title: Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus in the Metropolis of Lyon

summary:
The magnitude of seasonal RSV epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" or NPI. Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions.

On a previous study (see NTC 04944160), 519 infants were recruited in the Pre-Covid-19 season population, and 277 infants were recruited in the first Per-Covid-19 season population.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility:
Virology Lab
Pediatric Departement


title: Comparison of Mortality in Severe SARS-Cov-2 Infection Caused by the 501Y.V2 Variant and B.1.1.7 Variant

acronym: VARICOVID

summary: In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 ("English"), 20H/501Y.V2 ("South African"), and 20J/501Y.V3 ("Brazilian") variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Louis G, Belveyre T, Goetz C, Gibot S, Dunand P, Conrad M, Gaci R, Gette S, Ouamara N, Perez P, Cadoz C, Picard Y, Mellati N. Comparison of SARS-CoV-2 Variants of Concern Alpha (B.1.1.7) vs. Beta (B.1.351) in Critically Ill Patients: A Multicenter Cohort Study. Front Med (Lausanne). 2022 Mar 10;9:828402. doi: 10.3389/fmed.2022.828402. eCollection 2022.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHR Metz Thionville
CHRU Nancy

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Role of PET/CT With Fluorine-18 Tracers and of Diffusion Weighted Whole-body MRI in the Early Detection of Bone Metastases in Prostate Cancer

acronym: FLUPROSTIC

summary: Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer: diagnostic performance and impact on the patient management.Determine the lowest cost strategy according to the precise clinical circumstances.

time_perspective: Prospective

ReferenceCitation: Gauthé M, Zarca K, Aveline C, Lecouvet F, Balogova S, Cussenot O, Talbot JN, Durand-Zaleski I. Comparison of (18)F-sodium fluoride PET/CT, (18)F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France. BMC Med Imaging. 2020 Mar 2;20(1):25. doi: 10.1186/s12880-020-00425-y.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service Médecine Nucléaire - Hôpital TENON

intervention_type: Device


type: Registry Identifier

title: Neuronal Correlates of Agency in Dystonia

summary:
In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia:

(i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal underpinnings of the defective sense of agency in dystonia.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

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

intervention_type: Behavioral

status_simplified: Ongoing


title: Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly. A French Multicentered Prospective Interventional Study.

acronym: Caesar

summary:
Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned by this pathology, there is not much information about chronic alcohol misuse of this population in particular.

Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a biological marker of alcohol misuse, the specificity of the CDT is known to be superior to the GGT as well.

However, when it comes to the elderly, alcoholism diagnosis tools are based on research of younger populations.

This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the elderly.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Henni A, Bideau C, Routon X, Berrut G, Cholet J. [Prevalence and issues of screening for alcohol consumption among elderly inpatients admitted to acute geriatric inpatient unit]. Geriatr Psychol Neuropsychiatr Vieil. 2013 Mar;11(1):33-41. doi: 10.1684/pnv.2013.0397. French.

ReferenceCitation: Mundle G, Ackermann K, Munkes J, Steinle D, Mann K. Influence of age, alcohol consumption and abstinence on the sensitivity of carbohydrate-deficient transferrin, gamma-glutamyltransferase and mean corpuscular volume. Alcohol Alcohol. 1999 Sep-Oct;34(5):760-6.

ReferenceCitation: Hermansson U, Helander A, Huss A, Brandt L, Rönnberg S. The Alcohol Use Disorders Identification Test (AUDIT) and carbohydrate-deficient transferrin (CDT) in a routine workplace health examination. Alcohol Clin Exp Res. 2000 Feb;24(2):180-7.

ReferenceCitation: Anton RF, Lieber C, Tabakoff B; CDTect Study Group. Carbohydrate-deficient transferrin and gamma-glutamyltransferase for the detection and monitoring of alcohol use: results from a multisite study. Alcohol Clin Exp Res. 2002 Aug;26(8):1215-22.

