: Ring

full_name: Alistair Ring

given: Alistair

family: Cottu

full_name: Paul Cottu

given: Paul

family: Lu

full_name: Janice Lu

given: Janice

family: Ciruelos

full_name: Eva Ciruelos

given: Eva

family: Azim

full_name: Hamdy A. Azim

given: Hamdy A.

family: Chatterjee

full_name: Sanjoy Chatterjee

given: Sanjoy

family: Zhou

full_name: Katie Zhou

given: Katie

family: Wu

full_name: Jiwen Wu

given: Jiwen

family: Menon-Singh

full_name: Lakshmi Menon-Singh

given: Lakshmi

family: Zamagni

full_name: Claudio Zamagni

given: Claudio

journal_name: Breast Cancer Research and Treatment

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_country:
Jordan
Finland
Malaysia
Greece
Belgium
Russian Federation
Denmark
Oman
Taiwan
India
France
Panama
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Slovenia
Chile
Sweden
Saudi Arabia
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
Hungary
Portugal
United States
United Kingdom
Italy
Austria
Lebanon
Mexico
Czechia
Israel
Spain

location_facility: University of California Irvine UC Irvine (11)

location_facility: Oklahoma Cancer Specialists and Research Institute SC-2

location_facility: Virginia Mason Medical Center-Oncology SC

location_facility: California Pacific Medical Center Onc Dept

location_facility: Alaska Cancer Research and Education Center

location_facility: Indiana University Health Goshen Center for Cancer SC

location_facility: John Ochsner Heart and Vascular Institute Clinical Trials

location_facility: Foundation for Sickle Cell Disease Research

location_facility: University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center

location_facility: Arizona Oncology Associates Arizona Oncology Assoc. (2)

location_facility: Centura Health Research Center Centura Health Research Center

location_facility: Cancer Therapy and Research Center UT Health Science Center

location_facility: Sarah Cannon at Overland Park Regional Medical Center

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI

location_facility: Joliet Oncology-Hematology Associates Presence Cancer Center

location_facility: University of Kansas Cancer Center University of Kansas Med Ctr 9

location_facility: Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)

location_facility: Summit Cancer Care Summit Cancer Care (SC)

location_facility: Providence Regional Medical Centre of Everett

location_facility: McLeod Center for Cancer Treatment and Research

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Carolina Blood and Cancer Care of South Carolina

location_facility: Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr

location_facility: John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)

location_facility: Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee

location_facility: Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2

location_facility: Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)

location_facility: The Christ Hospital Cancer Center Research Program Linder Research Center

location_facility: Millennium Oncology Millennium Oncology - FL

location_facility: Oregon Health and Science University SC-5

location_facility: Poudre Valley Hospital Poudre Valley Health System

location_facility: Stroger Cook County Hospital Division of Hematology & Onc

location_facility: Maryland Oncology Hematology, P.A. Columbia

location_facility: Valley Medical Center Research Valley Medical Center

location_facility: Northwest Medical Specialties Dept.ofNW Med. Specialties

location_facility: Watson Clinic Center for Research 1730 Location


ReferenceCitation: Del Pozo Martín Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31.

family: del Pozo Martín

full_name: Yaiza del Pozo Martín

given: Yaiza

journal_name: The Lancet Haematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: 47th Annual Meeting of the EBMT

intervention_type: Drug

status: Completed

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

location_country:
Italy
Austria
United States
Switzerland
Germany
Croatia
France
Singapore
Australia
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Royal Liverpool and Broadgreen University Hospitals NHS Trust

location_facility: Medical University of South Carolina - PPDS

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Cincinnati Children's Hospital Medical Center - PIN

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Beatson West of Scotland Cancer Centre - PPDS

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

location_facility: University of Utah Health Sciences Center - PPDS

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: University Hospitals Cleveland Medical Center

location_facility: Feinberg School of Medicine Northwestern University

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: University of Texas Southwestern Medical Center

location_facility: Centre Hospitalier Universitaire Sainte-Justine

ipd_sharing: Yes

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

summary: The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sørensen T, Böhm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.

ReferenceCitation: Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlström U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsányi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2021 Oct 13. doi: 10.1001/jamacardio.2021.4027. [Epub ahead of print]

name: Division of Cardiology, Duke University School of Medicine, Durham, North Carolina

name: Duke Clinical Research Institute, Durham, North Carolina

family: Felker

full_name: G. Michael Felker

given: G. Michael

name: Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: Claggett

full_name: Brian Claggett

given: Brian

name: Instituto Cardiovascular de Rosario, Estudios Clínicos Latino América, Rosario, Argentina

family: Diaz

full_name: Rafael Diaz

given: Rafael

name: Cardiovascular Research Centre, British Heart Foundation, Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom

family: McMurray

full_name: John J. V. McMurray

given: John J. V.

name: Department of Medical and Surgical Specialties, University of Brescia, Brescia, Italy

family: Metra

full_name: Marco Metra

given: Marco

name: Division of Cardiovascular Medicine, University of Minnesota, Minneapolis

family: Anand

full_name: Inder Anand

given: Inder

name: Division of Cardiology, Universidad da Coruña, A Coruña, Galicia, Spain

family: Crespo-Leiro

full_name: Marisa G. Crespo-Leiro

given: Marisa G.

name: Department of Cardiology, Linköping University Hospital, Linköping, Sweden

family: Dahlström

full_name: Ulf Dahlström

given: Ulf

name: Department of Cardiology, Odd. Srdcovehozlyhavania a Transplantacie, Bratislava, Slovakia

family: Goncalvesova

full_name: Eva Goncalvesova

name: Division of Cardiology, Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada

family: Howlett

full_name: Jonathan G. Howlett

given: Jonathan G.

name: Heart Transplant Unit, St. Vincent’s Hospital Sydney, Darlinghurst, NSW, Australia

family: MacDonald

full_name: Peter MacDonald

given: Peter

name: Emergency Cardiology Department, Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine

family: Parkhomenko

full_name: Alexander Parkhomenko

given: Alexander

name: Cardiology Department, St. John of God Hospital, Budapest, Hungary

family: Tomcsányi

full_name: János Tomcsányi

given: János

family: Abbasi

full_name: Siddique A. Abbasi

given: Siddique A.

name: Clinical Research, Cytokinetics, South San Francisco, California

family: Heitner

full_name: Stephen B. Heitner

given: Stephen B.

family: Hucko

full_name: Thomas Hucko

given: Thomas

family: Kupfer

full_name: Stuart Kupfer

given: Stuart

name: Research and Development, Cytokinetics, South San Francisco, California

family: Malik

full_name: Fady I. Malik

given: Fady I.

name: Division of Cardiology, San Francisco VA Medical Center, San Francisco, California

name: Division of Cardiology, University of California San Francisco, San Francisco

family: Teerlink

full_name: John R. Teerlink

given: John R.

journal_name: JAMA Cardiology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sørensen T, Böhm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlström U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.

name: From the Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco (J.R.T.), Amgen, Thousand Oaks (L.S., J.C.L., N.H., S.A.A., C.E.K.), and Cytokinetics, South San Francisco (F.I.M.) — all in California; Estudios Clínicos Latino América, Rosario, Argentina (R.D.); the Division of Cardiology, Duke University School of Medicine and Duke Clinical Research Institute, Durham (G.M.F.), and the University of North Carolina...

repository_institution: Russian Cardiology Society - Russian Cardiology Journal

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Büchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6. Review.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain
Turkey

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

summary: The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).


title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

acronym: DIVERSITYLTE

summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

status: Enrolling by invitation

design_allocation: Non-Randomized

lead_sponsor: Gilead Sciences

location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Iceland
Ukraine
India
Croatia
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Sri Lanka
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Georgia
New Zealand
Spain

location_facility: Hyogo College of Medicine College Hospital

location_facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie

location_facility: Kitasato University Hospital,THE KITASATO INSTITUTE

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

location_facility: Universiti Kebangsaan Malaysia Medical Center

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Shiga University of Medical Science Hospital

location_facility: Gastroenterology Associates of Tidewater

location_facility: Gastroenterology Research of San Antonio

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Center for Interventional Endoscopy - Florida Hospital

location_facility: Seth G.S. Medical College & KEM Hospital

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: S.L. Raheja Hospital (A Fortis Associate)

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Gastroenterology Associates Of Central Georgia, LLC

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

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: Premier Medical Group of the Hudson Valley

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: Digestive Health Specialists Of The Southeast

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Ohmori Toshihide gastro-intestinal Clinic

location_facility: Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II

location_facility: GZA Ziekenhuizen, campus Sint-Vincentius

location_facility: Szent Margit Korhaz, Gasztroenterológiai Osztály

location_facility: University of Iowa Hospitals and Clinics

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: London Health Sciences Centre - University Hospital

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

location_facility: Delta Health Care/ Ponderas Academic Hospital

location_facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Illinois Gastroenterology Group - Gurnee

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

location_facility: Hutt Valley District Health Board - Hutt Valley Hospital

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Saitama Medical Center, Saitama Medical University

location_facility: Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern

location_facility: Southern California Research Center, Inc.

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: UOC Medicina Interna a Gastroenterologia

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Wellcome Trust HRB Clinical Research Facility

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Coral Sea Clinical Research Institute (Mackay)

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: University of Colorado Denver and Hospital

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego

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

location_facility: Centrul Medical Tuculanu, Gastroenterologie

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Hospital Universitario de Gran Canaria "Dr. Negrin"

location_facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

location_facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)

location_facility: Clinical Research Center Sp. z o.o. Medic-R Sp.k.

