title: Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation

summary: We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation. A comparaison of results before and after three weeks of treatment will be made.

lead_sponsor: Lallemand SAS


summary: Clinical and neuroradiologic study concerning patients suffering of cough, exertional and sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication, redescribe clinical headaches specifications, confirmed if cough headaches is a clinical entity and if it has neuroradiologic differences with effort or sexual activity headaches.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: French Society for the Study of Migraine Headache

location_facility: assistance publique hopitaux de marseille CHU Timone

lead_sponsor_type: industriel

status_simplified: Completed


title: Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases

summary:
The purpose of this study is to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases.

Randomised crossover dietary intervention study:

The main objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the lipid metabolism of volunteers as compared with the consumption of a "reference" oil.

Post prandial study:

The second objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the biomarkers of oxidative stress during post prandial period as compared with the consumption of a "reference" oil.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

intervention_type: Dietary Supplement

lead_sponsor_type: academique


title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

summary: The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.

intervention_type: Procedure


title: An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of breast cancer. It is not yet known whether giving docetaxel together with a phytochemical is more effective than giving docetaxel alone in treating patients with breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a phytochemical works compared with giving docetaxel alone as first- or second-line therapy in treating patients with breast cancer.

status: Terminated

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Centre Jean Perrin

intervention_type: Drug

status_simplified: Unknown


title: Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery

summary: The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems) for Measuring Energy Expenditure at Rest and in Dynamic Phase After a Meal in Adult Healthy and Obese Volunteers

acronym: Protocol Quark

summary: Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_facility: Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot

intervention_type: Device


title: Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

acronym: IsoTC

summary:
isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.

However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.

Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.

ReferenceCitation: Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Nantes University Hospital

location_facility: Service de Réanimation CHU de Nantes Boulevard Jean Monnet


title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

acronym: NEODEC

summary: Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Neuromuscular Transmission in Amyotrophic Lateral Sclerosis

acronym: NETALS

summary: Consistent data suggest that neuromuscular transmission is impaired in ALS patients. Neuromuscular junctions dysfunction may appear very early in the disease, as shown by data in animal models. The pathogenesis of this neuromuscular transmission impairment is unknown. Nogo A isoform, a possible marker of the disease over-expressed in skeletal muscle of ALS patients, can be involved. We will characterize the pathophysiological mechanisms implicated using a complete study of the structure and function of the NMJ on muscle biopsies, in a group of 20 ALS patients compared to 10 controls.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Association pour la Recherche sur la Sclérose Latérale Amyotrophique

collaborators: Association Française contre les Myopathies (AFM), Paris


title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

acronym: BCDE

summary: The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.

intervention_type: Other


title: Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.

summary: To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).

lead_sponsor: UCB Pharma


title: A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

lead_sponsor: LEO Pharma


title: RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum

acronym: BioDNase

summary: Serine proteases belonging to the elastase family are mainly responsible for lung tissue destruction as observed during cystic fibrosis. But anti-inflammatory therapies based on systemic or aerosolized protease-inhibitors administration, have not given the expected results until now. One reason would be the impaired access of therapeutic inhibitors to their molecular targets. It was recently shown that neutrophils actively secrete neutrophil extracellular traps (NETs) made of DNA that binds cationic proteases among other molecules. NETs together with DNA passively released from dead neutrophils contribute to the viscosity of CF expectorations which explains that rhDNase treatment fluidifies expectorations and improves the patient status. Preliminary experiments in our laboratory have shown that DNA degradation was associated with a significant increase of proteolytic activity in the sputum soluble fraction. However the efficacy of exogenous inhibitors is also improved in these conditions. Using the specific substrates and methodologies that we developed previously to measure cell-surface associated proteolytic activities, we will study the effects of DNase on the activity of individual proteases, their biodistribution in sputum and their regulation by potential therapeutic inhibitors. Enzymatic, immunochemical and microscopic (confocal and scanning) techniques will first be used for ex vivo studies on sputa freshly collected at the adult and paediatric CRCM in Tours, then on sputa from patients before and after administration of aerosolized rhDNase. We hypothesize that a better understanding of the biodistribution of neutrophil serine proteases and especially their binding to DNA will help designing new therapeutic strategies that facilitate inhibitor access to their protease targets.

study_start_date_type: Actual

primary_purpose: Basic Science

lead_sponsor: University Hospital, Tours


acronym: HEMOCARD

summary: the purpose of this study is to show that the vacuum control surgical bleeding helps stop bleeding extraMD (MD: Medical Device) at the orifice of the retrograde cannulation during a heart with Extra-corporeal circulation (ECC),

lead_sponsor: AdministrateurCIC


title: Efficacy and Safety of Bevacizumab for the Treatment Hemorrhagic Hereditary Telangiectasia (HHT) Associated With Severe Hepatic Vascular Malformations. Phase II Study.

acronym: METAFORE

summary:
The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered because of the molecular mechanisms implied in angiogenesis and HHT, as well as the mechanisms of action of this type of treatment. Two articles that have recently reported spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe liver involvement and cardiac effects support us in this sense.

Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver transplant, the disadvantages of which are both multiple and well known: long waiting lists, surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore, treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a subsequent liver transplant if necessary.

ReferenceCitation: Dupuis-Girod S, Ginon I, Saurin JC, Marion D, Guillot E, Decullier E, Roux A, Carette MF, Gilbert-Dussardier B, Hatron PY, Lacombe P, Lorcerie B, Riviere S, Corre R, Giraud S, Bailly S, Paintaud G, Ternant D, Valette PJ, Plauchu H, Faure F. Bevacizumab in patients with hereditary hemorrhagic telangiectasia and severe hepatic vascular malformations and high cardiac output. JAMA. 2012 Mar 7;307(9):948-55. doi: 10.1001/jama.2012.250.


title: Medical and Economical Impact of Predicting the Response to Anti-angiogenic Treatment in Metastatic Renal Cell Carcinoma Using Functional CT and MRI

acronym: REMISCAN

summary:
The goal is to study the impact of functional MRI and CT evaluation of changes in tumor vessels induced by anti-angiogenic treatment in patients with metastatic RCC.

The hypothesis is that good responders and poor responders will have different responses induced by anti-angiogenic treatment, and that the detection of theses changes by functional imaging can improve the therapeutic management.

Functional CT and MRI will be performed in 200 patients before the beginning of antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined by the RECIST criteria). Perfusion and diffusion parameters will be measured using a dedicated software.


title: Phase II Study of Treatment of Relapsed Agressive Lymphomas

summary: The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

lead_sponsor: French Innovative Leukemia Organisation


title: ERP Study of Brain Electrophysiological Patterns in Obesity

summary: There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.

ReferenceType: background

ReferenceCitation: Bauer LO, Hesselbrock VM. P300 decrements in teenagers with conduct problems: implications for substance abuse risk and brain development. Biol Psychiatry. 1999 Jul 15;46(2):263-72. doi: 10.1016/s0006-3223(98)00335-7.

ReferenceCitation: Patrick CJ, Bernat EM, Malone SM, Iacono WG, Krueger RF, McGue M. P300 amplitude as an indicator of externalizing in adolescent males. Psychophysiology. 2006 Jan;43(1):84-92. doi: 10.1111/j.1469-8986.2006.00376.x.

ReferenceCitation: Yoon HH, Iacono WG, Malone SM, McGue M. Using the brain P300 response to identify novel phenotypes reflecting genetic vulnerability for adolescent substance misuse. Addict Behav. 2006 Jun;31(6):1067-87. doi: 10.1016/j.addbeh.2006.03.036. Epub 2006 Apr 27.

lead_sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_facility: Centre de Recherche en Nutrition Humaine Rhone Alpes


title: Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases

acronym: Prolacsein

summary:
Prolactin is known to play an important role in breast development and differentiation. Thus proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative processes.

The aim of this project is to identify and to characterize new mutants of the prolactin receptor gene within cohorts of benign or malign breast diseases with low or high occurrence frequency in human populations

time_perspective: Cross-Sectional

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Institut Pasteur


title: What Part Does the Premotor Cortex Play in Subjective Visual Perception and in the Perception of Others' Actions?

summary: This project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. It includes a test where we ask subjects to detect visual information in front of a computer screen, and another test where we ask them to imitate finger movements.


title: Evaluation of in Vitro NMR Spectroscopy to Identify Inborn Errors of Metabolism in Patients With Complex Neurological Diseases

acronym: SPECMET

summary:
The search for metabolic abnormalities in patients with neurological disorders represents an important challenge 1) to identify new potentially treatable inherited metabolic diseases, and 2) to identify biomarkers or new treatments in more common neurodegenerative or neurogenetic disorders.

This approach is currently limited by the fact that techniques aiming at identifying abnormal metabolites in human fluids (metabolomics) only detect subsets of molecules and that no general assays is available to detect abnormalities in the metabolism of complex molecules that takes place within cell organelles. As a consequence, only limited parts of the metabolism can be studied simultaneously.

The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines, cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with complex neurological diseases.

location_facility: Neurology department, Pitié-Salpêtrière Hospital


title: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma

summary: Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.

ReferenceCitation: Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Bene MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.

oa_colors: green other

evidence: open (via free article)

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

repository_normalized: HAL

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ReferenceCitation: Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.

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

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

repositories_concat: HAL


title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

summary:
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier


title: A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS

summary:
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

acronym: EFU

summary: The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.


title: Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

acronym: LICITE

summary: The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

location_facility: Service de Médecine Physique et de Réadaptation - Hôpital BICHAT


title: Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

summary: The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

lead_sponsor: Bayer


title: Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.

summary: The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations


title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy

acronym: NEURODIAB

summary: The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.

ReferenceCitation: Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Said S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.


title: Evaluation of a Mechanical Insufflation-exsufflation Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders: a Prospective, Randomized, Controlled, Multicenter Study

acronym: Nemucough

summary: The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a decrease in the number of intubations and more rapid clinical improvement in children and adults with neuromuscular disease who are admitted for an acute respiratory exacerbation.In this prospective, randomised, multicenter study, 55 patients will be treated with standard treatment and a MI-E, and 55 patients with standard treatment and standard respiratory physiotherapy. The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group). The main secondary objectives are a reduction in hospital stay and an improvement in clinical condition, dyspnea and respiratory muscle function.

location_facility: Hospital Armand Trousseau, Pediatric Pulmonology Department and INSERM UMR S-893


title: Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.

acronym: VIVA

summary: The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of superior functions, with loss of autonomy, behaviour and mood degradation, associated with physical disabilities. The work hypothesis is that a loss of sensorial functions, particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of communication with outside circle. The protocol consists in investigating superior functions, autonomy, and behaviour troubles of the participating patients, with the help of a series of neuropsychological tests used one month before and three months after cataract operation on the eye with the worst vision. Independently of the study, patients must have given an informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim of the study is to evaluate whether the cataract surgery improves patients' behaviour, autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main objective targets to cataract surgery benefice on patients suffering from both Alzheimer's disease and impeding cataract, aiming to improve behaviour troubles. The specific objective is to measure this benefice in correlation with visual acuity improvement.

intervention_type: Behavioral


title: A Double Blind Randomized, Placebo-controlled, Cross-over Trial to Evaluate the Efficiency of a Mouthrinse, Containing Red Grape Seed Extract and nicométhanol Fluorhydrate, in the Control of Dental Plaque Deposit in a 4-days Plaque Regrowth Model

acronym: Bain de bouche

summary:
The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits.

The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.

ReferenceCitation: Addy M. Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures. Int Dent J. 1995 Jun;45(3):185-96.

ReferenceCitation: Guidelines for acceptance of chemotherapeutic products for the control of supragingival dental plaque and gingivitis. Council on Dental Therapeutics. J Am Dent Assoc. 1986 Apr;112(4):529-32. doi: 10.1016/s0002-8177(86)24021-0. No abstract available.

ReferenceCitation: Yates RJ, Shearer BH, Morgan R, Addy M. A modification to the experimental gingivitis protocol to compare the antiplaque properties of two toothpastes. J Clin Periodontol. 2003 Feb;30(2):119-24. doi: 10.1034/j.1600-051x.2003.00205.x.

ReferenceCitation: Furiga A, Lonvaud-Funel A, Dorignac G, Badet C. In vitro anti-bacterial and anti-adherence effects of natural polyphenolic compounds on oral bacteria. J Appl Microbiol. 2008 Nov;105(5):1470-6. doi: 10.1111/j.1365-2672.2008.03882.x. Epub 2008 Sep 13.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet


type: Registry Identifier

title: Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.

acronym: EXAOS

summary:
The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.

The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.

Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.

Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.

Methodology: Test physiopathological parallel group, controlled, randomized.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
AGIR à Dom


title: MESenchymal Stem Cells: Alterations in GEnome

acronym: MESSAGE

summary: The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.


title: Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact

acronym: SNA&Sepsis

summary: Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.


title: Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic

acronym: BIO-IRA

summary:
Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.

We propose to determine the more relevant marker combination in this case.

sponsor_collaborators:
University Hospital, Grenoble
Regional Clinical Research


title: Chronic Pain After Thoracotomy, an Incidence Study in a Single Surgical Center

summary: Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for development of chronic pain are investigated. Questionnaire survey.

time_perspective: Retrospective

lead_sponsor: Hopital Foch


title: Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients

acronym: PICCO-LungT

summary: Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation


title: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

summary:
Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it lacks objective evaluation methods.

The aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effectiveness of Routine Fetal RhD Genotyping for RhD- Pregnant Women

acronym: GENIFERH

summary: The study is divided in two sub-studies. The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women: the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management, i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13 maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support; it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies.

ReferenceCitation: Branger B, Winer N. [Epidemiology of anti-D allo-immunization during pregnancy]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S87-1S92. French.

ReferenceCitation: Parant O. [Comparison of the efficacy of different methods for the prevention of anti-D allo-immunization during pregnancy: targeted strategy limited to risk situations or associated with systematic prevention in the 3rd trimester]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S93-1S103. French.

ReferenceCitation: Bennett PR, Le Van Kim C, Colin Y, Warwick RM, Cherif-Zahar B, Fisk NM, Cartron JP. Prenatal determination of fetal RhD type by DNA amplification. N Engl J Med. 1993 Aug 26;329(9):607-10. doi: 10.1056/NEJM199308263290903.

ReferenceCitation: Aubin JT, Le Van Kim C, Mouro I, Colin Y, Bignozzi C, Brossard Y, Cartron JP. Specificity and sensitivity of RHD genotyping methods by PCR-based DNA amplification. Br J Haematol. 1997 Aug;98(2):356-64. doi: 10.1046/j.1365-2141.1997.2193040.x.

ReferenceCitation: Lo YM, Corbetta N, Chamberlain PF, Rai V, Sargent IL, Redman CW, Wainscoat JS. Presence of fetal DNA in maternal plasma and serum. Lancet. 1997 Aug 16;350(9076):485-7. doi: 10.1016/S0140-6736(97)02174-0.

ReferenceCitation: Lo YM, Tein MS, Lau TK, Haines CJ, Leung TN, Poon PM, Wainscoat JS, Johnson PJ, Chang AM, Hjelm NM. Quantitative analysis of fetal DNA in maternal plasma and serum: implications for noninvasive prenatal diagnosis. Am J Hum Genet. 1998 Apr;62(4):768-75. doi: 10.1086/301800.

ReferenceCitation: Brossard Y, Sender A, Cartron JP, Huchet J, Pinon F, Blot P, David G. [Value of RHD fetal genotyping in the prevention of anti-D immunization]. Bull Acad Natl Med. 2001;185(2):329-36. French.

ReferenceCitation: Faas BH, Beuling EA, Christiaens GC, von dem Borne AE, van der Schoot CE. Detection of fetal RHD-specific sequences in maternal plasma. Lancet. 1998 Oct 10;352(9135):1196. doi: 10.1016/s0140-6736(05)60534-x. No abstract available.

ReferenceCitation: Rouillac-Le Sciellour C, Puillandre P, Gillot R, Baulard C, Metral S, Le Van Kim C, Cartron JP, Colin Y, Brossard Y. Large-scale pre-diagnosis study of fetal RHD genotyping by PCR on plasma DNA from RhD-negative pregnant women. Mol Diagn. 2004;8(1):23-31. doi: 10.1007/BF03260044.

ReferenceCitation: Colin Y, Cherif-Zahar B, Le Van Kim C, Raynal V, Van Huffel V, Cartron JP. Genetic basis of the RhD-positive and RhD-negative blood group polymorphism as determined by Southern analysis. Blood. 1991 Nov 15;78(10):2747-52.

ReferenceCitation: Singleton BK, Green CA, Avent ND, Martin PG, Smart E, Daka A, Narter-Olaga EG, Hawthorne LM, Daniels G. The presence of an RHD pseudogene containing a 37 base pair duplication and a nonsense mutation in africans with the Rh D-negative blood group phenotype. Blood. 2000 Jan 1;95(1):12-8.

ReferenceCitation: Geifman-Holtzman O, Grotegut CA, Gaughan JP. Diagnostic accuracy of noninvasive fetal Rh genotyping from maternal blood--a meta-analysis. Am J Obstet Gynecol. 2006 Oct;195(4):1163-73. doi: 10.1016/j.ajog.2006.07.033.

ReferenceCitation: Lo YM, Hjelm NM, Fidler C, Sargent IL, Murphy MF, Chamberlain PF, Poon PM, Redman CW, Wainscoat JS. Prenatal diagnosis of fetal RhD status by molecular analysis of maternal plasma. N Engl J Med. 1998 Dec 10;339(24):1734-8. doi: 10.1056/NEJM199812103392402.

ReferenceCitation: Finning K, Martin P, Daniels G. A clinical service in the UK to predict fetal Rh (Rhesus) D blood group using free fetal DNA in maternal plasma. Ann N Y Acad Sci. 2004 Jun;1022:119-23. doi: 10.1196/annals.1318.019.

ReferenceCitation: van der Schoot CE. Molecular diagnostics in immunohaematology. Vox Sang. 2004 Jul;87 Suppl 2:189-92. doi: 10.1111/j.1741-6892.2004.00481.x. No abstract available.

ReferenceCitation: Cortey A, Brossard Y, Beliard R, Bourel D. [Prevention of fetomaternal rhesus-D allo-immunization. Perspectives]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S119-1S122. French.

ReferenceCitation: Zimmermann B, El-Sheikhah A, Nicolaides K, Holzgreve W, Hahn S. Optimized real-time quantitative PCR measurement of male fetal DNA in maternal plasma. Clin Chem. 2005 Sep;51(9):1598-604. doi: 10.1373/clinchem.2005.051235. Epub 2005 Jul 14.

ReferenceCitation: Chan KC, Ding C, Gerovassili A, Yeung SW, Chiu RW, Leung TN, Lau TK, Chim SS, Chung GT, Nicolaides KH, Lo YM. Hypermethylated RASSF1A in maternal plasma: A universal fetal DNA marker that improves the reliability of noninvasive prenatal diagnosis. Clin Chem. 2006 Dec;52(12):2211-8. doi: 10.1373/clinchem.2006.074997. Epub 2006 Oct 26.

ReferenceCitation: Daniels G, van der Schoot CE, Olsson ML. Report of the Second International Workshop on molecular blood group genotyping. Vox Sang. 2007 Jul;93(1):83-8. doi: 10.1111/j.1423-0410.2007.00926.x.

ReferenceCitation: Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.

ReferenceCitation: Darlington M, Carbonne B, Mailloux A, Brossard Y, Levy-Mozziconacci A, Cortey A, Maoulida H, Simon T, Rousseau A, Durand-Zaleski I; GENIFERH1 Study Group. Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women. BMC Pregnancy Childbirth. 2018 Dec 14;18(1):496. doi: 10.1186/s12884-018-2114-5.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

publisher_dissemination: Springer-Nature


title: Identification of Large-Scale Mutations of POLG Gene by QMPSF in Patients With Mitochondrial DNA Instability.

summary:
Mitochondrial diseases are a heterogeneous group caused by genetic defects in mitochondrial DNA or in nuclear genes. POLG is the most frequently involved gene in mtDNA instability diseases resulting in mtDNA multiple deletion and/or depletion. It encodes the DNA polymerase gamma (POLγ), the only known DNA polymerase found in mammalian mitochondria. Mutations in POLG could explain 45% of familial progressive external ophtalmoplegia associated with multiple mtDNA deletions. However, in more than 70%, the analysis of the genes involved in mtDNA instability remains unsuccessful.

To date, these genes are screened by sequencing methods that are not able to detect large-scale rearrangements. In order to detect possible large-scale rearrangements, the investigators propose to develop a new assay based on QMPSF (Quantitative Multiplex PCR of Short fluorescent Fragments) able to detect exon deletions and duplications. the investigators propose to screen the POLG gene by QMPSF in at least twenty patients with either no mutation or only one mutation detected in POLG and no mutation in other genes such as TWINKLE and ANT1.

This study would allow the investigators to know if large-scale rearrangements occur in the POLG gene and to estimate their frequency in patients with mtDNA instability. These data are important to know if the sequencing analysis of POLG should be completed by the screening for partial deletions and duplications to ensure an accurate molecular diagnosis of these syndromes. Moreover, this method could be extended to ANT1 and TWINKLE genes.

location_facility: Centre Hospitalier Universitaire de Nice- Hôpital ARCHET 2 -Laboratoire de Génétique Médicale

intervention_type: Genetic


title: Impact of a Geriatric Mobile Unit on the Screening of Psycho-cognitive Troubles in Internal Medicine Departments and Circumstances of Calling in This Unit.

acronym: EMG

summary: The main objective of the study is to assess the rate of patients with psycho-cognitive troubles among hospitalised elderly patients.

location_facility: Hopital Louis Mourier, Assistance Publique Hopitaux de Paris


title: Assessment of Thyroid Function Throughout Pregnancy With and Without Iodine Supplementation

summary:
Goals of the study :

To study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine
To establish reference values of thyroid function at different stages of pregnancy (3 trimesters)
To precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez


title: Assessment of Sleep Disturbance in Alzheimer Disease

summary:
The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.

This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings

location_facility: Centre Mémoire de Ressources et de Recherche, CHU de Nice


title: Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.

acronym: ICEP

summary: Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.

lead_sponsor: University Hospital, Caen


title: Pompe Prevalence Study in Patients With Muscle Weakness Without Diagnosis

acronym: POPS

summary:
An international consensual group recommends confirming the diagnosis of the Pompe disease after a dried blood spot (DBS) with a dosage of the enzymatic activity in other tissue. This strategy is currently used in the usual practice.

The aim is evaluate the prevalence of the Pompe disease among patients with progressive limb girdle muscular weakness and/or axial deficiency, and/or respiratory insufficiency. The diagnosis will be confirmed using DBS.


title: Efficacy and Safety of Combination Therapies With Oseltamivir & Zanamivir or Oseltamivir & Amantadine Versus Oseltamivir Monotherapy in the Treatment of Seasonal Influenza A Infection

acronym: Combina

summary:
Neuraminidase inhibitors (NAI) are effective anti-influenza antiviral treatment. During their use in experimentally infected patients, it has been shown that the viral load detected in the nasal fluid is decreasing significantly faster than in non treated patients. During clinical practice, the emergence of NAI-resistant strains has been observed. These strains remain rare, but their emergence seemed to be related to the mis-use of the NAI products (insufficient duration or dosage). This observation as well as the detection of NAI-resistant viruses in the community raises concerns about putative emergence of resistant clones in the specific context of a pandemic, when the use of NAI will be very large in the aim of reducing transmission, and subsequently the impact of the emerging virus.

In this context, it is important to determine the putative interest of alternative strategies.

Although zanamivir and oseltamivir are both issued from the same class , this combination may lead to a more rapid viral clearance in the infected cases, and to a reduction in the emergence of resistant sub-clones, and alternatively, might lead to a competitive inhibition. The evaluation of these combinations needs to be conducted in vivo.

Among available anti influenza antivirals, M2 blockers have been previously used. Although their efficacy against A H5N1 remains to be ascertained, their use in combination with NAI should also be evaluated in the context of a preparation for a possible pandemic and determination of the stockpile.

Therefore, the evaluation of combination therapies in the treatment of a virologically suspected influenza will be investigated in primary care during the winter season 2008-2009.

lead_sponsor: Hospices Civils de Lyon


title: Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT

acronym: CT-Nav

summary: The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.

ReferenceCitation: Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.

oa_host_type: repository

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

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

evidence: oa repository (via OAI-PMH title and first author match)

unpaywall_oa_status: green


title: Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)

acronym: PRIOD

summary: The purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.


title: The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

acronym: anémie

summary: Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

lead_sponsor: University Hospital, Limoges

intervention_type: Biological


title: Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients

summary: Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.


title: Assessment of Efficacy and Safety of Continuous Wound Infiltration With Local Anesthesics Through a Parietal Paravertebral Catheter for Postoperative Analgesia After Posterior Lumbar Arthrodesis

acronym: ICALP

summary:
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. The application of opioids are the most frequently used therapies for postoperative pain relief but it very often results side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. In the setting of spine surgery, a single bolus administration of a local anesthetic is a useful method (with a reduction in parenteral morphine consumption during the 48 first hours) but has a limited effect because of its short duration of action. Prolonged administration through a multi-holed catheter positioned by the surgeon at the end of the procedure could increase the duration of action and may thereby improve the efficacy of local wound infiltration. Easy and effective, this new modality of administration has expanded the indications for parietal infiltrations toward major painful procedures.

