title: Peripheral Endothelial Function in Asthmatic Patients

acronym: Endothasthm

summary: The aim of the study is to assess the peripheral endothelial function in adult asthmatic patients and the relationship between the peripheral endothelial function and the pulmonary function.

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ReferenceCitation: Henno P, Boitiaux JF, Douvry B, Cazes A, Lévy M, Devillier P, Delclaux C, Israël-Biet D. Tobacco-associated pulmonary vascular dysfunction in smokers: role of the ET-1 pathway. Am J Physiol Lung Cell Mol Physiol. 2011 Jun;300(6):L831-9. doi: 10.1152/ajplung.00251.2010. Epub 2011 Mar 4.

ReferenceCitation: Peinado VI, Barbera JA, Ramirez J, Gomez FP, Roca J, Jover L, Gimferrer JM, Rodriguez-Roisin R. Endothelial dysfunction in pulmonary arteries of patients with mild COPD. Am J Physiol. 1998 Jun;274(6):L908-13. doi: 10.1152/ajplung.1998.274.6.L908.

ReferenceCitation: Hughes R, Tong J, Oates C, Lordan J, Corris PA. Evidence for systemic endothelial dysfunction in patients and first-order relatives with pulmonary arterial hypertension. Chest. 2005 Dec;128(6 Suppl):617S.

ReferenceCitation: Wolff B, Lodziewski S, Bollmann T, Opitz CF, Ewert R. Impaired peripheral endothelial function in severe idiopathic pulmonary hypertension correlates with the pulmonary vascular response to inhaled iloprost. Am Heart J. 2007 Jun;153(6):1088.e1-7.

ReferenceCitation: Peled N, Bendayan D, Shitrit D, Fox B, Yehoshua L, Kramer MR. Peripheral endothelial dysfunction in patients with pulmonary arterial hypertension. Respir Med. 2008 Dec;102(12):1791-6. doi: 10.1016/j.rmed.2008.06.014. Epub 2008 Aug 3.

ReferenceCitation: Dorfmüller P, Perros F, Balabanian K, Humbert M. Inflammation in pulmonary arterial hypertension. Eur Respir J. 2003 Aug;22(2):358-63. Review.

ReferenceCitation: Friedman R, Mears JG, Barst RJ. Continuous infusion of prostacyclin normalizes plasma markers of endothelial cell injury and platelet aggregation in primary pulmonary hypertension. Circulation. 1997 Nov 4;96(9):2782-4.

ReferenceCitation: Christman BW, McPherson CD, Newman JH, King GA, Bernard GR, Groves BM, Loyd JE. An imbalance between the excretion of thromboxane and prostacyclin metabolites in pulmonary hypertension. N Engl J Med. 1992 Jul 9;327(2):70-5.

ReferenceCitation: Xu W, Kaneko FT, Zheng S, Comhair SA, Janocha AJ, Goggans T, Thunnissen FB, Farver C, Hazen SL, Jennings C, Dweik RA, Arroliga AC, Erzurum SC. Increased arginase II and decreased NO synthesis in endothelial cells of patients with pulmonary arterial hypertension. FASEB J. 2004 Nov;18(14):1746-8. Epub 2004 Sep 13.

ReferenceCitation: Schanen JG, Iribarren C, Shahar E, Punjabi NM, Rich SS, Sorlie PD, Folsom AR. Asthma and incident cardiovascular disease: the Atherosclerosis Risk in Communities Study. Thorax. 2005 Aug;60(8):633-8.

ReferenceCitation: Iribarren C, Tolstykh IV, Eisner MD. Are patients with asthma at increased risk of coronary heart disease? Int J Epidemiol. 2004 Aug;33(4):743-8. Epub 2004 May 6.

ReferenceCitation: Takemura M, Matsumoto H, Niimi A, Ueda T, Matsuoka H, Yamaguchi M, Jinnai M, Muro S, Hirai T, Ito Y, Nakamura T, Mio T, Chin K, Mishima M. High sensitivity C-reactive protein in asthma. Eur Respir J. 2006 May;27(5):908-12.

ReferenceCitation: Zureik M, Benetos A, Neukirch C, Courbon D, Bean K, Thomas F, Ducimetière P. Reduced pulmonary function is associated with central arterial stiffness in men. Am J Respir Crit Care Med. 2001 Dec 15;164(12):2181-5.

ReferenceCitation: Zureik M, Kauffmann F, Touboul PJ, Courbon D, Ducimetière P. Association between peak expiratory flow and the development of carotid atherosclerotic plaques. Arch Intern Med. 2001 Jul 9;161(13):1669-76.

ReferenceCitation: Ayer JG, Belousova EG, Harmer JA, Toelle B, Celermajer DS, Marks GB. Lung function is associated with arterial stiffness in children. PLoS One. 2011;6(10):e26303. doi: 10.1371/journal.pone.0026303. Epub 2011 Oct 25.

ReferenceCitation: Onufrak S, Abramson J, Vaccarino V. Adult-onset asthma is associated with increased carotid atherosclerosis among women in the Atherosclerosis Risk in Communities (ARIC) study. Atherosclerosis. 2007 Nov;195(1):129-37. Epub 2006 Oct 10.

ReferenceCitation: Cakmak A, Zeyrek D, Cece H, Erel O. The relationship between carotid intima media thickness and oxidative stress in asthmatic children. Asian Pac J Allergy Immunol. 2010 Dec;28(4):256-61.

ReferenceCitation: Yildiz P, Oflaz H, Cine N, Genchallac H, Erginel-Unaltuna N, Yildiz A, Yilmaz V. Endothelial dysfunction in patients with asthma: the role of polymorphisms of ACE and endothelial NOS genes. J Asthma. 2004 Apr;41(2):159-66.

ReferenceCitation: Hazarika S, Van Scott MR, Lust RM, Wingard CJ. Pulmonary allergic reactions impair systemic vascular relaxation in ragweed sensitive mice. Vascul Pharmacol. 2010 Nov-Dec;53(5-6):258-63. doi: 10.1016/j.vph.2010.09.005. Epub 2010 Oct 1.

location_facility: Hôpital Saint Antoine, Pulmonary function test laboratory


title: Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial

acronym: CARSPECT

summary: This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Jean Perrin
CHU Clermont-Ferrand

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: The Mediating Role of Dissociative Symptoms and Early Maladaptive Schemas in the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia

acronym: HADITRYOS

summary:
BACKGROUND It is demonstrated that strong associations between trauma suffered in childhood and having schizophrenia, and more specifically to experience acoustic-verbal hallucinations (AVH). A second generation of research is currently examining the cognitive and affective processes likely to play a mediating role in this association. These mediators appear to include early maladaptive personality patterns and dissociative experiences. Although these factors have most often been explored separately, recent research indicates that they could be associated, and thus contribute to AVH. More specifically, another study has shown that the association between childhood trauma and predisposition to AVH is not direct but depends on cognitive factors including the impact of violence suffered during childhood on early maladaptive schemas and dissociation. However, this study was carried out on a non-clinical sample of subjects with a predisposition to AVH.

OBJECTIVES: testing a structural model of AVH, childhood trauma, early maladaptive schemas and dissociative symptoms in large multicentric sample of inpatients diagnosed with schizophrenia and AVH (n=350). Secondary objectives are (i) test in the model the role of all the early patterns described by Jeffrey Young instead of targeting only the schemes that are part of the model tested in previous study as the one by Bortolon and colleagues, (ii) compare the quality of the adjustment of the confirmatory model to the quality of the adjustment of the exploratory model.

METHODS: one single visit in which subjects will receive self-reported questionnaires (Childhood trauma questionnaire, The Young schema questionnaire short form, Dissociative experiences scale, Launay-Slade hallucination scale and Cardiff Anomalous Perceptions Scale.

ANALYSES: Structural equation model performed additional analysis using Partial Least Squares Structural Equation Modelling. The primary endpoint corresponds to significant associations between the variables. The quality of the model will be assessed using a fit quality measure. The secondary endpoints are significant associations between the different variables (p <0.05) and the model quality assessed with a quality measure of the fit.

MAIN HYPOTHESIS: the association between childhood trauma and predisposition to AVH is not direct, but depends on the impact of violence suffered during childhood on early maladaptive schemas and dissociative symptoms in patients with schizophrenia.

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Daalman K, Diederen KM, Derks EM, van Lutterveld R, Kahn RS, Sommer IE. Childhood trauma and auditory verbal hallucinations. Psychol Med. 2012 Dec;42(12):2475-84. doi: 10.1017/S0033291712000761. Epub 2012 Apr 16.

ReferenceCitation: Varese F, Smeets F, Drukker M, Lieverse R, Lataster T, Viechtbauer W, Read J, van Os J, Bentall RP. Childhood adversities increase the risk of psychosis: a meta-analysis of patient-control, prospective- and cross-sectional cohort studies. Schizophr Bull. 2012 Jun;38(4):661-71. doi: 10.1093/schbul/sbs050. Epub 2012 Mar 29. Review.

ReferenceCitation: Williams J, Bucci S, Berry K, Varese F. Psychological mediators of the association between childhood adversities and psychosis: A systematic review. Clin Psychol Rev. 2018 Nov;65:175-196. doi: 10.1016/j.cpr.2018.05.009. Epub 2018 Jun 2.

ReferenceCitation: Bortolon C, Seillé J, Raffard S. Exploration of trauma, dissociation, maladaptive schemas and auditory hallucinations in a French sample. Cogn Neuropsychiatry. 2017 Nov;22(6):468-485. doi: 10.1080/13546805.2017.1387524. Epub 2017 Oct 12.

ReferenceCitation: Evans GJ, Reid G, Preston P, Palmier-Claus J, Sellwood W. Trauma and psychosis: The mediating role of self-concept clarity and dissociation. Psychiatry Res. 2015 Aug 30;228(3):626-32. doi: 10.1016/j.psychres.2015.04.053. Epub 2015 Jun 11.

ReferenceCitation: Bell V. A community of one: social cognition and auditory verbal hallucinations. PLoS Biol. 2013 Dec;11(12):e1001723. doi: 10.1371/journal.pbio.1001723. Epub 2013 Dec 3. Review.

ReferenceCitation: Bentall RP, Slade PD. Reality testing and auditory hallucinations: a signal detection analysis. Br J Clin Psychol. 1985 Sep;24 ( Pt 3):159-69.

ReferenceCitation: Larøi F, Marczewski P, Van der Linden M. Further evidence of the multi-dimensionality of hallucinatory predisposition: factor structure of a modified version of the Launay-Slade Hallucinations Scale in a normal sample. Eur Psychiatry. 2004 Feb;19(1):15-20.

ReferenceCitation: Cottraux J, & Blackburn IM. Psychothérapies cognitives des troubles de la personnalité. NPG Neurologie-Psychiatrie-Gériatrie. 2007; 7(37), 41.

ReferenceCitation: Larøi F, Billieux J, Defeldre A-C, Ceschi, G, Van der Linden M. Factorial structure and psychometric properties of the French adaptation of the Dissociative Experiences Scale (DES) in non-clinical participants. Revue Européenne de Psychologie Appliquée/European Review of Applied Psychology. 2013; 63(4): 203-208.

ReferenceCitation: Launay G, Slade P. The measurement of hallucinatory predisposition in male and female prisoners. Personality and Individual Differences. 1981; 2(3): 221-234.

ReferenceCitation: Mauchand P, Lachenal-Chevallet K, Cottraux J. [Empirical validation of the Young Schema Questionnaire-Short Form (YSQ-S2) in borderline personality disorder and control subjects]. Encephale. 2011 Apr;37(2):138-43. doi: 10.1016/j.encep.2010.04.014. Epub 2010 Jul 3. French.

ReferenceCitation: Briere J, Scott C. Assessment of trauma symptoms in eating-disordered populations. Eat Disord. 2007 Jul-Sep;15(4):347-58. Review.

ReferenceCitation: Darves-Bornoz JM, Degiovanni A, Gaillard P. Validation of a French version of the Dissociative Experiences Scale in a rape-victim population. Can J Psychiatry. 1999 Apr;44(3):271-5.

ReferenceCitation: Garrison JR, Moseley P, Alderson-Day B, Smailes D, Fernyhough C, Simons JS. Testing continuum models of psychosis: No reduction in source monitoring ability in healthy individuals prone to auditory hallucinations. Cortex. 2017 Jun;91:197-207. doi: 10.1016/j.cortex.2016.11.011. Epub 2016 Nov 22.

ReferenceCitation: Johns LC, Kompus K, Connell M, Humpston C, Lincoln TM, Longden E, Preti A, Alderson-Day B, Badcock JC, Cella M, Fernyhough C, McCarthy-Jones S, Peters E, Raballo A, Scott J, Siddi S, Sommer IE, Larøi F. Auditory verbal hallucinations in persons with and without a need for care. Schizophr Bull. 2014 Jul;40 Suppl 4:S255-64. doi: 10.1093/schbul/sbu005. Review.

ReferenceCitation: Perona-Garcelán S, Carrascoso-López F, García-Montes JM, Ductor-Recuerda MJ, López Jiménez AM, Vallina-Fernández O, Pérez-Álvarez M, Gómez-Gómez MT. Dissociative experiences as mediators between childhood trauma and auditory hallucinations. J Trauma Stress. 2012 Jun;25(3):323-9. doi: 10.1002/jts.21693. Epub 2012 May 15.

ReferenceCitation: Perona-Garcelan S, Garcia-Montes JM, Cuevas-Yust C, Perez-Alvarez M, Ductor-Recuerda MJ, Salas-Azcona R, Gomez-Gomez MT. A preliminary exploration of trauma, dissociation, and positive psychotic symptoms in a Spanish sample. J Trauma Dissociation. 2010;11(3):284-92. doi: 10.1080/15299731003786462.

ReferenceCitation: Pilton M, Varese F, Berry K, Bucci S. The relationship between dissociation and voices: A systematic literature review and meta-analysis. Clin Psychol Rev. 2015 Aug;40:138-55. doi: 10.1016/j.cpr.2015.06.004. Epub 2015 Jun 16. Review.

ReferenceCitation: Wright DB, Loftus EF. Measuring dissociation: comparison of alternative forms of the dissociative experiences scale. Am J Psychol. 1999 Winter;112(4):497-519.

ReferenceCitation: Wright MO, Crawford E, Del Castillo D. Childhood emotional maltreatment and later psychological distress among college students: the mediating role of maladaptive schemas. Child Abuse Negl. 2009 Jan;33(1):59-68. doi: 10.1016/j.chiabu.2008.12.007. Epub 2009 Jan 23.

ReferenceCitation: Young JE. Cognitive therapy for personality disorders : A schema-focused approach. Professional Resource Press/Professional Resource Exchange. 1999.

ReferenceCitation: Young JE, Brown G. Young schema questionnaire short form. New York: Cognitive Therapy Centre. 1998.

ReferenceCitation: Young JE, Klosko, JS, Weishaar, ME. Schema therapy : A practitioner's guide. 2005.

ReferenceCitation: Hair Jr JF, Hult GTM, Ringle C, Sarstedt M. A primer on partial least squares structural equation modeling (PLS-SEM). Sage publications. 2016.

ReferenceCitation: First MB, Spitzer RL, Gibbon M, Williams JB, et al. Structured clinical interview for DSM-IV axis I disorders. New York: New York State Psychiatric Institute. 1995.

ReferenceCitation: American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5®). American Psychiatric Pub. 2013.

ReferenceCitation: Bernstein DP, Ahluvalia T, Pogge D, Handelsman L. Validity of the Childhood Trauma Questionnaire in an adolescent psychiatric population. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):340-8.

ReferenceCitation: Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90.

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

location_facility:
Chu St Etienne
Grenoble University Hospital

intervention_type: Other

lead_sponsor_type: academique


title: Interventional, Open, Non-comparative, Multicenter Study to Assess the Safety and Effectiveness of the Use of the MakAir Artificial Ventilator in the Expected Situation of a Shortage of Technical Devices for Invasive Mechanical Ventilation, Linked to the Coronavirus COVID-19

acronym: COVRESP

summary: The objective of our study is to carry out an evaluation of the safety and the effectiveness of the use of the MakAir respirator as useful supplement in situation of shortage of technical devices of assistance to the mechanical invasive ventilation, related to COVID-19 through a protocol in 3 successive sequences.

primary_purpose: Supportive Care

lead_sponsor: Nantes University Hospital

location_facility:
CHRU Brest
CHU Nantes

intervention_type: Device


title: Impact de la Visualisation d'Une vidéo Explicative Sur la qualité de la préparation Intestinale

summary: The research hypothesis is that video visualization improves the quality of bowel preparation and the patients' understanding of the modalities of bowel preparation.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Créteil


title: Educational Follow-up in COPD Patients After Pulmonary Rehabilitation: a Cohort Study

acronym: EDURESPI

summary:
After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the program and increase physical activity.

As exercise training, education is the corner stone of pulmonary rehabilitation. Education allows to support behavioral changes in daily life.

Recommendations about modalities for maintaining physical activity are still clear, however for educational follow up recommendations need to be clarified.

After a pulmonary rehabilitation program, there is no defined plan for educational follow up nor location to perform education session.

The aim of this study is to evaluate the proportion of patients who succeed to establish and maintain the objectives they defined during the pulmonary rehabilitation program, one year after this program.

ReferenceCitation: Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

ReferenceCitation: Péran L, Le Ber C, Pichon R, Cabillic M, Beaumont M. [Follow-up and evaluation of plans developed during pulmonary rehabilitation]. Rev Mal Respir. 2018 Nov;35(9):929-938. doi: 10.1016/j.rmr.2018.08.002. Epub 2018 Sep 7. French.

lead_sponsor: University Hospital, Brest

location_facility:
BEAUMONT
CHRU de Brest


title: Value of Emicizumab Monitoring With UPLC-MS/MS for Bleeding Risk Prediction in Severe Hemophilia A

acronym: EMICARE

summary: Emicizumab is a monoclonal bispecific antibody with a terminal half-life of 28 days which is now licensed in the treatment of severe haemophilia A with or without inhibitors. Some heterogeneity in residual emicizumab concentrations have been reported according to age, body mass index or drug therapeutic regimen. Some cases of neutralizing antidrug antibodies have been also reported. Whether monitoring emicizumab plasma concentration could predict the residual bleeding risk under emicizumab is unknown. As conventional coagulation assays are not adapted for emicizumab monitoring, this study aims to assess the value of monitoring residual emicizumab plasma concentration by UPLC-MS/MS in bleeding risk prediction.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Lille

location_facility: Institut Coeur-Poumon, Pôle d'Hématologie-Transfusion, CHU


title: Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation

acronym: FAPA

summary:
Physical exercise has been identified as a major beneficial factor in the management of patients suffering from many chronic diseases especially cancer and in the context of cardiac or pulmonary transplantation. It contributes to an improvement of the quality of life and decreases treatment side effects and mortality. Aerobic fitness is constantly altered in cirrhotic patients and correlated to the severity of the hepatic disease. Moreover, in this setting, other etiological factors may be added like chronic obstructive bronchitis and alcoholic cardiomyopathy. In this population, muscle abnormalities with fatigue and cramps have been described. Muscle weakness in this condition may be comparable to that described in patients with chronic obstructive bronchitis and contributes to the decrease of aerobic fitness. Different causes such as muscle deconditioning, hypoxemia, denutrition, anti-rejection drugs increase this phenomenon after liver transplantation. Finally, the aerobic capacity or VO2max is a prognostic factor for survival and is linked to the number and the length of hospitalizations after liver transplantation (LT).

Therefore, physical activity is a valid and relevant way to improve quality of life, increase survival, and limit costs of hospitalizations. The aim of this study is to assess the effects of a personalized physical activity retraining program on aerobic capacity, strength and fatigue, in a population awaiting liver transplantation.

Purpose: The hypothesis is that an at home adapted retraining program conducted before LT, and including physical activity (aerobic and strength training), will improve aerobic fitness, peripheral strength, quality of life and decrease the hospitalization length in intensive care unit after LT.

status: Unknown status

design_allocation: Randomized

lead_sponsor: University Hospital, Limoges

location_facility:
Tours hospital
Limoges Hospital

status_simplified: Unknown


title: Neurophysiological Markers in the Depressive Episode Characterized by Anhedonic Drug Resistance: Evaluation of Motor Skills and P300 Wave

acronym: PHYDDOPA

summary: Depression is currently the leading cause of disability and suicide death worldwide. Several studies, however, have shown that a significant proportion of patients do not respond to standard antidepressants, especially since their symptomatology is dominated by anhedonia or psychomotor retardation reflecting central dopaminergic dysfunction. In order to improve the efficiency and speed of the antidepressant response, it seems essential to highlight this dopaminergic dysfunction, by defining a P300 wave profile specific to the subtype of depressed patients with anhedonic phenotype to whom personalized treatment targeting dopaminergic transmission could in the future be proposed earlier. The investigators therefore wish to highlight an increase in the latency time of P300 and a modification of motor skills (of the walking cycle and of the movement of the hands), without modification of the dopaminergic transmission measured by PETScan, specific to the sub-type of depressive patients, resistant to at least 2 antidepressants of different classes with an anhedonia score> 5/14 on the SHAPS scale. The increased latency of P300 could then be used in the future as a predictive biomarker of resistance to conventional antidepressant treatments specific to this population of anhedonic depressed patients

primary_purpose: Other

lead_sponsor: University Hospital, Rouen

location_facility:
CHSR du Rouvray
Rouen University Hospital

intervention_type: Procedure


title: Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients

acronym: DIAPERIO

summary: This study will assess the efficacy of periodontal treatment in diabetic patient. Patients will be randomized in the periodontal group or in the control group. The control group will received a periodontal treatment after the study.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

location_facility:
UH Bordeaux
UHToulouse

status_simplified: Completed


title: Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology

acronym: MoCA

summary: Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Centre François Baclesse


title: OCT Angiography in the Glaucoma Diagnosis : A Multicenter Study

acronym: OCTA

summary: Glaucoma is a chronic degenerative disease of the optic nerve. It is the second cause of blindness worldwide and a frequent cause of irreversible blindness. In 2020, epidemic health authorities have predicted about 80 million glaucoma patients. Glaucoma can be treated by topical treatment (eye drops), laser or surgery. A premature diagnosis of glaucoma is very important to prevent irreversible blindness. Pachymetry, Optical Coherence Tomography (OCT) and visual fields exams are fundamental for the development of the glaucoma diagnosis. The severity of glaucoma is defined with Hodapp-Parrish-Andersen visual field criteria. According to these criteria, glaucoma can be classified as early (with average visual field deviation, MD, of 0 to -6 dB), moderate (MD of -6 to -12 dB) and severe (MD worse than -12 dB). The progression of glaucoma is being identified by the visual fields tests, and also by the progression of alterations in the optic nerve head. The visual fields tests are long and difficult (30 minutes). It is therefore important to create additional tests and anticipate the diagnosis, in order to avoid the irreversibility of glaucoma.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Polyclinique de la Baie
Groupe Hospitalier Paris Saint-Joseph

intervention_type: Diagnostic Test


title: Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

acronym: Barrett

summary: The aim of this study was to determine whether the prevalence of Human PapillomaVirus (HPV) was increased in patients with Barrett esophagus compared with controls in a prospective study. Secondary objective was to identify, if present, the type of Human PapillomaVirus (HPV) associated in Barrett esophagus.

ReferenceType: derived

ReferenceCitation: Brochard C, Ducancelle A, Pivert A, Bodin M, Ricard A, Coron E, Couffon C, Dib N, Luet D, Musquer N, Rhun ML, Bertrais S, Michalak S, Lunel-Fabiani F, Cesbron-Metivier E, Caroli-Bosc FX. Human papillomavirus does not play a role in the Barrett esophagus: a French cohort. Dis Esophagus. 2017 Nov 1;30(11):1-7. doi: 10.1093/dote/dox088.

family: Brochard

full_name: C. Brochard

given: C.

sequence: first

family: Ducancelle

full_name: A. Ducancelle

given: A.

sequence: additional

family: Pivert

full_name: A. Pivert

family: Bodin

full_name: M. Bodin

given: M.

family: Ricard

full_name: A. Ricard

family: Coron

full_name: E. Coron

given: E.

family: Couffon

full_name: C. Couffon

family: Dib

full_name: N. Dib

given: N.

family: Luet

full_name: D. Luet

given: D.

family: Musquer

full_name: N. Musquer

family: Rhun

full_name: M. Le Rhun

given: M. Le

family: Bertrais

full_name: S. Bertrais

given: S.

family: Michalak

full_name: S. Michalak

family: Lunel-Fabiani

full_name: F. Lunel-Fabiani

given: F.

family: Cesbron-Metivier

full_name: E. Cesbron-Metivier

family: Bosc

full_name: F.-X. Caroli Bosc

given: F.-X. Caroli

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diseases of the Esophagus

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Angers

location_facility:
UH Nantes
UH Angers


title: Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy

summary:
Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some criteria were already proposed and the last one was proposed in 2011.

All these criteria integrated only clinical criteria without imaging assessment. In this context, ultrasound joint is daily performed without definition of remission. A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage. A definition of remission in RA could include erosions regression in subchondral bone (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)).

The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion.

Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage (progression of radiographic lesions). Recent data showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is a new technique emerging for bone erosions assessment in RA. Erosions size and volume could be reduced with anti-TNF, but with a large interindividual variability. There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
HCL - Hôpital EdouarD Herriot
CHU Saint-Etienne


title: Modulation of Painful Perception

acronym: MODOU

summary:
The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception.

It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating.

In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy.

The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.

location_facility:
CHU de SAINT-ETIENNE
Hospices Civils de LYON


title: Evaluation of the Impact of a Hydration Protocol "at Thirst" on Natremia of the Ultra Trail du Mont-Blanc, 2015 Runners

acronym: NATRITRAIL

summary: The main objective of this study is to evaluate the impact of a hydration protocol "at thirst" compared to other "not at thirst" hydration protocols on the changes in serum sodium in runners of the Ultra Trail Mont-Blanc (UTMB) in 2015.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


acronym: GENTAERO

summary:
Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection associated with the highest morbidity and mortality.

Respiratory infection with resistant organism are increasing in prevalence. Because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection.

Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for respiratory infections. Gentamicin,which is effective against numerous multi drug resistant Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option for nebulisation.

The investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.

lead_sponsor: Poitiers University Hospital

location_facility:
Dequin P-F
BOISSON Matthieu


title: Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up

acronym: Latarjet

summary: To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Clinique des Maussins
Hospital Ambroise Paré Paris


title: Fluid Responsiveness Evaluation by AbdomiNal Compression in Kids Based on the STARLING Concept

acronym: FRANCK

summary:
Purpose:

Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Only aortic velocity peak variation measured with transthoracic echocardiography during mechanical ventilation has been reported to predict fluid responsiveness in children. Besides some physician use a maneuver of abdominal compression to predict fluid responsiveness in children with circulatory failure. This strategy has never been formally evaluated.

The investigators will study the diagnosis accuracy of the stroke volume variation induced by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in children with circulatory failure.

Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the attending physician has decided a fluid load will be included. Hemodynamic parameters: arterial pressure, heart rate, stroke volume measured with echocardiography; will be recorded. This data collection will be performed before, after abdominal compression and after a fluid load of 10 ml/kg.

Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders. Fluid responders are defined as patients that show an increase greater than 15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an abdominal compression to predict fluid responsiveness will be investigate and receiving operative characteristic (ROC) curve will be built. The correlation between the variation of stroke volume during abdominal compression and during the fluid load will be studied. Other parameters such as arterial pressure and heart rate will also be investigated.

ReferenceCitation: Jacquet-Lagrèze M, Tiberghien N, Evain JN, Hanna N, Courtil-Teyssedre S, Lilot M, Baudin F, Chardonnal L, Bompard D, Koffel C, Portefaix A, Javouhey E, Fellahi JL. Diagnostic accuracy of a calibrated abdominal compression to predict fluid responsiveness in children. Br J Anaesth. 2018 Dec;121(6):1323-1331. doi: 10.1016/j.bja.2018.06.030. Epub 2018 Sep 6.

family: Jacquet-Lagrèze

full_name: M. Jacquet-Lagrèze

family: Tiberghien

full_name: N. Tiberghien

family: Evain

full_name: J.-N. Evain

family: Hanna

full_name: N. Hanna

family: Courtil-Teyssedre

full_name: S. Courtil-Teyssedre

family: Lilot

full_name: M. Lilot

family: Baudin

full_name: F. Baudin

family: Chardonnal

full_name: L. Chardonnal

given: L.

family: Bompard

full_name: D. Bompard

family: Koffel

full_name: C. Koffel

family: Portefaix

full_name: A. Portefaix

family: Javouhey

full_name: E. Javouhey

family: Fellahi

full_name: J.-L. Fellahi

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hopital Louis Pradel

location_facility: Intensive care and anesthesiology department, Hôpital Louis Pradel.

location_facility: Pediatric Intensive care, Hôpital Femme Mère Enfant


title: A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature

acronym: RUBY

summary: The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.

ipd_sharing: Yes

ipd_sharing_description: In the medical clinical patient file

lead_sponsor: UNICANCER

location_facility:
Centre Leon Berard
Institut Paoli Calmettes


title: Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects

acronym: DOUFISPORT

summary:
Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of widespread pain in all four quadrants of the body. Currently, there is no causal treatment of fibromyalgia syndrome.

The aim of this study is the evaluation of a specific training program on controls of pain in fibromyalgia patients by balancing the stress axis.

The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured during the test of the thermode (difference between the average VAS measured between the 10th and 40th second of P1 and the average VAS measured between the 10th and 40th of the second P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will be compared in the two groups..Salivary cortisol is also tested.

ReferenceCitation: Le Fur Bonnabesse A, Cabon M, L'Heveder G, Kermarrec A, Quinio B, Woda A, Marchand S, Dubois A, Giroux-Metges MA, Rannou F, Misery L, Bodéré C. Impact of a specific training programme on the neuromodulation of pain in female patient with fibromyalgia (DouFiSport): a 24-month, controlled, randomised, double-blind protocol. BMJ Open. 2019 Jan 25;9(1):e023742. doi: 10.1136/bmjopen-2018-023742.

family: Le Fur Bonnabesse

full_name: Anais Le Fur Bonnabesse

given: Anais

family: Cabon

full_name: Mathilde Cabon

given: Mathilde

family: L’Heveder

full_name: Gildas L’Heveder

given: Gildas

family: Kermarrec

full_name: Aurélie Kermarrec

given: Aurélie

family: Quinio

full_name: Bertrand Quinio

given: Bertrand

family: Woda

full_name: Alain Woda

given: Alain

family: Marchand

full_name: Serge Marchand

given: Serge

family: Dubois

full_name: Amandine Dubois

given: Amandine

family: Giroux-Metges

full_name: Marie-Agnes Giroux-Metges

given: Marie-Agnes

family: Rannou

full_name: Fabrice Rannou

given: Fabrice

family: Misery

full_name: Laurent Misery

given: Laurent

family: Bodéré

full_name: Céline Bodéré

given: Céline

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
CHRU Brest
CHU Rennes


title: Evaluation of the SARC-F Questionnaire, a New Screening Tool for Sarcopenia in People 65-year Old and Older in the Community

acronym: SARCORSICA

summary:
Background to the research: Sarcopenia is a geriatric syndrome defined by progressive generalised loss of skeletal muscle, mass, force and function.

Problem statement and objectives: To validate a simple, reproducible, screening tool, which is easy to use in the general practitioner's surgery is one of the challenges of the future.

The primary objective is to assess the sensitivity and specificity of the study screening test, the SARC-F, at a predetermined threshold of >= 4. A total score of >=4 is associated with poor physical performance and is also predictive of the clinical diagnosis of the disease. The secondary objectives are to assess the prevalence of sarcopenia in the study population, to carry out a subgroup analysis of statistical performance for the five questions tested by the SARC-F, to identify the main risk factors associated with the disease and to propose an algorithm, positioning the SARC-F at the heart of a systematic screening process for the disease.

Materials and methods: This is a diagnostic, cross-sectional study with a descriptive and analytical epidemiological component to analyse the secondary endpoints. It will be carried out in usual care over a period of 6 months in a homogeneous population of 65-year-old and older patients from the community consulting in primary care. The subjects will undergo the screening test (SARC-F questionnaire) and then the reference clinical assessment (gold standard) in succession.

Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a simple tool, appropriate for early screening of sarcopenia in primary care.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Cabinet de médecine générale
Cabinet de Médecine Générale


title: Validation of NICOM for the Detection of Modification of Stroke Volume

acronym: NICOM-VAL

summary: The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery

status: Terminated

lead_sponsor: Hopital Foch

location_facility:
Marc Fischler
Hôpital Lariboisière


title: Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances

acronym: VASCO

summary:
The transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.

The difficulty is to recognize an ischemic mechanism which imposes emergency cares.

A clinical score could help the clinician to recognize the etiology of the TVD .

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmologique Adolphe de Rothschild


title: Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.

acronym: DouReV

summary: Pain management is a priority axis of health insurance spending objectives and contributes to improving the quality of care.There are several types of pain: acute, chronic and induced. These are often found in the management of chronic wounds. The high prevalence of chronic wounds represents a major public health problem. Chronic wounds require long, painful and regular treatment. When dressing these wounds, pain management is essential. Indeed, it can generate healing delays. Usually, pharmacological methods are used to reduce the pain induced by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological techniques are emerging.The investigators therefore wish to assess the effect of virtual reality on pain induced by care during the repair of dressings in the management of chronic wounds.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire de Limoges


title: Study of the Efficacy and Tolerance of the B-Dyn Medical Device Compared to a Conventional Bolted Fusion With or Without Cage in the Treatment of Degenerative Lumbar Stenosis, With or Without Grade I Spondylolisthesis on the Degree of Postoperative Functional Disability, Preservation of Mobility and Prevention of the Adjacent Syndrome". Interventional, Prospective, Comparative, Randomized, Non-inferiority, Single Blind, International, Multicenter Clinical Study

acronym: BDYNCLIN

summary:
Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back. It causes pain and even disorders of the lower limbs. When the symptoms get worse and the individual feels functional discomfort despite medical treatment, surgical intervention is recommended. Two surgical options are available: Rigid Stabilization Devices as conventional fusion with or without cage, or dynamic stabilization system as B-DYN device, this system is called "dynamic" because it allows the stabilization of the operated part while preserving a certain mobility.

The main objective of this study is to evaluate the efficacy and tolerance of B-Dyn versus conventional bolted fusion (with or without cage) in the treatment of degenerative lumbar stenosis (DLS) on the degree of postoperative functional incapacity. So the investigator's hypothesis is that the use of the B-DYN device in the treatment of DLS could lead to the maintenance of functional disability related to low back pain (maintenance of walking and mobility).

Another important point to be demonstrated in this study is the preservation of the mobility of the stage overlying the assembly performed by B-Dyn. Indeed, the continued degeneration of segments adjacent to lumbar vertebral fusions is a concern for surgeons For B-Dyn, which is a dynamic stabilization, the combination of rigid and flexible parts allows the mobility of the overlying stage to be preserved and could also lead to a decrease in adjacent syndrome in the long-term compared to the use of conventional fusion.

The duration of patient follow-up is 60 months. The inclusion period is 24 months to recruit the necessary number of subjects for the study (a total of 216 patients is expected).

ReferenceCitation: Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Härtl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.

ReferenceCitation: Turner JA, Ersek M, Herron L, Deyo R. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine (Phila Pa 1976). 1992 Jan;17(1):1-8.

ReferenceCitation: Machado GC, Ferreira PH, Yoo RI, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher CG, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Nov 1;11:CD012421. Review.

ReferenceCitation: Radcliff KE, Kepler CK, Jakoi A, Sidhu GS, Rihn J, Vaccaro AR, Albert TJ, Hilibrand AS. Adjacent segment disease in the lumbar spine following different treatment interventions. Spine J. 2013 Oct;13(10):1339-49. doi: 10.1016/j.spinee.2013.03.020. Epub 2013 Jun 15. Review.

ReferenceCitation: Morishita Y, Ohta H, Naito M, Matsumoto Y, Huang G, Tatsumi M, Takemitsu Y, Kida H. Kinematic evaluation of the adjacent segments after lumbar instrumented surgery: a comparison between rigid fusion and dynamic non-fusion stabilization. Eur Spine J. 2011 Sep;20(9):1480-5. doi: 10.1007/s00586-011-1701-1. Epub 2011 Feb 8.

lead_sponsor: Quanta Medical

location_facility: CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery Unit


title: Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery

acronym: Eu-MultiNOL

summary:
The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).

The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients.

The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.

ReferenceType: result

ReferenceCitation: Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.

name: From the Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.

family: Meijer

full_name: Fleur S. Meijer

given: Fleur S.

family: Martini

full_name: Chris H. Martini

given: Chris H.

family: Broens

full_name: Suzanne Broens

given: Suzanne

family: Boon

full_name: Martijn Boon

given: Martijn

family: Niesters

full_name: Marieke Niesters

given: Marieke

family: Aarts

full_name: Leon Aarts

given: Leon

family: Olofsen

full_name: Erik Olofsen

given: Erik

family: van Velzen

full_name: Monique van Velzen

given: Monique

family: Dahan

full_name: Albert Dahan

given: Albert

journal_name: Anesthesiology

oa_colors: green hybrid

evidence: open (via free pdf)

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Nociception-guided versus Standard Care during Remifentanil–Propofol Anesthesia

location_facility: Hopital d'Instruction des Armées de Bégin


title: Epidemiological Study of the Covid-19 Presto Test Among Agents of the Local Authorities of CCTVL, Region Centre Val de Loire and Orleans Métropole. Correlation of IgM Level According to Contact With the Public

acronym: COVIDOR

summary: The "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community

ipd_sharing: Undecided

ipd_sharing_description:
Blood sample to be taken after self-bite. A consent form is given to the officer.

A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the gel.

Reading in 15 minutes

strip: negative result
bands: positive result

An authorized person, subject to medical confidentiality, reports the result in the medical file and informs the agent of the result.

He is given a paper document signed by the SMP with the procedure to follow.

lead_sponsor: Raphael Serreau

location_facility: Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole


title: Role of Inflammasomes in COVID-19 Disease

acronym: CoVInnate

summary:
As of March 25, 2020, 414,179 cases and 18,440 deaths secondary to Coronavirus 2019 disease (COVID-19) have been reported worldwide. The unfavorable course of the patients is characterized on the immunological level by an intense pro-inflammatory response which can go as far as a cytokinic storm. This pandemic affects a naive world population from an immunological point of view with respect to SARS-CoV-2 responsible for COVID-19. The evolution is favorable without hospitalization in almost 85% of cases. Among patients hospitalized for pneumonia, some will not require ventilatory support while others will need intensive care. To date, two main types of unfavorable evolution have been described. The first is a bi-phasic evolution beginning with a paucisymptomatic form which is worsened secondarily with respiratory distress associated with a decrease in the viral load in the airways. The second is associated with persistent high viral loads in the airways and detection of the virus in the blood. These different clinical profiles could depend on the quantitative and qualitative response of the innate immune system.

At the early stage of a viral infection the innate immunity is capable of detecting certain conserved microbial patterns (PAMP, pathogen-associated molecular pattern) recognized by receptors dedicated to these patterns (PRR, pattern recognition receptor). This process allows to initiate the pro-inflammatory response via different signaling pathways.

Activating multiprotein complexes called inflammasomes, which cause pro-IL-1β and pro-IL-18 to be transformed into active pro-inflammatory cytokines are one of these pathways.

The central role of inflammasomes in the secretion of these pro-inflammatory cytokines deserves an in-depth study of their activation during COVID-19, whereas the inadequate inflammatory response appears to be the determining factor in the unfavorable development of patients.

The objective of this project is to analyze the level of activation of the inflammasomes and then to search for inactivating or activating mutations among the genes which code for the proteins constituting the inflammasomes in Covid-19 patients. The identification of mutations in patients with a serious clinical presentation or even death would be followed by fundamental work by analyzing in a cellular model the impact of these mutations on the secretion of IL-1β.

ReferenceCitation: Courjon J, Dufies O, Robert A, Bailly L, Torre C, Chirio D, Contenti J, Vitale S, Loubatier C, Doye A, Pomares-Estran C, Gonfrier G, Lotte R, Munro P, Visvikis O, Dellamonica J, Giordanengo V, Carles M, Yvan-Charvet L, Ivanov S, Auberger P, Jacquel A, Boyer L. Heterogeneous NLRP3 inflammasome signature in circulating myeloid cells as a biomarker of COVID-19 severity. Blood Adv. 2021 Mar 9;5(5):1523-1534. doi: 10.1182/bloodadvances.2020003918.

name: Université Côte d’Azur, Inserm, C3M, Nice, France;

name: Université Côte d’Azur, CHU Nice, Nice, France;

family: Courjon

full_name: Johan Courjon

given: Johan

family: Dufies

full_name: Océane Dufies

given: Océane

name: Service de Médecine Intensive Réanimation, Centre Hospitalier de Cannes, Cannes, France; and

family: Robert

full_name: Alexandre Robert

given: Alexandre

name: Public Health Department, University Hospital of Nice, Université Côte d’Azur, Nice, France

family: Bailly

full_name: Laurent Bailly

family: Torre

full_name: Cédric Torre

given: Cédric

family: Chirio

full_name: David Chirio

given: David

family: Contenti

full_name: Julie Contenti

given: Julie

family: Vitale

full_name: Sébastien Vitale

given: Sébastien

family: Loubatier

full_name: Céline Loubatier

family: Doye

full_name: Anne Doye

given: Anne

family: Pomares-Estran

full_name: Christelle Pomares-Estran

given: Christelle

family: Gonfrier

full_name: Géraldine Gonfrier

given: Géraldine

family: Lotte

full_name: Romain Lotte

given: Romain

family: Munro

full_name: Patrick Munro

given: Patrick

family: Visvikis

full_name: Orane Visvikis

given: Orane

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Giordanengo

full_name: Valérie Giordanengo

given: Valérie

family: Carles

full_name: Michel Carles

given: Michel

family: Yvan-Charvet

full_name: Laurent Yvan-Charvet

family: Ivanov

full_name: Stoyan Ivanov

given: Stoyan

family: Auberger

full_name: Patrick Auberger

family: Jacquel

full_name: Arnaud Jacquel

given: Arnaud

family: Boyer

full_name: Laurent Boyer


title: HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital

acronym: H-Cov-Run

summary: Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world. The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.

status: Active, not recruiting

location_facility: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire Réunion


type: EudraCT Number

title: A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes

summary: This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas

summary: The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.

ReferenceCitation: Quak E, Blanchard D, Houdu B, Le Roux Y, Ciappuccini R, Lireux B, de Raucourt D, Grellard JM, Licaj I, Bardet S, Reznik Y, Clarisse B, Aide N. F18-choline PET/CT guided surgery in primary hyperparathyroidism when ultrasound and MIBI SPECT/CT are negative or inconclusive: the APACH1 study. Eur J Nucl Med Mol Imaging. 2018 Apr;45(4):658-666. doi: 10.1007/s00259-017-3911-1. Epub 2017 Dec 22.

family: Quak

full_name: Elske Quak

given: Elske

family: Blanchard

full_name: David Blanchard

family: Houdu

full_name: Benjamin Houdu

given: Benjamin

family: Le Roux

full_name: Yannick Le Roux

given: Yannick

family: Ciappuccini

full_name: Renaud Ciappuccini

given: Renaud

family: Lireux

full_name: Barbara Lireux

given: Barbara

family: de Raucourt

full_name: Dominique de Raucourt

given: Dominique

family: Grellard

full_name: Jean-Michel Grellard

given: Jean-Michel

family: Licaj

full_name: Idlir Licaj

given: Idlir

family: Bardet

full_name: Stéphane Bardet

given: Stéphane

family: Reznik

full_name: Yves Reznik

given: Yves

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

family: Aide

full_name: Nicolas Aide

given: Nicolas

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility:
CHU
Centre François Baclesse


title: Single Center Prospective Study Evaluating the Safety of Progressive Compressive Stockings for the Treatment of Venous Insufficiency in Patients With Peripheral Arterial Disease

summary:
Elastic compression stockings are recommended in the treatment venous insufficiency. Degressive compressive stockings have been used for many decades and are characterized by a high pressure applied at the ankle and a decreasing pressure from the ankle to the knee. Progressive compressive stockings were developed to have a maximal pressure at the calf. This concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings are strictly contraindicated for patients with PAD because highest pressures on ankle could slow down the superficial microcirculation.

On patients with PAD and venous insufficiency, the progressive compressive stockings could be well indicated. Strongest pressure at the calf should increase the pump effect and the muscle mechanical efficiency during the walk without deleterious effect.

location_facility:
Clinique Mutualiste Chrirugicale
CHU de Saint-Etienne


title: Treatment of Chronic Anterior Shoulder Instability by a Latarjet-type Bone Block Procedure Using the SEM (Science Et Medecine) Positioning Tool: Using a Scan to Assess Consolidation and Return to Normal Activity at 3 Months

acronym: IACE Scan

summary: The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as conditioned by the quality of the bone block consolidation.

primary_purpose: Prevention

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain

acronym: COP-PAIN

summary: The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability Index, ODI) at 6 months.

location_facility: CHRU de Montpellier - Hôpital Lapeyronie


title: Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

acronym: COVIPACT

summary:
This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus.

We will also assess the psychological impact of the pandemic in patients but also in caregivers

location_facility:
Centre Henri Becquerel
Centre François Baclesse


title: Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life

acronym: StVSII

summary:
This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.

The safety of the electrical stimulation of the left vagal nerve will also be evaluated.

Ten women, age between 18 and 60, will be included.

lead_sponsor: Hospices Civils de Lyon

location_facility: Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble

location_facility: Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon


title: Trans-Pulmonary Pressure and Prone Position in Ards Patients

summary:
Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. The challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. Recently, it has been proposed to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is obtained from the difference between airway pressure and measured esophageal pressure (Pes). Measured Pes values have been found positive in the supine position in ARDS patients, leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under investigation. Prone position ventilation significantly improves survival in severe ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.

The purpose of present project is to investigate Ptp at end-expiration in the prone position in severe ARDS. The project is centered on the question about what are the values of measured Pes in prone position. The hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.

location_facility:
Hôpital de la Croix Rousse
Hôpital de la Croix-Rousse


title: Study of Clinical and Immune Severity Profiles of Patients Infected With SARS-Cov2

acronym: REACOVIM

summary:
The SARS-CoV2 virus causes severe or even fatal disease in a fraction of infected people. The clinical severity is based on a complicated pneumopathy with acute respiratory distress syndrome that can lead to multi-visceral failure. The underlying mechanism is a cytokinergic storm, an emerging facet of immunological dysregulation.

This clinical trial is aimed to understand the mechanisms of this immunological dysregulation in order to identify therapeutic levers.

The main objective is to understand the relationships between clinical severity, death or morbidity of resuscitation management, and immune status (i.e., immune pathways activated or not). Immune status will be investigated at many levels of organization (i.e., circulating leukocytes, cytokines and chemokines, transcripts).

The secondary objectives are :

to understand what is responsible for clinical severity, viral load, or immune activation;
to highlight the consequences of immunological dysregulation on associated risks (i.e., immunosuppression leading to the emergence of infectious comorbidities) as well as the functioning of neurotransmission through metabolic pathway diversions. The impact of dysimmunity on these biological pathways will be assessed with a metabolomic analysis;
to understand the mechanisms of vulnerability related to the field. Moreover, while co-morbidities are likely to be a risk factor for severe disease progression, there are many situations in which they do not occur. Stress, with its neurovegetative and endocrinological dimensions, modulates the immune response. It is essential to know whether the stress response plays a role in immunological dysregulation. This analysis is a prerequisite for understanding the conditions of treatment with glucocorticoids.

Angiotensin converting enzyme type 2 (ACE2) also plays a likely role in host viral infection. It is also thought to play an important role in the emergence of severe syndromes by affecting the quality of vascular response.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
Bégin Military Teaching Hospital
Percy Military Teaching Hospital


title: Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Induction Followed by Autologous Stem Cell Transplantation, CRd Consolidation and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Old

acronym: IFM-CRd

summary: The purpose is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.

ReferenceCitation: Roussel M, Lauwers-Cances V, Wuilleme S, Belhadj K, Manier S, Garderet L, Escoffre-Barbe M, Mariette C, Benboubker L, Caillot D, Sonntag C, Touzeau C, Dupuis J, Moreau P, Leleu X, Facon T, Hébraud B, Corre J, Attal M. Up-front carfilzomib, lenalidomide, and dexamethasone with transplant for patients with multiple myeloma: the IFM KRd final results. Blood. 2021 Jul 15;138(2):113-121. doi: 10.1182/blood.2021010744.

name: Hématologie, Institut Universitaire du Cancer (IUC) Oncopole, Toulouse, France;

family: Roussel

full_name: Murielle Roussel

given: Murielle

name: Unité de Soutien Méthodologique à la Recherche (USMR), Service d’Épidémiologie, Centre Hospitalier Universitaire (CHU) Toulouse, France;

family: Lauwers-Cances

full_name: Valerie Lauwers-Cances

given: Valerie

name: Laboratoire d’Hématologie, CHU Nantes, France;

family: Wuilleme

full_name: Soraya Wuilleme

given: Soraya

name: Unité Hémopathies Lymphoïdes, CHU Henri Mondor, Créteil, France;

family: Belhadj

full_name: Karim Belhadj

given: Karim

name: Maladies du Sang, Centre Hospitalier Regional Universitaire (CHRU) de Lille, France;

family: Manier

full_name: Salomon Manier

given: Salomon

name: Service d’Hématologie et Thérapie Cellulaire, Hôpital Saint Antoine, Paris, France;

family: Garderet

full_name: Laurent Garderet

given: Laurent

name: Hématologie, CHU Pontchaillou, Rennes, France;

family: Escoffre-Barbe

full_name: Martine Escoffre-Barbe

given: Martine

name: Hématologie, Hôpital A. Michallon, Grenoble, France;

family: Mariette

full_name: Clara Mariette

given: Clara

name: Service Hématologie et Thérapies Cellulaires, CHRU Bretonneau, Tours, France;

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

name: Hématologie Clinique, CHU Dijon Bourgogne, France;

family: Caillot

full_name: Denis Caillot

given: Denis

name: Hématologie, Institut de Cancérologie Strasbourg Europe (ICANS), Strasbourg, France;

family: Sonntag

full_name: Cécile Sonntag

given: Cécile

family: Touzeau

full_name: Cyrille Touzeau

given: Cyrille

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Service d’Hématologie et Thérapie Cellulaire, Center Investigation Clinique (CIC) 1402, CHU Poitiers, France; and

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Facon

full_name: Thierry Facon

given: Thierry

family: Hébraud

full_name: Benjamin Hébraud

name: Unité de Génomique du Myélome, IUC Oncopole, Toulouse, France

family: Corre

full_name: Jill Corre

given: Jill

family: Attal

full_name: Michel Attal

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: University Hospital, Toulouse

location_facility:
University hospital of Toulouse
CHU de Toulouse


title: A RANDOMIZED NON-COMPARATIVE PHASE 2 PILOT STUDY TESTING THE VALUE OF IMATINIB MESYLATE AS AN EARLY TREATMENT OF COVID-19 DISEASE IN AGED HOSPITALIZED PATIENTS.

summary: High-throughput screening studies identified Abl kinase inhibitors (including imatinib) as inhibitors of coronaviruses SARS and MERS. The SARS-CoV-2 coronavirus depend on Abl2 kinase activity to fuse and enter into the cells. Pharmacokinetic studies demonstrated that IC50 of imatinib for ABL1, BCR-ABL1 and ABL2 kinase inhibition is less than 1 microM (around 0.3 microM) below the expected trough plasmatic concentrations of imatinib 400 mg/day (1.7 microM). The EC50 of imatinib for the inhibition of the virus is under investigation but we now have a first estimates with EC50 close to 2.5 microM. This plasmatic concentration is achievable with imatinib 800 mg/d. We hypothesize that clinically achievable imatinib concentration will block the first round of cell to cell virus infection and therefore stop or prevent from SARS-CoV-2 infection in human. Based on our 20 years' experience of prescribing imatinib in patients, we expect that most of the adverse events and pharmacological interactions of imatinib can be anticipated and corrected. The eligible population will be aged (>70y) patients hospitalized for a non-severe COVID-19 disease for less than 7 days. Patients will be randomized 1/1 between standard of care and imatinib 800 mg per day during 14 days. The primary endpoint will be the death rate by 30 days. Secondary endpoint will include progression to severe CIVID-19 disease, safety, outcome at 3 months. We plan to randomize 90 patients in order to show a 10% benefit in term of death rate reduction from 16% to 6%.

ReferenceCitation: Zhao H, Mendenhall M, Deininger MW. Imatinib is not a potent anti-SARS-CoV-2 drug. Leukemia. 2020 Nov;34(11):3085-3087. doi: 10.1038/s41375-020-01045-9. Epub 2020 Sep 30.

family: Zhao

full_name: Helong Zhao

given: Helong

family: Mendenhall

full_name: Michelle Mendenhall

given: Michelle

family: Deininger

full_name: Michael W. Deininger

given: Michael W.

journal_name: Leukemia

lead_sponsor: Versailles Hospital

location_facility:
CH de Versailles
CHU Bordeaux


title: Interest of Touch-massage in Hospital Day Care

acronym: TOMAS

summary:
In spite of progresses made in the medical and nurse announcement (linked to the cancer plan), still a lot of patients fell lost, anxious, especially during the first venue at the hospital day care for their chemotherapy. A longer time is necessary to give them again explanation, to reassure and to listen to them. However, patients are not always in ability to hear due to their psychological status. Young women seem to be more in distress, this is linked to the fear of the disease, the change of their social status and the future of their children.

It must be noted that there is an increase of complementary therapies including Touch-Massage. Studies showed its interest on quality of life, anxiety, pain and fatigue.

The concept Touch-massage (TM) is defined as a benevolent concern that takes shape through the touch and the sequence of gesture on all or parts of the body. This allows to calm, to relax, to get back into shape, to reassure, to communicate or simply to provide well-being, enjoyable to receive and to practice.

This treatment is already offered to the patients at the ICO, in priority while the first course of chemotherapy, but in an informal way. I has been noticed a better-being after the TM, and an increase of demand from the patients. This is why it would be interested to measure the evolution of quality of life of those patients having a chemotherapy for a breast cancer getting or not a TM.

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Behavioral


title: Sedation or General Anesthesia During Trancatheter Aortic Valve Implantation Procedure : ANESTAVI Study

acronym: ANESTAVI

summary:
Transcatheter aortic valve replacement TAVR is become the reference method for patients with severe aortic stenosis who are contraindicated or at risk for surgical aortic replacement. Initially performed under general anesthesia (GA), recent developpement of minimalist approach of TAVR include the use of local anesthesia (LA) with or without conscious sedation (CS) associated with full percutaneous access and no routine transoesophageal echocardiography (T0E). The aim is to simplify the procedure and to allow fast recovery of patients with early discharge and reduced cost.

Evidence guiding the decision of whether to perform TAVR under GA or LA-CS is limited to non-randomized trials and registry data Current evidence is however limited by probable patient selection bias, methodological variability between studies, various methods of anesthesia and a lack of agreement regarding appropriate clinical end-points. The potential benefits of TAVR with LA include reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. As LA with CS is preferred with good results in main centers, GA may be useful to facilitate intraprocedural TOE which is necessary in case of intraprocedural complications and may facilitate the procedure for the physician particularly when the patient is anxious or disturbed. A resulted better concentration without precipitation may influence the outcomes in term of valve positioning. The patient comfort could also be better during femoral puncture or rapid pacing. The aim of the study is to compare transfemoral TAVR under general anesthesia (experimental group) versus local anaesthesia with sedation (control group) with a safety primary combined end point of adverse events at 72 h follow-up (hemodynamic parameters and VARC 2 criteria). Secondary end points include hospitalization length, satisfaction of the patients and operators and 30 days mortality.

The hypothesis is a non inferoirity of the GA staregy regarding the primary end point.

lead_sponsor: University Hospital, Montpellier


title: Randomized Double Blinded Monocentric Clinical Trial to Assess the Impact of Auricular Vagus Nerve Neuromodulation in COVID-19 Positive Inpatients Outcome.

summary:
The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed.

A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome.

In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models.

Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities.

Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear.

Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

ReferenceCitation: Rangon CM, Barruet R, Mazouni A, Le Cossec C, Thevenin S, Guillaume J, Léguillier T, Huysman F, Luis D. Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study. Front Physiol. 2021 Aug 2;12:704599. doi: 10.3389/fphys.2021.704599. eCollection 2021.

family: Rangon

full_name: Claire-Marie Rangon

given: Claire-Marie

family: Barruet

full_name: Régine Barruet

given: Régine

family: Mazouni

full_name: Abdelmadjid Mazouni

given: Abdelmadjid

family: Le Cossec

full_name: Chloé Le Cossec

given: Chloé

family: Thevenin

full_name: Sophie Thevenin

given: Sophie

family: Guillaume

full_name: Jessica Guillaume

given: Jessica

family: Léguillier

full_name: Teddy Léguillier

given: Teddy

family: Huysman

full_name: Fabienne Huysman

given: Fabienne

family: Luis

full_name: David Luis

given: David

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Physiology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

location_facility:
Fondation Adolphe de Rothschild
Centre Hospitalier Simone Veil


title: Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa : Study of a Handheld in Vivo Confocal Microscope and of a Fluorescent in Vivo Confocal Microscope

acronym: INNOV-EYE

summary: In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


ReferenceCitation: Mebarki M, Iglicki N, Marigny C, Abadie C, Nicolet C, Churlaud G, Maheux C, Boucher H, Monsel A, Menasché P, Larghero J, Faivre L, Cras A. Development of a human umbilical cord-derived mesenchymal stromal cell-based advanced therapy medicinal product to treat immune and/or inflammatory diseases. Stem Cell Res Ther. 2021 Nov 13;12(1):571. doi: 10.1186/s13287-021-02637-7.

family: Mebarki

full_name: Miryam Mebarki

given: Miryam

family: Iglicki

full_name: Nathan Iglicki

given: Nathan

family: Marigny

full_name: Céline Marigny

given: Céline

family: Abadie

full_name: Camille Abadie

given: Camille

family: Nicolet

full_name: Claire Nicolet

given: Claire

family: Churlaud

full_name: Guillaume Churlaud

given: Guillaume

family: Maheux

full_name: Camille Maheux

family: Boucher

full_name: Hélène Boucher

given: Hélène

family: Monsel

full_name: Antoine Monsel

given: Antoine

family: Menasché

full_name: Philippe Menasché

family: Larghero

full_name: Jérôme Larghero

given: Jérôme

family: Faivre

full_name: Lionel Faivre

given: Lionel

family: Cras

full_name: Audrey Cras

given: Audrey

journal_name: Stem Cell Research & Therapy

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Européen Georges Pompidou - APHP

source: euctr

title: Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS

summary:
Whereas the pandemic due do Covid-19 continues to spread, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes Severe Acute Respiratory Distress Syndrome in 30% of patients with a 30%-60% mortality rate for those requiring hospitalization in an intensive care unit. The main physio-pathological hallmark is an acute pulmonary inflammation. Currently, there is no treatment.

Mesenchymal stem cells (MSC) feature several attractive characteristics: ease of procurement, high proliferation potential, capacity to home to inflammatory sites, anti-inflammatory, anti-fibrotic and immunomodulatory properties. If all MSC share several characteristics regardless of the tissue source, the highest productions of bioactive molecules and the strongest immunomodulatory properties are yielded by those from the Wharton's jelly of the umbilical cord. An additional advantage is that they can be scaled-up to generate banks of cryofrozen and thus readily available products. These cells have already been tested in several clinical trials with an excellent safety record.

The objective of this project is to treat intubated-ventilated patients presenting with a SARS-CoV2-related Acute Respiratory Distress Syndrome (ARDS) of less than 96 hours by three intravenous infusions of umbilical cord Wharton's jelly-derived mesenchymal stromal cells (UC-MSC) one every other day (duration of the treatment: one week). The primary endpoint is the PaO2/FiO2 ratio at day 7. The evolution of several inflammatory markers, T regulatory lymphocytes and donor-specific antibodies will also be monitored. The trial will include 40 patients, of whom 20 will be cell-treated while the remaining 20 patients will be injected with a placebo solution in addition to the standard of care. Given the pathophysiology of SARS-CoV2, it is thus sound to hypothesize that the intravenous administration of UC-MSC during the initial phase of ARDS could control inflammation, accelerate its recovery with improved oxygenation, reduced mechanical ventilation and ventilation weaning time and therefore reduced length of stay in intensive care.

The feasibility of the project is supported by the expertise of the Meary Cell and Gene Therapy Center, which is approved for the production of Advanced Therapy Medicinal Products and has already successfully prepared the first batches of cells, as well as by the involvement of a cardiac surgery team which will leverage its experience with stem cells for the treatment of heart failure to make it relevant to the Stroma-Cov-2 project.


title: INFO-AIDE-TABAC Study on the Level of Information on the Risks Related to Tobacco of Persons Consulting in Psychiatry and on Access to Aids in Case of Smoking, Comparing With Persons Consulting in Diabetology or in Addictology

summary: this is an observational study that involves providing a questionnaire to patients consulting in psychiatry, addictology (other than tobacco) and endocrinology to assess their knowledge of tobacco risks and access to smoking cessation aids

location_facility:
Hôpital Ferdinand Widal
Centre Hospitalier de Versailles


title: Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome

acronym: DRESSEO

summary: Drug Hypersensitivity Syndrome or DRESS for "Drug Reaction with Eosinophilia and Systemic Symptoms" is a serious drug allergy which can be life-threatening for patients with serious organ damage. The pathophysiology of DRESS is still not fully understood. In particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteria. Likewise, there is no data about the origin of eosinophils and few data are available concerning immune polarization of T-cells or the involvement of innate lymphoid cells type 2 in the recruitment of eosinophils. Our preliminary data on increase activation markers membrane expression of cutaneous eosinophils suggest that this approach could allow the identification of endotypes in which eosinophils are involved and contribute to organ damages. The correlation between tissue infiltration of eosinophils and their degree of activation would then justify the development of targeted therapeutic strategies in DRESS syndrome (anti-IL-5 therapy?). The aim of the project is: 1) Evaluate the activation status of circulating and cutaneous eosinophils in patients with DRESS compared with drug induced maculopapular exanthema without or with eosinophilia (but do not fulfill DRESS criteria) and healthy subjects; 2) Understand the pathophysiological mechanisms at the origin of this eosinophilia.

lead_sponsor: University Hospital, Lille

location_facility:
CH LENS
Hop Claude Huriez Chr Lille


title: Interest of Clinical Ultrasound in Patients Consulting for Dyspnea in the Emergency Department: an Observational Bicentric Study

acronym: ECUDYS

summary: The diagnostic value of Point-of-care ultrasound (POCUS) in emergency department (ED) dyspneic patients is shown by numerous studies with a limited number of patients. Recently, Zanobetti et al. showed the POCUS diagnostic performance in dyspneic patients in 2600 patients. This study was monocentric and few physicians performed the ultrasounds. Moreover they were experts. The POCUS diagnostic performance performed in a large number of dyspneic ED patients by many physicians with heterogeneous experience is not known. The investigators are carrying out a bicentric study in two large medical teams routinely practicing POCUS. The main objective of this study is to show the diagnostic concordance between the diagnosis resulting from the POCUS results in emergency department dyspneic patients and the diagnosis of discharge from the emergency department in a large medical team with a heterogeneous level of training and experience. The secondary objective is to study these different diagnostic concordances according to the level of ultrasound expertise of the ER practitioners.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Hôpital La Timone
CHU Nîmes


title: Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection

acronym: ENACOVID

summary: The symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.

location_facility: Réanimation médico-chirurgicale, Avicenne Hospital


title: Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer

acronym: MESORECT-VV

summary: This trial is assessing how Bladder filling variations and thus mesorectal movements are less when radiotherapy treatment is received with an empty bladder in rectal cancer

location_facility: Institut de Cacerologie de l'ouest - site Paul Papin


title: Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation

summary:
Therapeutic intensification followed by an autograft of hematopoietic stem cells is a standard of care for young patients with myeloma from the first line and for lymphoma from the second or third line of treatment. This procedure remains toxic in the short and medium term with significant mortality and morbidity: the average mortality varies from 1.4 to 5%. The causes of death are linked to a severe infection, visceral bleeding or vital organ failure. This risk of mortality is partly correlated with sarcopenia.

Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.

The positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.

The objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.

This is a feasibility study.

lead_sponsor: Weprom

location_facility: Centre Jean Bernard/Clinique Victor Hugo


title: Human Study of Interest on Cervical Ultrasound Exploration for Association With Criteria of Difficult Intubation in General Surgery

acronym: TUBECHO

summary: The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Besancon Minjoz
CHRU de Besançon


title: Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use

acronym: MobiCogIm

summary: 120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls will be administered a whole-brain imaging exam. The current research project constitutes a highly novel approach to understanding the pathophysiology of addiction through its combination of neuroimaging with state-of-the-art information concerning the real-time expression of risk factors.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Charles Perrens
CHU de Bordeaux


title: Prospective Study for Diagnosis Utility of Array-CGH Screening in Case of Non Syndromic Congenital Heart Defect in Prenatal Diagnosis (CAPA)

acronym: CAPA

summary:
Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect.

This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

lead_sponsor: Rennes University Hospital

location_facility:
St Brieuc University Hospital
Rennes University Hospital


acronym: LET

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

title: Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms

summary: The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.


title: Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

acronym: ATTRACT

summary: This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.

lead_sponsor: Poitiers University Hospital

location_facility:
Poitiers University Hospital
Polyclinic of POITIERS


title: Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura

acronym: FOX-TREG

summary: The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.

time_perspective: Cross-Sectional

intervention_type: Biological


title: Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy

acronym: TARCI

summary: The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.

lead_sponsor: Nantes University Hospital

location_facility:
Nouvelles cliniques Nantaises
CHU de Nantes


title: Screening Platform of EORTC for Clinical Trials Access in Brain Tumors

acronym: SPECTAbrain

summary:
The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:

Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
Identify or validate new molecularly defined subgroups of tumors;
Investigate the prevalence of novel biomarkers to plan future clinical trials;
Enable exploratory/future research;
Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;

status: Withdrawn

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

intervention_type: Genetic