title: Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)

summary: Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia. To date, no study assessed how these guidelines are followed in clinical practice. This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).


title: Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections

summary:
3rd generation cephalosporins (C3G) are the antibiotics recommended in probabilistic in most enteric infections in France including pyelonephritis and bacteraemia.

However, the prevalence of resistance of Enterobacteriaceae including E. coli to C3G is continuously increasing for several years. In 2012, in France, the proportion of E. resistant or intermediate coli categorized to C3G is 10 to 25% (EARSS data).

Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for patients in terms of morbidity and mortality and unnecessary prolongation of the DMS.

At St. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.

To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test for detection of resistance to C3G.

The Lacta ™ test could be used in this indication. This is a rapid test diagnostic orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic action of ESBL, cAMP-type cephalosporinases and carbapenemases. This test was initially marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial colonies in culture.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Mizrahi A, Naouri D, Hobson C, Amzalag J, Pilmis B, Couzigou C, Ganansia O, Le Monnier A. Impact of the beta-lacta test on the management of urinary tract infections at the emergency department. Infect Dis (Lond). 2021 Jan;53(1):52-60. doi: 10.1080/23744235.2020.1822543. Epub 2020 Sep 22.

name: Service de Microbiologie clinique, Groupe Hospitalier Paris Saint-Joseph, Paris, France

name: Institut Micalis UMR 1319, Université Paris-Saclay, INRAe, AgroParisTech, Châtenay Malabry, France

family: Mizrahi

full_name: Assaf Mizrahi

given: Assaf

sequence: first

name: Service des Urgences, Groupe Hospitalier Paris Saint-Joseph, Paris, France

family: Naouri

full_name: Diane Naouri

given: Diane

sequence: additional

name: Equipe mobile de Microbiologie clinique, Groupe Hospitalier Paris Saint-Joseph, Paris, France

family: Hobson

full_name: Claire Hobson

given: Claire

family: Amzalag

full_name: Jonas Amzalag

given: Jonas

family: Pilmis

full_name: Benoît Pilmis

given: Benoît

name: Comité de Lutte contre les Infections Nosocomiales, Groupe Hospitalier Paris Saint-Joseph, Paris, France

family: Couzigou

full_name: Carine Couzigou

given: Carine

family: Ganansia

full_name: Olivier Ganansia

given: Olivier

family: Le Monnier

full_name: Alban Le Monnier

given: Alban

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Infectious Diseases

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

lead_sponsor_type: academique

status_simplified: Completed


title: Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study

acronym: VELONAPS

summary:
Physical inactivity and sedentary are recognized as important risks factors for several diseases and total mortality. One of the main perceived barriers to physical activity is the lack of time and motivation. Active commuting during daily routine could overcome these barriers and e-bikes appears to be a promising and practical tool to meet physical activity guidelines.

E-bikes are a physically active transportation mode, with a riding intensity contributing to activities in the moderate-intensity range (3-6 METs) for any of the assistance mode. Electric assistance is provided only when a rider is pedaling. The study VELONAPS mainly aims at investigating if real-life usage of utilitarian e-bike is associated with significant changes on total physical activity and sedentary patterns. During up to 4 months of free use of an e-bike, our purpose is to quantify its usage along with total physical activity and sedentary levels. We hypothesize that using an e-bike for commuting increase the total physical activity of at least 7.5 MET-h/week, increasing as well adherence to physical activity guidelines.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Unknown


title: When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care? Retrospective Study of 100 Consecutive Biopsies

acronym: BIOPULCER

summary:
Leg ulcers are frequent. There are no epidemiological studies available in France, but international studies estimate the prevalence between 0.045 and 0.63% of the total population, prevalence increases with age, reaching 5% of patients over 80 years. Extrapolating these prevalences in the French population between 28 000 and 395 000 people are affected in France a leg ulcer.

It is a costly disease. In 2001, a French study conducted among 800 physicians, including 85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was estimated that the total cost of treatment per patient average was 888 32 euros. This is truly a public health problem.

Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed). However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis. These ulcers rare causes require specific treatments that can often heal. To diagnose, to perform a skin biopsy. Thus, the general practitioner must know when to put the indication for biopsy of a leg ulcer.

time_perspective: Retrospective

intervention_type: Other


title: Mediterranean Visceral Leishmaniasis With Leishmania Infantum: Genetic Characterization of the Host Parasite in Relation to Asymptomatic Human Carriage

acronym: AsymptoGen

summary:
L. infantum leishmaniasis is endemic in the South of France. For several years, there has been an expansion of the territory of sandflies (vector of leishmaniasis), with the appearance of cases of canine leishmaniasis in new outbreaks: West of the Occitania region (South-West). The transition from asymptomatic to disease depends largely on the immune status of the carrier, but many other factors specific to the parasite and host remain poorly defined. Asymptomatic carriage is present in a large majority of infected subjects, however, to date, only parasite isolates causing the patent form have been characterized.

In this PHRC, the team wishes to study the genetics of parasite isolates present in asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well as the genetics of the host.

The primary objective is the genetic characterization of L. infantum isolates by the microsatellite method, present in asymptomatic carriers in southeast and southwestern France.

The secondary objectives are:

Comparison of the genetic profiles of L. infantum isolates, by microsatellite method, from asymptomatic carriers of the new Southwestern outbreak with isolates from asymptomatic carriers of the historical Southwestern outbreak.
Comparison of the genetic profiles of L. infantum isolates, by the microsatellite method, present in asymptomatic carriers in the Southeast with the profiles of isolates present in patients in the same outbreak, for whom a microsatellite study has already been obtained previously.
the team is also conducting a preliminary study of the host genetic factors that would be associated with asymptomatic carriage by studying the association between potential host-related genetic risk factors (HLA typing, NLRP3 gene study) and asymptomatic carriage. Indeed, a recent study showed that the NLRP3 gene prevents the development of the patent form of leishmaniasis in the mouse model. This preliminary genetic study will identify potential host-related factors associated with asymptomatic carriage.

To meet these objectives, leuco-platelet layer parasites (CLP) obtained via EFS from the 2 sources of interest will be isolated.

This project is a research not involving the human person. It is multicentric and non-randomized.

As a result of this research, isolates from asymptomatic carriers of the historical outbreak will be studied and compared to those present in new endemic outbreaks, as well as to those of patients already studied in a previous study. A better knowledge of parasites circulating in asymptomatic carriers will make it possible to study in a comprehensive way the risk factors associated with the parasite. In addition, the study of asymptomatic carrying in new endemic outbreaks such as Occitania is very original, since no human studies have yet been undertaken in this region. The results obtained in this PHRC will be used to understand the factors associated with the development of visceral leishmaniasis.

status: Recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nice

status_simplified: Ongoing


title: Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study

acronym: PRisM

summary:
Avoidable care associated incidents are relatively frequent in primary care. In France for example, avoidable incidents rate is estimated to 22/1000 medical acts from general practitioners. Patient safety is now a growing issue in primary care. One tool to increase patient safety is incident reporting and analysis. It could reduce some important consequences for patients and could allow implementing substantial corrective actions.

The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk management program implemented in the french pluridisciplinary offices in primary care in association with a centralized incident reporting system, versus a centralized incident reporting system only.

lead_sponsor: Hospices Civils de Lyon


title: Prospective Epidemiological Study of Injuries Encountered in the Practice of CrossFit in Grand Nancy Clubs Over a Period of 8 Months.

acronym: CROSSFIT

summary:
CrossFit is a recent sport that has been democratized since the beginning of the 2000's in France. The 3 major studies of CrossFit injuries were conducted in the United States in 2014, Brazil in 2016 and the United States in 2017. They show a discrepancy in terms of injuries average, from 19.4% to 31% in relation to an upsurge in the number of CrossFit practitioners, the specific training or not of the coaches framing this activity, the practice or not in competition. The main locations of these wounds are highlighted at the shoulders, lumbar region and knees. In France, to date, no epidemiological studies have been conducted on this subject.

Hypothesis: High incidence of injuries related to a lack of framing, or bad practice and ignorance of CrossFit practitioners.

Objectives : Estimate the injuries incident due to the CrossFit practice over a 8-month period in an adult population who practice in clubs .

Research, among the anthropometric, sociodemographic, environmental, and the nature and frequency of practice and training sessions, those which are associated with the occurrence of injury in this cohort.

