acronym: EUCLID

summary: The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

ReferenceCitation: Szarek M, Hess C, Patel MR, Jones WS, Berger JS, Baumgartner I, Katona B, Mahaffey KW, Norgren L, Blomster J, Rockhold FW, Hsia J, Fowkes FGR, Bonaca MP. Total Cardiovascular and Limb Events and the Impact of Polyvascular Disease in Chronic Symptomatic Peripheral Artery Disease. J Am Heart Assoc. 2022 Jun 7;11(11):e025504. doi: 10.1161/JAHA.122.025504. Epub 2022 May 27.

repository_institution: University of Bern - Bern Open Repository and Information System

repositories_concat: PubMed Central;boris.unibe.ch

ReferenceCitation: Govsyeyev N, Nehler MR, Low Wang CC, Kavanagh S, Hiatt WR, Long C, Jones WS, Fowkes FGR, Berger JS, Baumgartner I, Patel MR, Goodney PP, Beckman JA, Katona BG, Mahaffey KW, Blomster J, Norgren L, Bonaca MP. Etiology and outcomes of amputation in patients with peripheral artery disease in the EUCLID trial. J Vasc Surg. 2022 Feb;75(2):660-670.e3. doi: 10.1016/j.jvs.2021.08.096. Epub 2021 Sep 28.

ReferenceCitation: Norgren L, North R, Baumgartner I, Berger JS, Blomster JI, Hiatt WR, Jones WS, Katona BG, Mahaffey KW, Mulder H, Patel MR, Rockhold FW, Fowkes FGR. World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial. Vasc Med. 2022 Feb;27(1):21-29. doi: 10.1177/1358863X211038620. Epub 2021 Sep 13.

repository_institution: University of Turku - UTUPub

ReferenceCitation: Hiatt WR, Hess CN, Bonaca MP, Kavanagh S, Patel MR, Baumgartner I, Berger JS, Blomster JI, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Fowkes FGR. Ankle-Brachial Index for Risk Stratification in Patients With Symptomatic Peripheral Artery Disease With and Without Prior Lower Extremity Revascularization: Observations From the EUCLID Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e009871. doi: 10.1161/CIRCINTERVENTIONS.120.009871. Epub 2021 Jul 13.

ReferenceCitation: Hsia J, Kavanagh ST, Hopley CW, Baumgartner I, Berger JS, Fowkes GR, Jones WS, Mahaffey KW, Norgren L, Patel MR, Rockhold F, Blomster J, Katona BG, Hiatt WR, Bonaca MP. Impact of chronic kidney disease on hemoglobin among patients with peripheral artery disease treated with P2Y12 inhibitors: Insights from the EUCLID trial. Vasc Med. 2021 Dec;26(6):608-612. doi: 10.1177/1358863X211017641. Epub 2021 Jun 3.

ReferenceCitation: Galani J, Mulder H, Rockhold FW, Weissler EH, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Hiatt WR, Katona BG, Norgren L, Mahaffey KW, Quint JK, Patel MR, Jones WS. Association of Chronic Obstructive Pulmonary Disease with Morbidity and Mortality in Patients with Peripheral Artery Disease: Insights from the EUCLID Trial. Int J Chron Obstruct Pulmon Dis. 2021 Mar 29;16:841-851. doi: 10.2147/COPD.S292978. eCollection 2021.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

ReferenceCitation: Kochar A, Mulder H, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Lopes RD, Al-Khalidi HR, Mahaffey KW, Norgren L, Hiatt WR, Patel MR, Jones WS. Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006550. doi: 10.1161/CIRCOUTCOMES.120.006550. Epub 2020 Nov 12.

ReferenceCitation: Gutierrez JA, Heizer GM, Jones WS, Rockhold FW, Mahaffey KW, Fowkes FGR, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster JI, Hiatt WR, Patel MR. CYP2C19 status and risk of major adverse cardiovascular events in peripheral artery disease: Insights from the EUCLID Trial. Am Heart J. 2020 Nov;229:118-120. doi: 10.1016/j.ahj.2020.07.017. Epub 2020 Aug 16. No abstract available.

ReferenceCitation: Fudim M, Hopley CW, Huang Z, Kavanagh S, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Ostrom C, Patel MR, Jones WS, Hiatt WR. Association of Hypertension and Arterial Blood Pressure on Limb and Cardiovascular Outcomes in Symptomatic Peripheral Artery Disease: The EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006512. doi: 10.1161/CIRCOUTCOMES.120.006512. Epub 2020 Aug 31.

ReferenceCitation: Long CA, Mulder H, Fowkes FGR, Baumgartner I, Berger JS, Katona BG, Mahaffey KW, Norgren L, Blomster JI, Rockhold FW, Hiatt WR, Patel MR, Jones WS, Nehler MR. Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Jul;13(7):e006399. doi: 10.1161/CIRCOUTCOMES.119.006399. Epub 2020 Jul 3.

ReferenceCitation: Haine A, Kavanagh S, Berger JS, Hess CN, Norgren L, Fowkes FGR, Katona BG, Mahaffey KW, Blomster JI, Patel MR, Jones WS, Rockhold FW, Hiatt WR, Baumgartner I; International Steering Committee and Investigators of the EUCLID Trial. Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2020 Feb 18;75(6):608-617. doi: 10.1016/j.jacc.2019.11.057.

ReferenceCitation: Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Vemulapalli S, Povsic TJ, Mehta R, Hiatt WR, Patel MR, Jones WS. Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J. 2020 Feb;220:51-58. doi: 10.1016/j.ahj.2019.11.007. Epub 2019 Nov 18.

ReferenceCitation: Hopley CW, Kavanagh S, Patel MR, Ostrom C, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial. Vasc Med. 2019 Oct;24(5):422-430. doi: 10.1177/1358863X19864172. Epub 2019 Jul 24.

ReferenceCitation: Hess CN, Huang Z, Patel MR, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Held P, Jones WS, Katona B, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Acute Limb Ischemia in Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):556-565. doi: 10.1161/CIRCULATIONAHA.119.039773. Epub 2019 Jun 26.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Kolls BJ, Sapp S, Rockhold FW, Jordan JD, Dombrowski KE, Fowkes FGR, Mahaffey KW, Berger JS, Katona BG, Blomster JI, Norgren L, Abramson BL, Leiva-Pons JL, Prieto JC, Sokurenko G, Hiatt WR, Jones WS, Patel MR. Stroke in Patients With Peripheral Artery Disease. Stroke. 2019 Jun;50(6):1356-1363. doi: 10.1161/STROKEAHA.118.023534. Epub 2019 May 16.

ReferenceCitation: Low Wang CC, Blomster JI, Heizer G, Berger JS, Baumgartner I, Fowkes FGR, Held P, Katona BG, Norgren L, Jones WS, Lopes RD, Olin JW, Rockhold FW, Mahaffey KW, Patel MR, Hiatt WR; EUCLID Trial Executive Committee and Investigators. Cardiovascular and Limb Outcomes in Patients With Diabetes and Peripheral Artery Disease: The EUCLID Trial. J Am Coll Cardiol. 2018 Dec 25;72(25):3274-3284. doi: 10.1016/j.jacc.2018.09.078. Erratum In: J Am Coll Cardiol. 2019 Jul 16;74(2):264-269.

ReferenceCitation: Olivier CB, Mulder H, Hiatt WR, Jones WS, Fowkes FGR, Rockhold FW, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster J, Patel MR, Mahaffey KW. Incidence, Characteristics, and Outcomes of Myocardial Infarction in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. JAMA Cardiol. 2019 Jan 1;4(1):7-15. doi: 10.1001/jamacardio.2018.4171.

ReferenceCitation: Baumgartner I, Norgren L, Fowkes FGR, Mulder H, Patel MR, Berger JS, Jones WS, Rockhold FW, Katona BG, Mahaffey K, Hiatt WR; Executive Committee and Investigators of the EUCLID Trial. Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1563-1572. doi: 10.1016/j.jacc.2018.07.046.

ReferenceCitation: Berger JS, Abramson BL, Lopes RD, Heizer G, Rockhold FW, Baumgartner I, Fowkes FGR, Held P, Katona BG, Norgren L, Jones WS, Millegard M, Blomster J, Reist C, Hiatt WR, Patel MR, Mahaffey KW. Ticagrelor versus clopidogrel in patients with symptomatic peripheral artery disease and prior coronary artery disease: Insights from the EUCLID trial. Vasc Med. 2018 Dec;23(6):523-530. doi: 10.1177/1358863X18775594. Epub 2018 Jul 11.

ReferenceCitation: Norgren L, Patel MR, Hiatt WR, Wojdyla DM, Fowkes FGR, Baumgartner I, Mahaffey KW, Berger JS, Jones WS, Katona BG, Held P, Blomster JI, Rockhold FW, Bjorck M; EUCLID Steering Committee and Investigators. Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial. Eur J Vasc Endovasc Surg. 2018 Jan;55(1):109-117. doi: 10.1016/j.ejvs.2017.11.006. Epub 2017 Dec 20.

ReferenceCitation: Hiatt WR, Fowkes FG, Heizer G, Berger JS, Baumgartner I, Held P, Katona BG, Mahaffey KW, Norgren L, Jones WS, Blomster J, Millegard M, Reist C, Patel MR; EUCLID Trial Steering Committee and Investigators. Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease. N Engl J Med. 2017 Jan 5;376(1):32-40. doi: 10.1056/NEJMoa1611688. Epub 2016 Nov 13.

repository_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Jones WS, Baumgartner I, Hiatt WR, Heizer G, Conte MS, White CJ, Berger JS, Held P, Katona BG, Mahaffey KW, Norgren L, Blomster J, Millegard M, Reist C, Patel MR, Fowkes FG; International Steering Committee and Investigators of the EUCLID Trial. Ticagrelor Compared With Clopidogrel in Patients With Prior Lower Extremity Revascularization for Peripheral Artery Disease. Circulation. 2017 Jan 17;135(3):241-250. doi: 10.1161/CIRCULATIONAHA.116.025880. Epub 2016 Nov 13.

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.

title: A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Slovakia
Hungary
United States
Ukraine
Romania
China
Philippines
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Bulgaria
Russian Federation
Sweden


title: A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) PET Scan Status and Cognitive Decline

summary: This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Avid Radiopharmaceuticals

sponsor_collaborators:
Avid Radiopharmaceuticals
Eli Lilly and Company

location_country:
United States
Italy
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

study_start_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Wuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7.

oa_host_type: repository

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

host_type: repository

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;epub.ub.uni-muenchen.de

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Engebraaten O, Yau C, Berg K, Borgen E, Garred O, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

repository_institution: University of Oslo - Duo Research Archive

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

repository_institution: California Digital Library - eScholarship

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

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

version: submittedVersion

repositories_institution: California Digital Library - eScholarship

repositories_institution: University of Oslo - Duo Research Archive

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Montemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Pena-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

repository_institution: University of Zaragoza Repository - Zaguan

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories_institution: University of Zaragoza Repository - Zaguan

unpaywall_oa_status: hybrid

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Luxembourg
Turkey
Croatia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Dominican Republic
Iceland
Indonesia
Belgium
China
Peru
Estonia
Italy
Guatemala
Ecuador
Norway
United Kingdom
Venezuela
Netherlands
Austria
Mexico
United Arab Emirates
Korea, Republic of
Spain
Greece
Panama
Taiwan
Bulgaria
Sweden

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Institut Gustave Roussy; Pathologie Mammaire

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie

location_facility: Gaziantep University Medical Faculty, Medical Oncology Department

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Gachon Medical School Gil Medical Center; Medical Oncology

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Kaposi Mor County Hospital; Dept. of Oncology

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol

location_facility: Centre Val Aurelle Paul Lamarque; Recherche Clinique

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: District Oncology Dispensary Wit Stationary

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

location_facility: Hospital Quiron Barcelona; Servicio de Oncologia

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Western General Hospital; Clinical Oncology

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: Dr. H. Bliss Murphy Cancer Centre; Oncology

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: MHAT Serdika; Department of medical oncology

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Hospital Privado De Comunidad; General Practice

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T

location_facility: Kyungpook National University Medical Center

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología

location_facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Orbis Medisch Centrum; Inwendige Geneeskunde

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hospital Xeral Cíes; Servicio de Oncologia

location_facility: Cipto Mangunkusumo General Hospital; Hematology & Oncology

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: University Hospital of Patras Medical Oncology

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Hopital Morvan; Oncologie - Radiotherapie

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

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

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: RCCS - Centro di Riferimento; Oncologia Medica B

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

location_facility: Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: University Hospital Birmingham Queen Elizabeth Hospital

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Landspitali University Hospital, Department of Medical Oncology

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Instituto de Oncologia y Hematologia UCV

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Haematology & Oncology Clinics of Australia Research Centre

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

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

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

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Ospedale Maggiore Della Carita; Oncologia Medica

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: Inst. Nacional de Cancerologia; Investigacion Clinica

location_facility: Westmead Hospital; Medical Oncology and Pallative Care

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Plymouth Oncology Centre; Clinical Trials Unit

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Yeovil District Hospital; Macmillan Cancer Unit

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: University Hospital coventry; Oncology Department

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

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

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Universitaetsfrauenklinik; Und Poliklinik Am Klinikum

location_facility: Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: Unidad de Mastologia y Atencion a la Mujer

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: University General Hospital of Heraklion

location_facility: Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: St George'S Hospital; Oncology Research Office /Oncology Opd

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Oslo Universitetssykehus HF; Ullevål sykehus

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie

location_facility: Centre Henry S Kaplan - CHU Bretonneau ; service oncologie

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze

location_facility: Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe


title: European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units

acronym: EUROPAINsurvey

summary:
EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study.

The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries.

The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes.

The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception.

The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Lago P, Frigo AC, Baraldi E, Pozzato R, Courtois E, Rambaud J, Anand KJ, Carbajal R. Sedation and analgesia practices at Italian neonatal intensive care units: results from the EUROPAIN study. Ital J Pediatr. 2017 Mar 7;43(1):26. doi: 10.1186/s13052-017-0343-2.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

ReferenceCitation: Carbajal R, Eriksson M, Courtois E, Boyle E, Avila-Alvarez A, Andersen RD, Sarafidis K, Polkki T, Matos C, Lago P, Papadouri T, Montalto SA, Ilmoja ML, Simons S, Tameliene R, van Overmeire B, Berger A, Dobrzanska A, Schroth M, Bergqvist L, Lagercrantz H, Anand KJ; EUROPAIN Survey Working Group. Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study. Lancet Respir Med. 2015 Oct;3(10):796-812. doi: 10.1016/S2213-2600(15)00331-8. Epub 2015 Sep 24. Erratum In: Lancet Respir Med. 2015 Dec;3(12):e44.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

lead_sponsor: Hôpital Armand Trousseau

location_country:
Finland
Germany
Cyprus
Italy
Lithuania
Poland
Portugal
Norway
United Kingdom
Sweden
Malta
Austria
Belgium
Netherlands
Spain
Greece
Estonia
France

location_facility: Universitäts-klinik für Kinder- und Jugendheilkunde Innsbruck

location_facility: 1st Dept of Neonatalogy, Aristole University of Thessaloniki

location_facility: TIN/Neonatologia- fondazione MBBM- H San Gerardo

location_facility: Complexo Hospitalario Universitario de A Coruña

location_facility: Paediatric Intensive Care Unit, Clinic of Anaesthesiology and Intensive Care, Tartu University Clinics

location_facility: TIN E Patologia Neonatale Dip. di Salute della donna e del bambino- Università di Padova

location_facility: Universitäts-klinik für Kinder und Jugendheilkunde Salzburg

location_facility: "Mitera" General Maternity and Pediatric Clinic

location_facility: IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: UO Neonatologia e TIN Ospedale Santa Chiara

location_facility: Department of obstetric and gynecology, medical University of Warsaw

location_facility: Children's Memorial Health Institute Warsaw

location_facility: Klinik fUr Kinder und Jugendliche Sozialstiftung Bamberg

location_facility: University Hospital Utrecht - Wilhelmina Children's Hospital

location_facility: Northampton General Hospital Neonatal Unit

location_facility: Karolinska University Hospital (Stockholm)

location_facility: Department of Anesthesiology and Intensive Care, Tallinn Children's Hospital

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Department of Paediatric and Adolescent Medicine University Hospital Erlangen

location_facility: Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust PICU

location_facility: Great Western Hospitals NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Oslo University Hospital - Rikshospitalet

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Jessop Wing, Sheffield Teaching Hospitals NHS Trust

location_facility: University Hospital Of North Staffordshire NHS Trust

location_facility: Great Ormond Street Hospital for Sick Children PICU

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Southport & Ormskirk & District General Hospital Neonatal Unit

location_facility: Azienda Ospedaliera Universitaria di Sassari

location_facility: Hospital Universitario Central de Asturias

location_facility: Departement of Neonato- logy Medical University in Wrocław

location_facility: UO TIN Neonatologia AOU Sant'Orsola Malpighi

location_facility: U.O. di Neonatologia e PatNeo con T.I. - Istituti Ospitalieri

location_facility: Patologia Neonatale Ospedale S.M.Misericordia

location_facility: 2nd Dept of Neonatalogy, Aristole University of Thessaloniki

location_facility: Neonatal Intensiv Care Unit, Arch. Makarios Hospital

location_facility: Isala Clinics Zwolle - Amalia Children's Hospital

location_facility: U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma

location_facility: Terapia Intensiva Neonatale e Pediatrica

location_facility: Department of Neonatology Lithuanian University of Health Sciences,

location_facility: James Cook University Hospital, Middlesborough

location_facility: Blackpool Teaching Hospital Foundation Trust

location_facility: Academic medical Center Amsterdam - Emma Children's Hospital

location_facility: University Hospital of South Manchester, Wythenshawe

location_facility: Universitäts klinik für Kinder-und Jugenheilkunde Wien

location_facility: Hospital Universitario Principe de Asturias

location_facility: TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI

lead_sponsor_type: academique


type: Other Identifier

title: COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

acronym: COMBI-AD

summary: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

ReferenceCitation: Dummer R, Hauschild A, Santinami M, Atkinson V, Mandala M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. doi: 10.1056/NEJMoa2005493. Epub 2020 Sep 2.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Dummer R, Brase JC, Garrett J, Campbell CD, Gasal E, Squires M, Gusenleitner D, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Flaherty K, Larkin J, Robert C, Kefford R, Kirkwood JM, Hauschild A, Schadendorf D, Long GV. Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAFV600-mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial. Lancet Oncol. 2020 Mar;21(3):358-372. doi: 10.1016/S1470-2045(20)30062-0. Epub 2020 Jan 30.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

ReferenceCitation: Schadendorf D, Hauschild A, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Lesimple T, Plummer R, Schachter J, Dasgupta K, Manson S, Koruth R, Mookerjee B, Kefford R, Dummer R, Kirkwood JM, Long GV. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 May;20(5):701-710. doi: 10.1016/S1470-2045(18)30940-9. Epub 2019 Mar 27.

oa_host_type: closed

ReferenceCitation: Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. doi: 10.1200/JCO.18.01219. Epub 2018 Oct 22.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Long GV, Hauschild A, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. doi: 10.1056/NEJMoa1708539. Epub 2017 Sep 10.

repository_institution: Newcastle Univesity - Newcastle University ePrints

ipd_sharing: Yes

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:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above

summary: The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).

primary_purpose: Prevention

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

lead_sponsor: GlaxoSmithKline

location_country:
Finland
United Kingdom
Belgium
Spain
France

intervention_type: Biological


title: A Multi-center, Randomized, Double-blind, Parallel-group, 20-week Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of XXB750 in Patients With Resistant Hypertension

summary: The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
Australia
Japan
Netherlands
Austria
United States
China
Spain
Taiwan
Czechia
Bulgaria
France

intervention_type: Other

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

summary: The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Canada
Serbia
France
Portugal
Denmark
Switzerland
United States
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

intervention_type: Combination Product


type: Registry Identifier

title: A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease

summary: The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.

status: Enrolling by invitation

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
United States
Spain
Canada
France

status_simplified: Unknown


title: A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With CAP Including COVID-19 Pneumonia.

acronym: TRICOVID

summary:
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia.

Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

ipd_sharing: No

lead_sponsor: Biotest

location_country:
Germany
Lithuania
Slovakia
Hungary
Argentina
Brazil
Austria
Belgium
Latvia
Spain
South Africa
Turkey
France

location_facility:
Investigational Site #4303
Investigational Site #5402
Investigational Site #4907
Investigational Site #3203
Investigational Site #2102
Investigational Site #2707
Investigational Site #3303
Investigational Site #3308
Investigational Site #5503
Investigational Site #2105
Investigational Site #3304
Investigational Site #9001
Investigational Site #3601
Investigational Site #5401
Investogational Site #4902
Investigational Site #5504
Investigational Site #5501
Investigational Site #7102
Investigational Site #3302
Investigational Site #5502
Investigational Site #3403
Investigational Site #5403
Investigational Site #4302
Investigational Site #9004
Investigational Site #2705
Investigational Site #7004
Investigational Site #3202
Investigational Site #5505
Investigational Site #7101
Investigational SIte #3603
Investigational Site #7003
Investigational Site #9005
Investigational Site #4904
Investigational Site #2702
Investigational Site #3306
Investigational Site #5507
Investigational Site #2701
Investigational Site #4304
Investigational Site #3201
Investigational Site #7001
Investigational Site #2101
Investigational Site #3307
Investigational Site #3301
Investigational Site #4901
Investigational Site #2103
Investigational Site #2704
Investigational Site #3404
Investigational Site #5506
Investigational Site #3401
Investigational Site #7002
Investigational Site #3305
Investigational Site #4903
Investigational Site #2104
Investigational Site #2703
Investigational site #2706


acronym: CAPYBARA

lead_sponsor: Galapagos NV

summary: Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

location_facility: Azienda Ospedaliero-Universitaria Pisana U.O. Gastroentrologia Stabilimento di Cisanello

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Universitair Ziekenhuis Leuven Campus Gasthuisberg

location_facility: Centre Hospitalier Lyon Sud Service d'Hépato-Gastroentérologie

location_facility: Yonsei University Health System Severance Hospital Gastroenterology

location_facility: H-T. Centrum Medyczne Spółka z Ograniczoną Odpowiedzialnością

location_facility: Santa Familia - Centrum Badań Profilaktyki i Leczenia

location_facility: DRK KliniKlinik für Innere Medizin Schwerpunkt Gastroenterologieken Berlin Westend

location_facility: Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

location_facility: IRCCS de Bellis Unità Operativa Complessa Gastroenterologia II

location_facility: Centre Hospitalier Universitaire de Nantes Hôtel Dieu Service d'hépato-gastroentérologie

location_facility: Hôpital Haut-Lévêque Service d'Hépato-Gastro-Entérologie et Nutrition

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Service d'Hépato-gastroentérologie

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

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas

location_facility: Azienda Ospedaliero-Universitaria Mater Domini Unita Operativa Fisopatologia Digestiva

location_facility: Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

location_facility: Saint Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: National Taiwan University Hospital Center for Infection Control

location_facility: Gastroenterology Associates of Tidewater

location_facility: Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie

status: Terminated

title: A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission

source: euctr

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Belgium
United States
Korea, Republic of
Spain
South Africa
Taiwan
Czechia
France


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

acronym: DAZALS

summary: The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

lead_sponsor: Corcept Therapeutics

location_country:
Germany
Ireland
Poland
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
France


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease Dementia

acronym: CELIA

summary:
In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD.

The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most.

To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB.

Clinicians use the CDR-SB to measure several categories of dementia symptoms.
The results for each category are added together for a total score. Lower scores are better.

Researchers will also learn more about the safety of BIIB080.

The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term.

A description of how the study will be done is given below.

After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine.
Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks.
After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks.
In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks.
Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods.
Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period.
After the screening period, most participants will visit the clinic every 6 weeks.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Japan
Netherlands
Sweden
Belgium
Switzerland
United States
Spain
Czechia
Canada
France

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Karolinska universitetssjukhuset - Huddinge

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: University of Texas Health Science Center at San Antonio

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of California San Francisco (PARENT)

location_facility: Rocky Mountain Movement Disorders Center, PC

location_facility: New York University Medical Center PRIME

location_facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

location_facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA

location_facility: Hôpitaux Universitaires de Genève - HUG- Centre de la mémoire, Bâtiment A1 - Morier

location_facility: Tokyo Metropolitan Institute for Geriatrics and Gerontology


title: A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)

acronym: Catalyst

summary: This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Gibney GT, Weiner LM, Atkins MB. Predictive biomarkers for checkpoint inhibitor-based immunotherapy. Lancet Oncol. 2016 Dec;17(12):e542-e551. doi: 10.1016/S1470-2045(16)30406-5.

ReferenceCitation: Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

publisher_dissemination: Springer

ReferenceCitation: Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.

ReferenceCitation: Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.

ReferenceCitation: Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-2199. doi: 10.1056/NEJMoa1406498. Epub 2014 Nov 19. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Vesely MD, Schreiber RD. Cancer immunoediting: antigens, mechanisms, and implications to cancer immunotherapy. Ann N Y Acad Sci. 2013 May;1284(1):1-5. doi: 10.1111/nyas.12105.

ReferenceCitation: Zappasodi R, Merghoub T, Wolchok JD. Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies. Cancer Cell. 2018 Apr 9;33(4):581-598. doi: 10.1016/j.ccell.2018.03.005. Erratum In: Cancer Cell. 2018 Oct 8;34(4):690.

ReferenceCitation: Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2. Erratum In: Lancet Oncol. 2019 May;20(5):e242.

ReferenceCitation: Goldmacher GV, Khilnani AD, Andtbacka RHI, Luke JJ, Hodi FS, Marabelle A, Harrington K, Perrone A, Tse A, Madoff DC, Schwartz LH. Response Criteria for Intratumoral Immunotherapy in Solid Tumors: itRECIST. J Clin Oncol. 2020 Aug 10;38(23):2667-2676. doi: 10.1200/JCO.19.02985. Epub 2020 Jun 18. No abstract available.

ipd_sharing: Undecided

lead_sponsor: Cytovation AS

sponsor_collaborators:
Cytovation AS
Merck Sharp & Dohme LLC

location_country:
Italy
Netherlands
United States
Spain
France

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

location_facility: Azienda Ospedaliero Universitaria Senese


title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

summary: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

ReferenceCitation: Klijn SL, Fenwick E, Kroep S, Johannesen K, Malcolm B, Kurt M, Kiff C, Borrill J. What Did Time Tell Us? A Comparison and Retrospective Validation of Different Survival Extrapolation Methods for Immuno-Oncologic Therapy in Advanced or Metastatic Renal Cell Carcinoma. Pharmacoeconomics. 2021 Mar;39(3):345-356. doi: 10.1007/s40273-020-00989-1. Epub 2021 Jan 11.

ReferenceCitation: Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ. A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC). Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S. Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025. Eur Urol. 2017 Sep;72(3):368-376. doi: 10.1016/j.eururo.2017.03.037. Epub 2017 Apr 12.

ReferenceCitation: Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators. CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma. Eur Urol. 2017 Dec;72(6):962-971. doi: 10.1016/j.eururo.2017.02.010. Epub 2017 Mar 3. Erratum In: Eur Urol. 2018 Jan 3;:

ReferenceCitation: Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Swansea University - Cronfa

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Denmark
United States
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Austria
Spain
Greece
Russian Federation
Israel

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Ucsf Helen Diller Family Comprehensive Cancer Center

location_facility: University Of Iowa Hospitals And Clinics