title: Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on the Risk of Multiple Sclerosis Clinical Relapse or Clinical Worsening

acronym: CONFISEP

summary:
Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS.

The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation.

This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France".

A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.

location_facility: Neurology Department, Hopital de la Pitié Salpêtrière


type: Other Identifier

title: Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood. Ancillary Study of the "Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France" Study

acronym: SALTO-SNA

summary:
The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining, in their initial treatment center, all patients (a cohort of 495 patients alive in 2011), diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the Rhône-Alpes and Auvergne regions.

The rationale for this study is based on the observation that although the survival rate of childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are high and greatly increase the risk of mortality in later years (estimated to be 14% in the literature).

The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor of cardiovascular morbidity to the individual.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Grenoble
CHU de Clermont-Ferrand
CHU de Saint-Etienne
IHOP

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom

acronym: RECHARGE

summary:
The successful re-opening of a blocked coronary artery has a beneficial effect on the further clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased heart function, etc.). However, some types of blockages are more difficult to open by means of percutaneous coronary intervention (PCI), a procedure which is commonly used for these kind of problems. This procedure makes use of a technique in which special wires, balloons, stents (metal or polymeric tube-like structures) and devices are utilized to re-open or revascularize a blockage in one of the blood vessels of the heart. This type of blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede the revascularization of the blood vessel.

Nevertheless, remarkable progress has been achieved over the past few years in the area of CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as guidewires, guiding catheters, devices, balloons and stents, as well as different techniques have been developed. However, at present, reluctance to open CTOs still exists, due to the indications and outcomes of percutaneous revascularization as well as the technical difficulties which commonly arise during these interventional procedures. The presence of these difficulties results in suboptimal success rates worldwide (±70-80%), despite these many innovations.

To increase these success rates and to make sure more interventional cardiologists will treat CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™ catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this algorithm. To be able to do this, data concerning the patients' demographics, CTO characteristics, procedure and outcome will be collected in the form of a registry. This registry will be performed in several European centra (Belgium, the Netherlands, United Kingdom, France). Since the study will only collect data and no intervention is performed, this will be an observational study. At regular time points, the data will be checked for errors or inconsistencies. To do this, site visits will be performed at pre-defined times.

ReferenceType: derived

ReferenceCitation: Maeremans J, Dens J, Spratt JC, Bagnall AJ, Stuijfzand W, Nap A, Agostoni P, Wilson W, Hanratty CG, Wilson S, Faurie B, Avran A, Bressollette E, Egred M, Knaapen P, Walsh S; RECHARGE Investigators. Antegrade Dissection and Reentry as Part of the Hybrid Chronic Total Occlusion Revascularization Strategy: A Subanalysis of the RECHARGE Registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom). Circ Cardiovasc Interv. 2017 Jun;10(6). pii: e004791. doi: 10.1161/CIRCINTERVENTIONS.116.004791.

name: From the Faculty of Medicine and Life Sciences, Universiteit Hasselt, Belgium (J.M., J.D.); Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium (J.M., J.D.); Department of Cardiology, Forth Valley Royal Hospital, Edinburgh, United Kingdom (J.C.S., W.W., S.W.); Department of Cardiology, Freeman Hospital, Newcastle upon Tyne, United Kingdom (A.J.B., M.E.); Institute of Cellular Medicine, Newcastle University, United Kingdom (A.J.B., M.E.); Department of Cardiology, VU University Medical...

family: Maeremans

full_name: Joren Maeremans

given: Joren

sequence: first

family: Dens

full_name: Jo Dens

given: Jo

sequence: additional

family: Spratt

full_name: James C. Spratt

given: James C.

family: Bagnall

full_name: Alan J. Bagnall

given: Alan J.

family: Stuijfzand

full_name: Wynand Stuijfzand

given: Wynand

family: Nap

full_name: Alexander Nap

given: Alexander

family: Agostoni

full_name: Pierfrancesco Agostoni

given: Pierfrancesco

family: Wilson

full_name: William Wilson

given: William

family: Hanratty

full_name: Colm G. Hanratty

given: Colm G.

full_name: Simon Wilson

given: Simon

family: Faurie

full_name: Benjamin Faurie

given: Benjamin

family: Avran

full_name: Alexandre Avran

given: Alexandre

family: Bressollette

full_name: Erwan Bressollette

given: Erwan

family: Egred

full_name: Mohaned Egred

given: Mohaned

family: Knaapen

full_name: Paul Knaapen

given: Paul

family: Walsh

full_name: Simon Walsh

family: Smith

full_name: Dave Smith

given: Dave

family: Chase

full_name: Alexander Chase

full_name: William H.T. Smith

given: William H.T.

family: Harcombe

full_name: Alun Harcombe

given: Alun

family: Kayaert

full_name: Peter Kayaert

given: Peter

full_name: Elliot J. Smith

given: Elliot J.

family: Kelly

full_name: Paul Kelly

family: Irving

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility: Universitair Medisch Centrum Utrecht (UMCU)


title: Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France

summary:
Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

The type of vaccine used (bivalent / quadrivalent / nonavalent)
The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

young girls aged 9 years or older with Cystic fibrosis
Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

Knowledge of HPV vaccination coverage in young girls with CF.
Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.

study_start_date_type: Actual

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Ressources et de Compétences de la Mucoviscidose Adultes


title: Study of Memory Problems Perceptions With the French Adaptation of the Illness Perception Questionnaire Memory, Among Patients Who Come for the First Time at a Memory Center Until Diagnosis Disclosure Post-visit

acronym: REMAD

summary: This study aims to prospectively examine the memory problem perceptions of patients with memory complaints [MCs] and their accompaniers during the diagnostic process.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Central Hospital, Nancy, France

location_facility: University Hospital of Nancy ,CHU Brabois, France

intervention_type: Behavioral

status_simplified: Unknown


title: Prophylaxis and On-demand Treatment for Persons With Haemophilia and Other Coagulation Deficiencies: a Comparison of Perceived and Observed Accessibility in the Auvergne-Rhône-Alpes Region (France)

acronym: PHAREO

summary: The current treatment of people with haemophilia and other bleeding deficiencies is largely based on clotting factor replacement therapy. The injections can be repeated several times a week according to a personalized schedule. To date, medications are exclusively dispensed in hospital pharmacies to ensure traceability and safety. This retrocession imposes accessibility constraints on patients and on their caregivers, increasing the burden of the disease, particularly in the organization of personal and professional daily life. The PHAREO study aims to investigate patients' perception of accessibility to anti-haemophilia drugs in relation to an evaluation of spatial accessibility in the Auvergne-Rhône-Alpes region (France) in order to consider, if necessary, ways of improving the pathway for patients and their caregivers.

status: Recruiting

ReferenceType: background

ReferenceCitation: Leroy V, Freyssenge J, Renard F, Tazarourte K, Négrier C, Chamouard V. Access to treatment among persons with hemophilia: A spatial analysis assessment in the Rhone-Alpes region, France. J Am Pharm Assoc (2003). 2019 Nov - Dec;59(6):797-803. doi: 10.1016/j.japh.2019.07.006. Epub 2019 Aug 9.

