title: Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life

summary:
Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands.

CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery.

Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN.

We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms.

We will evaluate the Influence of type of CTN injury on taste disturbance.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: The Role of the Embedded Participant on Learners' Performance During High- Fidelity Simulation

summary:
Simulation in medicine is a powerful and effective teaching tool that has become essential for the training of students and health professionals.

In this context, simulation instructor training have been implemented in recent years, where many subjects are addressed, such as the main principles of pedagogy, the integration of simulation, the construction of a scenario, briefing and debriefing.

However, scenario facilitation, in particular the role of the embedded participant (EP), is only vaguely discussed. The EP of a high-fidelity simulation session plays a very important role in driving the scenario. Indeed, he/she guides the learner in order to achieve all the educational objectives set by the main instructor of the scenario. He/she also manages unexpected behavior and possible technical issues that may arise. Finally, the EP supervises the physical and psychological risks inherent in the simulation in order to maintain a safe environment.

All of these key roles suggest that the EP can influence the performance of the learners. Little is known about the relationship between Facilitation and Learner Performance.

In this observational study, investigators aim to explore the influence of the embedded participant on learners' technical and non-technical performances during high-fidelity simulation by analysing previously recorded sessions.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Cooke JM, Rooney DM, Fernandez GL, Farley DR. Simulation center best practices: A review of ACS-accredited educational institutes' best practices, 2011 to present. Surgery. 2018 Apr;163(4):916-920. doi: 10.1016/j.surg.2017.11.004. Epub 2017 Dec 19.

ReferenceCitation: Paige JB, Graham L, Sittner B. Formal Training Efforts to Develop Simulation Educators: An Integrative Review. Simul Healthc. 2020 Aug;15(4):271-281. doi: 10.1097/SIH.0000000000000424.

ReferenceCitation: Lewis KL, Bohnert CA, Gammon WL, Hölzer H, Lyman L, Smith C, Thompson TM, Wallace A, Gliva-McConvey G. The Association of Standardized Patient Educators (ASPE) Standards of Best Practice (SOBP). Adv Simul (Lond). 2017 Jun 27;2:10. doi: 10.1186/s41077-017-0043-4. eCollection 2017.

ReferenceCitation: Boyer TJ, Mitchell SA. Utilization of Embedded Simulation Personnel in Medical Simulation. 2021 Jul 26. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562294/

ipd_sharing: No

lead_sponsor: Claude Bernard University

lead_sponsor_type: academique

status_simplified: Ongoing


title: Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

acronym: SLPRaresHvisc

summary:
Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. Although HVS is one of the most frequent criteria for initiating therapy in WM, few studies focused on its description and no diagnostic criteria are available.

The present study aims to identify a diagnostic system for HVS, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Other


title: A Pilot Open-label, Feasibility Study to Assess safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)

acronym: PERTINENCE

summary: The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer (NMIBC) patients.

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Drug

lead_sponsor_type: industriel


title: Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)

acronym: SPECKLEKIDNEY

summary: The SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. The secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.

time_perspective: Prospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors

summary:
This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.

It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

status_simplified: Completed


title: Evaluation of a CPAP Telemonitoring Algorithm for Newly Treated Patients: the TELEAP1 Multicenter Cohort Pilot Study

summary: TELEAP1 is a multicenter cohort pilot-study designed to evaluate the impact of a published SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm on the CPAP-compliance of newly treated patients with obstructive sleep apnea..


type: Other Identifier

title: Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients

acronym: STAR-PARK

summary:
In Parkinson's disease (PD), recent work has shown that dopaminergic treatments alter one of the two aspects of impulsivity: they do not alter the propensity to produce "automatic" responses, but deteriorate the ability to inhibit and correct (that is, control) them. In healthy subjects, the investigator's team has also demonstrated that transcranial direct current "cathodal" electrical stimulation (tDCS) of Supplementary Motor Areas decreases the frequency of behavioral errors by improving the ability to "correct" responses.

The main objective of this project is to determine whether cathodal tDCS of Supplementary Motor Areas in PD patients under dopaminergic treatment improves the control and correction of errors about to be made and compensates for the deficits induced by the treatment.

All participants will perform a reaction time task of choice (Simon's task), with and without ("sham" session) tDCS. The experimental design of this single-center, single-blind, randomized study will be that of 3 parallel groups (treated Parkinson's disease, untreated Parkinson's disease patient, and matched control subjects) with cross-over application of tDCS. All participants will be blind to the operating mode of the tDCS (either functional or in "sham" mode corresponding to a control condition). The order of the sessions (with and without tDCS) will be randomized within each of the 3 groups of subjects. The analysis of errors about to be made but inhibited in time (known as "early errors") will be carried out through electromyographic (surface) recording of muscle activities involved in motor responses.

tDCS is expected to improve the ability of treated patients to correct their errors about to be made. This study will thus provide a better understanding of the mechanisms of action control and possibly propose a new therapeutic approach for treatment-induced impulsivity disorders in Parkinson's disease.

design_allocation: Randomized

primary_purpose: Treatment

location_facility: Service Neurologie et pathologies du mouvement

intervention_type: Device


title: Quality of Life 3 Months After Cervical Ripening

acronym: MATUCOL-QOL

summary:
Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor.

A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction.

However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening.

The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Chronic Intestinal Pathologies Analytical Cohort at TouLouse

acronym: CAPITOL

summary: In the general population, the percentage of people with at least one digestive disease is 16.7%. Among these digestive diseases, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( FIT) in the stool will be studied. The aim of this project is to build a biological collection with associated clinical data for research projects.

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological


title: Prospective, Observational Study Evaluating the Feasibility of a Systematic and Standardized Assessment of Supportive Care Needs in Patients With Advanced Solid Cancer at the Inclusion in a Therapeutic Trial at the Institut Curie

summary: The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.

lead_sponsor: Institut Curie


title: Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation

summary: Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, alternative, soft technology, based on a cross action of LED light emission, a low intensity nanopulsed laser and a magnetic tunnel. The sessions last 10 minutes each, in total in the study two sessions will be delivered.

primary_purpose: Other

ReferenceCitation: Persico G, Vergani P, Cestaro C, Grandolfo M, Nespoli A. Assessment of postpartum perineal pain after vaginal delivery: prevalence, severity and determinants. A prospective observational study. Minerva Ginecol. 2013 Dec;65(6):669-78.

ReferenceCitation: Morin C, Leymarie MC. La douleur périnéale en post-partum: revue de la littérature. La Revue Sage-femme (2013) 12; 263-268

ReferenceCitation: Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.

ReferenceCitation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204.

ReferenceCitation: Turmo M, Echevarria M, Rubio P, Almeida C. Development of chronic pain after episiotomy. Rev Esp Anestesiol Reanim. 2015 Oct;62(8):436-42. doi: 10.1016/j.redar.2014.10.008. Epub 2014 Dec 30. English, Spanish.

ReferenceCitation: HAS. Douleur chronique: reconnaître le syndrome douloureux chronique, l'évaluer et orienter le patient. Consensus formalisé - December 2008

ReferenceCitation: Skovlund E, Fyllingen G, Landre H, Nesheim BI. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol. 1991;40(4):343-7.

ReferenceCitation: Behotas S, Chauvin A, Castiel J, Martin A, Boureau F, Barrat J, Lienhart A. [Analgesic effect of ibuprofen in pain after episiotomy]. Ann Fr Anesth Reanim. 1992;11(1):22-6. French.

ReferenceCitation: Gabelle C, Cassa S, Bouvard M, Knoepffler F. Intérêts des anti-inflammatoires non stéroïdes dans les douleurs périnéales du post-partum. J Gyneco. Obst. Biol. Reprod (2004) 33(1): 67 (10)

ReferenceCitation: Wehrle M. Prise en charge de la douleur post-épisiotomie en suites de couches: Analyse des pratiques professionnelles à la Maternité Régionale Universitaire de Nancy. Mémoire Université de Lorraine (2015) hal-02110831.

ReferenceCitation: Battut A, Nizard J. [Impact of pelvic floor muscle training on prevention of perineal pain and dyspareunia in postpartum]. Prog Urol. 2016 Mar;26(4):237-44. doi: 10.1016/j.purol.2015.09.006. Epub 2015 Oct 9. Review. French.

ReferenceCitation: Golka M. Haute fréquence et douleur périnéale du post-partum. Mémoire Université d'Aix Marseille (2017) dumas-01646228

ReferenceCitation: Boureau F, Luu M. Méthodes d'évaluation de la douleur. Douleur et Analgésie (1988) 6; 1(2): 65-78.

ReferenceCitation: Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.

ReferenceCitation: Moreira Rocha Jr A. Et al. Effects of Low-Level Laser Therapy on the progress of wound healing in humans: the contribution of in vitro and in vivo experimental studies. J. Vas. Bras 2007; 6(3): 258-266

ReferenceCitation: Luo L, Sun Z, Zhang L, Li X, Dong Y, Liu TC. Effects of low-level laser therapy on ROS homeostasis and expression of IGF-1 and TGF-β1 in skeletal muscle during the repair process. Lasers Med Sci. 2013 May;28(3):725-34. doi: 10.1007/s10103-012-1133-0. Epub 2012 Jun 20.

ReferenceCitation: Cidral-Filho FJ, Mazzardo-Martins L, Martins DF, Santos AR. Light-emitting diode therapy induces analgesia in a mouse model of postoperative pain through activation of peripheral opioid receptors and the L-arginine/nitric oxide pathway. Lasers Med Sci. 2014 Mar;29(2):695-702. doi: 10.1007/s10103-013-1385-3. Epub 2013 Jul 6.

ReferenceCitation: Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD. The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004 Aug;22(4):323-9.

ReferenceCitation: Ahangar FA et Al. Efficace of nano-pulsed magneto infrared Laser Therapy with a fixed dose combination tablet of oral Ibuprofen and paracetamol on the reduction of endodontie pain: a clinical study. Contemporary Med. Res. (2017); 4(8): 1782-1787

ReferenceCitation: Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13. Review. Erratum in: Lancet. 2010 Mar 13;375(9718):894.

ReferenceCitation: Ezzati K, Fekrazad R, Raoufi Z. The Effects of Photobiomodulation Therapy on Post-Surgical Pain. J Lasers Med Sci. 2019 Spring;10(2):79-85. doi: 10.15171/jlms.2019.13. Epub 2019 Feb 25. Review.

ReferenceCitation: FDA, Multiple Endpoints in Clinical Trials Guidance for Industry, January 2017

lead_sponsor: Elsan


title: 3D Personalized Modelization of the Hand Using EOS Imaging System

summary: This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review

summary:
ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up.

The Investigators hypothesise that patients with co-occurrence of these two diseases may have a singular clinical course.

ReferenceType: result

ReferenceCitation: Guellec D, Cornec-Le Gall E, Groh M, Hachulla E, Karras A, Charles P, Dunogué B, Abad S, Alvarez F, Gérard F, Devauchelle-Pensec V, Pers JO, Puéchal X, Guillevin L, Saraux A, Cornec D; CRI (Club Rhumatismes et Inflammation) and the French Vasculitis Study Group. ANCA-associated vasculitis in patients with primary Sjögren's syndrome: detailed analysis of 7 new cases and systematic literature review. Autoimmun Rev. 2015 Aug;14(8):742-50. doi: 10.1016/j.autrev.2015.04.009. Epub 2015 Apr 24. Review.

family: Guellec

full_name: Dewi Guellec

given: Dewi

sequence: first

family: Cornec-Le Gall

full_name: Emilie Cornec-Le Gall

given: Emilie

sequence: additional

family: Groh

full_name: Matthieu Groh

given: Matthieu

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Karras

full_name: Alexandre Karras

given: Alexandre

family: Charles

full_name: Pierre Charles

given: Pierre

family: Dunogué

full_name: Bertrand Dunogué

given: Bertrand

family: Abad

full_name: Sébastien Abad

given: Sébastien

family: Alvarez

full_name: Fernand Alvarez

given: Fernand

family: Gérard

full_name: Fréderic Gérard

given: Fréderic

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

family: Pers

full_name: Jacques-Olivier Pers

given: Jacques-Olivier

family: Puéchal

full_name: Xavier Puéchal

given: Xavier

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

family: Saraux

full_name: Alain Saraux

given: Alain

family: Cornec

full_name: Divi Cornec

given: Divi

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Autoimmunity Reviews

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: ANCA-associated vasculitis in patients with primary Sjögren's syndrome: Detailed analysis of 7 new cases and systematic literature review

ReferenceCitation: Lee SB, Choi H, Kim MK, Jung SM, Song JJ, Park YB, Lee SW. Can antineutrophil cytoplasmic antibody positivity at diagnosis predict the poor outcomes of Sjögren's syndrome? Rheumatol Int. 2020 Jul;40(7):1063-1070. doi: 10.1007/s00296-019-04476-5. Epub 2019 Nov 12.

family: Lee

full_name: Soo Bin Lee

given: Soo Bin

family: Choi

full_name: Hyeok Choi

given: Hyeok

family: Kim

full_name: Minyoung Kevin Kim

given: Minyoung Kevin

family: Jung

full_name: Seung Min Jung

given: Seung Min

family: Song

full_name: Jason Jungsik Song

given: Jason Jungsik

title: Can antineutrophil cytoplasmic antibody positivity at diagnosis predict the poor outcomes of Sjögren’s syndrome?

ReferenceCitation: Ramos-Casals M, Brito-Zerón P, Font J. The overlap of Sjögren's syndrome with other systemic autoimmune diseases. Semin Arthritis Rheum. 2007 Feb;36(4):246-55. Epub 2006 Sep 22. Review.


title: Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run

acronym: FAT-FLEX

summary: Carbon plates inserted in competitive running shoes have been increasingly used in the past 2-3 years and several investigations have shown that these plates increase the longitudinal bending stiffness (LBS) of the shoe. It leads to a redistribution of muscle work and to a modification of the force generation conditions, which may reduce the energy cost of running (Cr) and improve performance. Only one study has investigated the effects of LBS in running bouts longer than 8 minutes but on the biomechanics part, and their effects on neuromuscular fatigue and prolonged running performance. The aim of this study is to compare shoes with and without carbon plates during a prolonged (21 km) running exercise on Cr, plantar flexor neuromuscular fatigue and running kinetics and kinematics to estimate the changes high-LBS may induce on fatigue and subsequent performance.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Unités de Myologie et de Médecine du Sport


title: Comparison of Power Wheelchair Driving Performance in a Physical Simulator With CAVE, Immersive Helmet and Non-immersive Screen in a Population of Drivers With Neurological Disorders: Pilot Study

summary: This study aims to assess the impact of the choice of visual feedback solution (immersive via CAVE and VR headset; non-immersive via screen only) on driving performance and quality of experience on a physical driving simulator and its acceptability to wheelchair drivers with neurological disorders.

lead_sponsor: Pôle Saint Hélier


title: Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study

summary: Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Treatment is second-line surgery after failure of orthopedic treatment. This surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. The patients in this study will only be operated on openly.

lead_sponsor: University Hospital, Limoges


title: Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)

acronym: SEMSAS

summary: The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.

lead_sponsor: Thibaut Gentina


title: Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.

acronym: SPINOB

summary: The purpose of this study is to determine how an important weight loss after bariatric surgery affects obese patients ' spine, and the effects it has on low back pain, sagittal alignment and lipomatosis .

primary_purpose: Prevention

ReferenceCitation: Briggs MS, Givens DL, Schmitt LC, Taylor CA. Relations of C-reactive protein and obesity to the prevalence and the odds of reporting low back pain. Arch Phys Med Rehabil. 2013 Apr;94(4):745-52. doi: 10.1016/j.apmr.2012.11.026. Epub 2012 Nov 24.

ReferenceCitation: Khoueir P, Black MH, Crookes PF, Kaufman HS, Katkhouda N, Wang MY. Prospective assessment of axial back pain symptoms before and after bariatric weight reduction surgery. Spine J. 2009 Jun;9(6):454-63. doi: 10.1016/j.spinee.2009.02.003. Epub 2009 Apr 8.

ReferenceCitation: Koulischer S, Cadière B, Cadière GB, Fabeck L. [Evolution of low back pain after bariatric surgery]. Rev Med Brux. 2015 May-Jun;36(3):147-51. French.

ReferenceCitation: de Mello AP, Martins GCDS, Heringer AR, Gamallo RB, Martins Filho LFDS, de Abreu AV, Carvalho ACP, Gama MP. Back pain and sagittal spine alignment in obese patients eligible for bariatric surgery. Eur Spine J. 2019 May;28(5):967-975. doi: 10.1007/s00586-019-05935-0. Epub 2019 Mar 15.

ReferenceCitation: Beckworth WJ, McCarty EJ, Garcia-Corrada JE, Holbrook JF. Epidural Lipomatosis and Associated Spinal Stenosis-The Impact of Weight Loss: A Case Report. Am J Lifestyle Med. 2017 Jan 12;11(6):511-514. doi: 10.1177/1559827616686764. eCollection 2017 Nov-Dec.

ReferenceCitation: Joaquim AF, Helvie P, Patel AA. Bariatric Surgery and Low Back Pain: A Systematic Literature Review. Global Spine J. 2020 Feb;10(1):102-110. doi: 10.1177/2192568219826935. Epub 2019 Feb 5. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Diagnostic Test


title: Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia

acronym: SLP-rares

summary:
Waldenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. This chronic lymphoproliferative disorder requires treatment only in case of symptoms, according to accurate criteria described during the second Workshop on WM i.e. in case of cytopenia, bulky organomegaly, immunological or physicochemical consequences of the presence of IgM in circulating blood. A MYD88 mutation, typically a MYD88(L265P), is found in 90% of WM patients. Other gene abnormalities have been observed, the most frequent is a mutation in the CXCR4 gene. Overall, gene mutations in WM involve only a limited number of signalling pathways, yielding the activation of NFkB, namely : the TLR and MYD88 pathway (with an activation of NFkB and BTK in case of MYD88(L265P) mutation), the BCR pathway (involving btk and associated with activations of both NFkB, and erk akt pathway) and the CXCR4 pathway (CXCR4 is a receptor of CXCL12, it is also associated with activations of ERK/MAPK and PI3K). Abnormalities of some of genes, such as TP53, of the expression of the protein CXCL13 and genes involved in the interleukin 6 secretion have been associated with some clinical characteristics.

The purpose of this project is to define the prognostic role of the detection of circulating tumoral DNA (ctDNA) at the end of treatment for the progression/relapse risk within the first 3 years after the first 6 months of treatment.


title: Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes

acronym: RANKL-GLYC

summary:
The rapid normalization of hyperglycemia can cause a neuropathy called Diabetes Treatment-Induced Neuropathy (NITD). This phenomenon induces the presence of hyper vascularization and inflammation in contact with the nerve ends.

In another register in patients living with diabetes, it has been observed the development of a rare and devastating complication for the joints called the so-called neuroarthropathy of Charcot (CN).

lead_sponsor: Centre Hospitalier Sud Francilien


title: Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population

summary: In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery: A Prospective Randomized Open-label Study. Virtual Reality for Analgesia in Spine Surgery

acronym: ViRAgeSS

summary: The objective is to evaluate the effect of the association of virtual reality sessions with usual management on the cumulative consumption of morphine equivalent post-operatively in adolescents aged 13 to 18 years who have undergone scoliosis surgery.

primary_purpose: Supportive Care


title: Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

acronym: Pied-REM

summary: To evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

ReferenceCitation: van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:84-98. doi: 10.1002/dmrr.2701. Review.

ReferenceCitation: Bus SA, van Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Price PE; International Working Group on the Diabetic Foot. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:16-24. doi: 10.1002/dmrr.2696.

ReferenceCitation: Bus SA, Waaijman R, Arts M, de Haart M, Busch-Westbroek T, van Baal J, Nollet F. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care. 2013 Dec;36(12):4109-16. doi: 10.2337/dc13-0996. Epub 2013 Oct 15.

ReferenceCitation: Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. Review.


type: Registry Identifier

title: Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

acronym: H-ICMUS

summary:
The primary objective of this pilot study aims to describe the modifications of subcutaneous impedancemetry induced by dialysis.

As secondary objectives, the study aims to 1) describe the modifications of cutaneo-muscular impedancemetry induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events. 3) describe the relationship between modifications of cutaneo-muscular impedancemetry induced by dialysis and 1) describe the modifications of cutaneo-muscular impedance induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events.

location_facility: Service de Néphrologie, Hôpital Ambroise Paré, APHP


title: Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk

acronym: COROPIEDIAB

summary:
In the context of the COVID-19 pandemic, a number of factors, including the lockdown that was imposed to limit the spread of infection, the fear of being contaminated during hospital consultations and the difficulty in accessing general practitioners may have led to delays in the referral of patients to facilities specialized in the management of diabetic ulcers. Since the beginning of the coronavirus pandemic and during the first lockdown, we observed a clear decrease in hospitalizations and consultations for diabetic ulcers. Patients who had regular follow-up for the management of their diabetic ulcers cancelled their scheduled appointments for fear of being contaminated in the hospital. It is feared that the current epidemic context has favored the delay of referral of patients with diabetic ulcers to specialized facilities, with consequences on the prognosis of these patients and the risk of lower limb amputation.

In this context, this project aims to evaluate the impact of confinement on emergency hospitalizations for foot wounds and the effects on the risk of amputation during the lockdown and the three months following the end of the lockdown.

Our hypothesis is that the lockdown led to a decrease in hospitalizations for foot wounds, resulting in a delay in the management of these patients, and potentially leading to an increase in the number of amputations in the three months following the end of the lockdown.

In parallel, we will also study the impact of confinement on deferrable hospitalizations (glycemic imbalance, assessment of diabetic complications...) or theoretically non-deferrable (diabetic comas, ketoacidosis, diagnosis of type 1 diabetes, acute coronary syndrome, stroke...) of diabetes mellitus. This will allow us to evaluate whether our findings relative to diabetic ulcers could be extended to other complications of diabetes.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery

acronym: DVDDP

summary: Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.

ReferenceCitation: Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92. Review.

ReferenceCitation: Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623. Review.

ReferenceCitation: Denault AY, Beaubien-Souligny W, Elmi-Sarabi M, Eljaiek R, El-Hamamsy I, Lamarche Y, Chronopoulos A, Lambert J, Bouchard J, Desjardins G. Clinical Significance of Portal Hypertension Diagnosed With Bedside Ultrasound After Cardiac Surgery. Anesth Analg. 2017 Apr;124(4):1109-1115. doi: 10.1213/ANE.0000000000001812.

ReferenceCitation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010.

lead_sponsor: CMC Ambroise Paré


title: Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

acronym: AMYLYONCARP

summary: The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients

acronym: CapnoPause

summary:
Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and increase post operative respiratory complications. Furthermore, fluid administration is not always followed by a cardiac output increase.

Predicting preload responsiveness before administering fluid by reliable and reproductible methods is necessary in critically ill patients.

Dynamic indicators are approved at the bedside such as passive raising leg test, pulse pressure variation, respiratory variation of the diameter of the superior vena cava. However, all these tests cannot be used for all patients. For example in the cases of spine or pelvis injury, or traumatic brain injury, patients with difficult condition for transthoracic echography.

The investigators hypothesize that EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test could predict fluid responsiveness in mechanically ventilated patients in the intensive care units.

EtCO2 is a parameter which can be easy to collect, reproductible, and totally non invasive. This method could be especially appropriate for patients for whom the classical test of fluid responsiveness cannot be used

lead_sponsor: CHU de Reims


title: Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

summary: B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.

intervention_type: Genetic


title: A Clinico-biological Database on Atypical Venous Thrombosis in the Context of anticovid19 Vaccination

acronym: THROMBO-VAXCOV

summary:
In the context of anti-Covid19 vaccination, atypical thrombosis have occured and potential link with vaccination is under investigation.

This study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after antiCovid vaccination.

ipd_sharing: Yes

lead_sponsor: University Hospital, Lille


title: HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

acronym: HighFLO

summary: Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

lead_sponsor: HighLife SAS


type: EudraCT Number

title: Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement (ToGiAC)

acronym: TOGIAC

summary: A French multicenter randomised and placebo-controlled study recruiting patients who present neurovascular involvement related to GCA (> 60 years) with symptomatic (stroke) or asymptomatic forms. The aim of this study is to assess the efficacy of tocilizumab to induce complete remission of GCA with cerebrovascular involvement (clinical and biological) and absence of clinical and MRI ischemic stroke recurrence at 24 weeks.

location_facility: Saint Antoine Hospital, Neurology Unit, Assistance Publique-Hôpitaux de Paris


title: Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.

acronym: Algo Fréq

summary:
360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment.

Cochlear implants are indicated in severe to profound deafness in some cases. The principle of the cochlear implant is to directly stimulate the fibres of the auditory nerve via electrodes inserted into the cochlea. It stimulates the auditory nerve and sends electrical impulses to the brain where they are interpreted as sounds.

The steps in hearing rehabilitation are surgical placement of the cochlear implant, activation, and follow-up adjustments.

There is no formal consensus on the exact adjustment procedures during activation or follow-up, but principles are followed depending on the cochlear implant adjustment centers (jack). All centers focus on sound intensity adjustments to achieve the goals of tonal audiometry in open-field silence with cochlear implant alone between 20 and 40 db (30 db most frequently). However, it is common practice to observe that this means of assessment does not really represent the performance of the individual because hearing a sound does not mean that someone will be able to recognize it and interpret it. Some of the patients who achieve these goals have difficulty hearing well in a noisy environment. Speech audiometry in silence and especially in noise would be a better reflection of patient needs.

Bimodal hearing is having a cochlear implant and a contralateral hearing aid. In cochlear implants, having bimodal binaural hearing improves the patients ability to understand speech in silent and noisy contexts. It should thus be considered when a second cochlear implant is not indicated in the contralateral ear.

It has been shown that intelligibility and musical perception are altered when the frequency allocations are different from the manufacturer's default frequency allocations. The possible redundancy between the acoustic and electrical information on the contralateral ear can lead to metallic distortion of the voice, which is perceived as less natural. This is due to a different stimulation of the cochlear tonotopic zones concerning conversational frequencies, between the implanted side and the device side. However, the frequency distribution is not subject to adjustment in current practice. A modification of the frequency distribution is possible on cochlear implants, which could improve the intelligibility and comfort of the implanted patient.

This working hypothesis will be studied, and a simple protocol for frequency reallocation of the cochlear implant will be developed to optimize the daily hearing performance of the implanted patients. An evolutionary algorithm will be used. The search for new adjustment solutions will be carried out within the safety limits imposed by the adjusters (detection and comfort loudness threshold).


title: Osteoarticular Infections on Material in Children Under 16 Years Old at the CHU of Montpellier From 2014 to 2021

summary:
The management of osteoarticular infections on equipment is complex. In order to optimize the management of these infections, the French National Authority for Health (HAS) has published good practice recommendations for prosthesis infections in adults. However, in the pediatric population, this type of infection is rarer and their management less well codified.

The aim of this retrospective and descriptive monocentric study is to identify all osteoarticular infections in children under 16 years of age managed at the Montpellier University Hospital from 2014 to 2021, to study the epidemiology and bacterial ecology of these infections and to evaluate the effectiveness of the therapeutic strategy and side effects, long-term sequels

lead_sponsor: University Hospital, Montpellier


title: Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment.

acronym: PHARM-APO

summary: This monocentric and prospective trial aims firstly to assess the pharmacokinetic profile of continuous and diurnal subcutaneous apomorphine infusion in patients with Parkinson's disease under stabilized treatment and, secondly, to collect data highlighting the possible influence of pharmacogenetics.

lead_sponsor: Rennes University Hospital


title: Allergology: Information, Data and Knowledge Organization

acronym: ALLERGIDOC

summary:
Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work.

In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.

status: Active, not recruiting


title: Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

acronym: OFACAR

summary:
Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:

better analgesia and decreased postoperative morphine consumption,
better respiratory function,
better hemodynamic stability,
better postoperative cognitive function.

The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:

Improved intraoperative hemodynamic stability
A decrease in the incidence of postoperative complications
A reduction in intensive care and hospital length of stay


title: Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study

acronym: SIAGLA

summary:
Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients With Non Small Cell Lung Cancer Mass Tissue Imaging HyperIONTM

acronym: PREDICTION

summary:
Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment.

The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.

lead_sponsor: University Hospital, Brest


title: Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.

acronym: EyeTrackingFP

summary:
The facial palsy concerns between 15 and 40 people per 100000 inhabitants. They are of various etiologies such as infectious, tumoral, traumatic or idiopathic.

It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed palliative treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. In this context, patients' expectations and feelings about their care may become difficult for clinicians to apprehend.

The eye-tracking is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular. Published studies focus on the gaze of photographs, excluding any notion of dynamics and by the analysis of the gaze of outside observers, ignoring the patient's gaze.The main objective is to evaluate the attention paid to the facial side with abnormal facial movement by patients with facial paralysis compared to healthy volunteers.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Studies of the Characteristics of the Angle Kappa and the Angle Alpha in the Healthy Individual. Studies of the Angle Kappa and the Angle Alpha

acronym: EKAPS

summary:
Anatomical ophthalmological connections and their dynamics are still debated in the scientific community. However, their considering is essential in many surgeries (strabismus, cataract, refractive...) or in clinical practice.

The correlation between these biometric values would make it possible to refine the knowledge related to these landmarks and thus offer better ophthalmological management by integrating these variables into the clinical examination.

The aim of the study is to analyze the correlation between the angle alpha and the angle kappa in a healthy individual without ophthalmologic disorder.


title: Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX

acronym: ECMORIX

summary:
The Oxiris membrane is an AN-69 membrane whose surface is treated with polyethyleneimine (PEI) grafted with heparin. This property allows the removal of lipopolysaccharide and cytokines from the blood. During septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). Moreover, the literature suggests that the use of the Oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. To our knowledge (Pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ECLS.

The research hypothesis is that the early addition of an Oxiris membrane to the ECLS circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.

ReferenceType: derived

ReferenceCitation: Andrei S, Nguyen M, Berthoud V, Morgant MC, Bouhemad B, Guinot PG; ECMORIX Study Group. Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 11;8:738496. doi: 10.3389/fcvm.2021.738496. eCollection 2021.


title: Effects of Eccentric Pedaling at Different Rates on Neuromuscular Function

acronym: Exo-Mode 3

summary:
The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle function and exercise capacity. Despite its potential advantages, the optimal modalities of eccentric pedaling, in particular the choice of pedaling frequency, are still poorly understood, especially its effects on the neuromuscular system. Indeed, most training protocols impose a fixed pedaling power but with highly variable pedaling rates, ranging from 15 to 60 rpm (Besson et al., 2013; MacMillan et al., 2017). For a given pedaling power level (P), the choice of pedaling frequency (F) directly impacts the force torque (C) and thus the force applied to the pedals, since power is equal to the product of pedaling frequency and force torque (P = F.C). For frequencies varying from 15 to 60 rpm, the level of muscular tension during pedaling therefore varies from single to quadruple. These very large variations in force can influence the neuromuscular adaptations induced during a prolonged training period. For example, the use of low pedaling frequencies corresponding to high muscle tension could favor peripheral muscular adaptations (e.g. contractility) whereas higher pedaling frequencies could favor central (i.e. nervous) adaptations.

A better understanding of the neuromuscular adaptations induced by a period of eccentric pedaling at different cadences will allow for a more precise definition of training protocols for populations likely to undergo this type of training (e.g. elderly people, patients with heart failure).


title: Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry

acronym: Pro-knee

summary:
This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test.

This study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, JPS and threshold to detection of passive motion, TDPM) and flexors/extensors strength. At the same time, they performed a functional testing consisting of three Hop-tests (single, triple and cross-over) and the Lower Quarter Y-Balance Test (YBT-LQ). We tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Caen


title: X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device

summary:
Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum.

In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment .

The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI.

The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .

lead_sponsor: University Hospital, Limoges


title: Description of the Vasculature Pattern of the Bronchial Tree During Infection With SARS-CoV2 by Narrow Band Imaging Bronchoscopy

summary: Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.


title: Impact of an Olfactory Sensory Therapeutic Group in the Therapeutic Armamentarium for Adolescent Patients With Restrictive Anorexia Nervosa, Pilot Study

acronym: Sens'Orality

summary:
Anorexia nervosa is a severe eating disorder of multifactorial origin and for which there is, to date, no specific, standardized and protocolized management for anorexic patients or data on the superiority of anorexia. type of psychotherapy. The literature reports altered olfactory capacities in anorexia nervosa and the effectiveness of sensory-mediated therapies in several mental disorders.

This prospective, single-center, randomized and controlled study proposes the evaluation of the therapeutic impact of an olfactory sensory group carried out during the specialized care of patients aged 12 to 20 years, with anorexia. The main objective is to compare the clinical course of eating disorder, using the Eating Attitudes Test-40 (EAT-40) scale score performed at study inclusion and at 9 months at 9 months, of patients participating in an olfactory sensory therapeutic group compared to a body approach therapeutic group.

The secondary objectives of this study are to compare between a treatment associated with an olfactory sensory therapeutic group and a body approach therapeutic group, the evolution of the Body Mass Index at 9 months, overall functioning, evolution of cognitive and sensory capacities, and evolution of the therapeutic alliance at 9 months

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Adherence Between Thromboprophylaxis Prescriptions and Guidelines During the Post-partum Period After the Institution of a Local Protocol

summary: The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines.


title: Assessment of the Impact of Telemedicine in Insulin-dependent Diabetic Patients Through the ETAPES Program.

acronym: TLS-DIAB

summary: The purpose of this study is to assess glycemic control changes in insulin-treated patients with diabetes using a continuous glucose monitoring CGM system through the ETAPES telemedicine program.


title: Opinion Survey on Postpartum Pelvic Floor Rehabilitation According to the Quality of Information Provided by the Health Care Providers

acronym: PPFR

summary: The aim of this work is to evaluate the experience of Postpartum Pelvic Floor Rehabilitation (PPFR) according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the patient.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly An Open Label, Single-center, Randomized, Controlled Pilot Study

acronym: CHARM

summary:
Some authors suggest a possible clinical interest of anti-slip socks. The scientific literature presents studies with methodological limitations. It is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population.

The investigatorswould therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.


title: Oral Low Doses Tolerance INduction Study for Peanuts

acronym: OLDTINYpeanut

summary:
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.

To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.


title: Evaluation of Child Desire in Young Women With Premature Ovarian Failure

acronym: DESIOP

summary:
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.

Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.

The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area

acronym: STEMI

summary:
The rapid and complete restoration of coronary flow is a key issue in the management of STEMI. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy associated with antithrombotic drugs.

In daily practice, it is not rare that some patients may achieve reopening of the culprit artery without undergoing any mechanical reperfusion therapy, which is called " spontaneous reperfusion ". The latter is associated with improved outcomes in several studies but none of these studies were done in the modern antithrombotic strategy area including new P2Y12 inhibitors. The aim of this study is to report the incidence, characteristics and outcomes of consecutive patients with STEMI admitted for coronary angiography with angiographic clinical evidence of spontaneous reperfusion in the modern medical antithrombotic strategy associated with primary PCI.


title: Deciphering a Specific Signature of the Immunosenescence Induced in COVID-19+ Patients Versus Rheumatoid Arthritis Patients

acronym: SENO-COVID

summary: Immune aging or immunosenescence is characterized by a loss of T cell clonal diversity and a contraction of naïve T cells with proliferative capacity associated with the functional impairment of many others immune cells as well as a chronic low degree of inflammation. A restrictive T cell repertoire is likely more prone to antigen-mediated exhaustion observed during chronic viral infections. Notably, lymphopenia is the most consistent laboratory abnormality in COVID-19 infected patients and both lung-resident and circulating T cells potently up-regulate markers of T cell exhaustion. It is not clear today if the association of COVID-19 disease severity with age is mainly related with the immunosenescence of infected patients. Interestingly, T cell exhaustion and premature immunosenescence have also been observed in chronic inflammatory diseases such as rheumatoid arthritis (RA). To better understand the immunological mechanisms involved in SARS-Cov-2 pathophysiology, the investigators propose to compare the immunosenescence patterns observed during RA, aging and SARS-Cov-2 infected patients in order to design improved therapeutic interventions.

ReferenceCitation: Wang R, Pan M, Zhang X, Han M, Fan X, Zhao F, Miao M, Xu J, Guan M, Deng X, Chen X, Shen L. Epidemiological and clinical features of 125 Hospitalized Patients with COVID-19 in Fuyang, Anhui, China. Int J Infect Dis. 2020 Jun;95:421-428. doi: 10.1016/j.ijid.2020.03.070. Epub 2020 Apr 11.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

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family: Huang

full_name: Chaolin Huang

given: Chaolin

family: Wang

full_name: Yeming Wang

given: Yeming

family: Li

full_name: Xingwang Li

given: Xingwang

family: Ren

full_name: Lili Ren

given: Lili

family: Zhao

full_name: Jianping Zhao

given: Jianping

family: Hu

full_name: Yi Hu

given: Yi

family: Zhang

full_name: Li Zhang

given: Li

family: Fan

full_name: Guohui Fan

given: Guohui

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

family: Yu

full_name: Ting Yu

given: Ting

family: Xia

full_name: Jiaan Xia

given: Jiaan

family: Wei

full_name: Yuan Wei

given: Yuan

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title: Diagnostic Performance of Arterial Time for CT Assessment of Parietal Enhancement Defect for the Diagnosis of Ischemia in Mechanical Small Bowel Occlusions: a Comparative Study With Portal Time

acronym: PORTOGRELE

summary:
Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old.

Although 65 to 80% of patients are treated medically, small bowel obstruction remains a serious pathology, with a high mortality rate that can reach 25% in case of small bowel ischemia. It is necessary to systematically perform a CT scan in the initial workup of small bowel obstructions to confirm the diagnosis, identify the mechanism and detect signs of ischemia that would require emergency surgery.

The best sign for the diagnosis of ischemia is the defect or asymmetry of parietal enhancement of the dilated small bowel. In the literature, this sign is described almost exclusively at portal time. In case of suspicion of mesenteric ischemia (another serious pathology affecting the small bowel), it is recommended to perform an examination with three acquisitions (without injection, arterial time, and portal time).

The department's experience has shown that arterial time is sometimes more sensitive than portal time for visualizing a parietal enhancement defect of the small bowel in mechanical occlusions.

Very few studies have investigated the diagnostic performance of parietal enhancement asymmetry on arterial time in mechanical occlusions of the small bowel.

ReferenceCitation: Zins M, Millet I, Taourel P. Adhesive Small Bowel Obstruction: Predictive Radiology to Improve Patient Management. Radiology. 2020 Sep;296(3):480-492. doi: 10.1148/radiol.2020192234. Epub 2020 Jul 21. Review.

ReferenceCitation: Millet I, Taourel P, Ruyer A, Molinari N. Value of CT findings to predict surgical ischemia in small bowel obstruction: A systematic review and meta-analysis. Eur Radiol. 2015 Jun;25(6):1823-35. doi: 10.1007/s00330-014-3440-2. Epub 2015 Apr 8. Review.

ReferenceCitation: Ohira G, Shuto K, Kono T, Tohma T, Gunji H, Narushima K, Imanishi S, Fujishiro T, Tochigi T, Hanaoka T, Miyauchi H, Hanari N, Matsubara H, Yanagawa N. Utility of arterial phase of dynamic CT for detection of intestinal ischemia associated with strangulation ileus. World J Radiol. 2012 Nov 28;4(11):450-4. doi: 10.4329/wjr.v4.i11.450.

ReferenceCitation: Chuong AM, Corno L, Beaussier H, Boulay-Coletta I, Millet I, Hodel J, Taourel P, Chatellier G, Zins M. Assessment of Bowel Wall Enhancement for the Diagnosis of Intestinal Ischemia in Patients with Small Bowel Obstruction: Value of Adding Unenhanced CT to Contrast-enhanced CT. Radiology. 2016 Jul;280(1):98-107. doi: 10.1148/radiol.2016151029. Epub 2016 Feb 11.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Integrative Analysis of the Tumor Microenvironment and Optimization of the Immunotherapy Duration in Non-small Cell Lung Cancer Patients. OPTIMUNE-LUNG Study

acronym: OPTIMUNE-LUNG

summary: Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)

lead_sponsor: Institut Bergonié


title: Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

summary: Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status <3.

lead_sponsor: Association Francaise de Chirurgie


title: Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients

acronym: ELY

summary:
CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.

From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.

Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.

lead_sponsor: Hôpital Cochin


title: Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial

summary: The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.


title: Identification of Occupational Exposures in Patients With Interstitial Lung Diseases (ILD)

acronym: ILD

summary:
Diffuse interstitial lung disease brings together a heterogeneous group of pulmonary pathologies, characterized by infiltrating and diffuse lesions of the pulmonary interstitium. The evolving risk of these ILD is pulmonary fibrosis, with the development of chronic respiratory failure.

The process of the etiological diagnosis of ILD results from a multidisciplinary approach (pulmonologists, radiologists, occupational health specialists, anatomo-pathologists, etc…). Indeed, the multitude of possible causes of these diseases makes the etiological diagnosis difficult. Professional aetiologies are also frequently mentioned : pneumoconiosis, hypersensitivity pneumonitis, as a differential diagnosis.

It therefore appears essential to deepen the professional aspect during the diagnostic process for ILD.

Since May 2020, a professional interview has been systematically offered by the Occupational Pathology Consultation Center of the Hospital Center Lyon Sud, to patients followed by the team of Professor Vincent COTTIN, whose file was discussed in a multidisciplinary meeting.

The data collected to constitute a database are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de consultation de pathologie professionnelle, Centre Hospitalier Lyon Sud


title: Evaluation of a Cosmetic Product (Onco-Rash) to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies Which Are Known to Fragilize Epidermis

acronym: OPERA

summary:
It is important for patients treated with anti-EGFR therapies to get access to cosmetic options to preserve their skin condition during treatment. Anti-EGFR therapies are known to fragilize epidermis and to provoke rashes; which often lead to treatment discontinuation.

The aim of this study is to demonstrate that the Onco-Rash cream is able to preserve skin condition without side effects. Decreasing skin toxicity is expected to improve patients' life and facilitate treatment follow-up.

location_facility: Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud


title: Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile

summary:
The aim of the study is to evaluate the effects of an acute intake of two fermented fruits flours as part of a standardized breakfast, in comparison with the acute intake of a standardized breakfast without fermented fruits flour but with the same amount of available carbohydrates, on postprandial glycaemic response and overall metabolism in subjects at cardiometabolic risk.

The metabolic parameters will be assessed in fasting and in postprandial period after the consumption of the standardized breakfast.

primary_purpose: Basic Science

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes


title: Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19

acronym: MicroCovAging

summary:
During the ongoing COVID-19 pandemic, age was clearly the major factor of mortality. Increasing age was strongly associated with this risk, with the upper 80 years age group having more than 12-fold increased risk compared with those aged 50-59 years. Male gender was also associated with a doubling of risk.

The elderly subject is particularly exposed to global denutrition with risk of micronutrients deficiencies such as vitamins and trace elements. Those deficits expose to lower immunity. In addition, viral infection as COVID-19 can also worsen these deficits.

In general, low levels or intakes of micronutrients such as Zn, Se and vitamin A have been associated with adverse clinical outcomes during viral infections. This notion has been confirmed in a recent review proposing that besides vitamins A and D also B vitamins, vitamin C, omega-3 polyunsaturated fatty acids, as well as selenium, zinc and iron should be considered in the assessment of micronutrients in COVID-19 patients.

In this context, the MicroCovAging study will evaluate copper, zinc and selenium, vitamin A, D and E status in elderly subjects affected by COVID- 19 and to correlate this status with prognosis of this disease.

time_perspective: Other


title: Study of Blood Monocytes as a Predictive Marker of Cystic Fibrosis-related Bone Disease

acronym: MucOs

summary:
Hypothesis: Circulating monocytes RANK and MCSF-R expression is predictive of Cystic Fibrosis-related Bone Disease.

Study design: Single-center comparative cross-sectional study Population: Patients with a CFTR channel mutation causing cystic fibrosis consulting the Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) at Reims University Hospital will be recruited. Healthy controls will be recruited from donors at the Etablissement Français du Sang Grand Est, Reims.

Judgment criteria:

- Main judgment criterion: X Expression level of CD115 (MCSF receptor) and CD265 (RANK) evaluated by flow cytometry receptors on the membranes of circulating monocytes.

- Secondary judgment criteria: X Rate of circulating CD115 +, CD265 +, CD115 + / CD265 + monocytes X Number of multinucleated cells with more than 2 nuclei and with an actin ring observed under fluorescence microscopy after osteoclastic differentiation X Surface of dentin resorbed in vitro by osteoclasts during an osteoclastic functionality test on dentin X Serum S1P levels assayed by ELISA technique.

Investigation plan:

Any eligible patient will be offered to participate in the study during the consultation at the CRCM. If the patient agrees to participate in the study, he/she will be included. Participation in the study will not affect its coverage. Participation will lead to the collection of three tubes of whole blood additional to those used as part of usual care, as well as the collection of demographic data (age, sex, height, weight, body mass index), sports practice, clinical images and interpretation, medical history (diabetes, infectious status, bone metabolism disorders, drug treatments followed, psychiatric disorders). Any subsequent donor from the EFS GE collected under the ALC / PIL / DIR / AJR / FO / 606 agreement and presenting characteristics of age +/- 2 years and identical gender will then be included.

Statistical analysis plan:

Qualitative variables will be described in terms of number and percentage. The quantitative distribution variables according to the Normal law will be described in the form of mean +/- standard deviation or in the form of boxplots (median, quartiles, deciles) if a distribution not following the Normal law is observed. ANOVA test, non-parametric Wilcoxon signed-rank test or chi² test will be aplied depending on the application conditions. A value of p <0.05 will be considered statistically significant.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Salivary dysfuncTion After Radioiodine Treatment

acronym: START

summary:
Aim/Introduction:

The treatment of differentiated thyroid cancer includes generally a total thyroidectomy, followed by a radioiodine (131I)-therapy. Due to their ability to concentrate iodine, the salivary glands may present inflammation after administration of 131I, which may be symptomatic, may lead to longer-term chronic abnormalities, resulting in alterations in patients' nutrition and quality of life. The incidence of salivary dysfunctions after 131I-therapy varies considerably between studies due to methodological limitations. Also, the occurrence of these dysfunctions may be linked to increased uptake and/or retention of 131I in the salivary glands and/or individual radiosensitivity. However, no clinical or genetic factors have been identified to date to define patients at risk, allowing the delivered activity to be adapted to the expected risk of salivary dysfunctions. The aims of this study are to estimate the incidence of salivary dysfunctions after 131I-therapy, to characterize patients at risk of developing post-treatment dysfunctions using clinical, biomolecular and biochemical factors, and to validate a dosimetric method to calculate the dose received at the salivary gland level in order to analyse the dose response relationship between exposure of salivary glands to 131I and salivary dysfunctions.

Materials and Methods:

This prospective cohort aims to include 120 patients, candidates for a 131I-therapy in the context of their differentiated thyroid cancer, treated in the Nuclear Medicine department of the Pitié-Salpêtrière hospital (40 and 80 patients in a 1.1GBq and a 3.7GBq dose groups respectively). The follow-up is based on 3 scheduled visits: at inclusion (immediately before 131I therapy), 6months and 18months after treatment. For each visit, questionnaires on salivary disorders (validated French tool), quality of life (HAD-scale, MOS-SF-36), and nutritional status are administered. At inclusion and at T6, saliva samples and individual measurement of the salivary flow, without and with salivary glands stimulation, are performed.

External thermoluminescent dosimeters are placed opposite the salivary glands and at the sternal fork on the treatment's day before radioiodine administration and removed 5days after treatment. From dosimeters, a reconstitution of the dose received at the salivary glands will be established using physical and computational phantoms.

Genetic and epigenetic analyses will be performed to find biomarkers of predisposition to develop salivary disorders after 131I-therapy.

Expected results Inclusion of patients started in September 2020 and are still ongoing. Statistical analyses will study the links between salivary dysfunctions and the 131I dose received by the salivary glands, taking into account associated factors. In addition, impacts on the patients' quality of life will be analysed.

lead_sponsor: Institut de Radioprotection et de Surete Nucleaire


title: Reference Values of Aerobic Fitness in the Contemporary Paediatric Population: VO2max Z-scores

acronym: SAIN&NORMES

summary:
In most pediatric medical conditions, tremendous progress in pediatrics has significantly improved the overall prognosis and transferred the mortality from childhood to adulthood. Nevertheless, chronic diseases remain the leading cause of death and physical inactivity appears to be a major aggravating factor. Yet, a good physical activity has a positive impact on quality of life and prevents future health morbidities, such as obesity and cardiovascular disease. Therefore, after focusing on the survival of children with chronic diseases, more attention is being given to health-related quality of life and secondary prevention.

In this context, the cardio-pulmonary exercise test (CPET), which is a non-invasive and dynamic examination, has become the gold standard to identify subjects with impaired physical capacity and to identify the causes of their limitations (muscular, cardiac, respiratory, behavioral, etc.). Moreover, CPET is the key examination to enroll patients in personalized physical rehabilitation programs (muscle deconditioning, respiratory limitation, etc.).

Despite a growing interest in CPET and individualized rehabilitation programs for chronic diseases, the investigators still face the lack of reference values for pediatric CPET. In current practice, many CPET pediatric laboratories use the reference values of maximum oxygen uptake (VO2max) defined by Cooper et al. in 1984, from a cohort of 109 healthy children. However, their equations are linear and based on weight only. Non linear equations and the use of other anthropometric variables may be relevant in pediatrics. For instance, in the current era, normal CPET pediatric values should consider the prevalence of overweight and obesity in childhood general population (respectively 30% and 10% in Europa and 35% and 25% in North America), as well as in the population of children with chronic disease.

In the past decade, our group has developed a research program on physical capacity in children, with a focus on pediatric CPET and physical rehabilitation, from a cohort of nearly 1000 exercise tests in children. The lack of reliable pediatric reference values for VO2max, and all CPET variables as well, has become an important issue.

In this study, the investigators aim to define pediatric reference CPET values from a large cohort of 6 to 17 year-old children, using several anthropometric variables to define the most appropriate Z-scores equations (part 1). The investigators will also validate the Z-scores equations using an independent population (part 2).

lead_sponsor: University Hospital, Montpellier


title: Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims

summary: The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection

intervention_type: Behavioral


title: Classification and Functional Stratification of the Patients With Ciliopathy and Identification of Biomarkers to Improve Their Prognosis

acronym: CILLICORIRCM

summary:
The purpose of the C'IL-LICO RICM study is to develop innovative and transformative diagnostic and prognostic for patients suffering from ciliopathies leading to renal failure.

The objectives is to decipher disease mechanisms and highlight signaling pathways altered in at-risk to develop renal failure patient groups and to produce a prognostic biomarker-based kit to predict the evolution of ciliopathy patients towards renal impairment.


title: Oxygen Hemoglobin Saturation in COVID Patients: Comparison of Arterial Gasometry and Pulse Oximetry

acronym: SHOCOVID

summary:
In many patients, respiratory Sars-Cov2 infection causes arterial hypoxemia, which remains without signs of verbalized respiratory distress, up to a point. This phenomenon, called "happy" or "silent" hypoxemia, has a plural pathophysiological basis. Hypoxemia has been shown to be predictively associated with admission to the ICU. Therefore, the question of constant monitoring of oxygenation, practiced on a large scale, at home, in asymptomatic patients or contact cases, arises. A large number of portable pulse oximeter are currently freely available on the market; however, their clinical validation remains sometimes doubtful, or even absent from FDA standards.

The objective of this study is to evaluate the accuracy of SpO2 values provided by portable pulse oximeter in COVID patients, in comparison with the reference method. The study will be conducted on a population of adult patients with COVID, hospitalized in the ICU, for whom gasometry sampling is already scheduled in the usual management.

location_facility: Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR-R3S) Hôpital Pitié-Salpêtrière


title: Identification of IgA Monoclonal Antibodies Anti-Clostridium Difficile Surface Proteins

acronym: IgAClostridium

summary: Immunoglobulin A (IgA), the major mucosal antibody, plays a key role in maintaining diversity of the intestinal microbiota and eliminating intestinal pathogens. Dysbiosis is an important risk factor for Clostridium difficile infection, which is the leading cause of nosocomial diarrhea in industrialized countries. This study aims to develop IgA monoclonal antibodies targeting C. difficile surface proteins.

location_facility: Maladies infectieuses et tropicales, Hôpital Pitié-Salpêtrière


title: From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis

acronym: OUTCOMS

summary: MS is a heterogeneous disease either in its response to treatment or clinical manifestation. Indeed, the natural history of MS is varying from a benign condition to a devastating and rapidly incapacitating disease. Clinical heterogeneity could also be cellular and / or molecular. The aim is to identify from OMIC analyses, at the early stage of the disease, differentially expressed molecules and / or cell subpopulations derived from CD8 + T lymphocytes and / or CD4 + T lymphocytes and / or B lymphocytes and monocytes from patients with aggressive versus non-aggressive, compared to a cohort of healthy controls

lead_sponsor: Nantes University Hospital


title: RV3278AET0943 Cosmetic Product Efficacy Applied for 8 Weeks in Adults Having Oily and Acne Prone Skin: Comparative Study Versus Not Treated Group

summary:
The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:

The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the forehead
The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA score) of the face
The reduction in visible follicles
The standardized numerical photographs of face and ¾ right and left profile in normal, parallel polarized, cross polarized and UV light
The analysis of the skin lipids of the forehead
The qualitative and quantitative analysis of the sebum and comedones constituents (nose wings)

This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the face.

Each group includes 18 subjects.

lead_sponsor: Pierre Fabre Dermo Cosmetique