title: Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments

acronym: SILVER NA

summary:
The purpose of this study is identify the psychological impact of the coronavirus-19 pandemic on professionals in residential care facilities for old people and home help professionals in New-Aquitaine by :

Large-scale screening for the prevalence of mental health disorders among staff.
Identification of vulnerability and resilience factors.
Improving access to early care for affected professionals.

ReferenceCitation: Mohammed A, Sheikh TL, Poggensee G, Nguku P, Olayinka A, Ohuabunwo C, Eaton J. Mental health in emergency response: lessons from Ebola. Lancet Psychiatry. 2015 Nov;2(11):955-7. doi: 10.1016/S2215-0366(15)00451-4. No abstract available.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.

ReferenceCitation: Chua SE, Cheung V, McAlonan GM, Cheung C, Wong JW, Cheung EP, Chan MT, Wong TK, Choy KM, Chu CM, Lee PW, Tsang KW. Stress and psychological impact on SARS patients during the outbreak. Can J Psychiatry. 2004 Jun;49(6):385-90. doi: 10.1177/070674370404900607.

ReferenceCitation: Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.

publisher_dissemination: British Medical Journal

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment

summary: Effects of aging, genetics and environmental exposures on immune variation in a previously well-defined healthy population (NCT03905993).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.

ReferenceCitation: Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002.

ReferenceCitation: Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Mar;19(3):302-314. doi: 10.1038/s41590-018-0049-7. Epub 2018 Feb 23. Erratum In: Nat Immunol. 2018 May 3;:

lead_sponsor: Institut Pasteur

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports

summary:
This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer.

The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.

time_perspective: Retrospective

lead_sponsor: Perouse Medical

sponsor_collaborators:
Perouse Medical
Eclevar Medtech

intervention_type: Device

lead_sponsor_type: industriel


title: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C

summary:
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral).

Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.

ipd_sharing: No


title: Assessment of a Predictive Radiologic Score to Predict the Failure of the Non-operative Management of Adhesive Small Bowel Obstruction: a Prospective Cohort Analysis

acronym: PREDIFAIL

summary:
The management of acute adhesive small bowel obstruction remains challenging for the digestive surgeon. The Bologna guidelines recommend that conservative management of aSBO. The literature reports that this form of management has a failure rate between 10 and 40%.

A radiological score has been proposed and was associated with an increased risk of failure of conservative management.

This tool is promising to select patients further requiring surgery but it has to be assessed in a multi centric prospective cohort.

lead_sponsor: University Hospital, Angers


title: Endoscopic Sutured Gastroplasty With Endomina® Device Versus Standard of Care in Patients With Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial

acronym: ESTIME

summary: The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Endo Tools Therapeutics S.A.

status_simplified: Ongoing


title: Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

summary: To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.

lead_sponsor: University Hospital, Caen

intervention_type: Diagnostic Test


type: Other Identifier

title: Qualitative Phenomenological Study on Remote Therapeutic Education by Videoconferencing Crossing the Participant and Caregiver View

acronym: Visio ETP

summary:
Therapeutic patient education (TPE) is one of the mechanisms that make patients with chronic disease as competent as possible to manage illness and treatment by helping them to be autonomous and responsible for their decision-making.

The COVID-19 pandemic has changed the organization of care, prioritizing the emergency fight against the epidemic.

The French High Authority of Health (HAS) has recommended maintaining individual TPE sessions by videoconference or telephone, based on the usual stages of the educational process. Several working groups have looked into remote TPE and recommendations have been issued in the form of practical advice but without questioning the participants, who did not participate in the reflection. No consensus, including health authorities, has been reached on this subject.

At Necker Hospital, ETPs were carried out remotely, by videoconference. Understanding remote therapeutic education by videoconference through lived experience, by means of a one-hour interview, of the caregivers who deliver it and the parents of patients or the patients who receive it, will make it possible to better understand the effects of remote mode on therapeutic education sessions but also on professional practices and on participants.

The benefit will be twofold: for caregivers: to facilitate the deployment of this new educational offer. For patients and their carers: give priority access to TPE to families who are far from the healthcare system or to patients who are too fragile to travel and thus reduce inequalities and geographical barriers.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia

acronym: DEH-Somno

summary:
The aim of the study is to compare sleep efficiency by means of actigraphy in patients with hypohidrotic ectodermal dysplasia with healthy controls.

Sleep efficiency, assessed on actigraphy, sleep architecture assessed on on polysomnography, body temperature and urine melatonin levels will be compared between the patients with hypohidrotic ectodermal dysplasia with healthy controls.

design_allocation: Non-Randomized

primary_purpose: Diagnostic


title: Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

acronym: DECAD

summary:
Digital osteoarthritis is the second localization of symptomatic osteoarthritis, after the knee. Its cardinal symptoms are particularly intense pain and functional impairment in the case of the erosive form. There is currently no etiological treatment for osteoarthritis. Symptomatic treatments have a modest efficacy, which justifies the search for new treatments. The surgical options are arthrodesis or prosthesis, invasive techniques potentially sources of complications, and finally proposed infrequently given the prevalence of digital osteoarthritis.

DECAD is a prospective phase II trial aimed at evaluating the efficacy of surgical joint denervation in painful digital osteoarthritis.

primary_purpose: Supportive Care

location_facility: Rheumatology department Saint-Antoine Hospital

intervention_type: Procedure


title: Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

acronym: PIKOA

summary:
Intro:

Platelet rich plasma (PRP) is largely used in various musculoskeletal disorders such as chronic tendinopathies but also osteoarthritis (OA). Several therapeutic trials evaluating the effectiveness of intra-articular PRP injections in knee OA as well as meta-analyses have already been published. Most of them have compared PRP to Hyaluronic Acid (HA). Their design was very heterogeneous in terms of PRP characteristics and injection protocol. Moreover, the number of patients included was often very low. Only few studies have compared PRP to placebo (physiological serum) and presented the same methodological limitations (limited number of patients, heterogeneous protocols in terms of number and frequency of injections, characteristics of PRP, etc.).

Given the insufficient level of evidence related to these limitations, PRP injections are not recommended in the treatment of symptomatic knee OA by the main scientific societies such as American College of Rheumatology (ACR), Osteoarthritis Research Society International (OARSI), American Academy of Orthopedic Surgeons (AAOS) and French Society of Rheumatology (SFR). Experts in the field agree on the need for a placebo-controlled trial with hihg methodological quality and simple design in order to conclude with a good level of evidence to the benefit or not of this new therapeutic weapon in symptomatic knee osteoarthritis of moderate radiographic severity.


title: Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review

acronym: MARIENAIE

summary:
MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published.

This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).

primary_purpose: Other

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Prospective Pilot Study Evaluating the Prognostic Impact of a Neuro-vascular Examination Associated With Cerebral MRI in the Acute Phase of Infectious Endocarditis

acronym: POMPEI

summary:
Infectious endocarditis (IE) is a serious condition with an annual incidence of 3 to 10 per 100,000 people. Brain infarctions complicate approximately 20-40% of endocarditis.

Brain MRI can detect the presence of recent ischemic lesions and asymptomatic microbleeds. Preoperative brain imaging is part of the recommended assessment in the management of IEs, but the type of imaging and sequences are not codified and the impact of cerebral and vascular imaging findings on the therapeutic decision remains uncertain.

