title: Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled by Metformin and Basal Insulin, This One Having Been Properly Titrated.

summary:
The main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.

The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c less than 7%) after 3 months of treatment with Galvus or placebo

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


type: Other Identifier

title: Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation

summary: The low overall effectiveness of available smoking cessation treatment so far, indicate the need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a highly heterogeneous population. Identification of individual characteristics that predict success in smoking cessation is highly desirable to allow designing more specific strategies in order to enhance success in quitting tobacco.The main objective of this study is to assess whether the presence of certain neuropsychological deficits found before the initiation of smoking cessation is associated with a greater relapse rate.The secondary objectives concern how neuropsychological performance are involved in motivation and craving in the whole sample of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological factors associated with agood or poor prognosis for success and provived more specific and therefore more effective care.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Flaudias V, Picot MC, Lopez-Castroman J, Llorca PM, Schmitt A, Perriot J, Georgescu V, Courtet P, Quantin X, Guillaume S. Executive Functions in Tobacco Dependence: Importance of Inhibitory Capacities. PLoS One. 2016 Mar 8;11(3):e0150940. doi: 10.1371/journal.pone.0150940. eCollection 2016.

family: Flaudias

full_name: Valentin Flaudias

given: Valentin

sequence: first

family: Picot

full_name: Marie Christine Picot

given: Marie Christine

sequence: additional

family: Lopez-Castroman

full_name: Jorge Lopez-Castroman

given: Jorge

family: Llorca

full_name: Pierre-Michel Llorca

given: Pierre-Michel

family: Schmitt

full_name: Audrey Schmitt

given: Audrey

family: Perriot

full_name: Jean Perriot

given: Jean

family: Georgescu

full_name: Vera Georgescu

given: Vera

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Quantin

full_name: Xavier Quantin

given: Xavier

family: Guillaume

full_name: Sébastien Guillaume

given: Sébastien

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS ONE

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

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: University Hospital, Montpellier

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test

acronym: IPSO FACTO

summary: The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.

design_allocation: Randomized

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

intervention_type: Procedure


title: Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A

summary: This exploratory cross-sectional study proposes, firstly, to objectify in a population of Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording of electrical parameters and upper limb muscle strength of the thigh and in a second step, to seek a relationship between the measured parameters.

study_start_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Bihel L, Reynaud V, Givron P, Clavelou P, Cornut-Chauvinc C, Pereira B, Thomas E, Taithe F, Coudeyre E. Foot Function Index: A Promising Questionnaire for Individuals With Charcot-Marie-Tooth Disease Type 1A. Arch Phys Med Rehabil. 2019 Dec;100(12):2403-2406. doi: 10.1016/j.apmr.2019.06.003. Epub 2019 Jun 28.

family: Bihel

full_name: Lucie Bihel

given: Lucie

family: Reynaud

full_name: Vivien Reynaud

given: Vivien

family: Givron

full_name: Pascal Givron

given: Pascal

family: Clavelou

full_name: Pierre Clavelou

given: Pierre

family: Cornut-Chauvinc

full_name: Catherine Cornut-Chauvinc

given: Catherine

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Thomas

full_name: Eric Thomas

given: Eric

family: Taithe

full_name: Frederic Taithe

given: Frederic

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

journal_name: Archives of Physical Medicine and Rehabilitation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand


title: Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study

acronym: SYNAPark

summary: The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.

primary_purpose: Health Services Research

lead_sponsor: Nantes University Hospital

intervention_type: Other


title: Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass

summary: Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


type: EudraCT Number

title: Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis

acronym: RECOVER

summary: The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Bosello S, De Santis M, Lama G, Spanò C, Angelucci C, Tolusso B, Sica G, Ferraccioli G. B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial. Arthritis Res Ther. 2010;12(2):R54. doi: 10.1186/ar2965. Epub 2010 Mar 25.

ReferenceCitation: Simms RW, Lafyatis R. Rituximab: a potential therapeutic advance in scleroderma: what is the evidence? Rheumatology (Oxford). 2010 Feb;49(2):201-2. doi: 10.1093/rheumatology/kep421. Epub 2009 Dec 23.

ReferenceCitation: Daoussis D, Liossis SN, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Korfiatis P, Yiannopoulos G, Andonopoulos AP. Is there a role for B-cell depletion as therapy for scleroderma? A case report and review of the literature. Semin Arthritis Rheum. 2010 Oct;40(2):127-36. doi: 10.1016/j.semarthrit.2009.09.003. Epub 2009 Dec 11. Review.

ReferenceCitation: Daoussis D, Liossis SN, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Sirinian C, Karampetsou M, Yiannopoulos G, Andonopoulos AP. Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study. Rheumatology (Oxford). 2010 Feb;49(2):271-80. doi: 10.1093/rheumatology/kep093. Epub 2009 May 15.

ReferenceCitation: Lafyatis R, Kissin E, York M, Farina G, Viger K, Fritzler MJ, Merkel PA, Simms RW. B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis. Arthritis Rheum. 2009 Feb;60(2):578-83. doi: 10.1002/art.24249.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


title: Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition

acronym: TAMSU

summary: Catheter-associated urinary infections are the most common hospital-acquired infections and can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the failure of early catheter removal has been studied in elderly women hospitalized for an acute condition and experiencing acute urinary retention: 448 women 75-year old or more without an anatomical or neurological cause of urinary retention will be randomized to a 6 days course of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of tamsulosin and the need to replace another catheter within 72 hours will define a failed attempt.

status: Terminated

location_facility: Service de médecine interne, Hôpital Tenon

status_simplified: Unknown


title: Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

acronym: OXYTAM

summary:
This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.

Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.

The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).

design_allocation: Non-Randomized

lead_sponsor: Institut Claudius Regaud

lead_sponsor_type: industriel


acronym: EPOP

summary:
The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations.

Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards.

To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test.

The study protocol was approved by the local Ethic Committee.

primary_purpose: Prevention

ReferenceCitation: Eschalier B, Descamps S, Pereira B, Vaillant-Roussel H, Girard G, Boisgard S, Coudeyre E. Randomized blinded trial of standardized written patient information before total knee arthroplasty. PLoS One. 2017 Jul 5;12(7):e0178358. doi: 10.1371/journal.pone.0178358. eCollection 2017.

family: Eschalier

full_name: Benedicte Eschalier

given: Benedicte

family: Descamps

full_name: Stephane Descamps

given: Stephane

family: Vaillant-Roussel

full_name: Hélène Vaillant-Roussel

given: Hélène

family: Girard

full_name: Guillaume Girard

given: Guillaume

family: Boisgard

full_name: Stephane Boisgard

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

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


title: Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease?

summary:
Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently considered to be a priority for research, as disease modifying therapies are being evaluated. Many studies focus on the functional and morphological assessment of the hippocampal formation. However, neurofibrillary tangles, associated with cognitive deficits, initially affect the anterior subhippocampal cortex (transentorhinal, entorhinal and perirhinal cortex) before reaching the hippocampus. Studies from our group have tried to investigate if the assessment of subhippocampal regions using cognitive tools and neuroimaging techniques could contribute to the diagnosis of AD at a very early stage.

In a previous project, the investigators included 40 patients with single domain amnestic MCI (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI patients with a profile of subhippocampal dysfunction (impaired performance on a visual recognition memory task) display other clinical as well as imaging profiles of patients with early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently under way. Preliminary data indicates that evaluating the subhippocampal region using visual recognition tasks is highly predictive of AD over 6 years.

The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can contribute to the early diagnosis of AD.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Device


title: Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study

acronym: L'ERGONOME

summary:
The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:

experimental arm: these patients will use the ERGONOME device to help them sit up
standard arm: these patients will use traditional hanging triangle bar to help them sit up

primary_purpose: Supportive Care


title: Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia

acronym: PYO GEN

summary:
Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study.

The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.

lead_sponsor: University Hospital, Grenoble

location_facility: Medical ICU of Universitary Hospital of Grenoble


title: Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the "Quadhelix"

acronym: Ortholaser

summary:
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.

As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.


summary:
Different treatment trials have been published in acquired nystagmus in the last decade; gabapentin and memantine have been found to be efficient in treating pendular nystagmus in Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude, frequency and on visual acuity. None of the trials measured a functional visual score or oscillopsia score.

The aim of our study is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual acuity and vision-specific health-related quality of life score, in 10 patients with multiple sclerosis. The primary object is to find out the best variable to evaluate the efficiency of nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and memantine in a common population of patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Neurologique Unité de Neuro-Ophtalmologie


title: Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study

summary:
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.

Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".

ReferenceCitation: Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.

family: Greze

full_name: Jules Greze

given: Jules

family: Vighetti

full_name: Arnaud Vighetti

given: Arnaud

family: Incagnoli

full_name: Pascal Incagnoli

family: Quesada

full_name: Jean-Louis Quesada

given: Jean-Louis

family: Albaladejo

full_name: Pierre Albaladejo

family: Palombi

full_name: Olivier Palombi

given: Olivier

family: Tonetti

full_name: Jerome Tonetti

given: Jerome

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Payen

full_name: Jean-Francois Payen

given: Jean-Francois

journal_name: European Spine Journal

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: University Hospital, Departement of Anesthesia and Intensive Care


title: Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children

acronym: PEDIMA

summary: The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.

lead_sponsor: Rennes University Hospital


title: Protocole ULTRAFAST - ECHOTRACKING : Remodelage pariétal et rigidité artérielle Chez l'Hypertendu : Nouvelle étude de Leur Relation Utilisant l'élastographie Par Ultrafast-écho et la séparation Intima/média Par écho-tracking

summary: The aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in hypertensive arteries.

lead_sponsor: French Cardiology Society

location_facility: Hopital Européen Georges Pompidou / Service de Pharmacologie


title: Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room

acronym: EDDRA-Repro

summary: The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.


title: Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity: a Prospective,Controlled, Randomized, Multicentrique Study.

acronym: QUALISLEEVE

summary:
The bariatric surgery is recognized, at present, as the only effective therapeutic for the patients with morbid obesity. Two surgical procedures (said restrictive) are considered as consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.

A prospective,randomized study comparing these both techniques is necessary to determine a unique consensual technique


title: Validation of a New Sexuality Questionnaire: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse

summary: The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.


title: Validation of a French Version of the PISQ-R: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse

summary: The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.


title: Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog

acronym: LEA-PsyCog

summary:
The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders and psychocognitive impairments in adolescents surviving childhood leukemia .

The second objective is to explore the complex relationships between psycocognitive development and soiciodemodemographics data, main characteristics of leukemia, treatments, side-effects, quality of life and characteristics of proxyies environment.

3. Materials and Methods The LEA study is based on the constitution of a multi-centric prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980 (incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in complete remission and at month 48 for the ALL not grafted in first complete remission.

The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients 12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of people which corresponds to the Marseille and Nice centers). Patients from this two centers are the patients with the more important length of survey, allowing us to produce a not biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically dedicated to the psychological follow-up of children suffering from cancer.


title: Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies and Effect on Suck and Food Intake.

acronym: OTBB

summary: Background: Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder arising from the lack of expression of paternally inherited imprinted genes on chromosome 15q11-q13. The syndrome includes severe neonatal hypotonia with impaired suckling leading to failure to thrive in the most severe cases, subsequently followed by an early onset of morbid obesity with insatiable hunger, combined with other endocrine dysfunction probably due to hypothalamic dysfunction. The pathophysiological mechanism of the occurrence of the 2 main nutritional phases of PWS is unknown. A deficit in the oxytocin (OT)-producing neurons of the paraventricular nucleus in the brain of these patients has been reported. In addition of its well-known anorexigenic effect, OT is involved in establishing and maintaining social codes. Indeed, we have recently shown in a double blind placebo study, that OT administration to adult patients with PWS significantly decreased depressive mood tendencies and tantrums while increasing trust in others with some data on a trend to decrease appetite with higher satiety. Moreover in a PWS mouse model generated from a MAGEL2 KO gene a single OT injection at 5 hr of life prevent the early death observed in 50 % of the new born mice by recovering normal suckling. Interestingly this effect is no longer observed if OT injection takes place later. These data, OT deficit in PWS, good tolerance of OT and its effect after intranasal administration in adult patients with PWS and the recent striking data obtained in the MAGEL2 mouse model, prompted us to evaluate the tolerance of a single administration of intranasal OT in PWS newborns and its possible effect on suckling and food intake. Nowadays the diagnosis of PWS is done during the first months of life in our country. At this age, children still present with poor suckling suggesting that OT may be still efficient. Moreover in adult patients with PWS we have shown that OT improves some typical behavioral troubles. Therefore we first want to evaluate the tolerance of the intranasal administration of OT in 6 infants with PWS genetically confirmed and its effect on suckling, milk intake and weight gain.

lead_sponsor: University Hospital, Toulouse


title: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus

acronym: Lympho C

summary: An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

ReferenceCitation: Michot JM, Canioni D, Driss H, Alric L, Cacoub P, Suarez F, Sibon D, Thieblemont C, Dupuis J, Terrier B, Feray C, Tilly H, Pol S, Leblond V, Settegrana C, Rabiega P, Barthe Y, Hendel-Chavez H, Nguyen-Khac F, Merle-Béral H, Berger F, Molina T, Charlotte F, Carrat F, Davi F, Hermine O, Besson C; ANRS HC-13 Lympho-C Study Group. Antiviral therapy is associated with a better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, ANRS HC-13 lympho-C study. Am J Hematol. 2015 Mar;90(3):197-203. doi: 10.1002/ajh.23889. Epub 2014 Nov 24.

name: Department of Internal Medicine and Clinical Immunology; Paris Sud University; AP-HP, Hôpital Bicêtre Le Kremlin-Bicêtre France

family: Michot

full_name: Jean-Marie Michot

given: Jean-Marie

name: Department of Pathology; Paris 5 Descartes University; AP-HP, Hôpital Necker Paris France

family: Canioni

full_name: Danielle Canioni

given: Danielle

name: Epidemiology of Infectious Diseases INSERM Unité 707; Paris 6 Pierre et Marie Curie University; Paris France

family: Driss

full_name: Henda Driss

given: Henda

name: Department of Internal Medicine and Digestive Diseases; Toulouse 3 University; UMR 152 IRD, Hôpital Purpan Toulouse France

family: Alric

full_name: Laurent Alric

given: Laurent

name: Department of Internal Medicine; APHP; Hôpital Pitié-Salpétrière; Paris 6 Pierre et Marie Curie University; UMR 7211, INSERM, UMR S 959, CNRS Paris France

family: Cacoub

full_name: Patrice Cacoub

given: Patrice

name: Department of Adult Hematology; Paris 5 Descartes University; AP-HP, Hôpital Necker Paris France

name: Imagine Institute; Université Sorbonne Paris Cité; INSERM U 1163, CNRS ERL 8254 Paris France

family: Suarez

full_name: Felipe Suarez

given: Felipe

family: Sibon

full_name: David Sibon

given: David

name: Service d'hémato-oncologie; Université Paris Sorbonne P7; INSERM U728, AP-HP, Hôpital Saint-Louis Paris France

family: Thieblemont

full_name: Catherine Thieblemont

name: Department of Lymphoid Malignancies and Clinical Hematology; Paris 12 Est Créteil University; AP-HP, Hôpital Henri-Mondor Créteil France

