title: Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study

acronym: CAPTOCOVID

summary: Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.

ReferenceCitation: Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

name: From the State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (W.G., W.L., J.H., R.C., C.T., T.W., S.L., Jin-lin Wang, N.Z., J.H., W.L.), the Departments of Thoracic Oncology (W.L.), Thoracic Surgery and Oncology (J.H.), and Emergency Medicine (Z.L.), First Affiliated Hospital of Guangzhou Medical University, and Guangzhou Eighth People’s Hospital,...

family: Guan

full_name: Wei-jie Guan

given: Wei-jie

family: Ni

full_name: Zheng-yi Ni

given: Zheng-yi

family: Hu

full_name: Yu Hu

given: Yu

family: Liang

full_name: Wen-hua Liang

given: Wen-hua

family: Ou

full_name: Chun-quan Ou

given: Chun-quan

family: He

full_name: Jian-xing He

given: Jian-xing

family: Liu

full_name: Lei Liu

given: Lei

family: Shan

full_name: Hong Shan

given: Hong

family: Lei

full_name: Chun-liang Lei

given: Chun-liang

family: Hui

full_name: David S.C. Hui

given: David S.C.

family: Du

full_name: Bin Du

given: Bin

family: Li

full_name: Lan-juan Li

given: Lan-juan

family: Zeng

full_name: Guang Zeng

given: Guang

family: Yuen

full_name: Kwok-Yung Yuen

given: Kwok-Yung

family: Chen

full_name: Ru-chong Chen

given: Ru-chong

family: Tang

full_name: Chun-li Tang

given: Chun-li

family: Wang

full_name: Tao Wang

given: Tao

full_name: Ping-yan Chen

given: Ping-yan

family: Xiang

full_name: Jie Xiang

given: Jie

full_name: Shi-yue Li

given: Shi-yue

full_name: Jin-lin Wang

given: Jin-lin

full_name: Zi-jing Liang

given: Zi-jing

family: Peng

full_name: Yi-xiang Peng

ReferenceCitation: Li F, Li W, Farzan M, Harrison SC. Structure of SARS coronavirus spike receptor-binding domain complexed with receptor. Science. 2005 Sep 16;309(5742):1864-8.

ReferenceCitation: Imai Y, Kuba K, Rao S, Huan Y, Guo F, Guan B, Yang P, Sarao R, Wada T, Leong-Poi H, Crackower MA, Fukamizu A, Hui CC, Hein L, Uhlig S, Slutsky AS, Jiang C, Penninger JM. Angiotensin-converting enzyme 2 protects from severe acute lung failure. Nature. 2005 Jul 7;436(7047):112-6.

ReferenceCitation: Zhang H, Penninger JM, Li Y, Zhong N, Slutsky AS. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-590. doi: 10.1007/s00134-020-05985-9. Epub 2020 Mar 3.

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

location_facility:
CH de Compiègne-Noyon
Hôpital Tenon
Hôpital Antoine Béclère
CH Victor Dupuy- Argenteuil
Hôpital de la Pitié- Salpêtrière
Hôpital Avicenne,
Hôpital Avicenne
Hôpital de Tours
Groupe hospitalier Sud Ile de France
CHRU de Tours, Hôpital Bretonneau


title: Impact of the Choice of the Distal Vertebral When Posterior Instrumentation in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis

acronym: VD-SIA

summary:
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback.

The need to have a sufficient number of files with a minimum decline of 5 years for proposing a multicenter study that will be conducted within the framework of the Scoliosis Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES gathers most of the teams that support this pathology.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Fondation Lenval

location_country: France Lebanon

location_facility: Groupe Hospitalier Sud Réunion Terre Rouge Boissy

location_facility: Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen

location_facility: Institut François Calot/Centre Hélio-Marin

location_facility: Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire

location_facility: Hotel Dieu De France Hospital Youssef Souda

location_facility: Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL

location_facility: Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


acronym: SWIFT DIRECT

summary:
Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice.

The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT.