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Baylor College of Medicine - McNair Campus

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Lakeshore Hospital and Research Centre Ltd

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: CHA Bundang Medical Center, CHA University

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: UOC di Gastroenterologia ed Endoscopia Digestiva

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: New York University School of Medicine / NYU Gastroenterology Associates

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: University of Mississippi Medical Center

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Medical Center - Complete Medical Solutions OOD

location_facility: Hospital Universitario Central de Asturias

location_facility: The University of Texas Health Science Center at Houston

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

location_facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

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

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)

location_facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: The University of Chicago Medical Center (Clinic)

location_facility: Department of Surgery, B.J. Government Medical College & Sassoon General Hospital

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Kitasato University Kitasato Institute Hospital

status_simplified: Unknown


title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

summary:
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Iceland
Ukraine
India
Croatia
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Sri Lanka
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Georgia
New Zealand
Spain

location_facility: Hyogo College of Medicine College Hospital

location_facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie

location_facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego

location_facility: Medical corporation Ryowakai, Hamamatsu South Hospital

location_facility: Universiti Kebangsaan Malaysia Medical Center

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Shiga University of Medical Science Hospital

location_facility: Gastroenterology Associates of Tidewater

location_facility: Indiana University Health University Hospital

location_facility: Gastroenterology Research of San Antonio

location_facility: Victoria Hospital, Bangalore Medical College and Research Institute

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

location_facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC

location_facility: General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: University of Louisville, School of Medicine

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

location_facility: Texas Digestive Disease Consultants (IP Shipment)

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Complejo Hospitalario Universitario de Pontevedra

location_facility: Unidade Local de Saude do Alto Minho, EPE

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

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: Premier Medical Group of the Hudson Valley

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Ohmori Toshihide gastro-intestinal Clinic

location_facility: Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II

location_facility: Szent Margit Korhaz, Gasztroenterológiai Osztály

location_facility: University of Iowa Hospitals and Clinics

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: London Health Sciences Centre - University Hospital

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: New York University School of Medicine/NYU Gastroenterology Associates

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: Medstar Georgetown University Hospital (Patient Exams)

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

location_facility: Delta Health Care/ Ponderas Academic Hospital

location_facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals

location_facility: S.R.Kalla Memorial Gastro.&General Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: Spitalul Clinic Colentina, Gastroenterologie

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Illinois Gastroenterology Group - Gurnee

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)

location_facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

location_facility: Hutt Valley District Health Board - Hutt Valley Hospital

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Saitama Medical Center, Saitama Medical University

location_facility: Vestre Viken Hospital Trust, Baerum Hospital

location_facility: Southern California Research Center, Inc.

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Wellcome Trust HRB Clinical Research Facility

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: University Medical Center Groningen (UMCG)

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Coral Sea Clinical Research Institute (Mackay)

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Centre d'Investigation Clinique - CHU Hotel-Dieu

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: Great Lakes Gastroenterology Research, LLC,

location_facility: Kitasato University Hospital, THE KITASATO INSTITUTE

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

location_facility: University of Colorado Denver and Hospital

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

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

location_facility: Centrul Medical Tuculanu, Gastroenterologie

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Hospital Universitario de Gran Canaria "Dr. Negrin"

location_facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Lakeshore Hospital and Research Centre Ltd.

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: CHA Bundang Medical Center, CHA University

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Asian Institute of Gastroenterology Pvt Ltd

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: Gastroplus Digestive Disease Centre Pvt Ltd

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"

location_facility: UOC di Gastroenterologia ed Endoscopia Digestiva

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: University of Mississippi Medical Center

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: Center for Interventional Endoscopy - AdventHealth Orlando

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Digestive Health Specialists of the Southeast

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Medical Center - Complete Medical Solutions OOD

location_facility: Hospital Universitario Central de Asturias

location_facility: The University of Texas Health Science Center at Houston

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

status_simplified: Ongoing


location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Israel
Georgia
New Zealand
Spain

acronym: SELECTIONLTE

location_facility: Hyogo College of Medicine College Hospital

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: Kitasato University Hospital,THE KITASATO INSTITUTE

location_facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie

location_facility: SR Kalla Memorial Gastro and General Hospital

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

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: Digestive Health Specialists Of The Southeast

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: GZA Ziekenhuizen, campus Sint-Vincentius

location_facility: National Hospital Organization Sendai Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Colo-proctology Center Matsushima Clinic

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: Shiga University of Medical Science Hospital

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Gastroenterology Associates of Tidewater

location_facility: Gastroenterology Research of San Antonio

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

location_facility: Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

location_facility: L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: PCR-Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

location_facility: Centrum Innowacyjnych Terapii Sp. z o.o.

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Grant Medical Foundation Ruby Hall Clinic

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

location_facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

location_facility: Santa Familia, Centrum Badan, Profilaktyki i Leczenia

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

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).