title: Evolution and Genetic Basis of Menstruation in Women

acronym: EVOMENS

summary: This study examines gene expression and gene regulation in the uterine lining during menses in women, for evolutionary comparison with other primates which do or do not menstruate. Samples will be obtained by non-invasive collection of menstrual fluid from healthy donors.

location_facility: Institut de Biologie de l'Ecole Normale Superieure


title: Distress During the COVID-19 Pandemic in France: a National Assessment of At-risk Populations

summary:
There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention.

The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Chaix B, Delamon G, Guillemassé A, Brouard B, Bibault JE. Psychological distress during the COVID-19 pandemic in France: a national assessment of at-risk populations. Gen Psychiatr. 2020 Nov 26;33(6):e100349. doi: 10.1136/gpsych-2020-100349. eCollection 2020.

apc_source: doaj

family: Chaix

full_name: Benjamin Chaix

given: Benjamin

sequence: first

family: Delamon

full_name: Guillaume Delamon

given: Guillaume

sequence: additional

family: Guillemassé

full_name: Arthur Guillemassé

given: Arthur

family: Brouard

full_name: Benoît Brouard

given: Benoît

family: Bibault

full_name: Jean-Emmanuel Bibault

given: Jean-Emmanuel

bso_classification: Social sciences

currency_apc_doaj: EUR

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: General Psychiatry

oa_colors: green diamond

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via free pdf)

repository_normalized: medRxiv

version: submittedVersion

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

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repositories:
PubMed Central
medRxiv

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: No

lead_sponsor: Wefight

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?

acronym: JAZ-TOP

summary: The disruption of spatial orientation is considered the second most common cognitive symptom of dementia, affecting nearly all activities of daily living. Research in the field of environmental psychology has helped to highlight the influence of the environment on patients with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has been shown that an environment can provide support for cognitive failures in subjects if that particular space is adapted. While numerous studies have focused on the architectural environment (hospital, housing facility), none have explored the ability of patients to orient themselves in a natural environment such as a garden. Yet, in recent years, such gardens, known as healing gardens, have emerged in housing and care facilities, providing genuine support for the care management of patients with Alzheimer-type dementia. Various works have been published outlining recommendations for their management. However, with regard to spatial orientation, none of the available research has explored the basic principles on which to rely on in order to organize the elements of outdoor spaces into itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of such data, these authors recommend relying on five elements, identified by Lynch in his landmark book "Image of the City" (1960), that people use to orient themselves and find their way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The hypothesis to verify is that patients with Alzheimer's disease do not rely on the same elements of the garden as non-Alzheimer's subjects in making orientation decisions and to mentally picture this environment.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Central Hospital, Nancy, France

location_facility: University Hospital of Nancy , Saint Julien Hospital, France

lead_sponsor_type: academique


title: A France-based Study for Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome: SQUIDperi Study: A Non-interventional, Prospective, Single-arm, Multicenter Study

acronym: SQUIDperi

summary:
Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. The historic and most studied liquid embolic agent to date is Onyx. Results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. This systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with Onyx from 2005 to August 2014. There were 11 case series and 8 case reports but no prospective trial. The most common presenting symptoms were of gastrointestinal (GI) origin (n = 51). Rebleeding of the baseline lesion occurred in 7/131 patients. No deaths resulting from complications of the embolic procedure were reported. One patient died of persistent hemoptysis after treatment with Onyx. No deaths were directly attributable to the use of Onyx.

During a peripheral embolization procedure with available embolic agents other than SQUIDPERI, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. It was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. Additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. SQUIDPERI is a liquid embolic agent with various viscosities and radiopacities. It is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today.

The purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of SQUIDPERI for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Device

status_simplified: Ongoing


title: Post-Covid-19 Emotional Aspects of Hospital Staff

acronym: EMOCOV

summary:
The ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Health services have been put to the test, some staff being on the front line, others having faced the reorganization of the health system necessitated by such a pandemic.

Frontline caregivers have been compared to "fighters on the front lines." They encountered many difficulties, such as direct exposure to patients with a high viral load, exposure to the risk of contamination, physical exhaustion, reorganization of workspaces, adaptation to rigid work organizations, the management of the shortage of materials, the unusually high number of deaths among patients, colleagues or relatives, ethical questions relating to decision-making in a strained healthcare system.

The psychological impact on these hospital staff is an indirect issue of such a pandemic in terms of mental health.

The investigators have little data in the literature on the incidence of psychiatric episodes in the post-epidemic period. Work on the impact of two major pandemics of influenza A H1N1 (2009) and SARS-CoV-1 (2003) on the mental health of caregivers and other staff working in hospitals reports increased rates of mental disorders after discharge from anxiety-type crisis, depression and post-traumatic stress. This over-representation of mental disorders was still found several years after the epidemic.

Similar results are emerging in recent studies involving hospital staff who were used in the Covid-19 crisis. These highlight a certain number of risk factors for the occurrence of these disorders (young age, nursing profession, underlying psychiatric pathology, exercise carried out in the first line of Covid).

status: Active, not recruiting

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release.

acronym: WALA

summary:
The carpal tunnel release (CTR) is now performed almost exclusively under regional anesthesia (RA) in France. RA requires the use of a pneumatic tourniquet to limit blood flow to the operated extremity and create a bloodless surgical field for a clear visualization of the anatomic structures by the surgeon.

Multiple approaches to block the brachial plexus can be considered. The most common technique is the axillary block (BAX) that provides complete anesthesia for the patient's arm and forearm. This technique offers anesthesia not only for the surgical area but also for the root of the arm where the pneumatic tourniquet is placed. However this technique have limits: the persistence of a motor block in the arm and the forearm that is not compatible with a quick hospital discharge (short term ambulatory hospitalization) and the need for assistance with dressing and eating after surgery. More distal anesthetic techniques are proposed such as the troncular blocks (TRONC) that avoid motor block of the arm and offer an earlier recovery and autonomy for the patient. However, they lead to a poor tolerance to the tourniquet due to its application on a non-anesthetized area.The pain related to the pressure of the tourniquet can occur within the first few minutes of its inflation, get worse over time and persist for several minutes after its deflation. Therefore, TRONC procedure is less often performed compared to the BAX for major surgeries but it remains appropriate for CTR.

The Wide Awake Local Anesthesia No Tourniquet (WALANT) technique is widely used in Canada and has been proposed for hand and wirst minor surgeries. WALANT uses a combination of a local anesthetic (LA) and epinephrine to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet. Epinephrine is a vasoconstrictor agent that reduces blood flow at surgical site. This bloodless effect is visualized on the skin by a pale color. Thus, WALANT can provide a chemical tourniquet and eliminate the pain from a traditional arm tourniquet. However, this technique is performed with a short-acting LA and does not offer any postoperative analgesia.

The association of TRONC using long-acting LA with the WALANT technique could combine the comfort of a surgery without tourniquet to a long-acting analgesia and thus could provide a superior overall comfort.

The main objective of this prospective, multicentre, randomized, open-label, parallel-group controlled trial is to evaluate the interest of WALANT technique on patient comfort during CTR performed with TRONC, compared to the tourniquet.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: CMC Ambroise Paré

location_facility:
Clinique Rémusat
Clinique Jouvenet

intervention_type: Procedure


title: Epidemiology and Clinical Features of Uveitis in a Tertiary Referral Center in Montpellier, France

summary:
The aim of the study is to report the pattern of uveitis in patients attending a tertiary referral center at the University hospital in Montpellier. The patients seen at the specialized consultation for uveitis between 2002 and first semester 2018 were included.