The level of evidence of the recommendations remains low, especially for complicated IEs of stroke. There is very little neurological clinical data on patients with IEs. Similarly, neurologists do not systematically participate in multidisciplinary meetings during the management of an IE. It therefore seems interesting to carry out a neurological cohort of this population and to evaluate what would be the contribution of vascular neurologists in the management of infectious endocarditis.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Stroke Unit, Pierre Wertheimer hospital, GHE Hospices Civils de Lyon


title: Backward Masking Tasks to Decipher Impaired Input-Output Connections in MS @7T

summary: Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. People with MS frequently suffer from cognitive and visual impairment. Moreover, patients rank cognition and vision as two of the three most valuable bodily functions, in addition to mobility. Here the investigator use the established backward masking paradigm to study structural and functional alteration at the sub-milimeter scale in ultra-high field MRI in order to decipher the different input-output loops associated with the preservation and alteration of cognition in MS.

lead_sponsor: Assistance Publique Hopitaux De Marseille


type: Registry Identifier

title: Elaboration of an Algorithm of Automated Segmentation by Magnetic Resonance Imaging for Bone and Muscles of Shoulder

acronym: SEGMENTATION

summary: The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.

location_facility: Orthopaedics, Ambroise Paré hospital, APHP


title: An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma

summary: This is a prospective, single-center, controlled, open label, trial randomized in two parallel groups designed to assess the Quantra QStat System in trauma patients.

status: Active, not recruiting

lead_sponsor: HemoSonics LLC

sponsor_collaborators:
HemoSonics LLC
University Hospital, Lille


title: Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION

acronym: Dyslexie REMED

summary: Dyslexia is first described as a phonological deficit. Several studies report a neurovisual deficit in dyslexics. Some dyslexics have a visual deficit without phonological impairment, others have a pure phonological deficit, and still others have both types of deficits. From this observation the idea emerged to propose specific remediation protocols for people with visual impairments and to assess their effects on reading. At the theoretical level, if visual stimulation is able to improve reading performance, it is the demonstration of the existence of visual origin of dyslexia. At the clinical level, such a result not only opens the prospect of a different and more adapted rehabilitation for these types of dyslexia, but also the prospect, if the visual deficits are pre-existing to the learning of reading, to use them for early diagnosis and management.

primary_purpose: Basic Science

location_facility: Centre de Recherche en Neurosciences de Lyon

intervention_type: Behavioral


title: Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm

acronym: EPOP-AORTA

summary: This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

lead_sponsor: University Hospital, Toulouse


title: Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants

summary: Real-life evaluation of the safety and performance of EUROTEKNIKA dental implants

time_perspective: Other

lead_sponsor: Euroteknika

sponsor_collaborators: Euroteknika EVAMED


title: Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy

acronym: CILTUBE

summary: Primary Ciliary Dyskinesia associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of mobility of sperm but very little data on the structure and function of tubal cilia in women

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal Créteil


title: Neoadjuvant Treatment of Resectable or Locally Advanced Borderline Pancreatic Adenocarcinoma: Reproducibility of Tumor Measurement in CT Versus MRI

acronym: ReMeTTI

summary:
Despite important therapeutic advances, pancreatic adenocarcinoma remains one of the cancers with a high mortality rate (4th leading cause of cancer death in the US in 2021), poor prognosis (5-year overall survival rate of 10%) and increasing incidence.

Patients are often metastatic from the start or at an advanced stage at diagnosis, making curative treatment difficult to envisage. Although the gold standard of treatment for resecable pancreatic adenocarcinoma is initial surgery followed by adjuvant chemotherapy, considerable interest has emerged in a treatment strategy involving neoadjuvant therapy in patients at high risk for positive resection margins (R1) on initial imaging workup.

The assessment of response to neoadjuvant therapy is complex, especially for the evaluation of vascular invasion with a high risk of overestimating residual invasion after neoadjuvant therapy. Accurate assessment of tumor size before and after neoadjuvant treatment is therefore crucial to identify good responders (according to RECIST 1.1 criteria) and thus improve the selection of patients who can benefit from curative surgery with healthy resection margins (R0).

In clinical practice, tumor size assessment is performed by injected computed tomography (CT). The latter has certain advantages in terms of technical reproducibility, but has a number of limitations. Indeed, the delineation of the tumor mass in CT seems to be subject to a significant inter-observer variability. The same is true for vascular invasion. CT also seems to underestimate the size of the tumor compared to the anatomopathological examination of the surgical specimen. On the other hand, Magnetic Resonance Imaging (MRI) has been shown to be superior to CT in tumor detectability and diagnosis of malignancy in the presence of an indeterminate pancreatic mass. It has also been shown that tumor size, whether measured in diameter or volume, is frequently underestimated on CT compared to multiparametric MRI or pathological examination of the resection specimen.

In the latest recommendations of the National Comprehensive Cancer Network (NCCN), MRI is indicated at diagnosis in non-metastatic patients with indeterminate liver lesions on CT, or as a second-line alternative to CT for re-evaluation after neo-adjuvant therapy in patients with resectable or borderline resectable disease according to the NCCN classification. However, MRI is increasingly performed routinely in some centers, both at diagnosis and at re-evaluation after neo-adjuvant therapy. The question of which imaging modality between CT and multiparametric MRI is the most reproducible in terms of tumor size measurement becomes important, especially in the evaluation of the response to neoadjuvant therapy. A few studies have investigated the interobserver variability of tumor size measurement in CT versus MRI in the context of radiotherapy management for the delineation of an irradiation field, but to date investigators have not found any study evaluating the interobserver variability of tumor size measurement using RECIST criteria before and after neoadjuvant treatment for pancreatic adenocarcinoma.

ReferenceCitation: Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359.

ReferenceCitation: Saad AM, Turk T, Al-Husseini MJ, Abdel-Rahman O. Trends in pancreatic adenocarcinoma incidence and mortality in the United States in the last four decades; a SEER-based study. BMC Cancer. 2018 Jun 25;18(1):688. doi: 10.1186/s12885-018-4610-4.

ReferenceCitation: Kaufmann B, Hartmann D, D'Haese JG, Stupakov P, Radenkovic D, Gloor B, Friess H. Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma. Dig Surg. 2019;36(6):455-461. doi: 10.1159/000493466. Epub 2018 Nov 8.

ReferenceCitation: Tempero MA, Malafa MP, Al-Hawary M, Behrman SW, Benson AB, Cardin DB, Chiorean EG, Chung V, Czito B, Del Chiaro M, Dillhoff M, Donahue TR, Dotan E, Ferrone CR, Fountzilas C, Hardacre J, Hawkins WG, Klute K, Ko AH, Kunstman JW, LoConte N, Lowy AM, Moravek C, Nakakura EK, Narang AK, Obando J, Polanco PM, Reddy S, Reyngold M, Scaife C, Shen J, Vollmer C, Wolff RA, Wolpin BM, Lynn B, George GV. Pancreatic Adenocarcinoma, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Apr 1;19(4):439-457. doi: 10.6004/jnccn.2021.0017.

ReferenceCitation: Soloff EV, Al-Hawary MM, Desser TS, Fishman EK, Minter RM, Zins M. Imaging Assessment of Pancreatic Cancer Resectability After Neoadjuvant Therapy: AJR Expert Panel Narrative Review. AJR Am J Roentgenol. 2022 Apr;218(4):570-581. doi: 10.2214/AJR.21.26931. Epub 2021 Dec 1.

ReferenceCitation: Dalah E, Moraru I, Paulson E, Erickson B, Li XA. Variability of target and normal structure delineation using multimodality imaging for radiation therapy of pancreatic cancer. Int J Radiat Oncol Biol Phys. 2014 Jul 1;89(3):633-40. doi: 10.1016/j.ijrobp.2014.02.035. Epub 2014 Apr 20.

ReferenceCitation: Legrand L, Duchatelle V, Molinie V, Boulay-Coletta I, Sibileau E, Zins M. Pancreatic adenocarcinoma: MRI conspicuity and pathologic correlations. Abdom Imaging. 2015 Jan;40(1):85-94. doi: 10.1007/s00261-014-0196-8.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: A Cohort of Acute, Ischemic and Rare Neuropathies

acronym: CAIRN

summary:
Neuropathies are defined as the clinical, electrical, biological and histological manifestations of peripheral neuron damage. They represent a heterogeneous group of disorders and are responsible for disabling sensory and motor disorders. Their diagnosis is based on a set of clinical arguments confirmed by the electromyogram. This allows to specify the site of the damage, its severity, and to follow the evolution of the disease.

To date, the diagnosis of peripheral nerve injury secondary to occlusion of arterial trunks is rarely evoked; its clinical, electromyographic and prognostic characteristics are poorly known. Indeed, the rare cases reported in the literature are from vascular specialties, with little data on neurological symptoms, neurophysiological diagnostic elements and prognosis.

However, these unrecognized and underdiagnosed neuropathies are sometimes indicative of severe vascular damage for which urgent management is necessary. Neurological symptoms should then be treated as warning signs and the correct recognition of the early ischemic vascular etiology may lead to an optimized medical management.

The objectives of this study will be to describe the clinical presentation of these neuropathies, to discuss their electrophysiological diagnostic characteristics, to compare the demographic data with those from the literature, and to evaluate the functional prognosis of these attacks. A better knowledge of this rare etiology of neuropathy would allow to better inform the patients and to optimize the diagnostic and therapeutic management.

ReferenceCitation: Siao P, Kaku M. A Clinician's Approach to Peripheral Neuropathy. Semin Neurol. 2019 Oct;39(5):519-530. doi: 10.1055/s-0039-1694747. Epub 2019 Oct 22.

ReferenceCitation: Abdellaoui A, West NJ, Tomlinson MA, Thomas MH, Browning N. Lower limb paralysis from ischaemic neuropathy of the lumbosacral plexus following aorto-iliac procedures. Interact Cardiovasc Thorac Surg. 2007 Aug;6(4):501-2. doi: 10.1510/icvts.2007.151993. Epub 2007 Apr 17.

ReferenceCitation: Abdelhamid MF, Sandler B, Awad RW. Ischaemic lumbosacral plexopathy following aorto-iliac bypass graft: case report and review of literature. Ann R Coll Surg Engl. 2007 Jul;89(5):W12-3. doi: 10.1308/147870807X188470.

ReferenceCitation: Deylgat B, Wallaert P, De Smul G, Van Lysebeth L, Ceuppens H. Unilateral lower limb paralysis after aortobifemoral bypass graft for ruptured abdominal aortic aneurysm: a case report. Vasc Endovascular Surg. 2009 Dec;43(6):606-9. doi: 10.1177/1538574409345032. Epub 2009 Oct 14.

ReferenceCitation: Winston P, Bakker D. Ischemic Monomelic Neuropathy: The Case for Reintroducing a Little-Known Term. Can J Neurol Sci. 2020 Sep;47(5):697-699. doi: 10.1017/cjn.2020.88. Epub 2020 May 4.


title: Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification

acronym: LOBACOM

summary:
Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Contribution of Magnetic Resonance Imaging in Immune Effector Cell-Associated Neurotoxicity Syndrome

acronym: MR-ICANS

summary:
The treatment of large-cell B-cell lymphomas refractory to more than 2 lines of therapy has recently been revolutionized by the use of immunotherapies consisting of autologous genetically modified cells or CAR-T CELLS (chimeric antigen receptor-T cells), which very significantly increase progression-free survival and overall survival. Nevertheless, this therapy is frequently associated with cytokine release syndrome and in approximately 20% to 60% of patients with neurological complications that can sometimes be dramatic and are associated with a significant mortality rate.

The mechanisms behind this neurotoxicity are unclear.

Despite the frequent occurrence of neurological toxicity characterized in particular by headache, tremor, and encephalopathy that is most often transient, brain imaging by CT or, preferably, MRI are most often normal. The rare abnormalities that have been identified suggest the presence of cytotoxic edema associated with the existence of transient modifications of the blood-brain barrier.

To date, the management of neurotoxicity associated with CAR-T CELLS remains empirical. It combines early management of cytokine release syndrome (by administration of anti-IL6) and treatment with corticosteroids, the objective of which would be to control neurotoxicity more specifically. A better understanding of the pathophysiological mechanisms associated with this neurotoxicity appears essential today in order to be able to propose adapted prevention and treatment methods.

Main objectives are to compare tissue permeability by quantitative MRI measurement of Ktrans to the theoretical peak of neurotoxicity between patients with CAR-T Cell-induced neurotoxicity and those without neurotoxicity and to Study, by MRI, the evolution of tissue microcirculatory parameters (from D-3 to D7) between groups of patients with or without the occurrence of neurotoxicity associated with CAR-T CELL treatment.

For this purpose, 25 subjects will be included (the investigators hypothesize 40% with treatment-induced neurological impairment).

lead_sponsor: University Hospital, Montpellier

location_facility: Neurology department, Montpellier University Hospital


title: Non Inferiority Study of Glycemic Monitoring Via myDiabby Healthcare vs Conventional Diary in Patients With Gestational Diabetes Mellitus

acronym: TELESUR-GDM

summary: The purpose of the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary

lead_sponsor: Hôpital NOVO

location_facility: Endocrinology department - Centre Hospitalier René Dubos


title: Evaluation of the Interest of a Virtual Reality Headset on Pain and Anxiety During Epidural Injection Through the Sacrococcygeal Hiatus in Patients With Lumbar Radicular Pain.

acronym: Epi-RéV

summary:
For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities.

It has been evaluated in different studies on pain and anxiety in various medical situations.

A study has shown a correlation between a decrease in pain in a clinical way during a painful stimulation and a decrease in certain areas of the brain.

In this context, the use of the virtual reality headset could then be used in medical interventions that may be painful for the patient.

The lumbar radicular pain is a common disease in the world. The epidural injection is one of the treatment of this pathology. He may be performed to reduce the pain but sometimes this act is painful. Most of the time this procedure is performed without premedication.

To the knowledge of the investigators, there are currently no studies on the assessment of pain under a virtual reality headset during the performance of an epidural injection in rheumatology.

The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain and the anxiety during an epidural injection.

primary_purpose: Prevention

lead_sponsor: CHU de Reims


title: Evaluation of the Antidandruff Effect of a Shampoo on Subjects With Dandruff and Slight Itching. Single-blind, Monocentric Study Realized Under Dermatological Control

summary: The aim of this study was to investigate the changes in the scalp lipids and TEWL in dandruff subjects treated by 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo after an antidandruff treatment and after a remanence phase

lead_sponsor: L'Oreal


title: Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation.

summary:
This is a phase II, prospective, comparative, randomized, single-center, open-label, parallel-group therapeutic trial.

It is a non-inferiority trial to establish the efficacy of intra-articular injection of autologous microfat and PRP at the wrist in patients suffering from radiocarpal osteoarthritis in reference to wrist denervation.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

intervention_type: Drug


title: Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits Associated With Autistic and Psychotic Symptoms

acronym: FERmarkers

summary: Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier


title: Multidimensional Characterization of Dyspnea in Children

acronym: DYSPED

summary:
There is no specific tool existing to describe dyspnea in children in a multidimensional way.

