title: Evolution of the Incidence of Occupational Asthma at the Beginning of the Activity of Young Bakers, Pastry-makers and Hairdressers, and Exploration of Its Risk Factors

acronym: ABCD

summary:
Background: Occupational exposures are thought to be responsible for 10-15% of new-onset asthma cases in adults, with disparities across sectors. Because most of the data are derived from registries and cross-sectional studies, little is known about incidence of occupational asthma (OA) during the first years after inception of exposure. This study focuses on this early asthma onset period among young workers in the bakery, pastry making and hairdressing sectors in order to assess early incidence of OA in these "at risk" occupations according to exposure duration, and to identify risk factors of OA.

Methods: This study is a longitudinal retrospective study with a nested case-control to identify risk factors of OA. The assessment of incidence evolution is made by exploring a series of promotions (or retrospective cohorts) with increasing duration since at work. The study population is composed of subjects who graduated between 2001 and 2006 in sectors where they experience exposure to organic or inorganic allergenic or irritant compounds (with an objective of 150 subjects by year) and 250 young workers with no specific occupational exposure.

This study is a descriptive, monocentric, longitudinal and retrospective study with cross-sectional measurements.

ReferenceCitation: Remen T, Coevoet V, Acouetey DS, Gueant JL, Gueant-Rodriguez RM, Paris C, Zmirou-Navier D. Early incidence of occupational asthma among young bakers, pastry-makers and hairdressers: design of a retrospective cohort study. BMC Public Health. 2010 Apr 26;10:206. doi: 10.1186/1471-2458-10-206.


title: Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology

summary:
Benefits of physical activity (PA) as supportive care in cancer have been widely demonstrated by the scientific community. However, survivors who have completed chemo-radio-immunotherapy treatments doesn't achieve PA recommendations on average. This reinforces the need to identify factors influencing PA level, and to propose a multilevel model (macro-, meso-, micro-level) to understand better what facilitates the adoption and maintenance of active behaviour and what hinders it. To date, there is no ecological model in France explaining this behaviour in the post-treatment phase of breast, colorectal, prostate, and lung cancers. From this initial model, we seek to design an educational and motivational intervention in PA.

Thus, the investigators propose to test the feasibility of implementing an individualized program to increase and maintain level of physical activity and to decrease sedentary behaviours in physically inactive cancer survivors. This program is based through and identification of barriers and facilitators of an active lifestyle among this population.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: Université Sorbonne Paris Nord

sponsor_collaborators:
Université Sorbonne Paris Nord
Ligue contre le cancer, France
Garmin International
Stimulab

location_facility: Laboratoire Educations et Promotion de la Santé UR3412

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: EEG Analysis During Light Propofol Sedation

acronym: MOTANA

summary: The hypothesis of this study is that propofol sedation does not affect the detectability of a movement intention in the EEG motor cortex signal. EEG signals will be recorded during the realization of intentional movements and movement intentions by the healthy volunteers, as well as during median nerve stimulation before and during propofol perfusion according to a target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Blokland YM, Farquhar JD, Mourisse J, Scheffer GJ, Lerou JG, Bruhn J. Towards a novel monitor of intraoperative awareness: selecting paradigm settings for a movement-based brain-computer interface. PLoS One. 2012;7(9):e44336. doi: 10.1371/journal.pone.0044336. Epub 2012 Sep 6.

ReferenceCitation: Blokland Y, Farquhar J, Lerou J, Mourisse J, Scheffer GJ, Geffen GJ, Spyrou L, Bruhn J. Decoding motor responses from the EEG during altered states of consciousness induced by propofol. J Neural Eng. 2016 Apr;13(2):026014. doi: 10.1088/1741-2560/13/2/026014. Epub 2016 Feb 9.

ReferenceCitation: Lindig-Leon C, Bougrain L. Comparison of sensorimotor rhythms in EEG signals during simple and combined motor imageries over the contra and ipsilateral hemispheres. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3953-6. doi: 10.1109/EMBC.2015.7319259.

ReferenceType: derived

ReferenceCitation: Rimbert S, Schmartz D, Bougrain L, Meistelman C, Baumann C, Guerci P. MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation. Trials. 2019 Aug 28;20(1):534. doi: 10.1186/s13063-019-3596-9.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via 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 de Nantes

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility: Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy

intervention_type: Drug


title: Assessement of a Multi-organ Screening Procedure for the Detection of Pre-clinical Ischaemia in Antiphospholipid Syndrome The COBRA Study (CardiO-Brain Renal Involvement in Antiphospholipid Syndrome)

acronym: COBRA

summary:
Introduction

AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the presence of persistent thrombosis or obstetric manifestations together with the presence of persistent antiphospholipid antibodies (aPL). Patients are young and at high risk of recurrence. The current challenge is the identification of patients at high risk of organ damage that directly impact morbidity and mortality.

Small vessels thrombosis can be asymptomatic but detectable by MRI. Apart from APS, it was shown that the detection of asymptomatic ischemic events identify patients at risk for symptomatic ischemic events. Demonstrating this in patients with APS would prevent thrombotic complications.

The investigators' hypothesis is that a significant proportion of patients with APS would have asymptomatic organ involvement.

Objectives

The primary objective is to determine the frequency of asymptomatic target organ (s) (heart, brain, kidney) in APS patients.

Secondary objectives are (i) to determine the frequency of each type of MRI abnormality, (ii) to identify the factors associated with asymptomatic target organ lesion, (iii) to describe the parameters of echocardiography associated with cerebral and cardiac MRI, and (iv) to assess the feasibility of a one-time cardiovascular and brain MRI.

Methods and analysis

This is a prospective interventional, cross-sectional, non-randomized, monocentric clinical study. The investigators expect to include 50 consecutive patients with APS followed in the department of Vascular Medicine at Nancy University Hospital.

Within 15 days post-inclusion, a one-time cardiac and cerebral MRI will be performed. For each patient, the number of target organs involvements will be calculated and the frequencies will be compared by Fisher or chi-2 tests.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

intervention_type: Device

status_simplified: Completed


title: Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis

acronym: DOTAMIR

summary:
Infectious myocarditis are frequent, most of the time viral and can evolve to cardiac insufficiency. The diagnosis is difficult because they can mime an acute coronary syndrome. Approximately 10 % of patients with acute infarction suspected, have a normal angiography, and half of them has in fact a myocarditis, as showed studies of cardiac MRI among which some realized in our department . However, anomalies observed in MRI are not specific and it is necessary to use multiple criterions. A new radiopharmaceutical, the 68Ga-DOTATOC, specific of somatostatin's receptors which are over expressed by the inflammatory cells, has recently showed the capacity to identify myocarditis, but only in a small group of 6 patients.

The investigators make assumptions:

this radiopharmaceutical is enough sensitive to detect most of the acute inflammatory myocarditis which are identified by the MRI and
it could maybe allow to identify myocarditis with a persistent subacute or chronic inflammation, which are difficult to identify with cardiac MRI, and it would be a new information able to guide the medical decision.

