title: Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection

acronym: Ultra-Trail

summary:
Hypothesis: To verify whether the use of drugs, in particular performance-enhancing drugs, is prevalent amongst participants in a very long distance mountain trail.

Primary objective : To qualify and quantify drug use amongst participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.

ReferenceCitation: de Hon O, Kuipers H, van Bottenburg M. Prevalence of doping use in elite sports: a review of numbers and methods. Sports Med. 2015 Jan;45(1):57-69. doi: 10.1007/s40279-014-0247-x. Review.

ReferenceCitation: Dietz P, Ulrich R, Dalaker R, Striegel H, Franke AG, Lieb K, Simon P. Associations between physical and cognitive doping--a cross-sectional study in 2.997 triathletes. PLoS One. 2013 Nov 13;8(11):e78702. doi: 10.1371/journal.pone.0078702. eCollection 2013.

ReferenceCitation: McAnulty S, McAnulty L, Nieman D, Morrow J, Dumke C, Henson D. Effect of NSAID on muscle injury and oxidative stress. Int J Sports Med. 2007 Nov;28(11):909-15. Epub 2007 May 31.

ReferenceCitation: Millet GY, Banfi JC, Kerherve H, Morin JB, Vincent L, Estrade C, Geyssant A, Feasson L. Physiological and biological factors associated with a 24 h treadmill ultra-marathon performance. Scand J Med Sci Sports. 2011 Feb;21(1):54-61. doi: 10.1111/j.1600-0838.2009.01001.x.

ReferenceCitation: Robach P, Trebes G, Lasne F, Buisson C, Méchin N, Mazzarino M, de la Torre X, Roustit M, Kérivel P, Botré F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016.

lead_sponsor: University Hospital, Grenoble


title: Investigation of the Prevalence of Fecal Carriage of Extended Spectrum bêta-lactamase Producing Enterobacteriaceae (ESBL) and Carbapenemase Producing Enterobacteriaceae (CPE) in Nursing Homes

acronym: CARBEHPAD

summary:
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.

A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE fecal carriage. Epidemiological data on each resident will be collected to identify risk factors for such carriage.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Nantes University Hospital

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

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.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille

intervention_type: Other


title: Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI

acronym: IMATEM

summary:
Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to 80% against 10-20% in the general population.

The risk of VTE is very important in the first weeks after spinal cord injury, and then declines with a prevalence of VTE slightly higher than the general population after 12 weeks. However there is no prospective study of incidence of VTE in SCI patients after 3 months. The investigators wish to conduct such a study during the year following spinal cord injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial injuryassociated with a standardized clinical assessment, to know the incidence of VTE and determine prognostic factors for VTE.

status: Terminated

study_type: Interventional

primary_purpose: Other

ipd_sharing: No

status_simplified: Unknown


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.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device


title: Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia

acronym: Prenatal Dex

summary: The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for virilization of the external genitalia in girls through androgen hypersecretion during fetal life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen hypersecretion in affected girls and avoiding poor long-term results from reconstructive surgery. Prenatal DEX was used in Europe and the USA but its use was recently suspended: in 2007, a Swedish study conducted on 26 children treated with DEX in utero for a short period of time reported cognitive impairments. These data were not confirmed by an American study on the short-term DEX use, which showed potential cognitive impairments in CAH children exposed to DEX for long periods of time. These confusing and controversial results have caused the scientific community to question its position and have resulted in the suspension of the use of prenatal DEX with drastic consequences for CAH girls (virilization; genital surgery etc.). In this context, an evaluation of neuropsychological development under in utero DEX is essential to validate its indication for use during the prenatal period. This study will evaluate outcomes using prospective cognitive and emotional assessments. It will first focus on the unaffected children previously treated in utero in order to assess the adverse effects of the drug. The study will then assess the children with CAH for whom DEX could have beneficial effects.

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. 59 boulevard Pinel

intervention_type: Behavioral


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.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


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.

primary_purpose: Basic Science

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: 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: Clinical Results After Medical Therapy Alone or Medical Therapy Associated With Lumbar Traction in the Treatment of Nerve Root Pain of Lumbar Disc Herniation With Disco-radicular Conflict

summary: The purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.

status: Recruiting

design_allocation: Randomized

primary_purpose: Treatment

status_simplified: Ongoing


title: Evaluation of Advanced Glycation End Products of Proteins as a Long-term Retrospective Markers of Glycemic Control in a Population of Non-complicated Type 1 Diabetic Children.

acronym: AGEDIA

summary: The objective of the study is to quantify the products of non-enzymatic glycation of proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients without clinical complications in order to define the contribution of this markers in the long-term monitoring of glycemic control in these patients. The results will define the criteria for using these new markers in daily clinical practice for the monitoring of these patients

intervention_type: Biological


title: Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients

acronym: OBESAR

summary: This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.

primary_purpose: Screening


title: Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.

acronym: PrémaSoin

summary: This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery

summary:
In a recent study (Vignon 2017), respiratory variations of the diameter of superior vena cava had a greater diagnostic accuracy than pulse pressure variations and inferior vena cava respiratory variations in 540 medical and surgical ICU patients. But this indicator has not been investigated yet in cardiac surgery. The investigator aim to study respiratory variations of superior vena cava for predicting fluid responsiveness after cardiac surgery.

In post-operative cardiac surgery patients with hemodynamic failure, the investigator will measure respiratory vena caval variations with TEE (Trans oesophageal echocardiography). Then, the investigator will evaluate fluid responsiveness after a fluid challenge (Trendelenburg).

A ROC curve will be constructed in order to assess the optimal sensitivity and specificity of this parameter.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evolution of Maternal & Infantile Health Following Parental Refusal of Termination of Pregnancy Despite Such Option Being Allowable by the Centre Pluridisciplinary de Diagnostic Prenatal (Interdisciplinary Center for Prenatal Diagnostics)

summary:
More and more parents decide to maintain pregnancy which could have been interrupted because of serious fetal pathologies.

In this observational study, the investigators examine obstetrical and pediatric evolution of these pregnancies, from 2006 to 2016 in Montpellier University Hospital.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind

acronym: REVOR

summary: Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.

primary_purpose: Prevention

lead_sponsor: Lille Catholic University

intervention_type: Procedure


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


status: Withdrawn

intervention_type: Drug

title: Induction and Consolidation With Elotuzumab Before and After Peripheral Stem Cell Autologous Graft in Elderly Patients With Multiple Myeloma

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: EudraCT Number

source: euctr

location_facility: Hématologie et thérapie cellulaire, Hôpital Saint Antoine

summary: This is a multicenter, open-label phase II study, assessing the efficacy of elotuzumab in elderly patients with multiple myeloma undergoing peripheral stem cell autologous graft


title: A Single-center, Open-label, Randomized, Two-treatment Crossover Study to Investigate the Effect of Selexipag on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects

summary: The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

lead_sponsor: Actelion

lead_sponsor_type: industriel


title: Multicenter Pilot Study: Measuring the Evolution of Learning Words and Phrases in Children With Autism Spectrum Disorder Using an Innovative Edutainment Software (SEMATIC)

acronym: sematic

summary:
Use of the software could allow learning of reading code in subjects with ASD through the design of serious games for educational and therapeutic purposes.

This SEMATIC software could improve communication and could be integrated into medical management (speech therapy and neuropsychological).

The benefit of an action research will enable training professionals to autism, cognitive characteristics of autism and the use of IT support for this population.

lead_sponsor: Fondation Lenval

location_facility: Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Evaluation of Post-operative Morbidity and Mortality After Cardiac Surgery Performed in Bichat Hospital

acronym: Cardiobase

summary: The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.

ipd_sharing: Yes

ipd_sharing_description: with others French University Hospitals (Rennes, Nantes, Paris (PITIE SALPETRIERE) , Bordeaux)

location_facility: département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard


title: Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

summary:
Reusable (RU) flexible bronchoscopes (FB) require intermediate level disinfection operations to prevent transmission of infectious agents from patient to patient. These operations have a significant material and human cost and impact their availability in case of emergency. One alternative is the use of disposable FB.

The aim of the study is to evaluate the quality of FB during procedures carried out with each of the two solutions in intensive care unit (ICU), respiratory endoscopy (RE) and anesthesia (A) department.

A prospective non-interventional and non-randomized monocentric study compare the operator satisfaction of therapeutic procedures performed with RU FB (EB FujifilmTM range, FB/FI PentaxMedicalTM range, StorzTM intubation FB) versus disposable FB (aScope 3® and aScope 4® (AmbuTM), Broncoflex® (AxessvisionTM). An evaluation form is completed by the operator at the end of procedure. Judging criteria, rated from 0 to 10, concern handling, ergonomics, image and suction quality.

lead_sponsor: University Hospital, Limoges


title: Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)

acronym: MSOSuiStab

summary:
Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional.

It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Centered on problems of attachment, of framework, of trust. The implementation of the opiate substitution treatments and the lifting of the product dependence appears only as a preliminary to the background work with the patient ex-user of opiate.

Finally, the literature provides little information on the experience of general practitioners and their patients under opiate substitution treatments regarding follow-up consultations in the stability phase.

The objective of this work is therefore to study the feelings on follow-up consultations, general practitioners and their patients under opiate substitution treatments considered stabilized.

time_perspective: Other

lead_sponsor: University Hospital, Angers


title: Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study

acronym: talobot

summary: This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.


title: Nutritional Status Assessment in the Elderly Suffering From Cancer (NutriAgeCancer) : a National Cross-UCOG Survey

acronym: NutriAgeCancer

summary:
Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the "Unités de Coordination en Oncogériatrie".

The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.

lead_sponsor: Société Francophone d'Onco-Gériatrie


type: Registry Identifier

title: Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly

acronym: ATROPAGE

summary:
The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:

Pharmacoepidemiological: identify factors associated with postoperative confusion
Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.
Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).

In total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.

lead_sponsor: University Hospital, Toulouse


title: Hyperglycemic Response to Steroid Administration After Noncardiac Surgery in Patients With and Without Diabetes

acronym: DexGlySurg

summary: The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include > 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Starches Digestion After Obesity Surgery. A Comparative Study.

acronym: GLUBYPASS

summary:
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. The aim of this study is to study the digestion of starch as compared to that of glucose (same glucose load) before and after gastric bypass surgery in obese patients.

Volunteers will be recruited among the candidates to a gastric bypass, and will be studied before and 3 months after surgery. They will have on each occasion 2 random meals, corresponding to 30g glucose, one made of starch the other made of glucose, both naturally labeled with 13C. The digestion of starch will be assessed with the increase in the plasma 13C-glucose tracer. Plasma samples will be collected for 3 hours.

Some studies have already investigated time of absorption of glucose, but any study has examined the time of digestion of glucose. Other study always used glucose syrup, so they cannot have results about digestion. It is the reason why, in this study, glucose syrup and a starch meal will be taken by the same patient and glycaemia will be compared. In this way, results will be obtained about the kinetic of digestion of starch.

location_facility: Department of Endocrinology, metabolic diseases and nutrition


title: Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients

acronym: ONCOVIR

summary: The purpose of this study is to assess the duration of the viral shedding in hematology and oncology patients after a respiratory tract viral infection. This duration has not been much studied in that population whereas it is probably longer than that in immunocompetent patients. Thereby it may be a source of transmission amongst these immunocompromised patients.

lead_sponsor: Poitiers University Hospital

intervention_type: Diagnostic Test


title: Assessment of Coronary Endothelial Function and Myocardial Fibrosis in Positron Emission Tomography With the Waning of Acute Coronary Syndrome With Elevated ST Segment : Relationship With Left Ventricular Remodeling

acronym: REMOD-TEP

summary: Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.

status: Suspended

lead_sponsor: University Hospital, Caen


title: Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy

acronym: IMPRA

summary: The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.


title: Effects of Parabolic Flight on Spatial Cognition and Hippocampal Plasticity

acronym: HypoCampus

summary:
The main objective of this experiment is to assess the impact of parabolic flight on (1) spatial memory and orientation, (2) the changes in brain structure and function, and particularly the hippocampal formation, and (3) biochemical markers of stress and neuroplasticity.

A preliminary study will be performed with the aims (1) to test during weightlessness hardware used to administer visuo-spatial testing and (2) to determine the optimal body posture for testing under microgravity conditions (i.e. body posture for which change in visuo-spatial testing induced by weightlessness is maximal).

The main criteria are:

Structural and functional changes of brain evaluated by fMRI;
Cognitive performance, and specifically spatial cognition using a series computer-based tasks.
Key neurotrophins determined in venous blood samples The criteria used in the preliminary experiment is visuo-spatial performance evaluated with a computer-based test assessing spatial cognition.

The investigators hypothesize that hippocampal structure and function, and particularly the dentate gyrus, will be altered after parabolic flight compared to ground based controls. Specifically, the 3 tested hypotheses are:

Parabolic flight induces changes in hippocampal structure;
Weightlessness induces changes in cognitive performance, and specifically spatial cognition;
There is a correlation between changes in hippocampal structure and changes in visuo-spatial memory performance.
There is a correlation between changes in hippocampal structure and changes in key neurotrophins.

The hypothesis tested during the preliminary experiment is that body posture affects the changes in spatial cognition performance.


title: Conflict Detection Development During the Reasoning

acronym: DéCoR

summary: The study to explore the development of these abilities with age, and called "Development of the conflict detection during the reasoning - Decor" will take place at CYCERON center and will include two groups of 22 participants: adolescents and young adults (N = 44). More specifically, this study aims to compare the changes in the brain of adolescents and young adults when conducting reasoning tasks for which there may be a cognitive conflict. Both groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain and in which they will carry out two classic tasks covering the main areas of reasoning (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of making information call intuition to create or not a conflict between the correct answer (logic, normative) and biased response (intuitive, heuristic). Because of the major implication of this brain region in cognitive inhibition processes [of intuitive answer], measured brain activity in the anterior cingulate cortex (ACC) during both tasks version "with" or "no" conflict will be compared between groups. To better understand the links between the development of the CCA from adolescence to adulthood and conflict detection, activity measurements will be correlated with a part in morphometric measurements taken from the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly to cognitive measures (executive functions - inhibitory control). This cross-sectional study focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation of men / boys and women / girls will be balanced up.


title: Study of Collagen IV and XIX in Bronchoalveolar Lavage, Pulmonary Aspiration and Bronchial Biopsies

acronym: BRONCOLL

summary:
Collagens are proteins present in all tissues. Besides their structural role, recent data showed that they were able to regulate many cellular functions. Many interactions occur between extracellular matrix macromolecules, especially collagen, and various cell types. These interactions can be controlled by peptides derived extracellular matrix macromolecules, called matrikines. Previous work from the investigators laboratory and others have shown that several C-terminal domain (NC1 domains) from basement membrane-associated collagens could regulate many cellular activities.

Lung is an organ particularly abundant in basement membranes. It is likely that various lung diseases may affect metabolism of basement membrane associated collagens. To the investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in various pathophysiological situations.

The aim of this study are to:

Study the presence of collagen IV and XIX (or fragments) in different types of sampling such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies
Evaluate quantitative variations of expression of these collagen in different pulmonary diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia, pneumonitis or lung cancer.

ReferenceType: background

ReferenceCitation: Dupont-Deshorgue A, Oudart JB, Brassart B, Deslee G, Perotin JM, Diebold MD, Monboisse JC, Ramont L, Brassart-Pasco S. A competitive enzyme-linked immunosorbent assay for quantification of tetrastatin in body fluids and tumor extracts. Anal Biochem. 2015 Aug 1;482:16-21. doi: 10.1016/j.ab.2015.04.023. Epub 2015 Apr 29.


title: Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals

acronym: TREVORS

summary: The explanatory mechanism of the relationship between the volume of surgical procedures performed by individual hospitals and the occurrence of serious adverse events is not clear. Based on the " practice makes perfect " dogma, we will explore whether a learning effect can explain the volume-outcome relationship for complex surgical procedures using a nationwide dataset. Especially, we assume that increasing volume of procedures over time may be associated with improved outcomes.

ReferenceType: derived

ReferenceCitation: Payet C, Polazzi S, Lifante JC, Cotte E, Grinberg D, Carty MJ, Sanchez S, Rabilloud M, Duclos A. Influence of trends in hospital volume over time on patient outcomes for high-risk surgery. BMC Health Serv Res. 2020 Apr 1;20(1):274. doi: 10.1186/s12913-020-05126-4.

lead_sponsor: Hospices Civils de Lyon

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon


title: Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)

acronym: SUDEP

summary: The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.

location_facility: Hospices Civils de Lyon - Institut Médico-Légal


title: Comparison of the Mallampati Score in Supine or Sitting Position With and Without Phonation to Predict Difficult Airway Management

summary:
Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score. Furthermore, some patients cannot be evaluated in sitting position because (emergency, fractures, pain, supine position require for medical or surgical pathology...).

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.


title: Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity

summary:
Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term.

Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.


title: Evaluation of the Effect of Double Inhibition of Angiotensin II AT1 Receptor and Neprilysin Activity on Sympathic Nervous System Activity in Patient With Heart Failure

summary: The hyperactivation of the sympathetic nervous system is a feature of the heart failure and the determinants of disease progression and risk of sudden cardiac death. This research project aims to study, in the drug use conditions provided in the summary of product characteristics based on European marketing authorization (indications and dosage), the effect of the Entresto® on the activity of sympathic nervous system using the reference method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA). This study will try to determine if the double inhibition of AT1 receptor and neprilysin activity result in lower sympathic nervous system burst rate versus single AT1 receptor inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor.


title: Virtual Reality and Brain Stimulation, an Experiential Approach

acronym: REVISTIM-X

summary: The aim of this study is to assess feasibility, acceptability and efficacy of two VRET (Virtual Reality Exposition Therapy)session associated with either active anodal tDCS or sham tDCS on the ventromedial prefrontal cortex to decrease anxiety related to visual height intolerance

lead_sponsor: Nantes University Hospital


title: Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.

acronym: Honeymoon

summary:
Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.

Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.

lead_sponsor: University Hospital, Grenoble


title: Feasibility of Regional Lung Ventilation Imaging Using 3T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences (PULMOREM Study)

acronym: PULMOREM

summary: Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in regional lung ventilation. The quantitative assessment of structural and functional alterations in the lung is of great importance for the phenotyping and follow-up of CF patients. The goal of this study is to assess the feasibility of measuring the changes in proton density in the lung parenchyma with inflation and deflation during the respiratory cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates

acronym: PHYSIOMECO

summary:
During pregnancy, the foetus is therefore chronically exposed to a large number of substances. A number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). However, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. This is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected.

The PhysioMéco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. Sleep and respiratory control will be studied in these neonates nursed in incubators. Hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.


title: The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?

acronym: PROSPECT

summary:
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.

The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk

The secondary objectives are:

To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
To evaluate values of other clotting activation markers in patients with cancer

Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.

Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.

The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.

location_facility: Unité d'Hémostase Clinique Hôpital Louis Pradel


title: Role of the Posterior Parietal Cortex in the Processing of Sensory Information Modulating the Excitability of the Primary Motor Cortex in Humans

acronym: CORTEX

summary: Although the primary motor cortex is considered has the common final pathway of motor commands, it is influenced by several structures as, for example, the premotor cortex and the posterior parietal cortex which are involved in motor planning and programming and which integrates movement-induced sensory impute (parieto-frontal circuits). Several studies have shown that there are some direct functional connections between the premotor cortex and the posterior parietal cortex and from these two regions to the primary motor cortex. The posterior parietal cortex can then be considered as a sensorimotor interface whose function in planification and motor control of upper limb is well demonstrated. The hypothesis is that the posterior parietal cortex could participate to the modulation of motor cortex excitability by proprioceptive sensory inputs namely long latency afferent inhibition and afferent induced facilitation.

lead_sponsor: University Hospital, Lille


title: Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound

acronym: TPN

summary: the aim of the study is to evaluate the efficiency of the therapy with negative pression (TPN) and instillation in the debridement of chronic wound


title: A Pilot Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Pulmonary Fibrosis With Anti-myeloperoxydase (MPO) Antibodies or With Anti-MPO Associated Vasculitis."

acronym: PIRFENIVAS

summary: The purpose of this study is to determine wether pirfenidone is safe and effective in the treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary fibrosis with anti-MPO associated vasculitis.

ReferenceCitation: Hervier B, Pagnoux C, Agard C, Haroche J, Amoura Z, Guillevin L, Hamidou MA; French Vasculitis Study Group. Pulmonary fibrosis associated with ANCA-positive vasculitides. Retrospective study of 12 cases and review of the literature. Ann Rheum Dis. 2009 Mar;68(3):404-7. doi: 10.1136/ard.2008.096131. Epub 2008 Oct 28. Review.

ReferenceCitation: King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18. Erratum in: N Engl J Med. 2014 Sep 18;371(12):1172.

ReferenceCitation: Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.


title: Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient

acronym: VITRECAT

summary: This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: URC Fondation Ophtalmologique A de Rothschild


title: Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).

acronym: COMPULCE

summary: The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.

lead_sponsor: Thuasne


acronym: DBS V3

summary: Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.


title: Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery

acronym: SUCCESS

summary:
This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.

Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.

Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).

Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.

ReferenceCitation: Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. Review.

ReferenceCitation: Gavazzi A, Berzuini C, Campana C, Inserra C, Ponzetta M, Sebastiani R, Ghio S, Recusani F. Value of right ventricular ejection fraction in predicting short-term prognosis of patients with severe chronic heart failure. J Heart Lung Transplant. 1997 Jul;16(7):774-85.

ReferenceCitation: Christakis GT, Fremes SE, Weisel RD, Ivanov J, Madonik MM, Seawright SJ, McLaughlin PR. Right ventricular dysfunction following cold potassium cardioplegia. J Thorac Cardiovasc Surg. 1985 Aug;90(2):243-50.

ReferenceCitation: Durand M, Chavanon O, Tessier Y, Casez M, Gardellin M, Blin D, Girardet P. Right ventricular function after coronary surgery with or without bypass. J Card Surg. 2006 Jan-Feb;21(1):11-6.

ReferenceCitation: Mouren S, Delayance S, Mion G, Souktani R, Fellahi JL, Arthaud M, Baron JF, Viars P. Mechanisms of increased myocardial contractility with hypertonic saline solutions in isolated blood-perfused rabbit hearts. Anesth Analg. 1995 Oct;81(4):777-82.

ReferenceCitation: Ueti OM, Camargo EE, Ueti Ade A, de Lima-Filho EC, Nogueira EA. Assessment of right ventricular function with Doppler echocardiographic indices derived from tricuspid annular motion: comparison with radionuclide angiography. Heart. 2002 Sep;88(3):244-8.

ReferenceCitation: Hammarström E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9.

ReferenceCitation: Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22.

ReferenceCitation: Scolletta S, Bodson L, Donadello K, Taccone FS, Devigili A, Vincent JL, De Backer D. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med. 2013 Jun;39(6):1025-33. doi: 10.1007/s00134-013-2861-8. Epub 2013 Mar 9.

location_facility: Reanimation Cardiovasculaire Et Thoracique


title: Validation of an Ecological Assessment of Executive Function (Multiple Errands Test) in Patients With Schizophrenia : Study of Discriminant Validity

acronym: VALITEM

summary:
Schizophrenia (SZ) is a chronic, severe disease resulting in a misperception of reality, major social withdrawal and cognitive disturbances. Executive dysfunctions are widely considered as primary determinants of functional outcome. However, classic neuropsychological executive function measures poorly represent patients' functional outcome and seem inappropriate to evaluate the real-world functional impact of the disease.

In this perspective, Shallice and Burgess have developed for brain-damaged patients, the Multiple Errands Test (MET) allowing to assess planning, adaptation, problem solving and mental flexibility in real life settings, thus better capturing day-to-day abilities and including contextual (social, perceptive) influences. Setting the assessment outside the laboratory can help to identify subtle executive impairment not systematically expressed in standard care conditions and consequently improve the future care solutions. MET is based on the Supervisory Attentional System (SAS) model of executive functioning and attention control that specifies how thought and action schema become activated or suppressed for routine and non-routine circumstances .

MET has been designed to measure real-world executive performance confronting the participants to unpredictable affordances and interpersonal interactions while planning and problem solving. Patients are asked to accomplish several tasks of variable complexity in an unknown commercial district. A number of rules must be respected and thus an action plan, strategy formulation, time and space management with very little assistance of the examiner are required.

Most of the studies involving MET were conceived for patients with acquired brain damage. LeThiec offered an extensive protocol with the initial scoring system (in terms of inefficiencies, rule breaks, interpretation failures and task execution failures). Simplified versions of MET were also suggested to be more suitable in hospital settings. Only one study was done in SZ including a single patient, it is therefore difficult to draw conclusions about clinical utility in SZ. To date, no other studies investigated the suitability of MET in patients with psychosis, while executive impairment is well documented in this population The investigators hypothesized that the Multiple Errands Test (MET), an ecological assessment of executive function has a better ability to measure everyday adaptative functioning SZ, compared to conventional EF assessment methods.

The objectives of this study are: (1) establish normative data and (2) study discriminant validity of this tool with a large panel of EF measures.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

acronym: DALARI

summary: Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin

location_facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard


title: Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension Detected by an Artificial Nose: A Clinical Validation Study

summary:
In this prospective case-control study, the investigators will evaluate the diagnostic performance of a novel electronic nose (E-nose) for the detection of Pulmonary Arterial Hypertension (PAH). This study is designed to:

Assess the performance of the E-nose to discriminate controls from patients with PAH
Assess the performance of the E-nose to discriminate between different subtypes of pulmonary hypertension (PH), namely idiopathic PAH, heritable PAH with BMPR2 mutation and chronic thromboembolic PH
Assess the performance of the E-nose to discriminate controls from asymptomatic patients with PH who carry BMPR2 mutations.


title: Effect of Prehabilitation in Gastroesophageal Adenocarcinoma: Study Protocol of a Multicentric, Randomised Control Trial

acronym: PREHAB

summary:
Perioperative chemotherapy is the gold standard treatment in the resectable and advanced gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and evaluates chemosensitivity. Disease free and overall survival rates were significantly improved with perioperative chemotherapy compared to surgery alone. However, the limitation of these studies is that among all patients requiring chemotherapy, almost 70% of patients will not have the complete sequence. This sequence is defined by the administration of 2 to 4 cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major cause of absence or impossibility of realization of postoperative chemotherapy was the presence of postoperative complication, postoperative serious asthenia and impaired nutritional and physical status (1,2). Poor physical condition assessed by cardiopulmonary exercise testing, reflecting a reduced physiological reserve, is predictive of postoperative complications (3,4). A physical training, even during a short period and on a various population, is beneficial in improving physical condition, cardiopulmonary function and muscular mass of the patient (5-8). A prehabilitation over a 6 week period between surgical consultation and surgery decreases postoperative morbidity and the hospital stay in cardiovascular surgery but no study has ever been performed in the gastric or oesophageal cancer (7,9).

Prehabilitation revolves around three axes: 1) a physical training based on initial cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure the compliance of the nutrition program and adapt the nutritional management based on protein and energy needs and on the level of spontaneous oral intake and 2) a psychological treatment by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever focused on the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be particularly important because 1) this surgery is associated with a high postoperative morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional status of these patients is often precarious (cancer cachexia, gastroesophageal obstruction), and 3) the need to preoperative chemotherapy declines physical reserves and is associated with a lengthening of the time between consultation and surgery of more than 3 months (10). Also, the investigators hypothesize that with a physical training, a personalized nutritional support and a psychologist management may decrease postoperative complications, increase postoperative nutritional status and so, would allow for more patients to receive their full cancer treatment. The aim of this study was to evaluate, in gastroesophageal adenocarcinoma, the effect of prehabilitation compared to conventional care, the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board.

ReferenceCitation: Le Roy B, Pereira B, Bouteloup C, Costes F, Richard R, Selvy M, Pétorin C, Gagnière J, Futier E, Slim K, Meunier B, Mabrut JY, Mariette C, Pezet D. Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial-the PREHAB study. BMJ Open. 2016 Dec 7;6(12):e012876. doi: 10.1136/bmjopen-2016-012876.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

acronym: GASTROPOP

summary:
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.

By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.

ReferenceType: result

ReferenceCitation: Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotté P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.


title: Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)

summary: The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

location_facility: Clinical research center of Grenoble university hospital


title: Evaluation of Tissue Regeneration Potential (in the Skin) of Child's Adipose Cells During the Development.

acronym: cicASChild

summary: The beneficial effect related to the administration of adipose tissue-derived stromal cells (ADSC) is demonstrated in various situations of physiological and pathological wound healing, thus opening a new field for cell therapy. Despite the use of new technologies, management of burns in children as well as congenital malformation such as hypospadias and cleft lip and/ or cleft palate can lead to aesthetic and functional sequelae requiring multiple surgical procedures. Cell therapy based on the administration of the ADSC seems a promising issue in such indications, however, to date no study has been conducted with ADSC from a pediatric population. An initial study (Protocol 0808203) allowed investigors to obtain the first samples of adipose tissue from children and to conduct an in vitro comparative study on the characterization and properties of the ADSC from children compared to adults. In the continuity, this second study aims to complete knowledge on the efficacy and safety of children ADSC cell therapy assessed in an animal model of skin wound healing developed in the lab.

ReferenceCitation: Abbo O, Taurand M, Monsarrat P, Raymond I, Arnaud E, De Barros S, Auriol F, Galinier P, Casteilla L, Planat-Benard V. Comparison between pediatric and adult adipose mesenchymal stromal cells. Cytotherapy. 2017 Mar;19(3):395-407. doi: 10.1016/j.jcyt.2016.11.012. Epub 2016 Dec 28.


title: The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances

acronym: CHAM

summary: This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.

lead_sponsor: Centre d'Expertise sur l'Altitude EXALT


acronym: STERPROSER

summary:
Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.

Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.

Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

lead_sponsor: Hopital Foch


title: Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia

acronym: LICIdystonie

summary: Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.


title: Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular

acronym: DOM

summary: To better define the clinical characteristics of oromandibular dystonia, we aimed to study voice, speech and swallowing disorders in idiopathic oromandibular We planned to include consecutive patients followed in Lille Movement disorders department for idiopathic oromandibular dystonia and matched, healthy control subjects. Voice and speech disorders had to be assessed with the phonetic analysis, perceptive analysis and motor examination modules of the "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria), the Grade, Rough, Breathy, Asthenic, Strained scale, and a computer recording. Activities of daily living had to be assessed with the Oromandibular Dystonia Questionnaire, the Voice Handicap Index and the Deglutition Handicap Index.


title: Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination

acronym: VARI-IMM

summary:
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.

Secondary goals :

Correlation memory / Immunity;
Prevalence of VZV immunity in pregnant women;
Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
Evaluation of acceptability of vaccination in the post partum period in non immune patients.

Methods Not randomized prospective study,

Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients

ReferenceCitation: LAFORET EG, LYNCH CL Jr. Multiple congenital defects following maternal varicella; report of a case. N Engl J Med. 1947 Apr 10;236(15):534-7. doi: 10.1056/NEJM194704102361504.

ReferenceCitation: Alkalay AL, Pomerance JJ, Rimoin DL. Fetal varicella syndrome. J Pediatr. 1987 Sep;111(3):320-3.

ReferenceCitation: SAUERBREI A. Fetales varizellen syndrom. Monatsschr kinderheiledkd 2003;151:209-213.

ReferenceCitation: Miller E, Cradock-Watson JE, Ridehalgh MK. Outcome in newborn babies given anti-varicella-zoster immunoglobulin after perinatal maternal infection with varicella-zoster virus. Lancet. 1989 Aug 12;2(8659):371-3.

ReferenceCitation: ENDERS G. Varicella and herpes zoster in pregnancy and the newborn. . Varicella-zoster virus and clinical management. Arvin AM and Gershon AA, eds; UK: Cambridge University Press 2000:317-347.

ReferenceCitation: MIRLESSE V. Varicelle et grossesse. Les virus transmissibles de la mère à l'enfant. Denis F. Ed John Libey Eurotext, In Montrouge 1999:252-269.

ReferenceCitation: Khoshnood B, Debruyne M, Lançon F, Emery C, Fagnani F, Durand I, Floret D. Seroprevalence of varicella in the French population. Pediatr Infect Dis J. 2006 Jan;25(1):41-4.

ReferenceCitation: Wu MF, Yang YW, Lin WY, Chang CY, Soon MS, Liu CE. Varicella zoster virus infection among healthcare workers in Taiwan: seroprevalence and predictive value of history of varicella infection. J Hosp Infect. 2012 Feb;80(2):162-7. doi: 10.1016/j.jhin.2011.11.011. Epub 2011 Dec 19.

ReferenceCitation: Vandersmissen G, Moens G, Vranckx R, de Schryver A, Jacques P. Occupational risk of infection by varicella zoster virus in Belgian healthcare workers: a seroprevalence study. Occup Environ Med. 2000 Sep;57(9):621-6.

ReferenceCitation: Alp E, Cevahir F, Gökahmetoglu S, Demiraslan H, Doganay M. Prevaccination screening of health-care workers for immunity to measles, rubella, mumps, and varicella in a developing country: What do we save? J Infect Public Health. 2012 Apr;5(2):127-32. doi: 10.1016/j.jiph.2011.11.003. Epub 2012 Jan 18.

ReferenceCitation: Almuneef M, Memish ZA, Abbas ME, Balkhy HH. Screening healthcare workers for varicella-zoster virus: can we trust the history? Infect Control Hosp Epidemiol. 2004 Jul;25(7):595-8.

ReferenceCitation: Saadatian-Elahi M, Mekki Y, Del Signore C, Lina B, Derrough T, Caulin E, Thierry J, Vanhems P. Seroprevalence of varicella antibodies among pregnant women in Lyon-France. Eur J Epidemiol. 2007;22(6):405-9. Epub 2007 May 30.

ReferenceCitation: Reignier F, Romanò L, Thiry N, Beutels P, Van Damme P, Fau C, Gaspard C, Mamoux V, Zanetti A, Floret D. [Varicella-zoster virus seroprevalence in nursery and day-care workers in Lyon (France)]. Med Mal Infect. 2005 Apr;35(4):192-6. French.

ReferenceCitation: Dashraath P, Ong ES, Lee VJ. Seroepidemiology of varicella and the reliability of a self-reported history of varicella infection in Singapore military recruits. Ann Acad Med Singap. 2007 Aug;36(8):636-41.

ReferenceCitation: Fung LW, Lao TT, Suen SS, Chan OK, Lau TK, Ngai KL, Chan PK, Leung TY. Seroprevalence of varicella zoster virus among pregnant women in Hong Kong: comparison with self-reported history. Vaccine. 2011 Oct 26;29(46):8186-8. doi: 10.1016/j.vaccine.2011.08.090. Epub 2011 Sep 10.

ReferenceCitation: Pourahmad M, Davami MH, Jahromi AR. Evaluation of anti-varicella antibody in young women before their marriage: A sero-epidemiologic study in Iran. J Clin Virol. 2010 Aug;48(4):260-3. doi: 10.1016/j.jcv.2010.04.015. Epub 2010 Jun 9.

ReferenceCitation: Perella D, Fiks AG, Jumaan A, Robinson D, Gargiullo P, Pletcher J, Forke CM, Schmid DS, Renwick M, Mankodi F, Watson B, Spain CV. Validity of reported varicella history as a marker for varicella zoster virus immunity among unvaccinated children, adolescents, and young adults in the post-vaccine licensure era. Pediatrics. 2009 May;123(5):e820-8. doi: 10.1542/peds.2008-3310. Erratum in: Pediatrics. 2009 Aug;124(2):846.

ReferenceCitation: Koturoglu G, Kurugol Z, Turkoglu E. Seroepidemiology of varicella-zoster virus and reliability of varicella history in Turkish children, adolescents and adults. Paediatr Perinat Epidemiol. 2011 Jul;25(4):388-93. doi: 10.1111/j.1365-3016.2010.01180.x. Epub 2011 Apr 3.

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ReferenceCitation: Breuer J, Schmid DS, Gershon AA. Use and limitations of varicella-zoster virus-specific serological testing to evaluate breakthrough disease in vaccinees and to screen for susceptibility to varicella. J Infect Dis. 2008 Mar 1;197 Suppl 2:S147-51. doi: 10.1086/529448. Review.

ReferenceCitation: Maple PA, Rathod P, Smit E, Gray J, Brown D, Boxall EH. Comparison of the performance of the LIAISON VZV-IgG and VIDAS automated enzyme linked fluorescent immunoassays with reference to a VZV-IgG time-resolved fluorescence immunoassay and implications of choice of cut-off for LIAISON assay. J Clin Virol. 2009 Jan;44(1):9-14. doi: 10.1016/j.jcv.2008.08.012. Epub 2008 Sep 27.

ReferenceCitation: Sauerbrei A, Schäfler A, Hofmann J, Schacke M, Gruhn B, Wutzler P. Evaluation of three commercial varicella-zoster virus IgG enzyme-linked immunosorbent assays in comparison to the fluorescent-antibody-to-membrane-antigen test. Clin Vaccine Immunol. 2012 Aug;19(8):1261-8. doi: 10.1128/CVI.00183-12. Epub 2012 Jun 20.

ReferenceCitation: Tischer A, Gassner M, Richard JL, Suter-Riniker F, Mankertz A, Heininger U. Vaccinated students with negative enzyme immunoassay results show positive measles virus-specific antibody levels by immunofluorescence and plaque neutralisation tests. J Clin Virol. 2007 Mar;38(3):204-9. Epub 2007 Feb 7.

ReferenceCitation: Mancuso JD, Krauss MR, Audet S, Beeler JA. ELISA underestimates measles antibody seroprevalence in US military recruits. Vaccine. 2008 Sep 8;26(38):4877-8. doi: 10.1016/j.vaccine.2008.06.028. Epub 2008 Jun 27.

ReferenceCitation: Seward JF, Watson BM, Peterson CL, Mascola L, Pelosi JW, Zhang JX, Maupin TJ, Goldman GS, Tabony LJ, Brodovicz KG, Jumaan AO, Wharton M. Varicella disease after introduction of varicella vaccine in the United States, 1995-2000. JAMA. 2002 Feb 6;287(5):606-11.


title: Risk Factors for Further Bleeding in Patients Admitted to Intensive Care for Gastro Intestinal Bleeding

acronym: HDréa

summary:
Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit admission. Although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes.

This study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to ICU for GI bleeding.

lead_sponsor: University Hospital, Brest


title: Narcolepsy Protect Against Alzheimer's Disease? Protective Role of Low Rates of Orexin on the Occurrence of Intracerebral Amyloid Deposits Characteristic of the Alzheimer's Disease: A Pilot Study

acronym: PROTECMAN

summary: Links between orexin and amyloid processes have been underlined recently. During the Alzheimer's process an upregulation of the orexin mechanism has been observed. The pathophysiological mechanism of narcolepsy type 1 is linked to orexin deficiency. Thus, the investigators hypothesized that patients with narcolepsy may be protected from amyloid brain lesions, hallmarks of the Alzheimer's process. To test this hypothesis, the investigators analyzed the brain amyloid load measured by PET-scan amyloid brain imaging in patients with narcolepsy type 1 compared to controls without cognitive deficits.

ReferenceCitation: Bateman RJ, Munsell LY, Morris JC, Swarm R, Yarasheski KE, Holtzman DM. Human amyloid-beta synthesis and clearance rates as measured in cerebrospinal fluid in vivo. Nat Med. 2006 Jul;12(7):856-61. Epub 2006 Jun 25.

ReferenceCitation: Bateman RJ, Wen G, Morris JC, Holtzman DM. Fluctuations of CSF amyloid-beta levels: implications for a diagnostic and therapeutic biomarker. Neurology. 2007 Feb 27;68(9):666-9.

ReferenceCitation: Mawuenyega KG, Sigurdson W, Ovod V, Munsell L, Kasten T, Morris JC, Yarasheski KE, Bateman RJ. Decreased clearance of CNS beta-amyloid in Alzheimer's disease. Science. 2010 Dec 24;330(6012):1774. doi: 10.1126/science.1197623. Epub 2010 Dec 9.

ReferenceCitation: Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.

ReferenceCitation: Mendelsohn AR, Larrick JW. Sleep facilitates clearance of metabolites from the brain: glymphatic function in aging and neurodegenerative diseases. Rejuvenation Res. 2013 Dec;16(6):518-23. doi: 10.1089/rej.2013.1530. Review.

ReferenceCitation: Kang JE, Lim MM, Bateman RJ, Lee JJ, Smyth LP, Cirrito JR, Fujiki N, Nishino S, Holtzman DM. Amyloid-beta dynamics are regulated by orexin and the sleep-wake cycle. Science. 2009 Nov 13;326(5955):1005-7. doi: 10.1126/science.1180962. Epub 2009 Sep 24.

ReferenceCitation: Coogan AN, Schutová B, Husung S, Furczyk K, Baune BT, Kropp P, Häßler F, Thome J. The circadian system in Alzheimer's disease: disturbances, mechanisms, and opportunities. Biol Psychiatry. 2013 Sep 1;74(5):333-9. doi: 10.1016/j.biopsych.2012.11.021. Epub 2012 Dec 28. Review.

ReferenceCitation: Wu YH, Zhou JN, Van Heerikhuize J, Jockers R, Swaab DF. Decreased MT1 melatonin receptor expression in the suprachiasmatic nucleus in aging and Alzheimer's disease. Neurobiol Aging. 2007 Aug;28(8):1239-47. Epub 2006 Jul 11.

ReferenceCitation: Mirmiran M, Swaab DF, Kok JH, Hofman MA, Witting W, Van Gool WA. Circadian rhythms and the suprachiasmatic nucleus in perinatal development, aging and Alzheimer's disease. Prog Brain Res. 1992;93:151-62; discussion 162-3. Review.

ReferenceCitation: Hoogendijk WJ, van Someren EJ, Mirmiran M, Hofman MA, Lucassen PJ, Zhou JN, Swaab DF. Circadian rhythm-related behavioral disturbances and structural hypothalamic changes in Alzheimer's disease. Int Psychogeriatr. 1996;8 Suppl 3:245-52; discussion 269-72.

ReferenceCitation: Dauvilliers YA, Lehmann S, Jaussent I, Gabelle A. Hypocretin and brain β-amyloid peptide interactions in cognitive disorders and narcolepsy. Front Aging Neurosci. 2014 Jun 11;6:119. doi: 10.3389/fnagi.2014.00119. eCollection 2014.

ReferenceCitation: Liguori C, Romigi A, Nuccetelli M, Zannino S, Sancesario G, Martorana A, Albanese M, Mercuri NB, Izzi F, Bernardini S, Nitti A, Sancesario GM, Sica F, Marciani MG, Placidi F. Orexinergic system dysregulation, sleep impairment, and cognitive decline in Alzheimer disease. JAMA Neurol. 2014 Dec;71(12):1498-505. doi: 10.1001/jamaneurol.2014.2510.

ReferenceCitation: Slats D, Claassen JA, Verbeek MM, Overeem S. Reciprocal interactions between sleep, circadian rhythms and Alzheimer's disease: focus on the role of hypocretin and melatonin. Ageing Res Rev. 2013 Jan;12(1):188-200. doi: 10.1016/j.arr.2012.04.003. Epub 2012 Apr 30. Review.

ReferenceCitation: Yoshida Y, Fujiki N, Nakajima T, Ripley B, Matsumura H, Yoneda H, Mignot E, Nishino S. Fluctuation of extracellular hypocretin-1 (orexin A) levels in the rat in relation to the light-dark cycle and sleep-wake activities. Eur J Neurosci. 2001 Oct;14(7):1075-81.

ReferenceCitation: Roh JH, Jiang H, Finn MB, Stewart FR, Mahan TE, Cirrito JR, Heda A, Snider BJ, Li M, Yanagisawa M, de Lecea L, Holtzman DM. Potential role of orexin and sleep modulation in the pathogenesis of Alzheimer's disease. J Exp Med. 2014 Dec 15;211(13):2487-96. doi: 10.1084/jem.20141788. Epub 2014 Nov 24. Erratum in: J Exp Med. 2015 Jan 12;212(1):121.

ReferenceCitation: Wennström M, Londos E, Minthon L, Nielsen HM. Altered CSF orexin and α-synuclein levels in dementia patients. J Alzheimers Dis. 2012;29(1):125-32. doi: 10.3233/JAD-2012-111655.

ReferenceCitation: Gabelle A, Jaussent I, Bouallègue FB, Lehmann S, Lopez R, Barateau L, Grasselli C, Pesenti C, de Verbizier D, Béziat S, Mariano-Goulart D, Carlander B, Dauvilliers Y; Alzheimer's Disease Neuroimaging Initiative; Multi-Domain Intervention Alzheimer's Prevention Trial study groups. Reduced brain amyloid burden in elderly patients with narcolepsy type 1. Ann Neurol. 2019 Jan;85(1):74-83. doi: 10.1002/ana.25373. Epub 2018 Dec 19.

lead_sponsor: University Hospital, Montpellier

location_facility: Montpellier University Hospital, Gui de Chauliac


title: Impact on Adverse Events (AE) Occurrence of Two Types of Experience Feedback on AE Analysed During Local Morbidity Mortality Reviews (MMR), (by Multi Professional Simulation Education Versus Simple Diffusion of MMR Decisions)

acronym: RMM Simulation

summary:
After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total of 18 departments involved). This three arms will be: no intervention, education of department's staff by multi professional in situ simulation (adapted to the discovered adverse events), or simple but large diffusion of results and decisions of Morbidity Mortality Reviews.

The interventions will be performed during a two-years period.

ReferenceCitation: Michel N, Bui-Xuan B, Bapteste L, Rimmele T, Lilot M, Chollet F, Favre H, Duclos A, Michel P. Implementation of an in situ simulation-based training adapted from Morbidity and Mortality conference cases: effect on the occurrence of adverse events-study protocol of a cluster randomised controlled trial. Trials. 2022 Feb 2;23(1):106. doi: 10.1186/s13063-022-06040-2.

location_facility: Hospices Civils de Lyon - Direction DOQRU


title: Prognostic Value of Textural Indices Extracted From Pre-therapeutic 18-F FDG PET/CT in Head and Neck Squamous Cell Carcinoma.

acronym: ImpactTextureO

summary:
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800,000 new cases and 320,000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (SCC) 90% of the time.

Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade especially because of a high rate (up to 40%) of loco-regional recurrence. Moreover, two-third of local relapse and lymph node metastases occur in the first 2 years after treatment. Hence, predicting tumor response to therapy remains a real challenge in head and neck cancers.

Usual prognostic factors include the tumor size, the lymph node involvement, the presence of distant metastasis, the anatomic subsite, and the human papilloma virus (HPV 16, 18) infection status. However, pre-treatment selection of patients with poor prognosis or who require intensified therapy remains difficult despite their careful evaluation.

HNSCC also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones of high cellular proliferation and intra-tumoral angiogenic heterogeneity. A better characterization of tumor heterogeneity could help classify patients in different risk subgroups in order to improve their therapeutic management.

Pre-therapeutic 18F-fluorodeoxyglucose positron-emission tomography (FDG PET/CT) is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer. Its prognostic significance has already been suggested and a selection of patients at risk of recurrence appears possible using different quantitative parameters. Indeed, static (SUV = Standardized Uptake Value), volumetric (MTV = Metabolic Tumor Volume, TLG = Total Lesion Glycolysis) and kinetic (RI = Retention Index) parameters were demonstrated to be independent prognostic factors in several studies.

Texture analysis is currently highly studied in order to characterize tumor heterogeneity, and consists in extracting texture indices from different imaging modalities such as FDG PET/CT. Calculating texture indices relies on choosing a contouring method to delineate a tumor volume of interest and selecting several parameters such as the resampling method, matrix definitions and indices formula. Several studies conducted on small series of patients with HNSCC have showed promising results to predict survival, analyzing various cancer anatomic subsites, tumor segmentation methods and texture indices.

The objective of this study is to assess the prognostic value of texture indices in a large cohort of patients with HSNCC, including any anatomic subtype and staging.


title: Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer: Preliminary Results Concerning the Length of the Acquisition

acronym: QUIP

summary:
Prostate cancer is the most common cancer in men over 50 years old and the third leading cause of cancer death. Because of the variety of prostate cancers, different treatments exist.

Several criteria guide this management in daily practice: PSA level; TNM stage (digital rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological differentiation with the Gleason score, to which can be added other prognostic criteria: growth and doubling time of the serum PSA, number of positive biopsies and percentage of cancer lesions by biopsy.

Functional imaging by PET and MRI is increasingly used in daily clinical practice to characterize prostate cancer, either during initial discovery or during recurrence. In this context, it is the qualitative visual analysis that is mainly used. Quantitative image analysis could add new criteria to guide patient management.

Consequently, the objective of this study were:

Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer
Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both perfusion MRI and histological parameters.


title: Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)

summary:
Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT.

The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).


title: Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance: Interest of Pain Hetero-assessment by Coupling ANI-HRV-scales : ANI-DOL Study

acronym: ANI-DOL

summary:
Fighting against the pain caused by the disease or by the diagnostic and therapeutic procedures for children is a daily and essential concern of health care in the pediatric sector. The quantification of pain is needed to effectively adjust analgesic therapy while limiting the side effects of treatment. Nowadays many scales are validated for children, but they are based on one-off measures and hetero assessments are often subjective and dependent on many factors including the presence of staff to children's sides.

Recent developments in the analysis of the cardiac signal in real time under the influence of autonomic control, have led to the development of a new painful stress quantification index. A monitor has recently been developed and provides an index of nociception and analgesia (ANI index). The validation of this nociception index has not been validated for pediatric care in a sector where particular attention is given to control pain.

The main purpose of this study is to show the consistency of the index compared to a validated pain scale and used routinely in non-sedated children hospitalized in pediatric intensive care units. The caregiver will have the opportunity to fine tune the effective treatment.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Telmisartan Promotes the Differentiation of Monocytes Into Macrophages M2 in Diabetic Nephropathy?

summary:
The severity of the diabetic nephropathy is proportional to proteinuria rate and degree of renal interstitial fibrosis. Despite many treatments available today, diabetic nephropathy is responsible for a quarter of cases of end-stage renal disease (ESRD) requiring the use of renal replacement therapy or kidney transplantation. It develops as follows: chronic hyperglycemia of diabetes abyss renal glomeruli that allow proteins in the urine room. In response, the tubular epithelium produces monocyte chemoattractant protein-1 (MCP-1) that attracts monocytes circulating in the renal interstitium. Monocytes then differentiate into M1 or M2 macrophages. M1 macrophages increased MCP-1 production while M2 macrophages produce transforming growth factor beta (TGF-β) pro-fibrogenic. Renal fibrosis is negatively correlated with the glomerular filtration rate itself proportional to the number of nephrons. The decrease in the number of nephrons majorises secondarily proteinuria by the onset of focal segmental glomerulosclerosis lesions. Production of MCP-1 increases with the renal proteinuria because M1 macrophages earning kidneys reinforce the production of MCP-1, and fibrosis worsens because M2 macrophages infiltrate in turn kidneys and produce TGF -β.

A way of limiting renal fibrosis would be to decrease renal monocytic infiltration by promoting the differentiation of monocytes towards macrophages M2. Although more numerous, M2 macrophages no longer benefit the kidneys because the decline of M1 macrophages decrease renal MCP-1 production. Ex vivo IL1-β orients the differentiation of monocytes towards macrophages M1 and IL-4 to M2. By cons in vivo, the differentiating factors are poorly known. It is remarkable that metformin and telmisartan increase M2 macrophages M1 macrophages and decrease, respectively, in humans and mice. Moreover, telmisartan reduces proteinuria more than losartan in diabetic nephropathy in humans and Metformin decreases the amount of TGF-β intra-renal mice. This effect of telmisartan is independent of the type 1 receptor of angiotensin II (AT1R) since it is not obtained with losartan.

Telmisartan is a partial agonist of peroxisome proliferator-activated receptor gamma (PPARgamma), the working assumption is that telmisartan fosters the transition of monocytes to macrophages M2 form, and limit the recruitment of more monocytes in the kidneys and therefore proteinuria and renal fibrosis. To show this, it will be compared the ability of monocytes to differentiate ex vivo in M1 or M2 macrophages in diabetic nephropathy patients treated with losartan or telmisartan then it will characterize the role of PPARgamma in the monocyte / macrophage transition. Finally, it will be compared the urinary excretion of amino terminal propeptide of procollagen type 3 (PIIINP), considered a marker of renal fibrosis in patients receiving losartan or telmisartan.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of a Preoperative Pharmacological Protocol for Mydriasis in Femtosecond Laser-assisted Cataract Surgery

acronym: MYFLACS

summary: Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety and results of modern cataract surgery. However, this technique faces to some obstacles: economics in the one hand due to the cost and time spent for the laser procedure before the conventional surgery, and technical in the other hand, especially due to some loss of pupil dilation during the surgery, which is highly important to ensure a perfect procedure. The present study aims at assessing a pharmacological protocol to maintain an accurate pupil dilation all along the surgery in order to improve the whole procedure.

lead_sponsor: CHU de Reims


title: Positive Communication Within Healthcare Team and Clinical Performance: a Prospective, Randomised and Controlled Simulation Trial.

acronym: ComPerf

summary: The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.

ReferenceCitation: Bertrand B, Evain JN, Piot J, Wolf R, Bertrand PM, Louys V, Terrisse H, Bosson JL, Albaladejo P, Picard J. Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. Br J Anaesth. 2021 Apr;126(4):854-861. doi: 10.1016/j.bja.2020.12.011. Epub 2021 Jan 7.

lead_sponsor: University Grenoble Alps


title: Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients: Pilot Study Phase I/II

acronym: Nivo-TIL

summary:
To improve the efficacy of immunotherapy for cancer, recent studies focused on specific targets to redirect the immune network toward eradicating a variety of tumors and ameliorating the self-destructive process.

A clinically relevant immune escape mechanism in melanoma is the activation of the Programmed cell Death-1 (PD-1) receptor on infiltrating T cells. By blocking PD-1 receptors with anti-PD-1 monoclonal antibodies (mAbs), T-cells are unaffected by the PD-L1 expressed on tumor cells and the patients T cells are free to respond to melanoma antigens and attack tumor cells. So the objective of this trial is to evaluate the safety and the efficacy of a combined therapy Nivolumab and adoptive T cell therapy in metastatic melanoma patients.


title: Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.

acronym: ERGONOMIE

summary:
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:

60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.
60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.

The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery : a Multicenter, Prospective, Randomized and Controlled Trial

acronym: STOPORNOT

summary:
More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor Blockers (ARBs). To stop or not to stop these medications before major surgery remain unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain lacking and matter of debate. It is much likely that the strategy regarding management of RAS inhibitors in the peri-operative setting have important impact on peri-operative complications.

The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors management before major surgery. While French guidelines are to stop RAS inhibitors patients with hypertension to avoid profound anesthestic-drugs-induced hypotension, international guidelines differ. The American heart association task force states that continuation of RAS inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs before major non cardiac surgery.

ReferenceCitation: Legrand M, Payen D. Case scenario: Hemodynamic management of postoperative acute kidney injury. Anesthesiology. 2013 Jun;118(6):1446-54. doi: 10.1097/ALN.0b013e3182923e8a.

ReferenceCitation: Augoustides JG. Angiotensin blockade and general anesthesia: so little known, so far to go. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):177-9. doi: 10.1053/j.jvca.2008.01.002.

ReferenceCitation: Mets B, Hennrikus E. Perioperative angiotensin axis blockade, to continue or discontinue, that is the question? Anesth Analg. 2014 Nov;119(5):1223-4. doi: 10.1213/ANE.0000000000000430.

ReferenceCitation: Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1.

ReferenceCitation: Legrand M, Futier E, Leone M, Deniau B, Mebazaa A, Plaud B, Coriat P, Rossignol P, Vicaut E, Gayat E; STOP-OR-NOT study investigators. Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial). Trials. 2019 Mar 5;20(1):160. doi: 10.1186/s13063-019-3247-1.


title: CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer

acronym: CANPOS

summary: CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. This would represent a rational to develop personalized follow-up and prevention strategies

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon / Hôpital Neurologique Pierre Wertheimer