It has been shown in adult studies that multidimensional dyspnea evaluation scales are well correlated to quality of life and respiratory function impairments.

The investigators hypothesis is that using multidimensional dyspnea evaluation scales could allow for a more systematic and precise evaluation of this symptom in children, thus improving management and follow-up of patients presenting with acute (asthma attack, infectious diseases) and chronic (cystic fibrosis, primary ciliary diskynesia, neuromuscular diseases) respiratory insufficiency.

location_facility: Service de pneumologie pédiatrique, Hôpital Armand Trousseau


title: Evaluation of the Therapeutic Efficacy of a Mindfulness-Based Stress Reduction (MBSR) Program as an Adjuvant Therapy in Patients With Moderate Pruritic Inflammatory Dermatosis (Psoriasis or Atopic Dermatitis)

acronym: MediDermIn

summary: Psoriasis and atopic dermatitis are multifactorial inflammatory dermatoses, with a very high prevalence, reaching more than 120 million patients in the world. Although the physiopathological mechanisms are not yet clearly defined, these inflammatory dermatoses involve an interaction between the immune system and the epidermal cells, severe skin inflammation and often very intense pruritus. The objectives of an effective management should be to treat lesions in order to reduce them, but also to reduce itching and allow the patients to accept and cope with their pathology, without neglecting an improvement in the "Dermatology Life Quality Index" (DLQI) and in the psychological state, sometimes depressive, of the patient. Itching is defined as "a feeling that needs to be scratched urgently" and can cause significant distress along with pain. It severely impacts the quality of life and the quality of sleep. Chronic itching is associated with increased stress, anxiety, and other mood disorders. In turn, stress and anxiety exacerbate the itching, leading to a vicious cycle of pruritus - scratching that affects patient behavior (excessive scratching) and worsens disease prognosis and quality of life. Much research over the past few decades has demonstrated the effect of mindfulness meditation on emotional and cognitive responsiveness, cognitive flexibility, rumination, self-compassion and mindfulness, but also on acute pain, anxiety, stress, depression, cardiovascular disease, eating disorders, cancer and cognitive loss with age. Several studies have shown the impact of mindfulness on brain function and immunity, with evidence for the association between mindfulness and changes in the levels of markers characteristic of immune system activity and inflammation, known to be increased in psoriasis or atopic dermatitis. Our objective is to evaluate the effect of mental training in the regulation of stress and emotions through mindfulness meditation in patients with moderate, itchy atopic dermatitis or psoriasis, not treated with systemic agents (e.g.: biotherapies). This project is based on the premise that mental training in the regulation of stress and emotions through meditation would reduce the effects of the infernal itch-scratch cycle, alleviating pruritus, thus improving the well-being and mental health of patients while reducing their inflammatory skin lesions and limiting the appearance of new lesions.


title: Contribution of Optical Genome Mapping to the Prognostic Classification of Acute Myeloblastic Leukemia Evaluation of the Clinical Utility of DNA Optical Mapping in the Management of Acute Myeloblastic Leukemia (COALA)

acronym: COALA

summary: A retrospective study using a new technology will be performed: the Optical Genome Mapping (OGM) on acute myelogenous leukemia (AML) samples stored at the CRB-Cancer of the Bordeaux University Hospital and annotated in the DATAML clinical database. The main objective is to estimate the proportion of AML patients for whom OGM detects at least one additional abnormality compared to conventional techniques. This study will constitute an important step in the validation of COA as a reference technique for cytogenetic analysis in AML, replacing the classical techniques, and could also constitute a first argument for redesigning the prognostic classification of AML.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux, service Hématologie Biologique


title: Functional Study of Rare Disease Related Candidate Genes - ORIGIN

acronym: ORIGIN

summary: Next generation sequencing (NGS) allows some better diagnostic results, particularly, in the rare diseases field. At a twenty five percent rate, those exams highlight some variants which are not yet described in human pathology. The relationship between a variant found inside a candidate gene and a pathology, is able to be confirmed by functional studies at a protein level. This study aims to build a biological collection to feed further functional studies to confirm the relationship between NGS identified variants, and the clinical signs and symptoms.

lead_sponsor: University Hospital, Angers


title: Quality of Life Evaluation With the SRI Questionnaire of ALS Patient With Non-invasive Ventilation

acronym: Quality EvALS

summary:
This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV

This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Pneumology departement, Pitié-Salpêtrière hospital, GHU APHP-Sorbonne Université


title: Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.

acronym: SUURGE

summary:
Until now, the Mulhouse emergency department used a protocol for severe pain based on morphine titration. In order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil.

The primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. This new pain management protocol has been updated as part of the upcoming French High Authority for Health hospital certification, for which pain management is one of the priority criteria. This research does not change the routine care given to the patient.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

acronym: SOAL-VF

summary: A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

lead_sponsor: Centre Hospitalier de Valence


title: Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk

summary:
This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.

Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.

The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.

Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Cardiac Involvement in Wilson's Disease

acronym: WIL-HEART

summary: Heart damage by copper accumulation has been reported in Wilson's Disease. However, the disease epidemiology is still poorly understood. A number of studies on pediatric populations have not shown any significant cardiac involvement apart from early dysautonomia. This could suggest that the clinical manifestations related to the copper accumulation in the heart appears with the duration of the disease. Case-control studies on adult populations have highlighted various electrocardiographic (ECG) abnormalities more frequent in patients with Wilson's Disease than in healthy volunteers, but all these studies involved small number of patients (maximum 60). The hypothesis is that there is cardiac involvement in Wilson's Disease, requiring screening, follow-up and appropriate support.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Standardization of the Dry Immersion Model Used as a Ground-based Model to Mimic Weightlessness. Phase 2: a 5-day Dry Immersion Study on 20 Healthy Male Volunteers (VIVALDI2)

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

The main objective of the present study is to investigate the physiological effects of 5 days of dry immersion in 20 healthy male subjects, and to obtain DI-in-Men Reference Dataset. A set of measurements will assess the changes in the cardiovascular, neuro-ophthalmological, hematological, metabolic, sensorimotor, immune, muscle and bone systems.

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

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

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

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

lead_sponsor: Centre National d'Etudes Spatiales

sponsor_collaborators:
Centre National d'Etudes Spatiales
European Space Agency


title: Antalgic Effects of Well-being Treatments in Cancer Care; Foot Reflexology, Socio-aesthetics, Sophrology, Singing

acronym: Well Being

summary: observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.


title: Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer VIRECAPS2

summary:
The increase in the survival of cancer patients and the incidence of cancers leads to a rapid increase in the number of people living after a diagnosis of cancer.

Occupation during chemotherapy treatment time has been identified as an excellent way to support cancer patients. Studies show that distraction interventions increase tolerance to treatment, by decreasing the importance given to negative stimuli associated with chemotherapy and increasing pleasurable emotions.

In this context, virtual reality (VR) is a promising intervention for patients receiving chemotherapy. VR is considered a powerful painkiller, even more effective than other distractors, such as movies or video games for example.

Several studies have shown short-term beneficial effects of integrating VR in patients undergoing chemotherapy. This intervention would help patients better adhere to and tolerate treatment. Considering that positive emotions could be one of the underlying processes necessary for the effectiveness of VR, it would be possible to support the cancer patient towards better overall well-being thanks to these new technologies.

Investigators can therefore ask themselves the question of the impact that VR used during chemotherapy can have on the adaptation of patients to the disease and its treatments as well as on their psychological distress in the medium and long term.

ReferenceType: result

ReferenceCitation: Banos RM, Espinoza M, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility. Support Care Cancer. 2013 Jan;21(1):263-70. doi: 10.1007/s00520-012-1520-x. Epub 2012 Jun 13.

ReferenceCitation: Chirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275-87. doi: 10.1002/jcp.25117.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Cohn MA, Fredrickson BL, Brown SL, Mikels JA, Conway AM. Happiness unpacked: positive emotions increase life satisfaction by building resilience. Emotion. 2009 Jun;9(3):361-8. doi: 10.1037/a0015952.

ReferenceCitation: Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10.

publisher_dissemination: Cambridge University Press

ReferenceCitation: Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Schneider SM, Kisby CK, Flint EP. Effect of virtual reality on time perception in patients receiving chemotherapy. Support Care Cancer. 2011 Apr;19(4):555-64. doi: 10.1007/s00520-010-0852-7. Epub 2010 Mar 26.

ReferenceCitation: Schneider SM, Hood LE. Virtual reality: a distraction intervention for chemotherapy. Oncol Nurs Forum. 2007 Jan;34(1):39-46. doi: 10.1188/07.ONF.39-46.

ReferenceCitation: Tugade MM, Fredrickson BL, Barrett LF. Psychological resilience and positive emotional granularity: examining the benefits of positive emotions on coping and health. J Pers. 2004 Dec;72(6):1161-90. doi: 10.1111/j.1467-6494.2004.00294.x.

lead_sponsor: Ramsay Générale de Santé

collaborators: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis

acronym: SAHOSVAS

summary: a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.


title: Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty

summary: This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia.

ipd_sharing_description: IPD are protected by the French regulation and will not be shared

lead_sponsor: Hôpital de la Croix-Rousse

sponsor_collaborators:
Hôpital de la Croix-Rousse
Hospices Civils de Lyon

location_facility: Hopital de la Croix Rousse - Hospices Civils de Lyon


title: Exploration of Breast Milk by Culture Through "Microbial Culturomics" and by Targeted Metagenomics Through 16S Ribosomal RNA Gene Sequencing. Influence on the Development of Early and Late Neonatal Sepsis in Infants Under Three Months of Age.

acronym: MINEOS

summary:
Breast milk contains many microorganisms including bacteria that are beneficial to health (probiotics), but also bacteria that are generally considered pathogenic.

Several studies have described an increased risk of infections due to pathogenic germs in breast milk in premature newborns whose digestive system is immature and whose digestive flora is modified by repeated antibiotic treatments.

However, a breastfed baby is better protected against infectious diseases than a bottle-fed baby. The objective of this study is to define the breast milk microbiota of infants with confirmed early or late neonatal bacterial infection compared to the breast milk microbiota of infants with no evidence of bacterial infection. For that purpose, an exploration will be performed using the principle of "Microbial Culturomics" and targeted metagenomics (16S ribosomal RNA gene sequencing).

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views

summary:
Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).

The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.

Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.

The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).

sponsor_collaborators:
University Hospital, Bordeaux
DESKi


title: Effects of Chest Physiotherapy in Hyperventilation Syndrom : a Multicentric Observational Study

acronym: SHV

summary: Hyperventilation syndrome induce dyspnea and altered quality of life. the aim of this study is to assess the impact of chest physiotherapy on hyperventilation syndrome' symptoms

ReferenceCitation: Chenivesse C, Similowski T, Bautin N, Fournier C, Robin S, Wallaert B, Perez T. Severely impaired health-related quality of life in chronic hyperventilation patients: exploratory data. Respir Med. 2014 Mar;108(3):517-23. doi: 10.1016/j.rmed.2013.10.024. Epub 2013 Nov 7.

ReferenceCitation: Kiesel K, Burklow M, Garner MB, Hayden J, Hermann AJ, Kingshott E, McCullough G, Ricard R, Stubblefield G, Volz J, Waskiewicz D, Englert A. EXERCISE INTERVENTION FOR INDIVIDUALS WITH DYSFUNCTIONAL BREATHING: A MATCHED CONTROLLED TRIAL. Int J Sports Phys Ther. 2020 Feb;15(1):114-125.

lead_sponsor: Centre Hospitalier des Pays de Morlaix


title: Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial

acronym: BeSURE

summary:
The primary objective of the study is to demonstrate that hernia recurrence (VH) repair with non absorbable mesh concomitant to Bariatric Surgery (BS) decreases the risk of VH, with or without surgical repair, during the first two years after BS when compared to VH suture repair without mesh.

As secondary objectives, the study aims to assess the impact of concomitant VH repair with non absorbable mesh versus suture repair in morbidly obese BS candidates on the following measures: - hernia recurrence at 1 year after randomization; - reoperation for hernia recurrence at 2 years after randomization; - strangulated hernia, surgical infection and mesh bulging at one year after randomization; - postoperative morbidity and mortality at 90 days after randomization; - benefit-risk ratio; - chronic pain at three months, six months, one year and two years after randomization; - quality of life during the two years after randomization; - incremental cost utility ratio; - short- and mid-term weight loss. To study if the efficacy of mesh versus suture VH repair differs according to the type and size of VH and to the surgical technique.

location_facility: Department of visceral and digestive surgery, Louis Mourier hospital, APHP


title: Evaluation of Movement and Muscular Alterations in Subjects With Severe Knee Osteoarthritis Who Are to Receive a Total Knee Replacement

acronym: MOUV-GOPRO

summary:
Osteoarthritis (OA) is the most common joint disease. It is characterized by a progressive destruction of all the components of the joint, especially the cartilage. This leads to pain, loss of mobility and can be a major handicap for some patients.

Gonarthrosis, or osteoarthritis of the knee, affects 30% of people between the ages of 65 and 75 and is one of the most disabling conditions. In the final stage, the only therapeutic option to relieve patients is to replace the joint with a total knee prosthesis.

Thanks to the contribution of an evaluation technique based on inertial sensors (X-SENS device), our objective is to better evaluate and understand the movement deficit in knee OA subjects.

The hypothesis is that, thanks to the contribution of a technique based on inertial sensors (X-SENS), the investigators can better evaluate the movement deficit of knee OA subjects. The goal is to propose specific, rapid telekinetic biomarkers, allowing a better evaluation of functional improvements following therapeutic interventions, such as a total knee replacement.

lead_sponsor: University Hospital, Montpellier


title: Study of the VIsual Pathways MODEL for a Better Understanding of Neurodegeneration in Inflammatory and Demyelinating Disorders of Central Nervous System

acronym: VIP-MODEL

summary: In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. Both white and grey matter are systematically affected. Lesions of the perivascular spaces containing cerebrospinal fluid (CSF) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. Currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. In order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. In this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during MS and other CNS demyelinating diseases. Researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (MRI, optical coherence tomography - angiography, etc…).

lead_sponsor: University Hospital, Lille


title: Preliminary Evaluation of the Artificial Intelligence Software VX1+ for the Detection and Automatic Tagging on 3D Mapping of Spatio-temporal Dispersion Areas During Atrial Fibrillation or Atrial Tachycardia Ablation Procedures.

acronym: AMPERE

summary: Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3D-map in real-time.

ReferenceCitation: Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.

ReferenceCitation: Lotteau S, Seitz J, Bars C, et al. Bidirectional communication between an artificial intelligence device and a 3-dimensional navigation apparatus improves automation of multipolar electrogram mapping during paroxysmal and persistent atrial fibrillation. Cardiovascular Digital Health Journal. 2023;4(5):S8. doi:10.1016/j.cvdhj.2023.08.017

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

unpaywall_oa_status: gold

lead_sponsor: Volta Medical


title: Top Benefits of the Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia

acronym: DANATRESIA

summary:
Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.

Methods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive pregnancies, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.

lead_sponsor: Poitiers University Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers


title: PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

summary: Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. Cephalosporinase-producing Enterobacteriaceae have an increasing incidence. Infections in cephalosporinase-producing patients require the use of Cefepime during probabilistic antibiotic therapy, the repeated use of which will lead to a significant risk of selection of resistant mutants. The involvement of cephalosporinases being infrequent, the prediction of their presence during a VAP would make it possible to reduce the consumption of Cefepime and thus to take part in the prevention of selection of bacterial mutants resistant to beta-lactams. The main objective of the research is to determine the risk factors for the involvement of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia (VAP) in hospitalized patients. The secondary objectives are to describe the epidemiology of cephalosporinase-producing enterobacteria in the ICU and to compare the risk factors for the presence of a cephalosporinase-producing germ not without its production being derepressed with those present in situations of cephalosporinase derepression.

ReferenceCitation: Bouadma L, Sonneville R, Garrouste-Orgeas M, Darmon M, Souweine B, Voiriot G, Kallel H, Schwebel C, Goldgran-Toledano D, Dumenil AS, Argaud L, Ruckly S, Jamali S, Planquette B, Adrie C, Lucet JC, Azoulay E, Timsit JF; OUTCOMEREA Study Group. Ventilator-Associated Events: Prevalence, Outcome, and Relationship With Ventilator-Associated Pneumonia. Crit Care Med. 2015 Sep;43(9):1798-806. doi: 10.1097/CCM.0000000000001091.

ReferenceCitation: Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med. 2014 Jan 23;370(4):341-51. doi: 10.1056/NEJMsa1300991.

ReferenceCitation: Damas P, Layios N, Seidel L, Nys M, Melin P, Ledoux D. Severity of ICU-acquired pneumonia according to infectious microorganisms. Intensive Care Med. 2011 Jul;37(7):1128-35. doi: 10.1007/s00134-011-2255-8. Epub 2011 May 26.

ReferenceCitation: Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.

ReferenceCitation: Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.

ReferenceCitation: Crnich CJ, Safdar N, Maki DG. The role of the intensive care unit environment in the pathogenesis and prevention of ventilator-associated pneumonia. Respir Care. 2005 Jun;50(6):813-36; discussion 836-8.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis

acronym: FALLOT-XI

summary: The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.

lead_sponsor: University Hospital, Bordeaux

collaborators: Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)


title: Prevalence of Sexual Addiction in an Inmate Population at the Muret Detention Center in Haute-Garonne.

acronym: PAS-CD

summary:
Sexual addiction, also known as hypersexuality or compulsive sexuality, is a human sexual behavior that results in a continuous and persistent search for sexual pleasure. Replacing the former terms satyriasis and nymphomania, the World Health Organization (WHO) ICD-11 has referred to this disorder as "compulsive sexual behavior disorders".

From multiple causes (iatrogeny, neurological causes, psychiatric causes, psychopathological hypotheses), but still only partially known, the inclusion of this disorder among impulsivity-related disorders, obsessive-compulsive disorders or addiction-related disorders is still debated in the scientific literature. Thus, in the absence of sufficient robust scientific data, DSM-5 refused to include this disorder in its classification.

However, the consequences of this disorder on the psychosocial functioning of individuals are not negligible, which can go as far as the precipitation of a transition to an heteroaggressive act which can thus lead to incarceration.

The prevalence of this disorder in the general population is estimated between 2 and 6% based on current literature data. This rate appears to be higher among men and more specifically among sex offenders.

However, some authors have noted that the difficulty in determining a clear prevalence of sexual addiction may be related to the still poorly defined diagnostic criteria for this disorder as well as the choice of measurement tools.

In the inmate population, to our knowledge, there are no French prevalence studies of this disorder. In addition, no studies have been conducted to compare the prevalence of sexual addiction among sex offenders (SASO) with that among non-sex offenders (SANSO).

We hope that better screening for addiction would enable better management of patients with this disorder, promoting their psychosocial rehabilitation and well-being, so as to prevent the recurrence of a transition to sexual arousal.

lead_sponsor: Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie


title: Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.

acronym: MS-CSI

summary: Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Rennes University Hospital


title: Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery

acronym: LUSENT

summary:
After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy.

The objective of this study is to characterize the pulmonary status of patients after ENT cancer surgery.

We wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (PACU), at day 1 and at day 2 after ENT cancer surgery with tracheostomy.

ReferenceCitation: Goel N, Sen IM, Bakshi J. Lung ultrasonography as a tool to guide perioperative atelectasis treatment bundle in head and neck cancer patients undergoing free flap reconstructive surgeries: a preliminary observational study. Braz J Otorhinolaryngol. 2022 Mar-Apr;88(2):204-211. doi: 10.1016/j.bjorl.2020.05.030. Epub 2020 Jul 29.

ReferenceCitation: Touw HR, Parlevliet KL, Beerepoot M, Schober P, Vonk A, Twisk JW, Elbers PW, Boer C, Tuinman PR. Lung ultrasound compared with chest X-ray in diagnosing postoperative pulmonary complications following cardiothoracic surgery: a prospective observational study. Anaesthesia. 2018 Aug;73(8):946-954. doi: 10.1111/anae.14243. Epub 2018 Mar 12.

ReferenceCitation: Zieleskiewicz L, Papinko M, Lopez A, Baldovini A, Fiocchi D, Meresse Z, Boussuges A, Thomas PA, Berdah S, Creagh-Brown B, Bouhemad B, Futier E, Resseguier N, Antonini F, Duclos G, Leone M. Lung Ultrasound Findings in the Postanesthesia Care Unit Are Associated With Outcome After Major Surgery: A Prospective Observational Study in a High-Risk Cohort. Anesth Analg. 2021 Jan;132(1):172-181. doi: 10.1213/ANE.0000000000004755.

ReferenceCitation: Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

lead_sponsor: Centre Leon Berard


title: Lung Ultrasound-guided Hemodynamic Optimization in Major Non-cardiac Surgery: a Randomized Control

acronym: POINTBAR

summary:
The formalized expert recommendation of the French Society of Anesthesia and Intensive Care recommends guiding vascular filling by measuring the stroke volume (SV) in surgical patients considered at high risk. Vascular filling should be continued in the event of preload dependence and stopped in the event of the appearance of preload independence. The aim is to avoid vascular overload due to excessive vascular filling. The application of this recommendation has resulted in a reduction in postoperative morbidity, length of hospital stay and time to return to oral feeding. The superiority of this strategy is now being questioned and the predictive indices of response to vascular filling (static and dynamic) have many limitations. In addition, none of the cardiac output monitors are the gold standard for intraoperative use.

Through the study of artefacts, lung ultrasound has been gaining ground over the last twenty years, particularly in cardiology, nephrology and intensive care. By analogy with radiological B-lines, ultrasound B-lines result from the reverberation of ultrasound on the subpleural inter-lobular septa thickened by oedema. The Fluid Administration Limited by Lung Sonography (FALLS) protocol, described by Lichtenstein et al, is defined as the visualisation of new B lines during a vascular filling test. If a B-line appears in an area where it was not present during vascular filling, the most likely diagnosis is hydrostatic overload of the subpleural interstitial septum. This appearance of B-lines occurs at a sub-clinical stage.

The use of lung ultrasound could allow real-time assessment of vascular filling and its tolerance during the intraoperative period. The main objective of the study is to demonstrate a decrease in the incidence of postoperative complications (organ failure) (as defined by international guidelines) when using lung ultrasound-guided haemodynamic optimisation compared to standard optimisation.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency

acronym: MI-MVPS

summary: This aim of this study is the evaluation of the gut microbiota imbalance occurrence and its characterization in patients with common variable immunodeficiency associated to an enteropathy with or without porto-sinusoidal vascular disease.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Immunologie Clinique Hôpital Saint Louis

intervention_type: Biological


title: A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

acronym: PIONEER

summary:
This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.

The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Study of the Predictive Capacity of Peripheral Muscle Function on Quality of Life Impairment at 1 Year in Subjects With Obesity. A Cohort Study.

acronym: OBLITAM

summary:
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. Excess body fat in obese patients appears to be responsible for impaired muscle function. This causal link is probably linked to dysfunctions in adipose tissue, leading to a decrease in the expression of proteins responsible for muscle contraction. The recent literature highlights an alteration in quality of life, particularly in obese and elderly subjects, for which changes in muscle function are partly responsible.

Changes in muscle function can be assessed by simple, rapid and non-invasive tools. These changes in the obese patient could be predictive of reduced quality of life. To our knowledge, no study has evaluated the predictive capacity of muscle alteration assessed by ultrasound on the medium-term quality of life of obese patients.

The main objective of this study is to evaluate the predictive capacity of structural alteration of the quadriceps on the decrease in quality of life at 1 year in patients with obesity.

The secondary objectives are to assess the association between :

Grip strength and quality of life at 1 year;
Quadriceps muscle strength and quality of life at 1 year;
Ultrasound measurements of the quadriceps and quality of life at 1 year;
Ultrasound measurements of the quadriceps and autonomy at 1 year;
Grip strength and autonomy at 1 year.

This is a prospective, monocenter, observationnal and cohort study.

All outpatients for nutrition assessment will be included.

ReferenceCitation: Tamura LS, Cazzo E, Chaim EA, Piedade SR. Influence of morbid obesity on physical capacity, knee-related symptoms and overall quality of life: A cross-sectional study. Rev Assoc Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.

ReferenceCitation: Toselli S, Campa F, Spiga F, Grigoletto A, Simonelli I, Gualdi-Russo E. The association between body composition and quality of life among elderly Italians. Endocrine. 2020 May;68(2):279-286. doi: 10.1007/s12020-019-02174-7. Epub 2019 Dec 31.

ReferenceCitation: Tomlinson DJ, Erskine RM, Winwood K, Morse CI, Onambele GL. The impact of obesity on skeletal muscle architecture in untrained young vs. old women. J Anat. 2014 Dec;225(6):675-84. doi: 10.1111/joa.12248. Epub 2014 Oct 14.

ipd_sharing_description: The protocole, the statistical analysis plan and data will be available as supplementary materials with the publication. The other data that support the findings of this study will be available from the corresponding author upon reasonable request.

lead_sponsor: Hopital Forcilles


title: Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls

acronym: STROXCO

summary: Stroke is major public health issue. The investigators recommend post-stroke patients to practice physical activity. Nevertheless, the recommendations are not widely respected due to the intensity of exercises. Oxygen consumption is a parameter to assess the intensity of physical activity. in this sense, we want to measure the oxygen consumption during various walking tasks compared to healthy controls.

lead_sponsor: University Hospital, Limoges


title: Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine. Functional Evaluation on the Transit of Healthy Volunteers. A First in Man, Prospective, Monocentric, Not Randomized Study.

acronym: DIGEST

summary: For the first time in the world, the objective of this study is to evaluate on healthy volunteers, an innovative medical device for the capture of intestinal liquid.This medical device is not yet CE marked.

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Grenoble

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Reducing Inflammation in Ischemic Stroke With Colchicine, and Ticagrelor in High-risk Patients-extended Treatment in Ischemic Stroke

acronym: RIISC-THETIS

summary: REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

location_facility: URC Lariboisière-Fernand Widal-Saint Louis


title: Key Factors of Target Serum Concentrations Attainment From Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

acronym: SPT BETALACT

summary:
The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital.

The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients.

Clinical and biological features, as well as risk scores are collected and recorded into an electronic Case Report Form.

The primary outcome is to show the main characteristics related to adequate beta-lactams serum concentrations in critically ill inpatients.

Secondary outcomes include the key factors related to inadequate beta-lactams serum concentrations in critically ill inpatients, Therapeutic Drug Monitoring (TDM) impact in the achievement of target beta-lactams serum concentration and the correlation between Aminoglycosides and Beta-lactams serum concentrations. Do both antibiotics have similar elimination kinetics ?

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Contribution of Diaphragmatic Ultrasound for Monitoring Diaphragmatic Function in Patients With Amyotrophic Lateral Sclerosis

acronym: ALSUS

summary:
Amyotrophic lateral sclerosis (ALS) is a rare neuromuscular disease that occurs in adults. It is characterized by a progressive degeneration of the first and second motor neurons leading to muscle failure. In its spinal form, ALS manifests by a progressive worsening of limb involvement, whereas the bulbar form presents with swallowing disorders, dysarthria and feeding difficulties.

Respiratory impairment is the most serious feature of ALS. Phrenic nerve damage causes diaphragmatic weakness, which inevitably leads to chronic restrictive respiratory failure. At the stage of symptomatic nocturnal or diurnal alveolar hypoventilation, non-invasive ventilation (NIV) prolongs survival while improving quality of life by relieving respiratory symptoms.

The indication for the initiation of NIV is based on the appearance of respiratory symptoms but also on the demonstration of diaphragmatic insufficiency. A quarterly follow-up of diaphragmatic function has been recommended by the French Health Authority since 2006. It is based on functional respiratory explorations (VC in sitting and lying position, measurement of maximal inspiratory pressure) and screening for diurnal or nocturnal hypoventilation with the measurement of PaCO2 or the nocturnal recording of SpO2.

Access to these examinations remains limited and they are sometimes complex to perform (in particular issues with mouth occlusion during respiratory manoeuvres in case of bulbar damage). Thus, only 60% of patients undergo a complete evaluation. Moreover, these explorations are only late markers of diaphragmatic dysfunction, and it has recently been shown that they do not correlate with histological diaphragmatic amyotrophy.

The development of new, reliable, and easily available tools for the evaluation of diaphragmatic function, and that are capable of detecting diaphragmatic insufficiency early in the course of the disease, are therefore necessary. Such tools would make it easier to implement NIV at the optimal time, preventing episodes of acute respiratory distress.

Recently, diaphragmatic ultrasound has appeared in the ICU as a new tool for assessing diaphragmatic function. It has the advantage of being highly available, inexpensive, non-irradiating, quick to perform, reproducible and very sensitive and specific for the diagnosis of diaphragmatic dysfunction.

In ALS, few studies have investigated the contribution of ultrasound for the diagnosis or follow-up of diaphragmatic dysfunction. In addition, no study so far has compared diaphragmatic ultrasound to complete pulmonary function test (PFT) data or to direct measurement of diaphragmatic pressure (Pdi). Very few publications report the how the diaphragm changes on ultrasound imaging during the disease. Moreover, these studies do not analyse the interest of diaphragmatic ultrasound in the prediction of progression towards respiratory failure with respiratory support, or death. Finally, these studies use different ultrasound measurements of the diaphragm (stroke, thickness, thickening fraction, and thickening fraction ratio, among others) rather than a simple, consensual parameter.

The aim of this study is to describe the evolution of diaphragmatic ultrasound parameters, to identify the parameter that best correlates with other respiratory measures (PFT, PaCO2, nocturnal oximetry) and to determine the prognostic value of diaphragmatic ultrasound in predicting the initiation of NIV or death at 6 and 12 months.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of Impact of Different Micturition Modes on Patients With Medullar Injury of Their Quality of Life and Their Occupations

acronym: URO-ActSCi

summary: The primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.

location_facility: Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP


title: Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients With ARDS

summary:
Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. However, these airway pressures might not reflect the actual pressure applied to the lung. Transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (VILI).

One of the consequences of the VILI is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution.

So it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.

lead_sponsor: Bicetre Hospital

location_facility: Medical Intensive Care Unit, Bicêtre Hospital


title: Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M

acronym: CEFASTA

summary: Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Search for a Recanalization of the Sylvian Artery Electro-Physiological Biomarker

acronym: BEERS

summary: Early recanalization is a major prognostic factor in vascular accidents ischemic brain injury (AIC). The acute phase therapies of AIC aim to recanalization by intravenous thrombolysis and/or mechanical thrombectomy. Recanalization is identified immediately during thrombectomy by per-procedural arteriography. For the thrombolysis, only a performed MRI will validate the recanalization. This "proof of concept" study aims to identify an Electro-Encephalographic biomarker (EEG) of the recanalization in real time, the EEG being easy to set up. This biomarker will be sought during recanalization certified by thrombectomy in order to identify the window time for which the biomarker must be sought on the EEG. During this study, the identified EEG biomarker can be used to validate the recanalization during the intravenous thrombolysis in future studies

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders

acronym: IEvaEcoSchi

summary:
The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders.

Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could improve the care of this population, by making it possible to set with the patient objectives anchored in their daily life.

lead_sponsor: Centre Hospitalier Henri Laborit


title: Assessment of Personality Traits Associated With Exercise Addiction in Ultra Endurance Athletes

summary: Ultra endurance sports (events exceeding 6 hours) is becoming increasingly popular and Exercise Addiction (EA) is frequent in this type of sports, which are characterized by very high training volume. However, little is known about the personality traits of athletes who are more likely to develop EA. This study aims to assess the personality traits associated with EA in ultra endurance athletes. We designed a cross sectional study. Participants have to fill a web-based questionnaire including the Big Five Personality Test for assessing the personality traits and the Exercise Dependence Scale-Revised (EDS-R) for assessing EA. Also they have to fill a personal question about demographics (age, gender, work), sport practice and eating habits. A minimum sample size of 300 participants is expected. Statistical analyses will test the association between personality traits and the presence (or absence) of EA according to the EDS-R. Secondary analysis will test the association between the type of sport (running, cycling, triathlon, swimming), the volume of sport practice and the presence of eating disorders and EA.

lead_sponsor: University Hospital, Caen

collaborators: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie


title: Implementation of Game-based Training in Oral Rehabilitation of Edentulous Patients in Undergraduate Dental Course

acronym: Playdent

summary: Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students' learning outcomes.

lead_sponsor: Hôpital Rothschild


title: Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT

acronym: EURECAS

summary:
The optimal screening methods for coronary insufficiency, a frequent and pejorative complication in diabetics, are subject to debate, particularly in situations of silent myocardial ischemia. The contemporary strategy consists of pre-selecting asymptomatic patients at very high cardiovascular (CV) risk by performing a coronary calcium score. If this is found to be high >300 AU (Agatston units), the patient is suspected of being at high risk of silent myocardial ischemia (SMI), and the assessment is completed to exclude the presence of coronary artery disease likely to benefit from revascularization.

The complementary evaluation consists in evaluating the myocardial perfusion to judge the perfusion repercussions. The most common examination to date is myocardial scintigraphy, because stress tests are too frequently submaximal in diabetics. However, the reproducibility of scintigraphy is controversial and their sensitivity and specificity are debated in this indication.

This problem is similar in stable symptomatic coronary diabetic patients for whom an indication for functional examinations is justified.

The double-energy double-layer spectral scanner (SDEDC) could now become a relevant tool in this field, since it can combine not only anatomical data (identification of coronary stenosis) but also functional data (myocardial perfusion) during a stress protocol. thanks to the spectral images which make it possible to measure the tissue concentration of intramyocardial iodine downstream of the considered stenosis.

lead_sponsor: Hospices Civils de Lyon


title: A Retrospective Study of Vital Mechanism of NETs Formation vs. Suicidal Mechanism of NETs Formation During Normal Pregnancy and Preeclampsia

acronym: GrossNETs

summary: Formation of neutrophil extracellular traps (NETs) is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Two mechanisms of formation of NETs are described in the literature: vital mechanism via Toll Like Receptors (TLRs) and suicidal mechanism, dependent on the reactive oxygen species (ROS) pathway. The description of these two mechanisms of formation of NETs is recent and no data exist in the context of pregnancy.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: A Retrospective Study of Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide

summary:
Nitrous oxide (N2O) is a colorless, flammable, analgesic gas used in surgery and dentistry. The consumption of N2O has increased among young French people aiming to relax because of its short-lived neuropsychological effect (euphoria, depersonalization, analgesia) and its wide availability on the market.

It can be responsible in case of prolonged use and overdose of a vitamin B12 deficiency with possible neuropsychiatric complications: sensitivomotor neuropathy, myelopathy, behavioral and cognitive disorders of acute or sub-acute installation.

N2O inhibits the activitý of methionine synthase, decreases the activitý of methylmalonyl-CoA mutase leading to vitamin B12 deficiency but in addition to the interference with vitamin B12 metabolism there seems to be a direct toxicity of N20.

Myelin alteration was the typical electromyography finding but new axonal profiles were also described. Since myelopathy affects both the posterior and lateral cords, combined spinal cord sclerosis is the most common location of injury associated with N2O intoxication.


title: Predictivity and Evaluation of the Adherence of Ambulatory Patients Treated With a Direct Oral Anticoagulant for Atrial Fibrillation

summary:
The rhythm disorders of Atrial Fibrillation (AF) require continuous treatment with anticoagulants to prevent stroke. The introduction of direct oral anticoagulants (DOACs) quickly supplanted the administration of anti-vitamin K (AVK) which presented an elevated risk of hemorrhage.

However, the adherence of the treatments by the OAD is very poor, several studies show that 30 to 50% of the patients fail to adhere to their treatment very soon after starting it. In a recent study, in the United States, using data collected between 2010 and 2014 in more than 60,000 patients with AF, Yao et al show that less than 50% of patients can be considered "adherent".

They conclude in this study that adherence to anticoagulation is low in practice, although it may be slightly improved with DOACs. More recently a meta-analysis shows that 66% of patient treated by DOACs were considered adherent (PDC > 80 %). In addition, therapeutic adherence seems to be essential in patients with a CHA2DS2-VASc score ≥2. Indeed improving adherence reduces the risk of stroke occurrence. The investigators propose to evaluate during an interview in the pharmacy, the adherence of ambulatory patients (at the time of their renewal of treatment at the pharmacy) by the "Proportion of Days Covered" (PDC) of the treatment by AOD, and by a simplified questionnaire and to define a profile of patients treated for AF at risk of nonadherence to AOD (PDC adherence prediction score). The investigators perform an observational, prospective multicenter study , in which patients adherence will be quantified in a standardized method.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens