title: Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

summary: This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.

ReferenceCitation: De Santis M, Wiechno PJ, Bellmunt J, Lucas C, Su WC, Albiges L, Lin CC, Senkus-Konefka E, Flechon A, Mourey L, Necchi A, Loidl WC, Retz MM, Vaissière N, Culine S. Vinflunine-gemcitabine versus vinflunine-carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: results of an international randomized phase II trial (JASINT1). Ann Oncol. 2016 Mar;27(3):449-54. doi: 10.1093/annonc/mdv609. Epub 2015 Dec 16.

family: De Santis

full_name: M. De Santis

given: M.

family: Wiechno

full_name: P.J. Wiechno

family: Bellmunt

full_name: J. Bellmunt

given: J.

family: Lucas

full_name: C. Lucas

given: C.

family: Su

full_name: W.-C. Su

family: Albiges

full_name: L. Albiges

given: L.

family: Lin

full_name: C.-C. Lin

family: Senkus-Konefka

full_name: E. Senkus-Konefka

given: E.

family: Flechon

full_name: A. Flechon

given: A.

family: Mourey

full_name: L. Mourey

family: Necchi

full_name: A. Necchi

family: Loidl

full_name: W.C. Loidl

family: Retz

full_name: M.M. Retz

family: Vaissière

full_name: N. Vaissière

given: N.

family: Culine

full_name: S. Culine

given: S.

journal_name: Annals of Oncology

evidence: open (via crossref license)

repository_institution: National Academy of Sciences of Belarus - zvestiya of the National Academy of Sciences of Belarus

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Vinflunine–gemcitabine versus vinflunine–carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: results of an international randomized phase II trial (JASINT1)

lead_sponsor: Pierre Fabre Medicament


title: Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation

acronym: IMHUNIV

summary:
Protocol Summary:

Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and patient-ventilator interactions?
Aims

Main aim:

The primary endpoint of this study is to objectively evaluate the consequences of a humidification system's adjunction on quality of sleep, 2 months after treatment's beginning.

Second aims:

The secondary endpoints are to evaluate the consequences of a humidification system's adjunction on non invasive ventilation's efficacy / patient-ventilator asynchronies / patients' comfort / treatment adherence.

Before the clinical trial, the investigators conducted a bench study using a mechanical lung in order to evaluate the ventilator's behavior with and without a humidification system.

The clinical trial will include patients with chronic respiratory failure with an indication of long-term non invasive ventilation therapy. Patients will be included in the Pulmonology, Thoracic Oncology and Respiratory intensive care unit of Rouen University Hospital.

It will be a prospective monocentric study, including consecutively all eligible patients. Informed consent will be obtained from all of them.

At baseline, patients will be hospitalized for two consecutive nights for non invasive ventilation's set up. During the first night, a polysomnography will be performed without non invasive ventilation. Then, patients will be treated by non invasive ventilation with a bi-level self-regulated pressure mode and an open circuit.

Patients will be randomized in two groups: without a humidification system and with a humidification system. Partitioning by the physiopathological pattern (obstructive versus obesity hypoventilation syndrome vs. neuromuscular disease) will be done.

During each night, arterial blood gases will be measured at bedtime and awakening. Patients will be monitored by:

polysomnography (only during the first night)
transcutaneous capnography
accessory inspiratory muscles surface electromyography
pneumotachograph on non invasive ventilation's circuit
pressions measured at the mask.

Follow-up will take place at two months after non invasive ventilation's beginning with or without humidification. Patients will be hospitalized for one night only. Blood gases at bedtime and at awakening will be measured. A polysomnography with non invasive ventilation will be performed. Observance will be evaluated.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: ADIR Association

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Multi-Center Trial to Evaluate the Efficacy and Safety of Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression (ANRS 105 INTERVAC)

summary: The purpose of this study is to determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection.

status: Terminated

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Objective Markers of Pain Perception in Humans: a Study in Healthy Subjects

summary: Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of EEG and autonomic responses.

primary_purpose: Basic Science

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de SAINT-ETIENNE
Hospices Civils de LYON

intervention_type: Other


title: Study of the Communication of the Hypothalamus With the Periphery: Impact of Metformin on Leptin Transport in the Cerebrospinal Fluid of Obese Patients. A Monocentric Prospective Study

acronym: LEPTOB

summary: Obesity, a major health problem, is gradually transforming into a global epidemic. The current obesity treatment with long term efficacy is the bariatric surgery, however, the operative risk of this procedure is high and the post-operative iotrogeny may be important. Obesity is most often associated to the feeding behavior which depends on hypothalamic integration of peripheral signals such as leptin and glucose. High levels of circulating leptin are detected in obese patients. These elevated leptin levels fail to reduce appetite or increase energy expenditure. The mechanism underlying this non-integration of peripheral signals remains to be identified. The ratio of leptin levels in the cereprospinal fluid (CSF) and in the periphery is drastically decreased in obese patients when compared to lean individuals, therefore a defective transport of circulating leptin into the brain via the CSF is maybe linked to obesity.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Lille Catholic University

intervention_type: Drug

status_simplified: Ongoing


title: Effect of a DPP-IV Inhibitor Treatment on the Secretion of Glucagon in Patients Presenting With Type 1 Diabetes Mellitus With or Without Autonomic Neuropathy

acronym: DPPNAC

summary: The purpose of this study is to compare the effect of a single administration of a DPP-IV inhibitor (vildagliptin: Galvus ®) versus no treatment over two populations of diabetic patients: without diabetic autonomic neuropathy (NA, i.e. the control group) and with diabetic autonomic neuropathy (i.e. the neuropathy group). The investigators hypothesize that the therapeutic efficacy of DPP-IV inhibitors is partly mediated by the autonomic nervous system. This hypothesis will be validated if a lower glycemic response to DPP-IV inhibitor treatment is observed for the neuropathy group compared to control.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Toulouse


title: Sleep and Obesity in Teenagers: Impact of Sleep Length and Quality on Obesity and Diabetes Risks in Teenagers.

summary:
This study aims to investigate

whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers,
the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral


title: Application of Functional Electrophysiological Tests to Evaluate Pharmacological Treatments in Patients With Cystic Fibrosis

summary: Suppression of stop mutations in the CFTR gene with parenteral gentamicin can be predicted in vitro and is associated with clinical benefit and significant modification of the CFTR-mediated chloride transport in nasal and sweat gland epithelium.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Lipidrive Dietary Supplement Tolerance Study Based on Blood, Urine, and Hemodynamic Biological Parameters.

summary:
The objectives of this clinical study are to determine the tolerance of dietary supplement Lipidrive through the evaluation of several parameters :

Various blood biological parameters
Urinary parameters
Hemodynamic indicators
Cardiac function
Anthropometric variables

ipd_sharing: Yes

lead_sponsor: Valbiotis

intervention_type: Dietary Supplement


type: Registry Identifier

title: Learning Process of Fourth Year Medical Students During an Obligatory Doctor-patient Relationship Training, Including Role Play, Simulated Consultation, Balint Group and Courses: a Mixed Method Study

acronym: APTHERA

summary: This study aims to explore learning process for undergraduate students in this doctor-patient relationship course. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description:
For data about satisfaction and sociodemographic, it will be collected on a commun and secured base so as to support confrontation of analysis.

For qualitative data, they will be kept on secured informatics interface (of Dr Marie-Aude Piot) of University Hospital Institute "Mutualiste Montsouris". The qualitative researchers will have access to this base for data quotation.

location_facility: Paris Descartes University, Sorbonne Paris City, Faculty of Medicine


title: Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial

summary:
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of non-responders. Attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. V3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial LV lead in non-responders after at least 6 months of standard biventricular stimulation.

The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead in non-responders compared to standard CRT.

ReferenceType: background

ReferenceCitation: Bordachar P, Alonso C, Anselme F, Boveda S, Defaye P, Garrigue S, Gras D, Klug D, Piot O, Sadoul N, Leclercq C. Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3) trial. J Card Fail. 2010 Sep;16(9):709-13. doi: 10.1016/j.cardfail.2010.04.010. Epub 2010 Jun 8.

ReferenceType: derived

ReferenceCitation: Bordachar P, Gras D, Clementy N, Defaye P, Mondoly P, Boveda S, Anselme F, Klug D, Piot O, Sadoul N, Babuty D, Leclercq C. Clinical impact of an additional left ventricular lead in cardiac resynchronization therapy nonresponders: The V(3) trial. Heart Rhythm. 2018 Jun;15(6):870-876. doi: 10.1016/j.hrthm.2017.12.028. Epub 2017 Dec 26.

