ReferenceCitation: Clement PMJ, Dirven L, Eoli M, Sepulveda-Sanchez JM, Walenkamp AME, Frenel JS, Franceschi E, Weller M, Chinot O, De Vos FYFL, Whenham N, Sanghera P, Looman J, Kundu MG, Peter de Geus J, Nuyens S, Spruyt M, Gorlia T, Coens C, Golfinopoulos V, Reijneveld JC, van den Bent MJ. Impact of depatuxizumab mafodotin on health-related quality of life and neurological functioning in the phase II EORTC 1410/INTELLANCE 2 trial for EGFR-amplified recurrent glioblastoma. Eur J Cancer. 2021 Apr;147:1-12. doi: 10.1016/j.ejca.2021.01.010. Epub 2021 Feb 15.

family: Clement

full_name: Paul M.J. Clement

given: Paul M.J.

family: Dirven

full_name: Linda Dirven

given: Linda

family: Eoli

full_name: Marica Eoli

given: Marica

family: Sepulveda-Sanchez

full_name: Juan M. Sepulveda-Sanchez

given: Juan M.

family: Walenkamp

full_name: Annemiek M.E. Walenkamp

given: Annemiek M.E.

family: Frenel

full_name: Jean S. Frenel

given: Jean S.

family: Franceschi

full_name: Enrico Franceschi

given: Enrico

family: Weller

full_name: Michael Weller

given: Michael

family: Chinot

full_name: Olivier Chinot

given: Olivier

family: De Vos

full_name: Filip Y.F.L. De Vos

given: Filip Y.F.L.

family: Whenham

full_name: Nicolas Whenham

given: Nicolas

family: Sanghera

full_name: Paul Sanghera

given: Paul

family: Looman

full_name: Jim Looman

given: Jim

family: Kundu

full_name: Madan G. Kundu

given: Madan G.

family: Peter de Geus

full_name: Jan Peter de Geus

given: Jan

family: Nuyens

full_name: Sarah Nuyens

given: Sarah

family: Spruyt

full_name: Maarten Spruyt

given: Maarten

family: Gorlia

full_name: Thierry Gorlia

given: Thierry

family: Coens

full_name: Corneel Coens

given: Corneel

family: Golfinopoulos

full_name: Vassilis Golfinopoulos

given: Vassilis

family: Reijneveld

full_name: Jaap C. Reijneveld

given: Jaap C.

family: van den Bent

full_name: Martin J. van den Bent

given: Martin J.

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

ReferenceCitation: Van Den Bent M, Eoli M, Sepulveda JM, Smits M, Walenkamp A, Frenel JS, Franceschi E, Clement PM, Chinot O, De Vos F, Whenham N, Sanghera P, Weller M, Dubbink HJ, French P, Looman J, Dey J, Krause S, Ansell P, Nuyens S, Spruyt M, Brilhante J, Coens C, Gorlia T, Golfinopoulos V. INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma. Neuro Oncol. 2020 May 15;22(5):684-693. doi: 10.1093/neuonc/noz222. Erratum in: Neuro Oncol. 2021 Aug 2;23(8):1415.

name: Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands

name: Department of Neurology, Carlo Besta Institute, Milan, Italy

name: University Hospital 12 October, Madrid, Spain

name: Department of Radiology, Erasmus MC, Rotterdam, the Netherlands

name: Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands

name: Department of Medical Oncology, René Gauducheau Center for Cancer Care, Nantes, France

name: Department of Medical Oncology, Local Health Unit Agency/Scientific Institute for Research, Hospitalization, and Healthcare (AUSL/IRCCS) Neurological Sciences, Bologna, Italy

name: Department of Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium

name: Department of Neuro-Oncology, Institute of Neurophysiopathology, Aix-Marseille University, Marseille, France

name: Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands

name: Department of Medical Oncology, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium

name: University Hospitals Birmingham, Birmingham, UK

name: Department of Neurology, University Hospital Zurich, Zurich, Switzerland

name: Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands

name: Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.

name: Department of Neurology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA

name: Erasmus MC Cancer Institute, Rotterdam, Netherlands

name: School of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia

name: Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia

name: Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA

name: Northwestern University, Chicago, Illinois, USA

name: Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA

name: Department of Medical Oncology, University of Queensland School of Medicine, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia

name: Henry Ford Health System, Detroit, Michigan, USA

name: University of Alabama at Birmingham, Birmingham, Alabama, USA

name: South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, USA

name: The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

name: NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia

name: Medical Oncology, Royal North Shore Hospital, Sydney, New South Wales, Australia

name: AbbVie Inc., North Chicago, Illinois, USA

name: NorthShore University Health System, Evanston, Illinois, USA

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

title: Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients withEGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial

ReferenceCitation: Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.

name: Department of Medical Oncology, Austin Health and Olivia Newton-John Cancer Research Institute, Melbourne, Victoria, Australia

name: School of Cancer Medicine, La Trobe University School of Cancer Medicine, Melbourne, Victoria, Australia

name: Department of Neurology & Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, USA

name: Department of Neurology, NorthShore University HealthSystem, Evanston, Illinois, USA

name: Neuro-Oncology Unit, Erasmus MC Cancer Center, Rotterdam, the Netherlands

name: Department of Neurological Surgery, University of California, San Francisco, California, USA

name: South Texas Accelerated Research Therapeutics, San Antonio, Texas, USA

name: Department of Neurology, Northwestern University, Chicago, Illinois, USA

ReferenceCitation: Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Finland
Australia
Belgium
Taiwan
France
Poland
Canada
Korea, Republic of
Switzerland
Netherlands
Singapore
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Spain

location_facility: Universitair Medisch Centrum Groningen /ID# 138266

location_facility: Cliniques Universitaires Saint Luc /ID# 139391

location_facility: China Medical University Hosp /ID# 136976

location_facility: Guy's and St Thomas' NHS Found /ID# 140312

location_facility: Universitatsklinikum Tubingen /ID# 137923

location_facility: Children's Hospital Colorado /ID# 153677

location_facility: Azienda Ospedaliera Sant' Andrea /ID# 138337

location_facility: Southern Medical Day Care Ctr /ID# 134495

location_facility: Cleveland Clinic Main Campus /ID# 137540

location_facility: LMU Klinikum der Universität München /ID# 137922

location_facility: University Hospital St. Polten /ID# 139070

location_facility: UT Southwestern Medical Center /ID# 136718

location_facility: Taipei Veterans General Hosp /ID# 136974

location_facility: Institut de Cancer de l'Ouest /ID# 137914

location_facility: Universitaetsklinik Heidelberg /ID# 137924

location_facility: Instituto Catalán de Oncología (ICO) Badalona /ID# 140976

location_facility: Univ of Colorado Cancer Center /ID# 134882

location_facility: Univ Hospitals Birmingham NHS Foundation trust /ID# 136978

location_facility: Univ Klinik Eppendorf Hamburg /ID# 137921

location_facility: Montreal Neurological Institut /ID# 136309

location_facility: Christie NHS Foundation Trust /ID# 140313

location_facility: Port Macquarie Base Hospital /ID# 134569

location_facility: Universitatsklinik Regensburg /ID# 137920

location_facility: Long Island Brain Tumor Center /ID# 134496

location_facility: National University Hospital /ID# 135951

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395

location_facility: Clinica Universitar de Navarra - Pamplona /ID# 140047

location_facility: National Institute of Oncology /ID# 135970

location_facility: Helsinki Univ Central Hospital /ID# 140078

location_facility: AZ St-Jan Brugge-Oostende AV /ID# 137927

location_facility: Instituto Catalan de Oncologia (ICO) & Hosp. de Bellvitge /ID# 137688

location_facility: Ospedale Generale di Bolzano /ID# 138338

location_facility: Sarah Cannon Research Institute at HealthONE - Denver /ID# 141798

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 137919

location_facility: Debreceni Egyetem Klinikai Központ /ID# 135969

location_facility: Lucile Packard Children's Hosp /ID# 153678

location_facility: Wojewodzkie Wielospecjalistycz /ID# 137654

location_facility: Orszagos Klinikai Idegtudomany /ID# 135971

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 137916

location_facility: Taichung Veterans General Hosp /ID# 136977

location_facility: University College Hospitals /ID# 136879

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 139068

location_facility: Universitair Medisch Centrum Utrecht /ID# 137219

location_facility: Institut de Cancer de l'Ouest /ID# 137909

location_facility: Dana-Farber Cancer Institute /ID# 154210

location_facility: Linkou Chang Gung Memorial Ho /ID# 136944

location_facility: Helsinki Univ Central Hospital /ID# 153069

location_facility: Seoul National University Hospital /ID# 136840

location_facility: Barwon Health University Hospital Geelong /ID# 134493

location_facility: Vrije Universiteit Medisch Centrum /ID# 137221

location_facility: National Cancer Ctr Singapore /ID# 135952

location_facility: KK Women's & Children Hospital /ID# 153676

location_facility: Great Ormond St Hospital NHS /ID# 153421

location_facility: Centre Hospitalier Univ Vaudoi /ID# 137929

location_facility: Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 138335

location_facility: Seoul National Univ Bundang ho /ID# 136841

location_facility: Rush University Medical Center /ID# 137542

location_facility: Royal Brisbane and Women's Hospital /ID# 147091

title: INTELLANCE-2: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group

summary: This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.


title: Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma

summary: To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Educational/Counseling/Training

lead_sponsor: LEO Pharma

location_country:
Italy
France
Spain
Canada
United Kingdom

location_facility: E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)

location_facility: E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)

location_facility: E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)

location_facility: E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)

location_facility: E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: U.S. NIH Grant/Contract

title: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

acronym: ISCHEMIA

summary:
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.

SPECIFIC AIMS

A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.

B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.

Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH

Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH

Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Maron DJ, Stone GW, Berman DS, Mancini GB, Scott TA, Byrne DW, Harrell FE Jr, Shaw LJ, Hachamovitch R, Boden WE, Weintraub WS, Spertus JA. Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists. Am Heart J. 2011 Dec;162(6):1034-1043.e13. doi: 10.1016/j.ahj.2011.09.001.

ReferenceCitation: Phillips LM, Hachamovitch R, Berman DS, Iskandrian AE, Min JK, Picard MH, Kwong RY, Friedrich MG, Scherrer-Crosbie M, Hayes SW, Sharir T, Gosselin G, Mazzanti M, Senior R, Beanlands R, Smanio P, Goyal A, Al-Mallah M, Reynolds H, Stone GW, Maron DJ, Shaw LJ. Lessons learned from MPI and physiologic testing in randomized trials of stable ischemic heart disease: COURAGE, BARI 2D, FAME, and ISCHEMIA. J Nucl Cardiol. 2013 Dec;20(6):969-75. doi: 10.1007/s12350-013-9773-4. Review.

ReferenceCitation: ISCHEMIA Trial Research Group, Maron DJ, Hochman JS, O'Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, Shaw L, Berger JS, Ferguson TB Jr, Williams DO, Harrington RA, Rosenberg Y. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018 Jul;201:124-135. doi: 10.1016/j.ahj.2018.04.011. Epub 2018 Apr 21. Review.

ReferenceCitation: Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ; ISCHEMIA Research Group. Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):273-286. doi: 10.1001/jamacardio.2019.0014. Erratum in: JAMA Cardiol. 2019 May 1;4(5):497.

ReferenceType: derived

ReferenceCitation: Newman JD, Anthopolos R, Mancini GBJ, Bangalore S, Reynolds HR, Kunichoff DF, Senior R, Peteiro J, Bhargava B, Garg P, Escobedo J, Doerr R, Mazurek T, Gonzalez-Juanatey J, Gajos G, Briguori C, Cheng H, Vertes A, Mahajan S, Guzman LA, Keltai M, Maggioni AP, Stone GW, Berger JS, Rosenberg YD, Boden WE, Chaitman BR, Fleg JL, Hochman JS, Maron DJ. Outcomes of Participants With Diabetes in the ISCHEMIA Trials. Circulation. 2021 Oct 26;144(17):1380-1395. doi: 10.1161/CIRCULATIONAHA.121.054439. Epub 2021 Sep 15.

name: NYU Grossman School of Medicine, New York, NY

family: Newman

full_name: Jonathan D. Newman

given: Jonathan D.

sequence: first

family: Anthopolos

full_name: Rebecca Anthopolos

given: Rebecca

sequence: additional

name: Center for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada

family: Mancini

full_name: G. B. John Mancini

given: G. B. John

family: Bangalore

full_name: Sripal Bangalore

given: Sripal

family: Reynolds

full_name: Harmony R. Reynolds

given: Harmony R.

family: Kunichoff

full_name: Dennis F. Kunichoff

given: Dennis F.

name: Northwick Park Hospital-Royal Brompton Hospital, London, UK

family: Senior

full_name: Roxy Senior

given: Roxy

name: CHUAC, Universidad de A Coruña, CIBERCV, A Coruna, Spain

family: Peteiro

full_name: Jesus Peteiro

given: Jesus

family: Bhargava

full_name: Balram Bhargava

given: Balram

name: London Health Sciences Center, Western University, London, Ontario, Canada

family: Garg

full_name: Pallav Garg

given: Pallav

name: Instituto Mexicano del Seguro Social, Mexico City, Mexico

family: Escobedo

full_name: Jorge Escobedo

given: Jorge

name: Praxisklinik Herz und Gefaesse, Dresden, Germany

family: Doerr

full_name: Rolf Doerr

given: Rolf

name: Medical University of Warsaw, Warsaw, Poland

family: Mazurek

full_name: Tomasz Mazurek

given: Tomasz

name: Cardiology Department, Hospital Clínico Universitario. IDIS, CIBERCV Institution, Santiago de Compostela, Spain

family: Gonzalez-Juanatey

full_name: Jose Gonzalez-Juanatey

given: Jose

name: Department of Coronary Disease and Heart Failure, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland

family: Gajos

full_name: Grzegorz Gajos

given: Grzegorz

name: Clinica Mediterranea S.p.A, Naples, Italy

family: Briguori

full_name: Carlo Briguori

given: Carlo

name: Beijing Anzhen Hospital, Capital Medical University, Beijing, China

family: Cheng

full_name: Hong Cheng

given: Hong

name: DPC Hospital, National Institute of Hematology and Infectious Disease, Cardiovascular Department, Budapest, Hungary

family: Vertes

full_name: Andras Vertes

given: Andras

name: All India Institute of Medical Sciences, Delhi, India

family: Mahajan

full_name: Sandeep Mahajan

given: Sandeep

name: Instituto Medico DAMIC, Cordoba, Argentina

family: Guzman

full_name: Luis A. Guzman

given: Luis A.

name: Semmelweis University, Budapest, Hungary

family: Keltai

full_name: Matyas Keltai

given: Matyas

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

name: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York, NY

name: National Institute of Health- NHLBI, Bethesda, MD

name: VA New England Healthcare System, Boston University School of Medicine, Boston, MA

name: St Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis, MO

name: Department of Medicine, Stanford University, Stanford, CA

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Outcomes of Participants with Diabetes in the ISCHEMIA Trials

ReferenceCitation: Lopez-Sendon JL, Cyr DD, Mark DB, Bangalore S, Huang Z, White HD, Alexander KP, Li J, Nair RG, Demkow M, Peteiro J, Wander GS, Demchenko EA, Gamma R, Gadkari M, Poh KK, Nageh T, Stone PH, Keltai M, Sidhu M, Newman JD, Boden WE, Reynolds HR, Chaitman BR, Hochman JS, Maron DJ, O'Brien SM. Effects of initial invasive vs. initial conservative treatment strategies on recurrent and total cardiovascular events in the ISCHEMIA trial. Eur Heart J. 2021 Sep 13. pii: ehab509. doi: 10.1093/eurheartj/ehab509. [Epub ahead of print]

title: OUP accepted manuscript

ReferenceCitation: Reynolds HR, Shaw LJ, Min JK, Page CB, Berman DS, Chaitman BR, Picard MH, Kwong RY, O'Brien SM, Huang Z, Mark DB, Nath RK, Dwivedi SK, Smanio PEP, Stone PH, Held C, Keltai M, Bangalore S, Newman JD, Spertus JA, Stone GW, Maron DJ, Hochman JS. Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity. Circulation. 2021 Sep 28;144(13):1024-1038. doi: 10.1161/CIRCULATIONAHA.120.049755. Epub 2021 Sep 9.

name: Weill Cornell Medicine / New York Presbyterian Hospital, New York, NY

name: Duke Clinical Research Institute, Durham, NC

name: Massachusetts General Hospital and Harvard Medical School, MA

name: Brigham and Women's Hospital, Boston, MA

name: Dr. Ram Manohar Lohia Hospital, New Delhi, India

name: King George's Medical University, Lucknow, Uttar Pradesh, India

name: Instituto Dante Pazzanese de Cardiologia e Fleury Medicina e Saúde, São Paulo, Brazil

name: Dept of Medical Sciences, Cardiology, Uppsala University and Uppsala Clinical Research Center, Uppsala, Sweden

name: Saint Luke's Mid America Heart Institute/Univeristy of Missouri - Kansas City (UMKC), MO

title: Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity

ReferenceCitation: White HD, O'Brien SM, Alexander KP, Boden WE, Bangalore S, Li J, Manjunath CN, Lopez-Sendon JL, Peteiro J, Gosselin G, Berger JS, Maggioni AP, Reynolds HR, Hochman JS, Maron DJ. Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management: A Prespecified Analysis of the ISCHEMIA Trial. JAMA Cardiol. 2021 Sep 1;6(9):1023-1031. doi: 10.1001/jamacardio.2021.1651.

name: Green Lane Cardiovascular Services, Auckland City Hospital, University of Auckland, Auckland, New Zealand

name: Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina

name: VA New England Healthcare System, Boston University School of Medicine, Boston, Massachusetts

name: NYU Grossman School of Medicine, New York, New York

name: Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India

name: Hospital Universitario La Paz, Idipaz, Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBER-CV), Madrid, Spain

name: Hospital Universitario A Coruña, Universidad de A Coruña, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBER-CV), A Coruña, Spain

name: Montreal Heart Institute, Montreal, Quebec, Canada

name: Department of Medicine, Stanford University, Stanford, California

ReferenceCitation: Chaitman BR, Alexander KP, Cyr DD, Berger JS, Reynolds HR, Bangalore S, Boden WE, Lopes RD, Demkow M, Piero Perna G, Riezebos RK, McFalls EO, Banerjee S, Bagai A, Gosselin G, O'Brien SM, Rockhold FW, Waters DD, Thygesen KA, Stone GW, White HD, Maron DJ, Hochman JS; ISCHEMIA Research Group. Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons. Circulation. 2021 Feb 23;143(8):790-804. doi: 10.1161/CIRCULATIONAHA.120.047987. Epub 2020 Dec 3.

name: Saint Louis University School of Medicine, MO (B.R.C.).

name: Duke Clinical Research Institute, Durham, NC (K.P.A., D.D.C., R.D.L., S.M.O., F.W.R.).

name: New York University Grossman School of Medicine, New York (J.S.B., H.R.R., S.B., J.S.H.).

name: VA New England Healthcare System, Boston, MA (W.E.B.).

name: Institute of Cardiology, Warsaw, Poland (M.D.).

name: Ospedali Riuniti of Ancona, Italy (G.P.P.).

name: Heartcentre OLVG, Amsterdam, The Netherlands (R.K.R.).

name: Minneapolis V.A. Medical Center, MN (E.O.M.).

name: Veterans Affairs North Texas Health Care System, Dallas (S.B.).

name: Terrence Donnelly Heart Centre, St Michael’s Hospital, University of Toronto, ON, Canada (A.B.).

name: Montreal Heart Institute, QC, Canada (G.G.).

name: University of California, San Francisco (D.D.W.).

name: Aarhus University Hospital, Denmark (K.A.T.).

name: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and the Cardiovascular Research Foundation, New York, NY (G.W.S.).

name: Green Lane Cardiovascular Services, Auckland City Hospital, and University of Auckland, New Zealand (H.D.W.).

name: Department of Medicine, Stanford University School of Medicine, CA (D.J.M.).

name: On behalf of the ISCHEMIA Research Group

title: Myocardial Infarction in the ISCHEMIA Trial

ReferenceCitation: Lopes RD, Alexander KP, Stevens SR, Reynolds HR, Stone GW, Piña IL, Rockhold FW, Elghamaz A, Lopez-Sendon JL, Farsky PS, Chernyavskiy AM, Diaz A, Phaneuf D, De Belder MA, Ma YT, Guzman LA, Khouri M, Sionis A, Hausenloy DJ, Doerr R, Selvanayagam JB, Maggioni AP, Hochman JS, Maron DJ. Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial. Circulation. 2020 Nov 3;142(18):1725-1735. doi: 10.1161/CIRCULATIONAHA.120.050304. Epub 2020 Aug 29. Erratum in: Circulation. 2020 Oct 13;142(15):e236.

name: Duke University Medical Center, Durham, NC (R.D.L., M.K.).

name: Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).

name: NYU Grossman School of Medicine, New York (H.R.R., J.S.H.).

name: Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York (G.W.S.).

name: Wayne State University/Central Michigan University, Detroit (I.L.P.).

name: Northwick Park Hospital–Royal Brompton Hospital, London, UK (A.E.).

name: Hospital Universitario La Paz, IdiPaz, CIBER-CV, Madrid, Spain (J.L.L.-S.).

name: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (P.S.F.).

name: E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Moscow, Russia (A.M.C.).

name: CIUSSS-MCQ, University of Montreal, Campus Mauricie, Trois-Rivieres, Canada (A.D.).

name: Hôpital Pierre-Le Gardeur, Quebec, Canada (D.P.).

name: Barts Health NHS Trust, London, UK (M.A.D.).

name: First Affiliated Hospital of Xinjiang Medical University, Urumqi, China (Y.-t.M.).

name: DAMIC Medical Institute, Cordoba, Argentina (L.A.G.).

name: Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB–Sant Pau, CIBER-CV, Universitat Autònoma de Barcelona, Spain (A.S.).

name: The Hatter Cardiovascular Institute, Institute of Cardiovascular Sciences, University College London, UK (D.J.H.).

name: Cardiovascular & Metabolic Disorders Program, Duke–National University of Singapore Medical School (D.J.H.).

name: National Heart Research Institute Singapore, National Heart Centre (D.J.H.).

name: Yong Loo Lin School of Medicine, National University Singapore (D.J.H.).

name: Cardiovascular Research Center, College of Medical and Health Sciences, Asia University, Taiwan (D.J.H.).

name: Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.).

name: Flinders Medical Centre, Adelaide, Australia (J.B.S.).

name: ANMCO Research Center, Florence, Italy (A.P.M.).

ReferenceCitation: Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.

name: From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars–Sinai Medical Center, Los Angeles (D.S.B.) — both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York–Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York–Presbyterian Hospital (Z.A.A.), and Icahn...

repositories_institution: University of Zurich - Zurich Open Repository and Archive

title: Initial Invasive or Conservative Strategy for Stable Coronary Disease

ReferenceCitation: Spertus JA, Jones PG, Maron DJ, O'Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD, Mavromichalis S, Alexander KP, Cohen DJ, Bangalore S, Hochman JS, Mark DB; ISCHEMIA Research Group. Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1408-1419. doi: 10.1056/NEJMoa1916370. Epub 2020 Mar 30.

name: From Saint Luke’s Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri–Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research...

title: Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease

ReferenceCitation: Reynolds HR, Shaw LJ, Min JK, Spertus JA, Chaitman BR, Berman DS, Picard MH, Kwong RY, Bairey-Merz CN, Cyr DD, Lopes RD, Lopez-Sendon JL, Held C, Szwed H, Senior R, Gosselin G, Nair RG, Elghamaz A, Bockeria O, Chen J, Chernyavskiy AM, Bhargava B, Newman JD, Hinic SB, Jaroch J, Hoye A, Berger J, Boden WE, O'Brien SM, Maron DJ, Hochman JS; ISCHEMIA Research Group. Association of Sex With Severity of Coronary Artery Disease, Ischemia, and Symptom Burden in Patients With Moderate or Severe Ischemia: Secondary Analysis of the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):773-786. doi: 10.1001/jamacardio.2020.0822. Erratum in: JAMA Cardiol. 2021 Aug 1;6(8):980.

name: Weill Cornell Medicine, New York, New York

name: UMKC School of Medicine, Kansas City, Missouri

name: St Louis University School of Medicine, St Louis, Missouri

name: Cedars-Sinai Medical Center, Los Angeles, California

name: Massachusetts General Hospital and Harvard Medical School, Boston

name: Brigham and Women’s Hospital, Boston, Massachusetts

name: Cedars-Sinai Smidt Heart Institute, Los Angeles, California

name: Duke Clinical Research Institute, Durham, North Carolina

name: Hospital Universitario La Paz. Idipaz. UAM. CIBER-CV, Madrid, Spain

name: National Institute of Cardiology, Warsaw, Poland

name: Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom

name: Government Medical College, Kerla, India

name: National Research Center for Cardiovascular Surgery, Moscow, Russia

name: Guangdong General Hospital, Guangzhou, China

name: E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation (E.Meshalkin NMRC), Moscow, Russia

name: All India Institute of Medical Sciences, New Delhi, India

name: Wroclaw Medical University, T. Marciniak Hospital, Wroclaw, Poland

name: The University of Hull/Castle Hill Hospital, Cottingham, United Kingdom

name: VA New England Healthcare System/Boston, Boston, Massachusetts

ReferenceCitation: Azevedo DFC, Lima EG, Ribeiro MOL, Linhares Filho JPP, Serrano Júnior CV. Critical analysis of the classic indications for myocardial revascularization. Rev Assoc Med Bras (1992). 2019 Mar;65(3):319-325. doi: 10.1590/1806-9282.65.3.319. Epub 2019 Apr 11. Review.

ReferenceCitation: Shaw LJ, Xie JX, Phillips LM, Goyal A, Reynolds HR, Berman DS, Picard MH, Bhargava B, Devlin G, Chaitman BR. Optimising diagnostic accuracy with the exercise ECG: opportunities for women and men with stable ischaemic heart disease. Heart Asia. 2016 Jun 1;8(2):1-7. doi: 10.1136/heartasia-2016-010736. eCollection 2016. Review.

ReferenceCitation: Kataoka A, Scherrer-Crosbie M, Senior R, Gosselin G, Phaneuf D, Guzman G, Perna G, Lara A, Kedev S, Mortara A, El-Hajjar M, Shaw LJ, Reynolds HR, Picard MH. The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial. Cardiovasc Ultrasound. 2015 Dec 18;13:47. doi: 10.1186/s12947-015-0043-2.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

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

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

repositories_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Stone GW, Hochman JS, Williams DO, Boden WE, Ferguson TB Jr, Harrington RA, Maron DJ. Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise. J Am Coll Cardiol. 2016 Jan 5;67(1):81-99. doi: 10.1016/j.jacc.2015.09.056. Epub 2015 Nov 23. Review.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Wasilewski J, Poloński L, Lekston A, Osadnik T, Reguła R, Bujak K, Kurek A. Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center. Trials. 2015 Sep 15;16:411. doi: 10.1186/s13063-015-0934-4.

ipd_sharing_description: Data will be submitted to the NHLBI according to their guidelines within 3 years after the final patient follow-up (June 30, 2019) or 2 years after the main paper of the trial has been published, whichever comes first.

location_country:
Peru
North Macedonia
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
India
Spain
France
Japan
Lithuania
Poland
Thailand
Argentina
Canada
South Africa
Sweden
Saudi Arabia
Switzerland
Netherlands
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Egypt
New Zealand

location_facility: Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University

location_facility: Groote Schuur Hospital / University of Cape Town

location_facility: NYU Langone Medical Center-Bellevue Hospital

location_facility: Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases

location_facility: Sri Jayadeva Institute of Cardiovascular Sciences and Research

location_facility: New York University - Langone Cardiovascular Associates

location_facility: Cardiology and CCU - Ospedali Riuniti Ancona

location_facility: Federal Almazov North-West Medical Research Centre

location_facility: Indiana University/Krannert Institute of Cardiology

location_facility: Saint Luke's Hospital and Health Network

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: University of Iowa Hospitals and Clinics

location_facility: NYU-HHC Lincoln Medical and Mental Health Center

location_facility: TEDA International Cardiovascular Hospital

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: New York -Presbyterian/Brooklyn Methodist Hospital

location_facility: Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal

location_facility: National Cerebral and Cardiovascular Center

location_facility: E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

location_facility: Walter Reed National Military Medical Center

location_facility: Hospital Maternidade e Pronto Socorro Santa Lucia

location_facility: University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust

location_facility: Northwick Park Hospital Harrow/ Royal Brompton Hospital London

location_facility: Cardiology Associates of Schenectady P.C.

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol

location_facility: Chinese Academy of Medical Sciences, Fuwai Hospital

location_facility: Brigham & Women's Hospital, Harvard Medical School

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

location_facility: South Denver Cardiology Associates, P.C.

location_facility: Winchester Cardiology and Vascular Medicine, PC

location_facility: Santa Maria University Hospital, Cardiology Department, CHLN

location_facility: Liangxiang Hospital, Beijing Fangshan District

location_facility: UCSF - Fresno Community Regional Medical Center

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Medical University of Vienna, Department of Cardiology

location_facility: Northwest GTA Cardiovascular and Heart Rhythm Program

location_facility: First Affiliated Hospital of Xinjiang Medical University

location_facility: Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital

location_facility: Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw

location_facility: Luton and Dunstable University Hospital NHS FT

location_facility: Palo Alto Medical Foundation Research Institute

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)

location_facility: Centre Hospitalier de Regional Trois-Rivieres

location_facility: Medicus Alliance Clinical Research Org., Inc.

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Beijing Chao-yang Hospital, Capital Medical University

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)

location_facility: Louis Stokes Cleveland Veterans Affairs Medical Center

location_facility: George Gottsegen National Institute of Cardiology

location_facility: Affiliated Hospital of Jining Medical University

location_facility: Instituto Neuro Cardiovascular De Las Americas

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''

location_facility: Batra Hospital and Medical Research Centre (BHMRC)

location_facility: Karolinska Institutet at Danderyd Hospital

location_facility: Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College

location_facility: HUVA, Hospital Clínico Universitario Virgen De La Arrixaca

location_facility: Instituto Nacional de Cardiología "Ignacio Chávez"

location_facility: Ruby Hall Clinic,Grant Medical Foundation

location_facility: NYP Medical Medical Group Hudson Valley Cardiology

location_facility: National University Heart Center Singapore

location_facility: Szpital Kliniczny Przemienienia Pańskiego

location_facility: Coronary and Structural Heart Diseases Department, Institute of Cardiology

location_facility: University of California Irvine Medical Center

location_facility: Cardiovascular Research Unit, Craigavon Area Hospital

location_facility: Cardiovascular Specialists of Southwest Louisiana

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia

location_facility: King George's Medical University, Department of Cardiology

location_facility: Holy Spirit Hospital Cardiovascular Institute

location_facility: Heart Institute (InCor) University of São Paulo

location_facility: The James Cook University Hospital, Middlesbrough

location_facility: Instituto de Cardiologia de Porto Alegre

location_facility: UO Cardiologia Ospedale SS Cosma e Damiano

location_facility: Baylor Research Institute at Legacy Heart Center

location_facility: Department of Interventional Cardiology & Angiology, Institute of Cardiology

location_facility: Clinic for Cardiovascular Diseases, Clinical Center Nis

location_facility: AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"

location_facility: Saint Vincent Hospital at Worcester Medical Center

location_facility: The Second Affiliated Hospital of Zhengzhou University

location_facility: Sree Chitra Tirunal Institute for Medical Sciences and Technology

location_facility: University Hospital Center Bezanijska Kosa

location_facility: Hospital Italiano Regional del Sur Bahia Blanca

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain

location_facility: Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli

location_facility: Hero DMC Heart Institute, Dayanand Medical College and Hospital

location_facility: Samuel Stratton VA Medical Center of Albany NY

location_facility: Heart and Vascular Center, Semmelweis University

location_facility: MOSC Medical College Hospital, Kolenchery

location_facility: Affiliated Zhongshan Hospital of Dalian University

location_facility: Humanitas Research Hospital, Rozzano (MI)

location_facility: Clinica Romagosa and Clinica De La Familia

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Vilnius University Hospital Santariskes Clinic

location_facility: UAB Vascular Biology and Hypertension Program

location_facility: The University of Hull/Castle Hill Hospital

location_facility: National Medical Research Center for Cardiovascuar Surgery

location_facility: Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad

location_facility: Cardiology Clinic, Medical University in Lodz


title: Demonstration of the Presence of Carbonyl Stress in the Hair Follicles of Women With Reactive Hair Loss

summary: In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of women with telogen effluvium (ET) linked to stress of various origins (fatigue, infectious diseases, emotional stress ...).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Basic Science

ipd_sharing: No

ipd_sharing_description: Proof of concept study, with confidential data

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie

intervention_type: Other

status_simplified: Completed


title: Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children: a Cluster Multicenter Randomized Trial

acronym: SCRATCH

summary:
Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin.

Both groups will be treated twice, once at inclusion and the second time 10 days later. Both treatment regimens have been used widely and are safe to use.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Lyon
CH d'Argenteuil
CHU de Dijon
CHU de Nantes
CHU de Créteil - Hôpital Henry Mondor
CHU d'Angers
CHI de Fréjus
CHU de Nice
AP-HP - Hôpital Robert Debré
CHU de Montpellier
CHRU de Tours
CHU de la Réunion
CHU de Rennes
CHU de Bordeaux Hôpital Pellegrin
CH du Mans
CHG de Chalon sur Saône

lead_sponsor_type: academique


type: Other Identifier

title: Double-blind, Placebo-controlled, Randomized Pilot Clinical Trial to Evaluate the Efficacy and Safety of the Probiotic Strains Limosilactocillus Reuteri DSM 32910 and Lacticaseibacillus Paracasei DSM 32851 on Glucose Homeostatis in Prediabetic Adults

acronym: NOVOGLUCOSE

summary: The aim of this international, randomized, parallel arms, double-blind, placebo-controlled clinical trial is to investigate the safety and efficacy of a combination of the two Lactobacillus strains (NZ-GHMH-01) on glucose and insulin metabolism, in prediabetic subjects. This trial will include prediabetic (insulin resistant) subjects with excessive body weight (over-weight or obese, showing abdominal or visceral obesity) to be able to investigate the effect of the probiotic NZ-GHMH-01 on glycaemic control.

status: Recruiting

primary_purpose: Prevention

lead_sponsor: Novozymes A/S

location_country:
United Kingdom
France

location_facility:
Clinical Investigation Unit Paris
Clinical Investigation Unit Biofortis
CPS Research

intervention_type: Dietary Supplement

status_simplified: Ongoing


title: A Dose-escalation and Phase IIa Study of TG6002 Plus Flucytosine in Patients With Unresectable Colorectal Cancer With Liver Metastases

summary:
This study will include two parts:

Phase I part is a dose-escalation study to assess the safety of increasing doses of TG6002 in combination with oral flucytosine (5-FC) in consecutive cohorts of 3 to 6 patients with colorectal cancer and unresectable liver metastases according to a 3+3 design
Phase IIa part is an extension of the phase I part at the recommended phase II dose to evaluate the efficacy of TG6002 in combination with oral flucytosine (5-FC) in patients with colorectal cancer and unresectable liver metastases.

In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.

All patients will be followed until disease progression, death due to any cause or the date of data cut-off, whichever occurs first.

lead_sponsor: Transgene

location_facility:
Centre Léon Bérard
Institut Gustave Roussy
NHS St James's University Hospital


title: A Prospective, Single Arm Clinical Investigation Evaluating Safety and Performance of the Colibri Transcatheter Aortic Heart Valve System for the Treatment of Symptomatic Severe Aortic Stenosis Via Transfemoral Access in High Surgical Risk Patients

summary:
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. This study will be conducted in about 7 European sites. The study will evaluate the safety and performance of the Colibri Transcatheter Aortic Heart Valve System for the treatment of symptomatic severe aortic stenosis via transfemoral access in high surgical risk patients.

30 subjects suffering from symptomatic severe aortic tricuspid valve stenosis and who are at high surgical risk (logistic EuroSCORE I > 20% or other risk factors not included in this score such as frailty, porcelain aorta, sequelae of chest radiation or logistic EuroSCORE I < 20% but considered at high risk by local Heart Team evaluation) will be enrolled in this clinical investigation.

The primary objective of this clinical investigation is to evaluate the all-cause mortality at 30 days post implantation. The secondary objectives are to evaluate the safety and performance of the investigational device at 30 days, 6 and 12 months, and 2, 3, 4, 5 years post implantation.

ipd_sharing: Undecided

lead_sponsor: Colibri Heart Valve LLC

location_facility: Barts Heart Centre / St Bartholomew's Hospital

intervention_type: Device


lead_sponsor: Liquidia Technologies, Inc.

location_country: Germany France

location_facility: Studienambulanz fur Pulmonale Hypertonie at Medizinishe Klinik II, Universitatskinikum Giessen und Marburg GmbH

type: EudraCT Number

source: euctr

title: A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects

summary: Acute and chronic hemodynamic dose-response and safety evaluation of LIQ861 in PAH subjects.


title: Intestinal Microbiota and Vitamin K Levels in PXE Patients (IMPROVE Study)

acronym: IMPROVE

summary: This study aims to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin K, and severity of clinical manifestations of Pseudoxanthoma Elasticum (PXE).

ReferenceCitation: Jansen RS, Duijst S, Mahakena S, Sommer D, Szeri F, Váradi A, Plomp A, Bergen AA, Oude Elferink RP, Borst P, van de Wetering K. ABCC6-mediated ATP secretion by the liver is the main source of the mineralization inhibitor inorganic pyrophosphate in the systemic circulation-brief report. Arterioscler Thromb Vasc Biol. 2014 Sep;34(9):1985-9. doi: 10.1161/ATVBAHA.114.304017. Epub 2014 Jun 26.

ReferenceCitation: Jansen RS, Küçükosmanoglu A, de Haas M, Sapthu S, Otero JA, Hegman IE, Bergen AA, Gorgels TG, Borst P, van de Wetering K. ABCC6 prevents ectopic mineralization seen in pseudoxanthoma elasticum by inducing cellular nucleotide release. Proc Natl Acad Sci U S A. 2013 Dec 10;110(50):20206-11. doi: 10.1073/pnas.1319582110. Epub 2013 Nov 25.

ReferenceCitation: Pomozi V, Brampton C, van de Wetering K, Zoll J, Calio B, Pham K, Owens JB, Marh J, Moisyadi S, Váradi A, Martin L, Bauer C, Erdmann J, Aherrahrou Z, Le Saux O. Pyrophosphate Supplementation Prevents Chronic and Acute Calcification in ABCC6-Deficient Mice. Am J Pathol. 2017 Jun;187(6):1258-1272. doi: 10.1016/j.ajpath.2017.02.009. Epub 2017 Apr 14.

ReferenceCitation: Gheduzzi D, Boraldi F, Annovi G, DeVincenzi CP, Schurgers LJ, Vermeer C, Quaglino D, Ronchetti IP. Matrix Gla protein is involved in elastic fiber calcification in the dermis of pseudoxanthoma elasticum patients. Lab Invest. 2007 Oct;87(10):998-1008. Epub 2007 Aug 27.

ReferenceCitation: Hendig D, Zarbock R, Szliska C, Kleesiek K, Götting C. The local calcification inhibitor matrix Gla protein in pseudoxanthoma elasticum. Clin Biochem. 2008 Apr;41(6):407-12. doi: 10.1016/j.clinbiochem.2007.12.023. Epub 2008 Jan 11.

ReferenceCitation: Li Q, Jiang Q, Schurgers LJ, Uitto J. Pseudoxanthoma elasticum: reduced gamma-glutamyl carboxylation of matrix gla protein in a mouse model (Abcc6-/-). Biochem Biophys Res Commun. 2007 Dec 14;364(2):208-13. Epub 2007 Oct 4.

ReferenceCitation: Vanakker OM, Martin L, Schurgers LJ, Quaglino D, Costrop L, Vermeer C, Pasquali-Ronchetti I, Coucke PJ, De Paepe A. Low serum vitamin K in PXE results in defective carboxylation of mineralization inhibitors similar to the GGCX mutations in the PXE-like syndrome. Lab Invest. 2010 Jun;90(6):895-905. doi: 10.1038/labinvest.2010.68. Epub 2010 Apr 5.

ReferenceCitation: Gorgels TG, Waarsing JH, Herfs M, Versteeg D, Schoensiegel F, Sato T, Schlingemann RO, Ivandic B, Vermeer C, Schurgers LJ, Bergen AA. Vitamin K supplementation increases vitamin K tissue levels but fails to counteract ectopic calcification in a mouse model for pseudoxanthoma elasticum. J Mol Med (Berl). 2011 Nov;89(11):1125-35. doi: 10.1007/s00109-011-0782-y. Epub 2011 Jul 2.

ReferenceCitation: Shearer MJ, Bach A, Kohlmeier M. Chemistry, nutritional sources, tissue distribution and metabolism of vitamin K with special reference to bone health. J Nutr. 1996 Apr;126(4 Suppl):1181S-6S. doi: 10.1093/jn/126.suppl_4.1181S. Review.

ReferenceCitation: Ramotar K, Conly JM, Chubb H, Louie TJ. Production of menaquinones by intestinal anaerobes. J Infect Dis. 1984 Aug;150(2):213-8.

ReferenceCitation: Shearer MJ. Vitamin K. Lancet. 1995 Jan 28;345(8944):229-34. Review.

ReferenceCitation: Walther B, Karl JP, Booth SL, Boyaval P. Menaquinones, bacteria, and the food supply: the relevance of dairy and fermented food products to vitamin K requirements. Adv Nutr. 2013 Jul 1;4(4):463-73. doi: 10.3945/an.113.003855. Review.

ReferenceCitation: Bentley R, Meganathan R. Biosynthesis of vitamin K (menaquinone) in bacteria. Microbiol Rev. 1982 Sep;46(3):241-80. Review.

ReferenceCitation: Conly JM, Stein K. The production of menaquinones (vitamin K2) by intestinal bacteria and their role in maintaining coagulation homeostasis. Prog Food Nutr Sci. 1992 Oct-Dec;16(4):307-43. Review.

ReferenceCitation: Beulens JW, Booth SL, van den Heuvel EG, Stoecklin E, Baka A, Vermeer C. The role of menaquinones (vitamin K₂) in human health. Br J Nutr. 2013 Oct;110(8):1357-68. doi: 10.1017/S0007114513001013. Epub 2013 Apr 16. Review.

ReferenceCitation: Conly JM, Stein K. Quantitative and qualitative measurements of K vitamins in human intestinal contents. Am J Gastroenterol. 1992 Mar;87(3):311-6.

ReferenceCitation: Schurgers LJ, Teunissen KJ, Hamulyák K, Knapen MH, Vik H, Vermeer C. Vitamin K-containing dietary supplements: comparison of synthetic vitamin K1 and natto-derived menaquinone-7. Blood. 2007 Apr 15;109(8):3279-83. Epub 2006 Dec 7.

ReferenceCitation: Suttie JW. The importance of menaquinones in human nutrition. Annu Rev Nutr. 1995;15:399-417. Review.

ReferenceCitation: Usui Y, Tanimura H, Nishimura N, Kobayashi N, Okanoue T, Ozawa K. Vitamin K concentrations in the plasma and liver of surgical patients. Am J Clin Nutr. 1990 May;51(5):846-52.

ReferenceCitation: Berkner KL, Runge KW. The physiology of vitamin K nutriture and vitamin K-dependent protein function in atherosclerosis. J Thromb Haemost. 2004 Dec;2(12):2118-32. Review.

ReferenceCitation: Cranenburg EC, Schurgers LJ, Vermeer C. Vitamin K: the coagulation vitamin that became omnipotent. Thromb Haemost. 2007 Jul;98(1):120-5. Review.

ReferenceCitation: McCann JC, Ames BN. Vitamin K, an example of triage theory: is micronutrient inadequacy linked to diseases of aging? Am J Clin Nutr. 2009 Oct;90(4):889-907. doi: 10.3945/ajcn.2009.27930. Epub 2009 Aug 19. Review.

ReferenceCitation: Shearer MJ. Role of vitamin K and Gla proteins in the pathophysiology of osteoporosis and vascular calcification. Curr Opin Clin Nutr Metab Care. 2000 Nov;3(6):433-8. Review.

ReferenceCitation: Shanahan CM, Proudfoot D, Farzaneh-Far A, Weissberg PL. The role of Gla proteins in vascular calcification. Crit Rev Eukaryot Gene Expr. 1998;8(3-4):357-75. Review.

ReferenceCitation: Schurgers LJ, Spronk HM, Soute BA, Schiffers PM, DeMey JG, Vermeer C. Regression of warfarin-induced medial elastocalcinosis by high intake of vitamin K in rats. Blood. 2007 Apr 1;109(7):2823-31.

ReferenceCitation: Li Q, Guo H, Chou DW, Harrington DJ, Schurgers LJ, Terry SF, Uitto J. Warfarin accelerates ectopic mineralization in Abcc6(-/-) mice: clinical relevance to pseudoxanthoma elasticum. Am J Pathol. 2013 Apr;182(4):1139-50. doi: 10.1016/j.ajpath.2012.12.037. Epub 2013 Feb 15.

ReferenceCitation: Luo G, Ducy P, McKee MD, Pinero GJ, Loyer E, Behringer RR, Karsenty G. Spontaneous calcification of arteries and cartilage in mice lacking matrix GLA protein. Nature. 1997 Mar 6;386(6620):78-81.

ReferenceCitation: Theuwissen E, Smit E, Vermeer C. The role of vitamin K in soft-tissue calcification. Adv Nutr. 2012 Mar 1;3(2):166-73. doi: 10.3945/an.111.001628. Review.

ReferenceCitation: Shea MK, O'Donnell CJ, Hoffmann U, Dallal GE, Dawson-Hughes B, Ordovas JM, Price PA, Williamson MK, Booth SL. Vitamin K supplementation and progression of coronary artery calcium in older men and women. Am J Clin Nutr. 2009 Jun;89(6):1799-807. doi: 10.3945/ajcn.2008.27338. Epub 2009 Apr 22.

ReferenceCitation: Vermeer C, Shearer MJ, Zittermann A, Bolton-Smith C, Szulc P, Hodges S, Walter P, Rambeck W, Stöcklin E, Weber P. Beyond deficiency: potential benefits of increased intakes of vitamin K for bone and vascular health. Eur J Nutr. 2004 Dec;43(6):325-35. Epub 2004 Feb 5. Review.

ReferenceCitation: Geleijnse JM, Vermeer C, Grobbee DE, Schurgers LJ, Knapen MH, van der Meer IM, Hofman A, Witteman JC. Dietary intake of menaquinone is associated with a reduced risk of coronary heart disease: the Rotterdam Study. J Nutr. 2004 Nov;134(11):3100-5.

ReferenceCitation: Gast GC, de Roos NM, Sluijs I, Bots ML, Beulens JW, Geleijnse JM, Witteman JC, Grobbee DE, Peeters PH, van der Schouw YT. A high menaquinone intake reduces the incidence of coronary heart disease. Nutr Metab Cardiovasc Dis. 2009 Sep;19(7):504-10. doi: 10.1016/j.numecd.2008.10.004. Epub 2009 Jan 28.

ReferenceCitation: Beulens JW, Bots ML, Atsma F, Bartelink ML, Prokop M, Geleijnse JM, Witteman JC, Grobbee DE, van der Schouw YT. High dietary menaquinone intake is associated with reduced coronary calcification. Atherosclerosis. 2009 Apr;203(2):489-93. doi: 10.1016/j.atherosclerosis.2008.07.010. Epub 2008 Jul 19.

ReferenceCitation: Brandenburg VM, Schurgers LJ, Kaesler N, Püsche K, van Gorp RH, Leftheriotis G, Reinartz S, Koos R, Krüger T. Prevention of vasculopathy by vitamin K supplementation: can we turn fiction into fact? Atherosclerosis. 2015 May;240(1):10-6. doi: 10.1016/j.atherosclerosis.2015.02.040. Epub 2015 Feb 24. Review.

ReferenceCitation: Caluwé R, Pyfferoen L, De Boeck K, De Vriese AS. The effects of vitamin K supplementation and vitamin K antagonists on progression of vascular calcification: ongoing randomized controlled trials. Clin Kidney J. 2016 Apr;9(2):273-9. doi: 10.1093/ckj/sfv146. Epub 2015 Dec 29.

ReferenceCitation: Jandhyala SM, Talukdar R, Subramanyam C, Vuyyuru H, Sasikala M, Nageshwar Reddy D. Role of the normal gut microbiota. World J Gastroenterol. 2015 Aug 7;21(29):8787-803. doi: 10.3748/wjg.v21.i29.8787. Review.

ReferenceCitation: Carrillo-Linares JL, García-Fernández MI, Morillo MJ, Sánchez P, Rioja J, Barón FJ, Ariza MJ, Harrington DJ, Card D, Boraldi F, Quaglino D, Valdivielso P. The Effects of Parenteral K1 Administration in Pseudoxanthoma Elasticum Patients Versus Controls. A Pilot Study. Front Med (Lausanne). 2018 Apr 16;5:86. doi: 10.3389/fmed.2018.00086. eCollection 2018.

ReferenceCitation: Brampton C, Yamaguchi Y, Vanakker O, Van Laer L, Chen LH, Thakore M, De Paepe A, Pomozi V, Szabó PT, Martin L, Váradi A, Le Saux O. Vitamin K does not prevent soft tissue mineralization in a mouse model of pseudoxanthoma elasticum. Cell Cycle. 2011 Jun 1;10(11):1810-20. Epub 2011 Jun 1.

ReferenceCitation: Karlsson FH, Fåk F, Nookaew I, Tremaroli V, Fagerberg B, Petranovic D, Bäckhed F, Nielsen J. Symptomatic atherosclerosis is associated with an altered gut metagenome. Nat Commun. 2012;3:1245. doi: 10.1038/ncomms2266.

lead_sponsor: University Hospital, Angers

location_country: France Netherlands

location_facility: Department of Dermatology, University Hospital of Angers

location_facility: Department of Biochemistry, University Maastricht

intervention_type: Diagnostic Test


lead_sponsor: ThromboGenics

location_country: France Switzerland

location_facility:
Hôpital Ophtalmique Jules-Gonin
Hôpital Cochin
Hôpital Lariboisière

title: A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)

summary: This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).


title: Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients With Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study

acronym: Ulysse

summary:
W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers.

The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.

lead_sponsor: Pierre Fabre Medicament

location_country: France Spain

location_facility: VHIO IUCT IGR


title: Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy

acronym: RESCUE

summary: Multicentre prospective human experimental study to determine the effect of chyme reinfusion in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)

primary_purpose: Other

lead_sponsor: Rennes University Hospital

location_facility: Maastricht University, Research Laboratories at the Department of General Surgery


title: Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain: a Randomized Double-blind Study

acronym: MEOPA-PA

summary: Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. None randomized study has validated the use of premixed nitrous oxide and oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with out-of-hospital severe acute pain

ReferenceCitation: Jones JS, Johnson K, McNinch M. Age as a risk factor for inadequate emergency department analgesia. Am J Emerg Med. 1996 Mar;14(2):157-60.

ReferenceCitation: Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. Review.

ReferenceCitation: Doan BD. [Aging of population and medical workforce: a prospective view of health care provision in France in the year 2025]. Cah Sociol Demogr Med. 2004 Apr-Jun;44(2):243-66. French.

ReferenceCitation: Strange GR, Chen EH. Use of emergency departments by elder patients: a five-year follow-up study. Acad Emerg Med. 1998 Dec;5(12):1157-62.

lead_sponsor: University Hospital, Toulouse

location_country: France Réunion

location_facility:
SAMU St-Denis de la Réunion
SAMU Bobigny
SAMU Toulouse


title: Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct in Patients With Malignant or Post-operative Jaundice After Failure or Impossibility to Perform Endoscopic Retrograde Cholangiography

summary: At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. Recent developments in interventional endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.

lead_sponsor: Institut Paoli-Calmettes

location_country: Monaco France

location_facility:
Institut Paoli-Calmettes
Centre Hospitalier Princesse Grace
Hopital Nord


lead_sponsor: Novartis Pharmaceuticals

title: A Dose-finding Phase Ib Study Followed by an Open-label, Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative, Inoperable Locally Advanced or Metastatic Breast Cancer

summary: This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.


title: A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma

summary: This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.

ReferenceCitation: Stein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, Horak ID, Hansen HJ, Goldenberg DM. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and Its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004 Apr 15;10(8):2868-78.

ReferenceCitation: Stein R, Qu Z, Chen S, Solis D, Hansen HJ, Goldenberg DM. Characterization of a humanized IgG4 anti-HLA-DR monoclonal antibody that lacks effector cell functions but retains direct antilymphoma activity and increases the potency of rituximab. Blood. 2006 Oct 15;108(8):2736-44. Epub 2006 Jun 15.

ReferenceCitation: Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123. Review.

ReferenceType: result

ReferenceCitation: Franck Morschhauser1*, John P Leonard2, Bertrand Coiffier3*, et.al. INITIAL SAFETY AND EFFICACY RESULTS OF A SECOND-GENERATION HUMANIZED ANTI-CD20 ANTIBODY, IMMU-106 (HA20), IN NON-HODGKINS LYMPHOMA: ASH abstract 2005.

ReferenceCitation: Morschhauser F, Leonard JP, Coiffier B Petillon M, Coleman M,. Bahkti A, Teoh N, Wegener WA, Goldenberg DM. Phase I/II result of a seoncd-generation humanized anti- CD20 antibody, IMMU-106 (.hA20), in NHL: 2006 ASCO Annual Meeting.Proceedings; 24/18S Part I of II:429s

ReferenceCitation: Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon M, Coleman M,. Horne H, Teoh N, Wegener WA, Goldenberg DM. Low doses of humanized anti-CD20 antibody, IMMU-106 (hA20), in refractory or recurrent NHL: Phase I/II results. 2007 ASCO Annual Meeting.Proceedings; 25/18S Part I of II:449s

ReferenceCitation: Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.

name: From the Service des Maladies du Sang Centre Hospitalier Regional, Lille; Centre Hospitalier Lyon-Sud, Lyon, France; New York Presbyterian Hospital, Weill Cornell Medical College, New York, NY; The University of Texas M. D. Anderson Cancer Center, Houston, TX; Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA; Medical Research Council Toxicology Unit, Leicester University, Leicester, United Kingdom; Immunomedics, Inc, Morris Plains; and Garden State Cancer Center, Belleville, NJ.

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Leonard

full_name: John P. Leonard

given: John P.

family: Fayad

full_name: Luis Fayad

given: Luis

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Petillon

full_name: Marie-Odile Petillon

given: Marie-Odile

family: Coleman

full_name: Morton Coleman

given: Morton

family: Schuster

full_name: Stephen J. Schuster

given: Stephen J.

family: Dyer

full_name: Martin J.S. Dyer

given: Martin J.S.

family: Horne

full_name: Heather Horne

given: Heather

family: Teoh

full_name: Nick Teoh

given: Nick

family: Wegener

full_name: William A. Wegener

given: William A.

family: Goldenberg

full_name: David M. Goldenberg

given: David M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Humanized Anti-CD20 Antibody, Veltuzumab, in Refractory/Recurrent Non-Hodgkin's Lymphoma: Phase I/II Results

lead_sponsor: Gilead Sciences

location_facility:
Centre hospitalier Lyon
University of Leicester
Service Des Maladies Du Sang


title: A Single Arm, Multi-center, Prospective Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement

summary: The purpose of this study is to clinically assess the safety and performance of the EndoFast Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.

lead_sponsor: Endogun Medical Systems Ltd.

location_country: Israel France

location_facility: Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique


title: Phase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas

summary:
RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with temozolomide in treating patients with recurrent primary supratentorial glioma.

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating patients who have advanced solid tumors.

location_facility: Haemato-Onkologische Praxis und Tagesklinik


title: A Phase II Feasibility Study of Combined Accelerated External Radiation and Chemotherapy With 5FU and CDDP Following Transurethral Resection in Patients With Muscle Invasive Transitional Carcinoma of the Bladder - T2-T3, N0, M0 (UICC 1992)

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy combined with fluorouracil and cisplatin in treating patients who have stage II or stage III bladder cancer, and who have undergone transurethral resection.

ReferenceCitation: Poortmans PM, Richaud P, Collette L, Ho Goey S, Pierart M, Van Der Hulst M, Bolla M; EORTC Radiation Oncology Group. Results of the phase II EORTC 22971 trial evaluating combined accelerated external radiation and chemotherapy with 5FU and cisplatin in patients with muscle invasive transitional cell carcinoma of the bladder. Acta Oncol. 2008;47(5):937-40. doi: 10.1080/02841860801888799.

family: Poortmans

full_name: Philip M. Poortmans

given: Philip M.

family: Richaud

full_name: Pierre Richaud

given: Pierre

family: Collette

full_name: Laurence Collette

given: Laurence

family: Ho Goey

full_name: S. Ho Goey

given: S.

family: Pierart

full_name: Marianne Pierart

given: Marianne

family: Van Der Hulst

full_name: Marleen Van Der Hulst

given: Marleen

family: Bolla

full_name: Michel Bolla

given: Michel

journal_name: Acta Oncologica

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_facility:
Dr. Bernard Verbeeten Instituut
CHR de Grenoble - La Tronche
Institut Bergonie

intervention_type: Radiation


title: Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants

summary: This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Groupe SEBBIN

location_country: Belgium France

location_facility:
UZ Gent
Centre Hospitalier Lyon Sud


title: Association Between Fibrinogen Concentration and Intraoperative Bleeding in Liver Transplantation: a Retrospective Observational Study

summary:
Liver transplantation is the only treatment for end-stage liver disease. It is a high-risk surgery that can cause heavy intraoperative bleeding. Bleeding and transfusions of blood products are themselves associated with several postoperative complications. Few data have suggested beneficial interventions that can decrease this bleeding. Such interventions are necessary in order to improve these patients' outcomes. In order to better understand the potential therapeutic targets, a better comprehension of the variables associated with such bleeding is essential. Several previous studies have demonstrated a weak association between usual clotting times and bleeding in this population. However, few studies have evaluated the association between the concentration of fibrinogen and bleeding in this population.

The primary objective of this study is to assess the association between preoperative serum fibrinogen concentration and the volume of intraoperative bleeding. The secondary objective is to assess the association between preoperative serum fibrinogen concentration and the number of red blood cell units transfused during the intraoperative and immediate postoperative periods.

The hypothesis of the study is that a low concentration of preoperative fibrinogen will be associated with an increase in intraoperative bleeding and red blood cell transfusions.

time_perspective: Retrospective

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

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


title: BoStOn SCientific Rhythm MAnagemenT REgiStry

acronym: SOCRATES

summary: SOCRATES is part of BSC's Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

time_perspective: Other

lead_sponsor: Boston Scientific Corporation

location_facility:
Universitair Ziekenhuis Brussel
CHG de Pau


title: Chloride Transfer During Continuous Renal Replacement Therapy in the Intensive Care Unit: a Prospective Observational Cohort Study

acronym: CLODICUS

summary:
Acute kidney injury (AKI) is a frequently encountered complication in the intensive care unit (ICU), affecting on average 25 to 35% of patients. It is associated with an increased mortality, proportional to AKI severity. RRT induces important shifts of water and electrolytes. Thus, significant amount of chloride might unintentionally be transferred to patients.

Chloride is the main anion of the organism. It is involved in the regulation of numerous physiological processes. Thus, significant and rapid modification of chloride amount contained in the organism (as might be induced by renal replacement therapy) may be responsible for important, and potentially deleterious, consequences to critically ill patients.

Studies have shown that the administration of high amounts of chloride rich solutions (such as sodium chloride (NaCl) 0,9%) was associated with the development of hyperchloremic acidosis in a dose-dependent manner. This hyperchloremic acidosis could also be theoretically associated with deleterious physiological effects. However, the true clinical consequences of administration of high amounts of chloride rich solutions remains unclear. Their effect on mortality remains a matter of debate, the results of studies being very conflicting in that respect. Nevertheless, hyperchloremia itself and/or the rise of chloremia in the intensive care unit seems to be associated with increased mortality. Moreover, the impact of those chloride rich solutions on the development of acute kidney injury is also a subject of controversy, data from the literature being here again very conflicting.

A recent study already showed that continuous RRT (CRRT) techniques induce a significant transfer of sodium to patients benefiting from those techniques. In that study, the amount of sodium transferred depended mainly on the difference between patient's natremia and sodium concentration in dialysate and/or replacement fluid (usually higher than patient's natremia) used.

By analogy, it is likely that an occult transfer of chloride also happens during RRT, given the high chloride concentration of dialysate fluids (in continuous veno-venous dialysis, CVVD) and replacement fluids (in continuous veno-venous hemofiltration, CVVH), or when these 2 modalities are combined (continuous veno-venous hemodiafiltration, CVVHDF). Finally, the investigators suspect, although it remains undemonstrated so far, that the RRT technique (convective vs. diffusive) may influence this transfer, to an unknown extent. Nevertheless, this transfer and its potential determinants have never been studied yet.

If chloride overload (and its potential clinical consequences) induced by the administration of solutions such as NaCl 0,9% is being extensively studied, no study has ever focused on chloride transfer that may result from the use of renal replacement therapy. However, as mentioned above, it is very likely that such a chloride transfer to patients happens, and that its magnitude depends on different parameters such as RRT modality, RRT fluids characteristics, or patient's chloremia at the start of RRT.

The investigators conduct the present study to describe and compare the intensity of chloride transfer during the first 24 hours of renal replacement therapy by continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVD),or continuous veno-venous hemodiafiltration (CVVHDF), and to determine if that transfer is more important with one or the other of those two techniques, in ICU patients affected with severe AKI requiring RRT. Secondary aims are to describe and compare the effects of chloride transfer under 3 RRT modalities (CVVD, CVVH and CVVHDF) on patient's outcome, organ failures, electrolyte and acid-base balance, fluid balance and hemodynamics. Finally, the investigators aim to develop a pharmacokinetic compartment model of chloride transfer during different modalities of RRT.

lead_sponsor: Hospices Civils de Lyon

location_country: Australia France

location_facility: Austin Hospital, Department of Intensive Care

location_facility: Hôpital de la Croix-Rousse (Hospices Civils de Lyon) / Médecine Intensive - Réanimation


title: A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects

summary: This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

lead_sponsor: Samsung Bioepis Co., Ltd.

location_country:
United States
France

location_facility:
Biotrial Rennes
Biotrial


title: Combining Interventions of Fertility Preservation to Mitigate Fertility Loss After

acronym: Coimbra

summary: This clinical prospective randomised controlled trial will evaluate the impact of an ovarian biopsy on the oocyte yield after controlled ovarian stimulation before chemotherapy in view of breast cancer. The purpose of this trial is to learn about the possibility to combine these two fertility preservation procedures without decreasing the number of oocytes collected after an ovarian stimulation.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: De Vos M, Smitz J, Woodruff TK. Fertility preservation in women with cancer. Lancet. 2014 Oct 4;384(9950):1302-10. doi: 10.1016/S0140-6736(14)60834-5. Review. Erratum in: Lancet. 2015 Mar 7;385(9971):856.

ReferenceCitation: Garcia-Velasco JA, Domingo J, Cobo A, Martínez M, Carmona L, Pellicer A. Five years' experience using oocyte vitrification to preserve fertility for medical and nonmedical indications. Fertil Steril. 2013 Jun;99(7):1994-9. doi: 10.1016/j.fertnstert.2013.02.004. Epub 2013 Mar 1.

ReferenceCitation: Decanter C, Cloquet M, Dassonneville A, D'Orazio E, Mailliez A, Pigny P. Different patterns of ovarian recovery after cancer treatment suggest various individual ovarian susceptibilities to chemotherapy. Reprod Biomed Online. 2018 Jun;36(6):711-718. doi: 10.1016/j.rbmo.2018.02.004. Epub 2018 Mar 2.

ReferenceCitation: Cobo A, García-Velasco J, Domingo J, Pellicer A, Remohí J. Elective and Onco-fertility preservation: factors related to IVF outcomes. Hum Reprod. 2018 Dec 1;33(12):2222-2231. doi: 10.1093/humrep/dey321.

ReferenceCitation: Practice Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2019 Dec;112(6):1022-1033. doi: 10.1016/j.fertnstert.2019.09.013.

ReferenceCitation: Donnez J, Dolmans MM. Fertility Preservation in Women. N Engl J Med. 2017 Oct 26;377(17):1657-1665. doi: 10.1056/NEJMra1614676. Review.

ReferenceCitation: Diaz-Garcia C, Domingo J, Garcia-Velasco JA, Herraiz S, Mirabet V, Iniesta I, Cobo A, Remohí J, Pellicer A. Oocyte vitrification versus ovarian cortex transplantation in fertility preservation for adult women undergoing gonadotoxic treatments: a prospective cohort study. Fertil Steril. 2018 Mar;109(3):478-485.e2. doi: 10.1016/j.fertnstert.2017.11.018. Epub 2018 Feb 7.

ReferenceCitation: Deb S, Kannamannadiar J, Campbell BK, Clewes JS, Raine-Fenning NJ. The interovarian variation in three-dimensional ultrasound markers of ovarian reserve in women undergoing baseline investigation for subfertility. Fertil Steril. 2011 Feb;95(2):667-72. doi: 10.1016/j.fertnstert.2010.09.031. Epub 2010 Oct 25.

ReferenceCitation: Ueland FR, Depriest PD, Desimone CP, Pavlik EJ, Lele SM, Kryscio RJ, van Nagell JR Jr. The accuracy of examination under anesthesia and transvaginal sonography in evaluating ovarian size. Gynecol Oncol. 2005 Nov;99(2):400-3. Epub 2005 Aug 9.

ReferenceCitation: Amorim CA, Leonel ECR, Afifi Y, Coomarasamy A, Fishel S. Cryostorage and retransplantation of ovarian tissue as an infertility treatment. Best Pract Res Clin Endocrinol Metab. 2019 Feb;33(1):89-102. doi: 10.1016/j.beem.2018.09.002. Epub 2018 Sep 13. Review.

ReferenceCitation: Rodgers RJ, Reid GD, Koch J, Deans R, Ledger WL, Friedlander M, Gilchrist RB, Walters KA, Abbott JA. The safety and efficacy of controlled ovarian hyperstimulation for fertility preservation in women with early breast cancer: a systematic review. Hum Reprod. 2017 May 1;32(5):1033-1045. doi: 10.1093/humrep/dex027. Review.

ReferenceCitation: Dolmans MM, Marotta ML, Pirard C, Donnez J, Donnez O. Ovarian tissue cryopreservation followed by controlled ovarian stimulation and pick-up of mature oocytes does not impair the number or quality of retrieved oocytes. J Ovarian Res. 2014 Aug 26;7:80. doi: 10.1186/s13048-014-0080-8.

family: Dolmans

full_name: Marie-Madeleine Dolmans

given: Marie-Madeleine

family: Marotta

full_name: Maria-Laura Marotta

given: Maria-Laura

family: Pirard

full_name: Céline Pirard

given: Céline

family: Donnez

full_name: Jacques Donnez

given: Jacques

full_name: Olivier Donnez

given: Olivier

currency_apc_doaj: GBP

journal_name: Journal of Ovarian Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ipd_sharing: Yes

ipd_sharing_description: As this is a multicenter study, we plan to share IPD between the study sites. An electronical case report form (eCRF) will be set up and completed in all sites. Data will be handled in accordance with the general data protection regulation (GDPR).

lead_sponsor: Universitair Ziekenhuis Brussel

location_facility: Service de Médecine de la Reproduction et Préservation de la Fertilité, Hôpital Antoine Béclère

intervention_type: Procedure


title: A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

summary: This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083/V-591).

lead_sponsor: Institut Pasteur

location_facility: SGS Life Sciences, Clinical Pharmacology Unit


title: SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis

summary:
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.

Subjects with previous bare-metal or drug-eluting coronary stent will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB or SOC to include contemporary DES (zotarolimus-eluting stents and everolimus-eluting stents only) or non-DEB BA. A maximum of 418 randomized subjects will be included. Subjects will be followed for 5 years post-intervention. Primary endpoint will be target lesion failure (TLF) determined at 12-month clinical follow-up.

lead_sponsor: M.A. Med Alliance S.A.

location_facility:
Hôpital privé Jaques Cartier
HartCentrum Hasselt, Jessa Ziekenhuis


title: Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome

acronym: VPASS

summary:
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings Sleep is a non-contact device, along with an airbag placed under the mattress, which allows screening of SAS from four signals: movement, breathing, heart rate and snoring. The objective of the present study is to validate the diagnostic performance of the Withings Sleep for the detection of SAS compared to PSG.

ReferenceCitation: Edouard P, Campo D, Bartet P, Yang RY, Bruyneel M, Roisman G, Escourrou P. Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome. J Clin Sleep Med. 2021 Jun 1;17(6):1217-1227. doi: 10.5664/jcsm.9168.

family: Edouard

full_name: Paul Edouard

given: Paul

family: Campo

full_name: David Campo

given: David

family: Bartet

full_name: Pierre Bartet

family: Yang

full_name: Rui-Yi Yang

given: Rui-Yi

name: Chest Service, Saint-Pierre University Hospital, Brussels, Belgium

family: Bruyneel

full_name: Marie Bruyneel

given: Marie

name: AP-HP, Sleep Medicine Department, Antoine-Béclère Hospital, Clamart, France

family: Roisman

full_name: Gabriel Roisman

given: Gabriel

family: Escourrou

full_name: Pierre Escourrou

journal_name: Journal of Clinical Sleep Medicine

publisher: American Academy of Sleep Medicine (AASM)

lead_sponsor: Withings

location_facility: Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère

location_facility: Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre


title: A Phase 1, Open-Label, Dose-Escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 in Melanoma Patients Receiving Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes

acronym: TUNINTIL

summary: This is an open-label, phase 1, first-in-human (FIH), dose-escalation, multicenter, multinational trial evaluating the safety of oncolytic adenovirus TILT-123 as monotherapy and in association with T-cell therapy with TILs in metastatic melanoma patients.

ReferenceCitation: Havunen R, Kalliokoski R, Siurala M, Sorsa S, Santos JM, Cervera-Carrascon V, Anttila M, Hemminki A. Cytokine-Coding Oncolytic Adenovirus TILT-123 Is Safe, Selective, and Effective as a Single Agent and in Combination with Immune Checkpoint Inhibitor Anti-PD-1. Cells. 2021 Jan 27;10(2). pii: 246. doi: 10.3390/cells10020246.

family: Havunen

full_name: Riikka Havunen

given: Riikka

family: Kalliokoski

full_name: Riikka Kalliokoski

family: Siurala

full_name: Mikko Siurala

given: Mikko

family: Sorsa

full_name: Suvi Sorsa

given: Suvi

family: Santos

full_name: João M. Santos

given: João M.

family: Cervera-Carrascon

full_name: Victor Cervera-Carrascon

given: Victor

family: Anttila

full_name: Marjukka Anttila

given: Marjukka

family: Hemminki

full_name: Akseli Hemminki

given: Akseli

currency_apc_doaj: CHF

journal_name: Cells

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

ReferenceCitation: Cervera-Carrascon V, Quixabeira DCA, Havunen R, Santos JM, Kutvonen E, Clubb JHA, Siurala M, Heiniö C, Zafar S, Koivula T, Lumen D, Vaha M, Garcia-Horsman A, Airaksinen AJ, Sorsa S, Anttila M, Hukkanen V, Kanerva A, Hemminki A. Comparison of Clinically Relevant Oncolytic Virus Platforms for Enhancing T Cell Therapy of Solid Tumors. Mol Ther Oncolytics. 2020 Mar 19;17:47-60. doi: 10.1016/j.omto.2020.03.003. eCollection 2020 Jun 26.

family: Quixabeira

full_name: Dafne C.A. Quixabeira

given: Dafne C.A.

full_name: Joao M. Santos

given: Joao M.

family: Kutvonen

full_name: Emma Kutvonen

given: Emma

family: Clubb

full_name: James H.A. Clubb

given: James H.A.

repositories_institution:
PubMed Central - Europe PMC
University of Helsinki - Helda

location_facility: National Center for Cancer Immune Therapy Herlev Hospital, Copenhagen University


title: Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

summary: feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

location_facility: University of California Los Angeles (UCLA)


type: Other Grant/Funding Number

title: Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders

acronym: IMAGISION

summary: IMAGISION aims to explore, in a cohort of patients referred for geriatric consultation for neurocognitive evaluation, the contribution of functional neuroimaging (functional MRI and, if possible, high resolution EEG) to geriatric expertise, associated with the performance of a battery of neuropsychological tests in the evaluation of decision-making capacity.

primary_purpose: Diagnostic

ReferenceCitation: Tannou T, Godard-Marceau A, Joubert S, Daneault S, Kergoat MJ, Magnin E, Comte A, Gabriel D, Vidal C, Pazart L, Aubry R. Added value of functional neuroimaging to assess decision-making capacity of older adults with neurocognitive disorders: protocol for a prospective, monocentric, single-arm study (IMAGISION). BMJ Open. 2021 Sep 29;11(9):e053549. doi: 10.1136/bmjopen-2021-053549.

family: Tannou

full_name: Thomas Tannou

given: Thomas

family: Godard-Marceau

full_name: Aurelie Godard-Marceau

given: Aurelie

family: Joubert

full_name: Sven Joubert

given: Sven

family: Daneault

full_name: Serge Daneault

given: Serge

family: Kergoat

full_name: Marie-Jeanne Kergoat

given: Marie-Jeanne

family: Magnin

full_name: Eloi Magnin

given: Eloi

family: Comte

full_name: Alexandre Comte

given: Alexandre

family: Gabriel

full_name: Damien Gabriel

given: Damien

family: Vidal

full_name: Chrystelle Vidal

given: Chrystelle

family: Pazart

full_name: Lionel Pazart

given: Lionel

family: Aubry

full_name: Regis Aubry

given: Regis

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Centre Hospitalier Universitaire de Besancon