ReferenceCitation: Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Fléchon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.

family: Tagawa

full_name: Scott T. Tagawa

given: Scott T.

name: Perlmutter Cancer Center at NYU Langone Health, New York, NY

family: Balar

full_name: Arjun V. Balar

given: Arjun V.

name: Smilow Cancer Center, Yale School of Medicine, New Haven, CT

family: Petrylak

full_name: Daniel P. Petrylak

given: Daniel P.

family: Kalebasty

full_name: Arash Rezazadeh Kalebasty

given: Arash Rezazadeh

name: Institut de Cancérologie Gustave Roussy, Villejuif, France

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Fléchon

full_name: Aude Fléchon

given: Aude

name: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

family: Jain

full_name: Rohit K. Jain

given: Rohit K.

name: Huntsman Cancer Hospital, Salt Lake City, UT

family: Agarwal

full_name: Neeraj Agarwal

given: Neeraj

name: Rocky Mountain Cancer Centers, Littleton, CO

family: Bupathi

full_name: Manojkumar Bupathi

given: Manojkumar

name: Hôpitaux Universitaires de Strasbourg/Institut de Cancérologie Strasbourg Europe, Strasbourg, France

family: Barthelemy

full_name: Philippe Barthelemy

given: Philippe

family: Beuzeboc

full_name: Philippe Beuzeboc

name: University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

family: Palmbos

full_name: Phillip Palmbos

given: Phillip

name: University of Wisconsin Carbone Cancer Center, Madison, WI

family: Kyriakopoulos

full_name: Christos E. Kyriakopoulos

given: Christos E.

name: Institut Claudius Regaud/Cancer Comprehensive Center, IUCT, Toulouse, France

family: Pouessel

full_name: Damien Pouessel

given: Damien

family: Sternberg

full_name: Cora N. Sternberg

given: Cora N.

name: Immunomedics, a subsidiary of Gilead Sciences, Inc, Morris Plains, NJ

family: Hong

full_name: Quan Hong

given: Quan

family: Goswami

full_name: Trishna Goswami

given: Trishna

family: Itri

full_name: Loretta M. Itri

given: Loretta M.

name: Fred Hutchinson Cancer Research Center, University of Washington, Seattle Cancer Care Alliance, Seattle, WA

family: Grivas

full_name: Petros Grivas

given: Petros

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

design_allocation: Non-Randomized

lead_sponsor: Gilead Sciences

location_country:
United States
France

acronym: TROPHY U-01

location_facility: Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Precision Cancer Research / New Mexico Oncology & Hematology Consultants

location_facility: The University of Arizona Cancer Center-North Campus

location_facility: Hospitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Winship Cancer Institute, Emory University

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: Drug Shipping Address: New York-Presbyterian Hospital

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Utah - Huntsman Cancer Hospital (IP Shipping Address)

location_facility: Houston Methodist Hospital, Houston Methodist Cancer Center

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: University of Wisconsin Clinical Science Center

title: Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy

summary: The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy in participants with metastatic urothelial cancer (mUC).


title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

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: Anticipated

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Italy
Brazil
United States
Spain
Germany
France
Czechia
Poland
Israel
Argentina
Australia
New Zealand
Puerto Rico
Canada
United Kingdom

location_facility: Northern California Retina Vitreous Associates

location_facility: Retina Consultants of Southern California

location_facility: Cumberland Valley Retina Consultants, PC

location_facility: Retina Associates of New Jersey (NJ Retina)

location_facility: London North West University Hospital Trust

location_facility: Byers Eye Institute at Standford, Stanford School of Medicine

location_facility: The Gavin Herbert Eye Institute/UC Irvine

location_facility: Retina Institute of California Medical Group

location_facility: University of South Florida (USF) Eye Institute

location_facility: Emanuelli Research and Development Center

location_facility: Retina Institute of California dba Acuity Eye Grp

location_facility: Instituto da Visão - Hospital de Olhos Ltda

location_facility: Charlotte Eye Ear Nose and Throat Associates, PS

location_facility: Danbury Eye Physicians & Surgeons, P.C. - Danbury

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Retina Vitreous Associates Medical Group

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS

location_facility: Retina Specialists of Michigan / Foundation for Vision

location_facility: Eye Clinic, Acre Mill Outpatients, Huddersfield Royal Infirmary

location_facility: Retina Consultants of Austin (Retina Research Center)

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Vitreous Retina Macula Consultants of NY

location_facility: Florida Eye Microsurgical Institute, Inc.

location_facility: University Hospital Kralovske Vinochrady

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

sequence: additional

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

intervention_type: Drug

lead_sponsor: Vertex Pharmaceuticals Incorporated

enrollment_type: Actual

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Czechia
Greece
Australia
Belgium
Canada
United Kingdom

location_facility: Centre Hospitalier De L'Universite Laval

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: University of Arkansas for Medical Sciences

location_facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: Children's Hospital of Richmond at VCU, Children's Pavilion

location_facility: The University of Texas Southwestern Medical Center

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: UNM Clinical and Translational Science Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: General Hospital of Attika "Sismanoglio"(Adult CF center, NHS)

location_facility: Joe DiMaggio Cystic Fibrosis & Pulmonary Center

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: University of Virginia Primary Care Center

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Dell Children's Medical Center of Central Texas

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Children's Hospital of the King's Daughters

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: University of California Davis Medical Center

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Banner University of Arizona Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: Children's Specialty Services at North Druid Hills

location_facility: Azienda Ospedaliero Universitaria Ospendali Riuniti

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: The Cystic Fibrosis Center, Mount Sinai Beth Israel

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

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

location_facility: Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital

location_facility: Tampa General Hospital Cardiac and Lung Transplant Clinic

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center

type: EudraCT Number

source: euctr

title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

summary: This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation


ReferenceCitation: Middleton PG, Mall MA, Dřevínek P, Lands LC, McKone EF, Polineni D, Ramsey BW, Taylor-Cousar JL, Tullis E, Vermeulen F, Marigowda G, McKee CM, Moskowitz SM, Nair N, Savage J, Simard C, Tian S, Waltz D, Xuan F, Rowe SM, Jain R; VX17-445-102 Study Group. Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele. N Engl J Med. 2019 Nov 7;381(19):1809-1819. doi: 10.1056/NEJMoa1908639. Epub 2019 Oct 31.

name: From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité–Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of...

family: Middleton

full_name: Peter G. Middleton

given: Peter G.

sequence: first

family: Mall

full_name: Marcus A. Mall

given: Marcus A.

family: Dřevínek

full_name: Pavel Dřevínek

given: Pavel

family: Lands

full_name: Larry C. Lands

given: Larry C.

family: McKone

full_name: Edward F. McKone

given: Edward F.

family: Polineni

full_name: Deepika Polineni

given: Deepika

family: Ramsey

full_name: Bonnie W. Ramsey

given: Bonnie W.

family: Taylor-Cousar

full_name: Jennifer L. Taylor-Cousar

given: Jennifer L.

family: Tullis

full_name: Elizabeth Tullis

given: Elizabeth

family: Vermeulen

full_name: François Vermeulen

given: François

family: Marigowda

full_name: Gautham Marigowda

given: Gautham

family: McKee

full_name: Charlotte M. McKee

given: Charlotte M.

family: Moskowitz

full_name: Samuel M. Moskowitz

given: Samuel M.

family: Nair

full_name: Nitin Nair

given: Nitin

family: Savage

full_name: Jessica Savage

given: Jessica

family: Simard

full_name: Christopher Simard

given: Christopher

family: Tian

full_name: Simon Tian

given: Simon

family: Waltz

full_name: David Waltz

given: David

family: Xuan

full_name: Fengjuan Xuan

given: Fengjuan

family: Rowe

full_name: Steven M. Rowe

given: Steven M.

family: Jain

full_name: Raksha Jain

given: Raksha

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Elexacaftor–Tezacaftor–Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele

location_facility: Centre Hospitalier De L'Universite Laval

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: University of Arkansas for Medical Sciences

location_facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: Children's Hospital of Richmond at VCU, Children's Pavilion

location_facility: ProMedica Toledo Hospital/ Toledo Children's Hospital/ Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: The University of Texas Health Science Center at Tyler

location_facility: The University of Texas Southwestern Medical Center

location_facility: University of New Mexico Clinical & Translational Science Center

location_facility: Valley Children's Hospital/ Children's Hospital of Central California

location_facility: University of Oklahoma Health Sciences Center

location_facility: General Hospital of Attika "Sismanoglio"(Adult CF center, NHS)

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: University of Virginia Primary Care Center

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Children's Hospital of the King's Daughters

location_facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: University of California Davis Medical Center

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Banner University of Arizona Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: The Royal Belfast Hospital for Sick Children

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gathuisberg

location_facility: Miller Children's Hospital/ Long Beach Memorial

location_facility: Children's Speciality Services at North Druid Hills

location_facility: University Hospitals Cleveland Medical Center/ Rainbow Babies and Children's Hospital

location_facility: Massachusetts General Hospital Cystic Fibrosis Center

location_facility: Saint Francis Medical Center/ Children's Hospital of Illinois/OSF

title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


ReferenceCitation: Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Pérez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.

name: From the School of Medicine, Tulane University, New Orleans (O.S.); the Institute of Cancer Research and Royal Marsden Hospital, London (J.B.); the British Columbia Cancer Agency, Vancouver, Canada (K.N.C.); Gustave Roussy Institute, Paris-Saclay University, Villejuif, France (K.F.); the University of Duisberg–Essen and German Cancer Consortium, University Hospital Essen, Essen (K.H.), University Hospital Münster, Münster (K.R.), and Rostock University Medical Center, Rostock (B.J.K.) — all in Germany;...

family: Sartor

full_name: Oliver Sartor

given: Oliver

family: de Bono

full_name: Johann de Bono

given: Johann

family: Chi

full_name: Kim N. Chi

given: Kim N.

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Herrmann

full_name: Ken Herrmann

given: Ken

family: Rahbar

full_name: Kambiz Rahbar

given: Kambiz

family: Tagawa

full_name: Scott T. Tagawa

given: Scott T.

family: Nordquist

full_name: Luke T. Nordquist

given: Luke T.

family: Vaishampayan

full_name: Nitin Vaishampayan

family: El-Haddad

full_name: Ghassan El-Haddad

given: Ghassan

family: Park

full_name: Chandler H. Park

given: Chandler H.

family: Beer

full_name: Tomasz M. Beer

given: Tomasz M.

family: Armour

full_name: Alison Armour

given: Alison

family: Pérez-Contreras

full_name: Wendy J. Pérez-Contreras

given: Wendy J.

family: DeSilvio

full_name: Michelle DeSilvio

given: Michelle

family: Kpamegan

full_name: Euloge Kpamegan

given: Euloge

family: Gericke

full_name: Germo Gericke

given: Germo

family: Messmann

full_name: Richard A. Messmann

given: Richard A.

family: Morris

full_name: Michael J. Morris

given: Michael J.

family: Krause

full_name: Bernd J. Krause

given: Bernd J.

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer

ReferenceCitation: Sundlöv A, Sjögreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12.

family: Sundlöv

full_name: A. Sundlöv

given: A.

family: Sjögreen-Gleisner

full_name: K. Sjögreen-Gleisner

given: K.

title: Peptide Receptor Radionuclide Therapy – Prospects for Personalised Treatment

ReferenceCitation: Iravani A, Violet J, Azad A, Hofman MS. Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):38-52. doi: 10.1038/s41391-019-0174-x. Epub 2019 Oct 8. Review.

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:
United States
Sweden
Netherlands
Germany
France
Belgium
Puerto Rico
Denmark
Canada
United Kingdom

location_facility: Royal Free London NHS Foundation Trust Royal Free Hospital

location_facility: VA Greater Los Angeles Healthcare System

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: New Mexico Oncology & Hematology Consultants

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: University Hospital Essen, Clinic for Nuclear Medicine

location_facility: London Health Sciences Centre, Division of Nuclear Medicine

location_facility: Precision Cancer Research/ Dayton Physicians Network

location_facility: Centre d'Investigations et de Recherche Clinique en Oncologie Hospital SAINT-LOUIS

location_facility: Rigshospitalet - University Hospital Copenhagen, Department of Oncology

location_facility: University of Iowa Hospitals and Clinics Cancer Center Research

location_facility: Yale Cancer Center, Clinical Trials Office

location_facility: University of Michigan Medical Center, Division of Nuclear Medicine

location_facility: The Lank Center for Genitourinary Oncology

location_facility: University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine

location_facility: Hospital rechts der Isar, Department of Nuclear Medicine

location_facility: Oregon Health and Science University Nuclear Medicine Department

location_facility: Institute Claudius Regaud, Toulouse Cancer Research Center

location_facility: Washington University School of Medicine

location_facility: University Hospital Muenster, Department of Nuclear Medicine

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: GU Research Network/ Urology Cancer Center

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: Washington DC VA Medical Center, Nuclear Medicine Service

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Duke University School of Medicine, Duke Cancer Institute

location_facility: Sahlgrenska University Hospital, Department of Oncology

location_facility: Aalborg University Hospital Klinik Kirurgi-Kræft Clinical Research Unit Department of Oncology

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: John Cochran St. Louis Veterans Medical Center

location_facility: University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine

location_facility: St Bartholomew's Hospital, West Smithfield

title: VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

summary: The primary objective of this study is to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.


title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery

summary: This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Prevention

ReferenceCitation: Thielmann M, Corteville D, Szabo G, Swaminathan M, Lamy A, Lehner LJ, Brown CD, Noiseux N, Atta MG, Squiers EC, Erlich S, Rothenstein D, Molitoris B, Mazer CD. Teprasiran, a Small Interfering RNA, for the Prevention of Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Randomized Clinical Study. Circulation. 2021 Oct 5;144(14):1133-1144. doi: 10.1161/CIRCULATIONAHA.120.053029. Epub 2021 Sep 3.

name: Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Duisburg-Essen, Germany (M.T.).

family: Thielmann

full_name: Matthias Thielmann

given: Matthias

name: Sands Constellation Heart Institute, Rochester Regional Health, Rochester, NY (D.C.).

family: Corteville

full_name: David Corteville

given: David

name: Central German Heart Center University Hospital Halle (Saale), University Clinic and Polyclinic for Cardiac Surgery, Halle, Germany (G.S.).

family: Szabo

full_name: Gabor Szabo

given: Gabor

name: Division of Cardiothoracic Anesthesiology and Critical Care Medicine, Duke University Medical Center, Durham, NC (M.S.).

family: Swaminathan

full_name: Madhav Swaminathan

given: Madhav

name: David Braley Cardiac, Vascular and Stroke Research Institute, McMaster University, Hamilton, ON, Canada (A.L.).

family: Lamy

full_name: Andre Lamy

given: Andre

name: Department of Nephrology and Medical Intensive Care, Charité Universitätsmedizin, Berlin, Germany (L.J.L.).

family: Lehner

full_name: Lukas J. Lehner

given: Lukas J.

name: New Brunswick Heart Centre, The Saint John Regional Hospital, NB, Canada (C.D.B.).

family: Brown

full_name: Craig D. Brown

given: Craig D.

name: Division of Cardiac Surgery, University of Montreal Hospital Center, CHUM Research Center, Montreal, QC, Canada (N.N.).

family: Noiseux

full_name: Nicolas Noiseux

given: Nicolas

name: Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, MD (M.G.A.).

family: Atta

full_name: Mohamed G. Atta

given: Mohamed G.

name: Coastal Vista Consulting LLC, Half Moon Bay, CA (E.C.S.).

family: Squiers

full_name: Elizabeth C. Squiers

given: Elizabeth C.

name: Nephrology Division, Department of Medicine, Indiana University School of Medicine; Indiana Center for Biological Microscopy, Indianapolis (B.M.).

family: Erlich

full_name: Shai Erlich

given: Shai

name: Quark Pharmaceuticals, Inc, Newark, CA (S.E. D.R.).

family: Rothenstein

full_name: Daniel Rothenstein

given: Daniel

family: Molitoris

full_name: Bruce Molitoris

given: Bruce

name: Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Institute of Medical Sciences and Departments of Anesthesia and Physiology, University of Toronto, ON, Canada (C.D.M.).

family: Mazer

full_name: C. David Mazer

given: C. David

journal_name: Circulation

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Hinze C, Karaiskos N, Boltengagen A, Walentin K, Redo K, Himmerkus N, Bleich M, Potter SS, Potter AS, Eckardt KU, Kocks C, Rajewsky N, Schmidt-Ott KM. Kidney Single-cell Transcriptomes Predict Spatial Corticomedullary Gene Expression and Tissue Osmolality Gradients. J Am Soc Nephrol. 2021 Feb;32(2):291-306. doi: 10.1681/ASN.2020070930. Epub 2020 Nov 25.

family: Hinze

full_name: Christian Hinze

given: Christian

family: Karaiskos

full_name: Nikos Karaiskos

given: Nikos

family: Boltengagen

full_name: Anastasiya Boltengagen

given: Anastasiya

family: Walentin

full_name: Katharina Walentin

given: Katharina

journal_name: Journal of the American Society of Nephrology

location_country:
Austria
United States
Germany
France
Czechia
Australia
Belgium
New Zealand
Spain
Canada
United Kingdom

location_facility: University of Louisville Physicians (ULP)

location_facility: Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Lubeck

location_facility: East Carolina Heart Institute at East Carolina University

location_facility: Universitatklinicum Essen Westdeutsches Herzzentrum Essen

location_facility: Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire

location_facility: CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire

location_facility: Universitatsklinikum Heidelberg und Medizinische Fakultat

location_facility: Virginia Commonwealth University Medical Center

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular

location_facility: Klinikum der Friedrich-Schiller-Universitat Jena

location_facility: Krankenhaus der Barmherzigen Bruder Trier

location_facility: Hospital Clinico Universitario de Santiago-CHUS

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Royal Jubilee Hospital (Victoria Island Health Authority)

location_facility: Cardiac & Vascular Research Center of Northern Michigan

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

location_facility: Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie

location_facility: Hospital Universitario Central de Asturias

location_facility: CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire

location_facility: Universitatsklinikum "Carl Gustav Carus" der Technischen Universitat Dresden Klinik fur Herzchirurgle

location_facility: University of Alabama at Birmingham Hospital

location_facility: Foothills Medical Centre, Libin Cardiovascular Institute of Alberta, University of Calgary

location_facility: Hospital Clinic Universitario de Valencia

location_facility: Horizon Health Network, Saint John Regional Hospital

location_facility: Indiana University Health-Methodist Hospital

location_facility: Universitasklinikum Giessen und Marburg GmbH

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: University of Alberta Hospital / Mazankowski Alberta Heart Institute

location_facility: Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC

location_facility: Jacksonville Center for Clinical Research

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center

location_facility: McGill University Health Center - Royal Victoria Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK

location_facility: Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika

location_facility: London Health Sciences Center, University Hospital


title: An Open Label Phase Ib Dose Finding Study of BI 836880 in Combination With Ezabenlimab to Characterize Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer and in Other Solid Tumors

summary:
This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab.

BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor).

The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink.

The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants.

status: Recruiting

ipd_sharing: No

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

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

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

lead_sponsor: Boehringer Ingelheim

location_country:
United States
Hong Kong
France
Japan
Poland
Australia
Russian Federation
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

location_facility: State Budget Healthcare Institution "Saint-Petersburg clinical research center of specialized types of medical care (oncological)"

location_facility: State Budget Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Peninsula & South Eastern Oncology Group

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: The Ohio State University Wexner Medical Center

location_facility: Mandziuk Slawomir Specialist Medical Practice

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: Medical and Preventive Treatment Inst. Volyn Regional, Lutsk

location_facility: "Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, Chemotherapeutic Department with day patient facility".

location_facility: MED POLONIA SP Z O O, Clinical Trials Department,Poznan


title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed

summary:
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult subjects with current virologic suppression on a ≥3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and subject satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, ART-experienced, virologically suppressed subjects. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200.

This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel-group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). Approximately 550 HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL) at Week 144, these subjects will switch to DTG + 3TC up to Week 200.

ReferenceType: background

ReferenceCitation: van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

ReferenceCitation: van Wyk J, Ait-Khaled M, Santos J, Scholten S, Wohlfeiler M, Ajana F, Jones B, Nascimento MC, Tenorio AR, Smith DE, Wright J, Wynne B. Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):794-800. doi: 10.1097/QAI.0000000000002655.

family: van Wyk

full_name: Jean van Wyk

given: Jean

family: Ait-Khaled

full_name: Mounir Ait-Khaled

given: Mounir

family: Santos

full_name: Jesus Santos

given: Jesus

family: Scholten

full_name: Stefan Scholten

given: Stefan

family: Wohlfeiler

full_name: Michael Wohlfeiler

given: Michael

family: Ajana

full_name: Faïza Ajana

given: Faïza

family: Jones

full_name: Bryn Jones

given: Bryn

family: Nascimento

full_name: Maria-Claudia Nascimento

given: Maria-Claudia

family: Tenorio

full_name: Allan R. Tenorio

given: Allan R.

family: Smith

full_name: Don E. Smith

given: Don E.

family: Wright

full_name: Jonathan Wright

given: Jonathan

family: Wynne

full_name: Brian Wynne

given: Brian

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

title: Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study

ipd_sharing: Yes

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

lead_sponsor: ViiV Healthcare

location_country:
United States
Netherlands
Germany
France
Japan
Belgium
Australia
Spain
Canada
United Kingdom


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Austria
Mexico
Spain
Germany
France
Poland
Hungary
Argentina
Australia
Belgium
New Zealand
United States
United Kingdom
Canada
Colombia

acronym: LET vs VGCV for Prevention of CMV disease in Kidney Transplant Recipients

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0162)

location_facility: University of California-San Francisco ( Site 0236)

location_facility: Hospital El Cruce Nestor Carlos Kirchner ( Site 0351)

location_facility: Instituto de Nefrologia Nephrology S.A. ( Site 0182)

location_facility: Saint Barnabas Medical Center ( Site 0250)

location_facility: University of Nebraska Medical Center ( Site 0272)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0071)

location_facility: Pomorski Uniwersytet Medyczny ( Site 0167)

location_facility: Hospital Clinic i Provincial de Barcelona ( Site 0113)

location_facility: Vanderbilt University Medical Center ( Site 0275)

location_facility: Hospital Italiano de Buenos Aires ( Site 0188)

location_facility: Sociedad de Cirugia de Bogota Hospital de San Jose ( Site 0203)

location_facility: Szpital Wojewodzki w Poznaniu ( Site 0168)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0201)

location_facility: University of Alberta Hospital ( Site 0221)

location_facility: Centenario Hospital Miguel Hidalgo ( Site 0215)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0170)

location_facility: Medizinische Hochschule Hannover ( Site 0073)

location_facility: Universitair Ziekenhuis Antwerpen ( Site 0041)

location_facility: Universitaetsklinikum Essen ( Site 0074)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0226)

location_facility: Hospital Universitari Vall de Hebron ( Site 0112)

location_facility: University of Maryland Medical Center ( Site 0234)

location_facility: Virginia Commonwealth University ( Site 0245)

location_facility: Hospital Universitario Miguel Servet ( Site 0118)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0354)

location_facility: Allgemeines Krankenhaus Universitaetskliniken Wien ( Site 0032)

location_facility: Hospital San Vicente Fundación - Rionegro ( Site 0205)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 0055)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0210)

location_facility: The Ohio State University Wexner Medical Center ( Site 0264)

location_facility: Szpital Kliniczny Dzieciatka Jezus ( Site 0165)

location_facility: Princess Alexandra Hospital ( Site 0004)

location_facility: Wake Forest University Baptist Medical Center ( Site 0260)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0214)

location_facility: Medizinische Universitat Innsbruck ( Site 0033)

location_facility: Hopital Henri Mondor du Creteil ( Site 0063)

location_facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 0093)

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 0276)

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0213)

location_facility: Azienda Ospedaliera di Padova U.O.C. Trapianti Rene e Pancreas ( Site 0091)

location_facility: Columbia University Medical Center ( Site 0255)

location_facility: Hospital Universitari de Bellvitge IDIBELL ( Site 0114)

location_facility: Instituto Mexicano de Trasplantes S C ( Site 0212)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 0044)

location_facility: Instituto de Cardiología de Corrientes Juana F. Cabral ( Site 0181)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 0098)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0256)

location_facility: University of Washington Medical Center ( Site 0246)

location_facility: Duke University Medical Center ( Site 0243)

location_facility: Monash Health-Monash Medical Centre ( Site 0008)

location_facility: Royal Prince Alfred Hospital ( Site 0005)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0096)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0209)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 0136)

location_facility: Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 0042)

location_facility: Medical University of South Carolina ( Site 0257)

location_facility: Hospital Universitario Mayor Mederi CIMED ( Site 0206)

type: Other Identifier

title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

summary: The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.


title: Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies

acronym: STRONG-HF

summary: STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard oral heart failure medications during hospitalization for acute heart failure. Patients admitted for acute heart failure will be randomized within 2 days before discharge to either usual care or intensification of treatment with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor blocker ("high intensity care" arm). In the "high intensity care" arm, patients' clinical signs and symptoms of heart failure will be assessed, and routine laboratory measures and biomarkers will be measured, at frequent post-discharge visits. When these measures indicate that it is safe to do so, the doses of the oral heart failure medications will be increased to optimal levels. Patients will be followed through 180 days from randomization. Patients assigned to the usual care group will be followed by their general physician and/or cardiologist according to local medical standards. Patients who were screened but did not meet eligibility criteria will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.

ReferenceCitation: Kimmoun A, Cotter G, Davison B, Takagi K, Addad F, Celutkiene J, Chioncel O, Solal AC, Diaz R, Damasceno A, Duengen HD, Filippatos G, Goncalvesova E, Merai I, Metra M, Ponikowski P, Privalov D, Sliwa K, Sani MU, Voors AA, Shogenov Z, Mebazaa A. Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study. Eur J Heart Fail. 2019 Nov;21(11):1459-1467. doi: 10.1002/ejhf.1575. Epub 2019 Aug 19.

name: INSERM UMR‐S 942, St. Louis and Lariboisère University HospitalsParis University Paris France

family: Kimmoun

full_name: Antoine Kimmoun

given: Antoine

family: Cotter

full_name: Gad Cotter

given: Gad

family: Davison

full_name: Beth Davison

given: Beth

family: Takagi

full_name: Koji Takagi

given: Koji

name: Department of CardiologyAbderrahmen Mami University hospital Ariana Tunisia

family: Addad

full_name: Faouzi Addad

given: Faouzi

name: Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of MedicineVilnius University Vilnius Lithuania

family: Celutkiene

full_name: Jelena Celutkiene

given: Jelena

name: Emergency Institute for Cardiovascular Diseases ‘Prof. C.C. Iliescu’University of Medicine ‘Carol Davila’ Bucharest Romania

family: Chioncel

full_name: Ovidiu Chioncel

given: Ovidiu

name: Department of CardiologyLariboisère University Hospital Paris France

family: Solal

full_name: Alain Cohen Solal

given: Alain Cohen

name: Estudios Clínicos LatinoaméricaInstituto Cardiovascular de Rosario Rosario Argentina

family: Diaz

full_name: Rafael Diaz

given: Rafael

name: Eduardo Mondlane University Hospital Maputo Mozambique

family: Damasceno

full_name: Albertino Damasceno

given: Albertino

name: Department of Internal Medicine ‐ Cardiology, Campus Virchow KlinikumCharité ‐ Universitätsmedizin Berlin Berlin Germany

family: Duengen

full_name: Hans‐Dirk Duengen

given: Hans‐Dirk

name: Heart Failure Unit, Attikon University Hospital, National and Kapodistrian University of Athens, Greece; School of MedicineUniversity of Cyprus Nicosia Cyprus

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

name: Department of Heart Failure and TransplantationNational Institute of Cardiovascular Diseases Bratislava Slovak Republic

family: Goncalvesova

full_name: Eva Goncalvesova

given: Eva

name: Cardiac Care UnitMoscow City Hospital Moscow Russia

family: Merai

full_name: Imad Merai

given: Imad

name: Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public HealthUniversity of Brescia Brescia Italy

family: Metra

full_name: Marco Metra

given: Marco

name: Department of Heart DiseasesWroclaw Medical University Wroclaw Poland

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

name: Critical Cardiac UnitCity Clinical Hospital Moscow Russia

family: Privalov

full_name: Dmitry Privalov

given: Dmitry

name: Division of Cardiology, Department of MedicineGroote Schuur Hospital and University of Cape Town Cape Town South Africa

family: Sliwa

full_name: Karen Sliwa

given: Karen

name: Department of MedicineBayero University Kano Kano Nigeria

family: Sani

full_name: Mahmoud Umar Sani

given: Mahmoud Umar

name: Department of Cardiology, University of GroningenUniversity Medical Centre Groningen Groningen The Netherlands

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

name: Moscow SHI, City Clinical Hospital Moscow Russia

family: Shogenov

full_name: Zaur Shogenov

given: Zaur

name: Department of Anesthesiology and Critical Care MedicineSt. Louis and Lariboisère University Hospitals Paris France

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

title: Safety, Tolerability and efficacy of Rapid Optimization, helped by NT‐proBNP and GDF‐15, of Heart Failure therapies (STRONG‐HF): rationale and design for a multicentre, randomized, parallel‐group study

location_country:
Austria
South Africa
France
Mozambique
Israel
Slovakia
Tunisia
Hungary
Argentina
Nigeria
Russian Federation
Colombia

location_facility: Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital

location_facility: Department of Internal Medicine UVN SNP-FN

location_facility: Saint-Petersburg State Budget HealthCare Institution "City hospital 38 n.a. N.A. Semashko"

location_facility: State Budget Institution "Saint Petersburg state budget research institution of first aid named after I. I. Dzhanelidze"

location_facility: State Budget HealthCare Institution of Vladimir Region "City Hospital 4 of Vladimir"

location_facility: State Budget HealthCare Institution of Moscow "City clinical hospital 15 n.a. O.M. Filatov under Department of HealthCare of Moscow"

location_facility: State Institution of Healthcare of Yaroslavl Region "Clinical Hospital 8"

location_facility: State Budget HealthCare Institution of Moscow "City clinical hospital 29 n.a. N.E. Bauman under Department of HealthCare of Moscow"

location_facility: Saint-Petersburg State Budget Healthcare Institution City Hospital 15

location_facility: Internal Department, NsP Spisska Nova Ves

location_facility: Department of Internal Medicine Hospital Rimavska Sobota

location_facility: State Budget HealthCare Institution "First City clinical hospital named after E.E. Volosevich"

location_facility: V. Internal Clinic, LFUK and UNB Bratislava

location_facility: Rosario Clinical Research Institute - Delta

location_facility: Cardiomet Pereira Clinical Research Center Foundation

location_facility: Internal Department Hospital Arm General L. Svobodu Svidnik

location_facility: Internal Med. 1, St. Josef Hospital Braunau

location_facility: Internal Department, Hospital with Polyclinic Lucenec

location_facility: National Institute of Cardio and Vascular Diseases

location_facility: Cardiology Department at Hietzing Hospital with Neurological Center Rosenhugel

location_facility: Nelson Mandela Academic Hospital, Walter Sisulu University

location_facility: First Internal Clinic, Faculty Hospital with Polyclinic Nove Zamky

location_facility: Diagnostic and Treatment Medical Clinic SA

location_facility: Internal Department, Hospital with Polyclinic Brezno

location_facility: Clin. Dep. Internal Med 3, University Hospital St. Poelten

location_facility: Regional budget Healthcare Institution "Cardiological dispensary"

location_facility: Federal State Budget Educational Institution of Higher Education "Moscow State University n.a. M.V. Lomonosov", independent division Medical research Educational Centre

location_facility: Dept of Medicine Research unit, Maputo Central Hospital

location_facility: State Budget HealthCare Institution of Mosocw "City clinical hospital 51 under Department of HealthCare of Moscow"

location_facility: Center Hospital Regional University of Tours Trousseu Hospital

location_facility: Federal State Budget Educational Institution of Higher Education "Moscow State Medico-Dental University n.a. A.I. Evdokimov", under Ministry of Health of the Russian Federation

location_facility: Russian National Research Medical University n.a. N.I.Pirogov based at City Clinical hospital n.a. V.M.Buyanov DZM

location_facility: Primary Healthcare Unit of the RF Ministry of Internal Affairs in Moscow

location_facility: SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department

location_facility: Dep. Of Cardiology, Medical Univ. Vienna

location_facility: Mavalane Hospital, National Institute of Health

location_facility: Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

location_facility: Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot

location_facility: Municipal Government-financed Institution of Healthcare "City Emergency Hospital" of Rostov-on-Don City

location_facility: Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after academician I.P. Pavlov"

location_facility: Federal State Budget Educational Institution of Higher Education "North-West state medical university n.a. I.I. Mechnikov under the Ministry of Health of the Russian Federation"

location_facility: Internal Department, Dolnooravian Hospital of Dr. L.N.Jege

location_facility: Buda Hospital of the Hospitaller Order of Saint John of God


lead_sponsor: Avanir Pharmaceuticals

location_country:
Italy
South Africa
France
Czechia
Bulgaria
Poland
Hungary
Australia
Spain
United States
United Kingdom

location_facility: North West Boroughs Healthcare NHS Foundation Trust

location_facility: Avon and Wiltshire Mental Health Partnership NHS Trust

location_facility: Dr. Kenessey Albert Kórház-Rendelőintézet

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Clinical Research Associates of South Florida

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: Centro San Giovanni di Dio - Fatebenefratelli

location_facility: First Multiprofile Hospital for Active Treatment Sofia

location_facility: South London and Maudsley NHS Foundation Trust

location_facility: Alzheimer's Research and Treatment Center

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: INEP Medical s.r.o. Institut Neuropsychiatricke Pece

location_facility: Northamptonshire Healthcare NHS Foundation Trust

location_facility: Complejo Asistencial de Zamora Hospital Virgen de la Concha

location_facility: Australian Alzheimer's Research Foundation

location_facility: Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej

location_facility: Centre Hospitalier Universitaire Dijon Bourgogn

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord

location_facility: DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Università degli studi G.D'Annunzio Chieti Pescara

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire Toulouse - Casselardit Ancely

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Alliance for Wellness, Inc dba Alliance for Research

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Nathan S. Kline Institute for Psychiatric Research

location_facility: Clinline Services s.r.0 Psychiatricka Ambulance

location_facility: Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Research Institute for the Care of Older People

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

location_facility: CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság

location_facility: Valeomed Egeszsegugyi es Szolgaltato Kft

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

location_facility: Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

summary: This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.


title: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma

summary:
Brief Summary:

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

family: Stupp

full_name: Roger Stupp

given: Roger

family: Wong

full_name: Eric T. Wong

given: Eric T.

family: Kanner

full_name: Andrew A. Kanner

given: Andrew A.

family: Steinberg

full_name: David Steinberg

given: David

family: Engelhard

full_name: Herbert Engelhard

given: Herbert

family: Heidecke

full_name: Volkmar Heidecke

given: Volkmar

family: Kirson

full_name: Eilon D. Kirson

given: Eilon D.

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Liebermann

full_name: Frank Liebermann

given: Frank

family: Dbalý

full_name: Vladimir Dbalý

given: Vladimir

family: Ram

full_name: Zvi Ram

given: Zvi

family: Villano

full_name: J. Lee Villano

given: J. Lee

family: Rainov

full_name: Nikolai Rainov

given: Nikolai

family: Weinberg

full_name: Uri Weinberg

given: Uri

family: Schiff

full_name: David Schiff

family: Kunschner

full_name: Lara Kunschner

given: Lara

family: Raizer

full_name: Jeffrey Raizer

given: Jeffrey

family: Honnorat

full_name: Jerome Honnorat

given: Jerome

family: Sloan

full_name: Andrew Sloan

given: Andrew

family: Malkin

full_name: Mark Malkin

given: Mark

family: Landolfi

full_name: Joseph C. Landolfi

given: Joseph C.

family: Payer

full_name: Franz Payer

given: Franz

family: Mehdorn

full_name: Maximilian Mehdorn

title: NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

name: University Hospital Zurich and University of Zurich, Zurich, Switzerland2Lausanne University Hospital (CHUV), Lausanne, Switzerland

name: Assistance Publique des Hôpitaux de Paris, La Pitié-Salpétrière-University Hospital, Pierre and Marie Curie University, Paris, France

name: Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

name: Geisinger Health System, Danville, Pennsylvania

name: Tufts Medical Center, Boston, Massachusetts

name: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

name: Istituto Nazionale Neurologico Carlo Besta, Milan, Italy

name: Baylor University Medical Center, Dallas, Texas

name: Cleveland Clinic Foundation, Cleveland, Ohio

name: Baylor University Medical Center, Dallas, Texas13University of Texas Health Science Center, Houston

name: Swedish Neuroscience Institute, Seattle, Washington

name: University of Southern California, Los Angeles

name: Washington University Barnes-Jewish Hospital, St Louis, Missouri

name: Na Homolce Hospital, Prague, Czech Republic

name: New Jersey Neuroscience Institute, Edison

name: Fondazione Ospedale Maggiore Policlinico, Milan, Italy

name: Houston Methodist Hospital, Houston, Texas

name: Hospices Civils de Lyon, University Claude Bernard Lyon 1, Lyon, France

ReferenceCitation: Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum in: JAMA. 2018 May 1;319(17):1824.

name: Lou and Jean MalnatiBrain Tumor Institute of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Feinberg School of Medicine, Chicago, Illinois

name: Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland

name: Inserm U 1127, CNRS UMR 7225, Sorbonne Universités, UPMC Univ Paris 06 UMR S 1127, Institut du Cerveau et de la Moelle épinière, ICM, F-75013, Paris, France

name: Tel Aviv Medical Center, Tel Aviv, Israel

name: Baylor University Medical Center, Houston, Texas

name: University of Texas Health Sciences Center at Houston

name: University of Pennsylvania, Philadelphia

name: Seoul National University Bundang Hospital, Seoul National University College of Medicine, Bundang, Korea

name: Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

name: Hospital Universitario de Bellvitge, Barcelona, Spain

name: Juravinski Cancer Centre, Hamilton, Ontario, Canada

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Italy
Austria
United States
Hong Kong
Switzerland
Germany
Croatia
Czechia
France
Israel
Poland
Hungary
Belgium
Spain
Canada

location_facility: Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale

location_facility: Univ. Klinik für Innere Medizin III der PMU

location_facility: Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive

location_facility: Maryland Oncology Hematology, P.A - US Oncology Research

location_facility: HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC

location_facility: Willamette Valley Cancer Institute and Research Center - US Oncology Research

location_facility: Centre Hospitalier de I'Universitaire de de Montreal (CHUM)

location_facility: West Virginia University Cancer Institute

location_facility: Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine

location_facility: Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research

location_facility: A.O. SS Antonio e Biagio e Cesare Arrigo

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario Carlos Haya de Malaga

location_facility: Oncology and Radiotherapy Clinic, Oncology Center - Institute

location_facility: Texas Oncology - Bedford - US Oncology Reasearch

location_facility: Cancer and Hematology Centers of Western Michigan, PC

location_facility: Central Maine Medical Center, Clinical Research Department

location_facility: Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Jan Mikulicz-Radecki University Teaching Hospital

location_facility: University of Kansas Medical Cancer Center

location_facility: Texas Oncology - Tyler - US Oncology Research

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: Illinois Cancer Specialist - US Oncology Research

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Texas Oncology - Baylor - US Oncology Research

location_facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS

location_facility: Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research

location_facility: Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: A.O.U Città della Salute e della Scienza di Torino

location_facility: University of Maryland Comprehensive Cancer Center

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research

location_facility: Sourasky Medical Center, Oncology Department

location_facility: Centre Hospitalier de Bretagne Sud /Site du Scorff

location_facility: Arizona Oncology Associates, PC- HOPE - US Oncology Research

location_facility: Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie


status: Completed

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

lead_sponsor: UCB Biopharma S.P.R.L.

location_country:
Italy
United States
Mexico
Spain
Germany
France
Bulgaria
Czechia
Japan
Lithuania
Poland
Hungary
Belgium
Australia
Slovakia
Portugal
Turkey
Canada
United Kingdom

acronym: ARISE

title: A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

summary: The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

status_simplified: Completed


lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Italy
Austria
Sweden
Germany
Finland
France
Czechia
Poland
Israel
Hungary
Australia
Spain
Canada
United Kingdom

location_facility: Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5

location_facility: IRCSS Neuromed Istituto Neurologico Mediterraneo

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Seconda Univesità degli Studi di Napoli, AOU

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

location_facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

location_facility: CHU Montpellier-Nîmes - Hôpital Caremeau

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

title: A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)

summary: The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).


title: A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

summary: This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

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

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

location_facility: Institute of Neurology and Neurosurgery at St. Barnabas

location_facility: Hôpital Universitaire Necker-Enfants Malades Service de neurologie pédiatrique

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

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

location_facility: Massachusetts General Hospital For Children

location_facility: National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: CHRU de Lille Hopital Roger Salengro Neurophysiologie Clinique (RDC)

location_facility: MultiCare Institute for Research & Innovation

location_facility: AP-HM - CHU TIMONE ENFANTS Service de Neurologie Pédiatrique

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Hôpital des enfants- Pellegrin- CIC Pédiatrique

location_facility: Universitätsklinikum Freiburg Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: Universitätsklinikum Jena - Klinik für Neuropädiatrie /SPZ

location_facility: Istituto Scienze Neurologiche di Bologna, Ospedale Bellaria

location_facility: Hôpital Universitaire Des Enfants Reine Fabiola

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: Hospital Ruber Internacional Servicio de Neurologia

location_facility: Hôpital Robert Debré Pédiatrie Médicale Service Neurologie Et Maladies Métaboliques Robert-debré

location_facility: AOU Anna Meyer Clinica di Neurologia Pediatrica

location_facility: Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital

location_facility: Tokyo Women's Medical University Hospital

location_facility: Schoen Klinik Vogtareuth - Klinik fuer Neuropediatrie und Neurologische Rehabilitation

location_facility: Clinical Integrative Research Center of Atlanta, Panda Neurology


ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Lexicon Pharmaceuticals

location_country:
Italy
United Kingdom
Mexico
France
Czechia
Bulgaria
Slovakia
Russian Federation
Spain
United States
Latvia
Canada

acronym: SOTA-EMPA

location_facility:
Investigational Site Number 8408061
Investigational Site Number 2038004
Investigational Site Number 8408008
Investigational Site Number 8408011
Investigational Site Number 8408051
Investigational Site Number 6438013
Investigational Site Number 2508001
Investigational Site Number 1008011
Investigational Site Number 8408007
Investigational Site Number 8408028
Investigational Site Number 2038007
Investigational Site Number 2038001
Investigational Site Number 3808004
Investigational Site Number 4288006
Investigational Site Number 6438006
Investigational Site Number 8408037
Investigational Site Number 8408040
Investigational Site Number 7248006
Investigational Site Number 7248004
Investigational Site Number 1008001
Investigational Site Number 7248010
Investigational Site Number 2038011
Investigational Site Number 8408069
Investigational Site Number 8408074
Investigational Site Number 8408006
Investigational Site Number 1008007
Investigational Site Number 7038005
Investigational Site Number 3808010
Investigational Site Number 8408001
Investigational Site Number 8408035
Investigational Site Number 4848001
Investigational Site Number 8408022
Investigational Site Number 8408041
Investigational Site Number 1248007
Investigational Site Number 8408027
Investigational Site Number 8408016
Investigational Site Number 7248005
Investigational Site Number 1008003
Investigational Site Number 2038005
Investigational Site Number 4848005
Investigational Site Number 6438015
Investigational Site Number 8408009
Investigational Site Number 6438008
Investigational Site Number 7248007
Investigational Site Number 7038003
Investigational Site Number 4848007
Investigational Site Number 8408019
Investigational Site Number 7248002
Investigational Site Number 8268008
Investigational Site Number 1248009
Investigational Site Number 8408033
Investigational Site Number 1248001
Investigational Site Number 7248009
Investigational Site Number 2038006
Investigational Site Number 7038004
Investigational Site Number 8408067
Investigational Site Number 4288003
Investigational Site Number 8408047
Investigational Site Number 8268002
Investigational Site Number 8408042
Investigational Site Number 4288001
Investigational Site Number 7038006
Investigational Site Number 2038002
Investigational Site Number 8408049
Investigational Site Number 1008006
Investigational Site Number 4848011
Investigational Site Number 6438012
Investigational Site Number 2038013
Investigational Site Number 1248010
Investigational Site Number 3808009
Investigational Site Number 4288007
Investigational Site Number 6438003
Investigational Site Number 8408018
Investigational Site Number 4288008
Investigational Site Number 7038002
Investigational Site Number 8408012
Investigational Site Number 3808005
Investigational Site Number 1008005
Investigational Site Number 4848012
Investigational Site Number 3808008
Investigational Site Number 2038008
Investigational Site Number 4288004
Investigational Site Number 3808001
Investigational Site Number 1008008
Investigational Site Number 3808003
Investigational Site Number 8408013
Investigational Site Number 3808006
Investigational Site Number 2508006
Investigational Site Number 4848003
Investigational Site Number 8408004
Investigational Site Number 8408060
Investigational Site Number 8408054
Investigational Site Number 8408079
Investigational Site Number 2038010
Investigational Site Number 8268003
Investigational Site Number 8408082
Investigational Site Number 1248005
Investigational Site Number 8408010
Investigational Site Number 8408038
Investigational Site Number 8408059
Investigational Site Number 1248011
Investigational Site Number 2038003
Investigational Site Number 3808011
Investigational Site Number 6438002
Investigational Site Number 1008004
Investigational Site Number 7248003
Investigational Site Number 2508007
Investigational Site Number 8408044
Investigational Site Number 7038008
Investigational Site Number 8268001
Investigational Site Number 1008012
Investigational Site Number 2508005
Investigational Site Number 7248001
Investigational Site Number 8408005
Investigational Site Number 8408039
Investigational Site Number 1008010
Investigational Site Number 7038009
Investigational Site Number 8268004
Investigational Site Number 6438005
Investigational Site Number 1248008
Investigational Site Number 8268005
Investigational Site Number 1248003
Investigational Site Number 1248002
Investigational Site Number 8408068
Investigational Site Number 8408072
Investigational Site Number 3808007
Investigational Site Number 6438010
Investigational Site Number 6438014
Investigational Site Number 8408029
Investigational Site Number 8408056
Investigational Site Number 8408026
Investigational Site Number 4288002
Investigational Site Number 7038001
Investigational Site Number 6438011
Investigational Site Number 3808002
Investigational Site Number 4288005
Investigational Site Number 6438009
Investigational Site Number 8408045
Investigational Site Number 6438001
Investigational Site Number 8268006
Investigational Site Number 8408003
Investigational Site Number 1008002
Investigational Site Number 6438007
Investigational Site Number 8408032
Investigational Site Number 2038009
Investigational Site Number 7248008
Investigational Site Number 8408053
Investigational Site Number 8408031
Investigational Site Number 8268007
Investigational Site Number 8408052
Investigational Site Number 8408002
Investigational Site Number 1248004
Investigational Site Number 7038007
Investigational Site Number 8408036
Investigational Site Number 2508004
Investigational Site Number 4848002
Investigational Site Number 2508002
Investigational Site Number 8408064
Investigational Site Number 8408017
Investigational Site Number 2508003

title: A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

summary: The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.


ReferenceCitation: Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2021 Dec 3. doi: 10.1007/s10549-021-06450-x. [Epub ahead of print]

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
North Macedonia
Greece
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
Costa Rica
France
Japan
Poland
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
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Spain
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location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

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

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

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

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Memorial Sloan Kettering Cancer Center at Nassau

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

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

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: FSI Rostov research oncological institute of MoH and SD of RF; PAD

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Medipol University MF; Oncology Department

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy

location_facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

location_facility: National Cancer Centre; Medical Oncology

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Sakarya University Medical School; Medical Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

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

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: National Cancer Institute MOH of Ukraine

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: National Hospital Organization Osaka National Hospital

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Memorial Sloan Kettering Cancer Center; MSK Monmouth

location_facility: Ospedale Santa Maria Annunziata; Oncologia

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

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

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Clinico Universitario; Oncologia

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: Showa University Hospital; Breast Surgery

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

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

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Kinki University Hospital, Faculty of Medicine; Surgery

location_facility: Hospital de Donostia; Servicio de Oncologia

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: St. Marianna University School of Medicine Hospital

location_facility: University Hospital coventry; Oncology Department

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Memorial Sloan Kettering Cancer Center at Bergen

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Hosp Provincial D. Centenarios; Oncology Dept

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

title: A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

summary: This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.