title: A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.

acronym: PREGRALL

summary: Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.

ReferenceCitation: Cabridain C, Aubert H, Kaeffer B, Badon V, Boivin M, Dochez V, Winer N, Faurel-Paul E, Planche L, Riochet D, Maruani A, Perrotin F, Droitcourt C, Lassel L, Tching-Sin M, Rogers NK, Bodinier M, Barbarot S. Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e024974. doi: 10.1136/bmjopen-2018-024974.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

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

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

location_facility:
Centre Hospitalo Universitaire
CHU Nantes
CHD Vendée
CHU Angers
University Hospital

titre: Etude multicentrique, en double insu, randomisée versus placebo, visant à évaluer l'efficacité d'une supplémentation maternelle anténatale en prébiotiques GOS/Inuline sur la survenue d'une dermatite atopique à un an chez le nourrisson à risque d'atopie.

nom_porteur: AUBERT

prenom_porteur: Hélène


title: Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

acronym: ERHEA

summary:
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.

The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.

Secondary endpoint consist in:

Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
Estimate the embolic risk of haemophilia patients with atrial fibrillation

Population description:

Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Desjonqueres A, Guillet B, Beurrier P, Pan-Petesch B, Ardillon L, Pineau-Vincent F, Sigaud M, Fouassier M, Ternisien C, Gillet B, Bene MC, Horvais V, Lienhart A, Trossaert M. Bleeding risk for patients with haemophilia under antithrombotic therapy. Results of the French multicentric study ERHEA. Br J Haematol. 2019 May;185(4):764-767. doi: 10.1111/bjh.15606. Epub 2018 Oct 18. No abstract available.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: Nantes University Hospital

location_facility:
Lyon University Hospital
Le Mans Hospital
Tours University Hospital
Angers University Hospital
Brest University Hospital
Rennes University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (GTN)

acronym: TROPHIMMUN

summary:
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens.

Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life. There is a need for modern targeted agents with better benefit/toxicity profiles.

There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :

Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.

study_type: Interventional

primary_purpose: Treatment

ReferenceCitation: You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Joly F, Hajri T, Maucort-Boulch D, Bin S, Rousset P, Devouassoux-Shisheboran M, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Langlois-Jacques C, Mercier C, Villeneuve L, Freyer G, Golfier F. Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial. J Clin Oncol. 2020 Sep 20;38(27):3129-3137. doi: 10.1200/JCO.20.00803. Epub 2020 Jul 27.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole

intervention_type: Drug


title: Validation of an Allergic Rhinitis Control Test in Children

acronym: ARCTEnfants

summary: Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: University Hospital, Montpellier

location_facility:
Maison de santé de Lasalle
CH Louis Pasteur
Hôpital Trousseau,
Centre (Ctre) Medical Ravas - Malbosc
CH de MILLAU
University hospital of Montpellier

status_simplified: Ongoing


title: Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)

summary:
The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.

Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.

The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.

status: Active, not recruiting

design_allocation: Randomized

lead_sponsor: Poitiers University Hospital

location_facility:
Hospital center
Hospital Center
University Hospital Center

intervention_type: Behavioral


title: Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

acronym: Rexochir

summary: This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy

primary_purpose: Supportive Care

ReferenceCitation: Laurent H, Galvaing G, Thivat E, Coudeyre E, Aubreton S, Richard R, Kwiatkowski F, Costes F, Filaire M. Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial. BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: Centre Jean Perrin

location_facility: Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel

location_facility: CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,

location_facility: Centre de Recherche en Nutrition Humaine

lead_sponsor_type: industriel

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LUTTE CONTRE LE CANCER J.PERRIN

type_etablissement: CLCC

acronyme: Rexochir

titre: Effet d'une réadaptation à l'effort pré-opératoire avant chirurgie d'exérèse d'un cancer bronchopulmonaire

discipline_principale: cancer

nom_porteur: FILAIRE

prenom_porteur: Marc


summary: The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals

status: Unknown status

time_perspective: Retrospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
IME notre Ecole
IME Eclair
IME Le Reverdi
Association Agir et Vivre l'Autisme
Hôpital Sainte Anne
Association UNI-TEDS

status_simplified: Unknown


acronym: PANIRINOX

lead_sponsor: UNICANCER

summary:
National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.

Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.

location_facility: CHU Carémeau - Institut de Cancérologie du Gard

title: Phase II Randomized Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis

type: EudraCT Number

source: euctr

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

ipd_sharing: Yes


title: Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants

acronym: CACAOD

summary:
This is a prospective, multicentric, randomized, open labeled superiority trial

This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.

The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).

A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Angers

location_facility:
CH Le MANS
Chu Angers
CHU de Poitiers
CHU de St Etienne
CHU Clermont-ferrand

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: CACAOD

titre: Intérêt de l'administration de charbon activé pour les patients ayant un geste invasif reporté dû à un traitement anticoagulant oral direct CACAOD

discipline_principale: autre

nom_porteur: MOUMNEH

prenom_porteur: Thomas


title: Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

summary: Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

lead_sponsor: Oticon Medical

location_facility:
Hôpital la Pitié Salpêtrièr
CHU Tours Bretonneau
Hôpital Rothschild
CHU Lyon Hôpital Edouard Herriot
CHU Rennes Pontchaillou
CHRU Lille Hôpital Roger Salengro

intervention_type: Device


title: Evaluation in Real Life Conditions of Sacubitril-valsartan Combination in Patients With Chronic Heart Failure and Sleep Apnea Syndrome

summary:
Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS.

SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality.

The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Jaffuel D, Molinari N, Berdague P, Pathak A, Galinier M, Dupuis M, Ricci JE, Mallet JP, Bourdin A, Roubille F. Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design. ESC Heart Fail. 2018 Jun;5(3):222-230. doi: 10.1002/ehf2.12270. Epub 2018 Feb 22.

