title: ESSAI DE PHASE III RANDOMISE EVALUANT LE FOLFOX AVEC OU SANS DOCETAXEL (TFOX) EN 1ère LIGNE DE CHIMIOTHERAPIE DES ADENOCARCINOMES OESO-GASTRIQUES LOCALEMENT AVANCES OU METASTATIQUES

acronym: GASTFOX

summary:
Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a cure. The vast majority of patients, however, present with advanced disease from the outset (locally advanced or metastatic) or recurrent after resection of a localised form.

For metastatic or locally advanced stages of gastric or gastro-oesophageal junction adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as one of the first-line chemotherapy treatment standards.

The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it possible to improve the tumour response rate, the time to tumour progression and overall survival in a randomised phase III trial. This improvement in treatment efficacy was achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical practice due to its high toxicity.

Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus 5FU-cisplatin was associated with a non-significant improvement in median progression free survival rates, and overall survival.

All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than 5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of development of chemotherapy protocols for metastatic gastric cancer, the question therefore arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and also tolerance.

In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in advanced gastric cancer, but with progression-free survival and median survival rates that are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every 2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in phase II studies in terms of efficacy and tolerability, and these are worth confirming through a phase III randomised trial. In fact, if these results are confirmed in phase III, TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while limiting toxicity and preserving patients' quality of life, and could become the reference treatment to accompany the targeted therapies currently being developed for this disease.

The primary objective of this randomised phase III trial is to compare the progression-free survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with 5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the tumour response rate, toxicity, quality of life and the therapeutic index, defined as the ratio between the median progression-free survival and the febrile neutropenia rate.

ReferenceCitation: Zaanan A, Samalin E, Aparicio T, Bouche O, Laurent-Puig P, Manfredi S, Michel P, Monterymard C, Moreau M, Rougier P, Tougeron D, Taieb J, Louvet C. Phase III randomized trial comparing 5-fluorouracil and oxaliplatin with or without docetaxel in first-line advanced gastric cancer chemotherapy (GASTFOX study). Dig Liver Dis. 2018 Apr;50(4):408-410. doi: 10.1016/j.dld.2018.01.119. Epub 2018 Mar 1.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Martinique France

location_facility: Institut de Cancérologie de Bourgogne - GRRECC


title: Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F

summary: The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Institute of Myology, La Pitié-Salpêtrière Hospital

lead_sponsor_type: academique

status_simplified: Completed


title: Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients

acronym: ENVOL

summary: The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 ICU patients are included.

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Vigué B, Leblanc PE, Moati F, Pussard E, Foufa H, Rodrigues A, Figueiredo S, Harrois A, Mazoit JX, Rafi H, Duranteau J. Mid-regional pro-adrenomedullin (MR-proADM), a marker of positive fluid balance in critically ill patients: results of the ENVOL study. Crit Care. 2016 Nov 9;20(1):363.

lead_sponsor: ThermoFisher Scientific Brahms Biomarkers France

intervention_type: Other

lead_sponsor_type: industriel


type: EudraCT Number

title: A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy

summary:
This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patients with early Multiple System Atrophy (MSA).

In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A (with adjuvant) and 6 patients in the control group who will receive the reference substance (Placebo). Over a study duration of 52 weeks, the study participants will receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 30 to 75 years can participate in the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.

AFF009 is part of the project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Meissner WG, Traon AP, Foubert-Samier A, Galabova G, Galitzky M, Kutzelnigg A, Laurens B, Lührs P, Medori R, Péran P, Sabatini U, Vergnet S, Volc D, Poewe W, Schneeberger A, Staffler G, Rascol O; AFF009 Study Investigators. A Phase 1 Randomized Trial of Specific Active α-Synuclein Immunotherapies PD01A and PD03A in Multiple System Atrophy. Mov Disord. 2020 Nov;35(11):1957-1965. doi: 10.1002/mds.28218. Epub 2020 Sep 3.

name: Service de Neurologie, CRMR Atrophie Multisystématisée CHU Bordeaux  Bordeaux France

name: Univ. de Bordeaux CNRS, IMN, UMR 5293  Bordeaux F‐33000 France

name: Dept. Medicine University of Otago, Christchurch, and New Zealand Brain Research Institute  Christchurch New Zealand

family: Meissner

full_name: Wassilios G. Meissner

given: Wassilios G.

sequence: first

name: Service de Neurologie, CRMR Atrophie Multisystématisée CHU Toulouse, Toulouse– INSERM U 1048 Institut des Maladies Métaboliques et Cardiovasculaires  Toulouse France

family: Traon

full_name: Anne Pavy‐Le Traon

given: Anne Pavy‐Le

sequence: additional

name: INSERM U897, Public Health and Development Institute (ISPED) Bordeaux University  Bordeaux France

family: Foubert‐Samier

full_name: Alexandra Foubert‐Samier

given: Alexandra

family: Galabova

full_name: Gergana Galabova

given: Gergana

name: Clinical Investigation Center CIC1436, French Reference Centre for MSA University Hospital Toulouse, University Toulouse  France

family: Galitzky

full_name: Monique Galitzky

given: Monique

family: Kutzelnigg

full_name: Alexandra Kutzelnigg

family: Laurens

full_name: Brice Laurens

given: Brice

family: Lührs

full_name: Petra Lührs

given: Petra

family: Medori

full_name: Rossella Medori

given: Rossella

name: ToNIC, Toulouse NeuroImaging Center Université de Toulouse  Toulouse France

family: Péran

full_name: Patrice Péran

given: Patrice

name: Institute of Neuroradiology University Magna Graecia  Catanzaro Italy

family: Sabatini

full_name: Umberto Sabatini

given: Umberto

family: Vergnet

full_name: Sylvain Vergnet

given: Sylvain

name: Study Center PROSENEX Ambulatorium Betriebs GesmbH at Confraternität‐Privatklinik  Vienna Austria

family: Volc

full_name: Dieter Volc

given: Dieter

name: Department of Neurology Medical University of Innsbruck  Innsbruck Austria

family: Poewe

full_name: Werner Poewe

given: Werner

family: Schneeberger

full_name: Achim Schneeberger

given: Achim

family: Staffler

full_name: Günther Staffler

given: Günther

name: Université de Toulouse 3, CHU de Toulouse, INSERM, Centre de Reference AMS, Service de Neurologie et de Pharmacologie Clinique Centre d'Investigation Clinique CIC1436, Réseau NS‐Park/FCRIN et Centre of Excellence for Neurodegenerative Disorders (COEN) de Toulouse  Toulouse France

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Anheim

full_name: Mathieu Anheim

given: Mathieu

family: Castrioto

full_name: Anna Castrioto

given: Anna

family: Derkinderen

full_name: Pascal Derkinderen

given: Pascal

family: Drapier

full_name: Sophie Drapier

given: Sophie

family: Eusebio

full_name: Alexandra Eusebio

family: Grabli

full_name: David Grabli

given: David

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

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

title: A Phase 1 Randomized Trial of Specific Active α‐Synuclein Immunotherapies PD01A and PD03A in Multiple System Atrophy

location_facility: University Hospital Bordeaux (Pellegrin Hospital)


title: Functional Neuroimaging of Postural Reconstruction: Preliminary Study on a Dorsiflexion Motion of the Ankle and Comparison Between an Arm Following Postural Reconstruction Program and a Comparator Arm Following a Muscular Stretching Program

summary:
To study in two cross-sections of healthy volunteers, with single photon emission computed tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation techniques: the postural reconstruction and the muscular stretching. The changes in the cortical activation patterns will be estimated during a non-specific position of the ankle, held static.

The influence of each technique will be estimated though the evidence of a change in the functional mapping of the areas activated during the defined motor task on healthy volunteers.

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Radiation


title: Reduction of Inequalities in Overweight and Obesity Management Care Access Among High School Adolescents

acronym: PRALIMAP-INES

summary:
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management (CM) for socially less advantaged adolescents in school in the short and long term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.

Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as advantaged are allocated to the standard-CM and those less advantaged are randomized to standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The strengthened-CM consists of 5 collective sessions with the same standard operating procedure as the standard-CM with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after the intervention=T2). Process evaluation data are also collected during the trial.

Expected results: To confirm the effectiveness of overweight CM for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight care.

primary_purpose: Prevention

ReferenceCitation: Manneville F, Omorou AY, Legrand K, Lecomte E, Rydberg JA, Briançon S, Guillemin F; PRALIMAP Trial Group. Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents. Prev Med. 2021 Sep;150:106668. doi: 10.1016/j.ypmed.2021.106668. Epub 2021 Jun 1.

family: Manneville

full_name: Florian Manneville

given: Florian

family: Omorou

full_name: Abdou Y. Omorou

given: Abdou Y.

family: Legrand

full_name: Karine Legrand

given: Karine

family: Lecomte

full_name: Edith Lecomte

given: Edith

family: Rydberg

full_name: Jenny A. Rydberg

given: Jenny A.

family: Briançon

full_name: Serge Briançon

given: Serge

family: Guillemin

full_name: Francis Guillemin

given: Francis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Preventive Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Omorou AY, Manneville F, Langlois J, Legrand K, Böhme P, Muller L, Guillemin F, Briançon S, Lecomte E; PRALIMAP-INÈS Trial Group. Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity. Prev Med. 2020 May;134:106043. doi: 10.1016/j.ypmed.2020.106043. Epub 2020 Feb 22.

family: Langlois

full_name: Johanne Langlois

given: Johanne

family: Böhme

full_name: Philip Böhme

given: Philip

family: Muller

full_name: Laurent Muller

given: Laurent

family: De Lavenne

full_name: Rozenn De Lavenne

given: Rozenn

family: Gailliard

full_name: Cécile Gailliard

given: Cécile

ReferenceCitation: Saez L, Legrand K, Alleyrat C, Ramisasoa S, Langlois J, Muller L, Omorou AY, De Lavenne R, Kivits J, Lecomte E, Briançon S; PRALIMAP-INÈS Trial Group. Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study. BMJ Open. 2018 Jun 22;8(6):e019731. doi: 10.1136/bmjopen-2017-019731.

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

title: Using facilitator–receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study

ReferenceCitation: Saez L, Langlois J, Legrand K, Quinet MH, Lecomte E, Omorou AY, Briançon S; PRALIMAP-INÈS Trial Group. Reach and Acceptability of a Mobile Reminder Strategy and Facebook Group Intervention for Weight Management in Less Advantaged Adolescents: Insights From the PRALIMAP-INÈS Trial. JMIR Mhealth Uhealth. 2018 May 18;6(5):e110. doi: 10.2196/mhealth.7657.

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Legrand K, Lecomte E, Langlois J, Muller L, Saez L, Quinet MH, Böhme P, Spitz E, Omorou AY, Briançon S; PRALIMAP-INÈS trial group. Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INÈS trial protocol and inclusion data analysis. Contemp Clin Trials Commun. 2017 Jun 16;7:141-157. doi: 10.1016/j.conctc.2017.05.010. eCollection 2017 Sep.

journal_name: Contemporary Clinical Trials Communications

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

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


title: Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation by Combining the Analysis of the Unipolar Atrial Electrogram Modification With the Contact Force Sensing Technology: The Uniforce Study

acronym: Uniforce

summary: Prospective observational multicentric study evaluating the efficacy of considering unipolar signal modification during radio frequency catheter ablation of patients with symptomatic paroxysmal atrial fibrillation in France between November 2013 and January 2015. All procedures were conducted according to the standard clinical care and current guidelines. Pulmonary vein isolation was guided according to force (at least 10 grams) and application vector (perpendicular to the wall) developed until the atrial unipolar electrogram recording became a complete positive signal. Patients were discharged from hospital free of any anti-arrhythmic drugs. Recurrence of arrhythmias at 12 months (primary outcome) was assessed by continuous 48-hour Holter at 1, 3, 6, 9 and 12 months post-catheter ablation.

ReferenceType: result

ReferenceCitation: Bortone A, Brault-Noble G, Appetiti A, Marijon E. Elimination of the negative component of the unipolar atrial electrogram as an in vivo marker of transmural lesion creation: acute study in canines. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):905-11. doi: 10.1161/CIRCEP.115.002894. Epub 2015 Jun 19.

name: From the Service de Cardiologie, Hôpital Privé Les Franciscaines, Nîmes, France (A.B.); Département Anesthésie Réanimation Douleur Urgence, CHRU Caremeau, Nîmes, France (G.B.-N.); Biosense Webster France, Johnson & Johnson, Issy les Moulineaux, France (A.A.); Paris Cardiovascular Research Center (Inserm U970), Université Paris Descartes, Paris, France (E.M.); and Département de Cardiologie, Hôpital Européen Georges Pompidou, Paris, France (E.M.).

family: Bortone

full_name: Agustín Bortone

given: Agustín

family: Brault-Noble

full_name: Guillaume Brault-Noble

given: Guillaume

family: Appetiti

full_name: Anthony Appetiti

given: Anthony

family: Marijon

full_name: Eloi Marijon

given: Eloi

journal_name: Circulation: Arrhythmia and Electrophysiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Elimination of the Negative Component of the Unipolar Atrial Electrogram as an In Vivo Marker of Transmural Lesion Creation

ReferenceCitation: Bortone A, Appetiti A, Bouzeman A, Maupas E, Ciobotaru V, Boulenc JM, Pujadas-Berthault P, Rioux P. Unipolar signal modification as a guide for lesion creation during radiofrequency application in the left atrium: prospective study in humans in the setting of paroxysmal atrial fibrillation catheter ablation. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1095-102. doi: 10.1161/CIRCEP.113.000749. Epub 2013 Oct 4.

name: From the Service de Cardiologie, Hôpital Privé Les Franciscaines, Nîmes, France (A. Bortone, A. Bouzeman, E.M., V.C., J.-M.B., P.P.-B., P.R.); and Biosense Webster France, Johnson & Johnson, Issy les Moulineaux, France (A.A.).

family: Bouzeman

full_name: Abdeslam Bouzeman

given: Abdeslam

family: Maupas

full_name: Eric Maupas

given: Eric

family: Ciobotaru

full_name: Vlad Ciobotaru

given: Vlad

family: Boulenc

full_name: Jean-Marc Boulenc

given: Jean-Marc

family: Pujadas-Berthault

full_name: Pénélope Pujadas-Berthault

given: Pénélope

family: Rioux

full_name: Philippe Rioux

given: Philippe

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

title: Unipolar Signal Modification as a Guide for Lesion Creation During Radiofrequency Application in the Left Atrium

ReferenceCitation: Bortone A, Lagrange P, Cauchemez B, Durand C, Dieuzaide P, Prévot S, Mechulan A, Pambrun T, Martin R, Parlier P, Masse A, Marijon E, Albenque JP. Elimination of the negative component of the unipolar electrogram as a local procedural endpoint during paroxysmal atrial fibrillation catheter ablation using contact-force sensing: the UNIFORCE study. J Interv Card Electrophysiol. 2017 Sep;49(3):299-306. doi: 10.1007/s10840-017-0264-4. Epub 2017 Jun 22.

family: Lagrange

full_name: Philippe Lagrange

family: Cauchemez

full_name: Bruno Cauchemez

given: Bruno

family: Durand

full_name: Cyril Durand

given: Cyril

family: Dieuzaide

full_name: Pierre Dieuzaide

given: Pierre

family: Prévot

full_name: Sébastien Prévot

given: Sébastien

journal_name: Journal of Interventional Cardiac Electrophysiology


title: Infective Endocarditis in the Elderly: Description of the Geriatric Characteristics and Their Influence on Therapeutic Care and the Morbidity and Mortality at 3 Months (ELDERL-IE)

acronym: ELDERL-IE

summary:
ELDERL-IE is a multicenter national prospective observational study.

The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE).

The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

ReferenceCitation: Forestier E, Fraisse T, Roubaud-Baudron C, Selton-Suty C, Pagani L. Managing infective endocarditis in the elderly: new issues for an old disease. Clin Interv Aging. 2016 Sep 2;11:1199-206. doi: 10.2147/CIA.S101902. eCollection 2016. Review.

family: Forestier

full_name: Emmanuel Forestier

given: Emmanuel

family: Fraisse

full_name: Thibaut Fraisse

given: Thibaut

family: Roubaud-Baudron

full_name: Claire Roubaud-Baudron

given: Claire

family: Selton-Suty

full_name: Christine Selton-Suty

given: Christine

family: Pagani

full_name: Leonardo Pagani

given: Leonardo

currency_apc_doaj: USD

journal_name: Clinical Interventions in Aging

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Forestier E, Roubaud-Baudron C, Fraisse T, Patry C, Gavazzi G, Hoen B, Carauz-Paz P, Moheb-Khosravi B, Delahaye F, Sost G, Paccalin M, Nazeyrollas P, Strady C, Alla F, Selton-Suty C; AEPEI and the GInGer Elderl-IE study group; AEPEI and the GInGer Elderl-IE study group. Comprehensive geriatric assessment in older patients suffering from infective endocarditis. A prospective multicentric cohort study. Clin Microbiol Infect. 2019 Oct;25(10):1246-1252. doi: 10.1016/j.cmi.2019.04.021. Epub 2019 May 2.

full_name: E. Forestier

given: E.

full_name: C. Roubaud-Baudron

given: C.

full_name: T. Fraisse

given: T.

family: Patry

full_name: C. Patry

family: Gavazzi

full_name: G. Gavazzi

given: G.

family: Hoen

full_name: B. Hoen

given: B.

family: Carauz-Paz

full_name: P. Carauz-Paz

given: P.

family: Moheb-Khosravi

full_name: B. Moheb-Khosravi

family: Delahaye

full_name: F. Delahaye

given: F.

family: Sost

full_name: G. Sost

ReferenceCitation: Forestier E, Selton-Suty C, Roubaud-Baudron C. Managing infective endocarditis in older patients: do we need a geriatrician? Aging Clin Exp Res. 2021 Mar;33(3):719-722. doi: 10.1007/s40520-019-01400-6. Epub 2019 Nov 22.

journal_name: Aging Clinical and Experimental Research


title: EValuation of Cardiac Magnetic Resonance Imaging in Follow up assessmenT of Patients With Pulmonary Arterial Hypertension (EVITA)

acronym: EVITA

summary:
Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary vascular resistance leading to right ventricular failure and eventually to death. The therapeutic strategy has become complex and needs to perform recurring follow up evaluations including right heart catheterizations (RHC).

Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right ventricular volumes and important prognostic predictors such as cardiac index, stroke volume and right ventricular ejection fraction.

The main objective of EVITA is to assess the hemodynamic diagnosis performances at baseline and at follow up visits of cMRI in comparison with the results of the RHC (current guidelines) to detect an unfavorable hemodynamic status.

The primary endpoint is sensitivity and specificity of cMRI for the diagnosis of an unfavorable status defined by the current RHC criteria (with 95% confidence interval).

The secondary objectives are 1) to identify clinical and hemodynamic variables independently contributing to prognosis, 2) to describe complications due to cMRI and to RHC, 3) to compare acceptability and tolerability of cMRI over RHC for the patient and 4) to constitute biological collection of blood samples to determine diagnostic and prognostic PAH biomarkers.

PAH patients will be recruited in centers of the French network of severe pulmonary hypertension in a prospective cohort study.

180 subjects will be enrolled in the study: that size will give the study 90% power to find significant at the 5%-level.

If the primary endpoint were achieved, since first, strategies and procedures planed in this project are consistent with those currently used in routine and second, inclusion criteria are not limited to a sub-population of PAH patients, positive results could allow to broadly extend our findings.

Therefore, it will be possible to decrease the number of RHC, an invasive and cumbersome procedure without altering the prognosis. Moreover, all clinical procedures would be performed in outpatient clinics and thereby would reduce the cost to assess the severity of the disease. Current recommendations for evaluation of severity and follow-up being mainly derived from consensus of opinion of the experts, positive results will also improve the level evidence of severity assessment of PAH patients.

According to secondary objectives we expect to better predict morbimortality events with cMRI compared to RHC.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Procedure

status_simplified: Ongoing


title: Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

acronym: ORIENTIMPLANT

summary:
The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.

The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Supportive Care

status_simplified: Unknown


title: Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.

acronym: QolTENS

summary:
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.

The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU de Nantes
CHU Amiens Picardie
APHP - Hopital Saint Antoine
CHD La Roche Sur Yon
CHU Montpellier
CHU de Toulouse


title: Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery

summary:
The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life.

But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life.

This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.

location_facility: Centre Hospitalier Universitaire de Nancy


type: Other Identifier

title: Study of the Metrological Properties of Two Assessment Grids of the Driving Capacity After a Cerebrovascular Accident :Recommendations of the HAS (Hight Autority of Health in France) and Test Ride for Investigation Practical Fitness to Drive

acronym: ROADTRIP

summary:
Precise recommendations concerning the methods of evaluation for the resumption of the driving after a not evolutionary stroke were recommended recently by the High Authority of Health. These describe among others elements to be estimated during the test on the road, in the presence of the driving instructor who remains Gold standard.

However, no standardized assessment grid serving as decision-making tool is at present validated.

Actually the test made by the unit of evaluation of the automobile resumption of the university hospital on the road, in a car of apprenticeship with double pedals and in the presence of a professional binomial (driving instructor and occupational therapist) then validated by the opinion of the doctor of the service. The current standard is thus very subjective and lack of sensibility.

It is necessary to study the metrological properties of both available assessment grids (that established from the recommendations of the HAS and TRIP), none of them reached a level of validation enough in this population.

The TRIP is this day validated only at the elderly people. The hypothesis of the search is an insufficiency of TRIP to estimate the patients presenting aftereffects of cerebrovascular accident.

The main objective of this work is to validate the new assessment grid after a study of its metrological properties in the situation of the driving on the road.

status: Terminated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: Nutritional Assessment of French Hospitalized Patients Infected With COVID-19

acronym: DenutCOVID

summary:
The nutritional consequences of the infection by the SARS-CoV-2 are as follows:

A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.

Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).

lead_sponsor: Lille Catholic University


title: Relating the 'Experienced Present' With the Mechanisms of Neuronal Function: A Comparative Study in Patients With Schizophrenia and Healthy Controls Using Psychophysical and Neurophysiological Methods

summary: Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.

location_facility: Service de Psychiatrie Adulte & INSERM U841, Hôpital Albert Chenevier et Henri Mondor (AP-HP)

location_facility: INSERM U666 - Département de Psychiatrie - Hôpitaux Universitaires de Strasbourg


title: Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.

acronym: DOLOREAPEDIA

summary: The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.

ReferenceType: background

ReferenceCitation: Stanik-Hutt JA, Soeken KL, Belcher AE, Fontaine DK, Gift AG. Pain experiences of traumatically injured patients in a critical care setting. Am J Crit Care. 2001 Jul;10(4):252-9.

ReferenceCitation: Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63.

ReferenceCitation: Triltsch AE, Nestmann G, Orawa H, Moshirzadeh M, Sander M, Grosse J, Genähr A, Konertz W, Spies CD. Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study. Crit Care. 2005 Feb;9(1):R9-17. Epub 2004 Nov 10. Erratum in: Crit Care. 2005 Oct 5;9(5):426.

ReferenceCitation: Brocas E, Dupont H, Paugam-Burtz C, Servin F, Mantz J, Desmonts JM. Bispectral index variations during tracheal suction in mechanically ventilated critically ill patients: effect of an alfentanil bolus. Intensive Care Med. 2002 Feb;28(2):211-3. Epub 2002 Jan 12.

ReferenceCitation: Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. Epub 2006 May 12. French.

lead_sponsor: University Hospital, Grenoble

intervention_type: Drug


title: Leukemia Cell Cultures for Research of New Anti-cancer Therapies

summary:
The main objective of this project is not only a better understanding of the human leukemic disease but also to find new anti-leukemic or improve existing ones. This study has, the following aims:

To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade which leads to the expression of TRAIL in blood cells of patients with acute leukemia. This study will be complemented by the analysis of global gene expression (DNA chips) and of the DNA methylation state, and by chromatin immunoprecipitation experiences.
To determine the efficiency of inhibitors of enzymes responsible for the modification of chromatin (existing and new developments within the European consortium EPITRON coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of leukemic blasts.
To explore Ikaros genic and functional abnormalities (genomic deletions, mutations, abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these abnormalities may play a prognosis role.

location_facility: Service de Pédiaterie - Hôpital de Hautepierre


title: A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.

summary: This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting

lead_sponsor: VIFORFRANCE


title: Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI

summary: In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.

lead_sponsor: Pr Isabelle CONSTANT

location_facility: Departement d'anesthesie Hopital Armand Trousseau

intervention_type: Device


title: A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's Disease

summary: In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤ 40) in a randomized, double-blind, controlled study in 2 centers (France and the Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n = 50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be evaluated by measurements of caudate volume using volumetric magnetic resonance imaging and brain energy metabolism as evaluated by the ratio of inorganic phosphate/phosphocreatine, during visual stimulation, using 31P-MRS. Clinical improvement will be evaluated by UHDRS, TFC, and PBA-S scores as well as performance on the neuropsychological battery; patient quality of life will be evaluated with qualitative research methods after 6 months and with the SF-36 questionnaire before and after treatment; biological tolerance and compliance will be evaluated by routine biochemical blood tests, plasma and urine measurements of triheptanoin oil derivatives and patient report.

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

name: UCL Huntington’s Disease Centre, UCL Queen Square Institute of Neurology, University College London, London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal

name: Instituto de Medicina Molecular, Lisbon, Portugal

family: Rodrigues

full_name: Filipe B. Rodrigues

given: Filipe B.

name: CNS - Campus Neurológico Sénior, Torres Vedras, Portugal

family: Ferreira

full_name: Joaquim J. Ferreira

given: Joaquim J.

family: Wild

full_name: Edward J. Wild

given: Edward J.

journal_name: Journal of Huntington's Disease

oa_colors: green other

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Huntington’s Disease Clinical Trials Corner: June 2019

location_country: France Netherlands

location_facility:
Department of Neurology
Département de Génétique


title: Benefits of an Oocyte Pickup Simulation Training Program Using a High-fidelity Simulator for Obstetrics and Gynecology Residents

summary: The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France.

lead_sponsor: University Hospital, Angers


type: Registry Identifier

title: Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".

acronym: COGIT

summary:
Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Its anatomical substrates is based on connections between frontal and striatal areas.

Initially, a battery of behavioral tests measuring different types of impulsivity (motor, cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40 patients treated and 40 untreated) and 40 healthy volunteers.

Then, investigators will study the fronto-striatal connections in the TS group of 80 patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study of "resting state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging data to highlight the functional anatomical substrates of impulsivity in patients with TS.

Finally, investigators will look specifically using functional MRI activation, the anatomical and functional substrates of the three types of impulsivity (motor, cognitive and decision-making).

Through this study, investigators hope to elucidate the anatomical and functional bases of cognitive impulsivity in patients with TS and thus lay the basis for more targeted treatments.


title: Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Prevalence of Fish Allergy in Occupational Settings.

summary:
Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic agents, and have a high impact on human health.

Infestation results from the ingestion of living larvae from contaminated fishes. It can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. Allergic manifestations are frequently encountered in gastric forms, but isolated allergic symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous contact or Anisakis allergen inhalation have also been reported to induce allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy, Sicilia or South Africa. But no data is available in France.

In this context, the investigators propose to determine and compare the frequency and characteristics of fish allergy in fish workers (fishermen and fish-processing factory workers) and a control population of workers without occupational exposure to fish, in Boulogne-sur-Mer, which is an important fishing port in France, and the first European center for fish processing.

lead_sponsor: University Hospital, Lille

location_facility:
Service de Santé des Gens de Mer
Centre ASTIL
CHRU


title: Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome

summary:
The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.

In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.

ReferenceCitation: Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthélémy JC, Roche F. Thoracic impedance, in association with oximetry, in a multi-modal ECG Holter system is useful for screening sleep disordered breathing. Int J Cardiol. 2013 Feb 10;163(1):100-2. doi: 10.1016/j.ijcard.2012.06.082. Epub 2012 Jul 16.

family: Chouchou

full_name: Florian Chouchou

given: Florian

family: Poupard

full_name: Laurent Poupard

given: Laurent

family: Philippe

full_name: Carole Philippe

given: Carole

family: Court-Fortune

full_name: Isabelle Court-Fortune

given: Isabelle

family: Barthélémy

full_name: Jean-Claude Barthélémy

given: Jean-Claude

family: Roche

full_name: Frédéric Roche

given: Frédéric

journal_name: International Journal of Cardiology

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint-Etienne
Hôpital TENON - APHP


title: MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

acronym: MELIBIO

summary: determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

lead_sponsor: Hospital St. Joseph, Marseille, France


title: Influence of Age on amyloïd Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease Like Posterior Cortical Atrophy (PCA) and Logopenic Progressive Aphasia (LPA)Using Positron Emitting Tomography (PET) Imaging

acronym: BIOMAGE

summary:
The first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:

measuring the rate of cortical brain atrophy,
FDG imaging of glucose metabolism reflecting neuronal activity, and
for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.


title: Evaluation of the Repercussions of the Coronavirus (Covid 19) Infection on Nutritional Health Status and Nutritional Care : an Observational French Cohort Study One Month After Their Discharge From Hospital

summary: Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.


title: Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)

acronym: FLU-HOP

summary:
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:

What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?

Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:

Before the vaccination:

What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?

After the vaccination:

What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?

location_facility: Centre d'Investigations Cliniques (CIC), Hopital Cochin

intervention_type: Biological


title: A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit

acronym: TRAUMADORNASE

summary:
Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).

Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).

The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).

The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:

an improvement in static lung compliance
a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days
a reduction in the length of ICU stay
a reduction in the hospital length of stay
a reduction in multi-organ failure
a reduction in ventilator-associated pneumonia (VAP)
a reduction in mortality at day 28

ReferenceCitation: Pottecher J, Noll E, Borel M, Audibert G, Gette S, Meyer C, Gaertner E, Legros V, Carapito R, Uring-Lambert B, Sauleau E, Land WG, Bahram S, Meyer A, Geny B, Diemunsch P. Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients. Trials. 2020 Mar 18;21(1):274. doi: 10.1186/s13063-020-4141-6.

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Noll

full_name: Eric Noll

given: Eric

family: Borel

full_name: Marie Borel

given: Marie

family: Audibert

full_name: Gérard Audibert

given: Gérard

family: Gette

full_name: Sébastien Gette

given: Sébastien

family: Meyer

full_name: Christian Meyer

given: Christian

family: Gaertner

full_name: Elisabeth Gaertner

given: Elisabeth

family: Legros

full_name: Vincent Legros

given: Vincent

family: Carapito

full_name: Raphaël Carapito

given: Raphaël

family: Uring-Lambert

full_name: Béatrice Uring-Lambert

given: Béatrice

family: Sauleau

full_name: Erik Sauleau

given: Erik

family: Land

full_name: Walter G. Land

given: Walter G.

family: Bahram

full_name: Seiamak Bahram

given: Seiamak

full_name: Alain Meyer

given: Alain

family: Geny

full_name: Bernard Geny

given: Bernard

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

currency_apc_doaj: GBP

journal_name: Trials

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech


title: Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

acronym: INOGAD

summary: Older patients with cancer are poorly treated or not treated at all. A previous study in the south west of France (364 patients) showed that patients receiving chemotherapy had short survival times which strongly depended on nutritional status. In this study, the researchers would like to evaluate if individual dietician follow-up at each cycle of chemotherapy increases survival of patients at risk of undernutrition.

ReferenceCitation: Bourdel-Marchasson I, Blanc-Bisson C, Doussau A, Germain C, Blanc JF, Dauba J, Lahmar C, Terrebonne E, Lecaille C, Ceccaldi J, Cany L, Lavau-Denes S, Houede N, Chomy F, Durrieu J, Soubeyran P, Senesse P, Chene G, Fonck M. Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial. PLoS One. 2014 Sep 29;9(9):e108687. doi: 10.1371/journal.pone.0108687. eCollection 2014.

family: Bourdel-Marchasson

full_name: Isabelle Bourdel-Marchasson

given: Isabelle

family: Blanc-Bisson

full_name: Christelle Blanc-Bisson

given: Christelle

family: Doussau

full_name: Adélaïde Doussau

given: Adélaïde

family: Germain

full_name: Christine Germain

given: Christine

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Lahmar

full_name: Cyril Lahmar

given: Cyril

family: Terrebonne

full_name: Eric Terrebonne

family: Lecaille

full_name: Cédric Lecaille

given: Cédric

family: Ceccaldi

full_name: Joël Ceccaldi

given: Joël

family: Cany

full_name: Laurent Cany

given: Laurent

family: Lavau-Denes

full_name: Sandrine Lavau-Denes

given: Sandrine

family: Houede

full_name: Nadine Houede

given: Nadine

family: Chomy

full_name: François Chomy

given: François

family: Durrieu

full_name: Jessica Durrieu

given: Jessica

family: Soubeyran

full_name: Pierre Soubeyran

family: Senesse

full_name: Pierre Senesse

family: Chene

full_name: Geneviève Chene

given: Geneviève

family: Fonck

full_name: Mariane Fonck

given: Mariane

journal_name: PLoS ONE

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

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

title: Nutritional Advice in Older Patients at Risk of Malnutrition during Treatment for Chemotherapy: A Two-Year Randomized Controlled Trial

location_facility: Institut Bergonié - 229 Cours de l'Argonne

location_facility: Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque


title: RELATIONSHIP BETWEEN THORACIC AORTIC STRUCTURE ASSESSED BY PET/CT SCAN AND ARTERIAL STIFFNESS IN ELDERLY PATIENTS: FICTEP STUDY

acronym: FICTEP

summary:
The purpose of this study is to determine the relationship between thoracic aortic inflammation and arterial stiffness in elderly patients.

Vascular-aging is accompanied by a gradual remodeling affecting both cardiac and arterial walls. Arterial hypertension, an established cardiovascular risk factor, has been suggested to exert pro-inflammatory actions threw several biological mediators enhancing arterial stiffness. Both effects of aging and hypertension are associated with higher levels of arterial stiffness, but their respective role is not well established in the pathophysiology of arterial stiffening.

Few data are available neither on the real anatomic aortic impact of aging and hypertension on aortic compliance and ventricular function and its relationship to arterial stiffness assessed by carotid-femoral pulse wave velocity, nor on the reliability of cine phase contrast magnetic resonance imaging arterial stiffness measurements.

Recent studies using positron emission tomography imaging (PET) with 18 F fluorodeoxyglucose (FDG) has been advocated as a means of measuring arterial wall inflammation in various population referred for oncology staging. FDG uptake is correlated with the number of cardiovascular risk factors and even the risk of future cardiovascular events. This method, combined with X-ray computed tomography (CT), has also demonstrated that aortic calcifications quantified by CT and local signs of inflammation detected by FDG uptake contribute to arterial stiffness. A strong relationship between large vessels stiffening assessed by carotid-femoral pulse wave velocity measurement, aortic calcifications quantified by CT and inflammation evaluated by FDG uptake has been demonstrated.

Therefore, in the current study, we use FDG PET associated to CT to characterize aortic inflammation and aortic calcifications coupled to pulse wave velocity measurement and cardiac function in elderly individuals.

In fact, if vascular aging promoting a local inflammatory process is a risk factor for cardiovascular disease, then vascular changes assessed by non-invasive vascular imaging (MRI,FDG PET) could represent a potential target for treatment and prevention Thirty individuals ≥ 65 years of age were examined, 15 hypertensive subjects and 15 controls. Pulse wave velocity, a surrogate for aortic stiffness, was measured both by cine phase contrast magnetic resonance imaging and applanation tonometry. Brachial pulse pressure, carotid calculated pulse pressure and pulse pressure amplification (brachial to carotid ratio), predictors of cardiovascular mortality were also quantified. Thoracic aorta local inflammation and calcification were measured by 18 F-fluorodeoxyglucose positron emission tomography/computed tomography imaging. Moreover, biomarkers of low grade inflammation (high-sensitivity C-reactive protein, interleukin 6 were also determined).

ReferenceCitation: Joly L, Mandry D, Verger A, Labat C, Watfa G, Roux V, Karcher G, Marie PY, Benetos A. Influence of Thoracic Aortic Inflammation and Calcifications on Arterial Stiffness and Cardiac Function in Older Subjects. J Nutr Health Aging. 2016 Mar;20(3):347-54. doi: 10.1007/s12603-015-0574-0.

family: Joly

full_name: Laure Joly

given: Laure

family: Mandry

full_name: D. Mandry

given: D.

family: Verger

full_name: A. Verger

given: A.

family: Labat

full_name: C. Labat

given: C.

family: Watfa

full_name: G. Watfa

given: G.

family: Roux

full_name: V. Roux

given: V.

family: Karcher

full_name: G. Karcher

family: Marie

full_name: P.-Y. Marie

family: Benetos

full_name: A. Benetos

journal_name: The journal of nutrition, health & aging

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Influence of thoracic aortic inflammation and calcifications on arterial stiffness and cardiac function in older subjects


title: Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies

acronym: Psy-Greffe

summary: Identify the psychological factors (i.e. personality and transactional factors), beneficial and deleterious, at different phases of the transplant process, on the patient's mental health (quality of life, short and long-term post-transplant recovery) and physical health (e.g. infections, relapse, length of hospitalization or even death).

ReferenceCitation: Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, De La Tour RP, Dambrun M. Retrospective and prospective measures of post-traumatic growth reflect different processes: longitudinal evidence of greater decline than growth following a hematopoietic stem-cell transplantation. BMC Psychiatry. 2021 Jan 11;21(1):27. doi: 10.1186/s12888-020-03007-y.

family: Corman

full_name: Maya Corman

given: Maya

family: Rubio

full_name: Marie-Thérèse Rubio

given: Marie-Thérèse

family: Cabrespine

full_name: Aurélie Cabrespine

given: Aurélie

family: Brindel

full_name: Isabelle Brindel

given: Isabelle

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

family: De La Tour

full_name: Régis Peffault De La Tour

given: Régis Peffault

family: Dambrun

full_name: Michaël Dambrun

given: Michaël

journal_name: BMC Psychiatry

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

lead_sponsor: Saint-Louis Hospital, Paris, France

intervention_type: Behavioral


location_facility:
CHU de Saint-Etienne
Hopital Pitié Salpetrière - APHP


title: AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS

acronym: OPALINE

summary: A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.

time_perspective: Other

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition

location_facility: Hopital Edouard Herriot, Pavillion O, Oncologie Medicale

location_facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo

location_facility: Unite d'Oncologie Digestive, Departement d'HGE

location_facility: Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H

location_facility: Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive

location_facility: Hopital La Timone Service de Gastroenterologie et Oncologie Digestive

location_facility: Hopital de LA Source, Centre Hospitalier Regional


title: Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020

acronym: OBVIONCO

summary: This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.

status: Active, not recruiting

ReferenceCitation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

family: Chen

full_name: Nanshan Chen

given: Nanshan

family: Zhou

full_name: Min Zhou

given: Min

family: Dong

full_name: Xuan Dong

given: Xuan

family: Qu

full_name: Jieming Qu

given: Jieming

family: Gong

full_name: Fengyun Gong

given: Fengyun

family: Han

full_name: Yang Han

given: Yang

family: Qiu

full_name: Yang Qiu

family: Wang

full_name: Jingli Wang

given: Jingli

family: Liu

full_name: Ying Liu

given: Ying

family: Wei

full_name: Yuan Wei

given: Yuan

family: Xia

full_name: Jia'an Xia

given: Jia'an

family: Yu

full_name: Ting Yu

given: Ting

family: Zhang

full_name: Xinxin Zhang

given: Xinxin

full_name: Li Zhang

given: Li

journal_name: The Lancet

oa_colors: green hybrid

ReferenceCitation: Gliklich RE, Dreyer NA, Leavy MB, Christian JB, editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK493818/

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology

acronym: OCTAV

summary: OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).


acronym: GALAXY

summary: OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).


title: Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes

acronym: CATHY

summary: In a large prospective cross-sectional study, the investigators aimed to identify the determinants of thyroid surgery outcomes and quantify the relative influence of preoperative and intraoperative factors. For this purpose, the investigators considered the interplay of several characteristics specific to surgeons, patients, and surgical procedures.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


title: A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France

acronym: Lympho-TEC

summary:
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation because of lymphopenia, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants.

The secondary objectives of the study are characterization of lymphopenia; characterization of lymphopenia having led to DMF discontinuation treatment; description of the evolution of ALC during DMF treatment; description of discontinuation of DMF treatment; exploration of clinical outcomes in participants with lymphopenia on DMF and/or after DMF discontinuation due to lymphopenia; description of vigilance and participant management overall and in participants with lymphopenia who continued DMF treatment; incidence's assessment of opportunistic or serious infections; investigation of the potential impact of baseline demographic and disease characteristics in risk of developing lymphopenia while on DMF; investigation of the potential impact of baseline demographics on the kinetics of ALC reconstitution upon discontinuation of DMF; investigation of the changes of lymphocyte subtypes in participants on DMF if available.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen


title: High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study

summary:
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

lead_sponsor: Theraclion

location_facility: Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret


title: Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial

acronym: OBESITE

summary:
Faced with the current obesity epidemic, new avenues of research into effective weight loss must be developed.

Among the possible actions on obesity, vagus nerve stimulation has been shown in several studies to be effective in treating epilepsy or depression, at the same time inducing weight loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss in experimental animal studies. Vagus nerve stimulation has never been attempted in obese patients awaiting bariatric surgery.


title: Light Therapy in Parkinson's Disease : Effect on Motor Symptoms, Sleep, Circadian Rhythms, and Mood

summary: Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT) represents one such innovative therapeutic approach. Although light has an obvious to visual pathways within the brain, today it is known to additionally exert non-visual effects throughout the body. Recently our team has shown that non-visual, non-circadian light plays a major role in the regulation of sleep, as well as cognitive brain function in general. The retina, the primary conduit for the transmission of light information is weakened or thinned in Parkinson's patients. The dopamine system is known to enhance the processing of light information and intraocular injection of L-dopa in animal models of Parkinson's disease, can reverse associated motor symptoms. This allows for the possibility that LT would strengthen the dopaminergic tone in the central nervous system. However, to this date its effectiveness for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly controlled. Thus, through the convergence of basic and clinical data, a study examining the effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the effects on sleep, circadian system, mood, and cognitive functioning, is of extreme importance. With this information our hope is to determine if these polymorphisms allow for a predictive model of response to LT treatment.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
Hospices Civils de Lyon
University Hospital, Strasbourg, france


title: Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

acronym: SEROSARSCOV

summary:
Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instuction des Armées Sainte-Anne

location_facility: Hôpital d'Instruction des Armées Robert Picqué


title: Validation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography

acronym: TELERESP

summary: Determing optimal time of ventilator disconnection is a challenge for both acute and chronic neuromuscular disease. In one case it is helpful for weanning from ventilator and in the other to optimize daytime ventilation in the most severe patients. The investigators propose to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular patients in both acute and chronic conditions.

ReferenceCitation: Modalités pratiques de la ventialtion non invasive en pression positive, au long cours, a domicile, dans les maladies neuromusculaires. Rev Mal Respir 2006;23:S3-S40. Toussaint M, Steens M, Wasteels G, Soudon P. Diurnal ventilation via mouthpiece: survival in end-stage Duchenne patients. Eur Respir J 2006;28(3):549-55. Seneviratne J, Mandrekar J, Wijdicks EF, Rabinstein AA. Predictors of extubation failure in myasthenic crisis. Arch Neurol 2008;65(7):929-33. Prigent H, Orlikowski D, Letilly N, Falaize L, Annane D, Sharshar T, et al. Vital Capacity Versus Maximal Inspiratory Pressure in Patients with Guillain-Barre Syndrome and Myasthenia Gravis. Neurocrit Care. Kohler M, Clarenbach CF, Bahler C, Brack T, Russi EW, Bloch KE. Disability and survival in Duchenne muscular dystrophy. J Neurol Neurosurg Psychiatry 2009;80(3):320-5. Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr 1987;111(3):377-83. Calabrese P, Besleaga T, Eberhard A, Vovc V, Baconnier P. Respiratory inductance plethysmography is suitable for voluntary hyperventilation test. Conf Proc IEEE Eng Med Biol Soc 2007;2007:1055-7. Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol 2001;499:489-94. Redline S, Budhiraja R, Kapur V, Marcus CL, Mateika JH, Mehra R, et al. The scoring of respiratory events in sleep: reliability and validity. J Clin Sleep Med 2007;3(2):169-200.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III French Satellite

summary:
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

lead_sponsor: Biotronik France

location_facility: Hôpital Nord de Marseille, Service de Cardiologie

location_facility: Clinique St Augustin, Service Cardiologie Interventionnelle

location_facility: Clinique Convert, Cardiologie Interventionnelle

location_facility: CHU de Clermont Ferrand, Hôpital Gabriel Montpied


title: Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)

acronym: Becker-HS

summary: The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

lead_sponsor: Karim WAHBI


title: Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study

acronym: POINCARE

summary: Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.

ReferenceCitation: Agrinier N, Monnier A, Argaud L, Bemer M, Virion JM, Alleyrat C, Charpentier C, Ziegler L, Louis G, Bruel C, Jamme M, Quenot JP, Badie J, Schneider F, Bollaert PE. Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2. Contemp Clin Trials. 2019 Aug;83:109-116. doi: 10.1016/j.cct.2019.06.020. Epub 2019 Jun 29.

lead_sponsor: Central Hospital, Nancy, France

location_facility: Centre Hospitalier Régional et Universitaire

location_facility: CentreHospitalier Régional et universitaire


title: Evaluating of the Benefit to the Patient by Managing of His Anticoagulation Treatment by an Anti-coagulation Clinic

acronym: CREATIF

summary:
Main objective: To evaluate the impact of CREATIF (an anticoagulation clinic in Ile de France) on monitoring and management of patients treated with VKAs compared with usual primary care.

Study hypothesis: The investigators suppose that patients will have a better quality of anticoagulation when they are managed by CREATIF than by their usual General Physicians (GP)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'hématologie - Hôpital Lariboisière


title: Seroprevalence of SARS-CoV-2 Infection in Patients With HIV Infection

acronym: COCOVIH

summary:
As of May 26, 2020, 5,508,904 confirmed cases (145,279 in France) of COVID-19 and 346,508 deaths (28,457 in France) have been reported since December 8, 2019 worldwide. The rapid increase in the number of cases in our territory caused France to pass to level 3 of the epidemic on March 14, 2020.

The natural history of this disease is still poorly understood, particularly in patients infected with HIV, patients considered to be at higher risk for severe forms.

Knowing the seroprevalence in the population of people living with HIV will make it possible to better understand the Covid infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time, specify the protective nature or not of these antibodies detected.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: French Register of Patients With Spinal Muscular Atrophy

acronym: SMA

summary: The primary objectives of the study are to obtain clinically meaningful data on survival and outcomes of all the patients with spinal muscular atrophy (SMA) 5q types 1 through 4 (according to international classification), being followed in the reference centers of the disease in France between September 1, 2016 and August 31, 2024. The registry will collect retrospectively and prospectively the longitudinal data of the long-term follow-up for child and adult patients, under real life conditions of current medical practice, in order to document the clinical evolution of patients (survival, motor, respiratory, orthopedic and nutritional), the conditions of use of the treatments, the mortality rates of treated and untreated patients, the tolerance of the treatments, adverse events in order to better define their places in the therapeutic strategy.

location_facility: Unité neuromusculaire, Service de Neurologie et Réanimation Pédiatrique, (French neuromuscular reference network (FILNEMUS), Hôpital Raymond Poincaré,


title: Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia. A Randomized Controlled Trial

summary: This Multicenter, Randomized Controlled Trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND) with NIR vs without NIR use during surgery.

ReferenceCitation: Duclos A, Peix JL, Colin C, Kraimps JL, Menegaux F, Pattou F, Sebag F, Touzet S, Bourdy S, Voirin N, Lifante JC; CATHY Study Group. Influence of experience on performance of individual surgeons in thyroid surgery: prospective cross sectional multicentre study. BMJ. 2012 Jan 10;344:d8041. doi: 10.1136/bmj.d8041.

ReferenceCitation: McWade MA, Sanders ME, Broome JT, Solórzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9.

ReferenceCitation: Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chéreau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.

name: Endocrine Surgery Unit, Hôpital Européen Marseille, Marseille, France

family: Benmiloud

full_name: Fares Benmiloud

given: Fares

name: General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France

family: Godiris-Petit

full_name: Gaelle Godiris-Petit

given: Gaelle

name: Head and Neck Surgery Unit, Hôpital Saint-Joseph, Marseille, France

family: Gras

full_name: Régis Gras

given: Régis

family: Gillot

full_name: Jean-Charles Gillot

given: Jean-Charles

name: General and Endocrine Surgery Unit, Hôpital Saint-Joseph, Marseille, France

family: Turrin

full_name: Nicolas Turrin

given: Nicolas

name: Biostatistic, Alphabio, Marseille, France

family: Penaranda

full_name: Guillaume Penaranda

given: Guillaume

family: Noullet

full_name: Séverine Noullet

given: Séverine

family: Chéreau

full_name: Nathalie Chéreau

given: Nathalie

name: Aix Marseille Université, Assistance Publique–Hôpitaux de Marseille, Institut National de la Santé et de la Recherche Médicale, L'Institut de Recherche Pour le Développement, Sciences Économiques et Sociales de la Santé et Traitement de L'information Médicale, Hôpital Timone, BioSTIC, Biostatistics & Information and Communication Technology, Marseille, France

family: Gaudart

full_name: Jean Gaudart

given: Jean

name: Internal Medicine Unit, Hôpital Européen Marseille, Marseille, France

family: Chiche

full_name: Laurent Chiche

given: Laurent

family: Rebaudet

full_name: Stanislas Rebaudet

given: Stanislas

journal_name: JAMA Surgery

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hôpital Saint Joseph Marseille
Hopital La Pitie Salpetriere
Hopital Europeen


title: Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

summary:
In recent years, several studies confirm that some of preterm children have language developmental disabilities, in production, in comprehension, or in written language. These language impairments lead to learning disabilities. There are, however, contradictions concerning the origin and nature of language dysfunctions. Some studies find lexical disorders (number of words used by the child), others preferentially phonological disorders (sounds used in the language), others also disorders of the morphosyntaxe (organization of the sentences) and fragilities that affect pragmatics (understanding situations).

The computer-evaluation of the language is carried out at five and a half year coupled with the medical and neuropsychological examinations. The language assessment lasts 30 to 45 minutes per child. It is carried out using a laptop computer that allows the submission of stimuli and recording of the child's responses. The language evaluation scale is the battery CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language evaluation. The assessment includes three tests: comprehension of words and phrases, production of words and phrases, and judgment of sentences. Each time, the child sees images and hears words or phrases. Sometimes he has to say what he sees on the computer screen.

As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years in the context of the follow-up of children born very preterm.

The evaluation proposed to the child in this research will be carried out at a significant period of development, before writing. This assessment will not only assess the structure of the child's language, but also determine if there are possible difficulties in learning to read and write.

The expected benefits for the health of the children included in the trial therefore concern the detection or characterization of any developmental fragilities affecting the language. These screenings or characterizations will make it possible to advocate a speech rehabilitation if necessary.

lead_sponsor: University Hospital, Rouen


title: Impact of Health Literacy Training for General Practitioners and a Consumer Facing Intervention to Improve Colorectal Cancer Screening in Underserved Areas: A Multicentric Cluster Randomized Controlled Trial

acronym: DECODE

summary: The aim of this project is to assess the impact of a health literacy (HL) intervention combining HL and CRC screening training for general practitioners with a short brochure and video targeting eligible patients to increase CRC screening and other secondary outcomes in four underserved geographic areas in France. The investigators will use a two-arm randomized controlled cluster trial at 8 clusters (2 per area) primarily serving underserved populations across 4 geographic areas in France with 32 primary care physicians and 1024 patients recruited.

ReferenceCitation: Durand MA, Lamouroux A, Redmond NM, Rotily M, Bourmaud A, Schott AM, Auger-Aubin I, Frachon A, Exbrayat C, Balamou C, Gimenez L, Grosclaude P, Moumjid N, Haesebaert J, Massy HD, Bardes J, Touzani R, Diant LBEF, Casanova C, Seitz JF, Mancini J, Delpierre C. Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial. BMC Public Health. 2021 Sep 16;21(1):1684. doi: 10.1186/s12889-021-11565-3.

family: Durand

full_name: Marie-Anne Durand

given: Marie-Anne

family: Lamouroux

full_name: Aurore Lamouroux

given: Aurore

family: Redmond

full_name: Niamh M. Redmond

given: Niamh M.

family: Rotily

full_name: Michel Rotily

given: Michel

family: Bourmaud

full_name: Aurélie Bourmaud

given: Aurélie

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Auger-Aubin

full_name: Isabelle Auger-Aubin

given: Isabelle

family: Frachon

full_name: Adèle Frachon

given: Adèle

family: Exbrayat

full_name: Catherine Exbrayat

given: Catherine

family: Balamou

full_name: Christian Balamou

given: Christian

family: Gimenez

full_name: Laëtitia Gimenez

given: Laëtitia

family: Grosclaude

full_name: Pascale Grosclaude

given: Pascale

family: Moumjid

full_name: Nora Moumjid

given: Nora

family: Haesebaert

full_name: Julie Haesebaert

given: Julie

family: Massy

full_name: Helene Delattre Massy

given: Helene Delattre

family: Bardes

full_name: Julia Bardes

given: Julia

family: Touzani

full_name: Rajae Touzani

given: Rajae

family: Diant

full_name: Laury Beaubrun en Famille Diant

given: Laury Beaubrun en Famille

family: Casanova

full_name: Clémence Casanova

given: Clémence

family: Seitz

full_name: Jean François Seitz

given: Jean François

family: Mancini

full_name: Julien Mancini

given: Julien

family: Delpierre

full_name: Cyrille Delpierre

given: Cyrille

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

location_facility: Service de recherche et épidémiologie cliniques


title: Valuation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication

acronym: EGERIPP 2

summary:
Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs), prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects, symptomatic treatment of gastroesophageal reflux disease (GERD), esophagitis by GERD, maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome.

Several misuse situations had been identified by the High Authority of Health (HAS) in its reassessment in 2009.

Although these molecules are very well tolerated in the short term, studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections, Clostridium difficile infections and an increased risk of fractures.


title: Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide

acronym: SMOF

summary: SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.

status: Withdrawn

intervention_type: Dietary Supplement


title: Observational Study on Patients With Rasmussen Encephalitis Treated With Adalimumab: Efficacy and Tolerance in the Short and Long Term

summary: Since the initial study of cases reported between 2009 and 2015, adalimumab has become in France the immunomodulatory reference treatment used after failure of corticosteroids and immunoglobulins before a possible recourse to the hemispherotomy. This observational study is intended to document the long-term efficacy and safety of Adalimumab therapy in patients with Rasmussen encephalitis.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Inflatable Penile Prostheses : Predicting Factors of Pump Misuse and Unsatisfaction

summary:
Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of phosphodiesterase type 5 (PDE5) inhibitors in 1998. Nevertheless, a significant part of patients are intolerant or does not respond to PDE5 inhibitors and thus are looking for other treatment options.

Since the first implantation of foreign material intracarvernosally in 1966 by Beheri, multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance. First introduced in 1973 by Scott et al., inflatable prosthesis provides now high general satisfaction rates (69-94%), better than in malleable prostheses, except for few authors.

In addition to changes in materials and construction, the two main manufacturers of IPP, Boston scientific AMS (Marlborough, MA, USA) and Coloplast (Minneapolis, MN, USA), modernized the pump mechanism of their devices. Since the introduction of AMS IPP, three main pump formats have been used : the standard pump has been replaced in 2004 by the " Tactile " pump and then the " Momentary Squeeze " (MS) pump in 2006, smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation. Coloplast also replaced in 2008 their " Genesis " pump by a " One Touch Release " (OTR) pump, and finally in 2014 by the current " Touch " pump, smaller, and presenting a biconcave deflation button, easier to find.

Despite all technological advances, appropriate pre-operative counselling and careful post-operative teachning, a significant part of patients has still difficulties to handle the pump and thus, does not use their IPP, regardless of any material malfunction. That situation obviously leads to patient's dissatisfaction and highlights the operating risks of a useless surgical procedure.

The purposes of this study were:to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation, then to show a correlation between easy handling and post-operative satisfaction. And last but not least, to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling. That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction.

ipd_sharing_description: No data sharing plan has been established.

lead_sponsor: Centre Hospitalier Universitaire de Nice