title: Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children With Executive Functions Deficits Following Severe Acquired Brain Injury: a Single Case Experimental Design Study

summary:
Purpose:

Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration. Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning. The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. CO-OP is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the CO-OP approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles. It has been shown to be effective in a variety of populations, but has been little explored in children with ABI.

Objectives To assess whether the use of CO-OP could be of interest in children with executive functions deficits following ABI, to improve their occupational performance, their executive functioning in everyday life and their cognitive processes constituting EF.

ReferenceCitation: Lebrault H, Chavanne C, Abada G, Latinovic B, Varillon S, Bertrand AF, Oudjedi E, Krasny-Pacini A, Chevignard M. Exploring the use of the Cognitive Orientation to daily Occupational Performance approach (CO-OP) with children with executive functions deficits after severe acquired brain injury: A single case experimental design study. Ann Phys Rehabil Med. 2021 Sep;64(5):101535. doi: 10.1016/j.rehab.2021.101535. Epub 2021 Jul 17.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

license: cc-by-nc

license_normalized: cc-by-nc

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

lead_sponsor: Hopitaux de Saint-Maurice


title: Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.

acronym: CROSS-LEFT-AF

summary:
Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.

They will be prospectively followed during 6 months.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Nicolas Clementy, MD, PhD

sponsor_collaborators:
Nicolas Clementy, MD, PhD
Dr Arnaud BISSON

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy: a Proof of Concept Study

acronym: UF BIA

summary:
Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice.

Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy.

We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days.

We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

intervention_type: Diagnostic Test

lead_sponsor_type: academique


title: Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis

summary: Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

study_start_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Firalis SA


title: Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery

acronym: ESB-Sterno

summary: The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug

status_simplified: Completed


title: Cannabidiol for Reducing Drinking in Alcohol Use Disorder and Modifying the Effects of Alcohol on the Brain and the Liver: a Phase 2 Clinical Trial.-The CARAMEL Study

acronym: CARAMEL

summary: The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).

status: Not yet recruiting

lead_sponsor: Hôpital le Vinatier

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CH LE VINATIER

type_etablissement: EPSM

acronyme: CARAMEL

titre: Le cannabidiol dans le trouble d'usage d'alcool: intérêt pour réduire la consommation d'alcool et les effets de l'alcool sur le cerveau et le foie (essai clinique de phase 2).

discipline_principale: psychiatry

nom_porteur: ROLLAND

prenom_porteur: Benjamin


title: Evaluation of the Efficacy and Safety of the New URGO BD001 Compression System Versus a Reference Compression in the Local Treatment of Venous or Mixed Predominantly Venous Leg Ulcers: a Prospective Open-label RCT

acronym: FUTURE

summary: Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

lead_sponsor: Laboratoires URGO


title: Genetic Modifying Factors and Pheochromocytomas in Multiple Endocrine Neoplasia Type 2

summary: Multiple endocrine neoplasia type 2A (MEN2A) is a rare syndrome associated with activating mutations in the RET proto-oncogene, combining medullary thyroid cancer in approximately 100% of cases and pheochromocytoma in 10-80% of cases. While it is accepted that the RET mutation causes variable penetrance of pheochromocytoma in the MEN2A patient population, there is no pathophysiological explanation for the phenotypic variability among patients with the same mutation, including within the same family. The aim of this study is to better characterise the genetic factors that may explain the variable penetrance of pheochromocytoma in MEN2. To this end, the investigatoes plan to perform a whole exome analysis in 2 families carrying the p. Cys634Arg mutation causing NEM2A, followed in Marseille by the principal investigator: the 1st family has 11 members all aged over 35 years, for which 8 are carriers of pheochromocytoma while 3 have not developed it (while their age is higher than the latest age of diagnosis of pheochromocytoma in this family); the 2nd family has 3 members (father and daughter with pheochromocytoma developed before 25 years; son without pheochromocytoma at an age of 42 years). The investigators believe that the analysis of these patients should allow the isolation of variants on genes potentially involved in the genesis of a pheochromocytoma in MEN2.

status: Recruiting

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Biomechanical and Neurophysiological Evaluation of the Effect of a Motor Block and an Injection of Botulinum Toxin on the Stiffness of the Paretic Sural Triceps Muscle

acronym: RAI PAR BLOC

summary: The research "Biomechanical and neurophysiological evaluation of the effects of a motor block and an injection of botulinum toxin on the stiffness of the paretic sural triceps muscle" will study the response to passive stretching in the neurological patient presenting spastic paresis after a stroke.

primary_purpose: Other

lead_sponsor: Nantes University Hospital

intervention_type: Other


title: Surgical Anatomy of the Distal Portion of the Phrenic Nerve

acronym: DANP

summary: Prolonged mechanical ventilation has been shown to induce diaphragm dysfunction. Temporary diaphragm pacing is an interesting lead to halt or slow diaphragm dysfunction. A detailed description of the distal portion of the phrenic nerve would be the start for developing a new surgical approach for diaphragm pacing. Its in that perspective that we are launching a clinical observational study of the distal portion of the phrenic nerve in patients who undergo minimally invasive thoracic surgey. We hypothetize that the density of the fatty tissue surrounding the distal portion of the phrenic nerve might influence efficiency of the electrode during diaphragm pacing. The objective of this study is to find a correlation between the amount of fatty tissue around the nerve and the body mass index of individuals.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Tenon Hospital, Service : Chirurgie Vasculaire et Thoracique


title: Impact of a Multifactorial Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Autografted Patients Treated With Melphalan for Multiple Myeloma or Lymphoma : a Single-center, Randomized,Crontrolled Study, With 2 Parallel Arms.

acronym: RE-NEZ-SENS

summary: Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with Melphalan for therapeutic intensification with autologous transplantation of hematopoietic stem cells for multiple myeloma or lymphoma, and also improve their life quality, psychological well-being, and nutrition.