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

sequence: first

family: Gras

full_name: Daniel Gras

given: Daniel

sequence: additional

family: Clementy

full_name: Nicolas Clementy

given: Nicolas

family: Defaye

full_name: Pascal Defaye

given: Pascal

family: Mondoly

full_name: Pierre Mondoly

family: Boveda

full_name: Serge Boveda

given: Serge

family: Anselme

full_name: Frederic Anselme

given: Frederic

family: Klug

full_name: Didier Klug

given: Didier

family: Piot

full_name: Olivier Piot

given: Olivier

family: Sadoul

full_name: Nicolas Sadoul

family: Babuty

full_name: Dominique Babuty

given: Dominique

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Heart Rhythm

title: Clinical impact of an additional left ventricular lead in cardiac resynchronization therapy nonresponders: The V 3 trial

lead_sponsor: Medtronic Bakken Research Center


title: Primary Organoid Models and Combined Nucleic Acids Therapeutics for Innovative Anti-HPV Treatments in Cervico-vaginal Cancers and Precancerous Lesions

acronym: ORGANOIDES

summary:
Human papilloma virus (HPV) is responsible of the most common sexually transmitted infection. It can cause severe cancer lesions, of the cervix, vulva, vagina, penis and oropharynx. The International Agency for Cancer Research of World Health Organization (WHO) classified a dozen of HPV related high-risk cancer types, and recognized cervical cancer as the most common HPV-related disease. HPV 16 and 18 are responsible for 70% of cervical cancers.

Due to the few symptoms of cervical cancer, women are often diagnosed with advanced state. Current treatments imply cervical conisation or hysterectomy, with or without lymphadenectomy and or radiotherapy, or chemotherapy.

However, few pharmacological options are available against oncogenic papilloma viruses and thus against recurrences The aim of this project is to develop relevant organoids models from patient biopsies that will be used to identify biomarkers and evaluate in a closest preclinical setting novel nucleic acids based therapeutic strategy for HPV-cervical-vaginal dysplasia and cancers.

ReferenceCitation: Ngamkham J, Boonmark K, Phansri T. Detection and Type-Distribution of Human Papillomavirus in Vulva and Vaginal Abnormal Cytology Lesions and Cancer Tissues from Thai Women. Asian Pac J Cancer Prev. 2016;17(3):1129-34.

ReferenceCitation: Duke P, Godwin M, Ratnam S, Dawson L, Fontaine D, Lear A, Traverso-Yepez M, Graham W, Ravalia M, Mugford G, Pike A, Fortier J, Peach M. Effect of vaginal self-sampling on cervical cancer screening rates: a community-based study in Newfoundland. BMC Womens Health. 2015 Jun 10;15:47. doi: 10.1186/s12905-015-0206-1.

ReferenceCitation: Koo YJ, Min KJ, Hong JH, Lee JK. Efficacy of Poly-Gamma-Glutamic Acid in Women with High-Risk Human Papillomavirus-Positive Vaginal Intraepithelial Neoplasia: an Observational Pilot Study. J Microbiol Biotechnol. 2015 Jul;25(7):1163-9. doi: 10.4014/jmb.1503.03106.

ReferenceCitation: Mollers M, King AJ, Knol MJ, Scherpenisse M, Meijer CJ, van der Klis FR, de Melker HE. Effectiveness of human papillomavirus vaccine against incident and persistent infections among young girls: Results from a longitudinal Dutch cohort study. Vaccine. 2015 May 28;33(23):2678-83. doi: 10.1016/j.vaccine.2015.04.016. Epub 2015 Apr 14.

ReferenceCitation: Wang KD, Xu DJ, Wang BY, Yan DH, Lv Z, Su JR. Inhibitory Effect of Vaginal Lactobacillus Supernatants on Cervical Cancer Cells. Probiotics Antimicrob Proteins. 2018 Jun;10(2):236-242. doi: 10.1007/s12602-017-9339-x.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Using Repetitive Transcranial Magnetic Stimulation (rTMS) in the Rehabilitation of Chronic Spatial Neglect After Stroke: A Double Blind Study

acronym: NEGLECT

summary: Visuospatial neglect is a common neurological symptom which appears following strokes on regions of the right hemisphere of the brain. It affects patient's self representation and awareness of the space, impairing functional rehabilitation and adaptation back to a normal life. The primary purpose of this protocol is to assess the impact of 10 daily sessions of a non-invasive brain stimulation technique, low frequency repetitive Transcranial Magnetic Stimulation (rTMS), applied on the intact hemisphere of the brain to treat post stroke visuospatial neglect at the chronic stage. The hypothesis is that a regime of real but not sham rTMS on the left posterior parietal cortex of the brain will long-lastingly ameliorate visuospatial neglect in stroke patients as revealed by clinical paper-and-pencil and computer-based tests assessing search, detection and discrimination of stimuli presented in different areas of the visual field.


ReferenceCitation: Dartigeas C, Van Den Neste E, Léger J, Maisonneuve H, Berthou C, Dilhuydy MS, De Guibert S, Leprêtre S, Béné MC, Nguyen-Khac F, Letestu R, Cymbalista F, Rodon P, Aurran-Schleinitz T, Vilque JP, Tournilhac O, Mahé B, Laribi K, Michallet AS, Delmer A, Feugier P, Lévy V, Delépine R, Colombat P, Leblond V; CLL 2007 SA investigators; French Innovative Leukemia Organization (FILO). Rituximab maintenance versus observation following abbreviated induction with chemoimmunotherapy in elderly patients with previously untreated chronic lymphocytic leukaemia (CLL 2007 SA): an open-label, randomised phase 3 study. Lancet Haematol. 2018 Feb;5(2):e82-e94. doi: 10.1016/S2352-3026(17)30235-1. Epub 2017 Dec 20.

family: Dartigeas

full_name: Caroline Dartigeas

given: Caroline

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: Léger

full_name: Julie Léger

given: Julie

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

family: Berthou

full_name: Christian Berthou

given: Christian

family: Dilhuydy

full_name: Marie-Sarah Dilhuydy

given: Marie-Sarah

family: De Guibert

full_name: Sophie De Guibert

given: Sophie

family: Leprêtre

full_name: Stéphane Leprêtre

given: Stéphane

family: Béné

full_name: Marie C Béné

given: Marie C

family: Nguyen-Khac

full_name: Florence Nguyen-Khac

given: Florence

family: Letestu

full_name: Rémi Letestu

given: Rémi

family: Cymbalista

full_name: Florence Cymbalista

family: Rodon

full_name: Philippe Rodon

given: Philippe

family: Aurran-Schleinitz

full_name: Thérèse Aurran-Schleinitz

given: Thérèse

family: Vilque

full_name: Jean-Pierre Vilque

given: Jean-Pierre

family: Tournilhac

full_name: Olivier Tournilhac

family: Mahé

full_name: Béatrice Mahé

given: Béatrice

family: Laribi

full_name: Kamel Laribi

given: Kamel

family: Michallet

full_name: Anne-Sophie Michallet

given: Anne-Sophie

family: Delmer

full_name: Alain Delmer

given: Alain

family: Feugier

full_name: Pierre Feugier

family: Lévy

full_name: Vincent Lévy

given: Vincent

family: Delépine

full_name: Roselyne Delépine

given: Roselyne

family: Colombat

full_name: Philippe Colombat

family: Leblond

full_name: Véronique Leblond

given: Véronique

title: Single-agent Rituximab as Maintenance Treatment Versus Observation After Combined Induction Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients Older Than 65 Years With Previously Untreated Chronic Lymphocytic Leukemia: a Phase III Trial of FILO

summary:
RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL) despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen on B lymphocytes and leads to apoptosis of CD20 positive B lymphocytes. The highest response rate yet published in the treatment of first-line CLL has been obtained by the association of fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response can be improved, as some trials showed that eradication of minimal residual disease (MRD) in CLL is associated with a longer treatment-free and overall survival. Maintenance therapy using rituximab has been recently approved as a means of prolonging remission in patients with indolent non Hodgkin's lymphoma. Maintenance therapy with rituximab could be of interest in treatment of MRD in CLL and prolonging remission and survival times.

PURPOSE: The overall purpose of the study is to determine the value of immunotherapy maintenance with single agent rituximab in comparison with no further treatment (observation ) for previously untreated chronic lymphocytic leukaemia in elderly (>65 years) patients who respond to induction immunochemotherapy with FCR.


title: Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis

summary:
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.

In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.

location_facility:
Pontchaillou Hospital
Henri Mondor Hospital
Tenon Hospital
Pitié Salpetriere Hospital


title: Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population

summary: Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. However reference values have not yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et CD34+VEGF-R2+CD14- in healthy men and women blood donors.

status: Unknown status

ReferenceCitation: Parietti E, Pallandre JR, Deschaseaux F, Aupècle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1α are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.

lead_sponsor: Hopital Jean Minjoz


title: Medical Economic Analysis of the Interest of Hepcidin Quantitation by Quantitative Mass Spectrometry for the Diagnosis of Iron Deficiency in Anemic Critically Ill Patients

acronym: HEPCIDANE

summary:
Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at admission and more than 80% at intensive care unit discharge. Iron deficiency is also frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care Unit, critically ill patients are exposed to repeated blood samples and to other blood losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since inflammation induces an increase in plasma ferritin levels and a decrease in transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The characterization of iron metabolism regulation by the hormone hepcidin opened new ways for the understanding and the follow-up of these complex clinical situations (combining inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker of iron deficiency in critically ill patients. To date, standard immunological methods of hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in the clinical setting because it is too expensive. New approaches for hepcidin quantification, based on mass spectrometry are proposed and may be routinely implemented. We make the hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment.

