title: Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)

acronym: ORAMICAL

summary: The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass. Monocentric, Comparative, Randomized, Open Study.

acronym: ARG-BP

summary: Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Saint-Gregoire Private Hospital Center

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Medical Monitoring and Somatic Diseases in Children Who Suffer From Autism Spectrum Disorder (ASD)

acronym: SDA

summary: For many reasons, medical monitoring in autistic patients is very difficult. This study is designed to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases…) in patients suffering from ASD to prevent them or diagnose them earlier.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


type: Other Identifier

title: Estimation of the Precision of the Icare200 in the Measurement of Intraocular Pressure in Comparison to the Gold Standard : Goldmann Applanation Tonometer

summary:
In adult patients, intraocular pression readings are often taken with an air puff tonometer or goldmann tonometer. The current gold standard for IOP measurement is the Goldmann Applanation Tonometry (GAT). In some patients, measurement of intraocular pressure taken by applanation or by air puff may prove to be impossible for various reasons (obesity, handicap, mental disorder, blindness for Air Puff Tonometry, Anxiety, etc).

There are also many other devices that can be used to measure IOP, including those using rebound tonometry like the Icare 200.

The rebound tonometer would systematize IOP screening because of its ease of use, provided its measurements are reliable. In this prospective study, investigators will be measuring participant's IOP with Goldmann Applanation Tonometry, Icare 200 Tonometer and Air Puff Tonometry to see if there is an agreement in IOP between the different devices. Investigators will also look if there is a concordance between central corneal thickness and IOP. Moreover, investigators will look if there is a IOP concordance between the 3 different devices for hight BMI people. Indeed, higher body mass index tend to have difficulties with proper positioning at the slit lamp that may lead to inaccurate GAT measurements. Additionally, stress level of the patients with different tonometry devices will be recorded using a visual analog scale.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS

summary: This study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department. This is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software. All performances will be evaluated and compared.

lead_sponsor: Poitiers University Hospital


title: Evaluation of the Efficacy and Safety of Tacrolimus 0.1% Ophthalmic Solution in Children With Vernal Keratoconjunctivitis Resistant to Ciclosporin 2% Ophthalmic Solution: a Single-center Retrospective Cohort Study

acronym: KERAVER

summary:
Non-interventional single-center cohort study (Rothschild Foundation Hospital) of patients aged 0 to 18 years followed up in ophthalmology for KCV, treated with tacrolimus 0.1% eye drops previously treated with ciclosporin 2% with treatment failure.

Prospective collection of quality of life from the parents and/or, if possible, the children via the QUICK questionnaire and 6 additional questions
Retrospective collection of clinical data (secondary endpoints) from the patients' medical records, aiming to compare the period before the start of treatment and the period under treatment with TALYMUS

The objective of this study is to evaluate the response to TALYMUS® treatment in patients with Vernal keratoconjunctivitis who have failed ciclosporin 2% therapy, whether due to lack of efficacy, compliance difficulties or poor tolerance.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Other

lead_sponsor_type: industriel


title: Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)

acronym: EPERICARDIM

summary: This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: Ramsay Générale de Santé


title: A Comprehensive Retrospective Study of Cerebral MRI Anomalies in Mutated Transthyretin Amyloidosis Patients

acronym: TTR-SNC

summary:
Transthyretin amyloidosis (aTTR) initially described as a rare disease, became the most serious hereditary polyneuropathy of adult onset and family screening has made it possible to identify and follow up many asymptomatic patients and carriers of the mutation in the TTR gene.

Considered as a systemic disease with involvement of target organs (the heart, the eye, the kidney and peripheral nervous system), it seems to be more complex for neurologists according to recent publications raising the issue of central nervous system involvement.

Indeed, TTR amyloid deposits seem to be correlated with the duration of the disease. These deposits can cause cortical damage by different mechanisms: direct TTR toxicity or as a result of pathology related to cerebral amyloid angiopathy (intraparenchymal or subarachnoid hematomas, small infarcts, hemosiderin). A small number of mutations in the TTR gene cause a rare phenotype of systemic amyloidosis, the oculoleptomeningeal form, characterized by clinical neurological symptoms: progressive dementia, epilepsy, ataxia, spastic paraparesis, stroke-like episodes.

Hypothesis of the work: the central nervous system involvement is probably underestimated on the radiological description in patients with TTR mutation.

ReferenceType: background

ReferenceCitation: Ikeda SI. [Cerebral amyloid angiopathy with familial transthyretin-derived oculoleptomeningeal amyloidosis]. Brain Nerve. 2013 Jul;65(7):831-42. Review. Japanese.

ReferenceType: result

ReferenceCitation: Vieira M, Saraiva MJ. Transthyretin: a multifaceted protein. Biomol Concepts. 2014 Mar;5(1):45-54. doi: 10.1515/bmc-2013-0038. Review.

ReferenceCitation: Maia LF, Magalhães R, Freitas J, Taipa R, Pires MM, Osório H, Dias D, Pessegueiro H, Correia M, Coelho T. CNS involvement in V30M transthyretin amyloidosis: clinical, neuropathological and biochemical findings. J Neurol Neurosurg Psychiatry. 2015 Feb;86(2):159-67. doi: 10.1136/jnnp-2014-308107. Epub 2014 Aug 4.

ReferenceCitation: Nakagawa K, Sheikh SI, Snuderl M, Frosch MP, Greenberg SM. A new Thr49Pro transthyretin gene mutation associated with leptomeningeal amyloidosis. J Neurol Sci. 2008 Sep 15;272(1-2):186-90. doi: 10.1016/j.jns.2008.05.014. Epub 2008 Jun 24.

ReferenceCitation: Charidimou A, Gang Q, Werring DJ. Sporadic cerebral amyloid angiopathy revisited: recent insights into pathophysiology and clinical spectrum. J Neurol Neurosurg Psychiatry. 2012 Feb;83(2):124-37. doi: 10.1136/jnnp-2011-301308. Epub 2011 Nov 5. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.

acronym: PNEUMOCOVID

summary: As the investigators need data on long term outcome of Covid-19, especially respiratory sequelae, a national cohort is required. To better evaluate the potential respiratory sequelae after SARS-CoV-2 infection, it is fundamental to include patients with different management at the acute phase of the Covid-19: ambulatory management, hospitalization in non ICU and in ICU units. That is why the investigators will conduct a national cohort study with all components of french pneumology which will give the investigators the opportunity to include patients in general hospital, in university hospital and in private structure. As it is a "real life" study, the investigators will include all patients who will have a consultation with a pneumologist for an evaluation 5 to 7 months after a Covid-19 infection whatever their acute disease management. The investigators will collect all available data on Covid-19 acute phase, on patients characteristics and comorbidities, on persistent symptoms after Covid-19, on exams results during the outcome evaluation (CT-scan, 6 min walk test, spirometry and DLCO, blood gas, VO2 max if realized).

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Non-Randomized, Single-Center Pilot Trial Assessing The Safety/Efficacy Of Targeting Peripheral And Central Humoral Alloimmune Memory With Daratumumab And With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation

acronym: COMBAT

summary: While the number of kidney transplants is increasing worldwide every year, there is a clear imbalance between the high number of patients in the waiting list and those receiving a transplant and importantly, among waitlist patients there is a progressively higher number of highly sensitised patients that have very low or even no chance to receive a compatible organ. These patients remain for very long periods of time on dialysis therapy, having lower quality of life, lower life expectancy and produce higher health-related costs. Unfortunately, current desensitization therapies have shown very poor success and patients usually lose these grafts very fast if transplanted across a positive cross-match. Therefore, there is an urgent need for novel desensitization strategies capable of overcoming this immunological barrier and allow an increasing number of patients to receive a HLA-compatible kidney allograft.This is a non-randomized, single arm study, combination trial designed according to the Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. The study will enroll 12 patients with cPRA or TGI ≥99% on the deceased donor kidney transplant waiting list, who have not received a compatible donor offer for >3 year. According to inclusion and exclusion criteria patients will be screened to participate in the trial.

primary_purpose: Treatment

ReferenceCitation: Loupy A, Lefaucheur C. Antibody-Mediated Rejection of Solid-Organ Allografts. N Engl J Med. 2018 Sep 20;379(12):1150-1160. doi: 10.1056/NEJMra1802677. Review.

ReferenceCitation: Pruthi R, Hilton R, Pankhurst L, Mamode N, Hudson A, Roderick P, Ravanan R. UK Renal Registry 16th annual report: chapter 4 demography of patients waitlisted for renal transplantation in the UK: national and centre-specific analyses. Nephron Clin Pract. 2013;125(1-4):81-98. doi: 10.1159/000360023. Epub 2014 Feb 14.

ReferenceCitation: Wiebe C, Tambur A, Nickerson PW. A call to action-The transplant recipient's expectation of precision in transplant medicine. Am J Transplant. 2018 Dec;18(12):2845-2846. doi: 10.1111/ajt.15027. Epub 2018 Aug 13.

ReferenceCitation: Kiernan JJ, Ellison CA, Tinckam KJ. Measuring alloantibodies: a matter of quantity and quality. Curr Opin Organ Transplant. 2019 Feb;24(1):20-30. doi: 10.1097/MOT.0000000000000593. Review.

ReferenceCitation: Djamali A, Kaufman DB, Ellis TM, Zhong W, Matas A, Samaniego M. Diagnosis and management of antibody-mediated rejection: current status and novel approaches. Am J Transplant. 2014 Feb;14(2):255-71. doi: 10.1111/ajt.12589. Epub 2014 Jan 8. Review.

ReferenceCitation: Formica RN Jr, Kulkarni S. Being Thoughtful about Desensitization. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1878-1880. doi: 10.2215/CJN.09000817. Epub 2017 Oct 3.

ReferenceCitation: Cornell LD, Schinstock CA, Gandhi MJ, Kremers WK, Stegall MD. Positive crossmatch kidney transplant recipients treated with eculizumab: outcomes beyond 1 year. Am J Transplant. 2015 May;15(5):1293-302. doi: 10.1111/ajt.13168. Epub 2015 Mar 2.

ReferenceCitation: Luque S, Lúcia M, Crespo E, Jarque M, Grinyó JM, Bestard O. A multicolour HLA-specific B-cell FluoroSpot assay to functionally track circulating HLA-specific memory B cells. J Immunol Methods. 2018 Nov;462:23-33. doi: 10.1016/j.jim.2018.07.011. Epub 2018 Jul 31.

ReferenceCitation: Lúcia M, Luque S, Crespo E, Melilli E, Cruzado JM, Martorell J, Jarque M, Gil-Vernet S, Manonelles A, Grinyó JM, Bestard O. Preformed circulating HLA-specific memory B cells predict high risk of humoral rejection in kidney transplantation. Kidney Int. 2015 Oct;88(4):874-87. doi: 10.1038/ki.2015.205. Epub 2015 Jul 15.

ReferenceCitation: Perry DK, Pollinger HS, Burns JM, Rea D, Ramos E, Platt JL, Gloor JM, Stegall MD. Two novel assays of alloantibody-secreting cells demonstrating resistance to desensitization with IVIG and rATG. Am J Transplant. 2008 Jan;8(1):133-43. doi: 10.1111/j.1600-6143.2007.02039.x.

ReferenceCitation: Moreno Gonzales MA, Gandhi MJ, Schinstock CA, Moore NA, Smith BH, Braaten NY, Stegall MD. 32 Doses of Bortezomib for Desensitization Is Not Well Tolerated and Is Associated With Only Modest Reductions in Anti-HLA Antibody. Transplantation. 2017 Jun;101(6):1222-1227. doi: 10.1097/TP.0000000000001330.

ReferenceCitation: Kwun J, Burghuber C, Manook M, Iwakoshi N, Gibby A, Hong JJ, Knechtle S. Humoral Compensation after Bortezomib Treatment of Allosensitized Recipients. J Am Soc Nephrol. 2017 Jul;28(7):1991-1996. doi: 10.1681/ASN.2016070727. Epub 2017 Feb 23.

ReferenceCitation: Chen J, Yin H, Xu J, Wang Q, Edelblum KL, Sciammas R, Chong AS. Reversing endogenous alloreactive B cell GC responses with anti-CD154 or CTLA-4Ig. Am J Transplant. 2013 Sep;13(9):2280-92. doi: 10.1111/ajt.12350. Epub 2013 Jul 15.

ReferenceCitation: Yang J, Chen J, Young JS, Wang Q, Yin D, Sciammas R, Chong AS. Tracing Donor-MHC Class II Reactive B cells in Mouse Cardiac Transplantation: Delayed CTLA4-Ig Treatment Prevents Memory Alloreactive B-Cell Generation. Transplantation. 2016 Aug;100(8):1683-91. doi: 10.1097/TP.0000000000001253.

ReferenceCitation: Kim EJ, Kwun J, Gibby AC, Hong JJ, Farris AB 3rd, Iwakoshi NN, Villinger F, Kirk AD, Knechtle SJ. Costimulation blockade alters germinal center responses and prevents antibody-mediated rejection. Am J Transplant. 2014 Jan;14(1):59-69. doi: 10.1111/ajt.12526.

ReferenceCitation: Leibler C, Thiolat A, Hénique C, Samson C, Pilon C, Tamagne M, Pirenne F, Vingert B, Cohen JL, Grimbert P. Control of Humoral Response in Renal Transplantation by Belatacept Depends on a Direct Effect on B Cells and Impaired T Follicular Helper-B Cell Crosstalk. J Am Soc Nephrol. 2018 Mar;29(3):1049-1062. doi: 10.1681/ASN.2017060679. Epub 2018 Jan 10.

ReferenceCitation: Leibler C, Matignon M, Pilon C, Montespan F, Bigot J, Lang P, Carosella ED, Cohen J, Rouas-Freiss N, Grimbert P, Menier C. Kidney transplant recipients treated with belatacept exhibit increased naïve and transitional B cells. Am J Transplant. 2014 May;14(5):1173-82. doi: 10.1111/ajt.12721. Epub 2014 Apr 14.

ReferenceCitation: Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027. Erratum in: N Engl J Med. 2016 Feb 18;374(7):698.

ReferenceCitation: Bray RA, Gebel HM, Townsend R, Roberts ME, Polinsky M, Yang L, Meier-Kriesche HU, Larsen CP. Posttransplant reduction in preexisting donor-specific antibody levels after belatacept- versus cyclosporine-based immunosuppression: Post hoc analyses of BENEFIT and BENEFIT-EXT. Am J Transplant. 2018 Jul;18(7):1774-1782. doi: 10.1111/ajt.14738. Epub 2018 Apr 17.

ReferenceCitation: Kwun J, Burghuber C, Manook M, Ezekian B, Park J, Yoon J, Yi JS, Iwakoshi N, Gibby A, Hong JJ, Farris AB, Kirk AD, Knechtle SJ. Successful desensitization with proteasome inhibition and costimulation blockade in sensitized nonhuman primates. Blood Adv. 2017 Oct 26;1(24):2115-2119. doi: 10.1182/bloodadvances.2017010991. eCollection 2017 Nov 14. Erratum in: Blood Adv. 2018 Jan 23;2(2):89.

ReferenceCitation: Alishetti S, Farr M, Jennings D, Serban G, Uriel N, Sayer G, Vasilescu R, Restaino S, Chong AS, Habal MV. Desensitizing highly sensitized heart transplant candidates with the combination of belatacept and proteasome inhibition. Am J Transplant. 2020 Dec;20(12):3620-3630. doi: 10.1111/ajt.16113. Epub 2020 Jul 7.

ReferenceCitation: Jain D, Rajab A, Young JS, Yin D, Nadasdy T, Chong AS, Pelletier RP. Reversing donor-specific antibody responses and antibody-mediated rejection with bortezomib and belatacept in mice and kidney transplant recipients. Am J Transplant. 2020 Oct;20(10):2675-2685. doi: 10.1111/ajt.15881. Epub 2020 Apr 28.

ReferenceCitation: Moreno L, Perez C, Zabaleta A, Manrique I, Alignani D, Ajona D, Blanco L, Lasa M, Maiso P, Rodriguez I, Garate S, Jelinek T, Segura V, Moreno C, Merino J, Rodriguez-Otero P, Panizo C, Prosper F, San-Miguel JF, Paiva B. The Mechanism of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Multiple Myeloma. Clin Cancer Res. 2019 May 15;25(10):3176-3187. doi: 10.1158/1078-0432.CCR-18-1597. Epub 2019 Jan 28.

ReferenceCitation: Kwun J, Matignon M, Manook M, Guendouz S, Audard V, Kheav D, Poullot E, Gautreau C, Ezekian B, Bodez D, Damy T, Faivre L, Menouche D, Yoon J, Park J, Belhadj K, Chen D, Bilewski AM, Yi JS, Collins B, Stegall M, Farris AB, Knechtle S, Grimbert P. Daratumumab in Sensitized Kidney Transplantation: Potentials and Limitations of Experimental and Clinical Use. J Am Soc Nephrol. 2019 Jul;30(7):1206-1219. doi: 10.1681/ASN.2018121254. Epub 2019 Jun 21.

ReferenceCitation: Paller CJ, Bradbury PA, Ivy SP, Seymour L, LoRusso PM, Baker L, Rubinstein L, Huang E, Collyar D, Groshen S, Reeves S, Ellis LM, Sargent DJ, Rosner GL, LeBlanc ML, Ratain MJ. Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. Clin Cancer Res. 2014 Aug 15;20(16):4210-7. doi: 10.1158/1078-0432.CCR-14-0521. Review.

lead_sponsor: University Hospital, Grenoble

intervention_type: Combination Product


title: Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease

acronym: AttPark

summary: Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus: internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty older adults and thirty PD will participate in this study.

primary_purpose: Basic Science

ReferenceCitation: Baltadjieva R, Giladi N, Gruendlinger L, Peretz C, Hausdorff JM. Marked alterations in the gait timing and rhythmicity of patients with de novo Parkinson's disease. Eur J Neurosci. 2006 Sep;24(6):1815-20.

ReferenceCitation: Hausdorff JM. Gait dynamics, fractals and falls: finding meaning in the stride-to-stride fluctuations of human walking. Hum Mov Sci. 2007 Aug;26(4):555-89. Epub 2007 Jul 5. Review.

ReferenceCitation: Mahoney JR, Holtzer R, Izzetoglu M, Zemon V, Verghese J, Allali G. The role of prefrontal cortex during postural control in Parkinsonian syndromes a functional near-infrared spectroscopy study. Brain Res. 2016 Feb 15;1633:126-138. doi: 10.1016/j.brainres.2015.10.053. Epub 2015 Nov 6.

ReferenceCitation: Plotnik M, Giladi N, Dagan Y, Hausdorff JM. Postural instability and fall risk in Parkinson's disease: impaired dual tasking, pacing, and bilateral coordination of gait during the "ON" medication state. Exp Brain Res. 2011 May;210(3-4):529-38. doi: 10.1007/s00221-011-2551-0. Epub 2011 Jan 30.

ReferenceCitation: Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.

ReferenceCitation: Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.

ReferenceCitation: Wulf G, Höß M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

ReferenceCitation: Holtzer R, Verghese J, Allali G, Izzetoglu M, Wang C, Mahoney JR. Neurological Gait Abnormalities Moderate the Functional Brain Signature of the Posture First Hypothesis. Brain Topogr. 2016 Mar;29(2):334-43. doi: 10.1007/s10548-015-0465-z. Epub 2015 Nov 27.

ReferenceCitation: Maidan I, Bernad-Elazari H, Giladi N, Hausdorff JM, Mirelman A. When is Higher Level Cognitive Control Needed for Locomotor Tasks Among Patients with Parkinson's Disease? Brain Topogr. 2017 Jul;30(4):531-538. doi: 10.1007/s10548-017-0564-0. Epub 2017 Apr 24.

ReferenceCitation: Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. Review.

ReferenceCitation: Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015.

ReferenceCitation: Udina C, Avtzi S, Durduran T, Holtzer R, Rosso AL, Castellano-Tejedor C, Perez LM, Soto-Bagaria L, Inzitari M. Functional Near-Infrared Spectroscopy to Study Cerebral Hemodynamics in Older Adults During Cognitive and Motor Tasks: A Review. Front Aging Neurosci. 2020 Jan 21;11:367. doi: 10.3389/fnagi.2019.00367. eCollection 2019. Review.

ReferenceCitation: Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.

ReferenceCitation: Nieuwhof F, Reelick MF, Maidan I, Mirelman A, Hausdorff JM, Olde Rikkert MG, Bloem BR, Muthalib M, Claassen JA. Measuring prefrontal cortical activity during dual task walking in patients with Parkinson's disease: feasibility of using a new portable fNIRS device. Pilot Feasibility Stud. 2016 Sep 23;2:59. eCollection 2016.

ReferenceCitation: Yogev-Seligmann G, Sprecher E, Kodesh E. The Effect of External and Internal Focus of Attention on Gait Variability in Older Adults. J Mot Behav. 2017 Mar-Apr;49(2):179-184. doi: 10.1080/00222895.2016.1169983. Epub 2016 Aug 11.

ReferenceCitation: Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.

ReferenceCitation: Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe® Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry

acronym: PACTE

summary:
Venous thromboembolic disease (VTE) is a common clinical entity whose two manifestations are deep vein thrombosis (DVT) and pulmonary embolism (PE). After an acute PE, almost half of the patients complain residual dyspnea, despite well-conducted curative anticoagulation. Some will present persistent defects on lung scan-scintigraphy, without pulmonary hypertension. This condition defines Chronic-Thrombo-Embolic Disease(CTED). The prevalence of CTED after PE is poorly known as are its risk factors.

The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE.

The secondary objectives are:

To determine the potential risk factors for the occurrence of CTED.
To look for an association between the persistence of DVT and the occurrence of CTED.
To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up.
To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED.
To compare the impact on the quality of life (QoL) with or without CTED.
To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.


title: Stress and Resilience in Anesthesia Professionals

acronym: ResiStress

summary: The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.

intervention_type: Behavioral


title: Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy

acronym: H-TransPKR

summary:
surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile.

This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.


title: Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)

acronym: POMEROL

summary:
Study type : A 30 months, multicentre, open-label strategic randomized controlled trial

Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection).

Treatments :

Stratification at inclusion according to prophylactic therapy.

Patients randomized in 2 arms:

Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose.
Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards.

Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

intervention_type: Drug


title: Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial

acronym: OFATHA

summary:
Total hip arthroplasty (THA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management in THA requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). But, the best anesthesia strategy to provide optimal postoperative analgesia in THA remains controversial. Opioid free anesthesia could limit the episodes of hyperalgesia as well as tolerance and addiction to opioids.

The hypothesis of this study is that an opioid free anesthesia using dexmedetomidine could improve analgesia after THA.

The main objective of this monocenter, prospective, randomized, triple-blind, controlled trial is to assess the interest of opioid free anesthesia using dexmedetomidine on morphine consumption after THA.

lead_sponsor: CMC Ambroise Paré


title: Clinical and Radiological Evaluation of Two Mastoid Filling Products in Patients With Cholesteratoma.

acronym: MASTOS

summary: to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

lead_sponsor: University Hospital, Brest


title: EFFECT OF FOOD ALLERGENS ON DUODENAL MUCOSAUS BY CONFOCAL ENDOSCOPIC IMAGING Cellvizio

acronym: FAST

summary: Irritable Bowel Syndrome (IBS), or functional colopathy, is a chronic disease that affects 10% to 20% of the world's population.This syndrome is characterized by chronic abdominal pain or discomfort as well as a change in bowel habits (constipation or diarrhea) in the absence of structural or metabolic abnormalities (e.g. celiac disease, Crohn's disease). These symptoms have an impact on the quality of life of these patients who must therefore integrate the management of their disease into their daily life.IBS is subdivided into 3 subtypes according to the predominant symptom: the IBS-D subtype which groups together patients who have a predominance of diarrheal episodes, the IBS-C subtype which groups together patients who have a predominance of '' episodes of constipation and finally the IBS-M subtype which includes patients whose two symptoms mentioned above are observed without predominance

lead_sponsor: Clinique du Trocadéro

intervention_type: Device


title: Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

acronym: COLONEA

summary: The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail

summary:
PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail

SECONDARY OBJECTIVES :

To evaluate :

The main locations of blisters.
The severity of blisters
The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

lead_sponsor: Institut de Formation et de Recherche en Médecine de Montagne


title: Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy

acronym: HOPE

summary:
Constitution of a biological collection within the framework of the establishment of a diagnostic, prognostic and active surveillance test for prostate cancer from long non-coding RNA biomarkers, in 3 cohorts of patients, with cancer of the prostate, with suspected cancer without biopsy confirmation or with prostatic hyperplasia and healthy donors.

This biological collection will also be used as a support for further researches on the identification of biomarkers and genetic markers to improve the prognosis and diagnostic management of patients with prostate pathologies.

lead_sponsor: Institut Curie


title: Pilot Study Assessing the Feasibility and Reliability of Measurements of Skin's Parameters Hydration by Electrochemistry

acronym: SKINBIOSENSE

summary:
To date measuring the effect of dermocosmetic products on the main identified factors of aging and alteration of the skin barrier is based on invasive and expensive experiments. Electrochemistry enables to measure a specific signal for a substance of interest e.g. Vitamin C using an surface contact with an electrode.

Therefore, this study will evaluate the reliability and feasibility of measurements of skin's hydration parameters such as NMF and squalene using electrochemistry. These study will be made on three groups of individuals with different skin types: dry skin i.e. atopic dermatitis patients, oily skin i.e. acne skin and a control group of individual without facial dermatosis. Collects of parameters of interest will be made by using patch using electrochemistry (contact with an electrode and potentiostat to detect an electric signal) . It is a simple method that relies on a sensor / electrode pair that allows a study of the surface molecules of the skin. Application in the measurement of vitamin C in food products has already been validated.

On a second hand, a collect by chromatography of the parameters of interest will be carried out in order to compare the new method with the reference method.

This procedure has been developed via a procedure including collecting surface parameters using a patch an developping special electrodes and miniaturized detecting signal tool (potentiostat)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


title: VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs

acronym: VACATION

summary: Intro: Necrotizing and soft tissue infections (NSTI) are life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. The hospital mortality of NSTI is high, comprised between 20 and 30%. NSTIs represent the 4th cause of septic shock. Early management of NSTIs requires a coordinated and multidisciplinary approach, including broad-spectrum antibiotic administration, management of organ failures and aggressive surgical debridement with excision of all necrotic and infected tissues. NSTIs involve the lower limbs in about 70% of cases and lead in 15% of cases to limb amputation. During the early post-operative phase, daily wound care is required using conventional dressings. As soon as the infectious process is controlled, typically within 7 to 10 days of the initial debridement, the main goal of wound dressing is to allow for a granulation tissue to develop so that to perform a skin grafting. Negative pressure wound therapy (NPWT), which consists in applying a negative pressure on the wound surface, may be used to this effect. A dedicated dressing is connected to a device that generates a negative pressure and collects exudates. NPWT may have a positive effect on wound healing by removing exudate, increasing regional perfusion and patient comfort and reducing infections. Beneficial effects of NPWT have been suggested by case series. However, no randomized controlled trial are currently available to adequately assess its efficiency and the 2014 guidelines of the Infectious Diseases Society of America (IDSA) on NSTI did not provide recommendations regarding NPWT use for managing NSTI wounds. The study's hypothesis is that in patients managed for NSTIs, NPWT: 1) may accelerate skin grafting and complete wound healing; and 2) improve functional outcomes.


title: Evaluation of the Predictive Power of Double-product Increase Measured During an Exercise Test for the Prediction of Coronary Stenosis as Diagnosed by Cardiac CT Scan or Coronary Angiography.

summary:
The purpose of this study is to determine whether exercise testing can detect an obstruction in a coronary artery, and, thereby, can avoid performing a coronary imaging in some cases.

Patients with a suspicion of coronary artery disease perform an exercise test on an exercise bike with increasing load. EKG, blood pressure, and other parameters are monitored. Patients benefit also of either a cardiac CT scan or a coronary angiography to establish whether they really have coronary obstruction.

time_perspective: Other

lead_sponsor: Centre Hospitalier Sud Francilien


title: Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device

summary: The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

lead_sponsor: Diagast


title: Study of the Effects of Adolescent Weight Disorders (Obesity, Anorexia Nervosa) on Heart Function

summary:
The study aims to better understand the functioning of the heart of children and adolescents with anorexia nervosa or obesity, compared to the heart function of control subject. This project seeks to find out if a weight disorder affects the heart and whether a systematic cardiac assessment with appropriate management is then to be considered.

To meet this objective, several analyzes are planned including a speckle tracking echocardiography, allowing a non-invasive study of myocardial deformations.

The hypothesis is that two opposite weight disorders (anorexia nervosa and obesity) lead to similar complications: inflammation, fibrosis altering the myocardial structure and therefore its contractility. Both systolic and diastolic dysfunction appear. Investigator hypothesize that the determinants of this dysfunction involve part of the alteration of body mass, and partly qualitative alterations specific to each pathology.

lead_sponsor: University Hospital, Clermont-Ferrand


title: EVALUATION OF 30-DAY MORTALITY AFTER A VISIT TO THE LAPEYRONIE ADULT EMERGENCY DEPARTMENT OF THE CHU MONTPELLIER FOR SEPSIS OR SEPTIC SHOCK

summary: Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.

lead_sponsor: University Hospital, Montpellier


title: Oral Health Related Quality of Life of Patients With Rare Diseases Followed at Necker Hospital: a Qualitative Approach

summary: The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by semi-structured interviews.


title: Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age

acronym: SENSOCOEUR

summary: The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

ReferenceCitation: Dagenais L, Materassi M, Desnous B, Vinay MC, Doussau A, Sabeh P, Prud'homme J, BSc KG, Lenoir M, Charron MA, Nuyt AM, Poirier N, Beaulieu-Genest L, Carmant L, Birca A. Superior Performance in Prone in Infants With Congenital Heart Disease Predicts an Earlier Onset of Walking. J Child Neurol. 2018 Dec;33(14):894-900. doi: 10.1177/0883073818798194. Epub 2018 Sep 18.

ReferenceCitation: Abadie V. [Apparently isolated feeding behavior troubles in infant]. Arch Pediatr. 2008 Jun;15(5):837-9. doi: 10.1016/S0929-693X(08)71932-8. French.

ReferenceCitation: Dunn W, Westman K. The sensory profile: the performance of a national sample of children without disabilities. Am J Occup Ther. 1997 Jan;51(1):25-34.

ReferenceCitation: Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17.


title: Complex Post-traumatic Stress Disorder: What Symptomatological Specificities

acronym: StuCoTra

summary: A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.

lead_sponsor: Raincy Montfermeil Hospital Group

location_facility: USAP CHI Robert Ballanger Boulevard Robert Ballanger


title: Assessment of the Impact of the COVID-19 Pandemic on Drug Use and on the Perception of Remote Monitoring by Cancer Patients Followed in the ONCORAL Program

acronym: ONCORAL-Covid

summary:
The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus.

Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.

This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service Pharmaceutique, Hospices Civils de Lyon


title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

acronym: LISRACC

summary: Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Assessment of DEXAMETHASONE to Prevent Respiratory Complications After Non Urgent Thoracic Surgery

acronym: SURTHODEX

summary:
Thoracic surgery is at high risk of respiratory complications. Despite the improvement of surgical procedures such as video-thoracoscopy, respiratory complications appear in 15 to -20% of procedures. Thoracic surgery induces local pulmonary inflammation which is involved in the occurrence of post-operative respiratory failure. Similarly to the example of the acute respiratory distress syndrome, corticosteroids could reduce lung injury secondary to immunological stress. In addition, recent studies suggest that dexamethasone could lead to a reduction of respiratory complications after major non cardiothoracic surgery.

Since dexamethasone is recommended to prevent postoperative nausea and vomiting, around one in two patients receive dexamethasone during anesthetic induction. By retrospective analysis with compensation of bias by propensity score, the investigators aim to assess the effect of dexamethasone to prevent respiratory complications

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Effects of Two Stress Management Procedures on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students : Relaxing Breathing Combined With Biofeedback or Meditative Stimulation : ECOSTRESS Study

acronym: ECOSTRESS

summary:
Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical student and is a determinant part of the national competition they have to undergo.

Medical studies, especially during examen period, are significantly associated with risk of developping depressions or anxious trouble, wich led to lesser performance, impaired memorization and impaired workload capacities.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback and meditation are procedures used to reduce the stress level.

There is currently no study on the effect of stress management procedures on the performance during OSCE for medical student.

lead_sponsor: Claude Bernard University


title: Evaluation de l'Incidence Des évènements hémorragiques et ischémiques en Post-angioplastie Chez Des Patients Coronariens anticoagulés Dans le Cadre d'Une Fibrillation Auriculaire

acronym: FACOREV

summary:
Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose.

In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software

acronym: EasyPedia

summary:
Errors during a stressful pediatric critical situation occur more frequently than thought. The main aim of the study is to quantify the number and the type of errors made by pediatric paramedical teams during the management of vital emergencies (medication dosage calculation, compliance with algorithms for management of cardiac arrest…). Then, simulations with and without the EasyPédia software will be compared during a high-fidelity simulation of a standardized pediatric cardiac arrest scenario in order to evaluate its impact on reducing errors during the management of a resuscitation.

This study will be a single-center and observational trial in the pediatric intensive care unit of the Besançon University Hospital.


title: Evaluation of a Combined Analysis of Serum and Cerebrospinal Fluid Inflammatory Biomarkers to Help in Etiological Diagnosis of Central Nervous System Autoimmune Diseases

acronym: CyBIRD

summary:
Project rationale:

Since 2017, multiple sclerosis diagnosis should match the new McDonald criteria in which a "no better explanation than MS" should be fulfilled. However, many patients present with red flags that lead to a complex diagnostic work-up. There are no available biomarkers that permit to confirm or roll out MS diagnosis in such cases. Therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected MS.

Many studies have found that serum and cerebrospinal fluid (CSF) cytokines could help to differentiate MS from other diseases such as neuromyelitis optica spectrum disorders (i.e., IL-6) or neurosarcoidosis (i.e., sIL-2R). Serum and CSF kappa free light chains have also shown good diagnosis performance in MS. In daily practice, our MS tertiary center already perform the analysis of CSF concentrations of IL-1β, sIL-2R, IL-6, IL-10, and serum and CSF kappa and lambda free light chains to roll out other central nervous system (CNS) autoimmune diseases in patients presenting with white matter hyperintensities (WMH).

Objective:

To correlate CSF IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains with the final diagnosis in patients presenting to our MS tertiary center with suspected MS to identify a specific inflammatory biomarker profil involved in MS and other CNS autoimmune diseases.

The methodology:

This is an observational study. All patients ongoing a routine diagnostic work-up for suspected MS from june 2020 to june 2022 in our MS tertiary center will be analyzed. Cerebrospinal fluid IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find MS associated biomarkers.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Biological


title: Study of the Evolution of Olfactory Disorders in Patients With Persistent Loss of Smell Following COVID-19

acronym: ETOC

summary:
The COVID-19 pandemic is a novel medical challenge, particularly because of the systemic nature of this disease. Indeed, COVID-19 affects several organs and systems at once. The brain is affected in several ways: direct infection of nerve cells by SARS-CoV-2, inflammation of the central nervous system, severe systemic inflammation damaging nerve cells, global cerebral ischaemia related to respiratory failure, thromboembolic events related to increased intravascular coagulation and severe psychological stress. As a result, COVID-19 sometimes manifests as neurological and neuropsychiatric symptoms such as dizziness, sleep disturbances, cognitive deficits, delirium, or severe depression.

Sudden loss of smell is a common symptom associated with COVID-19 and SARS-CoV-2 infection of neurons in the olfactory system has been reported in both hamsters and humans. The vast majority of COVID-19 patients recover their olfactory function within a few weeks. However, a significant minority of infected individuals (1 in 5 cases) still suffers from olfactory disorders (anosmia, hyposmia and/or parosmia) several months after the primary infection. These olfactory disorders are frequently associated with depressive behaviour and cognitive complaints. In PET scans, it is even possible to correlate this cognitive dysfunction with hypometabolism of certain brain regions, including the olfactory gyrus.

This project proposes, during one year, to evaluate and follow the evolution of the olfactory capacities of patients suffering from persistent smell disorder since one year (+/- 4 months) following COVID-19. The issue is to study the link between viral persistence in the olfactory sensory organ, chronic inflammation, and central damage to the olfactory system. The follow-up of the evolution of olfactory and neurocognitive capacities, in an integrative way by means of molecular, physiological and behavioural approaches, will inform us on the specificities of "COVID-long" and on the level of peripheral and/or central damage of the olfactory system.

lead_sponsor: Institut Pasteur


title: Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas

summary: Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.


title: Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta

acronym: WOBIF

summary:
The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.

We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).

The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.


title: Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery

acronym: RVANG

summary: Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.


title: Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.

acronym: EDLIDL

summary:
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.

The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.


title: Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children and Neonates Using Transthoracic Echocardiography

acronym: PREDIPEN

summary:
Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. Only one-half of these patients respond to fluid administration by a significant increase in cardiac output. A positive fluid balance is a poor prognostic factor that increases mortality. There are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction.

In this work, the investigators propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation.

ReferenceCitation: Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.


title: Immunological Profile for Patients Treated With CAR-T Cells

acronym: SI-CART

summary:
In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.

A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed

lead_sponsor: Institut Paoli-Calmettes


title: Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score

summary: Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.


type: Other Grant/Funding Number

title: Evaluation of the Effect of Moderate and Controlled Hypercapnia on Ischemic Penumbra Vascular Collaterality During General Anesthesia for Anterior Circulation Acute Ischemic Stroke Mechanical Thrombectomy

acronym: COMET-AIS

summary: Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.

ReferenceCitation: Schönenberger S, Hendén PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sørensen LH, Ringleb PA, Wick W, Kieser M, Möhlenbruch MA, Rasmussen M, Rentzos A, Bösel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455. Erratum in: JAMA. 2019 Dec 24;322(24):2445.

ReferenceCitation: Slupe AM, Kirsch JR. Effects of anesthesia on cerebral blood flow, metabolism, and neuroprotection. J Cereb Blood Flow Metab. 2018 Dec;38(12):2192-2208. doi: 10.1177/0271678X18789273. Epub 2018 Jul 16. Review.

ReferenceCitation: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Review. Erratum in: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:.

ReferenceCitation: Willie CK, Macleod DB, Shaw AD, Smith KJ, Tzeng YC, Eves ND, Ikeda K, Graham J, Lewis NC, Day TA, Ainslie PN. Regional brain blood flow in man during acute changes in arterial blood gases. J Physiol. 2012 Jul 15;590(14):3261-75. doi: 10.1113/jphysiol.2012.228551. Epub 2012 Apr 10.

ReferenceCitation: Olsen TS, Larsen B, Herning M, Skriver EB, Lassen NA. Blood flow and vascular reactivity in collaterally perfused brain tissue. Evidence of an ischemic penumbra in patients with acute stroke. Stroke. 1983 May-Jun;14(3):332-41.


title: Respiratory Muscles and Work of Breathing in Children

summary:
Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.

The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.


title: Neurofunctional Characterization of Emotional Regulation and Its Links With the Eating Behaviour of Patients Suffering From Obesity, With or Without Binge Eating Disorder and Seeking Bariatric Surgery. Pilot Study

acronym: OBéMO

summary: Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. The purpose of this study is to fill this gap by comparing the neurofunctional profiles of emotion regulation between patients suffering from obesity, with or without BED and healthy participants during the performance of emotion regulation tasks. Results may help to understand the neural bases of the impairments observed in patients with obesity, with or without BED, which may in turn help to propose, in the long term, potential new therapeutic approaches.

lead_sponsor: CHU de Reims


title: Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery

acronym: ACTIBARIA

summary:
Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice.

So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.

primary_purpose: Prevention

ReferenceCitation: Baillot A, Audet M, Baillargeon JP, Dionne IJ, Valiquette L, Rosa-Fortin MM, Abou Chakra CN, Comeau E, Langlois MF. Impact of physical activity and fitness in class II and III obese individuals: a systematic review. Obes Rev. 2014 Sep;15(9):721-39. doi: 10.1111/obr.12171. Epub 2014 Apr 9. Review.

ReferenceCitation: Berggren JR, Boyle KE, Chapman WH, Houmard JA. Skeletal muscle lipid oxidation and obesity: influence of weight loss and exercise. Am J Physiol Endocrinol Metab. 2008 Apr;294(4):E726-32. doi: 10.1152/ajpendo.00354.2007. Epub 2008 Feb 5.

ReferenceCitation: Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. Review.

ReferenceCitation: Bond DS, Phelan S, Wolfe LG, Evans RK, Meador JG, Kellum JM, Maher JW, Wing RR. Becoming physically active after bariatric surgery is associated with improved weight loss and health-related quality of life. Obesity (Silver Spring). 2009 Jan;17(1):78-83. doi: 10.1038/oby.2008.501. Epub 2008 Nov 6.

ReferenceCitation: Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.

ReferenceCitation: Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591. Review.

ReferenceCitation: Herring LY, Stevinson C, Davies MJ, Biddle SJ, Sutton C, Bowrey D, Carter P. Changes in physical activity behaviour and physical function after bariatric surgery: a systematic review and meta-analysis. Obes Rev. 2016 Mar;17(3):250-61. doi: 10.1111/obr.12361. Epub 2016 Jan 18. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia: PHARM-LMC Study

acronym: PHARM-LMC

summary:
The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure.

In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation of the Efficacy, Tolerance of the Treatment, and Patient Satisfaction During the Management of an Arrested Pregnancy in the First Trimester According to the New Toulouse University Hospital Protocol

acronym: MYFEFACY

summary:
The clinical practice recommendations highlight the fact that the patient's choice concerning the management of her aborted pregnancy in the first trimester should be privileged, after clear and appropriate information on the available treatments, in order to improve his experience and reduce the negative psychological symptoms that can generate an alteration in the quality of life, in the aftermath of the loss of pregnancy.

The present study will describe the efficacy, satisfaction and tolerance of patients benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped during the first trimester at the Toulouse University Hospital

lead_sponsor: University Hospital, Toulouse


title: Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study

summary: Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.

lead_sponsor: Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancerologie Strasbourg Europe


title: Phenotypic, Biological and Functional Consequences of Mutations in the SPG7 Gene at the Heterozygous State

summary: Paraplegin, encoded by the SPG7 gene, is an ATP-dependent mAAA protease located in the inner mitochondrial membrane. Its function is not fully understood. Mutations in the SPG7 gene are responsible for spastic paraplegia type 7. Although spastic paraplegia type 7 is considered to be a recessive disease, some clinical observations also point to a detrimental effect of a variant in SPG7 in the heterozygous state. Thus, the presence of a single mutated variant of the SPG7 gene could be a risk factor for the development of neurological diseases. This has important implications for genetic counseling of patients and for the understanding of the function of the SPG7 protein and the mechanisms of disease development.


title: Bone Microarchitecture in Men With Hemophilia

acronym: HEMOS

summary:
Hemophilia A and B are hereditary sex-linked deficiencies of coagulation factors VIII and IX characterized by bleeding. Their modern therapy increases life expectancy and risk of age-related diseases, e.g., osteoporosis.

Hemophilia-specific risk factors impair formation of peak bone mass and accelerate bone loss. Fractures are more frequent in hemophilic men vs. age-matched men and induce bleeding which is aggravated by manipulations and surgical intervention.

The hypothesis of this study is that hemophilic men have poor bone microarchitecture (assessed by High-resolution peripheral quantitative computed tomography (HR-pQCT)) related to an imbalance between bone formation and resorption (assessed by bone turnover markers (BTM) and bone biomarkers).

The study aims to assess the difference in low trabecular number (Tb.N) at the distal radius between hemophilic men (cases) and age- height-weight-ethnicity and smoking-matched healthy men (controls). Correlation between BTM and Tb.N will be also studied.

Biologic markers of bone remodeling (C-terminal telopeptide of type I collagen (PINP), N-terminal propeptide of type I procollagen (CTX-I), periostin) will be studied.

location_facility: Hôpital Cardio-Vasculaire et Pneumologique

intervention_type: Radiation


title: Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center

acronym: TRODUMCRA

summary:
People in Administrative Detention Centers often come from areas of medium or high HIV, hepatitis C & B endemic, and are often unaware of their serological status. Currently, HIV, hepatitis C & B screening is not systematically performed at the CRA of Nîmes, and when performed, serological tests are used. The main disadvantage of this method is the length of time it takes to obtain the results, with subjects frequently discharged before receiving their results.

To improve the care of these vulnerable persons, the aim of this study is to estimate the prevalence of HIV, hepatitis C and hepatitis B in the detainees of the administrative detention center of Nîmes, by systematically screening with a rapid diagnosis test. In case of a positive rapid diagnosis test test, a serology test will confirm the rapid diagnosis test result.

time_perspective: Cross-Sectional


title: Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents

acronym: EPIRARE

summary:
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention.

The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations.

As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.

ipd_sharing_description: non available

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)

acronym: ATMAGD

summary:
Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.

The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Ramsay Générale de Santé

status_simplified: Unknown


title: Evaluation of the Decurarisation Kinetics of Rocuronium in Cervical Surgery

acronym: CIDEROC

summary:
Recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. A recent formalized expert guideline (RFE 2018) from the French Society of Anesthesia and Resuscitation, SFAR recommends administering a curare to facilitate tracheal intubation and limit laryngeal trauma . This study aims to determine if the level of neuromuscular recovery is consistent with monitoring the recurrent nerve after the use of rocuronium for intubation.

Primary endpoint: Achievement of quality intraoperative laryngeal recurrent nerve monitoring.

location_facility: Surgical anesthesia service - Cochin Hospital


title: Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy

acronym: MEDIIMYO

summary:
Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected.

Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated.

In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%.

In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Remote Assessment of Outpatient With SARS-CoV-2

acronym: EVIDENCE

summary:
Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of "at risk" patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active.

This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation.

lead_sponsor: University Hospital, Limoges


title: Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire

acronym: QaPEACH

summary:
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.

The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).


title: Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition

acronym: NPAD

summary:
Description of the life style of patients and families during the course of long term HPN.

Evaluation of the familial impact of HPN, and the way it is perceived
Evaluation of the satisfaction regarding the management by the multi-professional team (Medical, nursing, home care company and logistic, social, psychologist etc..) for improving the global management of these challenging patients
Analysis of the factors related to specific distress and the protective factors

lead_sponsor: Imagine Institute


title: Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease Grade II-IV in Adults and in Children Over 28 Days of Age

summary:
Leukotac (inolimomab) is not approved yet for marketing in any region. In the absence of medical options and based on the safety and efficacy data obtained during the clinical development program (in a phase III (INO-107) and in a Long Term Follow Up study), the French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for LEUKOTAC® (inolimomab) and approved the temporary use protocol .

This early access program has been granted to Leukotac (inolimomab) in adults and in children over 28 days of age, for treatment of acute cortico-resistant or cortico-dependent grades II-IV acute graft versus host disease (GvHD) according to the Glucksberg classification after allogeneic hematopoietic stem cell transplantation.

status: Available

study_type: Expanded Access

lead_sponsor: ElsaLys Biotech


title: Characterization of Suicidal Depression Within a Large Cohort of Inpatients: a One-year Prospective Study.

summary:
Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (SI) respond less well to antidepressant treatments. This suggests that patients with depression with SI may be different from those with depression without SI, thus requiring specific treatments for both SI reduction and depressive remission. In other words, suicidal depression may be a specific subtype of depression.

The study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression.

All data having already been collected during the particpation of patients in various clinical research studies of the department

lead_sponsor: University Hospital, Montpellier


title: Applicability of Fluid Responsiveness Indices in Patients With Acute Circulatory Failure (AFRIC Study)

acronym: AFRIC

summary: Fluid administration is one of the main strategies for patients with acute circulatory failure. However, about half of the patients could not benefit from the fluid administration after the ICU admission. Thus predict the effect of fluid responsiveness is essential. There are sevral indices or tests can be used, such as pulse pressure variation (PPV), end-expiratory occulsion test (EEOT), passive leg raising (PLR), etc. Question of the prevalence of cases in which the different predictive indices of fluid responsiveness in intensive care unit (ICU) are not applicable.

ReferenceCitation: Benes J, Kirov M, Kuzkov V, Lainscak M, Molnar Z, Voga G, Monnet X. Fluid Therapy: Double-Edged Sword during Critical Care? Biomed Res Int. 2015;2015:729075. doi: 10.1155/2015/729075. Epub 2015 Dec 22. Review.

ReferenceCitation: Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. Review.

ReferenceCitation: Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8.

ReferenceCitation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da. Review.

ReferenceCitation: Heenen S, De Backer D, Vincent JL. How can the response to volume expansion in patients with spontaneous respiratory movements be predicted? Crit Care. 2006;10(4):R102.

ReferenceCitation: Soubrier S, Saulnier F, Hubert H, Delour P, Lenci H, Onimus T, Nseir S, Durocher A. Can dynamic indicators help the prediction of fluid responsiveness in spontaneously breathing critically ill patients? Intensive Care Med. 2007 Jul;33(7):1117-1124. doi: 10.1007/s00134-007-0644-9. Epub 2007 May 17.

ReferenceCitation: Muller L, Louart G, Bousquet PJ, Candela D, Zoric L, de La Coussaye JE, Jaber S, Lefrant JY. The influence of the airway driving pressure on pulsed pressure variation as a predictor of fluid responsiveness. Intensive Care Med. 2010 Mar;36(3):496-503. doi: 10.1007/s00134-009-1686-y. Epub 2009 Oct 22.

ReferenceCitation: Malbrain ML, Reuter DA. Assessing fluid responsiveness with the passive leg raising maneuver in patients with increased intra-abdominal pressure: be aware that not all blood returns! Crit Care Med. 2010 Sep;38(9):1912-5. doi: 10.1097/CCM.0b013e3181f1b6a2.

ReferenceCitation: Delannoy B, Wallet F, Maucort-Boulch D, Page M, Kaaki M, Schoeffler M, Alexander B, Desebbe O. Applicability of Pulse Pressure Variation during Unstable Hemodynamic Events in the Intensive Care Unit: A Five-Day Prospective Multicenter Study. Crit Care Res Pract. 2016;2016:7162190. doi: 10.1155/2016/7162190. Epub 2016 Mar 31.

lead_sponsor: Bicetre Hospital


title: Evaluation of Rheumatoid Arthritis at the Time of Telemedicine

acronym: ePRAT

summary: The purpose of this study is to optimize the care of patients with RA seen in virtual consultation.

location_facility: Rheumatology Department, Cochin Hospital


title: Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020) : Why and How to Improve Antenatal Counseling ?

summary:
Objective :

Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation.

The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period.

The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling.

Materials and methods :

In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.


title: Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle

summary: This observational prospective clinical investigation will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

lead_sponsor: Cardiologs Technologies

location_facility: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier


title: Clinical Features Associated With Restless Legs Syndrome : Clin-RLS

acronym: Clin-RLS

summary: Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.


title: Integrative Study of Physiological Changes Induced by a 5-Day Dry Immersion, Used as a Ground-based Model to Mimic Weightlessness: a Pilot Study on 20 Healthy Female Volunteers (DI5-Women Study)

acronym: VivalDI

summary:
Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric. As a result, the immersed subject, who is freely suspended in the water mass, remains dry. Within a relatively short duration, the model can faithfully reproduce most physiological effects of actual microgravity, including centralization of body fluids, support unloading, and hypokinesia.

The objective of the study is to evaluate the physiological changes induced by 5 days of dry immersion in the female organism. The main physiological systems will be explored before, during and after the 5 days of immersion through a battery of specific tests and measurements. The results will be analyzed by scientists specializing in each field in order to better understand the dry immersion model, to compare its effects with those of the bedrest model and those of spaceflight. The clinical (adverse effects, comfort of subjects) and operational aspects are also part of the secondary objectives of the study.

ReferenceCitation: Navasiolava NM, Custaud MA, Tomilovskaya ES, Larina IM, Mano T, Gauquelin-Koch G, Gharib C, Kozlovskaya IB. Long-term dry immersion: review and prospects. Eur J Appl Physiol. 2011 Jul;111(7):1235-60. doi: 10.1007/s00421-010-1750-x. Epub 2010 Dec 14. Review.

ReferenceCitation: De Abreu S, Amirova L, Murphy R, Wallace R, Twomey L, Gauquelin-Koch G, Raverot V, Larcher F, Custaud MA, Navasiolava N. Multi-System Deconditioning in 3-Day Dry Immersion without Daily Raise. Front Physiol. 2017 Oct 13;8:799. doi: 10.3389/fphys.2017.00799. eCollection 2017.

ReferenceCitation: Kermorgant M, Leca F, Nasr N, Custaud MA, Geeraerts T, Czosnyka M, Arvanitis DN, Senard JM, Pavy-Le Traon A. Impacts of Simulated Weightlessness by Dry Immersion on Optic Nerve Sheath Diameter and Cerebral Autoregulation. Front Physiol. 2017 Oct 12;8:780. doi: 10.3389/fphys.2017.00780. eCollection 2017.

ReferenceCitation: Linossier MT, Amirova LE, Thomas M, Normand M, Bareille MP, Gauquelin-Koch G, Beck A, Costes-Salon MC, Bonneau C, Gharib C, Custaud MA, Vico L. Effects of short-term dry immersion on bone remodeling markers, insulin and adipokines. PLoS One. 2017 Aug 14;12(8):e0182970. doi: 10.1371/journal.pone.0182970. eCollection 2017.

lead_sponsor: Centre National d'Etudes Spatiales


title: Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network

acronym: SOPRAC

summary: As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

lead_sponsor: Research on Healthcare Performance Lab U1290


title: Effect of 5,25% Sodium Hypochlorite Enamel Deproteinization on the Initial Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets Bonded With a Self-etching Primer: An In Vitro Study on Human Bicuspids.

summary: The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.


title: Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study

acronym: ALTREVE

summary:
Inclusion (J0):

Information
Verification of inclusion and non-inclusion criteria
Collection of consent
MRI examination with injection of contrast product as part of the treatment comprising the sequences:

T1 TFE 1.0 iso 3D FLAIR injected Injected elliptical venous angiography 0.4mm iso or less 3D SWIp multiecho 3D T1 injected FABIR iso without injection (added as part of care in case of suspected ASH or meningitis) FLAIR 1.0 without injection (added as part of care for suspected ASH or meningitis) T2 BFFE XD (added by search) FABIR iso injected (added by research) 3D PD T1 0.55 MSDE iso injected (added by research)

Clinical information (SRM on inclusion, on discharge and at 3 months and recurrence within the year) will be collected from the patient's medical file

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild


title: Hemodynamic Estimation Per Procedure of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG)

acronym: MitraPOG

summary:
this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound.

The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.


title: Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction

acronym: STEMI

summary:
The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon.

We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia

lead_sponsor: Centre Hospitalier Universitaire Dijon