title: Identification of Neurocognitive Disorders by General Practitioners in Primary Care

acronym: TROCOMEGE

summary: Neurocognitive disorders (NCD) are today often largely underdiagnosed or diagnosed in late stages in France. Indeed the ALzheimer COoperative Valuation in Europe (ALCOVE) study stated that about 50% of people living with NCD remain undiagnosed until late severe stages with a deep autonomy loss inducing at risk behaviours and/or behavioural crisis. The French High Authority of Health (Haute Autorité de Santé - HAS) and ALCOVE recommend a timely diagnosis at a time when the specific intervention help to implement secondary or tertiary prevention dynamics that would delay severe complications and help to maintain a reasonable quality of life for both the patient and the caregiver. Moreover, the representatives of the National College of General Practitioners, the French Federation of Memory Centres, the French Federation of Gerontology and Geriatrics, the French Federation of Neurology, the French Society of Psychogeriatrics and the National Plan on Neurodegenerative Diseases designed a hierarchized and tailored diagnosis strategy of NCD promoting a shared diagnosis between the General Practitioner (GP) and specialists of NCD. It therefore appears crucial to determine the diagnosis value of a short duration strategy assessing the complaint, cognition and autonomy in primary care to detect NCD and referring to a specialist to perform the etiological diagnosis. The identification of NCD by GP in primary care (TROCOMEGE) study aims at assessing the positive and negative predictive values of a NCD diagnosis strategy through the assessment of the subjective memory complaint, the cognitive status and the autonomy level in primary care. It relies on the clinical impression of the GP, a cognitive complaint interview for complaint and functional assessment thanks to the General Practitioner assessment of Cognition (GP-Cog, part 2) tool and the cognitive assessment thanks to the Six-Item Cognitive Impairment test (6-CIT).


title: Evaluation of Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU

acronym: PORPOISE-REA

summary: Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France) during a 18-months period (June 2014 -December 2015) to study the independent association between hypophosphatemia and 90-day mortality.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Padelli M, Aubron C, Huet O, Héry-Arnaud G, Vermeersch V, Hoffmann C, Bettacchioli É, Maguet H, Carré JL, Leven C. Is hypophosphataemia an independent predictor of mortality in critically ill patients with bloodstream infection? A multicenter retrospective cohort study. Aust Crit Care. 2021 Jan;34(1):47-54. doi: 10.1016/j.aucc.2020.05.001. Epub 2020 Jul 27.

family: Padelli

full_name: Maël Padelli

given: Maël

sequence: first

family: Aubron

full_name: Cécile Aubron

given: Cécile

sequence: additional

family: Huet

full_name: Olivier Huet

given: Olivier

family: Héry-Arnaud

full_name: Geneviève Héry-Arnaud

given: Geneviève

family: Vermeersch

full_name: Véronique Vermeersch

given: Véronique

family: Hoffmann

full_name: Claire Hoffmann

given: Claire

family: Bettacchioli

full_name: Éléonore Bettacchioli

given: Éléonore

family: Maguet

full_name: Hadrien Maguet

given: Hadrien

family: Carré

full_name: Jean-Luc Carré

given: Jean-Luc

family: Leven

full_name: Cyril Leven

given: Cyril

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Australian Critical Care

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Brest

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.

summary: Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.


title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

summary:
The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem to need particularly a better metabolic control.

Working Hypothesis:

We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.

Objectives:

To show that nurse-counselling may improve levels of patient satisfaction.

Methodology:

The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".

This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.

The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up

study_type: Interventional

design_allocation: Randomized

ReferenceCitation: Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lièvre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.

apc_source: openAPC

family: Kassai

full_name: Behrouz Kassai

given: Behrouz

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Bernoux

full_name: Delphine Bernoux

given: Delphine

family: Michal

full_name: Catherine Michal

given: Catherine

family: Riche

full_name: Benjamin Riche

given: Benjamin

family: Ginhoux

full_name: Tiphanie Ginhoux

given: Tiphanie

family: Laudy

full_name: Valérie Laudy

given: Valérie

family: Terral

full_name: Daniel Terral

given: Daniel

family: Didier-Wright

full_name: Catherine Didier-Wright

family: Maire

full_name: Veronique Maire

given: Veronique

family: Dumont

full_name: Catherine Dumont

family: Cottancin

full_name: Gilles Cottancin

given: Gilles

family: Plasse

full_name: Muriel Plasse

family: Jeannoel

full_name: Guy-Patrick Jeannoel

given: Guy-Patrick

family: Khoury

full_name: Jamil Khoury

given: Jamil

family: Bony

full_name: Claire Bony

family: Lièvre

full_name: Michel Lièvre

given: Michel

family: Drai

full_name: Jocelyne Drai

given: Jocelyne

family: Nicolino

full_name: Marc Nicolino

given: Marc

currency_apc_doaj: GBP

journal_name: Trials

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


acronym: CHIRPAN

summary: This data base has been set in order to gather medical and surgical information from patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance Publique des Hôpitaux de Marseille, France.

status: Recruiting

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Other

status_simplified: Ongoing


title: AVENANCE - A Non-interventional Study to Provide Real-world Data on the Use of Avelumab as a Maintenance Treatment for Patients With Advanced or Metastatic Urothelial Carcinoma

acronym: AVENANCE

summary: A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.

study_completion_date_type: Anticipated

ipd_sharing: No

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

lead_sponsor: Pfizer

location_facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard

intervention_type: Drug

lead_sponsor_type: industriel


title: Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants

acronym: COSALE

summary:
Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied.

To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea.

The aim of this study is thus to:

show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
confirm the relationship between the diarrhoea and the infection with these viruses.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014

acronym: PMSIApp

summary:
Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.

Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.

The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours) have yet to be identified.

The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire, Amiens

status_simplified: Unknown


type: Other Identifier

title: In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM

summary: The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service médecine foetale-Hôpital Trousseau

intervention_type: Procedure


title: Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk

acronym: ESCAPE

summary:
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.

Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.

Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.

Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.

In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.

Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

primary_purpose: Prevention

ReferenceCitation: Lebeau JP, Cadwallader JS, Vaillant-Roussel H, Pouchain D, Yaouanc V, Aubin-Auger I, Mercier A, Rusch E, Remmen R, Vermeire E, Hendrickx K. General practitioners' justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology. BMJ Open. 2016 May 13;6(5):e010639. doi: 10.1136/bmjopen-2015-010639.

family: Lebeau

full_name: Jean-Pierre Lebeau

given: Jean-Pierre

family: Cadwallader

full_name: Jean-Sébastien Cadwallader

given: Jean-Sébastien

family: Vaillant-Roussel

full_name: Hélène Vaillant-Roussel

given: Hélène

family: Pouchain

full_name: Denis Pouchain

given: Denis

family: Yaouanc

full_name: Virginie Yaouanc

given: Virginie

family: Aubin-Auger

full_name: Isabelle Aubin-Auger

given: Isabelle

family: Mercier

full_name: Alain Mercier

given: Alain

family: Rusch

full_name: Emmanuel Rusch

given: Emmanuel

family: Remmen

full_name: Roy Remmen

given: Roy

family: Vermeire

full_name: Etienne Vermeire

given: Etienne

family: Hendrickx

full_name: Kristin Hendrickx

given: Kristin

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
irua

repositories_pmh: HAL europepmc.org irua

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: General practitioners’ justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology

ReferenceCitation: Pouchain D, Lièvre M, Huas D, Lebeau JP, Renard V, Bruckert E, Girerd X, Boutitie F; French National College of Teachers in General Practice. Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice. Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.

name: The French National College of Teachers in General Practice

lead_sponsor: Collège National des Généralistes Enseignants

location_facility:
French National College of GP Teatchers
Service de Pharmacologie Clinique


title: Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)

acronym: AlgoDARPEF

summary: Pain is common following surgery in children. Currently, no recent review of pain profiles at home has been performed on pediatric population in France following general surgery in children. The aim of this study is to evaluate the duration and severity of pain felt by children using a mobile phone application. All children operated in the different centers and leaving home will be included in the study. Children's pain scores will be measured using PPMP-SF scale (Postoperative Pain Measure for Parents Short Form). Data on prescribed and administered analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected. The expected results are an inventory's objective observation of postoperative pain profiles at home following the different pediatric surgeries in France. The study will also highlight the different risk factors of postoperative pain (type of surgery, parental causes, reasons due to the child, medical causes).

lead_sponsor: Fondation Lenval

location_facility: Hôpitaaux Pédiatriques de Nice CHU-Lenval


title: Design of an Organizational Infrastructure Pediatric Plan to Deal With Bronchiolitis Epidemics: Impact on Length of Stay and Quality of Care in a Tertiary Care Regional Hospital

acronym: OIPP

summary:
Acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in France. Over the years, the number of hospitalizations during the epidemic season appears to be increasing. Bronchiolitis epidemics lead to recurrent hospital disruption. The current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems.

In this context, the pediatric departments of Montpellier University Hospital, France, designed in 2014 a common organizational infrastructure pediatric plan (OIPP) to to adapt to these multiple constraints while respecting the quality of care.

This plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care.

The study aims to assess the impact of our OIPP on the overall length of stay for children hospitalized for bronchiolitis. The investigator also intend to measure the impact of the OIPP on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. The cost of the implementation of the OIPP in the structure will be analyzed.

ReferenceCitation: Lavilledieu D, Abassi H, Mercier G, Guiraud M, Chaffaut GD, Milesi C, Cambonie G, Gavotto A, Jeziorski E, Amedro P. Implementation of an organizational infrastructure paediatric plan adapted to bronchiolitis epidemics. J Infect Public Health. 2020 Feb;13(2):167-172. doi: 10.1016/j.jiph.2019.07.007. Epub 2019 Aug 2.

family: Lavilledieu

full_name: David Lavilledieu

given: David

family: Abassi

full_name: Hamouda Abassi

given: Hamouda

full_name: Gregoire Mercier

given: Gregoire

family: Guiraud

full_name: Myriam Guiraud

given: Myriam

family: Chaffaut

full_name: Guillaume Du Chaffaut

given: Guillaume Du

family: Milesi

full_name: Christophe Milesi

given: Christophe

family: Cambonie

full_name: Gilles Cambonie

given: Gilles

family: Gavotto

full_name: Arthur Gavotto

given: Arthur

family: Jeziorski

full_name: Eric Jeziorski

given: Eric

family: Amedro

full_name: Pascal Amedro

given: Pascal

currency_apc_doaj: USD

journal_name: Journal of Infection and Public Health

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: submittedVersion

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

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

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Five Hospital of the Alpine Region

acronym: PACAAP

summary: The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device

summary:
Focal treatment of localized prostate cancer aims to destroy the cancerous foci without damaging surrounding tissues to avoid the side effects of radical treatments. This is why focal treatment is positioned as an alternative to radical surgery as well as an alternative to active surveillance.

This study is a feasibility study. It aims at treating the index tumor (the most aggressive one) which determines the vital prognosis of patient, while preserving the maximum surrounding prostatic tissue to preserve quality of life. The expected result is the total destruction of aggressive tumor areas by focal or multifocal treatment strategy using the Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by the negative biopsy rate between 6 and 12 months post-treatment.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot

intervention_type: Device


title: Study of the Functional Effects of Nusinersen in 5q-spinal Muscular Amyotrophy Adults (SMA Type 2 or 3 Forms): a Multicenter Single-case Experimental Design in Multiple Baselines Across Subjects, Randomized, Single-blinded Evaluation

summary: Spinal Muscular Atrophy (SMA) is an autosomal recessive disease caused by a mutation of exon 7, in 95% of cases, encoding the gene for the motor neuron survival protein called SMN1 (Survival Motor Neuron) located on chromosome 5q. Patients with an SMA-5q mutation suffer from progressive muscle deficiency and subsequent atrophy induced by degeneration of motor neurons in the spinal cord. Gene therapy is now available for the management of spinal muscular atrophy and nusinersen is the first approved treatment. Nusinersen has been granted marketing authorization in France since May 30, 2017. Nusinersen has a high level of medical service rendered (MSR) for types I, II, and III, but the improvement in medical service rendered (IMSR) is assessed as moderate for types I and II. For Type III, IMSR is not known.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

lead_sponsor: CHU de Reims


title: Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation

acronym: PREDYSPE

summary:
Each year, between 50,000 and 60,000 children are born prematurely in France. Among them, 10% are born at 26 - 30 week's gestation and 5% are born before 26 week's gestation.

Bronchopulmonary dysplasia (BPD) affects at least one-quarter of infants born with a birth weight less than 1500 grams.

BPD is defined by the need for oxygen after 28 days of life in any children born prematurely. In addition, the severity of BPD can be categorized as mild (room air tolerated at 36 weeks), moderate (oxygen requirement between 22 and 29 %) and severe (oxygen requirement 30% or need for ventilation support).

Bronchopulmonary dysplasia is responsible for significant respiratory morbidity and impaired neurological outcomes.

Pulmonary imaging such as tomodensitometry, MRI or scintigraphy can be abnormal and therefore coud theorically be helpful for an early diagnosis. Unfortunatelly, theses examinations are irradiating, expensive or difficult to perform in an everyday practice. Therefore lung imaging for BPD diagnosis. Is not recommanded in current official guidelines.

Pulmonary ultrasound has already been studied in premature newborns. A pilot study carried out on 21 patients showed that pulmonary ultrasonography at one and two weeks of life could predict the risk of bronchopulmonary dysplasia. The score used in this study was the LUS score previously validated by Brat et al. Advantages of this examination are to be non-invasive and easily performed at the patient's bedside. Nevertheless this study focused on a small population with a low number of moderate / severe dysplasia.

In addition, Czernik et al. have highlighted that the index of myocardial performance of the right ventricle was increased at seven and ten days of life in children who subsequently developed BPD.

The investigators propose in this study to evaluate a new prediction score for DBP, the modified LUS score, associating the LUS score with an echographic evaluation of the right heart (myocardial performance index).

lead_sponsor: University Hospital, Limoges


title: Diet Interactions With Human Gut Microbiota. The Potential Role of Mediterranean Diet Adherence. DIAGRAM, a Pilot Study

acronym: DIAGRAM

summary:
Despite the strong evidence on health benefits of traditional MeD, not many studies have broadly and systematically been made for the potential role and relationship of the MeD in the composition of the gut microbiota.

Furthermore, little is known about the composition of the gut microbiota in individuals with defined dietary habits on the Mediterranean pattern.

This work is aiming at comparatively studying the gut microbiota of three different dietary oriented european populations. In particular, biological samples and related information will be collected from populations with high adherence to Mediterranean diet (MeD) in Crete - Greece and Molise region - Italy. These data will be comparatively assessed with those provided by a sample population with high adherence to Western diet in Auvergne - France.

status: Unknown status

lead_sponsor: University Hospital, Clermont-Ferrand


title: CuraChik : Double Blind Placebo-controlled Randomized Trial : Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease.

summary:
A severe outbreak of Chikungunya fever has been reported at La Réunion Island (France) in 2005-2006. Chikungunya is a viral disease. Chikungunya virus is an alphavirus transmitted to humans by the bite of infected mosquitoes, usually of the genus Aedes (Aedes albopictus in La Réunion).

To date, more than 266,000 cases were estimated to have occurred in the island (760,000 inhabitants). Most of cases are expressed as a mild disease, with intense fever and arthralgias, with rare but serious complications (encephalitis, liver, cardiac or renal failures.) having required a hospitalization in an intensive care unit. 273 of such serious cases (immediately life threatening condition) have been reported among the cases, in patients aged over 10 days (59% were 65+ age old). Chikungunya was proven in 246 serious cases; 101 patients had comorbidities, and 27% of confirmed cases eventually died. In addition 44 cases of mother-to-child infections were reported and 40 were confirmed (one died).

To date, in 248 death certificates, chikungunya was reported as the direct or indirect cause of death, with a median age of 79, range 0-102, and a sex-ratio (M/F) of 0.95. InVS, in collaboration with Inserm (French NIH) also reported (by June 6, 2006) a significant excess of mortality (from all causes) during the major outbreak which occurred from December, 2005 (+10%) to April, 2006 (10.1%), with a peak of excess mortality reached in February (+34.4%), concommitant to the peak of incidence.

Today, there is no antiviral treatment against Chikungunya. We showed from ex-vivo studies (in a sensitive model of cells culture to the viral infection) that chloroquine provides a significant inhibition on the replication of the Chikungunya virus. This efficacy seemed also to be reached at a plasmatic concentration of similar order of magnitude as recommended for treating malaria with this drug.

This trial aims to assess efficacy and safety of chloroquine as as therapeutic treatment of chikungunya disease.

status: Terminated

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Development, Validation and Impact of an Automatic Identification of Co-Prescription at Risk of Interactions in the Hospital Information System. The PRoSIT System.

acronym: PROSIT

summary: The French Public Health strategy 2018-2022 aims to reduce inappropriate prescriptions, as potentially dangerous for individuals and collectively. The reduction of co-prescriptions at Risk of Drug Interactions (RoDI) could decrease the prevalence of iatrogenic diseases, and increase the persistence of treatments with a growing efficacy of treatments, in particular in elderly populations. A recent study conducted by our team showed that, in out-patient setting, 2.7% of co-prescriptions contains medications at RoDI of high degree of severity (object of a contra-indication or non-recommended). Up today, there is no French experience concerning the identification of RoDI among the prescriptions performed at the end of a hospitalisation. In France, the recent development of hospital data warehouses is a huge opportunity to develop a system that can identify efficiently co-prescriptions at RoDI and provide feedback directly to prescribers in order to reduce their frequency in hospital context. The primary objective of this study is to evaluate the capacity of a system, called PRoSIT system, to automatically identify the RoDI of high level of severity at hospital discharge.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Rennes
Hôpital Européen George Pompidou


title: Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids

summary:
The study (forward-looking and opened) will concern 70 subjects having had a systemic prolonged treatment with corticosteroids for intestinal chronic inflammatory disease, recruited in the services of gastroenterology and endocrinology of the North Hospital of Marseille (France). The primary objective of the study is to estimate a new test, the "long" synacthen stimulation test, using an IM injection of 1 mg of delate synacthen, with regard to the definitive standard. Indeed, this long test could be realized in ambulatory conditions, and turn out more contributory than the definitive standard to estimate the capacities of answer of the adrenal glands in front of a prolonged stress, as it is the case during a surgical procedure for example.

The secondary objectives are: 1) to determine the relation between the value of basal cortisol and the peak of stimulation of cortisol during short and long tests. This could allow to clarify better the conditions in which it is absolutely necessary to realize a dynamic test, 2) to determine the relation between cortisol assay in the plasma and in the saliva. The sample of saliva is simple and non-invasive, and presents the advantage to be able to be realized in ambulatory conditions and by the patient himself.

The cortisonic withdrawal syndrome is another complication which can arise when a prolonged corticosteroid therapy is discontinued. Clinically, it looks like a chronic adrenocortical insufficiency, but with normal ranges of plasma cortisol. It is probably in touch with a physical dependence to the taking of above physiological doses of GC over a long period. Its physiopathology remains badly known, but could bring in a deficit of secretion of DHEA-S (dehydro-epiandrosterone sulphate), another hormone secreted by the adrenal glands. One of the secondary objectives of the study will consist in informing the variations of DHEA-S after a prolonged corticotherapy, in the basal state and after stimulation by the long synacthen stimulation test.

primary_purpose: Diagnostic

location_facility: Assistance Publique-Hopitaux de Marseille

intervention_type: Biological


title: Phase III Study, Randomized, Multicenter, Evaluating the Efficacy of a Cardiovascular Active Prevention Vs Usual Clinical Practice, on the Morbi-mortality Decrease in Chronic Myeloid Leukemia Patients Treated With Tyrosine Kinase Inhibitor

acronym: PALERMO

summary:
According to the French National Cancer Institute, 35 000 new hematologic cancers are observed in France representing 10% of the new cancers. Chronic Myeloid Leukemia (CML) is a cancer involving the bone marrow and blood cells, the median age at diagnosis is 53 years in the Western world. The prognosis is worse than many other cancers with net survival at 5 years of 26%.

Since the approval of imatinib, additional tyrosine kinase inhibitors (TKIs) have been approved by the European Medicine Agency, including the second-generation TKIs nilotinib, dasatinib, and bosutinib and the third-generation TKI ponatinib. Despite their effect on the evolution of CML, there is increasing of cardiovascular toxicities which can impact patient morbidity and mortality. The majority of the cardiovascular toxicities are associated with the second- and third-generation TKIs. Nilotinib and ponatinib cardiovascular toxicity including arterial and venous thromboembolism has decrease the benefit/risk ratio, 10% of patients treated with nilotinib 300 mg twice daily and 15.9% treated with 400 mg twice daily experienced a vascular complication including myocardial infarction /ischemic heart disease, cerebrovascular accidents, or peripheral arterial disease. Regarding ponatinib, serious arterial occlusive adverse reactions occurred in 19% of patients.

In an attempt to reduce major adverse cardiovascular events MACE due to nilotinib and ponatinib, currently, then approach is driven by usual clinical practice without any robust published evidence. The investigators aim to perform a national clinical trial, multicenter, prospective, randomized, with two parallel comparative arms: experimental group with cardiovascular active prevention vs non active cardiovascular active prevention based on usual clinical practice. Our hypothesis is that active prevention of cardiovascular toxicities with optimal medical treatment improves the benefit-risk ratio in CML patients. The primary objective is Event Free Survival (EFS) at month 24.

lead_sponsor: University Hospital, Angers

intervention_type: Combination Product


title: Predictors of Mortality at Day 28 of Patients Treated at Lille University Hospital for COVID-19

acronym: LICORNE

summary: The Lille University Hospital developped a research objective common to all the services which took care of patients, "suspected patient", "possible case", "probable case" or "confirmed case" infected with SARS-CoV-2 by constituting a prospective and a retrospective observational cohort which allowed pooling and sharing the resources and data collected. In the next two years the prospective cohort will allow to continue inclusions in a standardized way mainly for the constitution of a negative control group (excluded cases), to collect biological samples which had not been collected in the retrospective cohort so that the pathophysiology of the COVID-19 will be better apprehended as for example the inflammatory response to the viral infection. Finally in case of a second epidemic wave in the Hauts De France, it seems essential to have a defined research protocol which had already received all the necessary authorizations to guarantee cutting-edge (or quality ) research in a center like the Lille University Hospital.The aim objective of this study is to identify predictive factors of mortality to day 28 infection to SARS-CoV-2 for patients under medical care for the COVID-19 in the Lille University Hospital thanks to the constitution of an epidemiological, clinical, biological, immunological, genetic, microbiological, anatomopathologic, radiological, therapeutic database and so record the results of functional exploration exams.

lead_sponsor: University Hospital, Lille


title: Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.

acronym: MEDIAGENE

summary:
More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.

Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.

The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.

Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.

lead_sponsor: University Hospital, Brest

location_facility:
Institut du Thorax Nantes
Hôpital Sud Amiens
CHU de la Côte de Nacre Caen
Faculté de médecine Toulouse
CHRU de Brest
Hôpital La Timone Marseille
Hôpital Saint Philibert

intervention_type: Genetic


title: DDX3X Related Disorder : Clinical Phenotype, Neuropsychological Profile and Epigenetic Signature.

summary:
DDX3X related disorder is mainly characterised by developmental delay (DD) and intellectual disability (ID), ranging from mild to severe, and neuroimaging abnormalities.

The aims of this study are first to better delineate the clinical phenotype, as well as the neuropsychological profile and, second, to study the epigenetic signature in a cohort of individuals with DDX3X pathogenic variants. This work will conduct to a MD thesis of a clinical resident geneticist in France.

Physician that will participate will fill an Excel sheet regarding the clinical and neuropsychological assessment. The investigators will be also happy to have a DNA sample with a minimum 0.5ug of peripheral blood genomic DNA. The investigators will gather the DNA in Montpellier genetic lab (Dr Mouna BARAT) and send the batch to the Dr Sadikovic' lab.

Between 2018 and 2020, the investigators have already recruited data from individuals with DDX3X pathogenic variants from several European and Asian genetic centres

status: Enrolling by invitation

time_perspective: Other


title: Survival of Monocytes Collected From Patients With Atrophic AMD in Retinal Pigmented Epithelium Explants

acronym: SURViVOR

summary: Age-related macular degeneration (AMD) affects 2 million people in France and is the main cause of irreversible blindness in France. All patients initially have an early form of the disease. This early form can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, which has a more rapid evolution. While there are treatments for the exudative form of the disease, there is currently no therapy for the atrophic form of AMD. Recently, it has been demonstrated in atrophic AMD that there is accumulation of inflammatory cells, monocytes, in the sub-retinal space. This space is located between the retinal pigment epithelium (RPE) and photoreceptors. It is physiologically devoid of immune cells (immune privilege). Monocytes secrete many pro-inflammatory molecules, such as cytokines. Some cytokines (IL-1, IL6 and TNF) have a deleterious role on RPE and photoreceptors in mouse models. The identification of specific cytokines would help to better understand this disease and consider potential targeted therapies. Our project is based on the hypothesis that monocytes extracted from patients with AMD have a superior survival on RPE compared to monocytes extracted from healthy patients (without retinal pathology), and more particularly in atrophic forms of AMD. The main aim of this study is to compare the survival of monocytes extracted from patients with atrophic AMD to monocytes extracted from patients without retinal pathology (control) on retinal pigment epithelial cell lines (ARPE-19). Survival will be evaluated by automated counting of monocytes after 24 hours of culture on ARPE-19 after specific immunostaining of monocytes. If the survival of monocytes from patients with the late form of AMD is increased then therapy directly targeting this pathological accumulation of monocytes could be considered. Moreover, the identification of increased secretion of certain cytokines and the demonstration of their deleterious effect on retinal physiology could lead to targeted therapies against them.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

location_facility: Service d'ophtalmologie-HOSPICES CIVILS DE LYON - Hôpital de la Croix-Rousse


title: Frequency and Type of Genetic Abnormalities Found in Antenatal Corpus Callosum Malformation

summary:
Corpus callosum malformation (CCM) is the most frequently detected cerebral defect diagnosed in the prenatal setting. The most common CCM is corpus callosum agenesis (CCA) which is found in 2 to 3% of patients presenting with intellectual disability.

When CCM is diagnosed, the risk of chromosomal disorder is estimated to be 16%, be it aneuploidy such as trisomy 18, trisomy 13 or mosaic trisomy 8, or a chromosome structure anomaly, copy number variation or more complex rearrangement In France, since 2013 oligoarray-based comparative genomic hybridization (aCGH) analysis is performed in the prenatal period for most malformations after approval by a multidisciplinary prenatal diagnosis ethics committee (Centre Pluridisciplinaire de Diagnostic Prénatal, CPDPN) . However, to date only a few studies have been published which report recurrent Copy Number Variations (CNV) associated with CCM and estimate the risk for a chromosomal disorder, thus making counseling difficult in this context of prenatal diagnosis.


title: National Bank Alzheimer

acronym: BNA

summary:
The Alzheimer's disease (MY) is a major problem of public health. The French National Database Alzheimer ( BNA) registers(records) all the medical acts made by units of memory(report) and of independent specialists in France.

In 2008, the national Plan Alzheimer 2008 - 2012 had for objective to strengthen the search(research) on the Alzheimer's disease (MY) and for related disorders(confusions), to promote an early diagnosis and to improve at the same time the management of the patients and to support careers(quarries). A specific part(party) of this plan gave rise to the creation of the French national database Alzheimer ( BNA) to supply epidemiological data as well as indicators of activity. Since 2009 The information collected(taken in) in the BNA consists of a set(group) limited by data (CIMA of information minimum Corpus Alzheimer) concerning the demographic, clinical and diagnostic data defined by national consensus. The number of variables is limited to facilitate and to improve the participation in this national database. The participants are the Centers Report (CM)((LECTURE)) and Center Memory(Report) of Resources and Search(Research) (CMRR) and independent specialists. In 2015 more than 500 Centers send CIMA to the BNA.

The plan Disease Neurodegenerative 2014 - 2019 wishes to pursue and to amplify the BNA.

lead_sponsor: Centre Hospitalier Universitaire de Nice


type: Registry Identifier

title: Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization

summary: The transversus abdominis plane (TAP) block is a regional anesthetic technique for post operative pain control after abdominal surgical procedures. Its effectiveness in children undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate its analgesic efficacy over the first 24 post operative hours.


title: Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants

acronym: METHORIVAC

summary:
This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels:

Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10
Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Non-COVID Patient-safety Incidents Reported by Primary Care Professionals in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study

acronym: PSI-RECORd-XP

summary:
The COVID-19 epidemic is causing a global health crisis. In France, it has imposed a major reorganization of the healthcare system. This emergency reorganization is unprecedented. It involved first, second and third line care. Following this reorganization and from the first days of confinement, a decrease in care activity not related to COVID-19 was observed in médical offices, in emergency services, and in secondary and tertiary care services. This decrease in activity could indicate a decrease in pathologies related to work, transportation or non-COVID-19 infections, due to a favourable effect of lockdown. Nevertheless, some health professionals report the opposite in the media and on social networks, an unusual increase in events (appendicular peritonitis treated late, increase in domestic violence, etc.), while others are surprised by a decrease in activity that is difficult to explain (leukaemia diagnoses by biologists, for example). One hypothesis is that such changes could be related to the reorganisation of the health care system or to the consequences of lockdown.

The World Health Organization (WHO) recommends a systematic collection and analysis of patient safety incidents (also called "adverse events" in France). The objective is to assess the roles of the system and human factors in patient safety, in order to propose changes to the global system and local organisation. In France, there is a system for reporting serious adverse events related to care. Only 4% of the 820 serious adverse events reported in 2018 were reported by primary healthcare professionals (1). However, patient safety incidents in primary care are known to have specific mechanisms, types and mechanisms (2).

We hypothesize that the COVID-19 health crisis may have induced unusual patient safety incidents through new mechanisms in a context associating reorganization of the healthcare system and population lockdown. Such a scenario requires the implementation of a massive collection of potential incidents and their systematic and well-structured analysis.

Thus, the objective of our study is to describe patient safety incidents related to the reorganization of care and/or lockdown in the context of the COVID-19 health crisis (types, severity, mechanisms) reported by primary care professionals in France.

- HAS. Retour d'expérience sur les événements indésirables graves associés à des soins (EIGS) [Internet]. [cited 2020 Apr 7]. Available from: https://www.has-sante.fr/jcms/c_2882289/fr/retour-d-experience-sur-les-evenements-indesirables-graves-associes-a-des-soins-eigs
- Carson-Stevens A, Hibbert P, Avery A, Butlin A, Carter B, Cooper A, et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open. 2015 Dec 1;5(12):e009079.

lead_sponsor: Nantes University Hospital


title: Impact of Interprofessional Training and Co-ordination on Early Identification and Proactive Approach to End-of-life Situations in the Context of Primary Care

acronym: SCOP3 quali

summary:
More than 300,000 people die each year in France from a disease that may require palliative care. Nevertheless, only a small proportion of these patients are able to access this care, in particular because of a too late identification.

While several factors may hinder access to specialized palliative care resources, one of the major barriers to the initiation of palliative care, and particularly to the implementation of quality end-of-life care, Remains the failure to recognize that patients with advanced chronic illness are actually approaching the end of their lives.

However, it is now clearly established that early integration of palliative care in the care of people living with a serious, incurable and progressive disease:

has an impact on the quality (and sometimes the expectation) of life of these people,
avoids aggressive treatments and unplanned hospitalizations,
is associated with lower health costs than other end-of-life patients. Primary health care providers have a major role to play in facilitating access to palliative care, but their practice has been hampered in our country by the fragmented and poorly coordinated nature of primary care and Negligible in terms of training. However, they remain the first contact of the patients with the system of care, and are also structuring for the continuation of the patient's journey within the health system.

The first hypothesis is that the work of genuine interprofessional primary care teams in multi-professional health centers (MSPs), coupled with adequate training in the use of simple tools, can contribute to the early identification of patients approaching End of life, to meet their palliative care needs.

However, various European programs (Gold Standards Framework in the UK, NECPAL in Catalonia, RADPAC in the Netherlands) have shown that identification alone is not enough to increase access to specialized palliative care. The second hypothesis is that it must be articulated for this with a training of the professionals to carry out conversations of anticipated planning of the care with their patients.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: A Pilot Study of Deep Brain Stimulation of the Sub-thalamic Nucleus to Treat Treatment-resistant Cocaine Addiction With Severe Somatic or Psychiatric Complications

acronym: STUC

summary:
Cocaine addiction is a chronic condition with severe cardiac, neurologic, psychiatric and social complications. Cocaine is the second most consumed illicit drug in France. Its prevalence has been multiplied by 3 between 2000 and 2008, and is still on the rise. Craving, the compulsive need to consume, is a key feature of cocaine addiction. It is also predictive of treatment efficacy. However, there is no validated treatment for severe cocaine dependence yet. Response to current psychological and medical treatment is poor, with 73% relapse after 3 months. Patients with severe cocaine addiction are thus in a therapeutic deadlock.

To address these unmet medical needs, the investigators designed a pilot study (n=2) to evaluate the safety and the efficacy of the deep brain stimulation of the subthalamic nuclei (STN-DBS) in severe cocaine addiction with at least one cardiac, neurologic or psychiatric complication. Indeed, compulsivity is a critical component of craving, and severe treatment-resistant obsessive compulsive disorder (OCD) are already successfully treated using STN-DBS. Moreover, animal studies recently demonstrated a therapeutic effect of STN-DBS in rats addicted to cocaine. Together, these two lines of research suggest a therapeutic effect of STN-DBS in cocaine addiction mediated by an anti-obsessive mechanism on craving.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers

acronym: TYBRA

summary:
The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading cause of long-term disability. The specificity of stroke is the sequelae polymorphism that can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large extend of sequelae may have a different impact on daily life. Therefore, we have to consider the individual's own resources and in his whole environment to face the situation. We suppose that each situation, each post-stroke disability will have a different social impact in stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the standards for the assessment of the stroke impact on survivors' daily life. However, what is the real impact of an activity limitation in daily life? How consider the psychosocial impact of stroke only with functional indicators? For this study we will consider handicap and disability in a societal way. In fact, the WHO developed in 2001 the International Classification of functioning, disability and health that allows to bring the concept of participation restriction, this is to say the consequences of a disability in the real life. The ICF allows to bring a conceptual framework of participation restriction.

Psychosocial consequences of stroke are relatively unknown especially in France. According to our hypothesis, patients with major disabilities and their caregivers will experience more psychosocial consequences and participation restriction in terms of emotional health, quality of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes in terms of psychosocial consequences, participation restriction and quality of life.

TYBRA study is a prospective multicentric cohort study that mixes qualitative and quantitative approaches. The first aim of the quantitative approach is to explore factors related to patients and their caregivers at 6 months that predict participation restriction at 12 months post-stroke. The first aim of the qualitative study is to explore the experience of stroke in minor stroke patients and their proxys.


title: ESCAPE STUDY : A Specific Tool for Detecting Nursing Home Residents (With or Without Dementia) at Risk of Escaping for the Use of Caregivers: Psychometric Properties and Definition of Risk Levels

acronym: ESCAPE

summary:
Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices.

Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.

location_facility: Direction Recherche clinique et Innovation


title: Use of an Observer Tool to Improve Learning Outcomes of Incoming Anesthesia Residents During Procedural Simulation Training of Central Venous Catheter Insertion: a Randomized Controlled Trial of Simulation Training

summary:
Learning to insert a central venous catheter (CVC) is essential in anesthesiology and the use of simulation is recommended. Since 2017, this training has been integrated into the curriculum for incoming first year anesthesia residents in Île de France and combines a theoretical part (flipped classroom) and a practical part on a simulator. Given the large number of residents, the time to teach the procedure during the simulation session is limited. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation has been already conducted but not on their use during procedural simulation.

The objective of this study will be to assess the value of using an observer tool (OT) (including the key points during the insertion of an internal jugular CVC) to improve learning outcomes of incoming anesthesia residents during procedural simulation training.

status: Active, not recruiting

lead_sponsor: Université Paris-Sud


title: Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis

acronym: PERISTRAG

summary:
In ten years, the labor force has grown by 1.4 million people according to French national institute for statistical and economic studies. This increase is partly due to the increased presence of women in the labor market. Thus, the majority of some 800,000 annual births come from working women. However, some women in professional activity may be exposed to occupational risks, which may have effects on the develop-ment of the fetus during pregnancy. France benefits from protective legislative measures against pregnant women. Recommendations already exist.

But with medical desertification, pregnant women may have more difficulty contacting their occupational doctor or treating physician and to access information about the risks to her work-related pregnancy.

It seems to us important to be able to better quantify the information needs of women in this problem.


title: Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis

acronym: GK-SEP

summary:
Multiple sclerosis, chronic inflammatory disease of the central nervous system, affects approximately 100,000 peoples in France. It is the leading cause of disability in young adults. Tremor is a common symptom (25-58% of patients depending on the series) and can be particularly disabling. The drug treatments against tremor are ineffective or insufficient. Deep brain stimulation of the Vim (Small nucleus within thalamus) and stereotactic radiofrequency thalamotomy have shown their efficacy in this indication. However, in some cases these invasive procedures are impossible because of operational risk. Gamma knife thalamotomy can be an alternative choice. This procedure, less invasive, mainly because of the absence of craniotomy is used by several teams of international reputation for over fifteen years, with good to excellent results in essential tremor. The team of Marseille, which has an experience of 22 years in Gamma Knife radiosurgery has treated 250 patients with severe tremor (essential tremor or Parkinson's disease) by a unilateral thalamotomy with an improvement of 70% of functional scores.

In the literature, no formal studies of the effect of Gamma Knife in Multiple Sclerosis (MS) tremor is reported. There are only a few cases without specific evaluation of the efficacy in this disease. Hence the importance of studying in detail the effects of this technique, which allows a precise and limited lesion volume. Using an isocenter of 4mm and a dose of 130 Gy radiation lesion obtained is limited to a volume of 200 to 500 mm3.

The aim of this study is to assess through a minimally invasive technique with a circumscribed and reproducible lesion volume, the effect of thalamotomy on the particular tremor in multiple sclerosis with a prospective evaluation of its effects.

Patients with MS with a disabling tremor will be included in the study. They will be assessed with neurological examination, quality of life scales, neuropsychological assessment, functional scores and cerebral MRI.

This study will demonstrate the feasibility and effectiveness of Gamma Knife thalamotomy in MS patients with severe tremor.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens

acronym: DEEP

summary:
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.

In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®.

Several studies suggest that the needle length needle is sometim

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Impact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study

summary: The purpose of the clinical study is to compare the effect of hypnosis intervention on the emotional dimension of the dyspnea during a pulmonary rehabilitation program to the pulmonary rehabilitation program alone. This study will determine if the hypnosis intervention will lead to better maintenance of benefits obtained than the original described method.

primary_purpose: Supportive Care

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle la Solane
Clinique du Souffle la Vallonie


title: Improved Screening for Osteoporosis in Women Between 50 and 80 Years Hospitalized in Hospital Departmental Vendee

acronym: ADOV

summary:
Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and deterioration of bone microarchitecture , leading to increased fracture risk for low trauma, such as spinal fractures or femoral neck .

