title: Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology

acronym: ECOST

summary: In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.

primary_purpose: Health Services Research

ReferenceCitation: Guédon-Moreau L, Lacroix D, Sadoul N, Clémenty J, Kouakam C, Hermida JS, Aliot E, Kacet S; ECOST trial Investigators. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study. Europace. 2014 Aug;16(8):1181-8. doi: 10.1093/europace/euu012. Epub 2014 Mar 9.

name: Centre Hospitalier Régional Universitaire, F-59037 Lille, France

family: Guédon-Moreau

full_name: Laurence Guédon-Moreau

given: Laurence

family: Lacroix

full_name: Dominique Lacroix

given: Dominique

name: Centre Hospitalier Universitaire Brabois, F-54500 Nancy, France

family: Sadoul

full_name: Nicolas Sadoul

given: Nicolas

name: Centre Hospitalier Universitaire Haut-Lévêque, F-33064 Pessac, France

family: Clémenty

full_name: Jacques Clémenty

given: Jacques

family: Kouakam

full_name: Claude Kouakam

given: Claude

name: Centre Hospitalier Universitaire, F-80054 Amiens, France

family: Hermida

full_name: Jean-Sylvain Hermida

given: Jean-Sylvain

family: Aliot

full_name: Etienne Aliot

given: Etienne

family: Kacet

full_name: Salem Kacet

given: Salem

name: on behalf of the ECOST trial Investigators

journal_name: EP Europace

evidence: open (via crossref license)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Guédon-Moreau L, Kouakam C, Klug D, Marquié C, Brigadeau F, Boulé S, Blangy H, Lacroix D, Clémenty J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol. 2014 Jul;25(7):763-70. doi: 10.1111/jce.12405. Epub 2014 Apr 10.

name: Centre Hospitalier Régional Universitaire; Hôpital Cardiologique; Lille France

family: GUÉDON-MOREAU

full_name: LAURENCE GUÉDON-MOREAU

given: LAURENCE

family: KOUAKAM

full_name: CLAUDE KOUAKAM

given: CLAUDE

family: KLUG

full_name: DIDIER KLUG

given: DIDIER

family: MARQUIÉ

full_name: CHRISTELLE MARQUIÉ

given: CHRISTELLE

family: BRIGADEAU

full_name: FRANÇOIS BRIGADEAU

given: FRANÇOIS

family: BOULÉ

full_name: STÉPHANE BOULÉ

given: STÉPHANE

name: Centre Hospitalier Universitaire Brabois; Nancy France

family: BLANGY

full_name: HUGUES BLANGY

name: Centre Hospitalier Universitaire Haut-Lévêque; Pessac France

journal_name: Journal of Cardiovascular Electrophysiology

title: Decreased Delivery of Inappropriate Shocks Achieved by Remote Monitoring of ICD: A Substudy of the ECOST Trial

ReferenceCitation: Guédon-Moreau L, Lacroix D, Sadoul N, Clémenty J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.


title: The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.

acronym: ERAM

summary: Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Avicenne - Service de Chirurgie orthopédique

location_facility: POTEL Jean-François, Clinique Medipole Garonne

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization

acronym: ULTRA-VASC

summary:
Stroke is the second leading cause of death in the Western world and the leading cause of major lifelong disability. About 15% of strokes are secondary to thrombosis or embolization of an unstable atheromatous carotid plaque. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. Patients with stenosis over 70% are therefore offered an endarterectomy, an operation to remove carotid plaque, to prevent future strokes[1]. In asymptomatic patients, the degree of stenosis is a limited predictor, and better risk stratification is required to assess the degree of plaque vulnerability and stroke risk of the patient. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable and dependent benefit/risk balance for each patient. A number of imaging parameters have been studied: ulceration, heterogeneity, vascularization of the plaque for example, but their place is not well defined [2].

The usual evaluation of carotid stenosis is by conventional Doppler ultrasound with calculation of the degree of stenosis according to the NASCET criteria.

For symptomatic stenoses the intervention is recommended when above 70% and is discussed from 50% to 70% of NASCET stenosis degree.

For asymptomatic stenoses, the procedure is discussed when above 60% taking into account the patient's life expectancy, the risk of the surgery and the unstable nature of the plaque [2].

Destabilization of the carotid plaque is partially induced by inflammation associated with neo-vascularization. The detection of these new vessels by conventional contrast ultrasound has already shown a distinction between stable and unstable plaques, by the presence or absence of microbubbles in the plaque. However, this assessment is not very precise and only the most vascularized plaques can be detected. Ultrafast ultrasound Imaging is a new ultrasonic Imaging modality that allows detecting low speed flows, a tiny vascular structure within the vessel wall.

RESEARCH HYPOTHESIS Plaques neo-vascularization would be more precisely detected and characterized by ultrafast imaging coupled with microbubble injection than conventional ultrasound imaging.

A better assessment of plaque instability could improve the selection of patients for carotid endarterectomy and increase the benefit/risk ratio of this preventive surgery.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared

intervention_type: Device

status_simplified: Ongoing


title: Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks

acronym: DICODOM

summary:
In Paris, France, home hospice care for terminally ill patients is organized by four "palliative care networks". These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information.

The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care.

For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)

status: Completed

study_type: Observational

time_perspective: Prospective

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Reseau ENSEMBLE
Reseau QUIETUDE
Reseaux ParisOuest
Reseaux ROPE

lead_sponsor_type: industriel

status_simplified: Completed


title: MECHANISMS OF NEURONAL RESILIENCE IN ALZHEIMER'S DISEASE AND ITS FOCAL VARIANTS: A PET/MR STUDY

acronym: PET-AL

summary: Patients with Alzheimer's disease and with early onset of symptoms (<65 years) (AD-Y) have a multi-domain cognitive deficit, whereas memory disorders (typical of the elderly patient's AD) are less often in the foreground. In addition, some MA-J have an atypical phenotype indicating focal brain damage, although they have the same pathological lesions: amyloid deposits and tau protein deposition (DNF). This is the case of posterior cortical atrophy (PCA) characterized by complex visual disturbances and atrophy affecting the more posterior regions of the brain. Based on the clinical profile of PCA patients, a more refined anatomo-clinical classification was proposed, distinguishing a rather "ventral" form and a rather "dorsal" form. The recent arrival of tau-specific PET tracers now makes it possible to evaluate in vivo fibrillary neurodegeneration (FND), which is well correlated with the severity of cognitive disorders. Advances in MRI have shown that each neurodegenerative syndrome targets a large-scale neural network, which in turn shows a vulnerability for a specific biological disease. In the case of AD, the reason for such a difference in cognitive and anatomical impairment between patients with diffuse involvement and others with more focal involvement is not known. One possible explanation is the existence, in focal forms, of neuronal mechanisms that oppose vulnerability. These mechanisms may correspond to the so-called "resilience" phenomenon, defined as resistance to a neuropathological process by the ability to optimize cognitive performance via the efficient recruitment of neural networks. The mechanisms underlying resilience in neurodegeneration are unknown. Their identification is very important for the management and treatment of AD.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Non-Randomized

ipd_sharing: Undecided

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

location_facility: Service de Médecine Nucléaire - Hopital La Pitié Salpetriere

location_facility: Service Hospitalier Frédéric Joliot SHFJ


title: Multistate Relative Survival Modeling of Colorectal Cancer Progression and Mortality

acronym: MRS

summary:
Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57% in men to 60% in women. About one third of patients diagnosed with CRC will develop a metachronous recurrence during the following years. It is of paramount importance to accurately identify factors associated with the increased risk of progression and death, in order to develop effective follow-up and treatment strategies. However, to accurately assess the role of patients' specific characteristics in the progression of cancer several methodological challenges need to be overcome.

