title: Professional Rescuers Cardiopulmonary Resuscitation Performance After Implementation of a Defibrillation Algorithm for Early Treatment of Refibrillation, an Observational Study.

summary:
In the Paris (France) Medical Emergency system, in the early phase of Out-of-hospital Cardiac Arrest (OHCA), the treatment of a Ventricular Fibrillation (VF) consists of delivering an External Electric Shock (EES) by a rescuer with the use of an Automated External Defibrillator (AED). This latter realizes a cardiac rhythm analysis every two minutes. This analysis requires that chest compressions (CC) be interrupted for a while. However, CC interruptions are potentially harmful due to the brain, and heart perfusions decrease.

On the other hand, the recurrence of VF occurs mostly during the first minute after the shock, whereas the delay between 2 rhythm analysis is 2 minutes. The consequence is excessive time spent in VF, which is deleterious in terms of coronary and cerebral perfusion.

The investigator implements a new AED algorithm whose operating principle is as follows. One minute after an EES administration, the AED realizes a cardiac rhythm analysis during which the rescuers do not need to interrupt the chest compressions (CC): this is called the rhythm analysis " in presence of CC" The detection of a VF " in presence of CC " needs to be confirmed, " in absence of CC " The CC's are therefore interrupted for new rhythm analysis. Once the presence of VF is approved, the AED proposes a shock to be administred

The aim of the study

Study Design:

This is a prospective observational study.

The eligibility criteria are as follows:

Patients in Out-Of-Hospital Cardiac Arrest.
Basic Life support care with an AED.

The primary endpoint is the " chest-compression fraction (CCF) " that represents the CPR-time performance during the ten first minutes of BLS care ( or < 10 min in case of Return Of Spontaneus Circulation (ROSC))

ReferenceCitation: Baker PW, Conway J, Cotton C, Ashby DT, Smyth J, Woodman RJ, Grantham H; Clinical Investigators. Defibrillation or cardiopulmonary resuscitation first for patients with out-of-hospital cardiac arrests found by paramedics to be in ventricular fibrillation? A randomised control trial. Resuscitation. 2008 Dec;79(3):424-31. doi: 10.1016/j.resuscitation.2008.07.017. Epub 2008 Nov 4.

ReferenceCitation: Berdowski J, ten Haaf M, Tijssen JG, Chapman FW, Koster RW. Time in recurrent ventricular fibrillation and survival after out-of-hospital cardiac arrest. Circulation. 2010 Sep 14;122(11):1101-8. doi: 10.1161/CIRCULATIONAHA.110.958173. Epub 2010 Aug 30.

ReferenceCitation: Berdowski J, Tijssen JG, Koster RW. Chest compressions cause recurrence of ventricular fibrillation after the first successful conversion by defibrillation in out-of-hospital cardiac arrest. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):72-8. doi: 10.1161/CIRCEP.109.902114. Epub 2009 Dec 30.

ReferenceCitation: Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest. JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.

ReferenceCitation: Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002 Oct 17;347(16):1242-7.

ReferenceCitation: Cheskes S, Schmicker RH, Christenson J, Salcido DD, Rea T, Powell J, Edelson DP, Sell R, May S, Menegazzi JJ, Van Ottingham L, Olsufka M, Pennington S, Simonini J, Berg RA, Stiell I, Idris A, Bigham B, Morrison L; Resuscitation Outcomes Consortium (ROC) Investigators. Perishock pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Circulation. 2011 Jul 5;124(1):58-66. doi: 10.1161/CIRCULATIONAHA.110.010736. Epub 2011 Jun 20.

ReferenceCitation: Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.

ReferenceCitation: Fumagalli F, Silver AE, Tan Q, Zaidi N, Ristagno G. Cardiac rhythm analysis during ongoing cardiopulmonary resuscitation using the Analysis During Compressions with Fast Reconfirmation technology. Heart Rhythm. 2018 Feb;15(2):248-255. doi: 10.1016/j.hrthm.2017.09.003. Epub 2017 Sep 14.

ReferenceCitation: Gliner BE, White RD. Electrocardiographic evaluation of defibrillation shocks delivered to out-of-hospital sudden cardiac arrest patients. Resuscitation. 1999 Jul;41(2):133-44.

ReferenceCitation: Hasselqvist-Ax I, Riva G, Herlitz J, Rosenqvist M, Hollenberg J, Nordberg P, Ringh M, Jonsson M, Axelsson C, Lindqvist J, Karlsson T, Svensson L. Early cardiopulmonary resuscitation in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2307-15. doi: 10.1056/NEJMoa1405796.

ReferenceCitation: Hu Y, Tang H, Liu C, Jing D, Zhu H, Zhang Y, Yu X, Zhang G, Xu J. The performance of a new shock advisory algorithm to reduce interruptions during CPR. Resuscitation. 2019 Oct;143:1-9. doi: 10.1016/j.resuscitation.2019.07.026. Epub 2019 Aug 1.

ReferenceCitation: Jost D, Degrange H, Verret C, Hersan O, Banville IL, Chapman FW, Lank P, Petit JL, Fuilla C, Migliani R, Carpentier JP; DEFI 2005 Work Group. DEFI 2005: a randomized controlled trial of the effect of automated external defibrillator cardiopulmonary resuscitation protocol on outcome from out-of-hospital cardiac arrest. Circulation. 2010 Apr 13;121(14):1614-22. doi: 10.1161/CIRCULATIONAHA.109.878389. Epub 2010 Mar 29.

name: From the Service médical de la Brigade de Sapeurs-Pompiers de Paris, Paris, France (D.J., H.D., O.H., J.L.P., C.F., J.P.C.); Département d'Epidémiologie et de Santé Publique Nord, Ecole du Val-de-Grâce, Paris, France (D.J., C.V., R.M.); and Physio-Control, Redmond, Wash (I.L.B., F.W.C., P.L.).

family: Jost

full_name: Daniel Jost

given: Daniel

family: Degrange

full_name: Hervé Degrange

given: Hervé

family: Verret

full_name: Catherine Verret

given: Catherine

family: Hersan

full_name: Olivier Hersan

given: Olivier

family: Banville

full_name: Isabelle L. Banville

given: Isabelle L.

family: Chapman

full_name: Fred W. Chapman

given: Fred W.

family: Lank

full_name: Paula Lank

given: Paula

family: Petit

full_name: Jean Luc Petit

given: Jean Luc

family: Fuilla

full_name: Claude Fuilla

given: Claude

family: Migliani

full_name: René Migliani

given: René

family: Carpentier

full_name: Jean Pierre Carpentier

given: Jean Pierre

journal_name: Circulation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: DEFI 2005

ReferenceCitation: Kerber RE, Becker LB, Bourland JD, Cummins RO, Hallstrom AP, Michos MB, Nichol G, Ornato JP, Thies WH, White RD, Zuckerman BD. Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation. 1997 Mar 18;95(6):1677-82.

ReferenceCitation: Krasteva V, Jekova I, Dotsinsky I, Didon JP. Shock advisory system for heart rhythm analysis during cardiopulmonary resuscitation using a single ECG input of automated external defibrillators. Ann Biomed Eng. 2010 Apr;38(4):1326-36. doi: 10.1007/s10439-009-9885-9. Epub 2010 Jan 13.

ReferenceCitation: Roh YI, Jung WJ, Hwang SO, Kim S, Kim HS, Kim JH, Kim TY, Kang HS, Lee JS, Cha KC. Shorter defibrillation interval promotes successful defibrillation and resuscitation outcomes. Resuscitation. 2019 Oct;143:100-105. doi: 10.1016/j.resuscitation.2019.08.022. Epub 2019 Aug 20.

ReferenceCitation: Vaillancourt C, Everson-Stewart S, Christenson J, Andrusiek D, Powell J, Nichol G, Cheskes S, Aufderheide TP, Berg R, Stiell IG; Resuscitation Outcomes Consortium Investigators. The impact of increased chest compression fraction on return of spontaneous circulation for out-of-hospital cardiac arrest patients not in ventricular fibrillation. Resuscitation. 2011 Dec;82(12):1501-7. doi: 10.1016/j.resuscitation.2011.07.011. Epub 2011 Jul 18.