ReferenceCitation: Schwan R, Albuisson E, Malet L, Loiseaux MN, Reynaud M, Schellenberg F, Brousse G, Llorca PM. The use of biological laboratory markers in the diagnosis of alcohol misuse: an evidence-based approach. Drug Alcohol Depend. 2004 Jun 11;74(3):273-9.

ReferenceCitation: Allen JP, Litten RZ, Anton RF, Cross GM. Carbohydrate-deficient transferrin as a measure of immoderate drinking: remaining issues. Alcohol Clin Exp Res. 1994 Aug;18(4):799-812. Review.

ReferenceCitation: Bortolotti F, De Paoli G, Tagliaro F. Carbohydrate-deficient transferrin (CDT) as a marker of alcohol abuse: a critical review of the literature 2001-2005. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Sep 1;841(1-2):96-109. Epub 2006 May 24. Review.

ReferenceCitation: Salaspuro M. Carbohydrate-deficient transferrin as compared to other markers of alcoholism: a systematic review. Alcohol. 1999 Nov;19(3):261-71. Review.

ReferenceCitation: WHO Expert Committee on Problems Related to Alcohol Consumption. WHO Expert Committee on Problems Related to Alcohol Consumption. Second report. World Health Organ Tech Rep Ser. 2007;(944):1-53, 55-7, back cover.

ipd_sharing: No

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility:
Reseau d'Appui aux Generalistes (RAG)
GHRMSA

intervention_type: Procedure


title: CESIR-U2 : Influence of Drugs Use and Health Status

summary:
In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization < 24 hours) that represent around 73% of accidents.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Pellegrin
CH de Perigueux


title: Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory

acronym: CAPIVEIN

summary: The main objectives are to evaluate the concordance between the results of natremia, kalaemia and blood sugar levels obtained 1) by capillary puncture, analysed on a delocalized resuscitation machine GEM 4000 (Werfen) and 2) by venous sampling, analysed on the machine of the standard biology laboratory Gen. 2 COBAS (Roche).

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel

status_simplified: Unknown


title: Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle

acronym: FUSIMAGINE

summary:
A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)).

Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent.

This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity.

Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition.

The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI.

Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.

primary_purpose: Health Services Research

ReferenceCitation: Demené C, Deffieux T, Pernot M, Osmanski BF, Biran V, Gennisson JL, Sieu LA, Bergel A, Franqui S, Correas JM, Cohen I, Baud O, Tanter M. Spatiotemporal Clutter Filtering of Ultrafast Ultrasound Data Highly Increases Doppler and fUltrasound Sensitivity. IEEE Trans Med Imaging. 2015 Nov;34(11):2271-85. doi: 10.1109/TMI.2015.2428634. Epub 2015 Apr 30.


title: Influence of Age on amyloïd Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease Like Posterior Cortical Atrophy (PCA) and Logopenic Progressive Aphasia (LPA)Using Positron Emitting Tomography (PET) Imaging

acronym: BIOMAGE

summary:
The first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:

measuring the rate of cortical brain atrophy,
FDG imaging of glucose metabolism reflecting neuronal activity, and
for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.


title: Evaluation of the Repercussions of the Coronavirus (Covid 19) Infection on Nutritional Health Status and Nutritional Care : an Observational French Cohort Study One Month After Their Discharge From Hospital

summary: Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other


title: Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

acronym: MELIDIAB

summary:
Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey.

Honey is effective in the management of many infected or uninfected post-surgical wounds.

This study focuses on post surgical wounds after toe amputation in diabetic patients.

The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Metropole Savoie


title: Long Term Cognitive and Psychological Disorders After Severe COVID-19 Infection in Young Patients

acronym: NEUROCOG-COVID

summary: As COVID-19 pandemic is still ongoing, patients follow-up begins to reveal cognitive and psychological disorders. There are not yet well described, neither their physiopathology. This study will consist in the detection and characterization of cognitive and psychological impairments in young patients under 65 years of age who have been hospitalized more than 72 hours for a severe COVID-19 infection.

status: Recruiting

lead_sponsor: Central Hospital, Nancy, France

location_facility: Nancy University Hospital, Department of Neurology


title: Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)

acronym: FLU-HOP

summary:
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:

What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?

Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:

Before the vaccination:

What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?

After the vaccination:

What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?

status: Unknown status

location_facility: Centre d'Investigations Cliniques (CIC), Hopital Cochin

intervention_type: Biological


title: CHEMO RESISTANCE TO PLATINUM COMPOUNDS AND NOTCH PATHWAYS IN PATIENTS RECEIVING NEOADJUVANT CHEMOTHRERAPY FOR LOCALLY ADVANCED ADENOCARCINOMA OF THE LUNG.

acronym: NOTCH

summary: Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or induction chemotherapy). The reason of this combined modality treatment is the really poor prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when the lymph node under the carina is affected). Up till now, the five-year survival of patients who underwent surgical resection of N2 NSCLC does not exceed 15%

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier


title: A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit

acronym: TRAUMADORNASE

summary:
Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).

Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).

The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).

The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:

an improvement in static lung compliance
a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days
a reduction in the length of ICU stay
a reduction in the hospital length of stay
a reduction in multi-organ failure
a reduction in ventilator-associated pneumonia (VAP)
a reduction in mortality at day 28

ReferenceCitation: Pottecher J, Noll E, Borel M, Audibert G, Gette S, Meyer C, Gaertner E, Legros V, Carapito R, Uring-Lambert B, Sauleau E, Land WG, Bahram S, Meyer A, Geny B, Diemunsch P. Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients. Trials. 2020 Mar 18;21(1):274. doi: 10.1186/s13063-020-4141-6.

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Drug


title: Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study

acronym: LUNII

summary:
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.

The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.

primary_purpose: Supportive Care


title: Renal Replacement Therapy in Neonates : a Retrospective Monocentric Cohort Study

acronym: Neo-Renal

summary:
The circumstances for setting up dialysis in the neonatal period are multiple: congenital anomaly of the kidney and urinary tract (CAKUT), secondary acute renal failure whose etiologies are multiple (sepsis, hypovolemia, respiratory distress syndrome, neonatal asphyxia, Arterial or venous renal thrombosis, nephrotoxic drugs, etc.), metabolic diseases (mainly hyperammonemia and leucinosis) and post-operative management of heart disease: analysis of the characteristics of the patients in our study and comparison with existing epidemiological data in the literature.

The decision to set up dialysis in a newborn whose recovery of renal function is uncertain or in a context of acute multi-visceral failure is not always obvious and must be discussed carefully. multidisciplinary in connection with neonatologists, resuscitators and nephrologists as well as families with the consideration of the future quality of life of the child.

location_facility: Service de Pédiatrie 1 - CHU de Strasbourg - France


title: Adjustment of Adopted Adolescents in Their Families

acronym: EEAA

summary: The adjustment of adopted adolescents has been studied in the U.S. and England, but few other European countries have conducted research into this topic. As countries differ greatly in their cultural practices, a comparative study of the adjustment of internationally adopted teenagers in 4 European countries (France, Italy, Spain, Norway) is planned. The adjustment of teens and their families will be studied in relation to the openness of communication related to adoption within the families.

lead_sponsor: Centre Hospitalier St Anne


title: Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19) : COROBIOCHIC

acronym: COROBIOCHIC

summary:
Objective: To assess the prognostic value of high-sensitive cardiac troponin T (hs-cTnT) and N-terminal pro brain natriuretic peptide (NT-proBNP) at ICU admission in patients with coronavirus disease 2019 (COVID-19).