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France


type: Other Identifier

title: REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

acronym: REALYSA

summary:
REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data.

REALYSA is a platform perfectly set up to

Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)…
Document treatment effectiveness in real life and observance
Address socio-economical questions

ReferenceCitation: Ghesquières H, Rossi C, Cherblanc F, Le Guyader-Peyrou S, Bijou F, Sujobert P, Fabbro-Peray P, Bernier A, Belot A, Chartier L, Fornecker LM, Baldi I, Bouabdallah K, Laurent C, Oberic L, Morineau N, Le Gouill S, Morschhauser F, Haioun C, Damaj G, Guidez S, Labouré G, Fitoussi O, Lebras L, Gressin R, Salles G, Ysebaert L, Monnereau A. A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the "REal world dAta in LYmphoma and survival in adults" (REALYSA) cohort. BMC Public Health. 2021 Mar 2;21(1):432. doi: 10.1186/s12889-021-10433-4.

family: Ghesquières

full_name: Hervé Ghesquières

given: Hervé

family: Rossi

full_name: Cédric Rossi

given: Cédric

family: Cherblanc

full_name: Fanny Cherblanc

given: Fanny

family: Le Guyader-Peyrou

full_name: Sandra Le Guyader-Peyrou

given: Sandra

family: Bijou

full_name: Fontanet Bijou

given: Fontanet

family: Sujobert

full_name: Pierre Sujobert

given: Pierre

family: Fabbro-Peray

full_name: Pascale Fabbro-Peray

given: Pascale

family: Bernier

full_name: Adeline Bernier

given: Adeline

family: Belot

full_name: Aurélien Belot

given: Aurélien

family: Chartier

full_name: Loic Chartier

given: Loic

family: Fornecker

full_name: Luc-Matthieu Fornecker

given: Luc-Matthieu

family: Baldi

full_name: Isabelle Baldi

given: Isabelle

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Laurent

full_name: Camille Laurent

given: Camille

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Morineau

full_name: Nadine Morineau

given: Nadine

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Guidez

full_name: Stéphanie Guidez

given: Stéphanie

family: Labouré

full_name: Gaëlle Labouré

given: Gaëlle

family: Fitoussi

full_name: Olivier Fitoussi

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

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

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

title: A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort

location_facility: Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL

location_facility: Service d'Hématologie, Institut d'Hématologie de Basse Normandie

location_facility: Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

location_facility: Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor

location_facility: Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth

location_facility: Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE

location_facility: Département d'Hématologie Clinique, Hôpital Saint-Eloi,

location_facility: Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,

location_facility: Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

location_facility: Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand

location_facility: Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon

location_facility: Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes

location_facility: Unité d'Hématologie Clinique, CH D'ARRAS

location_facility: Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo

location_facility: Service Hématologie, Centre Hospitalier de Dunkerque

location_facility: Département d'Hématologie et Oncologie, Centre Léon Bérard

location_facility: METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,

location_facility: Service Hématologie, Institut Curie - Hôpital René HUGUENIN

location_facility: Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille

location_facility: Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers

location_facility: Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,

location_facility: Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,


title: MAKASI. An Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Order to Reduce Their Social and Health Vulnerabilities in Paris Greater Area

acronym: MAKASI

summary:
Background. Immigrants from Sub-Saharan Africa are the second group most affected by HIV in France. Part of these HIV infections occurred after arrival in France, in relation to social hardships. Immigrants coming from the non-French Caribbean islands face similar difficulties. Many actors strive for an easier access to healthcare services for immigrants; however the mere supply of knowledge and medicalised solutions is not enough to make persons adopt prevention behaviours. It seems necessary to act upon empowerment to bring resources to individuals and communities in order to improve their autonomy and action capacity. Civil Society Organisations and researchers join forces in the MAKASI interventional research which aims at reinforcing immigrants' empowerment in sexual health in order to reduce their exposure to sexual risks.

Objectives : The MAKASI intervention consists in a unique Empowerment interview based on the principles of motivational interviewing, using an Active Referral system to social or sanitary services relevant to the person's needs. Our hypothesis is that this intervention is going to reinforce four dimensions of empowerment in sexual health among immigrants: the capacity to express their needs, competencies in sexual, self-esteem, awareness of exposure to HIV and STIs. The proposed research aims at measuring the efficacy of the intervention on these four dimensions, and at evaluating its processes and efficiency (cost-efficacy).

Methods: The intervention is delivered within the mobile units of Afrique Avenir in the public spaces where African and Caribbean populations live and work. The evaluation uses integrated mixed-method approach, combining a quantitative evaluation of impact and a qualitative research on processes. The measure of impact will be done by comparing indicators on the four dimensions of empowerment in sexual health and indicators of exposure to sexual risks, between an arm where the intervention is immediate and an arm where the intervention is differed by 3 months (control arm). The qualitative evaluation of the intervention processes will be based upon an ethnographic approach of the intervention and the participants' experience.

Perspectives: This project will demonstrate the efficacy and the efficiency of an innovative intervention aiming at reducing Sub-Saharan and Caribbean immigrants' exposure to risks in sexual health.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Gosselin A, Carillon S, Coulibaly K, Ridde V, Taéron C, Kohou V, Zouménou I, Mbiribindi R, Derche N, Desgrées du Loû A; MAKASI Study Group. Participatory development and pilot testing of the Makasi intervention: a community-based outreach intervention to improve sub-Saharan and Caribbean immigrants' empowerment in sexual health. BMC Public Health. 2019 Dec 5;19(1):1646. doi: 10.1186/s12889-019-7943-2.

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


title: Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population

acronym: PRINTEMPS

summary: An interventional research study will be undertaken to assess the effectiveness of the promotion at the local level of an e-health tool for suicide and psychological distress prevention (the StopBlues application and website). This trial is a cluster-randomized, parallel group, controlled intervention study with local authorities as the unit of randomization. Local authorities will be randomly assigned to one of the following three arms: local authorities not promoting the e-health tool (control group); local authorities promoting the e-health tool without general practitioners (GPs) involvement; local authorities promoting the e-health tool including GPs' waiting room. The trial will last 24 months and after a 12-month post-randomization period, local authorities from the control group will be allowed for a further 12-month period to launch their promotional campaign supported by the research team through regular contacts and additional technical and financial resources (intensively sustained promotion). This will facilitate the recruitment of clusters as well as their adherence to the intervention during the first 12-month period. The main criterion will be the number of suicidal acts at nine months. Data will be collected both at the local authority level and at the individual e-health tool user level.

ReferenceCitation: Bertolote J, Fleischmann A. A global perspective on the magnitude of suicide mortality. The Oxford Textbook of Suicidology and Suicide Prevention: A Global Perspective. Oxford: Oxford University Press. Wasserman D., Wasserman C.; 2009. p. 91 98.

ReferenceCitation: Marie-Claude Mouquet, Bellamy V. Suicides et tentatives de suicide en France. Etude et Résultats. Mai 2006;(488).

ReferenceCitation: O'Dea D, Tucker S. The cost of suicide to society. Wellington: Ministry of Health. 2005.

ReferenceCitation: Kennelly B. The economic cost of suicide in Ireland. Crisis. 2007;28(2):89-94.

ReferenceCitation: du Roscoät E, Beck F. Efficient interventions on suicide prevention: a literature review. Rev Epidemiol Sante Publique. 2013 Aug;61(4):363-74. doi: 10.1016/j.respe.2013.01.099. Epub 2013 Jul 10. Review.

ReferenceCitation: Programme national d'actions contre le suicide 2011-2014. 2011

ReferenceCitation: Ministère des Affaires Sociales et de la Santé. Décret n° 2013-809 du 9 septembre 2013 portant création de l'Observatoire National du Suicide. 2013

ReferenceCitation: Atkinson NL, Saperstein SL, Pleis J. Using the internet for health-related activities: findings from a national probability sample. J Med Internet Res. 2009 Feb 20;11(1):e4. doi: 10.2196/jmir.1035.

ReferenceCitation: Dickerson S, Reinhart AM, Feeley TH, Bidani R, Rich E, Garg VK, Hershey CO. Patient Internet use for health information at three urban primary care clinics. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):499-504. Epub 2004 Aug 6.

ReferenceCitation: Haga SM, Drozd F, Brendryen H, Slinning K. Mamma mia: a feasibility study of a web-based intervention to reduce the risk of postpartum depression and enhance subjective well-being. JMIR Res Protoc. 2013 Aug 12;2(2):e29. doi: 10.2196/resprot.2659.

ReferenceCitation: Monshat K, Vella-Brodrick D, Burns J, Herrman H. Mental health promotion in the Internet age: a consultation with Australian young people to inform the design of an online mindfulness training programme. Health Promot Int. 2012 Jun;27(2):177-86. doi: 10.1093/heapro/dar017. Epub 2011 Mar 11.

ReferenceCitation: Allen J, Mohatt G, Fok CC, Henry D; People Awakening Team. Suicide prevention as a community development process: understanding circumpolar youth suicide prevention through community level outcomes. Int J Circumpolar Health. 2009 Jun;68(3):274-91.

ReferenceCitation: Bean G, Baber KM. Connect: an effective community-based youth suicide prevention program. Suicide Life Threat Behav. 2011 Feb;41(1):87-97. doi: 10.1111/j.1943-278X.2010.00006.x. Epub 2011 Jan 24.

ReferenceCitation: Ono Y, Sakai A, Otsuka K, Uda H, Oyama H, Ishizuka N, Awata S, Ishida Y, Iwasa H, Kamei Y, Motohashi Y, Nakamura J, Nishi N, Watanabe N, Yotsumoto T, Nakagawa A, Suzuki Y, Tajima M, Tanaka E, Sakai H, Yonemoto N. Effectiveness of a multimodal community intervention program to prevent suicide and suicide attempts: a quasi-experimental study. PLoS One. 2013 Oct 9;8(10):e74902. doi: 10.1371/journal.pone.0074902. eCollection 2013.

ReferenceCitation: Pearson A, Saini P, Da Cruz D, Miles C, While D, Swinson N, Williams A, Shaw J, Appleby L, Kapur N. Primary care contact prior to suicide in individuals with mental illness. Br J Gen Pract. 2009 Nov;59(568):825-32. doi: 10.3399/bjgp09X472881.

ReferenceCitation: Hegerl U, Althaus D, Schmidtke A, Niklewski G. The alliance against depression: 2-year evaluation of a community-based intervention to reduce suicidality. Psychol Med. 2006 Sep;36(9):1225-33. Epub 2006 May 17.

ReferenceCitation: Chabaud F, Debarre J, Serazin C, Bouet R, Vaïva G, Roelandt JL. [Study of population profiles in relation to the level of suicide risk in France: Study "Mental health in the general population"]. Encephale. 2010;36(3 Suppl):33-8. doi: 10.1016/S0013-7006(10)70016-6. French.

ReferenceCitation: Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661.

ReferenceCitation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

ReferenceCitation: Schmidtke A, Bille-Brahe U, DeLeo D, Kerkhof A, Bjerke T, Crepet P, Haring C, Hawton K, Lönnqvist J, Michel K, Pommereau X, Querejeta I, Phillipe I, Salander-Renberg E, Temesváry B, Wasserman D, Fricke S, Weinacker B, Sampaio-Faria JG. Attempted suicide in Europe: rates, trends and sociodemographic characteristics of suicide attempters during the period 1989-1992. Results of the WHO/EURO Multicentre Study on Parasuicide. Acta Psychiatr Scand. 1996 May;93(5):327-38.

ReferenceCitation: Réseau OSCOUR® / Surveillance syndromique - SurSaUD® / Veille et alerte / Dossiers thématiques / Accueil [Internet]. Disponible sur: http://www.invs.sante.fr/Dossiers-thematiques/Veille-et-alerte/Surveillance-syndromique-SurSaUD-R/Reseau-OSCOUR-R

ReferenceCitation: HAS. Choix méthodologiques pour l'évaluation économique à la HAS. 2011

ReferenceCitation: Gandré C, Le Jeannic A, Vinet MA, Turmaine K, Courtet P, Roelandt JL, Vaiva G, Giraudeau B, Alberti C, Chevreul K. The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France. Trials. 2020 Jun 22;21(1):553. doi: 10.1186/s13063-020-04464-2.

apc_source: openAPC

family: Gandré

full_name: Coralie Gandré

given: Coralie

family: Le Jeannic

full_name: Anaïs Le Jeannic

given: Anaïs

family: Vinet

full_name: Marie-Amélie Vinet

given: Marie-Amélie

family: Turmaine

full_name: Kathleen Turmaine

given: Kathleen

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Roelandt

full_name: Jean-Luc Roelandt

given: Jean-Luc

family: Vaiva

full_name: Guillaume Vaiva

given: Guillaume

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Alberti

full_name: Corinne Alberti

family: Chevreul

full_name: Karine Chevreul

given: Karine

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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-Nature

publisher_group: Springer-Nature

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

location_facility: Faculté de Médecine Paris Diderot Paris 7


acronym: Visage 3

summary:
The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging.

objectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients

acronym: EpleCsAT

summary:
Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A) are widely used. Their renal toxicity could be divided between an acute toxicity (toxic arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy, interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have shown the implication of the mineralocorticoid receptor (MR) activation in those toxic phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the renal function and kidney histological damages.

Several antagonists are available in France but none is indicated in kidney transplantation. Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and to have less adverse anti-androgenic effects than others molecules. Its principal adverse events are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists, especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced by calcineurin-inhibitors.

Classically, eplerenone is contra-indicated in patients presenting with an impaired renal function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a warning is especially notified for the association with cyclosporine A due to the fact that no study have been done in this context.

The investigators study first the safety of the use of eplerenone in association with cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will study its efficiency in a large randomized controlled trial.

primary_purpose: Treatment

ReferenceCitation: Bertocchio JP, Barbe C, Lavaud S, Toupance O, Nazeyrollas P, Jaisser F, Rieu P. Safety of Eplerenone for Kidney-Transplant Recipients with Impaired Renal Function and Receiving Cyclosporine A. PLoS One. 2016 Apr 18;11(4):e0153635. doi: 10.1371/journal.pone.0153635. eCollection 2016.

family: Bertocchio

full_name: Jean-Philippe Bertocchio

given: Jean-Philippe

family: Barbe

full_name: Coralie Barbe

family: Lavaud

full_name: Sylvie Lavaud

given: Sylvie

family: Toupance

full_name: Olivier Toupance

given: Olivier

family: Nazeyrollas

full_name: Pierre Nazeyrollas

given: Pierre

family: Jaisser

full_name: Frederic Jaisser

given: Frederic

family: Rieu

full_name: Philippe Rieu

currency_apc_doaj: USD

journal_name: PLOS ONE

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: CHU de Reims

location_facility: Centre Hospitalier Universitaire de Reims

intervention_type: Drug


title: Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers

acronym: ibid

summary:
Aims :

exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
comparing lorazepam effects to diazepam (0.3 mg/kg)effects
exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI

Hypothesis :

both diazepam and lorazepam will impair explicit memory performance, but lorazepam only will impair perceptual priming
lorazepam and diazepam will modify the normal correlates of information encoding within explicit memory
lorazepam only will alter the neural correlates of perceptual priming

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Centre d'investigation clinique, hôpital civil


title: Measurement of an Abdominal Aorta Calcium Scoring and Its Correlation With Cardiovascular Risk Factors

summary: Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.

location_facility: Service d'Hypertension, Maladies Vasculaires et Pharmacologie Clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

intervention_type: Device


title: Study of Prognostic Value by Molecular Analysis in Paediatric Osteosarcomas of the Chromosomal Regions Containing Rb, p16, p53, Cycline D1, APC, erbB2 and C-met Genes

summary: At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the histological response to preoperative chemotherapy. Our study was designed to identify new diagnostic markers that could eventually have a prognostic value and therapeutic consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal and biopsy samples were collected. In addition, surgical resection specimens, following preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an allelotyping analysis targeting microsatellites was planned. The studied DNA regions contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The techniques used in this molecular analysis comprised mainly allelotyping study, quantitative real-time PCR, gene sequencing , immunohistochemistry. The first results showed the prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003, Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21 targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).

location_facility: Laboratoire de Biologie Moléculaire, Hôpital de Hautepierre

location_facility: Service de Pédiatrie 3, Hôpital de Hautepierre


title: Genetics Tests : How to Improve Management Within Two Medical Specialities

acronym: ORGAGENE

summary: This survey will assess discrepancies between official clinical genetics guidelines and practices within 3 West regions of France.

time_perspective: Other

lead_sponsor: Rennes University Hospital


title: The Study of Capnography for the Follow-up of Cystic Fibrosis Children With or Without Gas Trapping

acronym: MUCOCAP

summary:
The respiratory system involvement in cystic fibrosis(CF) influences the prognosis and course of disease. Respiratory assessment is based on spirometry, but its main parameter, the maximal expiratory volume in the first second (FEV1), does not reflect the initial peripheral impairment of airways. Another pulmonary function test (PFT) validated for CF children follow-up is measurement of "gas trapping", reflecting ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by lung volume measurement (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are inconvenient for children due to their long length (~30min). A complete PFT is routinely performed once a year. It also includes a measurement of Lung Clearance Index (LCI) reflecting ventilation inhomogeneity. Capnography is a non-invasive PFT technique, does not require subject's active cooperation, is of short duration and could replace the traditional PFT for CF children follow-up. The capnograph is integrated into the device measuring LCI and data can be retrieved and analyzed afterwards. Capnographic indices reflect ventilation inhomogeneity.

