title: Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne

acronym: ScreenStaph

summary:
The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection, notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce the rate of S. aureus infection in this category of patients although the risk of emergence of antimicrobial resistance persists. Approximately one quarter of the general population is colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main categories of nasal carriers have been historically identified: persistent carriers (20%, 12-30%]), intermittent carriers (30%, [16-70%]) and non-carriers (50% [16-69%]). By contrast to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of S. aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery.

Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the carried strain. However, there is no consensual definition of this persistent carriage state. In previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from 5 weeks to 8 years. The index of carriage, corresponding to the number of samples positive for S. aureus divided by the total number of samples, has been proposed to standardize the definition of the carriage state. According to standard tools, it is almost impossible to determine the nasal carriage state in routine practice.

Recently, an algorithm based on one or two quantitative cultures from nasal samples taken within 2 days that was able to distinguish accurately persistent and non-persistent nasal carriers of S. aureus has been described; only one nasal sample was needed in more than 9 cases out of 10. The aim of the present study was to assess prospectively the reliability of this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to check its ability for identifying patients with the highest risk of S. aureus infection


title: Identification of Early Semantic Markers of Alzheimer's Disease by Using Eye Tracking in Reading Neutral and Predictable Sentences

acronym: ADAL

summary: The objective of this study is to identify early and accurate semantics markers of Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate semantic processing of patients with AD or related disorders which will be compared to age matched controls by taking neuropsychological tests. Then, the investigator will analyze the effect of contextual word predictability on eye movements in reading sentences with the help of the same participants by using an eye tracker. Both of these methods will be used twice with a time interval of 6 months.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Unknown


title: Immunization Anti HLA in the Liver Transplant Recipients (DSATH)

acronym: DSATH

summary:
Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to dysfunction and graft loss , especially among candidates for retransplantation, that have major immunization.

This study will analyzed immunization markers at the time of liver retransplantation and systematically in patients follow-up. This will allow to characterize the histological lesions due to humoral immunization, to establish further investigations and to adapt early immunosuppressive therapy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Unité Médicale de Transplantation Hépatique In Service d'Hépato-Gastro-Entérologie

intervention_type: Biological


type: EudraCT Number

title: Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Rituximab in Combination With Corticosteroids to Corticosteroids Plus Placebo in the Treatment of Non-infectious Active Mixed Cryoglobulinemia Vasculitis

acronym: ESBAM

summary: Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in combination with corticosteroids to corticosteroids plus placebo in the treatment of non-infectious active mixed cryoglobulinemia vasculitis.

status: Terminated

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

intervention_type: Drug


title: Impact of Two Standardized Clinical Care Protocols on Pregnancy Outcomes in Women With Monogenic Diabetes MODY2

summary:
Maturity-onset diabetes of youth (MODY) are the most frequent monogenic diabetes with autosomic dominant inheritance (2% of diabetes). The MODY2 diabetes is related to a defect in the glucokinase (GCK) enzyme, the first limiting step of insulin secretion. An abnormal GCK leads to a delayed insulin secretion. Patients with GCK mutations have only mild raised fasting plasma glucose. Treatment is usually unnecessary since hyperglycemia is stable and MODY2 patients have no microvascular complications of diabetes. In contrast, pregnancy in MODY2 women is a challenging situation. A non-mutated fetus will produce excess insulin in response to raised maternal blood glucose leading to an accelerated growth and a higher risk of macrosomia. The mother of non-mutated fetus should therefore be treated to normalize her blood glucose levels. On contrary, a mutated fetus will produce a delayed insulin secretion (as his MODY2 mother) in response to maternal hyperglycemia. Consequently insulin therapy during pregnancy would reduce fetal insulin secretion and result in a low birth weight.

Moreover, insulin therapy exposes pregnant women to more labor induction, prematurity and cesarean deliveries. In these MODY2 women whose glucose set point is physiologically higher, glycemic goals are difficult to achieve while often requiring extensive insulin therapy. An optimal situation would consist in initiating insulin therapy only for women with non-mutated offsprings. Unfortunately no antenatal diagnosis of the GCK mutation on fetal cells is available yet. In literature, birth weight differences between mutated and non-mutated neonates may reach up to 700g. In clinical practice, two strategies are used but without standardized protocol on glycemic targets, delay and doses of insulin : 1) insulin at diagnosis of pregnancy 2) treatment based on fetal abdominal circumference and fetal weight measurements by ultrasonography (US) and initiated if fetal biometry is greater than the 75th percentile.

The purpose of the study is to evaluate for the first time these two management strategies through a prospective and standardized study. Hypothesis: US assessment would be sufficient to identify fetuses at risk of macrosomia and to initiate insulin treatment in mothers.

status: Completed

primary_purpose: Other

intervention_type: Other

status_simplified: Completed


title: In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients

acronym: MiPECSE

summary:
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. The alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease.

In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease.

The confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. This technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. After injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ.

The characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.

lead_sponsor: University Hospital, Rouen

intervention_type: Device


title: Predicted Level of General Anaesthesia in Hip Fracture Surgery

acronym: NAPfem

summary: The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Leblanc D, Conté M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chrétien JM, Rony L, Rineau E, Lasocki S. SmartPilot® view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. 2017 Nov 1;119(5):1022-1029. doi: 10.1093/bja/aex317.

lead_sponsor: University Hospital, Angers


title: Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes

acronym: IMMUNEREP

summary:
The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.

The most "spectacular" consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).

The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.