The aim of this study is to evaluate the medical economic interest of a new diagnostic method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in critically ill anaemic patients.

primary_purpose: Diagnostic

ReferenceCitation: Lasocki S, Puy H, Mercier G, Lehmann S; Hepcidane study group. Impact of iron deficiency diagnosis using hepcidin mass spectrometry dosage methods on hospital stay and costs after a prolonged ICU stay: Study protocol for a multicentre, randomised, single-blinded medico-economic trial. Anaesth Crit Care Pain Med. 2017 Dec;36(6):391-396. doi: 10.1016/j.accpm.2017.04.009. Epub 2017 Sep 14.

ReferenceCitation: Lasocki S, Asfar P, Jaber S, Ferrandiere M, Kerforne T, Asehnoune K, Montravers P, Seguin P, Peoc'h K, Gergaud S, Nagot N, Lefebvre T, Lehmann S; Hepcidane study group. Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial. Crit Care. 2021 Feb 15;25(1):62. doi: 10.1186/s13054-020-03430-3.

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Jaber

full_name: Samir Jaber

given: Samir

family: Ferrandiere

full_name: Martine Ferrandiere

given: Martine

family: Kerforne

full_name: Thomas Kerforne

given: Thomas

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Montravers

full_name: Philippe Montravers

family: Seguin

full_name: Philippe Seguin

family: Peoc’h

full_name: Katell Peoc’h

given: Katell

family: Gergaud

full_name: Soizic Gergaud

given: Soizic

family: Nagot

full_name: Nicolas Nagot

given: Nicolas

family: Lefebvre

full_name: Thibaud Lefebvre

given: Thibaud

family: Lehmann

full_name: Sylvain Lehmann

given: Sylvain

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

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

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

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

location_facility: Department of Anesthesiology & Critical Care, Angers University Hospital, 4 rue larrey


title: Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration

acronym: ERTAPRO

summary: The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.

primary_purpose: Prevention

ReferenceCitation: Alhambra A, Cuadros JA, Cacho J, Gómez-Garcés JL, Alós JI. In vitro susceptibility of recent antibiotic-resistant urinary pathogens to ertapenem and 12 other antibiotics. J Antimicrob Chemother. 2004 Jun;53(6):1090-4. Epub 2004 Apr 29.

ReferenceCitation: Tomera KM, Burdmann EA, Reyna OG, Jiang Q, Wimmer WM, Woods GL, Gesser RM; Protocol 014 Study Group. Ertapenem versus ceftriaxone followed by appropriate oral therapy for treatment of complicated urinary tract infections in adults: results of a prospective, randomized, double-blind multicenter study. Antimicrob Agents Chemother. 2002 Sep;46(9):2895-900.

ReferenceCitation: Jimenez-Cruz F, Jasovich A, Cajigas J, Jiang Q, Imbeault D, Woods GL, Gesser RM; Protocol 021 Study Group. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults. Urology. 2002 Jul;60(1):16-22.

ReferenceCitation: Wells WG, Woods GL, Jiang Q, Gesser RM. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii67-74.


title: Ceramic Versus Composite in the Treatment by Inlays or Onlays of Posterior Teeth Affected by Tooth Substance Loss : a Multicenter Randomized Controlled Trial

acronym: CECOIA

summary: The main purpose of this trial is to determine which material, between ceramic and composite, is best to manufacture dental inlays and onlays in the treatment of moderate dental substance losses, generally due to dental caries. Restorations will be done using direct Computer Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which factors influence the success of these restorations.

ReferenceType: result

ReferenceCitation: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjör IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47. Review. Erratum in: J Adhes Dent. 2007 Dec;9(6):546.

ReferenceCitation: Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

family: Hickel

full_name: Reinhard Hickel

given: Reinhard

family: Peschke

full_name: Arnd Peschke

given: Arnd

family: Tyas

full_name: Martin Tyas

given: Martin

family: Mjör

full_name: Ivar Mjör

given: Ivar

family: Bayne

full_name: Stephen Bayne

given: Stephen

family: Peters

full_name: Mathilde Peters

given: Mathilde

family: Hiller

full_name: Karl-Anton Hiller

given: Karl-Anton

family: Randall

full_name: Ross Randall

given: Ross

family: Vanherle

full_name: Guido Vanherle

given: Guido

family: Heintze

full_name: Siegward D. Heintze

given: Siegward D.

journal_name: Clinical Oral Investigations

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations—update and clinical examples

ReferenceCitation: Fron Chabouis H, Prot C, Fonteneau C, Nasr K, Chabreron O, Cazier S, Moussally C, Gaucher A, Khabthani Ben Jaballah I, Boyer R, Leforestier JF, Caumont-Prim A, Chemla F, Maman L, Nabet C, Attal JP. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial. Trials. 2013 Sep 3;14:278. doi: 10.1186/1745-6215-14-278.

family: Fron Chabouis

full_name: Hélène Fron Chabouis

given: Hélène

family: Prot

full_name: Caroline Prot

given: Caroline

family: Fonteneau

full_name: Cyrille Fonteneau

given: Cyrille

family: Nasr

full_name: Karim Nasr

family: Chabreron

full_name: Olivier Chabreron

given: Olivier

family: Cazier

full_name: Stéphane Cazier

given: Stéphane

family: Moussally

full_name: Christian Moussally

given: Christian

family: Gaucher

full_name: Alexandre Gaucher

given: Alexandre

family: Khabthani Ben Jaballah

full_name: Inès Khabthani Ben Jaballah

given: Inès

family: Boyer

full_name: Renaud Boyer

given: Renaud

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

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

location_facility: Hôpital Charles Foix (APHP), Service d'odontologie


title: Transcranial Magnetic Stimulation (rTMS) and Autism.Implication of the Superior Temporal Sulcus in Normal and Abnormal Social Perception

acronym: TMSAUTISME

summary: In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal social cognition. With that purpose, we will measure the effect of inhibitory and excitatory rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the ability to recognize human voice/sounds.


title: The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

summary:
A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis.

This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences.

This will be the first clinical research work concerning adolescents and young adults using mental health services in the Seine Saint Denis Ouest.

primary_purpose: Other

lead_sponsor: Januel

location_facility:
URC Ville Evrard
CASADO
Relais Collégiens-Lycéens
CMP Adulte Saint-Ouen
CMP Adulte Saint-Denis


lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Martinique France

acronym: FUNGEMAX

location_facility:
Groupe Hospitalier La Pitié Salpêtrière
Hôpital Tenon
Clinique privée de l'Europe
CH Jacques Puel
CHU
CHRU de Nancy
CHU Hôtel Dieu
Hôpital Européen
CHU Estaing
CHU Avicenne
Hopital Européen Georges Pompidou
CHU Charles Nicolle
CHU Clarac
Hopitaux civils de Colmar
Institut de cancérologie de Bourgogne
Centre GF Leclerc
CH Saint Jean
CH Duchenne
CHU Dupuytren
Clinique privée Jean Mermoz
Hôpital Cochin
Institut Paoli Calmettes
CH Privé Sainte Marie
CH de la Côte Basque
CH Sud Francilien
CH Foch
CH
Hôpital privé
Centre Cario HPCA
Hôpital Privé Sainte Marie
Centre médical Oncogard
Hôpital Emile Roux
CH Docteur Schaffner

type: EudraCT Number

source: euctr

title: Randomized Phase II Study Comparing 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI Followed by Two Months of Gemcitabine+Nab-paclitaxel, in Metastatic Pancreatic Cancer

summary:
In Europe, pancreatic cancer (PC) is the 7th most common cancer and the 5th leading cause of cancer death in Europe. Each year, the number of deaths due to prostate cancer is almost as high as the number of new cases diagnosed reflecting the poor prognosis associated with this disease. PC is insidious and is often diagnosed late. Despite advances in the management of other more common gastrointestinal cancers, the treatment of PC has had few benefits inherent in recent advances in digestive oncology. Gemcitabine has thus remained the reference treatment for more than 10 years.

Recent studies have shown that gemcitabine/Nab-paclitaxel combination therapy is more effective in PC than gemcitabine-based therapy alone. In addition, multidrug therapy approaches (Irinotecan-5FU/LV) have also emerged to avoid the emergence of resistance to treatments while limiting toxicities. The recently developed Nal-IRI has also shown interesting efficacy in patients with metastatic PC previously treated with gemcitabine, with improved overall survival median and limited toxicity. Based on this information, the NAPOLI trial was conducted in patients with second line PC comparing the efficacy of Nal-IRI/5FU/LV or Nal-IRI and 5FU/LV alone; in this key study, the combination Nal-IRI/5FU/LV treatment was more effective than monotherapies (Nal-IRI or 5FU/LV alone).

Based on all these data, a Phase II trial testing the standard of care gemcitabine/nab-paclitaxel vs Nal-IRI/5FU/LV vs Nal-IRI/5FU/LV 2-months sequential regimen followed by gemcitabine/nab-paclitaxel will be performed. This will allow us to i) know the tolerance and efficacy of Nal-IRI/5FU/LV in the first line of treatment, ii) test a new sequential strategy with Nal-IRI but also iii) compare our results in the experimental arms with one of the two world standard therapeutic regimens: gemcitabine + nab-Paclitaxel. All this in order to improve the management of patients with PC from the first line of treatment.


ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Italy
United States
Netherlands
France
Poland
Spain
Germany
United Kingdom
Canada

location_facility: Hospital General Universitario Alicante /ID# 203764

location_facility: Progressive Clinical Research /ID# 202155

location_facility: Dermatology Specialists Resear /ID# 202145

location_facility: The University of Manchester /ID# 204720

location_facility: Przychodnia Specjalistyczna High-Med /ID# 203183

location_facility: Center for Clinical Studies - Webster TX /ID# 202154

location_facility: Progressive Medical Research /ID# 202183

location_facility: Hopital Larrey - CHU de Toulouse /ID# 203587

location_facility: Integrated Clinical Research LLC /ID# 202152

location_facility: Alliance Dermatology and MOHs /ID# 204336

location_facility: Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591

location_facility: Radboud Universitair Medisch Centrum /ID# 202560

location_facility: Hospital Universitario 12 de Octubre /ID# 203756

location_facility: Center for Clinical Studies - Houston (Binz) /ID# 202178

location_facility: Academisch Medical center Amsterdam /ID# 202556

location_facility: Dermatology and Skin Cancer Specialists, LLC /ID# 203938

location_facility: Oregon Medical Res Center PC /ID# 201651

location_facility: Dermed Centrum Medyczne Sp. z o.o /ID# 203171

location_facility: Beth Israel Deaconess Medical Center /ID# 204340

location_facility: Center for Dermatology Clin Res /ID# 202116

location_facility: Minnesota Clinical Study Center /ID# 202369

location_facility: Hospital Universitario Clinico San Cecilio /ID# 203760

location_facility: Hospital Universitario Arnau Vilanova /ID# 203763

location_facility: Guy's and St Thomas' NHS Found /ID# 204721

location_facility: Psoriasis Treatment Ctr of Central NJ /ID# 202107

location_facility: Hospital Universitario de la Princesa /ID# 203754

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 203928

location_facility: Advanced Research Associates - Glendale /ID# 204335

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 203053

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982

location_facility: Klinika Dermatologii Pod Fortem /ID# 204180

location_facility: Eastern Canada Cutaneous Resea /ID# 203045

location_facility: Bakersfield Derma & Skin Cance /ID# 202115

title: A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

summary: The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.


title: Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study

acronym: VITAC

summary: Multicentric French parallel double-blind randomized versus placebo study

ReferenceCitation: Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taïeb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.

family: Seneschal

full_name: Julien Seneschal

given: Julien

family: Duplaine

full_name: Alexandra Duplaine

given: Alexandra

family: Maillard

full_name: Hervé Maillard

given: Hervé

family: Passeron

full_name: Thierry Passeron

given: Thierry

family: Andreu

full_name: Nicolas Andreu

given: Nicolas

family: Lassalle

full_name: Régis Lassalle

given: Régis

family: Favary

full_name: Clélia Favary

given: Clélia

family: Droitcourt

full_name: Catherine Droitcourt

given: Catherine

family: Taïeb

full_name: Alain Taïeb

given: Alain

family: Ezzedine

full_name: Khaled Ezzedine

given: Khaled

journal_name: Journal of Investigative Dermatology

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital Center of Nice - Hôpital de l'Archet

location_facility: University Hospital Center of Rennes - Hôpital Pontchaillou

location_facility: University Hospital of Bordeaux - St André Hospital


title: Capillary Glycerolemia Evolution During Physical Exercise

acronym: LSEEGLYCEROL

summary:
Maximum fatty acid oxidation is known to occur at exercise intensities between 45 and 65% VO2max and in the fasting state.

However, the optimal level may depend on various unknown factors. Glycerolemia is a good marker of the fatty acid metabolism but its evolution remains poorly described, maybe due to the difficulty of the measure.

A new device allows an easy measurement of glycerolemia during exercise and could enable personalization strategies to optimize exercise efficacy.

In this study, the investigators plan to test three different exercise types and three different fasting conditions with three replicates each to evaluate the variability of glycerolemia and its evolution during exercise.


title: Clinical Significance of Heterozygosity for Mutations of the SLC12A3 Gene Coding for the Thiazide Sensitive Na-Cl Cotransporter

acronym: HEPHYGI

summary: Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to determine whether the heterozygous carriers present the metabolic risks and/or the benefits of this disease.

ReferenceCitation: Tago N, Kokubo Y, Inamoto N, Naraba H, Tomoike H, Iwai N. A high prevalence of Gitelman's syndrome mutations in Japanese. Hypertens Res. 2004 May;27(5):327-31.

ReferenceCitation: Fava C, Montagnana M, Rosberg L, Burri P, Almgren P, Jönsson A, Wanby P, Lippi G, Minuz P, Hulthèn LU, Aurell M, Melander O. Subjects heterozygous for genetic loss of function of the thiazide-sensitive cotransporter have reduced blood pressure. Hum Mol Genet. 2008 Feb 1;17(3):413-8. Epub 2007 Nov 1.

ReferenceCitation: Ji W, Foo JN, O'Roak BJ, Zhao H, Larson MG, Simon DB, Newton-Cheh C, State MW, Levy D, Lifton RP. Rare independent mutations in renal salt handling genes contribute to blood pressure variation. Nat Genet. 2008 May;40(5):592-599. doi: 10.1038/ng.118. Epub 2008 Apr 6.

ReferenceCitation: Hsu YJ, Yang SS, Chu NF, Sytwu HK, Cheng CJ, Lin SH. Heterozygous mutations of the sodium chloride cotransporter in Chinese children: prevalence and association with blood pressure. Nephrol Dial Transplant. 2009 Apr;24(4):1170-5. doi: 10.1093/ndt/gfn619. Epub 2008 Nov 25.

ReferenceCitation: Ren H, Qin L, Wang W, Ma J, Zhang W, Shen PY, Shi H, Li X, Chen N. Abnormal glucose metabolism and insulin sensitivity in Chinese patients with Gitelman syndrome. Am J Nephrol. 2013;37(2):152-7. doi: 10.1159/000346708. Epub 2013 Jan 31.

ReferenceCitation: Cruz DN, Simon DB, Nelson-Williams C, Farhi A, Finberg K, Burleson L, Gill JR, Lifton RP. Mutations in the Na-Cl cotransporter reduce blood pressure in humans. Hypertension. 2001 Jun;37(6):1458-64.

location_facility: Nephrology Department. Centre Hospitalier Universitaire, Hôpital Dupuytren

location_facility: Department of Functional Investigations. Assistance Publique Hôpitaux de Paris, Hôpital Tenon

location_facility: Department of Functional Investigations. Hospices Civils de Lyon, Hôpital Edouard Herriot.

location_facility: Clinical Research Center. Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou.

location_facility: Department of Functional Investigations. Centre Hospitalier Universitaire, Hôpital de Rangueil.


title: Phase II Open-label Randomized Multicenter Trial to Compare the Efficacy and Safety of Two Different Doses of Raltegravir and Efavirenz, All in Combination With Tenofovir and Lamivudine, in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

summary:
Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.

ReferenceCitation: Grinsztejn B, De Castro N, Arnold V, Veloso VG, Morgado M, Pilotto JH, Brites C, Madruga JV, Barcellos NT, Santos BR, Vorsatz C, Fagard C, Santini-Oliveira M, Patey O, Delaugerre C, Chêne G, Molina JM; ANRS 12 180 Reflate TB study group. Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Reflate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial. Lancet Infect Dis. 2014 Jun;14(6):459-67. doi: 10.1016/S1473-3099(14)70711-X. Epub 2014 Apr 9. Erratum in: Lancet Infect Dis. 2014 Jun;14(6):448.

family: Grinsztejn

full_name: Beatriz Grinsztejn

given: Beatriz

family: De Castro

full_name: Nathalie De Castro

given: Nathalie

family: Arnold

full_name: Vincent Arnold

given: Vincent

family: Veloso

full_name: Valdiléa G Veloso

given: Valdiléa G

family: Morgado

full_name: Mariza Morgado

given: Mariza

family: Pilotto

full_name: José Henrique Pilotto

given: José Henrique

family: Brites

full_name: Carlos Brites

given: Carlos

family: Madruga

full_name: José Valdez Madruga

given: José Valdez

family: Barcellos

full_name: Nêmora Tregnago Barcellos

given: Nêmora Tregnago

family: Santos

full_name: Breno Riegel Santos

given: Breno Riegel

family: Vorsatz

full_name: Carla Vorsatz

given: Carla

family: Fagard

full_name: Catherine Fagard

family: Santini-Oliveira

full_name: Marilia Santini-Oliveira

given: Marilia

family: Patey

full_name: Olivier Patey

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

family: Chêne

full_name: Geneviève Chêne

given: Geneviève

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

journal_name: The Lancet Infectious Diseases

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Brazil France

location_facility:
CHI Villeneuve Saint Georges
Ipec/Fiocruz
Hospitral Universitario Pr Edgar Santos
Hospital Nossa Senhora da Coceiçao
Hospital Sanatorio Pertenon
STD/AIDS department
Hôpital Saint-Louis
Hospital Genral de Nova Iguaçu
Hôpital Lariboisière


type: Other Grant/Funding Number

title: Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department

acronym: PACSCAN

summary:
Primary objective : to estimate impact of CT-scan on diagnostic for emergency department (ED) patients with suspected Community-acquired Pneumonia (CAP).

Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and site of care for ED patients with suspected CAP.

ReferenceCitation: Le Bel J, Pelaccia T, Ray P, Mayaud C, Brun AL, Hausfater P, Casalino E, Benjoar M, Claessens YE, Duval X; ESCAPED study group. Impact of emergency physician experience on decision-making in patients with suspected community-acquired pneumonia and undergoing systematic thoracic CT scan. Emerg Med J. 2019 Aug;36(8):485-492. doi: 10.1136/emermed-2018-207842. Epub 2019 Jun 24.

apc_source: openAPC

family: Le Bel

full_name: Josselin Le Bel

given: Josselin

family: Pelaccia

full_name: Thierry Pelaccia

given: Thierry

family: Ray

full_name: Patrick Ray

given: Patrick

family: Mayaud

full_name: Charles Mayaud

given: Charles

family: Brun

full_name: Anne-Laure Brun

given: Anne-Laure

family: Hausfater

full_name: Pierre Hausfater

given: Pierre

family: Casalino

full_name: Enrique Casalino

given: Enrique

family: Benjoar

full_name: Mikhael Benjoar

given: Mikhael

family: Claessens

full_name: Yann-Erick Claessens

given: Yann-Erick

family: Duval

full_name: Xavier Duval

given: Xavier

journal_name: Emergency Medicine Journal

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

ReferenceCitation: Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.

location_facility:
Bichat Hospital
Tenon Hospital
Cochin Hospital
La Pitié Salpêtrière Hospital


title: Comparison Between Manual Versus Closed-loop Titration of Propofol and Remifentanil Guided by the qCon and qNox Indexes During Induction and Maintenance of General Anesthesia in Adult Patients: a Multicentre Randomized Controlled Study

acronym: Conox-loop

summary: This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

family: Liu

full_name: Ngai Liu

given: Ngai

family: Chazot

full_name: Thierry Chazot

family: Hamada

full_name: Sophie Hamada

given: Sophie

family: Landais

full_name: Alain Landais

given: Alain

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Dussaussoy

full_name: Corinne Dussaussoy

given: Corinne

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Beydon

full_name: Laurent Beydon

given: Laurent

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Sessler

full_name: Daniel I. Sessler

given: Daniel I.

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Closed-Loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index

ReferenceCitation: Jensen EW, Valencia JF, López A, Anglada T, Agustí M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4.

name: Department ESAII; Centre for Biomedical Engineering Research; UPC BarcelonaTech; Barcelona Spain

family: JENSEN

full_name: E. W. JENSEN

given: E. W.

name: Department of Electronic Engineering; Universidad de San Buenaventura; Cali Colombia

family: VALENCIA

full_name: J. F. VALENCIA

given: J. F.

name: Anesthesiology Department; CMA-Section; Barcelona Spain

family: LÓPEZ

full_name: A. LÓPEZ

given: A.

family: ANGLADA

full_name: T. ANGLADA

given: T.

family: AGUSTÍ

full_name: M. AGUSTÍ

given: M.

name: Anesthesiology Department; SPEC-M Research Group; Hospital Clínic de Barcelona; Barcelona Spain

family: RAMOS

full_name: Y. RAMOS

given: Y.

family: SERRA

full_name: R. SERRA

given: R.

family: JOSPIN

full_name: M. JOSPIN

family: PINEDA

full_name: P. PINEDA

given: P.

family: GAMBUS

full_name: P. GAMBUS

location_facility: Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon


title: Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies

acronym: HIP

summary:
The management of coxofemoral pathologies is constantly increasing.

In addition to degenerative hip pathology, the orthopedic surgeon is now confronted with pathologies such as femoro-acetabular conflict, pathologies of the gluteus medius and pathologies of the labrum whose early management limits arthritis degeneration. These pathologies are mainly encountered in young subjects (<60 years).

Self-questionnaires play an important role in understanding patients' point of view on the impact of their coxofemoral pathologies and also allow an assessment of their condition after treatment.

For the evaluation of coxofemoral pathologies in the young subject (<60 years) the Super Simple Hip score (SUSHI-score) was developed and validated.

In the elderly subject with hip osteoarthritis, the HOOS score has the advantage of specifically measuring pain, symptoms, function and quality of life, but is made up of 40 items and is often considered rather heavy to submit. However, it has recently been simplified and the HOOS-12 (HOOS score with 12 items) has been developed and validated.

These two scores are useful in current clinical practice but they are only validated in English.

lead_sponsor: University Hospital Center of Martinique

location_facility:
Hôpital Lariboisière - AP-HP
Centre Hospitalier Privé Saint-Grégoire
CHU of Martinique


title: A Prospective, Multicenter Observational Trial Assessing the Safety and Efficacy of Gammanorm® in Autoimmune Diseases

summary: This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.

lead_sponsor: Octapharma

location_facility: CHU de la Martinique- Hopital Pierre Zobda Quitman


title: Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB) After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm

acronym: LBBB-TAVI

summary:
The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which is booming in the management of aortic stenosis. It concerns patients who have a high surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch Block (LBBB) is one of the most frequent complications of this procedure and represents an important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent pacing in 5 in 15 % of the cases in 1 year.

De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation. However, there are no predictive elements of these conductive disorders. Besides, the incidence and the deadline of appearance of this AV disorders are not established. It seems relevant to propose a new stratification based on ECG and endocavitary data. The monitoring of the conductive disorders is allowed by remote monitoring thanks to the implantation of a pacemaker or an implantable holter allowing to determine the incidence and the deadline of appearance of high grade AV conduction disorders.

ReferenceCitation: Massoullié G, Bordachar P, Irles D, Caussin C, Da Costa A, Defaye P, Jean F, Mechulan A, Mondoly P, Souteyrand G, Pereira B, Ploux S, Eschalier R. Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study. BMJ Open. 2016 Oct 26;6(10):e010485. doi: 10.1136/bmjopen-2015-010485.

family: Massoullié

full_name: Grégoire Massoullié

given: Grégoire

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

family: Irles

full_name: Didier Irles

given: Didier

family: Caussin

full_name: Christophe Caussin

given: Christophe

family: Da Costa

full_name: Antoine Da Costa

given: Antoine

family: Defaye

full_name: Pascal Defaye

given: Pascal

family: Jean

full_name: Frédéric Jean

given: Frédéric

family: Mechulan

full_name: Alexis Mechulan

given: Alexis

family: Mondoly

full_name: Pierre Mondoly

family: Souteyrand

full_name: Géraud Souteyrand

given: Géraud

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Ploux

full_name: Sylvain Ploux

given: Sylvain

family: Eschalier

full_name: Romain Eschalier

given: Romain

journal_name: BMJ Open

title: Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study

lead_sponsor: University Hospital, Clermont-Ferrand


title: Comparing the Impact of Weight Loss Induced by Bariatric Surgery or Through a Standard Nutritional Management on Sexual Function and Sperm Quality in Men With Severe Obesity - Multicenter, Prospective

acronym: SexOb

summary: Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity

lead_sponsor: University Hospital, Lille

location_facility:
Chu de Caen Normandie
CHRU, Hôpital Claude Huriez
Chu Rouen


title: Effectiveness of Two Stress Management Programs in the Adaptation Disorder With Anxiety (ADA) : Computer-based or Face- to -Face to Face Versus Control Group.Open Multicenter Prospective Randomized Controlled Therapeutic 3 Parallel Groups

summary: The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral treatment of stress management conducted via e-learning or face-to-face on patients responding to the diagnosis of adjustment disorder with anxiety (ADA) according to the DSM- 5 (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .

ReferenceCitation: Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.

ReferenceCitation: Drozd F, Raeder S, Kraft P, Bjørkli CA. Multilevel growth curve analyses of treatment effects of a Web-based intervention for stress reduction: randomized controlled trial. J Med Internet Res. 2013 Apr 22;15(4):e84. doi: 10.2196/jmir.2570.

ReferenceCitation: Eisen KP, Allen GJ, Bollash M, Pescatello LS. Stress management in the workplace: A comparison of a computer-based and an in-person stress-management intervention. Comput Hum Behav. 2008 Mar;24(2):486-96.

ReferenceCitation: Grime PR. Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism. Occup Med (Lond). 2004 Aug;54(5):353-9.

ReferenceCitation: Rose RD, Buckey JC Jr, Zbozinek TD, Motivala SJ, Glenn DE, Cartreine JA, Craske MG. A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Behav Res Ther. 2013 Feb;51(2):106-12. doi: 10.1016/j.brat.2012.11.003. Epub 2012 Nov 21.

ReferenceCitation: Ruwaard J, Lange A, Bouwman M, Broeksteeg J, Schrieken B. E-mailed standardized cognitive behavioural treatment of work-related stress: a randomized controlled trial. Cogn Behav Ther. 2007;36(3):179-92.

ReferenceCitation: Servant D, Rougegrez L, Barasino O, Demarty AL, Duhamel A, Vaiva G. [Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program]. Encephale. 2016 Oct;42(5):415-420. doi: 10.1016/j.encep.2016.03.010. Epub 2016 Apr 25. French.

ReferenceCitation: Leterme AC, Behal H, Demarty AL, Barasino O, Rougegrez L, Labreuche J, Duhamel A, Vaiva G, Servant D. A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial. Internet Interv. 2020 May 25;21:100329. doi: 10.1016/j.invent.2020.100329. eCollection 2020 Sep.

family: Leterme

full_name: A.C. Leterme

family: Behal

full_name: H. Behal

given: H.

family: Demarty

full_name: A.L. Demarty

family: Barasino

full_name: O. Barasino

given: O.

family: Rougegrez

full_name: L. Rougegrez

given: L.

family: Labreuche

full_name: J. Labreuche

given: J.

family: Duhamel

full_name: A. Duhamel

given: A.

family: Vaiva

full_name: G. Vaiva

given: G.

family: Servant

full_name: D. Servant

given: D.

bso_classification: Social sciences

currency_apc_doaj: USD

journal_name: Internet Interventions

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Servant D, Leterme AC, Barasino O, Rougegrez L, Duhamel A, Vaiva G. Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial. JMIR Res Protoc. 2017 Oct 2;6(10):e190. doi: 10.2196/resprot.7976.

full_name: Dominique Servant

given: Dominique

full_name: Anne-Claire Leterme

given: Anne-Claire

full_name: Olivia Barasino

given: Olivia

full_name: Laure Rougegrez

given: Laure

full_name: Alain Duhamel

given: Alain

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

location_facility:
CHRU , Hôpital FONTAN
Centre Esquirol CHU de Caen
Centre Pinel


title: Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

summary: The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.

ReferenceCitation: Galusca B, Traverse B, Costes N, Massoubre C, Le Bars D, Estour B, Germain N, Redouté J. Decreased cerebral opioid receptors availability related to hormonal and psychometric profile in restrictive-type anorexia nervosa. Psychoneuroendocrinology. 2020 Aug;118:104711. doi: 10.1016/j.psyneuen.2020.104711. Epub 2020 May 19.

family: Galusca

full_name: Bogdan Galusca

given: Bogdan

family: Traverse

full_name: Bastien Traverse

given: Bastien

family: Costes

full_name: Nicolas Costes

given: Nicolas

family: Massoubre

full_name: Catherine Massoubre

given: Catherine

family: Le Bars

full_name: Didier Le Bars

given: Didier

family: Estour

full_name: Bruno Estour

family: Germain

full_name: Natacha Germain

given: Natacha

family: Redouté

full_name: Jerome Redouté

given: Jerome

bso_classification: Biology (fond.)

journal_name: Psychoneuroendocrinology

oa_host_type: publisher

evidence: open (author manuscript)

version: acceptedVersion

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CNRH
CHU Clermont Ferrand
CHU Saint-Etienne


title: Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer

acronym: AMORCE-CBP

summary:
Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.

An ancillary study will evaluate the interest of blood predictive biomarkers.

primary_purpose: Screening

lead_sponsor: University Hospital, Caen

location_facility:
Le Havre Hospital
Rouen University Hospital
Caen University Hospital


title: Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy

acronym: BLOOD

summary: Main Objective: The purpose of this study is to demonstrate whether there is a correlation between perioperative blood loss and the degree of platelet inhibition assessed by a point of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet mono/bi-therapy

location_facility: Institute of cardiology - Pitié Salpêtrière Hospital

location_facility: CHU Toulouse - Hôpital de Rangueil - Anésthésie-Réanimation

location_facility: pôle Anesthesie -Réanimation- CHU Pitie -Salpetrière


title: Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

acronym: PRAVACUR

summary:
Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since 10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in human samples. In addition, the curative administration of Pravastatin improves established RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the quality of life of long-term cancer survivors without interfering with prior anticancer treatment.

This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented a cutaneous and/ or subcutaneous fibrosis (grade >= 2 according to NCI-CTCAE v4 toxicities scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound will be assessed at 6 months and at last, at the end of the treatment. Patients assessment will be performed at 6 and 12 months after the end of the treatment to look at a potential rebound effect.

Objective(s) of the clinical study

Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.

Second objective: To evaluate radio-induced fibrosis regression during the year following treatment stop.

ReferenceCitation: Bourgier C, Auperin A, Rivera S, Boisselier P, Petit B, Lang P, Lassau N, Taourel P, Tetreau R, Azria D, Bourhis J, Deutsch E, Vozenin MC. Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):365-373. doi: 10.1016/j.ijrobp.2019.02.024. Epub 2019 Feb 15.

family: Bourgier

full_name: Celine Bourgier

given: Celine

family: Auperin

full_name: Anne Auperin

given: Anne

family: Rivera

full_name: Sofia Rivera

given: Sofia

family: Boisselier

full_name: Pierre Boisselier

given: Pierre

family: Petit

full_name: Benoit Petit

given: Benoit

family: Lang

full_name: Philippe Lang

given: Philippe

family: Lassau

full_name: Nathalie Lassau

given: Nathalie

family: Taourel

full_name: Patrice Taourel

given: Patrice

family: Tetreau

full_name: Raphael Tetreau

given: Raphael

family: Azria

full_name: David Azria

given: David

family: Bourhis

full_name: Jean Bourhis

given: Jean

family: Deutsch

full_name: Eric Deutsch

given: Eric

family: Vozenin

full_name: Marie-Catherine Vozenin

given: Marie-Catherine

journal_name: International Journal of Radiation Oncology*Biology*Physics

oa_host_type: repository

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

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

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hôpital Européen Georges Pompidou
Institut Gustave Roussy
Centre Val d'Aurelle


title: Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

acronym: Surnutrition

summary: For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (MC) by blocking it. The MC is a little known entity. These patients wish to grow for her and others. Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY, GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated with osteoporosis in 25% of true MC who is 25 years old.

location_facility:
CRNH Rhône-Alpes
CHU de Saint-Etienne
CRNH Auvergne


title: Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome

summary:
People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of the upper airway, but also of central origin. According to published data, sleep apnea may occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart disease, accident due to day sleepiness, fatigue. This condition is treatable in people with Down syndrome, as it is in ordinary people.

Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In addition, data regarding age of apparition of this complication are missing, making repeated screening necessary.

Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it is time consuming and sleep departments are heavily busy.

location_facility:
CHU de Grenoble
Hospices Civiles de lyon
CHU de Saint-Etienne


title: Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study

acronym: MEANS

summary:
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.

The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.

Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

location_facility:
CH Roanne
CHU de Saint-Etienne
CHU de Dijon


title: Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates

summary:
The fractures of the wrist, affecting the distal end of the radius are frequent, in particular in the old subject and/or osteoporotic. Beside the simple fractures treated by mini-invasive surgical methods, there is a considerable number of strong comminuted fractures for which no method of osteosynthesis proves completely satisfactory, especially on osteoporotic bone. However, the restitution of the anatomy remains the principal concern of the surgeon eager to ensure a good functional result to its patient, with the proviso that the least aggressive possible method is used.

Until now, it is of use to rather largely use the external fixer bridging the radiocarpal articulation to maintain the length of the radius, more or less associated with an another method of internal osteosynthesis with minima. The major disadvantage of this kind of assembly is the high rate of neuroalgodystrophic syndromes of the wrist and losses of reduction, sometimes generators of painful after-effects and serious stiffening. These after-effects which are sometimes definitive can be very disabling when they occur among active people, a fortiori when they touch the dominant side.

The recent alternative to the use of the external fixer is the use of the plates with locking screws, affixed on the foreface of the radius, maintaining the length of the radius but not bridging the articulation. Thus, this kind of osteosynthesis does not generate ligamentary distraction nor of the radiocarpal capsule, factors which would be prevalent in the release of the algodystrophy and of the stiffening. On the other hand, this method of osteosynthesis is more invasive than the installation of an external fixer, because it requires the access of the foreface of the radius and cannot be practised in a percutaneous way. At present, there is any randomized comparative study, the published studies being only comparative retrospective and not controlled, carried out on nonhomogeneous series of fractures.

The principal objective of our study is to evaluate the interest of the locking plates in the maintenance of the radial length in the comminuted fractures of the distal end of the radius.

It is about a prospective, multicentric, randomized study in 2 parallel groups carried out patients from 40 to 80 years hospitalized in a service of Osseous Surgery.

Patients: articular displaced fractures of the lower end of the radius with strong metaphysar comminution (groups M3 and M4 of the classification MEC) with an important shortening of the radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side. Are excluded the articular explosions type E4. The patients of more than 40 years, autonomous and active, able to give an assent for the participation in a clinical study are included.

Treatment. The first group of patients would be treated by fore locked plate possibly associated with pins. The immobilization would be limited to a antibrachiopalmar splint for 45 days. If, peroperatively, a sufficient stability of the fracture cannot be obtained by the plate alone, and that a complementary stabilization by fixer proves to be necessary, then the case will be entered like a failure of stabilization by locked plate.

The second group of patients would be treated by external radiocarpal fixer in neutralization possibly associated with an internal osteosynthesis with minima (percutaneous pins). The fixer would be left in place during 45 days.

The reeducation would consist in the 2 groups of an active mobilization of the fingers at the beginning, then of an active reeducation of the wrist in flexion/extension and pronosupination starting from the 45th day.

About fifty patients should be included in each group, with a collection of the clinical and radiographic results at 21 days, 45 days, 3 months and 6 months.

lead_sponsor: University Hospital, Angers

location_facility:
UH of Angers
UH of Tours
UH of Besancon


title: Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit. A Randomized, Double Blind, Controlled Trial.

summary:
The aim of this study is to evaluate the effectiveness and the safety of deep brain stimulation in drug resistant epilepsy.

This is a double blind, controlled and randomized clinical trial with two cross-over groups and four phases.

Phase 1 : base line, open phase consisting of follow-up of patients with their standard treatment.

Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the stimulator switch OFF.

Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF depending on randomization allocation, followed by 3 months with the stimulator switch on the opposite position. The placebo consisting of turn OFF the stimulator.

Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.

ReferenceCitation: Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. Review.

ReferenceCitation: Ardouin C, Pillon B, Peiffer E, Bejjani P, Limousin P, Damier P, Arnulf I, Benabid AL, Agid Y, Pollak P. Bilateral subthalamic or pallidal stimulation for Parkinson's disease affects neither memory nor executive functions: a consecutive series of 62 patients. Ann Neurol. 1999 Aug;46(2):217-23.

ReferenceCitation: Benabid AL, Koudsie A, Benazzouz A, Vercueil L, Fraix V, Chabardes S, Lebas JF, Pollak P. Deep brain stimulation of the corpus luysi (subthalamic nucleus) and other targets in Parkinson's disease. Extension to new indications such as dystonia and epilepsy. J Neurol. 2001 Sep;248 Suppl 3:III37-47. Review.

ReferenceCitation: Benabid AL, Minotti L, Koudsié A, de Saint Martin A, Hirsch E. Antiepileptic effect of high-frequency stimulation of the subthalamic nucleus (corpus luysi) in a case of medically intractable epilepsy caused by focal dysplasia: a 30-month follow-up: technical case report. Neurosurgery. 2002 Jun;50(6):1385-91; discussion 1391-2.

ReferenceCitation: Chabardès S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93.

ReferenceCitation: Chkhenkeli SA, Chkhenkeli IS. Effects of therapeutic stimulation of nucleus caudatus on epileptic electrical activity of brain in patients with intractable epilepsy. Stereotact Funct Neurosurg. 1997;69(1-4 Pt 2):221-4.

ReferenceCitation: Cooper IS, Amin I, Gilman S. The effect of chronic cerebellar stimulation upon epilepsy in man. Trans Am Neurol Assoc. 1973;98:192-6.

ReferenceCitation: DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. Review.

ReferenceCitation: Dematteis M, Kahane P, Vercueil L, Depaulis A. MRI evidence for the involvement of basal ganglia in epileptic seizures: an hypothesis. Epileptic Disord. 2003 Sep;5(3):161-4.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital of Rennes
University Hospital of Grenoble
University Hospital of Strasbourg


title: Effect of N-3 Polyunsaturated Fatty Acids Supplementation on the Human Milk Composition of Lactating Women: Nutritional Intervention With Rapeseed Oil and n-3 Margarine Compared to Standard Olive Oil

acronym: Oméga 3

summary: We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women

ReferenceCitation: Lauritzen L, Hansen HS, Jørgensen MH, Michaelsen KF. The essentiality of long chain n-3 fatty acids in relation to development and function of the brain and retina. Prog Lipid Res. 2001 Jan-Mar;40(1-2):1-94. Review.

ReferenceCitation: Sauerwald TU, Hachey DL, Jensen CL, Chen H, Anderson RE, Heird WC. Intermediates in endogenous synthesis of C22:6 omega 3 and C20:4 omega 6 by term and preterm infants. Pediatr Res. 1997 Feb;41(2):183-7.

ReferenceCitation: Cunnane SC, Francescutti V, Brenna JT, Crawford MA. Breast-fed infants achieve a higher rate of brain and whole body docosahexaenoate accumulation than formula-fed infants not consuming dietary docosahexaenoate. Lipids. 2000 Jan;35(1):105-11. Review.

ReferenceCitation: Innis SM, Gilley J, Werker J. Are human milk long-chain polyunsaturated fatty acids related to visual and neural development in breast-fed term infants? J Pediatr. 2001 Oct;139(4):532-8.

ReferenceCitation: Jørgensen MH, Hernell O, Hughes E, Michaelsen KF. Is there a relation between docosahexaenoic acid concentration in mothers' milk and visual development in term infants? J Pediatr Gastroenterol Nutr. 2001 Mar;32(3):293-6.

ReferenceCitation: Simmer K, Patole SK, Rao SC. Long-chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000376. doi: 10.1002/14651858.CD000376.pub2. Review. Update in: Cochrane Database Syst Rev. 2011;(12):CD000376.

ReferenceCitation: Uauy R, Hoffman DR, Mena P, Llanos A, Birch EE. Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J Pediatr. 2003 Oct;143(4 Suppl):S17-25. Review.

ReferenceCitation: Hoffman DR, Birch EE, Castañeda YS, Fawcett SL, Wheaton DH, Birch DG, Uauy R. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003 Jun;142(6):669-77.

ReferenceCitation: SanGiovanni JP, Berkey CS, Dwyer JT, Colditz GA. Dietary essential fatty acids, long-chain polyunsaturated fatty acids, and visual resolution acuity in healthy fullterm infants: a systematic review. Early Hum Dev. 2000 Mar;57(3):165-88. Review.

ReferenceCitation: Innis SM, Adamkin DH, Hall RT, Kalhan SC, Lair C, Lim M, Stevens DC, Twist PF, Diersen-Schade DA, Harris CL, Merkel KL, Hansen JW. Docosahexaenoic acid and arachidonic acid enhance growth with no adverse effects in preterm infants fed formula. J Pediatr. 2002 May;140(5):547-54.

ReferenceCitation: Jensen CL, Voigt RG, Prager TC, Zou YL, Fraley JK, Rozelle JC, Turcich MR, Llorente AM, Anderson RE, Heird WC. Effects of maternal docosahexaenoic acid intake on visual function and neurodevelopment in breastfed term infants. Am J Clin Nutr. 2005 Jul;82(1):125-32.

ReferenceCitation: Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics. 2003 Jan;111(1):e39-44.

ReferenceCitation: Fidler N, Sauerwald T, Pohl A, Demmelmair H, Koletzko B. Docosahexaenoic acid transfer into human milk after dietary supplementation: a randomized clinical trial. J Lipid Res. 2000 Sep;41(9):1376-83.

ReferenceCitation: Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000 Mar;42(3):174-81.

ReferenceCitation: Innis SM. Human milk: maternal dietary lipids and infant development. Proc Nutr Soc. 2007 Aug;66(3):397-404. Review.

ReferenceCitation: Koletzko B, Lien E, Agostoni C, Böhles H, Campoy C, Cetin I, Decsi T, Dudenhausen JW, Dupont C, Forsyth S, Hoesli I, Holzgreve W, Lapillonne A, Putet G, Secher NJ, Symonds M, Szajewska H, Willatts P, Uauy R; World Association of Perinatal Medicine Dietary Guidelines Working Group. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J Perinat Med. 2008;36(1):5-14. doi: 10.1515/JPM.2008.001.

ReferenceCitation: Yuhas R, Pramuk K, Lien EL. Human milk fatty acid composition from nine countries varies most in DHA. Lipids. 2006 Sep;41(9):851-8.

ReferenceCitation: Gibson RA, Neumann MA, Makrides M. Effect of increasing breast milk docosahexaenoic acid on plasma and erythrocyte phospholipid fatty acids and neural indices of exclusively breast fed infants. Eur J Clin Nutr. 1997 Sep;51(9):578-84.

ReferenceCitation: Billeaud C, Bouglé D, Sarda P, Combe N, Mazette S, Babin F, Entressangles B, Descomps B, Nouvelot A, Mendy F. Effects of preterm infant formula supplementation with alpha-linolenic acid with a linoleate/alpha-linolenate ratio of 6: a multicentric study. Eur J Clin Nutr. 1997 Aug;51(8):520-6.

ReferenceCitation: Francois CA, Connor SL, Wander RC, Connor WE. Acute effects of dietary fatty acids on the fatty acids of human milk. Am J Clin Nutr. 1998 Feb;67(2):301-8.

ReferenceCitation: Moltó-Puigmartí C, Castellote AI, Carbonell-Estrany X, López-Sabater MC. Differences in fat content and fatty acid proportions among colostrum, transitional, and mature milk from women delivering very preterm, preterm, and term infants. Clin Nutr. 2011 Feb;30(1):116-23. doi: 10.1016/j.clnu.2010.07.013. Epub 2010 Aug 25.

location_facility: Lactarium Institut de Puériculture de Paris et de Périnatalogie

location_facility: Lactarium Hôpital Pellegrin Enfants CHU Bordeaux

location_facility: Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale


title: Avoiding Anticoagulation After IntraCerebral Haemorrhage

summary:
Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH). Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an intracerebral haemorrhage.

Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid anticoagulation and LAAC.

ReferenceCitation: Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2. Erratum in: Lancet Neurol. 2021 Jun 9;:.

family: Li

full_name: Linxin Li

given: Linxin

family: Poon

full_name: Michael T C Poon

given: Michael T C

family: Samarasekera

full_name: Neshika E Samarasekera

given: Neshika E

family: Perry

full_name: Luke A Perry

given: Luke A

family: Moullaali

full_name: Tom J Moullaali

given: Tom J

family: Rodrigues

full_name: Mark A Rodrigues

given: Mark A

family: Loan

full_name: James J M Loan

given: James J M

family: Stephen

full_name: Jacqueline Stephen

given: Jacqueline

family: Lerpiniere

full_name: Christine Lerpiniere

given: Christine

family: Tuna

full_name: Maria A Tuna

given: Maria A

family: Gutnikov

full_name: Sergei A Gutnikov

given: Sergei A

family: Kuker

full_name: Wilhelm Kuker

given: Wilhelm

family: Silver

full_name: Louise E Silver

given: Louise E

family: Al-Shahi Salman

full_name: Rustam Al-Shahi Salman

given: Rustam

family: Rothwell

full_name: Peter M Rothwell

given: Peter M

journal_name: The Lancet Neurology

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ipd_sharing_description: Prof Cordonnier (chief investigator of A3ICH) is a member of the international Collaboration Of Controlled Randomised trials of Oral Antithrombotic drugs after intraCranial Haemorrhage (COCROACH - coordination Prof Rustam Al-Shahi Salman, UK) working towards a pre-planned individual patient data meta-analysis

location_facility:
Hôpital Roger Salengro, CHU
GHICL
CH De Tourcoing


title: Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)

acronym: DAFNE

summary: The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).

ReferenceCitation: Guery B, Berger P, Gauzit R, Gourdon M, Barbut F; DAFNE study group, Dafne Study Group, Bémer P, Bessède E, Camou F, Cattoir V, Couzigou C, Descamps D, Dinh A, Laurans C, Lavigne JP, Lechiche C, Leflon-Guibout V, Le Monnier A, Levast M, Mootien JY, N'Guyen Y, Piroth L, Prazuck T, Rogeaux O, Roux AL, Vachée A, Vernet Garnier V, Wallet F. A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France. J Int Med Res. 2021 Jun;49(6):3000605211021278. doi: 10.1177/03000605211021278.

apc_source: doaj

name: University Hospital and University of Lausanne, Lausanne, Switzerland

family: Guery

full_name: Benoit Guery

given: Benoit

name: Paoli-Calmettes Institute, Marseille, France

family: Berger

full_name: Pierre Berger

given: Pierre

name: Cochin University Hospital, Paris, France

family: Gauzit

full_name: Remy Gauzit

given: Remy

name: Astellas Pharma S.A.S., Levallois-Perret, France

family: Gourdon

full_name: Magali Gourdon

given: Magali

name: National Reference Laboratory for C. difficile, Saint-Antoine Hospital, Paris, France

name: INSERM S-1139, Faculty of Pharmacy, University of Paris, Paris, France

family: Barbut

full_name: Frédéric Barbut

given: Frédéric

family: DAFNE study group:

full_name: DAFNE study group:

family: Bémer

full_name: Pascale Bémer

given: Pascale

family: Bessède

full_name: Emilie Bessède

given: Emilie

family: Camou

full_name: Fabrice Camou

given: Fabrice

family: Cattoir

full_name: Vincent Cattoir

given: Vincent

family: Couzigou

full_name: Carine Couzigou

given: Carine

family: Descamps

full_name: Dominique Descamps

given: Dominique

family: Dinh

full_name: Aurélien Dinh

given: Aurélien

family: Laurans

full_name: Caroline Laurans

given: Caroline

family: Lavigne

full_name: Jean-Philippe Lavigne

given: Jean-Philippe

family: Lechiche

full_name: Catherine Lechiche

given: Catherine

family: Leflon-Guibout

full_name: Véronique Leflon-Guibout

given: Véronique

family: Le Monnier

full_name: Alban Le Monnier

given: Alban

family: Levast

full_name: Marion Levast

given: Marion

family: Mootien

full_name: Joy Yoganaden Mootien

given: Joy Yoganaden

family: N’Guyen

full_name: Yohan N’Guyen

given: Yohan

family: Piroth

full_name: Lionel Piroth

given: Lionel

family: Prazuck

full_name: Thierry Prazuck

given: Thierry

journal_name: Journal of International Medical Research

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


title: Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).

summary: To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

ReferenceCitation: Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33.

ReferenceCitation: Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41.

ReferenceCitation: Zettl A, Lee SS, Rüdiger T, Starostik P, Marino M, Kirchner T, Ott M, Müller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79.

ReferenceCitation: Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Brière J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82.

lead_sponsor: Lymphoma Study Association

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: MAGMA

location_facility: Hôpital Européen Georges Pompidou-Service de chirugie orthopédique, AP-HP

location_facility: Hôpital européen Georges-Pompidou-Service hépato-gastroentérologie

location_facility: Clinique des maladies mentales et de l'encéphale

location_facility: Hôpital Européen Georges Pompidou-Service de médecine interne, AP-HP

location_facility: Institut MGEN la Verriere-service SSR addictologie

title: Multicenter Randomized Placebo Controlled Trial Assessing the Efficacy of Oral Adjuvant Magnesium Supplementation in the Treatment of Alcohol Withdrawal Syndrome

summary: This study examine the efficacy of oral magnesium supplementation as an adjuvant therapy for decreasing intensity of alcohol withdrawal symptoms among inpatients requiring pharmacological treatment of their AWS. This double blind randomized multicenter clinical trial planned to treat half of participants as usal plus placebo and the other half as usual plus magnesium.


title: Treatment of Major Depression by Magnetic Stimulation Repeated Transcranial on Prefrontal Cortex: Study of Underlying Mechanisms

acronym: DEPSTIM

summary: The study aims to evaluate the impact of repeated Transcranial Magnetic Stimulation (rTMS) on underlying neuronal mechanisms of adults suffering from major depression disorder (MDD). Short- and long-term effects are assessed by High-Resolution electroencephalography (HR-EEG) or Magnetic Resonance Imaging (MRI) records, experimental tasks and self-rated scales.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus

acronym: STIMAUT

summary: Difficulties in social interactions are the core feature of autism spectrum disorder (ASD) and are characterized by abnormal social perception, mainly concerning eye gaze. Anatomo-functional abnormalities within the superior temporal sulcus (STS), a key region of the social brain, have been described in ASD. The investigators had recently shown that it is possible to modulate the neural activity of the STS with transcranial magnetic stimulation (TMS) with an impact on social perception, measured by eye-tracking. In the context of ASD, stimulation of the STS with excitatory TMS could lead to an improvement in social perception, which would open up new therapeutic strategies. The purpose of this double-blind, randomized, placebo-controlled study is to apply a therapeutic TMS protocol (10 daily sessions) at the right STS in young adults with ASD to improve their social behavior, objectively measured using eye-tracking.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Hôpital Necker Enfants Malades - Service de radiologie pédiatrique