Design: Multicenter retrospective observational cohort study Setting: Three ICUs at three hospitals in Occitanie, France. Patients: Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission, from March 9, 2020, to May 9, 2020.

ipd_sharing_description: NC


title: Single-center Study, Transversal, Controlled and Not Randomized, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women

summary: In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. In addition, data from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding behavior of infertile women is more often disturbed than the general population. Moreover, the notions of desire for a child and maternal representations seem essential to address in the comprehensive care of women with infertility but also TCA integrating all conflicting issues reactivated at the time of motherhood. However, little work has been done on this subject. Thus, we propose a study on the desire for children and the eating disorders to infertile women, to update epidemiological data, but also to better characterize this particular patient population. Perspectives of this work are to improve screening measures and support through a joint work of doctors reproductive and psychiatrists.

lead_sponsor: Nantes University Hospital


title: Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

acronym: BIOSEPSIS

summary: Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.


title: Evaluation of the Emergency Imaging Strategy for the Diagnostic Management of Renal Colic

acronym: Renal-Colic

summary:
Emergency imaging is necessary for the diagnostic management of renal colic in the emergency department. Ultrasound is rapidly available and non-irradiating, allowing to look for a stone and a pyelocalic dilatation. But it is less sensitive when the stone is ureteral. CT has a sensitivity of 96% and a specificity of 100%. The latest French recommendations date from 2008, recommending ultrasound and an unprepared abdomen in cases of uncomplicated renal colic. For the European Society of Radiology, ultrasound should be the first-line examination. The place of a systematic CT scan as first-line examination for the diagnosis of renal colic in the emergency department is therefore still under discussion.

An evaluation of practice will make it possible to assess the imaging strategy applied in an emergency department.

location_facility: Service d'accueil des urgences - CHU de Strasbourg - France


title: The Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Labor Induction: a Randomized Controlled Trial (VIRTUALMAG)

acronym: VIRTUALMAG

summary: The labor induction concerns 22% of births in France. In the event of labor induction, in almost two thirds of cases, a cervical ripening method is used and the use of mechanical methods is observed for 8% of cervical ripening. Intra-cervical balloon placement is generally well tolerated but is frequently associated with pain and acute anxiety. There are few options for pain relief. Virtual reality, a relatively new intervention, has been studied as a distraction technique for pain relief, but never in the context of the induction of childbirth.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Diagnostic Performance of Coronary Calcification Detection on CT Scan for the Management of Patients Consulting for the Diagnosis of Acute Coronary Events in Patients Presenting With Low- or Intermediate-risk Chest Pain to the Emergency Department

acronym: Calci-DT

summary:
thoracic pain is one of the most frequent reasons for consulting the emergency room. Chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. Efficient triage of patients is therefore a crucial issue for emergency physicians in order not to ignore an acute coronary event requiring early and specific management.

The investigators seek to evaluate whether a diagnostic strategy based on a thoracic CT scan to rule out coronary calcifications and a single troponin assay can exclude an acute coronary event with sufficient accuracy compared to usual management.


title: Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery

acronym: PTSD-preterm

summary: Each year in France, between 50,000 and 60,000 children are born prematurely (< 37 weeks of amenorrhea). Literature has shown that preterm deliveries can be associated with the development of PTSD (Post-Traumatic Stress Disorder) in mothers. Around ¼ of women suffer from a PTSD after giving birth prematurely. Moreover, studies highlighted the consequences of a PTSD on the child-mother relationship. Beyond the importance of early detection, it could be important to predict factors that make women more likely to develop a PTSD. This study will focus on personal factors (5 dimensions of personality). Our hypothesis is that personality traits are associated with the likeliness of developing a PTSD after a preterm delivery.

lead_sponsor: CHU de Reims


title: Multicentre, Randomised, Open-label Study Comparing the Tolerability and Viral Reduction of the Combination of IFN Alpha-2b XL + Ribavirin Versus Peg IFN Alpha-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4.

acronym: COAT IFN

summary:
Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments

The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Evaluation of the Satisfaction of Patients With Conization Under Local Anesthesia, Prospective Study

acronym: ESCAL

summary:
In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of high quality cervical intraepithelial neoplasia (CIN) (2- 3) which, if persistent, can cause cervical cancer. Their results, also in the case of the persistence of a low-level lesion or of a cyto-histological discordance, indicate conization. Conization is a procedure performed by resection of the diathermic grip, allowing a simple and fast gesture compatible with a load under local anesthesia. In order to simplify the overall cost of the patient, more and more conizations of Montpellier and Nimes take place under local anesthesia. .

