title: Clinical Validation of the ISET Method for the Non Invasive Prenatal Diagnosis of Trisomy 21 by Genetic Analysis of Circulating Trophoblastic Cells

summary:
The objective of this project is to develop a non-invasive prenatal diagnostic test for trisomy 21 which is reliable, sensitive and cost-effective, and thus, offers an alternative to the currently employed invasive diagnostic tests amniocentesis and chorionic villus sampling.

Current prenatal screening methods (blood markers and ultrasound) for trisomy 21 (Down syndrome) detect about 90 % of cases and have a false positive rate of > 90 %. The results of these tests are expressed in risks for trisomy 21, the threshold being in France at 1/250. Women exhibiting a higher risk are offered to undergo invasive diagnostic testing, either by amniocentesis or chorionic villus sampling. However, these invasive diagnostic methods are associated with a considerable risk of miscarriage (1-3 %), and thus underline the importance to develop a safe and non-invasive prenatal diagnostic test for trisomy 21. The investigators have planned to assess the clinical impact of a non-invasive prenatal method to detect Trisomy 21 through genetic analysis of circulating trophoblastic cells.

status: Active, not recruiting

ReferenceCitation: Vona G, Sabile A, Louha M, Sitruk V, Romana S, Schütze K, Capron F, Franco D, Pazzagli M, Vekemans M, Lacour B, Bréchot C, Paterlini-Bréchot P. Isolation by size of epithelial tumor cells : a new method for the immunomorphological and molecular characterization of circulatingtumor cells. Am J Pathol. 2000 Jan;156(1):57-63.

ReferenceCitation: Vona G, Béroud C, Benachi A, Quenette A, Bonnefont JP, Romana S, Dumez Y, Lacour B, Paterlini-Bréchot P. Enrichment, immunomorphological, and genetic characterization of fetal cells circulating in maternal blood. Am J Pathol. 2002 Jan;160(1):51-8.

ReferenceCitation: Béroud C, Karliova M, Bonnefont JP, Benachi A, Munnich A, Dumez Y, Lacour B, Paterlini-Bréchot P. Prenatal diagnosis of spinal muscular atrophy by genetic analysis of circulating fetal cells. Lancet. 2003 Mar 22;361(9362):1013-4.

ReferenceCitation: Saker A, Benachi A, Bonnefont JP, Munnich A, Dumez Y, Lacour B, Paterlini-Brechot P. Genetic characterisation of circulating fetal cells allows non-invasive prenatal diagnosis of cystic fibrosis. Prenat Diagn. 2006 Oct;26(10):906-16.

ReferenceCitation: Bianchi DW, Simpson JL, Jackson LG, Elias S, Holzgreve W, Evans MI, Dukes KA, Sullivan LM, Klinger KW, Bischoff FZ, Hahn S, Johnson KL, Lewis D, Wapner RJ, de la Cruz F. Fetal gender and aneuploidy detection using fetal cells in maternal blood: analysis of NIFTY I data. National Institute of Child Health and Development Fetal Cell Isolation Study. Prenat Diagn. 2002 Jul;22(7):609-15.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Qualitative Study of the Consequences of Auto-immune Diseases on Quality of Life

acronym: QUALIMAIRAU

summary: Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. The vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. The aim of this study is to analyse the consequences of auto-immune diseases on quality of life. Current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. In this research, the quality of life of patients will be envisaged through their everyday lives. How do these patients construct the social reality of the disease? How do they perceive their health status and their social situation? How do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Arrêt du Traitement Antihypertenseur Chez Les Patients Hypertendus Suivis en Médecine Générale / Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care: The STOP-Trial

summary:
The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension, performed by General practitioners.

The study will be conducted in parallel in the Clinical Investigation Center Plurithematic (CIC-P)1433 of Nancy (the study coordinating center) by the general practitioners investigators of the CIC-P.

The main purpose of the study is to determine the factors associated with the rate of patients remaining normotensive one year after stopping their antihypertensive monotherapy or low dose dual therapy:

white coat hypertension
primary diagnosis by home blood pressure measurements (HBPM) /ambulatory blood pressure measurements (ABPM) /clinical measure
initial blood pressure level
compliance
therapeutic class versus others
age
gender
weight variation
modification of lifestyle
concomitant treatments and associated substances
...

The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values <135/85 mmHg).

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility: Centre d'Investigation Clinique module plurithématique 1433 Inserm/CHRU de Nancy

location_facility: Maison de Santé Pluridisciplinaire de GROSTENQUIN

intervention_type: Drug


title: Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care

acronym: ACR

summary:
With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio respiratory arrest is a public health issue.

The goal of this study is to evaluate the pupillary light reflex measured by the dimension of the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest. By participating to this study, the patient get the same tratments and exams than in a usual managing cares.

In addition of these events, the pupillary light reflex is studied as soon as the patient is accepted in the department, and then on the second day.

Currently, the evaluation of the neurological becoming rely on a multimodal clinical and paraclinical approach.

The study of the pupillary light reflex measured by the diameter of the pupil could be a prognosis factor of neurological evolution for patients in post cardiac arrest, so a reliable and available prognosis marker in patient care.

The goal of this study is to evaluate the pupillary light reflex (RPM), measured by the diameter of the pupil as a prognosis factor of neurological evaluation of admitted patients after a cardiac arrest.

Principal criteria of judgement is the percentage of the pupillary light reflex variation measured with Neurolight®, compared between two groups.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Gorgels AP, Gijsbers C, de Vreede-Swagemakers J, Lousberg A, Wellens HJ. Out-of-hospital cardiac arrest--the relevance of heart failure. The Maastricht Circulatory Arrest Registry. Eur Heart J. 2003 Jul;24(13):1204-9.

ReferenceCitation: Jennett B, Plum F. Persistent vegetative state after brain damage. A syndrome in search of a name. Lancet. 1972 Apr 1;1(7753):734-7.

ReferenceCitation: Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. Review.

ReferenceCitation: Rogove HJ, Safar P, Sutton-Tyrrell K, Abramson NS. Old age does not negate good cerebral outcome after cardiopulmonary resuscitation: analyses from the brain resuscitation clinical trials. The Brain Resuscitation Clinical Trial I and II Study Groups. Crit Care Med. 1995 Jan;23(1):18-25.

ReferenceCitation: Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006 Jul 25;67(2):203-10. Review.

ReferenceCitation: Edgren E, Hedstrand U, Kelsey S, Sutton-Tyrrell K, Safar P. Assessment of neurological prognosis in comatose survivors of cardiac arrest. BRCT I Study Group. Lancet. 1994 Apr 30;343(8905):1055-9.

ReferenceCitation: Kamps MJ, Horn J, Oddo M, Fugate JE, Storm C, Cronberg T, Wijman CA, Wu O, Binnekade JM, Hoedemaekers CW. Prognostication of neurologic outcome in cardiac arrest patients after mild therapeutic hypothermia: a meta-analysis of the current literature. Intensive Care Med. 2013 Oct;39(10):1671-82. doi: 10.1007/s00134-013-3004-y. Epub 2013 Jun 26. Review.

ReferenceCitation: Fischer C, Luauté J, Némoz C, Morlet D, Kirkorian G, Mauguière F. Improved prediction of awakening or nonawakening from severe anoxic coma using tree-based classification analysis. Crit Care Med. 2006 May;34(5):1520-4.

ReferenceCitation: Jørgensen EO. Course of neurological recovery and cerebral prognostic signs during cardio-pulmonary resuscitation. Resuscitation. 1997 Aug;35(1):9-16.

ReferenceCitation: Meeker M, Du R, Bacchetti P, Privitera CM, Larson MD, Holland MC, Manley G. Pupil examination: validity and clinical utility of an automated pupillometer. J Neurosci Nurs. 2005 Feb;37(1):34-40.

ReferenceCitation: Behrends M, Niemann CU, Larson MD. Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: a case series. Resuscitation. 2012 Oct;83(10):1223-8. doi: 10.1016/j.resuscitation.2012.05.013. Epub 2012 May 30.

family: Behrends

full_name: Matthias Behrends

given: Matthias

sequence: first

family: Niemann

full_name: Claus U. Niemann

given: Claus U.

sequence: additional

family: Larson

full_name: Merlin D. Larson

given: Merlin D.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Resuscitation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: A case series

ReferenceCitation: Taylor WR, Chen JW, Meltzer H, Gennarelli TA, Kelbch C, Knowlton S, Richardson J, Lutch MJ, Farin A, Hults KN, Marshall LF. Quantitative pupillometry, a new technology: normative data and preliminary observations in patients with acute head injury. Technical note. J Neurosurg. 2003 Jan;98(1):205-13.

ReferenceCitation: Hörburger D, Testori C, Sterz F, Herkner H, Krizanac D, Uray T, Schober A, Stöckl M, Stratil P, Weiser C, Wallmüller C, Holzer M. Mild therapeutic hypothermia improves outcomes compared with normothermia in cardiac-arrest patients--a retrospective chart review. Crit Care Med. 2012 Aug;40(8):2315-9. doi: 10.1097/CCM.0b013e31825333cf.

ReferenceCitation: Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63.

ReferenceCitation: Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. Erratum in: N Engl J Med 2002 May 30;346(22):1756.

ReferenceCitation: Nunnally ME, Jaeschke R, Bellingan GJ, Lacroix J, Mourvillier B, Rodriguez-Vega GM, Rubertsson S, Vassilakopoulos T, Weinert C, Zanotti-Cavazzoni S, Buchman TG. Targeted temperature management in critical care: a report and recommendations from five professional societies. Crit Care Med. 2011 May;39(5):1113-25. doi: 10.1097/CCM.0b013e318206bab2. Review.

ReferenceCitation: Nolan JP, Neumar RW, Adrie C, Aibiki M, Berg RA, Bbttiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T; International Liaison Committee on Resuscitation; Emergency Cardiovascular Care Committee, American Heart Association; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiopulmonary, Perioperative, and Critical Care; Council on Clinical Cardiology; Council on Stroke. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication: a scientific statement from the International Liaison Committee on Resuscitation; the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; the Council on Stroke (Part II). Int Emerg Nurs. 2010 Jan;18(1):8-28. doi: 10.1016/j.ienj.2009.07.001. Epub 2009 Aug 5.

ReferenceCitation: Gueugniaud PY, Garcia-Darennes F, Gaussorgues P, Bancalari G, Petit P, Robert D. Prognostic significance of early intracranial and cerebral perfusion pressures in post-cardiac arrest anoxic coma. Intensive Care Med. 1991;17(7):392-8.

ReferenceCitation: Álvarez-Fernández JA. [Transcranial Doppler ultrasound use in post-cardiac arrest coma]. Rev Neurol. 2011 Nov 1;53(9):545-54. Review. Spanish.

ReferenceCitation: Wessels T, Harrer JU, Jacke C, Janssens U, Klötzsch C. The prognostic value of early transcranial Doppler ultrasound following cardiopulmonary resuscitation. Ultrasound Med Biol. 2006 Dec;32(12):1845-51.

ReferenceCitation: Edgren E, Hedstrand U, Nordin M, Rydin E, Ronquist G. Prediction of outcome after cardiac arrest. Crit Care Med. 1987 Sep;15(9):820-5.

ReferenceCitation: Zandbergen EG, de Haan RJ, Stoutenbeek CP, Koelman JH, Hijdra A. Systematic review of early prediction of poor outcome in anoxic-ischaemic coma. Lancet. 1998 Dec 5;352(9143):1808-12.

ReferenceCitation: Zandbergen EG, Koelman JH, de Haan RJ, Hijdra A; PROPAC-Study Group. SSEPs and prognosis in postanoxic coma: only short or also long latency responses? Neurology. 2006 Aug 22;67(4):583-6.

ReferenceCitation: Nakabayashi M, Kurokawa A, Yamamoto Y. Immediate prediction of recovery of consciousness after cardiac arrest. Intensive Care Med. 2001 Jul;27(7):1210-4.

ReferenceCitation: Rothstein TL. The role of evoked potentials in anoxic-ischemic coma and severe brain trauma. J Clin Neurophysiol. 2000 Sep;17(5):486-97. Review.

ReferenceCitation: Vanhaudenhuyse A, Laureys S, Perrin F. Cognitive event-related potentials in comatose and post-comatose states. Neurocrit Care. 2008;8(2):262-70.

ReferenceCitation: Tzovara A, Rossetti AO, Spierer L, Grivel J, Murray MM, Oddo M, De Lucia M. Progression of auditory discrimination based on neural decoding predicts awakening from coma. Brain. 2013 Jan;136(Pt 1):81-9. doi: 10.1093/brain/aws264. Epub 2012 Nov 12.

ReferenceCitation: Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett PJ, Becker L, Bossaert L, Delooz HH, Dick WF, Eisenberg MS, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Circulation. 1991 Aug;84(2):960-75. Review.

ReferenceCitation: Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4.

ReferenceCitation: Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.

ReferenceCitation: Rana OR, Schröder JW, Kühnen JS, Saygili E, Gemein C, Zink MD, Schauerte P, Schiefer J, Schwinger RH, Weis J, Marx N, Kelm M, Meyer C, Saygili E. The Modified Glasgow Outcome Score for the prediction of outcome in patients after cardiac arrest: a prospective clinical proof of concept study. Clin Res Cardiol. 2012 Jul;101(7):533-43. doi: 10.1007/s00392-012-0423-7. Epub 2012 Feb 10.

ReferenceCitation: Bouzat P, Suys T, Sala N, Oddo M. Effect of moderate hyperventilation and induced hypertension on cerebral tissue oxygenation after cardiac arrest and therapeutic hypothermia. Resuscitation. 2013 Nov;84(11):1540-5. doi: 10.1016/j.resuscitation.2013.05.014. Epub 2013 May 30.

lead_sponsor: University Hospital, Grenoble


title: Tuberculosis Cohort in the North of Paris: Pilot Phase

summary:
Tuberculosis (TB) is the leading cause of death from infectious disease in the world, just behind HIV / AIDS. Since 2005, the department of Seine Saint Denis, the poorest of France with difficult socio-economic conditions, has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the rate of reporting was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia.

It is proposed to establish for the first time in France a cohort of patients with TB disease to better understand the characteristics of patients with adverse treatment outcomes and propose solutions to achieve better control of TB. This study would recruit 200 patients per year for 5 years associated with 5 years of follow-up for a total duration of the study which would be 10 years. Given the economic stakes induced by such a study, a pilot feasibility study will be carried out initially. This smaller cohort over a shorter inclusion and follow-up period will make it possible to assess the feasibility of the large-scale cohort (princeps cohort) and to propose possible improvements to the protocol or questionnaire if problems arise in the future after achievement of this pilot study.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

intervention_type: Genetic

status_simplified: Ongoing


title: Impact of an Assessment of Risk Factors for Falls and Personalized Care, on Mortality and Institutionalization, After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home

acronym: RISING-DOM

summary: In this project, the investigators are interested in a particular population, that of elderly subjects who used the UAS after a fall and who are not hospitalized or are hospitalized less than 24 hours. The scientific literature concerning this population is poor . However, this is a particularly vulnerable population. The DREES report notes that in 2005 in metropolitan France, 24% of people aged 65 to 75 said they had fallen in the last 12 months. Home falls among seniors may require emergency medical services (EMS).

primary_purpose: Other

lead_sponsor: University Hospital, Toulouse


title: Evaluation of the Right Use of Inhaled Therapeutics Prescribed in Asthma and COPD in Adults

acronym: ARGOS

summary:
Asthma and COPD have a significant impact on public health, affecting about 8 million people in France and generating health care costs of 5.5 billion euros, almost 50% of which are dedicated to long-term treatments are essentially inhaled therapies.

The good control of the disease depends on the patient's compliance, but also on the proper use of the devices used for the administration of inhaled drugs under penalty of the degradation of the control of the disease with major medical and medico-economic consequences.

Thus, education of these patients in the use of devices must be an integral part of medical care. It comes up against the complexity of the therapeutic arsenal on the one hand and on the other hand with its time-consuming nature: this makes it incompatible with a realization in consultation.

The "ARGOS" process is a telemonitoring project for the support of therapeutic education, consisting in setting up a concrete and real-time relay between prescribers and patients for the education of inhaled therapeutics.

Its objective is to provide the answer to what is currently an "unmet need" in the management of asthma and COPD, with the prospect of a positive impact on the observance of these treatments and by consequently their clinical and economic efficiency.

status: Unknown status

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

status_simplified: Unknown


title: IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study

summary:
Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions).

The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.

ReferenceType: derived

ReferenceCitation: Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Steeds RP. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry. Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019.

family: Rudolph

full_name: Tanja K. Rudolph

given: Tanja K.

family: Messika-Zeitoun

full_name: David Messika-Zeitoun

given: David

family: Frey

full_name: Norbert Frey

given: Norbert

family: Lutz

full_name: Matthias Lutz

family: Krapf

full_name: Laura Krapf

given: Laura

family: Passefort

full_name: Stephanie Passefort

given: Stephanie

family: Fryearson

full_name: John Fryearson

given: John

family: Simpson

full_name: Helen Simpson

given: Helen

family: Mortensen

full_name: Kai Mortensen

given: Kai

family: Rehse

full_name: Sebastian Rehse

given: Sebastian

family: Tiroke

full_name: Andreas Tiroke

given: Andreas

family: Dodos

full_name: Fotini Dodos

given: Fotini

family: Mies

full_name: Florian Mies

given: Florian

family: Pohlmann

full_name: Christiane Pohlmann

given: Christiane

family: Kurucova

full_name: Jana Kurucova

given: Jana

family: Thoenes

full_name: Martin Thoenes

given: Martin

family: Bramlage

full_name: Peter Bramlage

given: Peter

family: Steeds

full_name: Richard Paul Steeds

given: Richard Paul

currency_apc_doaj: GBP

journal_name: Open Heart

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings—design of the IMPULSE enhanced registry

ipd_sharing_description: no sharing of individual patient data is planned

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_facility: Department of Cardiology and Angiology, University of Kiel


title: Balloon to Induce Labor in Generous Women

acronym: BIGW

summary:
The rate of obesity increases continuously in France as in many developing countries.The risk of cesarean delivery is increased in obese compared to normal-weight women and postpartum complications as infections, thromboembolic events and related maternal death, are more common among obese women who deliver by cesarean than both normal-weight women with caesarean deliveries and obese women with vaginal deliveries. Unfortunately, obesity is associated with a higher rate of failed induction requiring a cesarean delivery and especially in nulliparous.

Methods of induction for obese women have to be improved to decrease the c-section rate but investigators should also be cautious on the type and dose of PG not to affect the neonatal wellbeing associated with uterine hyperstimulation.

The aim of this study is to demonstrate the efficacy of the association of mechanical and pharmacological cervical ripening (balloon catheter plus 50 µg oral prostaglandin E1) versus pharmacological cervical ripening alone (50 µg oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

ReferenceCitation: Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.

ReferenceCitation: Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.

ReferenceCitation: McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002. Review.

location_country:
Martinique
New Caledonia
France

location_facility:
CHRU Lille
CHU Saint Denis de la Reunion
CHU Antoine Beclère
CHU Nimes
Hôpital St Joseph
CHU Poitiers
CHU Fort de France
CHU Clermont-Ferrand
CHU Tours
CHI Poissy
CHU St Pierre de la Reunion
CHU Bordeaux
CHU Kremlin Bicêtre
CHU Montpellier
CHU St Etienne
CHU Nantes
CHU de Toulouse
CHU Noumea
Centre hospitalier St Joseph

intervention_type: Combination Product


type: Other Identifier

title: Screening for Neurodevelopmental Disorders in Children With Congenital Heart Disease Aged From 6 to 66 Months in Nord-Pas-de-Calais

acronym: NeuroDis-CHD

summary:
Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society.

The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up.

This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

ReferenceCitation: Billotte M, Deken V, Joriot S, Vaksmann G, Richard A, Bouzguenda I, Godart F, Baudelet JB, Rakza T, Nguyen The Tich S, Guillaume MP. Screening for neurodevelopmental disorders in children with congenital heart disease. Eur J Pediatr. 2021 Apr;180(4):1157-1167. doi: 10.1007/s00431-020-03850-x. Epub 2020 Oct 29.

family: Billotte

full_name: Morgane Billotte

given: Morgane

family: Deken

full_name: Valérie Deken

given: Valérie

family: Joriot

full_name: Sylvie Joriot

given: Sylvie

family: Vaksmann

full_name: Guy Vaksmann

given: Guy

family: Richard

full_name: Adélaïde Richard

given: Adélaïde

family: Bouzguenda

full_name: Ivan Bouzguenda

given: Ivan

family: Godart

full_name: François Godart

given: François

family: Baudelet

full_name: Jean-Benoit Baudelet

given: Jean-Benoit

family: Rakza

full_name: Thameur Rakza

given: Thameur

family: Nguyen The Tich

full_name: Sylvie Nguyen The Tich

family: Guillaume

full_name: Marie-Paule Guillaume

given: Marie-Paule

journal_name: European Journal of Pediatrics

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Lille


title: National Register of Oesophageal Atresia

acronym: REGATE

summary:
The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...).

The current prognosis for this ailment is good. However he persists a mortality (<10%) and significant morbidity, firstly related malformations (heart, kidney, for example), and secondly with particularly difficult anatomical forms (Forms long defect) .

The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an estimated ± 2,500 new cases over to 10 years in France.

The current project aims to set up a national registry (Metropolitan France and Dom Tom) to measure the prevalence of esophageal atresia among live births, phenotypic characteristics, the circumstances of their diagnosis, and their initial future at short-term during the first year of life, at which time occurs the vast majority of deaths and complications in this disease.

ReferenceCitation: Lejeune S, Sfeir R, Rousseau V, Bonnard A, Gelas T, Aumar M, Panait N, Rabattu PY, Irtan S, Fouquet V, Le Mandat A, Cocci SN, Habonimana E, Lamireau T, Lemelle JL, Elbaz F, Talon I, Boudaoud N, Allal H, Buisson P, Petit T, Sapin E, Lardy H, Schmitt F, Levard G, Scalabre A, Michel JL, Jaby O, Pelatan C, De Vries P, Borderon C, Fourcade L, Breaud J, Arnould M, Tolg C, Chaussy Y, Geiss S, Laplace C, Drumez E, El Mourad S, Thumerelle C, Gottrand F. Esophageal Atresia and Respiratory Morbidity. Pediatrics. 2021 Sep;148(3). pii: e2020049778. doi: 10.1542/peds.2020-049778. Epub 2021 Aug 19.

family: Lejeune

full_name: Stéphanie Lejeune

given: Stéphanie

family: Sfeir

full_name: Rony Sfeir

given: Rony

family: Rousseau

full_name: Véronique Rousseau

given: Véronique

family: Bonnard

full_name: Arnaud Bonnard

given: Arnaud

family: Gelas

full_name: Thomas Gelas

given: Thomas

family: Aumar

full_name: Madeleine Aumar

given: Madeleine

family: Panait

full_name: Nicoleta Panait

given: Nicoleta

family: Rabattu

full_name: Pierre-Yves Rabattu

given: Pierre-Yves

family: Irtan

full_name: Sabine Irtan

given: Sabine

family: Fouquet

full_name: Virginie Fouquet

given: Virginie

family: Le Mandat

full_name: Aurélie Le Mandat

given: Aurélie

family: Cocci

full_name: Stephan De Napoli Cocci

given: Stephan De Napoli

family: Habonimana

full_name: Edouard Habonimana

given: Edouard

family: Lamireau

full_name: Thierry Lamireau

given: Thierry

family: Lemelle

full_name: Jean-Louis Lemelle

given: Jean-Louis

family: Elbaz

full_name: Frédéric Elbaz

given: Frédéric

family: Talon

full_name: Isabelle Talon

given: Isabelle

family: Boudaoud

full_name: Nadia Boudaoud

given: Nadia

family: Allal

full_name: Hossein Allal

given: Hossein

family: Buisson

full_name: Philippe Buisson

given: Philippe

family: Petit

full_name: Thierry Petit

family: Sapin

full_name: Emmanuel Sapin

given: Emmanuel

family: Lardy

full_name: Hubert Lardy

location_facility:
AP-HP Robert-Debré
CHU Dijon Bourgogne
AP-HP Armand Trousseau
CH Le Mans
CHU de Pointe-à-Pitre
CHU de Strasbourg
CHU d'Angers
AP-HM La Timone
CHRU de Montpellier
CHU de Clermont-Ferrand
AP-HP CHU Kremlin-Bicêtre
CHRU de Tours
AP-HP Necker-Enfants malades
CHU de Rennes
CHU de Toulouse
CHU de Nancy
CHU de Bordeaux
CHU de Poitiers
CHU de Grenoble
AP-HM Nord
CHU de Caen
CHRU Brest
CHI Créteil
CHU de Nantes
CHU de Nice
CHU Félix-Guyon
HFME de Lyon
CHU de Martinique
CHU de Rouen
CHU Amiens-Picardie
CHU de Saint-Etienne
CHU de Reims
CHR d'Orléans
Hôpitaux Civils de Colmar
CHU de Limoges
CHRU Besançon
CHRU,Hôpital Jeanne de Flandres


title: Study of Smoking Prevalence at the "Hospices Civils de Lyon"

acronym: TABAC-HCL

summary:
Tobacco is the leading risk factor for avoidable mortality in France and around the world. It is also the second cause of life with disability in the world and the leading preventable risk factor for cancer in France and worldwide.
The "Health Barometer" studies carried out for 25 years in France by Santé-Publique France assessed prevalence of smoking in the lay population. These studies showed that smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014).
Data on the prevalence of smoking among hospital staff are contradictory. Some studies find a higher prevalence of active smoking than the general population; others have a lower prevalence. However, it appears that an active prevention policy with hospital staff can significantly and rapidly reduce the prevalence of active smoking.
The prevalence of active smoking in patients is logically higher than in the general population (at comparable age).
The data on the prevalence of smoking among medical students are also contradictory. Yet, this population is a special interest group given their future investment in patient care.
Cannabis use also appears to be an independent risk factor for respiratory diseases and broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of students). To our knowledge, the measurement of the prevalence of Cannabis use in an all-patient population of a hospital-university facility has never been achieved.
According to the health barometer 2014, about a quarter of 15-75 year olds have already tried electronic cigarettes and 6% are regular current users. Although the toxicity of the electronic cigarette and its interest in weaning remain controversial, its use to patients, staff or patients has been reported very little.

The aim of this study is to assess the impact of collective and individual tobacco control measures by measuring the prevalence of smoking on a given day at the "Hospices Civils de Lyon", among patients, staff and students present on a given day.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique - Hôpital Lyon-Sud


title: Pilot, Comparative, Not Randomized, Two Centers Study Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

acronym: BALLODINO

summary:
At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature.

There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®).

Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®).

The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures.

The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre Hospitalier Vendée
Centre Hospitalier

intervention_type: Device


title: Prospective Study of the Phenotypic Expression of Cystic Fibrosis (CF) Screened Positive Newborns With an Atypical Form of CF (DPAM)

acronym: DPAM

summary:
The strategy of neonatal screening for Cystic Fibrosis in France relies on Immuno Reactive Trypsinogen (IRT) at day 3/DNA analysis with a CF Elucigen 30 mutations kit/ IRT safety-net at day 21. This strategy has significantly improved the performance of CF neonatal screening (NNS) in terms of positive predictive value and sensitivity but revealed new difficulties. Up to 85-90% of CF patients detected through the NNS program has a classical CF form with a positive sweat test and 2, 1 or no CF causing mutations but the remainder has either 2 CFTR mutations with at least one non-CF causing mutation and a sweat test <60mmol/L or 1, 0 CFTR mutation and an intermediate sweat test value ≥ 30 et < 60mmol/L raising a diagnosis and prognosis dilemma. Meanwhile the vast majority of these cohorts will remain asymptomatic over time, some will develop symptoms prompting clinicians to maintain a rigorous surveillance for the entire atypical cohort, whose modalities vary a lot among centers and countries.

This prospective multicenter study with a standardized assessment of a matched cohort with "atypical" CF versus "classical" CF from 6 years of age (60-65 cases in each cohort) is aimed at evaluating pulmonary and nutritional status to, better define the best monitoring follow-up, therapeutic management and familial genetic counseling.

location_facility: Robert Debre Hospital - Assistance Puplique - Hôpitaux de Paris

intervention_type: Radiation


title: Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial

acronym: EPOLUX

summary:
The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.

In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.

A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.

The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.

lead_sponsor: Hopital Nord Franche-Comte

intervention_type: Procedure


title: Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice

acronym: INVICTUS

summary:
The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the absence of compression.

In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'Indication' Ulcer of venous origin or predominantly venous component, stage C6 CEAP classification with a systolic pressure index greater than 0.9 '.

The investigators propose to study the efficiency of Venotrain® Ulcertec in a diverse population in which it is prescribed according to the usual practices of venous leg ulceration of venous or predominantly venous origin.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Centre hospitalier universitaire d'Angers


title: Study of the Determinants Associated With Sustained Changes in Physical Activity Behaviors, and Their Effects on the Prevention and Treatment of Chronic Diseases, in Individuals Enrolled in an Adapted Physical Activity Program

acronym: SESAME

summary:
Introduction: Regular practice of exercise or physical activity (PA) is a recognized intervention as a determinant of good health acquisition, maintenance, or recovery for a large number of chronic pathologies. Nevertheless, few studies have evaluated adherence to an initial health-adapted PA (APA) program, and persistence of active behavior over the time in individuals with a chronic disease.

The aim of the study is to determine the brakes and levers associated with motivation and long-term compliance. In addition, the investigators aim to evaluate the cost-effectiveness of such program in term of care consumption. Finally, the investigators complete their interest for APA prescription from practitioners agreeing to enroll their patients in the present study.

Method: The investigators perform a prospective monocentric cohort, of 2024 patients affected of a chronic disease or long-term illness (LTI), enrolled from 2021 to 2024 (4 years, 506 per year), for a 16-week APA program, and followed 5 years with an annual fitness and habits of life and care consumption evaluation.

primary_purpose: Prevention

lead_sponsor: Mon Stade Sports Medicine Centre

intervention_type: Behavioral

lead_sponsor_type: industriel


title: Assessing the Expression and the Activity of Rac1 Protein in the Airway Smooth Muscle of

acronym: NaRacAS

summary:
Asthma is a chronic inflammatory respiratory disease affecting 6 to 7% of the French adult population and responsible of 1000 deaths in France every year. Many anti-inflammatory treatments are available but few had been developed to target hyperresponsiveness.Investigators and searchers of the Institut du thorax have recently demonstrated the main involvement of Rac1 monomeric G protein in the contraction of airway smooth muscle cells. They show that Rac1 is expressed in the airway smooth muscle cells in mice and its activity is increased in the bronchi of asthma induced mice sensitized to House-Dust Mite. They further demonstrate that Rac1 inhibition in mice by nebulisation reduces airway hyperresponsiveness and pulmonary inflammation. Investigators and searchers of the Institut du thorax would like to seek whether targeting Rac1 would be interesting in asthmatic patients. Primary objective of this study is to determine if Rac1 expression and activity in airway smooth muscle cells are increased in asthmatic patients compare to controlled samples (deceased donor samples). Secondary objective is to determine whether there is a correlation between Rac1 activity and asthma severity.

If Rac1 activity in airway smooth muscles is indeed increased in asthmatic patients depending on asthma severity, Rac1 could be a potential target to treat airway hyperresponsiveness.

primary_purpose: Basic Science

lead_sponsor: Nantes University Hospital


title: Impact of the COVID-19 Pandemic on Vaccination in Patients at Risk of Infection

acronym: COVIDVacImpac

summary:
The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.

The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.

The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract

acronym: FISTULENDO

summary: Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.

lead_sponsor: Aymeric Becq


title: Evaluation of the Dietary Supplement Refill Bypass Administered Sublingually to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery Type Gastric Bypass

acronym: Refill

summary:
This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months.

This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery.

Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon.

The main objective is to evaluate the efficacy of the dietary supplement Refill.

The primary endpoint is the reduction of iron deficiency.

lead_sponsor: Refill France

intervention_type: Dietary Supplement


title: Evaluation of Middle Ear Implants in the Therapeutic Strategy of Auditory Rehabilitation in Case of Failure of Conventional Hearing Aid

summary: The middle ear implant are used for patients with mild to severe sensorineural hearing loss, who cannot benefit from conventional hearing aids because of medical reasons such as chronic external otitis or external skin irritation. The device is also available for patients who are dissatisfied with the conventional hearing aids because of poor sound quality, feedback or occlusion of the ear canal. To date, more than 1500 patients have been implanted in Europe and about more than 600 patients in France. The aim of the present study is to compare in a randomized study the performances of the system to those of the conventional hearing aid in patients with similar degree of hearing loss.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.

summary: Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Haemoccult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitute an invasive method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasive method is required.

primary_purpose: Diagnostic

ReferenceCitation: Sacher-Huvelin S, Coron E, Gaudric M, Planche L, Benamouzig R, Maunoury V, Filoche B, Frédéric M, Saurin JC, Subtil C, Lecleire S, Cellier C, Coumaros D, Heresbach D, Galmiche JP. Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer. Aliment Pharmacol Ther. 2010 Nov;32(9):1145-53. doi: 10.1111/j.1365-2036.2010.04458.x. Epub 2010 Sep 16.

family: Sacher-Huvelin

full_name: S. Sacher-Huvelin

given: S.

family: Coron

full_name: E. Coron

given: E.

family: Gaudric

full_name: M. Gaudric

given: M.

family: Planche

full_name: L. Planche

given: L.

family: Benamouzig

full_name: R. Benamouzig

given: R.

family: Maunoury

full_name: V. Maunoury

given: V.

family: Filoche

full_name: B. Filoche

given: B.

family: Frédéric

full_name: M. Frédéric

family: Saurin

full_name: J.-C. Saurin

family: Subtil

full_name: C. Subtil

given: C.

family: Lecleire

full_name: S. Lecleire

family: Cellier

full_name: C. Cellier

family: Coumaros

full_name: D. Coumaros

given: D.

family: Heresbach

full_name: D. Heresbach

family: Galmiche

full_name: J. P. Galmiche

given: J. P.

journal_name: Alimentary Pharmacology & Therapeutics

oa_host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: submittedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley


title: Multicentric, Open Label With Retrospective Inclusion and 5 Years Prospective Follow-up of Acetabular Prothetic Implant "Polymax"

summary:
Total replacement of hip joint is one of the most important medical innovations of the twentieth century. More than 100,000 hip replacements are being laid each year in France.

Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects of continuous improvement.

Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons for joint replacement of the defective hip.

The anchor and friction torque are both essential to the survival of hip implants. Therefore acetabular implants without cement with ceramic insert or polyethylene in a metalback or full polyethylene coated with titanium grains without metalback are proposed, but they have their own complications (Squeaking, fractures, recovery difficulties, difficult radiographic analysis, high cost for ceramics, primary stability defects, instability of the instrument set, Titanium residues in absence of metalback. An alternative to these implants may be an acetabular component without cement with polyethylene insert with an end metalback to increase both polyethylene thickness and size of the head in order to expect a low complication rate with important longevity for a lower cost.

This study was conducted to ensure the safety and effectiveness of the acetabular implant "POLYMAX"

location_facility:
Purpan Hospital
Saint Grégoire Hospital


title: Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial

acronym: Cefasleeve

summary: With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal complications. The risk of mortality and morbidity are directly proportional to the importance of overweight and medical treatment alone is only moderately effective weight loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection (SSI). The SSI are the third most common nosocomial infection after urinary tract infections and airway. The fight against the ISO requires the administration of antibiotic prophylaxis acting on the main bacteria found in bariatric surgery. There are several studies in the literature interested in the dose of cefazolin in bariatric surgery. However, no published pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in these surgery. Only empirical recommendations are published, including the SFAR and the National Institute of Health in 2010. This study aims to determine whether the dose of 4 grams of cefazolin can achieve these goals of concentration and estimate an injection time of preoperative ideal for an adequate tissue concentration at the time of the incision.

ReferenceCitation: Cinotti R, Dumont R, Ronchi L, Roquilly A, Atthar V, Grégoire M, Planche L, Letessier E, Dailly E, Asehnoune K. Cefazolin tissue concentrations with a prophylactic dose administered before sleeve gastrectomy in obese patients: a single centre study in 116 patients. Br J Anaesth. 2018 Jun;120(6):1202-1208. doi: 10.1016/j.bja.2017.10.023. Epub 2017 Dec 6.

family: Cinotti

full_name: R. Cinotti

family: Dumont

full_name: R. Dumont

family: Ronchi

full_name: L. Ronchi

family: Roquilly

full_name: A. Roquilly

given: A.

family: Atthar

full_name: V. Atthar

family: Grégoire

full_name: M. Grégoire

family: Letessier

full_name: E. Letessier

family: Dailly

full_name: E. Dailly

family: Asehnoune

full_name: K. Asehnoune

given: K.

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific


title: Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery

acronym: BariaProG

summary:
Adequate equipment for lifelong health is essential to ensure healthy health for fetal development. In France, pregnant women with normal weight have increased protein intake to 0.78-0.95g / kg / day (ANC 2001). And more recently, AFSSA from 2007 proposed a recommended nutritional intake of 0.82-1g / kg / d. An increased requirements in the second and third trimester of 0.25 g / kg / day and 0.46 g / kg / day, respectively, compared with non-pregnancy values. However, the prevalence of the incompatibility remains unknown.

In addition, maternal protein intake is inadequate or excessively associated with both intra-uterine growth retardation and small gestational age weights. Neonatal hypotrophy is also associated with a risk of chronic diseases in adulthood, including cardiovascular disease, type 2 diabetes, insulin resistance, high blood pressure and coronary heart disease.

In obese women or patients undergoing surgery for bariatric surgery, there is currently no recommendation on the recommended protein intake. Or, maternal obesity plays a role in the metabolic development of children and bariatric surgery is associated with a major risk of maternal micronutrient deficiencies and intra-uterine growth retardation.

Prevalence of obesity in France is currently estimated at 17%. Moreover, bariatric surgery is also fast-growing in France with a number of interventions having tripled since 2006.

Thus, a better understanding of maternal food needs and applications throughout pregnancy is needed to improve dietary guidelines and promote fetal, neonatal and long-term health.

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand


title: Early Screening of Autism Spectrum Disorder in General and Pediatric Practices, Nurseries and Early Child Care Centers, Using Parent Questionnaires and Guidance for Addressing the Child

acronym: KitCAT

summary:
Early screening for Autism Spectrum Disorder has been validated using different screening tools, in particular M-CHAT-R and ITC in different countries. Unfortunaltely, in France, they are not often used. Thus, medium age for diagnosis in France is late. Yet, early interventions has shown efficiency (grade B of HAS 2010 recommendations, HAS 2018) . The American have described an efficient method using partnership between pediatricians and autism specialists (Miller et al). Autism Spectrum Disorders concern 1% of population. The third Autism Plan in France then HAS 2018 Recommandations and The 2018 National Strategy for Autism have propose to implement three levels for early diagnostic : the frontline is constituted by professionals who can detect the firsts signs ( in nurseries, general practice, pediatric practice, early childhood centers), the second line is constituted by the proximity network of professionals who can diagnose " simple " autism ( CMP, CAMSP, neurologic pediatricians), the third line is constituted by expert teem in specialized hospital centers for neurodevelopmental disorders diagnostic.

This organization is, for now, not efficient. First lines professionals are not always formed to autism detection. When the screening is efficient, professionals have difficulties to address children to proximity teem trained to autism diagnostic because of delays or lack of professionals. The second line professionals are note always trained to use diagnostic tools and tend to address all the children to the third line, even when the diagnostic is not complex. The third lign is saturated by all these requests.

lead_sponsor: Hôpital le Vinatier

intervention_type: Diagnostic Test


title: Impact of Information About Booster Vaccination Against DTPolio at 25 Years on This Booster Vaccination's Realization

acronym: Info-Vac

summary:
The aim of vaccination is to protect the patient against disease by stimulating his immune system. DTPolio is a tetravalent vaccine providing protection against pertussis, diphtheria, tetanus and polio.

In France, the vaccination schedule sets the vaccination recommendations applicable to people according to their age. In this schedule, a booster of DTPolio at the age of 25 is recommended.

The vaccination coverage for patients over 16 years of age is insufficient in France.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies: Randomized Trial

summary:
A large number of patients presenting to the emergency department will have an invasive or potentially painful treatment (suture, urinary catheterization, reduction of dislocation or fracture). This care is a source of pain and anxiety for patients.

Since 1998, the management of pain is a public health priority in France. Law No. 2002-3003 of 4 March 2002 on the rights of the sick and the quality of the health system has made pain management a right: "Everyone has the right to receive care to relieve his pain. This must be in all circumstances prevented, evaluated, taken into account and treated ".

In emergency departments, the use of antalgic drug treatments and local anesthetics is systematic.

ReferenceType: result

ReferenceCitation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3. Review. Update in: Cochrane Database Syst Rev. 2018 Oct 04;10:CD005179.

name: IWK Health Centre & Dalhousie University; Halifax Nova Scotia Canada

family: Uman

full_name: Lindsay S Uman

given: Lindsay S

name: IWK Health Centre; Centre for Pediatric Pain Research; K8536 (8th Floor, Children's site) 5850/5980 University Avenue, PO Box 9700 Halifax Canada B3K 6R8

family: Birnie

full_name: Kathryn A Birnie

given: Kathryn A

family: Noel

full_name: Melanie Noel

given: Melanie

family: Parker

full_name: Jennifer A Parker

given: Jennifer A

name: Department of Pediatrics (GI Division), IWK Health Centre; Department of Psychology, Dalhousie University; 5850/5980 University Avenue P.O. Box 9700 Halifax Noval Scotia Canada B3K 6R8

family: Chambers

full_name: Christine T Chambers

given: Christine T

family: McGrath

full_name: Patrick J McGrath

given: Patrick J

name: The University of Queensland; School of Population Health; Brisbane Australia

family: Kisely

full_name: Steve R Kisely

given: Steve R

journal_name: Cochrane Database of Systematic Reviews

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

repository_institution: The University of Queensland - Queensland's institutional digital repository

ReferenceCitation: Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.

family: Tashjian

full_name: Vartan C Tashjian

given: Vartan C

family: Mosadeghi

full_name: Sasan Mosadeghi

given: Sasan

family: Howard

full_name: Amber R Howard

given: Amber R

family: Lopez

full_name: Mayra Lopez

given: Mayra

family: Dupuy

full_name: Taylor Dupuy

given: Taylor

family: Reid

full_name: Mark Reid

given: Mark

family: Martinez

full_name: Bibiana Martinez

given: Bibiana

family: Ahmed

full_name: Shahzad Ahmed

given: Shahzad

family: Dailey

full_name: Francis Dailey

given: Francis

family: Robbins

full_name: Karen Robbins

given: Karen

family: Rosen

full_name: Bradley Rosen

given: Bradley

family: Fuller

full_name: Garth Fuller

given: Garth

family: Danovitch

full_name: Itai Danovitch

ReferenceCitation: Hoffman HG, Patterson DR, Soltani M, Teeley A, Miller W, Sharar SR. Virtual reality pain control during physical therapy range of motion exercises for a patient with multiple blunt force trauma injuries. Cyberpsychol Behav. 2009 Feb;12(1):47-9. doi: 10.1089/cpb.2008.0056.

name: Human Interface Technology Laboratory and Department of Mechanical Engineering, University of Washington, Seattle, Washington.

name: Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington.

name: Department of Anesthesiology, University of Washington School of Medicine, Seattle, Washington.

title: Virtual Reality Pain Control during Physical Therapy Range of Motion Exercises for a Patient with Multiple Blunt Force Trauma Injuries

ReferenceCitation: Schneider SM, Workman ML. Virtual reality as a distraction intervention for older children receiving chemotherapy. Pediatr Nurs. 2000 Nov-Dec;26(6):593-7.

ReferenceCitation: Miller KM, Wysocki T, Cassady JF Jr, Cancel D, Izenberg N. Validation of measures of parents' preoperative anxiety and anesthesia knowledge. Anesth Analg. 1999 Feb;88(2):251-7.

ReferenceCitation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31.


title: Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection

acronym: CPVP

summary: Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. The consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. Pre-eclampsia associates maternal hypertension with dysfunction kidney. There is no cure for pre-eclampsia or IUGR vascular during pregnancy. These pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. Primary prevention and secondary education and screening for these pathologies are still insufficient. A better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Prospective Multicentre Study to Determine Respiratory Microbiome Biomarkers for the Prognostic of Clinical Course of Influenza in Children

acronym: BMIG

summary:
Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms.

Hypotheses :

The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication)
The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.

location_facility: CIC groupement Hospitalier Est - Hospices Civils de Lyon

intervention_type: Biological


title: Factors Predisposing to Inappropriate Transfers of Nursing Home Residents to Emergency Departments

acronym: FINE

summary:
According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months or about 50% per year. These hospitalizations concern for half, transfers to emergency department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in France, confirm that intense flows between NH and ED. These studies also support the idea that these transfers to ED potentially expose some NH residents to iatrogenic complications, a risk of functional decline, an increased risk of mortality, and generate additional health costs. To transfer to ED residents who will benefit from emergency care and not to transfer to ED residents for whom this transfer generates a higher risk than the expected benefit is the goal to reach to guarantee the better quality of care for NH residents.

Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or palliative care known before transferring to ED and / or the presence of advance directives of non-hospitalization in the resident's file. This is a clinical situation that could be managed by other means that the transfer to ED without loss of opportunity for the patient.

The primary objective of our study is to determine the factors predisposing NH residents to inappropriate transfer to ED.

Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by factors accessible to interventions such as the organization of the NH care system or by improving the management of some diseases in NH. Investigators also hypothesize that the cost of inappropriate transfers to the ED is considerable. Acknowledgement of costs generated by inappropriate transfers to ED would allow policy makers to make strategic decisions to improve care system.

time_perspective: Retrospective

ReferenceCitation: Perrin A, Tavassoli N, Mathieu C, Hermabessière S, Houles M, McCambridge C, Magre E, Fernandez S, Caquelard A, Charpentier S, Lauque D, Azema O, Bismuth S, Chicoulaa B, Oustric S, Costa N, Molinier L, Vellas B, Bérard E, Rolland Y. Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol. Contemp Clin Trials Commun. 2017 Jul 21;7:217-223. doi: 10.1016/j.conctc.2017.07.005. eCollection 2017 Sep.

ReferenceCitation: Rolland Y, Mathieu C, Tavassoli N, Berard E, Laffon de Mazières C, Hermabessière S, Houles M, Perrin A, Krams T, Qassemi S, Cambon A, Magre E, Cantet C, Charpentier S, Lauque D, Azema O, Chicoulaa B, Oustric S, McCambridge C, Gombault-Datzenko E, Molinier L, Costa N, De Souto Barreto P. Factors Associated with Potentially Inappropriate Transfer to the Emergency Department among Nursing Home Residents. J Am Med Dir Assoc. 2021 May 5. pii: S1525-8610(21)00343-1. doi: 10.1016/j.jamda.2021.04.002. [Epub ahead of print]

family: Rolland

full_name: Yves Rolland

given: Yves

family: Mathieu

full_name: Celine Mathieu

given: Celine

family: Tavassoli

full_name: Neda Tavassoli

given: Neda

family: Berard

full_name: Emilie Berard

given: Emilie

family: Laffon de Mazières

full_name: Clarisse Laffon de Mazières

given: Clarisse

family: Hermabessière

full_name: Sophie Hermabessière

given: Sophie

family: Houles

full_name: Mathieu Houles

given: Mathieu

family: Perrin

full_name: Amélie Perrin

given: Amélie

family: Krams

full_name: Thomas Krams

given: Thomas

family: Qassemi

full_name: Soraya Qassemi

given: Soraya

family: Cambon

full_name: Amandine Cambon

given: Amandine

family: Magre

full_name: Elodie Magre

given: Elodie

family: Cantet

full_name: Christelle Cantet

given: Christelle

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

family: Lauque

full_name: Dominique Lauque

given: Dominique

family: Azema

full_name: Olivier Azema

given: Olivier

family: Chicoulaa

full_name: Bruno Chicoulaa

given: Bruno

family: Oustric

full_name: Stéphane Oustric

given: Stéphane

family: McCambridge

full_name: Cécile McCambridge

given: Cécile

family: Gombault-Datzenko

full_name: Eugénie Gombault-Datzenko

given: Eugénie

family: Molinier

full_name: Laurent Molinier

given: Laurent

family: Costa

full_name: Nadège Costa

given: Nadège

family: De Souto Barreto

full_name: Philipe De Souto Barreto

journal_name: Journal of the American Medical Directors Association

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study

summary: This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

ReferenceCitation: Scherrer D, Rouzier R, Noel Barrett P, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Pharmacokinetics and tolerability of ABX464, a novel first-in-class compound to treat HIV infection, in healthy HIV-uninfected subjects. J Antimicrob Chemother. 2017 Mar 1;72(3):820-828. doi: 10.1093/jac/dkw458.

family: Scherrer

full_name: Didier Scherrer

given: Didier

family: Rouzier

full_name: Regine Rouzier

given: Regine

family: Noel Barrett

full_name: P. Noel Barrett

given: P.

family: Steens

full_name: Jean-Marc Steens

given: Jean-Marc

family: Gineste

full_name: Paul Gineste

given: Paul

family: Murphy

full_name: Robert L. Murphy

given: Robert L.

family: Tazi

full_name: Jamal Tazi

given: Jamal

family: Ehrlich

full_name: Hartmut J. Ehrlich

given: Hartmut J.

journal_name: Journal of Antimicrobial Chemotherapy

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Abivax S.A.


title: Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination

summary:
More than 100 000 surgical abortions are annually performed in France. About four in ten women will have an abortion in their life. Abortion complications are cervical tearing (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%). These complications can first compromise the vital prognosis and are involved in 10% of the worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding), and are finally responsible for obstetrical pathologies as late miscarriages or premature delivery due to cervical insufficiency. All that complications are linked to cervical laceration of the surgical abortion, that can be reduced by the recommended use of mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks. However, it does not exist data evaluating the superiority of one of the two molecules or their combination. These data could optimize the cervical preparation and thus reduce the abortion complications with a direct impact on maternal mortality, infertility and obstetrical complications. Thus, it seems to be important to evaluate these two molecules and their combination.

Objectives To compare mifepristone, misoprostol and their combination in the cervical preparation of the surgical abortion between 12 and14 weeks for their efficacy, complications and side-effects.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump

acronym: MedInPS

summary: Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump

lead_sponsor: Medtrum France


title: Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

acronym: BIGDIAM

summary: Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.

lead_sponsor: Institut Paoli-Calmettes


title: Use of Care Services by Patients With Borderline Personality Disorder

acronym: EpiB

summary:
Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability and impulsivity. Several North American prospective studies support the high level of mental health care utilization in this population. There is little data in other systems of health organization, such as France. Furthermore, little is known on the variables associated with the mental health service utilization among BPD patients.

The main objective was to compare the utilization of mental health care among BPD patients, to the general population and patients with another personality disorder (PD) and to describe the demographic and clinical factors associated with the group of patients who use the most health care.

ReferenceCitation: Cailhol L, Thalamas C, Garrido C, Birmes P, Lapeyre-Mestre M. [Mental health service utilization among borderline personality disorder patients inpatient]. Encephale. 2015 Apr;41(2):115-22. doi: 10.1016/j.encep.2014.10.008. Epub 2014 Dec 17. French.

family: Cailhol

full_name: L. Cailhol

given: L.

family: Thalamas

full_name: C. Thalamas

given: C.

family: Garrido

full_name: C. Garrido

family: Birmes

full_name: P. Birmes

family: Lapeyre-Mestre

full_name: M. Lapeyre-Mestre

given: M.

journal_name: L'Encéphale

title: Utilisation des services de soin par les patients hospitalisés, présentant un trouble de personnalité borderline en Midi-Pyrénées

lead_sponsor: University Hospital, Toulouse


title: Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping

acronym: VINCI

summary: The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Brest


title: Diuretic Versus Placebo in Pulmonary Embolism With Right Ventricular Enlargement: a Double-blind Randomized Controlled Study

acronym: DiPER

summary:
Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about 75000 cases in France and a short-term mortality rate of about 10%. Death is usually related to an acute right ventricular (RV) failure due to the increase in right ventricular afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in case of shock. However several studies suggest that fluid expansion may worsen acute RV failure by increasing RV dilatation and ischemia and left ventricular compression by RV dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of fluid expansion. In a preliminary study published by our group, we showed that diuretic treatment in the setting of PE with RV dilatation is safe and is associated with an increase in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients with oliguria. This may be related to the decrease of ventricular interdependence and enhancement of both LV and RV function.

The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in patients referred for acute PE with RV dilatation compared to placebo. The combination of urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it indicates the disappearance of pre-shock symptoms and is therefore associated with a lower event risk. Thus, it allows early discharge of the patients from the intensive care unit.

ReferenceCitation: Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to the golden hour of hemodynamically significant pulmonary embolism. Chest. 2002 Mar;121(3):877-905. Review.

ReferenceCitation: Lee FA. Hemodynamics of the right ventricle in normal and disease states. Cardiol Clin. 1992 Feb;10(1):59-67. Review.

ReferenceCitation: Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galiè N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.

ReferenceCitation: Perlroth DJ, Sanders GD, Gould MK. Effectiveness and cost-effectiveness of thrombolysis in submassive pulmonary embolism. Arch Intern Med. 2007 Jan 8;167(1):74-80.

ReferenceCitation: Goldhaber SZ, Haire WD, Feldstein ML, Miller M, Toltzis R, Smith JL, Taveira da Silva AM, Come PC, Lee RT, Parker JA, et al. Alteplase versus heparin in acute pulmonary embolism: randomised trial assessing right-ventricular function and pulmonary perfusion. Lancet. 1993 Feb 27;341(8844):507-11.

ReferenceCitation: Lim P, Delmas C, Sanchez O, Meneveau N, Rosario R, Bouvaist H, Bernard A, Mansourati J, Couturaud F, Sebbane M, Coste P, Rohel G, Tardy B, Biendel C, Lairez O, Ivanes F, Gallet R, Dubois-Rande JL, Fard D, Chatelier G, Simon T, Paul M, Natella PA, Layese R, Bastuji-Garin S. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial. Eur Heart J Acute Cardiovasc Care. 2021 Oct 11. pii: zuab082. doi: 10.1093/ehjacc/zuab082. [Epub ahead of print]

name: Université Paris Est Creteil, INSERM, IMRB, Creteil F-94010, France

name: Department of Cardiology, AP-HP Hôpitaux Universitaires Henri-Mondor, Créteil, France

family: Lim

full_name: Pascal Lim

given: Pascal

name: Cardiology Department, CHU Rangueil, Toulouse, France

family: Delmas

full_name: Clément Delmas

given: Clément

name: Division of Respiratory and Intensive Care, AP-HP, Hôpital Europèen Georges Pompidou, Paris, France

name: INSERM UMR-S 1140, Innovative Therapies in Haemostasis, Paris, France

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

name: Cardiology Department, Besancon University Hospital, EA3920, University of Burgundy Franche-Comté, Besancon, France

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

name: Cardiology Department, Hôpital Saint-Joseph, Marseille, France

family: Rosario

full_name: Roger Rosario

given: Roger

name: Cardiology Department, CHU, Grenoble, France

family: Bouvaist

full_name: Helene Bouvaist

given: Helene

name: Cardiology Department, CHU, Tours, France and EA4245, Université de Tours, France

family: Bernard

full_name: Anne Bernard

given: Anne

name: Respiratory Department, CHRU de la Cavale Blanche, Brest, France and University Hospital of Brest and UBO (Université de Bretagne Occidentale)

family: Mansourati

full_name: Jacques Mansourati

given: Jacques

family: Couturaud

full_name: Francis Couturaud

given: Francis

name: Emergency Department, CHRU Lapeyronie, Montpellier, France

family: Sebbane

full_name: Mustapha Sebbane

given: Mustapha

name: Cardiology Department, Bordeaux University Hospital, France

family: Coste

full_name: Pierre Coste

given: Pierre

name: Cardiology Department, Military Hospital of Clermont Tonnerre, Brest, France

family: Rohel

full_name: Gwenole Rohel

given: Gwenole

name: Emergency Department, CHU Saint Etienne, Saint Pirest en Jarez, France

family: Tardy

full_name: Bernard Tardy

given: Bernard

family: Biendel

full_name: Caroline Biendel

given: Caroline

family: Lairez

full_name: Olivier Lairez

family: Ivanes

full_name: Fabrice Ivanes

given: Fabrice

family: Gallet

full_name: Romain Gallet

given: Romain

family: Dubois-Rande

full_name: Jean-Luc Dubois-Rande

given: Jean-Luc

family: Fard

full_name: Damien Fard

given: Damien

name: Clinical Research Department, AP-HP, Hôpital Européen Georges Pompidou, Paris, France

family: Chatelier

full_name: Gilles Chatelier

given: Gilles

name: Cinical Pharmacology, AP-HP, Hôpital Saint-Antoine, Paris, France

family: Simon

full_name: Tabassome Simon

given: Tabassome

name: AP-HP Hôpitaux Universitaires Henri-Mondor, Clinical Pharmacology, Créteil F-94010, France

family: Paul

full_name: Muriel Paul

name: Department of Public Health, AP-HP Hôpitaux Universitaires Henri-Mondor, Creteil F-94010, France

journal_name: European Heart Journal. Acute Cardiovascular Care

ReferenceCitation: Gallet R, Meyer G, Ternacle J, Biendel C, Brunet A, Meneveau N, Rosario R, Couturaud F, Sebbane M, Lamblin N, Bouvaist H, Coste P, Maitre B, Bastuji-Garin S, Dubois-Rande JL, Lim P. Diuretic versus placebo in normotensive acute pulmonary embolism with right ventricular enlargement and injury: a double-blind randomised placebo controlled study. Protocol of the DiPER study. BMJ Open. 2015 May 22;5(5):e007466. doi: 10.1136/bmjopen-2014-007466.


title: Contribution of Capillary Refilling Time and Skin Mottling Score to Predict Intensive Care Unit Admission of Patients With Septic or Haemorrhagic Shock Admitted to the Emergency Department

acronym: TRCMARBSAU

summary:
In the emergency department (ED), the severity assessment of shock is a fundamental step prior to the admission in intensive care unit (ICU). As biomarkers are time consuming to evaluate severity of the micro and macro-circulation alteration, capillary refill time and skin mottling score are 2 simples, available clinical criteria validated to predict mortality in the ICU.

The aim of this study is to provide clinical evidence that capillary refill time and skin mottling score assessed in the ED also predict ICU admission of patients with septic or haemorrhagic shock.

ReferenceCitation: Pottecher T, Calvat S, Dupont H, Durand-Gasselin J, Gerbeaux P; SFAR/SRLF workgroup. Haemodynamic management of severe sepsis: recommendations of the French Intensive Care Societies (SFAR/SRLF) Consensus Conference, 13 October 2005, Paris, France. Crit Care. 2006;10(4):311.

ReferenceCitation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10.

ReferenceCitation: Pickard A, Karlen W, Ansermino JM. Capillary refill time: is it still a useful clinical sign? Anesth Analg. 2011 Jul;113(1):120-3. doi: 10.1213/ANE.0b013e31821569f9. Epub 2011 Apr 25. Review.

ReferenceCitation: Ait-Oufella H, Bige N, Boelle PY, Pichereau C, Alves M, Bertinchamp R, Baudel JL, Galbois A, Maury E, Guidet B. Capillary refill time exploration during septic shock. Intensive Care Med. 2014 Jul;40(7):958-64. doi: 10.1007/s00134-014-3326-4. Epub 2014 May 9.

ReferenceCitation: Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.

ReferenceCitation: Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db.

ReferenceCitation: Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.

ReferenceCitation: Mrgan M, Rytter D, Brabrand M. Capillary refill time is a predictor of short-term mortality for adult patients admitted to a medical department: an observational cohort study. Emerg Med J. 2014 Dec;31(12):954-8. doi: 10.1136/emermed-2013-202925. Epub 2013 Sep 17.

ReferenceCitation: Jouffroy R, Saade A, Tourtier JP, Gueye P, Bloch-Laine E, Ecollan P, Carli P, Vivien B. Skin mottling score and capillary refill time to assess mortality of septic shock since pre-hospital setting. Am J Emerg Med. 2019 Apr;37(4):664-671. doi: 10.1016/j.ajem.2018.07.010. Epub 2018 Jul 6.

lead_sponsor: Hôpital Necker-Enfants Malades


title: Improving Therapeutic Adherence of Adult Patients With Cystic Fibrosis: Impact of a Co-constructed Program by Patients and Health Caregivers.

summary:
Background Cystic fibrosis is a life-threatening genetic disorder responsible for pulmonary failure and multi-systemic complications involving specific and large medical care burden. To date, no program has shown its effectiveness in improving therapeutic adherence. A new approach to develop a co-constructed program involving patients and professionals may contribute to improve therapeutic adherence.

Objectives The aim of the MUCOBS-Trial project is to create a program to increase therapeutic adherence and to evaluate its efficacy in adult patients with cystic fibrosis in 3 CF centers in France.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud


title: Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy

acronym: conneXion

summary:
Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system.

Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures.

So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.

lead_sponsor: Rennes University Hospital