We designed this study to determine whether local anesthetic (compared with saline solution) continuous wound infiltration during the first two days after posterior lumbar arthrodesis on degenerative spine, could improve postoperative analgesia at short-term but particularly at mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar pains (resulting in best life quality, opioid consumption limited and rehabilitation hastened) and postoperative hyperalgesia areas. The postoperative analgesic and antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and the safety of opioid administration and multi-holed parietal catheter will be compared in the two groups (control and study).


title: Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD

summary:
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.


title: Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

summary: Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy

lead_sponsor: University Hospital, Clermont-Ferrand


title: Exploratory Study of Natural Killer Cells in Human Skin

summary: Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de Dermatologie- Hopital Sainte Marguerite


acronym: EGB 761 in FRIEDREICH ATAXIA

lead_sponsor: Ipsen

summary: The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia

title: Efficacy of EGb761 120mg Bid Versus Placebo in Patients Suffering From Friedreich Ataxia. A 3 Month, Phase II, Randomised, Double Blind, Placebo Controlled, Parallel Group Clinical Study.

type: EudraCT Number

source: euctr


title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position

summary: The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.

lead_sponsor: Datascope Corp.


title: Immune Status of Elderly Population Admitted in an Acute Geriatric Unit

summary:
Ageing is associated with vulnerability against infections leading to increased morbidity with risk of death. Innate and adaptive immunities are altered with ageing responsible of deficits in immune response against pathogens and after vaccination, and favouring the elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal infections.

If immunity has been widely studied in immunosenescence, there are few prospective, comparative studies with elderly ill patients. Moreover among these studies, pathologies are not well defined.

The main objective of our project is to compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected with strict criteria, in order to precise the impact of polypathology and of various pathologies on immunity state.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: HOPITAL DE SAINTE MARGUERITE Service de Gériatrie Sud


title: Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery

summary:
Because local anesthetic infiltration has not been comparated to continuous infusion after spine fusion surgery, the investigators designed this study to determine whether this technique could enhance analgesia and improve patient outcome after posterior lumbar arthrodesis.

The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours.

In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL, and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.

The secondary outcomes are the consumption of morphine,the rate of the nausea and the postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration of hospital stay and the persistence of residual pain.


title: Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

summary: The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality at 30 days in case of subarachnoid hemorrhage.

ReferenceCitation: Litrico S, Almairac F, Gaberel T, Ramakrishna R, Fontaine D, Sedat J, Lonjon M, Paquis P. Intraventricular fibrinolysis for severe aneurysmal intraventricular hemorrhage: a randomized controlled trial and meta-analysis. Neurosurg Rev. 2013 Oct;36(4):523-30; discussion 530-1. doi: 10.1007/s10143-013-0469-7. Epub 2013 May 2.

oa_host_type: closed

repositories_concat: closed

location_facility: Neurosurgery department , Nice University Hospital


title: A Controlled Study of rTMS Over Supplementary Motor Area (SMA) in Obsessive Compulsive Disorder

acronym: TMS-TOC

summary: Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non invasive method of cerebral modulation) in patients suffering from chronic obsessive compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5 sessions each week), and its effects on OCD symptoms will be compared to those of a "sham" (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned to the comparison group. The maintenance of the therapeutic effects will be explored during 8 weeks following the end of the treatment. In addition to classical scales used to measure the treatment effects, all patients will be examined using a functional magnetic resonance imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of the Pharmacokinetic, Pharmacodynamic, Pharmacogenetic Relationships of Morphine and Metabolites After Severe Postoperative Pain in Adults

summary: The main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs sub acute).

ReferenceCitation: Aubrun F, Zahr N, Langeron O, Boccheciampe N, Cozic N, Belin L, Hulot JS, Khiami F, Riou B. Opioid-related genetic polymorphisms do not influence postoperative opioid requirement: A prospective observational study. Eur J Anaesthesiol. 2018 Jul;35(7):496-504. doi: 10.1097/EJA.0000000000000793.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

publisher_dissemination: Wolters Kluwer Health


title: Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation

acronym: OPTIDUAL

summary: To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.

ReferenceCitation: Helft G, Steg PG, Le Feuvre C, Georges JL, Carrie D, Dreyfus X, Furber A, Leclercq F, Eltchaninoff H, Falquier JF, Henry P, Cattan S, Sebagh L, Michel PL, Tuambilangana A, Hammoudi N, Boccara F, Cayla G, Douard H, Diallo A, Berman E, Komajda M, Metzger JP, Vicaut E; OPTImal DUAL Antiplatelet Therapy Trial Investigators. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J. 2016 Jan 21;37(4):365-74. doi: 10.1093/eurheartj/ehv481. Epub 2015 Sep 12.

oa_host_type: publisher

publisher_dissemination: Oxford University Press

ReferenceCitation: Helft G, Le Feuvre C, Georges JL, Carrie D, Leclercq F, Eltchaninoff H, Furber A, Prunier F, Sebagh L, Cattan S, Cayla G, Vicaut E, Metzger JP. Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial. Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fédération Française de Cardiologie

location_facility: Hopital la Pitié Salpêtrière Institut de Cardiologie


title: Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis

summary: The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.

location_facility: department of dermatology, Nice University Hospital


title: Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy

acronym: ADIPOKINES

summary:
Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels

Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients who developed LD versus those who did not developed LD during the first 3 months of a systemic therapy with corticosteroids

Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and PPARg in fat samples of patients before and after treatment with systemic corticosteroids and between LD+ and LD-patients To compare the fat morphology before and after treatment with glucosteroids


title: Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy

summary: It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo).

lead_sponsor: Department of Clinical Research and Innovation


title: Markers of Glomerular Filtration Rate in the HIV Infected Patient - Role of Body Composition

acronym: HIVERS

summary:
Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease. Patients survival has dramatically improved but complications may occur that need to be prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney disease, an affection that is not symptomatic until a very late stage secondary to HIV infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal function should be regularly assessed in HIV patients to perform early diagnosis for chronic kidney disease and allow initiation of preventive measures aimed at preserving renal function.

Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of renal function. Other markers like cystatin C may be used. None of these markers has been validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the gold standard measurement of glomerular renal function.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Sidaction


title: Study of Deep Brain Stimulation of the Pedunculo-pontin Nucleus (PPN) for the Treatment of Gait and Balance Disturbances in Patients With Parkinson's Disease (PPN-GAB-PARK Study)

summary: Disturbance of posture, gait and balance usually appear several years after Parkinson's disease (PD) onset. These axial signs, generally resistant to conventional drug and non-drug treatment, can generate a loss of autonomy and traumatic complications. Improvement of these axial signs by deep brain stimulation (DBS) of the pedunculo-pontin nucleus (PPN) has been described for a small number of patients. The objectives of the present prospective monocentric pilot study are to determine the optimal stimulation parameters of PPN-DBS, to evaluate the long term tolerance and the effect of PPN-DBS on axial signs and quality of life in five patients with severe PD. The use of detailed clinical rating scales and quantitative computer-based gait analysis will allow to identify the optimal stimulation parameters and relevant clinical efficacy parameters, mandatory for the design of further comparative large-scale studies.

location_facility: Neurology, Neurosugery of Nice University Hospital


summary: The investigators evaluated clinical tolerance, biological tolerance, feasibility and efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10 patients with facioscapulohumeral muscular dystrophy, the third most common inherited myopathy.

ReferenceCitation: Colson SS, Benchortane M, Tanant V, Faghan JP, Fournier-Mehouas M, Benaim C, Desnuelle C, Sacconi S. Neuromuscular electrical stimulation training: a safe and effective treatment for facioscapulohumeral muscular dystrophy patients. Arch Phys Med Rehabil. 2010 May;91(5):697-702. doi: 10.1016/j.apmr.2010.01.019.


title: Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme.

PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.

lead_sponsor: Centre Leon Berard


title: Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.

acronym: PK-rituximab

summary:
Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.

The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.

The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.

primary_purpose: Other

ReferenceCitation: Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease. Br J Clin Pharmacol. 2013 Nov;76(5):734-40. doi: 10.1111/bcp.12098.

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Toulouse


title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia

acronym: Dolastron

summary:
This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).

Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.

This treatment will be renewed after one month, after 2 months and after 3 months.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.


title: Functional Exploration of the Immune Response Using the B-Subunit of Cholera Toxin Administered by Mucosal Way in Healthy Adult Volunteer: Potential Role in Development of Vaccine Processes

summary: It is a biomedical research without direct individual benefit, exploring and comparing the mucosal immune response after oral, nasal and sublingual administration of B-subunit of non-toxic cholera toxin (CTB) in healthy adult volunteers.

location_facility: Laboratoire d'anatomo-pathologie, hôpital Pasteur


title: Evaluation of the Value Forecasts of the Identification of the Circulating Tumoral Cells (CTC) in the Broncho-lung Carcinomas Not in Small Cells of Stages I and II by the Method ISET (Insulation by Size of Epithelial Tumor Cells)

summary: The aim of this study is, i) to assess the presence and the frequency of CTC in NSCLC patients undergoing surgery by using cytopathological analysis after their isolation by size (ISET method), and, ii) to correlate the presence of CNHC with pTNM stage, histological subtype, and percentage of tumor cells present into the primary tumors.


title: Transcriptomic Study of ER 4017 Topical Application in Elderly Subject

summary:
The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface between the body and its outside environment. Its strategic position confers it a crucial role of protection against aggressions. After disruption, the kinetic of cutaneous barrier is slower in elderly comparatively to young subjects.

The purpose of this study is to investigate, by characterizing molecular events, the effectiveness of ER4017 (Hydroxypropyltetrahydropyrantriol) to restore kinetic barrier function after acute disruption of stratum corneum in ederly subjects.

10 male volunteers aged from 60 to 75 years are randomized to receive topical application of ER4017 versus placebo on skin inner forearms twice a day during 3 months. After sequential selloptape strips, epidermal samples of treated and control skin are removed under local anesthesia, using a dermatome. Differential gene expression analysis is performed using micro array techniques and quantitative RT-PCR.

treatment, randomized on the location, double blind, placebo control, internal control subject, prospective study.

lead_sponsor: L'Oreal

location_facility: Centre de recherche bioclinique -Hopital st louis


title: A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome

summary: Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.

ReferenceCitation: Bruckert E, Duchene E, Bonnefont-Rousselot D, Hansel B, Ansquer JC, Dubois A, Gaymard B. Proof of concept study: does fenofibrate have a role in sleep apnoea syndrome? Curr Med Res Opin. 2010 May;26(5):1185-92. doi: 10.1185/03007991003693581.

lead_sponsor: Solvay Pharmaceuticals


title: Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

acronym: Neu I

summary: The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

lead_sponsor: Neurim Pharmaceuticals Ltd.


title: Comparaison de la Chromo Endoscopie Virtuelle FICE (Fujinon Intelligent Chromoendoscopy) Avec la Coloscopie Conventionnelle Dans la détection de la Dysplasie Chez Patients Porteurs de Recto Colite ulcéro hémorragique (RCH).

summary: The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy with recommended targeted and random biopsies) in the endoscopic surveillance of patient with long-standing UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using each technique. The combined histological outcome following the two procedures will represent the gold-standard diagnosis for each patient. Secondary outcomes will be the number of patients with false-positive findings, the number of neoplastic lesions detected, the number of false-positive lesions per patient for each technique and the total time required for each procedure.

location_facility: Departement d'Endoscopie digestive - Hopital Archet 2, CHU de Nice


title: Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.

acronym: FcrèchMV

summary:
Direct DNA amplification, viral isolation and specific antibody measurement in saliva

From children in day care centers (samples collection will take place during a single week)
From children coming at the emergency department of our hospital during a three months period.

Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.


title: PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial

acronym: PRALIMAP

summary: The aim of this study is to compare the effectiveness of three public health intervention strategies to reduce weight excess and obesity prevalence among teenagers within the frame of a public health program aiming at promoting healthy eating and physical activity behaviors.

ReferenceCitation: Manneville F, Briancon S, Legrand K, Langlois J, Lecomte E, Omorou AY, Guillemin F. Physical Activity and Eating Behavior Inequalities Mediating the Effects of Socioeconomic Status and Sex on Adolescent Quality of Life: Insights of the PRALIMAP Trial. J Phys Act Health. 2022 Sep 13;19(10):648-657. doi: 10.1123/jpah.2022-0093. Print 2022 Oct 1.

publisher_dissemination: Human Kinetics

ReferenceCitation: Langlois J, Omorou AY, Vuillemin A, Briancon S, Lecomte E; PRALIMAP Trial Group. Association of socioeconomic, school-related and family factors and physical activity and sedentary behaviour among adolescents: multilevel analysis of the PRALIMAP trial inclusion data. BMC Public Health. 2017 Feb 8;17(1):175. doi: 10.1186/s12889-017-4070-9.

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

ReferenceCitation: Omorou AY, Langlois J, Lecomte E, Vuillemin A, Briancon S; PRALIMAP Trial Group. Adolescents' Physical Activity and Sedentary Behavior: A Pathway in Reducing Overweight and Obesity. The PRALIMAP 2-Year Cluster Randomized Controlled Trial. J Phys Act Health. 2015 May;12(5):628-35. doi: 10.1123/jpah.2014-0035. Epub 2014 Nov 13.

ReferenceCitation: Bonsergent E, Agrinier N, Thilly N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF, Briancon S; PRALIMAP Trial Group. Overweight and obesity prevention for adolescents: a cluster randomized controlled trial in a school setting. Am J Prev Med. 2013 Jan;44(1):30-9. doi: 10.1016/j.amepre.2012.09.055.

evidence: open (via free pdf)

ReferenceCitation: Legrand K, Bonsergent E, Latarche C, Empereur F, Collin JF, Lecomte E, Aptel E, Thilly N, Briancon S. Intervention dose estimation in health promotion programmes: a framework and a tool. Application to the diet and physical activity promotion PRALIMAP trial. BMC Med Res Methodol. 2012 Sep 19;12:146. doi: 10.1186/1471-2288-12-146.

ReferenceCitation: Briancon S, Bonsergent E, Agrinier N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF; PRALIMAP Trial Group. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies. Trials. 2010 Dec 6;11:119. doi: 10.1186/1745-6215-11-119.

lead_sponsor: University of Nancy

collaborators: National conservatory of arts and crafts (CNAM)

collaborators: Regional institute for health education (IRES)

collaborators: Local school office of the academy of Nancy-Metz


title: Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer

summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with kidney cancer that has spread to the brain.

lead_sponsor: Institut Claudius Regaud


title: Effects of Growth Hormone on Corticoid Myopathy in Children With Chronic Disease: Effects on Muscle Mass and Strength

summary:
Children suffering from chronic disease and receiving long-term glucocorticoid therapy suffer over years from severe growth retardation and profoundly altered body composition. They consist in a marked increase in fat mass and a decrease in lean body mass. Published studies have shown that Growth Hormone (GH) treatment in children with Juvenile Idiopathic Arthritis can improve body composition by increasing lean mass and by preventing increase in fat mass. The aim of the present protocol is to evaluate whether the increase in lean body mass observed during GH treatment is associated with changes in muscle strength and mass.

In order to be able to evaluate the effect of GH on the muscle a comparative group is needed. Therefore it will be proposed to delay in a group of patients the start of Growth Hormone(GH) treatment by 6 months. As most publications have shown a maximum effect of GH within the first year of treatment, six months should be enough to evaluate short-term effect of GH on the muscle. Therefore, this study will be a randomized trial: immediate start of Growth Hormone (GH) treatment versus start of Growth Hormone treatment 6 months later. After 6 months all children will be treated with GH. Therefore, the follow-up will be one year after baseline.

lead_sponsor: Association REMEDE

sponsor_collaborators:
Association REMEDE
Pfizer


title: Etude épidémiologique Multicentrique Des Douleurs Neuropathiques Post-opératoires

acronym: EDONIS

summary: This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent pain, as well as to describe the neuropathic features of this pain. It includes more than 3000 patients scheduled for different types of surgery, some of them already known to induce persistent pain, some being frequent procedures with no additional data. Clinical and genetical risk factors will be searched.

time_perspective: Other

ReferenceCitation: Niccolai P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchene P, Chirat C, Soule-Sonneville S, Duale C, Dubray C, Schoeffler P. Persistent neuropathic pain after inguinal herniorrhaphy depending on the procedure (open mesh v. laparoscopy): a propensity-matched analysis. Can J Surg. 2015 Apr;58(2):114-20. doi: 10.1503/cjs.008314.

ReferenceCitation: Blanc P, Genin E, Jesson B, Dubray C, Duale C; EDONIS-gene Investigating group. Genetics and postsurgical neuropathic pain: An ancillary study of a multicentre survey. Eur J Anaesthesiol. 2019 May;36(5):342-350. doi: 10.1097/EJA.0000000000000986.

ReferenceCitation: Richez B, Ouchchane L, Guttmann A, Mirault F, Bonnin M, Noudem Y, Cognet V, Dalmas AF, Brisebrat L, Andant N, Soule-Sonneville S, Dubray C, Duale C, Schoeffler P. The Role of Psychological Factors in Persistent Pain After Cesarean Delivery. J Pain. 2015 Nov;16(11):1136-46. doi: 10.1016/j.jpain.2015.08.001. Epub 2015 Aug 20.

ReferenceCitation: Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.

ReferenceCitation: Duale C, Ouchchane L, Schoeffler P; EDONIS Investigating Group; Dubray C. Neuropathic aspects of persistent postsurgical pain: a French multicenter survey with a 6-month prospective follow-up. J Pain. 2014 Jan;15(1):24.e1-24.e20. doi: 10.1016/j.jpain.2013.08.014. Epub 2013 Oct 25.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Pfizer


title: Open-label, Single Center, Uncontrolled Phase I/II Study Evaluating the Safety and Maximum Tolerated Dose of Daily Sorafenib Administered in Combination With Prolonged Temozolomide in Patients With Metastatic Melanoma

summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effect of Pioglitazone Administered to Patients With Friedreich's ATAXIA:Proof of Concept

acronym: ACTFRIE

summary:
Friedreich's ataxia (FA) is a rare progressive neurological disorder affecting approximately 1/30, 000 individuals. No treatment is presently available to counteract the neurodegeneration of this extremely severe disease.

Pioglitazone, a well known PPAR gamma (peroxysome proliferators-activated receptor gamma) ligand induces the expression of many enzymes involved in the mitochondrial metabolism, including the superoxide dismutases. This agent may be therapeutic by counteracting the disabled recruitment of antioxidant enzymes in FA patients. This potential neuroprotective agent crosses the brain blood barrier in human.

Primary objective: To explore the effects of Pioglitazone on neurological function in FA patients. We expect neurological benefits taking into account the natural course of the disease.

Population: Subjects for this study will be limited to patients not older than 25 years Methodology: Prospective, randomized double-blind trial of Pioglitazone versus placebo in FA patients. Patients will be treated two years and will undergo clinical exams and testing during three days each six months at the clinical investigation centre.

ReferenceCitation: Simon AL, Meyblum J, Roche B, Vidal C, Mazda K, Husson I, Ilharreborde B. Scoliosis in Patients With Friedreich Ataxia: Results of a Consecutive Prospective Series. Spine Deform. 2019 Sep;7(5):812-821. doi: 10.1016/j.jspd.2019.02.005.

evidence: open (author manuscript)

version: acceptedVersion


title: Soluble Form of the Receptor for Advanced Glycation End Products (sRAGE) Levels in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS and Severe Sepsis : an Observational Prospective Study.

summary: sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. The purpose of this observational prospective study is to determine whether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock.

ReferenceCitation: Jabaudon M, Blondonnet R, Roszyk L, Bouvier D, Audard J, Clairefond G, Fournier M, Marceau G, Dechelotte P, Pereira B, Sapin V, Constantin JM. Soluble Receptor for Advanced Glycation End-Products Predicts Impaired Alveolar Fluid Clearance in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Jul 15;192(2):191-9. doi: 10.1164/rccm.201501-0020OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Jabaudon M, Futier E, Roszyk L, Chalus E, Guerin R, Petit A, Mrozek S, Perbet S, Cayot-Constantin S, Chartier C, Sapin V, Bazin JE, Constantin JM. Soluble form of the receptor for advanced glycation end products is a marker of acute lung injury but not of severe sepsis in critically ill patients. Crit Care Med. 2011 Mar;39(3):480-8. doi: 10.1097/CCM.0b013e318206b3ca.


title: Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers

summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy.

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


type: Other Identifier

title: Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.

acronym: ETAT

summary:
Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some patients will develop tuberculosis and some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are now available.

The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy

ReferenceCitation: Freund R, Granger B, Francois C, Carcelain G, Ravaud P, Mariette X, Fautrel B. Cost-effectiveness analysis of strategies using new immunological diagnostic tests of latent tuberculosis infection before TNF-blockers therapy. Presse Med. 2018 Feb;47(2):e9-e13. doi: 10.1016/j.lpm.2017.09.029. Epub 2018 Feb 23.

ReferenceCitation: Mariette X, Baron G, Tubach F, Liote F, Combe B, Miceli-Richard C, Flipo RM, Goupille P, Allez M, Salmon D, Emilie D, Carcelain G, Ravaud P. Influence of replacing tuberculin skin test with ex vivo interferon gamma release assays on decision to administer prophylactic antituberculosis antibiotics before anti-TNF therapy. Ann Rheum Dis. 2012 Nov;71(11):1783-90. doi: 10.1136/annrheumdis-2011-200408. Epub 2012 Jan 17.


title: Non-inferiority Study of Bi-Profenid® 200 mg Versus Bi-Profenid® 300 mg in Patients Presenting With Pain Related to Closed, Benign, Acute Post-traumatic Conditions of the Motor System or Acute, Non-infectious Rheumatologic Conditions

summary:
Primary objective:

To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.

Secondary Objectives:

To describe concomitant analgesic treatments
To describe the time between baseline and use of a step I, II or III analgesic
To evaluate patients pain relief using a Likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at D5
To evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days
To evaluate the patients overall satisfaction at the end of treatment using a 4-point Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
To evaluate the patients overall satisfaction at the end of the study using a 4-point Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)
To compare the safety of the two treatments

lead_sponsor: Sanofi


title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

acronym: METHODA

summary:
The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.

ReferenceCitation: Goujon C, Viguier M, Staumont-Salle D, Bernier C, Guillet G, Lahfa M, Ferrier Le Bouedec MC, Cambazard F, Bottigioli D, Grande S, Dahel K, Berard F, Rabilloud M, Mercier C, Nicolas JF. Methotrexate Versus Cyclosporine in Adults with Moderate-to-Severe Atopic Dermatitis: A Phase III Randomized Noninferiority Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):562-569.e3. doi: 10.1016/j.jaip.2017.07.007. Epub 2017 Sep 28.

lead_sponsor: Hospices Civils de Lyon


title: Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors

summary:
RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy.

lead_sponsor: Centre Oscar Lambret

intervention_type: Radiation


title: Role of Mitochondria in Human Bronchial Smooth Muscle Remodeling in Non Severe Asthma

acronym: MITASTHME

summary: Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and remodelling. Bronchial remodelling is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. It can appear very early in the evolution of the disease and involves an increased mass of bronchial smooth muscle (BSM). The mechanism of such an increase has been related with an increase in smooth muscle cell proliferation. Recently, we have demonstrated that, BSM increased proliferation is induced by an enhanced mitochondrial biogenesis in severe asthma (T. Trian et al. J Exp Med 2007). The objective of this study is to investigate the role of smooth muscle cell mitochondria in non severe asthma

ReferenceCitation: Trian T, Benard G, Begueret H, Rossignol R, Girodet PO, Ghosh D, Ousova O, Vernejoux JM, Marthan R, Tunon-de-Lara JM, Berger P. Bronchial smooth muscle remodeling involves calcium-dependent enhanced mitochondrial biogenesis in asthma. J Exp Med. 2007 Dec 24;204(13):3173-81. doi: 10.1084/jem.20070956. Epub 2007 Dec 3.

ReferenceCitation: Girodet PO, Allard B, Thumerel M, Begueret H, Dupin I, Ousova O, Lassalle R, Maurat E, Ozier A, Trian T, Marthan R, Berger P. Bronchial Smooth Muscle Remodeling in Nonsevere Asthma. Am J Respir Crit Care Med. 2016 Mar 15;193(6):627-33. doi: 10.1164/rccm.201507-1404OC.

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital Bordeaux, Hôpital Haut-Lévêque


title: Evaluation Des Effets Anti-Stress D'un Probiotique Nomme PROBIOSTICK® Sur Des Sujets Humains Volontaires Sains Sensibles Au Stress De La Vie Quotidienne

acronym: BIOSTRESS

summary: The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.

lead_sponsor: Institut Rosell Lallemand


title: Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when given together with carboplatin and to see how well they work in treating patients with relapsed or metastatic cervical cancer.

lead_sponsor: ARCAGY/ GINECO GROUP


title: Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies

summary:
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I

acronym: DIAPASOM

summary:
The primary objectives are to compare the mean levels of the sleep quality parameters of subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of subjects with a nocturnal fall of SBP, DBP and MAP inferior to 10% (non dipper subjects).

The secondary objectives are :

Establish correlations between:

The quality of sleep parameters
The parameters of BP variations between the diurnal and nocturnal periods and the awake periods of sleep defined in reference to polysomnography.
The glycemia levels on 24h with a glycemic holter. The parameters of the sympathic system activation evaluated in reference to the measure of the baroreflex sensibility during the awake period.

primary_purpose: Screening

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. No abstract available.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Pr Mallion Jean-Michel
Pr BAGUET Jean-Philippe
Pr BENHAMOU Pierre-Yves
Pr LEVY Patrick
Dr MOURET Sandrine
Dr ORMEZZANO Olivier
Pr PEPIN Jean-Louis
Dr TAMISIER Renaud


title: A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection

summary: The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.

lead_sponsor: Light Chain Bioscience - Novimmune SA


title: Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy

acronym: Cytoven

summary:
The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy.

75 patients having a story of reaction to hymenoptera venom will be selected for this trial.

Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.

lead_sponsor: University Hospital, Limoges