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier

location_facility: Hematology Department, University Hospital Center


title: Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.

summary:
Differentiated thyroid cancer is the third cause of cancer in young men of childbearing age. Its treatment by irradiation with Radioactive Iodine 131 therapy (RAT) could alter spermatogenesis and result in azoospermia and permanent infertility. A preventive gametes cryopreservation was recommended before RAT, but without mentioning a period of teratogenic risk transmissible to the offspring. To date, RAT impact on human sperm nucleus is poorly known or even unknown, notably on telomere length.

Our objective is to define RAT effects on human sperm nucleus by in vitro irradiation exposure of human spermatozoa to mimicking that of the gonads in the context of irradiation with iodine131 used for thyroid cancer. We will analyze standard sperm parameters, major DNA alterations and telomere length using molecular and cellular assays. Nucleus morphology and chromatin organization will also be analyzed using 3D bio-imaging. This study will permit to optimize the indications for the preservation of fertility.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Agence de La Biomédecine


type: Other Identifier

title: Staphylococcus Aureus in Atopic Dermatitis Immunopathology

acronym: STADE

summary:
Atopic Dermatitis (AD) is a frequent inflammatory skin disease characterized by recurrent eczema. It associates genetic/epigenetic-induced alterations of epidermal barrier and type-2 inflammation/hypersensitivity, which may be triggered by different antigens that pass through the altered skin . Some studies have reported that environmental pathogens such as house dust mites are able to induce type-2 inflammation through particular activation of innate immunity .

Multiple staphylococcal strains are commonly found on the skin of AD patients. Interestingly, recent findings suggest that S. aureus may be a key factor of AD inflammation: (i) 90% of AD patients have S. aureus skin colonization on lesional skin , (ii) AD patients with S. aureus skin colonization have more increased type-2 inflammatory markers in comparison with AD patients without SA skin colonization , (iii) skin colonization by monoclonal S. aureus strains correlate with severe flares and (iv) S. aureus is detected in both epidermis and dermis during AD flares; In this study, our hypothesis is that S. aureus induces AD flares through a type 2 T cell-mediated hypersensitivity against S. aureus, involving innate and adaptive responses. Conversely, S. epidermidis, a commensal strain, has a protective effect against S. aureus dysbiosis. To this end, we will characterize, in the skin and the blood, the immune response induced by cutaneous application of : i) S. aureus isolated from patients with moderate-to-severe AD which will mimic the cutaneous dysbiosis occurring in the natural course of AD; ii) S. aureus toxins without bacteria to evaluate the skin response against those particular proteins; iii) a laboratory strain of S. epidermidis, a common well-tolerated skin commensal bacteria; iv) a mix of S. aureus and S. epidermidis to evaluate the regulatory effect of S. epidermidis on the S. aureus-induced AD inflammation.

Importantly, this characterization will be led in AD patients (with alterations of skin barrier), compared to healthy volunteers (without alterations of skin barrier), as controls.

design_allocation: Non-Randomized

primary_purpose: Basic Science


title: PITCHER (Peritoneal Carcinomatosis Heterogeneity)

summary:
How epigenetic deregulation affects gene expression patterns in subclones of the same tumor is poorly known. Peritoneal Carcinomatosis (PC) is a condition in which multiple metastases of the same abdominal tumor develop in the peritoneal cavity and intra-peritoneal organs, thus defining different ecosystems of the same cancer. PITCHER addresses the variations in epigenetically regulated gene expression between different subclones of PC in relation with cell mechanoresponses, providing insights on how cancer epigenetic landscapes evolve under environmental pressures and on strategies used by cancer cells to adapt to the transition from one ecosystem to the other.

PITCHER is a network of 10 teams from Lyon, Grenoble and Marseille, based on data and specimen collection of patients who have undergone a surgery for a peritoneal carcinomatosis of ovarian or colorectal origin. PC lesions and eventually matched specimens of primary tumors will be collected in the same patients at the time of the surgery or eventually retrieved from already existing samples. Epigenetic landscapes will be analyzed by a bioinformatics pipeline combining exome sequencing, transcriptome and methylome to identify "epigenetic hotspots", and their variations across lesions will be evaluated. These analyses will be realized in fresh (when available) or pre-existing samples. When possible, organoid cultures and animal models will be derived from multicellular structures in peritoneal fluids and membrane, cytoskeletal and nucleoskeletal mechanoresponses will be characterized using Atomic Force Microscopy. The role of tumor axonogenesis, a process of neo-formation of axon fibers in tumors, will be addressed. Experimental studies of cell responses to therapy will be performed to derive mathematical predictive models. All components will be integrated in a systems biology map of PC.

location_facility: Lyon SUD Hospital, Hospices Civils de Lyon


title: Quality of Life in Patients After Pharyngolaryngectomy

acronym: LARYNG-QDV

summary: Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.

time_perspective: Cross-Sectional

lead_sponsor: Université de Reims Champagne-Ardenne


title: Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study

acronym: DYSFHO

summary:
Several studies describe the existence of an association between sexual dysfunction and high blood pressure (hypertension), most often characterized by a decrease in the number of orgasms and the existence of dyspareunia.

Hypertension is a contributing factor, and nonadherence to medication could amplify it.

There are several ways to assess adherence to treatment: the use of declarative questionnaires, a method not without criticism because it is subject to the subjectivity of the declaration by the patient; and drug dosages, a standard technique, although insufficiently disseminated due to the high cost and greater weight of the survey protocols. Drug non-compliance is multifactorial. In addition, it has been shown that having undesirable drug effects and / or being afraid of developing them is one of the major causes of non-compliance with antihypertensive treatments.

The investigators hypothesize that DS is significantly more common among hypertensive women treated with non-observers compared to hypertensive women treated with observers.