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

family: Terrier

full_name: Benjamin Terrier

given: Benjamin

name: Department of Hepatology; Nantes University; Hôpital de Nantes Nantes France

family: Feray

full_name: Cyrille Feray

given: Cyrille

name: Department of Hematology; Rouen University; Centre Henri Becquerel Rouen France

family: Tilly

full_name: Hervé Tilly

given: Hervé

name: Department of Hepatology; Paris 5 Descartes University; INSERM U-1016, AP-HP, Hôpital Cochin Paris France

family: Pol

full_name: Stanislas Pol

given: Stanislas

name: Department of Clinical Hematology; Paris 6 Pierre et Marie Curie University; AP-HP, Hôpital Pitié-Salpêtrière Paris France

family: Leblond

full_name: Véronique Leblond

given: Véronique

name: Department of Biological Hematology and Cytogenetic; Paris 6 Pierre et Marie Curie University; AP-HP, Hôpital Pitié-Salpêtrière Paris France

family: Settegrana

full_name: Catherine Settegrana

family: Rabiega

full_name: Pascaline Rabiega

given: Pascaline

family: Barthe

full_name: Yoann Barthe

given: Yoann

name: Department of Biological Immunology and Hematology; Paris 11 Sud University; AP-HP, Hôpital Bicêtre Le Kremlin-Bicêtre France

family: Hendel-Chavez

full_name: Houria Hendel-Chavez

given: Houria

family: Nguyen-Khac

full_name: Florence Nguyen-Khac

given: Florence

family: Merle-Béral

full_name: Hélène Merle-Béral

name: Department of Pathology; Lyon Sud University, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud; Lyon France

family: Berger

full_name: Françoise Berger

given: Françoise

family: Molina

full_name: Thierry Molina

given: Thierry

name: Department of Pathology; Paris 6 Pierre et Marie Curie University; AP-HP, Hôpital Pitié-Salpêtrière Paris France

family: Charlotte

full_name: Frédéric Charlotte

given: Frédéric

family: Carrat

full_name: Fabrice Carrat

name: on behalf of the ANRS HC-13 Lympho-C Study Group


title: Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure.

acronym: PH-HF

summary: This study will better understand the post-capillary pulmonary hypertension in heart failure, to determine its prognostic role and to consider specific treatment of different forms of pulmonary hypertension in post-capillary pulmonary heart failure.

ReferenceCitation: Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J. 2003 Mar;24(5):442-63.

ReferenceCitation: Lainscak M, Cleland JG, Lenzen MJ, Follath F, Komajda M, Swedberg K. International variations in the treatment and co-morbidity of left ventricular systolic dysfunction: data from the EuroHeart Failure Survey. Eur J Heart Fail. 2007 Mar;9(3):292-9. Epub 2006 Oct 4.

ReferenceCitation: Metra M, Ponikowski P, Dickstein K, McMurray JJ, Gavazzi A, Bergh CH, Fraser AG, Jaarsma T, Pitsis A, Mohacsi P, Böhm M, Anker S, Dargie H, Brutsaert D, Komajda M; Heart Failure Association of the European Society of Cardiology. Advanced chronic heart failure: A position statement from the Study Group on Advanced Heart Failure of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2007 Jun-Jul;9(6-7):684-94. Epub 2007 May 3. Review.

ReferenceCitation: Ghio S, Gavazzi A, Campana C, Inserra C, Klersy C, Sebastiani R, Arbustini E, Recusani F, Tavazzi L. Independent and additive prognostic value of right ventricular systolic function and pulmonary artery pressure in patients with chronic heart failure. J Am Coll Cardiol. 2001 Jan;37(1):183-8.

ReferenceCitation: Kjaergaard J, Akkan D, Iversen KK, Kjoller E, Køber L, Torp-Pedersen C, Hassager C. Prognostic importance of pulmonary hypertension in patients with heart failure. Am J Cardiol. 2007 Apr 15;99(8):1146-50. Epub 2007 Mar 8.

ReferenceCitation: Damy T, Viallet C, Lairez O, Deswarte G, Paulino A, Maison P, Vermes E, Gueret P, Adnot S, Dubois-Randé JL, Hittinger L. Comparison of four right ventricular systolic echocardiographic parameters to predict adverse outcomes in chronic heart failure. Eur J Heart Fail. 2009 Sep;11(9):818-24. doi: 10.1093/eurjhf/hfp111.

ReferenceCitation: Damy T, Goode KM, Kallvikbacka-Bennett A, Lewinter C, Hobkirk J, Nikitin NP, Dubois-Randé JL, Hittinger L, Clark AL, Cleland JG. Determinants and prognostic value of pulmonary arterial pressure in patients with chronic heart failure. Eur Heart J. 2010 Sep;31(18):2280-90. doi: 10.1093/eurheartj/ehq245. Epub 2010 Aug 5.

ReferenceCitation: Galiè N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J. 2009 Oct;30(20):2493-537. doi: 10.1093/eurheartj/ehp297. Epub 2009 Aug 27. Erratum in: Eur Heart J. 2011 Apr;32(8):926.

ReferenceCitation: Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT), Galiè N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34(6):1219-63. doi: 10.1183/09031936.00139009. Epub 2009 Sep 12.

ReferenceCitation: Moraes DL, Colucci WS, Givertz MM. Secondary pulmonary hypertension in chronic heart failure: the role of the endothelium in pathophysiology and management. Circulation. 2000 Oct 3;102(14):1718-23.

ReferenceCitation: Gehlbach BK, Geppert E. The pulmonary manifestations of left heart failure. Chest. 2004 Feb;125(2):669-82. Review.

ReferenceCitation: Wharton J, Strange JW, Møller GM, Growcott EJ, Ren X, Franklyn AP, Phillips SC, Wilkins MR. Antiproliferative effects of phosphodiesterase type 5 inhibition in human pulmonary artery cells. Am J Respir Crit Care Med. 2005 Jul 1;172(1):105-13. Epub 2005 Apr 7.

ReferenceCitation: Nagendran J, Archer SL, Soliman D, Gurtu V, Moudgil R, Haromy A, St Aubin C, Webster L, Rebeyka IM, Ross DB, Light PE, Dyck JR, Michelakis ED. Phosphodiesterase type 5 is highly expressed in the hypertrophied human right ventricle, and acute inhibition of phosphodiesterase type 5 improves contractility. Circulation. 2007 Jul 17;116(3):238-48. Epub 2007 Jul 2.

ReferenceCitation: Galiè N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005 Nov 17;353(20):2148-57. Erratum in: N Engl J Med. 2006 Jun 1;354(22):2400-1.

ReferenceCitation: Lewis GD, Shah R, Shahzad K, Camuso JM, Pappagianopoulos PP, Hung J, Tawakol A, Gerszten RE, Systrom DM, Bloch KD, Semigran MJ. Sildenafil improves exercise capacity and quality of life in patients with systolic heart failure and secondary pulmonary hypertension. Circulation. 2007 Oct 2;116(14):1555-62. Epub 2007 Sep 4.

ReferenceCitation: Lewis GD, Lachmann J, Camuso J, Lepore JJ, Shin J, Martinovic ME, Systrom DM, Bloch KD, Semigran MJ. Sildenafil improves exercise hemodynamics and oxygen uptake in patients with systolic heart failure. Circulation. 2007 Jan 2;115(1):59-66. Epub 2006 Dec 18.

ReferenceCitation: Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. Review. Erratum in: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.


title: Use of a Fabric Mattress Cover for Patient Comfort

summary: The main objective of this research project is to measure the impact on patient satisfaction of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.


title: The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects

summary:
The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day.

This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day.

Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.

primary_purpose: Basic Science

lead_sponsor: Unilever R&D

intervention_type: Dietary Supplement


title: Description and Evaluation of Eating Disorders in Elite Athletes

acronym: TCA SHN

summary:
Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described.

Our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.


title: A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers

summary: This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.

primary_purpose: Other

lead_sponsor: Hoffmann-La Roche


title: Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain

acronym: HORMONES

summary: Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in maintaining homeostasis. The literature reports that pain in patients treated with opioids, significant changes are taking place in this axis with a collapse in hormone concentrations that are correlated with the decline on tests of quality of life and psychological testing. The investigators hypothesis is that this "endocrinopathy" could also be present in patients treated for neuropathic pain with other drug classes as opiates (antidepressants, antiepileptics), and may explain, at least in part, the impairement of the quality of life of these patients.

ReferenceCitation: Corriger A, Duclos M, Corcuff JB, Lambert C, Marceau G, Sapin V, Macian N, Roux D, Pereira B, Pickering G. Hormonal Status and Cognitivo-Emotional Profile in Real-Life Patients With Neuropathic Pain: A Case Control Study. Pain Pract. 2019 Sep;19(7):703-714. doi: 10.1111/papr.12800. Epub 2019 Jun 27.

name: Laboratoire Neuro‐Dol Inserm 1107 University Clermont Auvergne Clermont‐Ferrand France

family: Corriger

full_name: Alexandrine Corriger

given: Alexandrine

name: Sports Medicine Department University Hospital, CHU INRA UMR 1019, UNH, CRNH Clermont‐Ferrand France

family: Duclos

full_name: Martine Duclos

given: Martine

name: Hormone Laboratory Nuclear Medicine CHU Bordeaux UMR INRA 1286 ‐ University Bordeaux Bordeaux France

family: Corcuff

full_name: Jean‐Benoit Corcuff

given: Jean‐Benoit

name: Biostatistics Unit (DRCI) University Hospital Clermont‐Ferrand Clermont‐Ferrand France

family: Lambert

full_name: Céline Lambert

given: Céline

name: Biochemistry Department University Hospital CHU Clermont‐Ferrand France

family: Marceau

full_name: Geoffroy Marceau

given: Geoffroy

family: Sapin

full_name: Vincent Sapin

given: Vincent

name: Clinical Pharmacology Department CPC/CIC Inserm 1405 University Hospital CHU Clermont‐Ferrand France

family: Macian

full_name: Nicolas Macian

given: Nicolas

family: Roux

full_name: Delphine Roux

given: Delphine

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

journal_name: Pain Practice

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Hormonal Status and Cognitivo‐Emotional Profile in Real‐Life Patients With Neuropathic Pain: A Case Control Study


title: Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers

acronym: CURCUMIN

summary: The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

ReferenceCitation: Barber-Chamoux N, Milenkovic D, Verny MA, Habauzit V, Pereira B, Lambert C, Richard D, Boby C, Mazur A, Lusson JR, Dubray C, Morand C. Substantial Variability Across Individuals in the Vascular and Nutrigenomic Response to an Acute Intake of Curcumin: A Randomized Controlled Trial. Mol Nutr Food Res. 2018 Mar;62(5). doi: 10.1002/mnfr.201700418. Epub 2018 Feb 12.

name: INRA; Human Nutrition Unit; UCA; Clermont-Ferrand France

name: Department of Cardiology; Clermont-Ferrand University Hospital; Clermont-Ferrand France

family: Barber-Chamoux

full_name: Nicolas Barber-Chamoux

family: Milenkovic

full_name: Dragan Milenkovic

given: Dragan

family: Verny

full_name: Marie-Anne Verny

given: Marie-Anne

family: Habauzit

full_name: Véronique Habauzit

given: Véronique

name: Biostatistics unit (DRCI); Clermont-Ferrand University Hospital; Clermont-Ferrand France

name: Clinical pharmacology; Clermont-Ferrand University Hospital; Clermont-Ferrand France

family: Richard

full_name: Damien Richard

given: Damien

name: INRA; UMRH; Plate-Forme d'Exploration du Métabolisme; Clermont-Ferrand France

family: Boby

full_name: Céline Boby

family: Mazur

full_name: Andrzej Mazur

given: Andrzej

family: Lusson

full_name: Jean René Lusson

given: Jean René

family: Dubray

full_name: Claude Dubray

given: Claude

family: Morand

full_name: Christine Morand

given: Christine

bso_classification: Biology (fond.)

journal_name: Molecular Nutrition & Food Research


type: Registry Identifier

title: Genetic and Molecular Abnormalities in Congenital Cystic Adenomatoid Malformations

acronym: MAKP

summary: The aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of CCAM.

ReferenceCitation: Kotecha S, Barbato A, Bush A, Claus F, Davenport M, Delacourt C, Deprest J, Eber E, Frenckner B, Greenough A, Nicholson AG, Antón-Pacheco JL, Midulla F. Antenatal and postnatal management of congenital cystic adenomatoid malformation. Paediatr Respir Rev. 2012 Sep;13(3):162-70; quiz 170-1. doi: 10.1016/j.prrv.2012.01.002. Epub 2012 Apr 25. Review.

ReferenceCitation: Lezmi G, Vibhushan S, Bevilaqua C, Crapart N, Cagnard N, Khen-Dunlop N, Boyle-Freyssaut C, Hadchouel A, Delacourt C. Congenital cystic adenomatoid malformations of the lung: an epithelial transcriptomic approach. Respir Res. 2020 Feb 4;21(1):43. doi: 10.1186/s12931-020-1306-5.

family: Lezmi

full_name: Guillaume Lezmi

given: Guillaume

family: Vibhushan

full_name: Shamila Vibhushan

given: Shamila

family: Bevilaqua

full_name: Claudia Bevilaqua

given: Claudia

family: Crapart

full_name: Nicolas Crapart

family: Cagnard

full_name: Nicolas Cagnard

family: Khen-Dunlop

full_name: Naziha Khen-Dunlop

given: Naziha

family: Boyle-Freyssaut

full_name: Christine Boyle-Freyssaut

family: Hadchouel

full_name: Alice Hadchouel

given: Alice

family: Delacourt

full_name: Christophe Delacourt

given: Christophe

currency_apc_doaj: GBP

journal_name: Respiratory Research

intervention_type: Genetic


title: Prevalence and Epitope Specificity of Non-neutralizing Antibodies in Haemophilia A Patients Without Inhibitors, Immunogenicity of B Domain: A Prospective Study

summary:
Antibodies (Abs) directed against factorVIII (FVIII) remain the main iatrogenic complication in haemophilia A (HA) patients. Anti-FVIII Abs inhibiting pro-coagulant properties of the molecule are named inhibitors whereas Abs directed towards non-functional epitopes are named non-neutralizing antibodies (NNA). These NNA are poorly studied and their prevalence is ill-defined.

In a recent retrospective study the investigators evaluated, in a cohort of 210 patients without inhibitor, the NNA prevalence and the NNA epitope specificity against the heavy chain (HC)or the light chain(LC). For the first time, the investigators used two x-MAP based assays: the first to determine the specificity of anti-FVIII Abs against the HC or the LC, the second to display Abs directed towards the B domain. NNA were found in 38 out of 210 patients (18).

Among this NNA positive population, 74% and 13% of patients had anti-FVIII Abs against both chains. The proportion of NNA directed towards the B domain was 18%.

Considering an approximate inhibitor prevalence of 30% and a NNA prevalence of 19% in severe HA patients, approximately 50% of severe HA patients develop an immune response against infused FVIII. Due to their unclear relevance, the NNA detection does not yet belong to the routine clinical practice.

However, in 2006, Dimichele advancedf a hypothesis concerning the influence of NNA on the variations in the kinectics of FVIII observed in certain patients.

The mechanism explaining the role of these NNA in the FVIII in the FVIII kinectics has not still been demonstrated.

The investigators propose to perform a multicentre prospective study with the aim to confirm, in severe, moderate and mild HA treated patietns, the NNA prevalence observed in our retrospective study, to study the evolution over time of the epitopemapping of these NNA and to explore the correlation between these NNA and clinical/biological parameters.

status: Withdrawn

ReferenceType: result

ReferenceCitation: Lavigne-Lissalde G, Rothschild C, Pouplard C, Lapalud P, Gruel Y, Schved JF, Granier C. Characteristics, mechanisms of action, and epitope mapping of anti-factor VIII antibodies. Clin Rev Allergy Immunol. 2009 Oct;37(2):67-79. doi: 10.1007/s12016-009-8119-0. Review.

family: Lavigne-Lissalde

full_name: Géraldine Lavigne-Lissalde

given: Géraldine

family: Rothschild

full_name: Chantal Rothschild

given: Chantal

family: Pouplard

full_name: Claire Pouplard

given: Claire

family: Lapalud

full_name: Priscilla Lapalud

given: Priscilla

family: Gruel

full_name: Yves Gruel

given: Yves

family: Schved

full_name: Jean-François Schved

given: Jean-François

family: Granier

full_name: Claude Granier

journal_name: Clinical Reviews in Allergy & Immunology

publisher_dissemination: Springer

publisher_group: Springer

title: Characteristics, Mechanisms of Action, and Epitope Mapping of Anti-factor VIII Antibodies

ReferenceCitation: Lavigne-Lissalde G, Tarrade C, Lapalud P, Chtourou S, Schved JF, Granier C, Villard-Saussine S. Simultaneous detection and epitope mapping of anti-factor VIII antibodies. Thromb Haemost. 2008 Jun;99(6):1090-6. doi: 10.1160/TH07-08-0497.

family: Chtourou

full_name: Sami Chtourou

given: Sami

full_name: Geraldine Lavigne-Lissalde

given: Geraldine

family: Tarrade

full_name: Catherine Tarrade

given: Catherine

family: Villard-Saussine

full_name: Sylvie Villard-Saussine

given: Sylvie

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Lavigne-Lissalde G, Lacroix-Desmazes S, Wootla B, Tarrade C, Schved JF, Kaveri SV, Granier C, Villard-Saussine S. Molecular characterization of human B domain-specific anti-factor VIII monoclonal antibodies generated in transgenic mice. Thromb Haemost. 2007 Jul;98(1):138-47.

location_facility: CHU de Montpellier- Centre administratif André Benech

intervention_type: Biological


title: Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

acronym: VIDAZA-DLI

summary: Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.


title: Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes

acronym: INDAO

summary: This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the treatment of gestational diabetes.

ReferenceCitation: Sénat MV, Affres H, Letourneau A, Coustols-Valat M, Cazaubiel M, Legardeur H, Jacquier JF, Bourcigaux N, Simon E, Rod A, Héron I, Castera V, Sentilhes L, Bretelle F, Rolland C, Morin M, Deruelle P, De Carne C, Maillot F, Beucher G, Verspyck E, Desbriere R, Laboureau S, Mitanchez D, Bouyer J; Groupe de Recherche en Obstétrique et Gynécologie (GROG). Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1773-1780. doi: 10.1001/jama.2018.4072.

name: Assistance Publique–Hôpitaux de Paris, Department of Gynecology-Obstetrics, Bicêtre Hospital, Le Kremlin-Bicêtre, France

name: University of Paris-Sud, University of Medicine Paris-Saclay, Le Kremlin-Bicêtre, France

name: Centre for Research in Epidemiology and Population Health, Université Paris-Saclay, Université Paris-Sud, Université de Versailles Saint-Quentin-en-Yvelines, INSERM, Villejuif, France

family: Sénat

full_name: Marie-Victoire Sénat

given: Marie-Victoire

name: Assistance Publique–Hôpitaux de Paris, Department of Reproductive Endocrinology, Bicêtre Hospital, Le Kremlin-Bicêtre, France

family: Affres

full_name: Helene Affres

given: Helene

name: Assistance Publique–Hôpitaux de Paris, Department of Gynecology-Obstetrics, Béclère Hospital, Clamart, France

family: Letourneau

full_name: Alexandra Letourneau

given: Alexandra

name: Department of Endocrinology-Obstetrics, Toulouse University Hospital, Toulouse, France

family: Coustols-Valat

full_name: Magali Coustols-Valat

given: Magali

name: Department of Endocrinology, Lille University Hospital EA 4489–Environnement Périnatal et Santé, Lille, France

family: Cazaubiel

full_name: Marie Cazaubiel

given: Marie

name: Assistance Publique–Hôpitaux de Paris, Department of Gynecology and Obstetrics, Hôpital Louis Mourier, Colombes, France

family: Legardeur

full_name: Helene Legardeur

name: Department of Gynecology-Obstetrics, Poissy St-Germain Hospital, Poissy, France

family: Jacquier

full_name: Julie Fort Jacquier

given: Julie Fort

name: Assistance Publique–Hôpitaux de Paris, Department of Endocrinology, St Antoine Hospital Paris, France

family: Bourcigaux

full_name: Nathalie Bourcigaux

given: Nathalie

name: Department of Obstetrics, Gynecology and Fetal Medicine, University Hospital Center of Tours, Tours, France

family: Simon

full_name: Emmanuel Simon

given: Emmanuel

name: Department of Endocrinology, Caen University Hospital, Caen, France, France

family: Rod

full_name: Anne Rod

given: Anne

name: Department of Endocrinology, Rouen University Hospital–Charles Nicolle, Rouen, France

family: Héron

full_name: Isabelle Héron

given: Isabelle

name: Department of Endocrinology, St Joseph Hospital, Marseille, France

family: Castera

full_name: Virginie Castera

given: Virginie

name: Department of Obstetrics and Gynecology, Angers University Hospital, Angers, France

name: Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France

family: Sentilhes

full_name: Loic Sentilhes

given: Loic

name: Assistance Publique–Hôpitaux de Marseille; AMU, Aix-Marseille Université, Department of Gynecology and Obstetrics, Pole Femme Enfant, Marseille, France

family: Bretelle

full_name: Florence Bretelle

given: Florence

name: Assistance Publique–Hôpitaux de Paris, Department of Hepato-Enterology-Gastroenteritis, Béclère Hospital, Clamart, France

family: Rolland

full_name: Catherine Rolland

name: Department of Gynecology-Obstetrics, Toulouse University Hospital, Toulouse, France

family: Morin

full_name: Mathieu Morin

given: Mathieu

name: Department of Gynecology-Obstetrics, Lille University, EA 4489–Environnement Périnatal et Santé, Lille, France

family: Deruelle

full_name: Philippe Deruelle

given: Philippe

name: Assistance Publique–Hôpitaux de Paris, Department of Gynecology-Obstetrics, Trousseau Hospital, Paris, France

family: De Carne

full_name: Celine De Carne

given: Celine

name: Department of Internal Medicine, François-Rabelais University, University Hospital Center of Tours, Tours, France

family: Maillot

full_name: François Maillot

given: François

name: Department of Gynecology-Obstetrics, Caen University Hospital, Caen, France, France

family: Beucher

full_name: Gael Beucher

given: Gael

name: Department of Gynecology and Obstetrics, Rouen University Hospital–Charles Nicolle, Rouen, France

family: Verspyck

full_name: Eric Verspyck

given: Eric

name: Department of Gynecology-Obstetrics, St Joseph Hospital, Marseille, France

family: Desbriere

full_name: Raoul Desbriere

given: Raoul

name: Department of Endocrinology, Angers University Hospital, Angers, France

family: Laboureau

full_name: Sandrine Laboureau

given: Sandrine

name: Assistance Publique–Hôpitaux de Paris, Sorbonne Universities, University Pierre and Marie Curie, University Paris 06, Department of Neonatology, Armand Trousseau Hospital, Paris, France

name: for the Groupe de Recherche en Obstétrique et Gynécologie (GROG)


title: Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation

acronym: LENEA

summary: The LENEA study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the NANO LV lead system.

lead_sponsor: LivaNova


title: Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output

summary:
The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control.

Several questions on phenylephrine global and regional hemodynamics effects remain unresolved.

The investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.

The aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.

ReferenceCitation: Rebet O, Andremont O, Gérard JL, Fellahi JL, Hanouz JL, Fischer MO. Preload dependency determines the effects of phenylephrine on cardiac output in anaesthetised patients: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):638-44. doi: 10.1097/EJA.0000000000000470.

family: Rebet

full_name: Olivier Rebet

given: Olivier

family: Andremont

full_name: Olivier Andremont

family: Gérard

full_name: Jean-Louis Gérard

given: Jean-Louis

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

family: Hanouz

full_name: Jean-Luc Hanouz

family: Fischer

full_name: Marc-Olivier Fischer

given: Marc-Olivier

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Caen


title: Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae

acronym: COMBAT

summary:
Major changes in the epidemiological characteristics of bacterial meningitis have been observed as a result of changes in behaviour, human interventions (use of antibiotics, prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic outbreaks.

The objective of this study is to identify the determinants of in-hospital mortality of bacterial meningitis in adults.

Hypothesis : the standardized data collection concerning cases of bacterial meningitis in adults with telephone follow-up would allow analysis of the determinants of mortality and neurosensory sequelae, description of the psychosocial impact and proposal of new treatment strategies.

ReferenceCitation: Benadji A, Duval X, Danis K, Hoen B, Page B, Béraud G, Vernet-Garnier V, Strady C, Brieu N, Maulin L, Roy C, Ploy MC, Gaillat J, Varon E, Tubiana S; COMBAT Study Group; SIIP Study Group. Relationship between serotypes, disease characteristics and 30-day mortality in adults with invasive pneumococcal disease. Infection. 2021 Sep 1. doi: 10.1007/s15010-021-01688-5. [Epub ahead of print]

family: Benadji

full_name: Amine Benadji

given: Amine

family: Duval

full_name: Xavier Duval

given: Xavier

family: Danis

full_name: Kostas Danis

given: Kostas

family: Hoen

full_name: Bruno Hoen

given: Bruno

family: Page

full_name: Bernard Page

given: Bernard

family: Béraud

full_name: Guillaume Béraud

given: Guillaume

family: Vernet-Garnier

full_name: Véronique Vernet-Garnier

given: Véronique

family: Strady

full_name: Christophe Strady

given: Christophe

family: Brieu

full_name: Nathalie Brieu

given: Nathalie

family: Maulin

full_name: Laurence Maulin

given: Laurence

family: Roy

full_name: Carine Roy

given: Carine

family: Ploy

full_name: Marie-Cécile Ploy

given: Marie-Cécile

family: Gaillat

full_name: Jacques Gaillat

given: Jacques

family: Varon

full_name: Emmanuelle Varon

given: Emmanuelle

family: Tubiana

full_name: Sarah Tubiana

given: Sarah

family: Mourvillier

full_name: Bruno Mourvillier

family: Caron

full_name: François Caron

family: Bollaert

full_name: Pierre-Edouard Bollaert

given: Pierre-Edouard

ReferenceCitation: Tubiana S, Varon E, Biron C, Ploy MC, Mourvillier B, Taha MK, Revest M, Poyart C, Martin-Blondel G, Lecuit M, Cua E, Pasquet B, Preau M, Hoen B, Duval X; COMBAT study group. Community-acquired bacterial meningitis in adults: in-hospital prognosis, long-term disability and determinants of outcome in a multicentre prospective cohort. Clin Microbiol Infect. 2020 Sep;26(9):1192-1200. doi: 10.1016/j.cmi.2019.12.020. Epub 2020 Jan 10.

location_facility: Assistance Publique des Hôpitaux de Paris


title: Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach

acronym: VISIOTRAIN

summary:
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Apart from the substitutive method that uses prisms directly placed on glasses, two main rehabilitative methods have been explored previously: one restorative and one compensatory. The most effective methods seem to be based on compensatory training paradigms that target eye movements. They rely on voluntary mass-practice that induces changes in exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies using this method have shown changes in visual scanning patterns but with only a marginal profit in terms of functional benefit.

In the present study, the investigators developed a new approach to the compensatory visual field training based solely on a bottom-up mechanism. It does not require the patients' ability to voluntarily maintain attention oriented to the affected field, which may be difficult for brain-damaged patients. As previously reported in other pathological contexts (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing voluntary and conscious implication of the patient can produce improvements by a more automatic process.

The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by hemianopic patients to automatically improve targeted eye movements into their blind visual field; and 2) that this will lead to behavioural improvements on ecologically valid tests of visual search.

location_facility: Service de Médecine Physique et de Réadaptation,Hôpital Henry Gabrielle


title: Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies

acronym: REEF-CMH

summary: The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)


acronym: COLI-VLM

summary: Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals

lead_sponsor: Poitiers University Hospital


title: A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial

acronym: SUMMIT

summary: The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.

lead_sponsor: ALK-Abelló A/S


title: Study of the Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information in Patients With Parkinson's Disease

acronym: EMOPHYSIO

summary: The role of the basal ganglia in the processing of information with emotional or motivational content has been demonstrated by several lesion and functional imaging studies in humans and animals. Deep brain stimulation surgery provides an opportunity to study these structures in humans in electrophysiological terms. The aim of this study is to investigate modifications in the electrophysiological activity of the subthalamic nucleus (STN) during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson's disease who have just undergone implantation of a deep brain stimulator in the STN.


title: Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?

summary:
The potential clinical implications of this study are to optimise the selection of a population at risk for developing a diabetic cardiomyopathy among diabetic patients in order to develop early therapeutic strategies to prevent the left ventricular remodelling.

Therefore, the originality of this project is to hypothesize that :

Diabetes mellitus is often associated with a premature aging syndrome
Cellular senescence may potentiate the mechanisms that are involved in decreasing myocardial contractility in DM and,
DM associated to premature aging may increase the risk of developing a cardiomyopathy Thus, the modulation of telomerase activity and the control of telomere length, together with the attenuation of the formation of reactive oxygen species, might represent important new targets in order to develop therapeutic tools in prevention of diabetic cardiomyopathy.


title: Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams. Clinical Trial Prospective, Monocentric, Randomized in Double-blinded.

acronym: NEOTRANS

summary:
Clinical management of very low birth weight newborns (VLBW <1250g) consists in several challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a major cause of morbidity due to

the immaturity of GI functions (prolonged ileus, bacterial overgrowth and translocation),
the complication of GI tract immaturity: intestinal perforation and enterocolitis necrotizing)
the need of a prolonged parenteral nutrition and its complications (central venous catheter infections, sepsis, electrolyte disturbances) but without generate a high proof level on this targeted population (<1250g).

The GI functions are progressively acquired during development and are largely sensitive to the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate increases gradually after birth. The beneficial effects of butyrate are related to its properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and upon the enteric nervous system (network of neurons and glial cells) that regulate GI functions and in particular colonic motility.

To date, there is no clinical consensus to manage digestive disorders of VLBW. Several clinical studies have assessed the effects of prokinetic drugs, dietary supplements (probiotics, prebiotics) but without generate a high proof level on this targeted population. In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g.

The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen (in particular the flora).

Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic mechanisms.

Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design.

The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams, by facilitating the development of colic motility and clinical nutrition tolerance.


summary: Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.

ReferenceCitation: Calzia E, Asfar P, Hauser B, Matejovic M, Ballestra C, Radermacher P, Georgieff M. Hyperoxia may be beneficial. Crit Care Med. 2010 Oct;38(10 Suppl):S559-68. doi: 10.1097/CCM.0b013e3181f1fe70.

ReferenceCitation: Goertz AW, Mehl T, Lindner KH, Rockemann MG, Schirmer U, Schwilk B, Georgieff M. Effect of 7.2% hypertonic saline/6% hetastarch on left ventricular contractility in anesthetized humans. Anesthesiology. 1995 Jun;82(6):1389-95.

ReferenceCitation: Oliveira RP, Weingartner R, Ribas EO, Moraes RS, Friedman G. Acute haemodynamic effects of a hypertonic saline/dextran solution in stable patients with severe sepsis. Intensive Care Med. 2002 Nov;28(11):1574-81. Epub 2002 Oct 1.

ReferenceCitation: Junger WG, Hoyt DB, Davis RE, Herdon-Remelius C, Namiki S, Junger H, Loomis W, Altman A. Hypertonicity regulates the function of human neutrophils by modulating chemoattractant receptor signaling and activating mitogen-activated protein kinase p38. J Clin Invest. 1998 Jun 15;101(12):2768-79.

ReferenceCitation: Coimbra R, Hoyt DB, Junger WG, Angle N, Wolf P, Loomis W, Evers MF. Hypertonic saline resuscitation decreases susceptibility to sepsis after hemorrhagic shock. J Trauma. 1997 Apr;42(4):602-6; discussion 606-7.

ReferenceCitation: Commereuc M, Nevoret C, Radermacher P, Katsahian S, Asfar P, Schortgen F; HYPER2S investigators. Hyperchloremia is not associated with AKI or death in septic shock patients: results of a post hoc analysis of the "HYPER2S" trial. Ann Intensive Care. 2019 Aug 22;9(1):95. doi: 10.1186/s13613-019-0570-3.

family: Commereuc

full_name: Morgane Commereuc

given: Morgane

family: Nevoret

full_name: Camille Nevoret

given: Camille

family: Radermacher

full_name: Peter Radermacher

given: Peter

family: Katsahian

full_name: Sandrine Katsahian

given: Sandrine

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Schortgen

full_name: Frédérique Schortgen

given: Frédérique

journal_name: Annals of Intensive Care

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

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

repositories:
HAL
PubMed Central

title: Hyperchloremia is not associated with AKI or death in septic shock patients: results of a post hoc analysis of the “HYPER2S” trial

ReferenceCitation: Asfar P, Schortgen F, Boisramé-Helms J, Charpentier J, Guérot E, Megarbane B, Grimaldi D, Grelon F, Anguel N, Lasocki S, Henry-Lagarrigue M, Gonzalez F, Legay F, Guitton C, Schenck M, Doise JM, Devaquet J, Van Der Linden T, Chatellier D, Rigaud JP, Dellamonica J, Tamion F, Meziani F, Mercat A, Dreyfuss D, Seegers V, Radermacher P; HYPER2S Investigators; REVA research network. Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial. Lancet Respir Med. 2017 Mar;5(3):180-190. doi: 10.1016/S2213-2600(17)30046-2. Epub 2017 Feb 15. Erratum in: Lancet Respir Med. 2017 Aug;5(8):e28.

family: Boisramé-Helms

full_name: Julie Boisramé-Helms

given: Julie

family: Charpentier

full_name: Julien Charpentier

given: Julien

family: Guérot

full_name: Emmanuel Guérot

given: Emmanuel


title: Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study

acronym: GETEMED

summary:
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.

Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.

location_facility: Hospices Civils de Lyon- Hôpital Femme Mère Enfant


title: Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer

acronym: SPI COHERENCE

summary: This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).


title: Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction

summary: The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.

status: Recruiting

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon

status_simplified: Ongoing


title: Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

acronym: Post-coma DBS

summary: Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)

summary: The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma

ReferenceCitation: Piessen G, Messager M, Le Malicot K, Robb WB, Di Fiore F, Guilbert M, Moreau M, Christophe V, Adenis A, Mariette C. Phase II/III multicentre randomised controlled trial evaluating a strategy of primary surgery and adjuvant chemotherapy versus peri-operative chemotherapy for resectable gastric signet ring cell adenocarcinomas - PRODIGE 19 - FFCD1103 - ADCI002. BMC Cancer. 2013 Jun 10;13:281. doi: 10.1186/1471-2407-13-281.

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

family: Messager

full_name: Mathieu Messager

given: Mathieu

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Robb

full_name: William B Robb

given: William B

family: Di Fiore

full_name: Frédéric Di Fiore

given: Frédéric

family: Guilbert

full_name: Marie Guilbert

given: Marie

family: Moreau

full_name: Marie Moreau

family: Christophe

full_name: Véronique Christophe

given: Véronique

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Mariette

full_name: Christophe Mariette

given: Christophe

journal_name: BMC Cancer

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

title: Phase II/III multicentre randomised controlled trial evaluating a strategy of primary surgery and adjuvant chemotherapy versus peri-operative chemotherapy for resectable gastric signet ring cell adenocarcinomas – PRODIGE 19 – FFCD1103 – ADCI002

lead_sponsor: University Hospital, Lille

location_facility: General and digestive surgical department, Claude Huriez Hospital, University Hospital


title: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

summary: This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.

ReferenceCitation: van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.

name:
Unilever
Discover Vlaardingen, Olivier van Noortlaan 120, 3133 AT Vlaardingen, The Netherlands

name:
Laboratory
of Biophysics and Wageningen NMR Centre, Wageningen University, 6700 ET Wageningen, The Netherlands

name: Netherlands Metabolomics Centre, Einsteinweg 55, 2333 CL Leiden, The Netherlands

family: van Duynhoven

full_name: John van Duynhoven

given: John

name:
Laboratory
of Biochemistry, Wageningen University, 6700 ET Wageningen, The Netherlands

family: van der Hooft

full_name: Justin J. J. van der Hooft

given: Justin J. J.

family: van Dorsten

full_name: Ferdinand A. van Dorsten

given: Ferdinand A.

family: Peters

full_name: Sonja Peters

given: Sonja

family: Foltz

full_name: Martin Foltz

given: Martin

name: Plant Research International, Droevendaalsesteeg 1, 6708 PB Wageningen, The Netherlands

name: Centre for Biosystems Genomics, Droevendaalsesteeg 1, 6708 PB Wageningen, The Netherlands

family: Gomez-Roldan

full_name: Victoria Gomez-Roldan

given: Victoria

family: Vervoort

full_name: Jacques Vervoort

given: Jacques

family: de Vos

full_name: Ric C. H. de Vos

given: Ric C. H.

family: Jacobs

full_name: Doris M. Jacobs

given: Doris M.

journal_name: Journal of Proteome Research

publisher: American Chemical Society (ACS)

publisher_dissemination: American Chemical Society

publisher_group: American Chemical Society

publisher_normalized: American Chemical Society

title: Rapid and Sustained Systemic Circulation of Conjugated Gut Microbial Catabolites after Single-Dose Black Tea Extract Consumption


title: Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients

acronym: PPSA

summary: Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.


title: Study of the Effect of Food Vitamin K2 Intake in Association With a Fermented Dairy Product on Patients Treated With Vitamin K Antagonist (VKA)

acronym: SAFEK

summary: The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.In addition, the study evaluates if regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.

lead_sponsor: Danisco

location_facility: Unite de Recherches Therapeutiques, Hopital Lariboisiere


title: EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE

acronym: ETPARK

summary:
Parkinson's disease (PD) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. To improve the medical care of PD patients, the investigator have developed an educational program specific to PD.

The principal aim of this study is to evaluate the therapeutic education Program, comparing the quality of life of PD patients with or without the educational program after six month and one year follow-up.

The secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs.

This is a monocentric, comparative, prospective randomised study. The investigators will evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. Quality of life of PD patients is evaluated using a specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological states were assessed with UPDRS and HAD Scales. The educational program consisted of both individual and collective educational consultations.

The investigators supposed that the therapeutic education program will improve the quality of life of PD patients. The supposition that this improvement will correlate with the motor and psychological states.

ReferenceCitation: Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.

family: Ory Magne

full_name: F. Ory Magne

given: F.

family: Arcari

full_name: C. Arcari

given: C.

family: Canivet

full_name: C. Canivet

family: Sarrail

full_name: M. Sarrail

given: M.

family: Fabre

full_name: M.H. Fabre

family: Mohara

full_name: C. Mohara

family: Brefel Courbon

full_name: C. Brefel Courbon

journal_name: Revue Neurologique

title: Éducation thérapeutique chez le patient parkinsonien : le programme ETPARK


title: A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer

summary:
Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the hypothesis that omission of additional axillary dissection in case of positive sentinel node has a limited impact on overall survival and relapse free survival. However, these data are not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of inclusions and the predefined non inferiority margin was found to be too large (5% difference at 5 years for primary endpoint).

Prospective randomized trial is then urgently mandatory before omission of axillary node dissection becomes a usual practice without a sufficient scientific level of proof. Indeed, in several reviews, the rate of omission of axillary node dissection in case of micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.

The omission of axillary node dissection in case of positive sentinel node may have strong practical impacts on patients but also on medical and economical aspects: in avoiding a prolonged hospitalisation, secondary morbidities due to axillary dissection requiring secondary care and their costs, as well as costs for secondary axillary dissection (14 to 25% in case of positive sentinel node) and finally shortening surgery duration.

The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer

ReferenceCitation: Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

ReferenceCitation: Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.

family: Donker

full_name: Mila Donker

given: Mila

family: van Tienhoven

full_name: Geertjan van Tienhoven

given: Geertjan

family: Straver

full_name: Marieke E Straver

given: Marieke E

family: Meijnen

full_name: Philip Meijnen

given: Philip

family: van de Velde

full_name: Cornelis J H van de Velde

given: Cornelis J H

family: Mansel

full_name: Robert E Mansel

given: Robert E

family: Cataliotti

full_name: Luigi Cataliotti

given: Luigi

family: Westenberg

full_name: A Helen Westenberg

given: A Helen

family: Klinkenbijl

full_name: Jean H G Klinkenbijl

given: Jean H G

family: Orzalesi

full_name: Lorenzo Orzalesi

given: Lorenzo

family: Bouma

full_name: Willem H Bouma

given: Willem H

family: van der Mijle

full_name: Huub C J van der Mijle

given: Huub C J

family: Nieuwenhuijzen

full_name: Grard A P Nieuwenhuijzen

given: Grard A P

family: Veltkamp

full_name: Sanne C Veltkamp

given: Sanne C

family: Slaets

full_name: Leen Slaets

given: Leen

family: Duez

full_name: Nicole J Duez

given: Nicole J

family: de Graaf

full_name: Peter W de Graaf

given: Peter W

family: van Dalen

full_name: Thijs van Dalen

given: Thijs

family: Marinelli

full_name: Andreas Marinelli

given: Andreas

family: Rijna

full_name: Herman Rijna

given: Herman

family: Snoj

full_name: Marko Snoj

given: Marko

family: Bundred

full_name: Nigel J Bundred

given: Nigel J

family: Merkus

full_name: Jos W S Merkus

given: Jos W S

ReferenceCitation: Jagsi R, Chadha M, Moni J, Ballman K, Laurie F, Buchholz TA, Giuliano A, Haffty BG. Radiation field design in the ACOSOG Z0011 (Alliance) Trial. J Clin Oncol. 2014 Nov 10;32(32):3600-6. doi: 10.1200/JCO.2014.56.5838. Epub 2014 Aug 18.

ReferenceCitation: Houvenaeghel G, Cohen M, Raro P, De Troyer J, de Lara CT, Gimbergues P, Gauthier T, Faure-Virelizier C, Vaini-Cowen V, Lantheaume S, Regis C, Darai E, Ceccato V, D'Halluin G, Del Piano F, Villet R, Jouve E, Beedassy B, Theret P, Gabelle P, Zinzindohoue C, Opinel P, Marsollier-Ferrer C, Dhainaut-Speyer C, Colombo PE, Lambaudie E, Tallet A, Boher JM; Others investigators (SERC trial group). Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node. BMC Cancer. 2018 Nov 21;18(1):1153. doi: 10.1186/s12885-018-5053-7.

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


title: Influence of Telaprevir Exposure on the Severe Anemia Induced by Ribavirin/Pegylated Interferon/Telaprevir Tri-therapy in HCV Infected Patients

acronym: Ribatela

summary: The risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. The trough concentration or AUC of telaprevir could therefore be a predictive factor of the onset of anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve tolerance and SVR.


title: Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma

acronym: SARCOPENIE

summary: This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.

ipd_sharing: No

lead_sponsor: Centre Henri Becquerel


title: Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency

acronym: PRIMM

summary: The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography

acronym: PREFFORT

summary:
Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures elevated only at exercise (normal at rest).

Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as a "memory" of chronic elevation of filling pressures. We believe that it is possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure (LVEDP).

ReferenceCitation: Hammoudi N, Laveau F, Helft G, Cozic N, Barthelemy O, Ceccaldi A, Petroni T, Berman E, Komajda M, Michel PL, Mallet A, Le Feuvre C, Isnard R. Low level exercise echocardiography helps diagnose early stage heart failure with preserved ejection fraction: a study of echocardiography versus catheterization. Clin Res Cardiol. 2017 Mar;106(3):192-201. doi: 10.1007/s00392-016-1039-0. Epub 2016 Sep 30.

family: Hammoudi

full_name: Nadjib Hammoudi

given: Nadjib

family: Laveau

full_name: Florent Laveau

given: Florent

family: Helft

full_name: Gérard Helft

given: Gérard

family: Cozic

full_name: Nathalie Cozic

given: Nathalie

family: Barthelemy

full_name: Olivier Barthelemy

given: Olivier

family: Ceccaldi

full_name: Alexandre Ceccaldi

given: Alexandre

family: Petroni

full_name: Thibaut Petroni

given: Thibaut

family: Berman

full_name: Emmanuel Berman

given: Emmanuel

family: Komajda

full_name: Michel Komajda

given: Michel

family: Michel

full_name: Pierre-Louis Michel

given: Pierre-Louis

family: Mallet

full_name: Alain Mallet

given: Alain

family: Le Feuvre

full_name: Claude Le Feuvre

given: Claude

family: Isnard

full_name: Richard Isnard

given: Richard

journal_name: Clinical Research in Cardiology

oa_host_type: repository

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

location_facility: Pitié Salpêtrière Hospital - Cardiology Department


title: Identification of New Markers in the Hypereosinophilic Syndrome

acronym: SHE

summary: The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease.


title: Determination of Myocardial Relaxation Times Values in Healthy Volunters

acronym: HeartMS

summary:
T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial tissue content (water, fibrosis, iron).

The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in healthy volunters aged 18-69 years using 1.5T clinical MRI.

lead_sponsor: University Hospital, Rouen


title: Ano-rectal 3D High Resolution Manometry: Normal Values and Comparison With Ultrasound Examination in Healthy Volunteers, Patients With Fecal Incontinence and Patients With Constipation

acronym: NOMAD

summary: Ano-rectal manometry is indicative in patients with either fecal incontinence or constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure variations are measured circumferentially along the anal canal. It may allow a better understanding of anorectal disorders by displaying anal pressure asymmetry and it could be useful to assess the functional anatomy of the pelvic floor better than conventional manometry.

ReferenceCitation: Mion F, Garros A, Brochard C, Vitton V, Ropert A, Bouvier M, Damon H, Siproudhis L, Roman S. 3D High-definition anorectal manometry: Values obtained in asymptomatic volunteers, fecal incontinence and chronic constipation. Results of a prospective multicenter study (NOMAD). Neurogastroenterol Motil. 2017 Aug;29(8). doi: 10.1111/nmo.13049. Epub 2017 Mar 2.

name: Exploration Fonctionnelle Digestive; Hospital Edouard Herriot; Hospices Civils de Lyon; Lyon I University, and INSERM 1032 LabTAU; Lyon France

family: Mion

full_name: F. Mion

given: F.

name: Exploration Fonctionnelle Digestive; Hospital Edouard Herriot; Hospices Civils de Lyon; Lyon France

family: Garros

full_name: A. Garros

given: A.

name: Digestive Physiology and Gastroenterology; Pontchaillou Hospital; CHU de Rennes; Rennes France

family: Brochard

full_name: C. Brochard

given: C.

name: Digestive Physiology; North Hospital; Assistance Publique Hôpitaux de Marseille; Aix-Marseille University; Marseille France

family: Vitton

full_name: V. Vitton

given: V.

family: Ropert

full_name: A. Ropert

family: Bouvier

full_name: M. Bouvier

given: M.

family: Damon

full_name: H. Damon

given: H.

family: Siproudhis

full_name: L. Siproudhis

given: L.

family: Roman

full_name: S. Roman

given: S.

journal_name: Neurogastroenterology & Motility

oa_host_type: publisher

evidence: open (via free article)

location_facility: Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot


title: Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

summary: The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).

lead_sponsor: PiLeJe