The hypothesis is that capnographic indices change in the presence/absence of "gas trapping" in CF children.

The main objective is to show that the capnographic index of efficacy (EFFi) is significantly different between CF children "with gas trapping" and CF children "without gas trapping". The secondary objectives are:

to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F "CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping"

ReferenceCitation: Robinson PD, Latzin P, Ramsey KA, Stanojevic S, Aurora P, Davis SD, Gappa M, Hall GL, Horsley A, Jensen R, Lum S, Milla C, Nielsen KG, Pittman JE, Rosenfeld M, Singer F, Subbarao P, Gustafsson PM, Ratjen F; ATS Assembly on Pediatrics. Preschool Multiple-Breath Washout Testing. An Official American Thoracic Society Technical Statement. Am J Respir Crit Care Med. 2018 Mar 1;197(5):e1-e19. doi: 10.1164/rccm.201801-0074ST.

ReferenceCitation: BEDELL GN, MARSHALL R, DUBOIS AB, COMROE JH. Plethysmographic determination of the volume of gas trapped in the lungs. J Clin Invest. 1956 Jun;35(6):664-70.

ReferenceCitation: Kraemer R, Schöni MH. Ventilatory inequalities, pulmonary function and blood oxygenation in advanced states of cystic fibrosis. Respiration. 1990;57(5):318-24.

ReferenceCitation: O'Donnell CR, Bankier AA, Stiebellehner L, Reilly JJ, Brown R, Loring SH. Comparison of plethysmographic and helium dilution lung volumes: which is best for COPD? Chest. 2010 May;137(5):1108-15. doi: 10.1378/chest.09-1504. Epub 2009 Dec 18.

ReferenceCitation: Jarenbäck L, Tufvesson E, Ankerst J, Bjermer L, Jonson B. The Efficiency Index (EFFi), based on volumetric capnography, may allow for simple diagnosis and grading of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 27;13:2033-2039. doi: 10.2147/COPD.S161345. eCollection 2018.

ReferenceCitation: Ioan I, Demoulin B, Duvivier C, Leblanc AL, Bonabel C, Marchal F, Schweitzer C, Varechova S. Frequency dependence of capnography in anesthetized rabbits. Respir Physiol Neurobiol. 2014 Jan 1;190:14-9. doi: 10.1016/j.resp.2013.09.002. Epub 2013 Sep 12.

ReferenceCitation: Gustafsson PM, Aurora P, Lindblad A. Evaluation of ventilation maldistribution as an early indicator of lung disease in children with cystic fibrosis. Eur Respir J. 2003 Dec;22(6):972-9.

ReferenceCitation: You B, Peslin R, Duvivier C, Vu VD, Grilliat JP. Expiratory capnography in asthma: evaluation of various shape indices. Eur Respir J. 1994 Feb;7(2):318-23.

location_facility:
CHRU de NANCY
Hôpital ARMAND TROUSSEAU


title: Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years

acronym: ECUNancyLyon

summary:
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g.

NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.

The etiology and physiopathology are multifactorial, complex, and remain poorly understood. The mechanism of the lesions seems to involve factors including immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation.

Despite improved knowledge about this disease, the proportion of surviving patients has not improved for several years. It frequently leads to long-term sequelae depending on the severity of the NEC and its treatment.

Early diagnosis and early treatment of NEC may reduce the risk of mortality and morbidity. The aim of this retrospective bi-centric study is to look for risk factors allowing the prediction of NEC in order to prevent and improve the early management of this disease.

status: Enrolling by invitation

location_facility: Maternite Regionale Universitaire CHRU NANCY


title: Prognostic Significance of the TREM-1 Pathway Activation in COVID-19

summary:
Severe Acute Respiratory Syndrome-Corona Virus-2 infection results in a mild infection in most of the patients. However, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in Intensive Care Unit. There are no accepted predictive criteria for aggravation. Severe forms of Coronavirus induced disease-19 (COVID-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. The Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. TREM-1 is expressed on myeloid and endothelial cells. Its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. TREM-1 activation is associated with poor outcome during septic shock and myocardial infarction.

We here aim at investigating the relationship between TREM-1 pathway activation and clinical degradation and outcome of COVID-19 hospitalized patients.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility:
CHRU Limoges
Central hospital


title: Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection

acronym: Nancy-CovH-AKI

summary:
The Nancy Cov-H-AKI: study is a prospective, non-randomized, monocenter study performed in patients hospitalised for either the severe or the critical form of Covid-19.

The main objective of the Nancy Cov-H-AKI study is to evaluate the association of variations (from inclusion to 72H post-inclusion) of 5 blood-based cardio-vascular-renal biomarkers selected a priori, cardiac (NT-proBNP), coagulation (D-dimers), related to the renin angiotensin aldosterone system (ACE2) and renal (Penkid, and NGAL) with the appearance of acute kidney injury KDIGO grade 1 or higher OR cardiac injury in patients hospitalised for either the severe or the critical form of Covid-19

primary_purpose: Other

intervention_type: Procedure


title: Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides

acronym: APSregistry

summary: To constitute a registry of antiphospholipid antibodies positive-patients

location_facility:
CHRU de Lille
CHRU de Nancy

intervention_type: Diagnostic Test


title: Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe

acronym: AHF-CORE

summary:
The AHF-CORE study is a prospective, non-randomized, multicenter regional study.

The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.

Secondary objectives are:

Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure.
Assess the correlation between changes in congestion markers between the beginning and end of hospitalization.
Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization.
Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge.
Identify the association of ultrasound and biologic congestion markers assessed at admission and final discharge with NYHA class at 3 months after hospital discharge

location_facility:
CHR Metz-Thionville - Hôpital de Mercy
CHRU Nancy Hôpitaux de Brabois


title: Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week

acronym: SeCoIA

summary: The objective of this study is to describe the characteristics of patients on daily home hemodialysis and to confirm in real practice in France the effectiveness shown in studies, mainly American, both in terms of clinical outcomes and quality of life. Due to the few studies available in this population, the focus will be particularly on physical activity.

design_allocation: Non-Randomized

ReferenceCitation: Target N, Courivaud C, Michel PA, Daoud S, Thomas M. Comparison of physical activity and quality of life in home haemodialysis (HHD) patients versus conventional in-centre haemodialysis (ICHD) patients: the observational, longitudinal, prospective, international, multicentric SeCoIA study protocol. BMC Nephrol. 2020 Nov 23;21(1):500. doi: 10.1186/s12882-020-02127-7.

family: Target

full_name: Natalia Target

given: Natalia

family: Courivaud

full_name: Cécile Courivaud

given: Cécile

family: Michel

full_name: Pierre Antoine Michel

given: Pierre Antoine

family: Daoud

full_name: Salima Daoud

given: Salima

family: Thomas

full_name: Michel Thomas

given: Michel

journal_name: BMC Nephrology

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher_normalized: Springer

lead_sponsor: Physidia

lead_sponsor_type: industriel


title: Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process: Prospective Pilot Study

acronym: LTP

summary: The proposed study focuses on the relational characteristics of the family and their evolution in the course of family therapy, through the evolution of the family alliance (degree of coordination achieved by its members to perform a task) and co-parenting (support that the mother and father give each other in their roles as parents), assuming that the family therapy allows the improvement of these two aspects. The family alliance is evaluated via a standardized observation situation (Lausanne Family Play LFP adapted from the Lausanne Trilogy Play LTP) whose sessions are filmed. The alliance assessment is carried out by the coding and scales of the FASS (Family Alliance Assessment Scales,) tool during viewing.

status: Active, not recruiting

lead_sponsor: Centre hospitalier de Ville-Evrard, France


title: A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study in Adult Patients With Moderate to Severe Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

acronym: ALHENA

summary:
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is conducted at a national level, in France.

The patients will be randomised to receive ALOCROSS® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

lead_sponsor: Santen SAS

location_facility: Hopitaux Universitaires Paris-Sud - Hopital Bicetre


title: Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)

acronym: MEDIACONNEX

summary:
MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter controlled randomized trial (East of France) and there is a funding from the Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who are receiving SMS (or mail or other new media) from the unit of care in addition to the usual care will do less SA recurrence, than those who are receiving the usual care.

The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.

ReferenceCitation: 1. World Health Organization WHO. (2011). http://www.who.int/maternal_child_adolescent/topics/adolescence/fr/ Accessed April 2016

ReferenceCitation: Hawton K, Rodham K, Evans E, Weatherall R. Deliberate self harm in adolescents: self report survey in schools in England. BMJ. 2002 Nov 23;325(7374):1207-11.

ReferenceCitation: Moran P, Coffey C, Romaniuk H, Olsson C, Borschmann R, Carlin JB, Patton GC. The natural history of self-harm from adolescence to young adulthood: a population-based cohort study. Lancet. 2012 Jan 21;379(9812):236-43. doi: 10.1016/S0140-6736(11)61141-0. Epub 2011 Nov 16.

ReferenceCitation: Wong JP, Stewart SM, Claassen C, Lee PW, Rao U, Lam TH. Repeat suicide attempts in Hong Kong community adolescents. Soc Sci Med. 2008 Jan;66(2):232-41. Epub 2007 Oct 4.

ReferenceCitation: Miranda R, Scott M, Hicks R, Wilcox HC, Harris Munfakh JL, Shaffer D. Suicide attempt characteristics, diagnoses, and future attempts: comparing multiple attempters to single attempters and ideators. J Am Acad Child Adolesc Psychiatry. 2008 Jan;47(1):32-40. doi: 10.1097/chi.0b013e31815a56cb.

ReferenceCitation: Thompson MP, Light LS. Examining gender differences in risk factors for suicide attempts made 1 and 7 years later in a nationally representative sample. J Adolesc Health. 2011 Apr;48(4):391-7. doi: 10.1016/j.jadohealth.2010.07.018. Epub 2010 Oct 8.

ReferenceCitation: MacDonald R, Taylor J, Clarke D. The relationship between early suicide behaviors and mental health: results from a nine-year panel study. J Adolesc. 2009 Oct;32(5):1159-72. doi: 10.1016/j.adolescence.2009.01.012. Epub 2009 Mar 9.

ReferenceCitation: Ligier F, Guillemin F, Angot C, Bourion S, Kabuth B. Recurrence of suicide attempt in adolescents lost to contact early by clinicians: The 10-year REPEATERS cohort of French adolescents. J Adolesc. 2015 Aug;43:111-8. doi: 10.1016/j.adolescence.2015.05.011. Epub 2015 Jun 12. Erratum in: J Adolesc. 2017 Jan;54:135-136.

ReferenceCitation: Vaiva G, Jardon V, Vaillant A, Ducrocq F. [What can we do to prevent the suicide re-attempts?]. Rev Prat. 2011 Feb;61(2):202-3, 206-7. French.

ReferenceCitation: Davidson K, Norrie J, Tyrer P, Gumley A, Tata P, Murray H, Palmer S. The effectiveness of cognitive behavior therapy for borderline personality disorder: results from the borderline personality disorder study of cognitive therapy (BOSCOT) trial. J Pers Disord. 2006 Oct;20(5):450-65.

ReferenceCitation: Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. Erratum in: Arch Gen Psychiatry. 2007 Dec;64(12):1401.

ReferenceCitation: Weinberg I, Gunderson JG, Hennen J, Cutter CJ Jr. Manual assisted cognitive treatment for deliberate self-harm in borderline personality disorder patients. J Pers Disord. 2006 Oct;20(5):482-92.

ReferenceCitation: Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999 Oct;156(10):1563-9.

ReferenceCitation: Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S. Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm. Psychol Med. 1999 Jan;29(1):19-25.

ReferenceCitation: Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33.

ReferenceCitation: 16. Beautrais AL, Gibb SJ, Faulkner A, Mulder RT. A randomised controlled trial of a brief intervention to reduce repeat presentations to the emergency department for suicide attempt. Annals of Emergency Medicine. 2008;51:474

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. Epub 2005 Sep 23.

ReferenceCitation: Vaiva G, Walter M, Al Arab AS, Courtet P, Bellivier F, Demarty AL, Duhem S, Ducrocq F, Goldstein P, Libersa C. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters. BMC Psychiatry. 2011 Jan 2;11:1. doi: 10.1186/1471-244X-11-1.

ReferenceCitation: Czyz EK, Liu Z, King CA. Social connectedness and one-year trajectories among suicidal adolescents following psychiatric hospitalization. J Clin Child Adolesc Psychol. 2012;41(2):214-26. doi: 10.1080/15374416.2012.651998.

ReferenceCitation: Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-García E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.

family: Berrouiguet

full_name: Sofian Berrouiguet

given: Sofian

family: Alavi

full_name: Zarrin Alavi

given: Zarrin

family: Courtet

full_name: Philippe Courtet

family: Baca-García

full_name: Enrique Baca-García

given: Enrique

family: Vidailhet

full_name: Pierre Vidailhet

family: Gravey

full_name: Michel Gravey

family: Guillodo

full_name: Elise Guillodo

given: Elise

family: Brandt

full_name: Sara Brandt

given: Sara

family: Walter

full_name: Michel Walter

journal_name: BMC Psychiatry

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

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

ReferenceCitation: Milner AJ, Carter G, Pirkis J, Robinson J, Spittal MJ. Letters, green cards, telephone calls and postcards: systematic and meta-analytic review of brief contact interventions for reducing self-harm, suicide attempts and suicide. Br J Psychiatry. 2015 Mar;206(3):184-90. doi: 10.1192/bjp.bp.114.147819. Review.

ReferenceCitation: Brian RM, Ben-Zeev D. Mobile health (mHealth) for mental health in Asia: objectives, strategies, and limitations. Asian J Psychiatr. 2014 Aug;10:96-100. doi: 10.1016/j.ajp.2014.04.006. Epub 2014 Apr 27. Review.

ReferenceCitation: Collins JL, Champion JD. Assessment of mobile device and SMS Use for Diet and Exercise Information Among Rural Mexican-American adolescents. J Pediatr Nurs. 2014 Nov-Dec;29(6):493-502. doi: 10.1016/j.pedn.2014.03.020. Epub 2014 Mar 15.

ReferenceCitation: 24. Gibson K, Cartwright C. Young people's experiences of mobile phone text counseling: Balancing connection and control. Child Youth Ser Rev. 2014;73:96-104

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ReferenceCitation: Hinman RS, McCrory P, Pirotta M, Relf I, Crossley KM, Reddy P, Forbes A, Harris A, Metcalf BR, Kyriakides M, Novy K, Bennell KL. Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design. BMC Complement Altern Med. 2012 Sep 19;12:161. doi: 10.1186/1472-6882-12-161.

ReferenceCitation: Hatcher S, Sharon C, House A, Collins N, Collings S, Pillai A. The ACCESS study: Zelen randomised controlled trial of a package of care for people presenting to hospital after self-harm. Br J Psychiatry. 2015 Mar;206(3):229-36. doi: 10.1192/bjp.bp.113.135780. Epub 2015 Jan 22.

ReferenceCitation: Adamson J, Cockayne S, Puffer S, Torgerson DJ. Review of randomised trials using the post-randomised consent (Zelen's) design. Contemp Clin Trials. 2006 Aug;27(4):305-19. Epub 2006 Feb 7. Review.