ReferenceType: result

ReferenceCitation: Jaffuel D, Nogue E, Berdague P, Galinier M, Fournier P, Dupuis M, Georger F, Cadars MP, Ricci JE, Plouvier N, Picard F, Puel V, Mallet JP, Suehs CM, Molinari N, Bourdin A, Roubille F. Sacubitril-valsartan initiation in chronic heart failure patients impacts sleep apnea: the ENTRESTO-SAS study. ESC Heart Fail. 2021 Aug;8(4):2513-2526. doi: 10.1002/ehf2.13455. Epub 2021 Jun 8.

oa_host_type: repository

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

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

unpaywall_oa_status: green

ipd_sharing: Undecided

location_facility: Centre Hospitalier Universitaire de Montpellier


type: Other Grant/Funding Number

title: Assessment of the Prevalence and Severity of Urinary and Ano-rectal Functional Disorders and Their Impact on Quality of Life and Sexuality on CF Adults of the North-West CF Network

acronym: PerineoMuco

summary: This observational study evaluates prevalence of functional perinea disorders (stress urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and social life and relationships ; identify the medical and demographic factors associated with the severity of urinary and anorectal disorders and their impact and determine the relationship between the severity of these disorders, various repercussions, and risk factors.

lead_sponsor: Fondation Ildys

sponsor_collaborators:
Fondation Ildys
Vaincre la Mucoviscidose
University Hospital, Brest

location_facility: CF Center - Fondation Ildys Site de Perharidy

location_facility: CF Center - Groupe Hospitalier Sud Réunion


title: Benefits Evaluation of Selfia® Adapted Underwear for Multiple Sclerosis Patients With Severe to Moderate Handicap Performing Self-catheterization : a Multicenter, Prospective, Uncontrolled and Before/After Study.

acronym: KML

summary:
KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the realization of self-catheterisation (SC) for patients affected by multiple sclerosis with severe to moderate disability.

Secondly, the study aims to :

Estimate the effect of underwear on quality of life, tiredness linked to the act, comfort in the realization of SC, complications with SC, third party intervention ;
Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd week of evaluation ;
Measure if the patient reused underwear and if he bought it at 6 months and at 1 year

status: Withdrawn

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled Trial

acronym: AVASMUC

summary: Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial colonization is facilitated by a reduced mucociliary function and some previous studies suggest that the microbiology of the upper airways might influence the microbiology of the lower airway. The aim of this randomized control study is to demonstrate efficacy of antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores, quality of life and lung function

status: Terminated

ReferenceCitation: Aanaes K, von Buchwald C, Hjuler T, Skov M, Alanin M, Johansen HK. The effect of sinus surgery with intensive follow-up on pathogenic sinus bacteria in patients with cystic fibrosis. Am J Rhinol Allergy. 2013 Jan;27(1):e1-4. doi: 10.2500/ajra.2013.27.3829.

ReferenceCitation: Berkhout MC, Rijntjes E, El Bouazzaoui LH, Fokkens WJ, Brimicombe RW, Heijerman HG. Importance of bacteriology in upper airways of patients with Cystic Fibrosis. J Cyst Fibros. 2013 Sep;12(5):525-9. doi: 10.1016/j.jcf.2013.01.002. Epub 2013 Jan 26.

ReferenceCitation: Boucher RC. Human airway ion transport. Part one. Am J Respir Crit Care Med. 1994 Jul;150(1):271-81. doi: 10.1164/ajrccm.150.1.8025763. No abstract available.

ReferenceCitation: Boucher RC. Human airway ion transport. Part two. Am J Respir Crit Care Med. 1994 Aug;150(2):581-93. doi: 10.1164/ajrccm.150.2.8049852. No abstract available.

ReferenceCitation: Coste A, Gilain L, Roger G, Sebbagh G, Lenoir G, Manach Y, Peynegre R. Endoscopic and CT-scan evaluation of rhinosinusitis in cystic fibrosis. Rhinology. 1995 Sep;33(3):152-6.

ReferenceCitation: Digoy GP, Dunn JD, Stoner JA, Christie A, Jones DT. Bacteriology of the paranasal sinuses in pediatric cystic fibrosis patients. Int J Pediatr Otorhinolaryngol. 2012 Jul;76(7):934-8. doi: 10.1016/j.ijporl.2012.02.043. Epub 2012 Apr 17.

ReferenceCitation: Durand M, Pourchez J, Aubert G, Le Guellec S, Navarro L, Forest V, Rusch P, Cottier M. Impact of acoustic airflow nebulization on intrasinus drug deposition of a human plastinated nasal cast: new insights into the mechanisms involved. Int J Pharm. 2011 Dec 12;421(1):63-71. doi: 10.1016/j.ijpharm.2011.09.023. Epub 2011 Sep 21.

ReferenceCitation: Durand M, Le Guellec S, Pourchez J, Dubois F, Aubert G, Chantrel G, Vecellio L, Hupin C, De Gersem R, Reychler G, Pitance L, Diot P, Jamar F. Sonic aerosol therapy to target maxillary sinuses. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):244-50. doi: 10.1016/j.anorl.2011.09.002. Epub 2012 Aug 24.

ReferenceCitation: Gysin C, Alothman GA, Papsin BC. Sinonasal disease in cystic fibrosis: clinical characteristics, diagnosis, and management. Pediatr Pulmonol. 2000 Dec;30(6):481-9. doi: 10.1002/1099-0496(200012)30:63.0.co;2-n.

ReferenceCitation: Hansen SK, Rau MH, Johansen HK, Ciofu O, Jelsbak L, Yang L, Folkesson A, Jarmer HO, Aanaes K, von Buchwald C, Hoiby N, Molin S. Evolution and diversification of Pseudomonas aeruginosa in the paranasal sinuses of cystic fibrosis children have implications for chronic lung infection. ISME J. 2012 Jan;6(1):31-45. doi: 10.1038/ismej.2011.83. Epub 2011 Jun 30.

ReferenceCitation: Kahl BC, Duebbers A, Lubritz G, Haeberle J, Koch HG, Ritzerfeld B, Reilly M, Harms E, Proctor RA, Herrmann M, Peters G. Population dynamics of persistent Staphylococcus aureus isolated from the airways of cystic fibrosis patients during a 6-year prospective study. J Clin Microbiol. 2003 Sep;41(9):4424-7. doi: 10.1128/JCM.41.9.4424-4427.2003.

ReferenceCitation: Knowles MR, Robinson JM, Wood RE, Pue CA, Mentz WM, Wager GC, Gatzy JT, Boucher RC. Ion composition of airway surface liquid of patients with cystic fibrosis as compared with normal and disease-control subjects. J Clin Invest. 1997 Nov 15;100(10):2588-95. doi: 10.1172/JCI119802. Erratum In: J Clin Invest 1998 Jan 1;101(1):285.

ReferenceCitation: Konstan MW, Morgan WJ, Butler SM, Pasta DJ, Craib ML, Silva SJ, Stokes DC, Wohl ME, Wagener JS, Regelmann WE, Johnson CA; Scientific Advisory Group and the Investigators and Coordinators of the Epidemiologic Study of Cystic Fibrosis. Risk factors for rate of decline in forced expiratory volume in one second in children and adolescents with cystic fibrosis. J Pediatr. 2007 Aug;151(2):134-9, 139.e1. doi: 10.1016/j.jpeds.2007.03.006. Epub 2007 Jun 22.

ReferenceCitation: Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.

ReferenceCitation: Ramsey BW, Dorkin HL, Eisenberg JD, Gibson RL, Harwood IR, Kravitz RM, Schidlow DV, Wilmott RW, Astley SJ, McBurnie MA, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993 Jun 17;328(24):1740-6. doi: 10.1056/NEJM199306173282403.

ReferenceCitation: Regnis JA, Robinson M, Bailey DL, Cook P, Hooper P, Chan HK, Gonda I, Bautovich G, Bye PT. Mucociliary clearance in patients with cystic fibrosis and in normal subjects. Am J Respir Crit Care Med. 1994 Jul;150(1):66-71. doi: 10.1164/ajrccm.150.1.8025774.

ReferenceCitation: Robertson JM, Friedman EM, Rubin BK. Nasal and sinus disease in cystic fibrosis. Paediatr Respir Rev. 2008 Sep;9(3):213-9. doi: 10.1016/j.prrv.2008.04.003. Epub 2008 Jul 31.

ReferenceCitation: Vaughan WC, Carvalho G. Use of nebulized antibiotics for acute infections in chronic sinusitis. Otolaryngol Head Neck Surg. 2002 Dec;127(6):558-68. doi: 10.1067/mhn.2002.129738.

ReferenceCitation: Walter S, Gudowius P, Bosshammer J, Romling U, Weissbrodt H, Schurmann W, von der Hardt H, Tummler B. Epidemiology of chronic Pseudomonas aeruginosa infections in the airways of lung transplant recipients with cystic fibrosis. Thorax. 1997 Apr;52(4):318-21. doi: 10.1136/thx.52.4.318.

ReferenceCitation: Karanth TK, Karanth VKLK, Ward BK, Woodworth BA, Karanth L. Medical interventions for chronic rhinosinusitis in cystic fibrosis. Cochrane Database Syst Rev. 2022 Apr 7;4(4):CD012979. doi: 10.1002/14651858.CD012979.pub3.

lead_sponsor: Virginie ESCABASSE

sponsor_collaborators:
Virginie ESCABASSE
Henri Mondor University Hospital

location_facility: Centre Hospitalier Universitaire de Clermont ferrand

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de la Timone

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: CENTRE HOSPITALIER INTERCOM DE CRETEIL

acronyme: AVAS MUC

titre: Efficacité de l'Aérosolthérapie sonique nébulisée Vecteur d'Antibiotique (tobramycine) dans le traitement de la rhino-Sinusite chronique des patients atteints de MUCoviscidose (AVASMUC): un essai randomisé contrôlé en double aveugle

discipline_principale: orl

nom_porteur: ESCABASSE

prenom_porteur: Virginie


title: Regional Central Database Recording of Chronic Myeloid Leukemia

acronym: LMC

summary: It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: IPOXA, Phase I/II Dose Escalation Trial Aiming to Evaluate the Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis of Colorectal Origin and Uncertain Resectability.

acronym: IPOXA

summary:
Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of rare primary peritoneal cancers, or more frequently distant extension of digestive cancers (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be considered as a distinct oncological entity as its genesis, natural history, and response to systematic treatments differ to those of other metastases. The development of PC, observed in 25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of the disease. The prognosis is defined by the possibility of complete resection, possibly after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in patients with PC of colorectal origin has been demonstrated based on overall survival in several randomized trials, among which one evaluated oxaliplatin. The evaluation of the clinical benefit-risk related to the repeated administration of non-hyperthermic intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of colorectal origin is already being investigated by several international teams.

The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin, in this combination, could increase the response of peritoneal lesions known to be relatively insensitive to IV chemotherapy.

location_facility: Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud

location_facility: Service de Chirurgie Digestive et Cancérologique, CHU NORD

location_facility: Service de Chirurgie Digestive et de l'Urgence, CHU Albert Michallon

location_facility: Service Oncologie Médicale, INSTITUT DE CANCEROLOGIE DE LA LOIRE (ICL)

location_facility: Département de Chirurgie Cancérologique, Centre Léon Bérard

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: IPOXA

titre: Essai de phase I/II en escalade de dose visant à évaluer la tolérance de l'administration intra-péritonéale (IP) d'oxaliplatine en association avec une chimiothérapie systémique de type FOLFIRI bevacizumab chez des patients atteints de carcinose péritonéale d'origine colorectale de resecabilité incertaine.

nom_porteur: YOU

prenom_porteur: Benoit


title: Interest of Self-compression Technique on Tolerance of Mammography

acronym: ITACTs

summary:
Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

ReferenceCitation: Henrot P, Boisserie-Lacroix M, Boute V, Troufleau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169.

oa_colors: green other

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Institut de Cancérologie de Lorraine
Institut Bergonié
Polyclinique Majorelle
Cabinet de radiologie
Centre François Baclesse
Institut Curie


type: Other Identifier

title: Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial

acronym: PROVECS

summary:
Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.

The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.

ReferenceCitation: Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.

version: acceptedVersion

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

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

publisher_dissemination: Springer-Nature

ReferenceCitation: Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.

license: cc-by

license_normalized: cc-by

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: CHU MontpellierHôpital Arnaud de VILLENEUVE

intervention_type: Procedure

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: PROVECS

titre: Ventilation protectrice peropératoire en chirurgie cardiaque avec circulation extra-corporelle: un essai randomisé contrôlé multicentrique

nom_porteur: LAGIER


title: Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

acronym: Digi-NewB

summary: Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.

primary_purpose: Diagnostic

lead_sponsor: Rennes University Hospital

collaborators: National University of Ireland, Galway, Ireland

location_facility:
Nantes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Brest University Hospital
Rennes University Hospital


title: Evaluation of Changes in Consumption of Drugs and Substances After Incarceration

acronym: COSMOS

summary: To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject. This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.

location_facility:
La Roche sur Yon Hospital
Le Mans Hospital
Nantes University Hospital
Angers University Hospital
Fontenay Le Comte Hospital
Laval Hospital


title: Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset

summary: In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI

lead_sponsor: University Hospital, Grenoble

location_facility: H. Hartmann Institute of Radiotherapy and Radiosurgery

appel_a_projets: PHRCK

nom_etablissement: CHU GRENOBLE ALPES

acronyme: Neo APBI-01

titre: Irradiation partielle du sein combinée au traitement systémique  néo adjuvant, pour augmenter la réponse pathologique complète des cancers à risque intermédiaire et à haut risque de types luminal  et triples négatifs.

discipline_principale: radiothérapie, radiotherapy

nom_porteur: GABELLE-FLANDIN

prenom_porteur: Isabelle


title: Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients

summary: Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.

ReferenceCitation: Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27.

ReferenceCitation: Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81.

ReferenceCitation: Elbert NJ, van Os-Medendorp H, van Renselaar W, Ekeland AG, Hakkaart-van Roijen L, Raat H, Nijsten TE, Pasmans SG. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. J Med Internet Res. 2014 Apr 16;16(4):e110. doi: 10.2196/jmir.2790.

ReferenceCitation: Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.

ReferenceCitation: Lundell S, Holmner A, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27.

ReferenceCitation: Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28.

ReferenceCitation: Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-949. doi: 10.1378/chest.13-1656.

ReferenceCitation: Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare. 2013 Sep;19(6):326-37. doi: 10.1177/1357633X13503427. Epub 2013 Sep 25.

ReferenceCitation: Nakamura N, Koga T, Iseki H. A meta-analysis of remote patient monitoring for chronic heart failure patients. J Telemed Telecare. 2014 Jan;20(1):11-7. doi: 10.1177/1357633X13517352. Epub 2013 Dec 18.

ReferenceCitation: Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.

ReferenceCitation: Kitsiou S, Pare G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174.

ReferenceCitation: Kotb A, Cameron C, Hsieh S, Wells G. Comparative effectiveness of different forms of telemedicine for individuals with heart failure (HF): a systematic review and network meta-analysis. PLoS One. 2015 Feb 25;10(2):e0118681. doi: 10.1371/journal.pone.0118681. eCollection 2015.

ReferenceCitation: Pandor A, Gomersall T, Stevens JW, Wang J, Al-Mohammad A, Bakhai A, Cleland JG, Cowie MR, Wong R. Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. Heart. 2013 Dec;99(23):1717-26. doi: 10.1136/heartjnl-2013-303811. Epub 2013 May 16.

ReferenceCitation: Feltner C, Jones CD, Cene CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083.

ReferenceCitation: Kitsiou S, Pare G, Jaana M. Systematic reviews and meta-analyses of home telemonitoring interventions for patients with chronic diseases: a critical assessment of their methodological quality. J Med Internet Res. 2013 Jul 23;15(7):e150. doi: 10.2196/jmir.2770. Erratum In: J Med Internet Res. 2013;15(11):e253.

ReferenceCitation: Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006.

ReferenceCitation: Ekeland AG, Bowes A, Flottorp S. Methodologies for assessing telemedicine: a systematic review of reviews. Int J Med Inform. 2012 Jan;81(1):1-11. doi: 10.1016/j.ijmedinf.2011.10.009. Epub 2011 Nov 21.

ReferenceCitation: Conway A, Inglis SC, Clark RA. Effective technologies for noninvasive remote monitoring in heart failure. Telemed J E Health. 2014 Jun;20(6):531-8. doi: 10.1089/tmj.2013.0267. Epub 2014 Apr 14.

ReferenceCitation: Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10.

ReferenceCitation: Lefevre T, d'Ivernois JF, De Andrade V, Crozet C, Lombrail P, Gagnayre R. What do we mean by multimorbidity? An analysis of the literature on multimorbidity measures, associated factors, and impact on health services organization. Rev Epidemiol Sante Publique. 2014 Oct;62(5):305-14. doi: 10.1016/j.respe.2014.09.002. Epub 2014 Oct 25.

ReferenceCitation: Smith SM, Soubhi H, Fortin M, Hudon C, O'Dowd T. Managing patients with multimorbidity: systematic review of interventions in primary care and community settings. BMJ. 2012 Sep 3;345:e5205. doi: 10.1136/bmj.e5205.

ReferenceCitation: Fabbri LM, Boyd C, Boschetto P, Rabe KF, Buist AS, Yawn B, Leff B, Kent DM, Schunemann HJ; ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development. How to integrate multiple comorbidities in guideline development: article 10 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proc Am Thorac Soc. 2012 Dec;9(5):274-81. doi: 10.1513/pats.201208-063ST.

ReferenceCitation: Onder G, Palmer K, Navickas R, Jureviciene E, Mammarella F, Strandzheva M, Mannucci P, Pecorelli S, Marengoni A; Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). Time to face the challenge of multimorbidity. A European perspective from the joint action on chronic diseases and promoting healthy ageing across the life cycle (JA-CHRODIS). Eur J Intern Med. 2015 Apr;26(3):157-9. doi: 10.1016/j.ejim.2015.02.020. Epub 2015 Mar 18.

ReferenceCitation: Martin-Lesende I, Orruno E, Bilbao A, Vergara I, Cairo MC, Bayon JC, Reviriego E, Romo MI, Larranaga J, Asua J, Abad R, Recalde E. Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial). BMC Health Serv Res. 2013 Mar 28;13:118. doi: 10.1186/1472-6963-13-118.

ReferenceCitation: Sutherland D, Hayter M. Structured review: evaluating the effectiveness of nurse case managers in improving health outcomes in three major chronic diseases. J Clin Nurs. 2009 Nov;18(21):2978-92. doi: 10.1111/j.1365-2702.2009.02900.x. Epub 2009 Sep 11.

ReferenceCitation: Chow SK, Wong FK. A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. J Adv Nurs. 2014 Oct;70(10):2257-71. doi: 10.1111/jan.12375. Epub 2014 Mar 12.

ReferenceCitation: Prochaska JO, DiClemente CC. Transtheorical therapy toward a more integrative model of change. Psychotherapy: Theory, Research and Practice, 1982;19(3):276-287

lead_sponsor: Air Liquide Santé International

sponsor_collaborators:
Air Liquide Santé International
Inferential

location_facility: Cabinet Privé de Cardiologie - 2, rue jean jaurès

location_facility: Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

location_facility: Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet

location_facility: Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

location_facility: Cabinet privé de pneumologie - 28 avenue de Genève

location_facility: cabinet privé de médecine générale - 18, rue Louis Haase


title: Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial

acronym: WeightPump

summary: The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.

lead_sponsor: Icadom

sponsor_collaborators:
Icadom
AGIR à Dom

location_facility:
Marseille European Hospital
Alpes Léman Hospital
Grenoble University Hospital
Annecy-Genevois Hospital
Métropole Savoie Hospital
Pierre Oudot Hospital


title: Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?

acronym: RESOPSYBB

summary:
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.

This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.

The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.

lead_sponsor: Nantes University Hospital

location_facility:
Medical-social St-Etienne de Montluc
Medical-social Saint-Servan
Medical-social center Pilotière
Medical-social Center Dalby Millet
Medical-Social center Port Boyer
Medical-Social center Bellevue


title: A Phase I/II Trial to Assess the Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Recurrent Advanced/Metastatic Endometrial Cancer Patients

acronym: ENDOLA

summary:
Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/ year). The 5-year overall survivals of patients at diagnosis with locally advanced and metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment with platinum-based chemotherapy, there is lack of effective drug in this disease, which explains the poor prognosis of patients.

The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been shown to be effective beyond first chemotherapy line.

Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.

Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable toxicity profile.

