acronym: SELECTIONLTE

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

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

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

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: Washington University School of Medicine

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

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

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

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

location_facility: University Hospital, Kyoto Prefectural University of Medicine

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

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

location_facility: Kitasato University Hospital,THE KITASATO INSTITUTE

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

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

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

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

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: M S Ramaiah Medical College and Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

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

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

location_facility: Santa Familia, Centrum Badan, Profilaktyki i Leczenia

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

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

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

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

location_facility: Yonsei University Health System, Severance Hospital

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

location_facility: Toronto Digestive Disease Associates Inc.

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

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: The University of Texas Health Science Center at Houston

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Clinical Associates in Research Therapeutics of America, LLC

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

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

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

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Gastroenterology Associates of Orangeburg

location_facility: GZA Ziekenhuizen, campus Sint-Vincentius

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

location_facility: Colo-proctology Center Matsushima Clinic

location_facility: Gastroenterology Associates of Tidewater

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

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

location_facility: Gastroenterology Associates Of Central Georgia, LLC

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

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

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

location_facility: Medical Hospital, Tokyo Medical and Dental University

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

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

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

location_facility: The Gordon and Leslie Diamond Health Care Centre

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

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

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Hyogo College of Medicine College Hospital

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

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

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Baylor College of Medicine - Baylor Medical Center

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

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

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

location_facility: Centre Hospitalier Universitaire de Lyon Sud

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

location_facility: Shiga University of Medical Science Hospital

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

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Grant Medical Foundation Ruby Hall Clinic

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

location_facility: University of Calgary, Heritage Medical Research Clinic

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

location_facility: NYU Langone Long Island Clinical Research Associates

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

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

location_facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie

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

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Gastroenterology Research of San Antonio

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

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

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

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

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

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

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

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

location_facility: University of Iowa Hospitals and Clinics

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

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

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: University of Wisconsin Hospital & Clinics

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

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

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

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

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

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Miami Crohn's and Colitis Center

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

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

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

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: Digestive Health Specialists Of The Southeast

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

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

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


title: A Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme After Failure of Standard First Line Therapy

summary:
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: Study data will be shared with WPD Pharmaceuticals, Inc., sub-licensee of Berubicin.

lead_sponsor: CNS Pharmaceuticals, Inc.

location_country:
Spain
Italy
Switzerland
United States
France

location_facility: Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)

location_facility: Saint John's Cancer Institute at Providence Saint John's Health Center

location_facility: nstitut Universitaire du Cancer de Toulouse-

location_facility: Southern California Permanente Medical Group

location_facility: Servizio Sanitario Regionale Emilia-Romagna - Azienda USL di Bologna - Ospedale Bellaria

location_facility: Ospedale Busonera - IRCCS Istituto Oncologico Veneto (IOV)

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Wisconsin Hospital and Clinics

location_facility: UMass (ACC) - Hollings Cancer Center (HCC)

location_facility: University of Califonia San Diego Moores Cancer Center

location_facility: Institut de Recherche en Cancerologie de Montpellier

location_facility: University of Texas Health Science Center

location_facility: Hospital Regional Universitario de Malaga Carlos Haya

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: STARS

title: A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

lead_sponsor: VectivBio AG

type: EudraCT Number

source: euctr

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Argentina
Sweden
Korea, Republic of
France
United States
Israel
Norway
Belgium
Japan
Germany
Czechia

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

location_facility: Keimyung University Dongsan Medical Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Citta della salute e della Scienza di Torino Hospital

location_facility: University of Illinois, Outpatient Care Center

location_facility: Rennes University Hospital Center - Hospital Pontchaillou

location_facility: Fakultní nemocnice Královské Vinohrady, II. Interní klinika

location_facility: Vanderbilt University Medical Center, Center for Human Nutrition

location_facility: Universitair Ziekenhuis Leuven - Gasthuisberg

location_facility: M. Pirogow Provincial Specialized Hospital

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: China Medical University Hospital (CMUH)

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

location_facility: Stadmedica, Non-Public Healthcare Facility

location_facility: University General Hospital Gregorio Maranon

location_facility: National University Corportation Tohoku University Tohoku University Hospital

summary: The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.


ipd_sharing: Yes

intervention_type: Biological

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

type: Registry Identifier

ReferenceType: derived

ReferenceCitation: Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Belgium
Japan
South Africa
Portugal
Russian Federation
Australia
Israel
Turkey
Mexico
Canada
Hungary
China
Bulgaria
Greece
Estonia
Korea, Republic of
France

location_facility: Hospital Regional Universitario de Malaga ( Site 1905)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 2201)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 1807)

location_facility: Steve Biko Academic Hospital ( Site 5000)

location_facility: Clinic of National Cancer Institute ( Site 2101)

location_facility: Peking University Shenzhen Hospital ( Site 3118)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0069)

location_facility: Second Xiangya Hospital of Central-South University ( Site 3128)

location_facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)

location_facility: Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)

location_facility: Spitalul Municipal Ploiesti ( Site 2801)

location_facility: Texas Oncology - Dallas (Sammons) ( Site 0093)

location_facility: Providence Regional Cancer Partnership ( Site 0106)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

location_facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)

location_facility: Institut De Cancerologie De L Ouest ( Site 1110)

location_facility: A O U Policlinico di Modena ( Site 1503)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 4003)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 1506)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)

location_facility: Niigata Cancer Center Hospital ( Site 4004)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)

location_facility: Severance Hospital Yonsei University Health System ( Site 3304)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)

location_facility: The Cancer Institute Hospital of JFCR ( Site 4006)

location_facility: Seoul National University Bundang Hospital ( Site 3301)

location_facility: National Cancer Center Hospital ( Site 4015)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 3121)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 1505)

location_facility: Daping Hospital,Third Military Medical University ( Site 3136)

location_facility: Keimyung University Dongsan Hospital ( Site 3302)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1509)

location_facility: Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)

location_facility: Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 2200)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)

location_facility: University General Hospital of Larisa ( Site 1201)

location_facility: The Christie NHS Foundation Trust ( Site 2405)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 1401)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0123)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 4000)

location_facility: Ninewells Hospital and Medical School ( Site 2401)

location_facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)

location_facility: Saint Francis Cancer Center ( Site 0087)

location_facility: C.I.U. Hopital Ambroise Pare ( Site 1001)

location_facility: Western Health-Sunshine Hospital ( Site 3004)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0034)

location_facility: Memorial Sloan Kettering - Monmouth ( Site 0135)

location_facility: Loma Linda University Cancer Center ( Site 0011)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 3303)

location_facility: Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

location_facility: CHU UCL Namur Site de Godinne ( Site 1004)

location_facility: McGill University Health Centre ( Site 0210)

location_facility: Orszagos Onkologiai Intezet ( Site 1310)

location_facility: University General Hospital of Herakleion ( Site 1202)

location_facility: Hospital Universitari Vall d Hebron ( Site 1904)

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 3106)

location_facility: Fujian Provincial Cancer Hospital ( Site 3126)

location_facility: Hospital Universitario Central de Asturias ( Site 1900)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 3007)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

location_facility: Memorial Sloan Kettering - Basking Ridge ( Site 0133)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)

location_facility: Hospital Universitario 12 de Octubre ( Site 1902)

location_facility: Taunton and Somerset Hospital ( Site 2404)

location_facility: Penn State Hershey Cancer Institute ( Site 0081)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1806)

location_facility: Shandong Province Cancer Hospital ( Site 3100)

location_facility: Aichi Cancer Center Hospital ( Site 4010)

location_facility: Xiangya Hospital of Central South University ( Site 3137)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)

location_facility: Gold Coast University Hospital ( Site 3003)

location_facility: The University of Tennessee Medical Center ( Site 0116)

location_facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)

location_facility: Medipol Universite Hastanesi ( Site 2005)

location_facility: Tudogyogyintezet Torokbalint ( Site 1304)

location_facility: Memorial Sloan Kettering - Nassau ( Site 0131)

location_facility: Memorial Sloan Kettering- Commack ( Site 0132)

location_facility: Kyiv City Clinical Oncology Center ( Site 2100)

location_facility: Istituto Nazionale dei Tumori ( Site 1504)

location_facility: The First Hospital of Jilin University ( Site 3132)

location_facility: Zhejiang Cancer Hospital.... ( Site 3108)

location_facility: Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)

location_facility: Inje University Haeundae Paik Hospital ( Site 3307)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

location_facility: Osaka International Cancer Institute ( Site 4005)

location_facility: Nacionalinis Vezio Institutas ( Site 2300)

location_facility: Kansai Medical University Hospital ( Site 4009)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

location_facility: Istituto Europeo di Oncologia ( Site 1501)

location_facility: West China Hospital of Sichuan University ( Site 3114)

location_facility: Austin Health-Austin Hospital ( Site 3006)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1312)

location_facility: Ironwood Cancer & Research Centers ( Site 0007)

location_facility: Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)

location_facility: Juntendo University Hospital ( Site 4008)

location_facility: CHU Grenoble -Hop Michallon ( Site 1102)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

location_facility: VA Ann Arbor Healthcare System ( Site 0050)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 2408)

location_facility: Okayama University Hospital ( Site 4012)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

location_facility: Memorial Sloan Kettering - Bergen ( Site 0130)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 4011)

location_facility: Tongji Medical College Huazhong University of Science and Technology ( Site 3138)

location_facility: IRCCS Ospedale San Raffaele ( Site 1500)

location_facility: Shanghai Pulmonary Hospital ( Site 3101)

location_facility: Peking Union Medical College Hospital ( Site 3102)

location_facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

location_facility: Multicare Institute For Research And Innovation ( Site 0108)

summary:
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).

Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.

Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.


title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

acronym: SPECTA

summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

study_type: Observational

time_perspective: Prospective

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

location_country:
Croatia
Poland
Portugal
Romania
Slovenia
Greece
Austria
Estonia
Italy
Lithuania
Netherlands
Spain
Switzerland
United Kingdom
France
Belgium
Germany
Cyprus
Czechia

location_facility: UniversitaetsSpital Zurich - Neurology Clinic

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Saint Antoine

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

location_facility: Institut de Cancerologie de la Loire Lucien Neuwirth

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

location_facility: Institut de Cancerologie Strasbourg Europe (formar Paul Strauss)

location_facility: Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

location_facility: North Estonia Medical Centre - Mustamäe unit

location_facility: University Hospitals Coventry and Warwickshire NHS Trust - University Hospital

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro

location_facility: Hopital Nord Franche-Comte - Site du Mittan

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

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre

location_facility: Maria S. Curie Memorial Institute-Gliwice Branche

location_facility: Clinique Mutualiste de l'Estuaire - Centre d'oncologie

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: Velindre NHS Trust - Velindre Cancer Centre

location_facility: Centro Hospitalar do Porto- Hospital de Santo Antonio

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

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

location_facility: Centro Hospitalar de Lisboa Ocidental- San Francisco Xavier Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Universita Di Torino - Ospedale S. Luigi Gonzaga

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: IRCCS - Istituto Neurologico Carlo Besta

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Ospedale S. Luigi Gonzaga - Universita Di Torino

location_facility: Lithuanian Oncology Center-Nat. Cancer Inst

location_facility: Radboud University Medical Center Nijmegen

location_facility: Betsi Cadwaladr University Health Board - Glan Clwyd District General Hospital

location_facility: CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

location_facility: ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Hopitaux Universitaires - Institut Jules Bordet

location_facility: ICO L'Hospitalet- Hospital Universitari de Bellvitge

intervention_type: Genetic


status: Active, not recruiting

primary_purpose: Prevention

acronym: ENSEMBLE 2

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

lead_sponsor: Janssen Vaccines & Prevention B.V.

ReferenceCitation: Hardt K, Vandebosch A, Sadoff J, Le Gars M, Truyers C, Lowson D, Van Dromme I, Vingerhoets J, Kamphuis T, Scheper G, Ruiz-Guiñazú J, Faust SN, Spinner CD, Schuitemaker H, Van Hoof J, Douoguih M, Struyf F; ENSEMBLE2 study group. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Sep 13. pii: S1473-3099(22)00506-0. doi: 10.1016/S1473-3099(22)00506-0. [Epub ahead of print]

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

enrollment_type: Actual

location_country:
Brazil
Belgium
Spain
United Kingdom
France
United States
South Africa
Colombia
Philippines
Germany

location_facility: Powys Teaching Local Health Board - Bronllys Hospital

location_facility: Washington University School of Medicine

location_facility: Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center

location_facility: West Visayas State University Medical Center

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Asistencia Cientifica de Alta Complejidad S.A.S

location_facility: Centre of Tuberculosis Research Innovation

location_facility: Velocity Clinical Research, Hallandale Beach

location_facility: IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.

location_facility: Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ

location_facility: Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Ministerio da Saude - Hospital dos Servidores do Estado - RJ

location_facility: Quality of Life Medical & Research Center, LLC

location_facility: Centro de Referencia E Treinamento Dst/Aids

location_facility: The South Bend Clinic Center for Research

location_facility: CTI Clinical Trial and Consulting Services

summary: The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.


title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

acronym: BEACON

summary: This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

lead_sponsor: Kodiak Sciences Inc

location_country:
Poland
Spain
Italy
Latvia
Hungary
Puerto Rico
United States
France
Israel
Germany
Slovakia
Czechia

location_facility: Northern California Retina Vitreous Associates

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Retina Consultants of Southern California

location_facility: Hospital Universitari General de Catalunya - Grupo Quironsalud

location_facility: Hôpital Lariboisière - Service Pharmacie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

location_facility: Charlotte Eye Ear Nose & Throat Associates, P.A.

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Riga Eastern Clinical University Hospital Clinic Bikernieki

location_facility: The Macula Center/ Blue Ocean Clinical Research

location_facility: Miriam Kannenbaeumer or Andrea Koschinski

location_facility: Emanuelli Research & Development Center LLC

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

location_facility: Signes Ozolinas Doctor Praxis In Ophthalmology

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Retina Consultants of Texas - (Woodlands)

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Dr Nowosielska Okulistyka i Chirurgia Oka

location_facility: Gabinet Okulistyczny Prof. Edward Wylegala

location_facility: Dietrich Bonhoeffer Klinikum Neubrandenburg

location_facility: Centre Hospitalier Intercommunal de Créteil

intervention_type: Other


title: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

acronym: PREFER

summary: This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.

status: Completed

study_completion_date_type: Actual

primary_purpose: Other

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Croatia
Poland
Portugal
Slovenia
Italy
Latvia
Estonia
Russian Federation
Lithuania
Spain
Hungary
France
Israel
Malta
Belgium
Norway
Cyprus

intervention_type: Procedure

status_simplified: Completed


title: A NOVEL Observational longiTudinal studY on Patients With Asthma and/or COPD to Describe Patient Characteristics, Treatment Patterns and the Burden of Illness Over Time and to Identify Phenotypes and Endotypes.

acronym: NOVELTY

summary: The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.

ReferenceCitation: Hughes R, Rapsomaniki E, Janson C, Keen C, Make BJ, Burgel PR, Tomaszewski EL, Müllerová H, Reddel HK; NOVELTY study investigators. Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study. Respir Med. 2022 Aug-Sep;200:106921. doi: 10.1016/j.rmed.2022.106921. Epub 2022 Jun 20.

ReferenceCitation: Reddel HK, Vestbo J, Agustí A, Anderson GP, Bansal AT, Beasley R, Bel EH, Janson C, Make B, Pavord ID, Price D, Rapsomaniki E, Karlsson N, Finch DK, Nuevo J, de Giorgio-Miller A, Alacqua M, Hughes R, Müllerová H, Gerhardsson de Verdier M; NOVELTY study investigators. Heterogeneity within and between physician-diagnosed asthma and/or COPD: NOVELTY cohort. Eur Respir J. 2021 Sep 23;58(3). pii: 2003927. doi: 10.1183/13993003.03927-2020. Print 2021 Sep.

ReferenceCitation: Karlsson N, Atkinson MJ, Müllerová H, Alacqua M, Keen C, Hughes R, Janson C, Make B, Price D, Reddel HK; NOVELTY study investigators. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD. ERJ Open Res. 2021 Feb 1;7(1). pii: 00828-2020. doi: 10.1183/23120541.00828-2020. eCollection 2021 Jan.

ReferenceCitation: Reddel HK, Gerhardsson de Verdier M, Agustí A, Anderson G, Beasley R, Bel EH, Janson C, Make B, Martin RJ, Pavord I, Price D, Keen C, Gardev A, Rennard S, Sveréus A, Bansal AT, Brannman L, Karlsson N, Nuevo J, Nyberg F, Young SS, Vestbo J. Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Res. 2019 Feb 1;5(1). pii: 00036-2018. doi: 10.1183/23120541.00036-2018. eCollection 2019 Feb.

lead_sponsor: AstraZeneca

location_country:
Denmark
Brazil
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
Netherlands
Sweden
Korea, Republic of
United States
France
China
Norway
Colombia
Japan
Germany


title: An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.

acronym: PROSE

summary: Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

ReferenceCitation: da Silva N, Sommer R, Ortmann CE, Jagiello P, Bachhuber T, Augustin M. Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study. J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2241-2249. doi: 10.1111/jdv.17525. Epub 2021 Jul 31.

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

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

location_country:
Poland
Portugal
Romania
Spain
Greece
Italy
Estonia
Latvia
Lithuania
United Kingdom
France
Israel
Belgium
Germany
Bulgaria
Slovakia
Czechia


title: A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

lead_sponsor: Hoffmann-La Roche

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

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Czechia
Poland
Portugal
Russian Federation
Argentina
Puerto Rico
Turkey
Mexico
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
France

location_facility: University of California Davis Health System; Department of Neurology

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Jena, Klinik für Neurologie

location_facility: Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

location_facility: Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

location_facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: AOU Città della Salute e della Scienza; Neurologia 1

location_facility: Neurozentrum Stuttgart Mitte Sophienstraße; Neurologische Gemeinschaftspraxis

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: Szpital Specjalistyczny im. Rydygiera w Krakowie; Oddzial Neurologii i Udarow Mozgu

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Medizinische Hochschule Hannover, Klinik für Neurologie

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

location_facility: Petz Aladar Megyei Oktato Korhaz; Neurologiai Osztaly

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: University of Massachusetts Medical School

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: Texas Institute for Neurological Disorders

location_facility: Atrium Health Neurosciences Institute - Charlotte

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Regional clinical hospital named after prof. S.V. Ochapovsky

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: Neuro Institute of New England P.C.; Research

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Michigan Institute for Neurological Disorders

location_facility: AOU Senese; UOC Clinica Neurologica e Malattie neurometaboliche

location_facility: Krankenhaus Martha-Maria Hallo-Dölau, Klinik für Neurologie

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: University General Hospital of Larisa; Neurology Clinic

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Neurologia

location_facility: Federal center of brain research and neurotechnologies

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet; Neurology

location_facility: Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu

location_facility: Medical Center of Private Execution First Private Clinic

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA

location_facility: Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: N.P. Bechtereva Institute of the Human Brain

location_facility: Pest Megyei Flor Ferenc Korhaz; Neurology and Stroke Ambulance

location_facility: CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Cumhuriyet Universitesi Tip Fakultesi; Noroloji Bolumu

location_facility: University of Cincinnati; Department of Neurology

location_facility: SBEI of HPE "Bashkir State Medical University" of MoH RF

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia

location_facility: New Orleans Center for Clinical Research

location_facility: Haseki Training and Research Hospital; Department of Neurology

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badań Klinicznych

location_facility: Erciyes Universitesi; Pediatric Neurology

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Neurologie, Neurophysiol. neurolog.Reha/Schlaganfalleinh

location_facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Kantonsspital Aarau AG Medizin Neurologie; Neurologie

location_facility: National Center of Social Significant Disease

location_facility: University of Texas Southwestern Medical Center

location_facility: Centro Hospitalar de Setubal, EPE - Hospital São Bernardo; Serviço de Neurologia

location_facility: Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Neurologia

location_facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

summary: This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.


title: Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting

summary: This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.

location_country:
Denmark
United Kingdom
Ireland
Austria
Italy
Finland
Sweden
France
Norway
Germany

location_facility: Southampton General Hospital; Respiratory Department

location_facility: University Hospital of North Staffordshire; ILD Clinic

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: Medical University Graz; Department for Respiratory Diseases

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: Helsinki University Central Hospital; Dep. of Pulmonary Medicine

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare

location_facility: Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie

location_facility: Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik

location_facility: Queen Alexandra Hospital; Respiratory Centre

location_facility: Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo

location_facility: Klinikum Klagenfurt; Abteilung für Pulmologie

location_facility: Galway University Hospital; Department of Respiratory Medicine

location_facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

location_facility: University Hospital Aintree; Pulmonary Vascular Diseases Unit

location_facility: Lungenklinik Lostau gGmbH; Klinik für Pneumologie II

location_facility: Haukeland Hospital - University Of Bergen: Department of Resp Med

location_facility: Hopital De La Maison Blanche;Maladies Respiratoires

location_facility: Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH

location_facility: Papworth Hospital NHS Foundation Trust; Respiratory Department

location_facility: Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie

location_facility: Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie

location_facility: Nottingham University Hospitals City Campus

location_facility: Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica

location_facility: Castle Hill Hospital; Respiratory Medicine

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud

location_facility: Turku University Hospital; Dept of Pulmonology

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: Akademiska Sjukhuset; Lungmedicinska Kliniken

location_facility: Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie

location_facility: Carl-Thiem-Klinik Cottbus; Medizinische Klinik

location_facility: HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie

location_facility: Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin

location_facility: Ospedale Morgagni-Pierantoni; U.O. Pneumologia

location_facility: Universitätsklinikum Freiburg, Abteilung Pneumologie

location_facility: Aarhus University Hospital; Lungemed afd. B

location_facility: Klinik Löwenstein gGmbH Medizinische Klinik II

location_facility: Gentofte Hospital, Lungemedicinsk Afdeling

location_facility: University College London Hospital; Respiratory Medicine

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie

location_facility: Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik

location_facility: Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie

location_facility: Odense Universitetshospital, Lungemedicinsk Afdeling J

location_facility: Klinik Donaustauf Zentrum für Pneumologie

location_facility: Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

location_facility: LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: RoMed Klinikum Rosenheim, Medizinische Klinik III

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie

location_facility: Studienzentrum/Praxis Dr. Keller Frankfurt

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Oslo University Hospital Rikshospitalet; Lungeavdelingen

location_facility: Universitaetsklinikum des Saarlandes; Innere Medizin V

location_facility: Karolinska Universitetssjukhuset Solna; Lung Allergikliniken

location_facility: Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: St. Johanns-Spital; Abt. Für Lungenkrankungen

location_facility: Universitätsklinikum Jena; Medizinische Klinik I

location_facility: Tampere University Hospital; Lung Clinic

location_facility: Southmead Hospital; Respiratory Department

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

location_facility: Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre


title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa

acronym: EVADE

summary: Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

ReferenceCitation: Chastre J, François B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sánchez-García M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.

lead_sponsor: MedImmune LLC

location_country:
Croatia
Portugal
Spain
Greece
Austria
Ireland
United Kingdom
Hungary
United States
France
Israel
Turkey
Belgium
Czechia


title: EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction

summary:
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease.

People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes.

Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Serbia
Spain
Ukraine
United States
Romania
Japan
Poland
Russian Federation
Australia
Argentina
India
Israel
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Korea, Republic of
France
Netherlands

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Fejer County Saint George University Teaching Hospital

location_facility: CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: Clinical Medical Diagnostic Center Simedgroup

location_facility: Zhytomyr Regional Clinical Hospital, Dept. Endocrinology

location_facility: Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser

location_facility: Sion Hospital (Lokmanya Tilak Municipal Hospital)

location_facility: Emergency County Clinical Hospital, Sibiu

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet

location_facility: Medical Academy named after I. Mechnikov, St. Petersburg

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Hospital das Clínicas de Sao Paulo - INCOR

location_facility: MHAT Sv.Anna, Clinic of Internal Diseases, Sofia

location_facility: University of Florida Health Jacksonville

location_facility: Ivano-Frankivsk City Central Clinical Hospital

location_facility: GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan

location_facility: Amarillo Heart Clinical Research Institute, Incorporated

location_facility: Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.

location_facility: Komi Republican Cardiological Dispensary

location_facility: Prof.C.C.Iliescu Hospital, National Institute of Cardiology

location_facility: Seoul National University Bundang Hospital

location_facility: Xiangya Hospital, Central South University

location_facility: Oklahoma Heart Hospital Research Foundation, Incorporated

location_facility: Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag

location_facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

location_facility: Cardiology and Cardiovascular Rehabilitation Clinic

location_facility: Centro Especializado em Cardiol Loema Instituto de Pesq Clin

location_facility: Mahatma Gandhi Mission Medical College & Hospital

location_facility: University Clinical Center of Kragujevac

location_facility: Cardiovascular Diseases Institute "Prof. Georgescu", Iasi

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: Cardiovascular Consultants of South Georgia, LLC

location_facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research

location_facility: Multiprofile Hospital MHATEM 'Pirogov', Sofia

location_facility: ProHealth Care Research Institute and Cardiology Associates

location_facility: KEM Hospital and Seth G S Medical College

location_facility: Tokyo Bay Urayasu Ichikawa Medical Center

location_facility: Specialized Hospital for Active Treatment Sv. Georgi - Pernik

location_facility: Multiprofile Hospital For Active Treatment Dr. Nikola Vasiliev AD

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Tidewater Physicians Multispecialty Group

location_facility: IKARDIA - Center for Invasive Cardiology

location_facility: Advanced Heart Care, LLC, Medicoricum, LLC

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy

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

location_facility: Emergency Clinical Hospital "Bagdasar-Arseni"

location_facility: Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH

location_facility: Emergency Clinical County Hospital, Baia Mare

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

location_facility: Cardiovascular Associates of East Texas, PA

location_facility: SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv

location_facility: Emergency University Hospital, Bucharest

location_facility: Military Central Clinical Emergency Hospital

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Multiprofile Hospital For Active Treatment Pulse AD

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

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

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Hospital Universitário Evangélico de Curitiba

location_facility: Dr Alfred Sokołowski Specialist Hospital

location_facility: Sanjay Gandhi Post Graduate Inst. of Medical Sciences

location_facility: Regional Clinical Hospital No.1 n.a. Ochapovskiy, Krasnodar

location_facility: Cardiology Partners Clinical Research Institute

location_facility: The Chaim Sheba Medical Center Tel HaShomer

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar

location_facility: Cardiovascular Specialists of Central Maryland

location_facility: George Washington University Medical Faculty Associates

location_facility: Emergency Clinical Hospital "St. John" Bucharest

location_facility: Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia

location_facility: Eternal Heart Care Centre & Research Institute Pvt. Ltd.

location_facility: General Hospital Subotica, Internal Medicine

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

location_facility: The University of North Carolina at Chapel Hill

location_facility: Clincal Reabilitation Hospital, Cluj Napoca

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: KLES Dr.Prabhakar Kore Hospital and Medical Research Centre

location_facility: Multiprofile Hospital for Active Treatment AD Haskovo

location_facility: Multiprofile Hospital For Active Treatment - Pazardzhik AD

location_facility: Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"

location_facility: Transcarpathian Regional Clinical Center

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

location_facility: Institute for Cardiovascular diseases Dedinje

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: GB Pant Institute of Post Graduate Medical Education and Research

location_facility: Institute for Treatment and Rehabilitation, Niska Banja

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

location_facility: Republic Kareliya Republican Hosp. named after V.A. Baranov

location_facility: Centro de Investigacion Clinica Coronel Suarez

location_facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto

location_facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego

location_facility: Country Clinical Emergency Hospital, Targu-Mures

location_facility: City Joint Emergency Hospital, Dnepropetrovsk

location_facility: South Western Sydney Local Health District

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Beijing Luhe Hospital Capital Medical University

location_facility: Instituto de Ensino E Pesquisa Do Hospital Da Bahia

location_facility: IPECC - Instituto de Pesquisa Clínica de Campinas

location_facility: Hospital de Messejana Dr. Carlos Alberto Studart Gomes

location_facility: Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

location_facility: Cardiovascular Innovation and Research Center

location_facility: State Healthcare Institution Clinical Hosp. No. 51, Moscow

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Specialized Hospital for Active Treatment Cardiology Varna - EAD

location_facility: Penza Regional Clinical Hospital named after N.N.Burdenko

location_facility: Clinical Hospital Center Dr. Dragisa Misovic

location_facility: The Second Affiliated Hospital of Lanzhou Medical University

location_facility: Heart Institute "Niculae Stancioiu", Cluj Napoca

location_facility: Missouri Cardiovascular Specialists, LLP

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ

location_facility: Timisoara Municipal Emergency Clinical Hospital

location_facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

location_facility: The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow

location_facility: Clinical Medical Center Zvezdara, Belgrade

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: First City Clinical Hospital named after E. E. Volosevich

location_facility: Lady Davis Carmel Medical Center, Haifa 34362

location_facility: Bacs-Kiskun Megyei Onkormanyzat Hospital

location_facility: L.T. Malaya Institute of Therapy AMS of Ukraine

location_facility: Texas Health Presbyterian Hospital Allen

location_facility: Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

location_facility: Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako

location_facility: Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw

location_facility: Fundacao de apoio ao ensino e assitencia HCFMRP

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: CI of Healthcare Kharkiv CCH #8, Kharkiv

location_facility: Fundación Favaloro para la Docencia e Investigación Medica

location_facility: Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD


title: EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

summary: To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

ReferenceCitation: Miller R, Niazi M, Russial O, Poiset S, Shi W. Tumor treating fields with radiation for glioblastoma: a narrative review. Chin Clin Oncol. 2022 Jan;11(5):40. doi: 10.21037/cco-22-90.

ReferenceCitation: Miller R, Song A, Ali A, Niazi M, Bar-Ad V, Martinez N, Glass J, Alnahhas I, Andrews D, Judy K, Evans J, Farrell C, Werner-Wasik M, Chervoneva I, Ly M, Palmer J, Liu H, Shi W. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma. Front Oncol. 2022 Apr 29;12:896246. doi: 10.3389/fonc.2022.896246. eCollection 2022.

lead_sponsor: NovoCure GmbH

location_country:
Austria
Canada
Switzerland
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Massey Cancer Center - VCU Medical Center

location_facility: John Wayne Cancer Institute at St. John's Health Center

location_facility: Washington University School of Medicine

location_facility: Abbott Northwestern Hospital - Givens Brain Tumor Center

location_facility: Hoag Memorial Hospital - Hoag Cancer Center

location_facility: Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates

location_facility: University of California San Francisco Medical Center

location_facility: University of Colorado Cancer Center Anschutz

location_facility: Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center

location_facility: Lynn Cancer Institute, Marcus Neuroscience Institute

location_facility: Maine Medical Partners Neurology - Neurosurgery & Spine Associates

location_facility: Oregon Health & Science University (OHSU)

location_facility: UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences

location_facility: University of California at San Diego - Moores Cancer Center

location_facility: University of Louisville - James Graham Brown Cancer Center

location_facility: Norris Comprehensive Cancer Center at USC

location_facility: University Institute Cancer Toulouse Oncopole

location_facility: NYU Langone - Laura & Issac Perimutter Cancer Center

location_facility: Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita

location_facility: The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital

location_facility: Sunnybrook Research Institute - Odette Cancer Centre

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Novant Health Cancer Institute Radiation Oncology

location_facility: West Virginia University Cancer Institute

location_facility: New York Presbyterian - Columbia University

location_facility: John Peter Smith Health Network - JPS Cancer Center

location_facility: University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center

location_facility: Northwell Health System Brain Tumor Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology

location_facility: The University of Vermont Medical Center - University of Vermont Cancer Center

location_facility: JFK Neuroscience Institute, HMH JFK University Medical Center

location_facility: TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center

location_facility: University of California - Irvine/UCI Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Wake Forest Baptist Comprehensive Cancer Center

location_facility: MUSC Radiation Oncology Brain & Spine Tumor Program

location_facility: University of Minnesota Health Clinics and Surgery Center

location_facility: HCA Research Institute - Blue Sky Neurology - Denver

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center

location_facility: Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center

location_facility: NeuroMedical Center - Mary Bird Cancer Center

location_facility: Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine

location_facility: University of Cincinnati Cancer Institute

location_facility: Texas Oncology Midtown - Austin Brain Tumor Center

location_facility: The Emory Clinic - Emory Healthcare - Winship Cancer Institute

location_facility: University of Missouri - Ellis Fischel Cancer Center

location_facility: UW Medical Center - Alvord Brain Tumor Center

intervention_type: Device


title: A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.

ReferenceCitation: Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.

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

location_country:
Poland
Portugal
Spain
Greece
Austria
Australia
Italy
Russian Federation
United Kingdom
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: GBUZ Leningradskaya state clinical hospital

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

location_facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Consultants in Medical Oncology and Hematology

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

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V

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

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Huddersfield Royal Infirmary; The Learning Centre

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Seoul National University Bundang Hospital

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.


title: A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

lead_sponsor: Gilead Sciences

ReferenceType: background

ReferenceCitation: Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A.

ReferenceCitation: Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16.

ReferenceCitation: Bourlière M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31.

ReferenceType: result

ReferenceCitation: Bourlière M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Lédinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

location_country:
United Kingdom
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany

summary:
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.