acronym: PROOF 302

lead_sponsor: QED Therapeutics, Inc.

summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.

ReferenceCitation: Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, Sonpavde G, Fleming MT, Lerner SP, Loriot Y, Hoffman-Censits J, Valderrama BP, Andresen C, Schnabel MJ, Cole S, Daneshmand S. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul;18(21):2599-2614. doi: 10.2217/fon-2021-1629. Epub 2022 May 24.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

publisher_dissemination: Future Science Ltd

sponsor_collaborators:
QED Therapeutics, Inc.
Helsinn Healthcare SA

location_facility: Houston Methodist Hospital- Department of Urology

location_facility: Lakeland Regional Health Hollis Cancer Center

location_facility: Tulane University/Southeastern Louisiana VA Health Care

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Citta Della Salute e Della Scienz - Torino

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park

location_facility: Harold C. Simmons Comprehensive Cancer Center

location_facility: A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria

location_facility: Hospital Universitario Puerta Hierro-Majadahonda

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Winship Cancer Institute of Emory University

location_facility: Albany Medical Center - Division of Urology

location_facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Caritas-Krankenhaus St. Josef Klinik für Urologie

location_facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara

location_facility: Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Multiprofile Hospital For Active Treatment "Sveta Sofia"

location_facility: Althaia Xarxa Assistencial Universitària de Manresa

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: The Ohio State University College of Medicine

location_facility: Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie

location_facility: Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Loma Linda University Faculty Medical Clinics

location_facility: Saint Louis University- SLUCare Academic Pavilion

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

location_facility: Institut De Cancerologie De L'ouest - Site Saint-Herblain

location_facility: University Multiprofile Hospital For Active Treatment Deva Maria

location_facility: Centre de Lutte Contre le Cancer - Centre Léon Bérard

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Associated Medical Professionals - Syracuse

title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
United States
Spain
Greece
Bulgaria
Canada
France


title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis Stages F2 and F3

summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Inventiva Pharma

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Portugal
Hungary
United States
Ukraine
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Bulgaria
Israel

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: Consultorio de la Dra. Maria Sarai Gonzalez Huezo

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke

location_facility: Centro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. Pedro

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Consorci Hospital General Universitari de València

location_facility: Gastrointestinal Associates & Endoscopy Center - Flowood

location_facility: Beijing You'an Hospital,Capital Medical University

location_facility: Centro de Investigación y Gastroenterología

location_facility: Great Lakes Gastroenterology Research - Mentor

location_facility: Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: IMIC Research - International Medical Investigations Centers

location_facility: The First Affiliated Hospital , Zhejiang University School of Medicine

location_facility: Digestive Disease Associates - Catonsville

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown

location_facility: Del Sol Research Management - Tucson East

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: Affiliated Hospital of Nantong University

location_facility: Objective Health - Birmingham Gastroenterology Associates

location_facility: The Institute For Liver Health - Chandler

location_facility: Veterans Affairs Pittsburgh Healthcare System - University Drive Campus

location_facility: The Clinical Trials Network - Gastro Care Institute

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski

location_facility: South Denver Gastroenterology - Swedish Medical Center Office

location_facility: Xu, Jun The First Hospital of Shanxi Medical University Taiyun Shanxi

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Fundación de Investigación de Diego Clinical Research

location_facility: General Hospital of Tianjin Medical University

location_facility: GI Alliance - Gastroenterology Associates of Florida - Wellington

location_facility: University Hospitals Case Medical Center

location_facility: Instituto de Seguridad Social del Estado de Mexico y Municipios

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

location_facility: Research and Education Foundation of Atlanta Medical Center

location_facility: Hospital Clínico Universitario de Santiago

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: ARcare Center for Clinical Research - Conway

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: The Sixth People' s Hospital Of ShenYang

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

location_facility: Diagnostic Consulting Center 20 - Sofia Еооd

location_facility: PanAmerican Clinical Research - US Headquarters

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: Hospital Universitario Dr. José Eleuterio González

location_facility: MNGI Digestive Health - Northeast Minneapolis Clinic

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Covenant Metabolic Specialists LLC - Sarasota

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Consultants for Clinical Research - Montgomery Office

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: RuiAn People's Hospital - Ruixiang Branch

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: South Texas Research Institute - Brownsville

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" (Servicio de Gastroenterologia)

location_facility: Pontificia Universidad Católica de Chile - Escuela de Medicina

location_facility: Diagnostic Consultative Center Aleksandrovska

location_facility: The Sixth People's Hospital of Zhengzhou

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Unidade Local Saúde Alto Minho - Hospital de Santa Luzia

location_facility: USPA Advance Concept Medical Research Group

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: Hospital das Clinicas da Universidade Federal de Minas Gerais

location_facility: Centro De Investigaciones Clínicas Viña Del Mar

location_facility: Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

location_facility: Synexus Clinical Research SA- Watermeyer

location_facility: Università degli Studi di Napoli Federico II

location_facility: SYNEXUS Magyarország Egészségügyi Szolgáltató KFT

location_facility: Gastro One - Germantown Office - Wolf Park Drive

location_facility: First Affiliated Hospital of China Medical University

location_facility: Digestive Health Research of North Texas

location_facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen

location_facility: Clinovacare Medical Clinical Research Center

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: Hospital Universitario "Dr. José Eleuterio González" (Servicio de Endocrinología)

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: University of Kansas Medical Center Research Institute

location_facility: PanAmerican Clinical Research Mexico - Cuernavaca

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Beth Israel Deaconess Medical Center - Liver Center

location_facility: GI Alliance - Bay Area Gastroenterology - Webster

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Universitario Doctor José Eleuterio Gonzalez

location_facility: St. Joseph's Healthcare Hamilton - Charlton Campus

location_facility: Gastroenterology of the Piedmont, PA - Salem Office

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Centre de Médecine Métabolique de Lanaudière

location_facility: Kansas Medical Clinic - Gastroenterology

location_facility: Synexus - Mediclinic Southern Africa - Constantiaberg

location_facility: The First Affiliated Hospital of Henan University of Science and Technology

location_facility: Centro Hospitalar Universitário De São João

location_facility: The First Hospital of Lanzhou University

location_facility: Digestive Health Associates of Texas - Rockwall

location_facility: King's College Hospital NHS Foundation Trust

location_facility: National Research Institute - Panorama City

location_facility: Gastroenterology Consultants - Ellington

location_facility: Investigative Clinical Research - Annapolis

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse

location_facility: Chongqing university three gorges hospital

location_facility: Sefako Makgatho Health Sciences University

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

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: GI Alliance - Lubbock Digestive Disease Associates - Lubbock

location_facility: Xiangya Hospital - Central South University

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

location_facility: SSM Health Saint Louis University Hospital

location_facility: California Pacific Medical Center Research Institute

location_facility: University of Michigan Health-West Hospital

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Gastroenterology Associates - Baton Rouge

location_facility: Consorci Corporació Sanitària Parc Taulí de Sabadell

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Fourth Affiliated Hospital of Harbin Medical University

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Pinnacle Clinical Research - San Antonio

location_facility: University of Iowa Hospitals and Clinics

location_facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon

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

location_facility: Second Affiliated Hospital of Dalian Medical University

location_facility: South Texas Research Institute - Edinburg

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus

location_facility: Regional Infectious Diseases and Infusion Center

location_facility: Washington University School of Medicine in St. Louis

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Metropolitan Gastroenterology Associates - Metairie

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond

location_facility: Medical Center Center of Family Medicine Plus, LLC

location_facility: Summitt - Pinnacle Clinical Research - Georgetown

location_facility: Mengchao Hepatobiliary Hospital of FuJian Medical University

location_facility: Froedtert and Medical College of Wisconsin

location_facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Qingchun Campus

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

location_facility: The First Affiliated Hospital of Nanyang Medical College

location_facility: Hospital De Alta Complejidad en Red El Cruce

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Digestive and Liver Center of Florida - Orlando

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: The First Affiliated Hospital Sun Yat-sen University

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: First Affiliated Hospital of the Army Military Medical University (Southwest Hospital)

location_facility: The First People's Hospital of Yunnan Province

location_facility: Beijing Ditan Hospital, Capital Medical University

location_facility: The Eighth Affiliated Hospital,GuangZhou Medical University

location_facility: Charlotte Gastroenterology and Hepatology - Randolph Road Office

location_facility: Hospital Regional de Alta Especialidad de Zumpango

location_facility: Synexus - Helderberg Clinical Research Centre - Somerset West

location_facility: State University of New York - University at Buffalo

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Tandem Clinical Research - New York Clinic

location_facility: UOSD Interdipartimentale Degenza Medica a ciclo breve

location_facility: The Second Affiliated Hospital of Chongqing Medical University

location_facility: Digestive Health Research of Central Texas

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: Centro de Investigacion y Gastroenterologia, S.C.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Texas Liver Institute/American Research Corporation

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Ohio Gastroenterology Group, Inc. - Olentangy Office

location_facility: Digestive Health Specialist of the Southeast

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov

location_facility: Centor for Advanced Gastroenterology - Main Office - Maitland

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera®

summary: This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_facility: HOPITAL NORD; NEPH Transplantation Reanimation

location_facility: Ch Henri Duffaut; Nephrologie Hemodialyse

location_facility: Ch De Beauvais; Neph Endocrino Dialyse Diabeto

location_facility: Hopital Europeen Georges Pompidou; Service de Nephrologie

location_facility: Chi Du Val D Ariege; Gastro Enterologie Nephrologie

location_facility: Ch Lyon Sud; Nephrologie Sect Jules Courmont

location_facility: Hopitaux Du Leman Site Thonon;Nephrologie

location_facility: Centre Hospitalier De Sens; Nephrologie-Dialyse

location_facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

location_facility: Ch de Brive la Gaillarde; Nephrologie Hemodialyse

location_facility: Chi Poissy Saint Germain En Laye; Hemodialyse

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: Centre Hospitalier General; Service de Nephrologie-Hemodialyse

location_facility: Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse

location_facility: Association Pour L'Aide Des Uremiques de Bretagne

location_facility: Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse

location_facility: Hopital Prive De L Estuaire; Nephrologie Hemodialyse

location_facility: Hopital de La Source; Service de Nephrologie & Hemodialyse

location_facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse

location_facility: Chu La Miletrie;Nephrologie Transplantation

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse

location_facility: Ch Antoine Gayraud; Nephrologie Hemodialyse

location_facility: Hopital Clemenceau; Nephrologie Hemodialyse

location_facility: Polyclinique De La Louviere; Nephrologie

location_facility: Ch Germon Et Gauthier; Medecine Interne Nephrologie

location_facility: Hopital Bretonneau; Nephrologie Transplantations

location_facility: Centre De Sante Medical; Centre De Sante Republique

location_facility: Hopital Hotel Dieu; Medecine Geriatrique Nephrologie

location_facility: Hopital Hotel Dieu Et Hme; Hemodialyse Chronique

location_facility: Hopital Rangueil; Nephrologie Hemodialyse

location_facility: Hopital Albert Michallon; Clinique De Nephrologie

location_facility: Fondation Transplantation; Ctirc De Drevon

location_facility: Centre Hemodialyse St Augustin; Nephrologie

location_facility: Ch Pitie Salpetriere; Nephrologie Hemodialyse

location_facility: Association Aurad Aquitaine; Aurad Gradignan

location_facility: Hopital Saint Louis; Service de Nephrologie - Transplantation

location_facility: Clinique de Tournan; Service de Nephrologie

location_facility: Ch Bretagne Atlantique De Vannes; Nephrologie

location_facility: Chic Cote Basque Bayonne; Nephrologie Hemodialyse

status_simplified: Completed


lead_sponsor: Gilead Sciences

summary: This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

ReferenceType: derived

ReferenceCitation: Younossi ZM, Stepanova M, Racila A, Afendy A, Lawitz EJ, Schwabe C, Ruane PJ, Lalezari J, Reddy KR, Jacobson IM, Muir AJ, Gaggar A, Myers RP, Younossi I, Nader F. Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Younossi ZM, Stepanova M, Jacobson I, Muir AJ, Pol S, Zeuzem S, Younes Z, Herring R, Lawitz E, Younossi I, Racila A. Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening Patient-reported Outcomes. Clin Infect Dis. 2020 Feb 3;70(4):628-632. doi: 10.1093/cid/ciz243.

oa_host_type: publisher

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Center for HIV and Hepatogastroenterology

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

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: C.H.U. Strasbourg - Hôpital Hautpierre - Hématologie

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Nashville Gastrointestinal Specialists, Inc

location_facility: Waikato Hospital (District Health Board)

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases

location_facility: Alfred Hospital - Infectious Disease Unit

location_facility: Lehigh Valley Health Network, Network Office of Research and Innovation

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: University of North Carolina at Chapel Hill

location_facility: Veterans Administration Wadsworth Medical Center

location_facility: University of Miami Miller School of Medicine

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Service des Maladies de l'Appareil Digestif et de la nutrition

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Veterans Affairs Pittsburgh Healthcare System

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Universitätsklinikum Würzburg - Med Klinik und Poliklinik

location_facility: Ente Ospedaliero Ospedali Galliera di Genova

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy

location_facility: University of Manitoba, Health Sciences Center

location_facility: University of California, San Francisco School of Medicine

location_facility: Inova Fairfax Hospital Center for Liver Diseases

location_facility: Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive

location_facility: Kansas City Gastroenterology and Hepatology

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

location_facility: Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

location_facility: Washington University School of Medicine

location_facility: Universitair Medisch Centrum Sint Radboud

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Remedis, s.r.o., Nestátní zdravotnické zarízení, Vladimírova 10

location_facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Hôpital Saint Louis, Services des Maladies Infectieuses

location_facility: Advanced Clinical Research Institute, LLC

location_facility: Hospital Moncloa, Servicio de Enfermedades Infecciosas

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: The Gastroenterology Group of South Jersey

location_facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Research Center at Affiliates in Gastroenterology

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Dipartimento Polispecialistico - Malattie Infetive

location_facility: Azienda Ospedaliera-universitaria Policlinico P. Giaccone

location_facility: Liver Institute of Virginia, Bon Secours Health System

location_facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus

location_facility: University of Utah Pediatric Pulmonology

location_facility: University of Pennsylvania School of Medicine

location_facility: Medizinisches Zentrum - Klinik für Gastroenterologie und Hepatologie

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Schleinitz Research and Gastroenterology LLC

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Weill Medical College of Cornell Univeristy

location_facility: Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

location_facility: Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Azienda Ospedaliera Padova, U.O.C. Cardiologia

location_facility: Virginia Commonwealth University Medical Center

location_facility: University of Birmingham and Queen Elizabeth Hospital Birmingham

location_facility: Hospital General Universitario de Valencia

location_facility: Hôpital La Pitié Salpétrière, Service des Maladies Infectieuses

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Community Research Initiative of New England

location_facility: Gastroenterology Center of the MidSouth, P.C.

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: St. Luke's Health Baylor College of Medicine Medical Center

location_facility: Kaiser Permanente Institute for Health Research

location_facility: Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

location_facility: Southampton University Hospitals NHS Trust, Southampton General Hospital

location_facility: Institut für interdisziplinäre Medizin Studien GmbH an der Asklepiosklinik Saint Georg

title: A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

type: EudraCT Number

source: euctr

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Australia
Sweden
Netherlands
Austria
United States
Spain
Czechia
Canada
Estonia
Puerto Rico
France


title: A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.

summary: The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No

lead_sponsor: LG Chem

location_country:
United Kingdom
France

location_facility: Pitié Salpêtrière hospital and Sorbonne Université


title: Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study

acronym: PREFER-PP

summary: The preferences of pregnant women for postpartum thromboprophylaxis are largely unknown. The aims of this transversal study are to elicit the preferences of pregnant/postpartum women about postpartum thromboprophylaxis in semi-structured interviews, and to estimate the utility of the relevant health states (pulmonary embolism, deep vein thrombosis, postpartum hemorrhage, subcutaneous injections). In this second aim, the investigators will also compare the effect of 2 different techniques to estimate utilities (standard gamble vs. time trade-off), using a randomization of these techniques.

time_perspective: Cross-Sectional

lead_sponsor: Marc Blondon

location_country: Switzerland France

location_facility:
Marc Blondon
Justine Hugon-Rodin

intervention_type: Other


title: Natriuretic-ureothelic Adaptation of Body Fluid Homeostasis During SGLT-2 Inhibition and/or Mineralocorticoid Receptor Modulation in Patients With Chronic Kidney Disease. A 4-arm, Double-blind, Double-dummy, Parallel-group, Phase 2 Study to Investigate the Mechanistic Effects of Dapagliflozin, Dapagliflozin + Balcinrenone, Balcinrenone and Placebo on Body Solute and Water Homeostasis and Energy Metabolism in Male and Female Participants Over 50 Years of Age With Chronic Kidney Disease.

acronym: DapaBalci-Leap

summary:
The purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in participants with stage 3 chronic kidney disease. The study interventions will be administered orally, daily, in addition to current therapy, for a duration of 28 days. This will allow us to maximize our ability to detect a drug effect while minimizing the drop-out rate that accompanies longer studies. In order to understand the different mechanistic effects of these interventions on energy metabolism, the study will be conducted at two study sites. The study design and treatment allocation, treatment duration as well as sample analysis for evaluation of the primary endpoint will be identical for all participants, at both sites. Therefore, urine and plasma samples for analysis of water and electrolyte handling will be collected from all study participants at both sites.

In addition to the primary endpoint, the main study site (Nuremberg) will conduct a metabolic study to investigate the early- and late-effects of the interventions, while the second site, Marseille, will conduct an imaging sub-study to assess changes at the tissue level before and after treatment.

ReferenceType: background

ReferenceCitation: Marton A, Kaneko T, Kovalik JP, Yasui A, Nishiyama A, Kitada K, Titze J. Organ protection by SGLT2 inhibitors: role of metabolic energy and water conservation. Nat Rev Nephrol. 2021 Jan;17(1):65-77. doi: 10.1038/s41581-020-00350-x. Epub 2020 Oct 1.

ReferenceCitation: Kovarik JJ, Morisawa N, Wild J, Marton A, Takase-Minegishi K, Minegishi S, Daub S, Sands JM, Klein JD, Bailey JL, Kovalik JP, Rauh M, Karbach S, Hilgers KF, Luft F, Nishiyama A, Nakano D, Kitada K, Titze J. Adaptive physiological water conservation explains hypertension and muscle catabolism in experimental chronic renal failure. Acta Physiol (Oxf). 2021 May;232(1):e13629. doi: 10.1111/apha.13629. Epub 2021 Mar 7.

ReferenceCitation: Wild J, Jung R, Knopp T, Efentakis P, Benaki D, Grill A, Wegner J, Molitor M, Garlapati V, Rakova N, Marko L, Marton A, Mikros E, Munzel T, Kossmann S, Rauh M, Nakano D, Kitada K, Luft F, Waisman A, Wenzel P, Titze J, Karbach S. Aestivation motifs explain hypertension and muscle mass loss in mice with psoriatic skin barrier defect. Acta Physiol (Oxf). 2021 May;232(1):e13628. doi: 10.1111/apha.13628. Epub 2021 Feb 23.

ReferenceCitation: Kitada K, Daub S, Zhang Y, Klein JD, Nakano D, Pedchenko T, Lantier L, LaRocque LM, Marton A, Neubert P, Schroder A, Rakova N, Jantsch J, Dikalova AE, Dikalov SI, Harrison DG, Muller DN, Nishiyama A, Rauh M, Harris RC, Luft FC, Wassermann DH, Sands JM, Titze J. High salt intake reprioritizes osmolyte and energy metabolism for body fluid conservation. J Clin Invest. 2017 May 1;127(5):1944-1959. doi: 10.1172/JCI88532. Epub 2017 Apr 17.

lead_sponsor: Klinikum Nürnberg

location_country: Germany France

location_facility: Assistance Publique-Hopitaux de Marseille (AP-HM)


title: Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions (CBI-registry)

acronym: CBI-Registry

summary: The CBI registry is a prospective, interdisciplinary, multimodal observational registry of patients with covert brain infarction. Methods: A standardized workup in analogy to manifest ischemic stroke including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, laboratory work-up and risk factor assessment as well as noninvasive angiography of the cervical and intracranial arteries will be performed.

ReferenceCitation: Meinel TR, Kaesmacher J, Roten L, Fischer U. Covert Brain Infarction: Towards Precision Medicine in Research, Diagnosis, and Therapy for a Silent Pandemic. Stroke. 2020 Aug;51(8):2597-2606. doi: 10.1161/STROKEAHA.120.030686. Epub 2020 Jul 10. No abstract available.

ipd_sharing: Yes

ipd_sharing_description: Open to expand the registry to other centers. Can provide the materials:

lead_sponsor: Insel Gruppe AG, University Hospital Bern

location_facility: Centre Hospitalier Universitaire de Tours

lead_sponsor_type: academique


title: Identification of Novel Biomarker-s of Abusive Head Trauma on Serum by Proteomics

summary: The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.

lead_sponsor: University Hospital, Geneva

sponsor_collaborators:
University Hospital, Geneva
Hospices Civils de Lyon

location_facility:
Ginhoux Thiphanie
Wiskott Kim


title: An International Prospective Natural History Study in Children With a Type II Collagen Disorder With Short Stature

acronym: ROCKET

summary:
There are relatively few data available on type II collagen disorders, and evidence is lacking on the disease course in relation to symptoms and development of complications, the level of actual disease burden over time as well as data to support identification of possible risk factors.

This study aims to build a natural history data set through collection of a number of clinical, imaging, and laboratory assessments that may be specific predictors of type II collagen disorder progression and clinical outcome. Having a type II collagen disorder natural history data set can inform potential efficacy endpoints and biomarkers for future clinical trials.

This natural history study will follow up to 60 individuals diagnosed with a type II collagen disorder for up to 3 years. Visits will be conducted every 3 months for the first year and then every 6 months, during which several assessments will be performed in order to learn about the natural course of the disease, including changes in clinical and functional outcomes, imaging and biofluid biomarkers. Some of the study activities include: a physical exam, height measurements, vision and breathing tests and x-ray. A blood sample will be collected once or twice each year.

Most of the information collected, the tests done, and the schedule of visits in this study are the same as recommended for regular care of children with a type II collagen disorder.

ReferenceCitation: Savarirayan R, Bompadre V, Bober MB, Cho TJ, Goldberg MJ, Hoover-Fong J, Irving M, Kamps SE, Mackenzie WG, Raggio C, Spencer SS, White KK; Skeletal Dysplasia Management Consortium. Best practice guidelines regarding diagnosis and management of patients with type II collagen disorders. Genet Med. 2019 Sep;21(9):2070-2080. doi: 10.1038/s41436-019-0446-9. Epub 2019 Jan 30.

ReferenceCitation: Oh CW, Thacker MM, Mackenzie WG, Riddle EC. Coxa vara: a novel measurement technique in skeletal dysplasias. Clin Orthop Relat Res. 2006 Jun;447:125-31. doi: 10.1097/01.blo.0000203476.81302.24.

ReferenceCitation: Dhiman N, Albaghdadi A, Zogg CK, Sharma M, Hoover-Fong JE, Ain MC, Haider AH. Factors associated with health-related quality of life (HRQOL) in adults with short stature skeletal dysplasias. Qual Life Res. 2017 May;26(5):1337-1348. doi: 10.1007/s11136-016-1455-7. Epub 2016 Nov 19.

ReferenceCitation: Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20. doi: 10.1097/00004694-200409000-00011.

ipd_sharing: Undecided

lead_sponsor: Innoskel

location_country: Spain France

location_facility:
Hospital Universitario La Paz
Hopital Necker-Enfants Malades


title: Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

acronym: PREVENT

summary: The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of a PMCF Plan.

status: Terminated

lead_sponsor: Intuitive Surgical

location_country: Italy France

location_facility:
Istituto Europeo di Oncologia
Gustave Roussy Cancer Campus

intervention_type: Procedure

status_simplified: Unknown


title: Multicentre, Open-label, Uncontrolled, Pivotal Clinical Trial to Confirm the Efficacy and Safety of Autologous Fibrin-cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified for Restoration of Epidermis in Patients With Junctional Epidermolysis Bullosa

acronym: HOLOGENE 5

summary: Prospective, multicenter and multinational, open-label, uncontrolled clinical study to assess the safety and efficacy of autologous cultured epidermal grafts containing epidermal stem cells genetically modified transduced with a LAMB3-gamma retroviral vector. The purpose of this study is to demonstrate the safety and efficacy after one or more treatments with genetically corrected cultured epidermal autograft (Hologene 5) for restoration of the epidermis in patients with generalized intermediate LAMB3-dependent Junctional Epidermolysis Bullosa.

lead_sponsor: Holostem Terapie Avanzate s.r.l.

sponsor_collaborators:
Holostem Terapie Avanzate s.r.l.
IRCCS San Raffaele
University of Modena and Reggio Emilia

location_facility: Struttura Complessa di Dermatologia Azienda Ospedaliero Universitaria Policlinico di Modena


title: Health Status of Transgender Women in French Guiana and Paris: a Cross-sectional View (TransGuyane)

acronym: TransGuyane

summary: Assessing and comparing the life and health status of transgender or trans women in French Guiana and Paris. Conducting a questionnaire on physical, mental and sexual health, migration history, transition, and STI screening.

ReferenceCitation: Baral SD, Poteat T, Stromdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Mar;13(3):214-22. doi: 10.1016/S1473-3099(12)70315-8. Epub 2012 Dec 21.

ReferenceCitation: Grinsztejn B, Jalil EM, Monteiro L, Velasque L, Moreira RI, Garcia AC, Castro CV, Kruger A, Luz PM, Liu AY, McFarland W, Buchbinder S, Veloso VG, Wilson EC; Transcender Study Team. Unveiling of HIV dynamics among transgender women: a respondent-driven sampling study in Rio de Janeiro, Brazil. Lancet HIV. 2017 Apr;4(4):e169-e176. doi: 10.1016/S2352-3018(17)30015-2. Epub 2017 Feb 8.

ReferenceCitation: Silva-Santisteban A, Eng S, de la Iglesia G, Falistocco C, Mazin R. HIV prevention among transgender women in Latin America: implementation, gaps and challenges. J Int AIDS Soc. 2016 Jul 17;19(3 Suppl 2):20799. doi: 10.7448/IAS.19.3.20799. eCollection 2016.

ReferenceCitation: Baggaley RF, White RG, Boily MC. HIV transmission risk through anal intercourse: systematic review, meta-analysis and implications for HIV prevention. Int J Epidemiol. 2010 Aug;39(4):1048-63. doi: 10.1093/ije/dyq057. Epub 2010 Apr 20.

ReferenceCitation: Operario D, Burton J, Underhill K, Sevelius J. Men who have sex with transgender women: challenges to category-based HIV prevention. AIDS Behav. 2008 Jan;12(1):18-26. doi: 10.1007/s10461-007-9303-y. Epub 2007 Aug 19.

ReferenceCitation: Pinto RM, Melendez RM, Spector AY. Male-to-Female Transgender Individuals Building Social Support and Capital From Within a Gender-Focused Network. J Gay Lesbian Soc Serv. 2008 Sep 1;20(3):203-220. doi: 10.1080/10538720802235179.

ReferenceCitation: Reisner SL, Poteat T, Keatley J, Cabral M, Mothopeng T, Dunham E, Holland CE, Max R, Baral SD. Global health burden and needs of transgender populations: a review. Lancet. 2016 Jul 23;388(10042):412-436. doi: 10.1016/S0140-6736(16)00684-X. Epub 2016 Jun 17.

ReferenceCitation: Poteat T, Wirtz AL, Radix A, Borquez A, Silva-Santisteban A, Deutsch MB, Khan SI, Winter S, Operario D. HIV risk and preventive interventions in transgender women sex workers. Lancet. 2015 Jan 17;385(9964):274-86. doi: 10.1016/S0140-6736(14)60833-3. Epub 2014 Jul 22.

ReferenceCitation: Operario D, Soma T, Underhill K. Sex work and HIV status among transgender women: systematic review and meta-analysis. J Acquir Immune Defic Syndr. 2008 May 1;48(1):97-103. doi: 10.1097/QAI.0b013e31816e3971.

ReferenceCitation: Ferreira S Jr, Francisco PMSB, Nogueira PA. [Profile of transvestites and transgender women: tuberculosis and HIV/AIDS in the city of Sao Paulo]. Rev Panam Salud Publica. 2016 Dec;40(6):410-417. Portuguese.

ReferenceCitation: Zoni AC, Gonzalez MA, Sjogren HW. Syphilis in the most at-risk populations in Latin America and the Caribbean: a systematic review. Int J Infect Dis. 2013 Feb;17(2):e84-92. doi: 10.1016/j.ijid.2012.07.021. Epub 2012 Oct 12.

ReferenceCitation: Solomon MM, Mayer KH, Glidden DV, Liu AY, McMahan VM, Guanira JV, Chariyalertsak S, Fernandez T, Grant RM; iPrEx Study Team. Syphilis predicts HIV incidence among men and transgender women who have sex with men in a preexposure prophylaxis trial. Clin Infect Dis. 2014 Oct;59(7):1020-6. doi: 10.1093/cid/ciu450. Epub 2014 Jun 13.

ReferenceCitation: Keshinro B, Crowell TA, Nowak RG, Adebajo S, Peel S, Gaydos CA, Rodriguez-Hart C, Baral SD, Walsh MJ, Njoku OS, Odeyemi S, Ngo-Ndomb T, Blattner WA, Robb ML, Charurat ME, Ake J; TRUST/RV368 Study Group. High prevalence of HIV, chlamydia and gonorrhoea among men who have sex with men and transgender women attending trusted community centres in Abuja and Lagos, Nigeria. J Int AIDS Soc. 2016 Dec 7;19(1):21270. doi: 10.7448/IAS.19.1.21270. eCollection 2016.

ReferenceCitation: Wickersham JA, Gibson BA, Bazazi AR, Pillai V, Pedersen CJ, Meyer JP, El-Bassel N, Mayer KH, Kamarulzaman A, Altice FL. Prevalence of Human Immunodeficiency Virus and Sexually Transmitted Infections Among Cisgender and Transgender Women Sex Workers in Greater Kuala Lumpur, Malaysia: Results From a Respondent-Driven Sampling Study. Sex Transm Dis. 2017 Nov;44(11):663-670. doi: 10.1097/OLQ.0000000000000662.

ReferenceCitation: Kojima N, Park H, Konda KA, Joseph Davey DL, Bristow CC, Brown B, Leon SR, Vargas SK, Calvo GM, Caceres CF, Klausner JD. The PICASSO Cohort: baseline characteristics of a cohort of men who have sex with men and male-to-female transgender women at high risk for syphilis infection in Lima, Peru. BMC Infect Dis. 2017 Apr 11;17(1):255. doi: 10.1186/s12879-017-2332-x.

lead_sponsor: Centre Hospitalier de Cayenne

sponsor_collaborators:
Centre Hospitalier de Cayenne
Bichat Hospital

location_country:
French Guiana
France

location_facility: Centre Hopsitalier Uiversitaire de Bichat


title: Study Evaluating the Performance and Safety in the Medium Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,3.0,twinKon® U,EVL® S,EVL® K,EVL® C

summary: This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, 3.0, twinKon® UNIVERSAL, EVL® S, EVL® K and EVL® C.

status: Unknown status

time_perspective: Other

lead_sponsor: Global D

location_country: Greece France

intervention_type: Device


type: Other Identifier

type: Other Grant/Funding Number

title: Exploratory Multicenter Observational Study to Assess the Outcome of Infants With Perinatal SARS-COV-2 Infection and Its Link With the NO Pathway: the Minipuberty Hypothesis

acronym: miniNO-COVID

summary: Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal (HPG) axis, and specifically with its transient activation occurring during infancy, namely minipuberty, is a major concern. Among the various pathogenic features related to COVID-19, altered minipuberty could be a key factor underlying many multimorbidities later in life, suggesting that they could involve a common causative mechanism that occurs within this short and critical period of time following birth. Altered minipuberty together with NO deficiency seem to be key factors underlying many of these multimorbidities, suggesting that they involve a common causative mechanism that occurs within this short and critical period of time following birth

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
European Commission

location_facility: Uri-National and Kapodistrian University of Athens


title: AUDIOWOLF: A Phase II, Open-label, Efficacy Study of Daily Administration of Sodium Valproate in Patients Clinically Affected by Wolfram Syndrome Due to Monogenic Mutation.

acronym: AUDIOWOLF

summary: Open label, phase II study non randomized single group assignment of 20 evaluable patients 13 years and older, over 37,5 kg body-weight, with sensorineural hearing loss of at least 20 dB at 8 kHz in high frequency average (HFA), and with documented genetic mutations in the WFS1 gene and with at least one other major documented clinical symptom pertaining to Wolfram syndrome (i.e. diabetes mellitus, diabetes insipidus, optic atrophy). Every patients will receive over three years a treatment by VPA (Depakine chrono).

lead_sponsor: Centre d'Etude des Cellules Souches

sponsor_collaborators:
Centre d'Etude des Cellules Souches
Genethon

location_facility: Centro periférico de Especialidades de Almería


title: A Phase I/II Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors

acronym: Briga-PED

summary: This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.

design_allocation: Non-Randomized

primary_purpose: Other

ipd_sharing_description: all IPD that underlie results in a publication

lead_sponsor: Princess Maxima Center for Pediatric Oncology

location_country: Netherlands France

location_facility: Princess Máxima Center for Pediatric Oncology


title: Combining Default Choices and a Decision Aid to Improve Tobacco Cessation at 6 Months in Primary Care Patients: a Pragmatic, Cluster-randomized Trial

acronym: FIRST

summary: The FIRST cluster randomized trial will evaluate the effect of 1) a training program encouraging general practitioners to offer smoking cessation treatment as a default choice to all current smokers consulting a general practitioner (GP), and 2) an interactive, electronic decision aid to guide smoking cessation treatment, on the proportion of current smokers seen in primary care who have quit smoking 6 months after a baseline visit to their GP, as compared to enhanced usual care.

status: Active, not recruiting

primary_purpose: Prevention

ReferenceCitation: Jakob J, Cornuz J, Auer R, Jacot Sadowski I, Cardinaux R, Selby K. [Design and user-testing of a decision aid comparing medications for smoking cessation]. Rev Med Suisse. 2017 Jun 7;13(566):1191-1194. French.

ReferenceCitation: Hempel-Bruder C, Habfast-Robertson I, Durand MA, Berlin I, Marti J, Khazaal Y, Quinto C, Faouzi M, Selby K. Combining default choices and an encounter decision aid to improve tobacco cessation in primary care patients: protocol for a cluster-randomized trial. BMC Prim Care. 2022 Sep 24;23(1):246. doi: 10.1186/s12875-022-01859-9.

ipd_sharing_description: Anonymised data available upon request

lead_sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

collaborators:
Tobacco Control Fund Switzerland
Swiss Medical Association (FMH)

location_facility:
Unisante
Maison de santé Mermoz

intervention_type: Behavioral


title: Prospective Registry of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver With HepaSphere™ Microspheres Loaded With Irinotecan

acronym: mCRC

summary:
HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.

The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.

lead_sponsor: Merit Medical Systems, Inc.

location_facility:
European Hospital Georges Pompidou
Evgenidio Hospital/ATTIKO Hospital


title: Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds

acronym: NICE

summary: STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.

lead_sponsor: Laboratoires Vivacy

location_country: Poland France

location_facility:
Eurofins Dermscan Pharmascan
Eurofins Dermscan Poland


title: SMILE Study: Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips

acronym: SMILE

summary:
STYLAGE® M Lidocaine is a hyaluronic acid injectable gel CE (conformité européenne)-marketed since 2009 . It is indicated for the outline of the lips and/or for lips augmentation in lips mucosa. It is also indicated to fill skin depressions on the face. Lidocaine is intended to reduce the pain associated with the injection.

The aim of SMILE study is to demonstrate that STYLAGE® M Lidocaine is non-inferior to an active comparator that has shown its effectiveness in lips' volume augmentation and restoration in improving the aesthetic appearance of the lips evaluated by subjects.

In this study, 92 healthy volunteers between 18 and 65 years old, who expressed the wish for augmentation or restoration of the volume of the lips and/or lips' outline redefinition, confirmed by investigators at inclusion, who have given his/her informed consent and who met all the eligibility criteria, will be enrolled.

Subjects will randomly receive STYLAGE® M Lidocaïne or the active comparator (ratio 1:1) injection in the lips at first visit on Day 0. At second visit, one month after Day 0, an optional touch-up injection could be performed according to subject's and investigator's opinions and if the subject is still eligible.

Subjects will have a total of 6 visits over a 12 months follow-up period and a screening visit prior to first injection.

Proportion of subjects having a global aesthetic improvement of their lips (blinded self-evaluation), 3 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 6, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator, subjects' satisfaction, pain during injection and safety parameters will also be assessed during the study period.

collaborators: Eurofins Inferential

sponsor_collaborators:
Laboratoires Vivacy
Eurofins
Inferential


title: Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)

acronym: MAP-IN-HEART

summary: The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
European Commission

location_facility: Department of Cardiac Pacing and Electrophysiology, CHU Bordeaux


title: A Phase 1/2, Multicenter, Open-label, Dose-confirmation Trial to Evaluate the Safety and Preliminary Efficacy of DYN101 in Participants 2 to 17 Years of Age With Centronuclear Myopathy Caused by Mutations in MTM1 or DNM2

acronym: DyNaMic

summary: There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety and tolerability as well as pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DYN101 in participants 2 to 17 years of age with CNM caused by mutations in DNM2 or MTM1.The trial will consist of a pre-screening consent, a screening period, a run-in period (if applicable), and a Part 1 of 12 weeks with weekly infusion of DYN101 to evaluate safety and tolerability as well as PK, PD and preliminary efficacy. The dose level may need adjustment based on the Part 1 results of the current study and available data from the Unite-CNM study (DYN101-C101, NCT04033159). If a dose adjustment is needed, Part 2 will be conducted in the same participants and the newly selected dose level will be used to assess whether efficacy is seen after an additional 12 weeks of treatment. As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

status: Withdrawn

ReferenceCitation: Tasfaout H, Buono S, Guo S, Kretz C, Messaddeq N, Booten S, Greenlee S, Monia BP, Cowling BS, Laporte J. Antisense oligonucleotide-mediated Dnm2 knockdown prevents and reverts myotubular myopathy in mice. Nat Commun. 2017 Jun 7;8:15661. doi: 10.1038/ncomms15661.

lead_sponsor: Dynacure

location_facility:
Universitätsklinikum Essen
I-Motion Institute - Trousseau Hospital


title: A Study on Genetic Alterations (Polymorphism) in Key Genes in the Kynurenine Pathway on Suicidal Behavior

acronym: SuiKYN

summary: Current research has shown that an imbalance in the Kinurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO, KAT, KMO, 3HAO and QPRT which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but no studies have ever tried to find a link between these enzymes and suicidal behavior. The investigators hypothesize that people who have attempted to commit suicide will have pro-inflammatory genetic variations affecting the kynurenine pathway.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Genetic


title: Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

acronym: SCEI

summary: The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre de Recherche et d'Innovation Clinique

intervention_type: Diagnostic Test


title: e۰Sense® Clinical Investigation: Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for Performing Urodynamic Studies

summary: This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters). Data pertaining to the safety, effectiveness and usability of the catheters will be collected.

primary_purpose: Diagnostic

ReferenceCitation: Fleiss, J.L., Levin, B., & Cho Paik, M. (2003). Statistical Methods for Rates and Proportions (3rd ed.). New York, NY: Wiley

lead_sponsor: Laborie Medical Technologies Inc.

location_facility: Hôpital Tenon AP-HP (Sorbonne Université)


title: Role of Nasal Dysbiosis in Parkinson Disease

acronym: SMELLPARK

summary: Olfactory dysfunction is frequent in Parkinson Disease (PD) and may be present years before the motor symptoms appear. The early olfactory dysfunction could result from environmental factors acting through the nasal cavity such as microbial communities. In across-sectional bicentric study, groups of 160 PD patients and 160 controls will be compared for nasal microbiota composition according to their geographical origin. We will search an association between microbiota and the presence of an olfactory deficit, cognitive deficit and thymic disorder.

lead_sponsor: Institut Pasteur

location_country: Guadeloupe France

location_facility:
Pitie-Salpetriere Hospital
Centre Hospitalier Universitaire


title: Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

summary: Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

ReferenceType: result

ReferenceCitation: Derycke L, Perrin D, Cochennec F, Albertini JN, Avril S. Predictive Numerical Simulations of Double Branch Stent-Graft Deployment in an Aortic Arch Aneurysm. Ann Biomed Eng. 2019 Apr;47(4):1051-1062. doi: 10.1007/s10439-019-02215-2. Epub 2019 Jan 31.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Cornell University - arXiv

repository_normalized: arXiv

version: submittedVersion

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repositories: HAL arXiv

repositories_concat: HAL;arXiv

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Saint-Etienne
Rinjstate Hopital


title: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

acronym: DORAVIPEP

summary: Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

lead_sponsor: David Garcia Cinca

sponsor_collaborators:
David Garcia Cinca
Dr. Josep Mallolas

location_facility: Department and HIV & HCV Clinical Research Unit University Hospital Nantes


title: Clinical Application of the European Horizon 2020 Research Project "BRIDGES" - Study of the Psychological Impact of Breast Cancer Risk Communication in Cancer Genetics Based on the Personalized Estimation of the BOADICEA V5/PLUS Model

summary: Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").

lead_sponsor: Institut Curie

location_facility:
University Hospital of Cologne
Institut Curie


title: MOdified DIagnostic strateGy to Safely ruLe-out Pulmonary Embolism In the Emergency depArtment: A Non-Inferiority Cluster Cross-over Randomized Trial

acronym: MODIGLIA-NI

summary:
Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.

This is a non-inferiority, cluster cross-over randomized, international trial.

Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods.

All centers will recruit adult emergency patients with a suspicion of PE.

In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA.

In the intervention group (MODS) :

All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule :

- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised.

If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.

ReferenceCitation: Freund Y, Chauvin A, Jimenez S, Philippon AL, Curac S, Femy F, Gorlicki J, Chouihed T, Goulet H, Montassier E, Dumont M, Lozano Polo L, Le Borgne P, Khellaf M, Bouzid D, Raynal PA, Abdessaied N, Laribi S, Guenezan J, Ganansia O, Bloom B, Miro O, Cachanado M, Simon T. Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2141-2149. doi: 10.1001/jama.2021.20750.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Philippon AL, Dumont M, Jimenez S, Salhi S, Cachanado M, Durand-Zaleski I, Simon T, Freund Y. MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial. Trials. 2020 Jun 3;21(1):458. doi: 10.1186/s13063-020-04379-y.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: gold

ipd_sharing_description: Yes, upon request, after approval by the primary investigator and clinical research platform of East Paris. For the purpose of IPD meta-analysis, or secondary analysis. Unidentifying data will be shared.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Emergency department Hospital Pitié-Salpêtrière

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: MODIGLIANI

titre: Stratégie diagnostique modifiée pour écarter le diagnostic d'embolie pulmonaire aux urgences en toute sécurité : Un essai de non-infériorité randomisé en cluster cross-over.

discipline_principale: emergency medicine

nom_porteur: FREUND

prenom_porteur: Yonathan


title: FENIX™ Continence Restoration System Registry

summary: The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.

lead_sponsor: Torax Medical Incorporated

location_facility:
University Hospital of Nantes
Kliniken Essen-Mitte


title: Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP

acronym: TINE

summary: This study evaluates the addition of a comprehensive lifestyle program including dietary management and exercise to continuous positive airway pressure (CPAP) therapy in overweighted adults with obstructive sleep apnea. Half of the participants will receive CPAP therapy while the other half will have diet consultations, nordic walking sessions and CPAP.

lead_sponsor: Raphael Heinzer

sponsor_collaborators:
Raphael Heinzer
Swiss Lung Association
Ligue Pulmonaire Vaudoise

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire Saint-Etienne


title: Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy

acronym: BB-AQM

summary: This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.

lead_sponsor: University Hospital, Brest

location_country: Romania France

location_facility: Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of Elafibranor 120 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function

summary: This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of elafibranor 120 mg

primary_purpose: Basic Science

lead_sponsor: Genfit

location_facility: ARENSIA Exploratory Medicine Unit, Nephrology Hospital Dr. Carol Davilla


type: Registry Identifier

title: Controlled Randomized Clinical Trial to Assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients With Treatment Resistant Major Depression

acronym: FORESEE III

summary: The primary objective of this multicenter, randomized, sham-controlled, double blind (patient and observer blinded) clinical trial is to assess the antidepressant effect of Deep Brain Stimulation (DBS) in patients with treatment resistant major depression using the Boston Scientific implantable Vercise™ GEVIA™ DBS system compared to sham.

lead_sponsor: University Hospital Freiburg

sponsor_collaborators:
University Hospital Freiburg
Boston Scientific Corporation

location_facility:
Université Grenoble Alpes
University Hospital Freiburg


title: Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam

acronym: CoViet-C

summary: The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_country: Vietnam France

location_facility:
CHU Nimes
Hospital Viet Tiep


title: Evaluation of MDW for Early Detection of Sepsis In the Emergency Department

summary: The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults who have blood draw including Complete Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish & French hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).

ReferenceCitation: Hausfater P, Robert Boter N, Morales Indiano C, Cancella de Abreu M, Marin AM, Pernet J, Quesada D, Castro I, Careaga D, Arock M, Tejidor L, Velly L. Monocyte distribution width (MDW) performance as an early sepsis indicator in the emergency department: comparison with CRP and procalcitonin in a multicenter international European prospective study. Crit Care. 2021 Jun 30;25(1):227. doi: 10.1186/s13054-021-03622-5.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
PubMed Central
ddd.uab.cat

repositories_concat: HAL;PubMed Central;ddd.uab.cat

lead_sponsor: Beckman Coulter, Inc.

location_facility: Hospital Universitari Germans Trias I Pujol


title: A Non-interventional Patient Study to Demonstrate Medical Utility of the lncRNA to Predict HF in AMI Patients

acronym: HeartLinc

summary: HeartLinc is a non-interventional patient study to demonstrate medical utility of the lncRNA to predict HF in AMI patients. 300 patients are expected to be recruited.

lead_sponsor: Firalis SA

location_country:
Korea, Republic of
France

location_facility:
CHU de TOULOUSE
SNUH


title: Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles

acronym: CryoPID

summary: Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.

ReferenceCitation: Romagnoli M, Colby TV, Suehs CM, Vachier I, Molinari N, Bourdin A. Cryobiopsy Compared with Surgical Lung Biopsy in ILD: Reply to Maldonado et al., Froidure et al., Bendstrup et al., Agarwal et al., Richeldi et al., Rajchgot et al., and Quadrelli et al. Am J Respir Crit Care Med. 2019 Oct 1;200(7):944-946. doi: 10.1164/rccm.201906-1252LE. No abstract available.

ReferenceCitation: Bourdin A, Suehs CM, Colby TV, Vachier I, Molinari N, Romagnoli M. Reply to Wand et al.: Role of Transbronchial Cryobiopsy in Interstitial Lung Diseases: An Ongoing Tale. Am J Respir Crit Care Med. 2020 Jan 15;201(2):260-261. doi: 10.1164/rccm.201909-1736LE. No abstract available.

ReferenceCitation: Bourdin A, Romagnoli M, Gamez AS, Hireche K, Berthet JP, Mallet JP, Vachier I, Nava S, Reynaud P, Molinari N, Suehs C. Careful consideration of the bleeding caused by transbronchial lung cryobiopsies. Eur Respir J. 2020 May 21;55(5):1902415. doi: 10.1183/13993003.02415-2019. Print 2020 May. No abstract available.

ReferenceCitation: Romagnoli M, Colby TV, Berthet JP, Gamez AS, Mallet JP, Serre I, Cancellieri A, Cavazza A, Solovei L, Dell'Amore A, Dolci G, Guerrieri A, Reynaud P, Bommart S, Zompatori M, Dalpiaz G, Nava S, Trisolini R, Suehs CM, Vachier I, Molinari N, Bourdin A. Poor Concordance between Sequential Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy in the Diagnosis of Diffuse Interstitial Lung Diseases. Am J Respir Crit Care Med. 2019 May 15;199(10):1249-1256. doi: 10.1164/rccm.201810-1947OC.

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

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

repositories_concat: HAL

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: American Thoracic Society

ReferenceCitation: Suehs C, Bourdin A, Vachier I, Molinari N, Romagnoli M. Transbronchial cryobiopsy in the diagnosis of interstitial lung diseases: methodologies and perspectives from the Cryo-PID and COLDICE studies. Ann Transl Med. 2020 Oct;8(20):1330. doi: 10.21037/atm-20-2814. No abstract available.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: AME Publishing Company

ReferenceCitation: Reynaud P, Ahmed E, Serre I, Knabe L, Bommart S, Suehs C, Vachier I, Berthet JP, Romagnoli M, Vernisse C, Mallet JP, Gamez AS, Bourdin A. Club Cell Loss as a Feature of Bronchiolization in ILD. Front Immunol. 2021 Feb 26;12:630096. doi: 10.3389/fimmu.2021.630096. eCollection 2021.

location_facility: Arnaud de Villeneuve University Hospital


title: Cerebral Functional Modifications After Low Frequency Repetitive Transcranial Magnetic Stimulation in Refractory Depression. Assessment With 18F-FDG-PET Imaging.

acronym: SMTr-METAB

summary: Biological markers of depressive states have been studied, but their usefulness to predict the therapeutic response is unknown. This issue is major in all depressive states which have not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic stimulation) is a non-pharmacological alternative in the treatment of depression, but its effects on cerebral functioning are not known in episodes which have resist to conventional treatments. The investigators will include 50 depressive patients who have failed to respond to two successive antidepressant medication, and propose them a treatment with low frequency rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in order to measure induced metabolic changes and their correlation with clinical states. Patients who have responded to rTMS acute treatment may continue this therapeutic for six months, and the investigators will assess if efficacy maintenance is related with cerebral metabolic variations

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Monaco France

location_facility:
CHU de Nice
Hôpital Princesse Grace


title: Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Weekly Repeated Intravenous Infusions in Patients With Advanced Solid Tumors.

summary:
This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.

The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.

Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.

Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.

Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).

ReferenceCitation: Le Tourneau C, Becker H, Claus R, Elez E, Ricci F, Fritsch R, Silber Y, Hennequin A, Tabernero J, Jayadeva G, Luedtke D, He M, Isambert N. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors. ESMO Open. 2022 Oct;7(5):100576. doi: 10.1016/j.esmoop.2022.100576. Epub 2022 Sep 13.

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

lead_sponsor: Boehringer Ingelheim

location_facility:
Hospital Vall d'Hebron
CTR Georges-François Leclerc


title: Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study

acronym: SKINNOQ

summary: The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.

ReferenceCitation: Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn(R) Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8.

lead_sponsor: Aesculap AG

sponsor_collaborators:
Aesculap AG
B.Braun Surgical SA

location_facility: Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology


title: Cognitive Behavioural Therapy for Anxiety Disorders in Patients With Parkinson's Disease: a Randomized, Controlled Trial of the Clinical Effectiveness and Changes in Cerebral Connectivity

summary: Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life. With this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity. Effective CBT treatment of anxiety will provide patients with behavioural and anxiety management techniques that can give lasting benefits, not only on anxiety symptoms, but potentially also on motor symptoms.

ReferenceCitation: Mulders AEP, Moonen AJH, Dujardin K, Kuijf ML, Duits A, Flinois B, Handels RLH, Lopes R, Leentjens AFG. Cognitive behavioural therapy for anxiety disorders in Parkinson's disease: Design of a randomised controlled trial to assess clinical effectiveness and changes in cerebral connectivity. J Psychosom Res. 2018 Sep;112:32-39. doi: 10.1016/j.jpsychores.2018.04.002. Epub 2018 Apr 10.

repository_institution: Maastricht University - Research Publications

ipd_sharing_description: Treatment module will be made available for public use. Study data will be published in peer-reviewed journals.

lead_sponsor: Maastricht University Medical Center

collaborators: Michael J. Fox Foundation for Parkinson's Research

location_facility: Neurology and Movement Disorders Unit, Lille University Hospital