Metformin may increase the anti-proliferative effects of olaparib because it downregulates IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Oncologie Médicale, Centre François Baclesse

location_facility: Comité Gynécologique, Institut Gustave Roussy

location_facility: Service d'Oncologie Médicale, Institut Curie

location_facility: Département d'Oncologie Médicale, Centre Antoine Lacassagne

location_facility: Département de Cancérologie Cervico-Faciale et Thoracique, Centre Oscar Lambret


title: Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

acronym: AVATAR

summary: The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other complications; Kappetein et al 2012)..

ReferenceCitation: Girerd X, Radauceanu A, Achard JM, Fourcade J, Tournier B, Brillet G, Silhol F, Hanon O. [Evaluation of patient compliance among hypertensive patients treated by specialists]. Arch Mal Coeur Vaiss. 2001 Aug;94(8):839-42. French.

ReferenceCitation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Prospective Cohort of Patients Hospitalized in West French Intensive Care Units.

acronym: ATLANREA

summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

location_facility:
Nantes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Rennes University Hospital
CHU de Brest La Cavale Blanche


title: Validation d'un Algorithme Diagnostique de l'artérite Temporale Giganto-cellulaire basé Sur l'échographie-doppler Couleur Des artères Temporales Superficielles et Des Axes Cervico-encéphaliques

acronym: ECHORTON

summary: Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is based on a combination of clinical, biological and histological signs. Temporal artery biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since the description by Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as second line method, many authors suggest the possibility to do without TAB in many cases. In addition, many practitioners believe that it is not "ethical" to use an invasive unprofitable procedure like TAB, and have already been using CDU in their routine practice. However, no diagnostic algorithm validating this approach in a prospective series has been published to date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first screening method.

ReferenceCitation: Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1653. doi: 10.1056/NEJMc1409206. No abstract available.

ReferenceCitation: Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18.

ReferenceCitation: Petri H, Nevitt A, Sarsour K, Napalkov P, Collinson N. Incidence of giant cell arteritis and characteristics of patients: data-driven analysis of comorbidities. Arthritis Care Res (Hoboken). 2015 Mar;67(3):390-5. doi: 10.1002/acr.22429.

ReferenceCitation: Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511.

ReferenceCitation: Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French.

ReferenceCitation: Baslund B, Helleberg M, Faurschou M, Obel N. Mortality in patients with giant cell arteritis. Rheumatology (Oxford). 2015 Jan;54(1):139-43. doi: 10.1093/rheumatology/keu303. Epub 2014 Aug 13.

ReferenceCitation: Nuenninghoff DM, Hunder GG, Christianson TJ, McClelland RL, Matteson EL. Mortality of large-artery complication (aortic aneurysm, aortic dissection, and/or large-artery stenosis) in patients with giant cell arteritis: a population-based study over 50 years. Arthritis Rheum. 2003 Dec;48(12):3532-7. doi: 10.1002/art.11480.

ReferenceCitation: Kermani TA, Warrington KJ, Crowson CS, Ytterberg SR, Hunder GG, Gabriel SE, Matteson EL. Large-vessel involvement in giant cell arteritis: a population-based cohort study of the incidence-trends and prognosis. Ann Rheum Dis. 2013 Dec;72(12):1989-94. doi: 10.1136/annrheumdis-2012-202408. Epub 2012 Dec 19.

ReferenceCitation: Hunder GG, Bloch DA, Michel BA, Stevens MB, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of giant cell arteritis. Arthritis Rheum. 1990 Aug;33(8):1122-8. doi: 10.1002/art.1780330810.

ReferenceCitation: Hunder GG. The early history of giant cell arteritis and polymyalgia rheumatica: first descriptions to 1970. Mayo Clin Proc. 2006 Aug;81(8):1071-83. doi: 10.4065/81.8.1071.

lead_sponsor: Poitiers University Hospital

collaborators: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation

summary:
Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.

This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.

lead_sponsor: University Hospital, Brest

location_facility:
CHRU Brest
CHRU de Tours
Hôpital Edouard Herriot
CHU Poitiers
CHU Limoges
Hôpital la Pitié Salpetrière

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: OXYOP

titre: Evaluation d'un transporteur d'oxygène d'origine marine (HEMO2Life®) pour la préservation des organes : première étude en transplantation rénale chez l'homme

discipline_principale: néphrologie

nom_porteur: LE MEUR

prenom_porteur: Yannick


title: Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)

acronym: ADMED-AVC

summary:
Medication adherence is a major factor to prevent vascular recurrence after a first ischemic stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are needed to improve it.

A patient - centered and pluriprofessional structured intervention, targeting the medication, introduced at hospital discharge and continued at home (by regular telephone contact) could improve medication adherence one year after stroke.

This intervention would consist of semi structured interviews patient-pharmacist at different times during one year after stroke. The information about the therapeutic management of the patient will be shared between healthcare professionals : general practitioners (GP) and community pharmacists (CP), hospital clinical pharmacist (HCP) and physician (HPhys).

It will allow for decrease of the recurrent stroke and others cardiovascular complications based on a better adherence to preventive medication. Furthermore the decrease of the iatrogenic events and the improvement of the quality of life of patients may be also associated.

ReferenceCitation: Khettar S, Jacquin Courtois S, Luaute J, Decullier E, Bin S, Dupuis M, Derex L, Mechtouff L, Nighoghossian N, Dussart C, Rode G, Janoly-Dumenil A. Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study). Eur J Hosp Pharm. 2022 May;29(3):169-175. doi: 10.1136/ejhpharm-2020-002425. Epub 2020 Sep 25.

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

location_facility: Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP

location_facility: Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne

location_facility: Service de neurologie vasculaire, Hôpital P Wertheimer, HCL

location_facility: Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL

location_facility: Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand

location_facility: Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble

appel_a_projets: PREPS

acronyme: ADMED AVC

titre: Impact d'une intervention pluriprofessionnelle visant à améliorer l'ADhésion MEDicamenteuse (prévention secondaire cardio-neuro-vasculaire) chez les patients ayant présenté un Accident Vasculaire Cérébral Ischémique.

discipline_principale: médecine physique et réadaptation

nom_porteur: RODE

prenom_porteur: Gilles


title: Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older

acronym: MEDREV

summary:
The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older.

This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.

ReferenceCitation: Leguelinel-Blache G, Castelli C, Roux-Marson C, Bouvet S, Andrieu S, Cestac P, Collomp R, Landais P, Louliere B, Mouchoux C, Varin R, Allenet B; MEDREV Working Group; Bedouch P, Kinowski JM. Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study). Trials. 2018 Jan 8;19(1):19. doi: 10.1186/s13063-017-2412-7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Toulouse - Hôpital Paule de Viguier

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre


title: Prevalence, Characteristics and Risk Factors of HIV-Associated Neurocognitive Disorders in Subjects Between the Ages of 55 and 70 Years: An Exposed/Unexposed Cross Sectional Study

summary: The primary objective is to measure the prevalence of according to the Frascati classification in a HIV-infected population aged between 55 and 70 years (exposed group) and to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on age, gender, geographical origin and socioprofessional category.

ReferenceCitation: Makinson A, Dubois J, Eymard-Duvernay S, Leclercq P, Zaegel-Faucher O, Bernard L, Vassallo M, Barbuat C, Geny C, Thouvenot E, Costagliola D, Ozguler A, Zins M, Simony M, Reynes J, Berr C. Increased Prevalence of Neurocognitive Impairment in Aging People Living With Human Immunodeficiency Virus: The ANRS EP58 HAND 55-70 Study. Clin Infect Dis. 2020 Jun 10;70(12):2641-2648. doi: 10.1093/cid/ciz670.

oa_host_type: closed

publisher_dissemination: Oxford University Press

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Merck Sharp & Dohme LLC

location_facility: Hôpital Gui de Chauliac - Service des Maladies Infectieuses

location_facility: Hôpital Carémeau - Service des Maladies Infectieuses

location_facility: Hôpial Sainte Marguerite - Service d'hématologie-Cisih

location_facility: Hôpital Michallon- Service des Maladies Infectieuses

location_facility: Centre Hospitalier de Cannes - Service de Médecine Interne Oncologie

location_facility: Hôpital Bretonneau - Service des Maladies Infectieuses


title: Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes

acronym: ROC-HYPOX

summary:
The prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. These events occur partly during induction of anesthesia and are all the more frequent as the child is young.

The French recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. This recommendation is controversial In a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. This monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity.

The objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hôpital Jeanne de Flandre, CHRU de Lille

location_facility: Centre Hospitalier Intercommunal Creteil (CHIC)

nom_etablissement: HOPITAL FONDATION A DE ROTHSCHILD

type_etablissement: EBNL

acronyme: ROC-HYPOX

titre: Intérêt du curare pour diminuer les épisodes d'hypoxémie lors de l'intubation chez l'enfant de moins de 2 ans

nom_porteur: DONNETTE

prenom_porteur: François-Xavier


title: Multicentre Study Evaluating the Use of a Biodegradable Balloon for the Treatment of Prostate Cancer (of Intermediate Risk) by Intensity Modulated Conformal Radiotherapy (BioPro-RCMI)

acronym: BioPro-RCMI

summary:
The benefit of dose escalation in radiotherapy (RT) for biochemical control of prostate cancer is a clearly established fact based on the results of different published prospective trials. This benefit, acquired with three-dimensional conformal radiation technique is counterbalanced by an increase in urinary and gastrointestinal toxicity. The joint progress of dose planning systems and multileaf collimators (MLC) technology have enabled the Intensity Modulated Radiation Therapy (IMRT). Recently the contribution of "spacers" positioned in the septum between the rectum and the prostate could improve the functional results of IMRT in terms of rectal toxicity.

The aim of the investigators study is to assess the dosimetric gain from the contribution of the implantable BioProtect balloon on organs at risk.

status: Suspended

ReferenceCitation: Pasquier D, Bogart E, Bonodeau F, Lacornerie T, Lartigau E, Latorzeff I. BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol. BMC Cancer. 2018 May 16;18(1):566. doi: 10.1186/s12885-018-4492-5.

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Aquilab SAS

location_facility:
Institut Bergonié
Clinique Hartmann
Centre de Cancérologie Paris Nord
Centre Léonard de Vinci
Clinique Pasteur
Centre Oscar Lambret


title: Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors

acronym: EFFORR

summary: The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hépato-Gastroentérologie et oncologie digestive,

intervention_type: Dietary Supplement


title: Effect of Intramyocardial Mesenchymal Stem Cells Injection in Patients With Chronic Ischemic Cardiomyopathy and Left Ventricular Dysfunction Guide by NogaStar XP System Catheter.

summary: Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type and delivery method remain to be determined. Pre-clinical studies demonstrated improvement of cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine and immunosuppressive properties. Investigators initiated the MESAMI program by the bicentric pilot phase and highlighted the safety and feasibility of intramyocardial injections of MSCs from bone marrow in patients with chronic ischemic cardiomyopathy and left ventricular dysfunction, guide by the NOGA-XP system. The MESAMI program continues with the phase 2, multicenter, double-blind, randomized, placebo-controlled trial.The aim of this phase 2 study is to demonstrate a functional improvement, measuring peak VO2, at 3 months between the cell therapy group and the placebo group.

lead_sponsor: University Hospital, Toulouse

location_facility: University hospital of Pitié-Salpêtrière

location_facility: Cardiology Department of Rangueil Hospital - Rangueil Hospital


title: MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain

summary: Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.

ReferenceCitation: Cohen SP, Raja SN. Prevention of chronic postsurgical pain: the ongoing search for the holy grail of anesthesiology. Anesthesiology. 2013 Feb;118(2):241-3. doi: 10.1097/ALN.0b013e31827d4129. No abstract available.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Albi-Feldzer A, Mouret-Fourme E E, Hamouda S, Motamed C, Dubois PY, Jouanneau L, Jayr C. A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain. Anesthesiology. 2013 Feb;118(2):318-26. doi: 10.1097/ALN.0b013e31827d88d8.

ReferenceCitation: Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.

ReferenceCitation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

ReferenceCitation: Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.

lead_sponsor: Institut Curie

location_facility:
Institut de Cancérologie de Lorraine
Centre Léon Bérard
INSTITUT CURIE - Site Paris
Centre Jean PERRIN
Centre Antoine LACASSAGNE
Institut Curie site Saint-Cloud


title: Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1

summary: A national, multicenter, randomized, transverse clinical trial, estimating the existence of phonological deficits in children with NF1 children compared with control children without NF1 with the same reading level.

design_allocation: Non-Randomized

primary_purpose: Screening

ReferenceCitation: Biotteau M, Tournay E, Baudou E, Destarac S, Iannuzzi S, Faure-Marie N, Castelnau P, Schweitzer E, Rodriguez D, Kemlin I, Dorison N, Rivier F, Carneiro M, Preclaire E, Barbarot S, Lauwers-Cances V, Chaix Y. Reading Comprehension Impairment in Children With Neurofibromatosis Type 1 (NF1): The Need of Multimodal Assessment of Attention. J Child Neurol. 2021 Jul;36(8):625-634. doi: 10.1177/0883073820981270. Epub 2021 Jan 28.

publisher_dissemination: SAGE Publications

location_facility: Hopital femme-mére-enfant, Hospices civils de lyon


title: Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

acronym: BioFilm PieDia

summary:
This is an observational study that does not change routine care.

The primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of antibiotics.

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud

location_facility: CHU de Lyon - Hôpital de la Croix-Rousse

location_facility: CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied

intervention_type: Biological


title: Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial

acronym: IRRICO

summary:
Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube, leading to serious malformations of the nervous system. Caudal neuropore malformations almost always lead to sensory-motor deficits (including complete paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).

The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

ReferenceCitation: Brochard C, Jezequel M, Blanchard-Dauphin A, Kerdraon J, Perrouin-Verbe B, Leroi AM, Reymann JM, Peyronnet B, Morcet J, Siproudhis L. Transanal irrigation is a better choice for bowel dysfunction in adults with Spina bifida: A randomised controlled trial. Colorectal Dis. 2023 Jun;25(6):1267-1276. doi: 10.1111/codi.16518. Epub 2023 Mar 11.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repositories_concat: HAL

location_facility:
CHRU de Lille
CMRRF de Kerpape
Rennes University Hospital
CHRU de Nancy-Brabois
CHU de Nantes
CHU de Rouen


title: Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial

acronym: QUISERMAS

summary: The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.

ReferenceCitation: Ouldamer L, Bonastre J, Brunet-Houdard S, Body G, Giraudeau B, Caille A. Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 4;6(4):e009903. doi: 10.1136/bmjopen-2015-009903.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories:
HAL
PubMed Central
open-archive.highwire.org

repositories_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

lead_sponsor: University Hospital, Tours

location_facility:
Alliance Clinic
CHU de Poitiers
CHRU de Tours
Institut de Cancérologie de l'Ouest
Institut POALI-CALMETTES
Conception Hospital


title: AMYLO-CARTESIAN Study :Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.

acronym: AMYLOCARTESIAN

summary:
Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS) markedly increases with age. Aortic stenosis increases left ventricular pressure overload. Cardiac deposits have been observed in AS and the amount of these deposits has been correlated to post-surgical outcome. As they are strong echocardiographic and cardiac MRI imaging similarities between CA and AS, the investigators hypothesized that the deposit observed in AS is transthyretin amyloid deposit. The investigators objective is to demonstrate that amyloid deposit is associated with poor outcomes following aortic stenosis surgical valve replacement.

Materiel and methods: 180 patients with indication for surgical aortic valve replacement will be recruited prospectively and consecutively in 5 French centers. A replicative study will be performed in one Austrian center. Echocardiography, cardiac MRI and bone scintigraphy will be performed prior to surgery. During surgery, a basal LV septum biopsy will be collected for determination and quantification of interstitial deposits using specific staining which will be performed in a blind fashion. Clinical outcomes will be recorded during the hospitalization period following the surgery and at 1 year. Alive and re-hospitalization status will be determined. Patients will be classified according to the presence or not of amyloid deposits.

Expected results and impact: This study will emphasize how pressure overload stress accelerates and magnifies amyloid deposition usually known to be related to cardiac aging process. It will develop reliable imaging tools and markers to detect cardiac amyloid deposition. Correlation between anatomopathologic analyses and the three different imaging technics will identify accurate imaging markers of CA. A risk stratification model based on amyloid deposits level for the clinical management of these patients will be created combining imaging and biological markers.

lead_sponsor: French Cardiology Society

collaborators:
Pfizer
Henri Mondor University Hospital

sponsor_collaborators:
French Cardiology Society
Pfizer
Henri Mondor University Hospital

location_facility:
Hôpital Henri Mondor
CHU LYON
CHU de Toulouse
Chu Rennes
Centre Cardiologique du Nord
CHU Limoges


title: Assessment of Diagnostic Accuracy of 18FDG-PET-CT in Patients With Suspicion of Pacing or Defibrillation Lead Infection: a Prospective Multi-center Study

acronym: ENDOTEP

summary:
With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection.

The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction.

The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives.

Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity.

For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required.

The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.

location_facility:
CHU de Grenoble - Hôpital A. Michallon
AP-HM - Hôpital La Timone
Clinique Pasteur
CHRU de Lille - Hôpital R. Salengro
CHU de Nancy - Hôpital de Brabois
CHU de Bordeaux

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: ENDOTEP

titre: Evaluation de l'exactitude diagnostique du 18FDG-TEP-TDM dans le diagnostic d'infection sur sonde de stimulation ou de défibrillateur cardiaques : étude prospective multicentrique

discipline_principale: cardiologie

nom_porteur: BORDACHAR

prenom_porteur: Pierre


title: Prospective Multicenter Study on the Identification of Genetic Abnormalities Predisposing to Vasospasm From a Privileged Model: the Primary Raynaud's Phenomenon

acronym: RAY-GENE

summary:
Vasospasm is a transient contraction causing a decrease in caliber of a vessel and thus a decrease in vascularization in a vascular territory leading to suffering of tissue in the sector concerned. Vasospasm-related diseases have different clinical presentations such as migraine, spastic angina, hypertension related to vasospasm or primary Raynaud's phenomenon (RP). These diseases have few therapeutic methods due to poorly understood pathophysiology. For migraine and angina, the vascular exploration is problematic unlike for primary Raynaud's phenomenon (RP).

Primary Raynaud's phenomenon (RP) is a common peripheral vascular disease to cold with an estimated prevalence between 5-9 % of the general population. It is the expression of an extreme vasospasm microcirculation of the extremities linked to hypersensitivity to cold and that is clinically expressed by the occurrence of syncope stages where the fingers are anesthetized and white, followed by a stage with hyperemic restaining .

The objective of our study is to identify new metabolic pathways involved in vasospasm in order to consider new specific treatments, currently lacking.

The identification of these pathways will be made by the detection of genetic abnormalities causing vasospasm in Raynaud's phenomenon. This disease is a perfectly appropriate model to study vasospasm by its high frequency in the population, its hereditary nature and simple diagnosis. The powerful current genetic strategies will be applied to this model (exome sequencing combined to family connection analysis).

location_facility: CHD La Roche sur Yon - Service Angéiologie

location_facility: C.H.R. HOPITAL SUD - Service de Médecine interne

location_facility: CHRU HOPITAL CAVALE BLANCHE - Service de Médecine vasculaire

location_facility: CHU Angers - Service d'Explorations vasculaires

location_facility: CHU de NANTES - Service de Médecine Interne

intervention_type: Genetic


title: Prospective, Randomized, Controlled and Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery

acronym: Peeling

summary:
The epimacular membrane (EMM) is a degenerative condition associated with age, with a variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed by a peeling of the epimacular membrane using a microgripper. Peeling of the internal limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is expected to increase the success rate of EMM surgery by reducing the risk of recurrence of EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is not totally without consequence, it involves the risk of histological disorganization of the retina at the origin of one or several microscotomas, which are themselves responsible for a final visual discomfort. These microscotomas, resulting in the perception of somewhat black spots visible near the fixed point or the fixed image, may be highlighted by microperimetry and would be a loss of functional opportunity for the patient.

In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not alter the vision in half the patients. Furthermore, for those patients who are functionally affected by any such recurrence, a second epimacular membrane peeling surgery can be done.

The main objective of this study is to compare the difference in microscotoma(s) before surgery and 6 months later, between an "active ILM peeling" group and a "no ILM peeling" group. Given the more invasive nature of ILM peeling, the investigators believe that the rate of microscotomas in these patients is higher than those without peeling.

ReferenceCitation: Ducloyer JB, Ivan J, Poinas A, Lebreton O, Bonissent A, Fossum P, Volteau C, Tadayoni R, Creuzot-Garchet C, Le Mer Y, Perol J, Fortin J, Chiffoleau A, Billaud F, Ivan C, Weber M. Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial. Trials. 2020 Jun 8;21(1):500. doi: 10.1186/s13063-020-04433-9.

evidence: oa repository (via page says license)

repository_normalized: Research Square

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

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

location_facility: Fondation Ophtalmologique A. de Rothschild

nom_etablissement: CHU DE NANTES

acronyme: PEELING

titre: Etude prospective randomisée multicentrique contrôlée en simple insu, évaluant le rapport bénéfice/risque du pelage de la membrane limitante interne (MLI) lors de la chirurgie des membranes épimaculaires (MEM)

discipline_principale: ophtalmologie

nom_porteur: WEBER

prenom_porteur: Michel


title: A SINGLE ARM PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF Nab®-PACLITAXEL, IN SUBJECTS WITH PREVIOUSLY TREATED METASTATIC COLORECTAL CANCER

summary: The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel) in subjects with previously treated metastatic colorectal cancer. Subjects will be placed into two separate cohorts based on their RAS mutation status.

ReferenceCitation: Ducreux M, Bennouna J, Adenis A, Conroy T, Lievre A, Portales F, Jeanes J, Li L, Romano A. Efficacy and safety of nab-paclitaxel in patients with previously treated metastatic colorectal cancer: a phase II COLO-001 trial. Cancer Chemother Pharmacol. 2017 Jan;79(1):9-16. doi: 10.1007/s00280-016-3193-5. Epub 2016 Nov 19.

lead_sponsor: Celgene

location_facility: Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique

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


lead_sponsor: University Hospital, Grenoble

summary:
Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).

The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.

The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.

The investigators also asses side effects and patient satisfaction in both groups.

ReferenceCitation: Blancher M, Maignan M, Clape C, Quesada JL, Collomb-Muret R, Albasini F, Ageron FX, Fey S, Wuyts A, Banihachemi JJ, Bertrand B, Lehmann A, Bollart C, Debaty G, Briot R, Viglino D. Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med. 2019 Jul 16;16(7):e1002849. doi: 10.1371/journal.pmed.1002849. eCollection 2019 Jul.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repository_institution: Université de Lausanne - SERVAL

evidence: oa repository (semantic scholar lookup)

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

publisher_dissemination: Public Library of Science

sponsor_collaborators:
University Hospital, Grenoble
Fondation Apicil
SFMU

location_facility: Emergency Department - University Hospital of Grenoble

location_facility: Emergency Department - Hospital Albertville

location_facility: Emergency Department - Hospital Saint Jean de Maurienne

location_facility: Emergency Department - Hospital Chambéry

title: Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study

collaborators:
Fondation Apicil
SFMU


title: Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.

acronym: MURIELLE

summary: The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.

primary_purpose: Health Services Research

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU Toulouse Rangueil
CHU Cochin
CHU Grenoble
CHU Pitié salpêtrière
Clinique Pasteur
Chu Edouard Herriot


title: Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

acronym: TENSDEG

summary:
Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home.

The aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation.

Patients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected.

We wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Toulouse
UH Limoges
UH Bordeaux
Centre les Herbiers
AP-HP Fernand WIDAL
UH Rouen


title: Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain

acronym: MYOTOX

summary: Myofascial pains are frequently found during the clinical examination of the patients presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology of this component of the pain characterized by triggerpoints found in the clinical examination, remains uncertain; its coverage contributes to the improvement of the global pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent fibers) but are they superior to the injections of local anesthetics of triggerpoints? The literature remains poor on the subject, justifying this randomized double-blind protocol comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as long as the patient remains improved and maximum in 6 months.

ReferenceCitation: Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.

evidence: open (via crossref license)

publisher_dissemination: Elsevier

lead_sponsor: Nantes University Hospital

location_facility:
Clermont-Ferrand University Hospital
Clinique Axium
Nantes University Hospital
La Réunion University Hospital
Besançon University Hospital
Rennes University Hospital


title: Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

acronym: METABALS

summary: This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. While ALS appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.

location_facility: Centre de Recherche de l'Institut du Cerveau et de la moëlle UPMC Paris 6,Département des Maladies du Système Nerveux

location_facility: Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837

location_facility: Service de neurologie, CHU La Milétrie, POITIERS, Faculté de Médecine

location_facility: Pôle Neurosciences et Spécialités ,Service de Neurologie,CHU d'Angers


title: Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting

summary: The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.

ReferenceCitation: Callens C, Driouch K, Boulai A, Tariq Z, Comte A, Berger F, Belin L, Bieche I, Servois V, Legoix P, Bernard V, Baulande S, Chemlali W, Bidard FC, Fourchotte V, Salomon AV, Brain E, Lidereau R, Bachelot T, Saghatchian M, Campone M, Giacchetti S, Zafrani BS, Cottu P. Molecular features of untreated breast cancer and initial metastatic event inform clinical decision-making and predict outcome: long-term results of ESOPE, a single-arm prospective multicenter study. Genome Med. 2021 Mar 15;13(1):44. doi: 10.1186/s13073-021-00862-6.

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST René Gauducheau


title: Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

summary:
Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.

Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.

ReferenceCitation: Fontaine M, Tourasse C, Pages E, Laurent N, Laffargue G, Millet I, Molinari N, Taourel P. Local Tumor Staging of Breast Cancer: Digital Mammography versus Digital Mammography Plus Tomosynthesis. Radiology. 2019 Jun;291(3):594-603. doi: 10.1148/radiol.2019182457. Epub 2019 Apr 9.

publisher_dissemination: Radiological Society of North America (RSNA)

lead_sponsor: University Hospital, Montpellier

location_facility:
Oscar Lambret Center
Private Hospital oh Antony
Jean Mermoz Hospital
Hospital Valenciennes
UH Grenoble
UH Montpellier