title: Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in Chronic Obstructive Pulmonary Disease Patients

summary: The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.

ReferenceCitation: Roberts MM, Cho JG, Sandoz JS, Wheatley JR. Oxygen desaturation and adverse events during 6-min walk testing in patients with COPD. Respirology. 2015 Apr;20(3):419-25. doi: 10.1111/resp.12471. Epub 2015 Jan 20.

name: Respiratory Ambulatory Care Service; Western Sydney Local Health District; Westmead Australia

name: Ludwig Engel Centre for Respiratory Research; Westmead Millennium Institute; Westmead Australia

family: Roberts

full_name: Mary M. Roberts

given: Mary M.

name: Westmead Clinical School; Sydney Medical School; University of Sydney; Sydney New South Wales Australia

family: Cho

full_name: Jin-Gun Cho

given: Jin-Gun

name: Division of Respiratory Medicine; Ottawa Hospital; Ottawa Ontario Canada

family: Sandoz

full_name: Jacqueline S. Sandoz

given: Jacqueline S.

family: Wheatley

full_name: John R. Wheatley

given: John R.

journal_name: Respirology

ReferenceCitation: Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agustí A, Bakke PS, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Miller BE, Crim C, Yates J, Wouters EF, Celli B; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Study Investigators. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med. 2013 Feb 15;187(4):382-6. doi: 10.1164/rccm.201209-1596OC. Epub 2012 Dec 21.

family: Polkey

full_name: Michael I. Polkey

given: Michael I.

family: Spruit

full_name: Martijn A. Spruit

given: Martijn A.

family: Edwards

full_name: Lisa D. Edwards

given: Lisa D.

family: Watkins

full_name: Michael L. Watkins

given: Michael L.

family: Pinto-Plata

full_name: Victor Pinto-Plata

given: Victor

family: Vestbo

full_name: Jørgen Vestbo

given: Jørgen

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

family: Tal-Singer

full_name: Ruth Tal-Singer

given: Ruth

family: Agustí

full_name: Alvar Agustí

given: Alvar

family: Bakke

full_name: Per S. Bakke

given: Per S.

family: Coxson

full_name: Harvey O. Coxson

given: Harvey O.

family: Lomas

full_name: David A. Lomas

given: David A.

family: MacNee

full_name: William MacNee

given: William

family: Rennard

full_name: Stephen Rennard

given: Stephen

family: Silverman

full_name: Edwin K. Silverman

given: Edwin K.

family: Miller

full_name: Bruce E. Miller

given: Bruce E.

family: Crim

full_name: Courtney Crim

given: Courtney

name: on behalf of the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Study Investigators

journal_name: American Journal of Respiratory and Critical Care Medicine

repository_institution: The University of Manchester - Research Explorer

title: Six-Minute-Walk Test in Chronic Obstructive Pulmonary Disease

ReferenceCitation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30. Review.

repository_institution: University of Hasselt - Document Server@UHasselt


ReferenceType: derived

ReferenceCitation: Hirschfield GM, Beuers U, Kupcinskas L, Ott P, Bergquist A, Färkkilä M, Manns MP, Parés A, Spengler U, Stiess M, Greinwald R, Pröls M, Wendum D, Drebber U, Poupon R. A placebo-controlled randomised trial of budesonide for PBC following an insufficient response to UDCA. J Hepatol. 2021 Feb;74(2):321-329. doi: 10.1016/j.jhep.2020.09.011. Epub 2020 Sep 17.

family: Hirschfield

full_name: Gideon M. Hirschfield

given: Gideon M.

sequence: first

family: Beuers

full_name: Ulrich Beuers

given: Ulrich

sequence: additional

family: Kupcinskas

full_name: Limas Kupcinskas

given: Limas

family: Ott

full_name: Peter Ott

given: Peter

family: Bergquist

full_name: Annika Bergquist

given: Annika

family: Färkkilä

full_name: Martti Färkkilä

given: Martti

family: Manns

full_name: Michael P. Manns

given: Michael P.

family: Parés

full_name: Albert Parés

given: Albert

family: Spengler

full_name: Ulrich Spengler

family: Stiess

full_name: Michael Stiess

given: Michael

family: Greinwald

full_name: Roland Greinwald

given: Roland

family: Pröls

full_name: Markus Pröls

given: Markus

family: Wendum

full_name: Dominique Wendum

given: Dominique

family: Drebber

full_name: Uta Drebber

given: Uta

family: Poupon

full_name: Raoul Poupon

given: Raoul

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Hepatology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29. Review.

family: Mousa

full_name: Hani S Mousa

given: Hani S

family: Lleo

full_name: Ana Lleo

given: Ana

family: Invernizzi

full_name: Pietro Invernizzi

given: Pietro

family: Bowlus

full_name: Christopher L Bowlus

given: Christopher L

acronym: Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC

location_facility:
Hôpital Saint-Antoine
Universitätsklinikum Bonn

title: Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study Comparing the Combination of Ursodeoxycholic Acid Capsules Plus Budesonide Capsules to Ursodeoxycholic Acid Capsules Plus Placebo in the Treatment of Primary Biliary Cirrhosis

summary: The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at risk for disease progression. It is assumed that the combination therapy will result in a decrease of treatment failures after 3 years of treatment.


title: Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea

summary: The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceCitation: Perez T, Chanez P, Dusser D, Devillier P. Prevalence and reversibility of lung hyperinflation in adult asthmatics with poorly controlled disease or significant dyspnea. Allergy. 2016 Jan;71(1):108-14. doi: 10.1111/all.12789. Epub 2015 Nov 6.

name: Service de Pneumologie et des EFR; CHU Lille; et INSERM U1019; Université Lille; Lille France

family: Perez

full_name: T. Perez

given: T.

name: Clinique des Bronches; Allergie et Sommeil; Hôpital Nord; Chemin des Bourrelly; Marseille France

family: Chanez

full_name: P. Chanez

given: P.

name: Service de Pneumologie; Hôpital Cochin; AP-HP; Université Paris Descartes; Sorbonne Paris Cité; Paris France

family: Dusser

full_name: D. Dusser

given: D.

name: UPRES EA 220; Université Versailles Saint-Quentin; Hôpital Foch; Suresnes France

family: Devillier

full_name: P. Devillier

journal_name: Allergy

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Chiesi Farmaceutici S.p.A.

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Randomised, Placebo Controlled Trial of Azithromycin for the Prevention of Chronic Lung Disease of Prematurity in Preterm Infants

summary: The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Turner MA, Jacqz-Aigrain E, Kotecha S. Azithromycin, Ureaplasma and chronic lung disease of prematurity: a case study for neonatal drug development. Arch Dis Child. 2012 Jun;97(6):573-7. doi: 10.1136/adc.2010.195180. Epub 2011 Jun 22. Review.

ReferenceCitation: Pansieri C, Pandolfini C, Elie V, Turner MA, Kotecha S, Jacqz-Aigrain E, Bonati M. Ureaplasma, bronchopulmonary dysplasia, and azithromycin in European neonatal intensive care units: a survey. Sci Rep. 2014 Feb 12;4:4076. doi: 10.1038/srep04076.

ReferenceCitation: Lowe J, Watkins WJ, Edwards MO, Spiller OB, Jacqz-Aigrain E, Kotecha SJ, Kotecha S. Association between pulmonary ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis. Pediatr Infect Dis J. 2014 Jul;33(7):697-702. doi: 10.1097/INF.0000000000000239. Review.

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

location_country:
Italy
Luxembourg
Sweden
Netherlands
France
Hungary
Belgium
Germany
United Kingdom

location_facility: Semmelweis University Budapest, Faculty of Medicine (SOTE)

location_facility: Only for children pharmaceuticals (04CP)

location_facility: Institut National de la Santé et de la Recherche Médicale (INSERM)

location_facility: Advanced Biological Laboratories ABL (ABL SA)

location_facility: Erasmus-University Medical Center (ERAMUS)

location_facility: Assistance Publique Hôpitaux de Paris (APHP)

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Exploitation of a BAse of Genetic Data (Obtained by Next Generation SEquencing) for the Validation of a Clinical Algorithm for the Diagnosis of Recessive Cerebellar Ataxias

acronym: BASE-AAR

summary:
The field of clinical diagnosis of recessive cerebellar ataxias (ARCA) is particularly complex and Next Generation Sequencing (NGS) techniques have revolutionized this neuro-genetic field. The current challenge is to optimize the analysis of genetic data generated by NGS because: the processing of data remains very laborious; diagnostic yeld less than 50%; the interpretation of the variants sometimes very difficult. For this purpose of optimization, the team of the University Hospital of Strasbourg has developed a computer algorithm based on 124 clinical and para-clinical parameters (derived from the data of the literature), useful to guide the genes to be targeted in priority by genetic analysis, in the context of a suspicion of ARCA (> 60 known genes); this algorithm was validated retrospectively in 834 patients with genetically confirmed ARCA (92% Sense, 95% Spec). However, these 834 patients are often the same as those described in the literature and used for the elaboration of the algorithm. This introduces a bias in the initial evaluation of the algorithm, which therefore requires validation in clinical practice, from a cohort of patients referred for suspected ARCA (with or without a found genetic mutation). At the same time, Montpellier's genetics laboratory has developed a bioinformatic method for the search for copy number variations (CNV) that can be applied in a targeted manner to the genes predicted by the algorithm.

The principal aim of this study is the validation of a semi-automated clinical algorithm for NGS molecular diagnosis of ARCA; the secondary objective is to evaluate if the application of this algorithm coupled with a targeted bioinformatic analysis can increase the diagnostic yield of the NGS analysis.

study_start_date_type: Actual

status: Recruiting

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Ongoing


type: Other Identifier

title: Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation

acronym: EMSICA

summary: The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Labrunée M, Despas F, Marque P, Guiraud T, Galinier M, Senard JM, Pathak A. Acute electromyostimulation decreases muscle sympathetic nerve activity in patients with advanced chronic heart failure (EMSICA Study). PLoS One. 2013 Nov 12;8(11):e79438. doi: 10.1371/journal.pone.0079438. eCollection 2013.

family: Labrunée

full_name: Marc Labrunée

given: Marc

family: Despas

full_name: Fabien Despas

given: Fabien

family: Marque

full_name: Philippe Marque

given: Philippe

family: Guiraud

full_name: Thibaut Guiraud

given: Thibaut

family: Galinier

full_name: Michel Galinier

given: Michel

family: Senard

full_name: Jean Michel Senard

given: Jean Michel

family: Pathak

full_name: Atul Pathak

given: Atul

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Acute electromyostimulation Decreases Muscle Sympathetic Nerve Activity in Patients with Advanced Chronic Heart Failure (EMSICA Study)

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


title: A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe

summary: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.

ReferenceCitation: Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, Grande S, Goldstein N, Robinson C, Gaddah A, Bockstal V, Wiedemann A, Leyssen M, Luhn K, Richert L, Bétard C, Gibani MM, Clutterbuck EA, Snape MD, Levy Y, Douoguih M, Thiebaut R; EBOVAC2 EBL2001 study group. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2021 Apr;21(4):493-506. doi: 10.1016/S1473-3099(20)30476-X. Epub 2020 Nov 17.

family: Pollard

full_name: Andrew J Pollard

given: Andrew J

family: Launay

full_name: Odile Launay

given: Odile

family: Lelievre

full_name: Jean-Daniel Lelievre

given: Jean-Daniel

family: Lacabaratz

full_name: Christine Lacabaratz

given: Christine

family: Grande

full_name: Sophie Grande

given: Sophie

family: Goldstein

full_name: Neil Goldstein

given: Neil

family: Robinson

full_name: Cynthia Robinson

given: Cynthia

family: Gaddah

full_name: Auguste Gaddah

given: Auguste

family: Bockstal

full_name: Viki Bockstal

given: Viki

family: Wiedemann

full_name: Aurelie Wiedemann

given: Aurelie

family: Leyssen

full_name: Maarten Leyssen

given: Maarten

family: Luhn

full_name: Kerstin Luhn

given: Kerstin

family: Richert

full_name: Laura Richert

given: Laura

family: Bétard

full_name: Christine Bétard

family: Gibani

full_name: Malick M Gibani

given: Malick M

family: Clutterbuck

full_name: Elizabeth A Clutterbuck

given: Elizabeth A

family: Snape

full_name: Matthew D Snape

given: Matthew D

family: Levy

full_name: Yves Levy

given: Yves

family: Douoguih

full_name: Macaya Douoguih

given: Macaya

family: Thiebaut

full_name: Rodolphe Thiebaut

given: Rodolphe

family: McShane

full_name: Christopher McShane

given: Christopher

family: Callendret

full_name: Benoit Callendret

given: Benoit

family: Dincq

full_name: Stephanie Dincq


ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

family: Hirsch

full_name: Caroline Hirsch

given: Caroline

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

given: Maria

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

journal_name: Cochrane Database of Systematic Reviews

ipd_sharing_description: Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants. Anonymized data will be made publicly available using a data repository, including any programming code used to produce the trial results. De-identified data will be made available upon request and evaluation of the requestee's ability and willingness to maintain the integrity and privacy of the trial participants. Further details of data sharing will be given in a separate data sharing plan.

lead_sponsor: Oslo University Hospital

location_country: Italy Austria Luxembourg Spain France Czechia Greece Slovakia Norway Hungary Belgium Ireland Portugal Turkey Germany

acronym: EU-SolidAct

location_facility: CHLC-HCC - Hospital Curry Cabral, Centro Hospitalar Universitário Lisboa Central

location_facility: İstanbul Üniversitesi İstanbul Tıp Fakültesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı

location_facility: University of Debrecen (Clinic for Infectology)

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord, U.O.C. Malattie Infettive

location_facility: CHU Lille - Hopital Roger Salengro -Pôle Rèanimaition

location_facility: ASST - Spedali Civili di Brescia - University of Brescia

location_facility: ASL Frosinone - Ospedale Fabrizio Spaziani, U.O.C. Medicina Interna

location_facility: ASL Taranto - Ospedale Oncologico San Giuseppe Moscati, U.O.C. Pneumologia

location_facility: Hacettepe Üniversitesi Tıp Fakültesi, İnfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı (Site 2)

location_facility: Technische Universität München (TUM) - Klinikum rechts der Isar

location_facility: CHLN - Centro Hospitalar Universitário Lisboa Norte

location_facility: Medical University of Innsbruck (University Hospital for Neurosurgery)

location_facility: Ospedale S.M. Goretti di Latina, U.O.C. Malattie Infettive

location_facility: Medical Unversity of Innsbruck (Joint Institute for Emergency Medicine and Critical Care)

location_facility: CHLO - Centro Hospitalar de Lisboa Ocidental - HEM and HSFX

location_facility: AOU Policlinico "P. Giaccone", U.O.C. Malattie Infettive

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, U.O.C. Malattie Infettive

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), S.C. Malattie Infettive

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra

location_facility: CHUA-Faro - Centro Hospitalar Universitário do Algarve

location_facility: Ankara Üniversitesi Tıp Fakültesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı

location_facility: Ospedale Mater Salutis di Legnago, U.O.C. di Pneumologia

location_facility: Ospedale Mater Salutis di Legnago, U.O.S. di Malattie Infettive

location_facility: Ospedale Cardinal Massala di Asti, Malattie Infettive

location_facility: Hacettepe Üniversitesi Tıp Fakültesi, İnfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı (Site 1)

location_facility: CHU de Bordeaux / Hopital Pellegrin (ID)

location_facility: CHMT - Centro Hospitalar do Médio Tejo- Hospital de Abrantes

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria, U.O.S. Malattie Infettive e Tropicali

location_facility: CHU de Bordeaux / Hopital Pellegrin (ICU)

location_facility: Azienda Ospedaliera Universitaria Vanvitelli, U.O.C. Malattie Infettive

location_facility: Azienda Opsedaliera Universitaria Mater Domini, U.O. Malattie Infettive e Tropicali

location_facility: ATS Sardegna - PO SS Trinità, U.O.C. Malattie Infettive

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona, U.O.C. Malattie Infettive e Tropicali

location_facility: Dokuz Eylül Üniversitesi Tıp Fakültesi Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı

location_facility: Ospedale Santa Maria Annunziata, Malattie Infettive

location_facility: Hopital de la Croix - Rousse - HCL (ICU)

location_facility: Medical Unversity of Innsbruck (University Hospital for Anaesthesia and Intensive Care)

location_facility: ASST Santi Paolo e Carlo, S.C. Malattie Infettive

ipd_sharing: Yes

source: euctr

title: European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial

summary: EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.


title: Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device

acronym: ISOSTIFF

summary: The investigators designed this study to determine the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device in flexed and extended knee position. The second objective is to determine the clinical viability of the parameters using the coefficient of repeatability and to investigate the individual characteristics associated with increased calf stiffness or altered viscoelasticity

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Caen

intervention_type: Diagnostic Test


title: Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.

acronym: PREDICT-ACL

summary:
Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.

challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.


title: Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis

acronym: HSMDP

summary: The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event

ReferenceCitation: Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92.

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device


title: Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

acronym: SSRHAD

summary: The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.

status: Unknown status

ReferenceCitation: Tubach F, Baron G, Falissard B, Logeart I, Dougados M, Bellamy N, Ravaud P. Using patients' and rheumatologists' opinions to specify a short form of the WOMAC function subscale. Ann Rheum Dis. 2005 Jan;64(1):75-9.

ReferenceCitation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. Epub 2004 Jun 18.

ReferenceCitation: Baron G, Tubach F, Ravaud P, Logeart I, Dougados M. Validation of a short form of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale in hip and knee osteoarthritis. Arthritis Rheum. 2007 May 15;57(4):633-8.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

name: the ARS Ile de France telemedicine group

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Calinaud

full_name: Christine Calinaud

given: Christine

currency_apc_doaj: GBP

journal_name: BMC Health Services Research

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Fondation Santé Service, Pôle Rééducation- Handicap


title: Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial.

summary: Detoxification, in an inpatient or outpatient program, is the primary and essential step for managing alcohol dependence. The superiority of one or other method of detoxification has never been proved in several previous randomized clinical trials (RCT). The aim of this multicenter RCT was to compare efficiency, on the abstinence rate as the primary outcome, at 1 and 3 months follow-up of two alcohol detoxification programs (a 5/7-days inpatient detox vs. an ambulatory detox).

ReferenceCitation: Limosin F, Romo L, Batel P, Adès J, Boni C, Gorwood P. Association between dopamine receptor D3 gene BalI polymorphism and cognitive impulsiveness in alcohol-dependent men. Eur Psychiatry. 2005 May;20(3):304-6.

ReferenceCitation: Batel P, Reynaud-Maurupt C, Lavignasse P, Constant MV, Kopp P, Jourdain JJ, Videau B, Mucchielli A, Riff B, Lowenstein W. [Risk factors of early drop-out during induction of high-dose buprenorphine substitution therapy. A study of 1085 opiate addicts]. Presse Med. 2004 Oct 23;33(18 Suppl):5-9. French.

ReferenceCitation: Batel P, Balester-Mouret S. [Care network in addictive pathologies: where is it?]. Rev Prat. 2003 Jun 15;53(12):1335-9. French.

ReferenceCitation: Pessione F, Ramond MJ, Peters L, Pham BN, Batel P, Rueff B, Valla DC. Five-year survival predictive factors in patients with excessive alcohol intake and cirrhosis. Effect of alcoholic hepatitis, smoking and abstinence. Liver Int. 2003 Feb;23(1):45-53.

ReferenceCitation: Gorwood P, Limosin F, Batel P, Hamon M, Adès J, Boni C. The A9 allele of the dopamine transporter gene is associated with delirium tremens and alcohol-withdrawal seizure. Biol Psychiatry. 2003 Jan 1;53(1):85-92.

ReferenceCitation: Lavignasse P, Lowenstein W, Batel P, Constant MV, Jourdain JJ, Kopp P, Reynaud-Maurupt C, Riff B, Videau B, Mucchielli A. Economic and social effects of high-dose buprenorphine substitution therapy. Six-month results. Ann Med Interne (Paris). 2002 May;153(3 Suppl):1S20-6.

ReferenceCitation: Batel P, Michaud P. [Risky alcohol drinking or problems and brief interventions]. Gastroenterol Clin Biol. 2002 May;26(5 Suppl):B158-62. Review. French.

ReferenceCitation: Gorwood P, Aissi F, Batel P, Adès J, Cohen-Salmon C, Hamon M, Boni C, Lanfumey L. Reappraisal of the serotonin 5-HT(1B) receptor gene in alcoholism: of mice and men. Brain Res Bull. 2002 Jan 1;57(1):103-7.

ReferenceCitation: Gorwood P, Limosin F, Batel P, Duaux E, Gouya L, Adès J. The genetics of addiction: alcohol-dependence and D3 dopamine receptor gene. Pathol Biol (Paris). 2001 Nov;49(9):710-7.

ReferenceCitation: Batel P, Larivière P. [Late-onset alcohol withdrawal syndrome]. Ann Med Interne (Paris). 2000 Oct;151 Suppl B:B27-9. French.

ReferenceCitation: Gorwood P, Batel P, Adès J, Hamon M, Boni C. Serotonin transporter gene polymorphisms, alcoholism, and suicidal behavior. Biol Psychiatry. 2000 Aug 15;48(4):259-64.

ReferenceCitation: Batel P. Addiction and schizophrenia. Eur Psychiatry. 2000 Mar;15(2):115-22. Review.

ReferenceCitation: Gorwood P, Batel P, Gouya L, Courtois F, Feingold J, Adès J. Reappraisal of the association between the DRD2 gene, alcoholism and addiction. Eur Psychiatry. 2000 Mar;15(2):90-6.

ReferenceCitation: Batel P. [Alcohol withdrawal syndrome in the hospital]. Rev Prat. 1999 Feb 15;49(4):387-90. Review. French.

ReferenceCitation: Quiñones-Jenab V, Batel P, Schlussman SD, Ho A, Kreek MJ. Cocaine impairs maternal nest building in pregnant rats. Pharmacol Biochem Behav. 1997 Dec;58(4):1009-13.

ReferenceCitation: Batel-Copel LM, Kornblith AB, Batel PC, Holland JC. Do oncologists have an increasing interest in the quality of life of their patients? A literature review of the last 15 years. Eur J Cancer. 1997 Jan;33(1):29-32. Review.

ReferenceCitation: Batel P. A critique of chapter 3: "Individual drinking and degree of risk". Addiction. 1995 Nov;90(11):1450-1.

ReferenceCitation: Batel P. The treatment of alcoholism in France. Drug Alcohol Depend. 1995 Sep;39 Suppl 1:S15-21.

ReferenceCitation: Batel P, Pessione F, Maître C, Rueff B. Relationship between alcohol and tobacco dependencies among alcoholics who smoke. Addiction. 1995 Jul;90(7):977-80.

ReferenceCitation: Batel P, Pessione F, Bouvier AM, Rueff B. Prompting alcoholics to be referred to an alcohol clinic: the effectiveness of a simple letter. Addiction. 1995 Jun;90(6):811-4.

intervention_type: Procedure


title: Contribution of Anti-platelet Antibodies Identified With" Monoclonal Antibody Immobilization of Platelet Antigens" Assay (MAIPA) in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis

acronym: APAT

summary: Immune thrombocytopenia (ITP) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. ITP is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. No major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of ITP. The gold standard analysis for the determination of platelet antibodies, is the "monoclonal antibody immobilization of platelet antigens" assay (MAIPA), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. Therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in MAIPA to determine the autoimmune nature of a thrombocytopenia at diagnosis.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de médecine interne

intervention_type: Biological


title: Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)

acronym: SLEEPCONNECT

summary:
Continuous positive airway pressure (CPAP) is the first line therapy for Obstructive Sleep Apnea Syndrome (OSAS) but has limited impact for reducing cardio-metabolic risk.

Combined treatment strategies including physical activity and weight loss management have emerged in association with CPAP. Patient's engagement might be supported by connected devices and smartphone applications measuring physical activity, blood pressure, weight and sleep duration. Data fusion of these parameters with CPAP-remote telemonitoring will allow personalized coaching and integrated care of OSAS with cardio-metabolic co-morbidities.

primary_purpose: Other

ReferenceCitation: Lévy P, Kohler M, McNicholas WT, Barbé F, McEvoy RD, Somers VK, Lavie L, Pépin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. Review.

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Kohler

full_name: Malcolm Kohler

given: Malcolm

family: McNicholas

full_name: Walter T. McNicholas

given: Walter T.

family: Barbé

full_name: Ferran Barbé

given: Ferran

family: McEvoy

full_name: R. Doug McEvoy

given: R. Doug

family: Somers

full_name: Virend K. Somers

given: Virend K.

family: Lavie

full_name: Lena Lavie

given: Lena

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

journal_name: Nature Reviews Disease Primers

title: Obstructive sleep apnoea syndrome

ReferenceCitation: Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14. Review.

family: Malhotra

full_name: Atul Malhotra

given: Atul

family: Orr

full_name: Jeremy E Orr

given: Jeremy E

family: Owens

full_name: Robert L Owens

given: Robert L

journal_name: The Lancet Respiratory Medicine

oa_host_type: repository

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

version: acceptedVersion

ReferenceCitation: Arnaud C, Dematteis M, Pepin JL, Baguet JP, Lévy P. Obstructive sleep apnea, immuno-inflammation, and atherosclerosis. Semin Immunopathol. 2009 Jun;31(1):113-25. doi: 10.1007/s00281-009-0148-5. Epub 2009 Apr 29. Review.

ReferenceCitation: Aron-Wisnewsky J, Clement K, Pépin JL. Nonalcoholic fatty liver disease and obstructive sleep apnea. Metabolism. 2016 Aug;65(8):1124-35. doi: 10.1016/j.metabol.2016.05.004. Epub 2016 May 13. Review.

ReferenceCitation: McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

ReferenceCitation: Jullian-Desayes I, Joyeux-Faure M, Tamisier R, Launois S, Borel AL, Levy P, Pepin JL. Impact of obstructive sleep apnea treatment by continuous positive airway pressure on cardiometabolic biomarkers: a systematic review from sham CPAP randomized controlled trials. Sleep Med Rev. 2015 Jun;21:23-38. doi: 10.1016/j.smrv.2014.07.004. Epub 2014 Jul 31. Review.

ReferenceCitation: Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.

family: Craig

full_name: Sonya Elizabeth Craig

given: Sonya Elizabeth

family: Nicoll

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Pépin JL, Tamisier R, Barone-Rochette G, Launois SH, Lévy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

title: Comparison of Continuous Positive Airway Pressure and Valsartan in Hypertensive Patients with Sleep Apnea

ReferenceCitation: Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.

ReferenceCitation: Schwab RJ, Badr SM, Epstein LJ, Gay PC, Gozal D, Kohler M, Lévy P, Malhotra A, Phillips BA, Rosen IM, Strohl KP, Strollo PJ, Weaver EM, Weaver TE; ATS Subcommittee on CPAP Adherence Tracking Systems. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med. 2013 Sep 1;188(5):613-20. doi: 10.1164/rccm.201307-1282ST.

ReferenceCitation: Redline S, Dean D 3rd, Sanders MH. Entering the era of "big data": getting our metrics right. Sleep. 2013 Apr 1;36(4):465-9. doi: 10.5665/sleep.2524.

ReferenceCitation: Hwang D. Monitoring Progress and Adherence with Positive Airway Pressure Therapy for Obstructive Sleep Apnea: The Roles of Telemedicine and Mobile Health Applications. Sleep Med Clin. 2016 Jun;11(2):161-71. doi: 10.1016/j.jsmc.2016.01.008. Epub 2016 Mar 26. Review.


title: Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia

acronym: BIOCAI

summary: The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units ("Bedside to the Bench Strategy"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.


title: Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers

summary: The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.The aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.

ReferenceCitation: Campeotto F, Waligora-Dupriet AJ, Doucet-Populaire F, Kalach N, Dupont C, Butel MJ. [Establishment of the intestinal microflora in neonates]. Gastroenterol Clin Biol. 2007 May;31(5):533-42. Review. French.

location_facility: Neonatat unit, Saint Vincent de Paul Hospital

intervention_type: Dietary Supplement


title: Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students: Randomized, Placebo-controlled, Double-blind, Cross-over Clinical Trial

summary:
Available literature suggests that flavanols-rich foods, and more especially monomeric flavanols-rich foods such as grape, can have an acute effect on cognitive functions via different mechanisms such as cerebral blood flow improvement.

The objective of this study is to investigate the effect of a Standardized botanical blend rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in healthy students. Moreover, in order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.

The study design will be a double-blind, randomised, placebo controlled, crossover study. A total of 30 healthy volunteers will be included. Each participant will receive a single dose of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced order. There will be a 1 week washout period between the 2 experimental visits. During each experimental visit, after a training battery volunteers will be administered a cognitive test battery (COMPASS) before product intake and 6 times after product intake (B1 to B6, from 90 min post-dose to 160 min post-dose).

lead_sponsor: Activ'inside


title: Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention

summary:
The purposes of the study are:

To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.

ReferenceCitation: Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62.

lead_sponsor: Maternite Regionale Universitaire


title: Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit

acronym: FLY-MICU

summary: Patient care who requires fast and intensive care by a mobile intensive care unit in a rescue helicopter is a common practice in Auvergne since more than 3 years. Indeed, a complete team (nurse and emergency physician) is on Dragon 63 and HeliSMUR 63 (SMUR = emergency medical services ). There are multiple fields of action, with a primary rescue activity (patient care directly at the site of the operation) but also secondary transport (transfer of patients from one hospital to another). This allows a reduction in transport time and therefore unavailability of the MICU team in general hospitals, which are in short supply of attending physicians. In addition, this allows patients to be repatriated to the Clermont-Ferrand University Hospital Center, which is the reference center for many pathologies and has the Level 3 adult and pediatric Trauma Center.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Lactate and Sepsis : What Dosage Use as Triage Tool in Emergency Department for Patients With Suspected Infection.

summary:
Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.

We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect earlier those infections states and we want to find the most accurate site to detect severe sepsis (capillary, venous or arterial sample).

ReferenceCitation: Contenti J, Corraze H, Lemoël F, Levraut J. Effectiveness of arterial, venous, and capillary blood lactate as a sepsis triage tool in ED patients. Am J Emerg Med. 2015 Feb;33(2):167-72.

lead_sponsor: Hopital Saint Roch


title: Open, Randomized Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer

summary:
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer

SPONSOR:

SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

Reference protocol: 11/001

PRODUCT NAME: PA0903

MEDICAL DEVICE:

Class III: Root canal sealer Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)

lead_sponsor: Ascopharm Groupe Novasco

location_country:
United Kingdom
France

location_facility: Cabinet dentaire privé - 21, rue Fabre d'Églantine

location_facility: Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière


title: Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction

acronym: FA-O'DIDE

summary: Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this within SUD management, it is important to establish a confident relation between the patient and the care team to favorize acre observance. However, it demands an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. We postulated that an application called Ô DIDE for Digital Interaction for Detoxification Engagement, that aims to help the caregivers maintaining a link with the patient in order to facilitate confidence in the relationship, could favorize care observance especially consumption report.

study_start_date_type: Anticipated

status: Not yet recruiting


title: An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone

summary: The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

lead_sponsor: Q-Med AB

location_country: Sweden France

location_facility:
Akademikliniken
Mediti Center
Centre Medical Saint-Jean


title: Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis

summary:
It's clearly known that lymphocyte activation in particular Th17 response, plays a major role in the development of plaque psoriasis. New therapies targeting this pathway are showing great clinical efficacy in patients with moderate to severe plaque psoriasis.

Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes and they're functional role is supported by the inhibition of IL-17 production by a pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.

This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling responsible for the production of Th17 cytokines represents an interesting therapeutic target in Psoriasis.

The aim of the study is to explore biological functions related to the activation of the Cav1.4 pathway in Psoriasis.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility: Service de Dermatologie - Hôpital Larrey


title: Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.

summary: The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

status: Terminated


title: Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-40 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk

summary:
Young female counselees (18-40 years) belonging to HBOC families with a known mutation on BRCA-genes or not, receive a lot of information regarding their cancer risk. Information sources are numerous and sometimes contradictory. Unfortunately, these women face these issues at a key moment of there identity construction (self, relationship, sexuality) while they are not yet concerned by health prevention measures. A special psychoeducational intervention was designed to help these women to better cope with these difficulties.

Intervention consists in a week-end session in a thermal center (SPA) during which they will attend short conferences given by specialists (prevention measures, prophylactic surgery, assisted procreation, epidemiology...) and participate to role games and group sharing.

Intervention will be evaluated using self-questionnaires completed before intervention and during the following year.

ReferenceCitation: Cousson-Gélie F, Cosnefroy O, Christophe V, Segrestan-Crouzet C, Merckaert I, Fournier E, Libert Y, Lafaye A, Razavi D. The Ways of Coping Checklist (WCC): validation in French-speaking cancer patients. J Health Psychol. 2010 Nov;15(8):1246-56. doi: 10.1177/1359105310364438. Epub 2010 Aug 27.

ReferenceCitation: Bruchon-Schweitzer M, Cousson F, Quintard B, Nuissier J, Rascle N. French adaptation of the Ways of Coping Checklist. Percept Mot Skills. 1996 Aug;83(1):104-6.

ReferenceCitation: Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9.

ReferenceCitation: Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39.

ReferenceCitation: Levenson H. Multidimensional locus of control in psychiatric patients. J Consult Clin Psychol. 1973 Dec;41(3):397-404.

ReferenceCitation: Loas G, Dardennes R, Dhee-Perot P, Leclerc V, Fremaux D. [Operationalization of the "locus of control" concept: translation and first validation study of the Levenson control scale (IPC: the internal powerful others and chance scale)]. Ann Med Psychol (Paris). 1994 Aug-Sep;152(7):466-9. French.

ReferenceCitation: Power M, Harper A, Bullinger M. The World Health Organization WHOQOL-100: tests of the universality of Quality of Life in 15 different cultural groups worldwide. Health Psychol. 1999 Sep;18(5):495-505.

ReferenceCitation: Leplège A, Réveillère C, Ecosse E, Caria A, Rivière H. [Psychometric properties of a new instrument for evaluating quality of life, the WHOQOL-26, in a population of patients with neuromuscular diseases]. Encephale. 2000 Sep-Oct;26(5):13-22. French.

ReferenceCitation: Herth K. Enhancing hope in people with a first recurrence of cancer. J Adv Nurs. 2000 Dec;32(6):1431-41.

ReferenceCitation: Kwiatkowski F, Gay-Bellile M, Dessenne P, Laquet C, Boussion V, Béguinot M, Petit MF, Grémeau AS, Verlet C, Chaptal C, Broult M, Jouvency S, Duclos M, Bignon YJ. BRACAVENIR: an observational study of expectations and coping in young women with high hereditary risk of breast and ovarian cancer. Hered Cancer Clin Pract. 2019 Feb 27;17:7. doi: 10.1186/s13053-019-0107-7. eCollection 2019.

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Gay-Bellile

full_name: Mathilde Gay-Bellile

given: Mathilde

family: Dessenne

full_name: Pascal Dessenne

given: Pascal

family: Laquet

full_name: Claire Laquet

given: Claire

family: Boussion

full_name: Véronique Boussion

given: Véronique

family: Béguinot

full_name: Marie Béguinot

given: Marie

family: Petit

full_name: Marie-Françoise Petit

given: Marie-Françoise

family: Grémeau

full_name: Anne-Sophie Grémeau

given: Anne-Sophie

family: Verlet

full_name: Céline Verlet

given: Céline

family: Chaptal

full_name: Charlotte Chaptal

given: Charlotte

family: Broult

full_name: Marilyn Broult

given: Marilyn

family: Jouvency

full_name: Sylvie Jouvency

given: Sylvie

family: Duclos

full_name: Martine Duclos

given: Martine

family: Bignon

full_name: Yves-Jean Bignon

given: Yves-Jean

journal_name: Hereditary Cancer in Clinical Practice

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_normalized: HAL

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

ReferenceCitation: Kwiatkowski F, Dessenne P, Laquet C, Daures JP, Gay-Bellile M, Bignon YJ. BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18-30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial. Trials. 2016 Oct 21;17(1):509.


title: Effect of Adapted Physical Activity, During Rehabilitation Stay, on Abilities and Quality of Life of Huntington Patients and Their Relatives "HUNT'ACTIV-MH-REHAB MOVE MORE TO LIVE BETTER"

acronym: HUNT'ACTIV

summary:
Intro:

Huntington's disease is a neurodegenerative disease that affects the brain, inducing a dysfunction and death of the middle spiny striatal projection neurons and a progressive alteration of cognitive and motor functions, and psycho-behavioral problems. There is currently no curative treatment but we know hat a multidisciplinary care can optimize the functioning and the quality of life of the patients with Huntington's disease.

A meta-analysis of 18studies indicates that exercise and physical activity can improve motor function, gait speed and balance, and would also improve self-confidence, independence, well-being, reduced apathy and better socialization with family and friends.

Hypothesis/Objective The hypothesis is that the inclusion of a 4 week-program with Adapted Physical Activity (APA) during a rehabilitation stay will improve some motor, cognitive and psycho-behavioral abilities, compared to the control group.

Method

The patients will be randomized into two groups :

The control group will have the "classic" program performed in the standard of care with: kinesitherapy, soft gym, medico-social workshop, cognitive workshop, creative workshop, individual care (rehabilitation, rest, and creation).

The experimental APA group will have in addition of the classic program, 6 APA workshops per week with collective support : Adapted Physical workshops, adapted cycling, therapeutic (horseback/equestrian) riding, cultural or leisure outings, situation tests

For the two groups, at the start of the 4 weeks of rehabilitation program an initial visit will be performed with, as part of this research, a clinical examination, a neurological examination, a dietary consultation, as well as a biological assessment as part of habitual care.

The clinical examination, the neurological examination and the dietary consultation will be performed each week, during the 4 weeks of the program,

At the end of the study, one month after the rehabilitation of the patient, a visit by phone-call will be performed for the patient and his caregiver.

primary_purpose: Supportive Care

ipd_sharing_description: APHP IS DATA'S OWNER, PLEASE CONTACT BOARD


type: Registry Identifier

title: Protective Gr1low Monocytes and Macrophages in Compensated Cardiac Hypertrophy to Limit Decompensation and Heart Damaging

acronym: PROMOMA

summary: The working hypothesis is that cardiac macrophages specific for the compensated cardiac hypertrophic phase limit the progression toward the decompensated state of heart failure by promoting an inflammatory environment favouring cardiomyocyte survival and preservation of the pump function. The investigators will perform studies in human plasma and monos, cardiac tissues and macrophages to validate this hypothesis.


title: Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease

acronym: CORO-NASH

summary: Although the clinical relationship between NAFLD/NASH and cardiovascular (CV) risk is now well established, there is very little awareness of the hepatic disease and the way it may contribute to increased CV risk in patients seen in cardiology clinics for complications of coronary artery disease. Our clinical hypothesis is that NAFLD, possibly at a stage of advanced fibrosis, is common in patients with symptomatic coronary artery disease (CAD) and increases the risk of severe atherosclerotic lesions. The primary aim of this study is to determine (a) the prevalence and (b) the severity spectrum of NAFLD among patients with symptomatic coronary artery disease. The secondary aims are: to analyze the impact of the presence and the severity spectrum of NAFLD (steatosis, steatohepatitis and fibrosis) on the severity of CAD ; To determine the profile of NAFLD patients at risk to develop coronary lesions; To explore the mechanistic link between NAFLD and CAD beyond common metabolic risk factors.


title: Study of Coronary Calcification in Subjects With Autosomal Dominant Familial Hypercholesterolemia Heterozygous

acronym: FH-CALC

summary:
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder characterized by elevated plasma levels of LDL-C cholesterol. This early and significant elevation of LDL-C triggers premature atherosclerosis, particularly coronary artery disease.

The initiation and management of LDL-C therapies is based on cardiovascular risk assessment. Although this is undoubtedly higher than in normocholesterolemic patients, a significant heterogeneity in heFH patients still persists that is not completely explained. Moreover, the evaluation of cardiovascular risk in patients with heFH is difficult for many reasons: non-validity of risk scores, futility of a risk calculation limited to 10 years in a young patient, late positivity of stress tests .

Therefore, there is a clear need for new cardiovascular risk assessment tools to identify higher risk heFH patients who could benefit from early and aggressive treatment.

The Coronary Artery Calcium (CAC) Score has been widely studied in the US and validated in European recommendations, and has shown the best reclassification index for patients at intermediate cardiovascular risk. A CAC score of zero is associated with a very low risk of event irrespective of the number of risk factors.

Non-calcified plaques are by definition not detected by ACC and patients with CAC = 0 may only have soft non-calcified plaques. The prevalence of these non-calcified plaques in very high-risk patients with acute coronary syndrome is 5%. The prevalence in FH patients is unknown. It has also been shown that the extent of the atherosclerotic burden is related to cardiovascular risk.

CAC score has been poorly evaluated in heFH patients. However, hypercholesterolemia and calcifications have been shown to be correlated: supra-aortic calcified masses in homozygous FH patients, early calcifications associated with chronic exposure to high LDL-C (cholesterol burden, equivalent to cigarettes) and finally, the calcifying role of statins.

The early increase of LDL-C in patients with genetic forms of FH causes premature cardiovascular damage. Investigators' hypothesis is that patients with FH have earlier coronary atheroma (and thus calcifications and non-calcified plaques) due to exposure early in life to high levels of LDL-cholesterol.

intervention_type: Radiation


title: Intestinal Permeability in Obesity of Intercellular Tight Junctions to Metabolic Complications

acronym: LEAKY GUT

summary: In rodents, obesity is associated with changes in tight junctions' structure in small intestine, which impacts intestinal permeability and results in metabolic complications. Few data exist in human. We hypothesized that intestinal permeability is altered in obese subjects in comparison to lean subjects, linked to metabolic and inflammatory status and that these alterations are modified after gastric bypass.


title: Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo

summary: Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints

lead_sponsor: Olygose

location_facility: Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol


title: Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2

summary: The quality of the rehabilitation of deafness in children with cochlear implantation is a major prognostic factor for the outcome on speech comprehension and oral expression. This rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and by a speech therapist located near the child's home. The multi-weekly sessions represent a constraint for the child and his parents. Complementary training work at home would make it possible to balance the equity in the distribution of care in the territory, and should promote the progress of the child, who is more inclined to use a tool available at home.

ReferenceCitation: Diehl JJ, Schmitt LM, Villano M, Crowell CR. The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review. Res Autism Spectr Disord. 2012 Jan;6(1):249-262.

location_facility: University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie


title: Assessment of Brain Activity Associated With Inhibition of Action in Attention-deficit Hyperactivity Disorder

acronym: INHIB'MOV

summary: Inhibitory control allows individuals to suppress unwanted actions and to resist irrelevant stimuli. It is thought to be a core deficit in Attention-deficit/hyperactivity disorder (ADHD). The present study aims at evaluating this deficit in adults with ADHD. Executive and inhibitory capacities, as well as the neural mechanisms underlying inhibitory control, will be assessed in adults with ADHD and two control groups of participants.


title: Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1

acronym: SKINBIOTA

summary: The skin microbiome has been implicated in several cutaneous autoimmune pathologies such as psoriasis and atopic dermatitis. However, its role in vitiligo and vitiligo lesions occuring in patients receiving anti-PD-1 for metastatic melanoma

location_facility: Service de Dermatologie - Hôpital Saint-André


title: Characterization and Quantification of Motor Speech Disorders in Huntington's Disease: Identification of Acoustic Markers

acronym: TPMH

summary: The study proposes to identify deviant speech dimensions in patients with HD at presymptomatic and declared stages of the disease, compared to healthy subjects, using the computerized MonPaGe speech protocol. This tool is based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: 3D Modelling and Morphometric Characterisation of the Skull Deformations in Congenital Muscular Torticollis : Development of Physiopathological Sequences

summary: The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and the neck compared to shoulders' level of the newborn. The mainly affected muscle is the sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side affected by the CMT and a rotation on the opposite side. CMT comes with asymmetricalndeformation of the skull or plagiocephaly, facial asymmetry, skull and cranio-vertebral deformatioes in CMT are the results of a complex mechanism of biomechanical stresses upon a developing skull. The hypothesis of a traction force on the base of the skull from the SCM could explain most of all the asymmetrical deformatios encountered in CMT. It would be associated to a compression force at the occipital level


title: Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization in Unilateral Deaf Children

acronym: SUN

summary: This study aims to compare the auditory cortical activity in response to monaural and binaural stimuli, measured by functional Near-Infrared Spectroscopy (fNIRS) between Single-sided Deaf (SSD) Children, and Normal-Hearing (NH) children from 5 to 16 years. Binaural audiological performance, speech skills and quality of life (QoL) will be compared between the 2 groups and links to with the cortical activity will be assessed.


title: Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

acronym: BIOMUIR

summary:
The study aims at the identification and the quantification of urinary branched-chain amino acids (BCAAs) by mass spectometry in healthy subjects and patients with insulin resistance and correlating urinary BCAAs with HOMA index.

Blood and urine levels of BCAAs will be correlated with HOMA index to assess and quantify insulin resistance.

Identification and quantification of urine BCAAs by an innovative method based on synthetic biology will also be performed.

Correlations between mass spectometry and the innovative detection method of BCAAs will be searched.


title: Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing

acronym: TYPAMYL

summary: The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in > 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.

ReferenceCitation: Vrana JA, Gamez JD, Madden BJ, Theis JD, Bergen HR 3rd, Dogan A. Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009 Dec 3;114(24):4957-9. doi: 10.1182/blood-2009-07-230722. Epub 2009 Oct 1.

ReferenceCitation: Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013 Oct;48(10):1067-77. doi: 10.1002/jms.3264.


title: Identification of Acoustic and Perceptual Markers of Lower and Upper Motor Neuron Signs in Dysarthria of Patients With Amyotrophic Lateral Sclerosis : a Comparison With Primitive Lateral Sclerosis, Kennedy's Disease and Controls

acronym: SPEECH-ALS

summary: This study proposes to identify acoustic and perceptual markers related to upper motor neuron (UMN) degeneration and lower motor neuron (LMN) degeneration in the dysarthria of patients with amyotrophic lateral sclerosis (ALS) which involves the degeneration of both systems. ALS patients will be gathered in clinical groups according to electromyogram (EMG) and clinical signs observed in the bulbar site. UMN signs are defined as jaw clonus, gag reflex and pseudobulbar features (lability). LMN signs are defined as lingual atrophy and fasciculations. The dysarthria will be compared to dysarthria of patients involving an exclusive UMN system degeneration (in primitive lateral sclerosis) and an exclusive LMN system degeneration (Kennedy's disease). Patients will be compared to the controls who permitted to establish the standards of the "MonPaGe" tool. MonPaGe is a computerized tool based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.

ReferenceCitation: Slis A, Lévêque N, Fougeron C, Pernon M, Assal F, Lancia L. Analysing spectral changes over time to identify articulatory impairments in dysarthria. J Acoust Soc Am. 2021 Feb;149(2):758. doi: 10.1121/10.0003332.

name: LPP, UMR 7018, CNRS/University Sorbonne-Nouvelle, Paris, France

family: Slis

full_name: A. Slis

given: A.

name: APHP, Department of Neurology, Pitié-Salpêtrière Hospital, ALS Reference Center, France

family: Lévêque

full_name: N. Lévêque

given: N.

family: Fougeron

full_name: C. Fougeron

given: C.

name: Department of Clinical Neurosciences, Geneva University Hospital, Switzerland

family: Pernon

full_name: M. Pernon

given: M.

family: Assal

full_name: F. Assal

given: F.

family: Lancia

full_name: L. Lancia

given: L.

bso_classification: Physical sciences, Astronomy

journal_name: The Journal of the Acoustical Society of America

oa_host_type: publisher

evidence: open (via page says license)

publisher: Acoustical Society of America (ASA)

publisher_dissemination: Acoustical Society of America

publisher_group: Acoustical Society of America

publisher_normalized: Acoustical Society of America


title: Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?

summary: Some subsets of lymphocytes are able to inhibit immune response and thus, could be used to control auto-immune diseases and transplant reject. In mice, the main source of those anti-inflammatory lymphocytes is the peritoneal cavity. No data are available in human. This study aims at exploring the presence of those anti-inflammatory lymphocytes in human peritoneal cavity and at determine how to expand those cells.

location_facility: CHU montpellier - department of rheumatology


title: Endometrial Cancer and Fractalkine-receptor Axis of Fractalkine

summary:
The endometrial cancers are among the most common malignancies in postmenopausal women with an incidence on the rise. It is most often a endometrioid adenocarcinoma (grade I, II, III). Other histological types are represented mainly by the clear cell carcinoma, papillary serous carcinoma, the carcinosarcoma. The main risk factors for endometrial cancer are age, obesity, diabetes, hypertension, hormone replacement therapy with estrogen and tamoxifen.

Endometrial hyperplasia usually precedes endometrial cancer is classified by degree of cytologic atypia. Tumor grade quantifies the degree of differentiation and significantly influences the prognosis. Most research has been applied to define the role of estrogen in these cancers, however an accumulation of data indicate that the general process of tumorigenesis is closely related to immune and inflammatory microenvironment of the tumor. In fact, the microenvironment may be seen as a prognostic parameter of tumors or even predictive of therapeutic response.

Recognized as the key molecules responsible for leukocyte recruitment into the tissues, the chemokine-receptor pairs are key players in the immune response, including the anti-tumor immune response but also the inflammatory response. The chemokine-receptor pairs are also involved in many other basic processes such as proliferation, survival or cell death.

The objective of this study was to evaluate the prognostic value of the expression of the chemokine fractalkine (FKN) and its receptor CX3CR1 for the development of endometrioid adenocarcinomas.

Chemokine FKN has the particularity to exist in two forms, a soluble (FKNs), like all chemokines and membrane form (FKNm). The FKNs, resulting from proteolytic cleavage of the FKNm, is provided with chémoattractantes properties. FKNm the present adhesion molecule properties.

The role of FKN in cancer biology is complex.

To date, the role of FKN in endometrial cancer has not been reported. Similarly, the precise role of FKN in the physiology of the endometrium is unknown.

Nevertheless, fractalkine is one of the most expressed in endometrial chemokines. The expression of FKN and its CX3CR1 receptor is detected in the endometrium at all stages of the menstrual cycle. The respective levels of expression of each are fluctuating and largely dependent on the cycle of stage suggesting a possible control by estrogen and progesterone control described elsewhere ovarian level and endothelial. The cells of the endometrial glandular epithelium, macrophages, neutrophils and NK cells infiltrated in this tissue as well as the endothelial cells of blood vessels express FKN. Interestingly, all the cells mentioned above express CX3CR1, except for NK cells and unlike most tissues, the CD8 cells, present in the endometrium, do not express CX3CR1.

In addition, the strongest expression of FKN and CX3CR1 cells by endometrial epithelial coincides with the maximum activity of the glandular epithelium suggesting a possible autocrine loop promoting cell proliferation of the endometrium. Concurrently with the peak of fractalkine, an accumulation of monocytes / macrophages and neutrophils is observed in the endometrium. It appears, moreover, that the balance between the soluble and membrane forms of FKN is important for positioning, infiltration and activity of immune cells within the endometrium.

Current knowledge on the involvement of FKN / CX3CR1 axis in the physiology of the endometrium, although incomplete, point unequivocally the potential role of this ligand pair / receptor in the physiology of the tissue and also suggest that a malfunction of this axis could easily cause various diseases.

Chronic inflammation of a tissue, largely dependent on macrophage infiltration rate, generally represents the tumor development. The endometrium is subjected to physiologically cyclic and regular inflammatory episodes, mirrors for the expression of chemokines and leukocyte infiltration. However, prolonged leukocyte infiltration establishing chronic or prolonged inflammation of the endometrium could help shape a favorable microenvironment in tumor development. Curiously, the axis FKN / CX3CR1 is involved in the development of several inflammatory diseases, including obesity and diabetes are also risk factors for endometrial cancer.

A change in the expression of FKN and / or CX3CR1 is potentially capable of altering the inflammatory physiological cycle of the endometrium and therefore likely to be an element to consider in the evaluation of cancer risk factors of the endometrium.

The assumption is that the FKN / CX3CR1 couple could intervene in the pathophysiology of endometrioid adenocarcinomas.

lead_sponsor: Centre Hospitalier Universitaire de Nice


summary:
Myeloproliferative disorders (MPD) include chronic myeloid leukemia (CML) (Ph +) and essential thrombocythemia (ET), the polycythemia vera (PV), myelofibrosis (MF) called SMP Ph. CML is the ultimate model of carcinogenesis. SMP is a characterized by a malignant monoclonal proliferation of a pluripotent hematopoietic progenitor determined by the presence of a balanced translocation between chromosomes 9 and 22 (Ph chromosome) which leads to major changes of a large number of cell functions. Investigators now believe that within the bone marrow exist two types of "hematopoietic niches' niche osteoblastic / endosteal and vascular niche, controlling the maintenance and differentiation of hematopoietic stem cell pool. The endosteal niche, is a hypoxic region near the endosteal trabecular, which provides protection to deeply dormant stem cells. Data from the literature suggest that in the SMP, especially CML, the interaction of malignant stem cells with the microenvironment niche Endosteal could favor their survival and resistance to treatment. The therapeutic management of CML was upset by the use of tyrosine kinase inhibitors (TKIs). However, despite these advances, even in situations of undetectable residual disease, it has been observed relapses of the disease stopped TKI leaving suggest that there is a resistance of leukemic stem cell to TKI.

Work in the group Bipoa "Bio Engineering and Pathophysiology Osteo-Articular" helped develop a 3D model of ex vivo bone formation, which can mimic the endosteal niche. the goal is to apply this model to the SMP of hematopoiesis by referring to normal hematopoiesis. it will be tested the hypothesis that the endosteal ex vivo recess of the 3D modeling allows to highlight a special interaction can promote the persistence of the leukemia stem cell despite the use of effective therapies.


title: Plasticity and Cross-modal Interactions for Oral Communication in Profoundly Deaf Adults

acronym: PLASMODY

summary:
The aim of this study is to evaluate cerebral asymmetry for face processing in a group of profoundly deaf participants and a group of hearing controls by the mean of fMRI measure. To this end, we present chimeric faces (faces split into different halves), entire faces, or faces presented in divided visual field, and subjects perform a gender categorization task while lying in a fMRI scanner.

It is expected to find a reduced cerebral asymmetry in the Fusiform Face Area in deaf in comparison with hearing participants.

lead_sponsor: University Hospital, Grenoble


title: Post-fall Syndrome of the Aged Person : Contribution of SAFEWALKER for Rehabilitation

acronym: SAFEER

summary: The main objective of this study is to evaluate the feasibility and acceptability of the use of the robot "SAFEWALKER" complement classical rehabilitation in a group of elderly patients over 70 years during the rehabilitation of post-fall syndrome.

ReferenceCitation: Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22. Review.

ReferenceCitation: Büchele G, Becker C, Cameron ID, König HH, Robinovitch S, Rapp K. Predictors of serious consequences of falls in residential aged care: analysis of more than 70,000 falls from residents of Bavarian nursing homes. J Am Med Dir Assoc. 2014 Aug;15(8):559-63. doi: 10.1016/j.jamda.2014.03.015. Epub 2014 May 11.

ReferenceCitation: Cumming RG, Salkeld G, Thomas M, Szonyi G. Prospective study of the impact of fear of falling on activities of daily living, SF-36 scores, and nursing home admission. J Gerontol A Biol Sci Med Sci. 2000 May;55(5):M299-305.

ReferenceCitation: Denkinger MD, Lukas A, Nikolaus T, Hauer K. Factors associated with fear of falling and associated activity restriction in community-dwelling older adults: a systematic review. Am J Geriatr Psychiatry. 2015 Jan;23(1):72-86. doi: 10.1016/j.jagp.2014.03.002. Epub 2014 Mar 15. Review.

ReferenceCitation: Evitt CP, Quigley PA. Fear of falling in older adults: a guide to its prevalence, risk factors, and consequences. Rehabil Nurs. 2004 Nov-Dec;29(6):207-10. Review.


title: Development of New Cortical Excitability Methodologies Using Robotised and Neuronavigated Transcranial Magnetic Stimulation.

acronym: ROBEXCI

summary:
This study has two main goals :

to develop the cortcial excitbality (CE) measurement methodology using coupling between transcranial magnetic stimulation (TMS) and physiological recordings such as electroencephalography (EEG) and electromyography (EMG),
to automatize these measurements using robotized TMS.

Assessing CE is a preliminary and crucial step in any TMS protocol, in either fundamental or clinical research. It is an important indicator which determine the stimulation power applied on the cortical target during the TMS experiment, or during the rTMS cure (patients). CE is in general measured on the motor cortex using EMG activity as the main indicator of the system's response, whatever the real cortical target is located. The present study thus propose to generalize this measurement on other cortical areas in link with the actual targets, and using other external recordings such as EEG. Moreover, as neuronavigation systems significantly improved TMS precision in the past years, CE measurements could significantly gain to become fully automatized using robotized TMS.


title: Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test

acronym: CTRLSTRESS

summary: Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia or acrophobia, since it permits to have a better control (on occurrence of events or on the environment) during the therapy than in "in vivo" therapy. Our hypothesis here is that we can improves the therapeutic effects of the virtual exposure by giving control to acrophobic patients during their exposure.

lead_sponsor: Qualissima

location_facility: Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille


title: Evaluation and Medical Care of Oculomotor Dysfunction Leading to Vertigo in Children

acronym: VERVE

summary: The eye movements of vergence allow binocular vision whatever the viewing distance or the body movements are and the perception of depth. Vergence dysfunction can lead to erroneous visual sensation of movements. In our daily life using screens (computer, game boys..) is increasing and this approach heavily the ocular vergence and can lead to symptoms if oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate the vergence performances just evaluation in static condition is currently available in ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye movement recording to study ocular vergence in dynamic condition.


title: A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

summary:
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study.

A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.

lead_sponsor: CSL Behring

location_country:
Italy
Austria
United States
South Africa
Philippines
Germany
France
Bulgaria
Czechia
Israel
Japan
Malaysia
Australia
Spain
Canada

location_facility: Hospital of the University of Pennsylvania

location_facility: UOS Gestione e Organizzazione Funzlone Hub Emofilia

location_facility: St. Marianna University, School of Medicine, Seibu Hospital

location_facility: University of Occupational and Environmental Health

location_facility: Indiana Hemophilia & Thrombosis Center Inc.

location_facility: IRCCS Ospedale Maggiore[Centro emofilia e Trobosi]

location_facility: Department of Pediatrics, Medical University of Vienna

location_facility: Werlhof-Institute for Haemostasis and Thrombosis

location_facility: Centro Malattie Emorragiche e Trombotiche Ospedale

location_facility: SHAT "Joan Pavel" ODD [Hemorrhagic Diathesis & Anemia]

location_facility: Hopital Bicetre - Centre de Traitement del'Hemophilia

location_facility: Medical University of Vienna, Vienna General Hospital

location_facility: The Hospital of Hyogo College of Medicine


title: Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve (BAV) by Multimodal Imaging (MRI, Echocardiography and Ultrafast Ultrasound Imaging)

acronym: IRM-BAO

summary:
The objective is the development and validation of morphological markers informative of aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic aorta and of acute aortic syndrome for patients with bicuspid aortic valve (BAV).

The primary objective of this study is to demonstrate a correlation between the aortic local pulse wave velocity (PWV) measured with MRI and the progression of the thoracic aorta diameters measured by MRI after a follow-up of 2 years.

lead_sponsor: French Cardiology Society


title: Thymic Generation of Regulatory T Lymphocytes in Type I Diabetes Patients.

acronym: TregDiab

summary: Regulatory T lymphocytes play a major role in the protection from autoimmune pathology. Defects in immunosuppression mediated by these cells is therefore suspected to contribute to these diseases. This issue has very little been studied in humans.Regulatory T cells emigrated from the thymus will be isolated from the blood of patients and healthy controls. The repertoire of antigen-receptors will be analysed by high throughput sequencing and its diversity estimated using appropriate statistical models borrowed from ecology.

ReferenceCitation: Ferreira C, Singh Y, Furmanski AL, Wong FS, Garden OA, Dyson J. Non-obese diabetic mice select a low-diversity repertoire of natural regulatory T cells. Proc Natl Acad Sci U S A. 2009 May 19;106(20):8320-5. doi: 10.1073/pnas.0808493106. Epub 2009 Apr 9.

ReferenceCitation: Thiault N, Darrigues J, Adoue V, Gros M, Binet B, Perals C, Leobon B, Fazilleau N, Joffre OP, Robey EA, van Meerwijk JP, Romagnoli P. Peripheral regulatory T lymphocytes recirculating to the thymus suppress the development of their precursors. Nat Immunol. 2015 Jun;16(6):628-34. doi: 10.1038/ni.3150. Epub 2015 May 4.

ReferenceCitation: Steffens CM, Al-Harthi L, Shott S, Yogev R, Landay A. Evaluation of thymopoiesis using T cell receptor excision circles (TRECs): differential correlation between adult and pediatric TRECs and naïve phenotypes. Clin Immunol. 2000 Nov;97(2):95-101.

ReferenceCitation: Calder AE, Hince MN, Dudakov JA, Chidgey AP, Boyd RL. Thymic involution: where endocrinology meets immunology. Neuroimmunomodulation. 2011;18(5):281-9. doi: 10.1159/000329496. Epub 2011 Sep 22. Review.

ReferenceCitation: Sakaguchi S, Miyara M, Costantino CM, Hafler DA. FOXP3+ regulatory T cells in the human immune system. Nat Rev Immunol. 2010 Jul;10(7):490-500. doi: 10.1038/nri2785. Epub 2010 Jun 18. Review.

ReferenceCitation: Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12.

lead_sponsor: University Hospital, Toulouse


title: A Double-Blind, Placebo-Controlled, Balanced, 4-Way, Incomplete Block Design to Evaluate the Effects of a Single Administration of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG (qEEG) in Healthy Subjects

summary: Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects

summary:
Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.

Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.


title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Lecozotan SR Administered Orally to Healthy Young and Elderly Subjects

summary: To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.


title: Lanreotide In Polycystic Kidney Disease Study

acronym: LIPS

summary:
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.

An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies

acronym: MeteoFIV

summary:
The main purpose of the study is to assess the impact of environmental conditions on live-birth rates after intraconjugal IVF.

The second purposes are

to assess the impact on pregnancies (prematurity, preeclampsia);
to assess the impact on newborn's health (stunted growth);
to evaluate the consistency of results observed between assisted pregnancies and spontaneous pregnancies.


title: Long-Term Supervised Treatment Interruption in HIV-Infected Patients Who Started Antiretroviral Treatment With CD4 Over 350/mm3 and Plasma HIV RNA Below 50 000/mL ANRS 116 Trial SALTO

summary: This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.

ReferenceCitation: Weiss L, Piketty C, Assoumou L, Didier C, Caccavelli L, Donkova-Petrini V, Levy Y, Girard PM, Burgard M, Viard JP, Rouzioux C, Costagliola D; ANRS 116 SALTO study group. Relationship between regulatory T cells and immune activation in human immunodeficiency virus-infected patients interrupting antiretroviral therapy. PLoS One. 2010 Jul 21;5(7):e11659. doi: 10.1371/journal.pone.0011659.

family: Weiss

full_name: Laurence Weiss

given: Laurence

family: Piketty

full_name: Christophe Piketty

given: Christophe

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

family: Didier

full_name: Céline Didier

family: Caccavelli

full_name: Laure Caccavelli

given: Laure

family: Donkova-Petrini

full_name: Vladimira Donkova-Petrini

given: Vladimira

family: Levy

full_name: Yves Levy

given: Yves

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Burgard

full_name: Marianne Burgard

given: Marianne

family: Viard

full_name: Jean-Paul Viard

given: Jean-Paul

family: Rouzioux

full_name: Christine Rouzioux

given: Christine

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

bso_classification: Biology (fond.)

title: Relationship between Regulatory T Cells and Immune Activation in Human Immunodeficiency Virus-Infected Patients Interrupting Antiretroviral Therapy

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Service d'immunologie Clinique, Höpital Européen Georges Pompidou


title: Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults : a Randomized, Cross-over, Open-label, Clinical Study

summary:
Scientific research on the beneficial effects of botanical extracts has led to a better understanding of the role of its bioactive compounds, but the bioavailability in human remains largely unknown. Indeed, the most of publications investigated the bioavailability of metabolites of spices in in vitro cells model or animal experiments but few clinical studies have been conducted.

Therefore, the aim of this study is to characterize and quantify in blood, the main metabolite compounds of a botanical extract, following its administration by different routes (oral or sublingual) and with different preparations (extract or powder), in quantity equivalent to those having demonstrated biological properties.

lead_sponsor: Activ'inside

location_facility: CIC Inserm 1405, University Hospital Clermont-Ferrand,


title: Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt

acronym: COMPASS

summary:
Social interactions are part of daily life. To decide to interact with someone or not is a routine for humans. To ensure the quality of interpersonal relationships, emotional cues must be taken into account to adapt optimally the investigator's behavior.

Difficulties in interpersonal relationships often trigger suicidal behavior. Suicide attempters are characterized by an impaired decision - making associated with difficulties in familial relationships.

To date, little data on emotional recognition and social decision- making in clinical population is available.

The study aims to compare behavioral response to negative social cues in 82 depressed patients according to their history of suicide attempt using a computerized neuropsychological task.

lead_sponsor: University Hospital, Montpellier


title: Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies

acronym: FLUDATEP

summary:
The application of positron emission tomography with lymphoproliferative diseases today provides diagnostic and therapeutic information of major importance , especially in terms of speed and quality of response to treatment. The radiopharmaceutical used in clinical practice for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose ([18F]-FDG) . However , the uptake of this tracer is not elective in lymphoid tissues , with a lack of specificity. In addition , the avidity of this tracer is unequal according to the histological subtype (lack of sensitivity).

To try to improve the results of this clinical exploration of lymphoid malignancies, the investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine atom in the molecule and the pharmacokinetic characteristics of this drug. The [18F]-Fludarabine is a new radiopharmaceutical reproducing the same dosage formulation of fludarabine , a drug used for the treatment of certain types of lymphoproliferative diseases, especially those where the tumor cells have a low proliferation kinetics . This drug is used in therapy in particular pharmacokinetic effect for a high affinity for the lymphoid tissue . Preclinical results on normal and lymphoma xenograft -bearing mice showed a specificity restricted to lymphoid tissue fixation with [18F]-Fludarabine compared with [18F]-FDG .

Based on these encouraging results , the investigators propose in this work to explore the Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases : 1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has a wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with chronic lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered disappointing and did not, for this reason, experienced clinical development.

lead_sponsor: University Hospital, Caen