title: Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old

acronym: HUMERUS

summary:
Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates.

The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.

ReferenceCitation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

oa_host_type: repository

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

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Teesside University - TeesRep

repository_institution: Teesside University - Teesside University Research Portal

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
Pure (Denmark)
research.tees.ac.uk/ws/oai

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard


title: Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

acronym: PCNET

summary:
Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.

Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Moulier V, Fonteille V, Pelegrini-Issac M, Cordier B, Baron-Laforet S, Boriasse E, Durand E, Stoleru S. A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia. Int J Offender Ther Comp Criminol. 2012 Feb;56(1):50-60. doi: 10.1177/0306624X10392191. Epub 2011 Apr 24.

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

collaborators: Ministry of Higher Education and Research, France

location_facility: Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse

location_facility: Federation d'Endocrinologie, Hopital NeuroCardiologique

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Feasibility and Interest of Early Eye-Movement Desensitization and Reprocessing Provided in the Emergency Department for Patients With High Risk of Post Traumatic Syndrome

acronym: EMDR-ED

summary: Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and with daily life quality impairment. The investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of these symptoms

study_start_date_type: Actual

status: Completed

primary_purpose: Prevention

enrollment_type: Actual

ReferenceCitation: Gil-Jardine C, Evrard G, Al Joboory S, Tortes Saint Jammes J, Masson F, Ribereau-Gayon R, Galinski M, Salmi LR, Revel P, Regis CA, Valdenaire G, Lagarde E. Emergency room intervention to prevent post concussion-like symptoms and post-traumatic stress disorder. A pilot randomized controlled study of a brief eye movement desensitization and reprocessing intervention versus reassurance or usual care. J Psychiatr Res. 2018 Aug;103:229-236. doi: 10.1016/j.jpsychires.2018.05.024. Epub 2018 May 26.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing: Yes

lead_sponsor: University Hospital, Bordeaux

location_facility: Emergency department, Bordeaux University Hospital

intervention_type: Other

status_simplified: Completed


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.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceType: background

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. doi: 10.1027/0227-5910.28.2.89.

ReferenceCitation: du Roscoat 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.

ReferenceCitation: Warnet S. [New national program for the prevention of suicide]. Rev Infirm. 2011 Nov;(175):4. No abstract available. French.

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. doi: 10.1197/jamia.M1460. 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. doi: 10.3402/ijch.v68i3.18328.

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. doi: 10.1017/S003329170600780X. Epub 2006 May 17.

ReferenceCitation: Chabaud F, Debarre J, Serazin C, Bouet R, Vaiva 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. No abstract available.

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, Lonnqvist J, Michel K, Pommereau X, Querejeta I, Phillipe I, Salander-Renberg E, Temesvary 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. doi: 10.1111/j.1600-0447.1996.tb10656.x.

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: Turmaine K, Dumas A, Chevreul K; PRINTEMPS Consortium. Conditions for the Successful Integration of an eHealth Tool "StopBlues" Into Community-Based Interventions in France: Results From a Multiple Correspondence Analysis. J Med Internet Res. 2022 Apr 22;24(4):e30218. doi: 10.2196/30218.

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

host_type: repository

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: JMIR Publications

ReferenceCitation: Gandre 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.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

ipd_sharing: Undecided

collaborators: Centre Collaborateur OMS pour la recherche et la formation en santé mentale

collaborators: Institut de Recherche en Santé Publique, France

collaborators: UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch

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

location_facility: Faculté de Médecine Paris Diderot Paris 7


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.

ReferenceCitation: Gosselin A, Carillon S, Coulibaly K, Ridde V, Taeron C, Kohou V, Zoumenou I, Mbiribindi R, Derche N, Desgrees du Lou 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.

ipd_sharing: No

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

collaborators: Agence Regionale de Sante d'Ile de France

intervention_type: Behavioral


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.

study_type: Observational

time_perspective: Prospective

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: 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.

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.

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_concat: PubMed Central;figshare.com

publisher_dissemination: Public Library of Science

lead_sponsor: CHU de Reims

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

location_facility: Centre Hospitalier Universitaire de Reims


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

sponsor_collaborators:
Rennes University Hospital
IMT Atlantique Nantes - France
Université de Caen Normandie
Université Rennes 1 - France

appel_a_projets: PREPS

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: ORGAGENE

titre: Examen des caractéristiques génétiques d'une personne : identification et optimisation des organisations

discipline_principale: génétique

nom_porteur: Pasquier

prenom_porteur: Laurent


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

appel_a_projets: PHRCI

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: TéléCCCAP

titre: Evaluation de la faisabilité et de la qualité de consultation parTéléConsultation en Anesthésie Pédiatrique en Contexte de pandémie Covid 19.

discipline_principale: anesthésie pédiatrique anesthésie pédiatrique , téléconsultation , faisabilité , sécurité , qualité

nom_porteur: KERN

prenom_porteur: Delphine


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.

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: Physidia

lead_sponsor_type: industriel


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.

sponsor_collaborators:
University Hospital, Strasbourg, France
Eli Lilly and Company

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


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. doi: 10.1542/peds.2006-0565.

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):120. No abstract available.

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.

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.

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. doi: 10.1054/bjps.2001.3593.

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, Astruc D, Biran V, Marcus L, Flamein F, Le Bouedec S, Guillois B, Remichi R, Harbi F, Durrmeyer X, Casagrande F, Le Sache N, Todorova D, Bilal A, Olivier D, Reynaud A, Jacquin C, Roze JC, Layese R, Danan C, Jung C, Decobert F, Audureau E. An educational programme in neonatal intensive care units (SEPREVEN): a stepped-wedge, cluster-randomised controlled trial. Lancet. 2022 Jan 22;399(10322):384-392. doi: 10.1016/S0140-6736(21)01899-7.

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.

license: cc-by-nc

license_normalized: cc-by-nc

evidence: open (via page says license)

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Dr Caeymaex Laurence

sponsor_collaborators:
Dr Caeymaex Laurence
Paris 12 Val de Marne University
Ministry of Health, France

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

region: Île-de-France

nom_etablissement: CENTRE HOSPITALIER INTERCOM DE CRETEIL

acronyme: SEPADVEN

titre: Etude épidémiologique sur les évènements indésirables en réanimation néonatale. Evaluation de l'efficacité d'une intervention multi-facette sur la réduction du taux des évènements indésirables

discipline_principale: néonatalogie

nom_porteur: CAEYMAEX

prenom_porteur: Laurence


type: Other Identifier

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, Peoc'h M, Ginevra C, Andreoletti L, Pozzetto B, Pillet S. Enterovirus in arteriosclerosis: a pilot study. J Clin Virol. 2007 Jun;39(2):106-12. doi: 10.1016/j.jcv.2007.03.014. Epub 2007 May 10.

ReferenceCitation: Andreoletti L, Venteo 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. doi: 10.1016/j.jacc.2007.07.080. Epub 2007 Nov 19.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

intervention_type: Procedure


title: Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.

acronym: UniEndo

summary: To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.

ReferenceCitation: Arendrup M, Jensen IP, Justesen T. Diagnosing bacteremia at a Danish hospital using one early large blood volume for culture. Scand J Infect Dis. 1996;28(6):609-14. doi: 10.3109/00365549609037969.

ReferenceCitation: Dargere S, Parienti JJ, Roupie E, Gancel PE, Wiel E, Smaiti N, Loiez C, Joly LM, Lemee L, Pestel-Caron M, du Cheyron D, Verdon R, Leclercq R, Cattoir V; UBC study group. Unique blood culture for diagnosis of bloodstream infections in emergency departments: a prospective multicentre study. Clin Microbiol Infect. 2014 Nov;20(11):O920-7. doi: 10.1111/1469-0691.12656. Epub 2014 Jun 14.

ReferenceCitation: The 2015 ESC Guidelines for the management of infective endocarditis. Eur Heart J. 2015 Nov 21;36(44):3036-7. doi: 10.1093/eurheartj/ehv488.

ReferenceCitation: Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis. 2000 Apr;30(4):633-8. doi: 10.1086/313753. Epub 2000 Apr 3.

lead_sponsor: Central Hospital, Nancy, France

location_facility: Centre Hospitalier universitaire de Dijon

location_facility: Centre hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Univesitaire de Rennes

location_facility: Centre Hospitalier universitaire de Besançon


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

status: Recruiting

lead_sponsor: Santen SAS

location_facility: Institut Ophtalmologique Ouest Jules Verne

location_facility: Hopitaux Universitaires Paris-Sud - Hopital Bicetre

status_simplified: Ongoing


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


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. doi: 10.1136/bmj.325.7374.1207.

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. doi: 10.1016/j.socscimed.2007.08.031. 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. doi: 10.1521/pedi.2006.20.5.450.

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. doi: 10.1001/archpsyc.63.7.757. 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. doi: 10.1521/pedi.2006.20.5.482.

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. doi: 10.1176/ajp.156.10.1563.

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. doi: 10.1017/s003329179800765x.

ReferenceCitation: Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.

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. doi: 10.1136/bmj.38579.455266.E0. 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-Garcia 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.

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

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

publisher_dissemination: Springer

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.

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.

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

ReferenceCitation: Hawton K, Fagg J, Platt S, Hawkins M. Factors associated with suicide after parasuicide in young people. BMJ. 1993 Jun 19;306(6893):1641-4. doi: 10.1136/bmj.306.6893.1641.

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. doi: 10.1016/j.cct.2005.11.003. Epub 2006 Feb 7.

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. doi: 10.1016/j.jadohealth.2004.01.016.

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(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.

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

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

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.

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

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

titre: Rester connecté avec les adolescents suicidants : impact sur la récidive - Essai randomisé contrôlé


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

time_perspective: Retrospective


title: Lung Cancer Screening by Low Dose CT Scan in a French Department (DEP KP80)

summary:
Lung cancer is the leading cause of cancer death worldwide. The aims of this study were to assess the feasibility and effectiveness of a lung cancer screening pilot program with LD CT scan in a French department (Somme).

DEP KP80 was a single-arm, prospective study started in May 2016. The inclusion criteria were those of the National Lung Screening Trial. An annual LD CT scan was scheduled and 2 rounds were planned. Smoking cessation was encouraged as part of the protocol.

Subjects were selected by General Practitioner or Pneumologist who checked the inclusion criteria and prescribed the CT scan.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier d'Abbeville


title: National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis

acronym: ALTITUDES

summary: The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.

status: Active, not recruiting

primary_purpose: Other

ReferenceCitation: Penel N, Bonvalot S, Bimbai AM, Meurgey A, Le Loarer F, Salas S, Piperno-Neumann S, Chevreau C, Boudou-Rouquette P, Dubray-Longeras P, Kurtz JE, Guillemet C, Bompas E, Italiano A, Le Cesne A, Orbach D, Thery J, Le Deley MC, Blay JY, Mir O. Lack of Prognostic Value of CTNNB1 Mutation Profile in Desmoid-Type Fibromatosis. Clin Cancer Res. 2022 Sep 15;28(18):4105-4111. doi: 10.1158/1078-0432.CCR-21-4235.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Ligue contre le cancer, France
Institut Curie
Hôpital de la Timone

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut Curie Département Oncologie Pédiatrique

location_facility: Institut de Cancérologie de l'Ouest - Paul Papin

location_facility: Hôpital la Timone Service Oncologie Médicale

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

location_facility: Hôpital la Timone Enfants Service Oncologie Pédiatrique

location_facility: Institut Curie Département Oncologie Médicale


title: Development of Tools for Respiration and Circulation Studies and Exploration, Their Mutual Interactions and the Functions Involved in the Daily Life in Healthy Volunteers

acronym: MAPO-RCVQ

summary: This study is aimed to develop analysis methods and measurements tools for physiological variables : respiration, circulation and their mutual interactions and with the functions involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...). The devices that are used are non invasive. The development of these tools needs to be validated on physiological signals obtained in healthy volunteers.

ReferenceCitation: Fiamma MN, Straus C, Thibault S, Wysocki M, Baconnier P, Similowski T. Effects of hypercapnia and hypocapnia on ventilatory variability and the chaotic dynamics of ventilatory flow in humans. Am J Physiol Regul Integr Comp Physiol. 2007 May;292(5):R1985-93. doi: 10.1152/ajpregu.00792.2006. Epub 2007 Jan 11.

ReferenceCitation: Ben Lamine S, Calabrese P, Perrault H, Dinh TP, Eberhard A, Benchetrit G. Individual differences in respiratory sinus arrhythmia. Am J Physiol Heart Circ Physiol. 2004 Jun;286(6):H2305-12. doi: 10.1152/ajpheart.00655.2003. Epub 2004 Jan 29.

ReferenceCitation: Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol. 2001;499:489-94. doi: 10.1007/978-1-4615-1375-9_79. No abstract available.

ReferenceCitation: Emeriaud G, Eberhard A, Benchetrit G, Debillon T, Baconnier P. Calibration of respiratory inductance plethysmograph in preterm infants with different respiratory conditions. Pediatr Pulmonol. 2008 Nov;43(11):1135-1141. doi: 10.1002/ppul.20923.

ReferenceCitation: Fontecave-Jallon, Gumery P-Y, Calabrese P, Briot R, Baconnier P. A wearable technology revisited for cardio-respiratory functional exploration : Stroke volume estimation form respiratory inductive plethysmography. International journal of eHealth and Medical Communications, 4, 2013

lead_sponsor: University Hospital, Grenoble

collaborators: Centre National de la Recherche Scientifique, France

location_facility:
University Hospital
TIMC - pavillon Taillefer - CHU


title: Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

acronym: CO-RNPC

summary:
During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption.

The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).


title: Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4 in Bordeaux Urban Area, June 2011: Evaluation of Diagnostic, Prognostic and Pathophysiological Data

acronym: SHU O104 CUB

summary:
The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli of the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by its preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the kidneys, brain, liver, pancreas, and skin.

Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in adults who are usually not involved in typical E. coli O157H7 HUS.

The aim of the present study is to gain knowledge on these different aspects of the HUS, including response to therapy.

location_facility: Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin


title: Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years

acronym: PROOF

summary:
The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population.

This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired population, but should these levels decline overtime, to use this as a predictor of cardiovascular and cerebrovascular events, taking into account established cardiovascular risk factors.

ReferenceCitation: Roche F, Gaspoz JM, Da Costa A, Isaaz K, Duverney D, Pichot V, Costes F, Lacour JR, Barthelemy JC. Frequent and prolonged asymptomatic episodes of paroxysmal atrial fibrillation revealed by automatic long-term event recorders in patients with a negative 24-hour Holter. Pacing Clin Electrophysiol. 2002 Nov;25(11):1587-93. doi: 10.1046/j.1460-9592.2002.01587.x.

ReferenceCitation: Pichot V, Buffiere S, Gaspoz JM, Costes F, Molliex S, Duverney D, Roche F, Barthelemy JC. Wavelet transform of heart rate variability to assess autonomic nervous system activity does not predict arousal from general anesthesia. Can J Anaesth. 2001 Oct;48(9):859-63. doi: 10.1007/BF03017350.

ReferenceType: result

ReferenceCitation: Barthelemy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28. doi: 10.1159/000108914.

ReferenceCitation: Gosse P, Roche F, Dauphinot V, Maudoux D, Pichot V, Barthelemy JC. Components of arterial stiffness in a population of 65-year-old subjects: PROOF study. J Hypertens. 2008 Jun;26(6):1138-46. doi: 10.1097/HJH.0b013e3282fa142b.

ReferenceCitation: Rouch I, Anterion CT, Dauphinot V, Kerleroux J, Roche F, Barthelemy JC, Laurent B. Cognitive complaints, neuropsychological performance and affective disorders in elderly community residents. Disabil Rehabil. 2008;30(23):1794-802. doi: 10.1080/09638280701667825.

ReferenceCitation: Hupin D, Raffin J, Barth N, Berger M, Garet M, Stampone K, Celle S, Pichot V, Bongue B, Barthelemy JC, Roche F. Even a Previous Light-Active Physical Activity at Work Still Reduces Late Myocardial Infarction and Stroke in Retired Adults Aged>65 Years by 32%: The PROOF Cohort Study. Front Public Health. 2019 Mar 19;7:51. doi: 10.3389/fpubh.2019.00051. eCollection 2019.

publisher_dissemination: Frontiers

ReferenceCitation: Sforza E, Millasseau S, Hupin D, Barthelemy JC, Roche F. Arterial stiffness alteration and obstructive sleep apnea in an elderly cohort free of cardiovascular event history: the PROOF cohort study. Sleep Breath. 2019 Mar;23(1):201-208. doi: 10.1007/s11325-018-1683-x. Epub 2018 Jun 26.

ReferenceCitation: Celle S, Boutet C, Annweiler C, Barthelemy JC, Roche F. Sleep apnoea in the asymptomatic elderly: a real issue for the brain? Eur Respir J. 2018 Jun 14;51(6):1702450. doi: 10.1183/13993003.02450-2017. Print 2018 Jun.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ReferenceCitation: Monneret D, Barthelemy JC, Hupin D, Maudoux D, Celle S, Sforza E, Roche F. Serum lipid profile, sleep-disordered breathing and blood pressure in the elderly: a 10-year follow-up of the PROOF-SYNAPSE cohort. Sleep Med. 2017 Nov;39:14-22. doi: 10.1016/j.sleep.2017.07.028. Epub 2017 Sep 18.

ReferenceCitation: Saint Martin M, Labeix P, Garet M, Thomas T, Barthelemy JC, Collet P, Roche F, Sforza E. Does Subjective Sleep Affect Bone Mineral Density in Older People with Minimal Health Disorders? The PROOF Cohort. J Clin Sleep Med. 2016 Nov 15;12(11):1461-1469. doi: 10.5664/jcsm.6266.

oa_colors: green other

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Sforza E, Saint Martin M, Thomas T, Collet P, Garet M, Barthelemy JC, Roche F. Risk factors of osteoporosis in healthy elderly with unrecognized obstructive sleep apnea: role of physical activity. Sleep Med. 2016 Jun;22:25-32. doi: 10.1016/j.sleep.2016.04.010. Epub 2016 Jun 7.

ReferenceCitation: Sforza E, Saint Martin M, Barthelemy JC, Roche F. Mood disorders in healthy elderly with obstructive sleep apnea: a gender effect. Sleep Med. 2016 Mar;19:57-62. doi: 10.1016/j.sleep.2015.11.007. Epub 2015 Nov 25.

ReferenceCitation: Boutet C, Vassal F, Celle S, Schneider FC, Barthelemy JC, Laurent B, Barral FG, Roche F. Incidental findings on brain magnetic resonance imaging in the elderly:the PROOF study. Brain Imaging Behav. 2017 Feb;11(1):293-299. doi: 10.1007/s11682-016-9519-4.

ReferenceCitation: Sforza E, Celle S, Saint-Martin M, Barthelemy JC, Roche F. Hippocampus volume and subjective sleepiness in older people with sleep-disordered breathing: a preliminary report. J Sleep Res. 2016 Apr;25(2):190-3. doi: 10.1111/jsr.12367. Epub 2015 Dec 14.

ReferenceCitation: Sforza E, Pichot V, Martin MS, Barthelemy JC, Roche F. Prevalence and determinants of subjective sleepiness in healthy elderly with unrecognized obstructive sleep apnea. Sleep Med. 2015 Aug;16(8):981-6. doi: 10.1016/j.sleep.2015.03.010. Epub 2015 Apr 15.

ReferenceCitation: Sforza E, Sabri M, DaCosta A, Isaaz K, Barthelemy JC, Roche F. Echocardiographic Findings in Healthy Elderly People with Unrecognized Sleep Disordered Breathing. J Clin Sleep Med. 2015 Sep 15;11(9):975-80. doi: 10.5664/jcsm.5006.

ReferenceCitation: Saint Martin M, Roche F, Thomas-Anterion C, Barthelemy JC, Sforza E; PROgnostic OF cardiovascular and cerebrovascular events study group. Eight-year parallel change in baroreflex sensitivity and memory function in a sample of healthy older adults. J Am Geriatr Soc. 2015 Feb;63(2):270-5. doi: 10.1111/jgs.13252. Epub 2015 Feb 2.

ReferenceCitation: Martin MS, Sforza E, Roche F, Barthelemy JC, Thomas-Anterion C; PROOF study group. Sleep breathing disorders and cognitive function in the elderly: an 8-year follow-up study. the proof-synapse cohort. Sleep. 2015 Feb 1;38(2):179-87. doi: 10.5665/sleep.4392.

ReferenceCitation: Sforza E, Saint Martin M, Barthelemy JC, Roche F. Association of self-reported sleep and hypertension in non-insomniac elderly subjects. J Clin Sleep Med. 2014 Sep 15;10(9):965-71. doi: 10.5664/jcsm.4026.

ReferenceCitation: Saint Martin M, Sforza E, Thomas-Anterion C, Barthelemy JC, Roche F; PROOF Study Group. Baroreflex sensitivity, vascular risk factors, and cognitive function in a healthy elderly population: the PROOF cohort. J Am Geriatr Soc. 2013 Dec;61(12):2096-2102. doi: 10.1111/jgs.12548. Epub 2013 Nov 26.

ReferenceCitation: Sforza E, Thomas T, Barthelemy JC, Collet P, Roche F. Obstructive sleep apnea is associated with preserved bone mineral density in healthy elderly subjects. Sleep. 2013 Oct 1;36(10):1509-15. doi: 10.5665/sleep.3046.

ReferenceCitation: Martin MS, Sforza E, Barthelemy JC, Thomas-Anterion C, Roche F. Sleep perception in non-insomniac healthy elderly: a 3-year longitudinal study. Rejuvenation Res. 2014 Feb;17(1):11-8. doi: 10.1089/rej.2013.1457.

ReferenceCitation: Chouchou F, Pichot V, Pepin JL, Tamisier R, Celle S, Maudoux D, Garcin A, Levy P, Barthelemy JC, Roche F; PROOF Study Group. Sympathetic overactivity due to sleep fragmentation is associated with elevated diurnal systolic blood pressure in healthy elderly subjects: the PROOF-SYNAPSE study. Eur Heart J. 2013 Jul;34(28):2122-31, 2131a. doi: 10.1093/eurheartj/eht208. Epub 2013 Jun 11.

ReferenceCitation: Degache F, Sforza E, Dauphinot V, Celle S, Garcin A, Collet P, Pichot V, Barthelemy JC, Roche F; PROOF Study Group. Relation of central fat mass to obstructive sleep apnea in the elderly. Sleep. 2013 Apr 1;36(4):501-7. doi: 10.5665/sleep.2532.

ReferenceCitation: Dauphinot V, Rouch I, Kossovsky MP, Pichot V, Dorey JM, Krolak-Salmon P, Laurent B, Roche F, Barthelemy JC. Depressive symptoms and autonomic nervous system dysfunction in an elderly population-based study: the PROOF study. J Affect Disord. 2012 Dec 20;143(1-3):153-9. doi: 10.1016/j.jad.2012.05.045. Epub 2012 Aug 19.

ReferenceCitation: Sforza E, Gauthier M, Crawford-Achour E, Pichot V, Maudoux D, Barthelemy JC, Roche F. A 3-year longitudinal study of sleep disordered breathing in the elderly. Eur Respir J. 2012 Sep;40(3):665-72. doi: 10.1183/09031936.00133011. Epub 2012 Mar 9.

ReferenceCitation: Tonnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J. 2012 Sep;40(3):548-54. doi: 10.1183/09031936.00155811. Epub 2012 Feb 9.

ReferenceCitation: Assoumou HG, Bertholon F, Barthelemy JC, Pichot V, Celle S, Gosse P, Gaspoz JM, Roche F. Alteration of baroreflex sensitivity in the elderly: the relationship with metabolic syndrome components. Int J Cardiol. 2012 Mar 8;155(2):333-5. doi: 10.1016/j.ijcard.2011.12.050. Epub 2012 Jan 10. No abstract available.

ReferenceCitation: Sforza E, Chouchou F, Pichot V, Barthelemy JC, Roche F. Heart rate increment in the diagnosis of obstructive sleep apnoea in an older population. Sleep Med. 2012 Jan;13(1):21-8. doi: 10.1016/j.sleep.2011.04.011. Epub 2011 Nov 21.

ReferenceCitation: Dauphinot V, Barthelemy JC, Pichot V, Celle S, Sforza E, Achour-Crawford E, Gosse P, Roche F. Autonomic activation during sleep and new-onset ambulatory hypertension in the elderly. Int J Cardiol. 2012 Feb 23;155(1):155-9. doi: 10.1016/j.ijcard.2011.10.097. Epub 2011 Nov 9.

ReferenceCitation: Ntougou Assoumou HG, Pichot V, Barthelemy JC, Dauphinot V, Celle S, Collet P, Gaspoz JM, Roche F. Obesity-related autonomic nervous system disorders are best associated with body fat mass index, a new indicator. Int J Cardiol. 2011 Nov 17;153(1):111-3. doi: 10.1016/j.ijcard.2011.09.031. Epub 2011 Oct 2. No abstract available.

ReferenceCitation: Chouchou F, Sforza E, Celle S, Pichot V, Maudoux D, Garcin A, Barthelemy JC, Roche F; PROOF Study Group. Pulse transit time in screening sleep disordered breathing in an elderly population: the PROOF-SYNAPSE study. Sleep. 2011 Aug 1;34(8):1051-9. doi: 10.5665/SLEEP.1160.

ReferenceCitation: Castro-Lionard K, Thomas-Anterion C, Crawford-Achour E, Rouch I, Trombert-Paviot B, Barthelemy JC, Laurent B, Roche F, Gonthier R. Can maintaining cognitive function at 65 years old predict successful ageing 6 years later? The PROOF study. Age Ageing. 2011 Mar;40(2):259-65. doi: 10.1093/ageing/afq174. Epub 2011 Jan 20.

ReferenceCitation: Sforza E, Chouchou F, Collet P, Pichot V, Barthelemy JC, Roche F. Sex differences in obstructive sleep apnoea in an elderly French population. Eur Respir J. 2011 May;37(5):1137-43. doi: 10.1183/09031936.00043210. Epub 2010 Sep 3.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Detection of Usability Errors of a Medical Device Zeneo®

summary: The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
National Research Agency, France


title: Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis

summary:
To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.

Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.

At the third month, if the score for overall pain is still > 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).

ReferenceCitation: Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazieres B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.

lead_sponsor: Daiichi Sankyo, Inc.


title: Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves

summary: This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

ReferenceCitation: Azarnoush K, Pereira B, Duale C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.

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

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

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Edwards Lifesciences
Abbott Medical Devices
Sorin group, Italy
Ministry of Health, France


title: Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

summary: Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.

primary_purpose: Diagnostic

location_facility:
Hôpitaux Universitaires de Strasbourg
CHU de Besançon
CHU de Nancy


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. doi: 10.1172/JCI103323. No abstract available.

ReferenceCitation: Kraemer R, Schoni MH. Ventilatory inequalities, pulmonary function and blood oxygenation in advanced states of cystic fibrosis. Respiration. 1990;57(5):318-24. doi: 10.1159/000195864.

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: Jarenback 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. doi: 10.1183/09031936.03.00049502.

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. doi: 10.1183/09031936.94.07020318.

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.

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.

collaborators:
University Hospital, Limoges
Inotrem

sponsor_collaborators:
Central Hospital, Nancy, France
University Hospital, Limoges
Inotrem

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


title: Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial

acronym: AMBUSH

summary:
AMBUSH study is a multicenter randomized, controlled, open-label clinical trial (PROBE (Prospective Randomized Open Blinded End-point) type).

The main objective of AMBUSH study is to assess the effect of therapeutic management guided by pulmonary ultrasound and the assessment of the inferior vena cava in patients with heart failure seen in an ambulatory (outpatient) setting on a mixed clinical-biological endpoint (including variations of natriuretic peptides - NtProBNP) at 30 days.

location_facility:
CHRU de Nancy
CH de Mulhouse
CHU de Besançon
CHR de Metz
CHRU de Reims

region: Grand Est

nom_etablissement: CHRU DE NANCY

acronyme: AMBUSH

titre: Impact de la prise en charge thérapeutique de l'insuffisance cardiaque ambulatoire  guidée par l'échographie: Un essai clinique randomisé en ouvert

discipline_principale: aucune

nom_porteur: GIRERD

prenom_porteur: Nicolas


title: Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly

acronym: MAMI

summary: Society faces a major challenge with the management of the health and socio-economic burden caused by acute physical stress in the older population (>75 years). In particular, hip fracture (HF) represents a major health care preoccupation, affecting 1.6 M patients worldwide, resulting in a significant drop of life quality and autonomy. Nowadays, this trauma is still associated with a poor outcome of 20-30% one-year mortality in the elderly. This emphasizes the value of assessing biological factors that may predict clinical outcome after HF. The preliminary work pinpoints a central role of neopterin in loss of autonomy and death. Using HF as an acute stress model that accelerates the progressive course of aging, the aim is to validate neopterin as a predictive biomarker of pernicious clinical outcomes.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: GH Pitié-Salpêtrière / Service de gériatrie


title: Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.

summary:
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.

Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


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.

lead_sponsor: Centre hospitalier de Ville-Evrard, France


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: Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe

acronym: HOSPIVAC

summary:
In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.

Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.

lead_sponsor: Centre Hospitalier le Mans

intervention_type: Biological


title: Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers

acronym: CRESPI

summary:
CRESPI - RESPIratory health of Children in daycare

The CRESPI study, will be a cohort of 1500/2000 children attending daycare in Paris region, and will be initiated in November 2019.

The aim of the project is to study the impact of environmental exposures to cleaning products and disinfectants on respiratory health of infants and toddlers (< 3 years) in daycares

Two specific aims were defined:

evaluate environmental exposure to cleaning products by complementary and innovative tools: air quality measurements in daycares, specific standardized questionnaire, identification of compounds of the products via a database and a Smartphone application to scan bar codes and inform on product use
evaluate the impact of early exposure in daycares and at home on respiratory health of young children

study_start_date_type: Anticipated

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

collaborators: Centre Scientifique et Technique du Bâtiment

collaborators: Ecole des Hautes Etudes en Santé Publique

sponsor_collaborators: Agence Regionale de Sante d'Ile de France


summary: Tourette syndrome is rare. In France, about 3000 patients have a severe form of the disease. The aim of this study is to collect clinical characteristics in 200 patients with Tourette syndrome.

ReferenceCitation: Worbe Y, Mallet L, Golmard JL, Behar C, Durif F, Jalenques I, Damier P, Derkinderen P, Pollak P, Anheim M, Broussolle E, Xie J, Mesnage V, Mondon K, Viallet F, Jedynak P, Ben Djebara M, Schupbach M, Pelissolo A, Vidailhet M, Agid Y, Houeto JL, Hartmann A. Repetitive behaviours in patients with Gilles de la Tourette syndrome: tics, compulsions, or both? PLoS One. 2010 Sep 24;5(9):e12959. doi: 10.1371/journal.pone.0012959.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE


title: Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?

acronym: FERTI-EMBOL

summary:
Uterine leiomyomas (or fibroids) are a common disease (30% of women over 35 years of age) in women of childbearing age and can cause various symptoms such as menometrorrhagia, dysmenorrhoea, pelvic pain and heaviness, and infertility.

Uterine artery embolisation, first used in France in 1990, is a safe, effective and less invasive therapeutic technique than surgical treatment (myomectomy or hysterectomy), particularly in the case of numerous and large fibroids. This technique is validated by the French National College of Gynaecologists-Obstetricians (CNGOF) as an alternative treatment for women who do not wish to become pregnant (grade A recommendation), but at present there is little reliable data concerning fertility, the occurrence of pregnancy and the obstetrical prognosis after uterine artery embolisation for fibroids. A recent systematic review of the literature with meta-analysis published very recently showed that 40.5% of patients with a desire for pregnancy were able to become pregnant after embolisation (CI: 33.3%-48.2%) but that the rates of miscarriage, obstetric complications and low birth weight were not negligible (respectively 33.5% (95% CI: 26.3-41%), 25.4% (95% CI = 13-40.2%) and 10% (95% CI = 6.2-14.6%) (Ghanaati et al. 2020).

In France, uterine artery embolisation is performed in more than thirty centres in women who have completed their parental project. On the other hand, in the absence of consistent literature, it is performed in patients of childbearing age, when it represents the only acceptable alternative or in the event of contraindication or refusal of surgery by the patient. To our knowledge, there is no large-scale French study to date on the impact of embolisation on fertility and pregnancy outcomes.

The aim of this study is to compile a retrospective database of all cases of uterine artery embolisation for uterine pathology performed at the Georges-Pompidou European Hospital (HEGP) since 2007 and to assess the impact of embolisation on fertility in patients of childbearing age.

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

collaborators: Collège National des Gynécologues et Obstétriciens Français


title: Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera According to Conditions of Examination Execution: Assessment of Infarction or Ischemia, Injected Dye and Sequence of Injections

acronym: DSPECT

summary:
Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the presence and severity of abnormalities of myocardial perfusion, as well as the extension of infarction residua. However, actual imagery devices (gamma cameras) have low resolution and detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection sensitivity and could allow proportionally diminishing injected activities or recording times. Only one pilot study has been recently published on this type of camera, the D.SPECT camera.

This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the D.SPECT camera in terms of image quality.

location_facility: Service de Médecine Nucléaire, Clinique Louis Pasteur

location_facility: Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy

location_facility: Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris


title: Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women

acronym: PMAPT

summary:
This is a monocentric, retrospective, non-interventional study. The main objective is to describe the populations requesting assisted reproductive techniques (ART) with sperm donation ; and compare them between groups depending on their parental project..

The secondary objectives are to describe the center support process in the context of ART with sperm donation, to determine the initial/final orientation of support and the time to care The statistical analysis will be carried out to compare these parameters between groups depending on their parental project The study is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.


title: Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age

acronym: RAIPAo

summary: Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

intervention_type: Diagnostic Test


title: Pseudomonas Aeruginosa Infections Among COVID-19 Patients in Intensive Care Units at Nancy University Hospital During the First Three Epidemic Waves: a Retrospective Study (Pyo-COVID-3)

summary:
P. aeruginosa is an opportunistic bacterium known to be responsible for numerous healthcare-associated infections, particularly in intensive care units (ICU). The frequency of these infections seems to have increased during the first waves of the COVID-19 pandemic. Identifying cases of co-infection and secondary infections with P. aeruginosa in patients with COVID-19 would provide a better understanding of the epidemiological evolution and characteristics of infected patients.

Treatment of P. aeruginosa infections requires the use of antibiotics. Antibiotic resistance is a growing problem, with an increase in resistance among P. aeruginosa strains. The misuse of antibiotics to treat patients can accentuate the phenomenon of antibiotic resistance, and failure to take account of resistance revealed by antibiograms can compromise patient recovery. Analysis of bacteriological results and patient medical records would enable a posteriori evaluation of the proper use of antibiotics (choice and adaptation of molecules, doses and duration of prescriptions), and identify any areas for improvement.

The main objective is to describe the evolution of P. aeruginosa infections in ICU patients with COVID-19 during the first 3 waves of COVID-19 (01/03/2020 to 31/05/2021). Secondary objectives are to describe the typology of P. aeruginosa strains identified among included patients (sampling sites and resistance profiles), to assess antibiotic prescriptions for these patients and to describe the relapse rate of included patients with a first P. aeruginosa infection.

status: Not yet recruiting


title: A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation

acronym: COPAVEHDI

summary:
The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)

The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:

to be alive
without relapse of the hematological disease
without having required a new line of treatment for acute GVHD
without initiating a systemic treatment for chronic GVHD.


title: Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study

summary: Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

status: Suspended

lead_sponsor: Hopital Lariboisière


title: Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.

summary: P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Département de Gynécologie-Obstétrique - Hôpital de Hautepierre

location_facility: Service de Gynécologie-Obstétrique - Centre Hospitalier Général

location_facility: Service de gynécologie-obtétrique - Centre Hospitalier Général