The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.

study_type: Observational

time_perspective: Prospective


title: Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

acronym: VIRIDAE

summary: A recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. The aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. In particular, will be studied whether these drugs can induce virus reactivation "dormant" in the immune system. This study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.


title: PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III

acronym: CTC

summary:
After curative surgical resection, detection of metastatic lymph node remains the main prognostic validated criteria on which is based the decision of adjuvant therapy. To date, none of the molecular alterations, identified as potentially predictive factor, are used in routine for therapeutic decision. The circulating markers, either in the form of free circulating DNA or in the form of circulating tumoral cells seems important potential candidates. To investigators knowledge, only one study estimated with several interesting results the prognostic interest of a coupled detection of the free circulating mutant DNA (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain however difficult to achieve because of the small number of patient included (n=58) and the fact that this study included different stages. For colorectal cancer a Chinese team presented a series of results suggesting that the presence of CTC during the postoperative course is a factor significantly related to the risk of recurrence. In multivariate analysis integrating the lymph node status and the vascular invasion, the presence of CTC appeared as an independent factor for recurrence with a hazard ratio of 29.5.

The aim of the present study is to compare the prognostic value of two circulating tumoral markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA and circulating tumoral cells in localised colorectal cancer.


acronym: ALINEA

title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory Choroidal Neovascularization (CNV) in Young Patients.

lead_sponsor: Hospices Civils de Lyon

source: euctr

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

summary:
Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed.

InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need as many injections as in AMD.

ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. The first injection is mandatory. The other ones are injected only in case of active InCNV.


title: Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy

acronym: TRANSPLANTEETs

summary:
Endothelial lesions within the transplanted kidney are a major determinant of chronic allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.

The main goal of the investigators' study is to evaluate whether genetic polymorphisms of specific enzymes responsible for the bioavailability of EETs are associated with post-transplant kidney function.

To this end, 80 kidney transplant recipients will be included. Prespecified genetic polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined. Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated dilatation, EETs and circulating biomarkers of endothelial function will be measured in the radial artery.

The expected results of this study to provide preliminary evidence supporting a beneficial role of an increase in the bioavailability of EETs in kidney transplant recipients.

intervention_type: Procedure


title: Validation of the French Version of the London Chest Activity of Daily Living Scale (LCADL) and the Dyspnea-12 Questionnaire

acronym: LCADL

summary: The main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe).

lead_sponsor: University Hospital, Brest


ipd_sharing: Undecided

acronym: RIPORT

title: Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.

summary: Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the recurrence of thromboembolic event compared to an untreated group in patients with chronic portal vein thrombosis without high risk thrombophilia.


title: Phase IA/IB of Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With Non Small Cell Lung Cancer or Malignant Pleural Mesothelioma

acronym: NVB Metro

summary:
Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant Pleural Mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile.

Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol) with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as 12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the calibration of the average parameters of the model. Depending the phase Ia result, and after favorable decision of a consultative committee, the extension phase (phase Ib) will be an efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for the phase Ib.

An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.

Discussion: this ongoing trial is the first to prospectively test a mathematical optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer.

ReferenceType: derived

ReferenceCitation: Barlesi F, Imbs DC, Tomasini P, Greillier L, Galloux M, Testot-Ferry A, Garcia M, Elharrar X, Pelletier A, André N, Mascaux C, Lacarelle B, Cheikh RE, Serre R, Ciccolini J, Barbolosi D. Mathematical modeling for Phase I cancer trials: A study of metronomic vinorelbine for advanced non-small cell lung cancer (NSCLC) and mesothelioma patients. Oncotarget. 2017 Jul 18;8(29):47161-47166. doi: 10.18632/oncotarget.17562.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique des Hôpitaux de Marseille (CEPCM)


type: Other Identifier

title: How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling

acronym: PACTE

summary: This project aims to determine the respective impacts of two routine care regarding phobic of falling seniors on the mobility restriction. The investigators used a monocentric, randomized and controlled research according to two parallel groups : physical activity, home assessment and modification (rehabilitation group) versus physical activity, home assessment and modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The investigators will assess the efficacy of usual care (rehabilitation group) and the supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.


title: Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation

acronym: PSYCHE

summary: Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of Parkinson's disease (PD). However, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. The caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. In the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques

summary:
Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment.

The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers:

to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
to track their evolution in the parallel with the disease progression.

Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).

Secondary objective:

In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).
In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds.
In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

lead_sponsor: University Hospital, Montpellier

intervention_type: Radiation


title: Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)

acronym: REMASCO

summary:
Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.

The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.

primary_purpose: Basic Science

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

lead_sponsor_type: industriel


title: Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups.

summary:
Epidemiological data show that the incidence of carcinoma, the most common cancer, is strongly linked to the age. Non Melanoma Skin Carcinomas (NMSCs) (the most frequent cancers in the elderly population) derive from keratinocytes of the basal layer of the epidermis, from differentiated keratinocytes of the more superficial layers or from stem cells of hair follicles. Unlike NMSCs, soft-tissue sarcomas, including those deriving from dermal fibroblasts, are very rare (less than 1% of all cancers). Our overall purpose is to decipher the molecular pathways activated during the aging of these tissues that may explain why they have a so different propensity to undergo a malignant transformation. Given that senescent cells accumulate in the dermis and epidermis with age, we will constitute two groups : "young skin" that we arbitrarily limit to the range ≥ 18 and ≤ 40 and "aged skin" ≥ 55.

Thus the main objective of our study is to search within 2 age groups (≥ 18 and ≤ 40 years and ≥ 55 years) the expression of senescence markers on healthy skin tissue.


title: Analysis of Swallowing, Speech and Quality of Life of Patients With Stage T3-T4 Squamous Cell Carcinoma of the Oropharynx Before and After Multimodal Treatment With Curative Intent

summary:
The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.