ReferenceCitation: Affatato R, Li Y, Ristagno G. See through ECG technology during cardiopulmonary resuscitation to analyze rhythm and predict defibrillation outcome. Curr Opin Crit Care. 2016 Jun;22(3):199-205. doi: 10.1097/MCC.0000000000000297. Review.

family: Affatato

full_name: Roberta Affatato

given: Roberta

family: Li

full_name: Yongqin Li

given: Yongqin

family: Ristagno

full_name: Giuseppe Ristagno

given: Giuseppe

journal_name: Current Opinion in Critical Care

ReferenceCitation: van Alem AP, Post J, Koster RW. VF recurrence: characteristics and patient outcome in out-of-hospital cardiac arrest. Resuscitation. 2003 Nov;59(2):181-8.


title: Observatoire Multicentrique Français Des Porteurs de Défibrillateur Automatique Implantable en Prévention Primaire (Cardiopathie Ischémique ou Cardiomyopathie Dilatée)

acronym: DAI-PP

summary: The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Escande W, Boveda S, Defaye P, Leclercq C, Sadoul N, Perier MC, Deharo JC, Fauchier L, Marijon E, Piot O; DAI-PP Investigators. Outcomes in Guideline-Based Versus Off-Guideline Primary Prevention Implantable Cardioverter-Defibrillator Recipients. J Am Coll Cardiol. 2017 Sep 5;70(10):1302-1303. doi: 10.1016/j.jacc.2017.07.711.

family: Escande

full_name: William Escande

given: William

sequence: first

family: Boveda

full_name: Serge Boveda

given: Serge

sequence: additional

family: Defaye

full_name: Pascal Defaye

given: Pascal

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

family: Sadoul

full_name: Nicolas Sadoul

given: Nicolas

family: Perier

full_name: Marie-Cecile Perier

given: Marie-Cecile

family: Deharo

full_name: Jean-Claude Deharo

given: Jean-Claude

family: Fauchier

full_name: Laurent Fauchier

given: Laurent

family: Marijon

full_name: Eloi Marijon

given: Eloi

family: Piot

full_name: Olivier Piot

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Amara N, Boveda S, Defaye P, Klug D, Treguer F, Amet D, Perier MC, Gras D, Algalarrondo V, Bouzeman A, Piot O, Deharo JC, Fauchier L, Babuty D, Bordachar P, Sadoul N, Marijon E, Leclercq C; DAI-PP Investigators. Implantable cardioverter-defibrillator therapy among patients with non-ischaemic vs. ischaemic cardiomyopathy for primary prevention of sudden cardiac death. Europace. 2018 Jan 1;20(1):65-72. doi: 10.1093/europace/euw379.

family: Amara

full_name: Nelly Amara

given: Nelly

family: Klug

full_name: Didier Klug

given: Didier

family: Treguer

full_name: Fréderic Treguer

given: Fréderic

family: Amet

full_name: Denis Amet

given: Denis

full_name: Marie-Cécile Perier

given: Marie-Cécile

family: Gras

full_name: Daniel Gras

family: Algalarrondo

full_name: Vincent Algalarrondo

given: Vincent

family: Bouzeman

full_name: Abdeslam Bouzeman

ReferenceCitation: Clementy N, Challal F, Marijon E, Boveda S, Defaye P, Leclercq C, Deharo JC, Sadoul N, Klug D, Piot O, Gras D, Bordachar P, Algalarrondo V, Fauchier L, Babuty D; DAI-PP Investigators. Very high rate programming in primary prevention patients with reduced ejection fraction implanted with a defibrillator: Results from a large multicenter controlled study. Heart Rhythm. 2017 Feb;14(2):211-217. doi: 10.1016/j.hrthm.2016.10.024. Epub 2016 Oct 28.

ReferenceCitation: Escande W, Marijon E, Defaye P, Piot O, Leclercq C, Sadoul N, Deharo JC, Empana JP, Boveda S, Klug D. Electrical Storms in Patients With Implantable Cardioverter-Defibrillators for Primary Prevention. J Am Coll Cardiol. 2016 Sep 13;68(11):1248-1250. doi: 10.1016/j.jacc.2016.06.039.

ReferenceCitation: Providência R, Marijon E, Lambiase PD, Bouzeman A, Defaye P, Klug D, Amet D, Perier MC, Gras D, Algalarrondo V, Deharo JC, Leclercq C, Fauchier L, Babuty D, Bordachar P, Sadoul N, Piot O, Boveda S. Primary Prevention Implantable Cardioverter Defibrillator (ICD) Therapy in Women-Data From a Multicenter French Registry. J Am Heart Assoc. 2016 Feb 12;5(2). pii: e002756. doi: 10.1161/JAHA.115.002756.

name: Barts Heart Centre, Barts Health NHS Trust, London, United Kingdom

name: European Georges Pompidou Hospital and Paris Descartes University, Paris, France

name: Paris Cardiovascular Research Center, Inserm U970, Paris, France

name: Nouvelles Cliniques Nantaises, Nantes, France

name: Centre Cardiologique du Nord, Saint Denis, France

journal_name: Journal of the American Heart Association

title: Primary Prevention Implantable Cardioverter Defibrillator (ICD) Therapy in Women—Data From a Multicenter French Registry


acronym: SADR

summary:
Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.

Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.

Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

ReferenceType: background

ReferenceCitation: Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French.

lead_sponsor: CHU de Reims

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

acronym: WINTHER

summary: An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.

study_start_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Procedure


title: Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder

acronym: IMPACT

summary:
Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000 suicide attempts every year. SB management is therefore a major public health issue. Recently, investigators have demonstrated the interest of acceptance and commitment therapy (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in depressed patients having a history of suicide attempt within previous year (i.e actual SB disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly, previous functional MRI (fMRI) studies have also reported the modulation of these regions by ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to identify biomarkers of SB and its improvement by ACT.

The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB disorder. Patients having a history of SB within previous year were randomized in an ACT program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after the completion of the group, they performed 3 tasks during fMRI: implicit emotional visualization, Cyberball game, motivational task Investigators will compare cerebral activations between groups, between pre and post intervention as well as measure baseline cerebral activations associated with improvement of suicidal ideation during follow up.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

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

family: Witt

full_name: Katrina G Witt

given: Katrina G

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

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

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

family: Hazell

full_name: Philip Hazell

given: Philip

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

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

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

family: Townsend

full_name: Ellen Townsend

given: Ellen

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

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_normalized: University of Melbourne - Minerva Access

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

license: cc-by

license_normalized: cc-by

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

intervention_type: Behavioral

status_simplified: Unknown


title: Diagnostic Value of Plasma Ribavirin Assay During the Combination Therapy " Pegylated Interferon + Ribavirin " in Chronic Hepatitis C.

summary:
Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients.

The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40 patients approximately.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Hopital A Michallon


title: Patients With Alzheimer's Disease or Related Youth Disease

acronym: PARMAAJJ

summary: This study aims to determine factors related to diagnosis delay for patients with young onset dementia (first symptoms before 60 years old) who live in North of France.

lead_sponsor: University Hospital, Lille


title: Dijon Stroke Cohort

acronym: DISCO

summary:
The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic attacks (TIAs) within the city of Dijon since 1985.

As a result of the development of therapies for acute disease, the prognosis of patients has improved over time. Thus, the number of stroke survivors has increased by 90% between the 1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and functional impact of stroke for motor, cognitive or thymic function. In the absence of available data in France, the investigators wish to set up an extended cohort follow-up of patients in order to study their long-term prognosis and to study the impact of future therapies on the evolutionary course of the disease.

status: Recruiting

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

status_simplified: Ongoing


title: Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).

acronym: Masq-Aute

summary:
The current outbreak of Covid-19 requires the wearing of FFP2 respiratory protective devices by healthcare personnel to limit their contamination.

However, there is currently a shortage of masks in France due to insufficient national stocks while the disease is spreading.

There is an urgent need to save FFP2 masks to enable healthcare personnel to continue to provide care in complete safety. Contamination of staff due to insufficient masks would have consequences by limiting access to care for infected patients and putting caregivers at potential risk of death. Caregiver protection is also intended to contain the risk of nosocomial epidemics. We propose the use of ARFC masks by Covid-19+ units. These ARFC masks provide optimal security against the risk of aerosolization of contaminated biological liquids. They are masks modified to be usable by civilians, resulting from the technology of combat masks, specially designed for use in NRBC (Nuclear, Radiological, Biological and Chemical) atmosphere.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device


title: International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study

acronym: INR-Cap pilote

summary: The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

acronym: PaneLux PTCA

summary: The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.

primary_purpose: Treatment

ReferenceCitation: Roncalli J, Godin M, Boughalem K, Shayne J, Piot C, Huret B, Belle L, Cayla G, Faurie B, Amor M, Karsenty B, Leclercq F. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J Invasive Cardiol. 2019 Apr;31(4):94-100.

lead_sponsor: Biotronik France

lead_sponsor_type: industriel


title: Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille

acronym: TROCENDO

summary:
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .

French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.

Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.

With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.

Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Cross-Sectional

lead_sponsor: Hôpital Européen Marseille

intervention_type: Diagnostic Test


acronym: EDUCARTPED

summary:
Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes.

The education patient programs are in France centered on curative competencies of care.

It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers

primary_purpose: Prevention

lead_sponsor: Poitiers University Hospital

location_facility:
POITIERS
La rochelle
NIORT


title: Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section

acronym: ROMANCE

summary:
The cesarean section is one of the most commonly performed surgeries in the world and it represents 20% of the births in France. Postoperative pain is moderate-to-severe during the first 48 hours after this procedure. Thereby its control is prominent for the medical team in order to shorten the duration of hospital stay as well as to permit an early return to daily activities for these surgical patients.

Pain control after cesarean section is usually based on non-opioids and epidural administration of morphine if an epidural catheter has been previously placed for the procedure. However epidural morphine is associated with a number of side effects. Wound infiltration with local anesthetics has been widely used in the multimodal management of postoperative pain and it may reduce postoperative morphine consumption.

In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia (epidural morphine bolus). Quality of pain control will be assessed with the measurements of morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3 months, patients will be interviewed to assess their residual pain and their satisfaction.

It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural morphine analgesia to control pain after cesarean section, and be associated with a reduction of side effects related to the analgesics.

status: Active, not recruiting

ReferenceCitation: Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40.

ReferenceCitation: Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91.

ReferenceCitation: Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006954. doi: 10.1002/14651858.CD006954.pub2. Review.

ReferenceCitation: Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21.

ReferenceCitation: Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94.

ReferenceCitation: O'Neill P, Duarte F, Ribeiro I, Centeno MJ, Moreira J. Ropivacaine continuous wound infusion versus epidural morphine for postoperative analgesia after cesarean delivery: a randomized controlled trial. Anesth Analg. 2012 Jan;114(1):179-85. doi: 10.1213/ANE.0b013e3182368e87. Epub 2011 Oct 24.

ReferenceCitation: Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5.

ReferenceCitation: Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.

family: Rackelboom

full_name: Thibaut Rackelboom

given: Thibaut

family: Strat

full_name: Solenn Le Strat

given: Solenn Le

family: Silvera

full_name: Stephane Silvera

given: Stephane

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

family: Bassot

full_name: Agnes Bassot

given: Agnes

family: Goffinet

full_name: François Goffinet

given: François

family: Ozier

full_name: Yves Ozier

given: Yves

family: Beaussier

full_name: Marc Beaussier

given: Marc

family: Mignon

full_name: Alexandre Mignon

given: Alexandre

journal_name: Obstetrics & Gynecology

title: Improving Continuous Wound Infusion Effectiveness for Postoperative Analgesia After Cesarean Delivery

lead_sponsor: University Hospital, Grenoble

intervention_type: Drug


type: Registry Identifier

title: Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability Among French Adolescents: a Cluster Randomized Controlled Trial

acronym: PrevHPV

summary: This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. The primary outcome to measure acceptability is vaccine coverage. The three components are: adolescents and parents' education and motivation at school (component 1); general practitioners' training (component 2); and access to vaccination at school (component 3). Ninety municipalities are included and randomized into six groups of 15 municipalities, according an incomplete factorial plan.

ipd_sharing: Undecided

ipd_sharing_description: Not yet decided.

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

location_facility: Secondary schools and GPs' practices of the participating municipalities


title: Patient's Perception of Hospital Safety: Measure of the Patients' Perception and Correlation With Patient Safety Strategies in the Surgical Care Units

acronym: PERSEPOLIS

summary: The study aims to construct and validate a self-administrated questionnaire to assess the patients' perception of patient safety in surgical care units. The originality of the study is to perform sociological interviews of hospitalized patients to assess their own perception on the safety of their care and to create corresponding items which will be included in a new questionnaire. In a second step, patients' perception of patient safety will be assessed in numerous surgical care units in France, in order to analyze the psychometric properties of the questionnaire and consequently to validate the questionnaire. The patients' perception will be compared to the healthcare professionals' perception on patient safety and to the patient safety strategies in place in the care units.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche


title: Influence of Local Biopsy of the Endometrium Prior to Controlled Ovarian Stimulation for IVF or ICSI Procedure on the Rates of Embryo Implantation, Clinical Pregnancy and Live Birth in ART

acronym: NIDABRECHE

summary: In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.

primary_purpose: Health Services Research

ReferenceCitation: Bourgain C, Devroey P. The endometrium in stimulated cycles for IVF. Hum Reprod Update. 2003 Nov-Dec;9(6):515-22. Review.

ReferenceCitation: Richter KS, Bugge KR, Bromer JG, Levy MJ. Relationship between endometrial thickness and embryo implantation, based on 1,294 cycles of in vitro fertilization with transfer of two blastocyst-stage embryos. Fertil Steril. 2007 Jan;87(1):53-9. Epub 2006 Nov 1.

ReferenceCitation: Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22.

ReferenceCitation: Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201.

ReferenceCitation: Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. Review.

ReferenceCitation: Revelli A, Dolfin E, Gennarelli G, Lantieri T, Massobrio M, Holte JG, Tur-Kaspa I. Low-dose acetylsalicylic acid plus prednisolone as an adjuvant treatment in IVF: a prospective, randomized study. Fertil Steril. 2008 Nov;90(5):1685-91. Epub 2007 Dec 11.

ReferenceCitation: Khairy M, Banerjee K, El-Toukhy T, Coomarasamy A, Khalaf Y. Aspirin in women undergoing in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril. 2007 Oct;88(4):822-31. Epub 2007 May 16. Review.

ReferenceCitation: Silver MM, Miles P, Rosa C. Comparison of Novak and Pipelle endometrial biopsy instruments. Obstet Gynecol. 1991 Nov;78(5 Pt 1):828-30.

ReferenceCitation: Gellersen B, Brosens IA, Brosens JJ. Decidualization of the human endometrium: mechanisms, functions, and clinical perspectives. Semin Reprod Med. 2007 Nov;25(6):445-53. Review.

ReferenceCitation: Lindhard A, Ravn V, Bentin-Ley U, Horn T, Bangsboell S, Rex S, Toft B, Soerensen S. Ultrasound characteristics and histological dating of the endometrium in a natural cycle in infertile women compared with fertile controls. Fertil Steril. 2006 Nov;86(5):1344-55. Epub 2006 Sep 14.

ReferenceCitation: Homburg R, Pap H, Brandes M, Huirne J, Hompes P, Lambalk CB. Endometrial biopsy during induction of ovulation with clomiphene citrate in polycystic ovary syndrome. Gynecol Endocrinol. 2006 Sep;22(9):506-10.

ReferenceCitation: Sulewski JM, Ward SP, McGaffic W. Endometrial biopsy during a cycle of conception. Fertil Steril. 1980 Dec;34(6):548-51.

ReferenceCitation: Wentz AC, Herbert CM 3rd, Maxson WS, Hill GA, Pittaway DE. Cycle of conception endometrial biopsy. Fertil Steril. 1986 Aug;46(2):196-9.

ReferenceCitation: Balasch J, Vanrell JA, Márquez M, González-Merlo J. Endometrial biopsy inadvertently taken in the cycle of conception. Int J Gynaecol Obstet. 1984 Apr;22(2):95-9.

ReferenceCitation: Giorgetti C, Terriou P, Auquier P, Hans E, Spach JL, Salzmann J, Roulier R. Embryo score to predict implantation after in-vitro fertilization: based on 957 single embryo transfers. Hum Reprod. 1995 Sep;10(9):2427-31.

ReferenceCitation: Abramov Y, Elchalal U, Schenker JG. Severe OHSS: An 'epidemic' of severe OHSS: a price we have to pay? Hum Reprod. 1999 Sep;14(9):2181-3. Review.

ReferenceCitation: Balasch J, Fábregues F, Arroyo V. Peripheral arterial vasodilation hypothesis: a new insight into the pathogenesis of ovarian hyperstimulation syndrome. Hum Reprod. 1998 Oct;13(1O):2718-30. Review.

ReferenceCitation: Govaerts I, Devreker F, Delbaere A, Revelard P, Englert Y. Short-term medical complications of 1500 oocyte retrievals for in vitro fertilization and embryo transfer. Eur J Obstet Gynecol Reprod Biol. 1998 Apr;77(2):239-43.

ReferenceCitation: Perrier D'hauterive S, Charlet-Renard C, Goffin F, Foidart M, Geenen V. [The implantation window]. J Gynecol Obstet Biol Reprod (Paris). 2002 Sep;31(5):440-55. Review. French.

ReferenceCitation: Bourgain C. [Endometrial biopsy in the evaluation of endometrial receptivity]. J Gynecol Obstet Biol Reprod (Paris). 2004 Feb;33(1 Pt 2):S13-7. Review. French.

ReferenceCitation: Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.

ReferenceCitation: Cornier E. The Pipelle: a disposable device for endometrial biopsy. Am J Obstet Gynecol. 1984 Jan 1;148(1):109-10.

ReferenceCitation: Check JH, Chase JS, Nowroozi K, Wu CH, Chern R. Clinical evaluation of the Pipelle endometrial suction curette for timed endometrial biopsies. J Reprod Med. 1989 Mar;34(3):218-20.

ReferenceCitation: Henig I, Chan P, Tredway DR, Maw GM, Gullett AJ, Cheatwood M. Evaluation of the Pipelle curette for endometrial biopsy. J Reprod Med. 1989 Oct;34(10):786-9.

ReferenceCitation: Machado F, Moreno J, Carazo M, León J, Fiol G, Serna R. Accuracy of endometrial biopsy with the Cornier pipelle for diagnosis of endometrial cancer and atypical hyperplasia. Eur J Gynaecol Oncol. 2003;24(3-4):279-81.

ReferenceCitation: Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv. 1989 Jun;44(6):430-40. Review.

ReferenceCitation: Frantz S, Parinaud J, Kret M, Rocher-Escriva G, Papaxanthos-Roche A, Creux H, Chansel-Debordeaux L, Bénard A, Hocké C. Decrease in pregnancy rate after endometrial scratch in women undergoing a first or second in vitro fertilization. A multicenter randomized controlled trial. Hum Reprod. 2019 Jan 1;34(1):92-99. doi: 10.1093/humrep/dey334.

name: CHU de Bordeaux, Endocrinology and Metabolism, Reproductive Medicine Unit, Bordeaux, France

family: Frantz

full_name: Sandrine Frantz

given: Sandrine

name: CHU Toulouse, Department of Reproductive Medicine, Toulouse, France

family: Parinaud

full_name: Jean Parinaud

given: Jean

name: CHU de Bordeaux, Pôle de Santé Publique, Clinical Epidemiology Unit (USMR), F-33000 Bordeaux, France

family: Kret

full_name: Marion Kret

given: Marion

family: Rocher-Escriva

full_name: Gaelle Rocher-Escriva

given: Gaelle

name: CHU de Bordeaux, Biology of reproduction Unit-CECOS, Bordeaux, France

family: Papaxanthos-Roche

full_name: Aline Papaxanthos-Roche

given: Aline

family: Creux

full_name: Hélène Creux

given: Hélène

family: Chansel-Debordeaux

full_name: Lucie Chansel-Debordeaux

given: Lucie

family: Bénard

full_name: Antoine Bénard

given: Antoine

family: Hocké

full_name: Claude Hocké

given: Claude

journal_name: Human Reproduction

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Decrease in pregnancy rate after endometrial scratch in women undergoing a first or secondin vitrofertilization. A multicenter randomized controlled trial

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux, Hôpital Saint André, service de chirurgie gynécologie et médecine de la reproduction

location_facility: CHU de Toulouse, service de médecine et biologie de la reproduction


title: Validation and Norms for Attention Deficit/Hyperactivity Disorder Scales in Children and Adults. Description of Associated Factors.

acronym: ChiP-ARD

summary:
Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. This study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of Nice.

Children are pseudo-randomly selected from classes of randomly selected schools in the city of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. Since ADHD has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.

Additionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study.

ReferenceCitation: Caci HM, Morin AJ, Tran A. Prevalence and correlates of attention deficit hyperactivity disorder in adults from a French community sample. J Nerv Ment Dis. 2014 Apr;202(4):324-32. doi: 10.1097/NMD.0000000000000126.

family: Caci

full_name: Hervé M. Caci

given: Hervé M.

family: Morin

full_name: Alexandre J.S. Morin

given: Alexandre J.S.

family: Tran

full_name: Antoine Tran

journal_name: Journal of Nervous & Mental Disease

repository_institution: Australian Catholic University - Research Bank

version: submittedVersion

title: Prevalence and Correlates of Attention Deficit Hyperactivity Disorder in Adults From a French Community Sample

ReferenceCitation: Morin AJ, Tran A, Caci H. Factorial Validity of the ADHD Adult Symptom Rating Scale in a French Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 Jun;20(6):530-41. doi: 10.1177/1087054713488825. Epub 2013 May 31.

full_name: Alexandre J. S. Morin

given: Alexandre J. S.

name: Hôpitaux Pédiatrique de Nice–CHU Lenval, France

full_name: Hervé Caci

given: Hervé

journal_name: Journal of Attention Disorders

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Caci HM, Morin AJ, Tran A. Teacher Ratings of the ADHD-RS IV in a Community Sample: Results From the ChiP-ARD Study. J Atten Disord. 2016 May;20(5):434-44. doi: 10.1177/1087054712473834. Epub 2013 Feb 19.

name: Hôpitaux Pédiatriques de Nice CHU Lenval, France

full_name: Alexandre J. Morin

given: Alexandre J.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress

acronym: TADDOR

summary:
Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in France since 2002.

Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary regarding the tumor localisation, the population, intensity of the symptoms...

Incidence of ENT cancer is highly significant in France, it is one of the most important in the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of depression is the most important (22%-57%).

Researches appears necessary to assessed the efficacy of antidepressant treatments with as primary objective not only the decrease of depressive symptoms but also an ensemble of physic and psychological symptoms.


title: A Pilot Study of the Effect of Individualized Clinical Management Among Parent/Child Dyads on Continuity of Care and Interaction. Phase 1 : Retrospective Evaluation

acronym: Rétro-GUIDANCE

summary: this project aims to collect retrospective data on the conitinuity/disconitnuity rate for child care in the child psychiatry unit of the université hospital of Besançon, France.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

acronym: FRENCH CORONA

summary:
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France.

We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.


title: Evaluation of the Efficiency of a Hydration by Isotonic Solution With or Without Muscular Exercise of the Fainting Whole Blood Donors

acronym: EVASION

summary:
Blood donation is a generous act carried out by healthy male and female volunteer donors. The safety of blood donation in France is based on rigorous well documented biological and medical criteria, in particular concerning the volume of blood to be taken. While whole blood donation is very safe, some donors experience faintness during or after donation. Any injury resulting from a fall increases its seriousness, especially when it happens outside the donation site.

According to various studies, adverse reactions are experienced by between 0.28% and 2.72% of all donors and occur in all categories (sex and age).

A retrospective evaluation of the frequency of faintness incidents on during whole blood donation over 2012 in the Rhone Alpes' region of France shows a frequency ranging from 1.05% in mobile donation units in towns to 4.24% in donation units in high schools, with no reporting of delayed incidents of faintness by this donor population.

ReferenceCitation: V. Candas, B. Bothorel : Hydratation, travail et chaleur. , INRS CDU 613-3 Fiche d'hygiène de vie au travail, Cahier de notes documentaires n° 135, 2ème trimestre 1989 : 241 - 245

ReferenceCitation: France CR, France JL, Kowalsky JM, Ellis GD, Copley DM, Geneser A, Frame-Brown T, Venable G, Graham D, Shipley P, Menitove JE. Assessment of donor fear enhances prediction of presyncopal symptoms among volunteer blood donors. Transfusion. 2012 Feb;52(2):375-80. doi: 10.1111/j.1537-2995.2011.03294.x. Epub 2011 Aug 16.

ReferenceCitation: Eder AF, Hillyer CD, Dy BA, Notari EP 4th, Benjamin RJ. Adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds. JAMA. 2008 May 21;299(19):2279-86. doi: 10.1001/jama.299.19.2279.

ReferenceCitation: P. Tomasulo, M. Bravo et H. Kamel : Time course of vasovagal syncope with whole blood donation. ISBT Science Series, 2010 ; 5 : 52 - 58

ReferenceCitation: Wieling W, France CR, van Dijk N, Kamel H, Thijs RD, Tomasulo P. Physiologic strategies to prevent fainting responses during or after whole blood donation. Transfusion. 2011 Dec;51(12):2727-38. doi: 10.1111/j.1537-2995.2011.03202.x. Epub 2011 Jun 3. Review.

ReferenceCitation: Kowalsky JM, France JL, Wissel ME, France CR. Effect of applied muscle tension on cerebral oxygenation in female blood donors. Transfusion. 2011 Aug;51(8):1802-8. doi: 10.1111/j.1537-2995.2011.03075.x. Epub 2011 Mar 7.

ReferenceCitation: Eder AF. Improving safety for young blood donors. Transfus Med Rev. 2012 Jan;26(1):14-26. doi: 10.1016/j.tmrv.2011.07.008. Epub 2011 Aug 26. Review.

ReferenceCitation: Eder AF. Current efforts to reduce the risk of syncope among young blood donors. Curr Opin Hematol. 2012 Nov;19(6):480-5. doi: 10.1097/MOH.0b013e328358b15c. Review.

ReferenceCitation: van den Berg K, Lam J, Bruhn R, Custer B, Murphy EL. Water administration and the risk of syncope and presyncope during blood donation: a randomized clinical trial. Transfusion. 2012 Dec;52(12):2577-84. doi: 10.1111/j.1537-2995.2012.03631.x. Epub 2012 Apr 4.

ReferenceCitation: Physiologie Humaine 3e édition Hervé Guénard, ed Pradel. Rein : 307 - 313

ReferenceCitation: Eder AF, Notari EP 4th, Dodd RY. Do reactions after whole blood donation predict syncope on return donation? Transfusion. 2012 Dec;52(12):2570-6. doi: 10.1111/j.1537-2995.2012.03666.x. Epub 2012 Apr 27.

ReferenceCitation: Eder A. Evidence-based selection criteria to protect blood donors. J Clin Apher. 2010;25(6):331-7. doi: 10.1002/jca.20257. Epub 2010 Sep 7. Review.

ReferenceCitation: Eder AF, Dy BA, Kennedy JM, Notari Iv EP, Strupp A, Wissel ME, Reddy R, Gibble J, Haimowitz MD, Newman BH, Chambers LA, Hillyer CD, Benjamin RJ. The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006. Transfusion. 2008 Sep;48(9):1809-19. doi: 10.1111/j.1537-2995.2008.01811.x. Epub 2008 Jul 9.

ReferenceCitation: Bravo M, Kamel H, Custer B, Tomasulo P. Factors associated with fainting: before, during and after whole blood donation. Vox Sang. 2011 Nov;101(4):303-12. doi: 10.1111/j.1423-0410.2011.01494.x. Epub 2011 May 3.

ReferenceCitation: Carneiro-Proietti AB, Sabino EC, Sampaio D, Proietti FA, Gonçalez TT, Oliveira CD, Ferreira JE, Liu J, Custer B, Schreiber GB, Murphy EL, Busch MP. Demographic profile of blood donors at three major Brazilian blood centers: results from the International REDS-II study, 2007 to 2008. Transfusion. 2010 Apr;50(4):918-25. doi: 10.1111/j.1537-2995.2009.02529.x. Epub 2009 Dec 10.

ReferenceCitation: Trouern-Trend JJ, Cable RG, Badon SJ, Newman BH, Popovsky MA. A case-controlled multicenter study of vasovagal reactions in blood donors: influence of sex, age, donation status, weight, blood pressure, and pulse. Transfusion. 1999 Mar;39(3):316-20.

ReferenceCitation: Wiltbank TB, Giordano GF, Kamel H, Tomasulo P, Custer B. Faint and prefaint reactions in whole-blood donors: an analysis of predonation measurements and their predictive value. Transfusion. 2008 Sep;48(9):1799-808. doi: 10.1111/j.1537-2995.2008.01745.x. Epub 2008 May 14.

ReferenceCitation: Eder AF, Dy BA, Kennedy JM, Perez J, Demaris P, Procaccio A, Benjamin RJ. Improved safety for young whole blood donors with new selection criteria for total estimated blood volume. Transfusion. 2011 Jul;51(7):1522-31. doi: 10.1111/j.1537-2995.2011.03143.x. Epub 2011 Apr 29.

ReferenceCitation: Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J, Heringhausen J. The effect of a 473-mL (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion. 2007 Aug;47(8):1524-33.

ReferenceCitation: Ando S, Kawamura N, Matsumoto M, Dan E, Takeshita A, Murakami K, Kashiwagi S, Kiyokawa H. Simple standing test predicts and water ingestion prevents vasovagal reaction in the high-risk blood donors. Transfusion. 2009 Aug;49(8):1630-6. doi: 10.1111/j.1537-2995.2009.02189.x.

ReferenceCitation: France CR, Ditto B, Wissel ME, France JL, Dickert T, Rader A, Sinclair K, McGlone S, Trost Z, Matson E. Predonation hydration and applied muscle tension combine to reduce presyncopal reactions to blood donation. Transfusion. 2010 Jun;50(6):1257-64. doi: 10.1111/j.1537-2995.2009.02574.x. Epub 2010 Jan 22.

ReferenceCitation: Tomasulo P, Kamel H, Bravo M, James RC, Custer B. Interventions to reduce the vasovagal reaction rate in young whole blood donors. Transfusion. 2011 Jul;51(7):1511-21. doi: 10.1111/j.1537-2995.2011.03074.x. Epub 2011 Mar 7.

ReferenceCitation: Scott EM, Greenwood JP, Stoker JB, Gilbey SG, Mary DA. Water drinking and sympathetic activation. Lancet. 2000 Dec 9;356(9246):2013.

ReferenceCitation: A. F. Eder : can we improve safety for young blood donors ?. ISBT Science Series 2012;7:226-229

ReferenceCitation: Custer B, Rios JA, Schlumpf K, Kakaiya RM, Gottschall JL, Wright DJ; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Adverse reactions and other factors that impact subsequent blood donation visits. Transfusion. 2012 Jan;52(1):118-26. doi: 10.1111/j.1537-2995.2011.03216.x. Epub 2011 Jun 17.

ReferenceCitation: France CR, France JL, Wissel ME, Ditto B, Dickert T, Himawan LK. Donor anxiety, needle pain, and syncopal reactions combine to determine retention: a path analysis of two-year donor return data. Transfusion. 2013 Sep;53(9):1992-2000. doi: 10.1111/trf.12069. Epub 2013 Jan 11.

ReferenceCitation: France CR, France JL, Himawan LK, Stephens KY, Frame-Brown TA, Venable GA, Menitove JE. How afraid are you of having blood drawn from your arm? A simple fear question predicts vasovagal reactions without causing them among high school donors. Transfusion. 2013 Feb;53(2):315-21. doi: 10.1111/j.1537-2995.2012.03726.x. Epub 2012 Jun 7.

ReferenceCitation: Veldhuizen I, Atsma F, van Dongen A, de Kort W. Adverse reactions, psychological factors, and their effect on donor retention in men and women. Transfusion. 2012 Sep;52(9):1871-9. doi: 10.1111/j.1537-2995.2011.03551.x. Epub 2012 Feb 10.

ReferenceCitation: Ditto B, France CR, Albert M, Byrne N, Smyth-Laporte J. Effects of applied muscle tension on the likelihood of blood donor return. Transfusion. 2009 May;49(5):858-62. doi: 10.1111/j.1537-2995.2008.02067.x. Epub 2009 Jan 21.

ReferenceCitation: Kamel H, Tomasulo P, Bravo M, Wiltbank T, Cusick R, James RC, Custer B. Delayed adverse reactions to blood donation. Transfusion. 2010 Mar;50(3):556-65. doi: 10.1111/j.1537-2995.2009.02397.x. Epub 2009 Oct 5.

ReferenceCitation: Ditto B, France CR, Holly C. Applied tension may help retain donors who are ambivalent about needles. Vox Sang. 2010 Apr;98(3 Pt 1):e225-30.

ReferenceCitation: Masser B. Experienced donors, adverse events, and retention. Transfusion. 2012 Sep;52(9):1844-8. doi: 10.1111/j.1537-2995.2012.03829.x. Review.

ReferenceCitation: Sinclair KS, Campbell TS, Carey PM, Langevin E, Bowser B, France CR. An adapted postdonation motivational interview enhances blood donor retention. Transfusion. 2010 Aug;50(8):1778-86. doi: 10.1111/j.1537-2995.2010.02618.x. Epub 2010 Apr 23.

ReferenceCitation: May M, Jordan J. The osmopressor response to water drinking. Am J Physiol Regul Integr Comp Physiol. 2011 Jan;300(1):R40-6. doi: 10.1152/ajpregu.00544.2010. Epub 2010 Nov 3. Review.

ReferenceCitation: Schroeder C, Bush VE, Norcliffe LJ, Luft FC, Tank J, Jordan J, Hainsworth R. Water drinking acutely improves orthostatic tolerance in healthy subjects. Circulation. 2002 Nov 26;106(22):2806-11.

ReferenceCitation: Endo Y, Yamauchi K, Tsutsui Y, Ishihara Z, Yamazaki F, Sagawa S, Shiraki K. Changes in blood pressure and muscle sympathetic nerve activity during water drinking in humans. Jpn J Physiol. 2002 Oct;52(5):421-7.

ReferenceCitation: Mathias CJ, Young TM. Water drinking in the management of orthostatic intolerance due to orthostatic hypotension, vasovagal syncope and the postural tachycardia syndrome. Eur J Neurol. 2004 Sep;11(9):613-9. Review.

ReferenceCitation: Moreno IL, Pastre CM, Ferreira C, de Abreu LC, Valenti VE, Vanderlei LC. Effects of an isotonic beverage on autonomic regulation during and after exercise. J Int Soc Sports Nutr. 2013 Jan 4;10(1):2. doi: 10.1186/1550-2783-10-2.

ReferenceCitation: Charkoudian N, Eisenach JH, Joyner MJ, Roberts SK, Wick DE. Interactions of plasma osmolality with arterial and central venous pressures in control of sympathetic activity and heart rate in humans. Am J Physiol Heart Circ Physiol. 2005 Dec;289(6):H2456-60. Epub 2005 Sep 30.

ReferenceCitation: Ditto B, France CR, Albert M, Byrne N. Dismantling applied tension: mechanisms of a treatment to reduce blood donation-related symptoms. Transfusion. 2007 Dec;47(12):2217-22. Epub 2007 Aug 21.

lead_sponsor: Etablissement Français du Sang

location_facility:
EFS Lyon
EFS Grenoble


title: Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.

acronym: EMOCAR

summary:
In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid cross-clamping.

The objective of this prospective, multicentric, double-blinded and randomized study is to evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be conducted to estimate the impact of this monitoring versus standard care on direct and indirect postoperative costs during 120 days.

A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a serum marker of brain injury, protein S-100B

lead_sponsor: Nantes University Hospital

location_facility: Besancon University Hospital "Hôpital Jean Minjoz"

location_facility: Hospital de Marie Lannelongue Plessis Robinson

location_facility: Bordeaux University Hospital "Haut Lévêque"

location_facility: Lyon University Hospital "Hôpital Edouard Herriot"

location_facility: Bordeaux University Hospital "Hôpital Pellegrin"

location_facility: Brest University Hospital "La Cavale Blanche"

location_facility: Reims University Hospital "Robert Debré"

location_facility: Rennes University Hospital "Pontchaillou"

location_facility: Caen University Hospital "Côte de Nacre"

location_facility: Marseille University Hospital "Hôpital de la Timone"


title: Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

acronym: GONOCEF

summary:
Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.

Patients wanting STI screening can consult either they are symptomatic or not.

If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.

Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.

After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.

Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.

Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.

This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin

summary:
It is estimated to 7300 the number of new cases of gastric cancer each year in France.

According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly prolonged with a hazard ratio of 0.66.

The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years.

Preoperative radiochemotherapy is expected to increase the rate of curative resections, reduce gastrointestinal and hematologic toxicity.

Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.

The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous 5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV non-metastatic administered before surgery.

lead_sponsor: Institut Sainte Catherine

intervention_type: Radiation


title: Gestational Diabetes in Non Obese Women and Metformine

summary: Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
CHU de Reims
CHU Dijon,
Hôpitaux Civils de Colmar
Hôpitaux Universitaires de Strasbourg
Centre hospitalier de Mulhouse


title: Pain and Schizophrenia

summary: The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.

location_facility: Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg

location_facility: Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques

location_facility: Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg

location_facility: Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft

location_facility: Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg


title: Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff

acronym: COVIDIM

summary:
Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.

In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).

The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Biological


title: Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.

summary:
The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.

The aim of our project is to study its interest in diagnosis of scaphoid fractures.

Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.

Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.

Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.

MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.

The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.

Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.

location_facility: Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital


title: Is the Dynamic of the Pelvic Bone Altered After a Total Hip Replacement ?

acronym: DYPAMAT

summary:
Total hip replacement is one of the most common surgical procedure in France. In 2010, an estimated 147 513 total hip procedures were performed. This number is constantly increasing.

Although it is common, it can lead to many complications. The intra-prosthetic luxation is the second one after aseptic loosening.

The luxation risk is multifactorial and depends on the relative orientation of femoral et acetabular components. This orientation is influenced by statics and dynamics parameters.

So far, the literature shows that only static parameters are considered by surgeons. Thus, in reference to Lewinneck publication, which states that the luxation risk is lower if the cup is oriented with 15° +/- 10° of anteversion and 40°+/- 10° of inclination with respect to the anterior pelvic plan (APP). Defined by the two anterosuperior iliacs spines and pubic symphysis.

However, this approach is only static and do not take into account the variations of pelvic plan orientation during everyday life.

To consider these variations of pelvic inclination, it is possible to measure the angle between APP and the horizontal (in lying position) or the vertical (in standing position) plan.

Several devices allow the measure of pelvic inclination but they all have important limits (EOS radiography, scanner or navigation). A new device has been developed in Brest to measure this inclination in several positions of the daily life.This software has already been tested in healthy volunteers and results demonstrate an excellent accuracy and reproducibility.

The goal of this study is to described the dynamic of the pelvic bone thanks to this ultrasound based device, and to assess the amount of variation induced by hip replacement procedures.

primary_purpose: Other

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest


title: Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center: A Retrospective Observational Cohort Study

acronym: SurgiCovid

summary:
Background

After the emergence of Covid-19 in China, Hubei Province, the epidemic quickly spread to Europe. France was quickly hit and the Croix-Rousse hospital at the Hospices Civils de Lyon was one of the first French university hospital to receive patients infected with Sars-COV2. The predicted massive influx of patients motivated the cancellation of all elective surgical procedures planned to free hospitalization beds and to free intensive care beds. Nevertheless, patients who had to be canceled had to be properly selected to avoid a life threatening. The retained surgical indications were surgical emergencies, oncologic surgery and organ transplantation.

The objective was to describe the organization of the Croix-Rousse hospital to allow the continuation of these surgical activities while limiting the exposure of patients to the Sars Cov2.

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases

acronym: PREVALUNG

summary:
Lung cancer is the main cause of mortality by cancer in France. The lung cancer stage at time of diagnosis is a major determinant of survival. To date, 75% of lung cancer are diagnosed at an advanced stage with worse survival). Lung cancer screening is based on low dose CT scan which allows to decrease lung cancer related mortality of 20% in patients aged 55-74 years-old with a history of tobacco consumption ≥ 30 PY active of who quite < 15 years. These criteria for eligibility for lung cancer screening lead to 1 to 2% of lung cancer diagnosis at the first CT scan. In our experience regarding 1 year of lung cancer surgical resection, only 45% of the patients presented criteria for lung cancer screening. Moreover, the duration of tobacco consumption would provide a better stratification of lung cancer risk compared to only PY. Therefore, other criteria for lung cancer screening eligibility could be proposed. Currently, 9 out of 10 lung cancer is linked with tobacco consumption which is also a major risk factor for atherosclerosis-associated cardiovascular events. Around 40% of patients with a lung cancer have a history of atherosclerosis-associated cardiovascular event, mainly coronary artery diseases and peripheral artery diseases. Main Objective: The objective is to compare the observed rate of lung cancer prevalence in our study to the rate of around 2 % observed in lung cancer screening trials in south Europe (France and Italy).

The investigators hypothesize that the population of patients with a history of atherosclerotic cardiovascular event associated with tobacco consumption present a higher prevalence of lung cancer compared with the population of patients eligible for lung cancer screening program which is defined by age and history of tobacco consumption.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

summary:
Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. A blood sample will be proposed in the field of this research project, and the biological material will be stored at the DNA and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol.

Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial forms with early onset. In frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. The identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms not caused by the known genes, using linkage approaches and candidate gene analysis. The familial forms are also useful for identifying the modifier genes.

In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. The strategies will use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment.

Finally, correlations will be performed with seric markers according to each kind of dementia.

Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and in the study of neurological disorders of genetic origin.

ReferenceType: result

ReferenceCitation: Le Ber I, Guedj E, Gabelle A, Verpillat P, Volteau M, Thomas-Anterion C, Decousus M, Hannequin D, Véra P, Lacomblez L, Camuzat A, Didic M, Puel M, Lotterie JA, Golfier V, Bernard AM, Vercelletto M, Magne C, Sellal F, Namer I, Michel BF, Pasquier J, Salachas F, Bochet J; French research network on FTD/FTD-MND, Brice A, Habert MO, Dubois B. Demographic, neurological and behavioural characteristics and brain perfusion SPECT in frontal variant of frontotemporal dementia. Brain. 2006 Nov;129(Pt 11):3051-65.

ReferenceCitation: van der Zee J, Le Ber I, Maurer-Stroh S, Engelborghs S, Gijselinck I, Camuzat A, Brouwers N, Vandenberghe R, Sleegers K, Hannequin D, Dermaut B, Schymkowitz J, Campion D, Santens P, Martin JJ, Lacomblez L, De Pooter T, Peeters K, Mattheijssens M, Vercelletto M, Van den Broeck M, Cruts M, De Deyn PP, Rousseau F, Brice A, Van Broeckhoven C. Mutations other than null mutations producing a pathogenic loss of progranulin in frontotemporal dementia. Hum Mutat. 2007 Apr;28(4):416.

ReferenceCitation: Baba Y, Baker MC, Le Ber I, Brice A, Maeck L, Kohlhase J, Yasuda M, Stoppe G, Bugiani O, Sperfeld AD, Tsuboi Y, Uitti RJ, Farrer MJ, Ghetti B, Hutton ML, Wszolek ZK. Clinical and genetic features of families with frontotemporal dementia and parkinsonism linked to chromosome 17 with a P301S tau mutation. J Neural Transm (Vienna). 2007 Jul;114(7):947-50. Epub 2007 Feb 23.

ReferenceCitation: Le Ber I, van der Zee J, Hannequin D, Gijselinck I, Campion D, Puel M, Laquerrière A, De Pooter T, Camuzat A, Van den Broeck M, Dubois B, Sellal F, Lacomblez L, Vercelletto M, Thomas-Antérion C, Michel BF, Golfier V, Didic M, Salachas F, Duyckaerts C, Cruts M, Verpillat P, Van Broeckhoven C, Brice A; French Research Network on FTD/FTD-MND. Progranulin null mutations in both sporadic and familial frontotemporal dementia. Hum Mutat. 2007 Sep;28(9):846-55.

ReferenceCitation: Guedj E, Le Ber I, Lacomblez L, Dubois B, Verpillat P, Didic M, Salachas F, Vera P, Hannequin D, Lotterie JA, Puel M, Decousus M, Thomas-Antérion C, Magne C, Vercelletto M, Bernard AM, Golfier V, Pasquier J, Michel BF, Namer I, Sellal F, Bochet J, Volteau M, Brice A, Meininger V; French Research Network on FTD/FTD-MND, Habert MO. Brain spect perfusion of frontotemporal dementia associated with motor neuron disease. Neurology. 2007 Jul 31;69(5):488-90.

location_facility: Pitié-Salpêtrière Hospital - Fédération de Neurologie

location_facility: Pitié-Salpêtrière Hospital - Centre du Langage et de Neuropsychologie


title: Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.

lead_sponsor: University Hospital, Tours


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: GEMFOX

location_facility: APHP - Groupe Hospitalier Pitié-Salpêtrière

type: EudraCT Number

source: euctr

title: Randomized Phase 3 Trial Comparing FOLFOX to Gemcitabine in Metastatic First-line in Patients With Pancreatic Adenocarcinoma and Non-fit for FOLFIRINOX

summary:
Pancreatic adenocarcinoma (PAC) incidence increases regularly in Western countries and it is expected to become the second leading cause of cancer-related mortality in 2020. The prognosis of this disease remains very poor with an overall 5-year survival rate less than 5%.

The FOLFIRINOX regimen (5-fluorouracil [5-FU], folinic acid, irinotecan, and oxaliplatin) and the combination of nab-paclitaxel with gemcitabine demonstrated to be more effective than gemcitabine alone, and are both validated as standard first-line treatment options for metastatic PAC. However, the use of FOLFIRINOX is limited to patients with ECOG performance status (PS) 0-1 and aged less than 75 years. Nab-paclitaxel is currently not reimbursed in France.


title: In Individuals With Subjective Cognitive Decline, Age, Memory and Action Speed Scores at Baseline Predict Progression to Cognitive Impairment

acronym: SCD-CI

summary:
Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. The investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the SCD progressed to a mild or major NCD and people in whom the SCD remained stable.

The investigators retrospectively included patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart. The relationship between domain-specific scores and the global cognitive score (GCS, as a function of final status (stable SCD vs. progression toward a mild or major NCD)) was examined using a generalized linear mixed model.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of a Complementary Action of Recruitment of Patients With a Positive Screening Test and Not Realizing Optical Colonoscopy as Part of Organized Colorectal Cancer Screening

acronym: COCAGI

summary:
France is among the countries with a high incidence of colorectal cancer. The prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France since the end of 2008.

This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. But as part of this organized screening, 13% of those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the National Health Authority in 2010. But it has never been assessed as part of organized screening. Similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...).

Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive FOBT as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. This study aims to answer the question of the place of colic capsule as part of organized screening. An economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy.

The proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.

ReferenceCitation: Pioche M, Ganne C, Gincul R, De Leusse A, Marsot J, Balique J, Fond A, Bretagnolle M, Henry L, Billaud Y, Malezieux R, Lapalus MG, Chambon-Augoyard C, Del Tedesco E, Scalone O, Montoy JC, Russias B, Detry A, Veniat F, Qiu J, Valette PJ, Taillandier A, Saurin JC, Tomczyk-Ferrero J, Gandilhon C, Vecchiato L, Soler-Michel P, Ponchon T. Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial. Endoscopy. 2018 Aug;50(8):761-769. doi: 10.1055/s-0044-100721. Epub 2018 Feb 27.

name: Hepatogastroenterology department, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France

name: Lyon 1 University Claude Bernard, Lyon, France

family: Pioche

full_name: Mathieu Pioche

given: Mathieu

name: Research and Medical Information Division, Hospices Civils de Lyon, Lyon, France

family: Ganne

full_name: Christell Ganne

given: Christell

name: Hepatogastroenterology Department, Mermoz Hospital, Lyon, France

family: Gincul

full_name: Rodica Gincul

given: Rodica

family: De Leusse

full_name: Antoine De Leusse

name: Radiology Department, Mermoz Hospital, Lyon, France

family: Marsot

full_name: Julien Marsot

given: Julien

family: Balique

full_name: Julien Balique

family: Fond

full_name: Alain Fond

given: Alain

family: Bretagnolle

full_name: Michel Bretagnolle

given: Michel

name: Radiology Department, Clinique du Val d’Ouest, Lyon, France

family: Henry

full_name: Luc Henry

given: Luc

family: Billaud

full_name: Yann Billaud

given: Yann

name: Radiology Department, Clinique du Parc, Saint-Priest en Jarez, France

family: Malezieux

full_name: Romain Malezieux

given: Romain

name: Hepatogastroenterology Department, Hôpital Privé de L’est Lyonnais, Saint-Priest, France

family: Lapalus

full_name: Marie-Georges Lapalus

given: Marie-Georges

family: Chambon-Augoyard

full_name: Christine Chambon-Augoyard

given: Christine

name: Hepatogastroenterology Department, University Hospital Saint-Etienne, Saint-Priest en Jarez, France

family: Del Tedesco

full_name: Emilie Del Tedesco

given: Emilie

name: Hepatogastroenterology Department, Nord Ouest Hospital, Villefranche-sur-Saône, France

family: Scalone

full_name: Olivia Scalone

given: Olivia

name: Radiology Department, Clinique du Renaison, Roanne, France

family: Montoy

full_name: Jean-Charles Montoy

given: Jean-Charles

family: Russias

full_name: Benoit Russias

given: Benoit

family: Detry

full_name: Antoine Detry

family: Veniat

full_name: Frédéric Veniat

given: Frédéric

name: Hepatogastroenterology Department, Public hospital, Roanne, France

family: Qiu

full_name: Jin Qiu

given: Jin

name: Radiology Department, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France

family: Valette

full_name: Pierre-Jean Valette

given: Pierre-Jean

name: Departmental Screening Management Association Rhône ADEMAS 69, Lyon, France

family: Taillandier

full_name: Annabel Taillandier

given: Annabel

family: Saurin

full_name: Jean-Christophe Saurin

given: Jean-Christophe

name: Departmental Screening Management Association Loire Vivre 42, Saint-Etienne, France

family: Tomczyk-Ferrero


title: Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.


title: Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination

acronym: MMENSEA

summary:
The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).

The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool.

The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.

lead_sponsor: University Hospital Center of Martinique


title: Lupus and Observance

acronym: LUPOBS

summary:
A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.

New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.

Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.

The study primary objective is to determine risk factors for non-observance

The secondary objectives are to:

Measure the observance rate of patients with systemic lupus in Martinique.
Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.


title: Prognostic Evaluation of Fluor 18 Labelled FLUROMISONIDAZOLE (18F-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) in Head and Neck Squamous Cell Carcinomas

acronym: MISORL

summary: Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for assessment of distant metastases and synchronous second primary malignancies, hypoxia is one of the most important prognostic factors in radiotherapy of this type of tumors. The only gold standard method for direct determination of oxygen tension is based on using oxygen electrodes showing a good relation with clinical outcome but complex in its realisation. So, PET using 18F-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful tool for evaluation of new therapies and modification of volumes in radiotherapy.

location_facility:
Hôpital Robert Picqué
CHU de Bordeaux - Hôpital Pellegrin


title: Non-invasive Airway Management of Comatose Poisoned Emergency Patients

acronym: NICO

summary: A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended for patients with traumatic brain injury and coma, it remains unknown whether the benefit of an invasive management of airways with sedation, intubation and mechanical ventilation should be applied to other causes of coma in particular for acute poisoned patients. The investigator hypothesize that a conservative management with close monitoring without immediate endotracheal intubation of these patients is effective and associated with less in-hospital complications (truncated at 28 days) compared to routine practice management (in which the decision of immediate intubation is left to the discretion of the emergency physician).

location_facility: Emergency department Hospital Pitié-Salpêtrière


title: Evolution of Fibrosis Scores During Weight Loss in a Population of Patients Operated on for Morbid Obesity

acronym: FIBROTEST

summary:
Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has been widely used in obese patients to reduce their weight but also to decrease morbidity conditions related to obesity. It could be involved in an improvement in liver lesions observed in obese patients. To evaluate the severity of liver lesions, the gold standard is pathological examination of the liver using percutaneous or surgical biopsies, with a scoring called Fibrosis score stage. Alternative less invasive techniques have been developed to evaluate liver lesions. These tests are commonly used in clinical hepatology and consisted of serum levels determination of fibrosis markers (Fibrotest, Transthyretin).

The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a population of patients operated on for morbid obesity ( BMI > 40kg/m2 or BMI> 35kg/m2 with comorbidity). The primary end point is to evaluate the concordance between Fibrotest and transthyretin serum levels. The number of patients has been calculated on the basis of a concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in this study. According to the number of patients operated on in the 3 centres (>150/year), the time for recruitment is 12 months. Secondary end points will evaluate in these patients the excess weight loss, the improvement in fibrosis liver tests and the correlation with improvement in other obesity- related conditions, according to surgical procedures.

lead_sponsor: University Hospital, Rouen


title: Age Estimation of Adolescents for Legal Purposes: Determining the Medical Response

acronym: AGE-ADO

summary:
Economic globalisation has been associated with a rise of cross-border migration in Europe. In France, courts commonly demand appropriate medical tests aimed at age estimations of supposed minors without documentation. Determining the age of foreign adolescents may be important in order to define the rights and protection afforded them by law depending on this status, and the conditions in which they may be detained or held in police custody if they are under suspicion. Age estimation is considered to be ideally based on the combination of clinical, skeletal, and dental examinations. A number of forensic physicians do not integrate published recommendations or the results of published studies into their daily practice. Previous studies have shown that medical practice is heterogeneous in this area. Factors determining this heterogeneity are unknown.

We hypothesize that the personal and professional development of the physician, as well as the characteristics and the circumstances of medical examination can affect medical response on age determination, beyond clinical and radiological data. The purpose of this study is to identify factors determining medical response to courts.

ReferenceCitation: Pruvost MO, Boraud C, Chariot P. Skeletal age determination in adolescents involved in judicial procedures: from evidence-based principles to medical practice. J Med Ethics. 2010 Feb;36(2):71-4. doi: 10.1136/jme.2009.031948.

ReferenceCitation: Büken B, Safak AA, Yazici B, Büken E, Mayda AS. Is the assessment of bone age by the Greulich-Pyle method reliable at forensic age estimation for Turkish children? Forensic Sci Int. 2007 Dec 20;173(2-3):146-53. Epub 2007 Mar 27.

ReferenceCitation: Schmeling A, Olze A, Reisinger W, Geserick G. Age estimation of living people undergoing criminal proceedings. Lancet. 2001 Jul 14;358(9276):89-90.

ReferenceCitation: Garamendi PM, Landa MI, Ballesteros J, Solano MA. Reliability of the methods applied to assess age minority in living subjects around 18 years old. A survey on a Moroccan origin population. Forensic Sci Int. 2005 Nov 10;154(1):3-12. Epub 2004 Nov 10.

ReferenceCitation: Hassanali J. The third permanent molar eruption in Kenyan Africans and Asians. Ann Hum Biol. 1985 Nov-Dec;12(6):517-23.

location_facility: : Jean Verdier hospital, Department of forensic medicine


title: Clinical Pathways and Patients' Attitudes in Acute Low Back Pain

acronym: AcuteLBP

summary:
In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. It represents 60 to 70 % of low back pain but only 20% of the costs induced by low back pain in general. In fact, acute low back pain often heals spontaneously.

Risk factors for acute low back pain and risk factors for chronic low back pain have been the subject of many publications. They remain very difficult to prevent in practice because of their multiplicity. Preventing acute low back pain is part of the prevention of chronic low back pain. Patient care management of low back pain is well codified and consensual in the various international recommendations. However, their application is sometimes very disparate and bad habits on both patients and professionals persist. Advices recommended in the case of low back pain are widely disseminated but their applications are little studied. In 2017, in France, health insurance started a "back pain" prevention campaign with the objective of raising awareness of good attitudes in the event of back pain. It made an initial assessment of the different knowledges concerning spinal pain in the general population but also in the medical population with the aim of improving them. It appears that number of patients would not consult physician in this case. The many proposals of care and the diversity of medical professionals, paramedics and other stakeholders, proposing to cure low back pain form as many different clinical pathways. Use of alternative or unconventional medicines is poorly assessed. In this context, it seems relevant to evaluate patient clinical pathways and patients' attitudes.

lead_sponsor: CHU de Reims