The main objective is to compare the prevalence of sexual dysfunction between a group of hypertensive women treated as observers and a group of hypertensive women treated as non-observers.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological

appel_a_projets: PHRIP

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: DYSFHO

titre: Dysfonction sexuelle chez la femme hypertendue selon l'observance médicamenteuse : étude transversale multicentrique.

discipline_principale: cardiologie

nom_porteur: PIROU

prenom_porteur: Enora


title: In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study

acronym: ECMOCARD

summary: veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Effect of Social Stress in the Physiology and Cognition of Suicide Attempters: Heart Rate, Endocrine and Inflammatory Response, Decision Making

acronym: SUPHY

summary:
Only vulnerable patients, when facing environmental stressors, attempt or commit suicide. Previous research demonstrated that suicide attempters usually misunderstand the social context and show impairments in decision making. Heart activity, endocrine and inflammatory response to stress were related with these features. For that, suicide attempters, in a context of social stress, would have maladaptive physiological response impacting the following decision making. The main aim is to identify the physiological response (autonomous nervous system, endocrine and inflammatory response) of suicide attempters under social stress conditions and to investigate the association of this response with the posterior decision making.

The study aims to compare physiological response to social stress and posterior decision-making response in 80 euthymics women with a past mood disorder according to their history of suicide attempt


title: Developmental Coordination Disorder: Role of Perceptual Deficits and Body Representation

acronym: DYSENS

summary:
Developmental Coordination Disorder (DCD) corresponds to a clumsiness, a slowness and an inaccuracy of motor performance. This neurodevelopmental disorder affects 6% of school-aged children, and disturbs daily life activities and academic performances. The etiology of DCD is still unknown. An understanding of this disorder is necessary to improve interventions and therefore quality of life of these people.

A deficit of the so-called internal models is the most commonly described hypothesis of DCD. Indeed, children with DCD exhibit difficulties in predictive control. Internal models, useful for motor control, are closely related to the sensory system, as they are elaborated on and constantly fed by sensory feedback. Deficits in sensory performance are described in DCD, mostly in the visual system, which could in turn partly explain poor motor performance. However, visuo-perceptual deficits cannot explain the entire motor difficulties because some activities in daily life, as buttoning a shirt, are often performed without visual control. Although the integrity of proprioceptive and tactile systems is necessary for the building of internal models, and therefore for a stable motor control, these sensory systems have been very little investigated in DCD.

Moreover, using a tool is often disturbed in children with DCD. In neurotypical subjects, tool use induces a plasticity of body representation, as reflected by modifications of movement kinematics after tool use. Proprioceptive abilities are necessary for this update of the body schema. Thus, potential deficits of the proprioceptive system in children with DCD could impair the plastic modification of the body schema, and hence of motor performance, when using a tool. The aim of this study is to identify the main cause of the DCD, both by evaluating the tactile and proprioceptive abilities and by assessing the body schema updating abilities in children with DCD.

While some daily life activities improve with age, some motor difficulties persist in adults with DCD. To our knowledge, perceptual abilities have never been investigated in adults with DCD and it is thus unknown whether perceptual deficits are still present in adulthood. This information could allow us to understand if motor difficulties in adult DCD are caused by enduring perceptual deficits and/or impaired plasticity of body schema. The second aim of this study is to evaluate abilities of perception and of body schema plasticity in adults with DCD.

location_facility: Equipe IMPACT du CRNL INSERM U1028, CNRS UMR 5292

intervention_type: Behavioral


title: Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score

summary: This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery.

time_perspective: Retrospective


title: Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)

acronym: STROKAO

summary:
The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia.

Adaptive optics (AO) reveals retinal details that remain invisible with other current imaging techniques. Indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary.

In AO, studies on retinal vessels involve the calculation of wall thickness (WT), outer diameter (OD), inner diameter (ID), wall cross-sectional area (WCSA) and wall to lumen ratio (WLR). An increase in WLR > 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. This accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. For vessels > 300 microns in diameter, the increase in vessel wall thickness occurs without changing the ID, a process known as external hypertrophic remodeling. For small arteries < 300 microns, remodeling occurs differently. The total volume of the vessel wall remains constant, but the OD and ID each decrease, a process known as inward eutrophic remodeling.

The objective of this study is to describe the parameters measured in AO in patients in the acute phase of a stroke and then at 3 months.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Procedure


title: ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging

acronym: Adodream

summary: To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
European Clinical Trial Experts Network


title: Retro-prospective and Observational Study of 120 Patients for the Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

summary:
Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. Revision risk factors reported when considering the main surgical approaches. Studied from the Dutch arthroplasty registry found a revision rate in hemiarthroplasty (HA) of 1.6% at 1 year and 2.5% at 5 years postoperatively. For total hip replacement (THA), the rate was 2.4% at 1 and 4.3% at 5 years postoperatively. Analyze shows that the risk factors for hemiarthroplasty were male sex, age under 80 (regardless of gender), posterolateral approach and uncemented fixation. The risk factors for HAT were exactly the same, but they found that smoking also played a role. It should be noted that age as a risk factor for revision is not a risk during the first year after the fracture, but becomes one in the years that follow.

In order to maintain compliance with the directive on medical devices (93/42 / EEC [M5]) and the future regulation (EU) (2017/745) relating to medical devices, SERF has set up post-market clinical follow-ups ( PMCF). This PMCF study aims to improve knowledge related to the performance, safety and benefit / risk ratio of the Sagitta EVL-R stem and to monitor patient care strategy through this clinical evaluation. Significant clinical results as well as safety must be confirmed with this patient cohort. It is important to note that this cohort reflects the specific care strategy of the University Hospital of Poitiers. Therefore, the strategy could be different between hospitals and countries.

time_perspective: Other

ReferenceType: background

ReferenceCitation: Delaunay C, Epinette JA, Dawson J, Murray D, Jolles BM. Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population. Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. doi: 10.1016/j.otsr.2009.01.003. Epub 2009 Apr 3.

