title: ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome

acronym: ARDStrain

summary: Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.

ReferenceCitation: Lemarié J, Maigrat CH, Kimmoun A, Dumont N, Bollaert PE, Selton-Suty C, Gibot S, Huttin O. Feasibility, reproducibility and diagnostic usefulness of right ventricular strain by 2-dimensional speckle-tracking echocardiography in ARDS patients: the ARD strain study. Ann Intensive Care. 2020 Feb 13;10(1):24. doi: 10.1186/s13613-020-0636-2.

family: Lemarié

full_name: Jérémie Lemarié

given: Jérémie

family: Maigrat

full_name: Charles-Henri Maigrat

given: Charles-Henri

family: Kimmoun

full_name: Antoine Kimmoun

given: Antoine

family: Dumont

full_name: Nathalie Dumont

given: Nathalie

full_name: Pierre-Edouard Bollaert

given: Pierre-Edouard

family: Selton-Suty

full_name: Christine Selton-Suty

given: Christine

full_name: Sébastien Gibot

given: Sébastien

family: Huttin

full_name: Olivier Huttin

given: Olivier

journal_name: Annals of Intensive Care


title: Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin

acronym: Hemoped

summary: Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: 18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study

acronym: MAF

summary:
The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological criteria.

Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau + phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are unclassifiable.

18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET), selectively binds to amyloid plaques, with high detection sensitivity (98%).

Detection of amyloid plaques by PET imaging separate patients according to the criteria of Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.

If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent initiating unnecessary treatment, expensive for the community.

This is the first imaging study of amyloid plaques targeting population whose diagnosis of AD is uncertain according to the CSF biology.

The aim of this study is to describe the results of amyloid PET in case of intermediate CSF biology and to separate patients as AD or not according to the criteria of Dubois


title: Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"

acronym: EFFET

summary: The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

ipd_sharing_description: To be completed after discussions with the different research teams participating in the study

intervention_type: Other

status_simplified: Unknown


title: Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli

acronym: COLIFOX

summary:
Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. These give rise to major problems in standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is very frequently observed. The current therapeutic strategy involves the use of a carbapenem, which represents the last effective solution on an individual level. However, the growing use thereof is contributing, collectively, to the development of resistance due to the production of carbapenemases, which will become a major public health problem, with a potential therapeutic dead-end. This observation is particularly worrying due to the very small number of antibiotic agents currently in development.

Infectious disease specialists and microbiologists are thus examining alternative agents to carbapenems in the management of infections caused by ESBL-producing E. coli. One of the avenues which could be developed is the use of known agents, already on the market, which are active in vitro on ESBL-producing E. coli, but which are not currently recommended for this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an antibiotic belonging to the cephamycin group, could thus represent an alternative of particular interest in the treatment of infections caused by ESBL-producing E. coli, and help limit the use of carbapenems.

The implementation of a prospective, randomized, non-inferiority study on ertapenem and cefoxitin is of the most interest from a methodological perspective. It will enable recommendations to be drawn up, with a high level of evidence, very long-awaited in the field.

Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.

Secondary objectives:

To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin.
To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant bacteria in the gut flora.

status: Terminated

intervention_type: Drug


title: Contribution of Ultrasound for Peripheral Intravenous Catheter Placement by Intensive Care Nurses

acronym: IDECHO

summary: Peripheral intravenous access is a major intervention in patients admitted to an intensive care unit. Systematically performed by nurses, it is also an essential intervention when the central venous access has to be removed. However, in the intensive care unit, patient centered-characteristics such as previous history of intravenous drug abuse, obesity, history of multiple vascular punctures or fluid overload most often affect the success rate of this procedure. For these patients, failure consequences are numerous: 1) delayed discharge from the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of catheter-related bloodstream infections. The use of ultrasound has gained increasing popularity particularly for obtaining central venous access. We hypothesize that, among trained nurses, ultrasound-guided peripheral venous access could represent an attractive alternative compared to the traditional anatomical method in order to increase the success rate.

primary_purpose: Supportive Care

ReferenceType: derived

ReferenceCitation: Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.

family: Bridey

full_name: Céline Bridey

given: Céline

sequence: first

family: Thilly

full_name: Nathalie Thilly

sequence: additional

family: Lefevre

full_name: Thomas Lefevre

given: Thomas

family: Maire-Richard

full_name: Adeline Maire-Richard

given: Adeline

family: Morel

full_name: Maxime Morel

given: Maxime

family: Levy

full_name: Bruno Levy

given: Bruno

family: Girerd

full_name: Nicolas Girerd

given: Nicolas

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: CHU Nancy - Service de Réanimation Médicale Brabois


type: Other Identifier

title: TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.

acronym: TeleRea'nCo

summary:
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.

The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.

study_start_date_type: Anticipated

status: Recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: University Hospital, Strasbourg, France

status_simplified: Ongoing


title: Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients

acronym: CarDiab

summary: Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.

time_perspective: Other

location_facility: Service de Physiologie et d'Explorations Fonctionnelles


title: Prospective Randomized Versus Placebo Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

acronym: PlasmaFaisa

summary:
No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients.

OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

status: Active, not recruiting


title: Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study

acronym: ESMOSEPSIS

summary: Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.

ReferenceCitation: Levy B, Fritz C, Piona C, Duarte K, Morelli A, Guerci P, Kimmoun A, Girerd N. Hemodynamic and anti-inflammatory effects of early esmolol use in hyperkinetic septic shock: a pilot study. Crit Care. 2021 Jan 7;25(1):21. doi: 10.1186/s13054-020-03445-w.

family: Fritz

full_name: Caroline Fritz

given: Caroline

family: Piona

full_name: Caroline Piona

family: Duarte

full_name: Kevin Duarte

given: Kevin

family: Morelli

full_name: Andrea Morelli

given: Andrea

family: Guerci

full_name: Philippe Guerci

given: Philippe

journal_name: Critical Care

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repositories:
HAL
PubMed Central
iris.uniroma1.it

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management

summary: Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.

time_perspective: Retrospective

location_facility: Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg


title: Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer

acronym: CIRCUBRONCH

summary:
TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)

BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.

PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).

SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.

STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.

Duration of the inclusions: 54 months.

Duration of the study: 66 months.

PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.

SAMPLE SIZE : 200 patients

STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.


title: Home-based Assessment of Plasma Volume, Serum Potassium and Renal Function Variations in Patients With Heart Failure and Low Left Ventricular Ejection Fraction: Pilot Study BIOMIC. Biomarkers and Therapeutic Modelisation in Heart Failure

acronym: BIOMIC

summary:
The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial encouraging results. Decongestion is one of the main objectives in Congestive HF, but an appropriate titration of diuretics is warranted, since long-term use of diuretics was consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic effects, as assessed by an estimated plasma volume depletion, in addition to potassium-sparing properties, independently from renal function variations. These three parameters were independently associated with patient outcomes and may therefore be potential monitoring/and therapeutic targets in patients with congestive HF.

Main objective :

To assess the variations of estimated plasma volume, serum potassium and estimated glomerular filtration rate after an hospitalization for decompensated HF, by using a home-based finger capillary punction for 5 consecutive days per week during the two months postdischarge, using an approved dedicated device (ABOTT iSTAT).

Secondary objectives :

to assess the correlations between plasma volume, serum potassium and estimated glomerular filtration rate variations (as measured by Istat, and by a weekly venous punction) and body weight, home blood pressure measurement, dyspnea self assessment variations.
bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis

ReferenceCitation: Rossignol P, Fay R, Girerd N, Zannad F. Daily home monitoring of potassium, creatinine, and estimated plasma volume in heart failure post-discharge. ESC Heart Fail. 2020 Jun;7(3):1257-1263. doi: 10.1002/ehf2.12642. Epub 2020 Apr 10.

apc_source: openAPC

name: Centre d'Investigations Cliniques–1433 Université de Lorraine, Inserm, Inserm U1116, CHU Nancy, F‐CRIN INI‐CRCT  Nancy France

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Fay

full_name: Renaud Fay

given: Renaud

family: Zannad

full_name: Faiez Zannad

given: Faiez

journal_name: ESC Heart Failure

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories:
HAL
PubMed Central

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Daily home monitoring of potassium, creatinine, and estimated plasma volume in heart failure post‐discharge


title: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort.

summary: The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.


title: Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

summary:
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization.

Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.

location_facility: Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)


title: Nutrition Environnement et Santé Cardio Vasculaire NESCAV

acronym: NESCAV

summary:
Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy lifestyles. To prevent occurred of the cardiovascular affections is, more than ever, a major goal of Public health. The transborder "Great Area", localised zone in the middle of Europe between the very high cardiovascular risks of the North and the weaker risks of the South, constitutes a zone privileged for the action against the cardiovascular diseases. However, there to date does not exist any joint action in this geographical area. The Public Research centre of the Health of the Grand-Duchy of Luxembourg, the School of Public health of the University of Liege, the Clinical Center of Investigation of the University hospital of Nancy and the University hospital of the Saar wish to be linked and mutualiser their means available and their complementary competences in order to evaluate and to act on the cardiovascular health of the citizens of the "Great Area". Over one 3 years period the Nutrition project, Environment and Cardiovascular Health (NESCAV) aims at creating on the level of the Great Area a transborder alliance of prevention and promotion of cardiovascular health. This great multicentric transverse investigation and poly-set of themes will make it possible to collect relevant data on cardiovascular health of the population of the Great area.

Objective of this biomedical research project: It is about multicentric, transverse a Européenne epidemiological study aiming, through biological questionnaires and analyses, to collect information on the cardiovascular risk factors within the Great Area.


title: COhort for Bardet-Bield Syndrome and Alström Syndrome for Translational Research Etude Interventionnelle Monocentrique

acronym: COBBALT

summary:
ALMS and BBS syndromes are rare diseases with overlapping features of multiple sensory and metabolic impairments, including diabetes mellitus. There are to date no specific treatments available and limited information on the natural history of the diseases. the investigators aim to establish a French cohort for these diseases to improve patient care and assess the effect of actual therapies on quality of life.

The purpose of this study is to establish a cohort of Bardet-Bield syndrome (BBS) and ALström syndrome (ALMS) patients in order to formalize and address questions concerning the in-depth natural clinical and biological history of the disease on the long term for a given patient, establish the impact on the quality of life of various clinical manifestations

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Genetic


title: Multiparametric Study of Cardiac Remodeling After Myocardial Infarction Revascularized in Acute Phase : Relation With the Serum Concentrations in Aldosterone

acronym: REMI

summary: This study aims to determine whether aldosterone blood levels are predictive of cardiac remodeling at 6 months following myocardial infarction with ST elevation (STEMI), independently of conventional predictive factors (size of myocardial infarction, age, hypertension, etc.) in revascularized patients during the acute phase of MI.

ReferenceCitation: Huttin O, Mandry D, Eschalier R, Zhang L, Micard E, Odille F, Beaumont M, Fay R, Felblinger J, Camenzind E, Zannad F, Girerd N, Marie PY. Cardiac remodeling following reperfused acute myocardial infarction is linked to the concomitant evolution of vascular function as assessed by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 4;19(1):2. doi: 10.1186/s12968-016-0314-6.

family: Mandry

full_name: Damien Mandry

given: Damien

family: Eschalier

full_name: Romain Eschalier

given: Romain

family: Zhang

full_name: Lin Zhang

given: Lin

family: Micard

full_name: Emilien Micard

given: Emilien

family: Odille

full_name: Freddy Odille

given: Freddy

family: Beaumont

full_name: Marine Beaumont

given: Marine

family: Felblinger

full_name: Jacques Felblinger

given: Jacques

family: Camenzind

full_name: Edoardo Camenzind

given: Edoardo

full_name: Faïez Zannad

given: Faïez

family: Marie

full_name: Pierre Y. Marie

given: Pierre Y.

journal_name: Journal of Cardiovascular Magnetic Resonance

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

ReferenceCitation: Huttin O, Marie PY, Benichou M, Bozec E, Lemoine S, Mandry D, Juillière Y, Sadoul N, Micard E, Duarte K, Beaumont M, Rossignol P, Girerd N, Selton-Suty C. Temporal deformation pattern in acute and late phases of ST-elevation myocardial infarction: incremental value of longitudinal post-systolic strain to assess myocardial viability. Clin Res Cardiol. 2016 Oct;105(10):815-26. doi: 10.1007/s00392-016-0989-6. Epub 2016 Apr 23.