ReferenceCitation: Susen S, Gruel Y, Godier A, Harroche A, Chambost H, Lasne D, Rauch A, Roullet S, Fontana P, Goudemand J, de Maistre E, Chamouard V, Wibaut B, Albaladejo P, Négrier C. Management of bleeding and invasive procedures in haemophilia A patients with inhibitor treated with emicizumab (Hemlibra(®) ): Proposals from the French network on inherited bleeding disorders (MHEMO), the French Reference Centre on Haemophilia, in collaboration with the French Working Group on Perioperative Haemostasis (GIHP). Haemophilia. 2019 Sep;25(5):731-737. doi: 10.1111/hae.13817. Epub 2019 Jul 11. Review.

ipd_sharing: No

ipd_sharing_description: Patient information is held under legal and ethical obligations of confidentiality. As the disease is rare, information should not be used or disclosed in a form that might identify a patient without his or her consent.

lead_sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

location_facility: Centre Hospitalier Universitaire Grenoble - Alpes

location_facility: Centre Hospitalier Uuniversitaire Nord, Saint-Étienne

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hôpital de la Croix-Rousse, Hospices Civils de Lyon

location_facility: Centre Hospitalier Henri Mondor d'Aurillac

location_facility: Hôpital Edouard herriot, Hospices Civils de Lyon

location_facility: Centre Hospitalier Intercommunal Sud-Léman Valserine

location_facility: Centre Hospitalier de Chambéry - Hôpital Savoie

location_facility: Hôpital Nord Ouest de Villefranche-sur-Saône

location_facility: Pharmacie Centrale, Hospices Civils de Lyon

location_facility: Centre Hospitalier d'Ardèche Méridionale

location_facility: Groupement Hospitalier Est, Hospices Civils de Lyon

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Genetics of Mendelian Forms of Young Onset Alzheimer Disease. Identification of Novel Genetic Causes of AD Are of Importance in Completing the Mechanisms of the Amyloid Hypothesis. This Project is Useful to Promote the Guidelines on the Genetic Diagnosis of AD in France.

acronym: GMAJ

summary:
Genetics of mendelian forms of young onset Alzheimer Disease (GMAJ project)

Introduction : Autosomal dominant forms of Alzheimer disease (AD) are characterized by young age of onset. In France the prevalence was estimated at around 1000 cases. The Phenotypical Expression: There is diversity in phenotypical expression, associating dementia, spastic paraplegia, early extrapyramidal syndrome, ataxia or stroke caused by severe cerebral amyloid angiopathy. Diversity in neuropathological expression is demonstrated by the presence of cotton wool plaques, Lewy bodies with Lewy neurites and severe cerebral amyloid angiopathy.

The study of mendelian forms is decisive in the physiopathological comprehension of AD and related diseases, since the alteration of those genes involved is sufficient to cause the disease. In AD, identification of these genetic causes allows the formulation of the amyloid hypothesis, which is the basis of current therapeutic developments concerning the Ab peptide. Currently three genes (APP, PSEN1, PSEN2) are identified in early onset mendelian forms and their mutations are involved in 80% of the 139 French families, studied since 1993 within the framework of U614 and the National Reference Centre for Alzheimer Disease in young subjects (CNR-MAJ).These results are arguments in favor of the GMAJ project and have two main objectives:

(i) to identify new genes in mendelian AD forms without detectable alteration on known genes.

(ii) to correlate phenotypes and genotypes within families associated with known mutations and extend the description of the phenotypical spectrum.

Population: Families eligible for this study are those with at least 2 individuals with AD criteria (clinical or neuropathological) with onset before 65 years of age. Duration of inclusion is 3 years. This multicentre study groups 23 clinical centres. The inclusion number is 50 new families per year.

Method: Extension and description of families with unknown genetic causes, inclusion of novel families with autosomal dominant AD. The successive steps of the project are the following:

(i) Thorough phenotypical characterization in order to document family history and characterize the probands and affected related subjects according to standardized protocol for clinical, neuropsychological, biological (biomarker determination in plasma and cerebrospinal fluid) and imaging data (MRI, TEMP).

(ii) Identify known genetic causes (PSEN1/2, APP) with novel autosomal dominant families.

(iii) Extend analysis of the pedigrees of families with unknown genetic causes.

(iv) Identify novel genetic causes within these families which are negative for known mutations.

This study uses 3 methods:

pangenomic search is performed for microalterations (Copy Number Variants or CNV) by Comparative Genomic Hybridization (CGH) with high resolution (10 kb on average).
potential targets are then validated by the study of large control populations, intrafamilial cosegregation and functional validation.

the remaining families at the end of this stage will be characterized by means of high throughput sequencing of all exonic areas.

(v) Follow up study of patients and siblings with 2 goals:

evaluation of the disease course and consequences (individual, familial and social);
occurrence of novel AD cases within the family.

(vi) Neuropathological description with potential novel description of atypical AD cases.

Results and consequences: Identification of novel genetic causes of AD are of importance in completing the mechanisms of the amyloidergic hypothesis. This project is useful to promote the guidelines on the genetic diagnosis of AD in France.

lead_sponsor: University Hospital, Rouen


title: Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study

acronym: VacciPrema

summary:
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.

Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.

The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.

design_allocation: Randomized

primary_purpose: Prevention

location_facility: Centre Hospitalier Regional et Universitaire, Maternite Regionale

intervention_type: Biological


title: Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation

summary:
The primary objective of the study is to determine the correlation between mean pleural pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation.

In this research, oesophageal pressure will be measured by a nasogastric tube with an esophageal balloon (also suitable for feeding the patient) usually installed at the time of transplantation, pleural pressure will be measured by several Pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the surgery without additional skin intrusion.

primary_purpose: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Nord Assistance Publique Hôpitaux de Marseille


title: Staphylococcus Aureus Nasal Carriage Among Technical Staff of a Teaching Hospital: An Unexpected Group at Risk of Colonization

acronym: SANAC

summary:
The repeated exposition to S. aureus is considered as a determining factor of acquisition of the nasal colonization. The healthcare professionals are regularly in touch with this pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was the object of several studies but little took into account the respect for the rules of good hygienic practice. The results of our previous study carried out during the international congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between the work in a hospital environment and the increase of the risk of nasal carriage. On the contrary, the use of the hydro-alcoholic solutions had a protective effect against this carriage. However, sized of the health care population of our study was limited.

The goal of this study is to confirm our previous results on a larger cohort of healthcare professionals. The main objective is to estimate the prevalence of nasal carriage according to the professional category and by taking into account the degree of conformity with good hygiene practices including the use of hydro-alcoholic solutions.

location_facility: National Reference Center for Staphylococci, 59 boulevard Pinel


title: Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers

acronym: TABADO

summary:
Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.

Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.

The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.

ReferenceCitation: Minary L, Martini H, Wirth N, Thouvenot F, Acouetey DS, Martinet Y, Bohadana A, Zmirou-Navier D, Alla F. TABADO: "evaluation of a smoking cessation program among adolescents in vocational training centers": study protocol. BMC Public Health. 2009 Nov 13;9:411. doi: 10.1186/1471-2458-9-411.

family: Minary

full_name: Laetitia Minary

given: Laetitia

family: Martini

full_name: Hervé Martini

given: Hervé

family: Wirth

full_name: Nathalie Wirth

given: Nathalie

family: Thouvenot

full_name: Francine Thouvenot

given: Francine

family: Acouetey

full_name: Dovi-Stéphanie Acouetey

given: Dovi-Stéphanie

family: Martinet

full_name: Yves Martinet

given: Yves

family: Bohadana

full_name: Abraham Bohadana

given: Abraham

family: Zmirou-Navier

full_name: Denis Zmirou-Navier

given: Denis

family: Alla

full_name: François Alla

given: François

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Public Health

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: TABADO: "Evaluation of a smoking cessation program among Adolescents in Vocational Training Centers": Study protocol

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


title: Improving Access to Psychiatric Care and the Fluidity of Care Pathways for Patients Suffering From Mental Disorders in Primary Care in France: Evaluation of a Psychiatric Consultation-liaison System

acronym: DSPP-PSY

summary: Getting a consultation with a psychiatrist within an appropriate time is one of the main issues reported by general practitioners (GP) for patients suffering from mental disorders in primary care. Consultation liaison in psychiatry is a system focused on general medicine-psychiatry collaboration. The aim of the present study is to evaluate the impact of the consultation-liaison on the adequacy of the access time to a psychiatric consultation according to the degree of urgency evaluated by the GP.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse


title: Quality of Life of Very Preterm Children With Dysexecutive Disorders at Elementary School Age During the Confinement-deconfinement Period of Covid-19 Pandemic

acronym: GPE-QolVID

summary:
Since March 2020, a new HCoV, SARS-Cov2, originating in China, has been spreading around the world. As of 13 may 2020, almost 4.2 million cases of infections and 292 000 died were reported worldwide (140 000 infection cases and 27 000 died in France). Human coronaviruses (HCoV) usually cause common upper respiratory tract infections in children and sometimes exacerbate lung and asthma diseases.