Primary objectif: to determine if PET with 68Ga-DOTATOC is enough sensitive to identify myocarditis in acute inflammatory phase by hospitalized patients with suspected acute infarction and with normal angiography and who have a high probability of myocarditis identified by MRI. Disease prevalence will be close to 100 % at baseline Secondary objectives: 1. Estimate the frequency of inflammatory forms (subacute or chronicle), with a 68Ga-DOTATOC PET at 3 to 5 months from baseline, when classic signs of acute inflammatory generally disappeared (CRP, Troponin-I, myocardial oedema in MRI).

2. Analyze the concordance of the results of 68Ga-DOTATOC TEP by two readers


title: Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.

acronym: PACTEP

summary:
Cerebral glycolytic metabolism can be quantified by quantitative analysis of 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET). This allows to identify neurological diseases at an early stage of functional abnormalities, before any anatomical lesions, and to differentiate them from the "normal" brain aging. Aging mainly leads to atrophy with a decrease in cerebral metabolism in the prefrontal cortex, with consequent deterioration of cognitive processes, in particular executive functions (5).

In a population of 92 "control" subjects, investigators have already quantified the importance of the aging in frontal cortex hypometabolism. These patients were referred for a 18F-FDG PET in the follow-up of lymphoma considered to be in complete remission (PET without cerebral step), without any chemoradiotherapy within 2 months and with normal neuropsychological tests (Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Battery FAB).

However, cerebral aging can be "accelerated" by vascular risk factors, including increased central blood pressure, as investigators have recently reported in a pilot study involving elderly patients. This central pressure, which is directly linked to the cerebral micro-vascularization, can be easily measured by applanation tonometry. In this pilot study, investigators showed that a central pulse pressure equal or greater than 50 mmHg was associated with a significant frontal hypometabolism in elderly patients. This confirmed, at a stage of pre-clinical remodeling, the worse prognostic significance for this criterion, as reported in large epidemiological studies (increased risk of stroke and cardiac vascular events).

However, it is not yet known whether the level of central blood pressure interfere with the brain metabolism of younger subjects, especially with regard to aging observed throughout life. If this hypothesis is confirmed, preventive therapeutic strategies for accelerated aging, could thus integrate the monitoring of central pressure and cerebral metabolism.

The objective of this study is to determine, in a population of control subjects and on a larger scale, the impact of central blood pressure on brain metabolic aging , by using 18F-FDG PET.

primary_purpose: Prevention

ipd_sharing: Undecided


type: Other Identifier

title: Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

acronym: SEA-HD

summary: Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Biological


title: Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study

acronym: VIhVhEpb

summary: Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier de la côte Basque

sponsor_collaborators:
Centre Hospitalier de la côte Basque
University Hospital, Toulouse


title: Feasibility of Total Mastectomy in Ambulatory Care

acronym: AMASTEC

summary:
Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
Centre Hospitalier de Beauvais
Centre Hospitalier de Saint-Quentin

intervention_type: Procedure


title: Intravitreous CytokinE Level in pAtient With retiNal Detachment

acronym: ICELAND

summary:
Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis.

Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines.

RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.

ReferenceCitation: Conart JB, Blot G, Augustin S, Millet-Puel G, Roubeix C, Beguier F, Charles-Messance H, Touhami S, Sahel JA, Berrod JP, Leveillard T, Guillonneau X, Delarasse C, Sennlaub F. Insulin inhibits inflammation-induced cone death in retinal detachment. J Neuroinflammation. 2020 Nov 26;17(1):358. doi: 10.1186/s12974-020-02039-1.

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

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square


type: Registry Identifier

title: Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy

acronym: PARACAL

summary: The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.


title: Outcome Children Born After Pregnancy Denial

acronym: DENIGRO

summary:
The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).

The hypothesis is the denial of pregnancy may have repercussions on children's outcome.

intervention_type: Other


title: Visual Maturation in Prematurely Born Infants According to Factors Influencing Its Development. Premavision Follow-up at 18 Months Corrected Age, 4 and 7 Years of Age.

acronym: PrmvsionSuiv

summary:
This study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent age (TEA) with factors associated with impaired visual maturation. (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).

In this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Screening

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Benefit From a Proximity-incentive Strategy Based on Vaginal Self-sampling for Women Who do Not Participate to Cervical Cancer Screening in Aude and Hérault [French Departments]: an Interventional Research to Reduce Social and Territorial Inequalities.

acronym: RIDECA

summary:
In France, cervical cancer screening is based on a cervical smear for women aged 25 to 30 years and on High Risk- HPV (HR-HPV) testing for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program, up to 40% of women, which led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU), based on remind letters, starting in 2019.

Our project is a complementary strategy to DO CCU based on direct proposal of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home will increase their participation to cervical cancer screening.

This project will be held in the Departments of Hérault and Aude, which are among those in the region of Occitanie (south of France) with the lowest participation to cervical cancer screening.

Women aged 50 to 65 years with no cervical smear and/or gynecological examination for more than three years, will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care located in a particularly deprived area of Aude (Limoux-Quillan). In each site, non attendee-women will be proposed by a trained mid-wife, a vaginal self-sample device to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored.

The primary objective of this study will be to evaluate attendance of under-screened women to vaginal self-sampling for cervical cancer screening, i.e. the number of women who accepted a self-sample device among women to whom it has been proposed.

A second objective will be to analyse psycho-social factors associated with cervical cancer screening in this population of non-attendee women, i.e. their socio-economic environment and the way women perceive and are implicated in cervical cancer screening. This secondary objective will be based on a specific questionnaire at recruitment and on semi-directive phone interviews in a sub-group of women. The efficacy of this screening strategy (number of women who performed vaginal self sample and sent it to the laboratory, and number of women who completed follow-up in case of a positive HR-HPV test) will also be monitored.

The number of women to be recruited is 300 for each site. The total estimated duration of the project is 48 months, including 24 months for women's recruitment.

Expected results from this project are:

An increase in participation to cervical cancer screening of non-attendee women aged 50 to 65 years in the Departments of Hérault and Aude.
Women's education about cervical cancer screening through discussion with the midwife during recruitment and information tools developed for the project
Information of local health staff and community-based associations about cervical cancer screening and the place of HR-HPV testing.
Identification of psycho-social factors and potential barriers to compliance to cervical cancer screening.
Identification of organizational and practical difficulties that must be overcome to improve preventive actions towards deprived populations.

lead_sponsor: University Hospital, Montpellier

collaborators: Regional Center for Cancer Screening (CRCDC) - Region of Occitanie - Department of Herault

collaborators: Regional Center for Cancer Screening (CRCDC) - Region of Occitanie - Department of Aude

collaborators: Association for Breast Cancer Screening - Department of Herault (AMHDCS)

location_facility: Arnaud de Villeneuve Hospital, clinical trials Department


title: Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

acronym: NalmeCir

summary: Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.

status: Withdrawn

design_allocation: Randomized

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

type_etablissement: CH

acronyme: NalmeCir

titre: Essai multicentrique randomisé en double aveugle, testant le nalméfène versus placebo dans le traitement de l'addiction à l'alcool chez des patients avec une cirrhose alcoolique. Etude NalmeCir (Nalméfène Cirrhose).

discipline_principale: gastro-entérologie

nom_porteur: NGYUEN KHAC

prenom_porteur: Eric


title: Sexual Health Needs of Adolescents Living With HIV Since Childhood : a Qualitative Study

acronym: SSVIH

summary: To improve the knowdelge about the sexual health needs of perinatally HIV-infected adolescents living in France.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM CESP1018


title: Balloon to Induce Labor in Generous Women

acronym: BIGW

summary:
The rate of obesity increases continuously in France as in many developing countries.The risk of cesarean delivery is increased in obese compared to normal-weight women and postpartum complications as infections, thromboembolic events and related maternal death, are more common among obese women who deliver by cesarean than both normal-weight women with caesarean deliveries and obese women with vaginal deliveries. Unfortunately, obesity is associated with a higher rate of failed induction requiring a cesarean delivery and especially in nulliparous.

