title: Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation by Combining the Analysis of the Unipolar Atrial Electrogram Modification With the Contact Force Sensing Technology: The Uniforce Study

acronym: Uniforce

summary: Prospective observational multicentric study evaluating the efficacy of considering unipolar signal modification during radio frequency catheter ablation of patients with symptomatic paroxysmal atrial fibrillation in France between November 2013 and January 2015. All procedures were conducted according to the standard clinical care and current guidelines. Pulmonary vein isolation was guided according to force (at least 10 grams) and application vector (perpendicular to the wall) developed until the atrial unipolar electrogram recording became a complete positive signal. Patients were discharged from hospital free of any anti-arrhythmic drugs. Recurrence of arrhythmias at 12 months (primary outcome) was assessed by continuous 48-hour Holter at 1, 3, 6, 9 and 12 months post-catheter ablation.

ReferenceCitation: Bortone A, Brault-Noble G, Appetiti A, Marijon E. Elimination of the negative component of the unipolar atrial electrogram as an in vivo marker of transmural lesion creation: acute study in canines. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):905-11. doi: 10.1161/CIRCEP.115.002894. Epub 2015 Jun 19.

ReferenceCitation: Bortone A, Appetiti A, Bouzeman A, Maupas E, Ciobotaru V, Boulenc JM, Pujadas-Berthault P, Rioux P. Unipolar signal modification as a guide for lesion creation during radiofrequency application in the left atrium: prospective study in humans in the setting of paroxysmal atrial fibrillation catheter ablation. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1095-102. doi: 10.1161/CIRCEP.113.000749. Epub 2013 Oct 4.

ReferenceCitation: Bortone A, Lagrange P, Cauchemez B, Durand C, Dieuzaide P, Prevot S, Mechulan A, Pambrun T, Martin R, Parlier P, Masse A, Marijon E, Albenque JP. Elimination of the negative component of the unipolar electrogram as a local procedural endpoint during paroxysmal atrial fibrillation catheter ablation using contact-force sensing: the UNIFORCE study. J Interv Card Electrophysiol. 2017 Sep;49(3):299-306. doi: 10.1007/s10840-017-0264-4. Epub 2017 Jun 22.

lead_sponsor: Hôpital Privé Les Franciscaines

collaborators: Clinique Ambroise Paré, Neuilly sur Seine, France

collaborators: Hôpital Privé Clairval, Marseille, France

collaborators: Infirmerie Protestante de Lyon, Lyon, France

collaborators: Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France

collaborators: Centre Hospitalier Régional Universitaire Montpellier

collaborators: Paris Cardiovascular Research Center (Inserm U970)


title: Reduction of Inequalities in Overweight and Obesity Management Care Access Among High School Adolescents

acronym: PRALIMAP-INES

summary:
Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management (CM) for socially less advantaged adolescents in school in the short and long term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and obesity among socially advantaged adolescents.

Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as advantaged are allocated to the standard-CM and those less advantaged are randomized to standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The strengthened-CM consists of 5 collective sessions with the same standard operating procedure as the standard-CM with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after the intervention=T2). Process evaluation data are also collected during the trial.

Expected results: To confirm the effectiveness of overweight CM for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight care.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Manneville F, Omorou AY, Legrand K, Lecomte E, Rydberg JA, Briancon S, Guillemin F; PRALIMAP Trial Group. Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents. Prev Med. 2021 Sep;150:106668. doi: 10.1016/j.ypmed.2021.106668. Epub 2021 Jun 1.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: publishedVersion

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Omorou AY, Manneville F, Langlois J, Legrand K, Bohme P, Muller L, Guillemin F, Briancon S, Lecomte E; PRALIMAP-INES Trial Group. Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity. Prev Med. 2020 May;134:106043. doi: 10.1016/j.ypmed.2020.106043. Epub 2020 Feb 22.

oa_host_type: publisher

evidence: open (author manuscript)

license_normalized: no license

repositories_concat: closed

ReferenceCitation: Saez L, Legrand K, Alleyrat C, Ramisasoa S, Langlois J, Muller L, Omorou AY, De Lavenne R, Kivits J, Lecomte E, Briancon S; PRALIMAP-INES Trial Group. Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study. BMJ Open. 2018 Jun 22;8(6):e019731. doi: 10.1136/bmjopen-2017-019731.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ReferenceCitation: Saez L, Langlois J, Legrand K, Quinet MH, Lecomte E, Omorou AY, Briancon S; PRALIMAP-INES Trial Group. Reach and Acceptability of a Mobile Reminder Strategy and Facebook Group Intervention for Weight Management in Less Advantaged Adolescents: Insights From the PRALIMAP-INES Trial. JMIR Mhealth Uhealth. 2018 May 18;6(5):e110. doi: 10.2196/mhealth.7657.

license: cc-by

license_normalized: cc-by

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Legrand K, Lecomte E, Langlois J, Muller L, Saez L, Quinet MH, Bohme P, Spitz E, Omorou AY, Briancon S; PRALIMAP-INES trial group. Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INES trial protocol and inclusion data analysis. Contemp Clin Trials Commun. 2017 Jun 16;7:141-157. doi: 10.1016/j.conctc.2017.05.010. eCollection 2017 Sep.

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

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


title: Nutritional Assessment of French Hospitalized Patients Infected With COVID-19

acronym: DenutCOVID

summary:
The nutritional consequences of the infection by the SARS-CoV-2 are as follows:

A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.

Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Lille Catholic University

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Relating the 'Experienced Present' With the Mechanisms of Neuronal Function: A Comparative Study in Patients With Schizophrenia and Healthy Controls Using Psychophysical and Neurophysiological Methods

summary: Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.

lead_sponsor: University Hospital, Strasbourg, France

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

collaborators: Centre National de la Recherche Scientifique, France

collaborators: Institut de Physique Biologique de Strasbourg

location_facility: Service de Psychiatrie Adulte & INSERM U841, Hôpital Albert Chenevier et Henri Mondor (AP-HP)

location_facility: INSERM U666 - Département de Psychiatrie - Hôpitaux Universitaires de Strasbourg

intervention_type: Procedure


title: Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility

acronym: FabLife

summary:
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.

The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: FabLife

sponsor_collaborators:
FabLife
Keyrus Biopharma

location_facility:
Tenon Hospital (AP-HP)
Drouot Laboratory

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

summary: This multicenter, open-label, single arm, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2 points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever occurs first.

primary_purpose: Treatment

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug


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

acronym: VARICOVID

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

time_perspective: Retrospective

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

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHR Metz Thionville
CHRU Nancy


type: Other Identifier

title: EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

summary: The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Antia Therapeutics AG

location_facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France


title: Self-rehabilitation At Home After lumbaR Arthrodesis

acronym: SAHARA

summary:
Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.

