title: BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments

acronym: BYLieve

summary: Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed on or after prior treatments

ReferenceCitation: Rugo HS, Lerebours F, Ciruelos E, Drullinsky P, Ruiz-Borrego M, Neven P, Park YH, Prat A, Bachelot T, Juric D, Turner N, Sophos N, Zarate JP, Arce C, Shen YM, Turner S, Kanakamedala H, Hsu WC, Chia S. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021 Apr;22(4):489-498. doi: 10.1016/S1470-2045(21)00034-6. Erratum in: Lancet Oncol. 2021 May;22(5):e184.

family: Rugo

full_name: Hope S Rugo

given: Hope S

family: Lerebours

full_name: Florence Lerebours

given: Florence

family: Ciruelos

full_name: Eva Ciruelos

given: Eva

family: Drullinsky

full_name: Pamela Drullinsky

given: Pamela

family: Ruiz-Borrego

full_name: Manuel Ruiz-Borrego

given: Manuel

family: Neven

full_name: Patrick Neven

given: Patrick

family: Park

full_name: Yeon Hee Park

given: Yeon Hee

family: Prat

full_name: Aleix Prat

given: Aleix

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Juric

full_name: Dejan Juric

given: Dejan

family: Turner

full_name: Nicholas Turner

given: Nicholas

family: Sophos

full_name: Nickolas Sophos

given: Nickolas

family: Zarate

full_name: Juan Pablo Zarate

given: Juan Pablo

family: Arce

full_name: Christina Arce

given: Christina

family: Shen

full_name: Yu-Ming Shen

given: Yu-Ming

full_name: Stuart Turner

given: Stuart

family: Kanakamedala

full_name: Hemanth Kanakamedala

given: Hemanth

family: Hsu

full_name: Wei-Chun Hsu

given: Wei-Chun

family: Chia

full_name: Stephen Chia

given: Stephen

journal_name: The Lancet Oncology

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Chile
India
Mexico
Netherlands
Germany
France
Japan
Israel
Singapore
Belgium
Argentina
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: University of Calif Irvine Medical Center

location_facility: Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2)

location_facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

location_facility: Greater Baltimore Medical Center Cancer Center

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: University of Louisville Hospital/James Brown Cancer Ctr. SC

location_facility: University Hospitals of Cleveland Seidman Cancer Center


title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021 Mar 11;5(1):27. doi: 10.1186/s41687-021-00294-1.

family: Eek

full_name: Daniel Eek

given: Daniel

sequence: first

family: Ivanescu

full_name: Cristina Ivanescu

given: Cristina

sequence: additional

family: Corredoira

full_name: Laura Corredoira

given: Laura

family: Meyers

full_name: Oren Meyers

given: Oren

family: Cella

full_name: David Cella

given: David

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Patient-Reported Outcomes

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.

name: Università Vita-Salute San Raffaele, Milano, Italy

name: Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milano, Italy

family: Ghia

full_name: Paolo Ghia

given: Paolo

name: Szpital Specjalistyczny w Brzozowie im. Ks. Markiewicza, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku, Brzozow, Poland

family: Pluta

full_name: Andrzej Pluta

given: Andrzej

name: Department of Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland

family: Wach

full_name: Malgorzata Wach

given: Malgorzata

name: Fakultní Nemocnice Plzeň, Pilsen, Czech Republic

family: Lysak

full_name: Daniel Lysak

name: Fakultní Nemocnice Královske Vinohrady, Prague, Czech Republic

family: Kozak

full_name: Tomas Kozak

given: Tomas

name: University Hospital Hradec Králové, Hradec Králové, Czech Republic

family: Simkovic

full_name: Martin Simkovic

given: Martin

name: Dnipropetrovsk City Clinical Hospital No. 4, Dnipropetrovsk, Ukraine

family: Kaplan

full_name: Polina Kaplan

given: Polina

name: National Cancer Institute, Kiev, Ukraine

family: Kraychok

full_name: Iryna Kraychok

given: Iryna

name: University of Debrecen, Faculty of Medicine, Department of Hematology, Debrecen, Hungary

family: Illes

full_name: Arpad Illes

given: Arpad

name: Hospital Universitario 12 de Octubre, Madrid, Spain

family: de la Serna

full_name: Javier de la Serna

given: Javier

name: Saint John Regional Hospital, University of New Brunswick, St John, New Brunswick, Canada

family: Dolan

full_name: Sean Dolan

given: Sean

name: Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia

family: Campbell

full_name: Phillip Campbell

given: Phillip

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy

family: Musuraca

name: Royal Wolverhampton Hospital National Health Service Trust, Wolverhampton, United Kingdom

name: Nebraska Hematology Oncology, Lincoln, NE

name: Gachon University Gil Medical Center, Incheon, Republic of Korea

name: Acerta Pharma (a member of the AstraZeneca group), South San Francisco, CA

name: Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland

publisher: American Society of Clinical Oncology (ASCO)

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Croatia
France
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Hong Kong
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain


title: A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care , Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome

summary: The primary purpose of this study is to evaluate the safety, tolerability and efficacy of a single dose of ZX008 (Fenfluramine Hydrochloride) when added to standard of care and when added to Adjunctive Antiepleptic therapy to Stiripentol treatment in children and young adults with Dravet Syndrome

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Nov 2;93:154-159. doi: 10.1016/j.seizure.2021.10.024. [Epub ahead of print]

family: Cross

full_name: J. Helen Cross

given: J. Helen

family: Galer

full_name: Bradley S. Galer

given: Bradley S.

family: Gil-Nagel

full_name: Antonio Gil-Nagel

given: Antonio

family: Devinsky

full_name: Orrin Devinsky

given: Orrin

family: Ceulemans

full_name: Berten Ceulemans

given: Berten

family: Lagae

full_name: Lieven Lagae

given: Lieven

family: Schoonjans

full_name: An-Sofie Schoonjans

given: An-Sofie

family: Donner

full_name: Elizabeth Donner

given: Elizabeth

family: Wirrell

full_name: Elaine Wirrell

given: Elaine

family: Kothare

full_name: Sanjeev Kothare

given: Sanjeev

family: Agarwal

full_name: Anupam Agarwal

given: Anupam

family: Lock

full_name: Michael Lock

given: Michael

family: Gammaitoni

full_name: Arnold R. Gammaitoni

given: Arnold R.

journal_name: Seizure

oa_host_type: publisher

evidence: open (via page says license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Sullivan J, Perry MS, Wheless JW, Galer B, Gammaitoni A. Fenfluramine responder analyses and numbers needed to treat: Translating epilepsy trial data into clinical practice. Eur J Paediatr Neurol. 2021 Mar;31:10-14. doi: 10.1016/j.ejpn.2021.01.005. Epub 2021 Jan 22.

family: Sullivan

full_name: Joseph Sullivan

given: Joseph

family: Perry

full_name: M. Scott Perry

given: M. Scott

family: Wheless

full_name: James W. Wheless

given: James W.

full_name: Bradley Galer

given: Bradley

full_name: Arnold Gammaitoni

given: Arnold

journal_name: European Journal of Paediatric Neurology

ReferenceCitation: Nabbout R, Mistry A, Zuberi S, Villeneuve N, Gil-Nagel A, Sanchez-Carpintero R, Stephani U, Laux L, Wirrell E, Knupp K, Chiron C, Farfel G, Galer BS, Morrison G, Lock M, Agarwal A, Auvin S; FAiRE, DS Study Group. Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens: A Randomized Clinical Trial. JAMA Neurol. 2020 Mar 1;77(3):300-308. doi: 10.1001/jamaneurol.2019.4113.

name: Hôpital Universitaire Necker–Enfants Malades, Service de Neurologie Pédiatrique Centre de Référence Épilepsies Rares, Imagine Institute, Institut National de la Santé et de la Recherche Médicale,  Unite Mixté de Recherche 1163, Paris Descartes University, Paris, France

name: Paediatric Neurosciences Research Group, Royal Hospital for Children Glasgow, Glasgow, United Kingdom

name: Assistance Publique–Hôpitaux de Marseille, Department of Pediatric Neurology, Hôpital de la Timone, Marseille, France

name: Hospital Ruber Internacional, Madrid, Spain

name: Pediatric Neurology Unit, Clínica Universidad de Navarra, Pamplona, Spain

name: Department of Neuropediatrics, Christian-Albrechts-University, Kiel, Germany

name: Ann & Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois

name: University of Colorado, Children’s Hospital Colorado, Aurora

name: Pediatric Neurology, Necker-Enfants Malades Hospital, Institut National de la Santé et de la Recherche Médicale  Unite 1141, Paris, France

name: Robert Debré University Hospital, Université de Paris, Institut National de la Santé et de la Recherche Médicale Unite 1141, Paris, France

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_country:
United States
Netherlands
France
Spain
Germany
United Kingdom
Canada

location_facility: Krankenhaus Mara Ggmbh, Epilepsiezentrum Bethel

location_facility: Hôpital La Timone, Service de Neurologie Pédiatrique

location_facility: Cincinnati's Children's Hospital Medical Center

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: CENTRE REFERENT DES EPILEPSIES Hopital De Hautpierre

location_facility: HÔPITAL FEMME-MÈRE-ENFANT Hôpital Femme-mère-enfant Service De Neurologie Pédiatrique

location_facility: Ann & Robert Lurie Children'S Hospital of Chicago

location_facility: Alder Hey Children'S Nhs Foundation Trust

location_facility: CHRU LILLE Centre Hospitalier Régional Universitaire De Lille 2

location_facility: Universitätsklinikum Schleswig-Holstein, Klinik Für Neuropädiatrie

location_facility: Hospital Ruber Internacional Primera Planta Servicio de Neurologia

location_facility: Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

location_facility: Great Ormond Street Hospital For Children Nhs Foundation Trust

location_facility: Institute of Neurosciences Queens Elizabeth University

location_facility: Chu Amiens Picardie Service de Neurologie Pediatrique

location_facility: CHU DE BORDEAUX Service De Pédiatrie Médicale

location_facility: Chu Ste-Justine Hospital Neurology Department


type: EudraCT Number

title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an AMI

acronym: PARADISE-MI

summary: The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF..

ReferenceCitation: Pfeffer MA, Claggett B, Lewis EF, Granger CB, Køber L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, East C, Fernandez A, Jering K, Landmesser U, Mehran R, Merkely B, Vaghaiwalla Mody F, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Gong J, Braunwald E; PARADISE-MI Investigators and Committees. Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction. N Engl J Med. 2021 Nov 11;385(20):1845-1855. doi: 10.1056/NEJMoa2104508.

name: From the Cardiovascular Division (M.A.P., B.C., S.D.S., K.J., E.B.) and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division (E.B.), Brigham and Women’s Hospital and Harvard Medical School, Boston; the Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto (E.F.L.), and the Heart Failure and Preventive Cardiology Programs, Department of Veterans Affairs Greater Los Angeles, University of California, Los Angeles, Los Angeles (F.V.M.) — both in...

family: Pfeffer

full_name: Marc A. Pfeffer

given: Marc A.

family: Claggett

full_name: Brian Claggett

given: Brian

family: Lewis

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Køber

full_name: Lars Køber

given: Lars

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

family: Mann

full_name: Douglas L. Mann

given: Douglas L.

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Rouleau

full_name: Jean-Lucien Rouleau

given: Jean-Lucien

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: Steg

full_name: Philippe G. Steg

given: Philippe G.

family: Berwanger

full_name: Otavio Berwanger

given: Otavio

family: Cikes

full_name: Maja Cikes

given: Maja

family: De Pasquale

full_name: Carmine G. De Pasquale

given: Carmine G.

family: East

full_name: Cara East

given: Cara

family: Fernandez

full_name: Alberto Fernandez

given: Alberto

family: Jering

full_name: Karola Jering

given: Karola

family: Landmesser

full_name: Ulf Landmesser

given: Ulf

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Merkely

full_name: Béla Merkely

given: Béla

family: Vaghaiwalla Mody

full_name: Freny Vaghaiwalla Mody

given: Freny

family: Petrie

full_name: Mark C. Petrie

given: Mark C.

family: Petrov

full_name: Ivo Petrov

title: Angiotensin Receptor–Neprilysin Inhibition in Acute Myocardial Infarction

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

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
Croatia
France
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Switzerland
Netherlands
Philippines
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAF(V600) wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

name: Hospital de Clínicas de Porto Alegre Unidade de Pesquisa Clinica em Oncologia Porto Alegre Brazil

family: Azevedo

full_name: Sergio Jobim Azevedo

given: Sergio Jobim

name: Instituto Nacional de Câncer Rio de Janeiro Brazil

family: Melo

full_name: Andreia Cristina Melo

given: Andreia Cristina

name: Genentech/Roche South San Francisco CA USA

family: Roberts

full_name: Louise Roberts

given: Louise

family: Caro

full_name: Ivor Caro

given: Ivor

name: Hoffmann‐La Roche Limited Mississauga ON Canada

family: Xue

full_name: Cloris Xue

given: Cloris

name: Cenantron Centro Avançado de Tratamento Oncológico, Ltda. Belo Horizonte Brazil

family: Wainstein

full_name: Alberto Wainstein

journal_name: Pigment Cell & Melanoma Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: First‐line atezolizumab monotherapy in patients with advanced BRAF V600 wild‐type melanoma

ReferenceCitation: Gutzmer R, Stroyakovskiy D, Gogas H, Robert C, Lewis K, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Manikhas GM, Yan Y, Huang KC, Uyei A, McNally V, McArthur GA, Ascierto PA. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAF(V600) mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Jun 13;395(10240):1835-1844. doi: 10.1016/S0140-6736(20)30934-X. Erratum in: Lancet. 2020 Aug 15;396(10249):466.

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Stroyakovskiy

full_name: Daniil Stroyakovskiy

given: Daniil

family: Gogas

full_name: Helen Gogas

given: Helen

family: Robert

full_name: Caroline Robert

given: Caroline

family: Lewis

full_name: Karl Lewis

given: Karl

family: Protsenko

full_name: Svetlana Protsenko

given: Svetlana

family: Pereira

full_name: Rodrigo P Pereira

given: Rodrigo P

family: Eigentler

full_name: Thomas Eigentler

given: Thomas

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Demidov

full_name: Lev Demidov

given: Lev

family: Manikhas

full_name: Georgy Moiseevich Manikhas

given: Georgy Moiseevich

family: Yan

full_name: Yibing Yan

given: Yibing

family: Huang

full_name: Kuan-Chieh Huang

given: Kuan-Chieh

family: Uyei

full_name: Anne Uyei

given: Anne

family: McNally

full_name: Virginia McNally

given: Virginia

family: McArthur

full_name: Grant A McArthur

given: Grant A

family: Ascierto

title: Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAFV600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial

location_country:
Italy
Austria
Brazil
Netherlands
Spain
Germany
France
Korea, Republic of
Greece
Israel
Poland
Hungary
Australia
Belgium
New Zealand
Portugal
Russian Federation
United States
United Kingdom
Canada

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz

location_facility: Istituto Tumori "Giovanni Paolo II", Oncologia

location_facility: Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

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

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

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

location_facility: Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

location_facility: Elbekliniken Buxtehude; Klinik für Dermatologie

location_facility: LKH Innsbruck; Universitätsklinik für Dermatologie

location_facility: Sharett Institute - Hadassah Hebrew University Medical Center

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

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

location_facility: Universitatsklinikum Essen; Klinik für Dermatologie

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

location_facility: Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: LHSC - Victoria Hospital; London Regional Cancer Program

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

location_facility: Narodowy Inst.Onkol.im.Skłodowskiej-Curie Państw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Wellington Hospital; Wellington Blood and Cancer Centre

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Medical University of Graz, Department of Dermatology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

title: A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

summary: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.


ReferenceCitation: Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodríguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21. Erratum in: Lancet. 2021 Feb 20;397(10275):670.

family: Baas

full_name: Paul Baas

given: Paul

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: Nowak

full_name: Anna K Nowak

given: Anna K

family: Fujimoto

full_name: Nobukazu Fujimoto

given: Nobukazu

family: Peters

full_name: Solange Peters

given: Solange

family: Tsao

full_name: Anne S Tsao

given: Anne S

family: Mansfield

full_name: Aaron S Mansfield

given: Aaron S

family: Popat

full_name: Sanjay Popat

given: Sanjay

family: Jahan

full_name: Thierry Jahan

given: Thierry

family: Antonia

full_name: Scott Antonia

given: Scott

family: Oulkhouir

full_name: Youssef Oulkhouir

given: Youssef

family: Bautista

full_name: Yolanda Bautista

given: Yolanda

family: Cornelissen

full_name: Robin Cornelissen

given: Robin

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Grossi

full_name: Francesco Grossi

given: Francesco

family: Kowalski

full_name: Dariusz Kowalski

given: Dariusz

family: Rodríguez-Cid

full_name: Jerónimo Rodríguez-Cid

given: Jerónimo

family: Aanur

full_name: Praveen Aanur

given: Praveen

family: Oukessou

full_name: Abderrahim Oukessou

given: Abderrahim

family: Baudelet

full_name: Christine Baudelet

given: Christine

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

journal_name: The Lancet

oa_host_type: repository

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

repository_institution: University of Western Australia - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

version: submittedVersion

repository_institution: UWA - UWA Profiles and Research Repository

ReferenceCitation: Wright K. FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. Oncology (Williston Park). 2020 Nov 12;34(11):502-503. doi: 10.46883/ONC.2020.3411.0502.

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
France
Japan
Poland
Colombia
South Africa
Chile
Switzerland
Netherlands
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Turkey

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: H. Lee Moffitt Cancer Center & Research Inst, Inc

location_facility: Cancer & Hematology Centers Of Western Michigan

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Administradora Del Country S.A. - Clinica Del Country

location_facility: Hopital Albert Michallon - Chu De Grenoble

location_facility: Univ Of Maryland Greenbaum Cancer Center

title: A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

summary: The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.


title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

acronym: TRuST

summary: This rollover study will provide continuing availability to tazemetostat as a single agent to subjects who have completed their participation in an antecedent tazemetostat study (either with monotherapy or combination therapy).

enrollment_type: Anticipated

lead_sponsor: Epizyme, Inc.

location_country:
France
Poland
Belgium
Australia
United States
United Kingdom
Ukraine

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: Oncology and Haematology Clinical Trials Unit

location_facility: S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)

summary: The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

ipd_sharing: Yes

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Italy
Netherlands
Germany
France
Japan
Israel
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: Compass Oncology the Northwest Cancer Specialists

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

location_facility: Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Texas Oncology - Baylor Charles A. Sammons

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Maryland, Greenebaum Cancer Center

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Saitama Medical University International Medical Center

location_facility: UCSF Helen Diller Family Comprehensive Care Center

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio

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

location_facility: Calaway-Young Cancer Center at Valley View Hospital

location_facility: University of Wisconsic Hospital and Clinic

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Nottingham University Hospitals City Campus

location_facility: Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo

location_facility: TRIO - Comprehensive Cancer Centers of Nevada


ReferenceCitation: Goette A, Eckardt L, Valgimigli M, Lewalter T, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Tijssen JG, Vranckx P. Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis. Clin Res Cardiol. 2021 Jun;110(6):831-840. doi: 10.1007/s00392-020-01760-4. Epub 2020 Oct 24.

family: Goette

full_name: Andreas Goette

given: Andreas

family: Eckardt

full_name: Lars Eckardt

given: Lars

family: Valgimigli

full_name: Marco Valgimigli

given: Marco

family: Lewalter

full_name: Thorsten Lewalter

given: Thorsten

family: Laeis

full_name: Petra Laeis

given: Petra

family: Reimitz

full_name: Paul-Egbert Reimitz

given: Paul-Egbert

family: Smolnik

full_name: Rüdiger Smolnik

given: Rüdiger

family: Zierhut

full_name: Wolfgang Zierhut

given: Wolfgang

family: Tijssen

full_name: Jan G. Tijssen

given: Jan G.

family: Vranckx

full_name: Pascal Vranckx

given: Pascal

journal_name: Clinical Research in Cardiology

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

ReferenceCitation: Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.

full_name: Jan Tijssen

given: Jan

family: Gargiulo

full_name: Giuseppe Gargiulo

given: Giuseppe

family: Batushkin

full_name: Valerii Batushkin

given: Valerii

family: Campo

full_name: Gianluca Campo

given: Gianluca

ReferenceCitation: Vranckx P, Lewalter T, Valgimigli M, Tijssen JG, Reimitz PE, Eckardt L, Lanz HJ, Zierhut W, Smolnik R, Goette A. Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial. Am Heart J. 2018 Feb;196:105-112. doi: 10.1016/j.ahj.2017.10.009. Epub 2017 Oct 23.

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

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

repository_institution: University of Hasselt - Document Server@UHasselt

repositories_institution: University of Hasselt - Document Server@UHasselt

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

location_country:
Italy
Austria
Serbia
Switzerland
Netherlands
Spain
France
Poland
Lithuania
Romania
Hungary
Belgium
Portugal
Germany
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Vilnius University Hospital "Santariskiu Clinic"

location_facility: Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego

location_facility: Oradea Emergency County Clinical Hospital

location_facility: Zaporizhzhia Regional cardiology dispensary

location_facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: HFR Freiburg - Kantonsspital Kardiologie

location_facility: Communal Institution of Kyiv Regional Rada

location_facility: Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin

location_facility: II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca

location_facility: Odessa Regional Hospital, Cardiosurgery Center

location_facility: AOU Materdomini, Magna Graecia University

location_facility: Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie

location_facility: Communal Institution Dnepropetrovsk Regional Diagnostic Center

location_facility: "Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases

location_facility: Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta

location_facility: Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum

location_facility: Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)

location_facility: Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie

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

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin

location_facility: CI "Dnipropetrovsk Joint Emergency Hospital"

location_facility: Chernivtsi Regional Clinical Cardiology Dispensary

location_facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)

location_facility: Lithuanian University of Health Sciences hospital

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: "Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni

location_facility: Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco

location_facility: Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca

location_facility: Transcarpathian Regional Clinical Cardiology Clinic

location_facility: S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões

location_facility: Institute of Cardiovascular Diseases of Vojvodina

location_facility: Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center

location_facility: Oleksandrivska Kiyv City Clinical Hospital

location_facility: Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II

location_facility: Complejo Hospitalario Universitario de Granada

location_facility: Seoul National University Bundang Hospital

location_facility: State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II

location_facility: Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)

location_facility: Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin

location_facility: Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"

location_facility: X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca

location_facility: Universitätsklinikum Münster - Department für Kardiologie und Angiologie

location_facility: Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie

location_facility: Communal Institution Rivne Regional Clinical Hospital

location_facility: Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"

location_facility: Institutul de Boli Cardiovasculare Timisoara

location_facility: III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

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

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: China Medical University Hospital (CMUH)

location_facility: Emergency Institute of Cardiovascular Diseases and Transplantation

location_facility: St. Josefs-Hospital - Medizinische Klinik I, Kardiologie

location_facility: L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine

location_facility: Communal Institution of Sumy Regional Rada

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca

location_facility: Complejo Asistencial Universitario de León

location_facility: Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: Institute of CV Diseases Clinical Center of Serbia

location_facility: Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica

location_facility: Vinnytsya Regional Clinical Hospital n.a. Pyrogov

title: Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement.

summary: There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.


title: A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)

summary: The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).

lead_sponsor: Gilead Sciences

location_country:
Austria
United States
Switzerland
France
Belgium
Canada
United Kingdom

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust

location_facility: Methodist Healthcare Dallas - The Liver Institute

location_facility: University of Arkansas for Medical Sciences

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Nottingham University Hospitals NHS Trust

status_simplified: Completed


ReferenceType: result

ReferenceCitation: Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.

family: Zijlstra

full_name: Eric Zijlstra

given: Eric

family: Demissie

full_name: Marek Demissie

given: Marek

family: Graungaard

full_name: Tina Graungaard

given: Tina

family: Heise

full_name: Tim Heise

given: Tim

family: Nosek

full_name: Leszek Nosek

given: Leszek

name: Atlanta Diabetes Associates, Atlanta, GA, USA

family: Bode

full_name: Bruce Bode

given: Bruce

journal_name: Journal of Diabetes Science and Technology

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.

name: Diabetes Research InstituteMills‐Peninsula Medical Center San Mateo California

family: Klonoff

full_name: David C. Klonoff

given: David C.

name: Wellcome Trust/MRC Institute of Metabolic Science and Department of MedicineUniversity of Cambridge Cambridge UK

family: Evans

full_name: Mark L. Evans

given: Mark L.

name: Mountain Diabetes and Endocrine Center Asheville North Carolina

family: Lane

full_name: Wendy Lane

given: Wendy

name: Centre for Diabetes and Nutrition Ludwigshafen Ludwigshafen Germany

family: Kempe

full_name: Hans‐Peter Kempe

given: Hans‐Peter

name: Department of Endocrinology, Diabetes, and Nutrition and Clinical Investigation CentreMontpellier University Hospital, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier Montpellier France

family: Renard

full_name: Eric Renard

name: Academic Medical CenterUniversity of Amsterdam Amsterdam The Netherlands

name: Profil Institute of Metabolic Research Neuss Germany

family: DeVries

full_name: J. Hans DeVries

given: J. Hans

family: Hyseni

full_name: Agon Hyseni

given: Agon

family: Gondolf

full_name: Theis Gondolf

given: Theis

name: Department of Endocrinology, Diabetes and Metabolic DiseasesUniversity Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana Ljubljana Slovenia

family: Battelino

full_name: Tadej Battelino

given: Tadej

journal_name: Diabetes, Obesity and Metabolism

repositories_institution:
PubMed Central - Europe PMC
University of Cambridge - Apollo

title: A randomized, multicentre trial evaluating the efficacy and safety of fast‐acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5)

location_country:
United States
United Kingdom
Netherlands
Germany
France
Belgium
Russian Federation
Canada
Slovenia

title: Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.


type: Other Identifier

title: Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

acronym: OPAL

summary: The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.

status: Recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Janssen Biotech, Inc.

location_country:
Italy
Austria
Germany
France
Czechia
Greece
Korea, Republic of
Spain
United States
Canada

location_facility: Gastroenterology And Endoscopy Unit, University Hospital Of Parma

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten

location_facility: A.O.Citta della Salute e della Scienza di Torino

location_facility: Charité Universitatsmedizin Berlin, Campus Mitte Zentrum 13

location_facility: Städtisches Klinikum Dessau-Klinik Für Innere Medizin

location_facility: Fondazione Policlinico Universitario Al gemeli

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

location_facility: UOC Gastroenterologia Ed Epatologia, Dibimis, Policlinico Palermo

location_facility: Gastroenterology Research of America, LLC

location_facility: Allg. Krankenhaus der Landeshauptstadt St. Poelten

location_facility: TOR Vergata University - U.O.C. Gastroenterologia Dipartimento Di Medicina

location_facility: Seoul National University Bundang Hospital

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Gemeinschaftspraxis Dr Lars Helmstadter & Prof Dr Robert Ehehalt

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Universitätsklinikum Schlesw.-H., Campus Kiel/ Sektion für Stammzelll- und Immuntherapie - Germany

location_facility: Division Of Gastroenterology Medical School University Of Ioannina

location_facility: A.O. Ordine Mauriziano Di Torino - Ospedale Mauriziano Umberto

location_facility: Promedica Physicians Digestive Healthcare

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

location_facility: ifi-Institut für interdisziplinäre Medizin


title: Phase IIIb Randomized Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer. A Joint Study of the EORTC ROG and GUCG

acronym: PEGASUS

summary:
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.

Secondary objectives include:

documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline;
documentation of side effects and quality of life, I-PSS and urinary tract infections;
assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.

ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blümle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8:CD012548. doi: 10.1002/14651858.CD012548.pub2. Review.

name: Department of Urology and Paediatric Urology; University Hospital Ulm; Ulm Germany

name: UroEvidence@Deutsche Gesellschaft für Urologie; Berlin Germany

family: Zengerling

full_name: Friedemann Zengerling

given: Friedemann

family: Jakob

full_name: Joachim J Jakob

given: Joachim J

family: Schmidt

full_name: Stefanie Schmidt

given: Stefanie

name: Institute for Evidence in Medicine; Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; Freiburg Germany

name: Cochrane Germany; Cochrane Germany Foundation; Freiburg Germany

family: Meerpohl

full_name: Joerg J Meerpohl

given: Joerg J

family: Blümle

full_name: Anette Blümle

given: Anette

family: Schmucker

full_name: Christine Schmucker

given: Christine

name: Institute of Epidemiology and Medical Biometry; Ulm University; Ulm Germany

family: Mayer

full_name: Benjamin Mayer

given: Benjamin

name: Department of Urology and Pediatric Urology; University Hospital Erlangen; Erlangen Germany

name: Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN); Erlangen Germany

family: Kunath

full_name: Frank Kunath

given: Frank

journal_name: Cochrane Database of Systematic Reviews

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

location_country:
Italy
Switzerland
France
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

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

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro

location_facility: Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Hospital General Universitario Santa Lucia

location_facility: University Hospitals Copenhagen - Rigshospitalet

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

location_facility: Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie

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

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

intervention_type: Radiation


ReferenceCitation: Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum in: JAMA Neurol. 2020 Sep 1;77(9):1179.

name: Eli Lilly and Company, Indianapolis, Indiana

family: Wessels

full_name: Alette M. Wessels

given: Alette M.

name: Banner Alzheimer’s Institute, University of Arizona College of Medicine, Phoenix

family: Tariot

full_name: Pierre N. Tariot

given: Pierre N.

family: Zimmer

full_name: Jennifer A. Zimmer

given: Jennifer A.

family: Selzler

full_name: Katherine J. Selzler

given: Katherine J.

family: Bragg

full_name: Sonja M. Bragg

given: Sonja M.

family: Andersen

full_name: Scott W. Andersen

given: Scott W.

family: Landry

full_name: John Landry

given: John

family: Krull

full_name: James H. Krull

given: James H.

family: Downing

full_name: AnnCatherine M. Downing

given: AnnCatherine M.

family: Willis

full_name: Brian A. Willis

given: Brian A.

family: Shcherbinin

full_name: Sergey Shcherbinin

given: Sergey

name: AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland

family: Mullen

full_name: Jamie Mullen

given: Jamie

family: Barker

full_name: Peter Barker

given: Peter

family: Schumi

full_name: Jennifer Schumi

given: Jennifer

family: Shering

full_name: Craig Shering

given: Craig

family: Matthews

full_name: Brandy R. Matthews

given: Brandy R.

name: Alzheimer’s Disease Center, Boston University School of Medicine, Boston, Massachusetts

family: Stern

full_name: Robert A. Stern

given: Robert A.

name: Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Unités Mixtes de Recherche Institut National de la Santé et de la Recherche Médicale 1027, Université Toulouse III–Paul Sabatier, Toulouse, France

family: Vellas

full_name: Bruno Vellas

given: Bruno

name: Toronto Memory Program, Toronto, Ontario, Canada

family: Cohen

full_name: Sharon Cohen

given: Sharon

name: Re:Cognition Health, London, United Kingdom

family: MacSweeney

full_name: Emer MacSweeney

given: Emer

name: Research Center and Memory Clinic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociències Aplicades, Barcelona–Universitat Internacional de Catalunya, Barcelona, Spain

name: Networking Research Center on Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain

family: Boada

full_name: Mercè Boada

given: Mercè

family: Sims

full_name: John R. Sims

given: John R.

journal_name: JAMA Neurology

oa_colors: green other

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: The University of Arizona - UA Campus Repository

ReferenceCitation: Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjäll S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053.

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

location_country:
Italy
Mexico
Netherlands
Germany
Spain
France
Czechia
Japan
Korea, Republic of
Poland
Russian Federation
China
Denmark
United States
United Kingdom
Canada
Taiwan
Portugal

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Mexico Centre for Clinical Research SA de CV

location_facility: LLC City Neurological Centre Sibneuromed

location_facility: Xuanwu Hospital-Capital Medical University

location_facility: CSSS-Institut Universitaire Gériatric de Sherbrooke

location_facility: The Research Center of Southern California

location_facility: Research Center for Clinical Studies, Inc

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Institute for Neurodegenerative Disorders

location_facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Center for Clinical and Basic Research -CCBR

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: ISPG - Institut für Studien zur psychischen Gesundheit

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: True North Clinical Research Halifax, LLC

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Texas Medical Research Associates, L.L.C.

location_facility: SDN - Istituto di Ricerca Diagnostica e Nucleare

location_facility: Praxis für Neurologie und Psychiatrie Dr. med. Roth

location_facility: RSBIH Smolensk Regional Clinical Hospital

location_facility: Univ of North Texas Health Science Center

location_facility: Azienda Ospedaliera Citta della Salute della Scienza Torino

location_facility: Centro de Estudios Clinicos y Esp Medicas SC

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst

location_facility: Allied Biomedical Research Institute, Inc.

location_facility: Seoul National University Bundang Hospital

location_facility: Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Regional State Institution of Healthcare Tomsk Clinica Psych

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Instituto de Informacion en Salud Mental (INFOSAM)

location_facility: Neurology Specialists of Monmouth County

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: The Catholic University of Korea-Bucheon St. Mary's Hospital

location_facility: Jacksonville Center for Clinical Research

location_facility: Shanghai Huashan Hospital Affil to Fu Dan University

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: West China Hospital of Sichuan University

location_facility: Toronto Sunnybrook Regional Cancer Center

title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

summary: The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.


title: A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

summary: The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.

lead_sponsor: Celgene

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

location_facility: Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: Medizinische Hochschule HannoverZentrum Innere Medizin

location_facility: Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon

location_facility: Policlinico Agostino Gemelli - Istituto di Ematologia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: I.R.C.C.S. Policlinico San Matteo - Universita di Pavia

location_facility: Centre Hospitalier Universitaire d' Angers

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Ipo Instituto Portugues De Oncologia Porto

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE

location_facility: Complejo Hospitalario San Pedro de Alcantara

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine


title: Stellarex Vascular E-Registry

acronym: SAVER

summary: Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

ReferenceCitation: Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

name: Lankenau Heart Institute/Main Line Health, Philadelphia, PA (W.A.G.).

family: Gray

full_name: William A. Gray

given: William A.

family: Jaff

full_name: Michael R. Jaff

given: Michael R.

name: New York Presbyterian Hospital, Columbia University Irving Medical Center (S.A.P.).

family: Parikh

full_name: Sahil A. Parikh

given: Sahil A.

name: OhioHealth Heart and Vascular Physicians, Columbus (G.M.A.).

family: Ansel

full_name: Gary M. Ansel

given: Gary M.

name: Medical University Graz, Austria (M.B.).

family: Brodmann

full_name: Marianne Brodmann

given: Marianne

family: Krishnan

full_name: Prakash Krishnan

given: Prakash

family: Razavi

full_name: Mahmood K. Razavi

given: Mahmood K.

name: Ghent University Hospital, Belgium (F.V.).

family: Vermassen

full_name: Frank Vermassen

given: Frank

name: Universitäts – Herzzentrum, Freiburg, Germany (T.Z.).

family: Zeller

full_name: Thomas Zeller

given: Thomas

name: Syntactx, New York (R.W., K.O., M.A.A.).

family: White

full_name: Roseann White

given: Roseann

family: Ouriel

full_name: Kenneth Ouriel

given: Kenneth

family: Adelman

full_name: Mark A. Adelman

given: Mark A.

family: Lyden

full_name: Sean P. Lyden

given: Sean P.

journal_name: Circulation

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Spectranetics Corporation

location_country:
Italy
Austria
France
Belgium
Germany
United Kingdom

location_facility: Ev. Krankenhaus Königin Elisabeth Herzberge

location_facility: Krankenhaus der Barmherzigen Schwesterrn Reid

location_facility: Krankenhäuser Landkreis Freudenstadt GmbH

location_facility: Grand Hôpital de l'Est Francilien - Site de Marne la Vallée

location_facility: Âzienda Ospedaliera Per L'emergenza Cannizzaro

intervention_type: Device


title: A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors

acronym: MEDIOLA

summary: The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

ReferenceCitation: Domchek SM, Postel-Vinay S, Im SA, Park YH, Delord JP, Italiano A, Alexandre J, You B, Bastian S, Krebs MG, Wang D, Waqar SN, Lanasa M, Rhee J, Gao H, Rocher-Ros V, Jones EV, Gulati S, Coenen-Stass A, Kozarewa I, Lai Z, Angell HK, Opincar L, Herbolsheimer P, Kaufman B. Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Lancet Oncol. 2020 Sep;21(9):1155-1164. doi: 10.1016/S1470-2045(20)30324-7. Epub 2020 Aug 6.

family: Domchek

full_name: Susan M Domchek

given: Susan M

family: Postel-Vinay

full_name: Sophie Postel-Vinay

given: Sophie

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Park

full_name: Yeon Hee Park

given: Yeon Hee

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Alexandre

full_name: Jerome Alexandre

given: Jerome

family: You

full_name: Benoit You

given: Benoit

family: Bastian

full_name: Sara Bastian

given: Sara

family: Krebs

full_name: Matthew G Krebs

given: Matthew G

family: Wang

full_name: Ding Wang

given: Ding

family: Waqar

full_name: Saiama N Waqar

given: Saiama N

family: Lanasa

full_name: Mark Lanasa

given: Mark

family: Rhee

full_name: Joon Rhee

given: Joon

family: Gao

full_name: Haiyan Gao

given: Haiyan

family: Rocher-Ros

full_name: Vidalba Rocher-Ros

given: Vidalba

family: Jones

full_name: Emma V Jones

given: Emma V

family: Gulati

full_name: Sakshi Gulati

given: Sakshi

family: Coenen-Stass

full_name: Anna Coenen-Stass

given: Anna

family: Kozarewa

full_name: Iwanka Kozarewa

given: Iwanka

family: Lai

full_name: Zhongwu Lai

given: Zhongwu

family: Angell

full_name: Helen K Angell

given: Helen K

family: Opincar

full_name: Laura Opincar

given: Laura

repository_institution: The University of Manchester - Research Explorer

location_country:
Switzerland
Netherlands
France
Israel
United States
United Kingdom
Korea, Republic of


title: A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia

acronym: FUSION NHL 001

summary: This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

design_allocation: Non-Randomized

location_country:
Italy
United States
Netherlands
France
Japan
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Washington University School of Medicine

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Shands Cancer Center University of Florida

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Southampton University Hospitals NHS Trust

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine

location_facility: Medizinische Klinik III Klinikum der UniversitÃ¤t MÃ¼nchen-GroÃŸhadern


title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

summary: This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

lead_sponsor: Axovant Sciences Ltd.

location_country:
Italy
Netherlands
France
Spain
United States
United Kingdom
Canada


title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

acronym: PRONOUNCE

summary: The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

ReferenceCitation: Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sørensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30. Erratum in: Circulation. 2021 Oct 19;144(16):e273.

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

name: Division of Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA

family: Higano

full_name: Celestia S. Higano

given: Celestia S.

name: Genitourinary Oncology Service, Department of Medicine, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center, New York, NY

family: Slovin

full_name: Susan F. Slovin

given: Susan F.

family: Nelson

full_name: Adam J. Nelson

given: Adam J.

family: Bigelow

full_name: Robert Bigelow

given: Robert

name: Ferring Pharmaceuticals A/S, Copenhagen, Denmark

family: Sørensen

full_name: Per S. Sørensen

given: Per S.

name: Department of Medicine, Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; IQVIA, Durham, NC

family: Melloni

full_name: Chiara Melloni

given: Chiara

name: Division of Cardiology, St. Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada

family: Goodman

full_name: Shaun G. Goodman

given: Shaun G.

name: Department of Urologic Surgery, University of California, Davis, Sacramento, CA

family: Evans

full_name: Christopher P. Evans

given: Christopher P.

name: Department of Clinical Sciences Malmö, Lund University, Lund, Sweden

family: Nilsson

full_name: Jan Nilsson

given: Jan

name: Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

name: Department of Urology, The Christie and Salford Royal Hospitals Manchester, United Kingdom

family: Clarke

full_name: Noel W. Clarke

given: Noel W.

family: Olesen

full_name: Tine K. Olesen

given: Tine K.

family: Doyle-Olsen

full_name: Belinda T. Doyle-Olsen

given: Belinda T.

family: Kristensen

full_name: Henriette Kristensen

given: Henriette

family: Arney

full_name: Lauren Arney

given: Lauren

name: Department of Medicine, Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Verana Health, San Francisco, CA

family: Roe

full_name: Matthew T. Roe

given: Matthew T.

family: Alexander

full_name: John H. Alexander

given: John H.

title: Cardiovascular Safety of Degarelix versus Leuprolide in Patients with Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial

name: Department of Urology and Paediatric Urology; University Hospital Ulm; Ulm Germany

name: UroEvidence@Deutsche Gesellschaft für Urologie; Berlin Germany

family: Zengerling

full_name: Friedemann Zengerling

given: Friedemann

family: Jakob

name: Institute for Evidence in Medicine; Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; Freiburg Germany

name: Cochrane Germany; Cochrane Germany Foundation; Freiburg Germany

name: Institute of Epidemiology and Medical Biometry; Ulm University; Ulm Germany

name: Department of Urology and Pediatric Urology; University Hospital Erlangen; Erlangen Germany

name: Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN); Erlangen Germany

title: Degarelix for treating advanced hormone-sensitive prostate cancer

ReferenceCitation: Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.

location_country:
South Africa
Germany
Finland
France
Czechia
Greece
Poland
Slovakia
Russian Federation
United States
United Kingdom
Canada

location_facility: Advanced Urology Centers of New York Elmont Division

location_facility: Urologic Consultants of Southeaster PA LLP

location_facility: VA Greater Los Angeles Healthcare System

location_facility: SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: FBHI Privolzhskiy District Medical Centre FMBA of Russia

location_facility: Groote Schuur Hospital Department of Urology

location_facility: Royal Devon and Exeter Hospital (Wonford)

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

location_facility: Jewish General Hospital / McGill University

location_facility: FSBI "Moscow scientific research oncology institute"

location_facility: University of Arizona College of Medicine

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

location_facility: G. Kenneth Jansz Medicine Professional Corporation

location_facility: J. Giddens Medicine Professional Corporation

location_facility: Veterans Affairs Medical Center-Salisbury, NC

location_facility: Medical University of South Carolina (MUSC)

location_facility: BHI of Omsk region "Clinical Oncology Dispensary

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Urological Associates of Southern Arizona

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: University of Washington School of Medicine

location_facility: Urology Associates Urologic Medical Research

location_facility: Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer

location_facility: University General Hospital of Heraklion

location_facility: University of California, Irvine Medical Center

location_facility: SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov"

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt


lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Lithuania
Argentina
Korea, Republic of
Chile
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
United States
United Kingdom
Italy
Austria
Israel
Spain
Latvia

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Gartnavel General Hospital; Beatson West of Scotland Cancer Centre

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Azienda Ospedaliero Universitaria di Parma

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

location_facility: Tianjin Medical University General Hospital

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: HealthCare Research Network II, LLC - PPDS

location_facility: First Hospital of China Medical University

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Advanced Medical and Dental Institute; Kompleks Klinikal

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

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

location_facility: MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Hospital CUF Porto; Servico de Imunoalergologia

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

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Anhui Provincial Hospital; Respiratory Department

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Sydney Adventist Hospital; Clinical Trial Unit

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica

location_facility: Anhui Provincial Hospital; 2F,Tumor chemotherapy Department

location_facility: University of Kentucky; Markey Cancer Center

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Polyclinique de Limoges - Site Chenieux; Oncologie Medicale

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hopital d Instruction des Armees de Sainte Anne

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

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

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Centro de Investigacion; Clinica - Clinica Viedma S.A.

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: First Affliated Hospital of Anhui Medical University

location_facility: Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia

source: euctr

title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

summary: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.


title: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer

summary: The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase).

ipd_sharing: Undecided

lead_sponsor: Taiho Oncology, Inc.

location_country:
Netherlands
France
Belgium
Spain
United States
United Kingdom

location_facility: GU Research Network / Urology Cancer Center

location_facility: Institut Catala d Oncologia - L Hospitalet de Llobregat

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: Associated Medical Professionals of NY, PLLC

location_facility: The Christie NHS Foundation Trust- The Christie Clinic

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: University of Glasgow - Institute of Cancer Sciences;

location_facility: Florida Cancer Specialists & Research Institute

location_facility: UMMC-Cancer Center and Research Institute

location_facility: Royal Marsden Hospital (RMH) NHS Foundation Trust (DDU)

location_facility: Cambridge University Hospitals NHS Foundation

location_facility: Univeristy of California Davis Comprehensive Cancer Center


title: A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

acronym: KESTREL

summary: This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

ReferenceCitation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. Erratum in: Lancet Oncol. 2021 Apr;22(4):e134.

family: Hwang

full_name: Michael Hwang

given: Michael

family: Seiwert

full_name: Tanguy Y Seiwert

given: Tanguy Y

lead_sponsor: AstraZeneca

location_country:
Greece
Romania
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Thailand
Canada
Korea, Republic of
Vietnam
Philippines
United States
Germany
United Kingdom
Italy
Austria
Brazil
Spain