ReferenceCitation: Huttin O, Petit MA, Bozec E, Eschalier R, Juillière Y, Moulin F, Lemoine S, Selton-Suty C, Sadoul N, Mandry D, Beaumont M, Felblinger J, Girerd N, Marie PY. Assessment of Left Ventricular Ejection Fraction Calculation on Long-axis Views From Cardiac Magnetic Resonance Imaging in Patients With Acute Myocardial Infarction. Medicine (Baltimore). 2015 Oct;94(43):e1856. doi: 10.1097/MD.0000000000001856.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Lemarié J, Huttin O, Girerd N, Mandry D, Juillière Y, Moulin F, Lemoine S, Beaumont M, Marie PY, Selton-Suty C. Usefulness of Speckle-Tracking Imaging for Right Ventricular Assessment after Acute Myocardial Infarction: A Magnetic Resonance Imaging/Echocardiographic Comparison within the Relation between Aldosterone and Cardiac Remodeling after Myocardial Infarction Study. J Am Soc Echocardiogr. 2015 Jul;28(7):818-27.e4. doi: 10.1016/j.echo.2015.02.019. Epub 2015 Mar 31.

journal_name: Journal of the American Society of Echocardiography

ReferenceCitation: Huttin O, Lemarié J, Di Meglio M, Girerd N, Mandry D, Moulin F, Lemoine S, Juillière Y, Felblinger J, Marie PY, Selton-Suty C. Assessment of right ventricular functional recovery after acute myocardial infarction by 2D speckle-tracking echocardiography. Int J Cardiovasc Imaging. 2015 Mar;31(3):537-45. doi: 10.1007/s10554-014-0585-7. Epub 2015 Jan 6.

journal_name: The International Journal of Cardiovascular Imaging


title: Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology

summary: The objective of this pilot study is to estimate a procedure where the biological samples routinely obtained at the site of suspected infection could be guided by the early realization of a TEP with FDG coupled to scanner X, in patients hospitalized in ICU for severe sepsis of unspecified etiology.

design_allocation: Non-Randomized


title: Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

ReferenceType: background

ReferenceCitation: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myélome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18.


title: Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

acronym: Familles-COVID

summary:
The hospitalization of a patient in intensive care is a traumatic experience for his family members.

With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit.

At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time.

The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

ReferenceCitation: Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, Cunat S, Astrié M, Aquin C, Buis G, Gehant E, Granier A, Kercha H, Le Guillou C, Martin G, Roulot K, Meziani F, Putois O, Helms J. Psychological effects of remote-only communication among reference persons of ICU patients during COVID-19 pandemic. J Intensive Care. 2021 Jan 9;9(1):5. doi: 10.1186/s40560-020-00520-w.

family: Cattelan

full_name: Jessy Cattelan

given: Jessy

family: Castellano

full_name: Sara Castellano

given: Sara

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Audusseau

full_name: Jean Audusseau

given: Jean

family: Claude

full_name: Baptiste Claude

given: Baptiste

family: Feuillassier

full_name: Léa Feuillassier

given: Léa

family: Cunat

full_name: Sibylle Cunat

given: Sibylle

family: Astrié

full_name: Marc Astrié

given: Marc

family: Aquin

full_name: Camille Aquin

given: Camille

family: Buis

full_name: Guillaume Buis

given: Guillaume

family: Gehant

full_name: Edgar Gehant

given: Edgar

family: Granier

full_name: Amandine Granier

given: Amandine

family: Kercha

full_name: Hassiba Kercha

given: Hassiba

family: Le Guillou

full_name: Camille Le Guillou

family: Martin

full_name: Guillaume Martin

family: Roulot

full_name: Kevin Roulot

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Putois

full_name: Olivier Putois

given: Olivier

family: Helms

full_name: Julie Helms

given: Julie

currency_apc_doaj: EUR

journal_name: Journal of Intensive Care

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


title: Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit

summary:
Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.

The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).

Translated with www.DeepL.com/Translator (free version)

ReferenceCitation: Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.

family: Beloncle

full_name: François Beloncle

given: François

family: Studer

full_name: Antoine Studer

given: Antoine

family: Seegers

full_name: Valérie Seegers

given: Valérie

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Desprez

full_name: Christophe Desprez

given: Christophe

family: Fage

full_name: Nicolas Fage

given: Nicolas

family: Merdji

full_name: Hamid Merdji

family: Pavlovsky

full_name: Bertrand Pavlovsky

given: Bertrand

family: Mortaza

full_name: Satar Mortaza

given: Satar

family: Demiselle

full_name: Julien Demiselle

given: Julien

family: Brochard

full_name: Laurent Brochard

given: Laurent

family: Mercat

full_name: Alain Mercat

given: Alain


title: Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial

acronym: MIRE

summary:
Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Yet, in these patients with highly varied and often staggered nutritional intakes, insulin injection can result in an increased risk of postprandial hypoglycaemia, all the more so as CF patients exhibit decreased glucagon secretion.

Recent progress in the development of new insulins mimicking the physiological secretion more closely has led to ultra-fast insulins (fast aspart), allowing for postprandial hyperglycaemia to be better controlled. In Type 1 diabetics treated with basal-bolus, faster-acting aspart insulin injected after a meal enabled metabolic control comparable to injection of aspart insulin prior to the meal. Fast apart insulin is of particular interest with regard to CFRD, wherein postprandial hyperglycaemia occurs early. In CFRD, these insulins are likewise advantageous in that they can be injected after the meal, thus permitting more flexibility in patients with highly varied diets. Moreover, the insulin dose can be adapted depending on dietary intake, thus preventing hypoglycaemia secondary to highly-varied carbohydrate intakes. Due to its flexibility, this insulin therapy is likely to be better accepted by patients with cystic fibrosis.


title: Age-adjusted D-dimer Cut-off Levels to Rule Out Pulmonary Embolism: a Prospective Outcome Study.

acronym: ADJUST

summary:
Suspected pulmonary embolism (PE) is a frequent clinical problem and remains a diagnostic challenge. The diagnostic approach of PE relies on sequential diagnostic tests, such as plasma D-dimer measurement, multi-slice computed tomography (MSCT) and pulmonary angiography. In addition, the diagnostic workup is usually stratified according to the clinical probability of pulmonary embolism. Clinical probability has a fair predictive accuracy either evaluated implicitly or by clinical prediction rules1 and is useful for identifying patients with a low prevalence of pulmonary embolism who can be usually fully investigated by non invasive tests.The D-dimer test has been extensively evaluated in the exclusion of pulmonary embolism, particularly in outpatients. ELISA D-dimer and second-generation latex agglutination (immuno-turbidimetric tests) have a remarkably high sensitivity and have been proved safe first-line tests in association with clinical probability to rule out pulmonary embolism in outcome studies. The clinical usefulness of D-dimer is defined by the proportion of patients in whom pulmonary embolism may be ruled out by a normal result and it is determined by the specificity. However, ELISA and second-generation latex agglutination (immuno-turbidimetric tests) tests have a quite limited overall specificity of around 35% to 40%. Therefore, many investigators tried to increase the D-dimer thresholds in particular in elderly patients to increase the rate of patients in whom the diagnosis could be excluded by this easy and inexpensive test. Several studies have shown that D-dimer levels increase with age and which turns in a decreased specificity of the D-dimer test at the usual threshold in the elderly, and thus to a less useful test to exclude PE in older patients. Indeed, ELISA D-dimer is able to rule out PE in 60% of patients aged less than 40 years, but in only 5% of patients above the age of 80.8 In this study, raising the cut-off value to various points between 600 ng/ml and 1000 ng/ml increased specificity, but this came at the cost of safety with more false negative test results. In this analysis, however, no stratification was made for clinical probability and the sample was small.

Recently, the investigators retrospectively assessed the value of a progressive cut-off adjusted to age in a wide sample of 1712 patients. This "new" cut-off was defined for D-Dimer test positivity in each patient by multiplying patient's age by 10. All patients with a D-Dimer level below 500mg/ml, and all patients above 50 years whose D-Dimer levels were inferior to their age multiplied by 10 were considered as having a negative D-Dimer test. The exact derivation and validation of this "new" D-dimer cut-off is described hereafter. Using the conventional cutoff, the VIDAS® D-Dimer test was negative (below 500 mg/ml) in 512/1712 patients (29.9%) and none had PE during initial workup or the three-month follow-up period.

Using the cutoff adjusted to age (cutoff for D-Dimer test positivity equals age multiplied by ten, in mg/ml), the figure was as follows. D-Dimer levels were below the adjusted cutoff in 615/1712 patients (35.9%, number needed to test 2.8). This represented a statistically significant 20.1% increase in the number of patients in whom the D-Dimer test was considered as negative, p=0.0002. Of these 615 patients, 5 had PE during initial workup (0.8%, 95 percent confidence interval 0.4 to 1.9%).

These data suggest that adopting this progressive cut-off in patients above 50 years, could increase of about 20% the number of patients in whom PE could be excluded without further testing, with an acceptable safety profile as the three-month thromboembolic rate remained very low.

Therefore, the investigators plan a prospective outcome study in which this progressive or "new" cut-off (age X 10 ng/ml) in patients above 50 years will be used. In this multicentre study, clinical probability will be assessed by the simplified revised Geneva revised score (Table 1) and an ELISA D-dimer test will be performed [Vidas D-Dimer Exclusion® test (Biomérieux, Marcy l'Etoile, Paris, France)]. Patients with a non high clinical probability with the simplified revised Geneva score and a normal "new" D-dimer cut-off with the Vidas D-dimer Exclusion®, (Biomerieux, Marcy l'Etoile, France) will be considered as not having PE, and will be followed for three-months to assess possible VTE recurrences. The main outcome will be the rate of thromboembolic events during a formal 3-month follow-up in patients not anticoagulated on the basis of this strategy. Patients with positive D-dimers will be investigated with MSCT as currently admitted.

ReferenceCitation: Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135. Erratum in: JAMA. 2014 Apr 23-30;311(16):1694.

name: Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland

family: Righini

full_name: Marc Righini

given: Marc

name: Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands

family: Van Es

full_name: Josien Van Es

given: Josien

name: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

family: Den Exter

full_name: Paul L. Den Exter

given: Paul L.

name: Emergency Department, Centre Hospitalier Universitaire d’Angers, L'Université Nantes Angers Le Mans, Angers, France

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

name: Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

family: Verschuren

full_name: Franck Verschuren

given: Franck

name: Liège University Hospital, Liège, Belgium

family: Ghuysen

full_name: Alexandre Ghuysen

given: Alexandre

name: Emergency Department, Geneva University Hospital, Geneva, Switzerland

family: Rutschmann

full_name: Olivier T. Rutschmann

given: Olivier T.

name: Hôpital Européen Georges-Pompidou, Paris, France

family: Sanchez

full_name: Olivier Sanchez

name: Emergency Department, Brest University Hospital, Brest, France

family: Jaffrelot

full_name: Morgan Jaffrelot

given: Morgan

family: Trinh-Duc

full_name: Albert Trinh-Duc

given: Albert

name: Centre Hospitalier d’Argenteuil, Argenteuil, France

family: Le Gall

full_name: Catherine Le Gall

given: Catherine

name: Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

family: Moustafa

full_name: Farès Moustafa

given: Farès

name: Centre Hospitalier de Morlaix, Morlaix, France

family: Principe

full_name: Alessandra Principe

given: Alessandra

name: Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands

family: Van Houten

full_name: Anja A. Van Houten

given: Anja A.

name: Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands

family: Ten Wolde

full_name: Marije Ten Wolde

given: Marije

family: Douma

full_name: Renée A. Douma

given: Renée A.

name: Rijnstate Hospital, Arnhem, the Netherlands

family: Hazelaar

full_name: Germa Hazelaar

given: Germa

name: Maastricht University Medical Center, Maastricht, the Netherlands

family: Erkens

full_name: Petra M. G. Erkens

given: Petra M. G.

name: Van Weel-Bethesda Hospital, Dirksland, the Netherlands

family: Van Kralingen

full_name: Klaas W. Van Kralingen

given: Klaas W.

family: Grootenboers

full_name: Marco J. J. H. Grootenboers

given: Marco J. J. H.

name: Department of Hematology, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Durian

full_name: Marc F. Durian

given: Marc F.

family: Cheung

full_name: Y. Whitney Cheung

given: Y. Whitney

family: Meyer

full_name: Guy Meyer

given: Guy

name: Department of Vascular Medicine, University Medical Center Groningen, Groningen, the Netherlands

name: Ottawa Health Research Institute, Ottawa, Canada23Centre d’Investigations Cliniques, Université de Brest, Brest, France

repository_institution: University of Geneva - Archive ouverte UNIGE

title: Age-Adjusted D-Dimer Cutoff Levels to Rule Out Pulmonary Embolism

location_facility:
Angers University Hospital
Amsterdam University hospital
Geneva University Hospital
Grégoire Le Gal


title: Targeted Temperature Management With Therapeutic Hypothermia Using Esophageal COOLing After Cardiac Arrest: THE COOL STUDY

acronym: THE-COOL

summary:
To control patient's body temperature remains of major importance especially after cardiac arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most unconscious CA patients. However, available modalities for inducing TH have a number of technical (side effects), logistical (difficulties of placement), and financial (cost) barriers. The Esophageal Cooling Device (ECD) is a multi-chambered silicone heat exchanger placed in the esophagus providing highly efficient heat transfer to a patient. The ECD is a device that potentially improves the effectiveness of TH in minimizing the risks of existing methods (such as invasive cooling). Initial mathematical and animal studies have shown strong support for the efficacy and safety of the ECD. Placement of a naso-gastric probe is a systematic standard of care for all unconscious patients suffering from CA. The present study will replace the usual naso-gastric probe by the ECD that can be used for gastric suctioning as usually done in such patients.

The aim of this prospective, interventional study is to assess the feasibility and safety of the ECD in resuscitated CA-patients and treated with 32-34°C targeted TH. The primary outcome is the feasibility of inducing, maintaining, and rewarming patients from TH using the ECD (cooling rate, rewarming rate, and the percent of time within goal temperature during the goal-temperature maintenance period). Evaluation of adverse events (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, esophageal reflux and injury, and esophagitis) will be closely monitored during the whole period of the targeted temperature management (secondary endpoint).

lead_sponsor: IST cardiology

lead_sponsor_type: industriel


title: Evaluation of a Therapeutic Education Program for Pregnant Women With a First Child Diagnosed With an Autism Spectrum Disorder (ASD)

acronym: AUTMER

summary:
Autism Spectrum Disorder (ASD) is a heterogeneous set of severe developmental abnormalities of the nervous system characterized by deficits affecting social interactions and verbal and non-verbal communication, as well as the presence of restricted interests, repetitive behaviors, and atypical sensory manifestations . ASD affects approximately 1% of the general population (Elsabbagh et al., 2012). Studies of siblings of individuals with ASD show that ASD is present in 7-20% of the offspring in families where a child has had a diagnosis of ASD and this prevalence increases if there are two diagnosed children.

Several studies show the benefits of interventions targeting parents' interaction strategies in the early phases of development of infants at high risk for ASDs, in reducing the risk itself or its severity. Very early intervention, due to the presence of significant brain plasticity at these stages, may be particularly effective in changing these emerging trajectories, from a "preventive intervention" perspective that would aim to mitigate developmental risk and alter prodromal symptom trajectories, rather than eliminate a condition.

Our hypothesis is that the implementation of a specific therapeutic education program during a new pregnancy in the mother of a child with a diagnosis of ASD (MER Program) could improve the mother's well-being, increase parenting communication skills, and thereby improve interaction with the newborn at high risk for ASD. If the infant is affected, it may also reduce the symptoms of the disorder. Indirectly, it could also improve the well-being of the other parent involved in the interaction.

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening: a Multicenter Pragmatic Randomized Controlled Trial

acronym: PSAMG

summary:
Although the number of recommendations against systematic screening of prostate cancer, 70% of patients still request testing because they overestimate the benefits and are unaware of the limitations.

The investigators aim is to assess the impact of a short printed decision aid presenting benefits and limits of screening, on patients' intent to undergo prostate cancer screening.

primary_purpose: Screening

ReferenceCitation: Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17;157(2):120-34. doi: 10.7326/0003-4819-157-2-201207170-00459.

ReferenceCitation: Stacey D, Légaré F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 12;4:CD001431.

lead_sponsor: University Paris 7 - Denis Diderot


title: National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)

acronym: COVLA

summary:
The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia.

The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Institut Paoli-Calmettes - Hématologie 2

location_facility: CHU Reims - Hôpital Robert Debré - Hématologie Clinique

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique


title: Efficacy of an Online Cognitive Behavioral Therapy (CBT) Programme Aiming at Reducing the Stress of Health Workers Involved in the Care of Patients During the Covid-19 Epidemic: a Randomized-controlled Trial

acronym: REST

summary: Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up

ReferenceCitation: Weiner L, Berna F, Nourry N, Severac F, Vidailhet P, Mengin AC. Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial. Trials. 2020 Oct 21;21(1):870. doi: 10.1186/s13063-020-04772-7.

family: Weiner

full_name: Luisa Weiner

given: Luisa

family: Berna

full_name: Fabrice Berna

given: Fabrice

family: Nourry

full_name: Nathalie Nourry

given: Nathalie

family: Severac

full_name: François Severac

given: François

family: Vidailhet

full_name: Pierre Vidailhet

given: Pierre

family: Mengin

full_name: Amaury C. Mengin

given: Amaury C.

journal_name: Trials

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

intervention_type: Behavioral


title: STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19

summary: Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.

location_facility: Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg


title: Impact of Telephone Coaching on Physical Performance in a Physical Exercise Maintenance Program for Fallers Elderly Patients Living at Home

acronym: STEP-PA

summary:
At home, maintenance, physical performance declines more or less rapidly from 6 weeks depending advancing age and duration of the training period . It is feared that the advice or prescription of regular physical maintenance at the exit of the service, has only adherence to the 50% like the medication prescribed. A US study of 2000 on the observance of healthy living recommendations, despite the many messages promoting physical activity, shows that only 24% of Americans aged 65 to 74 were taking physical activity regular. There are no French-date data.

If physical maintenance is routinely recommended for the elderly living at home, so the way to encourage these people to practice more often possible these recommendations remains therefore a problem of public health.

The recent OSSEBO study (intervention for the prevention of injurious falls in elderly women: background and design) recalled the interest to propose a program of physical exercise to reduce trauma and falls in the elderly. It also shows the possibility to implement an effective program on a long-term and large scale in France. The study allowed patients to participate in collective sessions of physical exercises, within the framework of an association. Patients were invited to continue their home exercises they had learned.

Also, the investigators hypothesize that the monthly telephone coaching , directed by the physical therapist following a physical fitness exercise program which they have been trained during their hospitalization in SSR , would allow older patients to maintain fallers their physical performance at home for at least 6 months after leaving

primary_purpose: Other

lead_sponsor: Nantes University Hospital

location_facility:
Ch Cholet
Centre hospitalier départemental Vendée
CHU de Nantes


title: Multicentric Retrospective Study on the Use of Cinacalcet in an Off-label Phosphocalcic Context

acronym: CALCI-CINA

summary:
Currently, the indications used for MA (Marketing Authorization) Cinacalcet in France are hyperparathyroidism (hyperPTH) in adults, whether primary (for patients in whom parathyroidectomy is theoretically indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to a chronic kidney disease, and parathyroid carcinomas.

In pediatric patients, data on its use are restricted due to its recent marketing authorization (2017) and limited to dialysis patients suffering from secondary hyperPTH.

Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated off-label by cinacalcet in the presence of severe hyperPTH, without any other chronic treatment available to date.

The objective of this study is therefore to evaluate the use in France of cinacalcet in phosphocalcic pathologies without renal insufficiency, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Néphrologie pédiatrique - Clinique Médicale Pédiatrique

location_facility: Service de Néphrologie Pédiatrique -Hôpital Jeanne de Flandre

location_facility: Service d'endocrinologie et Diabétologie Pédiatrique-Hôpital Robert Debré

location_facility: Service de Diabétologie et endocrinologie pédiatriques - Centre Hospitalier Universitaire

location_facility: Service d'Endocrinologie, Maladies Osseuses, Gynécologie, Génétique

location_facility: Endocrinologie Diabète et Maladies Métaboliques - Hôpital Gabriel Montpied

location_facility: Service d'Endocrinologie Pédiatrique - Hôpital de la mère et de l'Enfant

location_facility: Pole Femme Mère Enfant - Pédiatrie spécialisée - Centre Hospitalier Universitaire

location_facility: Unité Endocrinologie, Nutrition, Diabétologie -Hôpital Bretonneau


title: Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

acronym: INTERSEP

summary:
Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (> 30%).

Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood.

Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock.

Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects.

Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo


title: Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients

summary:
Social isolation among elderly people is a frequent and major determinant for health.

The risk of premature death is 2 to 5 time higher for socially isolated people, similarly for morbidity, duration of healing and complications rate.

Denutrition is also frequent for elderly people with potentially serious consequences. Vitamin deficiency, especially in B9 and B12 vitamins, are often associated with denutrition among elderly people.

Folic acid (vitamin B9) is not influenced by inflammation and folic acid income are necessarily exogene. Vitamin B9 is provided by fresh fruits and vegetables, and giblets.

The investigators observed a high prevalence in folic acid deficiency for socially isolated elderly patients. The investigators made the hypothesis that a folic acid defiency is associated with social isolation for elderly people.

The primary purpose is the study of the association between folic acid deficiency (measured by dosing of plasma concentration of vitamin B9) and social isolation evaluated by Lubben Social Network Scale in 6 questions.

The secondary purposes are the study of the correlation between folic acid deficiency and social conditions, nutritional status, biological data, poly pharmacy, cognitive functions, dependency and length of stay at hospital.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

acronym: BKV-Pneumo

summary:
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.


title: Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

summary:
Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas.

pNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population


title: Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

summary:
The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.

The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.

The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.

ReferenceCitation: Charleux-Muller D, Hurel R, Fabacher T, Brigand C, Rohr S, Manfredelli S, Passot G, Ortega-Deballon P, Dubuisson V, Renard Y, Romain B. Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. 2021 Aug;25(4):1051-1059. doi: 10.1007/s10029-020-02366-5. Epub 2021 Jan 25.

family: Charleux-Muller

full_name: D. Charleux-Muller

given: D.

family: Hurel

full_name: R. Hurel

given: R.

family: Fabacher

full_name: T. Fabacher

given: T.

family: Brigand

full_name: C. Brigand

given: C.

family: Rohr

full_name: S. Rohr

given: S.

family: Manfredelli

full_name: S. Manfredelli

family: Passot

full_name: G. Passot

given: G.

family: Ortega-Deballon

full_name: P. Ortega-Deballon

given: P.

family: Dubuisson

full_name: V. Dubuisson

given: V.

family: Renard

full_name: Y. Renard

given: Y.

family: Romain

full_name: B. Romain

given: B.

journal_name: Hernia

location_facility: Service de chirurgie générale et digestive


title: Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy

acronym: Amox-Cloxa

summary:
2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identiﬁcation). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity.

The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.

location_facility: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg


title: Efficiency of the Imaging Strategy for the Management of Pneumonia in the Emergency Department

acronym: EFFI-PNEUMO

summary: For patients with suspected pneumonia presenting to the emergency room, the imaging strategy most often involves a frontal and lateral chest x-ray despite poor diagnostic input. Indeed, the radiography is not very sensitive and specific for the diagnosis of pneumopathy compared to the scanner. However, the scanner remains the gold standard, the major constraint of which concerns the irradiation to which the patient is exposed. The new scanners allow ultra-low-dose scans with better sensitivity than standard radiography with an equivalent dose of radiation. In addition, the ultra-low-dose scanner helps prevent diagnostic errors and unintended treatments. A low-dose CT scan for suspected pneumonia has been possible in the Strasbourg emergency department since March 2019. The investigators therefore hypothesize that a diagnostic strategy involving the performance of a low dose CT scan in the event of suspicion of pneumopathy in the emergency room makes it possible to improve the adequacy of the diagnosis made by the initial imaging examination and the diagnosis on discharge from hospitalization, to reduce respiratory or hemodynamic complications and to reduce the prescription of antibiotic therapy that is not suitable for the patient. course of the imaging result validated by a panel of emergency physicians and infectious disease specialists based on medical records in accordance with the recommendations.

location_facility: Service d'Accueil des Urgences - Hôpitaux Universitaires de Strasbourg


title: Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study

acronym: UTER-SEPTUM

summary:
Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.

A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.

Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).

The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.

location_facility: Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg


title: Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve

acronym: CAPNOBST

summary:
Obstructive respiratory diseases such as asthma or COPD are a common reason for emergency room visits. Currently, nasal gill capnography and oxygen saturation measurement (SpO2) are the only two non-invasive means of continuously monitoring a respiratory pathology. To date, Respiratory Functional Explorations (CFE) and more particularly spirometry, are considered as the reference examinations for the diagnosis or monitoring of asthma or COPD. However, physical and physical constraints make their use almost impossible in the context of the emergency with patients presenting to emergencies in respiratory distress, often require oxygen therapy or even non-invasive ventilation. Only pulmonary auscultation can make the diagnosis of acute decompensation of obstructive pathology. This technique is qualitative and imprecise, sometimes leading to a diagnostic uncertainty resulting in delay in taking charge and inappropriate therapy.

Studies have shown a change in the capnography curve in obstructive airway disorder and a strong correlation between some capnography parameters and spirometry parameters such as the Tiffeneau ratio (FEV1 / FVC), suggesting capnography as a simple and effective technique for the diagnosis of obstructive syndrome of patients in emergencies.


title: Analysis of Corrections of Adolescent and Young Adulte Scoliosis by Posterior Instrumentation

acronym: AIS

summary:
Thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis.

The objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.

location_facility: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg


title: Impact of Adult With Attention Deficit / Hyperactivity Disorder on Professional Activity, a Prospective Cohort Study

acronym: WORKTDA

summary:
Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired.

The investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels.

The main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview.

The secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.


title: Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.

summary:
After birth, the perineum has to be trained in order to recover its functions.

This study is designed to assess the quality of life evolution with the EMY connected device.

The secondary purposes are to evaluate patient compliance to the EMY probe, to observe the evolution of urine scores over the duration of the trial in order to consider a comparative study thereafter, and to evaluate the interest of using the EMY connected perineal probe in the context of stress urinary incontinence.


title: Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)

acronym: PREP

summary:
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.

Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.


title: Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas - Single-center Pilot Study of 32 Patients

acronym: SARCOMAS

summary: The aim of this pilot study is therefore to retrospectively measure the volume and percentage of necrosis on diagnostic MRI in T1 sequence and in parallel to study the expression of immunohistochemical markers of hypoxia (HIF-1α, CAIX , HIF-2α, pS6, phosphomTor, CD163 and CD68) on diagnostic biopsies of high-grade osteosarcomas from 2007 to 2018 in the Strasbourg center, focusing on the pediatric population. The investigators will systematically carry out a correlation analysis between these different parameters and with the clinical data of these same patients (response to chemotherapy, presence of metastases or not and overall and recurrence-free survival). This will eventually make it possible to highlight new prognostic markers at diagnosis.

location_facility: Service Pédiatrie Onco-hématologie - Pédiatrie III - Hôpitaux Universitaires de Strasbourg


title: Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

summary: To evaluate the regression characteristics of this Acoustic Neuroma population using volumetric data To study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.

location_facility: Service D'Orl Et de Chirurgie Cervico-Faciale


title: Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

acronym: HemostVAD

summary:
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.

The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.


title: Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies

acronym: OTP

summary:
Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life.

In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.

Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.

the aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques


title: Study of Febrile Syndromes After Tick Bite

acronym: FebriTick

summary: Febrile syndromes after tick bites can be caused by different microorganisms: bacteria (B. miyamotoi, A. phagocytophilum, R. helvetica…), parasites (Babesia spp) and viruses (TBE virus). The clinical picture is not specific but complications may appear depending on the microorganism identified (thrombosis with N. mikurensis, meningoencephalitis with B. miyamotoi and the TBE virus). Thus, in order to provide appropriate treatment and monitoring, the infection should be documented.

location_facility: Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg


title: Development of Growth Curves in Cockayne Syndrome Type 1 and Type 2

acronym: Curves-CS

summary:
Despite the natural progression of Cockayne's syndrome, affected patients also present with variable neurological and gastrointestinal damage (gastroesophageal reflux, recurrent vomiting, swallowing disorders, etc.) with varying repercussions on their growth. Acute intercurrent events such as seizures, constipation, infections can also interact with their metabolism, food intake and influence their growth. The nutritional deficit potentially involved in this growth retardation can be responsible for many manifestations such as anemia, bone fractures, fatigue, coagulation disorders responsible in total for the reduction in quality and life expectancy.

Faced with growth retardation in patients with Cockayne syndrome, medical management is difficult to establish. Is this delay part of the natural course of the pathology?

location_facility: Service de Pédiatrie1 - Hôpitaux Universitaires de Strasbourg


title: TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation

acronym: TRESTRICTT

summary: Urethral stenosis has a recurrent character. The clean intermittent self-catheterization can be proposed for repeat stenosis. This study seeks to explore the tolerance of clean intermittent self-catheterization in the evolution of urethral stenosis after urethrotomy.


title: Comparison of Cardiorespiratory Responses to Treadmill Running at Different Slopes in Well-trained Athletes

summary: The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.

primary_purpose: Health Services Research


title: Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit

acronym: EchoRéaPed

summary:
In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound.

However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department.

On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator.

We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.

intervention_type: Radiation


title: National Multicenter Retrospective Study: PEComas: Natural History and Prognostic

acronym: PEComas

summary:
Perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. They belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. Given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today.

This study is a national multicenter retrospective study to better understand the natural history of PEComas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas.

The primary purpose is the identification of prognostic markers impacting the relapse. Secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history


title: EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS

acronym: VACCHEPA

summary:
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.

Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.

The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.

Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.

The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.

The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.

A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.

Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.

location_facility: Service deChirurgie Générale Hépatique-Endocrinienne,et transplantation - Hôpitaux Universitaires de Strasbourg


title: Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial

acronym: ERIS

summary:
Primary purpose:

Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.

Primary outcomes:

Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.

Secondary purposes:

improvement of quality of life
study of MRI performance to predict pudendal nerve entrapment topography
show the feasibility and safety of robotic pudendal nerve decompression

intervention_type: Procedure


title: SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy

acronym: SERRATHOR

summary:
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.

Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.

The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.


title: Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study

acronym: HECODIAP

summary: Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

intervention_type: Biological


title: Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

summary:
The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).

However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.

There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.


title: Lung Nodule Characterization by Artificial Intelligence Techniques

acronym: CARANOD-IA

summary:
Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung nodules.

The primary purpose is to evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.

The secondary objectives are:

to evaluate the variation in the performances of the software based on various technical aspects of the CT, such as radiation dose, reconstruction algorithm, type of scanner,…
to compare the performances of this software to those of expert readers,
to analyze the potential impact of this software on patient's management.


title: Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light

acronym: DERMAPOL

summary:
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.

This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.

This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.


title: CT Evaluation of Intimal Flap Mobility as a Potential Predictor of Residual Type B Dissection Evolution

acronym: CT-MOBILITY

summary:
Type A aortic dissection is an emergency condition, defined by the appearance of an intimal flap within the ascending aorta. Urgent treatment is required, with surgical replacement of - at minima - the tubular portion of the ascending aorta.

After surgery, a majority of patients will still have a residual aortic dissection involving the aortic arch and/or the descending aorta. Long-term survival in these patients can be hindered by the apparition of an aneurysmal progression of the dissected aorta, with risk of rupture, thrombose and/or embolism. Consequently, this condition requires frequent follow-up imaging examinations, usually by Computed Tomography Angiography (CTA), to monitor the extension of the dissection and the diameters of the dissected aorta. Patient management is therefore based on passive follow-up of the disease, as no definitive clinical or imaging features can predict the potential evolution (or the absence of) towards an aneurysmal evolution.

Therefore, one can understand the important need for accurate predictors of aneurysmal dilatation of post-operative residual dissection.

CTA has the ability to visualize the intimal flap motion, by averaging at least 3 or 4 cardiac cycles over a non-gated arterial acquisition.

This intimal flap mobility varies greatly between patients, between the localization and the extension of the dissection, and between acute and chronic dissections. It is thought that chronic dissections with immobile flap might be less prone to aneurysmal evolution.

The investigators hypothesize that this mobility could be a prognostic marker for the evolution towards aortic dilatation: flap that would remain highly mobile after initial surgery could be an additional marker towards an aneurysmal evolution, while immobile flap could be on the contrary a marker of stability.

Intimal flap motion can already be qualitatively and quantitatively assessed in CTA when ECG-synchronization is used. However, this technique has a limited availability and significantly increases the total radiation dose, therefore limiting its use in routine practice. Being able to quantify this marker using routine non ECG-gated CTA could be a significant addition to the literature, as it is currently unknown if this is feasible/relevant.


title: Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized in Service de Soins de Suite et de Réadaptation Gériatrique (SSRG) at Hôpitaux Universitaires de Strasbourg (HUS)

acronym: ENCRAGE

summary:
The primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance.

This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the implementation of recommendations on technical assistance and home modifications following discharge after an hospitalization for fall.

The secondary outcome will measure the impact of the group program on the incidence of falls, the number of readmissions, fear of another fall and improvement in walking and balance skills.

location_facility: Service de Soins de Suite et de Réadaptation Gériatrique - Ergothérapie -Hôpitaux Universitaires de Strasbourg


title: Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities

acronym: DEFI

summary:
The aim of this study is to evaluate performances of a NIPT test based onto the study of the maternal blood to search known genetic mutations already detected in the family and potentially inherited by the fetus. This test will avoid an invasive prenatal diagnosis in those families with a known genetic risk.

The performance of this test will be evaluated in terms of sensitivity and specificity with an adapted statistic model.

Secondary objectives of the protocol are

To adapt NIPT to small DNA quantity (5-50 ng)
To adapt bioinformatics pipeline to low rate of mosaicism
To develop a tool to quantify the fetal fraction
To evaluate the robustness of the method

This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis.

intervention_type: Diagnostic Test


title: What is the Knowledge and Use of Emergency Contraception for Women Who Are Seeking Abortion in University Hospitals of Strasbourg

summary:
The main objective is to assess the knowledge of women seeking abortion about emergency contraception.

The secondary objectives are to evaluate the use of emergency contraception among women seeking abortion and to identify barriers to the efficacy and use of emergency contraception in these women.


title: Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation

acronym: PREVIP

summary: Nosocomial pneumonia is the third causes of nosocomial infection. In intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (IMV). One of the main mechanisms behind VAP (Ventilator-Associated Pneumonia) is the passage of germs colonizing the oropharynx to the subglottic airways. The presence of a nasogastric tube, immobilization, and strict dorsal decubitus increase the risk of colonization of the tracheobronchial tree and pneumonia in these patients. To reduce the incidence of VAP, several strategies have been developed in intensive care to try to control these different risk factors. These sets of measures, also called "bundle" systematically include the control of the elevation of the patient's head more than 30 °. Nevertheless, the strict and permanent control of the elevation of the patient's head is difficult to obtain. One of the reasons that may explain the difficulty of ensuring a correct elevation is the absence of visual cues that are easy to obtain on the beds of patients. An easily identifiable visual cue at the head of the bed would probably provide a satisfactory elevation (greater than 30 °) in patients intubated in intensive care. Our hypothesis is that the addition to the head of the patient's bed of a visible mark that is easily visible and easily interpretable by all the nurses will improve the elevation of the head of the patients in intensive care.


title: Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.

acronym: PENDICOQ

summary:
Hospitalization, for cancer patients, exposes to a risk of undernutrition which has the effect of significantly increasing infections, pressure ulcers, muscle wasting, loss of autonomy, impaired function and delayed healing.

All of these factors contribute to increase the length of stay in hospital, thus lengthening the spiral of undernutrition, which has serious consequences for the patient welbeing, health establishments and public health.

Undernutrition has been the subject of many studies over the last twenty years, that outline that an adequate nutritional management exerts a direct effect on the reduction of comorbidities and duration of hospitalization.

However, there are periods, in the preoperative course of care, where nutritional and phisical care are not realized in the current clinical practice whereas they could be done, for example, between the diagnosis and the consultation of anesthesia, between the anesthesia consultation and the surgical procedure and the end of hospitalization of the patient.

Current management is usually limited to the period of hospitalization which tends to be reduced. This situation is reinforced by the absence of relays at home, dietary consultations being not reimbursed by French health insurance.

Moreover, a preliminary survey, conducted in 2012 during the pre-operative outpatient anesthesia consultation, shows that 26% of patients are already clinically malnourished, with 16.5 % of them who have lost more than 10% of their weight.

location_facility: Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg


title: Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness

acronym: IRM-DU

summary:
IRM-DU is a prospective observational single center study conducted in an emergency department to evaluate the impact of a MRI scanner exclusively dedicated to emergency in the clinical management of patients presenting with dizziness or diplopia.

The study will compare 2 strategies : after and before availability of a MRI scanner dedicated to emergency.

The primary endpoint is the proportion of patients with a diagnosis of stroke confirmed by imaging (MRI or Computed tomography (CT)) in the group "before implementation of the emergency MRI scanner" and the group "after implementation of the emergency MRI scanner".

The hypothesis is that the availability of a MRI scanner dedicated to emergency will improve the diagnosis of stroke in patients presenting with dizziness or diplopia, and will reduce Emergency Department stay, hospital stay and hospitalisation costs.