Methods of induction for obese women have to be improved to decrease the c-section rate but investigators should also be cautious on the type and dose of PG not to affect the neonatal wellbeing associated with uterine hyperstimulation.

The aim of this study is to demonstrate the efficacy of the association of mechanical and pharmacological cervical ripening (balloon catheter plus 50 µg oral prostaglandin E1) versus pharmacological cervical ripening alone (50 µg oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

primary_purpose: Other

ReferenceCitation: Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.

ReferenceCitation: Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.

ReferenceCitation: McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.

lead_sponsor: University Hospital, Toulouse

location_country: Martinique France

location_facility:
CHU Fort de France
Hôpital St Joseph
CHU Nantes
CHU Kremlin Bicêtre
CHU Montpellier
CHU Antoine Beclère
CHU St Pierre de la Reunion
CHU Nimes
CHU de Toulouse
CHU Clermont-Ferrand
CHRU Lille
CHU Saint Denis de la Reunion
CHI Poissy
CHU Bordeaux
CHU Poitiers
CHU Tours
CHU St Etienne
Centre hospitalier St Joseph

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: BigW

titre: Le ballonnet pour l'induction du travail chez les femmes obèses à terme (The BigW trial)

discipline_principale: obstétrique

nom_porteur: VAYSSIERE

prenom_porteur: Christophe


title: Trajectories and Reactions of Users and Relatives Consulting French Youth Addiction Services (Consultations Jeunes Consommateurs)

acronym: TRYAD

summary:
In France, the "Consultations Jeunes Consommateurs" (CJC) are the services specialized in the reception of young people for addiction problems. There are more than 500 CJCs throughout France. Depending on the situation, the CJC develops an early intervention strategy aimed either at reducing the risk of developing an addiction or at accelerating entry into appropriate care. The CJCs also meet with family members or professionals who may also independently request help or advice.

Set up by the State since 2004, the action of the CJCs has never been formally evaluated. Only descriptive studies, carried out by the French Observatory of Drugs and Drug Addiction (OFDT), have made it possible to better understand the profile of people who consult CJCs. However, no longitudinal study has yet been carried out to understand the factors associated with the overall evolution of users consulting CJCs, nor with the level of satisfaction of users and those around them. Such objectives are complex, due to the diversity of situations encountered in CJCs and the heterogeneity of the CJCs themselves.

time_perspective: Other

lead_sponsor: Hôpital le Vinatier


title: Screening for Neurodevelopmental Disorders in Children With Congenital Heart Disease Aged From 6 to 66 Months in Nord-Pas-de-Calais

acronym: NeuroDis-CHD

summary:
Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society.

The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up.

This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

ReferenceCitation: Billotte M, Deken V, Joriot S, Vaksmann G, Richard A, Bouzguenda I, Godart F, Baudelet JB, Rakza T, Nguyen The Tich S, Guillaume MP. Screening for neurodevelopmental disorders in children with congenital heart disease. Eur J Pediatr. 2021 Apr;180(4):1157-1167. doi: 10.1007/s00431-020-03850-x. Epub 2020 Oct 29.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: University Hospital, Lille


title: Development of the General Scale Observance for Chronic Diseases (EGOMAC)

acronym: EGOMAC

summary:
The main objective is to assess the measurement characteristics (validity, reproducibility) and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease, by following the evolution of patient compliance at D0 and D15.

The second objective is to assess the sensitivity to change of scale EGOMAC following developments compliance 3 months.

ipd_sharing: Yes

ipd_sharing_description: open to partnership


title: Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

acronym: STAMP

summary:
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.

Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.

External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.

More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.

Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.

ReferenceCitation: Basso C, Perazzolo Marra M, Rizzo S, De Lazzari M, Giorgi B, Cipriani A, Frigo AC, Rigato I, Migliore F, Pilichou K, Bertaglia E, Cacciavillani L, Bauce B, Corrado D, Thiene G, Iliceto S. Arrhythmic Mitral Valve Prolapse and Sudden Cardiac Death. Circulation. 2015 Aug 18;132(7):556-66. doi: 10.1161/CIRCULATIONAHA.115.016291. Epub 2015 Jul 9.

ReferenceCitation: Huttin O, Pierre S, Venner C, Voilliot D, Sellal JM, Aliot E, Sadoul N, Juilliere Y, Selton-Suty C. Interactions between mitral valve and left ventricle analysed by 2D speckle tracking in patients with mitral valve prolapse: one more piece to the puzzle. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):323-331. doi: 10.1093/ehjci/jew075.

location_facility: Nancy University Hospital, Department of Cardiology


title: Expression of Ku70/XRCC6 and Others NHEJ Components in Waldenström's Macroglobulinemia in Comparison With Others B-cell Lymphoproliferative Disorders and Normal B Cells.

acronym: WAL-KU

summary:
Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present poorly understood, although a recurrent mutation (L265P MYD88) has recently been described. Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group showed that MW had a specific proteomic profile, and one of the differentially expressed proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .

The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic or epigenetic modification) in comparison with other lymphoid malignancies and normal B cells.


title: Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

acronym: IMAP

summary:
According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

to identify, compare and combine predictive markers of Alzheimer's disease
to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

status: Unknown status

ReferenceCitation: Chetelat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.

ReferenceCitation: Mevel K, Grassiot B, Chetelat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. French.

ReferenceType: result

ReferenceCitation: La Joie R, Fouquet M, Mezenge F, Landeau B, Villain N, Mevel K, Pelerin A, Eustache F, Desgranges B, Chetelat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.

ReferenceCitation: Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chetelat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.

lead_sponsor: University Hospital, Caen

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

location_facility:
University Hospital Tours
University Hospital Roger Salengro
University Hospital Rouen
University Hospital Pontchaillou
University Hospital Côte de Nacre


title: Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée

acronym: Pro-Pho-Dys

summary:
To show the interest of the association of proprioceptive and orthophonic care of dyslexic children. The assumption is that proprioceptive support by correcting a centrally located spatial localization instability restores the ability to automate.

It allows a gain of effectiveness of the orthophonic remediation of the reading of dyslexic children.