It is estimated that 3 million people are living in France , particularly women , with an incidence that increases with age .

This disease is a major public health issue in terms of morbidity and mortality , costs and risk of recurrence (after a first fracture episode) , including risk factors are identified.

However, although bone densitometry is a reliable diagnostic tool and preventive treatments are at our disposal, screening for osteoporosis is still insufficient .

The objective of our study is to improve the detection of osteoporosis in Hospital Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone densitometry or if risk factors are found. Based on the results , the patient will be sent in rheumatology consultation for implementation of treatment if necessary .

Therefore included women hospitalized in medical services , gynecology, surgery and orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women who could answer a simple questionnaire and those previously treated for osteoporosis or have already received a bone density there is less than 3 years old .

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Double-blind, Randomized, Multicenter Study Evaluating 200 mg Versus 600 mg of Mifegyne® on Pain in Medical Termination of Pregnancy (MToP) up to 7 Weeks of Amenorreha (WA). DoMy Study.

acronym: DoMy

summary:
In 2016, medical termination of pregnancy represent 64% of total abortions in France. Thus, it is a frequent act involving a large majority of women and a health-care public subject. The two medicines used in medical abortion are mifepristone and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater than 90% up to 7 SA. Medical abortion may be performed in outpatient basis or in short-terme hospitalization. One of the limits of this technique development is the pain caused by the drugs intake mainly due to the uterine contractions induced by misoprostol intake. Thus it is recommended a systematic analgesics intake but despite these guidelines, pain level reported by the patients remains significant. There is very limited data on the misoprostol influence or mifepristone dose on pain. In a recent observational multicenter study, mifepristone 600 mg was reported to be associated with decreased pain compared with mifepristone 200 mg.

In this context, it is important to confirm by a higher level evidence of study that the protocol using mifepristone 600 mg decreases the pain level of medical abortion compared to a protocol using mifepristone 200 mg. In the absence of benefit, we will not be able to conclude to a benefit on the prevention of pain with a protocol associating 600 mg of mifepristone and 400 μg of misoprostol. If the benefit on pain is confirmed, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of quality of care or medical and economic impact.

The clinical study is interventional, prospective, comparative, randomized, double-blind, multi-center, conducted in 11 French hospitals carrying out voluntary medical termination of pregnancy.

The data will be collected by the physician during the 4 consultations (initial consultation of abortion request, inclusion consultation with Mifegyne® intake, consultation of misoprostol intake (short-terme hospitalization), follow-up consultation from the available data in the patient's medical file and from the questionning and clinical examination data made during these 4 consultations.

location_facility: Assistance Publique Des Hopitaux de Marseille


title: EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer

acronym: EURECA

summary: Cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (CRCI): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. The frequency of CRCI in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. These cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. Despite an increasing number of studies on CRCI, a standard of care for patients with CRCI after breast cancer is yet to be established. In the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with CRCI, physical medicine and rehabilitation units in France have started providing day-hospital multidisciplinary interventions. The objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Pontchaillou - Service de Médecine Physique et de Réadaptation

location_facility: Hospices Civils de Lyon - Groupement hospitalier sud - Hôpital Henry Gabrielle - Service de médecine physique et de réadaptation

intervention_type: Behavioral


title: Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases : a Retrospective Multicenter Observational Study

acronym: covid19 fai2r

summary:
Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France.

This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.

ReferenceCitation: Avouac J, Drumez E, Hachulla E, Seror R, Georgin-Lavialle S, El Mahou S, Pertuiset E, Pham T, Marotte H, Servettaz A, Domont F, Chazerain P, Devaux M, Claudepierre P, Langlois V, Mekinian A, Maria ATJ, Banneville B, Fautrel B, Pouchot J, Thomas T, Flipo RM, Richez C; FAI2R/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors; FAIR/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. COVID-19 outcomes in patients with inflammatory rheumatic and musculoskeletal diseases treated with rituximab: a cohort study. Lancet Rheumatol. 2021 Jun;3(6):e419-e426. doi: 10.1016/S2665-9913(21)00059-X. Epub 2021 Mar 25.

family: Avouac

full_name: Jérôme Avouac

given: Jérôme

family: Drumez

full_name: Elodie Drumez

given: Elodie

family: Hachulla

full_name: Eric Hachulla

family: Seror

full_name: Raphaèle Seror

given: Raphaèle

family: Georgin-Lavialle

full_name: Sophie Georgin-Lavialle

given: Sophie

family: El Mahou

full_name: Soumaya El Mahou

given: Soumaya

family: Pertuiset

full_name: Edouard Pertuiset

given: Edouard

family: Pham

full_name: Thao Pham

given: Thao

family: Marotte

full_name: Hubert Marotte

given: Hubert

family: Servettaz

full_name: Amélie Servettaz

given: Amélie

family: Domont

full_name: Fanny Domont

given: Fanny

family: Chazerain

full_name: Pascal Chazerain

family: Devaux

full_name: Mathilde Devaux

given: Mathilde

family: Claudepierre

full_name: Pascal Claudepierre

family: Langlois

full_name: Vincent Langlois

given: Vincent

family: Mekinian

full_name: Arsène Mekinian

given: Arsène

family: Maria

full_name: Alexandre Thibault Jacques Maria

given: Alexandre Thibault Jacques

family: Banneville

full_name: Béatrice Banneville

given: Béatrice

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Pouchot

full_name: Jacques Pouchot

given: Jacques

family: Thomas

full_name: Thierry Thomas

given: Thierry

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: Richez

full_name: Christophe Richez

ReferenceCitation: FAI2R /SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis. 2020 Dec 2. pii: annrheumdis-2020-218310. doi: 10.1136/annrheumdis-2020-218310. [Epub ahead of print]

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


title: Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education

acronym: ESSTIM

summary:
This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

location_facility:
CH Hôpital Duchenne
CH du Dr Schaffner
CH Douai
CH Dunkerque
Victor Provo Hospital
Valenciennes hospital
CHRU, Hôpital Huriez


title: "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

acronym: CORONADO

summary:
COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death.

Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.

The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies.

This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

ReferenceCitation: Tramunt B, Smati S, Coudol S, Wargny M, Pichelin M, Guyomarch B, Al-Salameh A, Amadou C, Barraud S, Bigot E, Bordier L, Borot S, Bourgeon M, Bourron O, Charrière S, Chevalier N, Cosson E, Fève B, Flaus-Furmaniuk A, Fontaine P, Galioot A, Gonfroy-Leymarie C, Guerci B, Lablanche S, Lalau JD, Larger E, Lasbleiz A, Laviolle B, Marre M, Munch M, Potier L, Prevost G, Renard E, Reznik Y, Seret-Bégué D, Sibilia P, Thuillier P, Vergès B, Gautier JF, Hadjadj S, Cariou B, Mauvais-Jarvis F, Gourdy P. Sex disparities in COVID-19 outcomes of inpatients with diabetes: insights from the CORONADO study. Eur J Endocrinol. 2021 Jul 5;185(2):299-311. doi: 10.1530/EJE-21-0068.

name: 1Department of Diabetology, Metabolic Diseases and Nutrition, Toulouse University Hospital, Institute of Metabolic and Cardiovascular Diseases, UMR1297 INSERM/UPS, Toulouse University, Toulouse, France

family: Tramunt

full_name: Blandine Tramunt

given: Blandine

name: 2Nantes University, Nantes University Hospital, CNRS, INSERM, L’Institut du Thorax, Nantes, France

family: Smati

full_name: Sarra Smati

given: Sarra

family: Coudol

full_name: Sandrine Coudol

given: Sandrine

family: Wargny

full_name: Matthieu Wargny

given: Matthieu

family: Pichelin

full_name: Matthieu Pichelin

name: 4Research Department, Methodology and Biostatistics Platform, Nantes University Hospital, Nantes, France

family: Guyomarch

full_name: Béatrice Guyomarch

name: 5Department of Endocrinology, Diabetes Mellitus and Nutrition, Amiens University Hospital, Amiens, France

name: 6PériTox=UMR_I 01, University of Picardie Jules Verne, Amiens, France

family: Al-Salameh

full_name: Abdallah Al-Salameh

given: Abdallah

name: 7Department of Diabetology, Sud Francilien Hospital Center, Corbeil Essonne, France

family: Amadou

full_name: Coralie Amadou

given: Coralie

name: 8CRESTIC EA 3804, University of Reims Champagne Ardenne, UFR Sciences Exactes et Naturelles, Moulin de la Housse, Reims, France

name: 9Department of Endocrinology-Diabetes-Nutrition, Reims University Hospital, Avenue du Général Koenig, Reims, France

family: Barraud

full_name: Sara Barraud

given: Sara

name: 10Department of Biochemistry, Nantes University Hospital, G et R Laënnec Hospital, Bd Jacques Monod, Nantes, France

family: Bigot

full_name: Edith Bigot

given: Edith

name: 11Department of Endocrinology, Bégin Hospital, Saint-Mandé, France

family: Bordier

full_name: Lyse Bordier

given: Lyse

name: 12Department of Endocrinology, Diabetology and Nutrition, Besançon University Hospital, Besançon, France

family: Borot

full_name: Sophie Borot

name: 13Department of Endocrinology, Diabetology and Nutrition, Assistance Publique Hôpitaux de Paris, Paris Saclay University, Antoine Béclère Hospital, Clamart, Bicêtre Hospital, Le Kremlin Bicêtre, France

family: Bourgeon

full_name: Muriel Bourgeon

given: Muriel

name: 14Department of Diabetology, Sorbonne University, Assistance Publique Hôpitaux de Paris, La Pitié Salpêtrière-Charles Foix University Hospital, Inserm, UMR_S 1138, Cordeliers Research Center, Paris 06, Institute of Cardiometabolism and Nutrition ICAN, Paris, France

family: Bourron

full_name: Olivier Bourron

given: Olivier

name: 15Federation of Endocrinology – Louis Pradel Cardiovascular Hospital, Hospices Civils de Lyon, INSERM UMR 1060 Carmen, Claude Bernard Lyon 1 University, Lyon, France

family: Charrière

full_name: Sybil Charrière

given: Sybil

name: 16University of Côte d’Azur, University Hospital, Inserm U1065, C3M, Nice, France

family: Chevalier

full_name: Nicolas Chevalier

given: Nicolas

name: 17Department of Endocrinology, Diabetology and Nutrition, Assistance Publique Hôpitaux de Paris, Avicenne Hospital, Paris 13 University, Sorbonne Paris Cité, CRNH-IdF, CINFO, Bobigny, France

name: 18Paris 13 University, Sorbonne Paris Cité, UMR U557 Inserm/U11125 INRAE/CNAM/Paris13 University, Nutritional Epidemiological Research Unit, Bobigny, France

family: Cosson

full_name: Emmanuel Cosson

given: Emmanuel

name: 19Department of Endocrinology, Assistance Publique Hôpitaux de Paris, Saint-Antoine Hospital, Reference Center of Rare Diseases of Insulin Secretion and Insulin Sensitivity (PRISIS), Paris, France

name: 20Sorbonne University, Inserm UMRS 938, Saint-Antoine Research Center, Paris, France

family: Fève

full_name: Bruno Fève

name: 21Department of Endocrinology-Diabetology, Felix Guyon Site, University Hospital of la Réunion, Saint-Denis de la Réunion, France

family: Flaus-Furmaniuk

full_name: Anna Flaus-Furmaniuk

given: Anna

name: 22Department of Endocrinology, Diabetology and Nutrition, Hospital of Huriez, Lille University Hospital, Lille, France

family: Fontaine

full_name: Pierre Fontaine

given: Pierre

name: 23Department of Endocrinology, Diabetology and Nutrition, Bordeaux University Hospital and University of Bordeaux, Bordeaux, France

family: Galioot

full_name: Amandine Galioot

given: Amandine

name: 24Department of Endocrinology and Diabetology, Hospital of Pontoise, Pontoise, France

family: Gonfroy-Leymarie

full_name: Céline Gonfroy-Leymarie

given: Céline

name: 25Lorraine University and Endocrinology, Diabetology, Metabolic Diseases and Nutrition, Nancy University Hospital, Nancy, France

family: Guerci

full_name: Bruno Guerci

name: 26Grenoble Alpes University, INSERM U1055, LBFA, Endocrinology, Grenoble Alpes University Hospital, France

name: 27Department of Diabetology, Cochin Hospital, AP-HP, Paris University, Paris, France

name: 28Department of Endocrinology, Diabetology and Nutrition, Hospital of la Conception, Assistance Publique-Hôpitaux de Marseille, Marseille, France

name: 29Aix Marseille University, INSERM, INRA, C2VN, Marseille, France

name: 30Rennes University, Rennes University Hospital, Inserm, CIC 1414 (Clinical Investigation Center), Rennes, France

name: 31Ambroise Paré Neuilly-sur-Seine Hospital, Cordeliers Research Center, Paris Diderot University, Paris, France

name: 32Department of Endocrinology, Diabetology and Nutrition, Strasbourg University Hospitals, Strasbourg, France

name: 33Department of Endocrinology, Diabetology and Nutrition, Bichat Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

name: 34Cordeliers Research Center, Inserm, U-1138, Paris University, Paris, France

name: 35Department of Endocrinology, Diabetes and Metabolic Diseases, Normandie University, UNIROUEN, Rouen University Hospital, Rouen, France

name: 36Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Centre, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France

name: 37Department of Endocrinology and Diabetology, University Hospital of Côte de Nacre, Caen Cedex, France

name: 38Department of Diabetology, Hospital of Gonesse, Gonesse, France

name: 39Department of Endocrinology, Diabetology and Nutrition, Angers University Hospital, Angers, France

name: 40Department of Endocrinology, Brest University Hospital, EA 3878 GETBO, Brest, France

name: 41Department of Endocrinology, Diabetology and Metabolic Diseases, Hospital of Bocage, Dijon, France

name: 42Department of Diabetology and Endocrinology, Lariboisière Hospital, APHP, Paris, France

name: 43INSERM UMRS 1138, Paris Diderot-Paris VII University, Sorbonne Paris Cité, Paris, France

name: 44Section of Endocrinology, John W Deming Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA

name: 45Southeast Louisiana Veterans Health Care System Medical Center, New Orleans, Louisiana, USA

name: 46Tulane Center of Excellence in Sex-Based Biology and Medicine, New Orleans, Louisiana, USA

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

ReferenceCitation: Wargny M, Potier L, Gourdy P, Pichelin M, Amadou C, Benhamou PY, Bonnet JB, Bordier L, Bourron O, Chaumeil C, Chevalier N, Darmon P, Delenne B, Demarsy D, Dumas M, Dupuy O, Flaus-Furmaniuk A, Gautier JF, Guedj AM, Jeandidier N, Larger E, Le Berre JP, Lungo M, Montanier N, Moulin P, Plat F, Rigalleau V, Robert R, Seret-Bégué D, Sérusclat P, Smati S, Thébaut JF, Tramunt B, Vatier C, Velayoudom FL, Vergès B, Winiszewski P, Zabulon A, Gourraud PA, Roussel R, Cariou B, Hadjadj S; CORONADO investigators. Predictors of hospital discharge and mortality in patients with diabetes and COVID-19: updated results from the nationwide CORONADO study. Diabetologia. 2021 Apr;64(4):778-794. doi: 10.1007/s00125-020-05351-w. Epub 2021 Feb 17.

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

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

ReferenceCitation: Wargny M, Gourdy P, Ludwig L, Seret-Bégué D, Bourron O, Darmon P, Amadou C, Pichelin M, Potier L, Thivolet C, Gautier JF, Hadjadj S, Cariou B; CORONADO investigators. Type 1 Diabetes in People Hospitalized for COVID-19: New Insights From the CORONADO Study. Diabetes Care. 2020 Nov;43(11):e174-e177. doi: 10.2337/dc20-1217. Epub 2020 Aug 26.

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

ReferenceCitation: Cariou B, Hadjadj S, Wargny M, Pichelin M, Al-Salameh A, Allix I, Amadou C, Arnault G, Baudoux F, Bauduceau B, Borot S, Bourgeon-Ghittori M, Bourron O, Boutoille D, Cazenave-Roblot F, Chaumeil C, Cosson E, Coudol S, Darmon P, Disse E, Ducet-Boiffard A, Gaborit B, Joubert M, Kerlan V, Laviolle B, Marchand L, Meyer L, Potier L, Prevost G, Riveline JP, Robert R, Saulnier PJ, Sultan A, Thébaut JF, Thivolet C, Tramunt B, Vatier C, Roussel R, Gautier JF, Gourdy P; CORONADO investigators. Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study. Diabetologia. 2020 Aug;63(8):1500-1515. doi: 10.1007/s00125-020-05180-x. Epub 2020 May 29. Erratum in: Diabetologia. 2020 Jul 2;:.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

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


title: Targeted Nurse-driven HIV Screening Using Rapid Tests in Emergency Departments in the Metropolitan Paris Region

acronym: DICI-VIH

summary:
To reduce late HIV diagnosis that remains common in France, the national health agency has promoted non-targeted HIV screening in health care settings, including emergency departments (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at high-risk. Our findings, consistent with results from other international groups, suggest that a targeted strategy could be feasible, efficient and cost-effective with fewer tests required. However, the feasibility and the efficacy of this strategy remain unknown in France.

The main aim of the present study is to compare the efficacy of 2 strategies: 1) the combination of the nurse-driven HIV targeted screening and the current practice (physician-directed HIV diagnostic testing) versus 2) the current practice alone.

The strategies will be compared during 2 randomly assigned periods (cluster randomization and cross-over) in 8 EDs of metropolitan Paris.

During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years old, identified as high-risk by a self-administered questionnaire, not know to be HIV positive, not being seen for post-exposure prophylaxis or unstable medical illness, and accepting to participate by providing an informed consent.

In case of confirmed reactive rapid test result, a follow-up visit with an on-site infectious disease specialist will be arranged within the following 48 hours.

primary_purpose: Screening

ReferenceCitation: Leblanc J, Hejblum G, Costagliola D, Durand-Zaleski I, Lert F, de Truchis P, Verbeke G, Rousseau A, Piquet H, Simon F, Pateron D, Simon T, Crémieux AC; DICI-VIH (Dépistage Infirmier CIblé du VIH) Group. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial. Ann Emerg Med. 2018 Jul;72(1):41-53.e9. doi: 10.1016/j.annemergmed.2017.09.011. Epub 2017 Oct 31.

family: Leblanc

full_name: Judith Leblanc

given: Judith

family: Hejblum

full_name: Gilles Hejblum

given: Gilles

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Lert

full_name: France Lert

given: France

family: de Truchis

full_name: Pierre de Truchis

family: Verbeke

full_name: Geert Verbeke

given: Geert

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Piquet

full_name: Hélène Piquet

given: Hélène

family: Simon

full_name: François Simon

given: François

family: Pateron

full_name: Dominique Pateron

full_name: Tabassome Simon

given: Tabassome

family: Crémieux

full_name: Anne-Claude Crémieux

given: Anne-Claude

family: Duchêne

full_name: Gaëlle Duchêne

given: Gaëlle

family: Jegou

full_name: Carole Jegou

given: Carole

family: Adnet

full_name: Frédéric Adnet

given: Frédéric

family: Bouchaud

full_name: Olivier Bouchaud

family: Alloui

full_name: Chakib Alloui

given: Chakib

family: Jauneau

full_name: Christine Jauneau

given: Christine

family: Troisvallets

full_name: Didier Troisvallets

given: Didier

family: Vandemeulebroucke

full_name: Eric Vandemeulebroucke

given: Eric

family: Fossoux

full_name: Nadia Fossoux

given: Nadia

family: Raphaël

full_name: Maurice Raphaël

given: Maurice

ReferenceCitation: Leblanc J, Rousseau A, Hejblum G, Durand-Zaleski I, de Truchis P, Lert F, Costagliola D, Simon T, Crémieux AC. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. BMC Infect Dis. 2016 Feb 1;16:51. doi: 10.1186/s12879-016-1377-6.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

location_facility: Clinical Research Center (Centre de Recherche Clinique de l'Est Parisien, CRC-Est), Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Assistance Publique - Hôpitaux de Paris (AP-HP)


title: French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results

acronym: CALCIMIT

summary: The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

ReferenceType: background

ReferenceCitation: Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). [Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)]. G Ital Cardiol (Rome). 2013 Mar;14(3):167-214. doi: 10.1714/1234.13659. Italian.

ReferenceCitation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; ACC/AHA Task Force Members. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 10;129(23):e521-643. doi: 10.1161/CIR.0000000000000031. Epub 2014 Mar 3. Erratum in: Circulation. 2014 Jun 10;129(23):e651. Circulation. 2014 Sep 23;130(13):e120. Dosage error in article text.

ReferenceCitation: Wilkins GT, Weyman AE, Abascal VM, Block PC, Palacios IF. Percutaneous balloon dilatation of the mitral valve: an analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J. 1988 Oct;60(4):299-308.

ReferenceCitation: Abascal VM, Wilkins GT, Choong CY, Thomas JD, Palacios IF, Block PC, Weyman AE. Echocardiographic evaluation of mitral valve structure and function in patients followed for at least 6 months after percutaneous balloon mitral valvuloplasty. J Am Coll Cardiol. 1988 Sep;12(3):606-15.

ReferenceCitation: Palacios IF. Percutaneous mitral balloon valvuloplasty. Does it really last as long and do as well as surgery? Adv Cardiol. 2002;39:100-13. Review.

ReferenceCitation: Iung B, Cormier B, Ducimetière P, Porte JM, Nallet O, Michel PL, Acar J, Vahanian A. Immediate results of percutaneous mitral commissurotomy. A predictive model on a series of 1514 patients. Circulation. 1996 Nov 1;94(9):2124-30.

ReferenceCitation: Dreyfus J, Cimadevilla C, Nguyen V, Brochet E, Lepage L, Himbert D, Iung B, Vahanian A, Messika-Zeitoun D. Feasibility of percutaneous mitral commissurotomy in patients with commissural mitral valve calcification. Eur Heart J. 2014 Jun 21;35(24):1617-23. doi: 10.1093/eurheartj/eht561. Epub 2014 Jan 6.

ReferenceCitation: Bouleti C, Iung B, Himbert D, Messika-Zeitoun D, Brochet E, Garbarz E, Cormier B, Vahanian A. Relationship between valve calcification and long-term results of percutaneous mitral commissurotomy for rheumatic mitral stenosis. Circ Cardiovasc Interv. 2014 Jun;7(3):381-9. doi: 10.1161/CIRCINTERVENTIONS.113.000858. Epub 2014 Apr 29.

ReferenceCitation: Palacios IF, Block PC, Wilkins GT, Weyman AE. Follow-up of patients undergoing percutaneous mitral balloon valvotomy. Analysis of factors determining restenosis. Circulation. 1989 Mar;79(3):573-9.

ReferenceCitation: Ben-Farhat M, Betbout F, Gamra H, Maatouk F, Ben-Hamda K, Abdellaoui M, Hammami S, Jarrar M, Addad F, Dridi Z. Predictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy. Am Heart J. 2001 Dec;142(6):1072-9.

ReferenceCitation: Bouleti C, Iung B, Laouénan C, Himbert D, Brochet E, Messika-Zeitoun D, Détaint D, Garbarz E, Cormier B, Michel PL, Mentré F, Vahanian A. Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients. Circulation. 2012 May 1;125(17):2119-27. doi: 10.1161/CIRCULATIONAHA.111.055905. Epub 2012 Mar 28.

lead_sponsor: French Cardiology Society