ReferenceCitation: 29. Chou Kee-lee. Assessing Chinese adolescents' social support: the multidimensional scale of perceived social support. Pers Individ Dif. 2000;28: 299-307

ReferenceCitation: Osman A, Lamis DA, Freedenthal S, Gutierrez PM, McNaughton-Cassill M. The multidimensional scale of perceived social support: analyses of internal reliability, measurement invariance, and correlates across gender. J Pers Assess. 2014;96(1):103-12. doi: 10.1080/00223891.2013.838170. Epub 2013 Oct 3.

ReferenceCitation: Denis A, Callahan S, Bouvard M. Evaluation of the French version of the multidimensional scale of perceived social support during the postpartum period. Matern Child Health J. 2015 Jun;19(6):1245-51. doi: 10.1007/s10995-014-1630-9.

ReferenceCitation: 32. The KIDSCREEN Group Europe. The KIDSCREEN Questionnaires - Quality of life questionnaires for children and adolescents. Handbook. Lengerich: Pabst Science Publishers. 2006

ReferenceCitation: Sapin C, Simeoni MC, El Khammar M, Antoniotti S, Auquier P. Reliability and validity of the VSP-A, a health-related quality of life instrument for ill and healthy adolescents. J Adolesc Health. 2005 Apr;36(4):327-36.

ReferenceCitation: Chabrol H, Montovany A, Chouicha K, Duconge E. [Study of the CES-D on a sample of 1,953 adolescent students]. Encephale. 2002 Sep-Oct;28(5 Pt 1):429-32. French.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3:CD013667. doi: 10.1002/14651858.CD013667.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

name: Children and Young People Satellite, Cochrane Common Mental Disorders; The University of Auckland; Auckland New Zealand

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

ReferenceCitation: Ligier F, Kabuth B, Guillemin F. MEDIACONNEX: a multicenter randomised trial based on short message service to reduce suicide attempt recurrence in adolescents. BMC Psychiatry. 2016 Jul 19;16:251. doi: 10.1186/s12888-016-0965-8.

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

ipd_sharing_description: Study results will be restituted to each participant if they ask for it.

location_facility: Hôpital de Mercy. CHR de Metz-Thionville


title: Detection of Enterovirus RNA by RT-PCR in Atheromatous Lesions

acronym: ATH-ENTE

summary: Atherosclerosis is one of the first causes of morbidity-mortality in industrialized countries. Numerous works suggest that some infectious agents could be involved in the inflammatory process leading to the development of this pathology, such as Chlamydophila pneumoniae, cytomegalovirus or herpes simplex virus. Enteroviruses are small RNA viruses that have been incriminated in various acute or chronic cardiac diseases (pericarditis, myocarditis, dilated cardiomyopathy) and exhibit a tropism for vascular endothelia. Different clinical and experimental arguments suggest that they could play a cofactor role in the occurrence or maintenance of atherosclerosis lesions. A multicenter study developed in collaboration with colleagues of the University Hospital of Reims (France) showed that it was frequent to detect enterovirus RNA in cardiac biopsies from patients with myocardial infarction. Furthermore, a pilot study conducted in the University Hospital of Saint-Etienne (France) on atheromatous arterial samples from 18 patients allowed the detection of enterovirus RNA in 20% of them.

primary_purpose: Basic Science

ReferenceCitation: Schanen C, Nasri D, Bourlet T, Barral X, Favre JP, Bourrat D, Péoc'h M, Ginevra C, Andréoletti L, Pozzetto B, Pillet S. Enterovirus in arteriosclerosis: a pilot study. J Clin Virol. 2007 Jun;39(2):106-12. Epub 2007 May 10.

ReferenceCitation: Andréoletti L, Ventéo L, Douche-Aourik F, Canas F, Lorin de la Grandmaison G, Jacques J, Moret H, Jovenin N, Mosnier JF, Matta M, Duband S, Pluot M, Pozzetto B, Bourlet T. Active Coxsackieviral B infection is associated with disruption of dystrophin in endomyocardial tissue of patients who died suddenly of acute myocardial infarction. J Am Coll Cardiol. 2007 Dec 4;50(23):2207-14. Epub 2007 Nov 19.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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


title: Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU

acronym: SEPREVEN

summary:
Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator and catheter associated adverse events and medication errors. Severity of the patient's outcome after an adverse event can be classified using the National Coordinating Council for Medication Error Reporting and Preventing (NCC MERP) Index for categorizing medication errors.

The study will test the hypothesis that rates of adverse events in NICU patients will be reduced by the implementation of an educational program for the NICU caregivers (nurses and physicians), consisting of strategies for recognizing and preventing adverse events in their unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal complications and ventilator and catheter-associated adverse events.

This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France will be randomized to the timing of implementation of the educational program.

In order to describe the adverse events occurring during the study period, an anonymous voluntary adverse event reporting system will be provided to the caregivers of the participating units. A nested study will examine how caregivers communicate with the patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).

The rates of adverse events will be measured retrospectively using a neonatal NICU trigger tool.

ReferenceCitation: Sharek PJ, Horbar JD, Mason W, Bisarya H, Thurm CW, Suresh G, Gray JE, Edwards WH, Goldmann D, Classen D. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics. 2006 Oct;118(4):1332-40.

ReferenceCitation: Sharek PJ. The Emergence of the Trigger Tool as the Premier Measurement Strategy for Patient Safety. AHRQ WebM&M. 2012 May 1;2012(5). pii: 120.

ReferenceCitation: Chedoe I, Molendijk H, Hospes W, Van den Heuvel ER, Taxis K. The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F449-55. doi: 10.1136/fetalneonatal-2011-300989. Epub 2012 Apr 5.

ReferenceCitation: Dabliz R, Levine S. Medication safety in neonates. Am J Perinatol. 2012 Jan;29(1):49-56. doi: 10.1055/s-0031-1285831. Epub 2011 Aug 22. Review.

ReferenceCitation: Palmero D, Di Paolo ER, Beauport L, Pannatier A, Tolsa JF. A bundle with a preformatted medical order sheet and an introductory course to reduce prescription errors in neonates. Eur J Pediatr. 2016 Jan;175(1):113-9. doi: 10.1007/s00431-015-2607-4. Epub 2015 Aug 15.

ReferenceCitation: Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18.

ReferenceCitation: Smulders CA, van Gestel JP, Bos AP. Are central line bundles and ventilator bundles effective in critically ill neonates and children? Intensive Care Med. 2013 Aug;39(8):1352-8. doi: 10.1007/s00134-013-2927-7. Epub 2013 Apr 25. Review.

ReferenceCitation: Schulman J, Stricof R, Stevens TP, Horgan M, Gase K, Holzman IR, Koppel RI, Nafday S, Gibbs K, Angert R, Simmonds A, Furdon SA, Saiman L; New York State Regional Perinatal Care Centers. Statewide NICU central-line-associated bloodstream infection rates decline after bundles and checklists. Pediatrics. 2011 Mar;127(3):436-44. doi: 10.1542/peds.2010-2873. Epub 2011 Feb 21.

ReferenceCitation: Casanova D, Bardot J, Magalon G. Emergency treatment of accidental infusion leakage in the newborn: report of 14 cases. Br J Plast Surg. 2001 Jul;54(5):396-9.

ReferenceCitation: Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.

ReferenceCitation: Farquhar C, Armstrong S, Kim B, Masson V, Sadler L. Under-reporting of maternal and perinatal adverse events in New Zealand. BMJ Open. 2015 Jul 23;5(7):e007970. doi: 10.1136/bmjopen-2015-007970.

ReferenceCitation: Raju TN, Suresh G, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res. 2011 Jul;70(1):109-15. doi: 10.1203/PDR.0b013e3182182853.

ReferenceCitation: Garland JS, Alex CP, Uhing MR, Peterside IE, Rentz A, Harris MC. Pilot trial to compare tolerance of chlorhexidine gluconate to povidone-iodine antisepsis for central venous catheter placement in neonates. J Perinatol. 2009 Dec;29(12):808-13. doi: 10.1038/jp.2009.161. Epub 2009 Oct 8.

ReferenceCitation: Caeymaex L, Lebeaux C, Roze JC, Danan C, Reynaud A, Jung C, Audureau E. Study on preventing adverse events in neonates (SEPREVEN): A stepped-wedge randomised controlled trial to reduce adverse event rates in the NICU. Medicine (Baltimore). 2020 Jul 31;99(31):e20912. doi: 10.1097/MD.0000000000020912.

family: Caeymaex

full_name: Laurence Caeymaex

given: Laurence

family: Lebeaux

full_name: Cecile Lebeaux

given: Cecile

family: Roze

full_name: Jean Christophe Roze

given: Jean Christophe

family: Danan

full_name: Claude Danan

given: Claude

family: Reynaud

full_name: Audrey Reynaud

given: Audrey

family: Jung

full_name: Camille Jung

given: Camille

family: Audureau

full_name: Etienne Audureau

given: Etienne

journal_name: Medicine

oa_host_type: repository

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Dr Caeymaex Laurence

location_facility:
CH Poissy
CHU Angers
CHU Robert Debré, APHP
Centre Hospitalier Delafontaine
CHU Nice Archet
CHI Creteil
CHU Caen
CHU Bicêtre, APHP
CHU Grenoble
CH Pontoise René Dubos
CHU Strasbourg Hautepierre
CHU Lille Jeanne de Flandres


title: Assessment of Dissociative Traumatic Disorders

acronym: TEDI

summary:
More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed.

The goal of this research is :

to assess the prevalence of dissociative disorders using specific tools in patients suffering from PTSD.
to validate the French version of the DDIS interview (Ross, 1997) that the investigators have translated.

lead_sponsor: Januel


title: Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.

acronym: MISTRAL

summary: Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.

ReferenceCitation: Ohlmann P, Reydel P, Jacquemin L, Adnet F, Wolf O, Bartier JC, Weiss A, Lapostolle F, Gaultier C, Salengro E, Benamer H, Guyon P, Chevalier B, Catan S, Ecollan P, Chouihed T, Angioi M, Zupan M, Bronner F, Bareiss P, Steg G, Montalescot G, Monassier JP, Morel O. Prehospital abciximab in ST-segment elevation myocardial infarction: results of the randomized, double-blind MISTRAL study. Circ Cardiovasc Interv. 2012 Feb 1;5(1):69-76, S1. doi: 10.1161/CIRCINTERVENTIONS.111.961425. Epub 2012 Feb 7.

name: From the Pôle d'Activité Médico-Chirurgicale Cardiovasculaire (P.O., O.M., M.Z., F.B., P.B.) and SAMU 67 (P.R., J.C.B., A.W.), Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, France; Service de cardiologie (L.J., J.P.M.) and SAMU 68 (O.W.), Hôpital de Mulhouse, France; SAMU 93, Hôpital Avicenne, Bobigny, France (F.A., F.L.); Clinique de la Roseraie, 93300 Aubervilliers, France (C.G., E.S., H.B.); Centre Cardiologique du Nord, 93200 St Denis, France (P.G., B.C.); Hôpital Montfermeil,...

family: Ohlmann

full_name: Patrick Ohlmann

given: Patrick

family: Reydel

full_name: Philippe Reydel

given: Philippe

family: Jacquemin

full_name: Laurent Jacquemin

given: Laurent

family: Adnet

full_name: Frédéric Adnet

given: Frédéric

family: Wolf

full_name: Olivier Wolf

given: Olivier

family: Bartier

full_name: Jean-Claude Bartier

given: Jean-Claude

family: Weiss

full_name: Anne Weiss

given: Anne

family: Lapostolle

full_name: Frédéric Lapostolle

family: Gaultier

full_name: Cédric Gaultier

given: Cédric

family: Salengro

full_name: Emmanuel Salengro

given: Emmanuel

family: Benamer

full_name: Hakim Benamer

given: Hakim

family: Guyon

full_name: Philippe Guyon

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

family: Catan

full_name: Simon Catan

given: Simon

family: Ecollan

full_name: Patrick Ecollan

family: Chouihed

full_name: Tahar Chouihed

given: Tahar

family: Angioi

full_name: Michael Angioi

given: Michael

family: Zupan

full_name: Michel Zupan

family: Bronner

full_name: François Bronner

given: François

family: Bareiss

full_name: Pierre Bareiss

given: Pierre

family: Steg

full_name: Gabriel Steg

given: Gabriel

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Monassier

full_name: Jean-Pierre Monassier

given: Jean-Pierre

title: Prehospital Abciximab in ST-Segment Elevation Myocardial Infarction

location_facility: Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière


type: Registry Identifier

title: Assessment of the Feasibility and Quality of the Consultation by TeleConsultation in Pediatric Anesthesia in the Context of the Covid 19 Pandemic

acronym: TéléCCCAP

summary: Teleconsultation (TLC) being a new method of anesthesia consultation, deployed as an emergency in healthcare facilities in the Covid context, it has never been evaluated either in terms of feasibility or in terms of quality. An initial assessment will highlight the pitfalls and difficulties encountered and suggest areas for improvement.

lead_sponsor: University Hospital, Toulouse


title: Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons

acronym: DysGeMet

summary: Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls


title: Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy

summary:
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material.

The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

lead_sponsor: Meccellis Biotech

location_facility:
CHU Nantes Hôtel Dieu
CHU Estaing
Hôpital Haut-Lévèque- CHU de Bordeaux


title: Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection.

summary:
Context: Until 70% of thrombotic event are reported during Sars-CoV2 infection. Antiphospholipid antibodies (aPL) tests are often positive. We aim to determine if aPL positivity is involved in thrombose of Sars-CoV2 infection investigating the effect of aPL on thrombin generation (TG) and leucocyte pathway activation (neutrophils extracellular traps (NETs) and activation of triggering receptor expressed on myeloid cells 1 (TREM-1)).

Method: We will compare plasma from five groups of subjects: patients with antiphospholipid syndrome (APS) and patients hospitalized for Sars-CoV-2 infection with or without aPL, and as control, patients with acute venous thromboembolism event and healthy volunteers. For each subject, we will analyze aPL, activated protein C (APC) resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps (NETs) and soluble triggering receptor expressed on myeloid cells one (sTREM-1). We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event.

Results: we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS. Also, we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS.

Conclusion: our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19.

ReferenceCitation: Bowles L, Platton S, Yartey N, Dave M, Lee K, Hart DP, MacDonald V, Green L, Sivapalaratnam S, Pasi KJ, MacCallum P. Lupus Anticoagulant and Abnormal Coagulation Tests in Patients with Covid-19. N Engl J Med. 2020 Jul 16;383(3):288-290. doi: 10.1056/NEJMc2013656. Epub 2020 May 5.

ReferenceCitation: Zuily S, de Laat B, Guillemin F, Kelchtermans H, Magy-Bertrand N, Desmurs-Clavel H, Lambert M, Poindron V, de Maistre E, Dufrost V, Risse J, Shums Z, Norman GL, de Groot PG, Lacolley P, Lecompte T, Regnault V, Wahl D. Anti-Domain I β2-Glycoprotein I Antibodies and Activated Protein C Resistance Predict Thrombosis in Antiphospholipid Syndrome: TAC(I)T Study. J Appl Lab Med. 2020 Nov 1;5(6):1242-1252. doi: 10.1093/jalm/jfaa072.

ReferenceCitation: Yalavarthi S, Gould TJ, Rao AN, Mazza LF, Morris AE, Núñez-Álvarez C, Hernández-Ramírez D, Bockenstedt PL, Liaw PC, Cabral AR, Knight JS. Release of neutrophil extracellular traps by neutrophils stimulated with antiphospholipid antibodies: a newly identified mechanism of thrombosis in the antiphospholipid syndrome. Arthritis Rheumatol. 2015 Nov;67(11):2990-3003. doi: 10.1002/art.39247.

ReferenceCitation: Edel Y, Kliminski V, Pokroy-Shapira E, Oren S, Dortort Lazar A, Pri-Paz Basson Y, Egbaria M, Molad Y. Elevated plasma level of soluble triggering receptor expressed on myeloid cells-1 is associated with inflammation activity and is a potential biomarker of thrombosis in primary antiphospholipid syndrome. Arthritis Res Ther. 2019 Jan 7;21(1):10. doi: 10.1186/s13075-018-1779-5.

ipd_sharing: Yes


title: Évaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)

acronym: CHF-COV-P

summary:
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COV Preserved study is to identify congestion markers (clinical, biological and ultrasound) in day hospitalization for the monitoring of chronic HF with preserved left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.

primary_purpose: Diagnostic


title: Impact of SARSCoV2 on Allogeneic Stem Cell Transplantation Organization : a French Experience

acronym: covidallo

summary: the SARS-CoV2 pandemic has led to a major reorganization of the French Hematology and stem cell transplant departments since march 2020. Since the allogeneic stem cell transplant cannot be delayed especially when patients with hematological malignancies are in a fragile remission, risking relapse at any time, the necessity to maintain safe hematopoietic stem cell (HSC) donations from match unrelated or family donors appears rapidly mandatory during the pandemic period. To increase the safety of voluntary donations, a SARS-CoV2 Polymerase Chain Reaction test has been recommended to donors by regulatory agencies. However, due to the lack of homogeneity of care at European level, some countries do not require SARS-CoV-2 testing in asymptomatic donors. In this case, the test is performed on additional EDTA tube accompanying the graft on arrival or in the case of a missing tube (not collected or forgotten), on few milliliters of the HSC graft. This circuit had the consequence of forcing the clinicians to wait for the test result before starting the patient's conditioning regimen. The graft being already collected and received at the transplant center, and the conditioning regimen lasting on an average of 5 days, this resulted in its conservation during this minimum period and therefore its freezing by the associated cell therapy unit. However, this practice has so far been exceptional regarding allogeneic transplants, which are primarily freshly infused to ensure to the recipient the highest viability and functionality of stem cells. Since the entire freezing-thawing and washing process may impact cell viability and delay the patient's aplastic recovery, this study aimed to analyze the results of one year of allogeneic transplants infused after freezing in terms of graft quality after thawing and clinical consequences.


title: Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology

summary:
Bronchospasm during anaesthesia is a rare but potentially life-threatening event. They are classically part of IgE-dependent anaphylaxis but can also occur as an independent clinical entity, triggered by inflammatory factors such as smoking, chronic bronchitis, asthma, overweight and mechanical factors such as tracheal intubation.

The etiological diagnosis is currently established during an allergy-anaesthesia consultation after skin testing for drugs used for induction of anaesthesia and antibiotic therapy when it is attributable.

The aim of this study was to determine the characteristics that differ between 2 groups: isolated non-allergic bronchospasm and bronchospasm as part of an immediate allergic hypersensitivity reaction.

location_facility: Dermato-allergology department of the Nancy University Hospital


title: Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency Department of the Nancy's University Hospital Between 2011 and 2020 : Indentify Children at Low Risk of Intra Abdominal Injuries

summary:
The aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC.

This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of developing visceral lesions. Then, a management could be proposed which would rationalize the use of additional examinations and would favor the monitoring and the clinical reassessment after the initial management of a minor trauma.

The study of the data will then aim to establish a composite score (anamnestic and clinical) of initial evaluation, from which could result a uniform management protocol (clinical, biological and imaging) of the minor BATiC, of the intermediate BATiC and the major BATiC, applicable to pediatric emergencies at the Nancy's Hospital.


title: Comparison of ARDS Caused by COVID-19 and Influenza

summary: Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being disordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.


title: Interest of Medial Partial Arthrodesis in Degenerative and Inflammatory Damage of Lisfranc Tarsometatarsal Joint.

summary:
Research Hypothesis: Lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate.

Objective of the study: To analyze the clinical and radiographic results in the medium term of arthrodesis of the Lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.

ipd_sharing_description: No sharing data


title: Molecular Characterization and Cellular Infection Capacity of Urinary Viral Particles Isolated From SARS-CoV-2 and Association With Proximal Tubular Dysfunction, in Hospitalized Patients With COVID-19

acronym: CovUrinePTD

summary: The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)

ReferenceCitation: Kormann R, Jacquot A, Alla A, Corbel A, Koszutski M, Voirin P, Garcia Parrilla M, Bevilacqua S, Schvoerer E, Gueant JL, Namour F, Levy B, Frimat L, Oussalah A. Coronavirus disease 2019: acute Fanconi syndrome precedes acute kidney injury. Clin Kidney J. 2020 Jun 8;13(3):362-370. doi: 10.1093/ckj/sfaa109. eCollection 2020 Jun.


title: Development and Validation of a French Scale Measuring Preoperative Expectations of Parkinson's Disease Patients Candidate to Deep Brain Stimulation : the DBS-PS (Deep Brain Stimulation Perception Scale)

summary: Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. dysfunctional expectations for the result of neurosurgery, could interfere with postoperative result of DBS, even in case of motor improvement. Recent literature highlights the necessity to take these preoperative expectations into account, but to our knowledge, no specific scale investigating these cognitions in this PD-specific condition is available. So, the investigators developped the DBS-PS, a self-scale constructed to measure preoperative expectations for DBS, with 11 questions and visuo-analogical responses (1 to 10), theorically divided in three domains investigating the expectations concerning symptoms of PD, postoperative social-life and leisures, and postoperative familial and marital sphere. The investigators would like to validate this new-developped scale in the preoperative subthalamic nucleus deep brain stimulation population through patients recruited in the Predistim study, whereas the investigators did not recruite sufficiently patients through the PsyParkinson study, the one in which the DBS-PS scale was developed. The DBS-PS constitutes an interesting basis for the consideration of these cognitive and affective factors in preoperative PD patients.


title: Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients

acronym: ICODE

summary:
PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty.

METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).


title: Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy

summary:
To assess the efficacy of skin tests with platinum salts in patients suspects with immediate hypersensitivity reactions.

All patients adressed in consultation to the Allergy Department of university hospital of nancy for an immediate hypersensitivity reaction to platinum salts between 2015 and 2021 were retrospectively recruited.


title: Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)

acronym: IPMN

summary:
Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.

IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.

Pancreatic surgery remains invasive with high morbidity and mortality rates.


title: Monitoring of Patients With Chronic Respiratory Failure Traeted With Non-invasive Home Ventilation: Contribution of New Monitoring Tools

summary: Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.


title: Structural Cartography of the Insula in Temporal Epilepsy Patients

acronym: CON-INSULA

summary: The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.


title: Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse (STAMP-2 : STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2)

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

Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition.

More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia.

The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia.

The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.


title: SMART Identification of Ventricular Tachycardia Isthmus

acronym: SMARTIS

summary:
Context :

Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps.

The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive.

The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method.

Hypothesis :

The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc…) without the need for a reference recording of the clinical VT of the patient.


title: Diagnoses Associated With Persistent Elevation of Creatine Kinase

summary: Serum creatinine kinase (CK) level varies with age, gender, race and physical activity. For these reasons there is no normal serum CK level. Many pathological situations cause hyperCKemia, such as neuromuscular disorders (muscular dystrophy, inflammatory myositis, mitochondrial myopathy) and multiple systemic causes. The diagnostic approach to pauci or asymtomatic hyperCKemia can therefore be difficult and lead to multiple, and sometimes invasive tests, such as muscle biopsy. This study aims to describe the diagnoses associated with persistent elevation of serum creatine kinase and to precise the role of the muscule biopsy.


title: VOLTage Mapping in Atrial Fibrillation

acronym: VOLT-AF

summary:
The purpose of this study is to retrospectively analyze electroanatomical data collected during persistent atrial fibrillation ablation procedures, combined with pre-ablation cardiac CT data, in order to:

define a new method for quantifying left atrial voltage in atrial fibrillation via a total energy map instead of a peak-to-peak amplitude map
confirm the association between epicardial fat localization and atrial conduction slowing


title: Predictive Value of D-dimers Trends and Levels for Thrombosis in Patients With COVID-19

acronym: TRENDS

summary:
A high incidence of venous thromboembolic events (VTE) has been demonstrated in COVID-19. This incidence correlates with disease severity. Activation of coagulation secondary to sepsis combined with classical thrombotic risk factors may contribute to this prothrombotic state. Since the beginning of March 2020, the issue of venous thrombosis during SARS-CoV-2 infection has rapidly emerged as a major medical challenge since a significant rate of patients were thrombosing, some of them in spite of a well conducted preventive anticoagulation. Although D-dimers have been shown to be useful in identifying patients at risk of severe COVID-19 and even mortality, they cannot be used for diagnostic exclusion of pulmonary embolism. Indeed, since D-dimer levels rise non-specifically during infectious states, the exclusion threshold of 500 ng/ml cannot be used.

It would therefore be useful to study the predictive value of D-dimers for thrombosis in COVID-19 patients.


title: Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation

acronym: CELPerCutCHC

summary:
Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting.

The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.


title: Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years

summary:
This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.

The hydroxyapatite has a local effect which can improve cortical index.