The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility: AP-HP - Hôpital Européen Georges-Pompidou Paris, France

status_simplified: Ongoing


title: Study of ALN's OATF Vena Cava Filter

acronym: CONFIAL

summary:
Migration of a thrombus in the pulmonary circulation is the leading cause of pulmonary embolism (PE). It can be prevented mechanically by implanting a vena cava filter (VCF) in the inferior vena cava. The implation of a VCF is indicated for patients with acute PE and a contraindication to anticoagulation, with an acute deep vein thrombosis (DVT) without PE and a contraindication to anticoagulation or with acute venous thromboembolism (less than 3 months) in whom an interventional gesture at hemorrhagic and thromboembolic risk contraindicates anticoagulation.

The purpose of this study is to describe the rates of implantation, removal and complications associated with the use of the optional ALN OATF VCF in current practice.

status: Recruiting

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Aln2b SARL


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

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

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Grenoble Alps


title: Mechanism of Action of Interferon in the Treatment of Myeloproliferative Neoplasms

acronym: IFN&SMP

summary:
Classical BCR-ABL-negative myeloproliferative neoplasms (MPN) include: Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF). They are myeloid malignancies resulting from the transformation of a multipotent hematopoietic stem cell (HSC) caused by mutations activating the JAK2/STAT pathway. The most prevalent mutation is JAK2V617F. Type 1 and Type 2 calreticulin (CALR) and thrombopoietin receptor (MPL) mutations are also observed in ET and PMF. Additional non-MPN mutations affecting different pathways are also found, particularly in PMF, and are involved in disease initiation and/or in phenotypic changes and /or disease progression and/or response to therapy.

There is an obvious and urgent need for an efficient therapy for MPN. In particular, PMF remain without curative treatment, except allogeneic HSC transplantation and JAK inhibitors have limited effects on the disease outcome. Among novel therapeutic approaches, Peg-IFNα2a (IFN) is the most efficient harboring both high rates of hematological responses in JAK2V617F and CALRmut MPN patients and some molecular responses mainly in JAK2V617F patients including deep molecular response (DMR). Nevertheless, several studies, including our own, have demonstrated that the IFN molecular response in CALRmut patients is heterogeneous and overall much lower than in JAK2V617F patients. Moreover, some JAK2V617F MPN patients do not respond to IFN, and DMR is only observed in around 20% of JAK2V617F patients. Finally, long-term treatments are needed (2-5 years) to obtain a DMR, jeopardizing its success due to possible long-term toxicity.

The underlying reasons for failure, drug resistance, heterogeneous molecular response in CALRmut patients and the long delays for DMR in JAK2V617F patients remain unclear, largely because the mechanisms by which IFNα targets MPN malignant clones remain elusive.

Significant improvement of IFN efficacy cannot be achieved without basic and clinical research. Hence our two lines of research are to

Understand how IFNα specifically targets neoplastic HSCs
Predicting and improving patient response during IFNα therapy

ReferenceType: result

ReferenceCitation: James C, Ugo V, Le Couedic JP, Staerk J, Delhommeau F, Lacout C, Garcon L, Raslova H, Berger R, Bennaceur-Griscelli A, Villeval JL, Constantinescu SN, Casadevall N, Vainchenker W. A unique clonal JAK2 mutation leading to constitutive signalling causes polycythaemia vera. Nature. 2005 Apr 28;434(7037):1144-8. doi: 10.1038/nature03546.

ReferenceCitation: Klampfl T, Gisslinger H, Harutyunyan AS, Nivarthi H, Rumi E, Milosevic JD, Them NC, Berg T, Gisslinger B, Pietra D, Chen D, Vladimer GI, Bagienski K, Milanesi C, Casetti IC, Sant'Antonio E, Ferretti V, Elena C, Schischlik F, Cleary C, Six M, Schalling M, Schonegger A, Bock C, Malcovati L, Pascutto C, Superti-Furga G, Cazzola M, Kralovics R. Somatic mutations of calreticulin in myeloproliferative neoplasms. N Engl J Med. 2013 Dec 19;369(25):2379-90. doi: 10.1056/NEJMoa1311347. Epub 2013 Dec 10.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Mascarenhas J, Kosiorek HE, Prchal JT, Rambaldi A, Berenzon D, Yacoub A, Harrison CN, McMullin MF, Vannucchi AM, Ewing J, O'Connell CL, Kiladjian JJ, Mead AJ, Winton EF, Leibowitz DS, De Stefano V, Arcasoy MO, Kessler CM, Catchatourian R, Rondelli D, Silver RT, Bacigalupo A, Nagler A, Kremyanskaya M, Levine MF, Arango Ossa JE, McGovern E, Sandy L, Salama ME, Najfeld V, Tripodi J, Farnoud N, Penson AV, Weinberg RS, Price L, Goldberg JD, Barbui T, Marchioli R, Tognoni G, Rampal RK, Mesa RA, Dueck AC, Hoffman R. A randomized phase 3 trial of interferon-alpha vs hydroxyurea in polycythemia vera and essential thrombocythemia. Blood. 2022 May 12;139(19):2931-2941. doi: 10.1182/blood.2021012743.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Society of Hematology

ReferenceCitation: Mosca M, Hermange G, Tisserand A, Noble R, Marzac C, Marty C, Le Sueur C, Campario H, Vertenoeil G, El-Khoury M, Catelain C, Rameau P, Gella C, Lenglet J, Casadevall N, Favier R, Solary E, Cassinat B, Kiladjian JJ, Constantinescu SN, Pasquier F, Hochberg ME, Raslova H, Villeval JL, Girodon F, Vainchenker W, Cournede PH, Plo I. Inferring the dynamics of mutated hematopoietic stem and progenitor cells induced by IFNalpha in myeloproliferative neoplasms. Blood. 2021 Dec 2;138(22):2231-2243. doi: 10.1182/blood.2021010986.

repository_institution: City University London - City Research Online

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

version: submittedVersion

repositories:
HAL
PubMed Central
openaccess.city.ac.uk

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

ReferenceCitation: Dagher T, Maslah N, Edmond V, Cassinat B, Vainchenker W, Giraudier S, Pasquier F, Verger E, Niwa-Kawakita M, Lallemand-Breitenbach V, Plo I, Kiladjian JJ, Villeval JL, de The H. JAK2V617F myeloproliferative neoplasm eradication by a novel interferon/arsenic therapy involves PML. J Exp Med. 2021 Feb 1;218(2):e20201268. doi: 10.1084/jem.20201268.

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

ReferenceCitation: Gisslinger H, Klade C, Georgiev P, Krochmalczyk D, Gercheva-Kyuchukova L, Egyed M, Rossiev V, Dulicek P, Illes A, Pylypenko H, Sivcheva L, Mayer J, Yablokova V, Krejcy K, Grohmann-Izay B, Hasselbalch HC, Kralovics R, Kiladjian JJ; PROUD-PV Study Group. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol. 2020 Mar;7(3):e196-e208. doi: 10.1016/S2352-3026(19)30236-4. Epub 2020 Jan 31. Erratum In: Lancet Haematol. 2020 Feb 25;:

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Verger E, Cassinat B, Chauveau A, Dosquet C, Giraudier S, Schlageter MH, Ianotto JC, Yassin MA, Al-Dewik N, Carillo S, Legouffe E, Ugo V, Chomienne C, Kiladjian JJ. Clinical and molecular response to interferon-alpha therapy in essential thrombocythemia patients with CALR mutations. Blood. 2015 Dec 10;126(24):2585-91. doi: 10.1182/blood-2015-07-659060. Epub 2015 Oct 20.

ReferenceCitation: Knudsen TA, Skov V, Stevenson K, Werner L, Duke W, Laurore C, Gibson CJ, Nag A, Thorner AR, Wollison B, Hansen DL, Ellervik C, El Fassi D, de Stricker K, Ocias LF, Brabrand M, Bjerrum OW, Overgaard UM, Frederiksen M, Kristensen TK, Kruse TA, Thomassen M, Mourits-Andersen T, Severinsen MT, Stentoft J, Starklint J, Neuberg DS, Kjaer L, Larsen TS, Hasselbalch HC, Lindsley RC, Mullally A. Genomic profiling of a randomized trial of interferon-alpha vs hydroxyurea in MPN reveals mutation-specific responses. Blood Adv. 2022 Apr 12;6(7):2107-2119. doi: 10.1182/bloodadvances.2021004856.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Aalborg Universitet - VBN Forskningsportal

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


title: Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study

summary: A regional, single-center, prospective, observational academic cohort will follow subjects who previously participated in the INSIGHT study and who agree an extension of their follow-up in the INSIGHT-2 research for additional 5-6 years. An annual multimodal evaluation (cognitive, oculomotor, biological and neuroimaging) will be proposed in order to describe the natural history of preclinical Alzheimer's disease (AD). The primary endpoint is the conversion to the symptomatic stage in subjects at risk, identified by positive amyloid staining (A+) on florbetapir positron emission tomography (PET) imaging. The size of the cohort is estimated to around 240 participants (61 A+ subjects) among the 318 participants included in the main cohort (88 A+ subjects). The follow-up in the INSIGHT-2 cohort will be lightened compared to that of the main cohort with an annual frequency of visits rather than a six-monthly one.

primary_purpose: Other


type: Registry Identifier

title: Semantic Networks in Alcohol Use Disorder Patients: Exploratory Study

acronym: ALCOOLNET

summary:
Alcohol Use Disorder (AUD) is a major public health problem, characterized by a high rate of relapse. Chronic and excessive alcohol consumption notably induces frontal brain alterations and cognitive impairments such as executive dysfunction and an attentional bias for alcohol, participating to the risk of relapse. In effect, AUD patients preferentially process alcohol-related cues, which could reflect a reorganization of the patients' semantic network. The investigators hypothesize that in AUD patients, semantic associations in memory are reorganized with a higher centrality of alcohol-related elements. To the investigators knowledge, no studies have explored semantic associations and/or semantic networks in AUD.

A study, conducted in patients with neurological damage, showed that frontal lesions are associated with excessive strength in semantic associations, and difficulties to generate remote associations. This excessive strength in semantic associations could reduce the ability to inhibit automatisms and to adapt to new context.

Objective: The objective of this study is to explore whether and how AUD patients have a different organization of semantic associations than healthy controls, and whether this reorganization influences the alcohol consumption over the months following the withdrawal. The investigators will also explore how it relates to neuropsychological assessment of flexibility, executive functions, and impulsivity. To these purposes, the investigators will use two original verbal tasks (Free Generation of Associates Task, FGAT and Associative Judgment Task, AJT) assessing word associations and allowing the estimation of semantic networks using graph theory, in combination with neuropsychological testing, in AUD patients and in healthy controls.

Methods: This study will include a group of 30 AUD patients and a group of 30 healthy controls. Both groups will be assessed twice, at baseline (T1; early in abstinence for AUD patients) and after a three-month period (T3). For the two groups, T1 and T3 assessments will include the two semantic association tasks (FGAT and AJT). For AUD patients, assessments will also involve neuropsychological testing of impulsivity, flexibility, and attentional bias. Besides, in AUD patients, data about alcohol consumptions will be collected six weeks (T2) and three months (T3) following the baseline assessment to classify patients as relapsers or abstainers.

time_perspective: Cross-Sectional


title: How a Patient's Words Change the Rewarding Value of Food: Mapping the Neurocognitive Shift Generated by Motivational Interviewing During the Therapy of Food Addiction Onto the Brain - MOTIVFOOD

acronym: MOTIVFOOD

summary: Why in some situations can words soothe our cravings? This research proposal will test the power of self-generated reasons for behavioural change in food addiction, which concerns about three out of ten persons and causes major life hazards such as obesity, diabetes and cancer. While food addiction is becoming more and more frequent in western societies, not much is known about its underlying neurocognitive mechanisms and how to tackle it. This study aims to investigate if and why certain types of affirmation-based therapies such as motivational interviewing (MI) are beneficial for the treatment of food addiction. The working hypothesis proposes that cognitive regulation-based self-control underpins the neurocognitive shift of a patient's willingness to change addictive behaviour, generated by the patient during MI therapy of food addiction. To test this hypothesis this study combines functional magnetic resonance imaging with behavioural testing of dietary decision-making following a participant's change or sustain talk statements. It will compare three groups of participants with and without food addiction and obesity and lean controls. This study will contribute to the improvement of therapies based upon talking oneself in and out of addiction promoting goals. Findings will provide a better understanding of how our everyday life dietary decision-environments prompt good intentions such as improving long-term nutritional quality to actual behaviours such as forgoing immediate desire.

intervention_type: Behavioral


title: Neuronal Correlates of Agency in Dystonia

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

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

design_allocation: Non-Randomized

primary_purpose: Basic Science


title: Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".

acronym: COGIT

summary:
Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Its anatomical substrates is based on connections between frontal and striatal areas.

Initially, a battery of behavioral tests measuring different types of impulsivity (motor, cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40 patients treated and 40 untreated) and 40 healthy volunteers.

Then, investigators will study the fronto-striatal connections in the TS group of 80 patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study of "resting state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging data to highlight the functional anatomical substrates of impulsivity in patients with TS.

Finally, investigators will look specifically using functional MRI activation, the anatomical and functional substrates of the three types of impulsivity (motor, cognitive and decision-making).

Through this study, investigators hope to elucidate the anatomical and functional bases of cognitive impulsivity in patients with TS and thus lay the basis for more targeted treatments.


title: Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.

summary:
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used in many French and international centers for the treatment of severe forms of Parkinson's disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50 to 80% on average. The main advantage of DBS is that the surgery has low morbidity and mortality, it is adaptable to the patient's symptoms and its effect is reversible. This treatment is now a routine and more than 85,000 patients worldwide have benefited from the installation of this system. Since 1997, this treatment is available to patients followed in the Pitié Salpêtrière (GHPS).

The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve with the use of high-field MRI. However, several new issues and inherent in that high-field MRI should be evaluated before the images can be used directly.

The chosen sequences must be short to be feasible, minimizing patient discomfort, and evaluated on several patients to ensure the low interindividual variability. In addition, the quality of the display on all of the sections should provide a reliable three-dimensional information. Finally, the quality of targeting and its possible improvement should be checked.

ReferenceType: background

ReferenceCitation: Benabid AL, Koudsie A, Benazzouz A, Piallat B, Krack P, Limousin-Dowsey P, Lebas JF, Pollak P. Deep brain stimulation for Parkinson's disease. Adv Neurol. 2001;86:405-12. No abstract available.

ReferenceCitation: Bejjani BP, Dormont D, Pidoux B, Yelnik J, Damier P, Arnulf I, Bonnet AM, Marsault C, Agid Y, Philippon J, Cornu P. Bilateral subthalamic stimulation for Parkinson's disease by using three-dimensional stereotactic magnetic resonance imaging and electrophysiological guidance. J Neurosurg. 2000 Apr;92(4):615-25. doi: 10.3171/jns.2000.92.4.0615.

ReferenceCitation: Egidi M, Rampini P, Locatelli M, Farabola M, Priori A, Pesenti A, Tamma F, Caputo E, Chiesa V, Villani RM. Visualisation of the subthalamic nucleus: a multiple sequential image fusion (MuSIF) technique for direct stereotaxic localisation and postoperative control. Neurol Sci. 2002 Sep;23 Suppl 2:S71-2. doi: 10.1007/s100720200075.

ReferenceCitation: Longhi M, Ricciardi G, Tommasi G, Nicolato A, Foroni R, Bertolasi L, Beltramello A, Moretto G, Tinazzi M, Gerosa M. The Role of 3T Magnetic Resonance Imaging for Targeting the Human Subthalamic Nucleus in Deep Brain Stimulation for Parkinson Disease. J Neurol Surg A Cent Eur Neurosurg. 2015 May;76(3):181-9. doi: 10.1055/s-0033-1354749. Epub 2015 Mar 12.

ReferenceCitation: Lefranc M, Derrey S, Merle P, Tir M, Constans JM, Montpellier D, Macron JM, Le Gars D, Peltier J, Baledentt O, Krystkowiak P. High-resolution 3-dimensional T2*-weighted angiography (HR 3-D SWAN): an optimized 3-T magnetic resonance imaging sequence for targeting the subthalamic nucleus. Neurosurgery. 2014 Jun;74(6):615-26; discussion 627. doi: 10.1227/NEU.0000000000000319.

ReferenceCitation: Yelnik J, Bardinet E, Dormont D, Malandain G, Ourselin S, Tande D, Karachi C, Ayache N, Cornu P, Agid Y. A three-dimensional, histological and deformable atlas of the human basal ganglia. I. Atlas construction based on immunohistochemical and MRI data. Neuroimage. 2007 Jan 15;34(2):618-38. doi: 10.1016/j.neuroimage.2006.09.026. Epub 2006 Nov 15.

ReferenceCitation: Breit S, LeBas JF, Koudsie A, Schulz J, Benazzouz A, Pollak P, Benabid AL. Pretargeting for the implantation of stimulation electrodes into the subthalamic nucleus: a comparative study of magnetic resonance imaging and ventriculography. Neurosurgery. 2006 Feb;58(1 Suppl):ONS83-95. doi: 10.1227/01.NEU.0000192689.00427.C2.

ReferenceCitation: Cheng CH, Huang HM, Lin HL, Chiou SM. 1.5T versus 3T MRI for targeting subthalamic nucleus for deep brain stimulation. Br J Neurosurg. 2014 Aug;28(4):467-70. doi: 10.3109/02688697.2013.854312. Epub 2013 Nov 5.

ReferenceCitation: Patil PG, Conrad EC, Aldridge JW, Chenevert TL, Chou KL. The anatomical and electrophysiological subthalamic nucleus visualized by 3-T magnetic resonance imaging. Neurosurgery. 2012 Dec;71(6):1089-95; discussion 1095. doi: 10.1227/NEU.0b013e318270611f.

ReferenceCitation: Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.

ReferenceCitation: Liu T, Eskreis-Winkler S, Schweitzer AD, Chen W, Kaplitt MG, Tsiouris AJ, Wang Y. Improved subthalamic nucleus depiction with quantitative susceptibility mapping. Radiology. 2013 Oct;269(1):216-23. doi: 10.1148/radiol.13121991. Epub 2013 May 14.

ReferenceCitation: Xiao Y, Fonov VS, Beriault S, Gerard I, Sadikot AF, Pike GB, Collins DL. Patch-based label fusion segmentation of brainstem structures with dual-contrast MRI for Parkinson's disease. Int J Comput Assist Radiol Surg. 2015 Jul;10(7):1029-41. doi: 10.1007/s11548-014-1119-4. Epub 2014 Sep 24.

ReferenceCitation: Starr PA, Martin AJ, Ostrem JL, Talke P, Levesque N, Larson PS. Subthalamic nucleus deep brain stimulator placement using high-field interventional magnetic resonance imaging and a skull-mounted aiming device: technique and application accuracy. J Neurosurg. 2010 Mar;112(3):479-90. doi: 10.3171/2009.6.JNS081161.

ReferenceCitation: Bardinet E, Belaid H, Grabli D, Welter ML, Vidal SF, Galanaud D, Derrey S, Dormont D, Cornu P, Yelnik J, Karachi C. Thalamic stimulation for tremor: can target determination be improved? Mov Disord. 2011 Feb 1;26(2):307-12. doi: 10.1002/mds.23448. Epub 2010 Dec 13.


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

acronym: FUSIMAGINE

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

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

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

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

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

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

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


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

acronym: BIOMAGE

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

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


title: Interstitial Lung Disease: A Study From Infancy to Elderly Including Relatives

acronym: RaDiCo-ILD 2

summary:
The concerned patients are children and adults suffering from idiopathic interstitial pneumonias, other chronic fibrosing interstitial pneumonias with a progressive phenotype, and interstitial pneumonia associated with Scleroderma and related cases of patients carrying a mutation on one of the telomere-associated genes.

This is a national, observational, longitudinal, multicenter study that will be conducted retrospectively and prospectively. It aims to collect consistent and comparable clinical data for patients and their relatives, whether they carry a mutation or not, affected by diffuse idiopathic interstitial pneumopathy.

The expected duration of the study, including data analysis, is approximately 10 years (5 years for participant enrollment and 5 years of follow-up, in addition to the steps for data management and statistical analyses).

Each participating center will inform every participant by providing an information sheet, and their written consent will be obtained before including them in the study and commencing data collection.

Prospective medical data will be collected at 6 months to 1 year after enrollment and then at least once per year for patients up to 5 years and 5 years for their relatives.

Participants will complete a self-questionnaire during their regular follow-up consultations or by accessing a secure interface.

ipd_sharing: Undecided


title: Utility and Validation's Study of a Smartphone Application for Periodic Paralysis

acronym: RaDiCo-PP

summary:
Periodic paralyses (PP) are rare genetic disorders characterized by the occurrence of acute and reversible episodes of muscle weakness. Their episodic and highly variable nature makes it difficult to gather the necessary information for monitoring and therapeutic adaptation. Patients struggle to accurately report the number, duration, severity, and triggers of their attacks that have occurred between two consultations.

Currently, there are no validated scales or tools for precisely and standardizedly assessing paralytic episodes. Ecological Momentary Assessment (EMA) is a real-time data collection method used in research, historically on paper forms and then on expensive and cumbersome electronic devices (PDAs). The widespread use of smartphones opens up a new avenue in this field, and the use of a mobile application as a real-time data collection tool could be perfectly applicable to these conditions with episodic expression. It is hypothesized that systematic and real-time collection of paralysis episode characteristics will improve the quality and accuracy of the collected data, thus enhancing clinicians' understanding of the condition and patient management. Moreover, little is known about the medical and social impact of the disease. To address these specific issues, the investigators propose a study of patients with "Periodic Paralyses" based on prospective collection of clinical and medico-social data during routine consultations and in real-time during paralytic episodes using a dedicated smartphone application developed by Ad Scientiam in collaboration with Dr. Savine Vicart, the study coordinator.

The primary objective of this study is to evaluate the benefit of a smartphone application specifically developed for patients with periodic paralyses to collect real-time information and improve the quality of collected data regarding the characteristics of paralysis episodes (number, duration, intensity, triggering factors, location, treatment) compared to the retrospective questionnaire typically used in consultations.

The secondary objective is to assess the impact of this new data collection method on the medical management of patients.


title: National Cohort on Congenital Defects of the Eye: Natural History, Genetic Determinisms and Improved Ocular and Extra-ocular Outcome Prediction for Better Patient Management

acronym: RaDiCoACOEIL

summary:
Congenital malformations of the eye comprise various developmental defects including microphthalmia, anophthalmia, aniridia, and anterior segment anomalies (such as Peters and Axenfeld-Rieger anomalies). These malformations are frequently associated with extra-ocular features and intellectual disability. However, little is known about visual outcome, frequency and consequences of extra-ocular features in patients.

The originality of the project will be to include a spectrum of malformation thought to be a phenotypic continuum (anophthalmia, microphthalmia, aniridia, anterior segment dysgnesis). In addition, we aim to conduct a 10 year follow-up of these children, thus allowing determining ocular and neurological outcomes as any other medical event. We should also be able to determine phenotypic factors that would be associated with good or poor visual and neurologic outcomes

time_perspective: Other


title: Study of the Natural History of Alport Syndrome by Establishment of an International Database

acronym: Eurbio-Alport

summary:
Alport syndrome is a rare, inherited condition characterized by a combination of glomerular nephropathy progressing to kidney failure, deafness, and eye involvement. This disease is associated with mutations in the genes encoding one of the three IV collagen chains expressed in the glomerular basement membrane. Significant progress has been made in understanding the molecular mechanisms responsible for the disease, but relatively little in understanding the progression of renal failure and in the area of therapeutics. We have shown in a retrospective European study that blockers of the renin angiotensin system may slow disease progression, but no controlled studies have been performed. Finally, innovative therapies (anti-micro-RNA, stem cells) have recently shown their effectiveness in animal models of the disease, and industrials are planning to quickly carry out phase 1 trials to test molecules. Carrying out therapeutic trials in humans will require full knowledge of the natural history of the disease (isolated hematuria, microalbuminuria, macroalbuminuria, renal failure and its progression) and gathering a sufficient number of patients, especially in the early stages. These trials and the indications for treatments would be greatly facilitated by the discovery of biomarkers that make it possible to predict the progression to renal failure earlier than the onset of proteinuria.

The study aims to:

Establish a European database on Alport syndrome to assess the natural history of the disease.
To investigate the impact of the disease on the educational and professional life of patients and their families, and on the adherence and tolerance to renin-angiotensin system blockers prescribed to proteinuric patients.
Investigate access to molecular diagnostics and genetic counseling, as well as identify biomarkers that can predict progression of kidney disease.

This project will be carried out at a French level with the support and participation of the very active renal rare disease sector, in collaboration with various countries wishing to participate.


title: Brain Injury and Cognitive Function: Neuropsychology and Neuroimaging

summary:
The objective of this exploratory study is to elucidate the underlying cerebral mechanisms of cognitive deficits. To achieve this, the investigator will apply functional brain imaging techniques to patients suffering from cognitive deficits due to cerebral lesions.

The investigator will employ a "single-case" approach, suitable for studying rare behavioral profiles such as acquired reading disorders (alexia) or visual perception impairments (agnosia). If necessary, the investigator will use multiple non-invasive imaging methods in the same patients, including:

Magnetic Resonance Imaging (structural and functional), renowned for its spatial resolution and the diverse information it provides, and
Electrophysiological methods (MEG and EEG), notable for their temporal resolution.

The employed stimuli will consist of visual or auditory presentations of verbal material (words, sentences, numbers, etc.), potentially combined with the collection of simple vocal or motor responses (button presses).

The results will be interpreted by integrating the neuropsychological analysis of the deficit and the lesion topography.

Importantly, following the methodology of single-case neuropsychology, the stimulation protocols will be modulated and adapted to each individual case. Consequently, parallel data should be collected from healthy control subjects whenever necessary.

For protocol development, the investigator will also collect purely behavioral data, without brain imaging, from groups of control subjects.


title: A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's Disease

summary: In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤ 40) in a randomized, double-blind, controlled study in 2 centers (France and the Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n = 50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be evaluated by measurements of caudate volume using volumetric magnetic resonance imaging and brain energy metabolism as evaluated by the ratio of inorganic phosphate/phosphocreatine, during visual stimulation, using 31P-MRS. Clinical improvement will be evaluated by UHDRS, TFC, and PBA-S scores as well as performance on the neuropsychological battery; patient quality of life will be evaluated with qualitative research methods after 6 months and with the SF-36 questionnaire before and after treatment; biological tolerance and compliance will be evaluated by routine biochemical blood tests, plasma and urine measurements of triheptanoin oil derivatives and patient report.

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: IOS Press

location_country: Netherlands France

location_facility:
Département de Génétique
Department of Neurology


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

acronym: FLU-HOP

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

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

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

Before the vaccination:

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

After the vaccination:

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

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

intervention_type: Biological


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

acronym: TRAUMADORNASE

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

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

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

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

publisher_dissemination: Springer-Nature

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

type_etablissement: CH

acronyme: Traumadornase

titre: Evaluation prospective randomisée en double aveugle de la dornase alpha, administrée en aérosols, pour réduire l'incidence du syndrome de détresse respiratoire aigue modéré et sévère chez les patients traumatisés graves.

discipline_principale: autre

nom_porteur: POTTECHER

prenom_porteur: Julien


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

acronym: NEUROCOG-COVID

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

primary_purpose: Diagnostic

lead_sponsor: Central Hospital, Nancy, France

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Centre Hospitalier Régional Metz-Thionville

location_facility: Nancy University Hospital, Department of Neurology

intervention_type: Diagnostic Test


title: Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

acronym: BEBOP

summary:
Opioid use disorder (OUD) is a chronic and severe psychiatric condition, defined by problematic opioid use, that significantly impairs interpersonal and social functioning. Over the last 10 years, a dramatic increase in the prevalence of OUD and deaths by overdose has occurred in several developed countries, in particular the USA. In France, similarly, the burden associated with OUD is worsening, and now represents a major public health crisis. During last decades, it has been demonstrated that OUD results from combined effects of numerous factors, which have been robustly identified across a variety of research fields, including psychiatry, sociology, and neurobiology. This plurality is embodied in a comprehensive theoretical framework, the biopsychosocial model of addiction, composed of elements whose effects have been well defined individually, but remain poorly characterized and understood in combination. More recently, behavioral epigenetics has emerged as a promising discipline to identify molecular mechanisms that may help explain how life experiences, in particular psychiatric and sociological factors, modulate the regulation of genes, brain function, and emotional regulation. In this context, here we propose a multidisciplinary project that builds on the collaboration of psychiatrists, sociologists and neuro-epigeneticists. The investigators will simultaneously characterize major psychiatric and social factors in a large cohort of individuals with OUD, with the goal of covering the full spectrum of disease severity. By combining deep psychosocial evaluation with the investigation of blood-derived epigenetic biomarkers, they will seek to provide a new and deeper understanding of determinants of OUD severity.

The project builds on 3 main hypotheses:

Social and psychiatric factors together contribute to OUD severity;
Epigenetic mechanisms, measured in peripheral accessible tissues such as blood, represent biomarkers that may reflect pathophysiological processes resulting, at least in part, from the effects of psychosocial factors;
Measures of OUD severity combining both psychosocial factors and epigenetic biomarkers have the potential to improve our ability to describe OUD severity, and better predict its clinical course.

location_facility: Service d'Addictologie, Hôpitaux Universitaires de Strasbourg

location_facility: Service Universitaire d'Addictologie, Hospices Civils de Lyon

location_facility: Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)


title: Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area

acronym: COVAL-NANCY

summary:
In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area.

A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted.

The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study

primary_purpose: Screening

sponsor_collaborators:
Central Hospital, Nancy, France
University of Lorraine
Métropole du Grand Nancy


title: KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING: INTEREST IN INTRAVESTIBULAR DISLOCATIONS OF PISTONS OR CALIPER

acronym: Luxation

summary: Titanium pistons cause MRI artifacts that prevent interpretation of the vestibule. This disadvantage is not present on CT but the vestibule is not visible. Hence the interest in creating a model with 6 reference cuts in order to position the utricle and the saccule in the vestibule in CT. Furthermore, the scanner has fewer contraindications, greater availability and a shorter examination time than MRI.

location_facility: Service de Radiologie - CHU de Strasbourg - France


title: State of Play of Non-tuberculous Mycobacteria in Alsace: a Retrospective Study

acronym: Mycoba

summary:
Non-tuberculous mycobacteriosis (NTM) are infectious diseases caused by mycobacteria that are not part of the Tuberculosis complex. More than 190 species have been identified to date.

As an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. Varying in virulence depending on the species, most infections do not cause illness.

There is currently no coordinated care pathway for this pathology in Alsace. The means necessary to set up such a structure requires knowing the importance of the disease.

location_facility: Service de Pneumologie - CHU de Strasbourg - France


title: Analysis of Suicide Dynamics in Link to the COVID-19 Pandemic

summary:
Covid is a virus that first appeared in China in 2019 and was quickly described as a pandemic virus by its globalized nature. The unprecedented occurrence of the virus has led to several health and restrictive government measures. The Covid-19 pandemic and health measures have been able to contribute to the deterioration of the mental health of citizens as it has already been observed during the former pandemic context (Sars covid in 2003 in China or the Spanish flu).

Among the consequences of a negative impact on mental health, investigators assume that there is an increase in transitions to the completed suicidal act. However, current studies and observations tend to note that there has been no major change in the dynamics of successful suicides during the Covid period.

However, there are biases in the studies conducted: some suicide deaths may have been hidden and not reported as such, due to several factors. For example, the measure of the evolution of suicide attempts that was most often made by the measure of the evolution of the number of hospitalizations for this reason can be a source ofestimate whether people who did this gesture were not hospitalized after a visit to the emergency room or if they gave up attending because of the pandemic. Moreover, suicide deaths are more difficult to report as such when they occur at home than after hospitalization.

It is therefore interesting to study the dynamics of suicide during this health crisis retrospectively based on data from the Strasbourg Institute of Forensic Medicine containing the census of the Alsace region, which was hit hard by the pandemic.

location_facility: Service de Psychiatrie - CHU de Strasbourg - France


title: Inventory of the Management of Acute Community-acquired Pneumonia in the Pneumology Department of the Strasbourg University Hospitals

acronym: PPAC

summary:
Acute community-acquired pneumonia (CAP) refers to an acute infection of the lung parenchyma, occurring within the first 48 hours of hospitalization. It is a frequent, serious pathology with a strong economic impact. Viruses (rhinovirus, respiratory syncitial virus, influenza virus for the most common) and Streptococcus pneumoniae are the most frequently encountered pathogens. However, more than half of the PACs have no microbiological documentation. The management of CAPs is based on national and international recommendations. Several studies have shown imperfect compliance by clinicians with recommendations with a prognostic impact.

The various published studies insist on the variability of the incidence, the type of pathogen, the severity and the economic impact, depending on the series. They also insist on the need to know the local epidemiology, in particular microbiological, in order to adapt the recommendations.


title: Dietary Sodium Intake in Children on Chronic Dialysis: A Collaborative Study With the European Pediatric Dialysis Working Group

acronym: PeDialysis

summary:
Cardiovascular disease is common in patients with end-stage renal disease that began in childhood, and volume overload plays a key role in the development of hypertension, left ventricular hypertrophy (LVH) and alterations. cardiovascular disease in this population. Thus, inter-dialytic weight gain is correlated with blood pressure and left ventricular mass index in children on hemodialysis (HD). Significant inter-dialytic weight gain in dialysis patients is largely due to thirst secondary to salt ingestions: attempts at water restriction without concomitant sodium restriction will probably be in vain. Additionally, sodium overload negatively affects blood pressure and cardiovascular status through various mechanisms unrelated to volume expansion.

Soda extraction by dialysis is often difficult, and sodium control is largely dependent on restricting dietary sodium intake. Some studies in adults have shown that a low sodium diet reduced inter-dialytic weight gain, reduced intra-dialytic complications, improved blood pressure values, and lowered index. left ventricular mass and mortality in dialysis patients.

For children with chronic kidney disease, data from the American Chronic Kidney Disease (CKiD) study show that the median sodium intake in children without dialysis with chronic kidney disease exceeds the maximum recommended intakes for all patients. age groups.

No study to date has investigated the average dietary sodium intake of children on dialysis. And, more importantly, the relationship between dietary sodium intake and cardiovascular morbidity has never been studied in children on dialysis.

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


title: Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss

acronym: Cone-Beam

summary:
Conductive hearing loss is very common and the incidence increases with age. Until now, the scanner was the reference examination in the etiological diagnosis of deafness.

When performing a CT scan of temporal bones for the etiological diagnosis of conductive hearing loss, the quality of the image depends on the scanner brand and the acquisition parameters.

The investigators wish to show the usefulness of the cone beam in the diagnosis of conductive hearing loss

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


title: IImpact of Hyperuricemia on Psoriatic Arthritis

acronym: Psoriatic

summary: Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. There is currently no recommendation to treat hyperuricaemia without an episode of gout attack. We hypothesize that there is a link between hyperuricemia and severity of rheumatism. This would ultimately modify the therapeutic management of hyperuricemic patients followed for psoriatic arthritis.

location_facility: Service de Rhumatologie - CHU de Strasbourg - France


title: Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis

acronym: Ped-Urolithia

summary:
The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management.

This incidence is variable according to race, geographic region, socio-economic status and dietary habits.

Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe.

The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination.

Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another.

The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.


title: The Petro-trigeminal Line: a Simple Radiological Marker for the Diagnosis of Cephaloceles of the Petrous Apex on MRI

acronym: APEX

summary: cephaloceles are rare lesions of the petrous apex, inconsistently listed as meningoceles or arachnoid cysts. They're consistent with a herniation posterolateral of the Meckel cavum within the petrous apex. These lesions may be the cause of a symptomatology varied, or be discovered by chance in subjects who have not been asymptomatic. Currently, there is no evidence in the literature a simple, fast and reproducible radiological marker that allows for the diagnosis of cephaloceles of the petrous apex, in particular the small ones. The purpose of this study is to validate a radiological benchmark simple and reproducible, the trigeminal petrol line, in order to improve the diagnosis of petrous apex cephaloceles


title: How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

acronym: Pedia-Card

summary: Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.


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

acronym: Neo-Renal

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

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


title: Pediatric ANCA Associated-vasculitis : Latest Clinical Review and Therapeutic Outcomes. A Retrospective Epidemiological Study on a French Cohort

acronym: PediANCA

summary:
The incidence in pediatrics is very low (about 0.5 per million according to a French study) and therefore the data on the pathology very poor, especially on the therapeutic level.

Without appropriate treatment, the mortality rate of the pathology is very high.

Existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments.

Complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. The purpose of the study is to achieve a national comparison of clinical and therapeutic practices.


title: Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms

acronym: NeuroVasc

summary:
Training in microsurgical techniques for the management of intracranial aneurysms is carried out during the practical training of the DES in Neurosurgery and during the continuous training of neurosurgeons according to the indications of the patients of the department. Currently, the recent increase in indications for endovascular treatment compared to surgical indications has led to a decrease in surgical indications and in the experience of neurosurgeons. However, there are still surgical indications that are often complex situations that neurosurgeons must overcome with a specific simulation approach.

There are different simulation models for the treatment of intracranial aneurysms. The small animal (rodent) model has the disadvantage of being poorly suited to the reproduction of intracranial aneurysms (different extracranial vessel walls, too small intracerebral vessel caliber) and of being constraining to the establishment. The computerized stimulator model which has the advantage of being able to reproduce the anatomy of a patient but whose haptic sensitivity performance is difficult to reproduce for very fine movements, it is not very accessible because it is expensive. The placental model uses a fresh human placenta, the appearance of the vessels of which is very similar to those found intracerebrally, and dilations on their walls can be performed with a pediatric urinary catheter.

location_facility: Service de Neurochirurgie - CHU de Strasbourg - France


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

acronym: COAT IFN

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

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

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Flamel Technologies


title: Interference by Activated Protein C Resistance in the Determination of Protein S Activity

acronym: PS

summary: Protein S is an anticoagulant protein and a cofactor of protein C. It is recommended to explore it first by a functional (chronometric) technique by assessing its cofactor activity of activated protein C. Existing tests measure the prolongation of a coagulation time. These tests are all dependent on factor V, but some patients have mutations in factor V (including V Leiden) that make them resistant to activated protein C activity. It is suspected that these mutations lead to underestimations of protein S activity by chronometric technique.

location_facility: Laboratoire d'Hématologie - CHU de Strasbourg - France


title: Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)

acronym: HIT

summary: Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.


title: Thrombophilia Assessment Under Direct Oral Anticoagulants (DOAC): Efficacy of Activated Charcoal

acronym: DOAC-Stop

summary:
Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran).

AODs interfere with most coagulation tests, especially those performed by chronometric technique.

For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS.

Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.


title: Specific Role of Nurse in a Mobile Palliative Care Team (EMSP): Real Autonomy or Utopia

acronym: AutonInfSP

summary:
A bibliographic search carried out by the investigators demonstrated that there are few studies or data relating to the role and place of a State Registered Nurse (IDE) in a Mobile Palliative Care Team (EMSP) concerning the collection and the analysis of the needs expressed when formulating an evaluation request by the EMSP. The IDE collects, questions, analyzes needs and initiates an evaluation with the patient or, failing that, advises and/or redirects. This first necessary step before the overall evaluation led the investigators to question the autonomy of the IDE in an EMSP and to research what are the representations of an IDE in this role of collecting and analyzing needs. when making such a request?

The aim of this research is to explore the professional practices of nurses within other PMSCs in order to analyze them and move towards improving patient care.

location_facility: Service de soins Palliatifs - CHU de Strasbourg - France


title: Assessment of the Presence of Symptoms of End-of-life Discomfort and Their Management in Children With a Primary Brain Tumor in the Grand Est Region. Impact of the Development of Pediatric Palliative Care

acronym: PTB

summary:
Despite medical advances, cancer remains the leading cause of death by disease in children.

Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers.

The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor.

The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals.

Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.


title: Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome After a Fall in Elderly Persons

acronym: RM-SDP

summary: The post-fall syndrome or psychomotor disadaptation syndrome can be considered as a complication of a fall and can lead to a total loss of autonomy. This syndrome remains little studied, despite its important frequency in acute geriatric services or geriatric rehabilitation care, and despite its recognized seriousness. Decreased grip strength seems to be a risk factor for psychomotor disadaptation syndrome in after a fall, which is why we hypothesize that muscle strengthening adapted to the elderly subject would limit the appearance of this syndrome. By limiting this risk, it would reduce complications such as loss of functional independence, but also reduce the number and duration of hospitalization of elderly patients.

location_facility: Service de Gériatrie aigue - CHU de Strasbourg - France


title: Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease

acronym: OS-LERETRO

summary:
Hypophosphatemia induced by treatments with injectable iron is a frequent side effect already reported during marketing. Situations of osteomalacia secondary to these hypophosphatemias are rarer and reported in the form of case reports in the literature. Hypophosphatemia in this context is attributed to an excess of FGF-23 (defect of degradation linked to carbohydrates in martial preparations) with renal leakage of phosphate.

Rendu-Osler disease (ROM) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. Iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. Regular iron infusions, to avoid transfusions, are often necessary.

location_facility: Service de Médecine interne - CHU de Strasbourg - France


title: Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.

acronym: SODIVASC-II

summary:
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.

In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".

"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.

Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.

On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Platform of Clinical Investigation / Clinical Investigation Center French Institute of Health and Medical Research-1405 University Hospital


title: Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD. Indication of a Control Imaging ?

acronym: Head-Trauma

summary:
The non-neurosurgical management of post-traumatic cerebral hemorrhagic lesions is currently poorly codified. It consists of neurological monitoring for 24 to 48 hours, and the performance of an almost systematic brain scan. Anti-aggregation and anticoagulation treatments are stopped for 14 to 28 days and should be resumed according to the risk-benefit ratio and the advice of the patient's treating physicians and cardiologists.

If the bleeding lesions do not progress, the patients are allowed to return home. If the lesions progress, the patients remain hospitalized for further monitoring, a new brain scan and neurosurgical advice.

This study seeks to show that the performance of systematic brain imaging in the absence of clinical deterioration of patients admitted to the UHCD for post-traumatic intracranial hemorrhage could be avoided, and thus to administer an unnecessary dose of irradiation to the patients, and would also have a significant financial stake.

Several recent studies have shown that there is no need to perform a follow-up brain scan in the absence of neurological deterioration, even in anticoagulated patients or those on antiplatelet drugs. Despite the growing number of articles, no recommendation or consensus has been proposed.

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


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

acronym: Renal-Colic

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

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


title: Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

acronym: Trauma-Head

summary:
The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.

The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.

The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.


title: Diagnostic Performance of Coronary Calcification Detection on CT Scan

acronym: Calci-DT

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

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


title: Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)

acronym: Stereotactic

summary:
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management.

The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer.

Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.

location_facility: Service de chirurgie thoracique - CHU de Strasbourg - France


title: Spontaneous Pneumothorax in Adolescents: Inventory and Management

acronym: PNSA

summary:
Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing.

In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg

location_facility: Service de Chirurgie pédiatrique - CHU de Strasbourg - France


title: Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia

summary: Congenital duodenal atresia is a common cause of neonatal obstruction affecting 1 in 5000-10000 neonates. Laparoscopic management of this malformation is becoming increasingly common. However, few comparative studies exist and are often monocentric including few patients. This study will be multicentric, international and comparative to determine the place of laparoscopic surgery in the management of congenital duodenal atresia.


title: Primary Obstructive Megaureter Management in Eastern Interregional Area : Current Status and Perspectives

acronym: POMME

summary: Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and increased collagen 1 level. This malformation is accessible to antenatal screening from the second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed, this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney function.


title: Effects of Tango on Older People With Dementia. Randomized Controlled Study.

summary:
Cognitive impairment (CI) is the leading cause of loss of autonomy and has a huge impact on physical performance and quality of life (QOL) in older people. Pharmacological treatments currently available have modest efficacy at best. Dance as both artistic and physical activity, combining emotions, social interaction, and sensory stimulation, therefore appears as a non-pharmacological intervention, which could contribute to the prevention of functional decline.

Among all the existing dances, tango occupies a special place because of the cultural and emotional resonance it carries, but also because of what it leads to motor mobilization (variations in the rhythm of walking, rotation of the belts, weight transfers…). These characteristics seem to make the tango an excellent tool for the rehabilitation of balance and gait, as well as for the prevention of the loss of autonomy in older adults with CI.

The objective of this study is to evaluate and compare the effectiveness of an intervention based on tango and classical physical activity.

lead_sponsor: University of Burgundy

location_facility:
Centre Hospitalier du Mont d'Or
Ehpad Du Chg Le Val D'Or


title: Interest of Continuous Monitoring of the Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Gestures With a Flat Panel Detector

acronym: CIMVER

summary:
The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation.

The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection

location_facility: Service d'Imagerie Interventionnelle - CHU de Strasbourg - France


title: Transesophageal Echocardiography (TEE) and Simulation : a Preferred Learning Path

acronym: TEE

summary:
Transesophageal echocardiography (TEE) has gradually become the technique of choice for continuous functional examination of the heart despite the significant training required for its interpretation. It has proven to be the safest, fastest, and most reliable technique for diagnosing most intra- and postoperative hemodynamic problems. Indeed, the transesophageal route is particularly well adapted to the situation of intubated patients, whether in the operating room, in the outpatient department or in intensive care. It offers images that are easier to obtain and of better quality than the transthoracic route; it can be performed without interfering with surgical activity or resuscitation. However, TEE training is often poor during the DES training in anesthesia and resuscitation, reserved for the few interns who will learn in a specific department where TEE is used on a daily basis.

Thus, simulation is a logical and recognized means by which technical aspects, mechanisms involved in the understanding of a situation, reasoning and decision making can be analyzed and improved.

The RFE SFAR 2019 recommendations suggest the use of simulation for the learning of technical gestures in initial training in order to improve their acquisition.

This study is therefore part of a technical and diagnostic improvement of a practice, which appears to be essential in several fields in anesthesia and intensive care, for a technique still not sufficiently acquired by many future practitioners.

location_facility: Service de Réanimation Chirurgicale - CHU de Strasbourg - France


title: Non-opioid Anesthesia in Bariatric Surgery

acronym: BARIA

summary:
Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Studies are not yet numerous enough to affirm a real benefit.

Obese patients are potentially able to benefit from the reduction in the use of morphine during surgery, in terms of quality of postoperative analgesia, side effects (respiratory depression, ileus, somnolence) and early rehabilitation.