title: Value of Target-controlled Intravenous Anaesthesia (TCIVA) to Optimize Coverage of the Low Back Pain Territory in Patients With Chronic Refractory Postoperative Multifocal Low Back and Legpain

acronym: AIVOC

summary: Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.


title: Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group.

acronym: TARMIC

summary: Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Institut Bergonié

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: Impact of an Effort Rehabilitation Program for Overweight or Obese Children and Teens on Quality of Life and Wellbeing: A French Monocentric Prospective Study

acronym: PRESEVAL

summary: Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to exercize because of their physical condition start an effort rehabilitation program at the Organization. The study will evaluate the impact of this rehabilitation program on quality of life and appetency to physical activity for these children and teens.

status: Completed

study_completion_date_type: Actual

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Fulton JE, Garg M, Galuska DA, Rattay KT, Caspersen CJ. Public health and clinical recommendations for physical activity and physical fitness: special focus on overweight youth. Sports Med. 2004;34(9):581-99. Review.

ReferenceCitation: Bar-or O. Médecine du Sport chez l'enfant. Principes physiologiques et applications cliniques. Paris : Masson ; 1987

ipd_sharing: No

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

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Simultaneous Determination of Blood Pressure by Oscillometry and Photoplethysmography Compared to the Standard Inert Gas Rebreathing Technique

acronym: CeCi

summary:
Main objective of the experiment is threefold: 1) to technically test a device for central blood pressure estimation for its applicability in a spaceflight-related environment and on the International Space Station. 2) Furthermore the objective is to compare central blood pressure estimates based on arterial pressure readings of different peripheral arteries. For central blood pressure estimation mathematical transfer functions as described by Karamanoglu and colleagues (11) will be used. 3) Finally the experiments' objective is to simultaneously apply phonocardiography together with ECG and carotid plethysmography to determine cardiac systolic time intervals in parabolic flight during gravity transitions.

Secondary objective of the experiment is to simultaneously measure key variables of the central circulation during gravity transitions to expand the understanding of cardiovascular regulation in weightlessness. Furthermore spirometric measurements shall be performed during a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is central for cardiovascular regulation.

Our main hypothesis is that there is no difference between different methods of central arteria pressure determination.

Concerning our secondary objective, this experiment is designed as an observational study. Thus no clear hypothesis was generated but the measured cardiovascular and respiratory variables will be analysed regarding differences correlated to gravity.

status: Unknown status

lead_sponsor: University Hospital, Caen

status_simplified: Unknown


title: Neurocognitive Performance During Space Flight. Validation of a Test Battery

acronym: NeuroCog

summary:
The main objective of this experiment is to evaluate the alterations in brain cortical activity induced by micro- and hypergravity conditions.

A secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.

Another secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations


title: Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS

acronym: KTFIXPICC

summary:
PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines it's recommended to use sutureless device. The devices actually used are unsatisfactory because of the high risk of migration, accidental removal.

A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the possibility to simplify the after care. This device may stay on patient for 4 weeks. Others devices may be changed 1/week.

The investigators aimed to compare morbidity between this new device and the old one. The investigators also want to perform an economic evaluation of this device and compare patient quality of life.

design_allocation: Randomized

ipd_sharing: Yes

intervention_type: Device


title: Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit: a Randomized Study

summary:
Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.

In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.

The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:

An end-tidal plateau at 30 cmH20 for 30 seconds.
An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

acronym: ARCTICS

summary: The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.

status: Terminated


title: Identification of Molecular Defects in Idiopathic Cytopenia of Undetermined Significance

acronym: AMICUS

summary: The project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may be a precursor of MDS

intervention_type: Genetic


title: Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit: A Controlled, Randomized Trial: The ECHOGUIDE Study

acronym: ECHOGUIDE

summary:
The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.

The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.

Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Lazaar S, Mazaud A, Delsuc C, Durand M, Delwarde B, Debord S, Hengy B, Marcotte G, Floccard B, Dailler F, Chirossel P, Bureau-Du-Colombier P, Berthiller J, Rimmelé T. Ultrasound guidance for urgent arterial and venous catheterisation: randomised controlled study. Br J Anaesth. 2021 Dec;127(6):871-878. doi: 10.1016/j.bja.2021.07.023. Epub 2021 Sep 6.

family: Lazaar

full_name: Stephen Lazaar

given: Stephen

sequence: first

family: Mazaud

full_name: Amélie Mazaud

given: Amélie

sequence: additional

family: Delsuc

full_name: Claire Delsuc

given: Claire

family: Durand

full_name: Maeva Durand

given: Maeva

family: Delwarde

full_name: Benjamin Delwarde

given: Benjamin

family: Debord

full_name: Sophie Debord

given: Sophie

family: Hengy

full_name: Baptiste Hengy

given: Baptiste

family: Marcotte

full_name: Guillaume Marcotte

given: Guillaume

family: Floccard

full_name: Bernard Floccard

given: Bernard

family: Dailler

full_name: Frédéric Dailler

given: Frédéric

family: Chirossel

full_name: Pierre Chirossel

given: Pierre

family: Bureau-Du-Colombier

full_name: Pascale Bureau-Du-Colombier

given: Pascale

family: Berthiller

full_name: Julien Berthiller

given: Julien

family: Rimmelé

full_name: Thomas Rimmelé

given: Thomas

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Anaesthesia

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval

intervention_type: Procedure


title: Children Severe Traumatic Skin Lesions and Functional Outcome

summary: Traumatic skin lesions require an adapted and early patient care management

time_perspective: Retrospective


title: Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

acronym: PRADOTIM

summary: The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre de référence Prader-Willi - Hôpital Purpan


title: Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)

acronym: ALDO-AF

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence. Two main techniques are used today to restore sinus rhythm: electrical cardioversion and radiofrequency ablation.

Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a relatively high success rate (about 80%), a substantial number of patients require a second procedure to obtain sinus rhythm. Many publications have led to the study of predictors of failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to date no parameter is reliable and usable in daily practice.