One difficulty, common to prognostic studies of cancer, concerns the need to separate the effects of prognostic factors on different clinical endpoints, such as disease recurrence vs recurrence-free death. Another difficulty, encountered in prognostic studies, is that the cause of death is not available or not accurately coded. Yet, some patients are likely to die of causes not related to the disease of primary interest, especially in cancers with longer survival and in those that affect older subjects. Until recently, the existing statistical methodology was not able to simultaneously, deal with both difficulties, i.e. to account for (i) possibly different effects of prognostic factors on death vs recurrence, and (ii) unknown causes of death. However, this challenge has been addressed by the recent development of the Markov relative survival model (MRS) , which extends the Markov multi-state model to incorporate relative survival modelling. Simulations demonstrate that MRS is able to accurately estimate different effects of prognostic factors on the risk of each of several events, including separate effects on disease-specific vs other causes of death. To date, the MRS had not been applied in clinical or epidemiological studies.

The aim of this study was to assess the potential advantages of the new multi-state relative survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To this end, we compared the MRS results with those obtained with two more conventional analyses, based on Cox's proportional hazards model, and the multi-state Markov model proposed by Alioum and Commenges (2001). The three models were applied to explore the impact of prognostic factors on cancer-specific mortality and recurrence, in a large population-based French registry of colorectal cancer, with up to 25 years of follow-up.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire Dijon


type: Registry Identifier

title: Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke

summary:
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.

The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.

Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days

status: Unknown status

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Loubinoux I, Dechaumont-Palacin S, Castel-Lacanal E, De Boissezon X, Marque P, Pariente J, Albucher JF, Berry I, Chollet F. Prognostic value of FMRI in recovery of hand function in subcortical stroke patients. Cereb Cortex. 2007 Dec;17(12):2980-7. Epub 2007 Mar 26.

ReferenceCitation: Castel-Lacanal E, Gerdelat-Mas A, Marque P, Loubinoux I, Simonetta-Moreau M. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in healthy subjects and post-stroke patients. Exp Brain Res. 2007 Jun;180(1):113-22. Epub 2007 Jan 31.

ReferenceCitation: Castel-Lacanal E, Marque P, Tardy J, de Boissezon X, Guiraud V, Chollet F, Loubinoux I, Moreau MS. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients. Neurorehabil Neural Repair. 2009 May;23(4):366-72. doi: 10.1177/1545968308322841. Epub 2008 Dec 5.

ReferenceCitation: Conchou F, Loubinoux I, Castel-Lacanal E, Le Tinnier A, Gerdelat-Mas A, Faure-Marie N, Gros H, Thalamas C, Calvas F, Berry I, Chollet F, Simonetta Moreau M. Neural substrates of low-frequency repetitive transcranial magnetic stimulation during movement in healthy subjects and acute stroke patients. A PET study. Hum Brain Mapp. 2009 Aug;30(8):2542-57. doi: 10.1002/hbm.20690.

ReferenceCitation: Celnik P, Paik NJ, Vandermeeren Y, Dimyan M, Cohen LG. Effects of combined peripheral nerve stimulation and brain polarization on performance of a motor sequence task after chronic stroke. Stroke. 2009 May;40(5):1764-71. doi: 10.1161/STROKEAHA.108.540500. Epub 2009 Mar 12.

ReferenceCitation: Uy J, Ridding MC. Increased cortical excitability induced by transcranial DC and peripheral nerve stimulation. J Neurosci Methods. 2003 Aug 15;127(2):193-7.

ReferenceType: derived

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11:CD009645. doi: 10.1002/14651858.CD009645.pub4.

name: Department of Public Health; Dresden Medical School, Technical University Dresden; Dresden Germany

name: Department of Physiotherapy; SRH Hochschule für Gesundheit Gera; 07548 Gera Germany

family: Elsner

full_name: Bernhard Elsner

given: Bernhard

sequence: additional

name: Department of Public Health, Dresden Medical School; Technical University Dresden; Dresden Germany

family: Kugler

full_name: Joachim Kugler

given: Joachim

name: Neurological Rehabilitation; Helios Klinik Schloss Pulsnitz; Pulsnitz Germany

family: Pohl

full_name: Marcus Pohl

given: Marcus

family: Mehrholz

full_name: Jan Mehrholz

given: Jan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan)


title: Repeated Suicide Attempts in a Patient Suffering From Addiction to Tramadol: a Case Report

summary:
In France, over the last years the use weak opioid analgesics decreased́, whereas that of strong opioid analgesics (OFMA). Hospitalizations for opioid overdose increased́ by 128% from 2000 to 2015, and deaths related to prescribed opioid overdose increased significantly, by 161%, from 2000 to 2014.In addition, recent studies suggest a link between opioid system dysfunction and suicidal behavior.

In parallel, studies are emerging showing the potential interest of using Tramadol as an antidepressant. Indeed, this opiate analgesic also acts on the serotonergic and dopaminergic systems, and would have an antidepressant effect.Thus, the investigators can legitimately wonder whether the use of Tramadol as an antidepressant might not pose a problem in patients at risk of suicide.

This study aims to describe a clinical case of a patient hospitalized in the Department of Psychiatric Emergency and Post-Emergency (Montpellier University Hospital) who developed a severe addiction to Tramadol (consumption up to 5 times the maximum recommended dose per day) and evaluate whether this may have increased her suicidal risk, in order to warn prescribers about the suicidal risk of Tramadol.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region

acronym: ASPEGIC

summary: HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES ("Évaluation de la précarité et des inégalités de santé dans les centres d'examens de santé ", Evaluation of precariousness and health inequalities in health examination centers).

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Centre Hospitalier Annecy Genevois

intervention_type: Other


title: Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora in Healthy Subjects Aged 18 to 35 Years (BACTERIB)

acronym: BACTERIB

summary:
In France, two-thirds of adults over 35 years of age have at least a periodontal disease. The etiology is the accumulation of dental plaque, especially in interdental spaces. The cleaning of interdental spaces is particularly complex. This accumulation of dental plaque is at the origin of a modification of the bacterial flora in favor of periodontopathogenic bacteria. These pathogens can induce within the periodontal tissues an immune and inflammatory reaction that cause tissue degradation. The majority of studies focus on people over 30 years of age with gingivitis or periodontitis. However, young adults, in whom the initial or even reversible stages of periodontal disease are the most frequent, should be the preferred target of preventive measures for this pathology.

The main objective of this study is to quantify, in healthy patients, the evolution of the supragingival bacterial flora, in the interdental spaces, following the daily passage of brushes with the adapted diameter and single passage. The secondary objective is to evaluate the qualitative change in the bacterial flora (proportions of periodontal bacteria / commensal bacteria) following the interdental cleaning.

lead_sponsor: Claude Bernard University


title: Brief Intervention to Improve Colorectal Cancer Screening

acronym: Hem-FMG

summary:
Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC) screening in France The qualitative data indicated that improvement was needed in patient-centered communication. Educational material was developed based on these triangulated data with two different scenarios to improve communication with patients: one for a compliant patient, another for a non compliant patient The hypothesis is that a brief intervention on GPs can improve the patients' participation rate to colorectal screening

Method : cluster randomized control trial (cluster unit : GPs practices) With a brief intervention on a randomized population of GPs in the district of Val d'Oise Inclusion criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass screening

primary_purpose: Prevention

lead_sponsor: University Paris 7 - Denis Diderot

intervention_type: Behavioral


title: Autism Registry for French Guiana

acronym: REGUYAUT

summary: The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier de Cayenne


title: Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More (Hearing Handicap Inventory for the Elderly Screening Version)

acronym: VF DEPIST 60

summary:
Nowadays in France, there is no organized screening of the hearing loss in the elderly; however, it is a very common disease and simples tests to perform to detect it exist. Lots of studies use surveys to identify deaf people; but physicians often consider them too sensitive and less specific because lots of people were classified into " deaf " people meanwhile they have a subnormal tonal audiogram.

Now, it's known that it corresponds to the "Hidden Hearing Loss" concept: it's defined as an auditive disturbance in a noisy ambiance in people with a normal tonal audiometry; corresponding to infraclinical cochlear lesions. These lesions, if detected early, can be prevented to avoid an audition degradation in time.

The aim of the study is to determinate the values of sensitivity and specificity of the HHIE-S survey translated into French, so it could be used as a screening method of hearing loss in the elderly and as a prevention of cochlear damages.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Diagnostic Test


title: Sexual Quality of Patients After Bladder Cancer Cystectomy : A Prospective Observational Study

acronym: QSCO

summary: Bladder cancer is the second most prevalent urological cancer in France. About 1 in 5 new cases of bladder cancer infiltrate the muscles. The standard treatment is neoadjuvant chemotherapy followed by radical cystectomy associated with reconstruction of the urinary tract. The short-term effects on well-being and quality of life are well known. The long-term effects are, on the other hand, poorly understood, particularly sexual function. This study aim to asses the quality of sexual life in patients with cystectomy for bladder cancer. This will be done via various questionnaires given before and after surgery.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse


title: Assessment of Factors Involved in the Decision-making for ICU Patients' Care

summary:
A new law about the advance directives (AD) has been recently voted in France on February 2, 2016. This " Claeys-Leonetti " law has made the AD more binding, as in other countries. This should lead to a greater respect of the human autonomy principle. However, the interpretation of these guidelines is often difficult and may differ between doctors. Indeed, the subjectivity of these interpretations could lead to different medical decisions by physicians.

The investigators intend to assess the effect of advance directives (AD) on decision making in care by intensivists, using a simulated (hypothetical) situation.

ReferenceCitation: Smirdec M, Jourdain M, Guastella V, Lambert C, Richard JC, Argaud L, Jaber S, Klouche K, Medard A, Reignier J, Rigaud JP, Doise JM, Chabanne R, Souweine B, Bourenne J, Delmas J, Bertrand PM, Verdier P, Quenot JP, Aubron C, Eisenmann N, Asfar P, Fratani A, Dellamonica J, Terzi N, Constantin JM, Van Lander A, Guerin R, Pereira B, Lautrette A. Impact of advance directives on the variability between intensivists in the decisions to forgo life-sustaining treatment. Crit Care. 2020 Dec 2;24(1):672. doi: 10.1186/s13054-020-03402-7.

family: Smirdec

full_name: Margot Smirdec

given: Margot

sequence: first

family: Jourdain

full_name: Mercé Jourdain

given: Mercé

family: Guastella

full_name: Virginie Guastella

given: Virginie

family: Lambert

full_name: Céline Lambert

given: Céline

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Jaber

full_name: Samir Jaber

given: Samir

family: Klouche

full_name: Kada Klouche

given: Kada

family: Medard

full_name: Anne Medard

given: Anne

family: Reignier

full_name: Jean Reignier

given: Jean

family: Rigaud

full_name: Jean-Philippe Rigaud

given: Jean-Philippe

family: Doise

full_name: Jean-Marc Doise

given: Jean-Marc

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Bourenne

full_name: Jeremy Bourenne

given: Jeremy

family: Delmas

full_name: Julie Delmas

given: Julie

family: Bertrand

full_name: Pierre-Marie Bertrand

given: Pierre-Marie

family: Verdier

full_name: Philippe Verdier

given: Philippe

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Aubron

full_name: Cecile Aubron

given: Cecile

family: Eisenmann

full_name: Nathanael Eisenmann

given: Nathanael

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Fratani

full_name: Alexandre Fratani

given: Alexandre

family: Dellamonica

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

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


title: NOsocomial Dissemination Risk of SARS-Cov2

summary:
To date, in France, in the context of the SARS Cov2 pandemic,both the number of affected subjects and the number of severe forms requiring hospital care are increasing.

Several nosocomial transmission clusters have already been identified in hospitals (both pediatric and adult) but there is still limited data on the nosocomial spread of SARS-Cov2.

This nosocomial transmission affects both patients and caregivers. It is important to understand the spread of the virus within the hospital. This will help to optimize procedures to prevent transmission to caregivers and hospitalizedpatients not infected with SARS Cov2, and more generally this will contribute to control the spread of SARS Cov2 in the community


title: Prospective Study on the Prevalence on the Use of Prone Positioning in ARDS Patients

acronym: APRONET

summary:
Prone positioning has been shown to improve survival in patients with acute respiratory distress syndrome (ARDS). However, a recent large observational study found that prone positioning was used in only 7% of all ARDS patients, and 16% in the severe category. However, this study did not focus on the prone position per se. In present study, the investigators would like to explore the rate of use of prone positioning in ARDS patients and the reasons why this treatment was not applied. The present study is one-day prevalence study repeated four times over one year.

The hypothesis is that the rate of use of prone position is greater than 50% in the severe ARDS category.

lead_sponsor: Hospices Civils de Lyon

location_facility: Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France


title: Evaluation of the Prognostic Value of Clinical, Imaging, Immunological and Virological Markers in the Neonatal Period for the Development of Neurosensorial Sequelae at 1 Year in Children Infected by Cytomegalovirus in Utero.

acronym: CYMEPEDIA

summary:
The main objective of this study is to validate , in the neonatal period, a prognostic score for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological criteria .

The second objective of the study is to estimate the prevalence of this infection in France and to describe its epidemiology through the screening of 12,000 consecutive neonates.

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Leruez-Ville M, Magny JF, Couderc S, Pichon C, Parodi M, Bussières L, Guilleminot T, Ghout I, Ville Y. Risk Factors for Congenital Cytomegalovirus Infection Following Primary and Nonprimary Maternal Infection: A Prospective Neonatal Screening Study Using Polymerase Chain Reaction in Saliva. Clin Infect Dis. 2017 Aug 1;65(3):398-404. doi: 10.1093/cid/cix337.

family: Leruez-Ville

full_name: Marianne Leruez-Ville

given: Marianne

family: Magny

full_name: Jean-François Magny

given: Jean-François

family: Couderc

full_name: Sophie Couderc

given: Sophie

family: Pichon

full_name: Christine Pichon

given: Christine

family: Parodi

full_name: Marine Parodi

given: Marine

family: Bussières

full_name: Laurence Bussières

given: Laurence

family: Guilleminot

full_name: Tiffany Guilleminot

given: Tiffany

family: Ghout

full_name: Idir Ghout

given: Idir

family: Ville

full_name: Yves Ville

given: Yves

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

ReferenceCitation: Leruez-Ville M, Ren S, Magny JF, Jacquemard F, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Minodier P, Astruc D, Patural H, Ugolin M, Parat S, Guillois B, Garenne A, Parodi M, Bussières L, Stirnemann J, Sonigo P, Millischer AE, Ville Y. Accuracy of prenatal ultrasound screening to identify fetuses infected by cytomegalovirus which will develop severe long-term sequelae. Ultrasound Obstet Gynecol. 2021 Jan;57(1):97-104. doi: 10.1002/uog.22056.

name: EA 73‐28 Paris Descartes University, Sorbonne Paris Cité  Paris France

name: AP‐HP, Hospital Necker‐E.M. Virology Laboratory, Reference Laboratory for Cytomegalovirus Infections  Paris France

family: Leruez‐Ville

full_name: M. Leruez‐Ville

given: M.

family: Ren

full_name: S. Ren

given: S.

name: AP‐HP Hospital Necker‐E.M., Neonatal Intensive Care Unit  Paris France

full_name: J.‐F. Magny

name: American Hospital of Paris Prenatal Diagnostic Unit, Neuilly  France

family: Jacquemard

full_name: F. Jacquemard

given: F.

name: Hospital Intercommunal Poissy‐Saint Germain, Maternity  Poissy France

full_name: S. Couderc

name: AP‐HM, Hospital La Conception Neonatology and Intensive Care Department  Marseille France

family: Garcia

full_name: P. Garcia

given: P.

name: CHU Nice, Hospital L'Archet Neonatal Intensive Care Unit  Nice France

family: Maillotte

full_name: A.‐M. Maillotte

name: Toulouse University Hospital Department of Neonatology  Toulouse France

family: Benard

full_name: M. Benard

name: Rouen University Hospital Department of Neonatology  Rouen France

family: Pinquier

full_name: D. Pinquier

given: D.

name: AP‐HM, Hospital Nord Emergency Care Department  Marseille France

family: Minodier

full_name: P. Minodier

name: Strasbourg University Hospital Department of Neonatology  Strasbourg France

family: Astruc

full_name: D. Astruc

name: University Hospital Neonatal Intensive Care Unit  Saint‐Etienne France

name: CHU Rennes and CIC1414 Pediatric Department, Neonatology  Rennes France

name: AP‐HP Hospital Cochin, Maternity  Paris France

name: CHU de Caen, Department of Neonatology  Caen France

name: Université Caen Normandie Medical School  Caen France

name: CHRU Brest, Neonatal and Pediatric Intensive Care Unit  Brest France

name: AP‐HP, Hospital Necker‐E.M., Otology Department  Paris France

name: AP‐HP Hospital Necker‐E.M., Clinical Research Unit  Paris France

name: AP‐HP Hospital Necker‐E.M., Maternity  Paris France

name: AP‐HP, Hospital Necker‐E.M., Radiology Department  Paris France

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

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

title: Accuracy of prenatal ultrasound screening to identify fetuses infected by cytomegalovirus which will develop severe long‐term sequelae

ReferenceCitation: Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussières L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.

name: Equipe d’Accueil, Paris Descartes University, Sorbonne Paris CitéArchet, France

name: Maternity, Hospital Necker-E.M, Paris, France

name: Neonatal Intensive Care Unit, Hospital Necker-E.M, France

name: Otology Department, Assistance Publique de Paris, Hospital Necker-E.M, France

name: Maternity, Hospital Intercommunal Poissy-Saint Germain, Marseille, France

name: Neonatology and Intensive Care Department, Assistance Publique de Marseille, Hospital La Conception, Marseille, France

name: Neonatal Intensive Care Unit, Centre Hospitalier Universitaire Nice, Hospital L’Archet, Marseille, France

name: Department of Neonatalogy, Toulouse University Hospital, Saint-Etienne, France

name: Department of Neonatalogy, Rouen University Hospital, Saint-Etienne, France

name: Department of Neonatalogy, Strasbourg University Hospital, Saint-Etienne, France

name: Neonatal Intensive Care Unit, University Hospital, Saint-Etienne, France

name: Pediatric Department, Neonatology, Centre Hospitalier Universitaire Rennes and Centre d’Investigation Clinique, France

name: Maternity, Assistance Publique Hopitaux de Paris (AP-HP), Hospital Cochin, France

name: Department of Neonatalogy, Centre Hospitalier Universitaire de Caen, France

name: Medical School, Université Caen Normandie, France

name: Brest, Neonatal and Pediatric Intensive Care Unit, Centre Hospitalier Régional Universitaire, France

name: Clinical Research Unit, AP-HP, Hospital Necker-E.M., France

name: Virology Laboratory, Reference Laboratory for Cytomegalovirus Infections, AP-HP, Hospital Necker-E.M., France

name: Unité de Recherche Clinique et Département de Santé Publique, AP-HP, Hôpital Ambroise Paré, Boulogne, France

name: University Versaille-Saint-Quentin, Unité Mixte de recherche S, Université Versailles St-Quentin-en-Yvelines, Montigny, France


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

acronym: AMBUSH

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

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

lead_sponsor: Central Hospital, Nancy, France

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


title: Prospective, Single-center Observational Study to Assess the Feasibility and Evaluate the Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Mental and Physical Disabilities Undergoing Planned Surgery

acronym: INFRA

summary:
France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments.

The INFRA health circuit has been set up at the "Groupe Hospitalier Mutualiste de Grenoble" since June 2018 according to the guidelines published by the French High Authority for Health (HAS) on improving professional practices "Reception, support and organization of care in health establishments for people in situation of handicap "of July 2017. The INFRA nurse collects and anticipates the necessary adaptations for the patient's stay, in conjunction with their caregivers (whether family or institutional). They are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient's disability. Before hospitalization and until the patient is discharged, the INFRA nurse transmits to the personnel involved all the information necessary for the proper continuation of care. In addition to legal and regulatory obligations, the INFRA nurse ensures the effective accessibility of the establishment's facilities and premises, and helps maintaining patient autonomy.

The INFRA study is an observational study aimed at assessing the feasibility of the INFRA health circuit and evaluating the benefit for the patients and the healthcare staff.


title: Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment

acronym: GALATEE

summary:
Primary objective:

Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

Determination of the predictive criterion of HbA1c final,
Determination of the predictive criterion of weight variation,
Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

Adverse Event (AE)/Serious Adverse Event (SAE) assessments

lead_sponsor: Sanofi

intervention_type: Drug


title: An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study Internal Hernia After Laparoscopic Roux-en-Y Gastric Bypass: an Evaluation of the Impact on the Postoperative Course and a Quality of Life Case-control Study

acronym: ChirBar

summary:
A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization.

A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group).

ReferenceCitation: Lunca S, Vix M, Rikkers A, Rubino F, Marescaux J. Late gastric prolapse with pouch necrosis after laparoscopic adjustable gastric banding. Obes Surg. 2005 Apr;15(4):571-5.

ReferenceCitation: Donatelli G, Costantino F, Dhumane P, Vix M, Perretta S, D' Agostino J, Dallemagne B, Marescaux J. Endoscopic intragastric balloon: a bridge toward definitive bariatric surgical management of a morbidly obese patient with situs ambiguous and midgut malrotation (with videos). Gastrointest Endosc. 2012 Jan;75(1):217-8. doi: 10.1016/j.gie.2011.01.022. Epub 2011 Mar 27.

family: Donatelli

full_name: Gianfranco Donatelli

given: Gianfranco

family: Costantino

full_name: Federico Costantino

given: Federico

family: Dhumane

full_name: Parag Dhumane

given: Parag

family: Vix

full_name: Michel Vix

given: Michel

family: Perretta

full_name: Silvana Perretta

given: Silvana

family: d' Agostino

full_name: Jacopo d' Agostino

given: Jacopo

family: Dallemagne

full_name: Bernard Dallemagne

given: Bernard

family: Marescaux

full_name: Jacques Marescaux

given: Jacques

journal_name: Gastrointestinal Endoscopy

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Vix M, Diana M, Liu KH, D'Urso A, Mutter D, Wu HS, Marescaux J. Evolution of glycolipid profile after sleeve gastrectomy vs. Roux-en-Y gastric bypass: results of a prospective randomized clinical trial. Obes Surg. 2013 May;23(5):613-21. doi: 10.1007/s11695-012-0827-5.

family: Diana

full_name: Michele Diana

given: Michele

family: Liu

full_name: Keng-Hao Liu

given: Keng-Hao

family: D’Urso

full_name: Antonio D’Urso

given: Antonio

family: Mutter

full_name: Didier Mutter

given: Didier

family: Wu

full_name: Hurng-Sheng Wu

given: Hurng-Sheng

journal_name: Obesity Surgery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Evolution of Glycolipid Profile After Sleeve Gastrectomy vs. Roux-en-Y Gastric Bypass: Results of a Prospective Randomized Clinical Trial

ReferenceCitation: Vix M, Liu KH, Diana M, D'Urso A, Mutter D, Marescaux J. Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial. Surg Endosc. 2014 Mar;28(3):821-6. doi: 10.1007/s00464-013-3276-x. Epub 2013 Nov 7.

location_facility: Service de Chirurgie Digestive et Endocrinienne


title: Cost of Off-label Antibiotics in Osteoarticular Infections: Prospective Study Over 2 Years in a Reference Center for the Management of Complex Bone and Joint Infection

summary:
Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting.

The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)

location_facility: Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)


title: 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease

acronym: PRO-MH

summary: The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.

ReferenceCitation: Mochel F, Haller RG. Energy deficit in Huntington disease: why it matters. J Clin Invest. 2011 Feb;121(2):493-9. doi: 10.1172/JCI45691. Epub 2011 Feb 1. Review.

ReferenceCitation: Mochel F, Charles P, Seguin F, Barritault J, Coussieu C, Perin L, Le Bouc Y, Gervais C, Carcelain G, Vassault A, Feingold J, Rabier D, Durr A. Early energy deficit in Huntington disease: identification of a plasma biomarker traceable during disease progression. PLoS One. 2007 Jul 25;2(7):e647.

ReferenceCitation: Mochel F, Benaich S, Rabier D, Durr A. Validation of plasma branched chain amino acids as biomarkers in Huntington disease. Arch Neurol. 2011 Feb;68(2):265-7. doi: 10.1001/archneurol.2010.358.


title: Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

acronym: RACE

summary:
Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. Despite the development of therapeutics and paraclinic examinations, this rate of preterm delivery remains stable or even increases. The use of medically assisted procreation techniques alone can not explain this rate.

The analysis of the electrical activity of the uterus (electrohysterograms) is a promising technique for early diagnosis of the risk of premature delivery, allowing better management of the patients. This study is part of a European theme to study risk factors for the prevention of prematurity.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

acronym: PRESENCE

summary: The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

ReferenceCitation: Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.

name: From Paris Cardiovascular Research Center, Hôpital Necker-Enfants Malades, Hôpital Cochin, Université Paris Descartes-Sorbonne Paris Cité, Hôpital Saint-Louis, Université Paris Diderot – Paris VII, Hôpital Européen Georges Pompidou, and Paris Fire Brigade, Paris, France; Hôpital Avicenne, Université Paris 13, Bobigny, France; and Public Health–Seattle & King County and University of Washington, Seattle, Washington.

family: Jabre

full_name: Patricia Jabre

given: Patricia

family: Bougouin

full_name: Wulfran Bougouin

given: Wulfran

family: Dumas

full_name: Florence Dumas

given: Florence

family: Carli

full_name: Pierre Carli

given: Pierre

family: Antoine

full_name: Corinne Antoine

given: Corinne

family: Jacob

full_name: Laurent Jacob

given: Laurent

family: Dahan

full_name: Benjamin Dahan

given: Benjamin

family: Beganton

full_name: Frankie Beganton

given: Frankie

family: Empana

full_name: Jean-Philippe Empana

given: Jean-Philippe

family: Marijon

full_name: Eloi Marijon

given: Eloi

family: Karam

full_name: Nicole Karam

given: Nicole

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

family: Lefaucheur

full_name: Carmen Lefaucheur

given: Carmen

family: Jost

full_name: Daniel Jost

given: Daniel

family: Cariou

full_name: Alain Cariou

given: Alain

family: Adnet

full_name: Frédéric Adnet

given: Frédéric

family: Rea

full_name: Thomas D. Rea

given: Thomas D.

family: Jouven

full_name: Xavier Jouven

given: Xavier

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

ReferenceCitation: Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

family: Azoulay

full_name: Elie Azoulay

ReferenceCitation: Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.

title: Family Presence during Cardiopulmonary Resuscitation


acronym: MalaRia

type: EudraCT Number

source: euctr

title: Effectiveness and Safety Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria : a Multicentric Study

summary:
Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria.

The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.


title: Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis

summary:
Initial worsening following initiation of rituximab therapy in patients with cryoglobulinemic vasculitis was described in 3.6% of cases. This worsening is often a serious condition, with high levels of mortality.

The objective of our study is to evaluate the efficacy of preventive plasmapheresis prior to the introduction of rituximab performed in Montpellier France since 2013 by assessing the frequency and severity of this flare effect in these patients compared to those reported in the literature.


type: Other Grant/Funding Number

title: The Prevention of Post Operative Cognitive Dysfunction by Ketamine: a Prospective Multicenter Randomized Blinded Placebo-controlled Trial in Elderly Patients Undergoing Elective Orthopaedic Surgery

acronym: POCK

summary:
Over 30 million patients require a major surgery annually in the US alone and more than half of them are performed in patients over 60 years of age. Post-operative cognitive dysfunction (POCD) is a keystone complication of these surgeries and affects up to 40% of surgical patients aged over 60 years on discharge from the hospital. Despite controlled longitudinal studies have shown that POCD is transient, it is associated with delirium, higher mortality, earlier retirement, and greater utilization of social financial assistance The pathophysiology of persistent postoperative cognitive dysfunction and causal relationship between POCD and delirium remain incompletely understood. Identified clinical risk factors for both include advanced age, type of surgery, preexisting cognitive impairment, and drug addiction. We and others have provided evidence that the inflammatory response triggered by surgical trauma and pain may contribute to the development of delirium and cognitive impairment after surgery.

Ketamine, a N-methyl-D-aspartic acid receptor antagonist, is commonly used in anaesthesia and postoperative analgesia. By reducing both pain and glutamate excitotoxic effects on neuronal and microglial brain cells, it contributes to tone down the neuroinflammatory process associated with surgery. A recent body of evidence has shown that ketamine reduces the depressive-like behavior induced by inflammatory or stress-induced stimuli in mice. Ketamine was also found to reduce levels of inflammatory biomarkers in cardiac surgical patients.

Orthopaedic surgery is a high-risk situation for developing postoperative cognitive dysfunction. In patients undergoing non-cardiac surgery, the prevalence of POCD is 26% one week after surgery and decreased to 10% at 3 months postoperatively, and a similar prevalence is found 12 months after the operation. Postoperative delirium is associated with an increased risk of POCD. Hundred thousands of patients > 60 years undergo elective orthopaedic procedures per year around the world.

ReferenceCitation: Kurdi MS, Theerth KA, Deva RS. Ketamine: Current applications in anesthesia, pain, and critical care. Anesth Essays Res. 2014 Sep-Dec;8(3):283-90. doi: 10.4103/0259-1162.143110. Review.

ReferenceCitation: Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.

family: Jabre

full_name: Patricia Jabre

given: Patricia

family: Combes

full_name: Xavier Combes

family: Lapostolle

full_name: Frederic Lapostolle

given: Frederic

family: Dhaouadi

full_name: Mohamed Dhaouadi

given: Mohamed

family: Ricard-Hibon

full_name: Agnes Ricard-Hibon

given: Agnes

family: Vivien

full_name: Benoit Vivien

given: Benoit

family: Bertrand

full_name: Lionel Bertrand

given: Lionel

family: Beltramini

full_name: Alexandra Beltramini

given: Alexandra

family: Gamand

full_name: Pascale Gamand

given: Pascale

family: Albizzati

full_name: Stephane Albizzati

given: Stephane

family: Perdrizet

full_name: Deborah Perdrizet

given: Deborah

family: Lebail

full_name: Gaelle Lebail

given: Gaelle

family: Chollet-Xemard

full_name: Charlotte Chollet-Xemard

given: Charlotte

family: Maxime

full_name: Virginie Maxime

given: Virginie

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Bollaert

full_name: Pierre-Edouard Bollaert

given: Pierre-Edouard

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Anguel

full_name: Nadia Anguel

given: Nadia

family: Vicaut

full_name: Eric Vicaut

given: Eric

full_name: Frederic Adnet

ReferenceCitation: Riou B, Lecarpentier Y, Viars P. Inotropic effect of ketamine on rat cardiac papillary muscle. Anesthesiology. 1989 Jul;71(1):116-25.

ReferenceCitation: Riou B, Viars P, Lecarpentier Y. Effects of ketamine on the cardiac papillary muscle of normal hamsters and those with cardiomyopathy. Anesthesiology. 1990 Nov;73(5):910-8.

ReferenceCitation: Zanos P, Moaddel R, Morris PJ, Georgiou P, Fischell J, Elmer GI, Alkondon M, Yuan P, Pribut HJ, Singh NS, Dossou KS, Fang Y, Huang XP, Mayo CL, Wainer IW, Albuquerque EX, Thompson SM, Thomas CJ, Zarate CA Jr, Gould TD. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016 May 26;533(7604):481-6. doi: 10.1038/nature17998. Epub 2016 May 4.

ReferenceCitation: Harraz MM, Tyagi R, Cortés P, Snyder SH. Antidepressant action of ketamine via mTOR is mediated by inhibition of nitrergic Rheb degradation. Mol Psychiatry. 2016 Mar;21(3):313-9. doi: 10.1038/mp.2015.211. Epub 2016 Jan 19.

ReferenceCitation: Zorumski CF, Nagele P, Mennerick S, Conway CR. Treatment-Resistant Major Depression: Rationale for NMDA Receptors as Targets and Nitrous Oxide as Therapy. Front Psychiatry. 2015 Dec 9;6:172. doi: 10.3389/fpsyt.2015.00172. eCollection 2015. Review.

ReferenceCitation: Hudetz JA, Patterson KM, Iqbal Z, Gandhi SD, Byrne AJ, Hudetz AG, Warltier DC, Pagel PS. Ketamine attenuates delirium after cardiac surgery with cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):651-7. doi: 10.1053/j.jvca.2008.12.021. Epub 2009 Feb 23.

ReferenceCitation: Arrowsmith JE, Harrison MJ, Newman SP, Stygall J, Timberlake N, Pugsley WB. Neuroprotection of the brain during cardiopulmonary bypass: a randomized trial of remacemide during coronary artery bypass in 171 patients. Stroke. 1998 Nov;29(11):2357-62.


title: Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

acronym: ENMG-DIAPH

summary:
The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.

The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.

location_facility: Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France


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

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

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

family: Azarnoush

full_name: Kasra Azarnoush

given: Kasra

family: Pereira

full_name: Bruno Pereira

family: Dualé

full_name: Christian Dualé

family: Dorigo

full_name: Enrica Dorigo

given: Enrica

family: Farhat

full_name: Mehdi Farhat

given: Mehdi

family: Innorta

full_name: Andrea Innorta

given: Andrea

family: Dauphin

full_name: Nicolas Dauphin

given: Nicolas

family: Geoffroy

full_name: Etienne Geoffroy

given: Etienne

family: Chabrot

full_name: Pascal Chabrot

given: Pascal

family: Camilleri

full_name: Lionel Camilleri

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

lead_sponsor: University Hospital, Clermont-Ferrand


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

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

lead_sponsor: University Hospital, Lille


title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.

summary: Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

ReferenceCitation: Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.

family: Gras

full_name: Severine Gras

given: Severine

family: Roy-Gash

full_name: Fabian Roy-Gash

given: Fabian

family: Bruneau

full_name: Béatrice Bruneau

given: Béatrice

family: Salvi

full_name: Nadège Salvi

given: Nadège

family: Colas

full_name: Anne-Emmanuelle Colas

given: Anne-Emmanuelle

family: Skhiri

full_name: Alia Skhiri

given: Alia

family: Orliaguet

full_name: Gilles Orliaguet

given: Gilles

family: Dahmani

full_name: Souhayl Dahmani

given: Souhayl

family: Devys

full_name: Jean-Michel Devys

given: Jean-Michel

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

location_facility: Fondation ophtalmologique Adolphe de Rothschild


title: Study of the Genetic Factors Involved in Autism and Related Disorders

acronym: Gene&autism

summary: The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. The investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations.

ReferenceCitation: Delorme R, Ey E, Toro R, Leboyer M, Gillberg C, Bourgeron T. Progress toward treatments for synaptic defects in autism. Nat Med. 2013 Jun;19(6):685-94. doi: 10.1038/nm.3193. Epub 2013 Jun 6. Review.

family: Delorme

full_name: Richard Delorme

given: Richard

family: Ey

full_name: Elodie Ey

given: Elodie

family: Toro

full_name: Roberto Toro

given: Roberto

family: Leboyer

full_name: Marion Leboyer

given: Marion

family: Gillberg

full_name: Christopher Gillberg

given: Christopher

family: Bourgeron

full_name: Thomas Bourgeron

given: Thomas

journal_name: Nature Medicine

oa_host_type: repository

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

location_facility: Centre de rehabilitation psychosociale, Hopital Saint Egreve

intervention_type: Genetic


title: National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study

acronym: VIGIL

summary:
In order to clarify the current management of young sick children in France, whether or not they are cared for in community settings (nursery, schools), paediatricians have proposed an algorithm whose objective is to help define the indications for PCR-Sars-CoV-2 (https://www.infovac.fr/actualites/bulletin-special-mai-2020).

This algorithm, in two parts, can be used, when symptoms are detected in children, to orient and guide :

first, parents and community personnel to recognize the signs of infection call signs that should involve medical consultation;
but also, the physicians who will carry out this medical evaluation and will have to decide whether or not PCR screening is necessary, in parallel with their diagnostic and therapeutic management, which should not be altered in this particular context

Our main objective is to describe, after the confinement phase, the management of young sick children in the community (crèches, nursery and elementary schools, etc.) or not in order to best define the indications for PCR-Sars-CoV-2

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
PARI network
ACTIV network


summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of diarrhoea after POC tests.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


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

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

lead_sponsor: University Hospital, Strasbourg, France

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


title: Improving the Diagnosis of Pneumonia in Emergency Rooms

summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of pneumonia caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of pneumonia after POC tests.


acronym: STIMUPARK

summary:
Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking.

Spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. Experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in Parkinsons patients.

This exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of Parkinsons patients who are not adequately improved by drug therapy alone.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020

acronym: COVID-OISE

summary:
An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.

lead_sponsor: Institut Pasteur

location_facility:
Institut Pasteur
Hôpital de Crépy en Valois


title: Crucial Areas on Atrial Fibrillation Termination by Substrate Ablation: Relevance to Anatomy

summary:
Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation.

The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_country:
United Kingdom
France

location_facility:
Hôpital Privé Jacques Cartier;
Morphology Unit Royal Brompton Hospital
Institut Mutualiste Montsouris;
Hopital Saint Joseph


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

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

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

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

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

family: Richette

full_name: Pascal Richette

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Conrozier

full_name: Thierry Conrozier

given: Thierry

family: Euller-Ziegler

full_name: Liana Euller-Ziegler

given: Liana

family: Mazières

full_name: Bernard Mazières

given: Bernard

family: Maugars

full_name: Yves Maugars

given: Yves

family: Mulleman

full_name: Denis Mulleman

given: Denis

family: Clerson

full_name: Pierre Clerson

given: Pierre

family: Chevalier

full_name: Xavier Chevalier

given: Xavier

journal_name: Arthritis & Rheumatism

title: Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo-controlled trial

lead_sponsor: Daiichi Sankyo, Inc.


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

acronym: DSPECT

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

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

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

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

location_facility: Service de Médecine Nucléaire, Clinique Louis Pasteur


title: Mindfulness Meditation for Epilepsy: Effect of Mindfulness Meditation Practice on Quality of Life and EEG Activity in Refractory Epilepsy

acronym: MIME

summary:
In one-third of epileptic patients treated in France, seizures persist despite drug treatment. These so-called "refractory" epilepsies are among the most severe. Only a minority of patients with refractory epilepsy can undergo surgery. The other options available are based on brain or vagus nerve stimulation interventions which clinical effectiveness is still being studied. Alternative therapies are needed both to decrease the frequency of patients' seizures and to improve their quality of life.

The practice of mindfulness meditation has recently been included in the recommendations of the International League Against Epilepsy in order to alleviate anxiety or depression comorbid symptoms.

This study falls within this framework by targeting two aspects of the pathology.

lead_sponsor: Rennes University Hospital


title: Dissection of Aorta: Descending Part, Imaging

acronym: DADI

summary: Patients with dissection of the descending aorta will be followed up according to a precise timeline.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Pr Guillaume JONDEAU . Cardiologie. Hôpital Bichat

intervention_type: Radiation


title: Impact of Spa Treatments on the Consumption of Care in Children

acronym: PEDIATHERM

summary:
Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. The benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures.

Few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. Moreover, no real-life study of a large sample of children seems to have been conducted in this area. The present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.


title: COVID-19 Seroconversion Among Medical and Paramedical Staff in Emergency, ICU and Infectious Disease Services During the 2020 Epidemic

acronym: SEROCOV

summary: The epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.


title: Skin Diseases: Which Heathcare Professionals do Pregnant Women in Vendee Use?

summary:
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.

These pathological rashes can be dangerous for the mother or the fetus.

The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis

acronym: AGMA

summary: Prematurity is a major risk factor for poor neurodevelopmental outcomes. The clinical and neuroradiological evaluations proposed during the neonatal period to assess the developmental prognosis of children born prematurely are not sensitive and nor specific. The analysis of spontaneous motor activity by Prechtl's method has a better predictive value but is currently unfeasible in clinical routine. The study's principal objective is to describe the standardized values of complexity, variability, and fluidity of general movements.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of Sensory-motor Cortex Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients

summary:
The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect.

In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a cross-over randomized study.

Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI (motor activation) performed before the first rTMS session and the last day of each session of rTMS.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)


title: Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision

acronym: SORKYSA

summary:
Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).

The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM.

ReferenceCitation: Romain B, Mielcarek M, Delhorme JB, Meyer N, Brigand C, Rohr S; SORKYSA group. Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study). BJS Open. 2020 Apr;4(2):225-231. doi: 10.1002/bjs5.50259. Epub 2020 Feb 4.

name: Department of Digestive SurgeryStrasbourg University Hospital Strasbourg France

name: Laboratory of Stress Response and Innovative Therapies, Institut National de la Santé et de la Recherche Médicale (INSERM) IRFAC UMR_S1113University of Strasbourg Strasbourg France

family: Romain

full_name: B. Romain

given: B.

name: Department of Public HealthStrasbourg University Hospital Strasbourg France

family: Mielcarek

full_name: M. Mielcarek

given: M.

family: Delhorme

full_name: J. B. Delhorme

given: J. B.

family: Meyer

full_name: N. Meyer

given: N.

family: Brigand

full_name: C. Brigand

given: C.

family: Rohr

full_name: S. Rohr

given: S.

family: Chilintseva

full_name: N. Chilintseva

family: Knepfler

full_name: T. Knepfler

given: T.

family: Manfredelli

full_name: S. Manfredelli

family: Simeu

full_name: B. Simeu

family: Tréchot

full_name: B. Tréchot

family: Triki

full_name: E. Triki

given: E.

family: Valero

full_name: E. Valero

family: Di Liberatore

full_name: M. Di Liberatore

family: Gergeanu

full_name: S. Gergeanu

family: Ionescu

full_name: R. Ionescu

given: R.

family: Mihaescu

full_name: G. Mihaescu

given: G.

family: Nicolae

full_name: M. Nicolae

family: Patrice

full_name: D. Patrice

given: D.

family: Zeca

full_name: I. Zeca

given: I.

family: Barsotti

full_name: P. Barsotti

given: P.

family: Dan

full_name: S. Dan

title: Dialkylcarbamoyl chloride‐coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study)

location_facility: Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne

location_facility: Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France

location_facility: Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec

location_facility: Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté


title: Baseline Characteristics, Processes of Care, System-related Factors, and Clinical Outcomes Associated With the Quality and Safety of Initial Management for ST-segment Elevation Myocardial Infarction: A Multicenter Cohort Study

acronym: STEMI-Qual

summary:
This is a multicenter multidisciplinary study designed to investigate patient, provider, and system-related factors that are associated with the quality and safety of initial management for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12 hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for suspected STEMI independently relates to provider practice patterns and system barriers. It is further postulated that non-compliance with target delays in implementing percutaneous coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion therapy within target delays is associated with increased rates of false-positive cardiac catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events.

The project will be conducted in three emergency medical services and 23 public and private (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over the index hospital stay period will be retrospectively collected for all the patients included in an ongoing prospective regional hospital-based clinical registry of suspected STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is anticipated.

In this observational retrospective study, no specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. No enrollment or follow-up visits are planned.

The primary effectiveness outcome is timely acute reperfusion therapy. The secondary effectiveness outcomes include false-positive cardiac catheterization laboratory activation for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and major bleeding events. Multivariable logistic regression model will be developed to identify baseline characteristics that are independently associated with timely acute reperfusion therapy. Propensity score analysis will be performed for comparing clinical outcomes between timely acute reperfusion therapy recipients and non-recipients.

ReferenceCitation: Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarère J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.

ReferenceCitation: Belle L, Labarère J, Fourny M, Drouet E, Mulak G, Dujardin JJ, Vilarem D, Bonnet P, Hanssen M, Simon T, Ferrières J, Danchin N; French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction study investigators. Quality of care for myocardial infarction at academic and nonacademic hospitals. Am J Med. 2012 Apr;125(4):365-73. doi: 10.1016/j.amjmed.2011.11.015.

ReferenceCitation: Belle L, Motreff P, Mangin L, Rangé G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

name: From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology,...

family: Belle

full_name: Loic Belle

given: Loic

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Mangin

full_name: Lionel Mangin

given: Lionel

family: Rangé

full_name: Grégoire Rangé

given: Grégoire

family: Marcaggi

full_name: Xavier Marcaggi

family: Marie

full_name: Antoine Marie

given: Antoine

family: Ferrier

full_name: Nadine Ferrier

given: Nadine

family: Dubreuil

full_name: Olivier Dubreuil

given: Olivier

family: Zemour

full_name: Gilles Zemour

given: Gilles

family: Souteyrand

full_name: Géraud Souteyrand

given: Géraud

family: Caussin

full_name: Christophe Caussin

given: Christophe

family: Amabile

full_name: Nicolas Amabile

given: Nicolas

family: Isaaz

full_name: Karl Isaaz

given: Karl

family: Dauphin

full_name: Raphael Dauphin

given: Raphael

family: Koning

full_name: René Koning

given: René

family: Robin

full_name: Christophe Robin

family: Faurie

full_name: Benjamin Faurie

given: Benjamin

family: Bonello

full_name: Laurent Bonello

given: Laurent

family: Champin

full_name: Stanislas Champin

given: Stanislas

family: Delhaye

full_name: Cédric Delhaye

given: Cédric

family: Cuilleret

full_name: François Cuilleret

given: François

family: Mewton

full_name: Nathan Mewton

given: Nathan

family: Genty

full_name: Céline Genty

title: Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment–Elevation Myocardial Infarction

ReferenceCitation: Beygui F, Cayla G, Roule V, Roubille F, Delarche N, Silvain J, Van Belle E, Belle L, Galinier M, Motreff P, Cornillet L, Collet JP, Furber A, Goldstein P, Ecollan P, Legallois D, Lebon A, Rousseau H, Machecourt J, Zannad F, Vicaut E, Montalescot G; ALBATROSS Investigators. Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial. J Am Coll Cardiol. 2016 Apr 26;67(16):1917-27. doi: 10.1016/j.jacc.2016.02.033.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Fourny M, Lucas AS, Belle L, Debaty G, Casez P, Bouvaist H, François P, Vanzetto G, Labarère J. Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction. Am J Emerg Med. 2011 Jan;29(1):37-42. doi: 10.1016/j.ajem.2009.07.008. Epub 2010 Mar 9.

ReferenceCitation: Labarère J, Belle L, Fourny M, Vanzetto G, Debaty G, Delgado D, Brallet J, Vallet B, Danchin N; USIC 2000; FAST-MI. Regional system of care for ST-segment elevation myocardial infarction in the Northern Alps: a controlled pre- and postintervention study. Arch Cardiovasc Dis. 2012 Aug-Sep;105(8-9):414-23. Epub 2012 Jul 17.

ReferenceCitation: Labarere J, Belle L, Fourny M, Genès N, Lablanche JM, Blanchard D, Cambou JP, Danchin N; Unité de Soins Intendifs Coronaires 2000 Inverstigators. Outcomes of myocardial infarction in hospitals with percutaneous coronary intervention facilities. Arch Intern Med. 2007 May 14;167(9):913-20.

ReferenceCitation: Raskovalova T, Twerenbold R, Collinson PO, Keller T, Bouvaist H, Folli C, Giavarina D, Lotze U, Eggers KM, Dupuy AM, Chenevier-Gobeaux C, Meune C, Maisel A, Mueller C, Labarère J. Diagnostic accuracy of combined cardiac troponin and copeptin assessment for early rule-out of myocardial infarction: a systematic review and meta-analysis. Eur Heart J Acute Cardiovasc Care. 2014 Mar;3(1):18-27. doi: 10.1177/2048872613514015. Epub 2013 Nov 20. Review.

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title: Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance

summary: Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This is a prospective observational study of circulating MPs and blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU at baseline (D1), D2, D3, D4 and D7.

location_facility: Service Réanimation Médicale et Médecine Hyperbare, CHU

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil, Hôpitaux Universitaires


title: Identification of Markers Associated With the Risk of COVID-19 Infection and Symptomatic COVID+ Versus Asymptomatic COVID+ Status Through the Establishment of a Biological Collection During Serological Screening in APHP Professionals

acronym: COVID-HOP

summary:
The objective of the COVID-HOP study is to identify biological and non-biological markers associated to: a positive or negative serology anti SRAS-Cov-2; a positive serology and having presented symptoms or, on the contrary, not having had symptoms; the persistence of immunity or the loss of this immunity over time; the protective nature of the presence of anti SRAS-Cov-2 antibodies.

To answer these questions, a biological collection (serum, plasma, DNA, RNA, mono-nucleated cells and urine) and a collection of detailed clinical data during the serological screening for SARS-CoV-2 of hospital agents (medical and non-medical staff) of the Assistance Publique Hôpitaux de Paris (Paris, France) will be carried out. 4000 professionals in 5 hospitals will be included. As part of the research, the anti SRAS-CoV-2 serology will be monitored 6 months and 12 months after the initial serology. Numerous studies will be carried out from this biological collection and from the database to answer the primary and secondary endpoints.


title: Evaluation of the Benefit of the Training of the Manual Dexterity Post-stroke: Effect on the Function and Spontaneous Use of the Hand and the Cerebral Plasticity

acronym: DEXTRAIN

summary:
Stroke is the second leading cause of death and disability in France: more than half of stroke survivors have a disabling motor deficit, affecting mainly the upper limb. A lack of hand control makes everyday tasks more difficult and reduces the quality of life. The investigators lack approaches to specifically rehabilitate the hand after stroke.

Recently, a new tool has been developed to measure manual dexterity (the Finger Force Manipulandum or FFM). This tool, which records the forces applied by the fingers on pistons, allows to measure more finely the key components of manual dexterity during visuomotor tasks. The tool measures the ability to control and release the force applied by the fingers, to perform sequences, to track and maintain a frequency of tapping (temporality of movement) with the fingers, and to use the fingers independently one another.

lead_sponsor: Centre Hospitalier St Anne


title: An International Multicenter Phase II Randomised Trial Evaluating and Comparing Two Intensification Treatment Strategies for Metastatic Neuroblastoma Patients With a Poor Response to Induction Chemotherapy

acronym: VERITAS

summary: The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: France Netherlands

location_facility:
Princess Maxima Center
Gustave Roussy