To minimize the risk of contamination of SARS-Cov2 (Covid-19), the French government has put in place directives that modified the daily lives of students, teachers and families. The societal change imposed by the state of health emergency with a confinement and deconfinement period could strongly impact the quality of life of very preterm children with dysexecutive disorders. These children are a population vulnerable to changes, especially during the pivotal period of elementary school. The executive dysfunctions disrupt children's learning and schooling, as well as their social adaptation, compromising their personal development and therefore, their quality of life.

ipd_sharing: Undecided

location_facility: Assistance Publique des Hopitaux de Marseille


title: Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction.

summary:
To evaluate the prevalence of long-life catheters dysfunction and identify the risk factors associated to premature withdrawal in pediatric population.

For that: retrospective study, during 3 years, in CHU Nancy. Data collection by informatics file after patient agreement. Primary objective: mesure prevalence of long-life catheter dysfunction

Secondary objectives:

identify risk factors associated to premature withdrawals by thrombotic, infectious, accidental, mechanical complications.
mesure de time spent by anethesist to put long-life catheters in emergency. Benefit of creating à vascular access unit.

time_perspective: Retrospective


title: Evaluation of the Acceptability of HPV Self-sampling Among French Women Eligible for Cervical Cancer Screening

summary:
This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling.

These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations

ReferenceType: result

ReferenceCitation: Bertucci M, Bonnet E, Satger L, Kreiche A, Chappert JL, Loy-Morel S, Segondy M, Daurès JP, Boulle N. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Women Health. 2021 Jan;61(1):83-94. doi: 10.1080/03630242.2020.1831683. Epub 2020 Oct 26.

name: Department of Midwifery Studies, University of Montpellier, Montpellier, France

family: Bertucci

full_name: Martina Bertucci

given: Martina

name: UPRES EA2415 Clinical Research University Institute, University of Montpellier, Montpellier, France

family: Bonnet

full_name: Emmanuel Bonnet

given: Emmanuel

name: Department of Gynecology and Obstetrics, CHU Montpellier, Montpellier, France

family: Satger

full_name: Laura Satger

given: Laura

name: Department of Aude, Regional Coordinating Center for Cancer Screening, Occitanie, Carcassonne, France

family: Kreiche

full_name: Antoine Kreiche

given: Antoine

name: Department of Hérault, Regional Coordinating Center for Cancer Screening, Occitanie, Montpellier, France

family: Chappert

full_name: Jean-Loup Chappert

given: Jean-Loup

name: Department of Herault, Association for Breast Cancer Screening in Montpellier-Hérault (AMHDCS), Montpellier, France

family: Loy-Morel

full_name: Silvia Loy-Morel

given: Silvia

name: Pathogenesis and Control of Chronic Infections, University of Montpellier, INSERM, EFS, CHU Montpellier, Montpellier, France

family: Segondy

full_name: Michel Segondy

given: Michel

family: Daurès

full_name: Jean Pierre Daurès

given: Jean Pierre

name: Department of Pathology and Oncobiology, Laboratory of Solid Tumors, CHU Montpellier, Montpellier, France

family: Boulle

full_name: Nathalie Boulle

journal_name: Women & Health

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: University Hospital, Montpellier


title: Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation. A Randomized Double Blind Study

acronym: TMS

summary:
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was shown to be effective in the treatment of major depression.

The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference. Nevertheless, it has been criticized due to poor targeting accuracies attributed to inter-subject variability.

Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy.

Preliminary findings suggest that a more reproductible and accurate method, based upon a neuronavigation system could allow for a better efficacy. This finding has to be replicated with sound methodology.

Investigator's objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method.

primary_purpose: Treatment

lead_sponsor: Rennes University Hospital

location_facility:
CHGR
EPSM Morbihan
Centre Santé Mentale Angevin CESAME
CHU de Brest
Etablissement Public de Santé Mentale

intervention_type: Device


title: Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study

acronym: SACHS

summary:
In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.

In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.

primary_purpose: Health Services Research

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: COllaboration REsearch on Chronic Cough (COREC): a French Multicenter Database

acronym: COREC

summary:
Chronic cough (TC), defined by a duration exceeding 8 weeks, is a particularly frequent symptom with a prevalence observed at 9.6% 1. Chronic cough is the cause of a major handicap for patients with a impact on their quality of life 2.

Although CT is common, management is often delicate and complex. In studies, asthma, gastroesophageal reflux disease, posterior flushing, rhino-sinusitis, or taking tussigenic medications are common causes of chronic coughs. However, chronic refractory or unexplained cough, which corresponds to cough for which no cause has been found or the treatments directed against the cause of the cough have not made it possible to resolve the cough, is a real problem in practice. nick3.

There is currently no prospective data in France on the characteristics of chronic cough (etiologies, response to treatment) and the percentage of refractory cough.

The aim of the study is to constitute a French prospective multicenter hospital cohort of chronic cough patients in order to identify, for the first time in France in a prospective and multicenter manner, the frequency of patients with refractory cough among chronic cough patients.

status: Active, not recruiting


title: Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study

acronym: BADET

summary:
Background: In type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. Therapeutic patient education (TPE) is the key to successful management of the disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the Mediterranean region in France, and the care teams implementing them wish to promote joint reflection with sick teenagers and families to identify needs and expectations of everyone on priority skills to develop, to promote better management of the disease and improved quality of life.

Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions, to promote self-management of their disease and their treatment.

Method: Four audio-recorded focus groups will be organized in all 10 clinical settings (adolescents, parents and health professionals). Thematic analysis will be carried out from the transcript of the focus groups.

Expected results: The results will allow a joint reflection involving the participation of young patients, families, health professionals and the research team to build and implement new educational sessions that meet the identified needs. This action resulting from the research is expected to pool resources in different health facilities providing therapeutic education programs and to harmonize practices.

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Advanced Practice Nurse Intervention Versus Usual Care for Hypertension Control: Study Protocol for an Open-label Randomized Controlled Trial

summary: Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

lead_sponsor: Hotel Dieu University Hospital, France


title: Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over

summary: The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.

time_perspective: Other

lead_sponsor: International Longevity Centre France

location_facility: GERONTOPOLE of the Toulouse University Hospital


title: Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties

acronym: LAMETA

summary: New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

lead_sponsor: Henri Mondor University Hospital

location_facility: Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP


title: Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.

summary: In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.


title: Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs

summary:
Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence.

In France, the pap-smear test is currently the reference test in order to screen for cervical cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality due to cervical cancer by half in the two last decades. That said, many women are still not reached by prevention programs, especially women living in precarious conditions. In 2013, Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old visiting its medical facilities had never had of a pap-smear test.

The main study objectives are :

Primary objective

To compare the proportion of individuals with abnormal cytology across two screening strategies in order to determine which strategy detects a greater proportion of individuals with abnormal cytology.

These two strategies consist of a preventive consultation followed by:

Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) *A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.

First of secondary objectives:

To evaluate the proportion of individuals who completed cervical cancer screening in each study arm in order to determine which strategy resulted in greater screening participation.

The above clarification of the study objectives and the related changes in the study protocole have been approved by the Comité de Protection des Personnes Ile de France IV.

primary_purpose: Screening

ReferenceCitation: Reques L, Rolland C, Lallemand A, Lahmidi N, Aranda-Fernández E, Lazzarino A, Bottero J, Hamers F, Bergeron C, Haguenoer K, Launoy G, Luhmann N. Comparison of cervical cancer screening by self-sampling papillomavirus test versus pap-smear in underprivileged women in France. BMC Womens Health. 2021 May 26;21(1):221. doi: 10.1186/s12905-021-01356-8.

family: Reques

full_name: Laura Reques

family: Rolland

full_name: Camille Rolland

given: Camille

family: Lallemand

full_name: Anne Lallemand

given: Anne

family: Lahmidi

full_name: Najat Lahmidi

given: Najat

family: Aranda-Fernández

full_name: Ezequiel Aranda-Fernández

given: Ezequiel

family: Lazzarino

full_name: Antonio Lazzarino

given: Antonio

family: Bottero

full_name: Julie Bottero

given: Julie

family: Hamers

full_name: Françoise Hamers

given: Françoise

family: Bergeron

full_name: Christine Bergeron

given: Christine

family: Haguenoer

full_name: Ken Haguenoer

given: Ken

family: Launoy

full_name: Guy Launoy

given: Guy

family: Luhmann

full_name: Niklas Luhmann

given: Niklas

journal_name: BMC Women's Health

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: Médecins du Monde


type: Registry Identifier

title: Etude Des séquelles Neurocognitives à Long Terme Des Faibles Doses de Radiation Chez 150 Patients traités Par radiothérapie Dans l'Enfance Pour un hémangiome cutané à l'Institut Gustave Roussy (IGR) Entre 1941 et 1973

acronym: CogRad

summary:
Context: Studies that address specifically the neurocognitive consequences that can be caused by low-dose radiation receiving during the childhood have still to be performed. In this issue, we focus on an investigation with patients who have received radiotherapy for a benign tumor (skin hemangioma), in France.

Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy. These patients have been treated and followed by Gustave Roussy, so their clinical records can be tracked with great accuracy and the ionizing radiation dose to the brain have been estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A total of 150 patients is expected. They will be contacted by letter to explain the purpose and methods of carrying out tests. Two groups will be analysed according to the received ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory, arithmetic, orientation, etc.) will be used.

Expected results: We expect to describe the potential neurocognitive dysfunction or disorder and to identify risk factors and brain structures whose lesions are responsible for the neurocognitive dysfunction or disorder.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

ReferenceCitation: Fragu P, Lemarchand-Venencie F, Benhamou S, François P, Jeannel D, Benhamou E, Sezary-Lartigau I, Avril MF. Long-term effects in skin and thyroid after radiotherapy for skin angiomas: a French retrospective cohort study. Eur J Cancer. 1991;27(10):1215-22.

ReferenceCitation: Ron E, Modan B, Boice JD Jr, Alfandary E, Stovall M, Chetrit A, Katz L. Tumors of the brain and nervous system after radiotherapy in childhood. N Engl J Med. 1988 Oct 20;319(16):1033-9.

ReferenceCitation: Little MP, Hawkins MM, Shore RE, Charles MW, Hildreth NG. Time variations in the risk of cancer following irradiation in childhood. Radiat Res. 1991 Jun;126(3):304-16. Erratum in: Radiat Res 1992 Oct;132(1):126.

ReferenceCitation: Hall P, Adami HO, Trichopoulos D, Pedersen NL, Lagiou P, Ekbom A, Ingvar M, Lundell M, Granath F. Effect of low doses of ionising radiation in infancy on cognitive function in adulthood: Swedish population based cohort study. BMJ. 2004 Jan 3;328(7430):19.

ReferenceCitation: Haddy N, Andriamboavonjy T, Paoletti C, Dondon MG, Mousannif A, Shamsaldin A, Doyon F, Labbé M, Robert C, Avril MF, Fragu P, Eschwege F, Chavaudra J, Schvartz C, Lefkopoulos D, Schlumberger M, Diallo I, de Vathaire F. Thyroid adenomas and carcinomas following radiotherapy for a hemangioma during infancy. Radiother Oncol. 2009 Nov;93(2):377-82. doi: 10.1016/j.radonc.2009.05.011. Epub 2009 Jun 8.

ReferenceCitation: Haddy N, Mousannif A, Paoletti C, Dondon MG, Shamsaldin A, Doyon F, Avril MF, Fragu P, Labbé M, Lefkopoulos D, Chavaudra J, Robert C, Diallo I, de Vathaire F. Radiotherapy as a risk factor for malignant melanoma after childhood skin hemangioma. Melanoma Res. 2012 Feb;22(1):77-85. doi: 10.1097/CMR.0b013e32834dcff1.

ReferenceCitation: Haddy N, Dondon MG, Paoletti C, Rubino C, Mousannif A, Shamsaldin A, Doyon F, Labbé M, Robert C, Avril MF, Demars R, Molinie F, Lefkopoulos D, Diallo I, de Vathaire F. Breast cancer following radiotherapy for a hemangioma during childhood. Cancer Causes Control. 2010 Nov;21(11):1807-16. doi: 10.1007/s10552-010-9607-5. Epub 2010 Jul 7.

ReferenceCitation: Dondon MG, de Vathaire F, Shamsaldin A, Doyon F, Diallo I, Ligot L, Paoletti C, Labbé M, Abbas M, Chavaudra J, Avril MF, Fragu P, Eschwège F. Cancer mortality after radiotherapy for a skin hemangioma during childhood. Radiother Oncol. 2004 Jul;72(1):87-93.

ReferenceCitation: Ligot L, Diallo I, Shamsaldin A, Chavaudra J, BonaIti-Pellié C, de Vathaire F. Individualized phantom based on CT slices and auxological data (ICTA) for dose estimations following radiotherapy for skin haemangioma in childhood. Radiother Oncol. 1998 Dec;49(3):279-85.


summary: The purpose of this study is to describe the cardiovascular risk profile in subjects who consume a marketed drinkable low fat fermented milk enriched with plant sterol. Investigations are lead prospectively and retrospectively among adults enrolled from general practitioners' database.

lead_sponsor: Danone Research


title: Y a T-il Une désensibilisation Pendant le Sommeil après la réception de Violence Verbale ?

acronym: COREV

summary: There is a need for quantify the emotional and neurophysiological perception of verbal violence, in order to understand the impact it might have on a subject. This project aims at assessing the influence of time, sleep, and people interaction on the perception of verbal violence.

ReferenceCitation: Barros A, Uguccioni G, Salkin-Goux V, Leu-Semenescu S, Dodet P, Arnulf I. Simple behavioral criteria for the diagnosis of disorders of arousal. J Clin Sleep Med. 2020 Jan 15;16(1):121-128. doi: 10.5664/jcsm.8136. Epub 2019 Dec 4.

name: AP-HP, Pitié -Salpêtrière Hospital, Sleep Disorders Unit, Paris, France;

name: Centro Hospitalar de Lisboa Central, Lisboa, Portugal;

family: Barros

full_name: Ariana Barros

given: Ariana

family: Uguccioni

full_name: Ginevra Uguccioni

given: Ginevra

family: Salkin-Goux

full_name: Victoire Salkin-Goux

given: Victoire

name: IHU@ICM, Sorbonne University, Paris, France

family: Leu-Semenescu

full_name: Smaranda Leu-Semenescu

given: Smaranda

family: Dodet

full_name: Pauline Dodet

given: Pauline

family: Arnulf

full_name: Isabelle Arnulf

given: Isabelle

journal_name: Journal of Clinical Sleep Medicine

oa_colors: green other

evidence: open (via free pdf)

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

version: submittedVersion

publisher: American Academy of Sleep Medicine (AASM)

lead_sponsor: Centre National de la Recherche Scientifique, France

location_facility: Service des pathologies du sommeil, Hôpital Pitié Salpêtrière


title: Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests As a Tool for Screening and Access to Care Among At-Risk Populations

acronym: OPTISCREEN-III

summary:
This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).

Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.

The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.

ReferenceCitation: Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, Boo N, Dhotte P, Varsat B, Muller G, Cha O, Picard O, Nau J, Campa P, Silbermann B, Bary M, Girard PM, Lacombe K. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol. 2013 Mar;58(3):473-8. doi: 10.1016/j.jhep.2012.11.016. Epub 2012 Nov 23.

ReferenceCitation: Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.

name: Sorbonne Universités, Université Pierre-et-Marie-Curie Paris 06, Institut National de la Sante et de la Recherche Medicale (INSERM), Institut Pierre Louis d’Épidémiologie et de Santé Publique

name: Service de Maladies Infectieuses, Centre Hospitalier Universitaire (CHU) St. Antoine

family: Boyd

full_name: Anders Boyd

given: Anders

name: Laboratoire de Virologie, CHU St. Antoine

name: INSERM U1135 Centre d'Immunologie et des Maladies Infectieuses

family: Gozlan

full_name: Joel Gozlan

given: Joel

name: Département de Santé Publique, Hôpital St-Antoine, Assistance Publique-Hôpitaux de Paris

family: Carrat

full_name: Fabrice Carrat

given: Fabrice

name: Médecins du Monde, Centre d'Accueil de Soins et d'Orientation

family: Nau

full_name: Jean Nau

given: Jean

name: Médecins du Monde, Direction des Missions France, Paris, France

family: Pauti

full_name: Marie-Dominique Pauti

given: Marie-Dominique

family: Rougier

full_name: Hayette Rougier

given: Hayette

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Lacombe

full_name: Karine Lacombe

given: Karine

currency_apc_doaj: USD

journal_name: Open Forum Infectious Diseases

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

ipd_sharing: Yes

ipd_sharing_description: Data will be shared under the following conditions: (1) interested parties must submit a request for data access to the principal investigator and (2) the request is approved by the Scientific Committee.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility: Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)


title: Frequency, Consequences and Determinants of Sub-optimal Care in the Initial Care of Severe Bacterial Infections of the Child

acronym: Diabact

summary: The aim of the study is to determine the frequency of sub-optimal care in the initial care (before arrival at the intensive care unit) of children from "West France regions" suffering of severe bacterial infections.The characteristic "optimal or not" of the initial medical care will be determined by 2 independent experts, blinded from each other and blinded from the issue of the care. In case of a discordance between the two experts, a third expert will be demanded. Three possibilities of conclusion will be proposed to the experts: "sure sub-optimal medical care", "possible suboptimal care" and "optimal care".

lead_sponsor: Nantes University Hospital


title: Survey on Use and Characteristics of Definitive Contraception With ESsure®

acronym: SUCCES II

summary: Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.

lead_sponsor: Bayer


title: An Evaluation of Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Severely and Morbidly Obese Patients Undergoing BARiatric Surgery (CEFOBAR)

acronym: CEFOBAR

summary:
Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.

Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.

The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Drug


title: Evaluation of the Effect of tDCS on Cannabis Craving: Multicentre Randomized, Double-blind Study Versus Placebo

acronym: TCC

summary:
Cannabis is the most frequently consumed drug in France and its use continues to increase. Over the 18-64 age group as a whole, experimentation with cannabis at least once in a lifetime increased from 33% in 2010 to 42% in 2014, confirming the upward trend observed since the 1990.

Cannabis, like all drugs, disrupts the reward circuit whose neurons originate in the ventral tegmental area and project into the mesolimbic and cortical structures.

Acute cannabis use is thought to increase mesolimbic dopamine by affecting the Gabaergic or Glutamatergic system.

Chronic cannabis use usurps the reward system and leads to changes in the mesolimbic circuit (nucleus accumbens, ventral tegmental area, amygdala, and prefrontal cortex), inducing increased craving, with persistent craving for the substance and vulnerability to relapse.

Cognitively, addiction is associated with increased impulsivity, with a propensity to take risks leading to impaired decision-making.

There is currently no validated drug treatment for cannabis addiction. Non-invasive brain stimulation could be an interesting therapeutic alternative.

lead_sponsor: Januel


title: Development and Validation of a Regional Multi-scale System in Ile-de-France for the Prediction of the Patient Flow in the Emergency Department and the Need for Hospitalization

acronym: PRED-URG

summary: The main objective of this retrospective study is to validate a prediction system of emergencies department (ED) attendance on a wide range of time and the need for hospitalization, at various levels of perimeter (with all emergency departments or one ED in particular), with all patients or with one sub-group of patients (age, gravity, care).

study_start_date_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Emergency Department - Bry sur Marne Hospital


title: Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners

summary: This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.


title: FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)

acronym: FZR

summary: The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

ipd_sharing_description: The data will remain with the sponsor (Arcothova)

lead_sponsor: Arcothova

location_facility: Hôpital Européen Georges Pompidou, AP-HP


title: Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.

acronym: AHF-CODE

summary:
Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .

Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical.

intervention_type: Procedure


title: Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?

acronym: OPTISCREEN-B

summary:
With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.

In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.

The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.

ReferenceCitation: Bottero J, Boyd A, Gozlan J, Carrat F, Lemoine M, Rougier H, Varsat B, Boo N, Charlois-Ou C, Collignon A, Cha O, Campa P, Dhotte P, Girard PM, Lacombe K. Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study. Eur J Gastroenterol Hepatol. 2016 Jun;28(6):633-9. doi: 10.1097/MEG.0000000000000620.

family: Bottero

full_name: Julie Bottero

given: Julie

full_name: Joël Gozlan

given: Joël

family: Lemoine

full_name: Maud Lemoine

given: Maud

family: Varsat

full_name: Brigitte Varsat

given: Brigitte

family: Boo

full_name: Nicolas Boo

given: Nicolas

family: Charlois-Ou

full_name: Cécile Charlois-Ou

given: Cécile

family: Collignon

full_name: Anne Collignon

given: Anne

family: Cha

full_name: Olivier Cha

given: Olivier

family: Campa

full_name: Pauline Campa

family: Dhotte

full_name: Philippe Dhotte

given: Philippe

journal_name: European Journal of Gastroenterology & Hepatology

oa_host_type: repository

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

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

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing_description: Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.

location_facility: Centre d'examen de santé de la CPAM, antenne rue du Maroc

location_facility: Consultation Voyage de l'hôpital Saint-Antoine

location_facility: Consultation Policlinique de l'hôpital Saint-Antoine


title: The Impact of the SARS CoV-2 Lockdown Policy on Spontaneous Premature Birth at the Regional University Maternity Hospital of Nancy

acronym: CONFINéo

summary:
Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation.

It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed.

The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure.

During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region.

Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.

status: Enrolling by invitation

location_facility: Maternite Regionale Universitaire CHRU NANCY


title: Effects of Auditory Fatigue in Medical Regulation Assistants Working With Headset: Objective Measures

acronym: EchoSam

summary:
Auditory monitoring of employees is currently based on pure-tone audiometry. However, this clinical examination does not prevent from deafness but established it a posteriori. From a preventive standpoint, it is important to detect hearing professional pain before the development of irreversible(s) clinical(s) symptom(s). The investigators' hypothesis is that auditory fatigue results from damages of primary and secondary central auditory pathways involving cognitive processes.

The assessment of auditory fatigue includes the evaluation of speech intelligibility, short-term memory, working memory and perceived mental task load. The main objective of this study is to identify, among regulating medical assistants working with headset, a central auditory fatigue.


title: Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety

acronym: COLCHICORT

summary:
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.

International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.

The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease.

Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.

Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment.

Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population.

Oral steroids are an interesting alternative in this indication with a potential of being better tolerated, but comparative efficacy with colchicine needs to be studied.

From a broader point of view, colchicine and oral steroids have never been compared in any crystal related arthritis.

This is the first large randomized controlled trial for CPPD acute arthritis.

lead_sponsor: Lille Catholic University

location_facility:
CHRU Lille
Dr Rémi LEROY
Hôpital Bichat
Dr Nicolas SEGAUD
CH Valenciennes
Lille Catholic Hospital
Hôpital de Lariboisière


title: Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards

summary: Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.

ReferenceCitation: de Lastours V, Chau F, Tubach F, Pasquet B, Ruppé E, Fantin B. Independent behavior of commensal flora for carriage of fluoroquinolone-resistant bacteria in patients at admission. Antimicrob Agents Chemother. 2010 Dec;54(12):5193-200. doi: 10.1128/AAC.00823-10. Epub 2010 Sep 27.

name: Department of Internal Medicine, Beaujon Hospital, Assistance-Publique Hôpitaux de Paris, Clichy, France

name: EA3964 Laboratory and Medical School, Paris Diderot University, Paris, France

family: de Lastours

full_name: Victoire de Lastours

given: Victoire

family: Chau

full_name: Françoise Chau

given: Françoise

name: Department of Epidemiology, Statistics and Clinical Research, Bichat Hospital, Assistance-Publique Hôpitaux de Paris, Paris, France

family: Tubach

full_name: Florence Tubach

given: Florence

family: Pasquet

full_name: Blandine Pasquet

given: Blandine

family: Ruppé

full_name: Etienne Ruppé

given: Etienne

family: Fantin

full_name: Bruno Fantin

given: Bruno

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Independent Behavior of Commensal Flora for Carriage of Fluoroquinolone-Resistant Bacteria in Patients at Admission

lead_sponsor: Association Pour le Recherche en Infectiologie et en Médecine Interne


type: Other Grant/Funding Number

title: Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial

acronym: PERFID

summary: The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators hypothesized that the number of attempts to a successful placement of a peripheral IV, our primary outcome, would be shorter with the assistance of the Accuvein V400. It is also expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the technique-related pain.

location_facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France


title: Retrospective Study on Sexual Health in the Aftermath of an Obstetric Lesion of the Anal Sphincter

acronym: LOSA

summary:
Lesions of the anal sphincter complicate 0.8% of childbirth in France. The sexual health of patients following this type of lesion is little studied, there are only about twenty articles on the subject.

The objective of this search is to study of the obstetric lesions of the anal sphincter

status: Not yet recruiting

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg


title: A Survey of Best Practices of Abortions at Strasbourg University Hospitals

summary: The number of abortions in France and Strasbourg has been stable for several years. In 2017, 1847 were performed in the Gynecology-Obstetrics Department for 6146 deliveries (23% of all pregnancies). It therefore seems important to evaluate the professional practices, but also the experiences of the patients.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Characterization of New Candidate Genes in Cases of Human Inherited Thrombocytopenia (CATCH). Molecular Etiologies in Cases of Thrombocytopenia

acronym: CATCH

summary:
Circulating blood platelets are small cellular elements that help to control bleeding (a process called hemostasis) and to avoid hemorrhage when blood vessels are injured. Platelets originate from cells in the bone marrow, the megakaryocytes (MKs), following a complex process of morphological transformation and maturation, which finally leads to the production of blood platelets. Multiple genes are implicated in this process. Constitutive thrombocytopenia (CT) are rare hematological diseases characterized by a decreased number of circulating platelets that are often larger than normal, that may lead to more or less severe hemorrhagic events. However, CT can be difficult to diagnose and differentiate from various forms of acquired thrombocytopenia. The ultimate diagnosis for CT is thus based on the molecular diagnosis, obtained by identifying and characterizing the abnormal gene and protein. About 40 genes / proteins have been identified so far as causal in CT, however, in about half of the patients suspected to have CT, genomic analysis does not detect a variant in one of these genes, and etiology of CT thus remains unknown. But insuring the diagnosis of CT is important: it will avoid misdiagnosis and inefficient or deleterious therapeutic interventions, while allowing a proposal of an adapted curative/preventive medical action. At the Resource and Competence Center for Constitutional Hemorrhagic Diseases (CRCMHC) (University Hospital Robert Debré, Paris, France), the investigating team has evidenced in unrelated patients presenting with familial forms of thrombocytopenia and no known molecular diagnosis, variants of genes not yet described as formally implicated in the occurrence of CT. Molecular genetic evidence must be completed by functional studies. Such functional studies are conducted in a research laboratory from the National Institute for Health and Medical Research (Inserm), "Innovative Therapies in Haemostasis (IThEM)" (Faculty of Medical Sciences, University of Paris, Paris, France), and include:

an evaluation of how blood progenitor cells mature into MKs, by comparing cells obtained from patients to those of members free of the disease (the latter taken as normal control subjects);
an evaluation of platelet functionalities, such as ability to form a blood clot similar to what happens during hemostasis, with the aim to detect not only quantitative (number and size) but also any qualitative (functions) defects;
an evaluation of the ultrastructure (the structure of intracellular components) and biochemistry of MKs and platelets, focusing on the molecular pathways the variant protein is implicated in.

This clinical trial is aimed to precisely delineate the mechanism of action of newly identified CT genetic variants, and will fulfill the aims of (1) offering the patient(s) a formal molecular diagnosis of CT, (2) ameliorating patients' medical support, both for diagnosis and therapy, (3) providing patients and family members with a pertinent genetic counseling, and (4) expanding the validated panel of genes implicated in CT to be explored in new suspected cases of CT. It will also help in extending the basic knowledge of the process of MK and platelet formation.

ReferenceCitation: Vincenot A, Saultier P, Kunishima S, Poggi M, Hurtaud-Roux MF, Roussel A, Actn Study Coinvestigators, Schlegel N, Alessi MC. Novel ACTN1 variants in cases of thrombocytopenia. Hum Mutat. 2019 Dec;40(12):2258-2269. doi: 10.1002/humu.23840. Epub 2019 Nov 6.

ReferenceCitation: Boutroux H, David B, Guéguen P, Frange P, Vincenot A, Leverger G, Favier R. ACTN1-related Macrothrombocytopenia: A Novel Entity in the Progressing Field of Pediatric Thrombocytopenia. J Pediatr Hematol Oncol. 2017 Nov;39(8):e515-e518. doi: 10.1097/MPH.0000000000000885.

ReferenceCitation: Guillet B, Bayart S, Pillois X, Nurden P, Caen JP, Nurden AT. A Glanzmann thrombasthenia family associated with a TUBB1-related macrothrombocytopenia. J Thromb Haemost. 2019 Dec;17(12):2211-2215. doi: 10.1111/jth.14622. Epub 2019 Sep 29.

ReferenceCitation: Balduini CL, Melazzini F, Pecci A. Inherited thrombocytopenias-recent advances in clinical and molecular aspects. Platelets. 2017 Jan;28(1):3-13. doi: 10.3109/09537104.2016.1171835. Epub 2016 May 9. Review.

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

location_facility: Resource and Competence Center for Constitutional Hemorrhagic Diseases (CRCMHC), University Hospital Robert Debré

location_facility: Resource and Competence Center for Constitutional Hemorrhagic Diseases (CRCMHC), University Hospital Pontchaillou

intervention_type: Diagnostic Test


title: G Protein Coupled Receptor (GPCR)Signature as Biomarker of Chronic Pulmonary Inflammatory Diseases and of Therapeutic Follow-up

summary: The G protein-coupled receptors (GPCRs) are a family of proteins expressed at the cell membrane. They are composed of 380 members involved in the important functions of the organism and are privileged therapeutic targets.Their expression is highly modulated depending on the metabolic state of the cells, in particular in pathological situations.our study proposes to determine whether GPCR expression modulation could be used as a biomarker, either prognostic or diagnostic, of treatments.To do so , the investigators will determine the expression profile of the 380 human GPCRs in human blood cell samples in two chronic inflammatory pulmonary diseases : asthma and COPD (chronic obstructive pulmonary disease ) . These have opposed inflammatory infiltrates : asthma is associated with eosinophil and Th2 lymphocyte infiltration whereas COPD shows neutrophils and macrophages within the airways with a Th1 lymphocytic population. The GPCR signature (transcriptomic) will be determined on total white blood cells as well as on isolated mono- and poly-nuclear populations obtained from healthy subjects and patients selected at the asthma or COPD consultation. The expression profiling analysis will reveal sub-groups of GPCRs whose expression is modified in disease. The specificity of the variation of expression of these biomarker sub-populations will be determined, by a study recruiting a hundred patients and controls per disease on this restraint number of genes. The outcomes of the project will lead to establish GPCR "identity cards" for these chronic inflammatory diseases, which might therefore be used as diagnostic or prognostic biomarkers to follow the evolution of a disease or the efficacy of a given treatment. In addition, detailed analysis of the identified GPCRs will lead to propose new therapeutic targets for inflammatory diseases. This study has therefore the objective of validating GPCRs as potential biomarkers for inflammatory diseases.

ReferenceCitation: Gras D, Martinez-Anton A, Bourdin A, Garulli C, de Senneville L, Vachier I, Vitte J, Chanez P. Human bronchial epithelium orchestrates dendritic cell activation in severe asthma. Eur Respir J. 2017 Mar 8;49(3). pii: 1602399. doi: 10.1183/13993003.02399-2016. Print 2017 Mar.

family: Gras

full_name: Delphine Gras

given: Delphine

family: Martinez-Anton

full_name: Asuncion Martinez-Anton

given: Asuncion

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Garulli

full_name: Celine Garulli

given: Celine

family: de Senneville

full_name: Laure de Senneville

given: Laure

family: Vachier

full_name: Isabelle Vachier

given: Isabelle

family: Vitte

full_name: Joana Vitte

given: Joana

family: Chanez

full_name: Pascal Chanez

given: Pascal

journal_name: European Respiratory Journal

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

location_facility:
University Hospital, Strasbourg, France
Hospital
Pascal Chanez
Antoine Magnan
University Hospital


title: Predictive Value of Innovative Prognostic Markers (Gut Microbiota, Sarcopenia, Metabolic Syndrome and Obesity) on Surgical and Oncologic Results in the Management of Sporadic Colorectal Adenocarcinoma.

acronym: METABIOTE

summary:
Colorectal cancer (CRC), second leading cause of cancer worldwide, is associated with a poor prognosis, especially in patients with advanced disease. Therefore, there is still a need to develop new prognostic tools to replace or supplement those routinely used, with the aim to optimize treatment strategies.

Studies on gut microbiota composition provide new strategies to identify powerful biomarkers. Indeed, beyond its beneficial functions for the host, increasing evidences suggest that gut microbiota is a key factor involved in CRC carcinogenesis. Many clinical studies have described an imbalance in the gut microbiota (dysbiosis) in CRC patients, with the emergence of pathogenic bacterial species, Recent studies reported that pks-positive E. coli, a pathogenic bacterial producing toxin encoded by the pks genomic island, is more frequently detected in CRC patients, suggesting a possible role in tumor development. Therefore, this suggests the potential use of microbial signatures associated with CRC for prognostic assessment. Furthermore, influence of body composition profile (BMI, sarcopenia, metabolic syndrome) also appears to be a new relevant prognostic tool regarding surgical and oncological outcomes following CRC surgery.

The aim of this translational research project is to study the impact of these new prognostic tools on surgical and oncologic results in a prospective cohort of patients who underwent CRC surgery at the Digestive Surgery Department of the University Hospital of Clermont-Ferrand (France). This could allow to optimize treatment strategies and provide new ways to identify news promising biomarkers associations in order to better define high risk patients. Investigators aim to identify specific microbial signatures associated with some metabolic profiles in order to improve surgical morbidity and/or response to cancer therapies.

ReferenceCitation: Veziant J, Poirot K, Chevarin C, Cassagnes L, Sauvanet P, Chassaing B, Robin F, Godfraind C, Barnich N, Pezet D, Pereira B, Gagniere J, Bonnet M. Prognostic value of a combination of innovative factors (gut microbiota, sarcopenia, obesity, metabolic syndrome) to predict surgical/oncologic outcomes following surgery for sporadic colorectal cancer: a prospective cohort study protocol (METABIOTE). BMJ Open. 2020 Jan 7;10(1):e031472. doi: 10.1136/bmjopen-2019-031472.

family: Veziant

full_name: Julie Veziant

given: Julie

family: Poirot

full_name: Karine Poirot

given: Karine

family: Chevarin

full_name: Caroline Chevarin

given: Caroline

family: Cassagnes

full_name: Lucie Cassagnes

given: Lucie

family: Sauvanet

full_name: Pierre Sauvanet

given: Pierre

family: Chassaing

full_name: Benoit Chassaing

given: Benoit

family: Robin

full_name: Frederic Robin

given: Frederic

family: Godfraind

full_name: Catherine Godfraind

given: Catherine

family: Barnich

full_name: Nicolas Barnich

given: Nicolas

family: Pezet

full_name: Denis Pezet

given: Denis

family: Pereira

full_name: Bruno Pereira

family: Gagniere

full_name: Johan Gagniere

given: Johan

family: Bonnet

full_name: Mathilde Bonnet

given: Mathilde

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prevalence and Characteristics of Dental and Periodontal Lesions in Patients With Sjögren's Syndrome. Establishment of a Biological Saliva Collection.

acronym: CB-SJO

summary:
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands.The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been shown in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, although this has not been clearly identified in the literature.

Our main objective is to assess the prevalence of dental wear and gingival recession in patients with Sjögren's syndrome by analyzing of the Basic Erosive Wear Examination (BEWE) score for erosions, Basic Erosive Wear Abrasion (BEWA) score for attrition and percentage of sites with periodontal recessions greater than 3 mm in relation to the total number of sites.

Our secondary objectives are to investigate a correlation between the prevalence of dental and gingival wear, gingival inflammation, Decayed, Missing, and Filled Teeth (DMFT) index and (1) salivary parameters and (2) oral quality of life.

The salivary samples will be kept in a biological collection within the URP2496 for later analysis (biological collection CB-SJO).

ipd_sharing_description: The data (age, medical history, medication, dental brushing habits, tobacco consumption, periodontal charting, number of decayed teeth, number of teeth with fillings, number of missing teeth, BEWE score, salivary data, OHIP-14 and Xerostomia Inventory score) will be collected by the investigator on the Orbis medical record or on the paper CRF. They will be transferred by the investigator of the service or a co-investigator of the service on an anonymized excel database and will be sent by secured link for repatriation to the laboratory URP2496.


title: Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

acronym: PRAISE

summary:
This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life.

The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.


title: Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen

acronym: Thermasport

summary:
Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns young sportsmen. Consequences are limitation in physical and sporting activities and at work.

Main objective: to compare water and traditional rehabilitation after cruciate ligament injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities development.

ReferenceCitation: Peultier-Celli L, Mainard D, Wein F, Paris N, Boisseau P, Ferry A, Gueguen R, Chary-Valckenaere I, Paysant J, Perrin P. Comparison of an Innovative Rehabilitation, Combining Reduced Conventional Rehabilitation with Balneotherapy, and a Conventional Rehabilitation after Anterior Cruciate Ligament Reconstruction in Athletes. Front Surg. 2017 Nov 7;4:61. doi: 10.3389/fsurg.2017.00061. eCollection 2017.

family: Peultier-Celli

full_name: Laetitia Peultier-Celli

given: Laetitia

family: Mainard

full_name: Didier Mainard

given: Didier

family: Wein

full_name: Frank Wein

given: Frank

family: Paris

full_name: Nicolas Paris

family: Boisseau

full_name: Patrick Boisseau

given: Patrick

family: Ferry

full_name: Alexandre Ferry

given: Alexandre

family: Gueguen

full_name: René Gueguen

given: René

family: Chary-Valckenaere

full_name: Isabelle Chary-Valckenaere

family: Paysant

full_name: Jean Paysant

given: Jean

family: Perrin

full_name: Philippe Perrin

given: Philippe

journal_name: Frontiers in Surgery

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers


title: Descriptive Study of Emergency Room Visits From Nursing Home Residents for Behavioral Problems at the Nancy University Hospital: Place of the Advanced Practice Nurse

summary: The demographic evolution of old age is a reality. After the age of 75, 2 out of 3 people living in institutions have neurocognitive disorders. Behavioural disorders such as physical aggression, agitation, hallucinations, sleep disorders, generate difficulties in the management of these patients and lead to unscheduled emergency hospitalizations. Non-pharmacological management of behavioral disorders is recommended as a first-line treatment because of its low risk and potential improvement (Haute Autorité de Santé 2009). However, this management is not simple and obvious to put in place, especially since not all elderly people with Behavioural disorders are in adapted structures. The advanced practice nurse specializing in geriatrics has a place in this care pathway. Because of her skills, she could "organize multi-professional care, set up analyses of practices within the nursing homes, train caregivers appropriately, and limit hospitalizations due to behavioral problems" (SALIEGE L. 2020). Advanced practice nursing is in its infancy in France, and everything remains to be done (International Council of Nurses- directive). The aim of the study is to identify the number of emergency room visits by people aged 75 and over for behavioral problems in nursing home during a 6 month-period.


title: Efficiency in Population of Influenza Vaccination for Flu Prevention of the Hospitalized Adults

acronym: FLUVAC EV-03

summary:
This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France.

Also, To better understand the burden of other respiratory viruses such as respiratory syncytial virus (RSV) and SARS-CoV-2 in hospitalized adults, we need to describe and quantify the population hospitalized due to theses other respiratory viruses.

location_facility: Institut National de la Santé Et de la Recherche Médicale


title: Belgo-France Physician-initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System for the Treatment of Iliac Lesions (TASC A, B, C and D)

acronym: BeGraft+PMCF

summary: The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients with TASC C and D lesions will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6 and 12 month post-procedure. The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1 and 6 month, stent graft occlusion rate at pre-discharge, 1, 6 and 12 month follow-up, anke-brachial index (ABI) at 1, 6 and 12-month follow-up, amputation rate at 1, 6 and 12-month follow-up, performance success rate, freedom from target lesion revascularization (TLR), technical success and clinical success at 1, 6 and 12-month follow-up.

lead_sponsor: ID3 Medical

location_country: Belgium France

location_facility:
az Groeninge
RZ Heilig Hart
CHU de Nantes
A.Z. Sint-Blasius
O.L.V. Hospital
ZOL
ZNA
Imelda Hospital
AZ Jan Portaels


title: Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in Daily Clinical Practice - A French Cohort Within the Nationwide Claims and Hospital Database

acronym: BROTHER

summary: The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran

ReferenceCitation: Fauchier L, Blin P, Sacher F, Dureau-Pournin C, Bernard MA, Lassalle R, Droz-Perroteau C, Dallongeville J, Moore N. Reduced dose of rivaroxaban and dabigatran vs. vitamin K antagonists in very elderly patients with atrial fibrillation in a nationwide cohort study. Europace. 2020 Feb 1;22(2):205-215. doi: 10.1093/europace/euz285.

name: Service de Cardiologie, Centre Hospitalier, Universitaire Trousseau et Faculté de Médecine, Université François Rabelais, Centre Hospitalier Universitaire Trousseau, Tours, France

family: Fauchier

full_name: Laurent Fauchier

given: Laurent

name: Bordeaux PharmacoEpi, INSERM CIC 1401 Université de Bordeaux, CHU de Bordeaux, Bordeaux, France

family: Blin

full_name: Patrick Blin

name: IHU LIRYC, Univ. Bordeaux, INSERM 1045, Bordeaux, France

name: Service de Cardiologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

family: Sacher

full_name: Frédéric Sacher

given: Frédéric

family: Dureau-Pournin

full_name: Caroline Dureau-Pournin

given: Caroline

family: Bernard

full_name: Marie-Agnès Bernard

given: Marie-Agnès

family: Lassalle

full_name: Regis Lassalle

given: Regis

family: Droz-Perroteau

full_name: Cécile Droz-Perroteau

given: Cécile

name: INSERM U1167, Institut Pasteur, Lille, France

family: Dallongeville

full_name: Jean Dallongeville

name: INSERM U1219, Université de Bordeaux, Bordeaux, France

family: Moore

full_name: Nicholas Moore

given: Nicholas

journal_name: EP Europace


title: A retrospecTive and Prospective Non-Interventional Study to Assess the Clinical pracTice in Real Life for Patients With Wet AMD Refractory to raNibizumab and Switching to Aflibercept

acronym: TITAN

summary:
The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.

The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab

ReferenceCitation: Razavi S, Kodjikian L, Giocanti-Aurégan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.

family: Razavi

full_name: Sam Razavi

given: Sam

family: Kodjikian

full_name: Laurent Kodjikian

family: Giocanti-Aurégan

full_name: Audrey Giocanti-Aurégan

given: Audrey

family: Dufour

full_name: Ingrid Dufour

given: Ingrid

family: Souied

full_name: Eric Souied

given: Eric

journal_name: BMC Ophthalmology


title: The Issue of Late Recourse to HIV Testing. A Study of the Psychosocial Factors at Play Within Men Who Have Sex With Men in France.

acronym: ReTarD

summary:
The present study will try to investigate and analyze the psycho-social hindrances and levers concerning the recourse to late HIV testing among the MSM population.

This study is divided in two parts. The first one will consist of individual and groups interviews. Then, depending on the items that will rise from the first part of the study, groups interview will take place based on theses items. Finally, a questionnaire build from the collected information will be sent to MSM community in order to obtain quantitative results.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility:
Hopital Saint-Antoine
Le 190
Hôpital Bichat Claude-Bernard
Hôpital Pitié-Salpêtrière


title: Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study

acronym: ADHOMY

summary:
Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.

This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France.