title: Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement. Comparison With Baseline Low Molecular Weight Heparin Prophylaxis

acronym: TBP-ASPIR

summary:
Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Venous thrombosis is a potentially serious complication after PTH and PTG, justifying various prophylactic measures. In France, aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event.

More recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. While this molecule is potentially less effective than LMWHs or ADOs, it could decrease the risk of iatrogenic hemorrhage. The introduction of enhanced recovery procedures after surgery (RAAC) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current French recommendations when The operated follows such a protocol.

location_facility: Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg


type: Registry Identifier

title: Efficiency in Population of Influenza Vaccination for Seasonal 2012-2013 for Flu Prevention of the Hospitalized Adults: an Observational Study

acronym: FLUVAC EV-02

summary: This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Anticipated

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

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Grant/Funding Number

title: Effects of Early Crawling Training on the Motor Development of Very Premature Infants Without Major Brain Damage

summary:
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In our previous studies, we discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that we designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.

The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as median risk for developmental delay.

Methodology: We will study and follow three groups of very premature infants born between 24 and 32 weeks of gestational age without major brain lesions. These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), one group of infants will be trained at home by physiotherapists positioned prone on a mattress (Mattress group) and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1) their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 24 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 24 months CA : BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.

Expected results: Our first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive mattress training or no training.

study_start_date_type: Actual

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: IPD will be made available upon reasonable request to corresponding author

lead_sponsor: Marianne Barbu-Roth

sponsor_collaborators:
Marianne Barbu-Roth
Ecole Pratique des Hautes Etudes

location_facility:
Cnrs Umr 8002
APHP

intervention_type: Behavioral

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Heparin Free Hemodialysis for Patients With Bleeding High Risk in ICU. Randomized Study: Heparin Free Dialysis With Intermittent Saline Flushes Versus Heparin Free Dialysis With Nephral 400ST (AN69ST, Hospal, France)

summary: The purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding

lead_sponsor: Centre Hospitalier Départemental

intervention_type: Device


title: Prevention of PostConcussion-Like Symptoms for Patients Presenting at the Emergency Room: A Randomized Controlled Study of Early Single Eye Movement Desensitization and Reprocessing (EMDR) Intervention Versus Usual Care

summary: Millions people, all over the world, are admitted in the Emergency Department after a trauma or simply to receive medical cares. In France, it represents 10 million patients. Probably because of stress associated with the event, 20% will suffer a combination of non-specifics symptoms which persist for many months and with daily life quality impairment. The investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of these symptoms.

status: Completed

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Gil-Jardine C, Al Joboory S, Jammes JTS, Durand G, Ribereau-Gayon R, Galinski M, Salmi LR, Revel P, Regis CA, Valdenaire G, Poulet E, Tazarourte K, Lagarde E. Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial. Trials. 2018 Oct 12;19(1):555. doi: 10.1186/s13063-018-2902-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Centre Hospitalier de Cadillac, France
Hospices Civils de Lyon

location_facility: Emergency department, Bordeaux University Hospital

status_simplified: Completed


title: Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe

acronym: Euro-COVIMID

summary:
The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents.

In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases.

In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs.

Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Pope JE. What Does the COVID-19 Pandemic Mean for Rheumatology Patients? Curr Treatm Opt Rheumatol. 2020;6(2):71-74. doi: 10.1007/s40674-020-00145-y. Epub 2020 Apr 30.

ReferenceCitation: Favalli EG, Agape E, Caporali R. Incidence and Clinical Course of COVID-19 in Patients with Connective Tissue Diseases: A Descriptive Observational Analysis. J Rheumatol. 2020 Aug 1;47(8):1296. doi: 10.3899/jrheum.200507. Epub 2020 Apr 25. No abstract available.

ReferenceCitation: Mathian A, Mahevas M, Rohmer J, Roumier M, Cohen-Aubart F, Amador-Borrero B, Barrelet A, Chauvet C, Chazal T, Delahousse M, Devaux M, Euvrard R, Fadlallah J, Florens N, Haroche J, Hie M, Juillard L, Lhote R, Maillet T, Richard-Colmant G, Palluy JB, Pha M, Perard L, Remy P, Riviere E, Sene D, Seve P, Morelot-Panzini C, Viallard JF, Virot JS, Benameur N, Zahr N, Yssel H, Godeau B, Amoura Z. Clinical course of coronavirus disease 2019 (COVID-19) in a series of 17 patients with systemic lupus erythematosus under long-term treatment with hydroxychloroquine. Ann Rheum Dis. 2020 Jun;79(6):837-839. doi: 10.1136/annrheumdis-2020-217566. Epub 2020 Apr 24. No abstract available.

ReferenceCitation: Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2. No abstract available.

ReferenceCitation: Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16. No abstract available.

ReferenceCitation: Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.

ReferenceCitation: Saadoun D, Vieira M, Vautier M, Baraliakos X, Andreica I, da Silva JAP, Sousa M, Luis M, Khmelinskii N, Gracia JMA, Castrejon I, Gonzalez JCN, Scire CA, Silvagni E, Bortoluzzi A, Penn H, Hamdulay S, Machado PM, Fautrel B, Cacoub P, Resche-Rigon M, Gossec L. SARS-CoV-2 outbreak in immune-mediated inflammatory diseases: the Euro-COVIMID multicentre cross-sectional study. Lancet Rheumatol. 2021 Jul;3(7):e481-e488. doi: 10.1016/S2665-9913(21)00112-0. Epub 2021 Apr 28.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Universidad de Coimbra - Estudo Geral

repository_institution: Universidade de Coimbra - Estudo Geral

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

ipd_sharing: Undecided

lead_sponsor: Pitié-Salpêtrière Hospital

sponsor_collaborators:
Pitié-Salpêtrière Hospital
Università degli Studi di Ferrara
Rheumazentrum Ruhrgebiet
University College, London
University of Coimbra
Universidad Complutense de Madrid


title: National Retrospective Study of Duodenal Trauma

acronym: TRAUMADUOD

summary:
Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Additionally, the penetrating mechanism is four times more common than blunt trauma and the most common duodenal site of injury is the second portion (36 %), the least being the first duodenum (13 %). These particularities generate a high morbidity, ranging from 22 to 27.1 %, and a mortality still as high as 5.3 to 30 % today. When facing it, surgeons are usually challenged in their strategy. Indeed, when surgery is required, different options can be chosen depending on the grade of the lesion and the involvement of the papilla and/or other organs. Primary repairs, duodenal diverticulization, pyloric exclusion, gastrojejunostomy, retrograde duodenostomy, distal feeding tube, or even resection and Whipple procedures, have all been described. Since the classification of the American Association for the surgery of trauma (AAST), most studies stratified their management as such: drainage only or primary repair for grade 1 and 2, jejunostomy and/or pyloric exclusion for grade 3, Whipple for grade 4 or 5. However, reviews of the literature aren't clear if this decisional tree is in correlation with lower morbidities, and often different procedures have been reported for the same grade. The escalation of technical exclusions among severe grades became controversial. As an example, pyloric exclusion has been criticized in its preventive role of protecting the suture, being useless at least, or even worse at times. Thus, in the recent years, the management has been focused towards minimization. Indeed, in the retrospective review of the Pan-American trauma society primary repair alone was performed in 80 % of cases, all grades comprised. Although mortality was high, duodenal suture line leak was statistically lower among survivors over every grade.

To clear the situation, prospective studies are difficult if not impossible in such context. Thus, The investigators propose this national benchmark, to retrospectively review in France the management of duodenal trauma, depending on the grade, and its associated morbidity.

status: Recruiting

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation de la Formation Des infirmières à la Stimulation de l'oralité Des Nouveau-nés Dans Une unité de Réanimation néonatale et Néonatologie : Impact Sur Les Connaissances, Les Pratiques et Sur la qualité Des Soins

acronym: TOP

summary:
Poor oral motor development in preterm neonates is common. Feeding problems lead to longer hospital stay and higher hospital cost. Different interventions have shown their efficacy to accelerate transition and move faster to full oral feeding autonomy. Our study aimed to evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay of preterm neonates.

This is an interrupted time series study placed in Intensive Care and Neonatal unit of an university hospital located in Lyon, France. All preterm neonates are included in the study, from April 2013 to January 2016.

time_perspective: Prospective

ReferenceCitation: Touzet S, Beissel A, Denis A, Pillet F, Gauthier-Moulinier H, Hommey S, Claris O; TOP Study Group. Effectiveness of a nurse educational oral feeding programme on feeding outcomes in neonates: protocol for an interrupted time series design. BMJ Open. 2016 Apr 15;6(4):e010699. doi: 10.1136/bmjopen-2015-010699.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: British Medical Journal

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon


title: Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.

acronym: cSAH

summary:
Transient focal neurological episode (TFNE) is the most frequent presenting symptom of convexity subarachnoid haemorrhage (cSAH) in elderly patients with non-traumatic cSAH with suspected, possible or probable cerebral amyloid angiopathy (CAA). The aim of our study was to analyse in detail clinical and MRI characteristics in these patients.

Methods: We performed a retrospective study analysing baseline, acute clinical symptom (TFNE and headache), and MRI characteristics (acute cSAH and chronic CAA features) of consecutive elderly (≥55 years) patients, recruited and registered in the stroke database, between june 2008 and october 2020 of two centres (Nîmes and Montpellier University Hospital, France), presenting with cSAH with suspected, possible, or probable CAA.

ReferenceCitation: Autieri V, Gaillard N, Mourand I, Laurent-Chabalier S, Mura T, Trandafir C, Wacongne A, de Champfleur NM, Thouvenot E, Pereira F, Renard D. Primary acute convexity subarachnoid hemorrhage in older patients: analysis of baseline, clinical and MRI characteristics including quantitative surface study and topographical probabilistic mapping of convexity subarachnoid hemorrhage. Acta Neurol Belg. 2023 Apr;123(2):519-527. doi: 10.1007/s13760-022-02115-8. Epub 2022 Oct 14.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


type: Other Identifier

title: FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

acronym: FLOWER-MI

summary:
Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).

The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.

The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.

ReferenceCitation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

evidence: open (via free article)

repository_institution: University of Bern - Bern Open Repository and Information System

publisher_dissemination: Oxford University Press

ReferenceCitation: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

ReferenceCitation: Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025.

ReferenceCitation: Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.

ReferenceCitation: Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.

version: submittedVersion

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

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

repositories_concat: HAL

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

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

oa_host_type: publisher

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Puymirat E, Simon T, de Bruyne B, Montalescot G, Steg G, Cayla G, Durand-Zaleski I, Blanchard D, Danchin N, Chatellier G; FLOWER-MI study investigators. Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial. Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators:
Abbott
Ministry of Health, France

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Abbott
Ministry of Health, France

intervention_type: Procedure

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: FLOWER MI

titre: Apports de la mesure de la réserve coronaire pour guider la revascularisation coronaire percutanée chez les patients pluri tronculaires pris en charge pour un syndrome coronarien aigu avec sus décalage ST.

discipline_principale: cardiologie

nom_porteur: PUYMIRAT

prenom_porteur: Etienne


title: Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment

acronym: ORPHEE

summary: Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.

lead_sponsor: LivaNova

location_facility: CHU Groupe Hospitalo-universitaire Caremeau


title: Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

acronym: LA

summary:
Lupus anticoagulants (are antiphospholipid antibodies (PSA), the screening of which is done by demonstrating prolongation of coagulation times corrected by the intake of phospholipids (PL).

Learned societies (ISTH, CLSI) thus recommend, for the research of LA, to carry out initially two screening tests with a low concentration in PL: a time of diluted Russell viper venom (DRVVT) as well as a time activated partial thromboplastin (TCA). If one of these screening tests is positive, it is recommended to perform a second confirmation test using the same principle (DRVVT or TCA) and containing a higher concentration of PL.

The current LA screening method at the Hematology Laboratory of Strasbourg University Hospital includes: a pair of DRVVT screening / confirmation (STA-Staclot DRVV Screen and Confirm, Diagnostica Stago, France) and a screening TCA (PTT-A , Diagnostica Stago, France).

This study aims to compare with the current method of the investigators a pair of TCA screening / confirmation (Cephen LS / Cephen, Hyphen Biomed, France).

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg


title: Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department

acronym: BIODINER

summary: The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea.

lead_sponsor: ThermoFisher Scientific Brahms Biomarkers France

location_facility: Emergency department of Pitié Salpetriere Hospital


title: Implication of UNconventionaL T Lymphocytes in Cystic Fibrosis

acronym: UNLOCk

summary:
Cystic fibrosis (CF) is characterized by a decrease in mucociliary clearance, recurrent infections and airway inflammation. This inflammatory process in airway mucosa is persistent, uncontrolled, but, somewhat paradoxically, ineffective for pathogen clearance. Neutrophils are chronically recruited in the airway mucosa by proinflammatory mediators such as Interleukin (IL)-17. However, mechanisms involved in this dysregulated and persistent immune response are not well understood.

In this context, a heterogeneous subpopulation of T lymphocytes called "unconventional T cells" (UTC) should deserve greater attention. UTC play a key role in orchestrating the ensuing innate and adaptive immune responses and they are endowed with numerous regulatory and effector properties. UTC mainly establish residency at mucosal sites, including the lung. To date, however, data related to implication and behavior of UTC during cystic fibrosis are extremely limited.

The hypothesis is that, given UTC properties, their functions and behavior are altered in CF, and thus, these cells could be implicated in persistent inflammation and poor response to infections.

The objective is to study UTC properties and functions in cystic fibrosis using blood and sputum samples of patients with CF, in correlation with comprehensive clinical and microbiological data.

The study will enroll adult patients with CF followed-up at University Hospital of Tours, France. For each patient included, blood and sputum samples will be analyzed during 18 months 1/ from routine tests obtained at steady state and 2/ from tests performed during acute exacerbations. UTC will be explored in blood and sputum using flowcytometry approach, to evaluate their relative abundance, activation/inhibition profile and functions (cytokine production and cytotoxic ability). Correlation will be made with clinical status, with longitudinal comparison across the study period for each patient, and comparison with the other patients and healthy volunteers.

This study will add significant knowledge in CF immunopathology by comprehensively assess UTC presence, functions and activation in CF. Indeed, UTC could be explored for disease progression marker, and, in a long-term perspective, explored for therapeutic interventions aiming at modulating their function (by activating or inhibiting UTC), to reshape lung immune response during CF.

lead_sponsor: University Hospital, Tours

location_facility: Pulmonology Department, University Hospital, Tours

location_facility: Cystic Fibrosis Resource and Competence Center, University Hospital, Tours


title: Impact of th Covid-19 Epidemic on Acute Stroke Management

summary:
The Covid-19 pandemic is a pandemic of an emerging infectious disease, coronavirus 2019 (Covid-19), caused by the coronavirus SARS-CoV-2. It appears in November 2019 in the city of Wuhan, China, and spreads worldwide from February 2020. The first cases of infection in France were confirmed on 24 January 2020. As of April 14, 103,573 cases of infection were confirmed, 32,292 hospitalized cases, including 6,730 in intensive care, with 15,729 deaths recorded1. The most affected regions are Ile de France and the Grand Est (in particular the Haut-Rhin department). Containment of the entire French population was introduced on 17 March, with the aim of reducing the spread of the virus and relieving the burden on the health system, particularly the intensive care units.

This unprecedented health crisis, as well as the social containment measures in themselves, has repercussions on other acute medical pthologies, not directly related to the viral infection. It appears that the number of patients treated for acute stroke has suddenly declined since the beginning of the epidemic.

However, it is not clear whether it is the incidence of stroke that has declined or simply the proportion of patients presenting within the time frame that allows for treatment in the acute phase (by thrombolysis or thrombectomy).

time_perspective: Other

location_facility: Service de Neuroradiologie Interventionnelle


title: Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

acronym: ENS

summary: The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

primary_purpose: Supportive Care

ReferenceCitation: Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.

ReferenceCitation: Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.

ReferenceCitation: Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.

ReferenceCitation: Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.

lead_sponsor: Institut Mutualiste Montsouris

sponsor_collaborators:
Institut Mutualiste Montsouris
Fondation Paul Bennetot
Assistance Publique - Hôpitaux de Paris


title: Anatomical and Functional Assessment of Ex-vivo Coronary Perfusion

acronym: ECHORONEX

summary:
Heart transplantation is the gold standard treatment for advanced heart failure, with a survival rate >60% at 10 years. Heart transplantation activity has tended to decline significantly in France since 2017, with -5% of transplants per year according to the Agence de la Biomédecine report (La Plaine-Saint-Denis, France, https://rams.agence-biomedecine.fr). Graft selection criteria have been extended over the past two decades, in particular the average donor age, which currently exceeds 50 in France. These donors with extended criteria are more exposed to the risk of acquired coronary lesions. The current indications for donor coronary angiography are age >55 or >45 with at least two cardiovascular risk factors, but it is performed in only a third of these cases. Coronary angiography would increase the chances of graft acceptance by 9%.

At the same time, some heart transplants are rejected for lack of a complete functional evaluation, or because they present moderate left ventricular dysfunction. In catecholaminergic stress cardiomyopathy, left ventricular dysfunction is reversible, but its recovery kinetics are difficult to predict. Ex vivo resuscitation of these grafts on a perfusion machine could enable functional recovery and acceptance of these grafts for transplantation. This approach could also be applied to other cardiac grafts harvested from donors with extended criteria, such as prolonged cardiac arrest.

Graft preservation on ex vivo perfusion machines has enjoyed considerable growth over the past decade. The Organ Care System (OCS, TransMedics, Andover, USA) is currently the only transportable perfusion machine available and marketed for clinical use, with experience of over 1,000 transplants worldwide. OCS technology is based on isolated ex vivo perfusion of the heart with normothermic blood in Langendorff mode (retrograde aortic perfusion). This transportable platform enables metabolic evaluation of the graft based on the concentration of circulating lactate in the perfusate, a criterion of viability and "transplantability". The aims of this alternative method to static hypothermic preservation of heart grafts are threefold: 1) to extend the preservation time of the heart graft; 2) to assess graft viability prior to transplantation; 3) to resuscitate a heart graft harvested after controlled circulatory arrest (Maastricht 3).

Since February 2019, 31 heart grafts have been placed on OCS in France thanks to the implementation of an ex vivo perfusion program at the Lille and Rennes teaching hospitals, and the Marie Lannelongue Hospital. Our preliminary results have recently been accepted for publication. In this research project, we propose to analyze in real time the quality of coronary perfusion using vasculoscopy on isolated human hearts placed on OCS, and to put this anatomical and functional assessment into perspective with the results of heart transplantation.

Indeed, vasculoscopy is an innovative non-invasive imaging approach that has never before been applied in the cardiovascular field. We aim to validate this technology in the assessment of myocardial perfusion quality of the machine-perfused graft awaiting transplantation, by correlating the signal obtained with perfusion parameters on OCS (coronary flow, mean aortic pressure, arterial and venous lactate) as well as with transplant outcomes (primary graft failure rate, recipient survival rate at one month post-transplant). Myocardial perfusion parameters have never been correlated with heart transplantation outcomes to date.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: National, Multicentre, Non-interventional, Prospective and Retrospective Study in Adolescent Patients With Severe Uncontrolled Asthma Starting Treatment With Dupilumab (Dupixent®)

acronym: PEDIASTHMA

summary:
Primary objective:

- Describe the characteristics of enrolled severe asthma patients

Secondary objectives:

Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year
Assess the clinical objectives of the asthma care
Assess comorbidities associated with Type 2 inflammation
Assess safety during the year of treatment

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi


title: The SMS Study, a National Study on Prevalence of Unexplained Splenomegaly Etiologies

acronym: SMS

summary:
Primary Objective:

To estimate the prevalence of Gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams (e.g. full blood count, liver enzymes, reticulocytes)

Secondary Objective:

To describe the exams and tests conducted for diagnosis purpose and the more frequent associations


title: What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction

acronym: SAPRA

summary:
Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.

The purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.

Investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.


title: Measurement of Physical and Biochemical Markers of Reperfusion Edema During Primary Graft Dysfunction Following Lung Transplantation. Assessment of Their Diagnosis and Prognosis Values

summary: Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.

ReferenceCitation: Pottecher J, Roche AC, Degot T, Helms O, Hentz JG, Schmitt JP, Falcoz PE, Santelmo N, Levy F, Collange O, Uring-Lambert B, Bahram S, Schaeffer M, Meyer N, Geny B, Lassalle P, Diemunsch P, Massard G, Kessler R, Steib A; Groupe de Transplantation Pulmonaire des Hopitaux Universitaires de Strasbourg. Increased Extravascular Lung Water and Plasma Biomarkers of Acute Lung Injury Precede Oxygenation Impairment in Primary Graft Dysfunction After Lung Transplantation. Transplantation. 2017 Jan;101(1):112-121. doi: 10.1097/TP.0000000000001434.

location_facility: Service de Chirurgie thoracique - Nouvel Hôpital Civil - 1, Place de l'hôpital

location_facility: Service de Pneumologie - Nouvel Hôpital Civil -1, Place de l'hôpital

location_facility: Service d'Anesthésie-Réanimations chirurgicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Service de Physiologie et d'Explorations fonctionnelles - Nouvel Hôpital Civil - 1, Place de l'hôpital


title: Lyon Sarcoid Uveitis Cohort

acronym: LUCS

summary:
Sarcoidosis is a systemic disease with unknown etiology. Chronicity of the disease is observed in 1/3 of cases. Five percent of the affected patients are expected to die due to pulmonary worsening. After pulmonary complications, ocular complications are one of the most frequent complications. In hospital setting 2 to 15% of patients who come for initial uveitis diagnosis are after examination due to Sarcoidosis. Sarcoidosis diagnosis is based on paraclinical exams (biological, radiography) and histological confirmation. Corticotherapy (local or general) is usually used to cure sarcoid uveitis. In case of failure immunosuppressor or anti-tumor necrosis factor (TNF) can be used. In 10% of cases ocular symptoms including blindness are observed. Only treatment administrated quickly after diagnosis of sarcoid uveitis can prevent from ophthalmologic complications.

The main objective of the Lyon Sarcoid Uveitis Cohort study is to analyze the relevance of the paraclinical exam for sarcoid uveitis diagnosis, and to define a better visual and extra-ophthalmologic prognosis and describe the therapeutic practice in our Department.

This study is proposed to all patients diagnosed with Sarcoid uveitis with a histological confirmation and referred to the internal medicine department of the Croix-Rousse hospital, Lyon, France, for etiologic diagnosis or treatment.

ReferenceCitation: Danjou W, Pradat P, Jamilloux Y, Gerfaud-Valentin M, Kodjikian L, Trad S, Seve P. Usefulness of the QuantiFERON test for the diagnosis of tubercular uveitis and the predictions of response to antituberculosis treatment. Br J Ophthalmol. 2023 Apr;107(4):500-504. doi: 10.1136/bjophthalmol-2021-318868. Epub 2021 Oct 28.

ReferenceCitation: Cotte P, Pradat P, Kodjikian L, Jamilloux Y, Seve P. Diagnostic value of lymphopaenia and elevated serum ACE in patients with uveitis. Br J Ophthalmol. 2021 Oct;105(10):1399-1404. doi: 10.1136/bjophthalmol-2020-316563. Epub 2020 Sep 11.

oa_colors: green hybrid

evidence: open (via page says license)


title: Violence Sexual Incidence During the First Year of Residence in the French Territory on Asylum Seekers in Marseille and Nice

acronym: INCIDAVI

summary:
Asylum seekers women are particularly exposed to sexual violence. One in seven women in France and one in three in the world say they have been a victim of sexual violence at least once in her life.

The main objective of this study is to measure the incidence of sexual violence suffered by women in asylum proceedings during their first year of stay on French territory, in Marseille and Nice.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
Chu de Nice
AP-HM


intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.

title: A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)

type: EudraCT Number

source: euctr

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


title: Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.

summary: Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.

lead_sponsor: Hopital Foch


title: Analysis of Events of Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation

acronym: TubeObs-Covid

summary: The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.

location_facility: Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil


title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France

summary: Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Général Louis Pasteur

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: CH d'Avignon - Centre Hospitalier Henri Duffaut


title: Diagnostic and Prognostic Value of Cardiac Biomarkers and Echocardiography for Patients Hospitalized Due to Acute Dyspnea: Prospective Observational Multicenter Cohort Study

acronym: LEDA

summary:
LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective observational cohort multicenter clinical study. Project is carried out by Vilnius University together with a partner Lithuanian University of Health Sciences, in conjunction with a research protocol of international GREAT consortium (Global Research on Acute Conditions Team). The aim of this project is to find the specific novel biomarkers of acute heart failure (AHF), to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2) post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1 and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular mortality and rehospitalization.

During the project a sizeable national database (2000 Lithuanian patients) will be integrated into database of GREAT network. Novel cardiac biomarkers together with ultrasound parameters of right ventricular (RV) function are in the focus of the study. During the acute phase of heart failure, up to 15 novel cardiac, vascular, renal impairment and inflammation biomarkers in plasma samples will be investigated in Lithuania and France (INSERM laboratory). Plasma samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch analysis. The extensive evaluation of innovative ultrasound parameters of right ventricular structure and function will be performed in the early hospitalization period, along with standard echocardiography examination. The first database of AHF patients in Lithuania will provide demographic data and trends of morbidity and mortality, as well as analysis of diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the Baltic region. Quantitative parameters of RV systolic function and deformation will be measured. It is expected that optimal use of novel biomarkers and reproducible echocardiography parameters in the setting of emergency and critical care would reduce unnecessary hospitalizations, cost and hospital length of stay without decrease in the quality of diagnostics and treatment. An estimation of correlation of echocardiographic parameters and biomarkers could help create an accurate algorithm for risk stratification and diagnosis of AHF in an emergency setting.

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ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

ReferenceCitation: Zannad F, Mebazaa A, Juilliere Y, Cohen-Solal A, Guize L, Alla F, Rouge P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. doi: 10.1016/j.ejheart.2006.01.001. Epub 2006 Mar 3.

ReferenceCitation: Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.

ReferenceCitation: Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.

ReferenceCitation: Peacock WF, Emerman C, Costanzo MR, Diercks DB, Lopatin M, Fonarow GC. Early vasoactive drugs improve heart failure outcomes. Congest Heart Fail. 2009 Nov-Dec;15(6):256-64. doi: 10.1111/j.1751-7133.2009.00112.x.

ReferenceCitation: Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.

ReferenceCitation: Maisel AS, McCord J, Nowak RM, Hollander JE, Wu AH, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7. doi: 10.1016/s0735-1097(03)00405-4.

ReferenceCitation: Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032.

ReferenceCitation: Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.

ReferenceCitation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

publisher_dissemination: Wiley

ReferenceCitation: Chioncel O, Ambrosy AP, Bubenek S, Filipescu D, Vinereanu D, Petris A, Christodorescu R, Macarie C, Gheorghiade M, Collins SP; Romanian Acute Heart Failure Syndromes study investigators. Epidemiology, pathophysiology, and in-hospital management of pulmonary edema: data from the Romanian Acute Heart Failure Syndromes registry. J Cardiovasc Med (Hagerstown). 2016 Feb;17(2):92-104. doi: 10.2459/JCM.0000000000000192.

ReferenceCitation: Belohlavek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism. Exp Clin Cardiol. 2013 Spring;18(2):129-38.

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ReferenceCitation: Berlin DA, Bakker J. Understanding venous return. Intensive Care Med. 2014 Oct;40(10):1564-6. doi: 10.1007/s00134-014-3379-4. Epub 2014 Jun 26. No abstract available.

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ReferenceCitation: Markel TA, Wairiuko GM, Lahm T, Crisostomo PR, Wang M, Herring CM, Meldrum DR. The right heart and its distinct mechanisms of development, function, and failure. J Surg Res. 2008 May 15;146(2):304-13. doi: 10.1016/j.jss.2007.04.003. Epub 2007 Nov 26.

ReferenceCitation: Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068.

ReferenceCitation: Lankeit M, Jimenez D, Kostrubiec M, Dellas C, Hasenfuss G, Pruszczyk P, Konstantinides S. Predictive value of the high-sensitivity troponin T assay and the simplified Pulmonary Embolism Severity Index in hemodynamically stable patients with acute pulmonary embolism: a prospective validation study. Circulation. 2011 Dec 13;124(24):2716-24. doi: 10.1161/CIRCULATIONAHA.111.051177. Epub 2011 Nov 14.

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ReferenceCitation: Naito A, Tanabe N, Jujo T, Shigeta A, Sugiura T, Sakao S, Ishida K, Tatsumi K. Pentraxin3 in chronic thromboembolic pulmonary hypertension: a new biomarker for screening from remitted pulmonary thromboembolism. PLoS One. 2014 Nov 20;9(11):e113086. doi: 10.1371/journal.pone.0113086. eCollection 2014.

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ReferenceCitation: Zannad F, Adamopoulos C, Mebazaa A, Gheorghiade M. The challenge of acute decompensated heart failure. Heart Fail Rev. 2006 Jun;11(2):135-9. doi: 10.1007/s10741-006-9484-x.

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ReferenceCitation: De Luca L, Fonarow GC, Adams KF Jr, Mebazaa A, Tavazzi L, Swedberg K, Gheorghiade M. Acute heart failure syndromes: clinical scenarios and pathophysiologic targets for therapy. Heart Fail Rev. 2007 Jun;12(2):97-104. doi: 10.1007/s10741-007-9011-8.

ReferenceCitation: Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91. doi: 10.1001/jama.297.17.1883.

ReferenceCitation: Adamopoulos C, Zannad F, Fay R, Mebazaa A, Cohen-Solal A, Guize L, Juilliere Y, Alla F. Ejection fraction and blood pressure are important and interactive predictors of 4-week mortality in severe acute heart failure. Eur J Heart Fail. 2007 Sep;9(9):935-41. doi: 10.1016/j.ejheart.2007.06.001. Epub 2007 Jul 12.

ReferenceCitation: Pang PS, Cleland JG, Teerlink JR, Collins SP, Lindsell CJ, Sopko G, Peacock WF, Fonarow GC, Aldeen AZ, Kirk JD, Storrow AB, Tavares M, Mebazaa A, Roland E, Massie BM, Maisel AS, Komajda M, Filippatos G, Gheorghiade M; Acute Heart Failure Syndromes International Working Group. A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach. Eur Heart J. 2008 Mar;29(6):816-24. doi: 10.1093/eurheartj/ehn048. Epub 2008 Mar 1.

ReferenceCitation: Huvelle E, Fay R, Alla F, Cohen Solal A, Mebazaa A, Zannad F. Left bundle branch block and mortality in patients with acute heart failure syndrome: a substudy of the EFICA cohort. Eur J Heart Fail. 2010 Feb;12(2):156-63. doi: 10.1093/eurjhf/hfp180. Epub 2009 Dec 21.

ReferenceCitation: Mebazaa A, Pang PS, Tavares M, Collins SP, Storrow AB, Laribi S, Andre S, Mark Courtney D, Hasa J, Spinar J, Masip J, Frank Peacock W, Sliwa K, Gayat E, Filippatos G, Cleland JG, Gheorghiade M. The impact of early standard therapy on dyspnoea in patients with acute heart failure: the URGENT-dyspnoea study. Eur Heart J. 2010 Apr;31(7):832-41. doi: 10.1093/eurheartj/ehp458. Epub 2009 Nov 11.

ReferenceCitation: Bohm M, Link A, Cai D, Nieminen MS, Filippatos GS, Salem R, Cohen Solal A, Huang B, Padley RJ, Kivikko M, Mebazaa A. Beneficial association of beta-blocker therapy on recovery from severe acute heart failure treatment: data from the Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support trial. Crit Care Med. 2011 May;39(5):940-4. doi: 10.1097/CCM.0b013e31820a91ed.

ReferenceCitation: Laribi S, Aouba A, Nikolaou M, Lassus J, Cohen-Solal A, Plaisance P, Pavillon G, Jois P, Fonarow GC, Jougla E, Mebazaa A; GREAT network. Trends in death attributed to heart failure over the past two decades in Europe. Eur J Heart Fail. 2012 Mar;14(3):234-9. doi: 10.1093/eurjhf/hfr182. Epub 2012 Jan 10.

ReferenceCitation: Parissis JT, Rafouli-Stergiou P, Mebazaa A, Ikonomidis I, Bistola V, Nikolaou M, Meas T, Delgado J, Vilas-Boas F, Paraskevaidis I, Anastasiou-Nana M, Follath F. Acute heart failure in patients with diabetes mellitus: clinical characteristics and predictors of in-hospital mortality. Int J Cardiol. 2012 May 17;157(1):108-13. doi: 10.1016/j.ijcard.2011.11.098. Epub 2011 Dec 15.

ReferenceCitation: Mebazaa A, Vanpoucke G, Thomas G, Verleysen K, Cohen-Solal A, Vanderheyden M, Bartunek J, Mueller C, Launay JM, Van Landuyt N, D'Hondt F, Verschuere E, Vanhaute C, Tuytten R, Vanneste L, De Cremer K, Wuyts J, Davies H, Moerman P, Logeart D, Collet C, Lortat-Jacob B, Tavares M, Laroy W, Januzzi JL, Samuel JL, Kas K. Unbiased plasma proteomics for novel diagnostic biomarkers in cardiovascular disease: identification of quiescin Q6 as a candidate biomarker of acutely decompensated heart failure. Eur Heart J. 2012 Sep;33(18):2317-24. doi: 10.1093/eurheartj/ehs162. Epub 2012 Jun 24.

ReferenceCitation: Breidthardt T, Vanpoucke G, Potocki M, Mosimann T, Ziller R, Thomas G, Laroy W, Moerman P, Socrates T, Drexler B, Mebazaa A, Kas K, Mueller C. The novel marker LTBP2 predicts all-cause and pulmonary death in patients with acute dyspnoea. Clin Sci (Lond). 2012 Nov;123(9):557-66. doi: 10.1042/CS20120058.

ReferenceCitation: Mebazaa A, Gayat E, Lassus J, Meas T, Mueller C, Maggioni A, Peacock F, Spinar J, Harjola VP, van Kimmenade R, Pathak A, Mueller T, Tavazzi L, Disomma S, Metra M, Pascual-Figal D, Laribi S, Logeart D, Nouira S, Sato N, Parenica J, Deye N, Boukef R, Collet C, Van den Berghe G, Cohen-Solal A, Januzzi JL Jr; GREAT Network. Association between elevated blood glucose and outcome in acute heart failure: results from an international observational cohort. J Am Coll Cardiol. 2013 Feb 26;61(8):820-9. doi: 10.1016/j.jacc.2012.11.054. Epub 2013 Jan 16.

ReferenceCitation: Lassus J, Gayat E, Mueller C, Peacock WF, Spinar J, Harjola VP, van Kimmenade R, Pathak A, Mueller T, Disomma S, Metra M, Pascual-Figal D, Laribi S, Logeart D, Nouira S, Sato N, Potocki M, Parenica J, Collet C, Cohen-Solal A, Januzzi JL Jr, Mebazaa A; GREAT-Network. Incremental value of biomarkers to clinical variables for mortality prediction in acutely decompensated heart failure: the Multinational Observational Cohort on Acute Heart Failure (MOCA) study. Int J Cardiol. 2013 Oct 3;168(3):2186-94. doi: 10.1016/j.ijcard.2013.01.228. Epub 2013 Mar 26.

ReferenceCitation: Seronde MF, Gayat E, Logeart D, Lassus J, Laribi S, Boukef R, Sibellas F, Launay JM, Manivet P, Sadoune M, Nouira S, Solal AC, Mebazaa A; Great network. Comparison of the diagnostic and prognostic values of B-type and atrial-type natriuretic peptides in acute heart failure. Int J Cardiol. 2013 Oct 9;168(4):3404-11. doi: 10.1016/j.ijcard.2013.04.164. Epub 2013 May 14.

ReferenceCitation: Shah R, Gayat E, Januzzi JL Jr, Sato N, Cohen-Solal A, diSomma S, Fairman E, Harjola VP, Ishihara S, Lassus J, Maggioni A, Metra M, Mueller C, Mueller T, Parenica J, Pascual-Figal D, Peacock WF, Spinar J, van Kimmenade R, Mebazaa A; GREAT (Global Research on Acute Conditions Team) Network. Body mass index and mortality in acutely decompensated heart failure across the world: a global obesity paradox. J Am Coll Cardiol. 2014 Mar 4;63(8):778-85. doi: 10.1016/j.jacc.2013.09.072. Epub 2013 Dec 4.

ReferenceCitation: Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.

evidence: open (via crossref license)

ReferenceCitation: Pang PS, Collins SP, Sauser K, Andrei AC, Storrow AB, Hollander JE, Tavares M, Spinar J, Macarie C, Raev D, Nowak R, Gheorghiade M, Mebazaa A. Assessment of dyspnea early in acute heart failure: patient characteristics and response differences between likert and visual analog scales. Acad Emerg Med. 2014 Jun;21(6):659-66. doi: 10.1111/acem.12390.

ReferenceCitation: Mebazaa A, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

ReferenceCitation: Vodovar N, Seronde MF, Laribi S, Gayat E, Lassus J, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Ishihara S, Cohen Solal A, Januzzi JL Jr, Richards AM, Launay JM, Mebazaa A; GREAT Network. Post-translational modifications enhance NT-proBNP and BNP production in acute decompensated heart failure. Eur Heart J. 2014 Dec 21;35(48):3434-41. doi: 10.1093/eurheartj/ehu314. Epub 2014 Aug 24.

ReferenceCitation: Cohen-Solal A, Laribi S, Ishihara S, Vergaro G, Baudet M, Logeart D, Mebazaa A, Gayat E, Vodovar N, Pascual-Figal DA, Seronde MF. Prognostic markers of acute decompensated heart failure: the emerging roles of cardiac biomarkers and prognostic scores. Arch Cardiovasc Dis. 2015 Jan;108(1):64-74. doi: 10.1016/j.acvd.2014.10.002. Epub 2014 Nov 4.

ReferenceCitation: Parissis JT, Andreoli C, Kadoglou N, Ikonomidis I, Farmakis D, Dimopoulou I, Iliodromitis E, Anastasiou-Nana M, Lainscak M, Ambrosio G, Mebazaa A, Filippatos G, Follath F. Differences in clinical characteristics, management and short-term outcome between acute heart failure patients chronic obstructive pulmonary disease and those without this co-morbidity. Clin Res Cardiol. 2014 Sep;103(9):733-41. doi: 10.1007/s00392-014-0708-0. Epub 2014 Apr 10.

ReferenceCitation: Legrand M, Mebazaa A, Ronco C, Januzzi JL Jr. When cardiac failure, kidney dysfunction, and kidney injury intersect in acute conditions: the case of cardiorenal syndrome. Crit Care Med. 2014 Sep;42(9):2109-17. doi: 10.1097/CCM.0000000000000404.

ReferenceCitation: Kelly JP, Mentz RJ, Mebazaa A, Voors AA, Butler J, Roessig L, Fiuzat M, Zannad F, Pitt B, O'Connor CM, Lam CSP. Patient selection in heart failure with preserved ejection fraction clinical trials. J Am Coll Cardiol. 2015 Apr 28;65(16):1668-1682. doi: 10.1016/j.jacc.2015.03.043.

ReferenceCitation: Mebazaa A, Yilmaz MB, Levy P, Ponikowski P, Peacock WF, Laribi S, Ristic AD, Lambrinou E, Masip J, Riley JP, McDonagh T, Mueller C, deFilippi C, Harjola VP, Thiele H, Piepoli MF, Metra M, Maggioni A, McMurray J, Dickstein K, Damman K, Seferovic PM, Ruschitzka F, Leite-Moreira AF, Bellou A, Anker SD, Filippatos G. Recommendations on pre-hospital & early hospital management of acute heart failure: a consensus paper from the Heart Failure Association of the European Society of Cardiology, the European Society of Emergency Medicine and the Society of Academic Emergency Medicine. Eur J Heart Fail. 2015 Jun;17(6):544-58. doi: 10.1002/ejhf.289. Epub 2015 May 21.

ReferenceCitation: Mebazaa A, Longrois D, Metra M, Mueller C, Richards AM, Roessig L, Seronde MF, Sato N, Stockbridge NL, Gattis Stough W, Alonso A, Cody RJ, Cook Bruns N, Gheorghiade M, Holzmeister J, Laribi S, Zannad F. Agents with vasodilator properties in acute heart failure: how to design successful trials. Eur J Heart Fail. 2015 Jul;17(7):652-64. doi: 10.1002/ejhf.294. Epub 2015 Jun 4.

ReferenceCitation: Jaffe AS, Apple FS, Mebazaa A, Vodovar N. Unraveling N-terminal pro-B-type natriuretic peptide: another piece to a very complex puzzle in heart failure patients. Clin Chem. 2015 Aug;61(8):1016-8. doi: 10.1373/clinchem.2015.243626. Epub 2015 Jun 15. No abstract available.

ReferenceCitation: Gayat E, Caillard A, Laribi S, Mueller C, Sadoune M, Seronde MF, Maisel A, Bartunek J, Vanderheyden M, Desutter J, Dendale P, Thomas G, Tavares M, Cohen-Solal A, Samuel JL, Mebazaa A. Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure. Int J Cardiol. 2015 Nov 15;199:241-7. doi: 10.1016/j.ijcard.2015.07.039. Epub 2015 Jul 12.

ReferenceCitation: Vodovar N, Seronde MF, Laribi S, Gayat E, Lassus J, Januzzi JL Jr, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Cohen-Solal A, Richards AM, Launay JM, Mebazaa A; GREAT Network. Elevated Plasma B-Type Natriuretic Peptide Concentrations Directly Inhibit Circulating Neprilysin Activity in Heart Failure. JACC Heart Fail. 2015 Aug;3(8):629-36. doi: 10.1016/j.jchf.2015.03.011.

ReferenceCitation: Teixeira A, Parenica J, Park JJ, Ishihara S, AlHabib KF, Laribi S, Maggioni A, Miro O, Sato N, Kajimoto K, Cohen-Solal A, Fairman E, Lassus J, Mueller C, Peacock WF, Januzzi JL Jr, Choi DJ, Plaisance P, Spinar J, Mebazaa A, Gayat E; GREAT (Global Research on Acute Conditions Team) Network. Clinical presentation and outcome by age categories in acute heart failure: results from an international observational cohort. Eur J Heart Fail. 2015 Nov;17(11):1114-23. doi: 10.1002/ejhf.330. Epub 2015 Sep 30.

ReferenceCitation: Spinar J, Jarkovsky J, Spinarova L, Mebazaa A, Gayat E, Vitovec J, Linhart A, Widimsky P, Miklik R, Zeman K, Belohlavek J, Malek F, Felsoci M, Kettner J, Ostadal P, Cihalik C, Vaclavik J, Taborsky M, Dusek L, Littnerova S, Parenica J. AHEAD score--Long-term risk classification in acute heart failure. Int J Cardiol. 2016 Jan 1;202:21-6. doi: 10.1016/j.ijcard.2015.08.187. Epub 2015 Aug 28.

ReferenceCitation: Mebazaa A, Tolppanen H, Mueller C, Lassus J, DiSomma S, Baksyte G, Cecconi M, Choi DJ, Cohen Solal A, Christ M, Masip J, Arrigo M, Nouira S, Ojji D, Peacock F, Richards M, Sato N, Sliwa K, Spinar J, Thiele H, Yilmaz MB, Januzzi J. Acute heart failure and cardiogenic shock: a multidisciplinary practical guidance. Intensive Care Med. 2016 Feb;42(2):147-63. doi: 10.1007/s00134-015-4041-5. Epub 2015 Sep 14.

ReferenceCitation: Parissis J, Farmakis D, Kadoglou N, Ikonomidis I, Fountoulaki E, Hatziagelaki E, Deftereos S, Follath F, Mebazaa A, Lekakis J, Filippatos G. Body mass index in acute heart failure: association with clinical profile, therapeutic management and in-hospital outcome. Eur J Heart Fail. 2016 Mar;18(3):298-305. doi: 10.1002/ejhf.489. Epub 2016 Jan 28.

ReferenceCitation: Harjola VP, Mebazaa A, Celutkiene J, Bettex D, Bueno H, Chioncel O, Crespo-Leiro MG, Falk V, Filippatos G, Gibbs S, Leite-Moreira A, Lassus J, Masip J, Mueller C, Mullens W, Naeije R, Nordegraaf AV, Parissis J, Riley JP, Ristic A, Rosano G, Rudiger A, Ruschitzka F, Seferovic P, Sztrymf B, Vieillard-Baron A, Yilmaz MB, Konstantinides S. Contemporary management of acute right ventricular failure: a statement from the Heart Failure Association and the Working Group on Pulmonary Circulation and Right Ventricular Function of the European Society of Cardiology. Eur J Heart Fail. 2016 Mar;18(3):226-41. doi: 10.1002/ejhf.478.

ReferenceCitation: Van Aelst LN, Celutkiene J, Mebazaa A. Advanced heart failure: look right to prognosticate right! Eur J Heart Fail. 2016 May;18(5):573-5. doi: 10.1002/ejhf.533. No abstract available.

ipd_sharing_description: Individual participant data will be made available to other researchers via GREAT (Global REsearch on Acute Conditions Team) database

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

collaborators: Lithuanian University of Health Sciences

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

sponsor_collaborators: Lithuanian University of Health Sciences

location_facility: Lithuanian University of Health Sciences


title: Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)

summary: Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.

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

collaborators: Plateforme labellisée Inca - Institut Bergonié, Bordeaux

collaborators: Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris

location_facility: CEA / Centre National de Recherche en Génomique Humaine

intervention_type: Genetic


title: EVALUATION DE LA TOLERANCE ET DU PROFIL PHARMACOCINETIQUE DE DOSES ELEVEES DE FAVIPIRAVIR CHEZ LE VOLONTAIRE SAIN

acronym: FAVIDOSE

summary:
FAVIDOSE trial is a Phase I randomized, double blind controlled, monocentric, dose escalation clinical trial. The primary purpose of this trial is to evaluate tolerance of high doses of favipiravir for 14 days in healthy volunteers. This trial also looks to characterize favipiravir pharmacokinetics in blood and favipiravir levels in sperm. A pharmacogenetics analysis will be conducted in an attempt to identify genetic variants of metabolism and transport enzymes of favipiravir to explain the inter-individual variability of pharmacokinetic parameters of favipiravir.

Three sequential dose levels including distinctive participants:

level 1: D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning;
level 2: D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning;
level 3: D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning.

Three study groups of maximum of 8 participants, 6 receiving favipiravir and 2 receiving placebo per dose level, three dose levels proposed. Seven additional participants with the same follow up will be included and randomized (6:1 ratio) at the maximum tolerated dose level to allow a satisfactory accurate characterization of pharmacokinetics and pharmacogenetics of favipiravir and their determinants (maximum 39 participants in total, taking into account 8 participants - 2 per dose level - replaced because loss of follow-up before the end of treatment).

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: University Hospital Bichat - Claude Bernard


title: Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients

acronym: RESTIT

summary:
Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.

To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.

In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.

The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session

lead_sponsor: CHU de Reims


title: Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units

acronym: Co-PAP

summary:
Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process.

Kangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being.

Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity. This one can be assess by a new monitor called NIPΣ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone.

The investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity.

The study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)

acronym: FZR

summary: The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

ipd_sharing_description: The data will remain with the sponsor (Arcothova)

lead_sponsor: Arcothova

location_facility: Hôpital Européen Georges Pompidou, AP-HP


title: Longitudinal Study of the Effects of Neurofeedback Training on the Level of Relaxation in Healthy Population: Characterization at the Electrophysiological and Behavioral Levels

acronym: NEURORELAX

summary: This longitudinal study deals with the characterization of the electrophysiological and behavioral effects of alpha-based neurofeedback training on the brain networks involved in the relaxation process of healthy people.

primary_purpose: Basic Science

lead_sponsor: Centre National de la Recherche Scientifique, France

collaborators: Institut du Cerveau et de la Moelle Epinière

location_facility: Centre de Neuro-Imagerie de recherche (CENIR), ICM


title: Interest to Perform a Renal Biopsy Early in the Course of the Henoch-Schoenlein Nephritis

summary:
Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This condition is responsible for 10-15% of glomerulonephritis in children. The outcome is generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.

Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at 6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United Kingdom. The proportion of children with HS who develop renal disease is difficult to determine because the numbers reported in the literature are variable and depend greatly on the type of the reporting center, whether or not specialized in pediatric nephrology. Thus the proportion of renal disease varies from 20% to 100% of children with a HS.

The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions but histological classification is discussed and there is currently no consensus. Randomized studies are scarce and often do not allow to draw clear conclusions. A meta-analysis suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this study the definition of renal disease was very heterogeneous. The only classification of the HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC) which is the following: grade I: minimal glomerula abnormalities, grade II: pure proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI: pseudomesangiocapillary. However, this classification is questioned because it ignores other significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular and interstitial inflammation, the appearance of crescents (segmental or totally encompassing the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and arteriolar appearance in immunofluorescence.

There is currently no consensus on the criteria indicating the initiation of corticosteroid therapy whether oral or intra venous bolus. Some patients with severe clinical and / or histological initial presentation can evolve to remission spontaneously while others who have more moderate initial symptoms will evolve later to kidney failure. The management is therefore heterogeneous. In France, some centers perform a kidney biopsy almost always before starting treatment (or in the days following the start of treatment), while in other centers's treatment decision is based on the biology resulting from the glomerular disease, kidney biopsy being performed possibly in a second time in case of failure of the initial treatment.

Principal objective of the study: assessment of the interest for the long term outcome of performing early a kidney biopsy (before the establishment of treatment or within 15 days after the start of treatment) in children with HSN compare to kidney biopsy performed later (depending on the response to initial therapy) or not performed.

Secondary objective: assessment of the impact of early kidney biopsy (before the establishment of treatment or within of 15 days after the start of treatment) on the initial treatment HSN : does it modify or not the treatment started right before it (decided on clinical and biological criteria).


title: Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners

summary: This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.

primary_purpose: Other

ReferenceCitation: Essilini A, Le Dref G, Bocquier A, Kivits J, Welter A, Pulcini C, Thilly N; AntibioCharte scientific committee. French general practitioners' and patients' acceptability of a public commitment charter and patient information leaflets targeting unnecessary antibiotic use: a qualitative study. Antimicrob Resist Infect Control. 2022 Feb 8;11(1):32. doi: 10.1186/s13756-022-01065-3.

lead_sponsor: Central Hospital, Nancy, France

sponsor_collaborators:
Central Hospital, Nancy, France
University of Lorraine


title: Phonological Perception and Learning to Read : the Neuroanatomy of Reading in Congenitally Deaf Persons

summary: The aim of the research is to investigate phonological processing in deafness and to examine its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the ability to read is closely related to the ability to segment and represent speech units, the neuroanatomy of reading in deaf would be different from the one of hearing readers.

design_allocation: Non-Randomized

collaborators: Centre National de la Recherche Scientifique, France


title: Establishment of Normal Muscle Strength Measured by Hand-held Dynamometer and Muscle Mass Assessed by Ultrasonography for French Population

summary: Normal values for muscle strength using hand held dynamometer and muscle mass using echography are largely unknown. The objective of the present study is to establish normal values of these measurements in population living in France.

location_facility: Service d'exploration fonctionnelle Les Hôpitaux Universitaires de Strasbourg


title: Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards

summary: Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.

ReferenceCitation: de Lastours V, Chau F, Tubach F, Pasquet B, Ruppe E, Fantin B. Independent behavior of commensal flora for carriage of fluoroquinolone-resistant bacteria in patients at admission. Antimicrob Agents Chemother. 2010 Dec;54(12):5193-200. doi: 10.1128/AAC.00823-10. Epub 2010 Sep 27.

lead_sponsor: Association Pour le Recherche en Infectiologie et en Médecine Interne


title: Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

summary:
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.

Our project aims to study the performance and safety of personalized implants (personalized guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.

lead_sponsor: SLS France

sponsor_collaborators:
SLS France
Global D

location_country: Belgium France

location_facility:
Cabinet Orhognatic
Cabinet chirurgie Maxillo-faciale
Hôpital Villefranche sur Sâone


title: Study of the Prevalence of Fabry Disease in French Dialysis Patients

acronym: FABRYDIAL

summary:
Fabry Disease (FD) is a rare genetic lysosomal storage disease including an X-linked mutation and characterized by an alpha-galactosidase A (GLA) deficiency. It causes globotriaosylceramide (GB3) accumulation within blood vessels, tissues and organs. This accumulation leads to multisystemic deficiency, such as progressive kidney insufficiency. Due to its low prevalence and non-specific symptoms, FD is under-diagnosed. Its estimated incidence is ranged from 1/40,000 to 1/120,000 live births. A review of the international literature suggests a higher prevalence among dialysis patients. Its diagnosis could lead to an enzyme replacement therapy, in order to avoid the occurrence or aggravation of other organs irreversible lesions, and to enhance the familial screening.

We aim to conduct a multicentric cross-sectional prevalence study in 5 areas (Rhône-Alpes-Auvergne, Ile de France, Aquitaine, Picardie and department of Gard), involving biologic collection and genetic diagnosis test. Our objective is to measure the prevalence of FD among dialysis patients. Eligible patients will be included after signing the informed consent.

In the five participating areas, all of the dialysis centers will be asked for involvement. Nominative data of the French renal epidemiology and information network (REIN) registry will enable first patients screening for eligibility among prevalent dialysis patients. If needed (insufficient or absent data in the REIN registry), data will be completed with medical files.

A blood drop will be collected during a hemodialysis session (or the monthly test for peritoneal dialysis treated patients) and deposited on an anonymized blotting paper. For the diagnosis of FD, men will have a measure of the alpha-galactosidase activity, whereas screening in women will be established on the association of alpha-galactosidase activity and lyso-GB3 analysis. If results are compatible with FD, genetic mutation will be search in order to confirm the diagnosis for women, and, for all, to offer familial testing. Results will be transmitted to the nephrologist within the next 2 to 9 weeks. Patients diagnosed with FD will be managed in accordance with the guidelines of the French National Authority for Health (F.N.A.H.).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Necker, APHP Paris, Service de néphrologie-dialyse, 149 rue de Sèvres

location_facility: Hospices Civils de Lyon, Hôpital E Herriot, Service de néphrologie, 5 place d'Arsonval

location_facility: Hôpital Pellegrin Tripode, Service de néphrologie-Dialyse, place Amélie Rabat Léon

location_facility: CHU d'Amiens, Site Sud, Service de néphrologie, D408

location_facility: Hôpital Universitaire Carémeau, Service de Néphrologie, Place du Pr R. Debré

intervention_type: Biological


title: Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode

acronym: THROMBO-GYN

summary: The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare disease, but the majority of events occurring in women of childbearing age are associated with a particular hormonal context (mainly pregnancy and hormonal contraception). VTE is a multifactorial disease and the risk depends on the simultaneous presence of several triggers.

ReferenceType: result

ReferenceCitation: Mottais-Cosnefroy V, Pecourt M, Yannoutsos A, Fels A, Beaussier H, Alran S, Priollet P, Hugon-Rodin J. Hormone-dependent gynaecological disorders and contraceptive modalities in women with a history of venous thromboembolic event: The THROMBOGYN study. J Med Vasc. 2022 Nov-Dec;47(5-6):228-237. doi: 10.1016/j.jdmv.2022.10.015. Epub 2022 Nov 14.


title: Parents InformaTion in Child REHABilitation

acronym: PITChREHAB

summary:
In France, approximaly 3 million children have a chronic disease and require regular care such as paediatric rehabilitation. These cares are provided over long periods of time, most often throughout childhood and often into adulthood. Paediatric rehabilitation care involves multidisciplinary team working closely with families. During follow-up rehabilitation, communication between the children, families and the professionals is essential. To this end, digital health solutions can be helpful.

Digital health solutions are rapidly emerging in the field of paediatric rehabilitation. In this context of emergence of digital health solutions, it is essential to identify the needs and expectations of families of children with a chronic disease.

This project aims to identify the key points in terms of information exchange on rehabilitation monitoring. To identify these needs, a mixed study will be carried out from June 2022 to June 2023 involving focus groups to gather qualitative informations on parent's needs in terms of information exchange through digital apps and quantitative research with a survey that will allow to prioritise these needs.

ReferenceCitation: Nussbaum R, Kelly C, Quinby E, Mac A, Parmanto B, Dicianno BE. Systematic Review of Mobile Health Applications in Rehabilitation. Arch Phys Med Rehabil. 2019 Jan;100(1):115-127. doi: 10.1016/j.apmr.2018.07.439. Epub 2018 Aug 29.

ReferenceCitation: Maguire M. Methods to support human-centred design. International Journal of Human-Computer Studies. 1 oct 2001;55(4):587-634.

ReferenceCitation: O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available.

ReferenceCitation: de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.

lead_sponsor: Fondation Ildys

sponsor_collaborators:
Fondation Ildys
University Hospital, Brest


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

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

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

In the present study, the objective is to assess the epidemiology of RVS in infants from the birth cohorts of the tertiary teaching hospitals of Lyon, France, during the Pre-Covid-19 (2013-2020) and the Per-Covid-19 (2020-2025) years.

location_facility:
Pediatric departement
Virology Lab