The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Fischer U, Kaesmacher J, S Plattner P, Bütikofer L, Mordasini P, Deppeler S, Cognard C, Pereira VM, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Strbian D, Wiesmann M, Bressan J, Lerch S, Liebeskind DS, Saver JL, Gralla J. SWIFT DIRECT: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a randomized, controlled, multicentre study. Int J Stroke. 2021 Oct 14:17474930211048768. doi: 10.1177/17474930211048768. [Epub ahead of print]

name: Inselspital Bern, UniversitÃ¤tsklinik fÃ¼r Neurologie, Freiburgstrasse , Bern, Switzerland

family: Fischer

full_name: Urs Fischer

given: Urs

sequence: first

name: Inselspital, University Hospital Bern and University of Bern, Department of Neuroradiology, Bern, Switzerland

family: Kaesmacher

full_name: Johannes Kaesmacher

given: Johannes

sequence: additional

name: Inselspital University Hospital Bern, Institute of Diagnostic and Interventional Neuroradiology, Bern, BE, Switzerland

family: Plattner

full_name: Patricia S. Plattner

given: Patricia S.

name: University of Bern, CTU Bern, Bern, Bern, Switzerland

family: BÃ¼tikofer

full_name: Lukas BÃ¼tikofer

given: Lukas

family: Mordasini

full_name: Pasquale Mordasini

given: Pasquale

name: Inselspital University Hospital Bern, Neuro Clinical Trial Unit (NCTU) , Bern, BE, Switzerland

family: Deppeler

full_name: Sandro Deppeler

given: Sandro

name: University Hospital of Toulouse, Department of Diagnostic and Therapeutic Neuroradiology, Hopital Pierre paul RiquetPlace du Dr Baylac, Toulouse, France

family: Cognard

full_name: Christophe Cognard

given: Christophe

name: Toronto Western Hospital, Neuroradiolgy, Toronto, Ontario, Canada

family: Pereira

full_name: Vitor Pereira

given: Vitor

name: University at Buffalo, State University of New York, Neurosurgery, University at Buffalo Neurosurgery, 100 High Street, Suite B4, Buffalo, New York, United States

family: Siddiqui

full_name: Adnan Siddiqui

given: Adnan

name: Vanderbilt University Medical Center, Vanderbilt Cerebrovascular Program, Nashville, Tennessee, United States

family: Froehler

full_name: Michael T. Froehler

given: Michael T.

name: Case Western Reserve University, School of Medicine, Cleveland, Ohio, United States

name: Case Western Reserve University, , Cleveland, Ohio, United States

family: Furlan

full_name: Anthony Furlan

given: Anthony

name: Alfried Krupp Krankenhaus Ruttenscheid, Department of Intracranial Endovascular Therapy, Essen, Nordrhein-Westfalen, Germany

family: Chapot

full_name: Rene Chapot

given: Rene

name: Helsinki University Central Hospital, Neurology, Haartmaninkatu 4, Helsinki, Finland

family: Strbian

full_name: Daniel Strbian

given: Daniel

name: University Hospital Aachen, Institue for Diagnostic and Interventional Neuroradiology, Aachen, Germany

family: Wiesmann

full_name: Martin Wiesmann

given: Martin

name: Inselspital University Hospital Bern, Department of Neurology, Bern, BE, Switzerland

family: Bressan

full_name: Jenny Bressan

given: Jenny

family: Lerch

full_name: Stefanie Lerch

given: Stefanie

name: UCLA, Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine,, Los Angeles, California, United States

family: Saver

full_name: Jeffrey L Saver

given: Jeffrey L

family: Gralla

full_name: Jan Gralla

given: Jan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Stroke

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: EXPRESS: SWIFT DIRECT: Solitaireâ¢ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaireâ¢ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a randomized, controlled, multicentre study

lead_sponsor: University Hospital Inselspital, Berne

location_country:
Austria
Switzerland
Germany
Finland
France
Spain
Canada
United Kingdom

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Dept. of Neurology, Ospedale Civo of Lugano

location_facility: Dept. of Neurology, Bern University Hospital

location_facility: University of Calgary, Alberta Health Services

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitätsklinikum Knappschaftskrankenhaus GmbH Bochum

location_facility: Fondation Ophtalmologique A. de Rothschild

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

location_facility: Royal University Hospital, University of Saskatchewan

location_facility: GHU Paris Psychiatrie et Neurosciences, Sainte Anne

location_facility: Dept. of Neuroradiology, UniversitätsSpital Zürich

location_facility: Dept. of Neurology, Centre hospitalier universitaire vaudois (CHUV)

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Universitätsmedizin Mannheim, Universität Heidelber

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Vermeire

full_name: Severine Vermeire

given: Severine

family: Tyrrell

full_name: Helen Tyrrell

given: Helen

family: Hassanali

full_name: Azra Hassanali

given: Azra

family: Lacey

full_name: Stuart Lacey

given: Stuart

family: Tole

full_name: Swati Tole

given: Swati

family: Tatro

full_name: Amanda R. Tatro

given: Amanda R.

name: The Etrolizumab Global Steering Committee

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
LIRIAS (KU Leuven)
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Etrolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease: An Overview of the Phase 3 Clinical Program

intervention_type: Drug

status: Recruiting

lead_sponsor: Hoffmann-La Roche

enrollment_type: Anticipated

location_country:
Luxembourg
Romania
Australia
Belgium
Russian Federation
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

acronym: JUNIPER

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department

location_facility: Hôpital Nord - CHU Marseille; Service d'Oncologie Multidisciplinaire

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF

location_facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

location_facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

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

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Asheville Gastroenterology Associates, P.A.; Gastroenterology

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Gastroenterology Consultants and Endoscopy Center of Southwest Virginia; Office of Doctor Weiserbs

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: SEIH Prof. Education Rostov SMUH and social development

location_facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Kaplan Medical Center; Allergy and clinical immunology

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Bnai Zion Medical Center; Department of Internal Medicine B

location_facility: Centro de Investigacion Torre Medica Sanatorio Toluca

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Clinical Hospital Merkur; Coronary Care Unite

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Medical Center of Limited Liability Company Medical Center Concilium Medical

location_facility: Asociacion Civil para la Investigacion Gastroenterologica

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: SBHI of Yaroslavl region Clinical hospital #10; Vascular surgery

location_facility: Hadassah University Hospital - Ein Kerem; Oncology

location_facility: Marmara University Pendik Training and Research Hospital; Gastroenterelogy

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Firat University Medical Faculty; Infectious Diseases

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: University of Washington School of Medicine

location_facility: Winnipeg Regional Health Authority; Neurosurgery Department

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino; Dip. sperimentale Medicina e Farmacologia

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Transcarpathian Regional Clinical Hospital n a Andriy Novak; Gastroenterology department

location_facility: Innovative Medical Research of South Florida

location_facility: Cleveland Clinic Florida - Weston; Department of Gastroenterology

location_facility: Gastroenterology Research of San Antonio, LLC

location_facility: Digestive Disease Institute; Virginia Mason Medical Center

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: Texas Physicians Medical Research Group, LLC

location_facility: Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

location_facility: Haydarpasa Numune Training and Research Hospital; Gastroenterology

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: ULB Hopital Erasme; Service de Néphrologie

location_facility: Northwestern Uni-Feinberg School of Medicine

location_facility: Azienda Ospedaliero Universitaria di Parma; Clinica Pediatrica

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU

location_facility: Order of the Red Star MMMCC MMCH Clinic of Gastroenterology

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

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: University of Virginia; Gastroenterology and Hepatology

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: Massachusetts General Hospital; Crohn's & Colitis Center

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Atlantic Digestive Health Institute at Morristown

location_facility: Ankara Diskapi Yildirim Beyazit Training and Research Hospital; Gastroenterology

location_facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Cocuk Kardiyolojisi

location_facility: Hacettepe University Medical Faculty; Gastroenterology

location_facility: The Center for Gastrointestinal Disorders

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: McMaster University Health Sciences Center

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Clínic i Provincial; Servicio de Farmacia

location_facility: LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology

location_facility: Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Jewish General Hospital; Endoscopy Department

location_facility: Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Gastro Campus Research; Praxis am Germania Campus

location_facility: Tiervlei Trial Centre; Karl Bremer Hospital

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

location_facility: Oncoeste Pesquisa Clinica - HUST - Hospital Universitario Santa Terezinha

location_facility: California Medical Research Associates, Inc.

location_facility: Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council

location_facility: Acibadem Kozyatagi Hospital; Gastroenterology

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: University of Florida College of Medicine

location_facility: McGill University Health Centre - Glen Site

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Centro de Pesquisa Clinica Maimonides - Maimonides Day Hospital

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: Gemeinschaftspraxis Mohl, Juenglin, Hasenstein

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Amsterdam UMC, Locatie VUMC; Gastroenterology

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"

location_facility: University of North Carolina at Chapel Hill

location_facility: Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology

location_facility: LMU - Campus Grosshadern; Medizinische Klinik und Poliklinik II

location_facility: Seoul National University Bundang Hospital

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology

location_facility: Kyiv Railway Clinical Hospital#2 of Branch Health Center of the PJSC

location_facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

location_facility: Lviv Municipal City Clinical Hospital Dept of Gastroenterology; Internal diseases

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

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Hospital Privado de Comunidad; Cardiology

location_facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

location_facility: Municipal Noncommercial Enterprise City Clinical Hospital

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

location_facility: UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy

location_facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

location_facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: Digestive Care Associates, A Medical Corporation

location_facility: NorthShore University HealthSystem; Evanston Hospital

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: SBI HPE KSMU MoH and SD of RF; Chair of Hospital Therapy

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

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

location_facility: Specjalistyczne Gabinety Lekarskie Body Clinic

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: University of Mississippi Medical Center

location_facility: University of Texas Southwestern Medical Center; Internal Medicne

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Kyiv Clinical Hospital on Railway Station of Healthcare Center branch of JSC

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University of California San Diego Medical Center

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Gastroenterology Associates of New Jersey

location_facility: Medical Research Center of Connecticut, LLC

location_facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

location_facility: Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Allergisa Pesquisa Dermato-Cosmética Ltda

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department

location_facility: Medical Research Group of Central Florida

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Therapeutic Research Institute of Orange County

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: CHU de Rouen - Hôpital Charles Nicolle; Neurologie

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Digestive and Liver Disease Specialists, Ltd.

location_facility: Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Hospital Universitario Walter Cantidio - UFC

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: University Hospital - London Health Sciences Centre

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine

location_facility: University of Oklahoma Health Sciences Center; Stephenson Cancer Center

location_facility: Szt Janos Korhaz es EbudaiEgyesitettKorhazak

location_facility: University of California, Irvine Medical Center

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

type: EudraCT Number

source: euctr

title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144

summary: This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.


ReferenceCitation: Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Mishkin

full_name: Daniel S. Mishkin

given: Daniel S.

family: Oh

full_name: Young S. Oh

given: Young S.

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Hussain

full_name: Fez Hussain

given: Fez

family: Jacob

full_name: Rhian Jacob

given: Rhian

family: Daperno

full_name: Marco Daperno

given: Marco

journal_name: Gastrointestinal Endoscopy

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Impact of various central endoscopy reading models on treatment outcome in Crohn’s disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial

location_country:
Romania
Australia
Belgium
Russian Federation
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Switzerland
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department

location_facility: The University of Chicago Medical Center

location_facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

location_facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

location_facility: Riga East Clinical University Hospital; Clinic Gailezers

location_facility: Baylor College of Medicine; Gastroenterology

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Medeniyet University Goztepe Training and Research Hospital; Chest Diseases

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: University of Mississippi Medical Center; Division of Gastroenterology

location_facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology

location_facility: Transcarpathian Regional Clinical Hospital n a Andriy Novak; Gastroenterology department

location_facility: Innovative Medical Research of South Florida

location_facility: Digestive Disease Institute; Virginia Mason Medical Center

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU

location_facility: Gastroenterology Center of the MidSouth PC

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2

location_facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: L2IP -Instituto de Pesquisas Clínicas Ltda.

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hacettepe University Medical Faculty; Gastroenterology

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Clínic i Provincial; Servicio de Farmacia

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: Wolfson Medical Center; Obstetrics and Gynecology

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Peak Gastroenterology Associates; Gastroenterology

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Royal Wolverhampton hospital; McHale Building

location_facility: Oncoeste Pesquisa Clinica - HUST - Hospital Universitario Santa Terezinha

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council

location_facility: Acibadem Kozyatagi Hospital; Gastroenterology

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: University of Florida College of Medicine

location_facility: McGill University Health Centre - Glen Site

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: Universitaetsklinikum Magdeburg A.oe.R; Division of Cardiology

location_facility: Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology

location_facility: Seoul National University Bundang Hospital

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies

location_facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology

location_facility: Kyiv Railway Clinical Hospital#2 of Branch Health Center of the PJSC

location_facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Municipal Noncommercial Enterprise City Clinical Hospital

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

location_facility: UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

location_facility: Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit

location_facility: Digestive Care Associates, A Medical Corporation

location_facility: NorthShore University HealthSystem; Evanston Hospital

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

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

location_facility: Southwest Gastroenterology; DM Clinical Research

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: University of Texas Southwestern Medical Center; Internal Medicne

location_facility: University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Kyiv Clinical Hospital on Railway Station of Healthcare Center branch of JSC

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Federal State Military Educational Institution; High Professional Education Military Medical Acad

location_facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University of California San Diego Medical Center

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Allergisa Pesquisa Dermato-Cosmética Ltda

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: University of North Carolina At Chapel Hill

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

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

summary:
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.


location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Croatia
France
Lithuania
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

acronym: COTTONWOOD

location_facility: Gastroenterology Center of the Midsouth, P.C.

location_facility: MHAT 'Sv. Marina', EAD; First Children's Clinic

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology

location_facility: King Edward Memorial Hospital Research Centre

location_facility: Stavropol Regional Clinical Diagnostic Consultative Center

location_facility: Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

location_facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: CI Kherson Afanasii and Olha Tropiny City Clinical Hospital

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

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

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Centro Integral en Reumatología S.A. de C.V. (CIRSA)

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital

location_facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology

location_facility: Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia

location_facility: Clinical Hospital Sveti Duh; Department of Neurology

location_facility: Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM

location_facility: Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

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

location_facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: Massachusetts General Hospital; Crohn's & Colitis Center

location_facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: Ospedale di Circolo; Neuropsichiatria Infantile

location_facility: Medical and Sanitary Division of Severstal

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: A.Novak Transcarpathian Regional Clinical Hospital

location_facility: Ålborg Universitets Hospital; Gastromedicinsk

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF

location_facility: Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: University of Chicago Medical Center; Medicine, Section of Pulmonary

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Gazi University Medical Faculty; Gastroenterology

location_facility: Northwestern University Feinberg School Of Medicine

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

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Hospital Raja Perempuan Zainab II; Department of Medicine

location_facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Kyungpook National University Medical Center

location_facility: UC Health Clinical Trials Office; Division of Digestive Diseases

location_facility: University of North Carolina at Chapel Hill

location_facility: Seoul National University Bundang Hospital

location_facility: GZA Ziekenhuizen - Campus Sint-Vincentius

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Keimyung University Dongsan Medical Center

location_facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: CECIP - Centro de Estudos Clínicos do Interior Paulista

location_facility: University General Hospital of Heraklion

location_facility: University of California at San Francisco

location_facility: DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: University of Mississippi Medical Center

location_facility: Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

location_facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Medizinisches Zentrum Klinikum Lueneburg

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

location_facility: Bnai Zion Medical Center; Internal Medicine

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Hospital Universitario Walter Cantidio - UFC

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: University Hospital - London Health Sciences Centre

location_facility: SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Rigshospitalet; Medicinsk gastroenterologisk klinik

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: University of California, Irvine Medical Center

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

title: An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies

summary: This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.


type: Registry Identifier

title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

summary: The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

ReferenceCitation: Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Loftus

full_name: Edward V. Loftus

given: Edward V.

suffix: Jr.

family: Colombel

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Danese

full_name: Silvio Danese

given: Silvio

family: Rogers

full_name: Raquel Rogers

given: Raquel

family: Bornstein

full_name: Jeffrey D. Bornstein

given: Jeffrey D.

family: Chen

full_name: Jingjing Chen

given: Jingjing

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Lirio

full_name: Richard A. Lirio

given: Richard A.

journal_name: Gastroenterology

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Törüner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.

name: From the Icahn School of Medicine at Mount Sinai, New York (B.E.S., J.-F.C.); Nancy University Hospital, Nancy, France (L.P.-B.); Mayo Clinic College of Medicine, Rochester, MN (E.V.L.); Humanitas University, Milan (S.D.); Ankara University School of Medicine, Ankara, Turkey (M.T.); Lithuanian University of Health Sciences, Kaunas, Lithuania (L.J.); Takeda Development Centre Europe, London (B.A.); Takeda Development Center Americas, Cambridge, MA (J.C., R.R., R.A.L., J.D.B.); and the University Hospital...

family: Törüner

full_name: Murat Törüner

given: Murat

family: Jonaitis

full_name: Laimas Jonaitis

given: Laimas

family: Abhyankar

full_name: Brihad Abhyankar

given: Brihad

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
Hong Kong
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Israel
Spain
Estonia
Latvia

location_facility: Gastroenterology Research of San Antonio, LLC

location_facility: Haydarpasa Numune Training and Research Hospital

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

location_facility: CI A.and O. Tropiny City Clinical Hospital

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Centro de Investigacion Farmacologica del Bajio, S.C.

location_facility: Klaipeda University Hospital, Public Institution

location_facility: RSBIH "Smolensk Regional Clinical Hospital"

location_facility: Texas Digestive Disease Consultants - Dallas

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

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Klaipeda Republican Hospital, Public Institution

location_facility: Groupe Hospitalier Sud - Hopital Haut-Leveque

location_facility: Pauls Stradins Clinical University Hospital SLLC

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

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Universitair Medisch Centrum Groningen (UMCG)

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

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: California Medical Research Associates Inc.

location_facility: Alegent Creighton Clinic Gastroenterology

location_facility: Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Gastroenterology Associates of Tidewater

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

location_facility: Gastroenterology Associates of Central Georgia

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

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Medical Research Center of Connecticut, LLC

location_facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oost

location_facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew

location_facility: Long Island Clinical Research Associates

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Clinical Hospital Center "Sestre Milosrdnice"

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Center for Digestive Health and Nutritional Excellence

location_facility: SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: FSBI State Scientific Centre of Coloproctology" of the MoH of RF

location_facility: The Oregon Clinic-West Hills Gastroenterology

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: University of North Carolina at Chapel Hill

location_facility: McMaster University Health Sciences Center

location_facility: Ohio State University Clinical Trials Management Office

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Northwestern University Feinberg School of Medicine

location_facility: SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution

location_facility: SPb SBIH "City Hospital of Saint Martyr Elizaveta"

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

location_facility: FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Seconda Universita degli Studi di Napoli

location_facility: Expertia S.A- Mautalen Salud e Investigacion

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Texas Digestive Disease Consultants - Irving

location_facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

location_facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

location_facility: Medical University of South Carolina (MUSC)

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

location_facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

location_facility: Morales Vargas Centro de Investigacion, S.C.

location_facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

location_facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: SBIH of Yaroslavl region " Regional Clinical Hospital "

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital

location_facility: Gastroenterology Consultants of South Texas, PA

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

location_facility: SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

location_facility: SBEI HPE "Rostov State Medical University" of the MoH of the RF

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: Clinical Research Institute of Michigan, LLC


ReferenceCitation: Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2021 Nov 16. pii: S2468-1253(21)00298-3. doi: 10.1016/S2468-1253(21)00298-3. [Epub ahead of print]

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Vermeire

full_name: Severine Vermeire

given: Severine

family: Tyrrell

full_name: Helen Tyrrell

given: Helen

family: Hassanali

full_name: Azra Hassanali

given: Azra

family: Lacey

full_name: Stuart Lacey

given: Stuart

family: Tole

full_name: Swati Tole

given: Swati

family: Tatro

full_name: Amanda R. Tatro

given: Amanda R.

location_country:
Greece
Romania
Australia
Belgium
Denmark
France
Poland
Lithuania
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

acronym: HICKORY

location_facility: CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques

location_facility: Gastroenterology Center of the Midsouth, P.C.

location_facility: Atlanta Gastroenterology Specialists, PC

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

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Cliniques Universitaires Saint-Luc; Nephrology

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Klinikum Klagenfurt am Wörtersee; Acute geriatric care

location_facility: Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University of California San Diego Medical Center

location_facility: Massachusetts General Hospital; Crohn's & Colitis Center

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Kyungpook National University Hospital; Opthalmology

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: Hadassah University Hospital - Ein Kerem; Neurosurgery

location_facility: Ospedale di Circolo; Neuropsichiatria Infantile

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Ålborg Universitets Hospital; Gastromedicinsk

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Digestive and Liver Disease Specialists, Ltd.

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Fakultni nemocnice Brno; Interni kardiologicka klinika

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Rigshospitalet; Medicinsk gastroenterologisk klinik

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Vilnius University Hospital Santariskiu Clinic Public Insti

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Anticancer Hospital of Thessaliniki " Theagenio"

location_facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: University of California at San Francisco

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

title: Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

summary: This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.


ReferenceType: result

ReferenceCitation: Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.

family: Coghill

full_name: David Coghill

given: David

family: Banaschewski

full_name: Tobias Banaschewski

given: Tobias

family: Lecendreux

full_name: Michel Lecendreux

given: Michel

family: Soutullo

full_name: Cesar Soutullo

given: Cesar

family: Johnson

full_name: Mats Johnson

given: Mats

family: Zuddas

full_name: Alessandro Zuddas

given: Alessandro

family: Anderson

full_name: Colleen Anderson

given: Colleen

family: Civil

full_name: Richard Civil

given: Richard

family: Higgins

full_name: Nicholas Higgins

given: Nicholas

family: Lyne

full_name: Andrew Lyne

given: Andrew

family: Squires

full_name: Liza Squires

given: Liza

journal_name: European Neuropsychopharmacology

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

ReferenceCitation: Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.

full_name: David R. Coghill

given: David R.

family: Dittmann

full_name: Ralf W. Dittmann

given: Ralf W.

family: Otero

full_name: Isabel Hernández Otero

given: Isabel Hernández

family: Bloomfield

full_name: Ralph Bloomfield

given: Ralph

repository_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.

title: Health-Related Quality of Life and Functional Outcomes from a Randomized, Controlled Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention Deficit Hyperactivity Disorder

ReferenceCitation: Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.

location_country:
Italy
Sweden
Netherlands
France
Poland
Hungary
Belgium
Spain
Germany
United Kingdom

location_facility: Università degli Studi di Cagliari, Dipartimento di Neuroscienze

location_facility: Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5

location_facility: Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4

location_facility: Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10

location_facility: Lighthouse Child Development Centre, Snakes Lane

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10

location_facility: Hospital Universitario de Canarias C/Ofra

location_facility: Victoria Hospital, Paediatric Unit, Hayfield Road

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9

location_facility: Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica

location_facility: Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185

location_facility: Complejo Hospitalario Universitario de Badajoz

location_facility: Basildon Hospital, Child Developement Centre, Nethermayne

location_facility: Hôpital Gui de Chauliac, 80, avenue Augustin Fliche

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent

location_facility: Azienda Ospedaliera della 2 Universita di Napoli

location_facility: Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6

location_facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego

location_facility: Praxis für Neuropädiatrie, Schomburgstrasse 120

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,

location_facility: Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

location_facility: Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n

location_facility: Hospital Ramón y Cajal, Servicio de psiquiatría

location_facility: Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie

location_facility: Ryegate Children's Centre, Tapton Crescent Road

location_facility: Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003

location_facility: ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken

location_facility: Tayside Childrens Hospital, Clinical Research Facility, Level 4

location_facility: Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse

title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


title: Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography

acronym: CACTUS-PTS

summary: CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.

ReferenceCitation: Righini M, Robert-Ebadi H, Glauser F, Blondon M, Ouvry P, Diamand JM, Tissot A, Frappe P, Quere I, Kahn SR, Galanaud JP, Le Gal G. Effect of anticoagulant treatment on pain in distal deep vein thrombosis: an ancillary analysis from the cactus trial. J Thromb Haemost. 2019 Mar;17(3):507-510. doi: 10.1111/jth.14387. Epub 2019 Feb 3.

name: Division of Angiology and Hemostasis; Geneva University Hospital and Faculty of Medicine; Geneva Switzerland

family: Righini

full_name: Marc Righini

given: Marc

family: Robert-Ebadi

full_name: Helia Robert-Ebadi

given: Helia

family: Glauser

full_name: Frédéric Glauser

given: Frédéric

family: Blondon

full_name: Marc Blondon

name: Vascular Physician; St. Aubin sur Scie France

family: Ouvry

full_name: Pierre Ouvry

given: Pierre

family: Diamand

full_name: Jean-Marc Diamand

given: Jean-Marc

family: Tissot

full_name: Anne Tissot

given: Anne

name: Département de Médecine Générale and EA 3065; Saint-Etienne University Hospital; Saint-Etienne France

family: Frappe

full_name: Paul Frappe

given: Paul

name: Clinical Investigation Centre and Department of Internal and Vascular Medicine; Montpellier University Hospital; Montpellier France

family: Quere

full_name: Isabelle Quere

given: Isabelle

name: Department of Medicine and Lady Davis Institute; Jewish General Hospital; Montreal Canada

family: Kahn

full_name: Susan R. Kahn

given: Susan R.

name: Department of Medicine; Sunnybrook Health Sciences Centre and University of Toronto; Toronto Canada

family: Galanaud

full_name: Jean-Philippe Galanaud

given: Jean-Philippe

name: Department of Medicine; University of Ottawa; Ottawa Hospital Research Institute; Thrombosis Research Group; Ottawa Canada

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

journal_name: Journal of Thrombosis and Haemostasis

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Righini M, Galanaud JP, Guenneguez H, Brisot D, Diard A, Faisse P, Barrellier MT, Hamel-Desnos C, Jurus C, Pichot O, Martin M, Mazzolai L, Choquenet C, Accassat S, Robert-Ebadi H, Carrier M, Le Gal G, Mermilllod B, Laroche JP, Bounameaux H, Perrier A, Kahn SR, Quere I. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016 Dec;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4. Epub 2016 Nov 8.

family: Guenneguez

full_name: Hervé Guenneguez

given: Hervé

family: Brisot

full_name: Dominique Brisot

given: Dominique

family: Diard

full_name: Antoine Diard

given: Antoine

family: Faisse

full_name: Pascale Faisse

given: Pascale

family: Barrellier

full_name: Marie-Thérèse Barrellier

given: Marie-Thérèse

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Guanella R, Righini M. Serial limited versus single complete compression ultrasonography for the diagnosis of lower extremity deep vein thrombosis. Semin Respir Crit Care Med. 2012 Apr;33(2):144-50. doi: 10.1055/s-0032-1311793. Epub 2012 May 30. Review.

name: Division of Angiology and Hemostasis, Department of Internal Medicine, Geneva University Hospital, Geneva, Switzerland.

journal_name: Seminars in Respiratory and Critical Care Medicine

title: Serial Limited versus Single Complete Compression Ultrasonography for the Diagnosis of Lower Extremity Deep Vein Thrombosis

location_facility:
Royal University Hospital
Montpellier University Hospital
Hamilton General Hospital
Ottawa General Hospital
Jewish General Hospital
University Hospital of Geneva
Hopital Maisonneuve-Rosemont