title: A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

summary:
Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market.

The purpose of this study is to look at whether afamelanotide can reduce the number and severity of EPP symptoms when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP.

The study will involve the use of an implant, which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication).

Over 450 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days. Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve.

This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers.

Up to 70 people will participate in this study from study sites across Europe.

ReferenceCitation: Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FPJ, Sijbrands EJG, de Rooij FWM, Lebwohl M, Naik H, Goding CR, Wilson JHP, Desnick RJ. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015 Jul 2;373(1):48-59. doi: 10.1056/NEJMoa1411481.

lead_sponsor: Clinuvel Pharmaceuticals Limited

location_country:
Finland
Ireland
Germany
United Kingdom
Netherlands
France

location_facility: Department of Dermatology , Heinrich-Heine-University Duesseldorf

location_facility: Centre Français des Porphyries, Hôpital Louis Mourier

location_facility: Photobiology Unit - Hope Hospital, University of Manchester

location_facility: HUS:n Iho-ja allergiasairaala (Skin and Allergy Hospital)

location_facility: Beaumont Hospital, Department of Dermatology


type: Other Identifier

title: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

acronym: SENTICOLIII

summary:
SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).

There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Lecuru FR, McCormack M, Hillemanns P, Anota A, Leitao M, Mathevet P, Zweemer R, Fujiwara K, Zanagnolo V, Zahl Eriksson AG, Hudson E, Ferron G, Plante M. SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study. Int J Gynecol Cancer. 2019 May;29(4):829-834. doi: 10.1136/ijgc-2019-000332. Epub 2019 Mar 20.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: British Medical Journal

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country: China Japan Italy France

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

location_facility: Center de Lutte Contre le Cancer François Baclesse

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre Hospitalier Bichat - Claude Bernard

location_facility: Centre de Lutte Contre le Cancer Gustave Roussy

location_facility: Centre de Lutte Contre le Cancer Jean Perrin

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Cancer Hospital of University of Chinese Academy of Science

location_facility: Institut Universitaire du Cancer de Toulouse

location_facility: Institut de Cancérologie de Montpellier Val d'Aurelle

location_facility: Centre de Lutte Contre le Cancer Antoine Lacassagne

location_facility: Groupement Hospitalier Est - Hôpital Femme Mère Enfant

location_facility: CHU de Clermont-Ferrand - Hôpital d'Estaing

location_facility: Saitama Medical University International Medical Center

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCK

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: SENTICOL-III

titre: SENTICOL III : Validation prospective internationale de la biopsie du ganglion sentinelle dans les cancers du col utérin.

discipline_principale: cancer

nom_porteur: LECURU

prenom_porteur: Fabrice


title: European Surgical Outcomes Study: A Multi-centre, International Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Non-cardiac Surgery

acronym: EuSOS

summary:
The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.

Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceCitation: Ahmad T, Beilstein CM, Aldecoa C, Moreno RP, Molnar Z, Novak-Jankovic V, Hofer CK, Sander M, Rhodes A, Pearse RM. Variation in haemodynamic monitoring for major surgery in European nations: secondary analysis of the EuSOS dataset. Perioper Med (Lond). 2015 Sep 23;4:8. doi: 10.1186/s13741-015-0018-8. eCollection 2015.

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)

repository_institution: PubMed Central - Europe PMC

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

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

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: St George's University of London - St George's Online Research Archive

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: van Zaane B, van Klei WA, Buhre WF, Bauer P, Boerma EC, Hoeft A, Metnitz P, Moreno RP, Pearse R, Pelosi P, Sander M, Vallet B, Pettila V, Vincent JL, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Nonelective surgery at night and in-hospital mortality: Prospective observational data from the European Surgical Outcomes Study. Eur J Anaesthesiol. 2015 Jul;32(7):477-85. doi: 10.1097/EJA.0000000000000256.

oa_colors: green other

evidence: open (via free article)

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Jammer I, Ahmad T, Aldecoa C, Koulenti D, Goranovic T, Grigoras I, Mazul-Sunko B, Matos R, Moreno R, Sigurdsson GH, Toft P, Walder B, Rhodes A, Pearse RM; European Surgical Outcomes Study (EuSOS) group. Point prevalence of surgical checklist use in Europe: relationship with hospital mortality. Br J Anaesth. 2015 May;114(5):801-7. doi: 10.1093/bja/aeu460. Epub 2015 Jan 13.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

repository_institution: reroDoc Digital Library

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, Pearse RM, Metnitz P; European Surgical Outcomes Study (EuSOS) group for Trials Groups of European Society of Intensive Care Medicine; European Society of Anaesthesiology. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014 Sep;113(3):416-23. doi: 10.1093/bja/aeu098. Epub 2014 May 14.

oa_host_type: publisher

repositories_concat: closed

lead_sponsor: Queen Mary University of London

location_country:
Finland
Germany
Ireland
Poland
Croatia
Serbia
France
Czech Republic
Lithuania
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Iceland
Romania
Belgium
Estonia
Italy
Cyprus
Norway
United Kingdom
Netherlands
Spain
Greece
Sweden

status_simplified: Completed


title: A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

summary:
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

primary_purpose: Treatment

lead_sponsor: Seagen Inc.

sponsor_collaborators:
Seagen Inc.
Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Portugal
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Meizhou People's Hospital - Guangdong Province

location_facility: Nanjing Medical University (NMU) - Jiangsu Province Hospital

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

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Affiliated Hospital of Chengde Medical University

location_facility: Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento - Presidio Ospedaliero S. Chiara

location_facility: Institut de Cancerologie de lOuest - Site Rene Gauducheau

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: The First Hospital of China Medical University

location_facility: Institut Regional du Cancer de Montpellier

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

location_facility: Centro Hospitalar De Vila Nova De Gaia Espinho

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Liga Norte-Rio-Grandense Contra o Cancer

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego

location_facility: Complejo Hospitalario De Caceres - Hospital General San Pedro De Alcantara

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne

location_facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliero-Universitaria di Ferrara

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Sociedad de Investigaciones Medicas Limitada

location_facility: 900TH Hospital of Joint Logistics Support Force

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

location_facility: Thomayer University Hospital (Fakultní Thomayerova nemocnice)

location_facility: Institut Catala d'Oncologia Girona - ICO Girona

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Valencian Institute of Oncology Foundation

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Istituto Clinico Humanitas-Humanitas Cancer Center

location_facility: Centre de Lutte contre le Cancer (CLCC) - Centre Oscar Lambret

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine

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

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: The First Bethune Hospital of Jilin University

location_facility: Centre Hospitalier Universitaire Hopital Avicenne

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: UCLA Department of Medicine - Hematology & Oncology

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

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centre de Lutte contre le Cancer - François Baclesse

location_facility: Azienda Ospedaliera Universitaria (AOU) Federico II

location_facility: Hospital Clinico Universitario de Valencia

location_facility: INCAN - Instituto do Cancer - Hospital Pompeia

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: University General Hospital of Heraklion (PAGNI)

location_facility: Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: The Royal Marsden NHS Foundation Trust (RM)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi

location_facility: Central Hospital of the Ministry of National Defense

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Klinikum Rechts der Isar der Technischen Universitaet Muenchen

location_facility: University of Alberta / Cross Cancer Institute

location_facility: CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Medical College of Wisconsin (Milwaukee)

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: Hospital de Cancer de Barretos - Fundacao Pio XII

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: The Second Hospital of Anhui Medical University

location_facility: Fundação NAtonio Prudente (AC Camargo Cancer Center)

location_facility: Azienda USL 4 Prato - Ospedale Misericordia e Dolce di Prato

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

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Tianjin Medical University - Cancer Institute & Hospital

location_facility: The first Affiliated Hospital of Hainan Medical University

location_facility: Medical Faculty Mannheim, Heidelberg University

intervention_type: Drug

lead_sponsor_type: industriel


title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

summary:
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.

All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction.

This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

lead_sponsor: Abivax S.A.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
India
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Israel

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Twoja Przychodnia Opolskie Centrum Medyczne

location_facility: CHU Clermont Ferrand - Hopital d'Estaing

location_facility: Centre Hospitalier Départemental Les Oudairies

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

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: The 2nd Xiangya Hospital of Central South University

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Datta Meghe Institute of Medical Sciences (Deemed University)

location_facility: Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen

location_facility: Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Gastroenterology Associates of Pensacola, PA

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

location_facility: Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Polimedica Centrum Badań, Profilaktyki I Leczenia

location_facility: Gastroenterology Associates of Tidewater

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: London Health Sciences Centre (LHSC) - Victoria Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Universite de Lorraine - Faculte de Medecine - INSERM U954

location_facility: AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Our Lady of the Snow St. Mary's Hospital

location_facility: General Hospital of Eastern Theater Command

location_facility: NHO Kure Medical Center and Chugoku Cancer Center

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

location_facility: Fortis Escorts Heart Institute and Research Centre

location_facility: Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

location_facility: Shinseikai Sai Gastroenterology, Proctology

location_facility: Amrita Institute Of Medical Sciences and Research Centre

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

location_facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew

location_facility: Showa University Northern Yokohama Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Biopharma Informatic, Inc. Research Center

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

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: The People's Hospital of Guangxi Zhuang Autonomous Region

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force

location_facility: Xiangya Hospital, Central South University

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Northwestern University Feinberg School of Medicine

location_facility: CECIP - Centro de Estudos Clínicos do Interior Paulista

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: General Hospital of Thessaloniki "Hippokration"

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

location_facility: University of Arkansas for Medical Sciences

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

location_facility: General Hospital of Athens "Evangelismos"

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Army Specialty Medical Center of The Chinese People's Liberation Army

location_facility: S. R. Kalla Memorial Gastro & General Hospital

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: The Affiliated Hospital of Southwest Medical University

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Research Associates of South Florida, LLC

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Gastroenterology Center of the MidSouth PC

location_facility: SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

location_facility: Centre Hospitalier de Pau - Hôpital François Mitterrand

location_facility: Board of Regents of the University of Oklahoma Health Sciences Center

location_facility: CHA Bundang Medical Center, CHA University

location_facility: University General Hospital of Alexandroupolis

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: University of Louisville Research Foundation

location_facility: Chhatrapati Shahuji Maharaj (CSM) Medical University

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: University Clinical Centre of the Republic of Srpska

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

location_facility: NSZOZ Termedica - Centrum Badan Klinicznych

location_facility: Lakeshore Hospital and Research Centre Ltd.

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: Complejo Hospitalario Universitario de Ferrol

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

location_facility: Digestive Health Specialists of the Southeast

location_facility: University Hospitals Cleveland Medical Center

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

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

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

location_facility: Lokmanya Tilak Municipal General Hospital & Medical College

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Scott Shulman Medicine Professional Corporation

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Clarunis - Universitäres Bauchzentrum Basel

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

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

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Klaipeda University Hospital branch "Seamen's Hospital"

location_facility: Lithuanian University of Health Sciences Kaunas Hospital

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie

location_facility: Medical Research Center of Connecticut, LLC

location_facility: King Edward Memorial Hospital Research Centre

location_facility: Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Clinical Hospital Center "Bezanijska kosa

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: Shengjing Hospital of China Medical University, Hua Xiang branch hospital

location_facility: Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Toronto Immune & Digestive Health Institute

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Hospital das Clínicas da Faculdade de Medicina da UNICAMP

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

location_facility: The First Affiliated Hospital of University of South China

location_facility: Seoul National University Bundang Hospital

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: CINME - Centro De Investigaciones Metabolicas

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Medical Professional Clinical Research Center

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: University General Hospital of Heraklion

location_facility: Yijishan Hospital of Wannan Medical College

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: California Medical Research Associates Inc.

location_facility: Jiangxi Gannan Medical College Affiliated 1 st Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

location_country:
Germany
Poland
Argentina
Australia
Turkey
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Bulgaria

location_facility: Severance Hospital, Yonsei University Health System

location_facility: King Edward Memorial Hospital Research Centre

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt

location_facility: University of Louisville Research Foundation

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Chhatrapati Shahuji Maharaj (CSM) Medical University

location_facility: Twoja Przychodnia Opolskie Centrum Medyczne

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: CHU Clermont Ferrand - Hopital d'Estaing

location_facility: Biopharma Informatic, Inc. Research Center

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Nanfang Hospital of Southern Medical University

location_facility: The People's Hospital of Guangxi Zhuang Autonomous Region

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"

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

location_facility: The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force

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

location_facility: NSZOZ Termedica - Centrum Badan Klinicznych

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Xiangya Hospital, Central South University

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: Toronto Immune & Digestive Health Institute

location_facility: The 2nd Xiangya Hospital of Central South University

location_facility: Hospital Privado Centro Medico de Cordoba S.A

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

location_facility: Digestive Health Specialists of the Southeast

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

location_facility: General Hospital of Thessaloniki "Hippokration"

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern

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

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Shengjing Hospital of China Medical University

location_facility: Affiliated hospital of Tsingdao medical college

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Gastroenterology Associates of Pensacola, PA

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

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

location_facility: University of Arkansas for Medical Sciences

location_facility: Scott Shulman Medicine Professional Corporation

location_facility: General Hospital of Athens "Evangelismos"

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Gastroenterology Associates of Tidewater

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: Gastroenterology and Internal Medicine Research Institute

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: The First Affiliated Hospital of University of South China

location_facility: Army Specialty Medical Center of The Chinese People's Liberation Army

location_facility: Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

location_facility: AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

location_facility: S. R. Kalla Memorial Gastro & General Hospital

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Seoul National University Bundang Hospital

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

location_facility: General Hospital of Eastern Theater Command

location_facility: The Affiliated Hospital of Southwest Medical University

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Amrita Institute Of Medical Sciences and Research Centre

location_facility: Gastroenterology Center of the MidSouth PC

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Centre Hospitalier de Pau - Hôpital François Mitterrand

location_facility: CHA Bundang Medical Center, CHA University

location_facility: University General Hospital of Alexandroupolis

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza


lead_sponsor: Celgene

summary: This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

ReferenceCitation: Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_facility: Mid America Gastrointestinal Consultants

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: Centro de Investigación y Gastroenterología

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: University Of Kentucky Chandler Medical Center

location_facility: Advanced Research for Health Improvement

location_facility: Carolinas HealthCare System Digestive Health

location_facility: University of Massachusetts Memorial Medical Center

location_facility: GIRI Gastroenterology and Internal Medicine Research Institute

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: Connecticut Clinical Research Foundation

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Allergy, Asthma and Immunology Center, PC

location_facility: Atlanta Gastroenterology Associates, Llc

location_facility: Children's Center for Digestive Healthcare

location_facility: Research Associates of South Florida LLC

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: University of Pennsylvania Cancer Center

location_facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

location_facility: University Of Oklahoma Health Sciences Center

location_facility: VA Northern California Health Care System

location_facility: Washington University School Of Medicine

location_facility: The Center for Gastrointestinal Disorders

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: Biopharma Informatic Inc. Research Center

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

location_facility: UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit

location_facility: Henry Ford Medical Center - New Center One

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: University Of California At San Francisco

title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

type: Registry Identifier

type: EudraCT Number

source: euctr

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Senegal
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
China
Moldova, Republic of
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


summary: This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: Centro de Investigación y Gastroenterología

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Advanced Research for Health Improvement

location_facility: Carolinas HealthCare System Digestive Health

location_facility: University of Massachusetts Memorial Medical Center

location_facility: GIRI Gastroenterology and Internal Medicine Research Institute

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: Connecticut Clinical Research Foundation

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council

location_facility: Atlanta Gastroenterology Associates, Llc

location_facility: Children's Center for Digestive Healthcare

location_facility: Research Associates of South Florida LLC

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Universidad Nacional De Rosario - Hospital Provincial Del Centenario

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease


summary: This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

location_facility: University Of Kentucky Chandler Medical Center

location_facility: University Hospital of the Canary Islands (HUC) La Laguna

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Washington University School Of Medicine

location_facility: The Center for Gastrointestinal Disorders

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: Biopharma Informatic Inc. Research Center

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

location_facility: University Hospital Germans Trias i Pujol

location_facility: Penn State University Milton S Hershey Medical Center

title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
Moldova, Republic of
Italy
United Kingdom
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


acronym: INDEPENDENCE

summary:
The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions.

The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.

Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

location_facility: Tianjin Medical University General Hospital

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Texas Oncology-Baylor Charles A Sammons Cancer Center

location_facility: ICANS Institut de cancerologie Strasbourg Europe

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Kindai University Hospital- Osakasayama Campus

location_facility: Tokyo Women's Medical University Hospital

location_facility: Nanchang University - The Second Affiliated Hospital

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Azienda Policlinico Universitario Umberto I

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: The First Affiliated Hospital of Nanyang Medical College

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Complejo Hospitalario Universitario De Santiago

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: CTRC at The UT Health Science Center at San Antonio

location_facility: Centre Hospitalier Peltzer - La Tourelle

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: University Hospital - London Health Sciences Centre

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: Hospital Universitario De Gran Canaria Dr. Negrin

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: West Penn Allegheny Lupus Center of Excellence

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: First St Petersburg State Medical University na IP Pavlov

location_facility: Azienda Ospedaliera Universitaria Federico Ii

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: University Of Kentucky Markey Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

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

location_facility: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

location_facility: The First Affiliated Hospital Of Harbin Medical University

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Prince of Wales Hospital the Chinese University of Hong Kong

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Germany
Ireland
Poland
Argentina
Australia
Japan
Chile
Czechia
Canada
France
Colombia
Hungary
Hong Kong
United States
Romania
Lebanon
Belgium
China
Puerto Rico
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel

ipd_sharing: Yes


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

location_facility: Weill-Cornell-New York Presbyterian Hospital

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

location_facility: Meir Medical Center, 59 Tshernichovski st.

location_facility: Hospoital Universitari i Politecnic La Fe

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

location_facility: Centro Hospitalar de Santo António E.P.E.

location_facility: University Health Network-Toronto General Hospital

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

location_facility: LA Biomedical Research Institute Harbor-UCLA Medical Center

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

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: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: The Ohio State University Wexner Medical Center

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

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

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

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

location_facility: Xiangya Hospital Central South University

location_facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"

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

location_facility: University of Cincinnati-Medical Science Building

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

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

location_facility: Medical College of Wisconsin/Froedtert Hospital

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

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

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

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)

location_facility: Balcalı, Çukurova Üniversitesi Kardiyoloji ABD

location_facility: Hospital Privado Centro Medico de Cordoba S.A

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

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

location_facility: Fuwai Hospital, Chinese Academy of Medical Sciences

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

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

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és Rendelő

location_facility: Sentara Cardiovascular Research Institute

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

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

location_facility: University of California Davis Medical Center

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

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

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

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

location_facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

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

location_facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

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

location_facility: UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu

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

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

location_facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

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

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

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

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

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

location_facility: Carilion Clinic Pulmonary and Sleep Medicine

location_facility: Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü

location_facility: Washington University School of Medicine

location_facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah

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

location_facility: Gachon University Hospital Gil Medical Center

location_facility: Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

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

location_facility: The Methodist Hospital Research Institute

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

location_facility: University Clinic for Pulmonary Diseases, Jordanovac 104

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

location_facility: Royal Free London NHS Foundation Trust, Pond Street

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

location_facility: Gazi University Medical Faculty Hospital

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

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

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

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

location_facility: Premium Clinic Wrocław CM, Podwale 83/17

location_facility: Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address)

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

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: University of Iowa Hospitals and Clinics

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

location_facility: Beijing Shijitan Hospital, Capital Medical University

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

location_facility: Clinical Center of Serbia, Koste Todorovica 8

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

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: University General Hospital of Alexandroupolis

location_facility: Fuwai Central China Cardiovascular Hospital

location_facility: VA Greater Los Angeles Healthcare System

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Copenhagen University Hospital (Rigshospitalet)


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.

time_perspective: Retrospective

lead_sponsor: University of Zurich

sponsor_collaborators:
University of Zurich
Harvard University
University Hospital, Essen
Auckland City Hospital
University Hospital, Strasbourg, France
The Leeds Teaching Hospitals NHS Trust
Imperial College London
University College London Hospitals
St. Louis University

location_country:
Germany
New Zealand
United Kingdom
Switzerland
United States
France

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

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


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 and prevention of COVID-19 sequelae.

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 the vaccination and to different treatment strategies, including monoclonal antibodies.

status: Unknown status

ipd_sharing: Undecided

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_country: Italy Netherlands Belgium Spain Congo France

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

location_facility: University of Antwerp - Laboratory of Medical Microbiology

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

location_facility: Fondation Congolaise pour la Recherche Médicale

intervention_type: Other

status_simplified: Unknown


title: Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes: Analysis in Very High Field (7T) Brain MRI.

acronym: SODIPARK

summary:
Parkinson's disease (PD) is the most common degenerative Parkinson's syndrome and is linked, among other things, to the excessive accumulation of an abnormally aggregating protein, alpha-synuclein. Progressive Supranuclear Palsy (PSP) is another Parkinson's syndrome, linked, among other things, to the abnormal accumulation of the protein Tau, and expressed clinically by falls, early cognitive impairment and oculomotor disorders, not present in PD. The onset of these disorders is so gradual that differential diagnosis between the two diseases is only possible at a late stage, on average 3 to 5 years after the onset of symptoms.

To date, there is a lack of validated imaging biomarkers for diagnosing and monitoring PD and PSP. There is therefore an urgent need for the development of robust biomarkers capable of detecting neurodegeneration at an early stage, in order to aid differential diagnosis as soon as symptoms appear, and to potentially enable these patients to be included in specific therapeutic trials (as these diseases are pathophysiologically different) with potential neuroprotective effects.

The development of cutting-edge technologies such as 7T MRI, combined with optimized image processing methods, now enable non-invasive in vivo exploration and analysis of these small structures in terms of ion homeostasis (sodium), microstructure (volumetry, amount of iron and neuromelanin) and connectivity.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Privé La Casamance - Service de Neurologie

location_facility: Centre Hospitalier Avignon - Service de Neurologie

location_facility: CENTRE HOSPITALIER SAINTE MUSSE - Toulon

location_facility: CENTRE HOSPITALIER NIMES - Service de Neurologie

location_facility: CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie


title: Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study

summary:
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).

Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.

status: Active, not recruiting

time_perspective: Other

ipd_sharing: No

lead_sponsor: SpineVision

sponsor_collaborators: SpineVision EVAMED

location_facility:
Hôpital Privé du Dos Francheville
CHRU de Nancy
Clinique du Dos Terrefort
Centre Hospitalier Privé de l'Europe
Hôpital Robert Schuman - UNEOS
Polyclinique Majorelle

intervention_type: Device


title: A Randomized Comparative Prospective Multicenter Study of the Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers

acronym: PALLU

summary:
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.

In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.

lead_sponsor: Centre Leon Berard

location_facility:
ICM Val d'Aurelle
Institut de Cancérologie de Lorraine
Centre Léon Bérard
Institut Curie - Saint Cloud
Institut Gustave Roussy
Institut Curie - Paris


title: Study of the Consequences of Mutations of the RNU4ATAC and RTTN Genes by Transcriptomic, Biochemical and Cellular Approaches in Order to Determine the Pathophysiology of Their Associated Syndromes: Microcephalic Osteodysplastic Primordial Dwarfism Type I/III, Roifman Syndrome and Lowry-Wood Syndrome

acronym: ATAC

summary:
In the human genome, about 750 genes contain one intron excised by the minor spliceosome. These genes are named U12 genes, and these introns, minor or U12 introns. The minor spliceosome comprises its own set of snRNAs, among which U4atac. Its non-coding gene, RNU4ATAC, has been found mutated in Taybi-Linder (TALS), Roifman (RFMN) and Lowry-Wood syndromes (LWS). These rare developmental disorders associate ante- and post-natal growth retardation, microcephaly, skeletal dysplasia, intellectual disability, retinal dystrophy and immunodeficiency. Their physiopathological mechanisms remain unsolved: the number of U12 genes involved, their identity and function, or the cellular mechanisms impacted by the splicing defect, are still unknown.

The hypothesis of the study is that U12 genes coding for primary cilia components are particularly sensitive to minor splicing defects caused by RNU4ATAC mutations. Indeed, a child showing signs of TALS but negative for RNU4ATAC was found to carry a homozygous variant in the RTTN gene, coding for the rotatin protein located at the centrosome and the base of the primary cilia and playing a role in maintaining these structures. In addition, bi-allelic RNU4ATAC mutations were identified in five patients presenting with traits suggestive of the Joubert syndrome (JBTS), a well-characterized ciliopathy. These patients also present with traits typical of TALS/RFMN/LWS.

To better understand the causes of these pathologies, a cohort of patients with syndromes associated with bi-allele mutations of the RNU4ATAC or RTTN gene will be gathered, in order to conduct studies on the cells of these patients. Blood samples will be taken, as well as skin biopsies, if possible. These samples will be used to create induced pluripotent stem cell lines. Blood samples will also be collected from the parents of RNU4ATAC patients, to eliminate in transcriptomic analyses expression variations due to differences in genetic background. Biopsies of skin, muscle and brain tissue will be collected on foetuses carrying two-allele RNU4ATAC or RTTN mutations whose parents have had a miscarriage or have chosen to have a medical abortion. The biological samples collected will be used to study the transcription level of U12 genes, the splicing of their pre-messenger RNA, their main cellular functions, and the structural characteristics of tissues and cells.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence anomalies du développement de Lyon, Hôpital Femme Mère Enfant

location_facility: Centre de référence des anomalies du développement et syndromes malformatifs de l'Est, CHU de DIJON

location_facility: Centre de référence des anomalies du développement et syndromes malformatifs de l'inter région Nord-Ouest, Hôpital J de Flandre

location_facility: Centre de référence des anomalies du développement et syndromes malformatifs du Sud-Ouest Occitanie Réunion, CHU de Bordeaux-GH Pellegrin

location_facility: Unité Fonctionelle d'embryo-fœtopathologie, Hôpital Necker-Enfants Malades

location_facility: Centre de référence des anomalies du développement et syndromes malformatifs de l'Ouest, Hôpital Sud


title: Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

acronym: EMPIRE

summary: Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Boehringer Ingelheim

location_facility:
Institut Bergonié
Centre Léon Bérard
CHRU Poitiers
Centre Oscar Lambret
Centre Eugène Marquis
Centre Georges François Leclerc


title: Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders

summary:
The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:

Does virtual reality have an impact on symptoms of apathy in the elderly?
Is virtual reality well tolerated by the elderly? Participants will benefit from a 3-session virtual reality headset program with a healthcare professional. They will have one session per week for 3 weeks. They will be observed by another professional, who will complete observation grids on apathy, engagement in activity and tolerance of the virtual reality headset.

There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.

primary_purpose: Supportive Care

ipd_sharing_description: Each co-investigator coordinates his or her inclusions with the principal investigator, and sends him or her the data collected via secure messaging. The co-investigator is responsible for collating all the data.

lead_sponsor: RIVAGES

location_facility:
USLD Arcadie - CHU Rouen
Maison de retraite l'arc en ciel
EHPAD d'Enghien
Maison de retraite la Passerelle
EHPAD Louis Grassi
Hôpital Charles Foix


title: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A

summary: The goal of this clinical trial is to evaluate the impact of showing and handling a three-dimensional modelization of a patient's tumoral kidney the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D printed model, and information) using a randomization.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de CAEN
CHU de La CONCEPTION
CHU de NANTES
Hôpital Kremlin-Bicêtre
CHU d'ANGERS
CHU de Bordeaux


title: Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

acronym: CAPSACOX

summary: The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.

lead_sponsor: Nantes University Hospital

location_facility:
Confluent Private Hospital Centre
GH Paris saint Joseph
Nantes University Hospital
Rouen University Hospital
Brest University Hospital
Vendée Departmental Hospital


title: Professional Bladder Cancers and the Profession of Painter: Retrospective Study of the RNV3P Database Files

acronym: NEVPP

summary: This is a retrospective study on bladder cancer in French painters' population. The French agency ANSES collected data from all occupational and environmental diseases center in a specific database called RNV3P. We selected cases of bladder cancer in painters in four centers from 01/01/2010 to 31/12/2019. Those cases were analyzed in terms of occupational exposure, histology and sociodemographics data. Comparison between different histologic types of cancer, workplaces and occupational diseases process will be done.

lead_sponsor: University Hospital, Brest

location_facility:
Ch Cherbourg
CHRU de Brest
CHU de Caen
CHU de Lille
CHU de Rouen
CH le Havre


title: Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention

acronym: RectSexQol

summary: RectSexQoL is a study aiming at determining the prevalence of female sexual dysfunction after rectal cancer surgery. It has the goal as well to analyse the impact of an intervention given by a sexologist to such patients.

lead_sponsor: University Hospital, Limoges

location_facility:
Brive Hospital
Limoges University Hospital
Gueret Hospital
Saint Junien Hospital
Chenieux clinical
Les cedres Clinical


title: Milademetan and Fulvestrant in GATA3-mutant, ER-positive, HER2-negative Advanced or Metastatic Breast Cancer Patients: a Multicenter Phase II Trial

acronym: DEMETER

summary:
This is a single arm, multicentric phase II study of milademetan plus fulvestrant in patients with ER+, HER2- ABC harboring GATA3 mutation(s) in the tumor and/or in ctDNA who have progressed on or after prior treatments including a CDK4/6 inhibitor.

Frameshift or truncating GATA3 mutations will be identified by next generation sequencing (NGS) performed on either tissue or circulating DNA. Given the well-known safety profile of fulvestrant and the absence of significant toxicity expected from the association of fulvestrant and milademetan, a safety run-in is planned. During the course of the study, the Steering Committee will specifically review the occurrence of toxicities defined as DLTs in the safety run-in.

status: Terminated

ipd_sharing_description: Investigators will share de-identified data sets documents generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Rain Oncology Inc

location_facility:
Hopital Tenon Ap-Hp
Institut Du Cancer Montpellier
Centre Eugene Marquis
Centre Leon Berard
Institut Curie


title: A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.

summary: The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.

lead_sponsor: iVascular S.L.U.

location_facility: Hôpital d'instruction des Armées Sainte Anne


title: Prévalence de la stéato-fibrose hépatique Dans le Syndrome de Cushing

acronym: NAC

summary:
Cushing's Syndrome is a rare disease resulting from prolonged exposure to high levels of circulating cortisol. Clinical manifestations are variable but many patients present a metabolic syndrome (abdominal obesity, insulin resistance, dyslipidemia, hypertension). With regard to the liver, experimental data have shown that excess cortisol leads in an increase in lipogenesis and a reduction in the oxidation of fatty acids. This, in association with an accumulation of visceral adipose tissue and deregulation of adipokines, may contribute to the development of hepatic steatosis in animals. However, few data is available in humans with only one study of 50 patients with Cushing's syndrome estimating the prevalence of hepatic steatosis at 20%.

NAFLD (Non-Alcoholic Fatty Liver Disease), is defined as the presence of hepatic steatosis in the absence of secondary causes of intrahepatic fat accumulation. It is a heterogeneous disease ranging from simple liver steatosis, whose prognosis is generally considered to be benign, to inflammation (NASH, Non-Alcoholic Steato-Hepatitis) which may progress to fibrosis, cirrhosis and an increased risk of hepatocellular carcinoma. The prognosis for NAFLD is mainly related to the severity of hepatic fibrosis.

In Cushing's syndrome, normalization of cortisol production is the most effective strategy to improve co-morbidities associated with hypercortisolism. However, some of these complications, especially the metabolic co morbidities, could not be completely reversible and no data is available about resolution of hepatic steatosis.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital, Brest
University Hospital, Bordeaux
University Hospital, Rennes
University Hospital, Angers
University Hospital, Grenoble
University Hospital, Nantes

intervention_type: Diagnostic Test


title: SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population

acronym: SCREANIT

summary: The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation.

primary_purpose: Screening

location_facility:
Hopital Saint Joseph
Chu Angers
Centre Hospitalier de Lens
Chu Nancy
Chu Bordeaux
Chu Grenoble Alpes


title: What Treatment Adherence for Home Parenteral Nutrition in Patients With Chronic Intestinal Failure ?

summary: This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.

location_facility:
CHU de Grenoble
Hôpital de l'Archet
CHU Limoges
CHU Bordeaux
CHU de Nantes
Institut régional du cancer Montpellier


title: Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

summary:
The goal of this study is to characterize and validate a signature of circulating biomarkers in plasma, associated with the presence of gastric preneoplasia in patients with preexisting gastric lesion compared with a control group.

For this purpose:

Patients with pre-existing gastric lesions will be invited to participate to this study. If they are willing to participate an additional blood sample (10mL) will be collected at the time of the blood collection performed during their routine care
Healthy subjects will be invited to participate to constitute the control group. If they are willing to participate a blood sample (10 ml) will be drawn specifically for this study

ReferenceType: background

ReferenceCitation: Kotilea K, Bontems P, Touati E. Epidemiology, Diagnosis and Risk Factors of Helicobacter pylori Infection. Adv Exp Med Biol. 2019;1149:17-33. doi: 10.1007/5584_2019_357.

lead_sponsor: Institut Pasteur

sponsor_collaborators:
Institut Pasteur
Assistance Publique - Hôpitaux de Paris

location_facility: Kremlin Bicêtre Teaching Hospital (AP-HP)

location_facility: ICAReB - Investigation clinique (Institut Pasteur)


title: Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study

acronym: PRESTO

summary:
The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP:

Informing the general population about psychotic disorders
Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management
Articulation between APL and specialized psychiatric care

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Saint Etienne
Chu Grenoble
Chu Clermont-Ferrand
CHU de Nîmes
CHU de Montpellier
Hospices Civils de Lyon


title: EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-

summary: The goal of this clinical trial is to evaluate the effect of catheter ablation of persistent atrial fibrillation on cognitive function in patients with mild cognitive impairment. Participants will be randomized into antiarrhythmic drugs alone or atrial fibrillation ablation + antiarrhythmic drugs.

lead_sponsor: Poitiers University Hospital

location_facility:
Centre Cardiologique du Nord
Hopital Européen Georges Pompidou
University Hospital


title: "Impact of Remote Therapeutic Cooking Workshops in the Management of Adult Patients Living With Obesity on Dietary Balance: Randomized Interventional Study in Stepped Wedge Type Clusters"

acronym: CuisTO

summary:
The implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). The literature shows that adults participating in cooking workshops are satisfied and acquire cooking skills potentially useful for improving their health (WOLFSON, BLEICH, 2015; CARAHER, 1999). REICKS (2014, 2018) and REES (2012) point out, however, the low methodological quality of most of the studies conducted and, in fact, the effectiveness of therapeutic cooking workshops has not been formally demonstrated by rigorous randomized studies.

The Care and Prevention Research Unit (CRESP) of the Manhès Hospital Center then built a multicenter research protocol to demonstrate the impact of cooking workshops in the care of patients with obesity. The protocol involves 6 hospitals: Georges Pompidou European Hospital (HEGP) University Hospital Center (department of Prof S. CZERNICHOW), PITIE SALPETRIERE University Hospital Center (department of Prof J.M. OPPERT), Cognacq Jay Hospital Center, Forcilles Hospital Center, Bligny Hospital Center and Manhes Hospital Center .

The CuisTO protocol was selected by the PHRIP Jury of the DGOS (General Direction of the Care Offer French Ministry of Health) in 2019 as a high priority project.

The main objective of this research is to evaluate the effectiveness of remote cooking workshops in the management of obesity, through two methods of setting up therapeutic cooking workshops (so-called "classic" workshops and workshops in the form of "culinary challenges") to improve dietary balance in the context of the care of adult patients living with obesity. Dietary balance will be estimated by compliance with the recommendations of the latest National Health Nutrition Program (PNNS-4 2019-2023), "judged" by the PNNS-GS2 score, the consumption of fruits and vegetables, the frequency of cooking and a reduction in the consumption of ultra-processed dishes that have already been prepared.

This is a multicentre, open-label, controlled, comparative intervention study with sequential randomization in clusters (clusters) of the "stepped wedge" type

lead_sponsor: Centre Hospitalier FH Manhes

location_facility: La Pitié Salpêtrière AP-HP.Sorbonne Université

appel_a_projets: PHRIP

region: Île-de-France

nom_etablissement: CH FREDERIC HENRI MANHES

type_etablissement: EBNL

acronyme: CuisTO

titre: Impact des ateliers de cuisine thérapeutique dans la prise en charge du patient adulte vivant avec une obésité sur l'équilibre alimentaire : étude interventionnelle randomisée en clusters de type stepped wedge. Projet CuisTO (Cuisine Thérapeutique du patient Obèse)

discipline_principale: nutrition et obésité

nom_porteur: GALTIER

prenom_porteur: Damien


title: Renal Denervation in Hypertensive Women Planning to Become Pregnant

acronym: WHY-RDN

summary:
Renal denervation is a new method to lower blood pressure (BP) in hypertensive patients by reducing the impact of sympathetic nervous system. Its efficacy has been demonstrated in resistant hypertension and in lowering BP in essential hypertension as compared to a sham procedure in untreated hypertensive patients. This procedure is safe without any serious adverse events. However its effects during pregnancy are unknown.

Normal pregnancy is associated with an increase of sympathetic activity at rest and upon cardiovascular reflexes stimulation which returns to baseline after delivery. These changes maintain optimal utero placental blood flow. But excessive stimulation of sympathetic activity may play a role in preeclampsia. Drugs that may affect the sympathetic nervous system are considered as safe in pregnant women.

So there are reasonable evidence that renal denervation performed before pregnancy should not have deleterious effects for the fetus. The efficiency of renal denervation being greater in young patient and in women, a greater proportion of BP normalization can be expected in this population of young women .

location_facility: APHP - Hôpital Européen Georges-Pompidou


title: Ability of a Virtual-reality Based Solution Aiming to Reduce Patient Burden Related to Repetitive Intravenous Perfusions. A Proof-of-concept Study in Hemophilia Patients Receiving Prophylactic Factor VIII or Factor IX Infusions

summary:
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtual-reality (VR) based solution. The study also aims to find out how well the VR based solution is tolerated and how satisfied the participants, relatives, and doctors are with it.

The VR-based solution includes a mobile phone app and a 3D mask.

Participants will use the VR-based solution while receiving prophylactic Factor VIII and Factor IX infusions for 4 weeks at home. Participants will visit the clinic for the last infusion; at this time data will be collected from participants, relatives, and doctors

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_facility: Centre de Reference Hemophilie Unite D'Hemostase Clinique


title: Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode

acronym: PEPAMARKER

summary:
Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse.

The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses.

Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses.

At the radiological level, distinct changes in the volume of grey matter have been shown between thymic and nonthymic psychoses.

In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Dr Florian STEPHAN
Dr Vincent CAMUS
Dr Dominique DRAPIER
Dr Bénédicte GOHIER
Dr Sonia MARSELLA
Dr Anne SAUVAGET

intervention_type: Biological

appel_a_projets: PHRCI

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: PEPAMARKER

titre: Biomarqueurs prédictifs de l'évolution thymique et de la réponse thérapeutique à 2 ans de patients avec un premier épisode psychotique.

discipline_principale: autre

nom_porteur: STEPHAN

prenom_porteur: FLORIAN


title: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study)

acronym: EMMA

summary:
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction.

An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).

lead_sponsor: Symatese Aesthetics

location_facility: Clinique du Rond Point des Champs Elysées


title: Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy: An Open-label Phase II GERCOR Trial

acronym: NIPIRESCUE

summary: NIPIRESCUE is a national, single-arm, open-label phase II study. The study aims to evaluate the clinical activity of nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and anti- vascular endothelial growth factor (VEGF) or anti- epidermal growth factor receptor (EGFR) therapy.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
ICM Val d'Aurelle
Centre Léon Bérard
Hôpital Saint Antoine
CHRU Lille
CHU Poitiers
CHU Jean Minjoz


title: Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité

acronym: MECH-ORL

summary: Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

lead_sponsor: University Hospital, Tours

location_facility:
Hospital Le Mans
University Hospital BREST
Hospital Blois
University Hospital TOURS
Hospital La Pitié Salpêtrière-APHP
University Hospital NANTES

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

acronyme: MECH-ORL

titre: Intérêt du méchage en chirurgie d'otospongiose et de myringoplastie : essai contrôlé randomisé de non-infériorité.

nom_porteur: AUSSEDAT

prenom_porteur: CHARLES


title: ANRS EP69 BICTEVOIR : A Prospective Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing bictégravir, Emtricitabine and ténofovir alafénamide

summary: The main objective of the study is to evaluate the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

primary_purpose: Basic Science

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Gilead Sciences

location_facility:
Pitie Salpetriere Hospital
Hotel Dieu Hospital
Saint Antoine Hospital
Bicetre Hospital
Antoine-Beclere Hospita
Necker Hospital


title: Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study. Protocol

acronym: APM

summary: The aim of the study is to analyze the determinants (barriers and facilitators) of the daily physical activity level in a population of patients with cystic fibrosis. A population of patients will be included in order to realize an assessment of their daily physical activity level over an entire week. A specific questionnaire, designed from 3 different questionnaires, will be associated to the physical activity evaluation and will allow to asses psycho-social and environmental factors.

location_facility: CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte

location_facility: CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte

location_facility: CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique

location_facility: CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique

location_facility: CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte

location_facility: CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique