title: AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

summary: This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.

lead_sponsor: Syndax Pharmaceuticals

location_country:
Poland
Taiwan
Portugal
Spain
Greece
Italy
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Germany

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: Washington University School of Medicine

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University Hospital of West Attica - Attikon - Hematology Division

location_facility: Weill Medical College of Cornell University

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Citta della Salute e della Scienza di Torino - Ospedale le Molinette

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie

location_facility: University of Wisconsin - Carbone Cancer Center

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: The University of Chicago Medical Center (UCMC)

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Oklahoma - Health Sciences Center

location_facility: McGill University Health Center - Research Institute

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: University of Alabama at Birmingham - Children's of Alabama

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

location_facility: University Hospitals Cleveland Medical Center

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Fondazione Policlinica Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii

location_facility: Hospital Universitario Marquis de Valdecilla

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. (IPO-Lisboa)

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: General Hospital of Thessaloniki G. Papanikolaou - Hematology Department, BMT Unit

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe


type: Other Identifier

title: A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

acronym: SURPASS-SWITCH

summary: The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

location_country:
Belgium
Romania
United States
France
Mexico
Germany

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Unidad de Investigación Clínica y Atención Médica HEPA

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Medizinisches Versorgungszentrum am Bahnhof Spandau

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

location_facility: Instituto de Diabetes, Obesidad y Nutricion

location_facility: North Hills Family Medicine/North Hills Medical Research

location_facility: Diseno y Planeacion en Investigacion Medica

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Transplantation d'Ilots Pancreatiques Allogeniques Adultes Pour le Traitement du Diabete Insulino-dependant: Etude GRAGIL 2.

summary: This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with brittle type 1, insulin-dependent diabetes mellitus and to improve their metabolic control.

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tétaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

lead_sponsor: University Hospital, Grenoble

location_country: France Switzerland

location_facility: University Hospital, Department of Surgery

location_facility: University Hospital, Department of Endocrinology

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

study_start_date_type: Actual

status: Recruiting

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

lead_sponsor: AbbVie

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: The First Affiliated Hospital of Nanchang University /ID# 231934

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025

location_facility: Renown Medical Group - Oncology/Hematology /ID# 247942

location_facility: Nemocnice AGEL Novy Jicin, a.s. /ID# 232427

location_facility: San Juan Oncology Associates /ID# 244387

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 249000

location_facility: Ensino e Terapia de Inovacao Clínica AMO - Etica /ID# 231604

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023

location_facility: Hospital Universitario 12 de Octubre /ID# 240176

location_facility: National Taiwan University Hospital /ID# 238378

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uyg. Ve Arast. Merkezi /ID# 238337

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde /ID# 238488

location_facility: Guangxi Medical University Cancer Center /ID# 231855

location_facility: Hokkaido University Hospital /ID# 241289

location_facility: Clinical Research & Oncology Oaxaca /ID# 231883

location_facility: Guizhou Provincial People's Hospital /ID# 243614

location_facility: Edward-Elmhurst Cancer Center /ID# 238552

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 232216

location_facility: Instituto de Ensino e Pesquisa Sao Lucas /ID# 247417

location_facility: Dept of Oncology Steve Biko Academic Hospital /ID# 230883

location_facility: National Hospital Organization Mito Medical Center /ID# 241709

location_facility: The First Hospital of China Medical University /ID# 231924

location_facility: Osaka Habikino Medical Center /ID# 239989

location_facility: UOMi Cancer Center - Clinica Tres Torres /ID# 240584

location_facility: Uludag University Medical Faculty /ID# 234205

location_facility: Maastricht Universitair Medisch Centrum /ID# 233932

location_facility: SC RTC Radiology Therapeutic Center SRL /ID# 240744

location_facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 238591

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 232467

location_facility: Medizinische Universitaet Innsbruck /ID# 240981

location_facility: The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179

location_facility: Sjællands Universitetshospital, Roskilde /ID# 241842

location_facility: Yamagata University Hospital /ID# 240815

location_facility: Iwate Medical University Hospital /ID# 239027

location_facility: Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209

location_facility: Harbin Medical University Cancer Hospital /ID# 231941

location_facility: University of Miyazaki Hospital /ID# 242161

location_facility: Universitair Ziekenhuis Antwerpen /ID# 239971

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826

location_facility: Azienda Ospedaliera San Giovanni Addolorata /ID# 238618

location_facility: Gunma Prefectural Cancer Center /ID# 233723

location_facility: Hospital Universitario de Jaen /ID# 240588

location_facility: Taizhou Hospital, Zhejiang Province /ID# 232021

location_facility: Fujian Provincial Cancer Hospital /ID# 243134

location_facility: The Second Hospital of Dalian Medical University /ID# 239755

location_facility: Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339

location_facility: Juntendo University Hospital /ID# 239932

location_facility: The First Affiliated Hospital of Dalian Medical University /ID# 239717

location_facility: CHA University Bundang Medical Center /ID# 233318

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 244953

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241930

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 239658

location_facility: National Taiwan University Hospital - Hsinchu branch /ID# 238393

location_facility: Chung Shan Medical University Hospital /ID# 238444

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 240967

location_facility: Tianjin Medical University General Hospital /ID# 231839

location_facility: Osaka Metropolitan University Hospital /ID# 238895

location_facility: National Cancer Center Hospital East /ID# 233775

location_facility: Clinica Universidad Catolica del Maule /ID# 231294

location_facility: Xiangya Hospital Central South University /ID# 232005

location_facility: The Second Affiliated Hospital of Nanchang University /ID# 231935

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084

location_facility: Peking Union Medical College Hospital /ID# 233175

location_facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696

location_facility: Hirosaki University Hospital /ID# 242377

location_facility: Fukushima Medical University Hospital /ID# 249691

location_facility: University College London Hospitals NHS Foundation Trust /ID# 249407

location_facility: National Hospital Organization Kyushu Medical Center /ID# 238533

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 231509

location_facility: Tianjin Medical University Cancer Institute and Hospital /ID# 233176

location_facility: National Hospital Organization Tokyo Medical Center /ID# 246581

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572

location_facility: Hopital Arnaud de Villeneuve /ID# 239404

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 239575

location_facility: Yokohama City University Medical Center /ID# 246554

location_facility: Beijing Chest Hospital, Capital Medical University /ID# 232202

location_facility: Kanagawa Cardiovascular and Respiratory Center /ID# 239052

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247

location_facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928

location_facility: Henan Provincial People's Hospital /ID# 242187

location_facility: SMG-SNU Boramae Medical Center /ID# 233710

location_facility: Fundacion Arturo Lopez Perez /ID# 231151

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 234211

location_facility: Instituto de Oncologia Angel H. Roffo /ID# 231499

location_facility: Ibaraki Prefectural Central Hospital /ID# 246145

location_facility: Ege University Medical Faculty /ID# 234039

location_facility: The Edith Wolfson Medical Center /ID# 233781

location_facility: Kumamoto University Hospital /ID# 241039

location_facility: The Royal Marsden NHS Foundation Trust /ID# 246974

location_facility: The First affiliated Hospital of Nanyang Medical College /ID# 244652

location_facility: Karolinska University Hospital /ID# 229853

location_facility: Sociedad Prosalud Montes y Orlandi /ID# 231154

location_facility: The First Affiliated Hospital of Xiamen University /ID# 242381

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032

location_facility: Hospital Britanico de Buenos Aires /ID# 231495

location_facility: S.C. Sigmedical Services SRL /ID# 239108

location_facility: Vychodoslovensky onkologicky ustav, a.s. /ID# 230085

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 231880

location_facility: Sandton Oncology Medical Group PTY Ltd /ID# 230843

location_facility: Instytut Centrum Zdrowia Matki Polki /ID# 239024

location_facility: Wakayama Medical University Hospital /ID# 234004

location_facility: Affiliated Hospital Of Guangdong Medical University /ID# 233317

location_facility: Radboud Universitair Medisch Centrum /ID# 233755

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904

location_facility: Taipei Medical University Hospital /ID# 238380

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 233249

location_facility: Azienda Ospedaliera di Perugia /ID# 238473

location_facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191

location_facility: The Oncology Institute of Hope and Innovation - DTLA /ID# 239774

location_facility: Casa de Saúde Santa Marcelina /ID# 231605

location_facility: Cancer Hospital of Shantou University Medical College /ID# 242182

location_facility: Kaiser Permanente Moanalua Medical Center /ID# 238363

location_facility: West China Hospital, Sichuan University /ID# 233703

location_facility: Hiroshima University Hospital /ID# 241882

location_facility: Instituto D'or de Pesquisa e Ensino /ID# 233245

location_facility: Sahlgrenska University Hospital /ID# 229943

location_facility: Gyeongsang National University Hospital /ID# 234244

location_facility: Universitatsklinikum Mannheim /ID# 238331

location_facility: First Health of the Carolinas /ID# 241279

location_facility: Oncocenter - Oncologie Clinica Srl /Id# 239103

location_facility: Thoraxklinik Heidelberg gGmbH /ID# 239656

location_facility: Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228

location_facility: Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698

location_facility: Inonu Universitesi Turgut Ozal /ID# 234038

location_facility: Kitasato University Hospital /ID# 239958

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824

location_facility: Affiliated Hospital of Hebei University /ID# 239586

location_facility: Hospital Clinico Universitario de Valencia /ID# 240378

location_facility: Complex Oncology Center - Burgas /ID# 240532

location_facility: Kansai Medical University Hospital /ID# 233476

location_facility: Medizinische Universitaet Wien /ID# 230615

intervention_type: Biological


title: A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

enrollment_type: Actual

ReferenceCitation: Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2). pii: e002015. doi: 10.1136/jitc-2020-002015.

ipd_sharing: No

location_country:
Australia
United States
Taiwan
France

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 154441

location_facility: South Texas Accelerated Research Therapeutics /ID# 154442

location_facility: UC Davis Comprehensive Cancer Center - Main /ID# 154439

location_facility: HonorHealth Research Institute - Pima /ID# 155461


title: Clinico-biological Study/Characterization of Rhabdomyosarcoma in AYA (Adolescents and Young Adults, 15-25-year-old Patients)

summary:
Rhabdomyosarcoma (RMS) stands for the most frequent soft tissue sarcoma in children and, adolescents and young adults (AYA, 15-25-year-old population), accounting for approximately half of the whole soft tissue sarcomas in these populations.. Conversely, RMS represents a very small proportion of the soft tissue sarcomas in adults (3%), that is less than 1% of all solid cancers of adults.

To date, previous studies undertaken among the paediatric population have pointed out several prognostic factors such as tumor localisation, tumor invasiveness at diagnosis, tumor size, histological subset, and treatment plans. Age at diagnosis remains an independent prognostic factor.

RMS management is consensual in Europe for paediatric population, essentially based on the protocol RMS 2005 within the framework of the European Paediatric Soft tissue sarcoma Study Group (EpSSG). Care in AYAs remain heterogeneous and are either achieved in paediatric department, according to EpSSG guidelines, or in oncology department, known as "adult unit", depending on ESMO (European Society for Medical Oncology), which are non-specific recommendations for the management of rhabdomyosarcoma.

No consensus has been published yet for RMS in AYA despite the growing interest in cancers in AYA population - topic.supported by the French National Cancer Institute (INCa) - and the increasing network between paediatricians and adult-oncologists. Thus management of RMS in AYA remains patchy/unequal depending on the type of care unit.

Herein, with the support of the Oscar Lambret Center, we aim at assessing and identifying clinico-biological prognostic factors of rhabdomyosarcoma in AYA. Eventually, we hope to offer a standardized treatment to this population. Data collected from medical file will be anonymised in a confidential database of which the recipient is the sponsor of the study.

The ancillary study will aim at characterizing the molecular profile of the difficult-to-classify RMS subtypes (fusiform or pleomorphic subsets) in molecular biology for ambiguous cases.

From a scientific point of view, this study aims at understanding the parameters that may influence the prognosis of RMS in AYAs by evaluating various clinical and biological factors.

Biologically, molecular profiling of RMS in AYA may improve the characterization of this tumour in this age group.

At the clinical level, the completeness of the data collected will lead to a better description of RMS in AYAs. We hope to harmonize their therapeutic management by providing therapeutic adjustments according to population subsets.

Finally, these results could also help to adapt the therapeutic management of AYAs within the framework of the European protocol that is currently under construction, and will involve both children and adults.

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Oscar Lambret

location_facility: TOURS CHU-Bretonneau/Hôp G de Clocheville

location_facility: NANCY Institut de Cancérologie de Lorraine

location_facility: NANTES Institut de Cancérologie de l'Ouest

location_facility: LILLE Centre Oscar Lambret/ CHRU de Lille


title: Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Effect of a 30-week Caffeine Treatment on Cognition in Alzheimer's Disease at Beginning to Moderate Stages

acronym: CAFCA

summary:
Sporadic Alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. There is currently no curative treatment available.

Coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. Caffeine pharmacological properties enable its use like an Alzheimer's disease symptomatic treatment. Its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which Alzheimer's patients might be more vulnerable.

The main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in Alzheimer's disease dementia at beginning to moderate stage (MMSE 16-24).

lead_sponsor: University Hospital, Lille

location_facility: CHU Lille consultation mémoire Les Bâteliers


title: High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial

acronym: PASTA

summary:
This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.

Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease.

Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this.

Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.

The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.

This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

ipd_sharing_description: It is not planned to share individual participant data to other researchers.

lead_sponsor: University Hospital Inselspital, Berne

location_country:
United Kingdom
Austria
Australia
Switzerland
France
Germany

location_facility: Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin

location_facility: Luzerner Kantonsspital, Kinderspital, Neuropädiatrie

location_facility: Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie

location_facility: Ospedale Regionale di Bellinzona e Valli

location_facility: Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants

location_facility: Universitätsklinik für Kinder und Jugendheilkunde Wien


acronym: Hubble

title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

lead_sponsor: Takeda

type: Registry Identifier

source: euctr

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.

location_country:
Poland
United Kingdom
Netherlands
Canada
Ukraine
Hungary
United States
France
Israel
Belgium
Germany

location_facility: Indiana University School of Medicine - Indianapolis

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Kharkiv Regional Clinical Children's Hospital

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: University Hospitals Rainbow Babies & Children's Hospital

location_facility: National Scientific Center of Radiological Medicine of NAMS of Ukraine

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Children's and Women's Health Centre of British Columbia

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

location_facility: BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

location_facility: Schneider Children's Medical Center of Israel

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: McGill University Health Centre Glen Site

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Centre Hospitalier Universitaire Sainte-Justine

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

location_facility: Children's Specialty Group - Medical Center Location

location_facility: Universitatsmedizin Rostock - Kinder und Jugendklinik

location_facility: Nemours Childrens Specialty Care - Jacksonville

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku

location_facility: Nottingham University Hospitals NHS Trust

location_facility: London Health Sciences Centre University Hospital

location_facility: Children's Center for Digestive Healthcare

location_facility: The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

location_facility: Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE

summary: The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.


title: A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

acronym: STAR CNS

summary: The STAR CNS trial is a 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.

lead_sponsor: GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
New Zealand
Australia
United States
France

location_facility: Memorial Sloan Kettering Cancer Center Main Campus

location_facility: La Pitie-Salpetriere University Hospital

location_facility: CHU APHM la Timone / Aix Marseille University


title: OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

lead_sponsor: UNICANCER

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

ReferenceCitation: Lui G, Treluyer JM, Fresneau B, Piperno-Neumann S, Gaspar N, Corradini N, Gentet JC, Marec Berard P, Laurence V, Schneider P, Entz-Werle N, Pacquement H, Millot F, Taque S, Freycon C, Lervat C, Le Deley MC, Mahier Ait Oukhatar C, Brugieres L, Le Teuff G, Bouazza N; Sarcoma Group of UNICANCER. A Pharmacokinetic and Pharmacogenetic Analysis of Osteosarcoma Patients Treated With High-Dose Methotrexate: Data From the OS2006/Sarcoma-09 Trial. J Clin Pharmacol. 2018 Dec;58(12):1541-1549. doi: 10.1002/jcph.1252. Epub 2018 May 23.

ReferenceCitation: Tabone MD, Brugières L, Piperno-Neumann S, Selva MA, Marec-Bérard P, Pacquement H, Lervat C, Corradini N, Gentet JC, Couderc R, Chevance A, Mahier-Ait Oukhatar C, Entz-Werle N, Blay JY, Le Deley MC. Prognostic impact of blood and urinary angiogenic factor levels at diagnosis and during treatment in patients with osteosarcoma: a prospective study. BMC Cancer. 2017 Jun 15;17(1):419. doi: 10.1186/s12885-017-3409-z.

ReferenceCitation: Piperno-Neumann S, Le Deley MC, Rédini F, Pacquement H, Marec-Bérard P, Petit P, Brisse H, Lervat C, Gentet JC, Entz-Werlé N, Italiano A, Corradini N, Bompas E, Penel N, Tabone MD, Gomez-Brouchet A, Guinebretière JM, Mascard E, Gouin F, Chevance A, Bonnet N, Blay JY, Brugières L; Sarcoma Group of UNICANCER; French Society of Pediatric Oncology (SFCE); French Sarcoma Group (GSF-GETO). Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1070-1080. doi: 10.1016/S1470-2045(16)30096-1. Epub 2016 Jun 17.

ipd_sharing_description: IPD will not be shared at an individual level, they will be part of the study database including all enrolled patients.

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

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

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.


title: International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

lead_sponsor: University of Birmingham

location_country:
United Kingdom
Ireland
New Zealand
Australia
Switzerland
France

location_facility: Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Universitaire De Clermont-ferrand

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants

location_facility: Centre Hospitalier Universitaire De NICE

location_facility: Centre Hospitalier Universitaire Saint-etienne

location_facility: Centre Hospitalier Universitaire Vaudois Chuv Lausanne

location_facility: John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin

location_facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire D'angers

location_facility: Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville

location_facility: Centre Hospitalier Regional Universitaire Brest - Hopital Morvan

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Great Ormond Street Hospital For Children NHS Trust

location_facility: Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales

location_facility: Centre Hospitalier Universitaire De Rennes - Hopital Sud

location_facility: NHS Lothian, Royal Hospital for Sick Children

location_facility: Centre Hospitalier Universitaire De Poitiers

location_facility: Centre Hospitalier Universitaire De Grenoble

location_facility: NHS Greater Glasgow and Clyde, The Royal Hospital for Children

location_facility: Luzerner Kantonspital - Kinderspital Luzern

location_facility: Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants

location_facility: Centre Hospitalier Universitaire De Nancy

location_facility: Centre Hospitalier Universitaire De Limoges

location_facility: Centre Hospitalier Universitaire Amiens - Picardie

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Southampton University Hospitals NHS Trust

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Centre Hospitalier Universitaire De Caen

location_facility: Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve

location_facility: Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire De Rouen

summary:
The main purpose of this study is :

To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction
To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin (anthracycline) & cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.)
To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy.
To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine & cytarabine (FLA) in standard risk patients.
To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.


title: Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis

summary:
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.

The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

lead_sponsor: Galderma R&D

location_country: Spain Netherlands Sweden France Germany

location_facility:
Investigational site
Investigative site


title: Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive.

acronym: LIZ-BONE

summary: The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.

status: Unknown status

lead_sponsor: University Hospital, Tours

location_country: France Spain Italy

location_facility: Azienda Opedaliera Universitaria San Maria della Misericordia

location_facility: Centre de Chirurgie Orthopédique et de la Main

location_facility: Hospital General Universitario Gregorio Maranon

status_simplified: Unknown


title: Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

summary:
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:

Repair of root or furcation perforations.
Repair of root resorptions (internal and external).
Root-end filling in endodontic surgery (retrograde filling).
Apexification (tooth with open apex).
Revitalization procedure by means of revascularization.

Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.

time_perspective: Other

lead_sponsor: Septodont

location_facility:
AP-HP, Hôpital Louis Mourier
Private dental care office
CHU de Nantes
HCL de Lyon
CHU de Toulouse
CHU de Reims

intervention_type: Device


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis

summary: Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study. Rheumatology (Oxford). 2012 Sep;51(9):1687-96. doi: 10.1093/rheumatology/kes125. Epub 2012 May 30.

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis. Arthritis Care Res (Hoboken). 2012 Feb;64(2):290-4. doi: 10.1002/acr.20671.

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Elbaz M, Geher P, Thabut G, Leblanc V, Logeart I. Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE). Ann Rheum Dis. 2011 May;70(5):799-804. doi: 10.1136/ard.2010.139261. Epub 2011 Feb 13. Erratum in: Ann Rheum Dis. 2011 Jul;70(7):1349.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Hungary Germany France Netherlands

intervention_type: Other


title: Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome

acronym: MILESTONE

summary: The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. Patients will be randomized since the beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.

ReferenceType: background

ReferenceCitation: Stel VS, van de Luijtgaarden MW, Wanner C, Jager KJ; on behalf of the European Renal Registry Investigators. The 2008 ERA-EDTA Registry Annual Report-a précis. NDT Plus. 2011 Feb;4(1):1-13. Epub 2010 Nov 19.

ReferenceCitation: Grooteman MP, van den Dorpel MA, Bots ML, Penne EL, van der Weerd NC, Mazairac AH, den Hoedt CH, van der Tweel I, Lévesque R, Nubé MJ, ter Wee PM, Blankestijn PJ; CONTRAST Investigators. Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes. J Am Soc Nephrol. 2012 Jun;23(6):1087-96. doi: 10.1681/ASN.2011121140. Epub 2012 Apr 26.

ReferenceCitation: Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93.

ReferenceCitation: Locatelli F, Martin-Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R; Membrane Permeability Outcome (MPO) Study Group. Effect of membrane permeability on survival of hemodialysis patients. J Am Soc Nephrol. 2009 Mar;20(3):645-54. doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.

lead_sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_country: France Italy Spain Belgium


title: International, Phase II Study of CyberKnife® for Hepatic Metastases From Colorectal Cancer

summary: This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.

status: Terminated

lead_sponsor: Accuray Incorporated

location_country:
Germany
France
United Kingdom

intervention_type: Radiation


type: U.S. FDA Grant/Contract

title: A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride With Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

acronym: SeaSTAR

summary:
The purpose of this study is to determine if emixustat hydrochloride reduces the rate of progression of macular atrophy compared to placebo in subjects with Stargardt disease.

Funding Source -- FDA OOPD

ipd_sharing: Undecided

lead_sponsor: Kubota Vision Inc.

location_country:
Denmark
Brazil
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
South Africa
Germany

location_facility: University of Utah John Moran Eye Center

location_facility: Oxford Eye Hospital,Oxford University Hospitals NHS Foundation Trust

location_facility: AOU Università della Campania Luigi Vanvitelli

location_facility: Università Cattolica del Sacro Cuore - Fondazione Policlinico Gemelli

location_facility: The Wilmer Eye Institute Johns Hopkins University

location_facility: University of Michigan Kellogg Eye Center

location_facility: Medical College of Wisconsin-Eye Institute

location_facility: Retina-Vitreous Associates Medical Group

location_facility: UOC Oculistica Asst Fatebene Pratelli Sacco Universita delgi Studi di Milano

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Universitätsklinikum Tübingen, Department für Augenheilkunde

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Santa Casa de Misericórdia de Belo Horizonte


title: Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

summary: Management of participants with low-level persistent viremia

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital de Bicêtre
Hôpital Pellegrin
Hôpital de la côte de Nacre
Hôpital pitié Salpetrière
Hôpital Charles Nicoll
Hôpital Saint André
Hôpital Saint Louis
Hôpital Henry Mondor
Hôpital Européen Georges Pompidou
Hôpital Cochin
Hôpital Jean Verdier
Hôpital Tenon
Hôpital Pontchaillou
Hôpital Hôtel Dieu
Hôpital Necker
Hôpital de l'Hôtel Dieu
Hôpital Purpan
Hôpital Avicenne
Hôpital Lariboisière
Hôpital Bichat


title: International Randomized Phase II Trial of the Combination of Vincristine and Irinotecan With or Without Temozolomide (VI or VIT) in Children and Adults With Refractory or Relapsed Rhabdomyosarcoma

ReferenceCitation: Defachelles AS, Bogart E, Casanova M, Merks JHM, Bisogno G, Calareso G, Gallego Melcon S, Gatz SA, Le Deley MC, McHugh K, Probst A, Rocourt N, van Rijn RR, Wheatley K, Minard-Colin V, Chisholm JC. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Sep 20;39(27):2979-2990. doi: 10.1200/JCO.21.00124. Epub 2021 Aug 3.

location_facility: Hôpital des Enfants, Groupe Hospitalier Pellegrin

summary: This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma.


title: ACUTE CARE FOR PATIENTS EXPOSED TO A CHEMICAL, BIOLOGICAL, RADIOLOGICAL, NUCLEAR, EXPLOSIVE: ATTACK: PROTOCOL FOR AN INTERNATIONAL MULTICENTRIC OBSERVATIONAL STUDY

acronym: CBRNE Obs

summary: Observation study measuring medical response in contaminated environment.

status: Enrolling by invitation

ReferenceCitation: Bourassa S, Noebert D, Dauphin M, Rambaud J, Kawaguchi A, Léger F, Beijer D, Fortier Y, Dligui M, Ivanovski H, Simard S, Jouvet P, Leclerc J. Acute care for patients exposed to a chemical attack: protocol for an international multicentric observational study. BMJ Open. 2022 Sep 29;12(9):e065015. doi: 10.1136/bmjopen-2022-065015.

ipd_sharing_description: At this stage, we do have any plan. However, for the interest of pursuing the research, that matter will require to be addressed in due time.

lead_sponsor: St. Justine's Hospital

location_country: Japan Canada France

location_facility: Centre for Defence and Security Studies, University of Manitoba

location_facility: Tokyo Women's Medical University, Department of Intensive Care Medicine

location_facility: Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network

location_facility: Research Center of the CHU St-Justine, University of Montreal

location_facility: Research Centre, Quebec Heart and Lung Institute, Laval University


title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy

lead_sponsor: Tiziana Life Sciences, PLC

location_country:
United States
Italy
France

location_facility: TGen Clinical Research Services at Scottsdale Healthcare

location_facility: NIH, Center for Cancer Research, Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.


title: Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent Maintenance Therapy After a Successful Continuous Induction Therapy.

summary: Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads > 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).

ReferenceCitation: de Truchis P, Assoumou L, Landman R, Mathez D, Le Dû D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

location_facility:
Hôpital Saint-Antoine
Hôpital Bretonneau
Hôpital Raymond Poincaré
Hôpital Bicêtre
Centre Hospitalier Sud Francilien
Hôpital Gui de Chauliac
Hôpital Foch
Hôpital Européen Georges Pompidou
Hôpital Purpan
Hôpital Tenon
Hôpital Meynard
CHU Côte de Nacre
Hôpital Pitié-Salpêtrière
Hôpital Necker
Hôpital Avicenne
Hôpital Bichat
Hôpital Le Bocage


title: A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4counts Below 200 µL.

acronym: DATA

summary: A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.

ReferenceCitation: Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabié A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hopital Bichat
Centre Hospitalier D'Argenteuil
Hopital Saint-Andre
Hopital Lariboisiere
Hopital Zobda Quitman
Hopital Gustave Dron
Hopital Pitie-Salpetriere
Hopital Sainte-Marguerite
Hopital Avicenne
Hopital Europeen Georges Pompidou
Hopital Le Bocage
Hopital Bretonneau
Hopital Saint-Jean Roussillon
Hopital Saint-Jacques
Chu Cote de Nacre
Hopital Tenon
C.H.D de Vendee
Hopital Jean Verdier
Hopital Raymond Poincare
Hopital Cochin
Hopital Louis Mourier
Hopital Saint Antoine
Hopital Dupuytren
Hopital Civil
Centre Hospitalier de Melun
Hopital Necker
Hopital Rene Dubos
C.H.R.A
Hopital L'Archet


acronym: TEMO-CARB

title: Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP - Georges Pompidou European Hospital

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

summary: TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.


title: Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

summary: Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nantes
CHU Angers
CHU Nancy
AP-HP La Pitié Salpétrière
CHU Limoges
Centre Hospitalier Le Mans


acronym: PLEO-CMT-FU

title: International, Multi-center, Open Label, Follow-up Extension Study Assessing the Long-term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A

lead_sponsor: Pharnext SA

location_country:
Spain
United Kingdom
Canada
United States
France
Belgium
Netherlands

location_facility: Centre de Reference des Neuropathies Peripheriques Rare, Hopital Dupuytren, CHU Limoges

location_facility: Centre de Reference des Maladie Neuromusculaires, Hotel Dieu, CHU de Nantes

location_facility: Servicio de Neurologia, Hospital Universitario La Paz

location_facility: Department of Neurology, Cedars-Sinai Medical Center

location_facility: Centre de Reference des Maladie Neuromusculaires, CHU la Timone

location_facility: Department of Neurology, University of Minnesota

location_facility: Department of Neurology, McKnight Brain Institute

location_facility: Department of Neurology, Salford Royal NHS Foundation Trust

location_facility: Centro de Diagnostico y Tratamiento, Hospital Universitario Virgen del Rocio

location_facility: Service de Neurologie et du Sommeil, CHU Lyon Sud

location_facility: Departement of Neurology, Academic Medical Center

location_facility: Servicio de Neurologia, Hospital Universitario i Politécnic La Fe

location_facility: Service de Neurologie, Hopital Kremlin Bicetre

location_facility: Department of Neurology and Psichiatry, Saint Louis University

location_facility: Cntre de Reference des Maladies Neuromusculaires, Hopital Swynghedauwl, CHU Lille

location_facility: Peripheral Neuropathy Center, Neurological Institue Building, Columbia University Medical Center

location_facility: Department of neurology, Hospital Univesitario de Bellvitge

summary:
All randomised patients with Charcot-Marie-Tooth Type 1A (CMT1A) who completed the primary study CLN-PXT3003-02, i.e. treatment with PXT3003 or placebo, are eligible to continue in the extension study CLN-PXT3003-03.

Period 1: Patients randomised to PXT3003 dose 1 or placebo in the primary study (CLN-PXT3003-02) continued in the extension study on PXT3003 dose 1 (5 mL). Patients randomised to PXT3003 dose 2 (5 mL) in the primary study (CLN-PXT3003-02) continued in the extension study on PXT3003 dose 2 or PXT3003 twice dose 1 (2x5 mL).

Period 2: All patients continue on twice dose 1 (2X5mL).


title: Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Treatment Taken 4 Consecutive Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Therapy

acronym: QUATUOR

summary: The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months.

ReferenceCitation: Landman R, de Truchis P, Assoumou L, Lambert S, Bellet J, Amat K, Lefebvre B, Allavena C, Katlama C, Yazdanpanah Y, Molina JM, Petrov-Sanchez V, Gibowski S, Alvarez JC, Leibowitch J, Capeau J, Fellahi S, Duracinsky M, Morand-Joubert L, Costagliola D, Alvarez JC, Girard PM; ANRS 170 QUATUOR study group. A 4-days-on and 3-days-off maintenance treatment strategy for adults with HIV-1 (ANRS 170 QUATUOR): a randomised, open-label, multicentre, parallel, non-inferiority trial. Lancet HIV. 2022 Feb;9(2):e79-e90. doi: 10.1016/S2352-3018(21)00300-3. Erratum in: Lancet HIV. 2022 Feb 22;:.

location_facility: Centre Hospitalier Général de Saint Nazaire


title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT

acronym: PAIN-OUT

summary:
This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

What is the incidence of chronic post surgical pain (CPSP) in Europe?
What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
What are the difference in incidence and risk factors in different European countries?

ReferenceCitation: Fletcher D, Pogatzki-Zahn E, Zaslansky R, Meissner W; Pain Out Group. euCPSP: European observational study on chronic post-surgical pain. Eur J Anaesthesiol. 2011 Jun;28(6):461-2. doi: 10.1097/EJA.0b013e328344b4cd.

ReferenceCitation: Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.

ReferenceCitation: Stamer UM, Naef N, Porz R, Stuber F, Leva B, Meissner W, Fletcher D; euCPSP Study Group. Ethical procedures and patient consent differ in Europe. Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206. Erratum in: Eur J Anaesthesiol. 2015 Mar;32(3):222.

lead_sponsor: European Society of Anaesthesiology

location_country:
Romania
Spain
Italy
Ireland
United Kingdom
Switzerland
Ukraine
France
Belgium
Germany
Moldova, Republic of

location_facility: Ensemble Hospitalier de la Cote in Morges

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

location_facility: Central Universitty and Emergency Military Hospital "Dr. Carol Davila"

location_facility: University College Hospital NHS Foundation Trust


title: A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)

acronym: HALO

summary: Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

lead_sponsor: Debiopharm International SA

location_country:
France
Spain
United Kingdom

location_facility: Institut de Cancérologie de l'Ouest- Institut René Gauduchau


acronym: PDOne

title: Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis

lead_sponsor: Fresenius Medical Care Deutschland GmbH

location_country:
Denmark
United Kingdom
Sweden
France
Germany

location_facility: KfH-Nierenzentrum am Krankenhaus Oststadt

location_facility: KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder

location_facility: University of North Staffordshire - Renal Medicine - Royal Infirmary

summary: The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.


acronym: TREAT-CTC

title: TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)

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

ReferenceCitation: Ignatiadis M, Rack B, Rothé F, Riethdorf S, Decraene C, Bonnefoi H, Dittrich C, Messina C, Beauvois M, Trapp E, Goulioti T, Tryfonidis K, Pantel K, Repollet M, Janni W, Piccart M, Sotiriou C, Litiere S, Pierga JY. Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial. Eur J Cancer. 2016 Aug;63:97-104. doi: 10.1016/j.ejca.2016.04.024. Epub 2016 Jun 10. Review.

location_country:
Germany
France
United Kingdom
Belgium

location_facility: Gesellschaft für onkologische Studien, Praxismanagement und -Logistik

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: HELIOS Kliniken - HELIOS Klinik Rottweil

location_facility: Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH

location_facility: Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH

location_facility: Gemeinschaftspraxis Prof. Salat / Dr. Stötzer

location_facility: Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

location_facility: Staedtische Kliniken Frankfurt Am Main-Hoechst

location_facility: Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen

location_facility: St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Gemeinschaftspraxis Lorenz / Hecker / Wesche

location_facility: Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt

location_facility: Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer

location_facility: HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz

location_facility: Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

summary:
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.

Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.


title: Prospective, Multicenter, Observational cLinical triAl Measuring Safety and Technical Performance of plAstalgin and Plastalgin Fast in Patients Requiring a Dental Impression

summary:
The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation. The target population for this study is the same as the intended population specified in the study device's instructions for use: children from 5 years old and adults.

Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of participating patients during and after the study


title: Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility

acronym: APREVIO

summary:
Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. In order to fill this gap, teams members of the Addictopôle Occitanie in collaboration with a regional team are preparing the launch of a concrete longitudinal study to analyze the incidence of violence in populations suffering from addiction, but also to evaluate the need in terms of management of this violence.

Hypotheses: To analyze the prevalence of violence in populations suffering from addiction and the need for treatment of such violence using a robust protocol based on an anonymous questionnaire to assess the violence experienced or committed by a patient, taking into account his/her environment. This study would allow us to better understand the effects of addictions on the severity and frequency of violence, but also to implement concrete and adapted solutions in order to limit it. This study could lead to the creation of a regional Observatory of Violence related to Addictions.

Translated with www.DeepL.com/Translator (free version)

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Pascal PERNEY
Gaëlle SULTAN-TIHLL
Nicolas FRANCHITTO
Hélène DONNADIEU


title: Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer

acronym: SMALLHAN

summary:
The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head & neck cancer.

To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head & neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head & neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale


title: Étude Clinique Des Biomarqueurs de la résilience au Stress: rôle d'ELK1 et GPR56

acronym: GeBra-clin

summary:
70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). However, not all subjects have the same risk to develop a pathology, and resilience capacities, which depend on multiple factors are difficult to predict. Currently, there are no objective tools to stratify exposed subjects according to their risk of developing pathological responses to stress, which leads to difficulties in allocating means of prevention and treatment.

Recently, new biological hypotheses explaining vulnerability/resilience to stress and depression, implicating the GPR56 and ELK1 genes, have been described. Previous studies have shown that evaluation of the vulnerability risk can be obtained from clinical, cognitive, biological or brain imaging variables, but no study has integrated these different approaches. Therefore, the project presented here aims at integrating behavioral, biological and neuroimaging data to predict the development of psychiatric disease. In this study, a prospective cohort of 255 violent trauma victims will be set up in 3 French cities for a period of 2 years. Eligible subjects will be included in the month following PTE and will be followed longitudinally for 12 months. Evaluations at 1, 3, 6 and 12 months will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit.

We hypothesize that the genetic expression of ELK1 and GPR56 is predictive of the development of psychiatric pathologies at 6 and 12 months post-PTE. The ambition of this project is also to highlight the importance of a multimodal approach integrating a triad of markers (behavioral, biological and neuroimaging) to test this hypothesis.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHRU de Tours
CHU Montpellier
Hopital Sainte Marguerite
Hopital de la Conception


title: Tissue and Metabolic Characterization of Arrhythmogenic Cardiomyopathies by Hybrid PET-MRI Imaging, Impact of the Observed Profiles on the Phenotype and on the Evolution of Cardiomyopathy

acronym: CharACTPET-MR

summary:
Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation.

Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis).

Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data.

Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.

location_facility:
CHU de Nantes
CHU Angers
AP-HP La Salpêtrière
CHU Brest


title: Efficacy and Auditory Biomarker Analysis of Fronto-Temporal Transcranial Direct Current Stimulation (tDCS) in Targeting Cognitive Impairment Associated With Recent-onset Schizophrenia: A Randomized Double-blind Sham-controlled Trial

acronym: STICOG

summary:
Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial Direct Current Stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Further, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear.

Method: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham controlled, 4-centers trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS.

Discussion: Besides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct an RCT with follow-up assessments up to 3-months and a large sample size. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficits improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.

ipd_sharing_description: The data will be available from the principal investigator to other study investigators or scientists upon reasonable request.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Grenoble Alpes
CH Alpes-Isère
CHU Saint-Etienne
CH Le Vinatier


title: Correction of Hallux Valgus With the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device : Evaluation of Quality of Life Scores, Angular Correction, Bone Consolidation and Occurrence of Adverse Events

acronym: PECA

summary:
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.

The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.

The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.

primary_purpose: Other

lead_sponsor: Novastep

location_facility:
Policlinic Bordeaux North Aquitaine
Saint-Charles Clinic
Toulouse University Hospital
New Clinic Bel Air


title: Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network

acronym: OUTMEDIC-FR

summary: The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process.

ReferenceCitation: Roux B, Sirois C, Niquille A, Spinewine A, Ouellet N, Pétein C, Sibille FX, Csajka C, Reeve E, Villeneuve C, Laroche ML. Cross-cultural adaptation and psychometric validation of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in French. Res Social Adm Pharm. 2021 Aug;17(8):1453-1462. doi: 10.1016/j.sapharm.2020.11.004. Epub 2020 Nov 10.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: SSR Geriatric department - Hospital René Dubos

location_facility: SSR Geriatric department - Hospital Simone Veil

location_facility: Short stay Geriatric department - Hospital Simone Veil

location_facility: Short stay Geriatric department - Hospital René Dubos


title: Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study.

acronym: HospiFlow

summary:
High-flow nasal oxygen therapy is commonly used in intensive care unit (ICU). Intra-hospital transfer of critical patients is frequent: 1) to perform diagnostic 2) between emergency room or medical wards and ICU. During theses transfers, oxygenation should be continued.

There is high-flow nasal oxygen therapy for transport using an external battery. This mode of operation in transport mode allows about 30-45 min of autonomy.

Intra-hospital transport under high-flow nasal oxygen therapy has been previously described on children.

The objective of this study is to evaluate the occurrence of complications during intra-hospital transports under high-flow nasal oxygen of critical patients.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHR d'ORLEANS
Hospital Center of DAX
CH de Martigues
CH Bretagne Atlantique vannes-Auray


title: Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part I: Identification of Effusion and Detection of Basilic Vein

acronym: CLIN-ECHO-I

summary:
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.

This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.

The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.

The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.

primary_purpose: Screening

location_facility: Cochin Hospital - APHP - Emergency Department

location_facility: Avicenne Hospital - APHP - Hepatology Department

location_facility: Cochin Hospital - APHP - Pneumology department

location_facility: Paul Brousse Hospital - APHP - Hepatobiliary Center


title: A Phase II, Prospective, Multicenter Study Assessing the Contribution and Tolerance of a Multi-targeted Microbiotherapy in Addition to Venlafaxine, After Failure of a First-line Antidepressant Treatment in Depressed Patients

acronym: PROMOOD

summary: The study aims to evaluate the contribution of a multi-targeted microbiotherapy at 12 weeks in depressed-patients in a situation of failure of a 1st line of antidepressant treatment and treated in add-on with a 2nd antidepressant, venlafaxine.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Spécialisé Charles Perrens

intervention_type: Dietary Supplement


title: Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure in Patients With Persistent Atrial Fibrillation: a Randomized, Multicentric, and Comparative Study

acronym: PACIFIC

summary:
This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation.

All included patients will undergo an electric cardioversion, then:

Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients.

Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures:

PVI procedure alone
PVI procedure combined with substrate modulation

ReferenceCitation: Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Oct 21;42(40):4194. doi: 10.1093/eurheartj/ehab648.

ReferenceCitation: Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

ReferenceCitation: Sanders P, Hocini M, Jaïs P, Sacher F, Hsu LF, Takahashi Y, Rotter M, Rostock T, Nalliah CJ, Clémenty J, Haïssaguerre M. Complete isolation of the pulmonary veins and posterior left atrium in chronic atrial fibrillation. Long-term clinical outcome. Eur Heart J. 2007 Aug;28(15):1862-71.

ReferenceCitation: Knecht S, Hocini M, Wright M, Lellouche N, O'Neill MD, Matsuo S, Nault I, Chauhan VS, Makati KJ, Bevilacqua M, Lim KT, Sacher F, Deplagne A, Derval N, Bordachar P, Jaïs P, Clémenty J, Haïssaguerre M. Left atrial linear lesions are required for successful treatment of persistent atrial fibrillation. Eur Heart J. 2008 Oct;29(19):2359-66. doi: 10.1093/eurheartj/ehn302. Epub 2008 Jul 8.

ReferenceCitation: Valderrábano M, Peterson LE, Bunge R, Prystash M, Dave AS, Nagueh S, Kleiman NS. Vein of Marshall ethanol infusion for persistent atrial fibrillation: VENUS and MARS clinical trial design. Am Heart J. 2019 Sep;215:52-61. doi: 10.1016/j.ahj.2019.04.022. Epub 2019 May 11.

ReferenceCitation: Kim DT, Lai AC, Hwang C, Fan LT, Karagueuzian HS, Chen PS, Fishbein MC. The ligament of Marshall: a structural analysis in human hearts with implications for atrial arrhythmias. J Am Coll Cardiol. 2000 Oct;36(4):1324-7.

ReferenceCitation: Valderrábano M, Chen HR, Sidhu J, Rao L, Ling Y, Khoury DS. Retrograde ethanol infusion in the vein of Marshall: regional left atrial ablation, vagal denervation and feasibility in humans. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):50-6. doi: 10.1161/CIRCEP.108.818427.

ReferenceCitation: Dave AS, Báez-Escudero JL, Sasaridis C, Hong TE, Rami T, Valderrábano M. Role of the vein of Marshall in atrial fibrillation recurrences after catheter ablation: therapeutic effect of ethanol infusion. J Cardiovasc Electrophysiol. 2012 Jun;23(6):583-91. doi: 10.1111/j.1540-8167.2011.02268.x. Epub 2012 Mar 19.

ReferenceType: result

ReferenceCitation: Pambrun T, Denis A, Duchateau J, Sacher F, Hocini M, Jaïs P, Haïssaguerre M, Derval N. MARSHALL bundles elimination, Pulmonary veins isolation and Lines completion for ANatomical ablation of persistent atrial fibrillation: MARSHALL-PLAN case series. J Cardiovasc Electrophysiol. 2019 Jan;30(1):7-15. doi: 10.1111/jce.13797. Epub 2018 Dec 21.

ReferenceCitation: Rivard L, Hocini M, Rostock T, Cauchemez B, Forclaz A, Jadidi AS, Linton N, Nault I, Miyazaki S, Liu X, Xhaet O, Shah A, Sacher F, Derval N, Jaïs P, Khairy P, Macle L, Nattel S, Willems S, Haïssaguerre M. Improved outcome following restoration of sinus rhythm prior to catheter ablation of persistent atrial fibrillation: a comparative multicenter study. Heart Rhythm. 2012 Jul;9(7):1025-30. doi: 10.1016/j.hrthm.2012.02.016. Epub 2012 Feb 15.

ReferenceCitation: Boveda S, Metzner A, Nguyen DQ, Chun KRJ, Goehl K, Noelker G, Deharo JC, Andrikopoulos G, Dahme T, Lellouche N, Defaye P. Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial. JACC Clin Electrophysiol. 2018 Nov;4(11):1440-1447. doi: 10.1016/j.jacep.2018.07.007. Epub 2018 Aug 25.

ReferenceCitation: Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.

ReferenceCitation: Derval N, Duchateau J, Denis A, Ramirez FD, Mahida S, André C, Krisai P, Nakatani Y, Kitamura T, Takigawa M, Chauvel R, Tixier R, Pillois X, Sacher F, Hocini M, Haïssaguerre M, Jaïs P, Pambrun T. Marshall bundle elimination, Pulmonary vein isolation, and Line completion for ANatomical ablation of persistent atrial fibrillation (Marshall-PLAN): Prospective, single-center study. Heart Rhythm. 2021 Apr;18(4):529-537. doi: 10.1016/j.hrthm.2020.12.023. Epub 2020 Dec 29.

lead_sponsor: Elsan

location_facility: Clinique Pasteur Service de cardiologie/rythmologie

location_facility: Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie


title: Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol

acronym: MOTRICITE TSA

summary: This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.

ReferenceCitation: Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.

ReferenceCitation: Cazalets JR, Bestaven E, Doat E, Baudier MP, Gallot C, Amestoy A, Bouvard M, Guillaud E, Guillain I, Grech E, Van-Gils J, Fergelot P, Fraisse S, Taupiac E, Arveiler B, Lacombe D. Evaluation of Motor Skills in Children with Rubinstein-Taybi Syndrome. J Autism Dev Disord. 2017 Nov;47(11):3321-3332. doi: 10.1007/s10803-017-3259-1.

ReferenceCitation: D'Mello AM, Stoodley CJ. Cerebro-cerebellar circuits in autism spectrum disorder. Front Neurosci. 2015 Nov 5;9:408. doi: 10.3389/fnins.2015.00408. eCollection 2015. Review.

ReferenceCitation: Eggleston JD, Harry JR, Cereceres PA, Olivas AN, Chavez EA, Boyle JB, Dufek JS. Lesser magnitudes of lower extremity variability during terminal swing characterizes walking patterns in children with autism. Clin Biomech (Bristol, Avon). 2020 Jun;76:105031. doi: 10.1016/j.clinbiomech.2020.105031. Epub 2020 May 7.

ReferenceCitation: Hak L, Houdijk H, Beek PJ, van Dieën JH. Steps to take to enhance gait stability: the effect of stride frequency, stride length, and walking speed on local dynamic stability and margins of stability. PLoS One. 2013 Dec 13;8(12):e82842. doi: 10.1371/journal.pone.0082842. eCollection 2013.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux

location_facility:
Centre Hospitalier Charles Perrens
Centre Hospitalier Henri Laborit
CHU de LIMOGES
Centre Hospitalier La Rochelle Re Aunis

intervention_type: Behavioral


title: Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease

acronym: CoStemCells

summary: To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Hopital Tenon
Rousseau-Bussac
HEGP
Hopital Cochin


title: Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.

acronym: ECRIN

summary: This study aims to assess the efficacy at 4 months of a personalized strategy comparatively to a standard Psychodynamic Integrative Therapy, on childrens' symptom improvment

location_facility:
CHU de Montpellier
GHU Paris Psychiatrie et Neurosciences
CHU de Besançon
CHU de Reims


acronym: T-FORE

title: Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital

location_facility: Department of Pediatric Gastroenterology, Robert Debré Hospital

location_facility: Department of gastroenterology, Armand Trousseau Hospital

summary: The purpose of this study is to evaluate whether FMT by frozen stool capsules in pediatric UC patients in remission after corticosteroid treatment, can modify their dysbiotic gut microbiota by increasing the richness of their microbiota at 6 months.


title: Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry Coupled With FRAX / TBS in Allo-HSCT

acronym: REMODALLO

summary: Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.

lead_sponsor: University Hospital, Caen

location_facility:
Chu Rouen
Chu Amiens
CHU CAEN
Chu Lille


title: Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE® Ophthalmic Viscosurgical Device

acronym: PROMIR

summary:
I.SPACE® is a hyaluronic acid injectable gel CE (European Conformity) marketed since 2010. It is indicated for use as a surgical aid in ophthalmic anterior segment surgery. The aim is to protect the corneal endothelium and maintains the intraocular space.The product should be instilled in the anterior chamber of the eye and adjusted according to the volume of the aqueous humour.

In this study, 80 patients aged from 18 to 84 years' old at inclusion, who have at least one eye with cataract (mild to moderate severity) based on subjective ophthalmic examination by the investigator, who have given his/her informed consent and meet all the eligibility criteria, will be enrolled.

Subjects will come to a total of 7 visits over a period of 3 months. Protection of corneal endothelium (Mean percent change of CEC density) after baseline injection will be assessed. Surgeon's satisfaction during cataract surgery, mean change in Intraocular Pressure (IOP), percentage of eyes with IOP spikes ≥ 30mm mmHg, corneal thickness, intraocular inflammation, Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and safety will be also assessed.

lead_sponsor: Laboratoires Vivacy

location_facility: Clinique d'ANJOU Pôle de consultation Tassigny


title: Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

summary:
EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety

lead_sponsor: EUROS

location_facility:
Clinique Esquirol Saint Hilaire
Clinique St Roch
Centre Hospitalier SECLIN
Clinique de L'Atlantique


title: Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment

acronym: DEFISTEP

summary: The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.

ReferenceCitation: Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

ReferenceCitation: Barreto LC, Oliveira FS, Nunes PS, de França Costa IM, Garcez CA, Goes GM, Neves EL, de Souza Siqueira Quintans J, de Souza Araújo AA. Epidemiologic Study of Charcot-Marie-Tooth Disease: A Systematic Review. Neuroepidemiology. 2016;46(3):157-65. doi: 10.1159/000443706. Epub 2016 Feb 6. Review.

ReferenceCitation: Gholizadeh H, Abu Osman NA, Eshraghi A, Ali S, Razak NA. Transtibial prosthesis suspension systems: systematic review of literature. Clin Biomech (Bristol, Avon). 2014 Jan;29(1):87-97. doi: 10.1016/j.clinbiomech.2013.10.013. Epub 2013 Oct 29. Review.

ReferenceCitation: Zucker DR, Ruthazer R, Schmid CH. Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. J Clin Epidemiol. 2010 Dec;63(12):1312-23. doi: 10.1016/j.jclinepi.2010.04.020. Epub 2010 Sep 22.

ReferenceCitation: Spieler JF, Amarenco P. [Socio-economic aspects of stroke management]. Rev Neurol (Paris). 2004 Nov;160(11):1023-8. Review. French.

lead_sponsor: Thuasne

location_facility:
centre Louis PIERQUIN
Hôpital Rothschild
CHU Lille
CHU Strasbourg


title: INterest of the Negative Predictive Value of Integrons in Choosing a Narrow-spectrum Empirical anTibiotic Treatment vs Usual Empirical Antibiotic Treatment for Urinary Tract infectionS in the PEDiatric Emergency Department

acronym: INVICTUS PED

summary: INVICTUS PED primary objective is to show the non-inferiority of an empirical antibiotic therapeutic management guided by the early detection of integrons in the urine, compared to a usual empirical antibiotic treatment, for the recovery of children admitted to the pediatric emergency department (ED) with a non-severe urinary tract infection (UTI) with fever

primary_purpose: Basic Science

lead_sponsor: University Hospital, Limoges

location_facility:
Limoges university Hospital
Montpellier university Hospital
Toulouse university Hospital
Bordeaux university Hospital


title: Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial

acronym: SECOIA

summary:
Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion.

Histological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection.

If the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed.

Surgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance).

Percutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia.

The hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHD Vendée
CHU Nantes
Hopital Henri Mondor
Hopital Lariboisière