The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors

summary:
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.

In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).

One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).

ReferenceCitation: Gay A, Boutet C, Sigaud T, Kamgoue A, Sevos J, Brunelin J, Massoubre C. A single session of repetitive transcranial magnetic stimulation of the prefrontal cortex reduces cue-induced craving in patients with gambling disorder. Eur Psychiatry. 2017 Mar;41:68-74. doi: 10.1016/j.eurpsy.2016.11.001. Epub 2017 Feb 3.


title: Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH

acronym: FICT

summary: The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment and in patients under LMWH treatment will be recorded, depending on the location and type of cancer, metastases, and treatment of cancer.

ReferenceType: background

ReferenceCitation: Meyer G. [Looking for the best molecule. A short history of anticoagulants]. Rev Mal Respir. 2011 Oct;28(8):951-3. doi: 10.1016/j.rmr.2011.09.006. Epub 2011 Oct 15. Review. French.

ReferenceCitation: Campbell RA, Aleman M, Gray LD, Falvo MR, Wolberg AS. Flow profoundly influences fibrin network structure: implications for fibrin formation and clot stability in haemostasis. Thromb Haemost. 2010 Dec;104(6):1281-4. doi: 10.1160/TH10-07-0442. Epub 2010 Sep 30.

ReferenceCitation: Wolberg AS, Gabriel DA, Hoffman M. Analyzing fibrin clot structure using a microplate reader. Blood Coagul Fibrinolysis. 2002 Sep;13(6):533-9.

ReferenceCitation: Varin R, Mirshahi S, Mirshahi P, Kierzek G, Sebaoun D, Mishal Z, Vannier JP, Yvonne Borg J, Simoneau G, Soria C, Soria J. Clot structure modification by fondaparinux and consequence on fibrinolysis: a new mechanism of antithrombotic activity. Thromb Haemost. 2007 Jan;97(1):27-31.

ReferenceCitation: Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15.

ReferenceCitation: Longstaff C; subcommittee on fibrinolysis. Development of Shiny app tools to simplify and standardize the analysis of hemostasis assay data: communication from the SSC of the ISTH. J Thromb Haemost. 2017 May;15(5):1044-1046. doi: 10.1111/jth.13656. Epub 2017 Mar 17.

lead_sponsor: Diagnostica Stago R&D

location_facility: Internal Medecine Department - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)


title: Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study

acronym: Pilot pCLE

summary: Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.

ReferenceCitation: Wallace MB, Fockens P. Probe-based confocal laser endomicroscopy. Gastroenterology. 2009 May;136(5):1509-13. doi: 10.1053/j.gastro.2009.03.034. Epub 2009 Mar 28.

ReferenceCitation: Ignat M, Aprahamian M, Lindner V, Altmeyer A, Perretta S, Dallemagne B, Mutter D, Marescaux J. Feasibility and reliability of pancreatic cancer staging using fiberoptic confocal fluorescence microscopy in rats. Gastroenterology. 2009 Nov;137(5):1584-92.e1. doi: 10.1053/j.gastro.2009.07.045. Epub 2009 Jul 24.

ReferenceCitation: Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8.

ReferenceCitation: Ignat M, Lindner V, Vix M, Marescaux J, Mutter D. Intraoperative Probe-Based Confocal Endomicroscopy to Histologically Differentiate Thyroid From Parathyroid Tissue Before Resection. Surg Innov. 2019 Apr;26(2):141-148. doi: 10.1177/1553350618814078. Epub 2018 Nov 23.

lead_sponsor: IHU Strasbourg

location_facility: Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil


title: Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Microcirculation Following Trans-tibial Amputation for Peripheral Artery Disease

acronym: NIRS

summary:
50 patients will be included for each of the 2 procedures:

- For procedure 1: Patients will be selected during multidisciplinary consultations for amputees who are stabilized with their definitive prosthesis and have returned to their usual place of residence. The aim of this procedure is to show the validity and reproducibility of measurements of tissue oxygenation using NIRS (TcPO2 being the reference measurement), to determine the way in which NIRS measurements are more precise (i.e. in terms of validity and reproductibility) (values at rest with the patient lying perfectly flat or with the amputated limb raised 30°). These patients will require a single visit which will include measurements by NIRS and TCPO2, a walk test and the completion of 2 questionnaires (visual scale).

- For procedure 2: The patients will be included in the initial phase of postamputation rehabilitation, during the period of in-hospital rehabilitation. The main problems of healing and tolerance to the temporary prosthesis arise during this phase. The specific objectives will be: To show that measurement by NIRS predicts the quality of healing in trans-tibial amputees; to show that the zone of uncertainty concerning the predictive values for the viability of the stump is smaller with NIRS than with TcPO2 (better discrimination). NIRS and TCPO2 measurements as well as the evaluation of stump healing will be done 15, 30 and 45 days after the amputation.

ReferenceCitation: Laroche D, Barnay JL, Tourlonias B, Orta C, Obert C, Casillas JM. Microcirculatory Assessment of Arterial Below-Knee Stumps: Near-Infrared Spectroscopy Versus Transcutaneous Oxygen Tension-A Preliminary Study in Prosthesis Users. Arch Phys Med Rehabil. 2017 Jun;98(6):1187-1194. doi: 10.1016/j.apmr.2016.12.001. Epub 2016 Dec 31.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients

summary: Different tools may be used to monitor the efficacy of home mechanical ventilation. Investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.

time_perspective: Retrospective

ReferenceCitation: Ogna A, Nardi J, Prigent H, Quera Salva MA, Chaffaut C, Lamothe L, Chevret S, Annane D, Orlikowski D, Lofaso F. Prognostic Value of Initial Assessment of Residual Hypoventilation Using Nocturnal Capnography in Mechanically Ventilated Neuromuscular Patients: A 5-Year Follow-up Study. Front Med (Lausanne). 2016 Sep 13;3:40. doi: 10.3389/fmed.2016.00040. eCollection 2016.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study

acronym: PERIDANS

summary:
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.

Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).

The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.

There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).

primary_purpose: Prevention


title: Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer

acronym: LYMPHOLUNG

summary: With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would allow physicians to monitor the immune status of their patient's tumor and though to evaluate the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such blood marker has been validated so far. The LYMPHOLUNG study investigate the concordance between blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC. By the use of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The prognostic value of the circulating and intra-tumoral T regulator over total lymphocytes ratio for 2-year recurrence-free survival will also be addressed.


title: Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea

acronym: SIIMPA

summary: Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.

primary_purpose: Screening


title: Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton

acronym: BCI

summary: The BCI project falls within the very broad field of brain machine interfaces. Its multiple applications include the compensation of motor deficits. The subject of the present protocol is the first test of the system in man on the compensation of motor deficits by an epidural brain implant enabling an electrocorticogram (EcoG) to be recorded.

status: Recruiting

ReferenceCitation: Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.

ReferenceCitation: Larzabal C, Bonnet S, Costecalde T, Auboiroux V, Charvet G, Chabardes S, Aksenova T, Sauter-Starace F. Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients. J Neural Eng. 2021 Sep 9;18(5). doi: 10.1088/1741-2552/ac2003.

ReferenceCitation: Detection of Error Correlates in the Motor Cortex in a Long Term Clinical Trial of ECoG based Brain Computer Interface DOI: 10.5220/0010227800260034

doi: detection

ReferenceCitation: Śliwowski M, Martin M, Souloumiac A, Blanchart P, Aksenova T. Decoding ECoG signal into 3D hand translation using deep learning. J Neural Eng. 2022 Mar 31;19(2). doi: 10.1088/1741-2552/ac5d69.

ReferenceCitation: Moly A, Costecalde T, Martel F, Martin M, Larzabal C, Karakas S, Verney A, Charvet G, Chabardes S, Benabid AL, Aksenova T. An adaptive closed-loop ECoG decoder for long-term and stable bimanual control of an exoskeleton by a tetraplegic. J Neural Eng. 2022 Mar 30;19(2). doi: 10.1088/1741-2552/ac59a0.

ReferenceCitation: Larzabal C, Auboiroux V, Karakas S, Charvet G, Benabid AL, Chabardes S, Costecalde T, Bonnet S. The Riemannian spatial pattern method: mapping and clustering movement imagery using Riemannian geometry. J Neural Eng. 2021 Apr 8;18(5). doi: 10.1088/1741-2552/abf291.

lead_sponsor: University Hospital, Grenoble

status_simplified: Ongoing


title: Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle - A Monocentric Study

summary: Muscle alterations and modifications passive biomechanical properties that occur on a spastic muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is the reference treatment of the focused spasticity, and muscle source structural and biomechanical changes, very little studied in humans, especially since it is not one possibility of easily and reliably paraclinical assessment injections consequences.


acronym: COSIMH

summary: Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.


summary:
The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.

In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.


title: Evaluation of the Reproducibility of the Measurement by 2D Ultrasound and Sonoelastometry of the Pennation Angle and Elasticity of the Medial Gastrocnemius Muscle in Children/Adolescent/Adult Cerebral Hemiplegia After Stroke

summary: Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP) have both muscles spastic and paresis. These movement disorders are likely to cause muscle changes both structural and viscoelastic involved in the alteration of neuromotor functions such as walking. Therefore, it seems interesting to study the structure of these muscles with available imaging techniques. The medial gastrocnemius muscle presents architectural characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the calculation of the modulus of elasticity within a muscle tissue. This allows to consider new perspectives evaluation of the viscoelastic properties of the muscle. No studies have evaluated the reproducibility of this method in adults/children/ adolescent after stroke and hemiplegia.


title: Study of the Impact of Changes in Carbonemia on Microcirculation in Patients - A Monocentric Study

summary:
The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.

Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .

The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.

Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.


title: Study of the Effect of the Position of the Patient's Head With Brain Lesions on Cerebral Blood Flow

summary: The position of the head of the patient influences the cerebral venous return and cerebral perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC. Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected by changes of position of the head of the patient. But the whole of the literature on this subject has significant bias.


title: Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial

summary:
The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is most often based on analgesics combined with physical therapy. More recently authors have advocated the use of self-rehabilitation, that is to say, the use by the patient himself of physiotherapy exercises to perform at home regularly. However, if there are currently many studies on the effectiveness of self-rehabilitation for low back pain, there are few data on neck pain.

In this context we have chosen to implement a prospective, randomized study, on the effectiveness of self-rehabilitation in patients with chronic neck pain.


title: Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study

acronym: NANOPI

summary: Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.

ReferenceCitation: Forest V, Pourchez J, Pélissier C, Audignon Durand S, Vergnon JM, Fontana L. Relationship between Occupational Exposure to Airborne Nanoparticles, Nanoparticle Lung Burden and Lung Diseases. Toxics. 2021 Aug 30;9(9). pii: 204. doi: 10.3390/toxics9090204.


title: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension

summary: The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.

lead_sponsor: Centre Chirurgical Marie Lannelongue


type: Other Grant/Funding Number

title: Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial

acronym: SITE

summary:
In patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent US recommendations consider statins in people only between 40 and 75 years. Moreover, statins are associated with numerous side effects impacting quality of life of those people and represent a high cost for the French healthcare system.

The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin cessation in people ≥ 75 years treated in primary prevention.

status: Active, not recruiting

ReferenceCitation: Bonnet F, Bénard A, Poulizac P, Afonso M, Maillard A, Salvo F, Berdaï D, Salles N, Rousselot N, Marchi S, Hayes N, Joseph JP. Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):342. doi: 10.1186/s13063-020-04259-5.

ReferenceCitation: Bonnet F, Poulizac P, Joseph JP. Safety and efficacy of statins. Lancet. 2017 Mar 18;389(10074):1097-1098. doi: 10.1016/S0140-6736(17)30712-2.

lead_sponsor: University Hospital, Bordeaux


title: Analysis of the Biomechanics of Walking in the Senior Under the Terms of Footwear

summary:
The proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010.

One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al., 1992; Nevitt et al., 1991).

It therefore seems essential to study the locomotion of seniors to limit the maximum risk of falling into a public health measure.

Two factors may be involved:

The first corresponds to factors related to natural aging topics
The second is the environment that is a real problem for seniors (Rolling showers, presence of works ....) And especially the port of inappropriate footwear.

Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this parameter that will be highlighted in our study.


title: Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus in a Cohort of Adult Patients Hospitalized in Intensive Care at the University Hospital of St Etienne.

acronym: DigeSTAPH

summary:
Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .

This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.


title: Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving

summary:
Bulimic patients suffering from binge eating or "craving" a pressing need to eat, with a sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may be considered appropriately by using paradigms developed in the framework of embodied cognition theories.

In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for food in these patients, as measured by reaction time.

Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms have not yet been explored.


title: Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery

acronym: CURAREA

summary:
Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units.

The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.

ReferenceCitation: Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stéphan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.


title: Use of Specific Genetic Alteration s of Tumoral Cells Identified by NGS to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor -

acronym: NGSKids

summary: The search for genetic alterations in primary tumor by NGS techniques followed by the detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several steps and after the treatment could be a tool to monitor the response during and after the treatment.

lead_sponsor: Institut Curie


title: Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.

acronym: BOLUS

summary: The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.


acronym: EFFRITE

title: Intrathecal Rituximab in Progressive Multiple Sclerosis

lead_sponsor: Centre Hospitalier de PAU

ReferenceCitation: Bonnan M, Ferrari S, Bertandeau E, Demasles S, Krim E, Miquel M, Barroso B. Intrathecal rituximab therapy in multiple sclerosis: review of evidence supporting the need for future trials. Curr Drug Targets. 2014;15(13):1205-14. Review.

ReferenceCitation: Bonnan M. Intrathecal immune reset in multiple sclerosis: exploring a new concept. Med Hypotheses. 2014 Mar;82(3):300-9. doi: 10.1016/j.mehy.2013.12.015. Epub 2013 Dec 31.

location_facility: Centre hospitalier F. Mitterrand (CH Pau)

summary: The goal of investigators is to study the kinetics of action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in progressive MS patients. Various markers of central nervous system inflammation (osteopontin, Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament) are studied at multiple time-points, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action.


title: A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study

summary:
RAGE (the receptor for advanced glycation end-products) is a marker of alveolar type I cell injury and a pivotal mediator of acute inflammation and innate immunity. RAGE pathway is highly regulated; the interaction of the transmembrane receptor with its various ligands (e.g. HMGB1, S100A12) ultimately leads to NF-kB activation and RAGE upregulation itself, but precise RAGE functions and intracellular pathways remain underexplored. During ARDS, monocyte and macrophage activation could modulate alveolar inflammation and repair.

As RAGE is also expressed at the surface of monocytes/macrophages, we hypothesize that alveolar monocyte/macrophage activation may be mediated through a RAGE-TXNIP (thioredoxin interacting protein)-NLRP3/inflammasome intracellular pathway. The purpose of this observational prospective study is to compare alveolar monocyte/macrophage activation profiles (as assessed by Fluorescence-Activated Cell Sorting (FACS)) in mechanically ventilated patients with or without ARDS.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand


summary: This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.

lead_sponsor: Poitiers University Hospital


title: Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network

acronym: DOMOPLAIES

summary: Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).


title: Study on the Links Between Perception and Action in Schizophrenia, "Upside Down, Give me the Handle"

summary: In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible (Fuchs, 2005). However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and actions potentially associated (Gibson (1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual motor neurons leads us to postulate that the affordance effect can be assisted by a visuomotor priming of a hand in a position to grasp. With Tucker & Ellis sensory motor compatibility task, we study the capacity of affordance in schizophrenia, as well as the impact of perceptual motor priming on these affordance effects.


type: Registry Identifier

title: Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders

acronym: PHENOVIRTPSY

summary: The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.

lead_sponsor: University of Bordeaux


title: Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.

acronym: IRCADO

summary:
This is a prospective, multicentric study conducted in order to evaluate if MRI coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent coronary reimplantation in childhood.

Newborns suffering from transposition of the great vessels who underwent at neonatal age an arterial switch operation (ASO) with coronary reimplantation, may develop in time with growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same complications. Functional ischemic tests in a combination of three minimum are positive in only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in those patients.

In those patients, coronarography was recommended to be performed at least at 7 and 15 yo, without any clinical symptoms . It has also been recommended to examine those patients at 5, 10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT has been proven to be as efficient as coronarography to depict coronary reimplantation abnormalities .

Due to the invasiveness of angiography and to the development of cardiac CT, in our institution, the attitude is to performed cardiac CT instead of angiography with the same frequency in our patients.

Coronaro MRI has been established as a valid technique for evaluation of coronary arteries in patients after ASO .

The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as Cardiac Multislice CT for the depiction of coronary anomalies.

All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and eligible for MRI, over 5yo are included in this prospective multi centric study.

Both examinations are performed on the same day after informed consent, from the patient or from both parents if minor.

Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro angiography is performed as follow: excluding any contra indication to MR, the study requires one or two maximum 3D true FISP sequence without IV contrast injection, with cardiac gating, and free breathing.

3D images are evaluated blinded to the results of cardiac CT by two senior radiologists, with at least 5 years of experience in MR and CT cardiac imaging.

Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance and feasibility of the examination.

The study is designed for four years and benefits from a grant from the Assistance Publique-Hopitaux de Paris.


title: Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study

acronym: DOLOCHROREA

summary:
The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care.

Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU).

If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care.

The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.

ReferenceCitation: Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Dynamic Preload Dependence Indices in Laparoscopic Surgery

acronym: VPP Coelio

summary:
A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance.

The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.

lead_sponsor: Hospices Civils de Lyon


acronym: MediSein

summary: Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study

acronym: BALISTIC

summary:
A pilot study from the investigators group suggests that the prevalence of chronic obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) are largely unknown. Although immunization against organic dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.

This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in subjects without any occupational exposure (control arm) through a vast COPD detection program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and patients with COPD without any occupational exposure; (iv) identifying etiological factors of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy farmers with COPD and dairy farmers with normal pulmonary function tests); and (v) constituting a cohort of COPD patients and control subjects for further longitudinal studies.

Data from selected patients (either current or former smokers) with mild COPD and from matched controls will also be analyzed in an ancillary study which objectives are to compare exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.

ReferenceCitation: Degano B, Bouhaddi M, Laplante JJ, Botebol M, Annesi-Maesano I, Marescaux A, Roux P, Thaon I, Wolf JP, Regnard J, Dalphin JC. [COPD in dairy farmers: screening, characterization and constitution of a cohort. The BALISTIC study]. Rev Mal Respir. 2012 Nov;29(9):1149-56. doi: 10.1016/j.rmr.2012.08.007. Epub 2012 Oct 15. French.

ReferenceCitation: Veil-Picard M, Soumagne T, Vongthilath R, Annesi-Maesano I, Guillien A, Laurent L, Andujar P, Roche N, Jouneau S, Cypriani B, Laplante JJ, Degano B, Dalphin JC. Is atopy a risk indicator of chronic obstructive pulmonary disease in dairy farmers? Respir Res. 2019 Jun 17;20(1):124. doi: 10.1186/s12931-019-1082-2.


title: Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.

acronym: DECCODES

summary:
Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic predictors, cognitive and language to obtain optimum speech recognition with cochlear implants associated with a good communicative and language development of deaf children, the investigators intend to achieve a preliminary longitudinal study aimed to describe the cognitive, communicative and perceptive implanted deaf children.

The main objective of our study is to describe the cognitive and communicative development of deaf children implanted from the pre-implant assessment to 18 months post-implantation, by addressing the following aspects:

The psychomotor and cognitive development assessed using the Brunet-Lézine test;
The development of preverbal communication, evaluated using the Early Social Communication Scale.

lead_sponsor: University Hospital, Toulouse

location_facility: Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)


title: Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease: A Phase I Safety and Efficacy Study

acronym: SpinalPark

summary: Following the so call "honey moon" period, motor symptoms of Parkinson's Disease (PD) become difficult to control with dopaminergic treatments alone. Deep brain stimulation (DBS) of the subthalamic nucleus and internal globus pallidus helps to treat fluctuating parkinsonian patients restoring a decent quality of life. However, DBS need a long, complex and invasive surgery to succeed. Thus, there is a critical need to develop alternative treatments, more accessible and less invasive. Thoracic posterior spinal cord stimulation has been used for decades to treat chronic neuropathic pains. Safety and efficacy have already been demonstrated in neuropathic pain. Experimentally, SCS has also demonstrated to improve locomotor activity in two different rodents' models of parkinson's disease. The purpose of this study is to determine whether thoracic SCS is safe and could induce a benefit motor parkinsonian symptoms without any impact on cognitive function and axial disability.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

acronym: DREPASOM

summary:
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.

The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.


title: Evaluation of a Combination of Blood Biomarkers for the Early Diagnosis of Mycosis Fungoides

acronym: DIAPREMYF

summary:
Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and the differential diagnosis with inflammatory dermatoses is often very difficult. The histopathological diagnosis is also difficult and delayed. Therefore, it is important to develop biomarkers and/or a combination of biomarkers in order to improve the early diagnostic of MF.

In a previous trial, investigators included 490 patients in a study aiming at identifying skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This French institutional study demonstrated that the identification by PCR of a combination of 4 blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis of lymphoma in erythrodermic patients. This previously published study interestingly showed that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic tool for MF.

The aim of this study is to establishing an accurate blood diagnosis for early suspected MF by demonstrating that newly identified biomarkers or their combination [5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)] are differentially expressed by patients with MF and patients with inflammatory dermatoses closely resembling MF lesions.

Statistical analysis will establish the best combination of blood biomarkers allowing the differentiation between the two groups of patients, combination that could represent a suitable diagnostic tool for early MF.


title: Population Pharmacokinetics and Rationalization of Anti-infectives Administration in Critically Ill Children

acronym: OPTIMOME

summary:
Concentrations and effects of anti-infectives in critically ill children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill children. Rationalisation of anti-infectives in children is therefore desirable.

The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) and pharmacodynamics (PD) of anti-infectives including PK/PD targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill children. Covariates The effects of covariates on anti-infectives PK and PK/PDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens.

It will be a prospective PK study including 11 anti-infectives antibiotics. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were anti-infectives concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and 100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of anti-infectives exposure on patient outcome.

ReferenceCitation: de Cacqueray N, Boujaafar S, Bille E, Moulin F, Gana I, Benaboud S, Hirt D, Beranger A, Toubiana J, Renolleau S, Treluyer JM, Oualha M. Therapeutic Drug Monitoring of Antibiotics in Critically Ill Children: An Observational Study in a Pediatric Intensive Care Unit. Ther Drug Monit. 2022 Apr 1;44(2):319-327. doi: 10.1097/FTD.0000000000000918.

ReferenceCitation: Nguyen T, Oualha M, Briand C, Bendavid M, Béranger A, Benaboud S, Tréluyer JM, Zheng Y, Foissac F, Winter S, Gana I, Boujaafar S, Lopez V, Berthaud R, Demir Z, Bouazza N, Hirt D. Population Pharmacokinetics of Intravenous Ganciclovir and Oral Valganciclovir in a Pediatric Population To Optimize Dosing Regimens. Antimicrob Agents Chemother. 2021 Feb 17;65(3). pii: e02254-20. doi: 10.1128/AAC.02254-20. Print 2021 Feb 17.

ReferenceCitation: Abdalla S, Briand C, Oualha M, Bendavid M, Béranger A, Benaboud S, Tréluyer JM, Zheng Y, Capito C, Demir Z, Foissac F, Winter S, Gana I, Boujaafar S, Bouazza N, Hirt D. Population Pharmacokinetics of Intravenous and Oral Acyclovir and Oral Valacyclovir in Pediatric Population To Optimize Dosing Regimens. Antimicrob Agents Chemother. 2020 Nov 17;64(12). pii: e01426-20. doi: 10.1128/AAC.01426-20. Print 2020 Nov 17.

ReferenceCitation: Béranger A, Benaboud S, Urien S, Moulin F, Bille E, Lesage F, Zheng Y, Genuini M, Gana I, Renolleau S, Hirt D, Tréluyer JM, Oualha M. Piperacillin Population Pharmacokinetics and Dosing Regimen Optimization in Critically Ill Children with Normal and Augmented Renal Clearance. Clin Pharmacokinet. 2019 Feb;58(2):223-233. doi: 10.1007/s40262-018-0682-1.

ReferenceCitation: Béranger A, Oualha M, Urien S, Genuini M, Renolleau S, Aboura R, Hirt D, Heilbronner C, Toubiana J, Tréluyer JM, Benaboud S. Population Pharmacokinetic Model to Optimize Cefotaxime Dosing Regimen in Critically Ill Children. Clin Pharmacokinet. 2018 Jul;57(7):867-875. doi: 10.1007/s40262-017-0602-9.

location_facility: Hospital Necker - Enfants Malades (Public Hospitals of Paris)


title: Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

acronym: SMOFPILOT

summary: Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff

acronym: THIOCAL

summary: Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. US- guided needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. The goal of this procedure is to remove the calcific deposit that is believed to cause the sub-acromial impingement. However, studies have shown that complete and rapid disappearance of the calcification deposit after irrigation is rare. The treatment is thought to promote the spontaneous resorption that occurs the weeks and months after the procedure. However, due to this slow process, time to complete recovery can be long. Moreover, it has been shown an association between the amount of removed calcium and improved outcome. Therefore, there is a need to find a way to remove quickly and completely the calcific deposit after irrigation. Sodium thiosulfate has been used successfully in the treatment of calciphylaxis and subcutaneous calcification deposit. The mechanism of action involves chelation of calcium into calcium thiosulfate salts which are much more soluble than other salts of calcium. Our hypothesis is that injection of sodium thiosulfate after irrigation of the calcification will help to dissolve the calcific deposit and thus prompt the disappearance of the calcification.

ReferenceCitation: Darrieurtort-Laffite C, Bertrand-Vasseur A, Garraud T, Planche L, Le Goff B. Tolerance and effect of sodium thiosulfate in calcific tendinitis of the rotator cuff. Clin Rheumatol. 2020 Feb;39(2):561-569. doi: 10.1007/s10067-019-04793-x. Epub 2019 Nov 1.

lead_sponsor: Nantes University Hospital


title: Assessment of the Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging - A Monocentric Study

summary:
Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present, the only parameter for assessing the risk of complication is the maximum diameter of the aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the surgical threshold which remain stable. Conversely, complications have been described for aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple methods have been described in the literature. One of them relies on in vitro mechanical testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of complication better than the universally used criterion of diameter.

The pathophysiology of these aneurysms has also been explored from histological studies. The investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated with a degradation of elastin fibers and collagen that determine to a large extent its biomechanical behavior. Histological analysis appears inseparable from biomechanical analysis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study

summary: Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. This pathology is studied in psychology but not using the theories of embodied cognition in which "perception and action" interact through sensorimotor processes. They are the source of attitudes (unconscious) towards certain stimuli and influence our interpretation (conscious).


title: Prognosis Contribution of the 6 Minute Walk Test in Cystic Fibrosis : Prospective Multicenter Study

summary: The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a prognostic factor for cystic fibrosis patients.

ReferenceCitation: Martin C, Chapron J, Hubert D, Kanaan R, Honoré I, Paillasseur JL, Aubourg F, Dinh-Xuan AT, Dusser D, Fajac I, Burgel PR. Prognostic value of six minute walk test in cystic fibrosis adults. Respir Med. 2013 Dec;107(12):1881-7. doi: 10.1016/j.rmed.2013.10.001. Epub 2013 Oct 11.

ReferenceCitation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30. Review.

ReferenceCitation: Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30. Review.


title: Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

acronym: BRONDUSAL

summary: Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

ReferenceCitation: Beal G, Barbier C, Thoret S, Rubio A, Bonnet M, Mazet R, Ego A, Pin I. Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial. BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.


title: Can we Forget? Directed Forgetting and Embodied Cognition in Schizophrenia

summary: Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.


title: Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1

summary:
This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated.

Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).

ReferenceCitation: Marche P, Dubois S, Abraham P, Parot-Schinkel E, Gascoin L, Humeau-Heurtier A, Ducluzeau PH, Mahe G. Neurovascular microcirculatory vasodilation mediated by C-fibers and Transient receptor potential vanilloid-type-1 channels (TRPV 1) is impaired in type 1 diabetes. Sci Rep. 2017 Mar 13;7:44322. doi: 10.1038/srep44322.

lead_sponsor: University Hospital, Angers


title: Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)

acronym: VENDETTA

summary:
Crossover randomized controlled double blinded trial :

The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.

lead_sponsor: University Hospital, Grenoble


acronym: DROSOALLERG

summary: Allergy is a very common problem and can be a handicap in everyday life, specially when symptoms occur at work place. Some persons working with drosophila developed respiratory symptoms. Investigators tried to analyze if these manifestations could be due to a specific allergy to drosophila.


title: Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study

acronym: SSD

summary: The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.


title: Involvement of Reactive Oxygen Species Produced by the Xanthine Oxidase in Mitochondrial Alterations in Skeletal Muscle of Type 2 Diabetic Patients

acronym: DIAXO

summary: Our recent data in mice have demonstrated a key role of xanthine oxidase in hyperglycemia-induced by Reactive oxygen species production, and a preventive role of allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2 diabetic patients.


title: Ultra-Violet Fluorescence Bronchial Cancer Location

acronym: UVFBCL

summary:
Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.

The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.

location_facility: Pneumology departement CHU Saint-Etienne


title: Attentional Capacity and Working Memory in Coronary Artery Disease Patients: Impact of the Presence of a Sleep Apnea Syndrome and Chronic Effects of Treatment With a Continuous Positive Airway Pressure System (CPAP). Etude CAPCORSAS

acronym: CAPCORSAS

summary:
The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic patients do not complain in their daytime functioning. The objective of this study is to explore whether the objective cognitive assessment measures may be a good marker of the efficacy of CPAP treatment given to non-sleepy apneic CAD patients.

Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients should have a positive impact on cognitive performance, particularly on attention span and working memory measured by improvement in the Paced Auditory Serial Addition Test score (PASAT score).


title: Bone Microarchitectural Database Constitution From High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Device in Clinical Situation Potentially Associated With Bone Loss

acronym: DMPOs

summary:
Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some factors of fracture occurrence have been highlighted. For example, some diseases or therapy are known to increased risk of bone fracture only in some patients. Accordingly, it is important for clinicians to identify patients at risk for bone fracture. Right now, various tools are available for the clinicians:

clinical exam,
bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),
an algorithm based on interrogation, clinical exam and bone mineral density. However, prediction of bone fracture risk needs to be improved since only 50% of bone fractures can be predicted. DEXA provides information for fracture risk estimation, but it is unable to distinguish cortical part to trabecular part. It also fails to quantify the microstructural properties that influence bone strength. Bone microarchitecture, including the cortical compartment can now be assessed in vivo by the HR-pQCT. This technique allows access to several parameters: on the one hand the volumetric bone mineral density for the whole area measured as well as cortical and trabecular regions, and on the other hand, the thickness and cortical porosity and the number of trabecular, their orientation and distribution.

Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical and trabecular bone microarchitecture.


title: Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease

acronym: OXYPHEN

summary:
In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.

Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.


title: Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection

acronym: PLAQUETTE

summary:
HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction. Platelets may play a role in the occurrence of the inflammatory state: they contain big amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of platelets to the inflammatory state associated with HIV infection has been little studied. Thus, it has been shown that platelets in HIV patients are able to release interleukin (IL)-18. The group has shown with others that the platelet function could be altered during HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with platelets.

The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on the platelets activation markers.


title: Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography

acronym: SCOBIOMOD

summary:
The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography.

The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.

ReferenceCitation: de Sèze M, Cugy E. Pathogenesis of idiopathic scoliosis: a review. Ann Phys Rehabil Med. 2012 Mar;55(2):128-38. doi: 10.1016/j.rehab.2012.01.003. Epub 2012 Jan 27. Review. English, French.

ReferenceCitation: Bunnell WP. An objective criterion for scoliosis screening. J Bone Joint Surg Am. 1984 Dec;66(9):1381-7.

ReferenceCitation: Goldberg CJ, Kaliszer M, Moore DP, Fogarty EE, Dowling FE. Surface topography, Cobb angles, and cosmetic change in scoliosis. Spine (Phila Pa 1976). 2001 Feb 15;26(4):E55-63.

ReferenceCitation: Mínguez MF, Buendía M, Cibrián RM, Salvador R, Laguía M, Martín A, Gomar F. Quantifier variables of the back surface deformity obtained with a noninvasive structured light method: evaluation of their usefulness in idiopathic scoliosis diagnosis. Eur Spine J. 2007 Jan;16(1):73-82. Epub 2006 Apr 12.