Interventional comparative study over 9 months, of three modes of care: Speech-language, or proprioceptive, or combined (speech therapy or proprioceptive)

ReferenceCitation: Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Informa

lead_sponsor: Scalab CNRS 9193

lead_sponsor_type: industriel


title: Validity Assessment of the "LabForGames Warning" Serious Game

summary:
The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful educational tools since they allow both theory and practice training for an important number of learners, simultaneously. However, few studies have evaluated the validity and effectiveness of serious games.

Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a serious game named "LabForGames Warning" for nursing students with the following learning objectives: to recognize and to address the degradation of a patient's clinical condition and to work on the issue of inter-professional communication. The aim of the present study is to determine content and construct validities of the "LabForGames Warning" serious game before its use as a healthcare professional training tool.

ReferenceCitation: Blanie A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.

repositories_concat: PubMed Central

lead_sponsor: Université Paris-Sud


title: Promoting Parental Skills and Enhancing Attachment in Early Childhood

acronym: CAPEDP

summary: Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France

ReferenceCitation: Dugravier R. [Understanding consequences of hospitalization within attachment theory]. Arch Pediatr. 2010 Jun;17(6):723-4. doi: 10.1016/S0929-693X(10)70078-6. No abstract available. French.

ReferenceCitation: Guedeney A, Guedeney N, Tereno S, Dugravier R, Greacen T, Welniarz B, Saias T, Tubach F; CAPEDP Study Group. Infant rhythms versus parental time: promoting parent-infant synchrony. J Physiol Paris. 2011 Dec;105(4-6):195-200. doi: 10.1016/j.jphysparis.2011.07.005. Epub 2011 Jul 12.

ReferenceCitation: Saias T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guedeney A, Dugravier R, Tereno S, Falissard B, Tubach F; CAPEDP Study Group; Revah-Levy A. Evaluating fidelity in home-visiting programs a qualitative analysis of 1058 home visit case notes from 105 families. PLoS One. 2012;7(5):e36915. doi: 10.1371/journal.pone.0036915. Epub 2012 May 18.

ReferenceCitation: Greacen T, Welniarz B, Purper-Ouakil D, Wendland J, Dugravier R, Saias T, Tereno S, Tubach F, Haddad A, Guedeney A; CAPEDP STUDY GROUP. BEST PRACTICE IN INDIVIDUAL SUPERVISION OF PSYCHOLOGISTS WORKING IN THE FRENCH CAPEDP PREVENTIVE PERINATAL HOME-VISITING PROGRAM: RESULTS OF A DELPHI CONSENSUS PROCESS. Infant Ment Health J. 2017 Mar;38(2):267-275. doi: 10.1002/imhj.21630. Epub 2017 Feb 25.

publisher_dissemination: Wiley

ReferenceCitation: Dugravier R, Tubach F, Saias T, Guedeney N, Pasquet B, Purper-Ouakil D, Tereno S, Welniarz B, Matos J; CAPEDP Study Group; Guedeney A, Greacen T. Impact of a manualized multifocal perinatal home-visiting program using psychologists on postnatal depression: the CAPEDP randomized controlled trial. PLoS One. 2013 Aug 19;8(8):e72216. doi: 10.1371/journal.pone.0072216. eCollection 2013.

publisher_dissemination: Public Library of Science

ReferenceCitation: Tubach F, Greacen T, Saias T, Dugravier R, Guedeney N, Ravaud P, Tereno S, Tremblay R, Falissard B, Guedeney A; CAPEDP Study Group. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France. BMC Public Health. 2012 Aug 13;12:648. doi: 10.1186/1471-2458-12-648.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France


title: Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

acronym: FUSION

summary: This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

lead_sponsor: Laboratoires URGO


title: Impact of tDCS on Cannabis Craving in Patients With Schizophrenia and Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study

acronym: tCCS

summary: This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.

lead_sponsor: Centre hospitalier de Ville-Evrard, France

location_facility:
Youcef Bencherif
Ch Ville Evrard


title: Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery

acronym: BariaProG

summary:
Adequate equipment for lifelong health is essential to ensure healthy health for fetal development. In France, pregnant women with normal weight have increased protein intake to 0.78-0.95g / kg / day (ANC 2001). And more recently, AFSSA from 2007 proposed a recommended nutritional intake of 0.82-1g / kg / d. An increased requirements in the second and third trimester of 0.25 g / kg / day and 0.46 g / kg / day, respectively, compared with non-pregnancy values. However, the prevalence of the incompatibility remains unknown.

In addition, maternal protein intake is inadequate or excessively associated with both intra-uterine growth retardation and small gestational age weights. Neonatal hypotrophy is also associated with a risk of chronic diseases in adulthood, including cardiovascular disease, type 2 diabetes, insulin resistance, high blood pressure and coronary heart disease.

In obese women or patients undergoing surgery for bariatric surgery, there is currently no recommendation on the recommended protein intake. Or, maternal obesity plays a role in the metabolic development of children and bariatric surgery is associated with a major risk of maternal micronutrient deficiencies and intra-uterine growth retardation.

Prevalence of obesity in France is currently estimated at 17%. Moreover, bariatric surgery is also fast-growing in France with a number of interventions having tripled since 2006.

Thus, a better understanding of maternal food needs and applications throughout pregnancy is needed to improve dietary guidelines and promote fetal, neonatal and long-term health.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Early Screening of Autism Spectrum Disorder in General and Pediatric Practices, Nurseries and Early Child Care Centers, Using Parent Questionnaires and Guidance for Addressing the Child

acronym: KitCAT

summary:
Early screening for Autism Spectrum Disorder has been validated using different screening tools, in particular M-CHAT-R and ITC in different countries. Unfortunaltely, in France, they are not often used. Thus, medium age for diagnosis in France is late. Yet, early interventions has shown efficiency (grade B of HAS 2010 recommendations, HAS 2018) . The American have described an efficient method using partnership between pediatricians and autism specialists (Miller et al). Autism Spectrum Disorders concern 1% of population. The third Autism Plan in France then HAS 2018 Recommandations and The 2018 National Strategy for Autism have propose to implement three levels for early diagnostic : the frontline is constituted by professionals who can detect the firsts signs ( in nurseries, general practice, pediatric practice, early childhood centers), the second line is constituted by the proximity network of professionals who can diagnose " simple " autism ( CMP, CAMSP, neurologic pediatricians), the third line is constituted by expert teem in specialized hospital centers for neurodevelopmental disorders diagnostic.

This organization is, for now, not efficient. First lines professionals are not always formed to autism detection. When the screening is efficient, professionals have difficulties to address children to proximity teem trained to autism diagnostic because of delays or lack of professionals. The second line professionals are note always trained to use diagnostic tools and tend to address all the children to the third line, even when the diagnostic is not complex. The third lign is saturated by all these requests.


title: Arrêt du Traitement Antihypertenseur Chez Les Patients Hypertendus Suivis en Médecine Générale / Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care: The STOP-Trial

summary:
The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension, performed by General practitioners.

The study will be conducted in parallel in the Clinical Investigation Center Plurithematic (CIC-P)1433 of Nancy (the study coordinating center) by the general practitioners investigators of the CIC-P.

The main purpose of the study is to determine the factors associated with the rate of patients remaining normotensive one year after stopping their antihypertensive monotherapy or low dose dual therapy:

white coat hypertension
primary diagnosis by home blood pressure measurements (HBPM) /ambulatory blood pressure measurements (ABPM) /clinical measure
initial blood pressure level
compliance
therapeutic class versus others
age
gender
weight variation
modification of lifestyle
concomitant treatments and associated substances
...

The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values <135/85 mmHg).

location_facility: Maison de Santé Pluridisciplinaire de GROSTENQUIN

location_facility: Centre d'Investigation Clinique module plurithématique 1433 Inserm/CHRU de Nancy

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: CHRU DE NANCY

acronyme: STOP-Trial

titre: Arrêt du traitement antihypertenseur chez les patients hypertendus suivis en Médecine Générale Stopping antihypertensive Treatment amOng hypertensive patients in Primary care: The STOP-Trial

discipline_principale: cardiologie

nom_porteur: BOIVIN

prenom_porteur: Jean-Marc


title: Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. A Randomized Multicentric Open Trial

acronym: EMPASHOCK

summary:
Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock.

Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility:
CHU de Dijon Bourgogne
CHU Reims
CHRU de NANCY
CHU de Besançon
CHU Lille
CHR Metz - Thionville
Hôpitaux Universitaires de Strasbourg


title: Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor

acronym: ONIalloMDS

summary: The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.

lead_sponsor: Saint-Louis Hospital, Paris, France

sponsor_collaborators:
Saint-Louis Hospital, Paris, France
Hospital Avicenne
University Hospital, Grenoble
University Hospital, Clermont-Ferrand


title: Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs

acronym: FLARE-OA

summary:
The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is justified by the opportunities for development of clinical trials targeting hip and knee OA long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of symptoms. Such treatments are currently under development and will likely bring important changes in the treatment of patients. The development of a Flare-OA tool would be essential to capture the occurrence of flare, and to implement and adapt treatment strategies.

This project was elaborated with the aims to:

define the construct through development of a conceptual framework
use the conceptual framework to inform the development of a patient-reported outcome measure, Flare-OA tool, for people with OA
evaluate the psychometric properties of the new measure using the OMERACT (Outcome Measures in Rheumatology) filter 2.0 and Rasch measurement methods.

ReferenceCitation: King LK, Epstein J, Cross M, Buzzi M, Buttel T, Cembalo SM, Spitz E, Adams CL, Adebajo A, Bennell K, Blanco B, Courage U, Decary S, Gill M, Gill TK, Hajji R, Hinman RS, Jones A, Li LC, Mather K, Mani R, Nasef SI, Oo WM, Osteras N, Otobo TM, Ramiro S, Sharma S, April KT, Touma Z, Whittaker JL, Wluka AE, Grosskleg S, Hunter DJ, Shea B, Hawker GA, Callahan LF, March L, Guillemin F. Endorsement of the domains of knee and hip osteoarthritis (OA) flare: A report from the OMERACT 2020 inaugural virtual consensus vote from the flares in OA working group. Semin Arthritis Rheum. 2021 Jun;51(3):618-622. doi: 10.1016/j.semarthrit.2021.03.010. Epub 2021 Mar 20.

ReferenceCitation: Guillemin F, Ricatte C, Barcenilla-Wong A, Schoumacker A, Cross M, Alleyrat C, Buttel T, Cembalo M, Manseur H, Urban H, Fautrel B, Conaghan PG, Hawker G, Rutherford C, March L, Spitz E, Hunter DJ. Developing a Preliminary Definition and Domains of Flare in Knee and Hip Osteoarthritis (OA): Consensus Building of the Flare-in-OA OMERACT Group. J Rheumatol. 2019 Sep;46(9):1188-1191. doi: 10.3899/jrheum.181085. Epub 2019 May 15.

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Traore Y, Epstein J, Spitz E, March L, Maillefert JF, Rutherford C, Ricatte C, Alleyrat C, Cross M, King LK, Callahan LF, Fautrel B, Buttel T, Hawker G, Hunter DJ, Guillemin F. Development and validation of the Flare-OA questionnaire for measuring flare in knee and hip osteoarthritis. Osteoarthritis Cartilage. 2022 May;30(5):689-696. doi: 10.1016/j.joca.2021.12.011. Epub 2022 Jan 20.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: HAL

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_country: Australia Canada Martinique France

location_facility: Institute of Bone and Joint Research - University of Sydney


title: Factors Predisposing to Inappropriate Transfers of Nursing Home Residents to Emergency Departments

acronym: FINE

summary:
According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months or about 50% per year. These hospitalizations concern for half, transfers to emergency department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in France, confirm that intense flows between NH and ED. These studies also support the idea that these transfers to ED potentially expose some NH residents to iatrogenic complications, a risk of functional decline, an increased risk of mortality, and generate additional health costs. To transfer to ED residents who will benefit from emergency care and not to transfer to ED residents for whom this transfer generates a higher risk than the expected benefit is the goal to reach to guarantee the better quality of care for NH residents.

Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or palliative care known before transferring to ED and / or the presence of advance directives of non-hospitalization in the resident's file. This is a clinical situation that could be managed by other means that the transfer to ED without loss of opportunity for the patient.

The primary objective of our study is to determine the factors predisposing NH residents to inappropriate transfer to ED.

Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by factors accessible to interventions such as the organization of the NH care system or by improving the management of some diseases in NH. Investigators also hypothesize that the cost of inappropriate transfers to the ED is considerable. Acknowledgement of costs generated by inappropriate transfers to ED would allow policy makers to make strategic decisions to improve care system.

time_perspective: Retrospective

ReferenceCitation: Perrin A, Tavassoli N, Mathieu C, Hermabessiere S, Houles M, McCambridge C, Magre E, Fernandez S, Caquelard A, Charpentier S, Lauque D, Azema O, Bismuth S, Chicoulaa B, Oustric S, Costa N, Molinier L, Vellas B, Berard E, Rolland Y. Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol. Contemp Clin Trials Commun. 2017 Jul 21;7:217-223. doi: 10.1016/j.conctc.2017.07.005. eCollection 2017 Sep.

ReferenceCitation: Rolland Y, Mathieu C, Tavassoli N, Berard E, Laffon de Mazieres C, Hermabessiere S, Houles M, Perrin A, Krams T, Qassemi S, Cambon A, Magre E, Cantet C, Charpentier S, Lauque D, Azema O, Chicoulaa B, Oustric S, McCambridge C, Gombault-Datzenko E, Molinier L, Costa N, De Souto Barreto P. Factors Associated with Potentially Inappropriate Transfer to the Emergency Department among Nursing Home Residents. J Am Med Dir Assoc. 2021 Dec;22(12):2579-2586.e7. doi: 10.1016/j.jamda.2021.04.002. Epub 2021 May 5.

collaborators: Agence Régionale de la Santé - Midi Pyrénées

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease

acronym: RESECT-RGO

summary:
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques.

H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ.

Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.

status: Suspended

ReferenceCitation: Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.

ReferenceCitation: Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.

evidence: open (via page says license)

publisher_dissemination: Baishideng Publishing Group Inc.