Data about demography, clinical features and final diagnoses were collected and updated during the differenet visits. The medical records were restrospectively rewieved and analyzed.

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Oral Functions and Malocclusions: a Comprehensive Epidemiological Study on 358 Schoolchildren in France

acronym: MALODYS

summary: The aim of our research is to establish a link between malocclusions and oral dysfunctions. The clinical examination includes: caries screening (DMFT and dft scores), a quantification of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute Autorité de Santé HAS). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Rehabilitation Required Due to Functional Neurological Impairment and Respiratory Disorders After Severe SARS-CoV-2 Infection in ICU Units

acronym: REHABCOV

summary:
Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/).

Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.

status: Recruiting

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Strasbourg University Hospitals - Anesthesia and surgical resuscitation service


title: Study of the Prevalence, Risk Factors and Protective Factors of Burnout Among General Practitioners in France

acronym: BOUM

summary:
The main objective of this study is to assess the burnout prevalence among French general practitioners in private practice.

As secondary outcomes, this study aim to measure the impact of sociodemographic variables, organizational practice models and workload. the investigators also intend to characterize the prevalence of depression, anxiety, fatigue and stress, drugs and alcohol consumption, use of psychotropic medication, and preferred strategies to cope with their symptoms.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France

summary:
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.

The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013

ReferenceCitation: Blin P, Dureau-Pournin C, Bénichou J, Cottin Y, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Real-Life Effectiveness and Safety of Dabigatran or Rivaroxaban vs. Vitamin K Antagonists: A High-Dimensional Propensity Score Matched New Users Cohort Study in the French National Healthcare Data System SNDS. Am J Cardiovasc Drugs. 2020 Feb;20(1):81-103. doi: 10.1007/s40256-019-00359-z.

family: Blin

full_name: Patrick Blin

given: Patrick

family: Dureau-Pournin

full_name: Caroline Dureau-Pournin

given: Caroline

family: Bénichou

full_name: Jacques Bénichou

given: Jacques

family: Cottin

full_name: Yves Cottin

given: Yves

family: Mismetti

full_name: Patrick Mismetti

family: Abouelfath

full_name: Abdelilah Abouelfath

given: Abdelilah

family: Lassalle

full_name: Regis Lassalle

given: Regis

family: Droz

full_name: Cécile Droz

given: Cécile

family: Moore

full_name: Nicholas Moore

given: Nicholas

bso_classification: Medical research

journal_name: American Journal of Cardiovascular Drugs

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Blin P, Dureau-Pournin C, Cottin Y, Bénichou J, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Effectiveness and Safety of Standard or Reduced Dose Dabigatran vs. Rivaroxaban in Nonvalvular Atrial Fibrillation. Clin Pharmacol Ther. 2019 Jun;105(6):1439-1455. doi: 10.1002/cpt.1318. Epub 2019 Feb 6.

name: Bordeaux PharmacoEpiINSERM CIC1401Université de BordeauxCHU de Bordeaux Bordeaux France

family: Dureau‐Pournin

full_name: Caroline Dureau‐Pournin

name: Service de CardiologieCHU de Dijon Dijon France

name: INSERM U1219Université de Bordeaux Bordeaux France

name: CHU de RouenUnité de Biostatistique Rouen France

name: Unité de Recherche Clinique Innovation et PharmacologieHôpital Nord Saint‐Etienne France

journal_name: Clinical Pharmacology & Therapeutics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Boehringer Ingelheim

location_facility: 1160.263.1 Boehringer Ingelheim Investigational Site


title: Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex

acronym: THEN

summary:
Lung cancer is the leading cause of cancer deaths in France, Europe and the world. 50% of lung cancers are of the adenocarcinoma subtype. 60% of patients present with a metastatic disease (stage IV) at the time of diagnosis. Approximately 10% of patients present with a mutation of the epidermal growth factor receptor (EGFR) requiring an EGFR tyrosine kinase inhibitor (EGFR-TKI), namely erlotinib, gefitinib or afatinib. For the majority of chemotherapy-naïve patients without addictive mutation, platinum-based chemotherapy, frequently the platinum - pemetrexed doublet, provides disease control rate of up to 70% and improves survival from approximately 4.5 with best supportive care alone to 15 months. However, patients with non-small cell lung cancer (NSCLC) usually relapse within 4 to 6 months and benefit from a second-line chemotherapy. Authorized drugs in this setting are pemetrexed, docetaxel and erlotinib. The prescription of erlotinib for unselected patients whose tumor does not harbor an EGFR mutation is questionable . In the second line setting, docetaxel provides less than 10% of partial responses and progression-free survival of 10 to 12 weeks. There are no standard options following failure of two previous lines of standard chemotherapy. In view of these modest results, new agents and therapeutic strategies are greatly needed for this patient population.

Neurotensin (NTS) is a 13 amino acids peptide, present and biologically active in the central nervous system and in periphery. At the peripheral level, NTS is released by the endocrine cells of the intestinal mucosa after meals and acts as an endocrine hormone involved in the postprandial regulation of the motor functions of the gastrointestinal tract. The effects of NTS are mediated by three subtypes of receptor: NTSR1 and NTSR2 exhibit high and low affinity for NTS, respectively, and belong to the family of G protein receptors; NTSR3 is a single transmembrane domain receptor. Exogenous activation of NTSR1 leads to cell proliferation, survival, mobility and invasion in cancer cells from diverse origin. These effects are the result from the activation of kinases and effectors, such as PKC, MAPK, FAK, RHO-GTPase, RAS and Src. The PKC activation may induce MAPK by direct stimulation of Raf-1, or by transactivation of the EGFR. The activation of MAPK via NTSR1 is mainly associated with uncontrolled cell growth. Both NTS and NTSR1 are expressed in 40% of lung tumors, whereas they are never expressed in the normal tissue. NTSR1 high expression is a negative prognostic factor in stage I to III operated lung adenocarcinomas. Sustained stimulation of NTSR1 results in the activation of MMP1, the release of EGF "like" ligands such as HB-EGF as well as neuregulin 1 NGR1 (a specific ligand for HER3) followed by EGFR, HER2 and HER3 overexpression and activation. Accordingly, xenografted tumors expressing NTS and NTSR1 show a positive response to erlotinib, whereas tumors void of NTSR1 expression have no detectable response.

Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker. In preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in tumour growth inhibition and regression of established subcutaneous tumours derived from four human cell-lines known to co-express ErbB receptors.

Our claim is that patients harbouring the NTS/NTSR complex, without EGFR mutation, will respond to afatinib due to the sustained activation of EGFR/HER2 under neurotensin activation.

Presently, only EGFR mutated tumors are eligible to receive EGFR TKI representing 10% of all lung cancer patients. The aim of this study is to evaluate the efficacy of afatinib, an EGFR TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high level of expression. This subpopulation of patients represents approximately 20% of lung adenocarcinomas.

status: Withdrawn

primary_purpose: Treatment

intervention_type: Drug

status_simplified: Unknown


title: Extern Validation of a Predictive Score of Brain Death in Patients With Severe Stroke and Unfavourable Prognosis Identified by Organ Procurement and Transplant Coordinations

summary: There is currently a shortage of organ in France, for patients with chronic diseases who are on the waiting list for an organ. The first source of organ donor in France is patients with brain death. 58% of patients in brain death are patients with a severe stroke ( ischemic or hemorrhagic). In order to identify which patient with a severe stroke and with unfavorable prognosis who can evolve to brain death, we have conducted a retrospective study in Lorrain, in France, and we have built a predictive score of brain death in these patients. It is important to validate this predictive score in a prospective study on a greater scale than the first study.

status: Unknown status

ReferenceType: background

ReferenceCitation: Humbertjean L, Mione G, Fay R, Durin L, Planel S, Lacour JC, Enea AM, Richard S. Predictive factors of brain death in severe stroke patients identified by organ procurement and transplant coordination in Lorrain, France. Transpl Int. 2016 Mar;29(3):299-306. doi: 10.1111/tri.12695.

location_facility:
CH de Chalons-en-Champagne
CH Epinal
Hôpital Nord Franche
CH de Macon
CH de Mulhouse
CH de Charleville-Mézières
CHRU de Nancy
Lons Le Saunier
CH Sarreguemines
CH de Saint-Quentin
CH Troyes
CH Verdun
CH Nevers
CH de Colmar
CHU de Dijon
CH de Vesoul
CH de Haguenau
CHRU de Strasbourg
CHU Besançon
CHR Metz-Thionville
Ch de Compiègne
CHU de Reims
CH de Laon
CH d'Auxerre
CH de saverne


title: Study of the Attack Rate of COVID-19 Infection in Patients Infected With HIV and/or on Pre-exposure Prophylaxis (PrEP) and Possible Impact of Treatment With an HIV Protease Inhibitor

acronym: COVIDHIVPrEP

summary:
The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied.

In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients.

The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease.

Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.

lead_sponsor: Hospices Civils de Lyon

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Profiles of Empathy and Emotional Intelligence Promoted by Written Examination Combined to Oral Interviews During the Selection of 1st Year Health Students at the Paris University of Medicine

acronym: PREMIS

summary:
As the interpersonal skills such as empathy and emotional intelligence take more and more importance in the medical education, the Paris University of Medicine has introduced for the first time in 2019 some multiple mini-interviews (MMI) in addition to the traditional written examination, to graduate the 1st year student in health studies.

The selection process aims at promoting students with high academic results but also with good interpersonal abilities. In this new selection process, MMI will be used in addition to written tests, but only to attribute the last places available after a first ranking based on academic results.

So after the written examination, students with the best written exam marks will directly graduate, others will require MMI to graduate and some will directly fail.

The main hypothesis is that this selection procedure may promote stronger interpersonal abilities profiles in the group that succeed to enter one of the health studies course than in the group that failed.

This study will measure the clinical empathy and emotional intelligence abilities of all the 1st year students applying for this new selection process, using validate self-administered questionnaires.

Then the investigators will compare the scores of empathy and emotional intelligence in the group that succeed the selection process, to the group that failed. Furthermore, in the success group, the investigators will compare the scores between students that directly graduated and students that required MMI. Scores will also be compared considering some sociodemographic data.

The result of that studies could give strong arguments to modify the selection process and extend the use of MMI in medical school in France.

lead_sponsor: University of Paris 5 - Rene Descartes


title: Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.

acronym: ICONE

summary: The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.

primary_purpose: Screening

ReferenceCitation: Blackburn NA, Patel RC, Zibbell JE. Improving Screening Methods for Hepatitis C Among People Who Inject Drugs: Findings from the HepTLC Initiative, 2012-2014. Public Health Rep. 2016 May-Jun;131 Suppl 2:91-7.

ReferenceCitation: Chevaliez S, Poiteau L, Rosa I, Soulier A, Roudot-Thoraval F, Laperche S, Hézode C, Pawlotsky JM. Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care. Clin Microbiol Infect. 2016 May;22(5):459.e1-6. doi: 10.1016/j.cmi.2016.01.009. Epub 2016 Jan 22.

ReferenceCitation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

ReferenceCitation: Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2.

ReferenceCitation: Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13.

ReferenceCitation: Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9.

ReferenceCitation: Leon L, Kasereka S, Barin F, Larsen C, Weill-Barillet L, Pascal X, Chevaliez S, Pillonel J, Jauffret-Roustide M, LE Strat Y. Age- and time-dependent prevalence and incidence of hepatitis C virus infection in drug users in France, 2004-2011: model-based estimation from two national cross-sectional serosurveys. Epidemiol Infect. 2017 Apr;145(5):895-907. doi: 10.1017/S0950268816002934. Epub 2016 Dec 22.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis

summary:
Anaphylaxis is a hypersensitivity reaction systemic, generalized, severe, life-threatening that may result from exposure to a triggering factor. The prevalence of anaphylaxis is 0.05 to 2% in the general population. Most reactions appear within 30 minutes after contact with the triggering factor and last up to 6 hours. The main triggering factors are: 1/food, 2/hymenopteran bites, 3/drugs. The main treatment is the early administration of adrenaline by Intramuscular route on medical prescription or by AAI (adrenaline auto-injector) associated with the exclusion of the allergen. Adrenaline treatment should be administered as soon as possible, a failure or delay in the use of adrenaline is a risk factor for death. Anaphylaxis is a chronic disease and the patient must be informed from the first episode about the risk of recurrence and the risk of death he is exposed to. Patient education is essential for the complete removal of the triggering factor, recognition of anaphylaxis symptoms and use of AAI. The risk of recurrence is high given the difficulty to completely eliminate the favourable factor (mainly food causes and hymenopteran bites): 1/3 of deaths from food anaphylaxis occur at home, and the peak mortality rate is between 10 and 30 years old. The diagnosis of anaphylaxis can be difficult because the symptomatology can be so varied. It is under-diagnosed, which leads to a lack of medical care and therefore an under-prescription of AAI. Some American studies identifying emergency room visits for anaphylaxis find that in less than 30% of cases there is a prescription for AAI, in less than 40% of advices about triggering factor's eviction and in less than 20% a guidance to an allergology consultation. In France, the HAS published in 2013 a procedure to be followed after the treatment of a suspected anaphylaxis: the patient's management must be diagnostic, therapeutic and educational. It must be systematically based on three axes:

the prescription of AAI with an explanation of its use,
the provision of written information on the mechanism and symptoms of anaphylaxis, attitude to be followed in event of an anaphylactic reaction, and need for eviction if the allergen has been identified,
guidance to an allergology consultation.

Therapeutic education for anaphylactic patients is essential given the risk involved. In an American study, it was shown that only 60% of teens and young adults suffering from food allergies report having AAI systematically with them. Information and education is therefore essential for these patients.

ipd_sharing: Yes

location_facility:
Groupe Hospitalier Paris Saint Joseph
Maison de santé porte de Vanves


title: Study of Association Between Quantity (and Percentage) of Visceral Adipose Tissue and NAFLD-linked Liver Stifness as Mesured by Fibroscan in a Retrospective Cohort of Diabetes Mellitus Patients

summary:
Non Alcoholic Fatty Liver Disease (NAFLD) is an emergent disease worldwide, and soon the leading cause of hepatic transplant in the USA. Among this high number of patients, the current challenge is to detect or even predict patients at risk of inflammation (Non Alcoholic or Steatohepatitis or NASH) and end-stage fibrosis, which are the best predictors of liver-related mortality.

Visceral obesity is intimately associated with metabolic disease and adverse health outcomes, such as diabetes, and NAFLD. It has been demonstrated that visceral adipose tissue-linked inflammation was a risk factor of stroke, myocardial infarction, and others metabolic-related complications.

The aim of this study was to evaluate the association of the quantity and percentage of Visceral Adipose Tissue by Dual X-Ray Absorptiometry and liver stiffness by Fibroscan in patients with type 2 diabetes, and other predictors of fibrosis such as FIB-4 and Fibrotest. We retrospectively collected the data of all the diabetic patients who had undergone a DEXA and a Fibroscan between January 1st, 2014 and Decembre 31th, 2019, in the Universitary Hospital of Nancy, France.


status: Terminated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: COGNIBENZO

type: EudraCT Number

source: euctr

title: Cognitive Impact of Benzodiazepin Withdrawn After Curative Epilepsy Surgery in Children With Focal Epilepsy

summary:
Epilepsy is a frequent group of diseases, affecting 1% of the general population with a higher incidence in children. Anti-epileptic drugs are used as part of the drug treatment. Even if children with epilepsy have its own characteristics, as in adults, the choice of an anti-epileptic treatment is also based on the benefit-risk balance. The purpose of the treatment should not only be the seizure control. The occurence of side effects is a major factor to be taken into account. In the special populatIon of children with resistant epilepsy (20 to 30% of epilepsy), the treatment goal is not any more to be seizure free but to achieve the lowest possible frequency of seizures with the lowest level of side effects.

When assessing the benefit-risk balance of antiepileptic treatment, it is important to keep in mind that the child is a developing human being whose main activity is learning. Special attention should be paid to minimize treatments with excessive cognitive consequences. Be particularly wary of combination therapies (combinations of several antiepileptic treatments). Indeed, it is well established that they are more harmful than monotherapy. It is also important to avoid the use of drugs with too strong a cognitive effect. Some molecules such as phenobarbital or topiramate have been the subject of a few studies that have established their deleterious effect on the cognitive level. Among antiepileptics, benzodiazepines are sometimes used as disease-modifying therapy. In France, clobazam is the clonazepam have a Marketing Authorization for children.

However, there is no study to determine whether these molecules have cognitive consequences. In order to have more data to better establish the risk-benefit balance of benzodiazepines in the treatment of children with epilepsy, the investigators wish to conduct work to evaluate the cognitive consequences of benzodiazepines in children treated for epilepsy.


title: Prospective Randomized Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma

acronym: CINEXEN

summary: Glaucoma is a blinding optic neuropathy that affects 60 million people worldwide. Of all the types of existing glaucoma, primary open-angle glaucoma is the most common etiology. The therapeutic arsenal today includes drug lowering treatments, lasers and surgery. The most frequent glaucoma surgeries are, in France, trabeculectomy and non-perforating deep sclerectomy (NPDS). These are two filtering surgeries whose principle is to lower the intra ocular pressure (IOP) by creating an evacuation path of the aqueous humor from the anterior chamber (AC) of the eye to the space subconjunctival creating a filtration bubble (FB). These two procedures are currently considered the gold standard. They can be performed alone or at the same time as cataract surgery. The short-term complications encountered with these techniques are early hypotonia and its attendant complications (choroidal detachment, hypotonic maculopathy, hemorrhages, etc.), the most common cause of which is conjunctival leakage from the bubble. In the medium term, increases in blood pressure with deep AC testify to a scleral flap that is too tight which may require suture lysis. Finally, the problems of excessive conjunctival-Tenon healing concern 25 to 30% of those operated on and are responsible for the majority of late blood pressure increases. In the longer term, the most common complication is cataracts; the rarest, but most serious complication is infection of BF, which occurs more readily when the walls of the FB are ischemic or even perforated. It can be complicated by an extremely serious endophthalmitis. A new minimally invasive therapeutic option has been developed limiting per- and post-operative complications. Unlike traditional techniques which present an ab externo approach, the ab interno approach of the new technique proposed consists of the implantation of a tube of collagen 6 mm in length and 45 µm of light called Xen® through the AC .

primary_purpose: Prevention


title: Influence du Victoza (Liraglutide,Analogue GLP-1) Sur Les Performances Gustatives, le Rassasiement Sensoriel spécifique, le Liking et le Wanting Chez Les Patients diabétiques de Type 2.

summary:
Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1 analogues decrease satiety and food intake leading to a significant weight loss in patients. However, little is known about their effects on food hedonic sensations and taste perception.

The aim of this study is to investigate the impact of Liraglutide on the liking and wanting components of the food reward system, taste sensitivity and sensory specific satiety in type 2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models, it is expected that Liraglutide will modify food preference and gustative perception in humans.

Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the treatment administration. Olfactory liking, recalled liking and wanting for several food items will be assessed. Sensory specific satiety will be measured as well as detection thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on hunger, pleasure in eating, and food intake.

primary_purpose: Health Services Research


title: Enquête épidémiologique Sur la prévalence et le Pronostic de l'Histiocytose Langerhansienne Pulmonaire de l'Adulte en France

summary: The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.

location_facility: French national reference centre for Histiocytoses


title: A French, Multicentric, Randomized, Simple Blind, Superiority Study Comparing the Efficiency and the Safety at 24 Months of the Stent Titan2 Versus Bare Metal Stent in Cobalt-Chrome in All Comers Patients Among Which 40 % Present an ACS.

acronym: EVIDENCE II

summary: The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).

lead_sponsor: Hexacath, France

location_facility:
Centre Hospitalier Général
Hôpital Nord
Hôpital de Rangueil
Centre Hospitalier Laënnec
Clinique Claude Bernard
Clinique de l'Europe
Hôpital Saint-Joseph
CH Saint-Brieuc
CHI Toulon La Seyne
Centre Hospitalier de Lagny
Clinique La Fourcade
Clinique Saint-Hilaire
Clinique Beauregard
Clinique Les Fontaines
Hôpital Sud
HCL Croix-Rousse
HIA Val de Grâce
Hôpital Albert Schweitzer
Ch Sud Francilien
CH Cannes
CHU de Grenoble
Clinique Saint Laurent
Clinique Pasteur
Clinique Alleray Labrouste
Clinique Saint-Martin
Groupe Hospitalier Mutualiste
CHU Côte de Nacre
Hôpital Claude Galien- ICPS
Hôpital Gabriel Montpied
Centre hospitalier Louis Pasteur
Centre Hospitalier de Lille
Hôpital Emile Muller
CHU Angers
CH Pau
Nouvelles Cliniques Nantaises
CH Henri Duffaut
HCL Bron
Centre Hospitalier Départemental
Polyclinique de Bois Bernard
CH Valence
CHU Caremeau
CHRU Tours


type: Other Identifier

type: Other Grant/Funding Number

title: Prévention Des Erreurs médicamenteuses liées Aux Interruptions de tâches Des Soignants Lors de la préparation et de l'Administration Des médicaments : Essai contrôlé randomisé Multicentrique en Clusters

acronym: PERMIS

summary:
Serious medication administration errors are common in hospitals and nurse's interruptions during medication preparation and administration is associated with errors. Various interventions were developed to help prevention of errors such as visual intervention. Investigators aimed to study the effect of a medication safety vest to reduce medication errors. The vest serves as a visible signal to inform others that the nurse is preparing and administering medications and should not be disturbed. Patients and visitors are provided with an informational flyer to inform them about the use of medication safety vests.

The hypothesis is that the vest will reduce nurse's interruptions during medication preparation and administration, and ultimately reduce medication errors.

The study is a randomized controlled trial in 30 care units of four hospitals in France. Each unit will be randomized in either the control group or the experimental group using the medication safety vest. Nurses of the unit will be selected at random to determine who will be observed during the administration rounds.The observation method will be used to evaluate the error rates in the 2 groups. The number of interruptions and error rates will be evaluated.

ReferenceCitation: Berdot S, Sabatier B, Gillaizeau F, Caruba T, Prognon P, Durieux P. Evaluation of drug administration errors in a teaching hospital. BMC Health Serv Res. 2012 Mar 12;12:60. doi: 10.1186/1472-6963-12-60.

ReferenceCitation: Berdot S, Gillaizeau F, Caruba T, Prognon P, Durieux P, Sabatier B. Drug administration errors in hospital inpatients: a systematic review. PLoS One. 2013 Jun 20;8(6):e68856. doi: 10.1371/journal.pone.0068856. Print 2013. Review.

ReferenceCitation: Berdot S, Roudot M, Schramm C, Katsahian S, Durieux P, Sabatier B. Interventions to reduce nurses' medication administration errors in inpatient settings: A systematic review and meta-analysis. Int J Nurs Stud. 2016 Jan;53:342-50. doi: 10.1016/j.ijnurstu.2015.08.012. Epub 2015 Sep 7. Review.

ReferenceCitation: Westbrook JI, Woods A, Rob MI, Dunsmuir WT, Day RO. Association of interruptions with an increased risk and severity of medication administration errors. Arch Intern Med. 2010 Apr 26;170(8):683-90. doi: 10.1001/archinternmed.2010.65.

ReferenceCitation: Relihan E, O'Brien V, O'Hara S, Silke B. The impact of a set of interventions to reduce interruptions and distractions to nurses during medication administration. Qual Saf Health Care. 2010 Oct;19(5):e52. doi: 10.1136/qshc.2009.036871. Epub 2010 May 28.

ReferenceCitation: Berdot S, Vilfaillot A, Bezie Y, Perrin G, Berge M, Corny J, Thi TTP, Depoisson M, Guihaire C, Valin N, Decelle C, Karras A, Durieux P, Lê LMM, Sabatier B. Effectiveness of a 'do not interrupt' vest intervention to reduce medication errors during medication administration: a multicenter cluster randomized controlled trial. BMC Nurs. 2021 Aug 24;20(1):153. doi: 10.1186/s12912-021-00671-7.

family: Berdot

full_name: Sarah Berdot

given: Sarah

family: Vilfaillot

full_name: Aurélie Vilfaillot

given: Aurélie

family: Bezie

full_name: Yvonnick Bezie

given: Yvonnick

family: Perrin

full_name: Germain Perrin

given: Germain

family: Berge

full_name: Marion Berge

given: Marion

family: Corny

full_name: Jennifer Corny

given: Jennifer

family: Thi

full_name: Thuy Tan Phan Thi

given: Thuy Tan Phan

family: Depoisson

full_name: Mathieu Depoisson

given: Mathieu

family: Guihaire

full_name: Claudine Guihaire

given: Claudine

family: Valin

full_name: Nathalie Valin

given: Nathalie

family: Decelle

full_name: Claudine Decelle

family: Karras

full_name: Alexandre Karras

given: Alexandre

family: Durieux

full_name: Pierre Durieux

given: Pierre

family: Lê

full_name: Laetitia Minh Maï Lê

given: Laetitia Minh Maï

family: Sabatier

full_name: Brigitte Sabatier

given: Brigitte

currency_apc_doaj: GBP

journal_name: BMC Nursing

oa_colors: green gold

license: cc-by

license_normalized: cc-by

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

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

repository_normalized: HAL

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

title: Effectiveness of a ‘do not interrupt’ vest intervention to reduce medication errors during medication administration: a multicenter cluster randomized controlled trial


title: Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis

acronym: CINEBIOPHTA

summary: Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Despite the eye isolation from the rest of the body, germs can enter the eye either exogenously, during open globe surgery, following perforating eye trauma, or following anti-VEGF antibodies intravitreal injection, or other drugs such as corticosteroids for example, or by endogenous route, haematogenic as part of sepsis, usually during immunodepression. Post-operative endophthalmitis is the most feared complication following any endo-ocular surgery. It can be acute, occurring within 6 weeks post-operatively or delayed as after poor healing, or on a glaucoma filtration bubble. Endophthalmitis after cataract surgery is a complication with a low incidence of (0.030 to 0.047%) but which, due to interventions number carried out (830,000 in 2016, in France), appears significant. There are factors that favour endophtalmitis occurrence such as a vitreous exit from eyeball during surgical procedure, poor scar coaptation, premature removal of sutures, etc... They condition emergency care. Early diagnosis and appropriate treatment are essential for safeguarding the eye and its function. Therefore, therapeutic management requires endo-ocular sampling in front of any suspicion of endophtalmitis, to be done before any treatment, to carry out microbiological analysis (direct examination on slide, culture, universal and/or targeted PCR, antibiotic susceptibility test). Vitreous puncture is more contributive than anterior chamber puncture, underlining need for these two samples to identify the responsible germ. Once samples have been taken, a broad-spectrum antibiotic therapy introduction must be performed intra-vitreously combined with systemic and local administration. Intravitreal injections allow treatment to be provided at effective concentrations directly at the infection site. On the other hand, toxic risks must be taken into account, especially since the protocol may require multiple intravitreal injections.

ReferenceType: result

ReferenceCitation: Du DT, Wagoner A, Barone SB, Zinderman CE, Kelman JA, MaCurdy TE, Forshee RA, Worrall CM, Izurieta HS. Incidence of endophthalmitis after corneal transplant or cataract surgery in a medicare population. Ophthalmology. 2014 Jan;121(1):290-298. doi: 10.1016/j.ophtha.2013.07.016. Epub 2013 Aug 29.

family: Du

full_name: Dongyi (Tony) Du

given: Dongyi (Tony)

family: Wagoner

full_name: Austin Wagoner

given: Austin

family: Barone

full_name: Samuel B. Barone

given: Samuel B.

family: Zinderman

full_name: Craig E. Zinderman

given: Craig E.

family: Kelman

full_name: Jeffrey A. Kelman

given: Jeffrey A.

family: MaCurdy

full_name: Thomas E. MaCurdy

given: Thomas E.

family: Forshee

full_name: Richard A. Forshee

given: Richard A.

family: Worrall

full_name: Chris M. Worrall

given: Chris M.

family: Izurieta

full_name: Hector S. Izurieta

given: Hector S.

journal_name: Ophthalmology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Incidence of Endophthalmitis after Corneal Transplant or Cataract Surgery in a Medicare Population

ReferenceCitation: Clarke B, Williamson TH, Gini G, Gupta B. Management of bacterial postoperative endophthalmitis and the role of vitrectomy. Surv Ophthalmol. 2018 Sep - Oct;63(5):677-693. doi: 10.1016/j.survophthal.2018.02.003. Epub 2018 Feb 15. Review.

family: Clarke

full_name: Ben Clarke

given: Ben

family: Williamson

full_name: Thomas H. Williamson

given: Thomas H.

family: Gini

full_name: Giampaolo Gini

given: Giampaolo

family: Gupta

full_name: Bhaskar Gupta

given: Bhaskar

journal_name: Survey of Ophthalmology

ReferenceCitation: Goldschmidt P, Bensaid P, Semoun O, Chaumeil C. [Rational approach for the treatment of postoperative endophthalmitis in impoverished populations]. J Fr Ophtalmol. 2013 Mar;36(3):261-7. doi: 10.1016/j.jfo.2012.08.002. Epub 2013 Feb 11. French.

family: Goldschmidt

full_name: P. Goldschmidt

given: P.

family: Bensaid

full_name: P. Bensaid

family: Semoun

full_name: O. Semoun

given: O.

family: Chaumeil

full_name: C. Chaumeil

given: C.

title: Approche rationnelle pour le traitement des endophtalmies post-chirurgicales des populations vivant dans des conditions de pauvreté

ReferenceCitation: Kumar A, Sridhar MS, Dada T, Tewari HK, Gupta SK. Intravitreal pefloxacin therapy in postoperative endophthalmitis. Clin Exp Ophthalmol. 2000 Feb;28(1):38-40.

ReferenceCitation: Khera M, Pathengay A, Jindal A, Jalali S, Mathai A, Pappuru RR, Relhan N, Das T, Sharma S, Flynn HW. Vancomycin-resistant Gram-positive bacterial endophthalmitis: epidemiology, treatment options, and outcomes. J Ophthalmic Inflamm Infect. 2013 Apr 22;3(1):46. doi: 10.1186/1869-5760-3-46.

journal_name: Journal of Ophthalmic Inflammation and Infection

ReferenceCitation: Chiquet C, Labetoulle M. [Fluoroquinolones in ophthalmology: indications and current use]. J Fr Ophtalmol. 2008 Oct;31(8):803-8. Review. French.

ReferenceCitation: Adenis JP, Mounier M, Salomon JL, Denis F. Human vitreous penetration of imipenem. Eur J Ophthalmol. 1994 Apr-Jun;4(2):115-7.

ReferenceCitation: Bowen RC, Zhou AX, Bondalapati S, Lawyer TW, Snow KB, Evans PR, Bardsley T, McFarland M, Kliethermes M, Shi D, Mamalis CA, Greene T, Rudnisky CJ, Ambati BK. Comparative analysis of the safety and efficacy of intracameral cefuroxime, moxifloxacin and vancomycin at the end of cataract surgery: a meta-analysis. Br J Ophthalmol. 2018 Sep;102(9):1268-1276. doi: 10.1136/bjophthalmol-2017-311051. Epub 2018 Jan 11.

ReferenceCitation: Cornut PL, Chiquet C. [Intravitreal injection of antibiotics in endophthalmitis]. J Fr Ophtalmol. 2008 Oct;31(8):815-23. French.

ReferenceCitation: Gan IM, van Dissel JT, Beekhuis WH, Swart W, van Meurs JC. Intravitreal vancomycin and gentamicin concentrations in patients with postoperative endophthalmitis. Br J Ophthalmol. 2001 Nov;85(11):1289-93.

ReferenceCitation: Thompson AM. Ocular toxicity of fluoroquinolones. Clin Exp Ophthalmol. 2007 Aug;35(6):566-77. Review.


title: Evaluation of an Education Program for Patients With Hypermobility Type Ehlers-Danlos Syndrome

acronym: PREDUSED

summary:
The Ehlers-Danlos Syndrome (SED) comprises a group of clinically and genetically heterogeneous, inherited connective tissue diseases. The hypermobility type is the most frequent. It is characterized by a generalized joint hypermobility and a hyperextension skin.

Chronic pain syndrome is often present. Its psychological impact can be significant (anxiety, depression, impact on the quality of life of the patients). The disease also requires changes and a permanent adaptability (coping). It can lead to feelings of isolation and misunderstanding.

The French association of the Ehlers-Danlos Syndromes and the rehabilitation center of the 'Croix-Rouge Française des Massues' propose a patient education program for the patients with a hypermobility type SED (the PrEduSED program). This education program is open to patients and their caregivers located in France.

The research hypothesis is that the PrEduSED program improves their coping and reduces patient anxiety at 6 months (these are the two clinical criteria on which the PrEduSED could have the most impact, given the results of the first sessions).

location_facility: Pôle Information Médicale Evaluation Recherche - Hospices Civils de Lyon


title: Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid? : Multicenter Retrospective Study in France and Switzerland

summary:
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.

In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure.

The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology in a retrospective study from 1 January 2014 to 31 July 2016.

The study will be conducted using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. the investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Comparative Follow-up Schedule With Home Monitoring

acronym: COMPAS

summary: The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).

ReferenceCitation: Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012 May;33(9):1105-11. doi: 10.1093/eurheartj/ehr419. Epub 2011 Nov 29.

family: Mabo

full_name: Philippe Mabo

given: Philippe

family: Victor

full_name: Frédéric Victor

given: Frédéric

family: Bazin

full_name: Patrick Bazin

given: Patrick

family: Ahres

full_name: Saïd Ahres

given: Saïd

family: Babuty

full_name: Dominique Babuty

given: Dominique

family: Da Costa

full_name: Antoine Da Costa

given: Antoine

family: Binet

full_name: Didier Binet

given: Didier

family: Daubert

full_name: Jean-Claude Daubert

given: Jean-Claude

journal_name: European Heart Journal

oa_colors: green hybrid

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)

lead_sponsor: Biotronik France


title: Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.

lead_sponsor: University Hospital, Tours

intervention_type: Behavioral


title: Tele-expertise for Glycemic Control Monitoring in Patients With Diabetes Hospitalized for Covid-19 Infection

acronym: COVIDEX

summary: Diabetes is a major factor of morbi-mortality in Covid-19 infection. Currently, steroid therapy is required in patients under oxygen therapy. This treatment is associated with hyper glycaemia in patients with diabetes. Recommendations for the management of diabetes during Covid-19 infection is to use insulin treatment. The majority of units involves in the management of patient with Covid19 infection are not the experience in managing intensive insulin therapy and the time to ensure this follow-up. All the data in the literature are in favor of a positive impact of telemedicine on the metabolic control of diabetic patients. However, the routine use of telemedicine and more particularly tele-expertise within hospital units is very underdeveloped in France. The epidemic of Covid-19 represents a unique situation where the health authorities recommend to physicians to use telemedicine to ensure the follow-up and optimal management of patients. The aim of this study was to compare the metabolic control of diabetic patients infected with Covid-19 followed in tele-expertise to a group of diabetic patients infected with Covid-19 managed in standard conditions.


title: Evaluation of Effectiveness of Tabac Info Service (EE-TIS)

summary:
Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs).

Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results.

Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.

ReferenceCitation: Affret A, Luc A, Baumann C, Bergman P, Le Faou AL, Pasquereau A, Arwidson P, Alla F, Cambon L. Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. BMJ Open. 2020 Oct 27;10(10):e039515. doi: 10.1136/bmjopen-2020-039515.

family: Affret

full_name: Aurélie Affret

given: Aurélie

family: Luc

full_name: Amandine Luc

given: Amandine

family: Baumann

full_name: Cédric Baumann

given: Cédric

family: Bergman

full_name: Pierre Bergman

given: Pierre

family: Le Faou

full_name: Anne-Laurence Le Faou

given: Anne-Laurence

family: Pasquereau

full_name: Anne Pasquereau

given: Anne

family: Arwidson

full_name: Pierre Arwidson

family: Alla

full_name: François Alla

given: François

family: Cambon

full_name: Linda Cambon

given: Linda

journal_name: BMJ Open

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

ReferenceCitation: Cambon L, Bergman P, Le Faou A, Vincent I, Le Maitre B, Pasquereau A, Arwidson P, Thomas D, Alla F. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial. BMJ Open. 2017 Feb 24;7(2):e013604. doi: 10.1136/bmjopen-2016-013604.

full_name: L Cambon

given: L

full_name: P Bergman

given: P

full_name: Al Le Faou

given: Al

family: Vincent

full_name: I Vincent

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

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

title: Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

lead_sponsor: Ecole des Hautes Etudes en Santé Publique


intervention_type: Biological

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_facility:
Investigational Site Number 2500001
Investigational Site Number 2500002

title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France

summary:
Primary Objective:

To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) is non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at D28, ie, 14 days after the fourth vaccine injection.

Secondary Objective:

To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
To demonstrate that the proportion of subjects in the VRVg-2 + HRIG group achieving an RVNA titer ≥ 0.5 IU/mL at D28 is at least 95%.
To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at D14 (7 days after the third injection), at D28 (14 days after the fourth injection) and at D42 (14 days after the last injection).


title: Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)

acronym: COVER PRO LT

summary: The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.

location_facility: Service d'Accueil des Urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon

location_facility: Service d'Accueil des Urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon


title: Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment: an Ancillary Study of IDEA France Study

summary:
The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy.

Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment).

Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.

ReferenceCitation: Pagès F, André T, Taieb J, Vernerey D, Henriques J, Borg C, Marliot F, Ben Jannet R, Louvet C, Mineur L, Bennouna J, Desrame J, Faroux R, Kirilovsky A, Duval A, Laurent-Puig P, Svrcek M, Hermitte F, Catteau A, Galon J, Emile JF. Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France PRODIGE-GERCOR cohort study. Ann Oncol. 2020 Jul;31(7):921-929. doi: 10.1016/j.annonc.2020.03.310. Epub 2020 Apr 12. Erratum in: Ann Oncol. 2020 Sep;31(9):1276.

family: Pagès

full_name: F. Pagès

given: F.

family: André

full_name: T. André

given: T.

family: Taieb

full_name: J. Taieb

given: J.

family: Vernerey

full_name: D. Vernerey

given: D.

family: Henriques

full_name: J. Henriques

family: Borg

full_name: C. Borg

given: C.

family: Marliot

full_name: F. Marliot

family: Ben Jannet

full_name: R. Ben Jannet

given: R.

family: Louvet

full_name: C. Louvet

family: Mineur

full_name: L. Mineur

given: L.

family: Bennouna

full_name: J. Bennouna

family: Desrame

full_name: J. Desrame

family: Faroux

full_name: R. Faroux

family: Kirilovsky

full_name: A. Kirilovsky

given: A.

family: Duval

full_name: A. Duval

family: Laurent-Puig

full_name: P. Laurent-Puig

given: P.

family: Svrcek

full_name: M. Svrcek

given: M.

family: Hermitte

full_name: F. Hermitte

family: Catteau

full_name: A. Catteau

family: Galon

full_name: J. Galon

family: Emile

full_name: J.-F. Emile

journal_name: Annals of Oncology

evidence: open (via free article)

license: elsevier-specific: oa user license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

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

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group


title: Dose Finding and Early Efficacy Study of Erlotinib in Treatment of Chronic Hepatitis C Virus infection_proof of Concept Study

summary:
Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma world-wide. Current combination therapy of pegylated interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial side effects.

The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM) broadly inhibits HCV infection of all major genotypes including viral escape variants resistant to host immune responses.

Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral approach for prevention and treatment of HCV infection (European patent application EP 08 305 604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature Medicine 2011).

Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a well characterized safety profile in humans, the aim of the study is to investigate the safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in patients chronically infected with HCV. Following completion, this trial will set the stage for a further investigation of entry inhibitors as antivirals in combination with standard of care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical trial will be an important step in the development of novel urgently needed antiviral therapies overcoming resistance.

location_facility: Service d'Hépatogastroentérologie, NHC1, place de l'hôpital


title: The Role of the Living Environment in the Social Inequalities in the Physical Activities of Pregnant Women Residing in the Eurometropole of Strasbourg

acronym: ENVIFEM

summary:
Excessive weight gain during pregnancy can promote subsequent obesity or increase pre-existing maternal obesity, lead to complications during pregnancy, such as gestational diabetes, hypertension and pre-pregnancy eclampsia, which affect fetal growth.

What are the determinants of excessive weight gain? The first determinant of excessive weight gain is related to healthy living place and physical activity, noted as "PA". Many meta-analyses have demonstrated the role of PA in gestational weight gain.

The main objective is to study the role of the living environment in the PA practice of pregnant women and to identify the socio-environmental construction contributing to the disparities in the practice of PA in women during their pregnancy. This thesis is based on an innovative approach in France, combining both epidemiology and geography approaches to meet priority research objectives in a public health context. With regard to the general issue "What are the contextual determinants of pregnant women's PA practice beyond their individual characteristics that could explain the disparities in practice according to their socio-economic position?" This question underlies the following assumptions:

i) In addition to their individual characteristics, women with low PA and who have reduced PA during pregnancy reside in a more socio-economically deprived neighborhood.

ii)Beyond the socio-economic dimension, the physical characteristic of the residential place influences the level of PA practice of pregnant women.

iii) The combination of the socio-economic, physical and psychosocial environment contributes to reducing the level of PA among pregnant women.

iv) Pregnant women with an unfavourable living environment and low PA have adverse pregnancy outcomes.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects

acronym: CCOMET

summary: The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.

lead_sponsor: Central Hospital, Nancy, France

location_facility: Service de Cardiologie Pédiatrique, CHU Brabois Enfants


type: Registry Identifier

title: Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience

acronym: ACI-Coma

summary: Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.

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

location_facility: Institut National de la Santé et de la Recherche Medicale, U825


title: The Role of Social and Territorial Inequalities in the Management and Prognosis of Multiple Sclerosis - Longitudinal Observational Study - INESEP

acronym: INESEP

summary:
Although the majority of the French population is covered by social security, the effects of social inequalities on health are still very visible and are even increasing in France and in Europe. Thus, according to INSEE, excess mortality is observed among the most disadvantaged populations. Similarly, the prevalence of certain chronic diseases in France and Europe, particularly cardiovascular diseases, is linked to social inequalities and excess morbidity can be observed in the most disadvantaged populations.

In addition to social inequalities, which refer to disparities in health levels according to social category, there are the effects of territorial inequalities. In France, there are geographical areas of excess mortality, which essentially correspond to areas far from urban centers. Similarly, there are major geographical differences in terms of medical supply and equipment, and the distance between patients and health centers is a direct obstacle to the use of the health care network.

The underlying explanations for social inequalities in health are multiple. While it is likely that difficulties in accessing and using care play a role, it is also possible that they are due to differences in exposure to certain environmental (e.g. pollution) or individual (e.g. smoking) risk factors. But it is also possible that the causal relationship is the opposite and that diseases create or reveal social inequalities.

For multiple sclerosis (MS) the impact of social and territorial inequalities is more debated. Indeed, with regard to the relationship between disease prevalence and social inequalities, a recent literature review found 21 separate studies on the subject, of which 13 failed to show a link between socioeconomic status and MS risk, 5 concluded that there was an increased risk of MS in advantaged populations and 3 concluded that there was an increased risk of MS in disadvantaged populations. There are plausible pathophysiological explanations for either direction of the relationship, but the question remains open.

To our knowledge, the link between MS prognosis and social inequalities has been little studied, as disadvantaged populations are more often exposed to the poor prognostic factor of smoking [6-8], the hypothesis of a negative prognostic role of social inequalities remains plausible. Similarly, the current consensus is that the diagnosis and treatment of MS should be as early as possible [9,10] in order to preserve brain capital. Easy access to a neurologist and MRI are therefore potentially prognostic factors for MS in relation to territorial inequalities. It should be noted that the link between social and geographical inequalities and a potential delay in treatment has not been demonstrated in France in the case of cancer, but it is possible that the importance of the means implemented in the fight against cancer erases these effects. In MS, a study showed a link between delay in starting a second disease-modifying therapy and socio-economic status.

While the causal link between MS and socio-professional status has not yet been demonstrated, the socio-economic impact of MS has been measured. In particular, it has been shown that having MS is associated with an increased risk of unemployment and/or early retirement.

The primary objective of our study is to determine whether delay in treatment, as a marker of difficulties in access to care in MS, is associated with social and territorial inequalities in MS. Secondary objectives will be to explore the link between MS prognosis and social and territorial inequalities.

Exposure to sunlight is a known protective factor and is consistent with the north-east-south-west gradient observed in France. The choice of centers associated with the research, spread over the French territory, will make it possible to monitor and measure this effect in the prognosis of MS.

As the available treatments have evolved considerably over the last ten years, and in order to avoid a period effect, the patients recruited in the study will have to have a date of onset of the disease after 1 January 2009.

Primary objective Determining the relationship between socio-economic inequalities and the time to start disease-modifying therapy in MS Secondary objective

To determine the relationship between geographical inequalities and delay in starting disease-modifying therapy in MS
To determine the relationship between socio-economic inequalities and time to walking disability (EDSS 4)
To determine the relationship between geographical inequalities and time to walking disability (EDSS 4)
To measure the impact of disability on socioeconomic status in MS patients

location_facility: Service de Neurologie et Maladies inflammatoires du Système nerveux central

location_facility: CIC 1433 Épidémiologie CliniqueInserm, CHRU, Université de Lorraine


title: Evaluation of the Persistence in 2016 of Vaccinal Immunity Against Meningococcus C Among Children and Teenagers Who Received Meningococcus C Conjugate Vaccine in January 2002 During the Puy-de-Dôme Campaign and of Natural Immunity Among Unvaccinated People

summary:
Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European countries, France introduced meningococcus C conjugate vaccine in 2009 but this recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in 2015).

The situation in France is very different from UK and there is no data on the subject. The vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison between vaccinated and unvaccinated people, among which meningococcus circulation could maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and natural immunity among Puy-de-Dôme population.


title: Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study

acronym: NUTRI-REAPED

summary:
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.

As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.

Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.

Secondary objectives:

Determine the children's nutritional status on admission.
Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
Describe the practices regarding nutritional care in each center.

Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.

lead_sponsor: University Hospital, Montpellier


title: Constitution of a Centralized Biological Resources Collection and Associated With a Clinical Database for Childhood Liver Tumors Diagnosed in France (Retrospective Collection From 1990 and Prospective)

acronym: HEPATOBIO

summary: Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.

time_perspective: Other

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty

summary: analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty


title: Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

acronym: Pro-SEPS

summary:
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.

This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)

140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.

The primary outcome is the rate of patients undergoing antibiotic treatment at D5.

Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.

Duration of patient enrollment is 30 days.

primary_purpose: Supportive Care

lead_sponsor: Brahms France

location_facility:
ICU in Ambroise Paré hospital
ICU in Purpan hospital
ICU in Avicenne hospital
ICU in J.Minjoz hospital
ICU in Raymond Poincaré hospital
ICU in St Etienne hospital
ICU in Rangueil hospital
ICU in André Boulloche hospital
ICU in Centre hospitalier général


title: Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study

summary: The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.

location_facility:
Bocage Hospital
Central hospital


title: A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept

acronym: APOLLON

summary:
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).

This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.

lead_sponsor: Bayer


title: Almitrine and Severe COVID-19 Patients in ICU [Almitrine et Patients COVID-19 en Reanimation (French)]

summary:
In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary vasodilation with altered hypoxic pulmonary vasoconstriction (HPV). Besides prone positioning, other non-ventilatory strategies may reduce the intrapulmonary shunt. This study has investigated almitrine, a pharmacological option used in standard care to improve oxygenation.

A case control series of mechanically ventilated confirmed COVID-19 patients was recorded.

At stable ventilatory settings, consecutive patients received two doses of almitrine (4 and 12 mcg/kg/min) at 30-45 min interval each, and were compared to 7 "control" COVID-matched patients conventionally treated.

The end-point was the reduction of intra-pulmonary shunt, with an increase in partial pressure of arterial oxygen (PaO2) and central venous oxygen saturation (ScvO2).

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

family: Chen

full_name: Nanshan Chen

given: Nanshan

family: Zhou

full_name: Min Zhou

given: Min

family: Dong

full_name: Xuan Dong

given: Xuan

family: Qu

full_name: Jieming Qu

given: Jieming

family: Gong

full_name: Fengyun Gong

given: Fengyun

family: Han

full_name: Yang Han

given: Yang

family: Qiu

full_name: Yang Qiu

family: Wang

full_name: Jingli Wang

given: Jingli

family: Liu

full_name: Ying Liu

given: Ying

family: Wei

full_name: Yuan Wei

given: Yuan

family: Xia

full_name: Jia'an Xia

given: Jia'an

family: Yu

full_name: Ting Yu

given: Ting

family: Zhang

full_name: Xinxin Zhang

given: Xinxin

full_name: Li Zhang

given: Li

journal_name: The Lancet

evidence: open (via free pdf)

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

full_name: Fei Zhou

given: Fei

family: Du

ReferenceCitation: Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE.

ReferenceCitation: Payen DM, Gatecel C, Plaisance P. Almitrine effect on nitric oxide inhalation in adult respiratory distress syndrome. Lancet. 1993 Jun 26;341(8861):1664.

ReferenceCitation: B'chir A, Mebazaa A, Losser MR, Romieu M, Payen D. Intravenous almitrine bismesylate reversibly induces lactic acidosis and hepatic dysfunction in patients with acute lung injury. Anesthesiology. 1998 Oct;89(4):823-30.

ipd_sharing_description: Collaborative register on COVID-19 having benn treated with almitrine


title: Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer

summary: Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be performed on 110 patients and the CarolIReS camera will be used preoperatively to localize SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named CarolIReS and their activity will be measured with a gamma ray counter. At the end of surgery, the CarolIReS camera will be used again to check the quality of surgery which will be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective of this study is to evaluate the performances of the CarolIReS camera in assessing the axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the possible correlation between the activity, the size, and the metastatic involvement of the SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve the efficiency of the SLN procedure

lead_sponsor: University Hospital, Strasbourg, France

location_facility: CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique


title: Multidisciplinary Consultation at the GHM Hospital of Grenoble (France) for the Establishment of an Oral Anti-cancer Drug Therapy : Feasibility, Security, and Evaluation of Patients' and City Health Professionals' Satisfaction.

acronym: MinOS

summary:
During the last few years, the medical care of oncohematologic cancers diagnosed patients was shaken by the arrival of new therapies : targeted therapies. Very efficient, these therapies use the oral pathway in most cases, and are taken at home. These treatments show plenty of drug interactions and side effects aren't rare and require, in their own, a rigorous follow up in order to reduce their occurrence, intensity and their impact on patients' quality of life. A bad management of the treatment could lead to an inacceptable toxicity, or to its premature interruption.

With all the new administration and follow up strains in mind, we want to elaborate the medical pathway structure for these patients by reinforcing the nurse coordination and by integrating another healthcare professional : the hospital pharmacist, which is a professional especially implicated in the drug delivery, the control of drug interactions and medical advices relative to the given drug.

Private healthcare professionals (referring physicians, pharmacists, private nurses), unsufficiently trained and informed about these new treatments and their side effects, are asking for further information concerning the drugs prescribed to their patients, and are willing to keep open a communication line for the home follow up.

These patients, who are autonomously taking their medication, are in need to be informed and supported to insure the good management of the drug, while taking in account their environment, their knowledge of their cancer and treatment and also of all the issues that could occur during their therapy, in order to resolve them.

We propose a multidisciplinary medical care taking place at the very beginning of an oral therapy treatment, in order to ensure the security of the drug administration. Patients and healthcare professionals will be closely followed during the first two treatment cycles. After this, side-effects incidence are less frequent and the usual oncohematologic follow up is sufficient.

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lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble