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

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey
Latvia

location_facility: The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center

location_facility: Unidad de Atención Médica e Investigación en Salud (UNAMIS)

location_facility: GastroIntestinal Biosciences Clinical Trials

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: PanAmerican Clinical Research Mexico S.A. de C.V.

location_facility: London Health Science Centre - Victoria Hospital

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

location_facility: The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA

location_facility: Clinical Trials Center of Medical Institute

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: CIPREC-Centro de Investigacion y Prevencion Cardiovascular-

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Instituto de Especialidades de la Salud Rosario

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Tokushukai Sapporo Higashi Tokushukai Hospital

location_facility: Northshore Gastroenterology Research, LLC

location_facility: St. Marienkrankenhaus-Medizinische Klinik I

location_facility: University of Oklahoma Health Sciences Center

location_facility: Gastroenterologische Praxis Dres Behrens, Steudel, Fechner

location_facility: National Center for Global Health and Medicine

location_facility: State Scientific Centre of Coloproctology

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: Nickalus Children's Hospital Research Institute

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: The University of Texas Southwestern Children's Medical Center

location_facility: Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Synexus North East Clinical Research Centre

location_facility: NonState Healthcare Institution Central Clinical Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Goryeb Children's Hospital / Atlantic Health System

location_facility: Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Communal Non-Commercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu

location_facility: University of Texas Medical Branch at Galveston

location_facility: University of Texas Health Services Center - Houston

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Loema Instituto de Pesquisa Clinica e Consultores Ltda

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: Hopital de Hautepierre - Service d'Hépatogastroentérolgie

location_facility: Synexus Midlands Clinical Research Center

location_facility: Gastro I s.r.o., Gastroenterologická ambulancia

location_facility: Synexus Clinical Research US, Inc - Orlando

location_facility: University Hospitals Cleveland Medical Center

location_facility: Konya Necmettin Erbakan Gastroenterology

location_facility: Shengjing Hospital of China Medical University

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases

location_facility: Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: University of Mississippi School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Università degli Studi c/o Spedali Civili

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Research Associates of South Florida, LLC

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi

location_facility: Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV

location_facility: Associacao Paranaense de Cultura - PUCPR

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Medical and Sanitary Division of Severstal

location_facility: Paediatric Clinical Research Facility Royal Hospital for Children and Young People

location_facility: Schneider Med Center Pediatric Gastro Hepatology

location_facility: Clinical Research Management Group, Inc.

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Oblastni nemocnice Nachod-Endoskopicke centrum

location_facility: Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Jiangsu Province Hospital of Chinese Medicine

location_facility: L2IP - Instituto de Pesquisas Clinicas Ltda.

location_facility: MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Institute klinicke a experimentalni mediciny - IKEM

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: International Institute of Clinical Trials LLC

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: RCI Chernivtsi Regional Clinical Hospital

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: MGG Group, Inc.., Co., Chevy Chase Clinical Research

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Kharkiv Regional Council Regional Clinical Hospital

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

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: USPA Advance Concept Medical Research Group LLC.

location_facility: Synexus - Colorado Springs Family Practice

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: The First Hospital Affiliated to AMU (Southwest Hospital)

location_facility: The Second Affiliated Hospital of Zhejiang University School of Med

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Xiangya Hospital, Central South University

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: Nemours Childrens Clinic - Delaware Valley of The Nemours Foundation

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Woodholme Gastroenterology Associates PA

location_facility: Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii

location_facility: The First Hospital of China Medical University

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Kyiv Railway Clinical Hospital 2 of branch Health Center of the JSC Ukrainian Railway

location_facility: CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

location_facility: The Catholic University of Daejeon St. Mary's Hospital

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: The Second Affiliated Hospital of Wenzhou Medical College

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: CHU de Poitiers- Service d'Hépato-gastro-entérologie,

location_facility: Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: University of Alabama-The Kirklin Clinic

location_facility: Università di Cagliari - Presidio Policlinico Monserrato

location_facility: Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center

location_facility: University of Washington School Medicine

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Spitalul Universitar de Urgență București

location_facility: Tianjin Medical University General Hospital

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Eskisehir Osmangazi University Gastroenterology

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Advanced Clinical Research-Spokane Gastroenterology

location_facility: Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit

location_facility: Gastroenterology Associates of the Piedmont

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

location_facility: Synexus Manchester Clinical Research Centre

location_facility: The First People's Hospital of Yunnan Province

location_facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie

location_facility: Digestive Health Specialists of the Southeast

location_facility: Ivano-Frankivsk State Medical University

location_facility: Health Pharma Professional Research S.A. de C.V:

location_facility: Hospital Universitario Central de Asturias

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin

location_facility: Gastroenterology Associates of Orangeburg

location_facility: LLC Scientific Research Centre EKO-Bezopasnost

location_facility: Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Allen Whey Khye Lim Professional Corporation

location_facility: Synexus Clinical Research GmbH-Leipzig Research Centre

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: The First People's Hospital of Changzhou

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Nizhegorodskiy Regional Clinical Hospital N.A.Semashko

location_facility: Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul

location_facility: Caguas Gastroenterology and Hepatology Center, LLC

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

location_facility: Endomed, s.r.o.- Gastroenterologicka ambulancia

location_facility: Synexus Clinical Research - St. Petersburg

location_facility: Azienda ospedaliero-universitaria Mater Domini

location_facility: Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC

location_facility: Azienda Ospedaliera Policlinico Consorziale

location_facility: Hacettepe University Faculty of Medicine

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Post Graduate Institute of Medical Education & Research

source: euctr

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

summary: The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Eli Lilly and Company

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Argentina
Korea, Republic of
Sweden
Switzerland
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

acronym: eMonarcHER

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: South Broward Hospital District - Memorial Healthcare System

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed

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

location_facility: Hospital General Universitario de Alicante-Oncology

location_facility: Kaiser Permanente Center for Health Research

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Samara Regional Clinical Oncology Center

location_facility: Ordensklinikum Linz Gmbh Barmherzige Schwestern

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: ÜBAG-Med. Versorgungszentrum - VK&K Studien GbR

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: National Hospital Organization Osaka National Hospital

location_facility: University of Maryland- Biological Sciences

location_facility: St Marianna University School of Medicine Hospital

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Ospedale Regionale di Bellinzona e Valli - Bellinzona

location_facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F.

location_facility: Scott & White Memorial Hospital & Clinic

location_facility: Inova Dwight and Martha Schar Center Institute

location_facility: Xiangya Hospital Central South University

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Dwight D. Eisenhower Army Medical Center, Hem/Onc Svc

location_facility: Hospital de Base Fac de Medicina de Sao Jose do Rio Preto

location_facility: Hospital Araujo Jorge da Assoc. Combate ao Cancer em Goias

location_facility: Real e Benemerita Associação Portuguesa de Beneficiencia

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Gemeinschaftspraxis Dres. Uthgenannt, Kisro, Weber

location_facility: Centro de Investigaciones Metabólicas (CINME)- Sede Uriburu

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie GbR

location_facility: Charleston Hematology Oncology Associates

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Karolinska Universitetssjukhuset i Solna

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Instituto de Investigaciones Metabolicas

location_facility: New England Cancer Specialists - Scarborough

location_facility: Sunshine Coast Haematology & Oncology Clinic

location_facility: Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise

location_facility: Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Fujian Medical University Union Hospital

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

location_facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Texas Oncology Cancer Care and Research Ctr

location_facility: CIPREC-Centro de Investigacion y Prevencion Cardiovascular

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: University of Massachusetts Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Walter Reed National Military Medical Center

location_facility: Stockton Hematology Oncology Medical Group

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Dalian University - The Affiliated Zhongshan Hospital

location_facility: Oncology and Hematology of South Texas PA

location_facility: Dongnam Institute of Radiological and Medical Sciences

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Cancer Trtmt Ctrs of Am, SE Reg Med Ctr., Inc.

location_facility: Texas Oncology - Methodist Charlton Cancer Center

location_facility: Gynäkologisch-Onkologische Praxis am Pelikanplatz

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Seoul National University Bundang Hospital

location_facility: University of Texas Health Science Center - San Antonio

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: California Cancer Associates in Research and Excellence

location_facility: University General Hospital of Heraklion

location_facility: Shamir (Assaf HaRofeh) Medical Center-Oncology

location_facility: Central Care Cancer Center - Garden City

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: University of California, Davis - Health Systems

location_facility: National Taiwan University Hospital Hsin-Chu

location_facility: Instituto de Pesquisa Notredame Intermedica

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Eastern Connecticut Hematology/ Oncology Associates (ECHO)

location_facility: COT - Centro Oncológico do Triângulo S.A.

location_facility: Tianjin Medical University General Hospital

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: Grupo COI - Clínicas Oncológicas Integradas

location_facility: Tang Du Hospital, The Second Teaching Hospital of FMMU

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: S.C. R.T.C. Radiology Therapeutic Center S.R.L.

location_facility: Rosmedtech Scientific Research Institute of Oncology

location_facility: Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

location_facility: Centro de Investigaciones Clínicas - Clínica Viedma

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Fovarosi Onkormanyzat Szent Margit Korhaza

location_facility: Kaluga Regional Clinical Oncology Center

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: Texas Oncology - Dallas Presbyterian Hospital

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

location_facility: Koo Foundation Sun Yan-Sen Cancer Center

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Valley Breast Care and Women's Health Center

location_facility: Klinikum Mannheim gGmbH Universitätsmedizin

location_facility: Cancer and Hematology of Western Michigan

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

summary: The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study

acronym: HYPERION

summary:
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.

name: From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR)...

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

sequence: first

family: Merdji

full_name: Hamid Merdji

given: Hamid

sequence: additional

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Grillet

full_name: Guillaume Grillet

given: Guillaume

family: Girardie

full_name: Patrick Girardie

given: Patrick

family: Coupez

full_name: Elisabeth Coupez

given: Elisabeth

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Cariou

full_name: Alain Cariou

given: Alain

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Brule

full_name: Noelle Brule

given: Noelle

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Pichon

full_name: Nicolas Pichon

given: Nicolas

family: Landais

full_name: Mickael Landais

given: Mickael

family: Plantefeve

full_name: Gaëtan Plantefeve

given: Gaëtan

family: Quenot

full_name: Jean-Pierre Quenot

family: Chakarian

full_name: Jean-Charles Chakarian

given: Jean-Charles

family: Sirodot

full_name: Michel Sirodot

given: Michel

family: Legriel

full_name: Stéphane Legriel

given: Stéphane

family: Letheulle

full_name: Julien Letheulle

given: Julien

family: Thevenin

full_name: Didier Thevenin

given: Didier

family: Desachy

full_name: Arnaud Desachy

given: Arnaud

ReferenceCitation: Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.

name: for the Clinical Research in Intensive Care and Sepsis (CRICS) Group and the HYPERION Study Group

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

location_facility:
CHU Pointe à Pitre
Medical Surgical Intensive Care Unit
Cochin University Hospital Center
Medical Intensive Care Unit


intervention_type: Radiation

status: Active, not recruiting

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: Groupe Oncorad Garonne Clinique Du Pont de Chaume

location_facility: Institut de Cancérologie LUCIEN NEUWIRTH

location_facility: Institut de Cancérologie de l'Ouest -Site Paul Papin

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

location_facility: GUSTAVE ROUSSY, Cancer Campus, Grand Paris

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Hôpital d'Instruction des Armées du Val de Grâce

ipd_sharing: No

title: A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

summary: The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.


title: Prospective, Sequential Multiple Assignment, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia

acronym: LGL

summary:
LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients.

Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide.

Thus, there are four objective in this study :

to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T/NK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease
to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious
to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy
to evaluate the response rate according to the phenotypic subtype of LGL leukemia.

lead_sponsor: Rennes University Hospital

location_facility: Hematology Service - CH François Baclesse

location_facility: Intern medecine Service - CH Antibes-Juan-les-Pins

location_facility: Hematology Service - CH Docteur Duchenne

location_facility: Oncology Unit - Institut de cancérologie de la Loire

location_facility: Hôpital André Mignot Centre Hospitalier de Versailles

location_facility: Hematology Unit CH Notre Dame Bon Secours

location_facility: Hematology Service - CH de la cote basque

location_facility: CHU Henri Mondor Lymphoid Hemopathy Unit

location_facility: Hematology Unit - Institut Paoli-Calmettes

location_facility: Hematology Service - Hopital La Pitié Salpetrière

lead_sponsor_type: academique


title: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

acronym: CERPASS

summary: To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

lead_sponsor: Replimune Inc.

location_country:
United States
France
Poland
Greece
Australia
Spain
Canada

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: University Of North Carolina at Chapel Hill

location_facility: Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

location_facility: John Theurer Cancer Center at Hackensack University

location_facility: Winship Cancer Institute of Emory University

location_facility: University of Iowa Hospitals and Clinics

location_facility: Perlmutter Cancer Center at NYU Langone Health

location_facility: Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy

location_facility: CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC


lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Centre Hospitalier intercommunale Meulan les mureaux

title: A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."

summary:
This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.

Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH

summary: Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

lead_sponsor: United Therapeutics

location_country:
Greece
Romania
Australia
Belgium
Denmark
Taiwan
Ukraine
Croatia
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Sweden
Netherlands
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"

location_facility: Hospital Clinic de Barcelona, C/ Villarroel, 170

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

location_facility: University of Cincinnati-Medical Science Building

location_facility: CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.

location_facility: VA Greater Los Angeles Healthcare System

location_facility: The Lady Davis Carmel Medical Center, 7 Michal st.

location_facility: Weill-Cornell-New York Presbyterian Hospital

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

location_facility: The Ohio State University Wexner Medical Center

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

location_facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

location_facility: Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

location_facility: NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Gachon University Hospital Gil Medical Center

location_facility: MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

location_facility: University Clinic for Pulmonary Diseases, Jordanovac 104

location_facility: Meir Medical Center, 59 Tshernichovski st.

location_facility: University General Hospital of Alexandroupolis

location_facility: Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

location_facility: Fuwai Hospital, Chinese Academy of Medical Sciences

location_facility: Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

location_facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah

location_facility: "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

location_facility: CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne

location_facility: University Health Network-Toronto General Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E.

location_facility: Tel Aviv Sourasky Medical Center, 6 Weizmann St.

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

location_facility: CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

location_facility: SMBD Jewish General Hospital d/b/a Jewish General Hospital

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

location_facility: Premium Clinic Wrocław CM, Podwale 83/17

location_facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

location_facility: University of California Davis Medical Center

location_facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

location_facility: Royal Free London NHS Foundation Trust, Pond Street

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Washington University School of Medicine

location_facility: The Methodist Hospital Research Institute

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Medical College of Wisconsin/Froedtert Hospital

location_facility: Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

location_facility: Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

location_facility: Sentara Cardiovascular Research Institute

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

location_facility: AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

location_facility: SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

location_facility: Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

location_facility: Unidad de Investigacion Clinica en Medicina, S.C.

location_facility: Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

location_facility: Clinical Center of Serbia, Koste Todorovica 8

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

location_facility: Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

location_facility: AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

location_facility: Xiangya Hospital Central South University

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

location_facility: University General Hospital Attikon, 1 Rimini Street

location_facility: Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5


title: Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) in Non-Cirrhotic Patients - A Double Blind International Multicenter Study

acronym: MRevaluation

summary: The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: University of Zurich

location_country:
United States
Switzerland
France
New Zealand
Germany
United Kingdom

location_facility: University Hospital Zurich, Department of Interventional and Diagnostic Radiology

location_facility: University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center

intervention_type: Other


title: ORCHESTRA WP2 - Follow-up of Covid-19 Long Term Sequelae

summary:
The protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management of COVID-19 sequelae and to their prevention.

The follow-up will be organized in multiple levels of tests according to the capability of each cohort and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to different treatment strategies, including monoclonal antibodies and vaccination.

time_perspective: Prospective

ipd_sharing: Undecided

location_country: Italy Congo Netherlands France Belgium Spain

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

location_facility: Hosp. Univ. Virgen Macarena / Universidad de Sevilla

location_facility: University of Antwerp - Laboratory of Medical Microbiology

location_facility: Fondation Congolaise pour la Recherche Médicale


title: Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study

acronym: CROHN-PREP

summary:
The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease.

In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence.

In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol.

Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

location_facility:
Cholet hospital
Vendée departmental hospital
Rennes University hospital
Angers University Hospital
Brest University hospital
Nantes University Hospital


title: Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families

acronym: COPA

summary:
Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis.

In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize.

The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial

acronym: Fibrepik

summary:
Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. These symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition.

Remedee Labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. These endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep.

The Remedee Solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment.

The hypothesis of this study is that regular use of the Remedee Solution for three months improves the quality of life of fibromyalgia patients.

lead_sponsor: Remedee SA

location_facility:
Centre Hospitalier de Valenciennes
University Hospital of Grenoble Alps
Médipôle hôpital mutualiste
CHU de Montpellier
Cabinet libéral Dr. Lorenzi-Pernot
Hôpital Foch

intervention_type: Device


title: Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder for Patients Presenting at the Emergency Room: A Multi-center Cluster Randomized Cross-over Implementation Study.

acronym: SOFTERIV

summary:
Promising results of an early EMDR (Eye Movement Desensitization and Reprocessing) intervention on PCLS (PostConcussion-Like Syndrome) at three months have been shown, suggesting that the availability of psychological care in emergency departments will be useful. The real impact of such a care service remains to be measured. Several factors may modulate the impact of such a measure, leaving the extent of its public health benefit uncertain.

In the SOFTER III trial, the results suggest that high levels of self-rated stress at admission probably play a key role in the development of CPSP and psychological intervention.

The most appropriate study design for such an objective is to follow a cohort of patients in the Emergency Department and to assess the main risk factors for CPSD 3 months later. To this end, all consecutive patients should be asked to participate in a study and complete a risk factor questionnaire, regardless of their level of risk for CPSD.

SOFTER IV offers the opportunity to evaluate the impact of a psychological intervention to reduce the incidence of chronic pain. By acting on the emotions experienced in the Emergency Department, a reduction in acute pain and perhaps in the longer term in chronic pain can be expected. Its psychological aspects, and more specifically the emotional dimension, are known to be related to acute pain. As for the relationship with chronic pain, it exists, but its meaning is not clear because the emotional state is assessed when the pain has already become chronic. It is proposed to integrate the assessment of emotions at inclusion in the project, and to follow up patients 12 months after inclusion to assess the incidence of chronic pain and identify the factors that modulate it. Early intervention in the emergency department, including an early short one-hour EMDR intervention R-TEP (Recent Traumatic Episode Protocol), could thus reduce the incidence of chronic pain.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Edouard Herriot
Hopital Pellegrin
Hôpital Purpan
Hôpital Louis Mourier
CH de Libourne
Hôpital Beaujon


title: Phase I/II Study of AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

acronym: NANO-GBM

summary:
This is a phase I/II clinical trial evaluating the association of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma.

The primary objectives of this study were to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period (phase I) and to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate (PFS) (phase II)

Three dose levels of intravenous AGuIX nanoparticles will be explored: 50 mg/kg, 75 mg/kg and 100 mg/kg.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancérologie Strasbourg Europe


title: Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

acronym: COATING

summary: To assess safety and efficacy of p48/p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p48/p64 MW Flow Modulation Device under dual antiplatelet therapy.

lead_sponsor: Phenox GmbH

location_facility:
CHU Toulouse
CHU de Montpellier
CHU Bordeaux
CHU Reims - Hôpital Maison Blanche
CHU de Lyon
Hôpital Bicêtre


title: Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination

summary: This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children). The study objective is to develop predictive indicators of homogeneous propagation of ultrasound and elastic waves to define an optimal region of interest for the measurement of liver stiffness during VCTE examination.

lead_sponsor: Echosens

location_facility:
CHU de Nancy
CHU d'Angers
CHU de Lille
CHU d'Amiens
CHU de Nice
Hôpital Saint Eloi


acronym: SERODIFF

summary:
Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection.

This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months.

There are also building biological samples collections clinically documented: sera, stool and strains.

design_allocation: Non-Randomized

lead_sponsor: Versailles Hospital

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache

intervention_type: Biological


title: Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

acronym: HYDRA

summary: The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

primary_purpose: Diagnostic

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU Angers
CHRU Brest
CHU Clermont-Ferrand
HEGP
CHU Saint-Etienne
Hôpital Louis Mourier - APHP

intervention_type: Procedure


lead_sponsor: NETRIS Pharma

acronym: GYNET

location_facility:
Centre Eugène Marquis
Institut claudius Regaud
Centre Léon Bérard
Centre François Baclesse
Institut Bergonié
ICM - Val d'Aurelle

type: Other Grant/Funding Number

title: A Randomized, Multicenter, Open Label, Phase I/II Study to Evaluate the Safety, Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination With Carboplatin Plus Paclitaxel and/or Pembrolizumab in Patients With Locally Advanced/Metastatic Endometrial Carcinoma or Cervix Carcinoma Progressing/Relapsing After at Least One Prior Systemic Chemotherapy.

summary: The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).


title: Evaluation of the Activating Consciousness Technique (Hypnosis) in Anxiety in a General Practice

acronym: MG HYPNOSIS

summary:
Anxiety is an emotion considered unpleasant but resulting from a normal phenomenon. It corresponds to an adaptive response to events, to stress and helps to ensure our survival.

On the other hand, it becomes embarrassing when it becomes uncontrollable. It can even lead to interfere with activities of daily living. Thus, we can speak of anxiety disorder.

Anxiety disorders are among the most prevalent psychiatric disorders. They are often associated with other comorbidities such as depression, which makes them more difficult to treat and diagnose.

Different treatments are offered to best treat the patient with anxiety : drug treatment (antidepressants, anxiolytics) ; non-drug (psychotherapy, meditation, cognitive behavioral therapies).

The emergence of hypnosis in medical practice in recent years seems to be a technique that can bring benefits to the patient.

A review of clinical studies does not seem to find a benefit to hypnosis in anxiety disorders. In contrast, a study in children with school phobia showed the effectiveness of hypnosis. The limits addressed by this review seem to relate to the number of people included in the studies. Contrariwise, it has been pointed out that hypnosis can have a beneficial effect in the long term.

Thus, it seems interesting to deepen this technique in the practice of a general practitioner exercising the activating consciousness technique in anxiety.

The study will be composed of patients presenting with anxiety and consulting their general practitioner, with: Group 1, patients consulting a doctor not practicing hypnosis Versus Group 2, patients consulting a doctor practicing hypnosis.

During the first consultation and the following 2 consultations scheduled by the general practitioner (spaced 15 days apart), the following data are noted, in addition to the monitoring usually performed by the doctor:

COVI scale
Comfort scale 0 to 10
Management: drugs, TAC, others
Quality of life survey SF36 Patients will be called back at 6 months to reassess quality of life (self-administered survey SF 36) The primary endpoint is to evaluated the change of anxiety from inclusion (J0) to 6 months using COVI scale in the two different groups.

For secondary endpoints, the consumption of drug medicine will be quantified and the quality of life will be measured using Quality of life survey SF36.

ReferenceType: background

ReferenceCitation: Pelissolo A. [Hypnosis for anxiety and phobic disorders: A review of clinical studies]. Presse Med. 2016 Mar;45(3):284-90. doi: 10.1016/j.lpm.2015.12.002. Epub 2016 Mar 2. Review. French.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Dr Maud BINARD
Dr Matthieu DEMOURGUES
Dr Aurélien BARADEL
Dr Stéphane FOLACHER
Dr Christian SAINT-CYR
Dr Céline HUMBERT

intervention_type: Behavioral


title: An Observational Study of the Prevalence of Patients Requiring Palliative Care in the French Anti Cancer Centers.

summary:
The purpose of this observational study is to determine the proportion of patients with a score greater than 3/10 to the questionnaire PALLIA-10.

This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at helping the providers of care to identify patients who would require palliative cares.

According to the notice of the questionnaire, patients with a score greater than 3 would be taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire, it seems that a large majority of patients would have a score greater than 3 in the context of anti cancer centers.

To date, palliative teams are not designed to take in charge such an amount of patients.

time_perspective: Cross-Sectional

lead_sponsor: Centre Leon Berard

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole


ipd_sharing_description: Individual Participant Data (IPD) will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

title: Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

summary: Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).


title: Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress

acronym: ANTIGRIPPE

summary: Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

location_facility: Centre de Biologie et de Pathologie Nord

location_facility: Hôpital de la Croix Rousse-service réanimation adulte médicale

location_facility: Hôpital de la Croix Rousse-service réanimation adulte chirurgicale


title: Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)

acronym: BICAFMS

summary:
Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory.

Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).

location_facility: Centre Hospitalier Saint Vincent de Paul


title: Identification of Composite Clinical and Lab Scores Associated With a Favorable Clinical Response With Thiopurines in Patients With IBD (Inflammatory Bowel Disease): an International Clinical Trial

summary: Inflammatory bowel disease (IBD) groups together Crohn's Disease (CD) and ulcerative colitis (UC). Its prevalence is high representing approximately 0.4% of the population. The peak incidence for these diseases ranges between 2 and 30 years of age with a second peak for CD recently reported at 60. These diseases develop over time into complications requiring in 2/3 of cases surgical resection procedures in CD and colectomy in over 20% of cases. Cohort data has recently shown that the early use of azathioprine from the first year would decrease the need for surgery. Aside from biologics, azathioprine is the most widely used immunosuppressant in IBD management. Its metabolism is highly variable in the overall population since over 10% of patients are slow metabolizers and 15% fast metabolizers. This explains partly treatment failures and side effects with thiopurines. A lot of research has shown that metabolite measurement of azathioprine (6-TGN end methylated derivatives) could be used clinically even if these results remain controversial. In fact, their positive predicative value (PPV) in clinical response does not exceed 60%. This costly testing cannot be done everywhere, is not reimbursed by national health services, and may not be used in some countries. It is, however, key in order optimize these drugs at a time when only two anti-TNFs are possible in the event of failure on thiopurines. Older studies have shown that MCV and lymphonenia could be markers for thiopurine impregnation. Recently, an American study provided a mathematic formula enabling to achieve over 80% PPV for the clinical response on AZA but this calculation needs to be confirmed and it is, moreover, patented (costly).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHRU Lilles
CHU Caen
CHR Orléans
CHU Reims
CHU Jean Minjoz
CHU Montpellier
CHU Bordeaux
CHU Saint-Etienne
CHU Dijon
CHU Nice
CHU Nancy
Hôpital Saint-Antoine
CHU Rennes
CHU Nantes - Hôtel-Dieu
CH Lyon Sud


status: Unknown status

lead_sponsor: University Hospital, Clermont-Ferrand

acronym: Btx-HT

location_facility:
CH Narbonne
CH F. Mittérand
Hôpital de Hautepierre
CHU d'Amiens
CHU de Clermont-Ferrand
Hôpital de la Timone
Hôpital Caremeau
Fondation Rothschild
CHU de Poitiers
Hôpital Jean Minjoz
CHU Gui de Chauliac
Hôpital neurologique
Hôpital R Salendro
Centre Hospitalier Pays D'Aix
AP-HP
CHU de Toulouse
Hôpital Haut-Levêque

title: Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor by a Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study

summary:
Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses, leading to a reduction of pathological muscle movement. Very little information is available on its efficacy on HT. Two published reports suggested that local Btx A injections could be an effective and safe approach for treating HT. Given the scarcity of published data (small samples, open studies, different doses of Btx used, heterogeneous populations, several muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx injections in essential HT by a multi-center, randomized, double-blind, parallel-group, placebo-controlled study.

Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment of head tremor.

Secondary objectives:

- To evaluate the tolerance of botulinum toxin injections in the treatment of head tremor.
- To evaluate the impact of botulinum toxin injections on the patients' quality of life and embarrassment.
To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D accelerometer wireless portable system (Xsens MTw wireless motion tracker system) (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a new video system device to analyze head tremor characteristics

status_simplified: Unknown


title: Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.

summary: This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

ReferenceCitation: Kornowski R, Chevalier B, Verhoye JP, Holzhey D, Harnath A, Schӓfer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Tchétché D; VIVA Investigators. Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study). Am J Cardiol. 2021 Apr 1;144:118-124. doi: 10.1016/j.amjcard.2020.12.047. Epub 2020 Dec 28.

family: Kornowski

full_name: Ran Kornowski

given: Ran

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

family: Verhoye

full_name: Jean-Philippe Verhoye

given: Jean-Philippe

family: Holzhey

full_name: David Holzhey

given: David

family: Harnath

full_name: Axel Harnath

given: Axel

family: Schӓfer

full_name: Ulrich Schӓfer

given: Ulrich

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Manigold

full_name: Thibaut Manigold

given: Thibaut

family: Modine

full_name: Thomas Modine

given: Thomas

family: Souteyrand

full_name: Geraud Souteyrand

given: Geraud

family: Champagnac

full_name: Didier Champagnac

family: Oh

full_name: Jae K. Oh

given: Jae K.

family: Li

full_name: Shuzhen Li

given: Shuzhen

family: Tchétché

full_name: Didier Tchétché

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Cardiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Tchétché D, Chevalier B, Holzhey D, Harnath A, Schäfer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Verhoye JP, Kornowski R; VIVA Investigators. TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study. JACC Cardiovasc Interv. 2019 May 27;12(10):923-932. doi: 10.1016/j.jcin.2019.02.029.

family: Schäfer

full_name: Ulrich Schäfer

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis

acronym: ACTIVE

summary:
PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids.

STUDY TREATMENTS : All patients :

Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days.

Combination therapy arm:

Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day.

Azathioprine arm:

Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Besancon
Chu Kremlin Bicetre
CHRU Lille
Hopital Louis Mourrier
Hopital Saint Louis
Henri Mondor Hospital
Chu Rouen
Hopital St Antoine
CHU de CLERMONT FERRAND- Hopital Estain
Hopital Saint Joseph
CHU de NICE- Hopital Archet 2
Chu Saint Etienne
Chu Montpellier
CHU RENNES - Hopital Pontchaillou
CHU NANCY - Hopital Brabois
APHP- Hopital BEAUJON


title: Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions

acronym: EPIRMEX

summary:
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.

These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.

Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.

The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation pédiatrique, Néonatologie

location_facility: Médecine Néonatale et Réanimation Pédiatrique

location_facility: Médecine Infantile - Néonatologie - Périnatologie

location_facility: Service de Pédiatrie Néonatale et Réanimation

location_facility: Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE


title: Assessment of the Clinical Value of a Docetaxel, Cisplatin and 5-fluorouracil (DCF) Strategy Adapted to Patients for the Management of Metastatic or Locally Advanced Anal Resistant Radiochemotherapy Squamous Cell Anal Carcinoma.

summary:
Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients' death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent.

Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen.

Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients.

ReferenceCitation: Kim S, Jary M, Mansi L, Benzidane B, Cazorla A, Demarchi M, Nguyen T, Kaliski A, Delabrousse E, Bonnetain F, Letondal P, Bosset JF, Valmary-Degano S, Borg C. DCF (docetaxel, cisplatin and 5-fluorouracil) chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma. Ann Oncol. 2013 Dec;24(12):3045-50. doi: 10.1093/annonc/mdt396. Epub 2013 Oct 10.

ReferenceCitation: Kim S, Meurisse A, Spehner L, Stouvenot M, François E, Buecher B, André T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

ReferenceCitation: Spehner L, Kim S, Vienot A, François E, Buecher B, Adotevi O, Vernerey D, Abdeljaoued S, Meurisse A, Borg C. Anti-Telomerase CD4(+) Th1 Immunity and Monocytic-Myeloid-Derived-Suppressor Cells Are Associated with Long-Term Efficacy Achieved by Docetaxel, Cisplatin, and 5-Fluorouracil (DCF) in Advanced Anal Squamous Cell Carcinoma: Translational Study of Epitopes-HPV01 and 02 Trials. Int J Mol Sci. 2020 Sep 17;21(18). pii: E6838. doi: 10.3390/ijms21186838.

ReferenceType: result

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

family: Kim

full_name: Stefano Kim

given: Stefano

family: François

full_name: Eric François

given: Eric

family: André

full_name: Thierry André

given: Thierry

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Jary

full_name: Marine Jary

given: Marine

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Baba-Hamed

full_name: Nabil Baba-Hamed

given: Nabil

family: Pernot

full_name: Simon Pernot

given: Simon

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

family: Zoubir

full_name: Mustapha Zoubir

given: Mustapha

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: De La Fouchardiere

full_name: Christelle De La Fouchardiere

given: Christelle

family: Smith

full_name: Denis Smith

given: Denis

family: Deberne

full_name: Mélanie Deberne

given: Mélanie

family: Spehner

full_name: Laurie Spehner

given: Laurie

family: Badet

full_name: Nicolas Badet

given: Nicolas

family: Adotevi

full_name: Olivier Adotevi

family: Anota

full_name: Amélie Anota

given: Amélie

family: Meurisse

full_name: Aurélia Meurisse

given: Aurélia

family: Vernerey

full_name: Dewi Vernerey

ReferenceCitation: Kim S, Jary M, André T, Vendrely V, Buecher B, François E, Bidard FC, Dumont S, Samalin E, Peiffert D, Pernot S, Baba-Hamed N, El Hajbi F, Bouché O, Desrame J, Parzy A, Zoubir M, Louvet C, Bachet JB, Nguyen T, Abdelghani MB, Smith D, De La Fouchardière C, Aparicio T, Bennouna J, Gornet JM, Jacquin M, Bonnetain F, Borg C. Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study). BMC Cancer. 2017 Aug 25;17(1):574. doi: 10.1186/s12885-017-3566-0.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University hospital of Besançon
Mutualist Montsouris Institute
Paris Saint-Joseph Hospital Group
Antoine Lacassagne Center
Pitié Salpétrière Hospital
Paul Strauss Center
Jean Mermoz Private Hospital
Saint-Antoine Hospital
Hospital of Belfort-Montbeliard
European Georges Pompidou Hospital
Curie Institute
University Robert Debré Hospital
Regional Institute of Cancer
Oscar Lambret center
FNLCC center Georges François Leclerc
Institute of Cancerology of Lorraine


title: Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study

acronym: OVNI-Dom

summary: The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.

primary_purpose: Supportive Care

lead_sponsor: IP Santé Domicile

location_facility: CHU de Grenoble site Nord - Hôpital Albert Michallon


title: Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home

summary:
The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.

The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.

The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility:
Garches
CHU de Dijon
CHU de Nancy
CHU d'Angers
CHU de Lille
CHU de Limoges
Hôpital Edouard Rist
CHU de Strasbourg
CH de Cannes
AP-HP Pitié-Salpêtrière
CHU de Grenoble
CHD de la Réunion
Hôpital Robert Schuman
CHU de Rouen
CHU de Toulouse
CHU de Besançon


title: Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection

acronym: SABATO

summary:
Increasing resistance to antibiotic agents has been recognized as a major health problem worldwide that will even aggravate due to the lack of new antimicrobial agents within the next decade [1]. This threat underscores the need to maximize clinical utility of existing antibiotics, through more rational prescription, e.g. optimizing duration of treatment.

Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000 cases occurring annually in Europe [2]. A course of at least 14 days of intravenous antimicrobials is considered standard therapy [3-5] in "uncomplicated" SAB. This relatively long course serves to prevent SAB-related complications (such as endocarditis and vertebral osteomyelitis) that may result from hematogenous dissemination to distant sites. However, there is insufficient evidence that a full course of intravenous antibiotic therapy is always required in patients with a low risk of SAB-related complications.

In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional 14-days course of intravenous therapy regarding efficacy and safety. An early switch from intravenous to oral therapy would provide several benefits such as earlier discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.

ReferenceCitation: Kaasch AJ, Rommerskirchen A, Hellmich M, Fätkenheuer G, Prinz-Langenohl R, Rieg S, Kern WV, Seifert H; SABATO trial group. Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection. Trials. 2020 Feb 12;21(1):175. doi: 10.1186/s13063-020-4102-0.

apc_source: openAPC

family: Kaasch

full_name: Achim J. Kaasch

given: Achim J.

family: Rommerskirchen

full_name: Anna Rommerskirchen

given: Anna

family: Hellmich

full_name: Martin Hellmich

given: Martin

family: Fätkenheuer

full_name: Gerd Fätkenheuer

given: Gerd

family: Prinz-Langenohl

full_name: Reinhild Prinz-Langenohl

given: Reinhild

family: Rieg

full_name: Siegbert Rieg

given: Siegbert

family: Kern

full_name: Winfried V. Kern

given: Winfried V.

family: Seifert

full_name: Harald Seifert

given: Harald

currency_apc_doaj: GBP

journal_name: Trials

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-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Kaasch AJ, Fätkenheuer G, Prinz-Langenohl R, Paulus U, Hellmich M, Weiß V, Jung N, Rieg S, Kern WV, Seifert H; SABATO trial group (with linked authorship to the individuals in the Acknowledgements section). Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial. Trials. 2015 Oct 9;16:450. doi: 10.1186/s13063-015-0973-x.

name: for the SABATO trial group (with linked authorship to the individuals in the Acknowledgements section)

family: Paulus

full_name: Ursula Paulus

given: Ursula

family: Weiß

full_name: Verena Weiß

given: Verena

family: Jung

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

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

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

location_country:
Netherlands
France
Spain
Germany
United Kingdom

location_facility:
Utrecht
Düsseldorf
Paris 2
Nantes
Nottingham
Quimper
Barcelona I
Palma
UMC Groningen
Ulm
Jena
VUmc Amsterdam
Uniklinik Köln
Paris 5
Paris 3
Sevilla II
Berlin
Hannover
Barcelona II
Lübeck
Groningen
Rennes
Annecy
Grenoble
Freiburg
Orléans
Amsterdam
Breda
Paris 4
Chambéry
Krefeld
Paris 1
Tours
Sevilla
St. Etienne
Frankfurt
Tilburg
Leverkusen
La Roche-sur-Yon
Diakonessenhuis Utrecht


lead_sponsor: Hoffmann-La Roche

acronym: ANTHALYA

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Centre Rene Huguenin; Chir Generale Oncologique

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Centre Val Aurelle Paul Lamarque; Chir A1

location_facility: Hopital Rangueil; CHIR Generale Et Gynecologique

location_facility: Hop Europeen Georges Pompidou; Gynecologie

location_facility: Centre Jean Perrin; Chir Generale Oncologie

location_facility: Centre Francois Baclesse; Chir Gynecologique

location_facility: Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn

location_facility: Institut Curie; Chir Generale Gyneco Oncologique

title: A Randomized, Open-Label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable

summary: This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery [IDS]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.


title: Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response

summary: This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

lead_sponsor: Novo Nordisk A/S


title: CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia

acronym: CLINPCT

summary: CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.

ReferenceCitation: Montassier E, Javaudin F, Moustafa F, Nandjou D, Maignan M, Hardouin JB, Annoot C, Ogielska M, Orer PL, Schotté T, Bouget J, Agha Babaei S, Raynal PA, Eche A, Duc AT, Cojocaru RA, Benaouicha N, Potel G, Batard E, Talan DA. Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial. Ann Emerg Med. 2019 Oct;74(4):580-591. doi: 10.1016/j.annemergmed.2019.02.025. Epub 2019 Apr 11.

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Javaudin

full_name: François Javaudin

given: François

family: Moustafa

full_name: Farès Moustafa

given: Farès

family: Nandjou

full_name: Demeno Nandjou

given: Demeno

family: Maignan

full_name: Maxime Maignan

given: Maxime

family: Hardouin

full_name: Jean-Benoit Hardouin

given: Jean-Benoit

family: Annoot

full_name: Caroline Annoot

given: Caroline

family: Ogielska

full_name: Maja Ogielska

given: Maja

family: Orer

full_name: Pascal-Louis Orer

given: Pascal-Louis

family: Schotté

full_name: Thibault Schotté

given: Thibault

family: Bouget

full_name: Jacques Bouget

given: Jacques

family: Agha Babaei

full_name: Syamak Agha Babaei

given: Syamak

family: Raynal

full_name: Pierre-Alexis Raynal

given: Pierre-Alexis

family: Eche

full_name: Antoine Eche

given: Antoine

family: Duc

full_name: Albert Trinh Duc

given: Albert Trinh

family: Cojocaru

full_name: Ruxandra-Aimée Cojocaru

given: Ruxandra-Aimée

family: Benaouicha

full_name: Nesrine Benaouicha

given: Nesrine

family: Potel

full_name: Gilles Potel

given: Gilles

family: Batard

full_name: Eric Batard

given: Eric

family: Talan

full_name: David A. Talan

given: David A.

journal_name: Annals of Emergency Medicine

lead_sponsor: Nantes University Hospital

location_facility: University Hospital of Saint Antoine Paris


title: Assessment of ONYX in Endovascular Cerebral AVM. Prospective, Multi-centre and Observational French Study.

acronym: cAVM

summary: To assess safety and efficacy of ONYX treatment for cAVM:

ipd_sharing_description: No individual participant data will be available

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_facility:
Chu Pellegrin
CHU Strasbourg
Fondation Ophtamoligique Rothschild
CHU Toulouse
CHU Gabriel Montpied
Hôpital Beaujon
CHP Clairval
CHU Pontchaillou
HIA Sainte Anne
Hôpital GUI DE CHAULLAC
CHI Dijon
CHU Besançon
CHU Nantes
CHRU Tours
Hôpital Bicêtre
Groupe Hospitalier Pitier Salpetrière
CHU Côte de Nacre