type: EudraCT Number

title: Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial

summary:
RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Ruhstaller T, Thuss-Patience P, Hayoz S, Schacher S, Knorrenschild JR, Schnider A, Plasswilm L, Budach W, Eisterer W, Hawle H, Mariette C, Hess V, Mingrone W, Montemurro M, Girschikofsky M, Schmidt SC, Bitzer M, Bedenne L, Brauchli P, Stahl M; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian 'Arbeitsgemeinschaft Medikamentose Tumortherapie' (AGMT); Federation Francophone de Cancerologie Digestive (FFCD)/Federation de Recherche en Chirurgie (FRENCH). Neoadjuvant chemotherapy followed by chemoradiation and surgery with and without cetuximab in patients with resectable esophageal cancer: a randomized, open-label, phase III trial (SAKK 75/08). Ann Oncol. 2018 Jun 1;29(6):1386-1393. doi: 10.1093/annonc/mdy105.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: von Holzen U, Schmidt S, Hayoz S, Steffen T, Grieder F, Bartsch D, Schnider A, Knoefel WT, Piessen G, Kettelhack C, Marti WR, Schafer M, Fugger R, Koigsrainer A, Gloor B, Furrer M, Gerard MA, Hawle H, Walz MK, Alesina P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK), the German Esophageal Cancer Study Group, the Austrian Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT), the Federation Francophone de Cancerologie Digestive (FFCD)/Federation de Recherche en Chirurgie (FRENCH). Surgical Outcomes After Neoadjuvant Chemoradiation Followed by Curative Surgery in Patients With Esophageal Cancer: An Intergroup Phase III Trial of the Swiss Group for Clinical Cancer Research (SAKK 75/08). Ann Surg. 2022 Jun 1;275(6):1130-1136. doi: 10.1097/SLA.0000000000004334. Epub 2020 Aug 26.

oa_host_type: repository

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

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Fehr M, Hawle H, Hayoz S, Thuss-Patience P, Schacher S, Riera Knorrenschild J, Durr D, Knoefel WT, Rumpold H, Bitzer M, Zweifel M, Samaras P, Mey U, Kung M, Winterhalder R, Eisterer W, Hess V, Gerard MA, Templeton A, Stahl M, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT); Federation Francophone de Cancerologie Digestive (FFCD) / Federation de Recherche en Chirurgie (FRENCH). High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08. BMC Cancer. 2020 Feb 28;20(1):166. doi: 10.1186/s12885-020-6623-z.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

location_country: Germany Hungary Switzerland Austria France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Charite University Hospital - Campus Virchow Klinikum

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Universitaetsklinikum Giessen und Marburg GmbH


intervention_type: Drug

lead_sponsor: Pierre Fabre Medicament

summary: In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes, antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs, therapeutic options are very limited. Alkylating agents showed a modest activity in pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.

ReferenceType: derived

ReferenceCitation: Cortes J, Perez-Garcia J, Levy C, Gomez Pardo P, Bourgeois H, Spazzapan S, Martinez-Janez N, Chao TC, Espie M, Nabholtz JM, Gonzalez Farre X, Beliakouski V, Roman Garcia J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051.

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

status: Completed

title: Phase III Trial of IV Vinflunine Versus an Alkylating Agent in Patients With Metastatic Breast Cancer Previously Treated With or Resistant to an Anthracycline, a Taxane, an Antimetabolite, and a Vinca-alkaloid (Study L00070 IN 308 B0)

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Belarus
Italy
Portugal
United Kingdom
Argentina
Austria
Belgium
Spain
South Africa
Taiwan
Ukraine
Russian Federation
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma

summary: This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Wang M, Ramchandren R, Chen R, Karlin L, Chong G, Jurczak W, Wu KL, Bishton M, Collins GP, Eliadis P, Peyrade F, Lee Y, Eckert K, Neuenburg JK, Tam CS. Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study. J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x.

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Jagiellonian University - Jagiellonian University Repository

repository_institution: University of Nottingham - Repository@Nottingham

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;nottingham-repository.worktribe.com;ruj.uj.edu.pl

lead_sponsor: Pharmacyclics LLC.

sponsor_collaborators:
Pharmacyclics LLC.
Janssen Research & Development, LLC

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
Turkey
Czechia
Canada
Ukraine
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Universitatsklinikum Essen, Klinik fur Hamatologie

location_facility: Institut Paoli Calmettes, Service Hematologie

location_facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria

location_facility: Ondokuz Mayiz universitesi Tip Fakultesi

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino

location_facility: ICO l'Hospitalet- Hospital Duran i Reynals

location_facility: FN Brno, Interni hematologicka a onkologicka klinika

location_facility: Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy

location_facility: Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology

location_facility: Kliniken Ostalb Stauferklinikum Schwab. Gmund

location_facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszcz

location_facility: Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center

location_facility: SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Gazi Universitesi Tip Fakultesi, Besevler

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ

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

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie

location_facility: Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I

location_facility: Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg

location_facility: Azienda Ospedaliera S. Croce e Carle Cuneo

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: University of Texas MD Anderson Cancer Center

location_facility: The University of Arizona Cancer Centre-North Campus

location_facility: Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin

location_facility: UCLA Department of Medicine-Hematology/Oncology

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi

location_facility: Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1

location_facility: Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi

location_facility: National Inst. of Cancer, Scientific and Research Dept of Chemotherapy of Hemoblastosis and Adjuvant Treatment Methods, Dept of Oncohematology with Sector of Adjuvant treatment methods

location_facility: Gemeinschaftpraxis Haematologie und Onkologie

location_facility: Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika

location_facility: Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia

location_facility: Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology

status_simplified: Ongoing


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

ReferenceCitation: Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):363-371. doi: 10.1097/QAI.0000000000002454.

oa_host_type: closed

location_facility: Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I

location_facility: Hennepin County Medical Center, Positive Care Clinic

location_facility: Instituto de Investigacion Cientifica del Sur

location_facility: John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

location_facility: Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: AIDS Healthcare Foundation - South Beach

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Maple Leaf Research / Maple Leaf Medical Clinic

location_facility: Clinique de Médecine Urbaine du Quartier Latin

location_facility: Mercer University, Department of Internal Medicine

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Medical University of South Carolina (MUSC)

location_facility: Claudia T Martorell, MD., LLC d/b/a The Research Institute

location_facility: MultiCare Rockwood HIV Critical Care Clinic

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Chronical Viral Illness Service/McGill University Health Care (MUHC)

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

location_facility: Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg

location_facility: Abbott Northwestern Hospital part of Allina Health

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie

location_facility: The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

location_facility: Community Research Initiative of New England

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: Palmetto Health Richland (Regulatory and Study Supply Shipping)

location_facility: Highland Hospital - Alameda Health System

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care

location_facility: Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68

location_facility: Infectious Disease Research Institute Inc

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Kaiser Permanente, Department of Infectious Diseases

location_facility: Hepatitis/HIV Clinical Trials Group (HHCTG)

location_facility: University of Miami Divison of Infectious Diseases Clinical Research Unit

location_facility: Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz

location_facility: EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH

location_facility: Providence Hospital Center for Infectious Diseases

location_facility: Hôpital Gui de Chauliac, CHU de Montpellier

location_facility: AIDS Arms Inc/ Trinity Health and Wellness Center

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

location_country:
Germany
Austria
United States
Canada
Puerto Rico
France

ipd_sharing: Yes


title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)

acronym: WAVE bd

summary: This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

study_type: Observational

ReferenceCitation: Vieta E, Langosch JM, Figueira ML, Souery D, Blasco-Colmenares E, Medina E, Moreno-Manzanaro M, Gonzalez MA, Bellivier F. Clinical management and burden of bipolar disorder: results from a multinational longitudinal study (WAVE-bd). Int J Neuropsychopharmacol. 2013 Sep;16(8):1719-32. doi: 10.1017/S1461145713000278. Epub 2013 May 13.

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Vieta E, Blasco-Colmenares E, Figueira ML, Langosch JM, Moreno-Manzanaro M, Medina E; WAVE-bd Study Group. Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd study). BMC Psychiatry. 2011 Apr 11;11:58. doi: 10.1186/1471-244X-11-58.

lead_sponsor: AstraZeneca

location_country: Germany Portugal Venezuela Romania Brazil Austria Belgium Turkey Ukraine France


lead_sponsor: Genentech, Inc.

summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

ReferenceCitation: Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28.

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

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repositories_concat: PubMed Central;digitalcommons.wustl.edu

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

publisher_dissemination: Wiley

ReferenceCitation: Cheson BD, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Sehn LH, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.

sponsor_collaborators:
Genentech, Inc.
Roche Pharma AG

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: University of Florida; Division of Hematology/Oncology

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Toronto East General Hospital; Main Pharmacy G Wing Basement

location_facility: Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Republican Clinical Hospital n.a. Baranov; Haematology

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

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: I Interni klinika; Vseobecna fakultni nemocnice

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

title: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

type: Other Identifier

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Canada
Russian Federation
France


acronym: CheckMate 915

intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

ReferenceCitation: Weber JS, Schadendorf D, Del Vecchio M, Larkin J, Atkinson V, Schenker M, Pigozzo J, Gogas H, Dalle S, Meyer N, Ascierto PA, Sandhu S, Eigentler T, Gutzmer R, Hassel JC, Robert C, Carlino MS, Di Giacomo AM, Butler MO, Munoz-Couselo E, Brown MP, Rutkowski P, Haydon A, Grob JJ, Schachter J, Queirolo P, de la Cruz-Merino L, van der Westhuizen A, Menzies AM, Re S, Bas T, de Pril V, Braverman J, Tenney DJ, Tang H, Long GV. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). J Clin Oncol. 2023 Jan 20;41(3):517-527. doi: 10.1200/JCO.22.00533. Epub 2022 Sep 26.

repositories_concat: PubMed Central;usiena-air.unisi.it

ReferenceCitation: Yoshino T, Oki E, Misumi T, Kotaka M, Manaka D, Eto T, Hasegawa J, Takagane A, Nakamura M, Kato T, Munemoto Y, Nakamura F, Bando H, Taniguchi H, Sakamoto Y, Shiozawa M, Nishi M, Horiuchi T, Yamagishi H, Sakamoto J, Mizushima T, Ohtsu A, Mori M. Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial. J Clin Oncol. 2022 Oct 10;40(29):3419-3429. doi: 10.1200/JCO.21.02628. Epub 2022 May 5.

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Hospital Regional Universitario De Malaga

location_facility: Providence Cancer Center Oncology And Hematology Care

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Centre Hospitalier Universitaire Dijon Bocage

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha

location_facility: Hospital Universitario Y Politecnico La Fe

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

location_facility: The Beatson West Of Scotland Cancer Centre

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: University Of Washington Cancer Care Alliance

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych

location_facility: Washington University School Of Medicine

location_facility: Azienda Ospedaliera Universitaria Senese

title: A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Czechia
Canada
France
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Austria
Spain
Greece
Russian Federation
Israel


acronym: PARADIGM-HF

lead_sponsor: Novartis Pharmaceuticals

summary: The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

ReferenceCitation: Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available.

evidence: open (via free pdf)

ReferenceCitation: Toenges G, Mutze T, Jahn-Eimermacher A. A comparison of semiparametric approaches to evaluate composite endpoints in heart failure trials. Stat Med. 2021 Nov 20;40(26):5702-5724. doi: 10.1002/sim.9149. Epub 2021 Jul 30.

ReferenceCitation: Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.

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

repository_normalized: HAL

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

ReferenceCitation: Ehteshami-Afshar S, Mooney L, Dewan P, Desai AS, Lang NN, Lefkowitz MP, Petrie MC, Rizkala AR, Rouleau JL, Solomon SD, Swedberg K, Shi VC, Zile MR, Packer M, McMurray JJV, Jhund PS, Hawkins NM. Clinical Characteristics and Outcomes of Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease: Insights From PARADIGM-HF. J Am Heart Assoc. 2021 Feb 16;10(4):e019238. doi: 10.1161/JAHA.120.019238. Epub 2021 Jan 30.

ReferenceCitation: Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.

ReferenceCitation: Dewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum In: Circ Heart Fail. 2020 Jan;13(1):e000036.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

ReferenceCitation: Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.

ReferenceCitation: Selvaraj S, Claggett B, Pozzi A, McMurray JJV, Jhund PS, Packer M, Desai AS, Lewis EF, Vaduganathan M, Lefkowitz MP, Rouleau JL, Shi VC, Zile MR, Swedberg K, Solomon SD. Prognostic Implications of Congestion on Physical Examination Among Contemporary Patients With Heart Failure and Reduced Ejection Fraction: PARADIGM-HF. Circulation. 2019 Oct 22;140(17):1369-1379. doi: 10.1161/CIRCULATIONAHA.119.039920. Epub 2019 Sep 12.

ReferenceCitation: Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Balmforth C, Simpson J, Shen L, Jhund PS, Lefkowitz M, Rizkala AR, Rouleau JL, Shi V, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJV. Outcomes and Effect of Treatment According to Etiology in HFrEF: An Analysis of PARADIGM-HF. JACC Heart Fail. 2019 Jun;7(6):457-465. doi: 10.1016/j.jchf.2019.02.015. Epub 2019 May 8.

ReferenceCitation: Myhre PL, Vaduganathan M, Claggett B, Packer M, Desai AS, Rouleau JL, Zile MR, Swedberg K, Lefkowitz M, Shi V, McMurray JJV, Solomon SD. B-Type Natriuretic Peptide During Treatment With Sacubitril/Valsartan: The PARADIGM-HF Trial. J Am Coll Cardiol. 2019 Mar 26;73(11):1264-1272. doi: 10.1016/j.jacc.2019.01.018. Epub 2019 Mar 4.

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Zile MR, O'Meara E, Claggett B, Prescott MF, Solomon SD, Swedberg K, Packer M, McMurray JJV, Shi V, Lefkowitz M, Rouleau J. Effects of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFrEF. J Am Coll Cardiol. 2019 Feb 26;73(7):795-806. doi: 10.1016/j.jacc.2018.11.042.

ReferenceCitation: Bouabdallaoui N, Claggett B, Zile MR, McMurray JJV, O'Meara E, Packer M, Prescott MF, Swedberg K, Solomon SD, Rouleau JL; PARADIGM-HF Investigators and Committees. Growth differentiation factor-15 is not modified by sacubitril/valsartan and is an independent marker of risk in patients with heart failure and reduced ejection fraction: the PARADIGM-HF trial. Eur J Heart Fail. 2018 Dec;20(12):1701-1709. doi: 10.1002/ejhf.1301. Epub 2018 Sep 11.

ReferenceCitation: O'Meara E, Prescott MF, Claggett B, Rouleau JL, Chiang LM, Solomon SD, Packer M, McMurray JJV, Zile MR. Independent Prognostic Value of Serum Soluble ST2 Measurements in Patients With Heart Failure and a Reduced Ejection Fraction in the PARADIGM-HF Trial (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). Circ Heart Fail. 2018 May;11(5):e004446. doi: 10.1161/CIRCHEARTFAILURE.117.004446.

ReferenceCitation: Packer M, Claggett B, Lefkowitz MP, McMurray JJV, Rouleau JL, Solomon SD, Zile MR. Effect of neprilysin inhibition on renal function in patients with type 2 diabetes and chronic heart failure who are receiving target doses of inhibitors of the renin-angiotensin system: a secondary analysis of the PARADIGM-HF trial. Lancet Diabetes Endocrinol. 2018 Jul;6(7):547-554. doi: 10.1016/S2213-8587(18)30100-1. Epub 2018 Apr 13.

ReferenceCitation: Chandra A, Lewis EF, Claggett BL, Desai AS, Packer M, Zile MR, Swedberg K, Rouleau JL, Shi VC, Lefkowitz MP, Katova T, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2018 Jun 1;3(6):498-505. doi: 10.1001/jamacardio.2018.0398.

ReferenceCitation: Shen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.

repository_institution: Australian Catholic University - Research Bank

repositories_institution: Australian Catholic University - Research Bank

ReferenceCitation: Kristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.

ReferenceCitation: Lewis EF, Claggett BL, McMurray JJV, Packer M, Lefkowitz MP, Rouleau JL, Liu J, Shi VC, Zile MR, Desai AS, Solomon SD, Swedberg K. Health-Related Quality of Life Outcomes in PARADIGM-HF. Circ Heart Fail. 2017 Aug;10(8):e003430. doi: 10.1161/CIRCHEARTFAILURE.116.003430.

ReferenceCitation: Zile MR, Claggett BL, Prescott MF, McMurray JJ, Packer M, Rouleau JL, Swedberg K, Desai AS, Gong J, Shi VC, Solomon SD. Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol. 2016 Dec 6;68(22):2425-2436. doi: 10.1016/j.jacc.2016.09.931.

ReferenceCitation: Nadruz W Jr, Claggett BL, McMurray JJ, Packer M, Zile MR, Rouleau JL, Desai AS, Swedberg K, Lefkowitz M, Shi VC, Prescott MF, Solomon SD. Impact of Body Mass Index on the Accuracy of N-Terminal Pro-Brain Natriuretic Peptide and Brain Natriuretic Peptide for Predicting Outcomes in Patients With Chronic Heart Failure and Reduced Ejection Fraction: Insights From the PARADIGM-HF Study (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial). Circulation. 2016 Nov 29;134(22):1785-1787. doi: 10.1161/CIRCULATIONAHA.116.024976. No abstract available.

ReferenceCitation: Desai AS, Vardeny O, Claggett B, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Zile MR, Lefkowitz M, Shi V, Solomon SD. Reduced Risk of Hyperkalemia During Treatment of Heart Failure With Mineralocorticoid Receptor Antagonists by Use of Sacubitril/Valsartan Compared With Enalapril: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2017 Jan 1;2(1):79-85. doi: 10.1001/jamacardio.2016.4733.

ReferenceCitation: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ; PARADIGM-HF Investigators and Committees*. Effects of Sacubitril/Valsartan in the PARADIGM-HF Trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) According to Background Therapy. Circ Heart Fail. 2016 Sep;9(9):e003212. doi: 10.1161/CIRCHEARTFAILURE.116.003212.

ReferenceCitation: Solomon SD, Claggett B, Packer M, Desai A, Zile MR, Swedberg K, Rouleau J, Shi V, Lefkowitz M, McMurray JJV. Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Oct;4(10):816-822. doi: 10.1016/j.jchf.2016.05.002. Epub 2016 Jul 6.

ReferenceCitation: Kristensen SL, Martinez F, Jhund PS, Arango JL, Belohlavek J, Boytsov S, Cabrera W, Gomez E, Hagege AA, Huang J, Kiatchoosakun S, Kim KS, Mendoza I, Senni M, Squire IB, Vinereanu D, Wong RC, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJ. Geographic variations in the PARADIGM-HF heart failure trial. Eur Heart J. 2016 Nov 1;37(41):3167-3174. doi: 10.1093/eurheartj/ehw226. Epub 2016 Jun 28.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Desai AS, Solomon S, Claggett B, McMurray JJ, Rouleau J, Swedberg K, Zile M, Lefkowitz M, Shi V, Packer M. Factors Associated With Noncompletion During the Run-In Period Before Randomization and Influence on the Estimated Benefit of LCZ696 in the PARADIGM-HF Trial. Circ Heart Fail. 2016 Jun;9(6):e002735. doi: 10.1161/CIRCHEARTFAILURE.115.002735.

ReferenceCitation: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ; PARADIGM-HF Investigators and Committees*. Importance of Clinical Worsening of Heart Failure Treated in the Outpatient Setting: Evidence From the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial (PARADIGM-HF). Circulation. 2016 Jun 7;133(23):2254-62. doi: 10.1161/CIRCULATIONAHA.115.020729. Epub 2016 Apr 20.

ReferenceCitation: Solomon SD, Claggett B, Desai AS, Packer M, Zile M, Swedberg K, Rouleau JL, Shi VC, Starling RC, Kozan O, Dukat A, Lefkowitz MP, McMurray JJ. Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Trial. Circ Heart Fail. 2016 Mar;9(3):e002744. doi: 10.1161/CIRCHEARTFAILURE.115.002744.

ReferenceCitation: Kristensen SL, Preiss D, Jhund PS, Squire I, Cardoso JS, Merkely B, Martinez F, Starling RC, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial. Circ Heart Fail. 2016 Jan;9(1):e002560. doi: 10.1161/CIRCHEARTFAILURE.115.002560.

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

repository_institution: Keele University - Keele Research Repository

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: Keele University - Keele Research Repository

ReferenceCitation: Simpson J, Jhund PS, Silva Cardoso J, Martinez F, Mosterd A, Ramires F, Rizkala AR, Senni M, Squire I, Gong J, Lefkowitz MP, Shi VC, Desai AS, Rouleau JL, Swedberg K, Zile MR, McMurray JJV, Packer M, Solomon SD; PARADIGM-HF Investigators and Committees. Comparing LCZ696 with enalapril according to baseline risk using the MAGGIC and EMPHASIS-HF risk scores: an analysis of mortality and morbidity in PARADIGM-HF. J Am Coll Cardiol. 2015 Nov 10;66(19):2059-2071. doi: 10.1016/j.jacc.2015.08.878.

ReferenceCitation: Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.

ReferenceCitation: Jhund PS, Fu M, Bayram E, Chen CH, Negrusz-Kawecka M, Rosenthal A, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur Heart J. 2015 Oct 7;36(38):2576-84. doi: 10.1093/eurheartj/ehv330. Epub 2015 Jul 31.

ReferenceCitation: Desai AS, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Chen F, Gong J, Rizkala AR, Brahimi A, Claggett B, Finn PV, Hartley LH, Liu J, Lefkowitz M, Shi V, Zile MR, Solomon SD. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J. 2015 Aug 7;36(30):1990-7. doi: 10.1093/eurheartj/ehv186. Epub 2015 May 28.

ReferenceCitation: McMurray J, Packer M, Desai A, Gong J, Greenlaw N, Lefkowitz M, Rizkala A, Shi V, Rouleau J, Solomon S, Swedberg K, Zile MR, Andersen K, Arango JL, Arnold M, Belohlavek J, Bohm M, Boytsov S, Burgess L, Cabrera W, Chen CH, Erglis A, Fu M, Gomez E, Gonzalez A, Hagege AA, Katova T, Kiatchoosakun S, Kim KS, Bayram E, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires F, Refsgaard J, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire I, Starling RC, Vinereanu D, Teerlink JR, Wong R; PARADIGM-HF Committees and Investigators. A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure. Eur Heart J. 2015 Feb 14;36(7):434-9. doi: 10.1093/eurheartj/ehu455.

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Packer M, McMurray JJ, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile M, Andersen K, Arango JL, Arnold JM, Belohlavek J, Bohm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzalez-Medina A, Hagege AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan O, Llamas EB, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires FJ, Refsgaard J, Rosenthal A, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire IB, Starling RC, Teerlink JR, Vanhaecke J, Vinereanu D, Wong RC; PARADIGM-HF Investigators and Coordinators. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015 Jan 6;131(1):54-61. doi: 10.1161/CIRCULATIONAHA.114.013748. Epub 2014 Nov 17.

ReferenceCitation: McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ReferenceCitation: McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau J, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Committees and Investigators. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail. 2013 Sep;15(9):1062-73. doi: 10.1093/eurjhf/hft052. Epub 2013 Apr 5.

title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

location_country:
Finland
Germany
Poland
Argentina
Brazil
Thailand
Turkey
Chile
Canada
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Dominican Republic
Iceland
India
Romania
Belgium
China
Malaysia
Peru
Estonia
Philippines
Italy
Guatemala
Ecuador
Singapore
United Kingdom
Venezuela
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

ReferenceCitation: Zhu AX, Chen D, He W, Kanai M, Voi M, Chen LT, Daniele B, Furuse J, Kang YK, Poon RT, Vogel A, Chiang DY. Integrative biomarker analyses indicate etiological variations in hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):296-304. doi: 10.1016/j.jhep.2016.04.015. Epub 2016 Apr 27.

ReferenceCitation: Zhu AX, Kudo M, Assenat E, Cattan S, Kang YK, Lim HY, Poon RT, Blanc JF, Vogel A, Chen CL, Dorval E, Peck-Radosavljevic M, Santoro A, Daniele B, Furuse J, Jappe A, Perraud K, Anak O, Sellami DB, Chen LT. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA. 2014 Jul 2;312(1):57-67. doi: 10.1001/jama.2014.7189.

publisher_dissemination: American Medical Association

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU

location_facility: Compassionate Cancer Care Medical Group CCCMG

location_facility: University of California San Diego - Moores Cancer Center SC - 3

location_facility: Methodist Charlton Cancer Center Methodist

location_facility: Northwest Cancer Specialists Rose Quarter Cancer Center

location_facility: Queen's Medical Center Queens Cancer Center

location_facility: Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care

location_facility: University of Rochester Medical Center Rochester

location_facility: Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4)

location_facility: Midwest Cancer Care Physicians Research Medical Center

location_facility: Massachusetts General Hospital Dept. of Mass General Hospital

location_facility: California Pacific Medical Center California Pacific Med

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS

title: A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study

location_country:
Germany
Italy
Hungary
Hong Kong
Israel
Australia
Japan
Austria
Belgium
United States
China
Korea, Republic of
Spain
Greece
Thailand
Taiwan
Canada
France


title: Icatibant Outcome Survey (IOS) Registry

summary: The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

status: Recruiting

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Maurer M, Aberer W, Caballero T, Bouillet L, Grumach AS, Botha J, Andresen I, Longhurst HJ; IOS Study Group. The Icatibant Outcome Survey: 10 years of experience with icatibant for patients with hereditary angioedema. Clin Exp Allergy. 2022 Sep;52(9):1048-1058. doi: 10.1111/cea.14206. Epub 2022 Aug 7.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Cambridge - Apollo

ReferenceCitation: Guilarte M, Sala-Cunill A, Baeza ML, Cabanas R, Hernandez MD, Ibanez E, de Larramendi CH, Lleonart R, Lobera T, Marques L, de San Pedro BS, Botha J, Andresen I, Caballero T; IOS Study Group. Hereditary angioedema due to C1 inhibitor deficiency: real-world experience from the Icatibant Outcome Survey in Spain. Allergy Asthma Clin Immunol. 2021 Dec 29;17(1):137. doi: 10.1186/s13223-021-00641-3.

ReferenceCitation: Longhurst HJ, Dempster J, Lorenzo L, Buckland M, Grigoriadou S, Symons C, Bethune C, Fabien V, Bangs C, Garcez T. Real-world outcomes in hereditary angioedema: first experience from the Icatibant Outcome Survey in the United Kingdom. Allergy Asthma Clin Immunol. 2018 Aug 6;14:28. doi: 10.1186/s13223-018-0253-x. eCollection 2018.

repository_institution: PubMed Central - Europe PMC

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Caballero T, Zanichelli A, Aberer W, Maurer M, Longhurst HJ, Bouillet L, Andresen I; IOS Study Group. Effectiveness of icatibant for treatment of hereditary angioedema attacks is not affected by body weight: findings from the Icatibant Outcome Survey, a cohort observational study. Clin Transl Allergy. 2018 Mar 23;8:11. doi: 10.1186/s13601-018-0195-x. eCollection 2018.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

ReferenceCitation: Aberer W, Maurer M, Bouillet L, Zanichelli A, Caballero T, Longhurst HJ, Perrin A, Andresen I; IOS Study Group. Breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis are responsive to icatibant: findings from the Icatibant Outcome Survey. Allergy Asthma Clin Immunol. 2017 Jul 5;13:31. doi: 10.1186/s13223-017-0203-z. eCollection 2017.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

ReferenceCitation: Zanichelli A, Longhurst HJ, Maurer M, Bouillet L, Aberer W, Fabien V, Andresen I, Caballero T; IOS Study Group. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting. Ann Allergy Asthma Immunol. 2016 Oct;117(4):394-398. doi: 10.1016/j.anai.2016.08.014.

ReferenceCitation: Longhurst HJ, Aberer W, Bouillet L, Caballero T, Maurer M, Fabien V, Zanichelli A; IOS Study Group. The Icatibant Outcome Survey: treatment of laryngeal angioedema attacks. Eur J Emerg Med. 2016 Jun;23(3):224-7. doi: 10.1097/MEJ.0000000000000292.

ReferenceCitation: Longhurst HJ, Aberer W, Bouillet L, Caballero T, Fabien V, Zanichelli A, Maurer M; IOS Investigators. Analysis of characteristics associated with reinjection of icatibant: Results from the icatibant outcome survey. Allergy Asthma Proc. 2015 Sep-Oct;36(5):399-406. doi: 10.2500/aap.2015.36.3892. Erratum In: Allergy Asthma Proc. 2015 Nov-Dec;36(6):511.

ReferenceCitation: Hernandez Fernandez de Rojas D, Ibanez E, Longhurst H, Maurer M, Fabien V, Aberer W, Bouillet L, Zanichelli A, Caballero T; IOS Study Group. Treatment of HAE Attacks in the Icatibant Outcome Survey: An Analysis of Icatibant Self-Administration versus Administration by Health Care Professionals. Int Arch Allergy Immunol. 2015;167(1):21-8. doi: 10.1159/000430864. Epub 2015 Jun 25.

ReferenceCitation: Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

collaborators: Takeda Development Center Americas, Inc.

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Denmark
Australia
Brazil
Sweden
Austria
Spain
Greece
Czechia
France

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

acronym: RENEW

summary:
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).

This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

status: Terminated

ReferenceCitation: Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.

lead_sponsor: Celgene

location_country:
Germany
France
Italy
Poland
Portugal
United Kingdom
United States
Spain
Czechia
Puerto Rico
Russian Federation
Israel

location_facility: Weill Cornell Medical College/New York Presbyterian Hospital

location_facility: CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique

location_facility: Barts & The London NHS Trust Medical Oncology

location_facility: Klinikum der Universität München - Großhadern, Medizinische Klinik III

location_facility: State Educational Institution of High Professional Education

location_facility: CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie

location_facility: Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia

location_facility: Ospedale Cardinale G. Panico - Ematologia e Immunoematologia

location_facility: UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie

location_facility: Università del Piemonte Orientale "Amedeo Avogadro"

location_facility: Sharp Healthcare Oncology Associates of San Diego

location_facility: Sverdlovsk Regional Clinical Hospital - Volgogradskaya

location_facility: Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe

location_facility: CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne

location_facility: Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika

location_facility: Instituto Português de Oncologia (IPO) do Porto

location_facility: Hospital Universitario Vall d´Hebrón Hematology Department

location_facility: CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire

location_facility: Azienda Ospedaliera Universitaria "San Martino"

location_facility: Az. Osp. SS.Antonio e Biagio SC Ematologia

location_facility: Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia

location_facility: Clinic of Oncology Faculty Hospital Motol

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli

location_facility: Republican Clinical Oncological Dispensary

location_facility: Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria

location_facility: Dolnoslaskie Centrum Transplantacji Komórkowych

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies

location_facility: CHD Les Oudairies, Service d'Oncologie Hématologie

location_facility: IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia

location_facility: State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1

location_facility: Instituto Português de Oncologia (IPO) de Lisboa

location_facility: Hôpital Henri Mondor Unité Hémopathies Lymphoides

location_facility: Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency

location_facility: Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie

location_facility: Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

location_facility: Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico

location_facility: Policlinico San Matteo - Dip. Di Ematologia

location_facility: Salisbury NHS Foundation Trust, Haematology

location_facility: Hematology Dept, Azienda Ospedaliero Universitaria Careggi

location_facility: Fondazione San Raffaele del Monte Tabor I.R.C.C.S.

location_facility: Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie

location_facility: Soroka Medical Center The Institute of Hematology

location_facility: CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)

location_facility: Ospedale Regionale di Bolzano - Divisione di Ematologia

location_facility: Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation

location_facility: A,O Ospedale Niguarda Ca Granda Dept Hematology

location_facility: Universitätsklinikum Essen Zentrum für Innere Medizin

location_facility: Hôpital Pontchaillou Hématologie Clinique

location_facility: Davidoff Cancer Center The Institute of Hematology

location_facility: Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia

location_facility: CHU de Reims, Hôpital Robert Debré, Hématologie Clinique

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Clinica Universitaria de Navarra, Hematology

status_simplified: Unknown


title: An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke

summary: The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

ReferenceCitation: Fheodoroff K, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Turner-Stokes L. Factors influencing goal attainment in patients with post-stroke upper limb spasticity following treatment with botulinum toxin A in real-life clinical practice: sub-analyses from the Upper Limb International Spasticity (ULIS)-II Study. Toxins (Basel). 2015 Apr 8;7(4):1192-205. doi: 10.3390/toxins7041192.

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: MDPI

ReferenceCitation: Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P. Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open. 2013 Jun 20;3(6):e002771. doi: 10.1136/bmjopen-2013-002771.

repository_institution: King's College London - Research Portal

repositories_concat: PubMed Central;kclpure.kcl.ac.uk

repositories_institution:
King's College London - Research Portal
PubMed Central - Europe PMC

publisher_dissemination: British Medical Journal

ReferenceCitation: Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P, Zakine B. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice. BMJ Open. 2013 Mar 18;3(3):e002230. doi: 10.1136/bmjopen-2012-002230.

lead_sponsor: Ipsen

location_country:
Finland
Germany
Australia
Thailand
Czechia
France
Portugal
Denmark
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden

location_facility: Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)

location_facility: Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)

location_facility: Northshore Private Hospital (site 036003)

location_facility: Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)

location_facility: UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)

location_facility: NÖ LKH Grimmenstein-Hochegg (site 040002)

location_facility: Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)

location_facility: State Institution "Interregional clinical diagnostic centre" (site 643002)

location_facility: State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)

location_facility: Läkarhuset Odenplan, Neuro Unit (site 752003)

location_facility: Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)

location_facility: Kinik für Neurologie Paracelsusring 6a (site 276003)

location_facility: Hospital Pardubice, Neurology dept. (site 203001)

location_facility: Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)

location_facility: Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)

location_facility: CHU Lapeyronie /Rééducation fonctionnelle (site 250014)

location_facility: Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)

location_facility: Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)

location_facility: Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)

location_facility: Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)

location_facility: Hospital La Paz / Servicio de Rehabilitación (site 724006)

location_facility: Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016)

location_facility: Praxis für Neurologie, Dalberger Str. 6 (site 276007)

location_facility: Mälarsjukhuset, Dept. Of Neurology (site 752001)

location_facility: Metropolitan Medical Center (site 608001)

location_facility: West Midlands/Rehabilitation Centre (826005)

location_facility: Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)

location_facility: Dept. for Rehabilitation Asan Medical Center (site 410005)

location_facility: Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)

location_facility: Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)

location_facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)

location_facility: Perpetual Succour Hospital (site 608002)

location_facility: Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005)

location_facility: Hôpital Rangueil/Médecine Physique réadaptation (site 250015)

location_facility: Herlev Hospital, Herlev Ringvej (Site 208004)

location_facility: Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)

location_facility: China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)

location_facility: Azienda Ospedaliera Universitaria (site 380012)

location_facility: State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)

location_facility: Paracelsus Klinik Werdauer Str. 68 (site 276002)

location_facility: Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)

location_facility: CHU Hôpital SUD/Institut de Rééducation (site 250007)

location_facility: Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)

location_facility: Hopital Albert Chenevier/Neurologie, (site 250010)

location_facility: Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)

location_facility: Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)

location_facility: Royal Prince Alfred Hospital (site 036005)

location_facility: Municipal health care institution "City clinical hospital #3" (site 643006)

location_facility: CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)

location_facility: Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)

location_facility: Neurologiska Polikliniken, Tampere University Hospital (site 246001)

location_facility: Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)

location_facility: Hospital Universitario La Fe (Site 724003)

location_facility: Dept. Of Neurology, Nyköping Hospital (site 752002)

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)

location_facility: Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)

location_facility: Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)

location_facility: Centro de Medicina de Reabilitação de Alcoitão (site 620001)

location_facility: King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)

location_facility: Praxis für Neurologie Mittelstr. 4 (site 276008)

location_facility: Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)

location_facility: Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)

location_facility: Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)

location_facility: Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)

location_facility: Dewsbury District Hospital (site 826004)

location_facility: Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003)

location_facility: Ospedale Valduce, Costa Masnaga (site 380001)

location_facility: Ryde Rehabilitation Center (site 036002)

location_facility: Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)

location_facility: Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005)

location_facility: CHRU Lille/Rééducation Neurologique (site 250018)

location_facility: Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021)

location_facility: NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1

location_facility: Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)

location_facility: Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)

location_facility: Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)

location_facility: Hospital Distrital de Faro (site 620004)

location_facility: Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)

location_facility: Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002)

location_facility: Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)

location_facility: Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)

location_facility: AZ St. Jan, Ruddershove 10, (site 056002)


title: A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pretreatment At the Time of Diagnosis in Patients With Non-ST-Elevation Myocardial Infarction (NSTEMI): The ACCOAST Study

acronym: ACCOAST

summary: The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

ReferenceCitation: Silvain J, Rakowski T, Lattuca B, Liu Z, Bolognese L, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Miller D, Portal JJ, Collet JP, Vicaut E, Montalescot G, Dudek D; ACCOAST Investigators. Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Mar 5;73(8):906-914. doi: 10.1016/j.jacc.2018.11.055.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories_concat: HAL

ReferenceCitation: Porto I, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Le Gall N, Zagar AJ, LeNarz LA, Miller D, Montalescot G; ACCOAST Investigators. Impact of Access Site on Bleeding and Ischemic Events in Patients With Non-ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy. JACC Cardiovasc Interv. 2016 May 9;9(9):897-907. doi: 10.1016/j.jcin.2016.01.041.

ReferenceCitation: Dudek D, Dziewierz A, Widimsky P, Bolognese L, Goldstein P, Hamm C, Tanguay JF, LeNarz L, Miller DL, Brown E, Ten Berg J, Montalescot G; ACCOAST Investigators. Impact of prasugrel pretreatment and timing of coronary artery bypass grafting on clinical outcomes of patients with non-ST-segment elevation myocardial infarction: From the A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST-Elevation Myocardial Infarction (ACCOAST) study. Am Heart J. 2015 Nov;170(5):1025-1032.e2. doi: 10.1016/j.ahj.2015.07.017. Epub 2015 Jul 26.

ReferenceCitation: Widimsky P, Motovska Z, Bolognese L, Dudek D, Hamm C, Tanguay JF, Ten Berg J, Brown E, LeNarz L, Miller DL, Montalescot G; ACCOAST Investigators. Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel. Heart. 2015 Aug;101(15):1219-24. doi: 10.1136/heartjnl-2015-307686. Epub 2015 Jun 9.

ReferenceCitation: Montalescot G, Collet JP, Ecollan P, Bolognese L, Ten Berg J, Dudek D, Hamm C, Widimsky P, Tanguay JF, Goldstein P, Brown E, Miller DL, LeNarz L, Vicaut E; ACCOAST Investigators. Effect of prasugrel pre-treatment strategy in patients undergoing percutaneous coronary intervention for NSTEMI: the ACCOAST-PCI study. J Am Coll Cardiol. 2014 Dec 23;64(24):2563-2571. doi: 10.1016/j.jacc.2014.08.053.

ReferenceCitation: Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg J, Widimsky P, Luo J, Miller DL, Goedicke J. A comparison of prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis in patients with non-ST-segment elevation myocardial infarction: design and rationale for the ACCOAST study. Am Heart J. 2011 Apr;161(4):650-656.e1. doi: 10.1016/j.ahj.2010.10.017. Epub 2011 Feb 25.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.

location_country:
Finland
Germany
Poland
Turkey
Canada
France
Czech Republic
Lithuania
Portugal
Slovakia
Hungary
Latvia
Romania
Belgium
Italy
Sweden
Netherlands
Austria
Israel

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

summary: This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

lead_sponsor: Axovant Sciences Ltd.

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
Canada
France


lead_sponsor: Boehringer Ingelheim

summary: The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

ReferenceCitation: Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13.

location_facility: 1218.62.82004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11011 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305I Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11014 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11012 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302G Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39012 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11013 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39010 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305F Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39011 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302I Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302B Boehringer Ingelheim Investigational Site

title: 12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

location_country:
Italy
India
Netherlands
Belgium
Korea, Republic of
Spain
Malaysia
Canada
France


title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

summary: The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

ReferenceCitation: Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Hong Kong
United States
Romania
China
Peru
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: California Pacific Medical Center Research Institute


title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

ReferenceCitation: Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.

publisher_dissemination: SAGE Publications

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
United States
Israel
Germany
France

location_facility: Praxis Oehlwein Outpatient clinic for PD, DBS, Movement Disorders

location_facility: AS Clinical Research Consultants of North Texas, PLLC

location_facility: University of South Florida Parkinson's Disease and Movement Disorders Center

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: University of South Florida Faculty Office Building

location_facility: University of South Florida Carol and Frank Morsani Center for Advanced Health Care

location_facility: St Joseph's Hospital and Medical Center, Barrow Neurology Clinics

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of Toledo, Gardner-McMaster Parkinson Center


summary: The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

ReferenceCitation: Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Fundacio ACE Institut Catala de Neurociences Aplicades

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Carolina Neuropsychological Services, Inc.

location_facility: Alexian Brothers Neurosciences Institute Clinical Research

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: National Hospital Organization Niigata National Hospital

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: The Center for Pharmaceutical Research, P.C.

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: Rhode Island Mood and Memory Research Institute

location_facility: Kansai Medical University Takii Hospital

location_facility: Memory Enhancement Center of America, Inc.

location_facility: The McCusker Foundation for Alzheimer's Disease Research

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Research Center for Clinical Studies, Inc.

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: Centre Hospitalier Universitaire Charles Nicolle

location_facility: Llandough Hospital, Universtity Hospital of Wales

location_facility: Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Dept. of Neurosciences Charing Cross Hospital

location_facility: Bendheim Infusion Center, Greenwich Hospital

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Alzheimer's Research Corp./Merician Institute for Aging

location_facility: Center for Healthy Aging, Greenwich Hospital

location_facility: Southern Illinois University School of Medicine Department

location_facility: National Hospital Organization Maizuru Medical Center

location_facility: Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou

location_facility: Unita' Operativa C - Riabilitazione Neurologica

location_facility: Providence Brain Institute-Cognitive Assessment Clinic

location_facility: Palm Beach Neurological Center, Advanced Research Consultants, Inc.

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: Neurological Research Center of Hattiesburg Clinic

location_facility: National Hospital Organization Kokura Medical Center

location_facility: Memory Service North, Grenoside Grange Hospital

location_facility: Medical University of South Carolina Hospitals and Clinics

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Banner Good Samaritan Medical Center (Imaging

location_facility: Sezione di Neurologia - Dipartimento di Neuroscienze

title: A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.

design_allocation: Non-Randomized

location_country:
Finland
Poland
New Zealand
Argentina
Australia
Japan
Chile
France
Portugal
Slovakia
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Spain
South Africa
Sweden


summary: To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
publicatt.unicatt.it

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;publicatt.unicatt.it

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Behr J, Kolb M, Song JW, Luppi F, Schinzel B, Stowasser S, Quaresma M, Martinez FJ. Nintedanib and Sildenafil in Patients with Idiopathic Pulmonary Fibrosis and Right Heart Dysfunction. A Prespecified Subgroup Analysis of a Double-Blind Randomized Clinical Trial (INSTAGE). Am J Respir Crit Care Med. 2019 Dec 15;200(12):1505-1512. doi: 10.1164/rccm.201903-0488OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Kolb M, Raghu G, Wells AU, Behr J, Richeldi L, Schinzel B, Quaresma M, Stowasser S, Martinez FJ; INSTAGE Investigators. Nintedanib plus Sildenafil in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 Nov 1;379(18):1722-1731. doi: 10.1056/NEJMoa1811737. Epub 2018 Sep 15.

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Az. Ospedaliera Universitaria Polic.Tor Vergata

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: University of Texas Southwestern Medical Center

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Hospital General Universitario de Valencia

location_facility: University of Florida College of Medicine

location_facility: Sanjivani Superspeciality Hospital Pvt. Ltd.

location_facility: Nuevo Hospital Civil de Guadalajara DR. JUAN I. MENCHACA

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

title: INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment

location_country:
Germany
Italy
India
United Kingdom
Australia
Japan
Mexico
Belgium
United States
Korea, Republic of
Spain
Canada
France