It is the same for electrical cardioversion. Despite a relatively high immediate success rate of approximately 80%, a significant number of patient relapse arrhythmia in short and long term. Many publications have led to the study of predictive factors of failure (seniority and type of AF, uncontrolled hypertension, size of the OG, mitral valve disease...) but so far the results are disappointing.

In AF patients with heart disease underlying, it has been well demonstrated that the renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well established that elevated plasma aldosterone as in primary hyperaldosteronism is associated with a significantly increased risk of occurrence of cardiovascular events. The high plasma concentrations were also highlighted in the acute phase of myocardial infarction, or heart failure and are associated with an increase in major cardiovascular event rate, especially arrhythmias. In some experimental models of heart failure, it has been demonstrated a suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The arrhythmogenic effect of aldosterone has also been shown in animal models. All these results indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and the FA.

The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency ablation or via electrical cardioversion.


title: Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database

acronym: AZITHRO

summary:
Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients. It was shown that this treatment taken every day or every week for 12 months, can improve the respiratory state of patients. From the second year of treatment, it would appear there is more profit to continue such treatment.

The main objective is to study the association between continuous use of azithromycin and lung function measured by Forced expiratory volume in one second (FEV1), after two years of treatment.

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


title: Diagnostic Ability of Diffusion MRI and Diffusion Tensor in Renal Graft Biopsies: Pilot Study

summary:
While renal graft outcomes were really improved for the last decade, long time outcomes remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect precociously renal injuries at a reversible stage before clinical manifestation. However, renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a non-invasive diagnostic tool allowing the early detection of renal injuries, especially allograft rejection without hemorrhagic risk. This tool could be applied routinely to the renal allograft recipient in replacement of protocol biopsies.

Here, aim of this study is to correlate the results from diffusion MRI of renal graft with pathologic findings from protocol renal graft biopsies.

In this view, the investigators include prospectively all recipients of renal transplantation who beneficiate of a protocol renal graft biopsy without barrier to peform MRI examination. Thus, the investigators exclude patients who are not be able to beneficiate of a MRI examination and patient obstacle to renal graft biopsy.

Expected results are the Banff classification from the histopathologic analysis of biopsies. The expected results for MRI examination are signal intensity, diffusive coefficient, anisotropy fraction and change of the diffusion way. Next, the investigators search an association between these features by statistical analysis (Wilcoxon test, Chi², Fisher, Pearson or Spearman).

The investigators performed this study since 01/06/2014 and projected end-time to 01/06/2017.

lead_sponsor: CHU de Reims


title: Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data

acronym: NNP-MULTIMODAL

summary:
This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In this context, the investigators have developed know-how and specific acquisition and analysis tools (2 patents and several publications), allowing them to apply this know-how in children with patent ductus arteriosus.

Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of cardiac output towards the pulmonary circulation. The direct consequences of this shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other systemic organs are deprived of part of their normal perfusion and are subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical dysfunction, the analysis of which constitutes one of the objectives of this project.

primary_purpose: Basic Science


title: Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects: Study of Their Association With Cardiovascular Risk Factors, Markers of Arterial Inflammation and Markers of Oxidative Stress

acronym: SAPL

summary:
Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies, predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA). Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the context of APS, APL can also be observed in various clinical situations and in healthy subjects. Published studies have reported a variable prevalence of APL in healthy subjects, essentially ACL and/or LA, and their clinical significance currently remains unclear.

Several studies have highlighted the link between APL and atherosclerosis. It therefore appears interesting to more specifically study the association between the presence of APL and the presence of cardiovascular risk factors in a population of healthy subjects. Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a complex interaction between atherogenic plasma factors and cells of the arterial wall. Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid peroxidation also plays a major role during the atherogenesis process. It will therefore also be important to correlate APL with markers of vascular inflammation and markers of oxidative stress.

A prospective case-control study will therefore be conducted on 1,500 healthy blood donors. Subjects screened APL-positive will be compared to APL-negative subjects in terms of cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular disease will not be studied). In the context of a blood donation, all subjects wishing to participate in this study will attend a medical interview and a clinical examination during which various data will be collected, mainly the presence of cardiovascular risk factors. A blood sample will also be taken to assay the various laboratory markers studied.

This study should provide a better understanding of the role of APL in healthy subjects and more clearly specify their possible link with atherosclerosis in this population.

intervention_type: Biological


title: Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life

acronym: PREMARISQ

summary: Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.


title: HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin.

summary: Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration (IMMUNOSEPSIS)

acronym: IMMUNOSEPSIS

summary:
Septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). New promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however relies on the investigators capacity in identifying the patients who could benefit from it, as there is no clinical sign of immune dysfunctions. The main objectives are:

to identify the best biomarkers for sepsis-induced immunosuppression and
to evaluate ex vivo whether drugs could rejuvenate immune functions.

location_facility: Hospices Civils de Lyon - Hopital Edouard Herriot


title: Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound.

summary: Benefit of MRI in pathological nipple discharge.

ReferenceCitation: Boisserie-Lacroix M, Doutriaux-Dumoulin I, Chopier J, Boyer B, Depetiteville MP, Hoppe S, Brouste V, Chamming's F. Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study. Eur Radiol. 2021 Oct;31(10):7783-7791. doi: 10.1007/s00330-021-07790-4. Epub 2021 Apr 13.

family: Boisserie-Lacroix

full_name: Martine Boisserie-Lacroix

given: Martine

family: Doutriaux-Dumoulin

full_name: Isabelle Doutriaux-Dumoulin

given: Isabelle

family: Chopier

full_name: Jocelyne Chopier

given: Jocelyne

family: Boyer

full_name: Bruno Boyer

given: Bruno

family: Depetiteville

full_name: Marie-Pierre Depetiteville

given: Marie-Pierre

family: Hoppe

full_name: Stéphanie Hoppe

given: Stéphanie

family: Brouste

full_name: Véronique Brouste

given: Véronique

family: Chamming’s

full_name: Foucauld Chamming’s

given: Foucauld

journal_name: European Radiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)

summary:
Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the canal opening with a hermetic sealing material.

The analysis of the literature on intracanal therapeutic shows great variability of the results obtained, the reported success rate is 53 to 95%.

This is explained by the difficulty of the surgical procedure, but also by the multiplicity of possible factors of failure, related practitioner, canal anatomy, the operating procedures, the preparation techniques and root canal filling. This success rate is variable depending on the presence or absence of periapical pathology before treatment: more than 85% for teeth treated without initial periapical pathology against only 62% for teeth with pathology before treatment. Furthermore, the literature review revealed two contradictory assumptions about the dominant factor failure in endodontics: the failure of the sealing canal system (bad level shutter) against the failure of the endovascular disinfection.

Main hypothesis of the research objectives:

The probability of success in a year endodontic treatments carried out according to the recommendations and the operating standards on teeth with periapical pathology is approximately 60%.

The primary prognostic factors would be the existence of intracanal obstacles (stop calcification ...) responsible for a sub-obturation of the canal, factors inherent to the tooth (situation ductal anatomy and complexity), the operating techniques used, the practitioner ( skill level), the quality of the restoration.

lead_sponsor: Nantes University Hospital


title: Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

acronym: Keratite

summary: Infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of infectious keratitis are favourable, some lead to serious injury of the cornea, or even corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This negative evolution is encountered while the infectious keratitis due to tedious germs of difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of routine is based on the systematic search for pathogens tedious from invasive sampling of cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Microbiological Diagnosis of Infectious Uveitis to Pathogenic Fastidious Germs

summary:
Our research project is to use a new microbiological diagnostic strategy of uveitis, allowing detection of the fastidious pathogens of infectious Uveitis who are not diagnosed by laboratory methods used in diagnostic routine. This new diagnostic strategy is to automatically detect the presence of a pathogen fastidious in cell culture using the same patient's serum to reveal a positive culture, based on the assumption that this serum contains antibodies specific pathogen tedious.

Finally, the main purpose of this study is to improve the etiological diagnosis of Uveitis by establishing a new diagnostic strategy.


title: Investigation of Endemic and Emerging Diseases in Populations of Homeless Households in Marseille.

acronym: SDF

summary:
Hypothesis:

Homeless people have infections not diagnosed with a potential impact on their health status.

Main Purpose: Improve the etiological diagnosis of endemic and/or emerging pathologies among homeless people.


title: Evaluation of Drug's Risk in Pregnant Women

acronym: EFEMERIS

summary: Medication during pregnancy can lead to the occurrence of birth defects or neonatal pathologies. Thalidomide or diethylstilbestrol (Distilbene°) are prominent examples. Many drugs remain insufficiently evaluated in this area and doctors are too often deprived of relevant information when prescribing drugs in pregnant women.

status: Recruiting

ReferenceType: result

ReferenceCitation: Hurault-Delarue C, Lacroix I, Bénard-Laribière A, Montastruc JL, Pariente A, Damase-Michel C. Antidepressants during pregnancy: a French drug utilisation study in EFEMERIS cohort. Eur Arch Psychiatry Clin Neurosci. 2019 Oct;269(7):841-849. doi: 10.1007/s00406-018-0906-2. Epub 2018 May 26.

family: Hurault-Delarue

full_name: Caroline Hurault-Delarue

given: Caroline

family: Lacroix

full_name: Isabelle Lacroix

family: Bénard-Laribière

full_name: Anne Bénard-Laribière

given: Anne

family: Montastruc

full_name: Jean-Louis Montastruc

given: Jean-Louis

family: Pariente

full_name: Antoine Pariente

given: Antoine

family: Damase-Michel

full_name: Christine Damase-Michel

given: Christine

journal_name: European Archives of Psychiatry and Clinical Neuroscience


title: A Multicenter, Randomised, Double-blind Placebo-controlled Trial Assessing the Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children.

summary: Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim of this study is to assess the efficiency of a 6-months levamisole course, given early after first remission, on maintaining a relapse-free course at 12 months.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: EudraCT Number

title: Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics Between Peritoneal and Vascular Compartments

acronym: ARAM

summary: Refractory ascites is an indication for liver transplantation, and includes ascites that is resistant to, or intractable by diuretic therapy (International Ascites Club). This definition is partly subjective; it can be established only a posteriori, following diuretic therapy administration to all patients, including those in whom untoward effects are prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would avoid giving diuretic therapy to patients in whom it will fail and identify rapidly candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic (PK) study of radiolabeled albumin between the peritoneal cavity and serum.

study_start_date_type: Anticipated

intervention_type: Radiation


title: Development of Maternal Voice Recognition in Preterm Neonates

acronym: PREMAVOIX

summary:
Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition, tend to be processed by the right hemisphere. Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the presence of anatomical and functional asymmetries by the first months of life. What are the causes of these asymmetries? How do they develop? Are they necessary for functioning or effective learning?

This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of development at which hemispheric dominance for voice recognition is first observed and to identify the brain structure involved in preterm neonates whose sound environment is usually very different from that of the foetus. The impact of this environment on the infant's brain development and early learning will be evaluated.


title: Role of the Interaction Between AGEs and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients

acronym: RAGE-VASCU

summary: Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest, advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the role of RAGE in the calcification process of hemodialyzed patients, in a correlative and prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while accumulation of AGEs will be measured in the serum and in the skin (non invasive). Additionally factors influencing RAGE activation such as genetic polymorphism and level of soluble forms of RAGE will be measured and analyzed.


title: Anticipating and Tracking: Pack of Gerontological Assessment Embedded

acronym: ARPEGE

summary:
ARPEGE project fits within the general framework of maintaining functional autonomy in the frail elderly. The early identification of elderly people at risk of frailty is essential to be able to make corrective actions to maintain a quality of life desired by the person. ARPEGE offers tracking and monitoring based on a corpus mobile evaluation of frailty, that could be used in various environments (home, prevention center, office of the general practitioner, geriatric consultation), and manipulated intuitively by professionals not specialists.

This four-year project spearheaded by the University of technology of Troyes in partnership with the University of Reims Champagne-Ardenne also brings a set of partners and experts in the region and outside, so that the proposed solution has the qualities necessary for its deployment in terms of value diagnostic, use, acceptability and perfectly controlled ethics.

The Region has made "longevity aging" theme one of its priorities. This image of driver of innovation in this area can only be enhanced by a program like ARPEGE. Beyond the scientific and technological results expected, one can imagine the potential socio-economic benefits if this tracking solution is deployed on a large scale.

primary_purpose: Other


title: Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

acronym: AFTC

summary:
In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems.

By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction.

In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach.

Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).


title: The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care

summary: The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of the overall study is the time of ulcer healing. The number of amputation, hospital admissions and surgical procedure will be also reported. Investigators hope to include 150 patients in this study.


title: Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)

summary:
This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall.

All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project.

The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

ReferenceCitation: Amouroux M, Salleron J, Huin-Schohn C, Ali S, Berthaud S, Rizo P, Schneider S, Vever-Bizet C, Bourg-Heckly G, Guillemin F, Le Coupanec P, Galbrun E, Daouk J, Daul C, Blondel W, Eschwège P. Clinical evaluation of a device providing simultaneous white-light and fluorescence video streams as well as panoramic imaging during fluorescence assisted-transurethral resection of bladder cancer. J Opt Soc Am A Opt Image Sci Vis. 2019 Nov 1;36(11):C62-C68. doi: 10.1364/JOSAA.36.000C62.

lead_sponsor: Institut de Cancérologie de Lorraine


acronym: HypCor

summary: The purpose of this study is to confirm the utility for hypnosis in the coronary angiographic examination. The technique would be an alternative to prevent the consumption of anesthesic drugs.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

intervention_type: Behavioral


title: Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease

acronym: GERIOX

summary:
According to several reports, the oxidative stress and the nutrition could have an impact in the Alzheimer disease.

The association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders.

This is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints.

The objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments.

The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of MRI contraindication) will be realized during the study inclusion phase in the usual intake of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the Day hospital dedicated to the routine intake of patients issued from the memory consultation.

In this study, the principal evaluation criteria will be the MMSE score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. It will allow evaluating the correlation between the cognitive decline evolution measured by MMSE during the Alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.

location_facility: Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.


title: Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

acronym: FOOP

summary:
Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :

to describe the different type of odontoid fracture and to characterize bone status in elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma energy.
To describe short and long term outcomes


title: Lyon BJI Cohort Study

summary:
The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed.

Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment.

Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected.

This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.

location_facility: Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse


title: Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?

acronym: Narcolepsy

summary:
A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children. There is no specific study on the population and the consequences of overweight in the lives of these long-term patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is also known that weight gain is not related to the treatment of narcolepsy. The etiology of obesity in narcoleptic patients is not established. Several assumptions were made (physical activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and obesity in this population therefore remain unclear.

In this study, potential change in the total metabolism (24h) for narcoleptic children that could explain their tendency to obesity will be assessed ?

location_facility: Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant


title: Feedbacks' Influence on Decision Making Processes

acronym: Feedbacks

summary:
The purpose of this research is to identify and probe the neural networks involved in feedback processing. It aims at translating this knowledge to clinical populations in which this network is disrupted or compromised.

It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of feedback processing on decision making using different types of feedback (neutral, social and monetary) presented either infra- or supra-laminary and 2) probing the role of one structure, the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy subjects. The interventional part consists in the administration of Galvanic Vestibular Stimulation (GVS), which by means of small intensity currents activates the vestibular organs and subsequently vestibular-related brain areas. GVS will be delivered to healthy participants engaged in behavioural tasks requiring the processing of feedbacks of different nature (e.g. social or monetary feedbacks)

location_facility: Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON


title: Comparison of Mood Disorders Screening Scales in Geriatric Oncology

acronym: Thymog

summary:
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).

The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.

It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .


title: PTMDP (Post-translational Modification Derived Products) as Markers of Frailty in Elderly Subjects

acronym: MAFRA

summary:
Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. Screening and treating frailty seem to be a good start towards preventing dependency.

On the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (PTMDP) represents an innovative evaluation method. These include advanced glycation end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. This would make it possible to adapt treatment accordingly in elderly subjects.


title: Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)

summary: Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction

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


title: Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.

acronym: pEsition

summary: Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress SyndromeARDS patients in order to set ventilator settings. There might be variations of the measured value according to the patient position (0° vs 30°) at the time of measurements.


title: Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)

acronym: LANGLAT

summary: Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.


title: PROne POsition and Volumetric CAPnography

acronym: PROPOCAP

summary: Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.

ReferenceCitation: Jochmans S, Mazerand S, Chelly J, Pourcine F, Sy O, Thieulot-Rolin N, Ellrodt O, Mercier Des Rochettes E, Michaud G, Serbource-Goguel J, Vinsonneau C, Vong LVP, Monchi M. Duration of prone position sessions: a prospective cohort study. Ann Intensive Care. 2020 May 24;10(1):66. doi: 10.1186/s13613-020-00683-7.

family: Jochmans

full_name: Sebastien Jochmans

given: Sebastien

family: Mazerand

full_name: Sandie Mazerand

given: Sandie

family: Chelly

full_name: Jonathan Chelly

given: Jonathan

family: Pourcine

full_name: Franck Pourcine

given: Franck

family: Sy

full_name: Oumar Sy

given: Oumar

family: Thieulot-Rolin

full_name: Nathalie Thieulot-Rolin

given: Nathalie

family: Ellrodt

full_name: Olivier Ellrodt

given: Olivier

family: Mercier Des Rochettes

full_name: Emmanuelle Mercier Des Rochettes

given: Emmanuelle

family: Michaud

full_name: Gaël Michaud

given: Gaël

family: Serbource-Goguel

full_name: Jean Serbource-Goguel

given: Jean

family: Vinsonneau

full_name: Christophe Vinsonneau

given: Christophe

family: Vong

full_name: Ly Van Phach Vong

given: Ly Van Phach

family: Monchi

full_name: Mehran Monchi

given: Mehran

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

lead_sponsor: Hopital of Melun


title: Impact of Telemedicine on Avoiding Emergency Hospital Admissions and Hospitalization for Nursing Home Residents

acronym: GERONTACCESS

summary:
Telemedicine-based care provides remote health and social care to maintain people's autonomy and increase their quality of life. The rapidly aging population has come with a significant increase in the prevalence of chronic diseases and their effects, and thus the need for increased care and welfare.

This solutions give a new opportunity for diagnosis, treatment, education, and rehabilitation, and make it possible to monitor patients with a number of chronic diseases. It also reduces socioeconomic disparity with regard to access to care and gives equal chances to patients from urban and rural areas.

This a randomized trial of telemedicine versus usual care alone to reduce hospitalization and emergency hospital admissions for Nursing Home Residents .

After an initial assessment , each participant is monitored by teleconsultation on six occasions over 12 months. Patients with usual care have an initial and a 12 months assessments.

primary_purpose: Prevention

lead_sponsor: University Hospital, Limoges


title: InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study

acronym: pre-TAPIOCA

summary:
Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge.

Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will experiment POI.

A new approach during preoperative era, using mastication or preoperative physical activity, has been proposed to improve postoperative course. This leads to a vagal activation (action especially on upper GI).

Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower GI.

The aim of this study was to assess the efficacy and the feasibility of PTNS during perioperative course, to prevent POI with respect with placebo.

lead_sponsor: University Hospital, Angers


title: Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias

acronym: PVL

summary:
Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet, 2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet, 2002;359:753-9). Ten year after the first description of this disease and a number of controversies in the scientific literature, the question arise as to whether PVL remains an independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain unanswered yet; these are:

(i) which factors, including treatment regimen, are associated with favourable outcome?,
(ii) what is the susceptibility toward antibiotics of strains associated with this disease ?
(iii) is there any genetic susceptibility of the host to explain both the rarity, and the explosive presentation of the disease ? To address the above questions a prospective observational study at the nationwide level will be set up. All French hospitals will be invited to describe the clinical features of all new cases of S. aureus community-acquired pneumonia with severity criteria, regardless PVL production. The study will include an investigation of a possible innate immune dysfunction in collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté Necker, Paris). Hence, in addition to collecting clinical and biological data from all pneumonia cases as well as all strains of S. aureus isolated, the patients with PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome sequencing and functional studied)

location_facility: Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel


title: "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders

acronym: COGNITUS

summary: Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.

ReferenceCitation: Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the "COGNITUS & MOI" study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.

family: Favre

full_name: Emilie Favre

given: Emilie

family: Peyroux

full_name: Elodie Peyroux

given: Elodie

family: Babinet

full_name: Marie-Noelle Babinet

given: Marie-Noelle

family: Poisson

full_name: Alice Poisson

given: Alice

family: Demily

full_name: Caroline Demily

given: Caroline

journal_name: BMC Psychiatry

title: Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the «COGNITUS & MOI» study protocol for a randomized controlled trial

lead_sponsor: Hôpital le Vinatier


title: Study of Electrophysiological Effects of NACOS and AVK on the Pulmonary Veins and the Left Atrium of Patients Referred for Paroxysmal AF Catheter Ablation

acronym: NACO-VP

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these pulmonary veins, medicated way (antiarrhythmic) or interventional. Ablation (radiofrequency or cryotherapy) has become in this context recognized and effective treatment of AF. In addition, antithrombotic treatments in this context is a major treatments for the prevention of stroke (stroke). They are most often associated with antiarrhythmic treatment to prevent recurrence of AF or to slow it during a relapse.

Recent experimental studies have highlighted the direct electrophysiological properties of dabigatran and rivaroxaban in the pulmonary veins and the left atrium. Dabigatran demonstrated in this study that it induced a prolongation of potential action in the pulmonary veins and the left atrium and it decreased the incidence of FA-induced by stimulation. Conversely, rivaroxaban induces shortening of the action potential in the left atrium (untested properties in the pulmonary veins). To our knowledge, apixaban and warfarin have not been studied in this context.

It is therefore possible that some of the new oral anticoagulants (NACOS) or some AVK (fluindione and warfarin), have direct electrophysiological effects in the pulmonary veins and on the left atrium and could influence AF recurrences (with effect " antiarrhythmic-like "or rather a pro-arrhythmic effect) after ablation.A retrospective analysis conducted at the University Hospital of Caen on very low numbers suggest that patients on dabigatran would have less pulmonary veins connected in early ablation procedure that patients on warfarin or rivaroxaban. Despite the limitations inherent in this analysis (very low numbers, retrospective analysis, unique setting and having studied his own limits), these results are consistent with the fundamental studies, and thus encourage us to pursue our hypothesis to obtain more statistical power and reliability in our measurements and results.

We therefore propose the study of the electrophysiological effects of NACOS (apixaban, dabigatran, rivaroxaban) and warfarin (warfarin and fluindione) on the pulmonary veins and the left atrium of patients referred for ablation of paroxysmal AF (radiofrequency or cryotherapy ) the CHU of Caen and Tours and clinic Saint Martin Caen.


title: Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)

summary: Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pépin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pépin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x.

family: Borel

full_name: A.-L. Borel

family: Benhamou

full_name: P.-Y. Benhamou

family: Baguet

full_name: J.-P. Baguet

family: Halimi

full_name: S. Halimi

given: S.

family: Levy

full_name: P. Levy

given: P.

family: Mallion

full_name: J.-M. Mallion

family: Pépin

full_name: J.-L. Pépin

journal_name: Diabetic Medicine

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Borel AL, Pépin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.

family: Pepin

full_name: J.-L. Pepin

family: Nasse

full_name: L. Nasse

given: L.

family: Netter

full_name: S. Netter

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Short Sleep Duration Measured by Wrist Actimetry Is Associated With Deteriorated Glycemic Control in Type 1 Diabetes

ReferenceCitation: Pallayova M, Banerjee D, Taheri S. Novel insights into metabolic sequelae of obstructive sleep apnoea: a link between hypoxic stress and chronic diabetes complications. Diabetes Res Clin Pract. 2014 May;104(2):197-205. doi: 10.1016/j.diabres.2014.01.007. Epub 2014 Jan 14. Review.

ReferenceCitation: Seidell JC. Waist circumference and waist/hip ratio in relation to all-cause mortality, cancer and sleep apnea. Eur J Clin Nutr. 2010 Jan;64(1):35-41. doi: 10.1038/ejcn.2009.71. Epub 2009 Jul 29. Review.

ReferenceCitation: van Dijk M, Donga E, van Dijk JG, Lammers GJ, van Kralingen KW, Dekkers OM, Corssmit EP, Romijn JA. Disturbed subjective sleep characteristics in adult patients with long-standing type 1 diabetes mellitus. Diabetologia. 2011 Aug;54(8):1967-76. doi: 10.1007/s00125-011-2184-7. Epub 2011 May 15.

ReferenceCitation: Vgontzas AN, Papanicolaou DA, Bixler EO, Hopper K, Lotsikas A, Lin HM, Kales A, Chrousos GP. Sleep apnea and daytime sleepiness and fatigue: relation to visceral obesity, insulin resistance, and hypercytokinemia. J Clin Endocrinol Metab. 2000 Mar;85(3):1151-8.

ReferenceCitation: Young T, Peppard PE, Taheri S. Excess weight and sleep-disordered breathing. J Appl Physiol (1985). 2005 Oct;99(4):1592-9.

lead_sponsor: University Hospital, Grenoble


title: Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

summary: Pancreatectomy represents the classic approach for resectable lesions of the pancreas, duodenum and periampullary region. Due to the technical skills required, the complex anatomy and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still considered to be at risk of postoperative complication mainly due to pancreatic juice leaks. Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the activation of pancreatic enzymes and the following infectious and hemorrhagic complications. Severe complications negatively affect postoperative outcomes, long-term survival, quality of life, and costs. Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization. But in pancreatic surgery mortality rates within 90 days after pancreatic resection are double those at 30 days. In the present study, the investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh postoperative day before discharging the patients to detect undiagnosed postoperative complication.


title: In Vivo Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy: Implications for Recurrent Equinus.

acronym: EQUINUS

summary: This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Mechanical insights to the pathophysiology of the targeted muscles will lead to better understanding and, thus, to a better medical and surgical management of equinus deformity. Secondary aim will provide an important insight whether key gait parameters can be exclusively relied upon for surgical treatment planning and evaluation. In a medium-term perspective, depending upon the results of this study, dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case of cerebral palsy.

lead_sponsor: University Hospital, Brest


title: Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

acronym: OB-APE

summary:
Background :

Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.

Objective :

The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

Strategy and method:

A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).

Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.

Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.

Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.

Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.

lead_sponsor: University Hospital, Lille

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

acronym: PropEHG

summary: The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Electrohaemodynamic Activity in Epileptic Children: Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis

acronym: NIRS Epilepsie

summary: Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci


title: Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.

acronym: TCI-IRMdiff

summary:
Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological substrates of these symptoms are largely unknown.

The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging (DTI).

More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD and patients without ICD. Secondary objectives are to demonstrate a difference in volume of VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus accumbens, amygdala), and in number of fibers between VTA and the other structures of reward system between this two groups. Other objective is to measure and compare these same variables between Parkinson's patients and healthy controls.

We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's patients to ICD.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm

acronym: ERAMPPCI

summary: Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia, particularly the medial globus pallidus, and the clinical expression of these two diseases is characterized by a combination of motor and cognitive disorders, but with two opposing patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive origin. Far fewer studies have been conducted in Huntington's disease. However, all of these studies were performed with different methodologies in small cohorts and the value of the proposed study is to use a validated and standardized computerized mental chronometry paradigm, providing a better understanding of the mechanisms of action slowing in these two diseases and to more clearly define a disease-specific profile.


title: Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task

acronym: SCP TCI NIRS

summary:
Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.


title: Hepatitis C Virus Particles-bound Human Proteins : Identification in Clinical Samples and Implication in the Viral Life Cycle

summary:
The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough understanding of the biology of one of its major causative agents, the hepatitis C virus (HCV). HCV particles acquire via budding and encapsidation cellular proteins. There is mounting evidence on several viral species that virion-bound proteins are prone to be involved either at the replication, budding/egress or entry/release steps of the viral cycle.

Identifying such targets may yield ideal candidates for gaining insight on the dependence of HCV upon a restricted subset of host proteins, therefore providing refined sets of genetically stable targets for therapy. This project's goals are to set up adequate conditions for robust and reproducible purification of HCV virions in clinical samples, followed by the identification of their HCV-bound host proteins and the characterization of their functions. Proteomics profiling of HCV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HCV particles during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HCV virions; (ii) define the modalities of their interaction with HCV proteins; (iii) decipher the topology and subcellular localization of their association with HCV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hépato-Gastroentérologie Lyon Croix-Rousse Hospices Civils de Lyon


title: AlcoholPredict: Neuropsychology, Brain Imaging and Genetic Polymorphisms in Binge Drinking

acronym: AlcoolPredict

summary: The purpose of this study is to specify the psychological, cognitive, neuro-functional and genetic profile associated with binge drinker behaviors among young adults. Results will help identifying more precisely vulnerability factors associated with this pattern of alcohol consumption and guiding prevention efforts.

primary_purpose: Health Services Research

lead_sponsor: CHU de Reims


title: Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia

summary: This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia


title: Effects of Motor Imagery Practice Combined With Transcranial Direct Current Stimulation in the Learning of a Complex Motor Sequence in Young and Elderly Subjects

acronym: MISt

summary:
The mental repetition of movements - or motor imagery (MI) practice - facilitates motor learning. It allows avoiding fatigue that occurs during physical practice; this method is thus particularly interesting for elderly people. Transcranial direct current stimulation (tDCS) is a noninvasive method of neurostimulation during which a low direct current is applied to the brain via electrodes placed on the scalp. This method has been successfully used to enhance motor learning in both young and elderly subjects.

The main aim of this study is to assess the impact of MI practice combined with tDCS on the learning of a complex finger sequence, in young and elderly subjects.

For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly Stim, and Elderly Sham.

All subjects will participate to three training sessions spread over five days, and a retention test one week after the third training session.

During training they will mentally repeat a complex finger sequence with the left hand, for 13 min:

Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.
Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

Immediately before (pretest) and after (posttest) each training session, as well as during the retention test, subjects will repeat the sequence as many times of possible, for 1 min. During these tests (pretests, posttests and retention test) electroencephalographic activity will be recorded to assess the Mu rhythm power.

location_facility: Hospices Civils de Lyon - Hôpital des Charpennes - 27, rue Gabriel Péri


acronym: INTUITIVE

summary:
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:

long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),
long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).

These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.

lead_sponsor: University Hospital, Bordeaux

location_facility: CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque


title: Functional Magnetic Resonance Imaging of Formal Thought Disorders in Bipolar Disorder

acronym: i-TCP

summary: Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. The observations of the patient's speech and language behaviour due to flight of ideas or loss of goal probably result from an underlying disturbance in semantic networks dealing with semantic associations. The aim of our study will be to have a better comprehension of thought disorders in bipolar disorder by cognitive exploration of semantic processing.


title: Morning / Afternoon Variation in Myocardial Ischemia Tolerance

acronym: TOMIS

summary: This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.

ReferenceCitation: Montaigne D, Marechal X, Modine T, Coisne A, Mouton S, Fayad G, Ninni S, Klein C, Ortmans S, Seunes C, Potelle C, Berthier A, Gheeraert C, Piveteau C, Deprez R, Eeckhoute J, Duez H, Lacroix D, Deprez B, Jegou B, Koussa M, Edme JL, Lefebvre P, Staels B. Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbα antagonism: a single-centre propensity-matched cohort study and a randomised study. Lancet. 2018 Jan 6;391(10115):59-69. doi: 10.1016/S0140-6736(17)32132-3. Epub 2017 Oct 26.

family: Montaigne

full_name: David Montaigne

given: David

family: Marechal

full_name: Xavier Marechal

given: Xavier

family: Modine

full_name: Thomas Modine

given: Thomas

family: Coisne

full_name: Augustin Coisne

given: Augustin

family: Mouton

full_name: Stéphanie Mouton

given: Stéphanie

family: Fayad

full_name: Georges Fayad

given: Georges

family: Ninni

full_name: Sandro Ninni

given: Sandro

family: Klein

full_name: Cédric Klein

given: Cédric

family: Ortmans

full_name: Staniel Ortmans

given: Staniel

family: Seunes

full_name: Claire Seunes

given: Claire

family: Potelle

full_name: Charlotte Potelle

given: Charlotte

family: Berthier

full_name: Alexandre Berthier

given: Alexandre

family: Gheeraert

full_name: Celine Gheeraert

given: Celine

family: Piveteau

full_name: Catherine Piveteau

given: Catherine

family: Deprez

full_name: Rebecca Deprez

given: Rebecca

family: Eeckhoute

full_name: Jérome Eeckhoute

given: Jérome

family: Duez

full_name: Hélène Duez

given: Hélène

family: Lacroix

full_name: Dominique Lacroix

given: Dominique

full_name: Benoit Deprez

given: Benoit

family: Jegou

full_name: Bruno Jegou

given: Bruno

family: Koussa

full_name: Mohamed Koussa

given: Mohamed

family: Edme

full_name: Jean-Louis Edme

given: Jean-Louis

family: Lefebvre

full_name: Philippe Lefebvre


title: Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression

acronym: EmoStim

summary: Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.


title: Influence of Patient Characteristics on the Tracheobronchial Anatomy Evaluated by a CT Examination

acronym: Scan-Bronchi

summary:
The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge of the tracheobronchial anatomy in order to establish the best choice for the patient. The literature is limited regarding major bronchi dimensions. In addition, the measurement method is not always adequate or properly described and some publications have evaluated only the left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has been little used.

The project is to conduct a prospective study to compare patient characteristics (age, height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if available), and dimensions of the trachea and of the main bronchi from CT scans with 3D reconstruction.

ReferenceCitation: Jit H, Jit I. Dimensions & shape of the trachea in the neonates, children & adults in northwest India. Indian J Med Res. 2000 Jul;112:27-33.

ReferenceCitation: Chunder R, Nandi S, Guha R, Satyanarayana N. A morphometric study of human trachea and principal bronchi in different age groups in both sexes and its clinical implications. Nepal Med Coll J. 2010 Dec;12(4):207-14.

ReferenceCitation: Zahedi-Nejad N, Bakhshayesh-Karam M, Kahkoei S, Abbasi-Dezfoully A, Masjedi MR. Normal dimensions of trachea and two main bronchi in the Iranian population. Pol J Radiol. 2011 Oct;76(4):28-31.

ReferenceCitation: Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38.

ReferenceCitation: Robinson CL, Müller NL, Essery C. Clinical significance and measurement of the length of the right main bronchus. Can J Surg. 1989 Jan;32(1):27-8. Review.

ReferenceCitation: Eberle B, Weiler N, Vogel N, Kauczor HU, Heinrichs W. Computed tomography-based tracheobronchial image reconstruction allows selection of the individually appropriate double-lumen tube size. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):532-7.

ReferenceCitation: Olivier P, Hayon-Sonsino D, Convard JP, Laloë PA, Fischler M. Measurement of left mainstem bronchus using multiplane CT reconstructions and relationship between patient characteristics or tracheal diameters and left bronchial diameters. Chest. 2006 Jul;130(1):101-7.

ReferenceCitation: Breatnach E, Abbott GC, Fraser RG. Dimensions of the normal human trachea. AJR Am J Roentgenol. 1984 May;142(5):903-6.

ReferenceCitation: Kamel KS, Lau G, Stringer MD. In vivo and in vitro morphometry of the human trachea. Clin Anat. 2009 Jul;22(5):571-9. doi: 10.1002/ca.20815.

ReferenceCitation: Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50.

ReferenceCitation: Mrudula C, Krishnaiah M. The study of bronchial tree. International Journal of Pharma and Bio Sciences 2011;2:B166-B172

ReferenceCitation: Otoch JP, Minamoto H, Perini M, Carneiro FO, de Almeida Artifon EL. Is there a correlation between right bronchus length and diameter with age? J Thorac Dis. 2013 Jun;5(3):306-9. doi: 10.3978/j.issn.2072-1439.2013.03.12.

ReferenceCitation: Kim JH, Park SH, Han SH, Nahm FS, Jung CK, Kim KM. The distance between the carina and the distal margin of the right upper lobe orifice measured by computerised tomography as a guide to right-sided double-lumen endobronchial tube use. Anaesthesia. 2013 Jul;68(7):700-5. doi: 10.1111/anae.12208. Epub 2013 May 8.

lead_sponsor: Hopital Foch


title: Clinical and Social Trajectories of Children and Adolescents With Disruptive Behavior: Multidisciplinary Approach of Pediatric and Psychiatric Emergencies in the Rhône-Alpes Auvergne Region

acronym: TRAJECTORIES

summary:
Conduct disorders are defined as "repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms are violated". So defined, these disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder management is a public health issue and a societal question. Conduct disorders affect 5 to 9% of 15-year old boys.

Care management of children and adolescents admitted for disruptive behaviors in emergency rooms is an issue. No consensus or official recommendation exists. However, use of emergency care in this context is increasing in most western countries and it exposes to several risks (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and suicide risk). The Trajectories project is designed to describe children and adolescents with disruptive behaviors, their care management and to follow their life trajectory and psychiatric evolution after admission to emergency rooms. Better understanding this population will improve their medical and social care management, thereby giving professionals the right tools.

The main objective of this project is to implement a multidisciplinary and integrative research combining clinical considerations and social sciences to determine the "trajectory" of this population.


title: Pathophysiology Analysis of "Costello Syndrome" on Cellular Models

acronym: COSTELLO

summary: The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and the effects of this mutation on energy metabolism and mitochondrial physiology.


title: Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome

acronym: JUMP

summary: Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire de La Réunion


title: Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.

acronym: IPSAASU

summary:
Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and inhibition of 1,25-OH vitamin D).

There are no published studies on the role of FGF23 in undernourished anorexic adolescents taking oral phosphorus supplements.


title: Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers

summary:
Sarcopenia (loss of muscle mass and function) can be observed at any age and results of multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply impacts the physical performance and the basal metabolism, and induces cardiovascular disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on postoperative course in digestive oncology. The search for sarcopenia, complementary nutritional status, is now a source of great interest with 62 ongoing projects in the United States.

The first objective of this study is to evaluate the impact of preoperative sarcopenia on 30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative sarcopenia on the long term outcomes (12 months) on the same patients.


title: Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease

acronym: TAMA

summary: In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.


title: Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept

acronym: SIMMUNIDIA

summary:
Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at the origin of type 2 diabetes and about its complications could make it possible to improve the prevention and the treatment of this disease.

Research team developped a new research axis : the microbiota of the intestinal mucosa. They proved a translocation process of intestinal bacteria from the intestinal mucosa to different tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes and obesity is ongoing.

In parallel, the same team explored the role of intestinal immunity modifications in the bacteria translocation from the gut to the blood circulation. They already have some results on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4 Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity development and type 2 diabetes.

The aim of this study is to explore this hypothesis in human to have therapeutic solution later.

lead_sponsor: University Hospital, Toulouse


type: Registry Identifier

title: LUMIER² Study : LUpus Molecular Immunomonitoring to Evaluate the Risk of Relapse

summary: We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with SLE that are clinically quiescent at inclusion Systemic Lupus Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. Current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with SLE disease activity

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la conception Assistance Publique Hôpitaux de Marseille


title: Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®

summary:
The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile.

The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to anticoagulate the hemodialyzer, on platelet function will be assessed.

primary_purpose: Screening


title: Feasibility and Reproducibility of T1 Rho MRI in the Evaluation of Hip Cartilage

summary: Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage modifications could provide better patient treatment. The T1rho MRI sequence allows the quantification of the cartilage signal that is correlated to modifications of the cartilage matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the measurements. T1rho and T2 mapping sequences were acquired twice during the same session with 30 minutes interval to see if values were modified after a 30 minutes delay in a supine position. The secondary objective was to assess the correlation between T1rho and T2 values.

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie


title: Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness

acronym: SUPRA-PAM

summary: Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.

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


title: Creation and Validation of an Instrument for Measuring the Quality of Experience of a Hemodialysis of Chronic Renal Insufficiency Subject

acronym: VecuHD

summary: Chronic Hemodialysis is a treatment for kidney failure. It involves the construction of three treatment sessions per week extrarenal lasting 4 hours each. This treatment is necessary but it has an impact on the quality of life of patients.The investigators believe that to improve the overall quality of life in hemodialysis patients, the quality of each hemodialysis session must be improved. The quality criterion is not only medical, it must also take into account the patient's perception about the course of its meeting : that's what we call quality of experience of the dialysis session. Our daily healthcare practice shows that each hemodialysis session is experienced differently by the patient according to different factors : physical, psychological, relational, technical, temporal. The quality of the experience of a hemodialysis session could be positively influenced by the use of supplements occupational assets or liabilities, for improving patient satisfaction or by enhancing its relationship with the staff. Indeed, a preliminary study ( in the nephrology unit of our establishment in January 2012) of 8 patients undergoing active occupational educational activity during hemodialysis, showed that the experience of the hemodialysis session was potentially improvable (experienced patients improved, reduced cramps ... ). However, to assess the impact of such measures on the lives of the dialysis session and the quality of life in general, the investigators need to measure the quality of living of a dialysis session. There is not, at present, specific tool to measure the quality of the experience of a hemodialysis session. This tool would measure the impact of a caregiver support occupational during dialysis sessions. The main objective of this study is to create and validate an instrument to measure the quality of living of a hemodialysis of chronic renal insufficiency subject.