ReferenceCitation: Girard J, Roche O, Wavreille G, Canovas F, Le Beguec P. Stem subsidence after total hip revision: 183 cases at 5.9 years follow-up. Orthop Traumatol Surg Res. 2011 Apr;97(2):121-6. doi: 10.1016/j.otsr.2010.10.006. Epub 2011 Mar 23.

ReferenceCitation: Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141.

ReferenceCitation: Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6.

ReferenceCitation: Tangsataporn S, Safir OA, Vincent AD, Abdelbary H, Gross AE, Kuzyk PR. Risk Factors for Subsidence of a Modular Tapered Femoral Stem Used for Revision Total Hip Arthroplasty. J Arthroplasty. 2015 Jun;30(6):1030-4. doi: 10.1016/j.arth.2015.01.009. Epub 2015 Jan 21.

lead_sponsor: Societe dEtude, de Recherche et de Fabrication


title: Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.

summary: The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.

lead_sponsor: NexStep Medical


title: Study of the Inflammatory Response to Enterovirus Meningitis in Newborns, Infants and Children, as Assessed by Cytokine Levels in Blood and Cerebrospinal Fluid. Case-control Comparison Using an Existing Cohort.

acronym: Bledi-Cytokine

summary:
Enteroviruses (EV) are the most frequent cause of acute meningitis in the paediatric population. Detection of enterovirus in cerebrospinal fluid (CSF) specimens by Polymerase Chain Reaction (PCR) is the gold standard diagnostic test. Recently, our laboratory published the BLEDI study which highlighted the interest of detecting EV in the blood of the paediatric population : (i) EV was found in more than a quarter of cases in the blood of infants admitted to hospital with isolated fever and (ii) detection of EV was more frequent in the blood than in CSF in neonates and infants with isolated fever, sepsis or meningitis. However, the pathophysiology of EV infections is poorly understood and little work has been done on the inflammatory response to these infections. In EV meningitis, the inflammatory response has been studied primarily in children infected with enterovirus A71 (EV-A71). Indeed, in these children, inappropriate cytokine secretion (cytokine storm) leads to severe neurological and cardiopulmonary damage, which can progress to death. The study of the inflammatory response during meningitis due to other types of EV remains poorly

The objective of BLEDI-CYTOKINES (ancillary study of the BLEDI study) is to study the inflammatory response during EV meningitis in neonates, infants and children, as assessed by cytokine levels in blood and cerebrospinal fluid, by comparing case-controls from an existing cohort.

ReferenceCitation: Lafolie J, Labbe A, L'Honneur AS, Madhi F, Pereira B, Decobert M, Adam MN, Gouraud F, Faibis F, Arditty F, Marque-Juillet S, Guitteny MA, Lagathu G, Verdan M, Rozenberg F, Mirand A, Peigue-Lafeuille H, Henquell C, Bailly JL, Archimbaud C; Blood Enterovirus Diagnosis Infection (BLEDI) in paediatric population study team. Assessment of blood enterovirus PCR testing in paediatric populations with fever without source, sepsis-like disease, or suspected meningitis: a prospective, multicentre, observational cohort study. Lancet Infect Dis. 2018 Dec;18(12):1385-1396. doi: 10.1016/S1473-3099(18)30479-1. Epub 2018 Oct 30.

collaborators: Laboratory of virology, National Enterovirus and parechovirus Reference Center, University Hospital of Clermont-Ferrand


title: Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery

summary: The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation Clinique et Cyto-histologique du Traitement Laser CO2 fractionné Sur Les Syndromes Génito-Urinaires de la Ménopause liés à l'Atrophie Vaginale

acronym: ATROVENANS

summary:
Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned.

The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.

status: Active, not recruiting

lead_sponsor: Hopital Nord Franche-Comte


title: Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer

summary:
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.

The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.

The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.

lead_sponsor: Institut de Cancérologie de Lorraine

sponsor_collaborators:
Institut de Cancérologie de Lorraine
Vitadx


type: Registry Identifier

title: Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction

acronym: ANGIOPAG

summary: The main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR.


title: Evaluation of the Dental Movements Caused by Oral Appliance in Syndrome Sleep Apnea Syndrome(DPOAM)

acronym: DPOAM

summary:
The DO OAM study is a mono-center, interventional, prospective study carried out in CH VALENCE.

It will estimate the prevalence of dental movements in patients treated by oral Appliance for Sleep Apnea syndrome.

The investigators will used fingerprinting technique by taking multiple photographs of the teeth that allow for the three-dimensional reconstruction of the teeth

this study will provide a better understanding of dental movement caused by oral appliance

lead_sponsor: Centre Hospitalier de Valence

sponsor_collaborators:
Centre Hospitalier de Valence
Claude Bernard University


title: Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively: Patients Operated on the Dominant Side vs. Patients Operated on the Non-dominant Side vs. Healthy Controls

acronym: Dom Lat

summary: The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.


title: Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler

acronym: ACTIFER

summary: The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.


title: Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis

acronym: AMYLOCARP

summary: This study is based on the hypothesis that MRI could make it possible to non-invasively detect these amyloid deposits at the level of the wrist using parametric sequences known as T1 mapping, in the form of an extension of T1 in the wrists. areas where amyloid deposits are found in the wrist.

primary_purpose: Screening


title: Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults

acronym: SURDICOG

summary: A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.

ipd_sharing_description: All data will be collected and analysed into the GH Pitié-Salpêtrière (AP-HP)

location_facility: Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière


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

acronym: ARG-BP

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

lead_sponsor: Saint-Gregoire Private Hospital Center


title: Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.

acronym: MALROT

summary:
Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels

ipd_sharing_description: NC


title: Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions

acronym: IRM SAOS

summary: The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.

lead_sponsor: CHU de Reims


title: Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial

acronym: IMPROVED

summary:
Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.

The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.

collaborators: Federation of Research in Surgery (FRENCH)

collaborators: PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou


type: EudraCT Number

title: A Randomized, Open-label, 3-period, Single-dose, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of GLPG3970 Given as an Oral Tablet Formulation Versus the Oral Solution Formulation of GLPG3970 and to Assess the Effect of Food on the Oral Tablet Formulation.

summary: This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.

lead_sponsor: Galapagos NV


title: Protocol for the Collection of Clinical Samples for Evaluation and Implementation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

acronym: SeroCOV

summary:
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months.

In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.

lead_sponsor: University Hospital, Rouen


title: MRI Exploration of Meningeal Inflammatory Disease

acronym: EIME

summary:
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which two additional sequences of 6 minutes duration will be added.

The MRI of routine care includes at least the following sequences:

3D T1 TFE 1.0 isotropic (2 minutes)
T2 TSE (2 minutes)
3D FLAIR pre-injection (opt) (3 minutes)
3D FLAIR post-injection (3 minutes)

As part of the research, the following sequences will be acquired:

FABIR pre-injection (3 minutes)
FABIR post-injection (3 minutes)

Patients hospitalized for a foreseeable duration of at least 24 hours will be offered participation in the longitudinal tab of the study, for which four non-injected MRI examinations will be performed. The examinations will be carried out remotely from the injected MRI (1h, 2h, 12h-15h, 24h-36h). These exams dedicated to research will include the following sequences for a maximum of 8 minutes:

3D T1 TFE 1.0 isotropic (2 minutes)
3D FLAIR (3 minutes)
FABIR (3 minutes)

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild


title: Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study

acronym: REPOPREGARD

summary:
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:

To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule

To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule

lead_sponsor: University Hospital, Clermont-Ferrand


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

acronym: EPERICARDIM

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


title: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus

acronym: HEMATOPLUS

summary: Accelerated atherosclerosis in patients with systemic lupus erythematosus (SLE) is not fully explained by Framingham risk factors. The detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (CHIP) - predisposes to cardiovascular events (CVE) in general population. We aimed to determine whether CHIP is associated with CVE in SLE.

ReferenceType: derived

ReferenceCitation: David C, Duployez N, Eloy P, Belhadi D, Chezel J, Guern VL, Laouenan C, Fenwarth L, Rouzaud D, Mathian A, de Almeida Chaves S, Duhaut P, Fain O, Galicier L, Ghillani-Dalbin P, Kahn JE, Morel N, Perard L, Pha M, Sarrot-Reynauld F, Aumaitre O, Chasset F, Limal N, Desmurs-Clavel H, Ackermann F, Amoura Z, Papo T, Preudhomme C, Costedoat-Chalumeau N, Sacre K. Clonal haematopoiesis of indeterminate potential and cardiovascular events in systemic lupus erythematosus (HEMATOPLUS study). Rheumatology (Oxford). 2022 Nov 2;61(11):4355-4363. doi: 10.1093/rheumatology/keac108.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: submittedVersion

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pr Nathalie COSTEDOAT-CHALUMEAU


title: Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

acronym: PWV follow-up

summary:
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

ReferenceCitation: Bironneau V, Tamisier R, Trzepizur W, Andriantsitohaina R, Berger M, Goupil F, Joyeux-Faure M, Jullian-Desayes I, Launois S, Le Vaillant M, Martinez MC, Roche F, Pepin JL, Gagnadoux F. Sleep apnoea and endothelial dysfunction: An individual patient data meta-analysis. Sleep Med Rev. 2020 Aug;52:101309. doi: 10.1016/j.smrv.2020.101309. Epub 2020 Mar 13.

lead_sponsor: University Hospital, Grenoble


title: Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care

acronym: COMEBAC

summary: To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia


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

acronym: COMBAT

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

ReferenceCitation: Loupy A, Lefaucheur C. Antibody-Mediated Rejection of Solid-Organ Allografts. N Engl J Med. 2018 Sep 20;379(12):1150-1160. doi: 10.1056/NEJMra1802677. No abstract available.

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

ReferenceCitation: Wiebe C, Tambur A, Nickerson PW. A call to action-The transplant recipient's expectation of precision in transplant medicine. Am J Transplant. 2018 Dec;18(12):2845-2846. doi: 10.1111/ajt.15027. Epub 2018 Aug 13. No abstract available.

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

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

ReferenceCitation: Formica RN Jr, Kulkarni S. Being Thoughtful about Desensitization. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1878-1880. doi: 10.2215/CJN.09000817. Epub 2017 Oct 3. No abstract available.

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

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

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

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

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

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

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

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

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

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

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

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

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

version: publishedVersion

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

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

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

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

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

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

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

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

sponsor_collaborators:
University Hospital, Grenoble
Bristol-Myers Squibb

intervention_type: Combination Product


title: Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions

summary:
The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia).

Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.

lead_sponsor: Poitiers University Hospital


title: Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM

acronym: COGEM

summary:
The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure.

The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.

lead_sponsor: University Hospital, Montpellier


title: Assessment of Visual and Refractive Results, and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery: a Prospective Cohort Study - STATE

acronym: STATE

summary:
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.

The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson & Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.

No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines Using Delphi Consensus Statement

summary: French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Because several systemic treatments have been marketed since then, new guidelines are mandatory. The aim of this study coordinated by the Centre of Evidence of the French Society of Dermatology is to update the available French guidelines using a Delphi method.

ReferenceType: result

ReferenceCitation: Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.

oa_colors: green hybrid

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Wiley


title: Evaluation of the Performance of COVIDISC Rapid Test for Diagnosis of SARS-CoV-2

acronym: COVIDISC

summary:
The Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours.

Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP).

The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%).

The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.

lead_sponsor: CMC Ambroise Paré


title: Neonatal Precursors of Neurodevelopment

acronym: NEOPRENE

summary: The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.

lead_sponsor: University Hospital, Caen


title: Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies

acronym: GEN-HEMO-INF

summary:
Patients with monoclonal gammopathies either benign or malignant may develop inflammatory symptoms such as Schnitzler syndrome. We proposed to name those cases as monoclonal gammopathy of inflammatory significance, or MGIS.

The aim of the study is to search for inflammatory pathway that may be activated in case MGIS and to search if the genetic of tumoral cell could explain those activations.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM UMR 1163


title: Modifications Electrophysiologiques et de la Pulsatilité Cérébrale à la détection de Stimuli Nouveaux (Electro-PulCe)

acronym: Electro-Pulce

summary:
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of standard stimuli.

Other studies have recently suggested that, in addition to neuronal activation, certain other physiological processes related to cerebrovascular reactivity, such as the Brain Tissue Pulsatility (BTP), could also be sensitive to various cognitive processes and in particular to attentional processes.

In one of the latest studies published in collaboration with our group, it was shown that the amplitude of the electrophysiological response classically associated with attentional activity (P300 wave) was significantly correlated with the amplitude of BTP, suggesting the involvement of cerebrovascular processes in attentional functions. Nevertheless, in this study, the two methods of EEG and Tissue Pulsatility Imaging (TPI) were not synchronized, since TPI was performed at rest and not during the oddball task itself, and to date no study has sought to couple the methods of EEG and ultrasound TPI in an oddball paradigm, for a simultaneous characterization of neuronal and cerebrovascular responsiveness during attentional processes.

The general objective of this study will be to evaluate changes in BTP during the detection of novel stimuli in an oddball task in healthy volunteers, in which the two methods of TPI and EEG will be coupled and synchronized.

lead_sponsor: University Hospital, Tours

location_facility: Paedopsychiatry department, University Hospital, Tours


title: Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders

acronym: DEMUse

summary:
Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.

However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.

primary_purpose: Supportive Care

lead_sponsor: Hospices Civils de Lyon


title: Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty

acronym: game-ready

summary: The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint

lead_sponsor: Clinique Bizet


title: Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff

acronym: ESHABC

summary: Its a prospective, non-interventional, single-center study, involving the human person evaluating the impact of self-hypnosis training on anxiety level and burn out in nursing and medical staff

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital

summary: The investigators aimed to identify prognosis factors associated with in-hospital complications and assess the epidemiology, management, and outcomes of community-acquired pneumonia in a kidney transplant recipients' cohort. The investigators intend to identify each stay by a national database. Then they will be consulted by 2 clinicians to assert CAP clinical definition. After that radiographic evidence will be reviewed to validate CAP diagnoses. Then clinical data are collected in each center.


title: A Retrospective Study Using Mass Spectrometry to Characterize Post-translational Modifications to Circulating Histones in Pregnant Women Developing Pre-eclampsia

acronym: GHISPE

summary:
This is a descriptive pilot study on a ready-constituted biobank (outside the Jardé Law). It is an ancillary study to the "GrossPath" cohort (RCB ID number: 2014-A01120-47).

Pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies responsible for significant maternal-fetal morbidity and mortality. Understanding and exploring the cellular and molecular mechanisms of dysfunctions of the vascular-placental interface could provide arguments to understand the systemic vascular risk, characterize it and finally detect it on the basis of new markers, thus opening the way for targeted preventive management to reinforce the general principles of precision medicine.

Netosis is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Netosis occurs in pregnancy and is increased in vascular-placental complications. It can be studied by measuring circulating histones, particularly the citrullinated histone H3. Levels of this modified histone H3, as well as those of two other modifications, have recently been shown to increase during pregnancy. These levels have also been shown to be even greater in pregnancy complications.

The aim of this study is to complete this mapping in order to obtain a precise signature for all post-translational histone modifications in normal pregnancies and pregnancies complicated by pre-eclampsia from the "GrossPath" cohort in order to propose new circulating biomarkers for placental vascular pathologies.

The post-translational histone modification profiles (mapping) of pregnant women with normal pregnancies will be compared with those developing pre-eclampsia.

ipd_sharing_description:
All data collection and management will be carried out by the BESPIM (Biostatistique, Epidémiologie clinique, Santé Publique & Innovation en Méthodologie).

The conditions of transfer of all or part of the research database are decided by the principal investigator and the research sponsor and are the subject of a written contract.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Fall Risk Assessment in a Population of Charcot-Marie-Tooth Disease Type 1A (CMT 1A) by Timed Up and Go Test

acronym: DeteCTCMT

summary:
The main objective of this study is to explore the relationship between the onset of fall and the time taken to complete the Timed Up and Go test (TUG) in this CMT1A patient population.

The investigators hypothesize that patients with balance disorders and therefore a risk of major fall will require a longer time to perform the Timed Up and Go test. In addition, it seems important to confirm that the severity of the disease has a negative impact on the frequency of balance disorders.

ReferenceCitation: Reilly MM, Shy ME, Muntoni F, Pareyson D. 168th ENMC International Workshop: outcome measures and clinical trials in Charcot-Marie-Tooth disease (CMT). Neuromuscul Disord. 2010 Dec;20(12):839-46. doi: 10.1016/j.nmd.2010.08.001. Epub 2010 Sep 17. No abstract available.

ReferenceCitation: Ramdharry GM, Thornhill A, Mein G, Reilly MM, Marsden JF. Exploring the experience of fatigue in people with Charcot-Marie-Tooth disease. Neuromuscul Disord. 2012 Dec;22 Suppl 3:S208-13. doi: 10.1016/j.nmd.2012.10.016.

ReferenceCitation: Ribiere C, Bernardin M, Sacconi S, Delmont E, Fournier-Mehouas M, Rauscent H, Benchortane M, Staccini P, Lanteri-Minet M, Desnuelle C. Pain assessment in Charcot-Marie-Tooth (CMT) disease. Ann Phys Rehabil Med. 2012 Apr;55(3):160-73. doi: 10.1016/j.rehab.2012.02.005. Epub 2012 Mar 6. English, French.

