title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

acronym: AEGEAN

summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Peru
Romania
Belgium
Russian Federation
Taiwan
Ukraine
India
Costa Rica
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Philippines
Vietnam
Bulgaria
Hungary
Puerto Rico
China
Germany
United States
Italy
Austria
Brazil
Mexico
Spain


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

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 and Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen-Cilag Ltd.

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Czechia
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of

acronym: POWER

location_facility: University of Mississippi Medical Center

location_facility: Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Northshore Gastroenterology Research, LLC

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

location_facility: Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Pennine Acute Hospitals-Fairfield General Hospital

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Gastroenterology Research of America, LLC

location_facility: Universitätsklinikum Frankfurt/ Medizinische Klinik 1

location_facility: Universitätsklinikum Ulm, Klinik für Innere Medizin II

location_facility: Washington University School of Medicine

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: University of Kentucky Chandler Medical Center

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Southampton University Hospitals NHS Trust

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Gloucestershire Hospitals NHS Foundation Trust - Cheltenham

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

summary: The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase II, Single Arm Study Assessing Efficacy of Osimertinib With Savolitinib in Patients With EGFRm+ MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study)

acronym: SAVANNAH

summary: This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib

ReferenceType: derived

ReferenceCitation: Schmid S, Früh M, Peters S. Targeting MET in EGFR resistance in non-small-cell lung cancer-ready for daily practice? Lancet Oncol. 2020 Mar;21(3):320-322. doi: 10.1016/S1470-2045(19)30859-9. Epub 2020 Feb 3.

family: Schmid

full_name: Sabine Schmid

given: Sabine

sequence: first

family: Früh

full_name: Martin Früh

given: Martin

sequence: additional

family: Peters

full_name: Solange Peters

given: Solange

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Targeting MET in EGFR resistance in non-small-cell lung cancer—ready for daily practice?

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Italy
Brazil
Chile
India
Vietnam
France
Japan
Korea, Republic of
Israel
Puerto Rico
Spain
Denmark
United States
Canada
Taiwan


intervention_type: Radiation

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Switzerland
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Israel
Spain

acronym: MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC

location_facility: Seoul National University Bundang Hospital ( Site 0703)

location_facility: Providence Portland Medical Center ( Site 1843)

location_facility: Inova Schar Cancer Institute ( Site 2026)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0355)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)

location_facility: Clinical oncology dispensary of Dnipro ( Site 1706)

location_facility: Northwell Health Cancer Institute ( Site 2030)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)

location_facility: Hopital Europeen Georges Pompidou ( Site 0358)

location_facility: University of Vermont Medical Center ( Site 2009)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0406)

location_facility: Hospital Universitario La Paz ( Site 1201)

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0450)

location_facility: National Taiwan University Hospital ( Site 1300)

location_facility: University of Massachusetts Memorial Medical Center ( Site 1875)

location_facility: McGill University Health Centre ( Site 0210)

location_facility: Hospital Provincial del Centenario ( Site 0008)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0171)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0654)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0251)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)

location_facility: Oncologos del Occidente S.A. ( Site 0310)

location_facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1702)

location_facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)

location_facility: UT Southwestern Medical Center ( Site 1841)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)

location_facility: University of Utah, Huntsman Cancer Institute ( Site 1855)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 0935)

location_facility: UVA Health System - Emily Couric Cancer Center ( Site 1826)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)

location_facility: University of Colorado Cancer Center ( Site 1838)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0300)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1857)

location_facility: Centro Regional Integrado de Oncologia ( Site 0160)

location_facility: Rush University Medical Center ( Site 1823)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1920)

location_facility: Saint Alphonsus Regional Medical Center ( Site 2021)

location_facility: Washington University School of Medicine ( Site 1800)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)

location_facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)

location_facility: Universitaetsklinikum Frankfurt ( Site 0403)

location_facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)

location_facility: Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)

location_facility: Universitaetsklinikum Hamburg Eppendorf ( Site 0407)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)

location_facility: National Cheng Kung University Hospital ( Site 1302)

location_facility: Tokyo Medical University Hospital ( Site 0659)

location_facility: Kyiv City Clinical Oncology Centre ( Site 1701)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)

location_facility: University of Kansas Cancer Center ( Site 2004)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)

location_facility: Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)

location_facility: Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1206)

location_facility: Royal Marsden Hospital - Fulham Road London ( Site 1609)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)

location_facility: Loyola University Medical Center [Maywood, IL] ( Site 1817)

location_facility: Instituto de Oncologia de Rosario ( Site 0002)

location_facility: Chaim Sheba Medical Center. ( Site 0553)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0660)

location_facility: Aichi Cancer Center Hospital ( Site 0658)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0704)

location_facility: National Cancer Center Hospital ( Site 0650)

location_facility: Wake Forest Compenhensive Cancer Center ( Site 2029)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 1818)

location_facility: The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0153)

location_facility: Hospital Universitario Austral ( Site 0009)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)

location_facility: Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 1859)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)

location_facility: Hospital Aleman Buenos Aires Argentina ( Site 0004)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 2034)

location_facility: Royal Brisbane and Women s Hospital ( Site 0050)

location_facility: Yokohama City University Hospital ( Site 0657)

location_facility: St. Joseph Heritage Healthcare ( Site 1806)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)

location_facility: Universitätsklinikum Schleswig-Holstein ( Site 0411)

location_facility: Hospital Britanico de Buenos Aires ( Site 0012)

location_facility: Chonnam National University Hwasun Hospital ( Site 0705)

location_facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)

location_facility: Hospital Clinico Universitario de Santiago ( Site 1207)

location_facility: Orszagos Onkologiai Intezet ( Site 0454)

location_facility: NorthShore University HealthSystem ( Site 1812)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0554)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Hiroshima University Hospital ( Site 0655)

location_facility: Oregon Health Sciences University ( Site 1871)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: University of Southern California Norris Comprehensive Cancer Center ( Site 1850)

location_facility: Medizinische Universitaet Wien ( Site 1903)

location_facility: City Clinical Hosp.4 of DCC ( Site 1705)

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont ( Site 0453)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 1604)

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0165)

location_facility: Centro de Investigacion Clinica del Country ( Site 0304)

location_facility: Ukrainian Center of Tomotherapy ( Site 1708)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0175)

location_facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)

location_facility: George Washington University Medical Faculty Associates ( Site 2035)

location_facility: The University of New Mexico Comprehensive Cancer Center ( Site 1882)

location_facility: St. Luke's University Health Network ( Site 1801)

location_facility: Instituto de Oncología Angel Roffo ( Site 0003)

location_facility: Taichung Veterans General Hospital ( Site 1301)

title: A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

summary: This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

summary: The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

status: Active, not recruiting

ipd_sharing: No

lead_sponsor: Rigel Pharmaceuticals

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
France
Norway
Canada
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Georgia
Belarus
Spain

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Institut d'hématologie de Basse Normandie, CHU Caen

location_facility: ULSS8 Berica Ospedale San Bortolo - Unità Operativa Complessa di Ematologia

location_facility: Marshfield Clinic Cancer Center - Stevens Point

location_facility: CHU Estaing - Chirurgie digestive et Médecine interne

location_facility: "University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski " EAD, Clinic of Clinical Hematology, Department of Clinical Hematology

location_facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

location_facility: Ospedale Maggiore, SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina

location_facility: East Kent Haemophilia Centre, Kent and Canterbury Hospital

location_facility: Clinical Center Nis, Clinic for Hematology

location_facility: Princess Alexandra Hospital - Cancer Trials Unit

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: Kyiv City Clinical Hospital №9, hematology department №1

location_facility: Semmelweis Egyetem, Általános Orvostudományi Kar, I.sz. Belgyógyászati Klinika, Haematológiai Osztály,

location_facility: Pécsi Tudományegyetem, Klinikai Központ, I.számú Belgyógyászati Klinikai, Hematológiai Tanszék

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology Cluj-Napoca

location_facility: "University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski" EAD, Pleven, Clinic of Clinical Haematology

location_facility: Hospital Universitario y Politecnico La Fe - Servicio de Hematología

location_facility: "Specialized Hospital for Active Treatment of Hematological Diseases" EAD, Sofia, Clinic of Clinical Haematology

location_facility: State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

location_facility: State Budgetary Healthcare Institution of Moscow city "City Clinical Hospital No 40 Department of Healthcare of Moscow city"

location_facility: Universitair Ziekenhuis Antwerpen - Hematologie

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Aarhus University Hospital - Dept of Hematology

location_facility: CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses

location_facility: Texas Oncology - Baylor Research Institute

location_facility: Clinical Centre of Vojvodina, Clinic for Hematology

location_facility: Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

location_facility: University Hospital Medical Center "Bezanijska Kosa", Department of Hematology

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: SCDU Ematologia AOU "Maggiore della Carità"

location_facility: City Clinical Hospital № 4, Hematology Center

location_facility: American Oncology Network Vista Oncology Division

location_facility: "University Multiprofile Hospital for Active Treatment "Sveta Marina"" EAD, Varna, Clinic of Clinical Haematology

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region "City Clinical Hospital №2"

location_facility: Rutgers - Robert Wood Johnson Medical School

location_facility: "University Multiprofile Hospital for Active Treatment 'Alexandrovska" EAD, Clinic of Clinical Haematology

location_facility: The Royal London Hospital, Bart's Health NHS Trust

location_facility: ASST degli Spedali Civili di Brescia, Ematologia UOC

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

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Universitätsklinik Innsbruck - Innere Medizin V

location_facility: Hamilton Health Sciences- McMaster University Medical Centre

location_facility: Cherkasy Regional Oncology Dispensary, Hematology Center

location_facility: Arizona Oncology Associates, PC--HOPE Division

location_facility: University of Leipzig Medical Center, Medical Department I - Haematology and Cell Therapy, Medical Oncology, Hemophilia

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"

location_facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia

location_facility: Fakultni nemocnice Ostrava Klinika hematoonkologie


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

summary: This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD).

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

name: UCL Huntington’s Disease Centre, UCL Queen Square Institute of Neurology, University College London, London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal

name: Instituto de Medicina Molecular, Lisbon, Portugal

family: Rodrigues

full_name: Filipe B. Rodrigues

given: Filipe B.

name: CNS - Campus Neurológico Sénior, Torres Vedras, Portugal

family: Ferreira

full_name: Joaquim J. Ferreira

given: Joaquim J.

family: Wild

full_name: Edward J. Wild

given: Edward J.

journal_name: Journal of Huntington's Disease

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says Open Access)

host_type: publisher

license: implied-oa

license_normalized: implied-oa

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
PubMed Central
UCL Discovery

repositories_institution: University College London - UCL Discovery

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Huntington’s Disease Clinical Trials Corner: June 2019

ReferenceCitation: Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001. Review.

name: UCL Huntington’s Disease Centre, UCL Queen Square Institute of Neurology, University College London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, PT

name: Clinical Pharmacology Unit, Instituto de Medicina Molecular, Lisbon, PT

name: Department of Biobehavioral Sciences, Teachers College, Columbia University, USA

family: Quinn

full_name: Lori Quinn

given: Lori

evidence: open (via free pdf)

version: submittedVersion

title: Huntington’s Disease Clinical Trials Corner: January 2019

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
United States
Chile
Switzerland
Netherlands
Spain
Germany
France
Japan
Poland
Argentina
Australia
New Zealand
Russian Federation
Denmark
Canada
United Kingdom

location_facility: University of California Davis Medical System

location_facility: Fundacion Jimenez Diaz; Servicio de Neurología

location_facility: Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences

location_facility: Hospital Universitario de Badajoz; Servicio de Neurología

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica

location_facility: Research Center of Neurology; Neurology Department #5

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: The University of Texas Health Science Center at Houston; McGovern Medical School

location_facility: Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: Centro de Trastornos del Movimiento (CETRAM); CETRAM

location_facility: A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: WESTMEAD HOSPITAL; Deparment of Neurology

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Сlinical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy

location_facility: German Center for Neurodegenerative Diseases (DZNE)

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Uniklinik RWTH Aachen; Klinik für Neurologie

location_facility: Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine

location_facility: Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.

location_facility: George-Huntington- Institut GmbH; Technologiepark Münster

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen

location_facility: Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: Washington University School of Medicine

location_facility: John Hopkins University School of Medicine

location_facility: Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Rocky Mountain Movement Disorders Center

location_facility: IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare

location_facility: National Hospital For Neurology and Neurosurgery

location_facility: University of Utah Clinical Neurosciences Center

location_facility: Hopital Henri Mondor; Service de Neurologie

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

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

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration

location_facility: National Hospital Organization Niigata National Hospital

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Georgetown University; Research Division, Psychiatry

location_facility: IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica

location_facility: Auckland DHB - Neurlogy Department; Neurology Department

location_facility: National Center of Neurology and Psychiatry

location_facility: Aberdeen Royal Infirmary; Medical Genectics

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: CHU Angers, Batiement Larrey 2, Neurologie

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Wellington Hospital; Department of Neurology

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie


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

lead_sponsor: Cytokinetics

enrollment_type: Actual

location_country:
Italy
United States
Sweden
Netherlands
France
Poland
Hungary
Germany
Canada

acronym: METEORIC-HF

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Universite de Montreal Institut de Cardiologie de Montreal ICM Montreal Heart Institute MHI

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Glacier View Research Institute, Cardiology

location_facility: Universitair Medisch Centrum Utrecht - Wilhelmina Kinderziekenhuis

location_facility: Wake Forest University School of Medicine

location_facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana

location_facility: Uniwersyteckie Centrum Kliniczne Kliniczne Centrum Kardiologii

location_facility: Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

location_facility: Divisione di Cardiologia con Utic ed Emodinamica

location_facility: Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)

location_facility: Oddzial Kliniczny Choroby Wiencowej i Niewydolnosci Serca z Pododdzialem Intensywnego Nadzoru Kardiologicznego

location_facility: Erasmus MC - Universitair Medisch Centrum Rotterdam

location_facility: Centrum Chorob Serca, Uniwersytecki Szpital Kllniczny im. Jana Mikulicza Radeckiego we Wrociawiu

location_facility: Massachusetts General Hospital (MGH) - Cardiac Unit Associates

location_facility: Instytut Kardiologii Heart Failure Clinic

location_facility: University of Texas - Southwestern Medical Center

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Universite De Nantes - L'Institut Du Thorax

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologiczny

location_facility: Broward Research Center - Pembroke Pines

location_facility: Hartford Hospital-University of Connecticut School of Medicine

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

location_facility: Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer

location_facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

location_facility: Onze Lieve Vrouwe Gasthuis (OLVG) Locatie West

location_facility: Mcgill University Health Centre (MUHC)-The Montreal General Hospital (MGH)

location_facility: Enhet Klinisk forskning, hjartmedicin, Skanes Universitet Sjukhus

location_facility: London Health Sciences Centre - University Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Baylor Scott and White Heart and Vascular Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance

summary: The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo


title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

summary: This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Sweden
Netherlands
France
Korea, Republic of
Poland
Romania
Russian Federation
Spain
Germany
Canada


title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

acronym: CYCLONE 2

summary: This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Netherlands
Spain
Germany
France
Japan
Romania
Australia
China
Denmark
United States
United Kingdom
Korea, Republic of

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: St. Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Second affiliated hospital of anhui medical university

location_facility: Urologie am Nordplatz - Urologische Facharztpraxis Dr. med. Silvio Szymula

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: S.C. R.T.C. Radiology Therapeutic Center S.R.L.

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Yijishan Hospital of Wannan Medical College

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: Urologische Arztpraxis in Eisleben - Dr. med. Ralf Eckert

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Toho University School of Medicine, Sakura Hospital

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: HuaShan Hospital Affiliated To Fudan University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kobe City Medical Center General Hospital

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Scott & White Memorial Hospital & Clinic

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology


ReferenceCitation: Tabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12.

name: Vall d'Hebron Hospital Campus & Institute of Oncology, UVic-UCC, IOB-Quiron, 08035, Barcelona, Spain

family: Tabernero

full_name: Josep Tabernero

given: Josep

name: Seoul National University College of Medicine, 103 Daehak-ro, Ihwa-dong, Jongno-gu, Seoul, South Korea

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

name: University Hospitals Gasthuisberg Leuven & KU Leuven, Leuven, Belgium

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

name: Yale Cancer Center & Smilow Cancer Hospital, New Haven, CT 06511, USA

family: Fuchs

full_name: Charles S Fuchs

given: Charles S

name: Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

family: Janjigian

full_name: Yelena Yuriy Janjigian

given: Yelena Yuriy

name: Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Bhagia

full_name: Pooja Bhagia

given: Pooja

family: Li

full_name: Kan Li

given: Kan

family: Adelberg

full_name: David Adelberg

given: David

name: PLA Cancer Centre of Nanjing, Jinling Hospital, Nanjing, 34210002, China

family: Qin

full_name: Shu Kui Qin

given: Shu Kui

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

location_country:
Peru
Guatemala
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Costa Rica
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Switzerland
Hungary
Ireland
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Aalborg University Hospital ( Site 3204)

location_facility: Soroka University Medical Center ( Site 1305)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0809)

location_facility: Universitas Annex National Hospital ( Site 1701)

location_facility: Greater Baltimore Medical Center ( Site 0102)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2609)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 1704)

location_facility: Instituto do Cancer do Ceara ( Site 0407)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2611)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2204)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1204)

location_facility: Kumamoto University Hospital ( Site 2602)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)

location_facility: Princess Margaret Hospital. ( Site 2502)

location_facility: Sunnybrook Research Institute ( Site 0202)

location_facility: The First Hospital of Jilin University ( Site 2416)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2015)

location_facility: University of Debrecen Medical Center Clinic of Oncology ( Site 3300)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)

location_facility: Blokhin National Medical Oncology ( Site 1604)

location_facility: Xiangya Hospital Central-South University ( Site 2419)

location_facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)

location_facility: City Clinical Hosp.4 of DCC ( Site 2201)

location_facility: Odense Universitets Hospital ( Site 3201)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)

location_facility: McGill University Health Centre ( Site 0208)

location_facility: Kobe City Medical Center General Hospital ( Site 2603)

location_facility: Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)

location_facility: Minnesota Oncology Hematology, PA ( Site 8000)

location_facility: Edith Wolfson Medical Center ( Site 1307)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2430)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0403)

location_facility: National Cancer Center Hospital East ( Site 2617)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1801)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)

location_facility: The Affiliated Hospital of Qingdao University ( Site 2405)

location_facility: Aichi Cancer Center Hospital ( Site 2619)

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)

location_facility: Fujian Provincial Cancer Hospital ( Site 2414)

location_facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2213)

location_facility: Princess Margaret Cancer Centre ( Site 0203)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 2436)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 3104)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0902)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 2440)

location_facility: Niigata Cancer Center Hospital ( Site 2613)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1101)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 1007)

location_facility: National Cancer Center Hospital ( Site 2606)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1804)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0605)

location_facility: Hospital de Caridade de Ijui ( Site 0402)

location_facility: Centro Oncologico Riojano Integral ( Site 0313)

location_facility: Universitaetsspital Zuerich ( Site 1902)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2612)

location_facility: Cancer Treatment Centers of America - Philadelphia ( Site 0112)

location_facility: Fakultni Thomayerova nemocnice ( Site 3101)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 1503)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1703)

location_facility: Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 1413)

location_facility: Orszagos Onkologiai Intezet ( Site 3303)

location_facility: Yancheng First People s Hospital ( Site 2426)

location_facility: Fundacion Favaloro - Hospital Universitario ( Site 0302)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1301)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)

location_facility: National Taiwan University Hospital ( Site 2900)

location_facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)

location_facility: Tallaght University Hospital ( Site 1202)

location_facility: Osaka International Cancer Institute ( Site 2607)

location_facility: Hospital General Universitario de Elche ( Site 1803)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)

location_facility: Southern Medical Day Care Centre ( Site 2303)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 2407)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)

location_facility: The Oncology Centre Overport and Umhlanga ( Site 1705)

location_facility: Istituto Europeo di Oncologia ( Site 1411)

location_facility: Instituto Nacional de Cancerologia. ( Site 0804)

location_facility: Hacettepe University Medical Faculty ( Site 2017)

location_facility: MI Odessa Regional Oncological Centre ( Site 2212)

location_facility: Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)

location_facility: UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)

location_facility: University College London Hospital ( Site 1211)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)

location_facility: Cancercare Rondebosch Oncology ( Site 1709)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)

location_facility: Harbin Medical University Cancer Hospital ( Site 2401)

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1907)

location_facility: Kitasato University Hospital ( Site 2618)

location_facility: Instituto de Investigaciones Metabolicas ( Site 0312)

location_facility: Christus Muguerza Clinica Vidriera ( Site 0802)

location_facility: Medical Centre LLC Oncolife ( Site 2202)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0604)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0501)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 1616)

location_facility: City Clinical Oncology Center ( Site 1603)

location_facility: Instituto Medico Alexander Fleming ( Site 0307)

location_facility: Zhongshan Hospital Xiamen University ( Site 2447)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0502)

location_facility: Zhejiang Provincial People's Hospital ( Site 2446)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2605)

location_facility: Hospital Universitario General de Asturias ( Site 1802)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Peking Union Medical College Hospital ( Site 2425)

location_facility: 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)

location_facility: Universitaetsklinikum Leipzig ( Site 1114)

location_facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0703)

location_facility: National Cheng Kung University Hospital ( Site 2901)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0400)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0500)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)

location_facility: Peking University Shenzhen Hospital ( Site 2442)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1700)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2610)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1614)

location_facility: Clinic of National Cancer Institute ( Site 2203)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)

location_facility: Fujian Medical University Union Hospital ( Site 2410)

location_facility: Severance Hospital Yonsei University Health System ( Site 2800)

location_facility: Masarykuv onkologicky ustav ( Site 3103)

location_facility: Kansai Medical University Hospital ( Site 2608)

location_facility: Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)

location_facility: Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)

type: Registry Identifier

title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)

summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.

The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).


title: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Chile
Spain
Germany
France
Czechia
Poland
Norway
Singapore
Argentina
Australia
Belgium
Puerto Rico
United States
United Kingdom
Canada

location_facility: Universitatsklinikum Carl Gustav Carus Dresden

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University Of California San Francisco-Fresno

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Nationales Centrum Fur Tumorerkrankungen (Nct)

location_facility: University of Washington,Seattle Cancer Care Alliance


title: XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease

summary: The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

ReferenceCitation: Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martínez N, Neven P, Lee KS, Morales S, Pérez-Fidalgo JA, Adamson D, Gonçalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortés J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.

full_name: Peter Schmid

given: Peter

family: Sablin

full_name: Marie-Paule Sablin

given: Marie-Paule

family: Bergh

full_name: Jonas Bergh

given: Jonas

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Lu

full_name: Yen-Shen Lu

given: Yen-Shen

family: Martínez

full_name: Noelia Martínez

given: Noelia

family: Neven

full_name: Patrick Neven

given: Patrick

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

family: Morales

full_name: Serafín Morales

given: Serafín

family: Pérez-Fidalgo

full_name: J. Alejandro Pérez-Fidalgo

given: J. Alejandro

family: Adamson

full_name: Douglas Adamson

given: Douglas

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Prat

full_name: Aleix Prat

given: Aleix

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Schlieker

full_name: Laura Schlieker

given: Laura

family: Espadero

full_name: Rosa-Maria Espadero

given: Rosa-Maria

family: Bogenrieder

full_name: Thomas Bogenrieder

given: Thomas

family: Huang

full_name: Dennis Chin-Lun Huang

given: Dennis Chin-Lun

family: Crown

full_name: John Crown

given: John

family: Cortés

full_name: Javier Cortés

given: Javier

currency_apc_doaj: GBP

journal_name: Breast Cancer Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

location_country:
Italy
United States
Spain
Germany
France
Greece
Belgium
Australia
Portugal
Canada
United Kingdom

location_facility: Kortrijk - HOSP AZ Groeninge Kennedylaan

location_facility: The Center for Cancer and Blood Disorders

location_facility: Euromedica Kyanous Stavros General Hospital

location_facility: Hospital Regional Universitario de Málaga

location_facility: University Hospital of Larisa, Oncology Clinic

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

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: University General Hospital of Heraklion

location_facility: Hematology Oncology Associates of Rockland


lead_sponsor: Janssen Research & Development, LLC

location_country:
Malaysia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Argentina
Korea, Republic of
South Africa
Sweden
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

location_facility: Hospital de Messejana dr. Carlos Alberto Studart Gomes

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Queen Sirikit National Institute of Child Health

location_facility: Red Cross War Memorial Children's Hospital - Dept. of Paediatrics and Child Health

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: SP Dzieciecy Szpital Kliniczny Oddzial kliniczny Obserwacyjno-Izolacyjny i Pediatrii

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Infectious Clinical Hospital #1 Of The Moscow City Health Department

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: University of Arizona Health Sciences Center

location_facility: Yaroslavl State Medical University Based On Children Polyclinics #5

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

location_facility: Instituto Nacional de Enfermedades Respiratorias

location_facility: Department of Pediatrics University of Pavia, Policlinico San Matteo

location_facility: Hospital General Dr. Manuel Gea González

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Nucleo de Pesquisa do Hospital Pequeno Princípe

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Tropical Medicine Hospital, Mahidol University

location_facility: Ankara Health of Child Hematology and Oncology Training Research Hospital

location_facility: University of Tennessee at Memphis Le Bonheur Children's Hospital

location_facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas

location_facility: City Children Clinical Outpatient Clinic #5

location_facility: Specjalistyczna Indywidualna Praktyka Lekarska

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: Dipartimento di Pediatria dell'Ospedale Luigi Sacco

location_facility: Santa Casa de Misericórdia de Votuporanga

location_facility: Rostov-On-Don Children City Outpatient Clinic #4

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Wojewodzki Szpital Specjalistyczny im.Bieganskiego Od.Chorob Zakaznych,Tropikalnych i Pasozytniczych

location_facility: Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej

location_facility: Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym

location_facility: Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

location_facility: Szpital Bielanski im. Ks.J.Popieluszki, Kliniczny Oddzial Pediatryczny

location_facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

location_facility: Kinderarztpraxis Dr. med. Karsten Jünger

location_facility: Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Shirao Clinic of Pediatrics and Pediatric Allergy

location_facility: Osrodek Badan Klinicznych In-Vivo Sp. z o.o.

location_facility: Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy

location_facility: Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház

location_facility: Asociacion de Investigacion Pediatrica y Adulto

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi

location_facility: Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: Children Outpatient Clinic 45 Of Nevskiy Region

location_facility: Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

location_facility: CMPC - Consultoria Médica e Pesquisa Clínica

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

location_facility: Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ

location_facility: SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Kinder- und Jugendärztliche Gemeinschaftspraxis Bedikian & Bouikidis

location_facility: Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais

title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection

summary: The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).


title: An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

acronym: ALITHIOS

summary:
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

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:
Peru
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
Croatia
France
Lithuania
Japan
Poland
Norway
Slovakia
Argentina
Thailand
Canada
Turkey
South Africa
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Austria
Mexico
Czechia
Israel
Spain
Estonia
Latvia

intervention_type: Biological


title: An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

summary: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

ipd_sharing_description: EMD Serono: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
United States
Brazil
Hong Kong
Netherlands
Spain
Germany
France
Japan
Greece
Belgium
Argentina
China
Turkey
Canada
Korea, Republic of
Taiwan
Ukraine

location_facility: IRCCS Centro di Riferimento Oncologico - Oncologia Medica A

location_facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico

location_facility: Stronach Regional Cancer Centre - at Southlake

location_facility: The University of Chicago Medical Center

location_facility: Universitair Medisch Centrum Groningen (UMCG) - Parent

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

location_facility: Hospital Regional Universitario de Malaga

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: Universitaetsklinikum Schleswig- Holstein Campus Luebeck

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: The Chinese University of Hong Kong - Emergency Medicine

location_facility: Saitama Medical University International Medical Center - Dept of Respiratory Medicine

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: Maastricht University Medical Center - Dept of Medical Oncology

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia

location_facility: Communal Non-profit Enterprise Regional Center of Oncology - Parent

location_facility: University General Hospital of Heraklion "PAGNI"

location_facility: Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia

location_facility: Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada

location_facility: Oncology Specialties, PC; Clearview Cancer Institute

location_facility: General Hospital Papageorgiou-2nd Department of Dermatalogy

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Trakya University Medical Faculty - Medical Oncology

location_facility: National Cancer Center Hospital - Dept of Respiratory Medicine

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II

location_facility: Vivantes Klinikum Am Urban - Haematologie und Onkologie

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT

location_facility: Seoul National University Bundang Hospital

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

location_facility: Medizinische Hochschule Hannover - Pneumologie

location_facility: NHO Hokkaido Cancer Center - Dept of Respiratory Medicine

location_facility: CHU Rennes - Hopital Pontchaillou - service de pneumologie

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy

location_facility: Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

location_facility: Cancer Specialists, LLC - Department of Clinical Research

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic

location_facility: Adana Numune Training and Research Hospital - Cardiology Department

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Decatur Memorial Hospital - Clinical Research

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I

location_facility: Kocaeli University Research and Application Hospital

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

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica


status: Completed

location_country:
Netherlands
Germany
France
Denmark
United States
Canada

acronym: NOVA

location_facility: Dr Wei Jing Loo Medicine Professional Corporation

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: York Dermatology Clinic and Research Centre

study_completion_date_type: Actual

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

status_simplified: Completed


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

acronym: RHINE

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Australia
Russian Federation
Denmark
Taiwan
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Switzerland
Singapore
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Spain
Turkey

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Hospital General de Catalunya; Servicio de oftalmologia

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: University of Colorado; dept of ophthalmology

location_facility: Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

location_facility: Vitreous Retina Macula Specialists of Toronto

location_facility: Fisabio-Ofalmologia Medica; Servicio de Oftalmología

location_facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Hospital Universitario de Bellvitge; Servicio de oftalmologia

location_facility: Northern California Retina Vitreous Associates

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: Universitätsklinikum Würzburg, Augenklinik und Poliklinik

location_facility: Hôpital PURPAN - CHU TOULOUSE; Ophtalmologie

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Southwest Hospital , Third Military Medical University; Ophthalmology

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Rajavithi Hospital; Ophthalmology Department

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

location_facility: Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

location_facility: King Chulalongkorn Memorial Hospital; Ophthalmology Department

location_facility: Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: FN Hradec Králové, Oční klinika; Ophthalmology clinic

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Third Affiliated Hospital of Third Military Medical University; Ophthalmology

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Hospital Clinico San Carlos; Servicio de oftalmologia

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: National University Hospital; Ophthalmology Department

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Seoul National University Bundang Hospital

location_facility: Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: University Health Network Toronto Western Hospital

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

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

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: University of Rochester Flaum Eye Institute

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: University Retina and Macula Associates, PC

location_facility: James Paget University Hospitals NHS Foundation Trust

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Semmelweis Egyetem Szemészeti Vizsgálóhely

intervention_type: Procedure


lead_sponsor: Sanofi

location_country:
United States
South Africa
Netherlands
Germany
France
Japan
Israel
Belgium
Argentina
Canada

location_facility:
Investigational Site Number :276006
Investigational Site Number :276011
Investigational Site Number :392021
Investigational Site Number :392132
Investigational Site Number :392012
Investigational Site Number :840062
Investigational Site Number :124017
Investigational Site Number :250008
Investigational Site Number :392164
Investigational Site Number :392163
Investigational Site Number :392146
Investigational Site Number :840099
Investigational Site Number :392167
Investigational Site Number :840087
Investigational Site Number :032010
Investigational Site Number :124002
Investigational Site Number :840907
Investigational Site Number :032005
Investigational Site Number :392122
Investigational Site Number :840070
Investigational Site Number :392165
Investigational Site Number :392007
Investigational Site Number :840922
Investigational Site Number :276009
Investigational Site Number :392133
Investigational Site Number :392112
Investigational Site Number :840057
Investigational Site Number :840132
Investigational Site Number :840079
Investigational Site Number :840004
Investigational Site Number :276010
Investigational Site Number :392008
Investigational Site Number :124001
Investigational Site Number :392043
Investigational Site Number :392127
Investigational Site Number :392045
Investigational Site Number :392002
Investigational Site Number :124007
Investigational Site Number :840102
Investigational Site Number :392034
Investigational Site Number :124012
Investigational Site Number :840008
Investigational Site Number :710011
Investigational Site Number :840402
Investigational Site Number :392036
Investigational Site Number :032097
Investigational Site Number :032091
Investigational Site Number :124014
Investigational Site Number :392108
Investigational Site Number :840068
Investigational Site Number :840077
Investigational Site Number :392152
Investigational Site Number :840067
Investigational Site Number :124016
Investigational Site Number :710001
Investigational Site Number :392044
Investigational Site Number :392106
Investigational Site Number :392177
Investigational Site Number :392029
Investigational Site Number :392005
Investigational Site Number :840124
Investigational Site Number :032003
Investigational Site Number :250002
Investigational Site Number :376002
Investigational Site Number :392158
Investigational Site Number :392169
Investigational Site Number :056003
Investigational Site Number :840023
Investigational Site Number :392006
Investigational Site Number :032004
Investigational Site Number :710006
Investigational Site Number :840091
Investigational Site Number :710007
Investigational Site Number :250009
Investigational Site Number :840055
Investigational Site Number :032002
Investigational Site Number :710009
Investigational Site Number :392119
Investigational Site Number :840951
Investigational Site Number :032006
Investigational Site Number :250001
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title: Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial

summary:
Primary Objective:

To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).


title: A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia

summary: This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

lead_sponsor: GlycoMimetics Incorporated

location_country:
Italy
United States
Netherlands
France
Ireland
Australia
Spain
Canada
United Kingdom

location_facility: The Ohio State University Wexner Medical Center and James Cancer Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital Universitario Fundación Jiménez Diaz

location_facility: Columbia University Herbert Irving Comprehensive Cancer Center

location_facility: IRCCS Casa Sollievo della Sofferenza Hospital

location_facility: University of Alberta Princess Margaret Hospital

location_facility: University Health Network (UHN) - Princess Margaret Cancer Centre

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Washington University School of Medicine

location_facility: Università Cattolica del Sacro Cuore (UNICATT)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: University Hospital Cleveland Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University Hospital of Hospital Marqués de Valdecilla

location_facility: The Leukemia/BMT Program of BC Vancouver General Hospital

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Vanderbilt-Ingram Cancer Center Clinical Trials Office

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Radcliffe Hospitals and University of Oxford

location_facility: Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)

location_facility: Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"

location_facility: Charles A. Sammons Cancer Center at Dallas

location_facility: University of California, Los Angeles - UCLA

location_facility: Fondazione Policlinico Tor Vergata, U.O.C. Ematologia


title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

lead_sponsor: Incyte Corporation

location_country:
Italy
United States
Switzerland
Germany
France
Czechia
Poland
Hungary
Australia
Spain
Canada
United Kingdom

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: McGill University Health Centre/Glen Site/Cedars Cancer Centre

location_facility: London Health Sciences Centre Lhsc - South Street Hospital

location_facility: Royal Cornwall Hospital Truro Sunrise Centre

location_facility: ONCOLOGIA ï¿½ IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA

location_facility: Szte Borgyogyszati Es Allergologiai Klinika

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: Centre Hospitalier Universitaire Vaudois (Chuv)

location_facility: HOPITAL CHARLES NICOLLE CHU ROUEN - Hï¿½PITAL DE BOIS-GUILLAUME

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: University of California San Francisco Comprehensive Cancer Center

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr

location_facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika


title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

acronym: STEP 1

summary: This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

ReferenceType: background

ReferenceCitation: Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.

ReferenceType: result

ReferenceCitation: Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

name: From the Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool (J.P.H.W.), University College London Centre for Obesity Research, Division of Medicine, University College London (R.L.B.), the National Institute of Health Research, UCLH Biomedical Research Centre (R.L.B.), the Centre for Weight Management and Metabolic Surgery, University College London Hospital (R.L.B.), and the Department of Diabetes and Endocrinology,...

family: Wilding

full_name: John P.H. Wilding

given: John P.H.

family: Batterham

full_name: Rachel L. Batterham

given: Rachel L.

family: Calanna

full_name: Salvatore Calanna

given: Salvatore

family: Davies

full_name: Melanie Davies

given: Melanie

family: Van Gaal

full_name: Luc F. Van Gaal

given: Luc F.

family: Lingvay

full_name: Ildiko Lingvay

given: Ildiko

family: McGowan

full_name: Barbara M. McGowan

given: Barbara M.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Tran

full_name: Marie T.D. Tran

given: Marie T.D.

family: Wadden

full_name: Thomas A. Wadden

given: Thomas A.

family: Wharton

full_name: Sean Wharton

given: Sean

family: Yokote

full_name: Koutaro Yokote

given: Koutaro

family: Zeuthen

full_name: Niels Zeuthen

given: Niels

family: Kushner

full_name: Robert F. Kushner

given: Robert F.

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

family: O'Neil

full_name: Patrick M O'Neil

given: Patrick M

family: Birkenfeld

full_name: Andreas L Birkenfeld

given: Andreas L

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
United States
India
Mexico
Germany
Finland
France
Bulgaria
Japan
Poland
Belgium
Argentina
Puerto Rico
Russian Federation
Denmark
Canada
United Kingdom
Taiwan