ReferenceCitation: Kellokumpu I, Voutilainen M, Haglund C, Farkkila M, Roberts PJ, Kautiainen H. Quality of life following laparoscopic Nissen fundoplication: assessing short-term and long-term outcomes. World J Gastroenterol. 2013 Jun 28;19(24):3810-8. doi: 10.3748/wjg.v19.i24.3810.

ReferenceCitation: Marret H, Pierre F, Chapron C, Perrotin F, Body G, Lansac J. [Complications of laparoscopy caused by trocars. Preliminary study from the national registry of the French Society of Gynecologic Endoscopy]. J Gynecol Obstet Biol Reprod (Paris). 1997;26(4):405-12. French.

ReferenceCitation: Rickenbacher N, Kotter T, Kochen MM, Scherer M, Blozik E. Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis. Surg Endosc. 2014 Jan;28(1):143-55. doi: 10.1007/s00464-013-3140-z. Epub 2013 Sep 10. Erratum In: Surg Endosc. 2014 Jun;28(6):2002.

publisher_dissemination: Springer

ReferenceCitation: Mahmood Z, Byrne PJ, McMahon BP, Murphy EM, Arfin Q, Ravi N, Weir DG, Reynolds JV. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in the treatment of uncomplicated reflux disease. Am J Gastroenterol. 2006 Mar;101(3):431-6. doi: 10.1111/j.1572-0241.2006.00534.x.

ReferenceCitation: Triadafilopoulos G. Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28;20(24):7730-8. doi: 10.3748/wjg.v20.i24.7730.

ReferenceCitation: Feretis C, Benakis P, Dimopoulos C, Dailianas A, Filalithis P, Stamou KM, Manouras A, Apostolidis N. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc. 2001 Apr;53(4):423-6. doi: 10.1067/mge.2001.113912.

ReferenceCitation: Cicala M, Gabbrielli A, Emerenziani S, Guarino MP, Ribolsi M, Caviglia R, Costamagna G. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut. 2005 Feb;54(2):183-6. doi: 10.1136/gut.2004.040501.

ReferenceCitation: Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc. 2005 May;61(6):753-6. doi: 10.1016/s0016-5107(04)02645-8. No abstract available.

ReferenceCitation: Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A. A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc. 2003 Nov;58(5):770-6. doi: 10.1016/s0016-5107(03)02027-3.

ReferenceCitation: Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.

ReferenceCitation: Satodate H, Inoue H, Yoshida T, Usui S, Iwashita M, Fukami N, Shiokawa A, Kudo SE. Circumferential EMR of carcinoma arising in Barrett's esophagus: case report. Gastrointest Endosc. 2003 Aug;58(2):288-92. doi: 10.1067/mge.2003.361. No abstract available.

ReferenceCitation: Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.

ReferenceCitation: Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996 Sep;183(3):217-24.

ReferenceCitation: Laquiere A, Trottier-Tellier F, Urena-Campos R, Lienne P, Lecomte L, Katsogiannou M, Penaranda G, Boustiere C. Evaluation of Antireflux Mucosectomy for Severe Gastroesophageal Reflux Disease: Medium-Term Results of a Pilot Study. Gastroenterol Res Pract. 2022 Feb 21;2022:1606944. doi: 10.1155/2022/1606944. eCollection 2022.


title: A Prospective Study Comparing the Evolution of Visual Acuity Measured by Electronic Tablet or Computer and the Visual Acuity Measured by ETDRS in Patients Monitored and Treated for Exudative AMD

summary:
This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs) over a long period (several months or even years).

Increasing the number of patients to be followed and treated poses increasing problems for ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory functional results.

Moreover, this regular follow-up imposes enormous constraints on patients and their families (some children or patients are still working).

Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at home, seems a logical step to help us improve the quality of patient follow-up while spacing controls.

The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's AV decreases, and whatever the reason

lead_sponsor: Hospital St. Joseph, Marseille, France


title: Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

summary: This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation


title: Evaluation of the Prevalence of Asthma in a Cohort of Children Born After In Vitro Fertilization (Aged 11-15) Compared With Spontaneously Conceived Children of the Same Age Range

acronym: EMCeFIV

summary:
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART.

According to the literature, children born after ART are more likely to be at higher risk of health problems than spontaneously conceived ones. Interestingly, recent studies suggested an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).

The purpose of this study is to evaluate the prevalence of asthma in school adolescents from a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to a control group composed of the same age range spontaneously conceived individuals.

The expected outcome of this study will provide new information regarding these children to ART professionals of and to their own families, by focusing on an age range (between 11 and 15 years) for which very little information is available to date.

ReferenceCitation: Anzola AB, Pauly V, Geoffroy-Siraudin C, Gervoise-Boyer MJ, Montjean D, Boyer P. The first 50 live births after autologous oocyte vitrification in France. J Assist Reprod Genet. 2015 Dec;32(12):1781-7. doi: 10.1007/s10815-015-0603-2. Epub 2015 Oct 30.

ReferenceCitation: Meddeb L, Boyer M, Pauly V, Tourame P, Rossin B, Pfister B, Boyer P. [Procedure used to follow-up a cohort of IVF children. Interests and limits of tools performed to longitudinal follow up for a monocentric cohort]. Rev Epidemiol Sante Publique. 2011 Apr;59(2):97-105. doi: 10.1016/j.respe.2010.11.004. Epub 2011 Mar 22. French.


title: Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.

acronym: ELOUAN

summary: Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).


title: Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse

summary:
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.

Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

collaborators:
DRRC
Medtronic - MITG


title: Optimized Phase III Trial of Immuno-stimulation With Maraviroc, a CCR5 (Chemokine Receptor 5) Antagonist, Combined With Anti Retroviral Therapy in Advanced, Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event and/or CD4 (Cluster of Differentiation 4) Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL

acronym: OPTIMAL

summary:
The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death.

It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.

ReferenceCitation: Levy Y, Lelievre JD, Assoumou L, Aznar E, Pulido F, Tambussi G, Crespo M, Meybeck A, Molina JM, Delaugerre C, Izopet J, Peytavin G, Cardon F, Diallo A, Lancar R, Beniguel L, Costagliola D. Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial. Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.

publisher_dissemination: American College of Physicians

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Pfizer


title: Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer

acronym: TRECAM

summary: In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.

ReferenceCitation: Barranger E, Uzan S, Pitre S, Duval MA, Charon Y. [Development of a hand-held gamma camera (POCI) in the sentinel node biopsy for breast cancer]. Pathol Biol (Paris). 2008 Jul;56(5):254-6. doi: 10.1016/j.patbio.2007.09.009. Epub 2008 Feb 21. No abstract available. French.

ReferenceCitation: Medina-Franco H, Abarca-Perez L, Garcia-Alvarez MN, Ulloa-Gomez JL, Romero-Trejo C, Sepulveda-Mendez J. Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol. 2008 Feb 1;97(2):108-11. doi: 10.1002/jso.20880.

ReferenceCitation: Lavoue V, Nos C, Clough KB, Baghaie F, Zerbib E, Poulet B, Lefrere Belda MA, Ducellier A, Lecuru F. Simplified technique of radioguided occult lesion localization (ROLL) plus sentinel lymph node biopsy (SNOLL) in breast carcinoma. Ann Surg Oncol. 2008 Sep;15(9):2556-61. doi: 10.1245/s10434-008-9994-y. Epub 2008 Jun 24.

ReferenceCitation: Monti S, Galimberti V, Trifiro G, De Cicco C, Peradze N, Brenelli F, Fernandez-Rodriguez J, Rotmensz N, Latronico A, Berrettini A, Mauri M, Machado L, Luini A, Paganelli G. Occult breast lesion localization plus sentinel node biopsy (SNOLL): experience with 959 patients at the European Institute of Oncology. Ann Surg Oncol. 2007 Oct;14(10):2928-31. doi: 10.1245/s10434-007-9452-2. Epub 2007 Aug 1.

ReferenceCitation: Kerrou K, Pitre S, Coutant C, Rouzier R, Ancel PY, Lebeaux C, Huchet V, Montravers F, Pascal O, Duval MA, Lefebvre F, Menard L, Uzan S, Charon Y, Barranger E. The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med. 2011 Sep;52(9):1346-53. doi: 10.2967/jnumed.111.090464. Epub 2011 Aug 17.

ReferenceCitation: Bricou A, Duval MA, Charon Y, Barranger E. Mobile gamma cameras in breast cancer care - a review. Eur J Surg Oncol. 2013 May;39(5):409-16. doi: 10.1016/j.ejso.2013.02.008. Epub 2013 Mar 7.

ReferenceCitation: The Tumor Resection Camera (TReCam), a multipixel imaging probe for radio-guided surgery.E. Netter, L. Pinot, L. Ménard, M.-A. Duval, B. Janvier, F. Lefebvre, R. Siebert, Y. Charon. Nuclear Science Symposium Conference Record (NSS/MIC), 2009 IEEE, 2573-2576

collaborators: Centre National de la Recherche Scientifique, France


type: Other Grant/Funding Number

title: Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.

acronym: TGV-MOA

summary:
The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). The intervention consists of personalized measurements and calculations of the different pressures inside the thorax. The main question to answer is:

• Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings than suggested by a strategy largely used in ARDS patients in France?

A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired.

Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefit of this personalized approach.

ReferenceCitation: Diehl JL, Talmor D. When could airway plateau pressure above 30 cmH2O be acceptable in ARDS patients? Intensive Care Med. 2021 Sep;47(9):1028-1031. doi: 10.1007/s00134-021-06472-5. Epub 2021 Jul 8. No abstract available.

ReferenceCitation: Coudroy R, Vimpere D, Aissaoui N, Younan R, Bailleul C, Couteau-Chardon A, Lancelot A, Guerot E, Chen L, Brochard L, Diehl JL. Prevalence of Complete Airway Closure According to Body Mass Index in Acute Respiratory Distress Syndrome. Anesthesiology. 2020 Oct 1;133(4):867-878. doi: 10.1097/ALN.0000000000003444.

oa_host_type: publisher

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Florio G, Ferrari M, Bittner EA, De Santis Santiago R, Pirrone M, Fumagalli J, Teggia Droghi M, Mietto C, Pinciroli R, Berg S, Bagchi A, Shelton K, Kuo A, Lai Y, Sonny A, Lai P, Hibbert K, Kwo J, Pino RM, Wiener-Kronish J, Amato MBP, Arora P, Kacmarek RM, Berra L; investigators of the lung rescue team. A lung rescue team improves survival in obesity with acute respiratory distress syndrome. Crit Care. 2020 Jan 15;24(1):4. doi: 10.1186/s13054-019-2709-x.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Rowley DD, Arrington SR, Enfield KB, Lamb KD, Kadl A, Davis JP, Theodore DJ. Transpulmonary Pressure-Guided Lung-Protective Ventilation Improves Pulmonary Mechanics and Oxygenation Among Obese Subjects on Mechanical Ventilation. Respir Care. 2021 Jul;66(7):1049-1058. doi: 10.4187/respcare.08686. Epub 2021 Apr 20.

publisher_dissemination: Daedalus Enterprises

ReferenceCitation: Sarge T, Baedorf-Kassis E, Banner-Goodspeed V, Novack V, Loring SH, Gong MN, Cook D, Talmor D, Beitler JR; EPVent-2 Study Group. Effect of Esophageal Pressure-guided Positive End-Expiratory Pressure on Survival from Acute Respiratory Distress Syndrome: A Risk-based and Mechanistic Reanalysis of the EPVent-2 Trial. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1153-1163. doi: 10.1164/rccm.202009-3539OC.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Thoracic Society

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility: AP-HP, Hôpital Européen Georges Pompidou


title: Epidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes

acronym: CASCADE

summary:
Out-of-hospital cardiac arrest (OHCA) is a public health problem, affecting 50,000 people per year in France. Intervention time (initiation of cardiopulmonary resuscitation (CPR) and advanced CPR) are associated with a better prognosis. Despite this, the latest published data show a very low overall survival (5%). Our territory has only three centers distributed hospitals with both a 24-hour coronary angiography platform and an intensive care unit. Finally, although 60% of ACEHs receive coronary angiography in the Île de France region, it is performed on only 15% of patients in the Reims University Hospital.

Therefore, it seems essential to conduct a study on the reality of the support of ACEH and to study the clinical and biological factors as well as the influence of the geographical distribution of specialized technical platforms on the prognosis of patients.

lead_sponsor: Stephane Sanchez


title: Observational Study of Allergic Rhinitis in Children

acronym: ORACLE

summary: Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.

lead_sponsor: ALK-Abelló A/S

location_facility: Hôpital Necker-Enfants malades - AP-HP Service de Pneumologie et Allergologie Pédiatriques


title: Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

acronym: VISTA CARE

summary: The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

lead_sponsor: University Hospital, Grenoble


title: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients - Estimabl

acronym: Estimabl

summary:
In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.

Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

ReferenceCitation: Schlumberger M, Leboulleux S, Catargi B, Deandreis D, Zerdoud S, Bardet S, Rusu D, Godbert Y, Buffet C, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Toubert ME, Kelly A, Benhamou E, Borget I. Outcome after ablation in patients with low-risk thyroid cancer (ESTIMABL1): 5-year follow-up results of a randomised, phase 3, equivalence trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):618-626. doi: 10.1016/S2213-8587(18)30113-X. Epub 2018 May 26.

ReferenceCitation: Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroide Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: LONG-TERM EFFECTS TOLERANCE AND THE Ulipristal Acetate IN DISEASE Charcot-MARIE-TOOTH TYPE OF 1A

acronym: UPACOMT

summary:
The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal dominant, associated with a duplication of the chromosome 17p11.2 region which leads to overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major component of peripheral myelin.

In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in the prognosis evolution of the disease. Furthermore, several studies have shown that the administration of progesterone increased the expression of PMP22 gene (measured in a skin biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22 and improve symptoms in rat CMT1A.