ReferenceCitation: Reynaud V, Muti D, Pereira B, Greil A, Caillaud D, Richard R, Coudeyre E, Costes F. A TUG Value Longer Than 11 s Predicts Fall Risk at 6-Month in Individuals with COPD. J Clin Med. 2019 Oct 22;8(10):1752. doi: 10.3390/jcm8101752.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

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

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ReferenceCitation: Anens E, Emtner M, Hellstrom K. Exploratory study of physical activity in persons with Charcot-Marie-Tooth disease. Arch Phys Med Rehabil. 2015 Feb;96(2):260-8. doi: 10.1016/j.apmr.2014.09.013. Epub 2014 Oct 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier


title: Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)

acronym: STEPPER

summary: The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients

lead_sponsor: Lille Catholic University


title: Identification of the Determinants of the Perceived Workload of Intensive Care and Pediatric Continuous Monitoring Nurses

acronym: CHARMIREA

summary: The purpose of this study is to identify the determinants of the perceived workload of intensive care and pediatric continuous monitoring nurses (factors liked to the care service, staff, patients treated)

ReferenceCitation: Lebet RM, Hasbani NR, Sisko MT, Agus MSD, Nadkarni VM, Wypij D, Curley MAQ. Nurses' Perceptions of Workload Burden in Pediatric Critical Care. Am J Crit Care. 2021 Jan 1;30(1):27-35. doi: 10.4037/ajcc2021725.

ReferenceCitation: Helmreich RL. On error management: lessons from aviation. BMJ. 2000 Mar 18;320(7237):781-5. doi: 10.1136/bmj.320.7237.781. No abstract available.

ReferenceCitation: Llenore E, Ogle KR. Nurse-patient communication in the intensive care unit: a review of the literature. Aust Crit Care. 1999 Dec;12(4):142-5. doi: 10.1016/s1036-7314(99)70599-0.

ReferenceCitation: Gurses AP, Carayon P, Wall M. Impact of performance obstacles on intensive care nurses' workload, perceived quality and safety of care, and quality of working life. Health Serv Res. 2009 Apr;44(2 Pt 1):422-43. doi: 10.1111/j.1475-6773.2008.00934.x. Epub 2008 Dec 16.

ReferenceCitation: Nasirizad Moghadam K, Chehrzad MM, Reza Masouleh S, Maleki M, Mardani A, Atharyan S, Harding C. Nursing physical workload and mental workload in intensive care units: Are they related? Nurs Open. 2021 Jul;8(4):1625-1633. doi: 10.1002/nop2.785. Epub 2021 Feb 17.

ReferenceCitation: Young G, Zavelina L, Hooper V. Assessment of workload using NASA Task Load Index in perianesthesia nursing. J Perianesth Nurs. 2008 Apr;23(2):102-10. doi: 10.1016/j.jopan.2008.01.008.

ReferenceCitation: Tubbs-Cooley HL, Mara CA, Carle AC, Gurses AP. The NASA Task Load Index as a measure of overall workload among neonatal, paediatric and adult intensive care nurses. Intensive Crit Care Nurs. 2018 Jun;46:64-69. doi: 10.1016/j.iccn.2018.01.004. Epub 2018 Feb 12.


title: Post-Stroke Medication Relay

acronym: REMEDIPA

summary:
Prior to discharge from hospital and return home, patients managed for ischemic stroke will receive a pharmaceutical interview to discuss their discharge prescription (indication, method of administration, precautions, and possible side effects).

Improvements in the use of medications in the community and in hospital follow-up.

Telephone interviews or teleconsultations will make it possible to assess the patient's knowledge of his or her treatment and to re-explain it if necessary to improve patient compliance with treatment.

location_facility: Service de Neurologie Vasculaire, Unité 201 Hôpital Neurologique Pierre Wertheimer, HCL


title: BREGS - IL-2 Signaling and Polarization of Regulatory LBs: Involvement in Multiple Sclerosis

acronym: BREGS

summary:
Multiple sclerosis (MS) has long been considered a disease mediated primarily by CD4+ T cells. However, recent clinical trials demonstrating significant efficacy of B-lymphocyte depletive therapies have highlighted the major role of this cell population in the development of MS. Among B-Ls, regulatory ("anti-inflammatory") B-Ls (Bregs) have protective functions in autoimmune diseases including MS, however the mechanisms that regulate the development and function of Bregs are poorly characterized. In our research laboratory (INSERM UMR1236), one of the lines of research focuses on the role of interleukin-2 (IL-2) signaling in the fate of the B lymphocyte. Numerous studies conducted in both human and mouse models of MS demonstrate the major role of this IL-2/IL2R signaling pathway in the pathogenesis of autoimmune diseases.

The hypothesis is that IL-2/IL2R pathway could contribute, by a mechanism intrinsic to B lymphocytes, to the development of autoimmune diseases such as MS.

While a defect in IL-2 signaling plays a critical role in the pathogenesis of MS, the impact of this defective signaling on regulatory B lymphocyte populations, which has been shown to play a protective role in the development of the disease, has never been studied. This study could help establish a new mechanism predisposing patients to develop the disease.

lead_sponsor: Rennes University Hospital


title: Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)

acronym: FNIRS

summary:
Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants.

Hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS.

The use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Fondation William Demant


title: Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)

acronym: CTCO

summary:
Head and neck cancers (HNSCC) are primarily squamous cell cancers represented by tumors of the upper aerodigestive tract. Locally advanced stages (stages III and IV) account for 50 to 70% of all presentations. The three main risk factors are smoking, alcohol and oropharyngeal infection with human papilloma virus (HPV).

Apart from HPV status, there is no biomarker for the prognosis in HSNCC patients. Circulating Tumor Cells (CTCs) can provide "real-time" information on tumor behavior and are already used in various cancers (colon, lung). Their detection has limited sensitivity and biomarkers cannot be used for early diagnosis, but may be useful during follow-up to assess local, regional or metastatic early tumor recurrence.

By using blood samples at different times (at diagnosis, after initial treatment and during follow-up), we will be able to measure the variation in quantification and establish a predictive role of these CTCs for the response to treatment.

Our hypothesis is that CTCs may have a key role, in addition to clinical and radiological examination, in detecting early tumor relapse.

We believe that the joint consideration of clinical parameters, treatment strategy and quantification of CTCs could optimize patient follow-up and management.

The CTC extraction system, ClearCell® FX from Biolidics, is an automated microfluidic enrichment system. It has the advantage of recovering fully intact and viable CTCs from a standard blood sample. The gentle sorting principle allows to preserve cell integrity and thus the expression of surface antigens. The CTCs thus isolated can then be re-cultured or analyzed by immunostaining. This high-performance technique, in operation since December 2017 in the Biochemistry Department of Pr Claire Rodriguez-Lafrasse (HCL), has demonstrated its usefulness in lung cancer.

Transcriptomic analysis of CTCs can be performed at the scale of a cell after isolation of the CTCs. CTCs can then be sequenced in RNAseq either in bulk (pool of cells) or cell by cell on our Illumina (Nextseq) sequencer, in order to define the heterogeneity of the tumor. Transcriptome analysis then provides information on the state of the cell as to its position in the epithelio-mesenchymal transition thanks to a molecular signature by phenotype. A priori-free characterization is therefore possible thanks to the RNAseq single-cell. This highly sensitive and innovative technique will allow the study of the gene expression profile of CTCs.

location_facility: Service ORL Chirurgie Cervico-faciale (Pr Philippe CERUSE)


title: Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)

summary:
The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).

The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.

lead_sponsor: Adeline BLOT

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

intervention_type: Dietary Supplement


title: Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma

acronym: SIMILY

summary:
This trial is a translational, prospective, open-label, monocentric research.

The study will be conducted in a population of 60 patients with diffuse large B-cell lymphoma (DLBCL) for whom first-line treatment with R-CHOP is planned as part of their standard of care.

SIMILY program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during R-CHOP, and at 24 months or time of progression.

Each patient will be followed during 2 years.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
AstraZeneca

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Mercuri Analysis Contribution on Handicap Evaluation in ArthrogypOsis, a Congenital Neuromuscular Disease

acronym: MACHAON

summary: The aim is to evaluate the correlation of quantified fibro-adipous infiltration of muscles, using the MRI-based Mercuri score, with deficiencies, activity limitations and social participation in patients with arthrogryposis multiplex congenita.

ReferenceCitation: Liu CY, Yao J, Kovacs WC, Shrader JA, Joe G, Ouwerkerk R, Mankodi AK, Gahl WA, Summers RM, Carrillo N. Skeletal Muscle Magnetic Resonance Biomarkers in GNE Myopathy. Neurology. 2021 Feb 2;96(5):e798-e808. doi: 10.1212/WNL.0000000000011231. Epub 2020 Nov 20.

ReferenceCitation: Hall JG. Arthrogryposis multiplex congenita: etiology, genetics, classification, diagnostic approach, and general aspects. J Pediatr Orthop B. 1997 Jul;6(3):159-66.

ReferenceCitation: Mercuri E, Pichiecchio A, Counsell S, Allsop J, Cini C, Jungbluth H, Uggetti C, Bydder G. A short protocol for muscle MRI in children with muscular dystrophies. Eur J Paediatr Neurol. 2002;6(6):305-7. doi: 10.1016/s1090-3798(02)90617-3.

ReferenceCitation: Figueroa-Bonaparte S, Segovia S, Llauger J, Belmonte I, Pedrosa I, Alejaldre A, Mayos M, Suarez-Cuartin G, Gallardo E, Illa I, Diaz-Manera J; Spanish Pompe Study Group. Muscle MRI Findings in Childhood/Adult Onset Pompe Disease Correlate with Muscle Function. PLoS One. 2016 Oct 6;11(10):e0163493. doi: 10.1371/journal.pone.0163493. eCollection 2016.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

ReferenceCitation: Dai S, Dieterich K, Jaeger M, Wuyam B, Jouk PS, Perennou D. Disability in adults with arthrogryposis is severe, partly invisible, and varies by genotype. Neurology. 2018 May 1;90(18):e1596-e1604. doi: 10.1212/WNL.0000000000005418. Epub 2018 Apr 6.

publisher_dissemination: Wolters Kluwer Health


title: Psychiatry and Individual Liberties: a Study of Institutions Characterized by a Reduced Use of Coercion

acronym: (PLAID-Care)

summary: Psychiatric establishments show significant disparities in terms of coercion: while some use it frequently, others use it only exceptionally. This project aims at a better understanding of the less coercive establishments, which are currently little investigated and whose study may allow to identify the levers of a psychiatry more respectful of individual liberties.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: École Nationale des Solidarités, de l'Encadrement et de l'Intervention Sociale (ENSEIS)


title: Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.

acronym: CLIO

summary:
In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.

Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

acronym: LISRACC

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

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

acronym: OPM

summary:
This research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers.

The measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. It is the only one, along with EEG and related techniques, to provide data related to the speed of the brain. MEG, by virtue of the properties of magnetic fields, has a greater potential than EEG for the detection and localization of the neuronal sources which cause it.

The MEG sensors used until now use Superconducting Quantum Interference Devices (SQUID) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost.

The alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type.

This preliminary study proposes to compare SQUID sensors with MPO He4 sensors for their ability to detect abnormal activities recorded in epileptic patients. Measurements that cannot be recorded simultaneously Two types of measurement will be compared with the reference that constitutes in-depth recording (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

The expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of SQUIDs.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM