title: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

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:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
United States
India
Romania
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Wannan Medical College Yijishan Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari General de Catalunya

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: USO - Arizona Oncology Associates - HOPE

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Grant Medical Foundation - Ruby Hall Clinic

location_facility: Reinier de Graaf Ziekenhuis, locatie Delft

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: CIO - Centro de Inmuno-Oncología de Occidente

location_facility: Onkologische Schwerpunktpraxis Heidelberg, Dr. med. Andreas Karcher, Dr. med. Daniel Debatin, Dr. med. Stefan Fuxius

location_facility: Institut für Versorgungsforschung Dr. Michael Maasberg, Dr. med. Maria Theresia Keller, Marion Schmitz

location_facility: University of Rochester - Wilmot Cancer Institute

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

location_facility: Thomas Jefferson University, Aria Jefferson Health

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Cancer Hospital Chinese Academy of Medical Science

location_facility: Centro de Estudios Y Prevencion Del Cancer

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital

location_facility: Capital Health Medical Center - Hopewell

location_facility: University of California Davis (UC Davis) Comprehensive Cancer Center

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

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

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research

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

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Guangdong Maternity and Child Health Care Hospital

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: H.R.U Málaga - Hospital Materno-infantil

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: The Center for Cancer and Blood Disorders

location_facility: Investigaciones Clinicas Moleculares (ICM)

location_facility: Groupe Hospitalier La Rochelle-Ré-Aunis - Hôpital Saint Louis

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Sunnybrook Research Institute - Odette Cancer Centre

location_facility: The First People's Hospital of Changde City

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

location_facility: Instituto de Assist├ncia M├dica ao Servidor P

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: Hwa Mei Hospital University of Chinese Academy of Sciences

location_facility: Dana-Farber - New Hampshire Oncology/Hematology

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Kapiolani Medical Center for Women and Children

location_facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

location_facility: zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi

location_facility: Dongnam Institute of Radiological and Medical Sciences

location_facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

location_facility: Laura and Isaac Perlmutter Cancer Center

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: CHA Bundang Medical Center, CHA University

location_facility: CENEIT Oncológicos. Centro Especializado en Investigación y Tratamientos Oncológicos

location_facility: Kaiser Permanente San Diego Mission Road

location_facility: Amphia Ziekenhuis, locatie Breda Molengracht

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: PanAmerican Clinical Research - Querétaro - Avenida Antea

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Dana-Farber Cancer Institute - Merrimack Valley

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: National Hospital Organization Takasaki General Medical Centar

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Xiangya Hospital Central South University

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: The University of Vermont Medical Center Inc.

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Centro Oncologico Estatal ISSEMyM ( COEI )

location_facility: Yuncheng Central Hospital - Eastern Hospital

location_facility: Zuckerberg San Francisco General Hospital and Trauma Center

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Chemotopia - Kumamoto Breast & Gastrointestinal Surgical Hospital

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Uniklinikum Salzburg, Universitaetsklinik für Innere Medizin III der PMU

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou

location_facility: Banner MD Anderson Cancer Center at McKee Medical Center

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: CHU de Charleroi - Hopital Civil Marie Curie

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Mugla Sitki Kocman Universitesi Egitim ve Arastirma Hastanesi

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi

location_facility: Jining Medical University - Affiliated Hospital

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Général de Mont de Marsan - Hôpital Layné

location_facility: Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

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

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

location_facility: The First Affiliated Hospital of Soochow University

location_facility: KLES Dr. Prabhakar Kore Hospital & M.R.C

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

location_facility: Dana-Farber Cancer Institute - Foxborough

location_facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center

location_facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

location_facility: The University of Kansas Cancer Center - Westwood

location_facility: Walter Reed National Military Medical Center

location_facility: Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Centro de Oncología e Investigación de Buenos Aires

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: Hospital General Universitario de Alicante

location_facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Mass General Cancer Center at Newton-Wellesley

location_facility: The Second People's Hospital of Neijiang

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: University General Hospital of Heraklion

location_facility: Mercy Health - St. Vincent Medical Center

location_facility: Albert Schweitzer Ziekenhuis, locatie Dordwijk

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center

location_facility: West Cancer Center and Research Institute

location_facility: Chang Gung Medical Foundation-Linkou Branch


type: EudraCT Number

title: Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial

acronym: PEMBROSARC

summary: This is a multicenter study assessing the efficacy of different therapeutic strategy in patients with advanced sarcomas.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Spalato-Ceruso M, Bouteiller F, Guegan JP, Toulmonde M, Bessede A, Kind M, Cousin S, Buy X, Palussiere J, Le Loarer F, Dadone-Montaudie B, Pulido M, Italiano A. Pembrolizumab combined with low-dose cyclophosphamide and intra-tumoral injection of the toll-like receptor 4 agonist G100 in patients with advanced pretreated soft tissue sarcoma: results from the PEMBROSARC basket study. J Hematol Oncol. 2022 Oct 27;15(1):157. doi: 10.1186/s13045-022-01377-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Italiano A, Bessede A, Pulido M, Bompas E, Piperno-Neumann S, Chevreau C, Penel N, Bertucci F, Toulmonde M, Bellera C, Guegan JP, Rey C, Sautes-Fridman C, Bougouin A, Cantarel C, Kind M, Spalato M, Dadone-Montaudie B, Le Loarer F, Blay JY, Fridman WH. Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort. Nat Med. 2022 Jun;28(6):1199-1206. doi: 10.1038/s41591-022-01821-3. Epub 2022 May 26.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Le Cesne A, Marec-Berard P, Blay JY, Gaspar N, Bertucci F, Penel N, Bompas E, Cousin S, Toulmonde M, Bessede A, Fridman WH, Sautes-Fridman C, Kind M, Le Loarer F, Pulido M, Italiano A. Programmed cell death 1 (PD-1) targeting in patients with advanced osteosarcomas: results from the PEMBROSARC study. Eur J Cancer. 2019 Sep;119:151-157. doi: 10.1016/j.ejca.2019.07.018. Epub 2019 Aug 21.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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.

publisher_dissemination: Informa

ReferenceCitation: Toulmonde M, Penel N, Adam J, Chevreau C, Blay JY, Le Cesne A, Bompas E, Piperno-Neumann S, Cousin S, Grellety T, Ryckewaert T, Bessede A, Ghiringhelli F, Pulido M, Italiano A. Use of PD-1 Targeting, Macrophage Infiltration, and IDO Pathway Activation in Sarcomas: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):93-97. doi: 10.1001/jamaoncol.2017.1617.

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

lead_sponsor: Institut Bergonié

collaborators: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_facility:
Institut Bergonié
Centre Léon Bérard
Institut Claudius Regaud
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Institut Gustave Roussy
Institut Paoli Calmettes
Institut Curie

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown

appel_a_projets: PHRCK

region: Nouvelle-Aquitaine

nom_etablissement: INSTITUT BERGONIE

type_etablissement: CLCC

acronyme: PEMBROSARC-TLS

titre: Immunothérapie par Pembrolizumab chez les patients porteurs d'un sarcome des tissus mous avancé avec infiltrat immunologique: essai multicentrique de phase II

discipline_principale: cancer

nom_porteur: ITALIANO

prenom_porteur: Antoine


type: Other Identifier

title: Prevention of Atrial Fibrillation by the Prescription of Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

acronym: PREFACE

summary:
Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation [RFA] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias.

When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate.

Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching ["stretch"], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib.

This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.

status: Terminated

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Da Costa A, Thevenin J, Roche F, Romeyer-Bouchard C, Abdellaoui L, Messier M, Denis L, Faure E, Gonthier R, Kruszynski G, Pages JM, Bonijoly S, Lamaison D, Defaye P, Barthelemy JC, Gouttard T, Isaaz K; Loire-Ardeche-Drome-Isere-Puy-de-Dome Trial of Atrial Flutter Investigators. Results from the Loire-Ardeche-Drome-Isere-Puy-de-Dome (LADIP) trial on atrial flutter, a multicentric prospective randomized study comparing amiodarone and radiofrequency ablation after the first episode of symptomatic atrial flutter. Circulation. 2006 Oct 17;114(16):1676-81. doi: 10.1161/CIRCULATIONAHA.106.638395. Epub 2006 Oct 9.

ReferenceCitation: Da Costa A, Romeyer-Bouchard C, Zarqane-Sliman N, Messier M, Samuel B, Kihel A, Faure E, Isaaz K. Impact of first line radiofrequency ablation in patients with lone atrial flutter on the long term risk of subsequent atrial fibrillation. Heart. 2005 Jan;91(1):97-8. doi: 10.1136/hrt.2003.033308. No abstract available.

ReferenceCitation: Madrid AH, Peng J, Zamora J, Marin I, Bernal E, Escobar C, Munos-Tinoco C, Rebollo JM, Moro C. The role of angiotensin receptor blockers and/or angiotensin converting enzyme inhibitors in the prevention of atrial fibrillation in patients with cardiovascular diseases: meta-analysis of randomized controlled clinical trials. Pacing Clin Electrophysiol. 2004 Oct;27(10):1405-10. doi: 10.1111/j.1540-8159.2004.00645.x.

ReferenceCitation: Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301. Erratum In: 2000 May 4;342(18):1376. N Engl J Med 2000 Mar 9;342(10):748.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators:
Sanofi
Ministry of Health, France
LivaNova

location_facility:
CHU de Saint-Etienne
Polyclinique des Fleurs
CHU de Clermont-Ferrand
CHU de Montpellier
CHU de Brest
CHU de Grenoble
CHU de Rennes
CHU de Rouen

lead_sponsor_type: academique


title: Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection

acronym: GUMIBONE

summary:
Bone and joint infections (BJI) is a public health issue in industrialized countries.

Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.

A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).

Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.

Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.

The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
University of Lyon

location_facility: Hôpital de la Croix Rousse-Service de chirurgie orthopédique

location_facility: Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales

location_facility: Centre Hospitalier Lyon Sud-Service des maladies infectieuses

location_facility: Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique

intervention_type: Biological


title: A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism

acronym: OPTIMEV

summary:
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
Is it necessary to obtain a detailed history of thromboembolic disease ?
Do older patients have particular risk factors ?
Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
Do predictive clinical scores have the same performance for both in and outpatients ?
Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.

ReferenceCitation: Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20. doi: 10.1001/archinte.160.22.3415.

ReferenceCitation: Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.

ReferenceCitation: Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9. doi: 10.1001/archinte.163.10.1213.

ReferenceCitation: Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quere I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. doi: 10.1016/s0398-0499(05)88206-x. French.

ReferenceCitation: Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quere I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.

publisher_dissemination: Georg Thieme

ReferenceCitation: Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quere I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.

lead_sponsor: University Hospital, Grenoble

collaborators: SFMV (Société Française de Médecine Vasculaire)

location_country: Guadeloupe Belgium France

location_facility: Office-based Specialist in vascular medecine

location_facility: University Hospital ND des Bruyeres Liege

intervention_type: Other

status_simplified: Completed


type: Other Grant/Funding Number

title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

summary: The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

status: Recruiting

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
University Hospital, Lille
National Cancer Institute, France
University Hospital, Montpellier

location_facility: Centre Aliénor d'Aquitaine, Hôpital Pellegrin

intervention_type: Procedure

status_simplified: Ongoing


acronym: AGADIR

summary: Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

sponsor_collaborators:
Institut Bergonié
Roche Pharma AG
National Cancer Institute, France
Seven and Eight Biopharmaceuticals Inc

location_facility:
Institut Bergonié
Centre Georges François Leclerc
Chu Brest
IUCT Oncopôle
CHU Poitiers
Hôpital La Timone
Centre Oscar Lambret
Centre Eugène Marquis
Centre François Baclesse
Institut Paoli Calmettes
Institut Curie

title: Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

source: euctr


lead_sponsor: Kyowa Kirin, Inc.

summary: The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).

location_facility: Hospital Universitario Professor Edgard Santos- UFBA

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

location_facility: Washington University School of Medicine

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: University of Miami / Sylvester Comprehensive Cancer Center

title: Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

location_country:
United Kingdom
Brazil
Belgium
United States
Peru
France


title: Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients With Unprovoked Venous Thromboembolism

summary:
Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost issue for patients who want to know if an underlying cancer might have triggered the VTE.

An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).

primary_purpose: Screening

ReferenceCitation: Robin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8.

ReferenceCitation: Carrier M, Lazo-Langner A, Shivakumar S, Tagalakis V, Zarychanski R, Solymoss S, Routhier N, Douketis J, Danovitch K, Lee AY, Le Gal G, Wells PS, Corsi DJ, Ramsay T, Coyle D, Chagnon I, Kassam Z, Tao H, Rodger MA; SOME Investigators. Screening for Occult Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704. doi: 10.1056/NEJMoa1506623. Epub 2015 Jun 22.

ReferenceCitation: van Es N, Le Gal G, Otten HM, Robin P, Piccioli A, Lecumberri R, Jara-Palomares L, Religa P, Rieu V, Rondina M, Beckers MM, Prandoni P, Salaun PY, Di Nisio M, Bossuyt PM, Buller HR, Carrier M. Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data. Ann Intern Med. 2017 Sep 19;167(6):410-417. doi: 10.7326/M17-0868. Epub 2017 Aug 22.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

collaborators: Canadian Institutes of Health Research (CIHR)

location_country: Canada France

location_facility:
Hôpital Européen Georges Pompidou
Sunnybrook Research Institute
University of Manitoba
Ottawa Hospital Research Institute
McGill University Health Centre
McMaster University
Hôpital Saint Musse - CH Toulon
CHU de Dijon
CHU Saint-Etienne
CHU Angers
University of Calgary
Brest University Hospital
CH Agen
London Health Sciences Centre
CHU de Clermont-Ferrand
CH des Pays de Morlaix
CHU de Limoges
Jewish General Hospital
University Health Network
Hopital Montfort

intervention_type: Diagnostic Test

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

titre: Intérêt de la Tomographie par Emission de Positons au 18F-fluorodeoxyglucose dans le dépistage du cancer chez les patients atteints de maladie veineuse.

discipline_principale: médecine vasculaire

nom_porteur: SALAUN

prenom_porteur: Pierre-Yves


title: A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.

summary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.

lead_sponsor: AstraZeneca

location_country:
United States
United Kingdom
France


title: A Double-blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone

summary: This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

ReferenceCitation: Schrader J, Salvetti A, Calvo C, Akpinar E, Keeling L, Weisskopf M, Brunel P. The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg. Int J Clin Pract. 2009 Feb;63(2):217-25. doi: 10.1111/j.1742-1241.2008.01977.x.

lead_sponsor: Novartis Pharmaceuticals

location_country: Finland Germany Italy Ecuador Argentina Norway Sweden Switzerland Spain Turkey Chile France

location_facility:
sites in France
sites in Finland
sites in Spain
sites in Chile
sites in Italy
sites in Argentina
sites in Ecuador
sites in Switzerland
sites in Norway
sites in Turkey
sites in Sweden
sites in Germany


title: Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

acronym: CREMS-HF

summary: The purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.

primary_purpose: Supportive Care

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
Gulf Estuarine Research Society (GERS)
Bourgogne Association of Cardiology
Ile-de-France Association of Cardiology

location_facility: Hôpital de jour de soins de suite et de réadaptation Léopold Bellan

location_facility: Centre de réadaptation cardiaque Leopold Bellan

location_facility: Centre de réadaptation spécialisé Saint Luc

location_facility: Hôpital Intercommunal Sud Léman Valserine

intervention_type: Device


title: Cancer of the Upper Aero-digestive Tract and Socio-professional Future

acronym: CARDEL

summary: The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.

sponsor_collaborators:
Centre Oscar Lambret
University Lille 3
Région Nord-Pas de Calais, France
University Hospital, Lille

location_facility:
Hôpital privé de l'Estuaire
CHU de Caen
Centre Antoine Lacassagne
CHRU de Lille
Centre Oscar Lambret
CHU de Rouen
Hôpital de la Timone
Centre François Baclesse

intervention_type: Behavioral


title: Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.

acronym: LYNCH-CHROMO

summary: This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome

primary_purpose: Diagnostic

ReferenceCitation: Cellier C, Perrod G, Colas C, Dhooge M, Saurin JC, Lecomte T, Coron E, Rahmi G, Savale C, Chaussade S, Bellanger J, Dray X, Benech N, Le Rhun M, Barbieux JP, Pereira H, Chatellier G, Samaha E. Back-to-Back Comparison of Colonoscopy With Virtual Chromoendoscopy Using a Third-Generation Narrow-Band Imaging System to Chromoendoscopy With Indigo Carmine in Patients With Lynch Syndrome. Am J Gastroenterol. 2019 Oct;114(10):1665-1670. doi: 10.14309/ajg.0000000000000386.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ARC Foundation for Cancer Research

location_facility: AP-HP - Hôpital Européen Georges-Pompidou


lead_sponsor: Pierre Fabre Medicament

summary:
Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.

The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.

location_facility: Lithuania Poland Romania Estonia France

title: Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.

location_country: Lithuania Poland Romania Estonia France


title: Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

summary:
Primary Objective:

To explore associations between biomarkers of atopic dermatitis (AD) and:

Disease state and time course of AD,
Disease state and evolution of selected atopic comorbid conditions,
Effectiveness of specific AD treatments.

status: Active, not recruiting

lead_sponsor: Sanofi

location_country:
Colombia
Argentina
Australia
Brazil
Netherlands
Mexico
United States
Spain
Canada
France

location_facility:
Investigational site Brazil
investigational site Netherlands
investigational site Colombia
Investigational site Spain
Investigational Site United States
Investigational site Australia
Investigational site Mexico
Investigational site Argentina
Investigational site Canada
investigational site France


summary: The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

location_facility:
Sites in Belgium
Sites in France
Sites in Sweden
Sites in Germany
Sites in Italy
Sites in USA
Sites in Hungary
Sites in India
Sites in Poland
Sites in Turkey
Sites in Slovakia

title: A Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension

location_country:
Germany
Italy
Poland
India
Slovakia
Hungary
Sweden
Belgium
United States
Turkey
France


title: Combination of Baricitinib and Anti-TNF vs. Baricitinib in Patients With Rheumatoid Arthritis: a Randomized Placebo-controlled Phase III Trial

acronym: CRI-RA

summary:
As stated by the European League Against Rheumatism (EULAR) and the Société Française de Rhumatologie (SFR), treatment of patients with rheumatoid arthritis (RA) should target sustained remission or at least low disease activity. However, despite significant advances based on various combinations of conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic DMARDs, RA therapies meet treatment goals only in some patients:

40 to 50% of patients with early RA, treated with methotrexate (MTX) monotherapy as first-line therapy,
20 to 30% of patients treated with a combination of MTX and biologic as second-line therapy.
Less than 10% of patients treated with a combination of MTX and another targeted DMARD, such as baricitinib, as third-line therapy.

Therefore, new strategies targeted at achieving a higher percentage of remission are needed, that do not require waiting for multiple failed therapies. Combinations of biologics have shown synergistic improvement of symptoms in murine models of RA relative to the improvement observed with either agent alone. However, in RA patients, only five randomised clinical trials (RCTs) have explored the efficacy and safety of combining tumour necrosis factor (TNF) inhibitor with another biologic (anakinra, abatacept, rituximab or bimekizumab).

Baricitinib is a selective, reversible and competitive inhibitor of Janus kinases (Jaki). This treatment is efficient in a number of therapeutic scenarios in RA and showed a clinical superiority over adalimumab in one RCT (RA-BEAM study in MTX inadequate responders). Of note, baricitinib inhibits many of the pro-inflammatory cytokines involved in the pathogenesis of RA but does not block signalling downstream of TNF. Owing to the interest in combining different mechanisms of action, the investigators plan to assess the efficacy and safety of combination therapy with baricitinib and a TNF inhibitor. The investigators are aware that combining targeted therapies is not recommended due to a potential increase in the frequency of serious adverse events. However, several case series on patients treated with a combination of targeted therapies have been published, suggesting a certain efficacy in patients with refractory RA. The first ones focused on inflammatory bowel diseases and psoriasis, but more recently, combination of tofacitinib (which belongs to the same Jaki family as baricitinib) with various biologics has been reported in a sample of RA patients. No serious adverse effects were reported over a mean of approximately 11 months of therapy. The clinical improvement was mild but noticeable in these refractory RA cases.

Recently, data of interest from the RA-BEAM study have been reported. Patients who switched from adalimumab to baricitinib showed improvements in disease control. Because the switch from adalimumab to baricitinib occurred without a washout period, and because adalimumab has a mean circulating half-life of approximately 14 days, patients would have received several weeks of dual TNF and Jak1/Jak2 inhibition in the course of the change of treatment. The observation of increased efficacy, with no apparent acute safety issues during the weeks when patients were exposed to both adalimumab and baricitinib, is of interest, and supports our strategy to combine the two treatments for patients with refractory RA.

The investigators consider that there is a need for investigation into the addition of anti-TNF to baricitinib in patients suffering of refractory RA (inadequate response to TNF inhibitors). The investigators hypothesize that in this population, based on ACR50 score, this combination therapy will decrease disease activity more efficiently than a switch to another targeted DMARD, such as baricitinib.

lead_sponsor: University Hospital, Bordeaux

collaborators: Ministry for Health and Solidarity, France

location_country: Monaco France

location_facility: CHU de Toulouse - service de rhumatologie

location_facility: CHU de Montpellier - service de rhumatologie

location_facility: AP-HP - Hôpital Bichat - service de rhumatologie

location_facility: AP-HP - Hôpital La Pitié-Salpetrière - service de rhumatologie

location_facility: CH de la Côte Basque - service de rhumatologie

location_facility: Clinique de l'Infirmerie - service de rhumatologie

location_facility: service de Rhumatologie - CH Princesse Grace

location_facility: CHRU de Strasbourg - service de rhumatologie

location_facility: Nouvel Hôpital Orléans La Source - service de rhumatologie

location_facility: CHU de Saint-Etienne- service de rhumatologie

location_facility: CHU de Clermont-Ferrand - service de rhumatologie

location_facility: CH de Saint-Malo - service de rhumatologie

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille - service de rhumatologie

location_facility: AP-HP - Hôpital Kremlin-Bicêtre - service de rhumatologie

location_facility: AP-HP - Hôpital Cochin - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

location_facility: Polyclinique de Limoges - service de rhumatologie

location_facility: Hôpital Saint-Joseph - service de rhumatologie

location_facility: AP-HP - Hôpital Saint-Antoine - service de rhumatologie

location_facility: Hospices Civils de Lyon - service de rhumatologie

appel_a_projets: PHRCN

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: CRI-RA

titre: Efficacité et tolérance de la combinaison tofacitinib/adalimumab vs. tofacitinib seul dans le traitement de la polyarthrite rhumatoïde: essai clinique randomisé de phase 3

discipline_principale: rhumatologie

nom_porteur: Richez

prenom_porteur: Christophe


title: Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV: The ANRS CO3 Aquitaine Cohort - AquiVIH-NA

acronym: AquiVIH-NA

summary:
HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are largely available. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects.

The main objective of the cohort is to describe and study the evolution of HIV infection in ART-treated individuals.

ReferenceCitation: Barger D, Hessamfar M, Neau D, Vareil MO, Lazaro E, Duffau P, Rouanes N, Leleux O, Le Marec F, Erramouspe M, Wittkop L, Dabis F, Bonnet F. Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study. Health Qual Life Outcomes. 2020 Jul 10;18(1):220. doi: 10.1186/s12955-020-01451-8.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

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

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

ReferenceCitation: Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Wittkop L, Dabis F, Bonnet F. Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation. JMIR Form Res. 2019 Dec 18;3(4):e15013. doi: 10.2196/15013.

version: submittedVersion

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: JMIR Publications

ReferenceCitation: Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Dabis F, Bonnet F. Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study. JMIR Res Protoc. 2018 Jun 7;7(6):e147. doi: 10.2196/resprot.9439.

collaborators: National Agency for Research on AIDS and Viral Hepatitis (ANRS)

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

collaborators: French Ministry of Health through the COREVIH Aquitaine

location_facility: service de médecine interne - CH de Libourne

location_facility: service de médecine interne - CH d'Arcachon

location_facility: service de médecine inter et maladies infectieuses - Hopital Saint André

location_facility: service de médecine interne et maladies infectieuses - CH de Périgueux

location_facility: service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

location_facility: Médecine interne et Maladies Infectieuses - CHU de Poitiers

location_facility: service de maladies infectieuses - CH de la Côte Basque

location_facility: service de médecine interne et maladies infectieuses - CH de Pau

location_facility: service de médecine interne et maladies infectieuses - Groupe hospitalier Sud

location_facility: service de médecine interne et maladies infectieuses - CH de Dax

location_facility: service de médecine interne - CH de Mont de Marsan

location_facility: service de médecine interne et maladies infectieuses - Hôpital Saint-André

location_facility: service de médecine interne - CH d'Orthez

location_facility: Médecine Interne - CH de Saint-Jean-D'Angely

location_facility: service de maladies infecteieuses - CH Saint-Cyr


title: Title Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients - ACTI-PAIR 2 Multicenter, Randomized Stepped-wedge Study

summary:
Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active.

Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence.

Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care.

Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity.

However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity.

This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients:

1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers)
2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up
3-Support by health professionals (attending physician) through the prescription of physical activity.

The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.

ReferenceCitation: Bonn SE, Sjolander A, Lagerros YT, Wiklund F, Stattin P, Holmberg E, Gronberg H, Balter K. Physical activity and survival among men diagnosed with prostate cancer. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):57-64. doi: 10.1158/1055-9965.EPI-14-0707. Epub 2014 Dec 19.

ReferenceCitation: Richman EL, Kenfield SA, Stampfer MJ, Paciorek A, Carroll PR, Chan JM. Physical activity after diagnosis and risk of prostate cancer progression: data from the cancer of the prostate strategic urologic research endeavor. Cancer Res. 2011 Jun 1;71(11):3889-95. doi: 10.1158/0008-5472.CAN-10-3932. Epub 2011 May 24.

ReferenceCitation: Phillips SM, Stampfer MJ, Chan JM, Giovannucci EL, Kenfield SA. Physical activity, sedentary behavior, and health-related quality of life in prostate cancer survivors in the health professionals follow-up study. J Cancer Surviv. 2015 Sep;9(3):500-11. doi: 10.1007/s11764-015-0426-2. Epub 2015 Apr 16.

ReferenceCitation: Steindorf K, Depenbusch J, Haussmann A, Tsiouris A, Schmidt L, Hermann S, Sieverding M, Wiskemann J, Ungar N. Change patterns and determinants of physical activity differ between breast, prostate, and colorectal cancer patients. Support Care Cancer. 2020 Jul;28(7):3207-3218. doi: 10.1007/s00520-019-05097-1. Epub 2019 Nov 13.

ReferenceCitation: Blaney JM, Lowe-Strong A, Rankin-Watt J, Campbell A, Gracey JH. Cancer survivors' exercise barriers, facilitators and preferences in the context of fatigue, quality of life and physical activity participation: a questionnaire-survey. Psychooncology. 2013 Jan;22(1):186-94. doi: 10.1002/pon.2072. Epub 2011 Oct 6.

ReferenceCitation: Livingston PM, Craike MJ, Salmon J, Courneya KS, Gaskin CJ, Fraser SF, Mohebbi M, Broadbent S, Botti M, Kent B; ENGAGE Uro-Oncology Clinicians' Group. Effects of a clinician referral and exercise program for men who have completed active treatment for prostate cancer: A multicenter cluster randomized controlled trial (ENGAGE). Cancer. 2015 Aug 1;121(15):2646-54. doi: 10.1002/cncr.29385. Epub 2015 Apr 15.

ReferenceCitation: Tudor-Locke C, Lauzon N, Myers AM, Bell RC, Chan CB, McCargar L, Speechley M, Rodger NW. Effectiveness of the First step Program delivered by professionals versus peers. J Phys Act Health. 2009 Jul;6(4):456-62. doi: 10.1123/jpah.6.4.456.

ReferenceCitation: Buman MP, Giacobbi PR Jr, Dzierzewski JM, Morgan AA, McCrae CS, Roberts BL, Marsiske M. Peer Volunteers Improve Long-Term Maintenance of Physical Activity With Older Adults: A Randomized Controlled Trial. J Phys Act Health. 2011 Sep;8(s2):S257-S266. doi: 10.1123/jpah.8.s2.s257.

ReferenceCitation: Pinto BM, Stein K, Dunsiger S. Peers promoting physical activity among breast cancer survivors: A randomized controlled trial. Health Psychol. 2015 May;34(5):463-72. doi: 10.1037/hea0000120. Epub 2014 Aug 11.

ReferenceCitation: Galvao DA, Newton RU, Girgis A, Lepore SJ, Stiller A, Mihalopoulos C, Gardiner RA, Taaffe DR, Occhipinti S, Chambers SK. Randomized controlled trial of a peer led multimodal intervention for men with prostate cancer to increase exercise participation. Psychooncology. 2018 Jan;27(1):199-207. doi: 10.1002/pon.4495. Epub 2017 Jul 27.

ReferenceCitation: Baudot A, Barth N, Colas C, Garros M, Garcin A, Oriol M, Roche F, Chauvin F, Mottet N, Hupin D; on behalf the Acti-Pair investigators. The physical activity experience of prostate cancer patients: a multicentre peer motivation monitoring feasibility study. The Acti-Pair study. Pilot Feasibility Stud. 2022 Jan 21;8(1):12. doi: 10.1186/s40814-022-00966-9.

collaborators: Sport Health Center of Auvergne-Rhône Alpes

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Activité Physique Adaptée - CDOS Ardèche


title: The MOVE-study: Morning Versus Evening Administration of 500 mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma

summary:
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

ReferenceCitation: Bateman ED, Bousquet J, Aubier M, Bredenbroker D, O'Byrne PM. Roflumilast for asthma: Efficacy findings in non-placebo-controlled comparator and dosing studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S11-9. doi: 10.1016/j.pupt.2015.10.002. Epub 2015 Oct 8.

location_country:
Australia
Belgium
Spain
South Africa
France


title: Multicentre Trial, With Stepped Wedge Randomized Controled Clusters, on Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

summary: This medico-economic research project (PRME) aim to analyse NeLLY service efficiency for not on dialysis severe chronic kidney disease (DFG < 30ml/mn) patients care. NeLLY is a service that includes telemonitoring, educational therapy and support for patients with severe chronic kidney disease.

study_start_date_type: Anticipated

primary_purpose: Health Services Research

lead_sponsor: Calydial

sponsor_collaborators:
Calydial
Hospices Civils de Lyon

location_facility: Centre hospitalier Saint Joseph Saint Luc

appel_a_projets: PRME

region: Auvergne-Rhône-Alpes

nom_etablissement: CALYDIAL - IRIGNY

type_etablissement: EBNL

acronyme: NeLLY

titre: Impact médico économique du service NeLLY pour la Maladie Rénale Chronique sévère non dialysée

discipline_principale: néphrologie

nom_porteur: Caillette-Beaudoin

prenom_porteur: Agnes


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited

location_facility:
Germany
Ohio
Missouri
Canada
France
Florida
Texas
Michigan
Maryland
Colorado
South Carolina
New York
New Mexico
North Carolina
Massachusetts
Virginia
Puerto Rico
California
Alabama
Georgia

title: EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

location_country:
Germany
United States
Canada
Puerto Rico
France


title: Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

acronym: Cough-IPF

summary: In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice. The hypothesis is that Pirfenidone will decrease cough and increase quality of life.

lead_sponsor: Erasmus Medical Center

collaborators: Royal Brompton & Harefield NHS Foundation Trust

location_country: Italy Netherlands France

location_facility: University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel

location_facility: Erasmus MC Rotterdam, Dep. of Pulmonology

location_facility: Regional Centre for Rare Lung Disease University of Catania.


type: Registry Identifier

title: Nasal High Flow in Early Management of Patients Admitted to the Emergency Department for Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis : a Randomized Controlled Non Inferiority Study

acronym: HiCOPD

summary: The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.

status: Not yet recruiting

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Fisher and Paykel Healthcare

location_facility: Centre hospitalier universitaire de Nimes

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre hospitalier universitaire de Montpellier


title: Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment

summary: The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month after intervention.

lead_sponsor: Aesthetic Group

sponsor_collaborators:
Aesthetic Group
EVAMED

location_facility:
Clinique Eiffel
Clinique Pasteur
Clinique Phenicia


title: Evaluation of the Change in Caloric Intake Before and 12 Months After the Initiation of Treatment With Elexacaftor/Tezacaftor/Ivacaftor, in Patients With Cystic Fibrosis.

acronym: NUTRIMUCO

summary: The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

lead_sponsor: University Hospital, Toulouse

location_facility: UHBordeaux UHLimoges UHToulouse


title: Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.

summary: Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Clermont-Ferrand
Polyclinique Urbain V
CHU de Saint-Étienne


title: Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies

acronym: iMonitORL

summary:
Epidermoid Carcinoma of the Upper Aerodigestive Tract (CEVADS) is the 6th most common cancer worldwide. Despite current therapies (radiotherapy, surgery and chemotherapy), cancers of the Upper Aerodigestive Tract (UAT) have a poor prognosis, with a 10-year survival rate of no more than 20%.

For recurrent or metastatic CEVADS, the therapeutic arsenal, based for many years on chemotherapy and anti-EGFR (Epidermal Growth Factor Receptor) agents, has been enriched by a new therapeutic class: PD-1 inhibitors. For CEVADS, PD-1 inhibitors have been approved for second-line treatment of nivolumab for over a year, and are now used in first-line treatment of pembrolizumab.

The results of this therapeutic class in CEVADS are not as spectacular as for melanoma or bronchial cancer. Indeed, only 20% of patients have a favorable response, compared with half who experience disease progression. This low proportion of responders can be explained by tumor heterogeneity within CEVADS and poor patient selection.

The only marker used to select patients is PD-L1 expression detected by ImmunoHistochemistry (IHC). However, it seems that this marker, described as imperfect, is still little explored in ENT. It needs to be compared with the expression of other cell lines in the tumor microenvironment, which could play an important role in resistance to PD-1 inhibitors.

IHC identifies all macrophages using the CD68 marker, while the CD163 marker is specific to M2 macrophages.

Other targets in the microenvironment are also being investigated, with the discovery of a Tertiary Lymphocyte Structure (TLS) in melanoma treated with immunotherapy.

It therefore seems necessary to gain a better understanding of the mechanisms of tumor progression under immunotherapy in order to develop strategies to optimize response to treatment. This would enable better selection of patients likely to benefit from immunotherapy, and open up prospects for therapeutic combinations.

The hypothesis is that macrophages, but also other cells and factors in the CEVADS microenvironment, play a decisive role in resistance to PD-1 inhibitors. The aim is therefore to continue these macrophage analyses, extend them to other cells in the microenvironment and link them to other prognostic factors under investigation.

A prospective study will analyze tumor tissue during treatment with PD-1 inhibitors, in order to correlate all the factors studied with response or resistance to immunotherapies.

In addition, the oral microbiota, in the lineage of the intestinal microbiota, has been shown to be highly stable over time and to play a role in the oncogenesis of certain cancers, notably CEVADS. Like the intestinal microbiota, it could also represent a prognostic factor in the response to immunotherapies.

Of all the bacteria in this oral microbiota, one has been shown to play a major role: Fusobacterium nucleatum (F. nucleatum). However, little is known about the mechanism of action of intratumoral F. nucleatum on the development of CEVADS. In particular, it is thought to play a role in local cancer immunity, via macrophages, regulatory T cells (Tregs) and TLRs. Finally, it appears that specific antimicrobial T-cell responses may cross-react with tumor antigens, hence the importance of also analyzing the metabolome of commensal bacteria.The aim of this study was to evaluate the evolution of the presence of this bacterium in saliva, as well as the specific immune response to F. nucleatum in patients with CEVADS during immunotherapy treatment.

primary_purpose: Other

ReferenceCitation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

ReferenceCitation: Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ; KEYNOTE-040 investigators. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156-167. doi: 10.1016/S0140-6736(18)31999-8. Epub 2018 Nov 30. Erratum In: Lancet. 2019 Jan 12;393(10167):132.

ReferenceCitation: Leemans CR, Snijders PJF, Brakenhoff RH. The molecular landscape of head and neck cancer. Nat Rev Cancer. 2018 May;18(5):269-282. doi: 10.1038/nrc.2018.11. Epub 2018 Mar 2. Erratum In: Nat Rev Cancer. 2018 Oct;18(10):662.

ReferenceCitation: Evrard D, Hourseau M, Couvelard A, Paradis V, Gauthier H, Raymond E, Halimi C, Barry B, Faivre S. PD-L1 expression in the microenvironment and the response to checkpoint inhibitors in head and neck squamous cell carcinoma. Oncoimmunology. 2020 Nov 19;9(1):1844403. doi: 10.1080/2162402X.2020.1844403.

ReferenceCitation: Wondergem NE, Nauta IH, Muijlwijk T, Leemans CR, van de Ven R. The Immune Microenvironment in Head and Neck Squamous Cell Carcinoma: on Subsets and Subsites. Curr Oncol Rep. 2020 Jun 29;22(8):81. doi: 10.1007/s11912-020-00938-3.

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Hôpital Bichat
Hôpital Saint-Louis
Hôpital Saint-Joseph


title: Subsequent Bevacizumab Treatment in Patients With HHT After the End of BABH Interventional Study. A Descriptive Study.

acronym: BEST

summary:
Bevacizumab is widely prescribed for the treatment of severe bleeding related to epistaxis or gastrointestinal bleeding in HHT.

We studied the efficacy of bevacizumab on severe bleeding in HHT patients in a randomized study recently published (NCT03227263, J Int Med 2023). In this study, 24 patients were included, 12 patients received bevacizumab and 12 patients received placebo. The duration of patient participation was 6 months, including the 2.5-month treatment period and 3.5 month follow-up after treatment.

We describe the evolution of the number of RBC transfused in HHT patients who received bevacizumab during the year after the end of the study.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers


title: Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome

acronym: FREESCA

summary:
Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance.

Hyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes.

Metabolically, several situations can be distinguished:

Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c < 6.5%).
Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement).

To our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM.

Published studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements.

The freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.

Our hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.

location_facility:
University Hospital of Montpellier
Hospital of Pau
Hospital of Béziers


title: Moving While Thinking or Thinking While Moving? Comparison of the Cognitive, Dual-task and Physical Effects of 6 Programs With Older Adults

summary:
While the association of physical and/or motor and/or cognitive components with training can generate synergistic effects and thus create an efficient cognitive enrichment program, very few studies have focused on finding an optimal combined program for older adults. According to the model of Herold and his colleagues, there are two modalities of simultaneous combined training: Thinking While Moving (TwM), when the additional cognitive task is not linked to the motor task, and Moving While Thinking (MwT), when the cognitive task is integrated into the motor task. They assume the latter approach is the most promising for improving cognitive reserve. Nevertheless, to the investigators' knowledge, only one study has compared these two modalities in older adults and none has broadened the question by comparing several MwT trainings.

The goal of this interventional study will be to compare the cognitive, dual-task, and physical effects of 6 physical and/or cognitive programs in healthy but inactive older adults. The main questions it will aims to answer are:

Will the Moving While Thinking and Thinking While Moving programs have the same effects?
If they have different effects, which will be the best way to improve cognitive, dual-task, and physical functions? The study is being set up between 2023 and 2025 to compare the cognitive, dual- ask and physical effects of 6 programs (3 months, 2 sessions of 1 hour per week). Three experimental MwT programs will be studied: Immersive and interactive wall exergames (I2WE), Complex Cognitive and Motor Activities (2CMA), and exergames with Switch (EXER). They will be compared to an experimental TwM program of stationary bike simultaneous to the Switch (Video games + bike) and 2 control programs: inactive video games (VG) and stationary bike (BIKE). A control group (CON) will be also created.

Cognitive, dual-task, and physical pre-tests (before the program), post-tests (after the program), and retention tests (3 months after the end of the program) will be realized to evaluate the effects of the programs.

ReferenceCitation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

ReferenceCitation: de Souto Barreto P. Construct and convergent validity and repeatability of the Questionnaire d'Activite Physique pour les Personnes Agees (QAPPA), a physical activity questionnaire for the elderly. Public Health. 2013 Sep;127(9):844-53. doi: 10.1016/j.puhe.2012.10.018. Epub 2012 Nov 10.

ReferenceCitation: Eggenberger P, Schumacher V, Angst M, Theill N, de Bruin ED. Does multicomponent physical exercise with simultaneous cognitive training boost cognitive performance in older adults? A 6-month randomized controlled trial with a 1-year follow-up. Clin Interv Aging. 2015 Aug 17;10:1335-49. doi: 10.2147/CIA.S87732. eCollection 2015.

ReferenceCitation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

ReferenceCitation: Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822-9. doi: 10.1097/mss.0b013e31803349c6.

ReferenceCitation: Herold F, Hamacher D, Schega L, Muller NG. Thinking While Moving or Moving While Thinking - Concepts of Motor-Cognitive Training for Cognitive Performance Enhancement. Front Aging Neurosci. 2018 Aug 6;10:228. doi: 10.3389/fnagi.2018.00228. eCollection 2018.

ReferenceCitation: Kraft E. Cognitive function, physical activity, and aging: possible biological links and implications for multimodal interventions. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(1-2):248-63. doi: 10.1080/13825585.2011.645010.

lead_sponsor: Alexandra Perrot

sponsor_collaborators:
Alexandra Perrot
Université Paris Cité

location_facility:
UFR STAPS Paris Cité
Club seniors Kennedy
Centre Sportif Arthur Ashe


title: Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)

acronym: QUAPSY

summary:
This is an observational, prospective multicentric study designed to develop medical knowledge.

The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb amputee patients.

The questionnaire is administered twice to each patient, once during the consultation and again when they return home. Patients also undergo a 6-minute walk test.

lead_sponsor: FondationbHopale

location_facility:
CHRU Lille - Hôpital Swynghedauw
Institut Calvé
CRF les HAUTOIS- CRO


title: SatisfACtion: A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With Heavily Pre-treated PSMA Positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy.

summary: The purpose of the study is to characterize the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of 225Ac-PSMA-R2 in male adult participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor pathway inhibitors in post-177Lu and pre-177Lu settings.

lead_sponsor: Novartis Pharmaceuticals


title: Sleep-4-all-2.0 Study: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia - A Prospective Real-life Study

summary: Determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional)

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy
Centre Léon Bérard
Institut de Cancérologie de Montpellier


title: Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

acronym: SinocaRT

summary:
The patient is randomized to one of the following groups:

Experimental group: IMRT in painting dose on histoscannographic mapping
Control group: standard pan-sinus IMRT

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Oscar Lambret
CHU CAEN
Centre Francois Baclesse

intervention_type: Radiation


title: Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock.

acronym: Woodstock

summary:
The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.

In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.

The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.

This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.

lead_sponsor: Centre Hospitalier de Lens

sponsor_collaborators:
Centre Hospitalier de Lens
University Hospital, Lille

location_facility:
CHU Lille
Ch Germon Et Gauthier
CHU de Dijon


title: Ferroptosis Study in SF3B1-mutant Myelodysplastic Syndromes (FerMDS)

acronym: FerMDS

summary: Myelodysplastic syndromes (MDS) are clonal diseases of hematopoietic stem cells (HSC) characterized by dysplastic and inefficient hematopoiesis related to excessive progenitor cell death. Ferroptosis is a recently described cell death mechanism and we think that it could be a major player in the pathophysiology of MDS, involved in the cell death that characterizes these diseases and contributing to cytopenias. The study aims to demonstrate that there is a significant activation of this phenomenon in MDS patients compared to a population of subjects without MDS.

location_facility: CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire

location_facility: CHU de Bordeaux, Service de Médecine Interne

location_facility: CHU de Bordeaux, Laboratoire d'Hématologie


title: Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease

acronym: GliSyn

summary:
This study aims to analyse, in vivo, the interplay between microglial activation and tau pathology in Alzheimer's disease (AD) using [18F]-DPA-714 and [18F]-Ro948 tracers by Position Emission Tomography (PET), and their consequences on synaptic density using [11C]-UCB-J, a recent PET radioligand.

By coupling advanced neuroimaging techniques in AD patients, while comparing them to controls, we will be able to study, for the first time in humans, the interaction between neuroinflammation, tau pathology, synaptic density, and their impact on AD progression. Joint analyses of peripheral immune biomarkers, carried out as a secondary objective, will further aim at defining peripheral correlates of this interplay.

Overall, we aim to refine AD subgroup classification in order to improve and to refine the design of new therapeutic trials.

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
Roche Pharma AG

location_facility: GHU Saint Anne Psychiatrie & Neurosciences


title: Contribution of an Antiviral Drug (Valaciclovir) in the Treatment of Generalized Periodontitis (Stage III or IV and Grade A, B or C): Prospective, Randomized and Double Blind Clinical Trial

acronym: HERPARO

summary:
Periodontitis is an inflammatory pathology that destroys periodontitis and causes tooth loosening. Its high incidence, combined with very high oral and systemic morbidity, places this pathology at the heart of global public health priorities. The current therapeutic management of periodontitis is not satisfactory because it often leads to a stabilization of the disease, marked by frequent recurrences, especially severe forms. Improving the treatment of patients with periodontitis is therefore an essential priority.

If gingival bacterial dysbiosis is a major contributing factor, this model has clinical-biological limitations that suggest that other etiological factors are involved, and worsen the pathology. In particular, the literature provides clear evidence that periodontal lesions are mostly infected with Herpes EBV, CMV and HSV-1 viruses and that periodontal infection with these viruses is very directly correlated with disease progression (severity). In addition, our work provides new cellular and molecular data that demonstrate mechanisms of active EBV infection of cells and periodontal structures, and highlight inflammatory and necrotic effects associated with this infection. Given these observations and the high pathogenicity of herpes viruses, all known to be powerful inflammatory, lytic and immunomodulatory agents, it seems difficult not to evoke a direct etiopathogenic role of these viruses capable of acting synergistically with periodontopathogenic bacteria.

In this context, the use of an antiviral appears as a very attractive therapeutic proposal to effectively treat periodontitis in combination with conventional treatments. This original and innovative proposal can also be easily and quickly validated in a randomized therapeutic trial through the availability of antiviral molecules that are non-toxic and very specific to human herpes viruses that are derivatives of aciclovir.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
APHM
CHU de Rennes


title: Evaluation of the Diagnostic Performance of 4 Dynamic Tests Evaluating Preload Dependence in Patients With Acute Respiratory Distress Syndrome in the Prone Position

acronym: PROLOAD

summary:
Predicting fluid responsiveness is primordial when caring for patients with circulatory shock as it allows correction of preload-dependent low cardiac output states, while preserving patients of the deleterious effects of excessive fluid resuscitation.

Patients with severe acute respiratory distress syndrome (ARDS) treated with prone positioning (PP) are a specific subset of patients, as 1) they frequently present with shock; 2) excessive fluid administration may lead to respiratory worsening due to increased hydrostatic oedema with potential subsequent worse clinical outcome; and 3) all available dynamic tests evaluating fluid responsiveness can only be performed in patients in the supine condition (which in the case of severe ARDS patients in PP occurs only for 8h over 24h). These elements warrant the development of specific tests allowing the clinician to predict fluid responsiveness with enough exactitude when caring for these patients.

We hypothesize that there exists diagnostic heterogeneity in the predictive performance of 4 clinical tests to identify fluid responsiveness in ARDS patients in PP. For the matter of this study, these 4 tests are the Trendelenburg maneuver, the end-expiratory occlusion test, the end-expiratory occlusion test associated with the end-inspiratory occlusion test, and the tidal volume challenge. The diagnostic reference of the study will be the relative change in cardiac index measured by transpulmonary thermodilution before and after a 500 ml fluid bolus, and will allow the adjudication of patients as being fluid responsive or not.

The primary objective of the study is to determine the area under the ROC curve of each of the 4 tests, with their respective 95% confidence interval.

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. Patients will only participate once. The expected duration of study participation is 30 minutes maximum.

location_facility: Hôpital de la Croix Rousse, Hospices Civils de Lyon


title: Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department

acronym: IMMEDIAT

summary: The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone standard X-rays prescibed by the ED.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Saint Antoine
Hôpital Tenon
Hôpital Salpétrière


title: Predictive Factors Associated With Continued Driving in Old Age : a Mixed Methods Approach

summary:
The goal of this observational study is to learn about predictors associated with maintaining driving in old age. The main questions it aims to answer are :

which and how medical factors can influence stopping or maintaining driving (quantitative research)
how social environment can influence stopping or maintaining driving (quantitative research)
what are the needs of all the actors in the field (qualitative research)
know about the opinions and practices of all the actors in the field (qualitative research) Participants will be ask to answer questions in an interview taking about an hour. Quantitative research will ask participants to fill out a questionnaire about social environment.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Centre de Recherche Hospitalier Universitaire de Marseille

location_facility:
Nathalie Barth
François Puisieux
Sylvie Bonin-Guillaume


title: Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

summary:
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.

The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Tours Regional University Hospital (Bretonneau)


title: Airway Occlusion Pressure (P0.1) to Predict Extubation Failure in Critically Ill Patients: A Prospective Cohort Study

summary:
Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). EF is associated with prolonged MV, as well as increased morbidity and mortality (2). Therefore, the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes.

EF can result from different factors (respiratory, metabolic, neuromuscular), particularly cardiac factor, and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load (1,3).

Respiratory drive represents the intensity of the neural stimulus to breathe. In mechanically ventilated patients, it can be abnormally low (i.e., suppressed or insufficient) or abnormally high (i.e., excessive), and thus result in excessively low or high inspiratory effort, leading to potential injury to the respiratory muscles (i.e., myotrauma) (4,5) or to the lungs. A high incidence of abnormal drive (low or high) may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation (6).

Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (7). P0.1 measurement is not perceived by the patient and does not influence respiratory pattern. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics (8). P0.1 has also been correlated with inspiratory effort (9, 10) and it has been shown that in patients under assisted mechanical ventilation P0.1 might be able to detect potentially excessive inspiratory effort (11).

P0.1 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it. Originally, a high P0.1 during a spontaneous breathing trial was associated with failure, suggesting that a high respiratory drive could predict weaning failure. However, only a few and old clinical studies investigated the association between P0.1 and extubation failure (EF) and were not conclusive (12,13). We hypothesized that patients with EF would have increased P0.1 values during spontaneous breathing trial (SBT). Therefore, the aims of our study will be to (1) to evaluate the ability of changes in P0.1 (Delta-P0.1) during SBT to predict EF and (2) to assess if Delta-P0.1 is an independent predictor of EF.

ReferenceType: result

ReferenceCitation: Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

ReferenceCitation: Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.

publisher_dissemination: American Thoracic Society

ReferenceCitation: MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.

ReferenceCitation: Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.

ReferenceCitation: Goligher EC, Brochard LJ, Reid WD, Fan E, Saarela O, Slutsky AS, Kavanagh BP, Rubenfeld GD, Ferguson ND. Diaphragmatic myotrauma: a mediator of prolonged ventilation and poor patient outcomes in acute respiratory failure. Lancet Respir Med. 2019 Jan;7(1):90-98. doi: 10.1016/S2213-2600(18)30366-7. Epub 2018 Nov 16.

ReferenceCitation: Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.

oa_host_type: repository

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

unpaywall_oa_status: green

ReferenceCitation: Telias I, Damiani F, Brochard L. The airway occlusion pressure (P0.1) to monitor respiratory drive during mechanical ventilation: increasing awareness of a not-so-new problem. Intensive Care Med. 2018 Sep;44(9):1532-1535. doi: 10.1007/s00134-018-5045-8. Epub 2018 Jan 19. No abstract available.

ReferenceCitation: Whitelaw WA, Derenne JP, Milic-Emili J. Occlusion pressure as a measure of respiratory center output in conscious man. Respir Physiol. 1975 Mar;23(2):181-99. doi: 10.1016/0034-5687(75)90059-6.

ReferenceCitation: Alberti A, Gallo F, Fongaro A, Valenti S, Rossi A. P0.1 is a useful parameter in setting the level of pressure support ventilation. Intensive Care Med. 1995 Jul;21(7):547-53. doi: 10.1007/BF01700158.

ReferenceCitation: Mancebo J, Albaladejo P, Touchard D, Bak E, Subirana M, Lemaire F, Harf A, Brochard L. Airway occlusion pressure to titrate positive end-expiratory pressure in patients with dynamic hyperinflation. Anesthesiology. 2000 Jul;93(1):81-90. doi: 10.1097/00000542-200007000-00016.

ReferenceCitation: Rittayamai N, Beloncle F, Goligher EC, Chen L, Mancebo J, Richard JM, Brochard L. Effect of inspiratory synchronization during pressure-controlled ventilation on lung distension and inspiratory effort. Ann Intensive Care. 2017 Oct 6;7(1):100. doi: 10.1186/s13613-017-0324-z.

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_concat: PubMed Central;localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

ReferenceCitation: Sassoon CS, Te TT, Mahutte CK, Light RW. Airway occlusion pressure. An important indicator for successful weaning in patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1987 Jan;135(1):107-13. doi: 10.1164/arrd.1987.135.1.107.

ReferenceCitation: Fernandez R, Raurich JM, Mut T, Blanco J, Santos A, Villagra A. Extubation failure: diagnostic value of occlusion pressure (P0.1) and P0.1-derived parameters. Intensive Care Med. 2004 Feb;30(2):234-240. doi: 10.1007/s00134-003-2070-y. Epub 2003 Nov 8.

lead_sponsor: Cleveland Clinic Abu Dhabi

location_facility:
Dijon University Hospital
Amiens University Hospital
Centre Hospitalier d'Arras


title: Etude du Microenvironnement médullaire Dans Les Leucémies Aiguës de l'Enfant

acronym: MILA

summary: Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and/or progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases.

lead_sponsor: University Hospital, Tours

location_facility: Service d'onco-hématologie pédiatrique -CHRU Tours

location_facility: Service de chirurgie orthopédique pédiatrique -CHRU TOURS

location_facility: Service d'hématologie biologique-CHRU TOURS