The main objective of our study is to evaluate the overall satisfaction of patients in the case of conisation under local anesthesia.

The goal is to promote local anesthesia for the management of congested patients, which simplifies overall management, reduces cost and reduces complications associated with general anesthesia.


title: Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes

acronym: EPF

summary:
The investigators wish to study the obstetrical data of pregnant women who had an ultrasound estimation of fetal weight and who delivered at the University Hospital of Strasbourg over the last 20 years. These retrospectively collected data are a valuable source of scientific information since they are "real life data", currently of growing interest in the scientific community, and have a large volume and quality due to the number of years included and the variety of information collected in the computerized media records.

From this study, the investigators hope not only to better understand the consequences of ultrasound screening for fetal growth, but also to improve its accuracy and to develop useful models in obstetrical decision making in order to decrease maternal and neonatal morbidity.

location_facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France


title: PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial

acronym: PREMAPESSAIRE

summary:
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.

After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.

A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.

The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.

To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.


title: Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the University Hospital of Strasbourg (HUS)

acronym: BKV-Allograf

summary:
The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally asymptomatic, occurs during childhood. The virus then persists in latent form in the body, mainly in the epithelial cells of the kidney and urinary tract. Cellular immunosuppression favors BKV replication. It is responsible for pathologies of the renal-urinary tract such as BKV-associated nephropathy (BKVAN) in kidney transplant recipients, hemorrhagic cystitis (HC) in hematopoietic stem cell (HSC) recipients or ureteral stenosis.

To date, there is no specific antiviral treatment against BKV. The management of patients is essentially symptomatic and requires a multidisciplinary approach. It is therefore necessary to identify early prognostic markers for the occurrence of CH and to develop new therapeutic strategies.

location_facility: Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France


title: Alcohol and Women : Screening in General Medicine.

summary: The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.


title: A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM

summary:
Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.

Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.

Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.

The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.

location_facility:
CH de Nancy
CH d'Amiens
CH de Valenciennes
CH de Dijon
Hospices civils de Colmar
AURAL Clinique Sainte Anne
AURAL Colmar
CH de Mulhouse
CH de Besançon
AURAL Mulhouse
AURAL Strasbourg
Clinique Sainte Anne
Hôpitaux Universitaires de Strasbourg


title: Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome

acronym: COVID-EP

summary:
Multicentric case-control study that is aims at:

evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP)
and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.

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ReferenceCitation: Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.

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ReferenceCitation: Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.

ReferenceCitation: Marietta M, Ageno W, Artoni A, De Candia E, Gresele P, Marchetti M, Marcucci R, Tripodi A. COVID-19 and haemostasis: a position paper from Italian Society on Thrombosis and Haemostasis (SISET). Blood Transfus. 2020 May;18(3):167-169. doi: 10.2450/2020.0083-20. Epub 2020 Apr 8.

ReferenceCitation: Akima S, McLintock C, Hunt BJ. RE: ISTH interim guidance to recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 Aug;18(8):2057-2058. doi: 10.1111/jth.14853. Epub 2020 Jul 15.

ReferenceCitation: Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17. Review.

ReferenceCitation: Oudkerk M, Büller HR, Kuijpers D, van Es N, Oudkerk SF, McLoud T, Gommers D, van Dissel J, Ten Cate H, van Beek EJR. Diagnosis, Prevention, and Treatment of Thromboembolic Complications in COVID-19: Report of the National Institute for Public Health of the Netherlands. Radiology. 2020 Oct;297(1):E216-E222. doi: 10.1148/radiol.2020201629. Epub 2020 Apr 23.

ReferenceCitation: Léonard-Lorant I, Delabranche X, Séverac F, Helms J, Pauzet C, Collange O, Schneider F, Labani A, Bilbault P, Molière S, Leyendecker P, Roy C, Ohana M. Acute Pulmonary Embolism in Patients with COVID-19 at CT Angiography and Relationship to d-Dimer Levels. Radiology. 2020 Sep;296(3):E189-E191. doi: 10.1148/radiol.2020201561. Epub 2020 Apr 23.

ReferenceCitation: Grillet F, Behr J, Calame P, Aubry S, Delabrousse E. Acute Pulmonary Embolism Associated with COVID-19 Pneumonia Detected with Pulmonary CT Angiography. Radiology. 2020 Sep;296(3):E186-E188. doi: 10.1148/radiol.2020201544. Epub 2020 Apr 23.

ReferenceCitation: Poissy J, Goutay J, Caplan M, Parmentier E, Duburcq T, Lassalle F, Jeanpierre E, Rauch A, Labreuche J, Susen S; Lille ICU Haemostasis COVID-19 Group. Pulmonary Embolism in Patients With COVID-19: Awareness of an Increased Prevalence. Circulation. 2020 Jul 14;142(2):184-186. doi: 10.1161/CIRCULATIONAHA.120.047430. Epub 2020 Apr 24.

ReferenceCitation: Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.

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ReferenceCitation: Middeldorp S, Coppens M, van Haaps TF, Foppen M, Vlaar AP, Müller MCA, Bouman CCS, Beenen LFM, Kootte RS, Heijmans J, Smits LP, Bonta PI, van Es N. Incidence of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020 Aug;18(8):1995-2002. doi: 10.1111/jth.14888. Epub 2020 Jul 27.

ReferenceCitation: Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23.

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ReferenceCitation: PROTECT Investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group, Cook D, Meade M, Guyatt G, Walter S, Heels-Ansdell D, Warkentin TE, Zytaruk N, Crowther M, Geerts W, Cooper DJ, Vallance S, Qushmaq I, Rocha M, Berwanger O, Vlahakis NE. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2011 Apr 7;364(14):1305-14. doi: 10.1056/NEJMoa1014475. Epub 2011 Mar 22.

ReferenceCitation: Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. doi: 10.7326/0003-4819-153-1-201007060-00004.

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

ReferenceCitation: Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Perception of Female Hormonal Contraception by the Main Prescribers

acronym: CHF

summary:
The recommendations for contraception, after researching contraindications to certain methods, are to offer clear and honest information to allow the patient to make an informed choice, adapted to her lifestyle. The best contraception is the one chosen by the patient. The choice of contraception illustrates the difficulty of assessing the benefit-risk balance in the context of functional and preventive treatment.

Taking into account this imbalance between patient beliefs and medical advice is an essential step in improving the provision of gynecological care.

location_facility: Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France


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.


title: Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital

acronym: Meningitis

summary: The diagnostic and therapeutic management of patients with aseptic meningitis is a challenge for the practitioner. There are many etiologies of this condition (infectious, inflammatory, neoplastic, drug-induced), which it is necessary to know how to evoke and look for specifically.

location_facility: Service de Médecine interne et d'Immunologie Clinique - CHU de Strasbourg - France


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


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

lead_sponsor: Centre Hospitalier de Cayenne


title: Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results

acronym: IPRA

summary: Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation. The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients earlier who meet predefined criteria (young patient, absence of comorbidities, absence of intraoperative transfusion) in order to limit the occurrence of complications of mechanical ventilation (pneumopathies, tracheal wound, muscle loss, etc.) On the other hand, improved rehabilitation in this case was often synonymous with early extubation in the operating room. Few studies, on the other hand, relate the implementation of a complete rehabilitation protocol including pre-, intra- and postoperative guidelines.

location_facility: Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France


title: Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis

acronym: Prophylaxis

summary:
The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection.

Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics.

The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours.

The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery:

sepsis
superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)
catheterization infection,
urinary tract infection or
respiratory infection such as pneumopathy acquired under mechanical ventilation

The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics

location_facility: Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France


title: Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018

acronym: ELSSA

summary: Evaluation of the prevalence of post-traumatic stress disorder (PTSD), associated risk factors, health care consumption, and sleep disorders in a civilian population exposed to the December 11, 2018, attacks in Strasbourg. Terrorist attacks have unfortunately become all too frequent on our territory in recent years. A better knowledge of the psychological and psychiatric repercussions on exposed populations is essential in order to better prevent and treat disorders that can have a major functional impact on the lives of exposed individuals and to adapt care during future similar events

location_facility: Service de Psychiatrie d'Urgences, de Liaison et de Psychotraumatologie - CHU de Strasbourg - France


title: Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

summary: Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.

location_facility: Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France


title: Liver Status in Psychiatric Inpatients

acronym: LIVERSPIN

summary:
Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease).

The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients.

The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology

lead_sponsor: Hôpital le Vinatier

intervention_type: Diagnostic Test


type: EudraCT Number

title: Preventive Effect of ACE Inhibitor Perindopril)on the Onset or Progression of Left Ventricular Dysfoction in Subjects at a Preclinical Stage From Families With Dilated Cardiomyopathy

acronym: PRECARDIA

summary:
This is a multicentre European double-blind,randomized and controlled trial with 2 parallel groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated cardiomyopathy).

Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a mutation (leading to a genetic form of heart failure) but have not yet developed DCM.

Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with autosomal dominant inheritance, and underlying genes and mutations are increasingly identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related penetrance (or delayed-onset), that means that the cardiac expression of the disease (echocardiographic abnormalities) is usually absent for a long period and progressively appears with advanced age, usually after 20 years of age

Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical stage).

Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge derived from basic research (genes identification in DCM) will be translated into clinical practice (early identification of subjects at high risk of developing heart failure through predictive genetic testing) with the development of new therapeutic management (early ACEi) that will help to decrease the morbidity and mortality associated with the disease. This will constitute a paradigm of the development of preventive medicine thanks to the development of genetics in the cardiovascular field.

Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible for DCM and are at a preclinical stage of the disease. Total duration of treatment (perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled (100 in each group) in 7 centres.

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

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
France
Germany

location_facility: Academisch Medisch Centrum AMC and InterUniversity Institute AMC/ICIN

location_facility: The Heart Hospital, University College London NHS Foundation Trust

location_facility: Health in Code SL (SME) - Hospital Marítimo de Oza.

location_facility: Academic Hospital IRCCS Foundation Policlinico San Matteo (OSM)

location_facility: Skejby University Hospital SUH, Aarhus Universit Hospital


title: Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions

summary:
Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed.

HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination.

Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status.

The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.

ipd_sharing_description: All the data are anonymized.

lead_sponsor: University Hospital, Brest


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

acronym: EpleCsAT

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

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

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

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

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

location_facility: Centre Hospitalier Universitaire de Reims


title: Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous

acronym: CLOPUS

summary: CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement. As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André

location_facility: Service de Médecine Interne et Immunopathologie


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

acronym: UniEndo

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

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

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

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

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

location_facility: Centre Hospitalier universitaire de Dijon

location_facility: Centre hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Univesitaire de Rennes

location_facility: Centre Hospitalier universitaire de Besançon


title: 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

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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

acronym: TéléCCCAP

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

lead_sponsor: University Hospital, Toulouse


title: Inhibitory rTMS Applied on Laryngeal Motor Cortex in Wilson's Disease Patients With Dysarthria

summary:
Wilson disease is a hereditary hepatic and neurological disease associated with copper accumulation. Neurological symptoms are of extra-pyramidal, cerebellar and dystonic origin. Dysarthria is one of the debilitating symptoms of Wilson disease poorly responsive to pharmacological treatment. The most common form is a dystonic hyperkinetic Dysarthria.

Pathophysiology of dystonia is still not elucidated. Motor cortex hyperexcitability has been demonstrated in various forms of dystonia. Furthermore, rTMS inhibitory applied over motor cortex has been shown to transitory reduce dystonic symptoms in various forms of dystonia.

In the present study, we investigate the effect of a single 1Hz 20-minutes inhibitory rTMS session applied over the motor laryngeal cortex on dyasarthria is the main kinetic dysarthria has been shown to be associated with inhibition of laryngeal motor cortex in Parkinson disease.

location_facility: Service de Physiologie Clinique-Explorations Fonctionnelles, AP-HP, Hôpital Lariboisière

location_facility: Service de Neurologie, Hopital Fondation Adolphe de Rothschild


title: Oral Therapies in Oncology: Cognitive Function and Compliance

summary: The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis "Living during and after cancer" highlighted in the Cancer Plan

lead_sponsor: Centre Francois Baclesse


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

acronym: SEPREVEN

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

lead_sponsor: Dr Caeymaex Laurence

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


title: PLACE OF THE 18F-FDG-PET/CT IN THE DIAGNOSTIC WORKUP IN PATIENTS WITH CLASSICAL FEVER OF UNKNOWN ORIGIN (FUO)

summary:
Objective : To explore the diagnostic contribution of the 18F-FDG-PET/CT in a population of patients with classical fever of unknown origin (FUO), to precise its place in the diagnostic decision tree in a real-life setting and to identify factors associated with a diagnostic 18F-FDG-PET/CT.

Methods: All adult patients (age≥18 years) with a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT in the University Hospital of Montpellier (France) between April 2012 and December 2017 were included. True positive 18F-FDG-PET/CT which evidenced a specific disease causing FUO were considered to be contributive.

ipd_sharing_description: nc

lead_sponsor: University Hospital, Montpellier


summary:
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of sexually transmitted infections caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC sexually infection transmitted tests .

Most sexually transmitted infections can be diagnosed from an anal swab which is not routinely performed. In this study, we suggest to test the hypothesis that anal swab in addition to the routine genital swab would increase by at least 5% the diagnosis capacity of sexually transmitted infections after the POC tests.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


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

acronym: ATH-ENTE

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

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

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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


title: Pain Perception in Suicidal Behavior Vulnerability

acronym: DOCS

summary:
In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked.

The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters.

The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts.

After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).

primary_purpose: Other


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

acronym: MUCOCAP

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

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

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

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

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

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

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

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

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

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

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

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

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Hôpital ARMAND TROUSSEAU
CHRU de NANCY


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).

ReferenceType: result

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.

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.

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.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne


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

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

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

location_facility:
CHRU Limoges
Central hospital


title: Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform

summary:
Targeted population:

Sleep apnea patients at high cardiovascular risk newly treated by CPAP

Hypothesis:

Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

lead_sponsor: Fédération Française de Pneumologie

location_facility: Respiratory physician in private practice


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

acronym: APSregistry

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

location_facility:
CHRU de Lille
CHRU de Nancy


title: Burden of Influenza at Emergency Department Level : BIED

acronym: BIED

summary:
Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system.

Increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients.

The study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the Emergency Rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service Hygiène, Epidémiologie et Prévention


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: Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

acronym: EMBOL-EI

summary:
EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection.

The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in infective endocarditis (IE) in the light of the improved current knowledge on these aPL.

The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.

ReferenceCitation: Selton-Suty C, Maigrat CH, Devignes J, Goehringer F, Erpelding ML, Alla F, Thivilier C, Huttin O, Venner C, Juilliere Y, Doco-Lecompte T, Lecompte T; Endocarditis Team of the University Hospital of Nancy, France. Possible relationship between antiphospholipid antibodies and embolic events in infective endocarditis. Heart. 2018 Mar;104(6):509-516. doi: 10.1136/heartjnl-2017-312359. Epub 2018 Jan 5.

location_facility:
CHU de Besancon
CHU de Nancy