The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal acetate and (EllaOne®). Few side effects have been reported including a few cases of endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare cases of adrenal androgen and failure have been observed. However, EllaOne® has low antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The investigators therefore believe that it will be well tolerated in humans and will reduce the synthesis of PMP22 and the action of oxidative stress by improving disability of patients.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service d'Explorations et pathologies neuro- musculaires

location_facility: Département de Neurologie Centre de Référence des Maladies Neuromusculaires Grand Est (CERNEST) Hôpital de Hautepierre

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

acronyme: UPACOMT

titre: Effet à long terme et tolérance de l'ulipristal acétate dans la maladie de Charcot-Marie-Tooth de type 1A

discipline_principale: autre

nom_porteur: ECHANIZ-LAGUNA

prenom_porteur: Andoni


title: Changes in the Consumption of Psychoactive Substances by People Incarcerated at the Villeneuve-Lès-Maguelone Prison During Containment Linked to COVID-19.

summary:
The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.

On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.

Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.

However,prisoners have a higher prevalence of substance use disorders than the general population.

What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.

Anonymous questionnaire from the start
Collection of socio-demographic data
Collection of consumption data before and during containment
Collection of monitoring data

time_perspective: Cross-Sectional

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer.

acronym: PREOP-PSMA

summary:
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.

Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.

Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.

Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.

Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.

Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Etat BUCCO-dentaire de Patients Atteints de SCHIZophrénie et de Troubles Schizo-affectif Suivis au Centre Hospitalier de Charles Perrens

acronym: BUCCOSCHIZ

summary: The aim of the study is to describe the oral health status of patients suffering from schizophrenia and schizoaffective disorders in a psychiatric institute in France.

ReferenceCitation: Denis F. [The oral health of patients in psychiatric institutions and related comorbidities]. Soins Psychiatr. 2014 Jan-Feb;(290):40-4. French.

ReferenceCitation: Curien R. & al; Evaluation de l'influence des psychotropes sur la santé bucco-dentaire chez une population de patients hospitalisés en secteur psychiatrique. Information Dentaire. 88 : (2006): 439-441

ReferenceCitation: Bertaud-Gounot V, Kovess-Masfety V, Perrus C, Trohel G, Richard F. Oral health status and treatment needs among psychiatric inpatients in Rennes, France: a cross-sectional study. BMC Psychiatry. 2013 Sep 21;13:227. doi: 10.1186/1471-244X-13-227.

ReferenceCitation: Catteau C, Blaizot A, Duhamel A, Delzenne A, Devillers A, Frimat P. [Dental status and related factors in an occupational health service in Northern France]. Sante Publique. 2013 Nov-Dec;25(6):747-55. French.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

summary:
Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. A blood sample will be proposed in the field of this research project, and the biological material will be stored at the DNA and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol.

Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial forms with early onset. In frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. The identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms not caused by the known genes, using linkage approaches and candidate gene analysis. The familial forms are also useful for identifying the modifier genes.

In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. The strategies will use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment.

Finally, correlations will be performed with seric markers according to each kind of dementia.

Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and in the study of neurological disorders of genetic origin.

ReferenceCitation: Le Ber I, Guedj E, Gabelle A, Verpillat P, Volteau M, Thomas-Anterion C, Decousus M, Hannequin D, Vera P, Lacomblez L, Camuzat A, Didic M, Puel M, Lotterie JA, Golfier V, Bernard AM, Vercelletto M, Magne C, Sellal F, Namer I, Michel BF, Pasquier J, Salachas F, Bochet J; French research network on FTD/FTD-MND; Brice A, Habert MO, Dubois B. Demographic, neurological and behavioural characteristics and brain perfusion SPECT in frontal variant of frontotemporal dementia. Brain. 2006 Nov;129(Pt 11):3051-65. doi: 10.1093/brain/awl288.

ReferenceCitation: van der Zee J, Le Ber I, Maurer-Stroh S, Engelborghs S, Gijselinck I, Camuzat A, Brouwers N, Vandenberghe R, Sleegers K, Hannequin D, Dermaut B, Schymkowitz J, Campion D, Santens P, Martin JJ, Lacomblez L, De Pooter T, Peeters K, Mattheijssens M, Vercelletto M, Van den Broeck M, Cruts M, De Deyn PP, Rousseau F, Brice A, Van Broeckhoven C. Mutations other than null mutations producing a pathogenic loss of progranulin in frontotemporal dementia. Hum Mutat. 2007 Apr;28(4):416. doi: 10.1002/humu.9484.

ReferenceCitation: Baba Y, Baker MC, Le Ber I, Brice A, Maeck L, Kohlhase J, Yasuda M, Stoppe G, Bugiani O, Sperfeld AD, Tsuboi Y, Uitti RJ, Farrer MJ, Ghetti B, Hutton ML, Wszolek ZK. Clinical and genetic features of families with frontotemporal dementia and parkinsonism linked to chromosome 17 with a P301S tau mutation. J Neural Transm (Vienna). 2007 Jul;114(7):947-50. doi: 10.1007/s00702-007-0632-9. Epub 2007 Feb 23.

ReferenceCitation: Le Ber I, van der Zee J, Hannequin D, Gijselinck I, Campion D, Puel M, Laquerriere A, De Pooter T, Camuzat A, Van den Broeck M, Dubois B, Sellal F, Lacomblez L, Vercelletto M, Thomas-Anterion C, Michel BF, Golfier V, Didic M, Salachas F, Duyckaerts C, Cruts M, Verpillat P, Van Broeckhoven C, Brice A; French Research Network on FTD/FTD-MND. Progranulin null mutations in both sporadic and familial frontotemporal dementia. Hum Mutat. 2007 Sep;28(9):846-55. doi: 10.1002/humu.20520.

ReferenceCitation: Guedj E, Le Ber I, Lacomblez L, Dubois B, Verpillat P, Didic M, Salachas F, Vera P, Hannequin D, Lotterie JA, Puel M, Decousus M, Thomas-Anterion C, Magne C, Vercelletto M, Bernard AM, Golfier V, Pasquier J, Michel BF, Namer I, Sellal F, Bochet J, Volteau M, Brice A, Meininger V; French Research Network on FTD/FTD-MND; Habert MO. Brain spect perfusion of frontotemporal dementia associated with motor neuron disease. Neurology. 2007 Jul 31;69(5):488-90. doi: 10.1212/01.wnl.0000266638.53185.e7. No abstract available.

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

location_facility: Pitié-Salpêtrière Hospital - Fédération de Neurologie

location_facility: Pitié-Salpêtrière Hospital - Centre du Langage et de Neuropsychologie


title: Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial

acronym: iIPA

summary:
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.

Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.

The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.

The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital


title: Patients With Alzheimer's Disease or Related Youth Disease

acronym: PARMAAJJ

summary: This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.

lead_sponsor: University Hospital, Lille


title: Gestational Diabetes in Non Obese Women and Metformine

summary: Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.

location_facility:
Hôpitaux Civils de Colmar
CHU de Reims
CHU Dijon,
Centre hospitalier de Mulhouse
Hôpitaux Universitaires de Strasbourg


title: Pain and Schizophrenia

summary: The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.

primary_purpose: Health Services Research

location_facility: Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques

location_facility: Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft

location_facility: Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg

location_facility: Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg