title: Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

ReferenceCitation: Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. doi: 10.1200/JCO.20.03318. Epub 2021 Aug 26.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Belarus
Greece
Ireland
Estonia
Latvia
Finland
New Zealand
France
Netherlands

location_facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461

location_facility: Debreceni Egyetem Klinikai Központ /ID# 126119

location_facility: Betsi Cadwaladr Univ Health Bo /ID# 127177

location_facility: North Estonian Medical Centre /ID# 128215

location_facility: Volgograd Regional Clinical Oncology Dispensary /ID# 126350

location_facility: Goshen Center for Cancer Care /ID# 123875

location_facility: Inselspital, Universitaetsklinik /ID# 126347

location_facility: Petz Aladar Megyei Oktato Korh /ID# 126110

location_facility: Akdeniz University Medical Fac /ID# 126997

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 127815

location_facility: University of Florida - Archer /ID# 126476

location_facility: Marmara University Medical Fac /ID# 126187

location_facility: University Hospital Limerick /ID# 126175

location_facility: Nebraska Hematology Oncology /ID# 127699

location_facility: Franciscan St. Francis Health /ID# 126678

location_facility: Klinicki bolnicki centar Osijek /ID# 132214

location_facility: Barwon Health University Hospital Geelong /ID# 125606

location_facility: Virginia Oncology Associates /ID# 127458

location_facility: Riga East Clinical Univ Hosp /ID# 125597

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309

location_facility: P. Stradins Clinical Univ Hosp /ID# 126322

location_facility: University Hospital Bezanijska /ID# 128761

location_facility: Parkland Health and Hosp Syste /ID# 128518

location_facility: Bekes Megyei Pandy Kalman Korhaz /ID# 126117

location_facility: The Clatterbridge Cancer Ctr /ID# 125695

location_facility: Comprehensive Cancer Ctrs Neva /ID# 127491

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 125877

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548

location_facility: Haukeland University Hospital /ID# 126338

location_facility: Tudogyogyintezet Toeroekbalint /ID# 126111

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120

location_facility: Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098

location_facility: Northeast Arkansas Clinical Ch /ID# 128071

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149

location_facility: Centre Hosp Intercommunal de Creteil /ID# 125922

location_facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 125755

location_facility: Hopital Larrey - CHU de Toulouse /ID# 128394

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223

location_facility: State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460

location_facility: Bobruysk Interdistrict Onco. /ID# 128999

location_facility: Nemocnice Kyjov, prispevkova organizace /ID# 125819

location_facility: University of Texas MD Anderson Cancer Center /ID# 127946

location_facility: Ege University Medical Faculty /ID# 126189

location_facility: Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738

location_facility: VA Caribbean Healthcare System /ID# 124562

location_facility: The Queen Elizabeth Hospital /ID# 125607

location_facility: Mazowiecki Szpital Onkologiczn /ID# 126546

location_facility: North Devon District Hospital /ID# 125689

location_facility: Belgorod Oncology Dispensary /ID# 129899

location_facility: Hospital Universitario Virgen del Rocio /ID# 125207

location_facility: St. Luke's Mountain States Tumor Institute - Boise /ID# 124059

location_facility: Azienda Ospedaliero Uni Parma /ID# 125703

location_facility: Istituto Oncologico del Medite /ID# 132844

location_facility: Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 126676

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234

location_facility: Naser Institute for Res & Dev /ID# 129263

location_facility: Istituto Europeo di Oncologia /ID# 125702

location_facility: Texas Oncology - South Austin /ID# 127476

location_facility: Cairo Uni Hosp Al Kasr El Ainy /ID# 128338

location_facility: Gabrail Cancer Center Research /ID# 127415

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385

location_facility: Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708

location_facility: Cancercare Outeniqua Oncology Unit /ID# 126103

location_facility: Smolensk Regional Onc Clin Dis /ID# 127144

location_facility: The Royal Bournemouth Hospital /ID# 125690

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228

location_facility: Flinders Centre for Innovation /ID# 125605

location_facility: Cancerologia de Queretaro S.C. /ID# 125920

location_facility: University Hospital Linkoping /ID# 126443

location_facility: Minnesota Oncology Hematology, PA /ID# 127473

location_facility: CHRU de Brest - Hopital Morvan /ID# 127903

location_facility: Sverdlovsk Regional Oncology Center Dispensary /ID# 128457

location_facility: VA Eastern Colorado Healthcare System /ID# 128065

location_facility: Sunshine Coast University Hosp /ID# 125608

location_facility: Vrije Universiteit Medisch Centrum /ID# 125578

location_facility: Odense Universitets Hospital /ID# 125996

location_facility: Fejer Megyei Szent Gyorgy Korh /ID# 126118

location_facility: Princess Margaret Cancer Centre /ID# 126155

location_facility: Assaf Harofeh Medical Center /ID# 127076

location_facility: Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220

location_facility: Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761

location_facility: Helsinki Univ Central Hospital /ID# 125897

location_facility: Hospital Universitario Vall d'Hebron /ID# 125159

location_facility: Veszprem Megyei Tudogyogyintez /ID# 126121

location_facility: NZOZ Magodent Ctr. Med. Ostro /ID# 126545

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 128221

location_facility: Guy's and St Thomas' NHS Found /ID# 125694

location_facility: Univerzitna Nemocnica Bratislava /ID# 126342

location_facility: Hospital Angeles Centro Medico /ID# 127620

location_facility: Mogilev Reg Clin Oncology Dis /ID# 128639

location_facility: Centro Estatal de Cancerologia /ID# 127583

location_facility: Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699

location_facility: Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217

location_facility: Texas Oncology - Austin Midtown /ID# 127477

location_facility: Winship Cancer Institute of Emory University /ID# 124061

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736

location_facility: Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704

location_facility: Fundacion Instituto Valenciano Oncologia IVO /ID# 125205

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 126112

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176

location_facility: Stavanger University Hospital /ID# 126336

location_facility: Orenburg Regional Clinical Onc /ID# 137474

location_facility: SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477

location_facility: Hadassah University Hospital /ID# 127077

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 128585

location_facility: University Hospital Waterford /ID# 126178

location_facility: Opca bolnica Dr. Josip Bencevi /ID# 126539

location_facility: Norfolk and Norwich Univ Hosp /ID# 125697

location_facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 126335

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156

location_facility: Northwest Cancer Specialists, P.C. /ID# 127488

location_facility: Institute for Oncology and Rad /ID# 128721

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186

location_facility: Netcare Oncology Intervent Ctr /ID# 126100

location_facility: Southern Medical Day Care Ctr /ID# 125604

location_facility: Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 125876

location_facility: Appalachian Regional Healthcare, Inc (ARH) /ID# 128061

location_facility: Northwest Cancer Specialists, P.C. /ID# 127486

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815

location_facility: UT Southwestern Medical Center /ID# 127876

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 126353

location_facility: CCA Braga - Hospital de Braga /ID# 125837

location_facility: Hospital Universitario HM Sanchinarro /ID# 125162

location_facility: Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160

location_facility: Klinika za plucne bolesti Jordanovac /ID# 126537

location_facility: Instituto COI de Educacao e Pesquisa /ID# 127739

location_facility: Institute For Pulmonary Diseas /ID# 128737

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 125875

location_facility: Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219

location_facility: Cairo Uni Hosp Al Kasr El Ainy /ID# 128340

location_facility: East Kent Hosp Univ NHS Trust /ID# 125698

location_facility: University of Vermont Medical Center /ID# 128064

location_facility: Dartmouth-Hitchcock Medical Center /ID# 128075

summary: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).


ipd_sharing: Yes

status: Recruiting

primary_purpose: Treatment

acronym: VIALE-T

intervention_type: Other

title: A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)

study_completion_date_type: Anticipated

lead_sponsor: AbbVie

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

enrollment_type: Anticipated

location_country:
Taiwan
Brazil
Spain
Greece
Italy
Australia
United Kingdom
Canada
Switzerland
Hungary
Korea, Republic of
United States
France
China
Israel
Japan
Germany
Czechia

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197

location_facility: Linkou Chang Gung Memorial Hospital /ID# 215319

location_facility: Hospital Santa Creu i Sant Pau /ID# 240397

location_facility: The Chaim Sheba Medical Center /ID# 214305

location_facility: Perelman Center for Advanced Medicine - /ID# 214518

location_facility: CHU de Nice - Hôpital Archet 1 /ID# 214056

location_facility: Peking University People's Hospital /ID# 215551

location_facility: Universitaetsklinikum Leipzig /ID# 245892

location_facility: Xiangya Hospital Central South University /ID# 219025

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 215120

location_facility: Jichi Medical University Hospital /ID# 216091

location_facility: St Jude Children's Research Hospital /ID# 214074

location_facility: University General Hospital Attikon /ID# 238812

location_facility: Universitaetsklinikum Muenster /ID# 215213

location_facility: Zhongda Hospital Southeast University /ID# 218926

location_facility: AP-HP - Hopital Saint-Antoine /ID# 216957

location_facility: CHU de Besancon - Jean Minjoz /ID# 241171

location_facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282

location_facility: Hospital Universitario Virgen del Rocio /ID# 215463

location_facility: Seoul National University Hospital /ID# 214891

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 241123

location_facility: Penn State Hershey Medical Ctr /ID# 217120

location_facility: Hospital Clinic de Barcelona /ID# 215108

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552

location_facility: The Affiliated Hospital of Xuzhou Medical University /ID# 239098

location_facility: Tel Aviv Sourasky Medical Center /ID# 214508

location_facility: Fred Hutchinson Cancer Research Center /ID# 214436

location_facility: University of North Carolina /ID# 215814

location_facility: Nanfang Hospital of Southern Medical University /ID# 215553

location_facility: Universitaetsklinikum Halle (Saale) /ID# 239585

location_facility: Medizinische Hochschule Hannover /ID# 214243

location_facility: University Hospitals - Seidman Cancer Center /ID# 239260

location_facility: Jichi Medical University Saitama Medical Center /ID# 216092

location_facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 239203

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359

location_facility: Roswell Park Comprehensive Cancer Center /ID# 217857

location_facility: National Center for Child Health and Development /ID# 242479

location_facility: Massachusetts General Hospital /ID# 215765

location_facility: Colorado Blood Cancer Institute /ID# 215980

location_facility: Hokkaido University Hospital /ID# 215937

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 216096

location_facility: Hospital Universitario La Paz /ID# 218103

location_facility: Montefiore Medical Center - Moses Campus /ID# 241669

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550

location_facility: Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 239711

location_facility: Hospital Clinico Universitario de Valencia /ID# 215106

location_facility: University General Hospital of Patras /ID# 238811

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 244849

location_facility: University of Arizona Cancer Center - Tucson /ID# 242507

location_facility: TriStar Centennial Medical Center /ID# 218750

location_facility: The University of Chicago Medical Center /ID# 215616

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735

location_facility: Schneider Children's Medical Center /ID# 224326

location_facility: University College London Hospitals NHS Foundation Trust /ID# 215662

location_facility: Weill Cornell Medical College /ID# 214887

location_facility: Columbia University Medical Center /ID# 240875

location_facility: Universitaetsklinikum Wuerzburg /ID# 215212

location_facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939

location_facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680

location_facility: Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363

location_facility: Indiana Blood & Marrow Transpl /ID# 215842

location_facility: Princess Margaret Cancer Centre /ID# 215344

location_facility: IEO -Istituto Europeo di Oncologia /ID# 242579

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679

location_facility: National Taiwan University Hospital /ID# 215245

location_facility: Fujian Medical University Union Hospital /ID# 215555

location_facility: The Royal Marsden NHS Foundation Trust /ID# 215124

location_facility: University of Arkansas for Medical Sciences /ID# 239804

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148

location_facility: Guangdong Provincial People's Hospital /ID# 218666

location_facility: University of California, Los Angeles /ID# 218199

location_facility: National Cancer Center Hospital /ID# 242639

location_facility: Hadassah Medical Center-Hebrew University /ID# 218697

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892

location_facility: NHS Greater Glasgow and Clyde /ID# 215663

location_facility: UCHSC Anschultz Cancer Pavilion /ID# 215618

location_facility: Osaka Metropolitan University Hospital /ID# 215227

location_facility: Karmanos Cancer Institute - Dresner Clinic /ID# 214581

location_facility: The First Affiliated Hospital of Nanchang University /ID# 239168

location_facility: The First Affiliated Hospital of Soochow University /ID# 216605

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244

location_facility: Fakultni nemocnice Hradec Kralove /ID# 214814

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516

location_facility: Kobe City Medical Center General Hospital /ID# 215388

location_facility: Texas Oncology - Medical City Dallas /ID# 216720

location_facility: ASST Spedali civili di Brescia /ID# 215997

location_facility: University of Mississippi Medical Center /ID# 239343

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 217916

location_facility: Taipei Veterans General Hosp /ID# 239289

location_facility: Greenebaum Comprehensive Cancer Center - UM /ID# 213855

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591

location_facility: Taichung Veterans General Hospital /ID# 239288

location_facility: Loyola University Medical Ctr /ID# 215617

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 215253

location_facility: Hyogo Medical University Hospital /ID# 215389

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 214060

location_facility: Chinese PLA General Hospital /ID# 216287

location_facility: Zhujiang Hospital of Southern Medical University /ID# 216333

location_facility: Shenzhen Second People's Hospital /ID# 239401

location_facility: Ustav hematologie a krevni transfuze /ID# 215133

location_facility: Hospital Universitario Ramon y Cajal /ID# 218102

location_facility: Hospital General Universitario Gregorio Maranon /ID# 215107

location_facility: General Hospital of Athens Evangelismos /ID# 238810

location_facility: Hospital de Clinicas de Porto Alegre /ID# 215042

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546

location_facility: Children's Hospital of Philadelphia - Main /ID# 215410

location_facility: Oregon Health & Science University /ID# 215874

location_facility: University of Oklahoma, Stephenson Cancer Center /ID# 215611

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 213834

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 214055

location_facility: King's College Hospital NHS Foundation Trust /ID# 215338

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373

location_facility: Kanazawa University Hospital /ID# 242955

location_facility: Universitaetsklinik Heidelberg /ID# 216623

location_facility: Imperial College Healthcare NHS Trust /ID# 215665

location_facility: China Medical University Hospital /ID# 215198

summary:
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).

This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

intervention_type: Drug

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hébuterne X, D'Haens G, Nakase H, Panés J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum in: Lancet. 2022 Sep 24;400(10357):996.

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22. Erratum in: Gastroenterology. 2020 Sep;159(3):1192.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

enrollment_type: Actual

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Belarus
Greece
Ireland
Estonia
Latvia
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Clin Res Inst of Michigan, LLC /ID# 153027

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 200006

location_facility: Universal Axon Clinical Research /ID# 213461

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125

location_facility: Gazi Universitesi Tip Fakultes /ID# 150127

location_facility: Virginia Mason Medical Center /ID# 153026

location_facility: Huron Gastroenterology Assoc /ID# 152710

location_facility: Gastoenterology Group of Rochester /ID# 151079

location_facility: University Clinical Centre of the Republic of Srpska /ID# 150209

location_facility: Kitasato University Kitasato Institute Hospital /ID# 152686

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 217216

location_facility: Caprock Gastro Research, LLC /ID# 214754

location_facility: Omega Research Maitland, LLC /ID# 200269

location_facility: Encore Borland-Groover Clinical Research /Id# 170912

location_facility: Hiroshima University Hospital /ID# 151951

location_facility: Mautalen Salud e Investigacion /ID# 171173

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732

location_facility: Medical College of Wisconsin /ID# 151843

location_facility: Bekes Megyei Kozponti Korhaz /ID# 151572

location_facility: General Hospital of Athens Laiko /ID# 208669

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807

location_facility: Utah Gastroenternology - St. Mark's Office /ID# 163101

location_facility: Sapporo Medical University Hospital /ID# 206492

location_facility: Emeritas Research Group, LLC /ID# 150258

location_facility: Digestive Disease Specialists /ID# 201056

location_facility: Toyohashi Municipal Hospital /ID# 171457

location_facility: Chung Shan Medical University Hospital /ID# 150573

location_facility: Dartmouth-Hitchcock Medical Center /ID# 150549

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370

location_facility: Hyogo College of Medicine College Hospital /Id# 152434

location_facility: Tokai University Hachioji Hospital /ID# 152587

location_facility: Taipei Veterans General Hosp /ID# 151748

location_facility: St.Luke's International Hospital /ID# 208074

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 152607

location_facility: Washington University-School of Medicine /ID# 150485

location_facility: Hospital Universitario de San /ID# 155387

location_facility: Macquarie University Hospital /ID# 211951

location_facility: Klinicki bolnicki centar Rijeka /ID# 150708

location_facility: Tianjin Medical University General Hospital /ID# 170604

location_facility: East Tallinn Central Hospital /ID# 150417

location_facility: Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396

location_facility: Agaplesion Markus Krankenhaus /ID# 161982

location_facility: The First Affiliated Hospital of Nanchang University /ID# 211750

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611

location_facility: Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785

location_facility: Erciyes University Medical Fac /ID# 150129

location_facility: Next Innovative Clinical Research - Chicago /ID# 216060

location_facility: Akershus universitetssykehus /ID# 150317

location_facility: CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940

location_facility: Osaka City University Hospital /ID# 152682

location_facility: Vitebsk Regional Advanced Clin /ID# 169612

location_facility: Clinical Center University of Sarajevo /ID# 150208

location_facility: Universitaetsklinimum Tuebingen /ID# 150767

location_facility: NorthShore University HealthSystem /ID# 150555

location_facility: Western Connecticut Medical Group /ID# 169210

location_facility: CliniCore International, LLC /ID# 152062

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770

location_facility: Hospital Universitario La Paz /ID# 214539

location_facility: East Tennessee Research Institute /ID# 203610

location_facility: University Clinical Hospital Mostar /ID# 150705

location_facility: CHU Amiens-Picardie Site Sud /ID# 163456

location_facility: South Denver Gastroenterology /ID# 151223

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 165782

location_facility: Ottawa Hospital Research Institute /ID# 151820

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088

location_facility: Hadassah Medical Center-Hebrew University /ID# 165118

location_facility: CB Flock Research Corporation /ID# 165980

location_facility: Klaipeda University Hospital /ID# 158862

location_facility: Duplicate_Stavropol State Medical Univ /ID# 150387

location_facility: Republican hospital named after V.A. Baranov /ID# 206506

location_facility: Radboud Universitair Medisch Centrum /ID# 151700

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609

location_facility: University General Hospital of Ioannina /ID# 164248

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821

location_facility: MediSphere Medical Research Center /ID# 152064

location_facility: Montreal General Hospital - McGill University Health Centre /ID# 170012

location_facility: Hospital Universitario Reina Sofia /ID# 151066

location_facility: Private Practice Dr MN Rajabally /ID# 155144

location_facility: Pauls Stradins Clinical University Hospital /ID# 151409

location_facility: InSite Digestive Health Care - Oxnard /ID# 163414

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 209130

location_facility: Wake Forest Baptist Medical Center /ID# 150448

location_facility: Yokkaichi Hazu Medical Center /ID# 214347

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 203411

location_facility: Universitetssykehuset Nord-Norge /ID# 152835

location_facility: West China Hospital, Sichuan University /ID# 167040

location_facility: Tokyo Medical And Dental University Hospital /ID# 152016

location_facility: Percuro Clinical Research, Ltd /ID# 150367

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 201533

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 152335

location_facility: Xiangya Hospital Central South University /ID# 167229

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 213539

location_facility: Lenasia Clinical Trial Centre /ID# 214344

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602

location_facility: Toho University Sakura Medical Center /ID# 151936

location_facility: The Sixth Affiliated Hosp Sun /ID# 150456

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484

location_facility: Carl R. Meisner Medical Clinic /ID# 171061

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150306

location_facility: Hospital Universitario y Politecnico La Fe /ID# 150611

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 150382

location_facility: Duplicate_Helsinki Univ Central Hospital /ID# 150407

location_facility: CHA University Bundang Medical Center /ID# 159479

location_facility: Minnesota Gastroenterology PA /ID# 151678

location_facility: University of Iowa Hospitals and Clinics /ID# 157058

location_facility: AGA Clinical Research Associates, LLC /ID# 153040

location_facility: Atlantic Digestive Health Inst /ID# 150447

location_facility: Moonshine Research Center, Inc /ID# 152533

location_facility: Houma Digestive Health Special /ID# 151844

location_facility: Atlanta Gastroenterology Spec /ID# 150548

location_facility: Universitair Ziekenhuis Leuven /ID# 150332

location_facility: Indianapolis Gastroenterology /ID# 162901

location_facility: Texas Digestive Disease Consultants /ID# 209804

location_facility: Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 209521

location_facility: Advanced Research Institute, Inc /ID# 163098

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981

location_facility: University Clinical Center Serbia /ID# 150428

location_facility: Marmara University Medical Fac /ID# 213969

location_facility: Klinicki bolnicki centar Zagreb /ID# 150709

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 150379

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868

location_facility: Umraniye Training and Res Hosp /ID# 162659

location_facility: Nature Coast Clinical Research - Inverness /ID# 154064

location_facility: Southern Star Research Institute, LLC /ID# 169396

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365

location_facility: Tyler Research Institute, LLC /ID# 169146

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607

location_facility: Asahikawa Medical University Hospital /ID# 170289

location_facility: Clinical Hosp Center Zvezdara /ID# 150427

location_facility: Velocity Clinical Research - Salt Lake City /ID# 163181

location_facility: Premier Medical Group - GI Division /ID# 153357

location_facility: Hayang University GuriHospital /ID# 150344

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207422

location_facility: Hampshire Hospitals NHS Foundation Trust /ID# 150380

location_facility: The First Affiliated Hospital, Sun Yat-sen University /ID# 150455

location_facility: Hospital Universitario Ramon y Cajal /ID# 151067

location_facility: Nagoya City University Hospital /ID# 151950

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742

location_facility: Niigata University Medical & Dental Hospital /ID# 218048

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080

location_facility: CCA Braga - Hospital de Braga /ID# 151608

location_facility: Louisana Research Center, LLC /ID# 150446

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 203911

location_facility: China Medical University Hospital /ID# 150571

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811

location_facility: Medical Research Center of CT /ID# 150482

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 150372

location_facility: The University of Chicago DCAM /ID# 150547

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 201260

location_facility: National Hospital Organization Mito Medical Center /ID# 152631

location_facility: Klinicki bolnicki centar Split /ID# 213988

location_facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256

location_facility: Hospital Garcia de Orta, EPE /ID# 151613

location_facility: Ctr for Gastrointestinal Healt /ID# 153360

location_facility: Lviv Regional Clinical Hospital /ID# 150375

location_facility: Kitakyushu Municipal Med Ctr /ID# 152588

location_facility: Yamagata University Hospital /ID# 171454

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 211168

location_facility: Medizinische Universitaet Wien /ID# 150614

location_facility: Options Health Research, LLC /ID# 150554

location_facility: North Estonia Medical Centre /ID# 160870

location_facility: Newport Huntington Medical Group /ID# 217005

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452

location_facility: Ohio Clinical Research Partner /ID# 154068

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610

location_facility: Columbia Univ Medical Center /ID# 163410

location_facility: Montefiore Medical Center - Moses Campus /ID# 150543

location_facility: Faculdade de Medicina do ABC /ID# 152481

location_facility: Kanazawa University Hospital /ID# 205099

location_facility: United Medical Doctors - Murrieta /ID# 151211

location_facility: Juntendo University Urayasu Hospital /ID# 208781

location_facility: Shengjing Hospital of China Medical University /ID# 166920

location_facility: Theageneio Anticancer Hospital /ID# 163896

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580

location_facility: Atlantic Gastroenterology Clinical Research /ID# 151899

location_facility: Yamanashi Prefectural Central Hospital /ID# 151908

location_facility: Klinicki bolnicki centar Zagreb /ID# 150225

location_facility: University Clinical Center Kragujevac /ID# 150430

location_facility: Soroka University Medical Center /ID# 156561

location_facility: TX Clinical Research Institute /ID# 151526

location_facility: Sahlgrenska University Hospital /ID# 151496

location_facility: Universitair Medisch Centrum Utrecht /ID# 152775

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 210117

location_facility: Hospital Privado Univesitario /ID# 164185

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 150426

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725

location_facility: Medical Center CONSILIUM MEDICAL /ID# 217446

location_facility: Healthcare Research Consultant /ID# 163100

location_facility: Great Lakes Medical Research, LLC /ID# 201772

location_facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 150216

location_facility: Northwest Health Care Associates /ID# 151590

location_facility: Revival Research Institute, LLC /ID# 207280

location_facility: Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275

location_facility: St Vincent's University Hospital /ID# 150318

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100

location_facility: Citrus Valley Gastroenterology /ID# 151914

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 207135

location_facility: Massachusetts General Hospital /ID# 165676

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484

location_facility: Aichi Medical University Hospital /ID# 151993

location_facility: NW State Medical Univ na Mechn /ID# 169322

location_facility: Yokohama City University Medical Center /ID# 169899

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815

location_facility: Kaiser Clinica e Hospital Dia /ID# 152483

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606

location_facility: Consultants for Clinical Research /ID# 151679

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305

location_facility: Hospital de Clinicas de Porto Alegre /ID# 153743

location_facility: Plains Clinical Research Center, LLC /ID# 170290

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 150912

location_facility: National Hospital Organization Sendai Medical Center /ID# 209527

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710

location_facility: Japanese Red Cross Osaka Hospital /ID# 209476

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 150250

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 152606

location_facility: Kazan State Medical University /ID# 166042

location_facility: National Taiwan University Hospital /ID# 150574

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 151360

location_facility: The Vancouver Clinic, INC. PS /ID# 162333

location_facility: University of Maryland Med Ctr /ID# 150449

location_facility: NYU Langone Long Island Clinical Research Association /ID# 155272

location_facility: Mentahaz Maganorvosi Kozpont /ID# 205884

location_facility: Hospital Britanico de Buenos Aires /ID# 209495

location_facility: Showa University Fujigaoka Hospital /ID# 208222

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208487

location_facility: Birmingham Gastroenterology Associates P.C /ID# 151276

location_facility: Shoyukai Fujita Gastroenterological Hospital /ID# 216492

location_facility: Hospital Universitario de Salamanca /ID# 150509

location_facility: Digestive Health Partners, P.A /ID# 167237

location_facility: Yeungnam University Medical Center /ID# 150345

location_facility: Crystal Pharmacology Research /ID# 151841

location_facility: Univ of California San Francis /ID# 164581

location_facility: Universitatsklinikum Mannheim /ID# 150173

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 211325

location_facility: Shanghai Tenth People's Hospital /ID# 150460

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 209479

location_facility: Hometown Urgent Care and Resea /ID# 200065

location_facility: CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372

location_facility: University of Mississippi Medical Center /ID# 213139

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 151100

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309

location_facility: The First Hospital of Jilin University /ID# 209986

location_facility: Centro de Investigaciones Clínicas Viña del Mar /ID# 150212

location_facility: CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361

location_facility: Leids Universitair Medisch Centrum /ID# 152624

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253

location_facility: Gastro Health & Nutrition - Victoria /ID# 167761

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 150486

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564

location_facility: NHS Greater Glasgow and Clyde /ID# 163787

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357

location_facility: Toronto Digestive Disease Asso /ID# 150363

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 170712

location_facility: University Clinical Center of Nis /ID# 151903

location_facility: Hamamatsu University Hospital /ID# 205708

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766

location_facility: Hospital Universitario Dr. Negrin /ID# 203937

location_facility: Hospital Clinic de Barcelona /ID# 150612

location_facility: Inselspital, Universitätsspital Bern /ID# 152590

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461

location_facility: Medical Center of the "Health /ID# 151274

location_facility: Richmond University Medical Center /ID# 201859

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 150338

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 167182

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212424

location_facility: Hospital Nossa Senhora das Graças /ID# 152480

location_facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359

location_facility: University Clinical Centre of the Republic of Srpska /ID# 150706

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545

location_facility: Calderdale and Huddersfield NHS Foundation Trust /ID# 217658

location_facility: Fukuoka University Chikushi Hospital /ID# 152628

location_facility: Dayton Gastroenterology, Inc. /ID# 167631

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 209267

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 150313

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 151065

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 150541

location_facility: National University Hospital /ID# 150453

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 154453

location_facility: National Cheng Kung University Hospital /ID# 151749

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204499

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838

location_facility: Aurora Medical Center - Grafto /ID# 151717

location_facility: Yonsei University Health System Severance Hospital /ID# 159478

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575

location_facility: West Tallinn Central Hospital /ID# 150419

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358

location_facility: Universitatsklinikum Munster /ID# 150158

location_facility: St. Marianna University School of Medicine Hospital /ID# 208654

location_facility: Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454

location_facility: Riga East Clinical University Hospital /ID# 150354

location_facility: Centex Studies, Inc. - Houston /ID# 201216

location_facility: Texas Digestive Disease Consultants /ID# 209947

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822

location_facility: St Vincent's Hospital Melbourne /ID# 152472

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506

location_facility: Northwest Gastroenterology Clinic /ID# 152527

location_facility: Delsol Research Management, Ll /Id# 170131

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140

location_facility: National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709

location_facility: Atrium Health Carolinas Medical Center /ID# 156971

location_facility: Slovak Research Center Team Me /ID# 150257

location_facility: East View Medical Research, LLC /ID# 171183

location_facility: Tokyo Women's Medical University Hospital /ID# 205977

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 216620

location_facility: University Clinical Center Tuzla /ID# 150211

location_facility: Pusan National University Hospital /ID# 159481

location_facility: Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405

location_facility: Inland Empire Clinical Trials, LLC /ID# 216038

location_facility: Vanderbilt University Medical Center /ID# 153355

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201790

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 208374

location_facility: Immanuel Kant Baltic Federal University /ID# 200719

location_facility: Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723

location_facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337

summary: This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

status_simplified: Completed


title: BRD 06/2-D (Quidam) "Evaluation of the Interest of Oral Hydroquinidine Administration to Treat Patients With Brugada Syndrome, High Cardiac Arrhythmic Risk and Implanted With an Implantable Cardioverter Defibrillator"

acronym: Quidam

summary: The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).

status: Terminated

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nantes
CHU Tours
CHU Lyon
AP-HM Marseille
AP-HP Paris Lariboisière
CHU Strasbourg
CHU Poitiers
CHU Montpellier
CHU Angers
CHU Bordeaux
CHU Brest
CHU Rennes
CHU Toulouse
CHU Nancy
CHU Grenoble
CHU Amiens
CHRU Lille

lead_sponsor_type: academique

status_simplified: Unknown


title: A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

summary: The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

ReferenceCitation: Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.

ReferenceCitation: Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Duléry R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32.

lead_sponsor: Acute Leukemia French Association

location_facility:
Hopital Edouard Herriot
IGR
Hospital Central
Hopital Saint-Louis
Hopital Avicenne
CHU
CNLCC
CH
Hopital Pitie-Salpetriere
Hopital Percy


title: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.

acronym: MRP

summary: This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

ReferenceCitation: Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.

ReferenceCitation: Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Chu de Bordeaux
Chu La Conception
Hopital Henri Mondor
Hopital Cochin
Hopital de L'Antiquaille
Chu Purpan
Hopital Beaujon
Hopitial Saint Antoine
Hotel Dieu
Chu D'Angers
Chu de Clermont-Ferrand
Hopital Ambroise Pare
Hopital de La Croix-Rousse
Institut Paoli-Calmettes
Centre Val D'Aurelle Paul Lamarque
Hopital Pitie-Salpetriere
Hopital Tenon
Hospices Civils de Lyon
Hopitaux Universitaires de Strasbourg
Hopital Pontchaillou

intervention_type: Procedure


title: Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey

acronym: PANORAMA

summary: The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review & an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Bradley C, Eschwège E, de Pablos-Velasco P, Parhofer KG, Simon D, Vandenberghe H, Gönder-Frederick L. Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes. Diabetes Care. 2018 Feb;41(2):267-276. doi: 10.2337/dc16-2655. Epub 2017 Nov 28.

ReferenceCitation: Simon D, de Pablos-Velasco P, Parhofer KG, Gönder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwège E, Bradley C. Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study. Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007. Epub 2015 Oct 9.

ReferenceCitation: de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwège E, Gönder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf). 2014 Jan;80(1):47-56. doi: 10.1111/cen.12119. Epub 2013 May 6.

ReferenceCitation: Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwège E, Gönder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design. Prim Care Diabetes. 2011 Dec;5(4):231-9. doi: 10.1016/j.pcd.2011.04.004. Epub 2011 Jul 14.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Ireland
Greece
Netherlands
United Kingdom
France
Germany


title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

summary: The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.

time_perspective: Prospective

ReferenceCitation: Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.

lead_sponsor: Lymphoma Study Association

location_country: France Italy

location_facility:
Clinique Victor Hugo
CHU Purpan
CHU Robert Debré
Centre Paoli-Calmettes
Hôpital Bretonneau
Centre Bergognié
CHU Brabois
CHU - Nantes
CHU - Besançon
Ospedale Cuneo
CHU - Limoges
Institut Gustave Roussy
Hôpital Necker
Hôpital Saint-Louis
CHRU Lille
CHU Avicenne
Centre Hospitalier - Lens
CHU Lyon Sud
CHU de Dijon
Hôpital Pitié-Salpêtrière
Centre Henri Becquerel
Hôpital Henri Mondor


title: Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

summary:
This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma.

To this end, the study seeks to predict the following parameters in these patients:

The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination.
Progression-free survival and overall survival.

Prediction of the treatment response and the occurrence of adverse effects will be based on:

An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations.
An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression).

Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Miannay B, Minvielle S, Roux O, Drouin P, Avet-Loiseau H, Guérin-Charbonnel C, Gouraud W, Attal M, Facon T, Munshi NC, Moreau P, Campion L, Magrangeas F, Guziolowski C. Logic programming reveals alteration of key transcription factors in multiple myeloma. Sci Rep. 2017 Aug 23;7(1):9257. doi: 10.1038/s41598-017-09378-9.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility:
CH Mulhouse
Centre Antoine LACASSAGNE
CHU LYON
Chu Rennes
Chu Grenoble
Chu Nancy
CHR METZ
LYON SUD
CHRU Angers
BORDEAUX
Ipc Marseille
Chu Nantes
René Huguenin
CH ALBI
CHRU Lille
CH Yves Le Foll
CH Côte basque
Chalon sur Saone
CHD Vendée
Institut Curie
Chu Toulouse
Chu Poitiers
Chu Tours
CH Blois
Ch Dunkerque
CHU Dijon


title: Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting

acronym: ENTERRA

summary:
The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment. Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or due to diabetes mellitus. The duration of the study will be 28 months for each patient.

After a run-in period of 4 months during which a prospective assessment of healthcare resources utilization and of the severity of the symptoms will be obtained, patients will be implanted. The follow-up period after implantation of the device will last 24 months in every patients and will be divided in two parts: a) After the first postoperative month during which the device will remained on the "OFF" position, the first phase of the study will be a randomized double-blind cross-over study with 2 periods of 4 months during which the device will be activated or not. After the 9th month of follow up, the trial will be an open trial and the device will be activated in all patients.

During the whole trial, patients will record all types of healthcare resources utilizations (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of the treatment will be assessed by standard questionnaires at the following visits scheduled at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in diabetic patients. A delayed gastric emptying will not be a selection criteria but we have planned to analyze the clinical results of the treatment in taking into account a delayed or normal gastric emptying during the pre-implantation period. Moreover, gastric emptying studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric electrical stimulation on gastric emptying.

ReferenceCitation: Gourcerol G, Coffin B, Bonaz B, Hanaire H, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi P, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Ducrotte P, Guerci B; ENTERRA Research Group. Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1857-1866.e1. doi: 10.1016/j.cgh.2020.11.011. Epub 2020 Nov 13.

ReferenceCitation: Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B; ENTERRA Research Group. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020 Feb;158(3):506-514.e2. doi: 10.1053/j.gastro.2019.10.018. Epub 2019 Oct 21.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Rennes
UH Grenoble
UH Poitiers
AP-HP Louis Mourier
UH Nice
UH Lyon
UH Lille
UH Marseille
UH Tours
AP-HP Jean Verdier
UH Nimes
Corbeil Essones Hospital
UH Toulouse
UH Strasbourg
UH Clermont Ferrand
UH Bordeaux
UH Montpellier
UH Besancon
UH Rouen
UH Nancy
UH Nantes

intervention_type: Device


title: A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy

acronym: TOPO-LAPA

summary: The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.

lead_sponsor: Centre Francois Baclesse

location_facility:
Institut Jean Godinot
Centre Paul Strauss
APHP Hopital TENON
Institut de Cancérologie de la Loire
CHD Les Oudairies
Centre François Baclesse
Centre G-F Leclerc
CHU Jean MINJOZ
Centre Antoine Lacassagne
Hôpital Diaconesses
Institut Gustave Roussy
Institut Bergonié
Centre René Gauducheau
Centre azuréen de cancérologie
Institut CURIE
Centre Val d'Aurelle
Centre Catherine de Sienne
Centre Jean Bernard
Centre Paul Papin
Centre Alexis vautrin
Institut Claudius regaud


title: A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk MDS and AML With Del 5q

acronym: GFM-Chimio-Rev

summary: In this trial, the investigators will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients.

status: Unknown status

ReferenceCitation: Ades L, Prebet T, Stamatoullas A, Recher C, Guieze R, Raffoux E, Bouabdallah K, Hunault M, Wattel E, Stalnikiewicz L, Toma A, Dombret H, Vey N, Sebert M, Gardin C, Chaffaut C, Chevret S, Fenaux P. Lenalidomide combined with intensive chemotherapy in acute myeloid leukemia and higher-risk myelodysplastic syndrome with 5q deletion. Results of a phase II study by the Groupe Francophone Des Myélodysplasies. Haematologica. 2017 Apr;102(4):728-735. doi: 10.3324/haematol.2016.151894. Epub 2016 Dec 29.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hopital Purpan Service d'Hématologie Clinique


title: A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol)

summary: The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.

lead_sponsor: Exonhit

location_facility: Purpan-Casselardit Hospital - University of Toulouse


title: Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia : A Prospective Study for a Blood Diagnostic Test in Alzheimer's Disease - (Protocol n° EHTAD/002).

summary: The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.

primary_purpose: Diagnostic


type: Other Identifier

title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

acronym: GALAXI

summary: The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

status: Active, not recruiting

ReferenceCitation: Sandborn WJ, D'Haens GR, Reinisch W, Panés J, Chan D, Gonzalez S, Weisel K, Germinaro M, Frustaci ME, Yang Z, Adedokun OJ, Han C, Panaccione R, Hisamatsu T, Danese S, Rubin DT, Sands BE, Afzali A, Andrews JM, Feagan BG; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 May;162(6):1650-1664.e8. doi: 10.1053/j.gastro.2022.01.047. Epub 2022 Feb 5.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Tunisia
Puerto Rico
India
Israel
Turkey
Malaysia
Slovakia
Bosnia and Herzegovina
Brazil
Lebanon
Canada
Hungary
North Macedonia
China
Germany
Taiwan
Belarus
Jordan
Greece
Georgia
Latvia
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: The Second Affiliated Hospital of Zhejiang University

location_facility: Military Hospital of Instruction of Tunis

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: NZOZ Vivamed Zespol Lekarzy Specjalistow

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

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Gastroenterology Associates of Tidewater

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: The First Affiliated Hospital of NanChang University

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Gastroenterology Consultants of Southwest Virginia

location_facility: GBUZ of Moscow Region City Clinical Hospital #3

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Hadassah Hebrew University Medical Center

location_facility: Second Military Medical University (SMMU)

location_facility: Mustafa Kemal University Research and Practise Hospital

location_facility: Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: LLC Treatment and Diagnostic Center Adonis Plus

location_facility: Elite Research Network - Nature Coast Clinical Research, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: King Abdul Aziz Medical City for National Guard Health Affairs

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina

location_facility: Tokitokai Tokito Clinic Coloproctology Center

location_facility: Special hospital for Internal diseases, Oncomed system

location_facility: Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

location_facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: American Universitty of Beirut Medical Center

location_facility: Israel Georgian medical research clinic Helsicore

location_facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

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

location_facility: Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Sisli Etfal Egitim ve Arastirma Hospital

location_facility: Universitätsklinikum Salzburg - Landeskrankenhaus

location_facility: University North Carolina at Chapel Hill

location_facility: ZhuJiang Hospital of Southern Medical University

location_facility: FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch

location_facility: LSUHSC Shreveport Feist-Weiller Cancer Center

location_facility: National Hospital Organization Mito Medical Center

location_facility: 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

location_facility: SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

location_facility: University Clinic of Gastroenterohepatology

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: The first affiliated hospital of suzhou University

location_facility: Huron Gastroenterology Associates Center for Digestive Care

location_facility: King Abdullah Medical City in Holy Capital

location_facility: National Hospital Organization Higashi Ohmi General Medical Center

location_facility: Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

location_facility: Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj

location_facility: Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

location_facility: MNCE'City Clinical Hospital №2 named after prof. O.O. Shalimov' of the Kharkiv City Council

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Harmony Medical Research Institute, Inc.

location_facility: Surat Institute of Digestive Sciences Hospitals

location_facility: KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha

location_facility: Clinical Hospital #122 n.a. after L.G. Sokolov

location_facility: Zhangzhou Municipal Hospital of Fujian Province

location_facility: Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

location_facility: ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c.

location_facility: St.Petersburg State Medical University n.a.Pavlov

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: The First Affiliated Hospital Sun Yat-Sen University

location_facility: Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura

location_facility: Pharmaceutical Integrated Research Company

location_facility: LTD Unimed Kakheti- Telavi Referral Hospital

location_facility: The second Xiangya Hospital of Central South University

location_facility: Kyongpook national university Medical center

location_facility: Wexner Medical Center at the Ohio State University

location_facility: University of Alberta- Ziedler Ledcor Centre

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

location_facility: Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

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

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Atlantic Digestive Health Institute/ Atlantic IBD Center

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro

location_facility: State Scientific Centre of Coloproctology

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Shiga University of Medical Science Hospital

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: Universitaetsklinikum Charite, Campus Virchow Klinikum

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

location_facility: Gastroenterology Research of America, LLC

location_facility: Republican Research Centre of Radiation Medicine and Human E

location_facility: National Hospital Organization Osaka National Hospital

location_facility: City Hospital named after St. Martyr Elizabeth

location_facility: Centre Hospitalier Universitaire (CHU) de Caen

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Charlotte Gastroenterology and Hepatology, PLLC

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

location_facility: Hopital Regional Mohamed Tahar El Maamouri

location_facility: NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova

location_facility: Digestive Health Specialists of the Southeast

location_facility: LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Japan Community Health Care Organization Saitama Medical Center

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Corporacion para Estudios en Salud Clinica CES - Gastroenterology

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

location_facility: Gastroenterologie und Hepatologie am Johannisplatz

location_facility: GBOU VPO Rostov State Medical University

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: Shengjing Hospital of China Medical University

location_facility: St Georges Hospital university medical centre

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: O.O.Bogomolets National Medical University, Kyiv City Clinical Hospital #18,

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Healthcare Institution,Minsk Scientific center for surgery,

location_facility: The Military General Hospital of Beijing PLA

location_facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Northwest Gastroenterology Associates - USA

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

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

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: The Second Affiliated Hospital of Chongqing Medical University

location_facility: Groupement Hospitalier Universitaire Ouest

location_facility: National Hospital Organization Kochi National Hospital


title: A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isolated Non-surgical Below-Knee Injury

acronym: FONDACAST

summary: The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg injuries below the knee that require a cast or other type of immobilization but not surgery.

primary_purpose: Prevention

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
Russian Federation
Netherlands
France
Germany


title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Turkey
Singapore
Slovakia
Cyprus
Brazil
Lebanon
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Estonia
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Clinical Center Nis, Pulmonary Diseases Clinic

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

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

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia

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

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Kemerovo SPI Regional Clinical Oncology Dispensary

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Seconda Università degli Studi di Napoli

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

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

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

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan

location_facility: SBIH "Leningrad Regional Oncological Dispensary"

location_facility: Murmansk Regional Clinical Hospital named after Bayandin

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Seoul National University Bundang Hospital

location_facility: Gallipoli Medical Research Foundation Ltd

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

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

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Complejo Hospitalario Universitario de Vigo

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

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

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

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

location_facility: Baskent University Adana Application and Research Center

location_facility: Kartal Lutfi Kirdar Research and Training Hospital

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: SBIH "Samara Regional Clinical Oncological Dispensary"

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Spitalul Militar de Urgenta "Dr.Constantin Papilian"Cluj -Napoca

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

location_facility: CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: American University of Beirut Medical Center

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Hammoud Hospital University Medical Center

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

location_facility: SBIH "Oncological Dispensary # 2" of the MoH of Krasnodar territory

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

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

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: University General Hospital of Heraklion

location_facility: Instituto Nacional de Enfermedades Neoplásicas

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

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

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

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: FSBHI Clinical research institute of phthisiopulmonology

location_facility: CI Kryvyi Rih Oncological Dispensary of DRC

location_facility: Adana Numune Training and Research Hospital

location_facility: University Clinic for Pulmonary Diseases

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: SI S.P.Grygoriev Institute of Medical Radiology of NAMSU

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

location_facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente

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

location_facility: CRIO - Centro Regional Integrado de Oncologia

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

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: General Hospital of Athens of Chest Diseases "SOTIRIA"

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology

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

location_facility: Hospital Regional Universitario de Malaga

location_facility: SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"

location_facility: Institutul Oncologic "Prof. Dr. Al. Trestioreanu"

location_facility: University of Pretoria Oncology Department

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: Okmeydani Research and Training Hospital

location_facility: IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Fundación Oftalmológica de Santander - FOSCAL

location_facility: Hospital Professor Doutor Fernando Fonseca, E.P.E.

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

summary: The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors


title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

acronym: Neo-PDGF

summary: Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

ReferenceCitation: Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
MICHALLON Hospital
CHU Nantes, Hotel-Dieu Hospital
Necker Hospital
Bois Guillaume Hospital
RANGUEIL Hospital
MONDOR Hospital
TENON Hospital
MAISON BLANCHE Hospital
FOCH Hospital
Amiens hospital
ALBERT CALMETTE Hospital
Georges Pompidou European Hospital
LA MILETRIE Hospital
BRETONNEAU Hospital
LA CAVALE BLANCHE Hospital
Kremlin Bicêtre Hospital
CHU Nice, Pasteur Hospital


title: Profile of Hypertensive Patients Aged of 75 Years and Older Seen in General Practitioner According to Their Renal Damage.

acronym: SERENITE

summary: Describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage