acronym: PsychoVHL

summary:
Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost complete penetrance) that predisposes to many tumors including some associated with a poorer outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality.

The diagnosis of VHL disease may be challenging because tumors have an asynchronous and multi-organ development and there is often no apparent hereditary context. As it is admitted that VHL disease is underdiagnosed, some countries have decided to recall patients presenting one of the potentially VHL disease-associated tumors to screen them for VHL mutation. Screening is currently recommended in guidelines but many patients may have not been previously screened.

Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population enables the diagnosis of other tumor types at an early stage of development since HB is chronologically the second tumor occurring during the VHL disease history.

But it raises critical problems and questions: difficult announcement of a potentially severe disease and psychosocial dimension related to inheritance of the disease.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


type: Other Identifier

title: Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.

acronym: HELP-MOM

summary: To assess the impact and to identify the main risk factors for psychological and cardiac morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum hemorrhage

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Département Anesthésie et Réanimation - Hôpital Lariboisière

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

title: Multicenter, Prospective, Randomized, Controlled, Double-blind Trial on the Impact of Rosuvastatin on Subclinical Markers of Atherosclerosis in Patients With Primary Necrotizing Vasculitides

acronym: STATVAS

summary: The purpose of this study is to assess whether rosuvastatin could reduce the subclinical markers of atherosclerosis and the incidence of major cardiovascular events in patients with primary necrotizing vasculitides.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

intervention_type: Drug


title: EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients

acronym: EMISEP

summary: The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Gros C, De Leener B, Badji A, Maranzano J, Eden D, Dupont SM, Talbott J, Zhuoquiong R, Liu Y, Granberg T, Ouellette R, Tachibana Y, Hori M, Kamiya K, Chougar L, Stawiarz L, Hillert J, Bannier E, Kerbrat A, Edan G, Labauge P, Callot V, Pelletier J, Audoin B, Rasoanandrianina H, Brisset JC, Valsasina P, Rocca MA, Filippi M, Bakshi R, Tauhid S, Prados F, Yiannakas M, Kearney H, Ciccarelli O, Smith S, Treaba CA, Mainero C, Lefeuvre J, Reich DS, Nair G, Auclair V, McLaren DG, Martin AR, Fehlings MG, Vahdat S, Khatibi A, Doyon J, Shepherd T, Charlson E, Narayanan S, Cohen-Adad J. Automatic segmentation of the spinal cord and intramedullary multiple sclerosis lesions with convolutional neural networks. Neuroimage. 2019 Jan 1;184:901-915. doi: 10.1016/j.neuroimage.2018.09.081. Epub 2018 Oct 6.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

license_normalized: no license

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

host_type: repository

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

repository_normalized: HAL

version: publishedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repository_institution: Cornell University - arXiv

repository_normalized: arXiv

version: submittedVersion

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
HAL
PubMed Central
UCL Discovery
arXiv

repositories_concat: HAL;PubMed Central;UCL Discovery;arXiv

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Rennes University Hospital

intervention_type: Device

status_simplified: Unknown


title: Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes

summary: This prospective study aimed to validate a new prognostic approach of endothelial progenitor cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made prospectively by two centers of Inter -region South Mediterranean,

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: assistance Publique Hopitaux de Marseille

intervention_type: Other


title: Evaluation of the Manifestation of Patient Aggresivity in an Emergency Department

acronym: ASAU

summary: The main objective of this study is to determine the average total number of violent events per observation period occurring in the emergency department at the Nîmes University Hospital. The list of violent events is pre-determined and based on a series of interviews with emergency department staff.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

appel_a_projets: PHRIP

region: Occitanie

nom_etablissement: CHU NIMES

type_etablissement: CH

acronyme: ETUDE ASAU

titre: Evaluation de l'impact des transmissions professionnelles orales sur les manifestations d'agressivité des patients accueillis aux urgences.

discipline_principale: médecine d'urgence

nom_porteur: CHAZEL

prenom_porteur: Muriel


title: Accelerated Immunosenescence and Chronic Kidney Disease

acronym: IRIS

summary: The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Biological


title: The Value of Labial Biopsy in 65 Patients With Tuberculosis Disease

summary:
The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician.

The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.

lead_sponsor: Hopital Lariboisière


title: A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors

acronym: CABA-GCT

summary:
Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs.

Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Physiotherapy Efficiency With Caycedian Sophrology on Child Asthma: Randomized, Controlled Study

summary: The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.

ReferenceType: result

ReferenceCitation: Romieu H, Charbonnier F, Janka D, Douillard A, Macioce V, Lavastre K, Abassi H, Renoux MC, Mura T, Amedro P. Efficiency of physiotherapy with Caycedian Sophrology on children with asthma: A randomized controlled trial. Pediatr Pulmonol. 2018 May;53(5):559-566. doi: 10.1002/ppul.23982. Epub 2018 Mar 1.

oa_host_type: repository

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

repositories_concat: HAL

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Montpellier

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital


title: Cohort Analysis of Clinical and Biological Severe Childhood Asthma

acronym: COBRAPed

summary:
The purpose of this prospective study is:

to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
to determine the clinical and functional outcomes,
to identify the factors associated with severe asthma from childhood to adulthood.

status: Active, not recruiting

ReferenceCitation: Lezmi G, Lejeune S, Pin I, Blanchon S, Bouazza N, Jolaine V, Marguet C, Houdoin V, Berger P, Fayon M, Dubus JC, Reix P, Pellan M, Brouard J, Chiron R, Giovannini-Chami L, Deschildre A, de Blic J; COBRAPed Study Group. Factors Associated with Asthma Severity in Children: Data from the French COBRAPed Cohort. J Allergy Clin Immunol Pract. 2021 May;9(5):1969-1979. doi: 10.1016/j.jaip.2020.12.027. Epub 2020 Dec 24.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

location_facility: Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades

status_simplified: Ongoing


title: Analysis of Clinical and Immunological Characteristics, as Well as Pathophysiological Mechanisms in a French Cohort of Patients With Idiopathic CD4 Lymphocytopenia

summary:
Definition: Idiopathic CD4+ T lymphocytopenia (ICL) is an immune deficiency first described in 1992 and characterized by the US Centers for Disease Control (CDC) as absolute CD4+ T-lymphocyte count < 300/mm3 or < 20% of total T cells on more than one cell count; no evidence of infection with HIV-1/2 or human T-cell lymphotropic 1/2 (HTLV-1/2); and lack of a defined immune-deficiency disease or therapy for lymphocytopenia. Epidemiologic, clinical and immunological characteristics of the syndrome were described in 1993 and ICL is now considered a heterogeneous syndrome not caused by an infectious agent. Patients with ICL may show opportunistic infections such as disseminated Cryptococcus neoformans infection, Pneumocystis jiroveci pneumonia and John Cunningham (JC) virus infection as a result of profound cell-mediated immune-response deficiency.

Few studies have focused on the pathophysiology of ICL. CD4+ T-lymphocyte phenotyping revealed increased CD95 expression that could be responsible for excess apoptosis leading to lymphocytopenia. Moreover, the membrane expression of C-X-C chemokine receptor type 4 (CXCR4) was found impaired in T lymphocytes with ICL, and CXCR4 trafficking was improved with interleukin 2 (IL-2) treatment in some patients. Recently, mutations in nunc119, MAGT1 and Rag were found associated with CD4+ T lymphocytopenia. In a prospective study of 39 patients, CD8+ T lymphocytopenia (<180/mm3) and degree of CD4+ T-cell activation measured by human leukocyte antigen DR (HLA-DR) expression was found associated with poor prognosis.

ICL is a heterogeneous disorder often associated with deficiencies in CD8+, CD19+, and/or NK cells. Long-term prognosis may be related to initial CD4+ and NK cell deficiency.

Larger studies are needed to better identify the patients who might benefit from IL-2 therapy. This is why the investigators conduct the Lympho-4 study, in which the investigators plan to include 200 patients with a suspected/proven diagnosis of ICL.

intervention_type: Genetic


title: The Formation of a Cohort of HLHa Patients in Order to Study Their Physiopathological Characteristics

acronym: HLH-genes

summary:
Different study of HLHa patients :

Diagnosis criteria, because criteria are based on pediatric genetic studies.
Physiopathological studies: genetic studies have demonstrated the role of CD8+ cells, in particular because they have a genetic defect affecting their cytotoxic functions in HLH pediatric. the aim is to establish if the same defect is found in both some or in all of HLHa patients. If this is the case, to then establish whether hypomorphic genetic mutations are responsible.

collaborators: Laboratory of normal and pathological development Immune System - IFR 94 U768

collaborators: Reference Centre for Hereditary Immunodeficiency: CEREDIH


title: An Open-Label, Multicenter, Phase II Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia Refractory to Conventional Chemotherapy or in Molecular Relapse. Intergroupe Français Des leucémie aiguë myéloblastique

acronym: DasaCBF

summary: In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal Residual Disease level at the end of consolidation or in molecular relapse, maintenance by the inhibitor dasatinib is proposed.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers


title: Study of Modification of the Density of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine

acronym: MAIS

summary: The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized countries. The macular pigment (lutein and zeaxanthin) could play an important role in the arisen of the AMD. The food supplementation by corn with strong concentration in macular pigment could increase the density of the macular pigment. This could, in the future, represent a strategy of prevention of the AMD. The main objective of this study is to detect an increase of the macular pigment density after the consumption of this corn at healthy volunteers.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Vilmorin & Cie


summary:
Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark for the treatment of chronic refractory neuropathic pain and is now commonly used in some countries to target back pain. However, the potential value of combining SCS and PNS as "hybrid stimulation" remains poorly described with only isolated case reports or limited experience in various indications.

The "CUMPNS" comparative randomized study is designed to demonstrate the potential analgesic efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain component pain in refractory FBSS patients.

lead_sponsor: Poitiers University Hospital


title: Osteoporosis in RETT Syndrome. Understanding the Mechanisms and Identification of Biomarkers.

acronym: OSRETT

summary:
Based on our clinical observations, many girls with RETT syndrome, a severe neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early age (before age 10) and can lead to fractures, pain and a limitation in mobility. Few epidemiological studies have estimated the frequency of osteoporosis in girls with RETT syndrome and showed that they are more exposed then children with other neuro-developmental diseases with a same degree of neurological handicap. However, the mechanisms that lead to early osteoporosis in RETT syndrome remain unknown. Mutations in the MECP2 gene are found in 95% of RETT patients and preliminary experimental studies have shown that this can lead to abnormal expression of the gene that codes for osteoprotegerin, a protein implicated in bone remodelling by interacting with RANK-ligand.

In order to identify risk factors of osteoporosis in RETT syndrome and to understand the pathophysiological mechanisms the study protocol includes:

Clinical evaluation of bone health (history of bone fractures, pain, nutritional status, pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability, vitamin D satus)
evaluation of the mineral density at the lumber spine using DEXA
measuring concentrations of osteoprotegerin and RANK-ligand

primary_purpose: Diagnostic


title: Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia

summary:
Social cognition impairments was highlighted for persons suffering with schizophrenia by numerous studies. The use of treatment programs intended to treat specifically these deficits through procedures of cognitive remediation, will allow decreasing their impact on everyday life by improving abilities to understand and interact with others. Such tools could allow also profits in terms of reduction of positive and negative of schizophrenia. The Gaïa program is intended to improve the perception of the facial affects which is one of social cognition processes impaired in schizophrenia.

Methods:

This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manuel of Mental disorders, 4th edition (DSM-IV-TR).

The GAÏA program will be compared to an already validated neurocognitive remediation program, training attentional processes (RECOS).

100 patients will be randomized as follows: Arm 1, experimental: Gaïa (20h with therapist, computer assisted method) Arm 2, control: RECOS (20h with therapist, computer assisted method)

Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation

Hypothesis:

A targeted cognitive remediation will more increased abilities in facial affects recognition processes than a non specific, attentional cognitive remediation.

Primary outcome measures:

- Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after 10 weeks and 20 session of treatment.

Secondary outcome measures

Change from baseline in clinical, psychosocial, social cognition and neurocognitive measures, after 10 weeks and 20 session of treatment and at 6 months follow-up.
Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after treatment and 6 months follow-up.

ReferenceType: background

ReferenceCitation: Vianin P.Cognitive Remediation for schizophrenia. Presentation of the RECOS program.Anales Medico psychologiques 165: 200-205, 2007

ReferenceCitation: Franck N, Duboc C, Sundby C, Amado I, Wykes T, Demily C, Launay C, Le Roy V, Bloch P, Willard D, Todd A, Petitjean F, Foullu S, Briant P, Grillon ML, Deppen P, Verdoux H, Bralet MC, Januel D, Riche B, Roy P; Other members of the Cognitive Remediation Network; Vianin P. Specific vs general cognitive remediation for executive functioning in schizophrenia: a multicenter randomized trial. Schizophr Res. 2013 Jun;147(1):68-74. doi: 10.1016/j.schres.2013.03.009. Epub 2013 Apr 9.

ReferenceCitation: Gaudelus B, Franck N. Troubles du traitement des informations faciales. Le programme GAÏA. In Franck N, editor.La remédiation cognitive. Paris: Eselvier Masson: 169-81,2012.

ReferenceCitation: Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

ReferenceCitation: Peters E, Joseph S, Day S, Garety P. Measuring delusional ideation: the 21-item Peters et al. Delusions Inventory (PDI). Schizophr Bull. 2004;30(4):1005-22. doi: 10.1093/oxfordjournals.schbul.a007116.

ReferenceCitation: Birchwood M, Smith J, Drury V, Healy J, Macmillan F, Slade M. A self-report Insight Scale for psychosis: reliability, validity and sensitivity to change. Acta Psychiatr Scand. 1994 Jan;89(1):62-7. doi: 10.1111/j.1600-0447.1994.tb01487.x.

ReferenceCitation: Lecomte T, Corbiere M, Laisne F. Investigating self-esteem in individuals with schizophrenia: relevance of the Self-Esteem Rating Scale-Short Form. Psychiatry Res. 2006 Jun 30;143(1):99-108. doi: 10.1016/j.psychres.2005.08.019. Epub 2006 May 24.

ReferenceCitation: Leguay D, Cochet A, Matignon G, Hairy A, Fortassin O, Marion JM. [Social Autonomy Scale. First validation data]. Encephale. 1998 Mar-Apr;24(2):108-19. French.

ReferenceCitation: Corcoran R, Frith CD. Thematic reasoning and theory of mind. Accounting for social inference difficulties in schizophrenia. Evolutionary Psychology 3, 2005.

ReferenceCitation: Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Bayle MC, Passerieux C. Quantitative assessment of attribution of intentions to others in schizophrenia using an ecological video-based task: a comparison with manic and depressed patients. Psychiatry Res. 2009 May 15;167(1-2):28-35. doi: 10.1016/j.psychres.2007.12.010. Epub 2009 Apr 5.

ReferenceCitation: Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51.

ReferenceCitation: Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.

ReferenceCitation: Reniers RL, Corcoran R, Drake R, Shryane NM, Vollm BA. The QCAE: a Questionnaire of Cognitive and Affective Empathy. J Pers Assess. 2011 Jan;93(1):84-95. doi: 10.1080/00223891.2010.528484.

ReferenceCitation: Bydlowski S, Corcos M, Paterniti S, Guilbaud O, Jeammet P, Consoli SM. [French validation study of the levels of emotional awareness scale]. Encephale. 2002 Jul-Aug;28(4):310-20. French.

ReferenceCitation: Gaudelus B, Virgile J, Peyroux E, Leleu A, Baudouin JY, Franck N. [Measuring impairment of facial affects recognition in schizophrenia. Preliminary study of the facial emotions recognition task (TREF)]. Encephale. 2015 Jun;41(3):251-9. doi: 10.1016/j.encep.2014.08.013. Epub 2014 Sep 17. French.

lead_sponsor: Hôpital le Vinatier

collaborators: Centre Hospitalier Intercommunal Clermont de l'Oise

location_facility: centre de réhabilitation - Hôpital le Vinatier

intervention_type: Behavioral


title: Exploration of Neural Bases in Social Cognition

acronym: IRM-COG

summary:
An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.

Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).

Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Caen


title: a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.

acronym: tDCS(HE)

summary:
Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.

We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

repositories_concat: PubMed Central

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

lead_sponsor_type: industriel


title: Quantification of Muscle Specific microRNAs in the Serum of Patients With Duchenne Muscular Dystrophy (DMD) and Becker (BMD) : Evaluation of the Inters-est of These Biomarkers in Patients Care

acronym: biodystromirs

summary:
Duchenne muscular dystrophy (DMD) , caused by mutations in the DMD gene, is the most common and most severe progressive dystrophy of the child. Although the development is rapidly progressive , there is variability in the severity of the disease between DMD patients that do not correlate with the type of mutations in the DMD gene. There are no easily measurable biomarkers for monitoring the DMD or moderate form of the disease, Becker muscular dystrophy (BMD ) . MicroRNAs (miRNAs) are involved in most cellular processes , and their expression pattern is a signature of the state of a cell . They represent a potential class of diagnostic and prognostic biomarkers. Some are specific for the skeletal myogenesis , and changes in their pattern of expression are associated with muscle diseases including muscular dystrophy. The levels of muscle- specific miRNAs are indeed greatly increased in the serum of DMD and BMD compared to control patients .

The main objective of this is to validate the use of serum muscle-derived microRNAs as biomarkers of DMD patients (compared with healthy subjects). Secondary objectives are i) to investigate the relationship between circulating levels of these miRNAs and the severity of the dystrophinopathy (DMD vs BMD) and also the progression of the disease (longitudinal study), ii) to assess the specificity of these markers for dystrophinopathy (comparison with other patients with muscular dystrophy), iii) to test candidate miRNAs recently identified but not yet analyzed in the serum of patients.

Clinical data and samples will be recorded at each regular consultation. miRNA levels will be quantified using Real Time Quantitative RT-PCR.


title: Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn

acronym: ACTISUCROSE

summary: The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)

lead_sponsor: University Hospital, Brest

intervention_type: Procedure


title: Magnetic Resonance Imaging Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility

summary: The main objective of this study is to compare the data of Hystérosalpingo-MRI with intra cavitary injection of diluted gadolinium salts with the classic hysterography, which allows to realize at once with no irradiating examination, a complete assessment of the female infertility.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service d'imagerie médicale Hôpital Archet II

intervention_type: Radiation


title: Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

acronym: EVACIRC

summary:
The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.

Currently, two technologies of irrigated ablation catheters are available for PVI.

One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.

The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.

These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.

lead_sponsor: Association de Recherche pour le Traitement des Arythmies Cardiaques


acronym: ALEGORI

lead_sponsor: Hospices Civils de Lyon

summary:
Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (~ 1/6000) but ubiquitous genetic disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance, leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.

Anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.

The aim of this study is to evaluate 3 months after the end of the treatment the efficacy on the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab administered as a nasal spray in a repeated manner (3 administrations) in patients with Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.

This randomized, double-blind, placebo-controlled, seamless phase II/III study is to be carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for second step

ReferenceCitation: Dupuis-Girod S, Ambrun A, Decullier E, Fargeton AE, Roux A, Breant V, Colombet B, Riviere S, Cartier C, Lacombe P, Chinet T, Blivet S, Blondel JH, Gilbert-Dussardier B, Dufour X, Michel J, Harle JR, Dessi P, Faure F. Effect of Bevacizumab Nasal Spray on Epistaxis Duration in Hereditary Hemorrhagic Telangectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):934-42. doi: 10.1001/jama.2016.11387.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

status: Terminated

title: Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

source: euctr

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: ALEGORI

titre: Efficacité du bevacizumab en spray nasal pour le traitement des épistaxis dans la maladie de Rendu-Osler.

discipline_principale: médecine interne

nom_porteur: DUPUIS GIROD

prenom_porteur: Sophie


title: Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.

acronym: EducAA

summary:
The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.

This study also show us if therapeutic education has an effect on the quality of life of child's family.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
French Society of Allergology
Stallergenes laboratories
Picot-Lactalis laboratory
ALK Industries


title: Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures

summary:
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.

The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.

lead_sponsor: Société Française d'Endoscopie Digestive


title: Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma

acronym: MSN

summary: Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.

primary_purpose: Screening

ReferenceCitation: Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbo F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, Besse B. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics. Eur J Cancer. 2021 Jul;151:211-220. doi: 10.1016/j.ejca.2021.03.011. Epub 2021 May 19.

oa_host_type: closed

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: Non-inferiority and Tolerance of Conversion From Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation

acronym: Conversion

summary: The best period for the conversion from Prograf (tacrolimus administered twice daily) to Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this prospective, randomized, multicenter trial is to prove the non-inferiority of the early conversion (at D7) versus the conversion at D90 after liver transplantation. The primary objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the 6 first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two strategies will be compared in terms of superiority. 250 patients will be included. Three ancillary studies will be added : a PK study in a subgroup of 40 patients (20 patients per arm), an assay of the calcineurin activity on a subgroup of 40 patients, and a medicoeconomic study in all patients

ReferenceCitation: Allard M, Puszkiel A, Conti F, Chevillard L, Kamar N, Noe G, White-Koning M, Thomas-Schoemann A, Simon T, Vidal M, Calmus Y, Blanchet B. Pharmacokinetics and Pharmacodynamics of Once-daily Prolonged-release Tacrolimus in Liver Transplant Recipients. Clin Ther. 2019 May;41(5):882-896.e3. doi: 10.1016/j.clinthera.2019.03.006. Epub 2019 Apr 17.

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

location_facility: Hôpital Pitié Salpêtrière unité médicale de transplantion hépatique


title: A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence

acronym: SiFEPI

summary:
Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. In parallel with these encouraging results regarding biochemical control, the authors described excellent urinary and digestive tolerance, notably the absence of grade > 2 complications. However, it should be noted, in this study, that special protection was provided to the anterior aspect of the rectum by means of a 10 ml transperineal injection of hyaluronic acid into the prostate-rectal interspace.

The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90% local control rate for spinal metastases after a single dose at 18 to 24 Gy.

The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days) observed following interstitial high dose rate prostate brachytherapy delivering a total dose of 20 Gy in one fraction.

lead_sponsor: Centre Antoine Lacassagne


title: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial

acronym: STBETA

summary:
Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.

The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.


title: Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance

acronym: Tele-VAD

summary:
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. This hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment.

For this reasons, the NIV installation at home could be an interesting alternative for both the patient and the medical staff.

The aim of this pilot study is to test the feasibility of NIV installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.

sponsor_collaborators: Centre d'Investigation Clinique et Technologique 805


title: Influence of ABCB1 Polymorphisms on Plasma Concentrations of New Oral Anticoagulants in Case of Serious Adverse Events

acronym: Pgp NACO

summary:
Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now available on the market. These NOACs, like all anticoagulant drugs, continue to be associated with an increased risk of bleeding. In addition, the lack of antidote and the absence of valid data regarding biological monitoring can pose problems in case of overdose or when emergency surgery is required. Studies investigating the pharmacokinetic properties of rivaroxaban and dabigatran, two NOACs now approved for the market, have shown high variability between individuals, with coefficients of variation of up to 60% for some pharmacokinetic parameters in patients treated after orthopaedic surgery. The relation between plasma concentrations of NOAC and bleeding risk has been clearly established in clinical trials.

Dabigtran, rivaroxaban and apixaban are known substrates of P-glycoprotein (Pgp). Pgp activity can be affected by pharmacological inducing or inhibiting agents. This can lead to a significant change in the pharmacokinetics of NOACs, with a decrease or increase (respectively) in the level of intestinal absorption, leading to respectively reduced or increased plasma concentrations of the drug. Furthermore, there exist genetic mutations of Pgp, presenting in particular a lower level of activity than the non-mutated protein. We hypothesized that the polymorphisms (mutations) of the ABCB1 gene that codes for Pgp could influence plasma concentrations of dabigatran, rivaroxaban and apixaban, and consequently, impact on the concentration of NOACs and as a corollary, on the bleeding and thromboembolic risk of patients treated with these molecules.

The main objective of this study is to study the relation between polymorphisms of the ABCB1 gene that codes for Pgp and plasma concentrations of NOACs in patients treated for a hemorrhagic or thromboembolic complication occurring under NOAC therapy.

Secondary objectives are to evaluate the distribution of ABCB1 polymorphisms among the various hemorrhagic risk factors, and to compare the frequency of the polymorphism in patients from the study population vs the general population.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


summary: The purpose of this study is to evaluate the effect of cysteamine in patients with symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo) on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study group 1996).


title: Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)

summary: The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

ReferenceCitation: Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories:
DiVA.org
PubMed Central
irua

repositories_concat: DiVA.org;PubMed Central;irua

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

publisher_dissemination: British Medical Journal

lead_sponsor: Laboratoires Thea


acronym: TOCITAKA

summary: First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and induction of remission in Takayasu arteritis (TA).

ReferenceCitation: Mekinian A, Neel A, Sibilia J, Cohen P, Connault J, Lambert M, Federici L, Berthier S, Fiessinger JN, Godeau B, Marie I, Guillevin L, Hamidou M, Fain O; Club Rhumatismes et Inflammation, French Vasculitis Study Group and Societe Nationale Francaise de Medecine Interne. Efficacy and tolerance of infliximab in refractory Takayasu arteritis: French multicentre study. Rheumatology (Oxford). 2012 May;51(5):882-6. doi: 10.1093/rheumatology/ker380. Epub 2012 Jan 5.

ReferenceCitation: Abisror N, Mekinian A, Lavigne C, Vandenhende MA, Soussan M, Fain O; Club Rhumatismes et Inflammation, and SNFMI. Tocilizumab in refractory Takayasu arteritis: a case series and updated literature review. Autoimmun Rev. 2013 Oct;12(12):1143-9. doi: 10.1016/j.autrev.2013.06.019. Epub 2013 Jun 29.

ReferenceCitation: Nishimoto N, Nakahara H, Yoshio-Hoshino N, Mima T. Successful treatment of a patient with Takayasu arteritis using a humanized anti-interleukin-6 receptor antibody. Arthritis Rheum. 2008 Apr;58(4):1197-200. doi: 10.1002/art.23373.

ReferenceCitation: Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. doi: 10.1002/acr.21750.

ReferenceCitation: Salvarani C, Magnani L, Catanoso MG, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Rescue treatment with tocilizumab for Takayasu arteritis resistant to TNF-alpha blockers. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S90-3. Epub 2012 May 11.

ReferenceCitation: Mekinian A, Saadoun D, Vicaut E, Thietart S, Lioger B, Jego P, Bleibtreu A, Limal N, Connault J, Gottenberg JE, Lhorte P, Bertola JP, Delforge J, Ferreira-Maldent N, Perlat A, Talib Z, Vautier M, Savey L, Quiere I, Cacoub P, Fain O; French Takayasu network. Tocilizumab in treatment-naive patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial. Arthritis Res Ther. 2020 Sep 17;22(1):218. doi: 10.1186/s13075-020-02311-y.

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

evidence: oa repository (via page says license)

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square
univOAK

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Chugai Pharmaceutical

title: Efficacy and Tolerance of First-line Treatment With Tocilizumab in Active Takayasu Arteritis French Prospective Multicenter Study


title: Effect of Exercise on the Neural Response to Food Cues and Energy Intake in Lean and Obese Adolescents

summary: Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the neural system in the post exercise drive to eat. This study tends to explore whether or not an acute bout of exercise can affect the neural response to food cues in adolescents, obese or lean.

status: Withdrawn

time_perspective: Cross-Sectional

lead_sponsor: Université Blaise Pascal, Clermont-Ferrand


title: Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.

acronym: EDONOT

summary:
Currently, it is established that the voltage-gated calcium channels modulate pain perception due to an influence on the neuronal transmission and excitability. In the past, attention has focused on the modulation of high voltage activated calcium channel. More recently, scientific interest has proven to the low voltage activated calcium channel, also called T-type channels. The data from the literature show significant involvement of these channels in the physiology of nociception and pathophysiology of acute and chronic pain. Moreover, in several animal pain models (acute, neuropathic, inflammatory), T-type channels inhibition alleviates painful behaviours.

Analgesics treatments available in clinic are ineffective in some patients with chronic pain (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical use of selective inhibitors of T-type channels could not only help the development of new therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a pharmaco-economic impact due to the low selling price of their inhibitor currently available: Zarontin®.

The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with peripheral neuropathic pain compared to a control group.

ReferenceCitation: Kerckhove N, Pereira B, Soriot-Thomas S, Alchaar H, Deleens R, Hieng VS, Serra E, Lanteri-Minet M, Arcagni P, Picard P, Lefebvre-Kuntz D, Maindet C, Mick G, Balp L, Lucas C, Creach C, Letellier M, Martinez V, Navez M, Delbrouck D, Kuhn E, Piquet E, Bozzolo E, Brosse C, Lietar B, Marcaillou F, Hamdani A, Leroux-Bromberg N, Perier Y, Vergne-Salle P, Gov C, Delage N, Gillet D, Romettino S, Richard D, Mallet C, Bernard L, Lambert C, Dubray C, Duale C, Eschalier A. Efficacy and safety of a T-type calcium channel blocker in patients with neuropathic pain: A proof-of-concept, randomized, double-blind and controlled trial. Eur J Pain. 2018 Aug;22(7):1321-1330. doi: 10.1002/ejp.1221. Epub 2018 Apr 18.

ReferenceCitation: Kerckhove N, Mallet C, Pereira B, Chenaf C, Duale C, Dubray C, Eschalier A. Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT-protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial. BMJ Open. 2016 Dec 16;6(12):e013530. doi: 10.1136/bmjopen-2016-013530.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Fondation Apicil

appel_a_projets: PHRCI

nom_etablissement: CHU DE CLERMONT-FERRAND

acronyme: EDONOT

titre: Evaluation de l'efficacité de l'éthosuximide dans le traitement de douleurs neuropathiques d'origine traumatique

discipline_principale: neurologie

nom_porteur: ESCHALIER

prenom_porteur: Alain


acronym: ANRS 160 RalFE

lead_sponsor: ANRS, Emerging Infectious Diseases

summary: The purpose of this study is to assess the evolution of raltegravir concentration in the mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate, when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined antiretroviral regimen.

ReferenceCitation: Zheng Y, Hirt D, Delmas S, Lui G, Benaboud S, Lechedanec J, Treluyer JM, Chenevier-Gobeaux C, Arezes E, Gelley A, Amri I, Urien S, Bouazza N, Foissac F, Warszawski J, Ghosn J. Effect of Pregnancy on Unbound Raltegravir Concentrations in the ANRS 160 RalFe Trial. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00759-20. doi: 10.1128/AAC.00759-20. Print 2020 Sep 21.

publisher_dissemination: American Society for Microbiology

title: Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy


title: The Randomized TOPIC Study : Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome

acronym: TOPIC

summary: Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for ACS. Efficiency and tolerance évaluation

lead_sponsor: Hôpital de la Timone

location_facility: CHU Timone hospital . Sc CARDIOLOGIE. Rue saint Pierre.


title: Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study

acronym: HEMOCOEUR

summary:
Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible first for biological disorder in blood iron parameters and minor clinical disorders, before evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and congestive heart failure.

The improvement of screening and treatments made those severe affections rare enough not to evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless this myocardial iron overload might have severe implications on cardiac function on a long term basis.

A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed a myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects.

The main objective of this study is to precisely estimate cardiac iron overload in treatment naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac morbidity in HHC.

lead_sponsor: Rennes University Hospital


title: Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease

acronym: IMPACT-Crohn

summary: Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.

ReferenceCitation: Sokol H, Landman C, Seksik P, Berard L, Montil M, Nion-Larmurier I, Bourrier A, Le Gall G, Lalande V, De Rougemont A, Kirchgesner J, Daguenel A, Cachanado M, Rousseau A, Drouet E, Rosenzwajg M, Hagege H, Dray X, Klatzman D, Marteau P; Saint-Antoine IBD Network; Beaugerie L, Simon T. Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. Microbiome. 2020 Feb 3;8(1):12. doi: 10.1186/s40168-020-0792-5.

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

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

location_facility: Gastroenterology department, Saint Antoine Hospital


title: Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury

summary: This prospective study focuses on the interest of the echocardiography for cirrhotic patients, who present acute kidney injury corresponding to the criteria of hepatorenal syndrome. This echocardiography will be done before the volemic expansion and the final diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe the hemodynamic characteristics of this population at the time of acute kidney injury and their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of the study after the echocardiography and will not undergo volemic expansion but appropriate management.

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


summary: Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM

lead_sponsor: Lionel Bouvet


title: Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.

acronym: BABYDOUL

summary: Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: BABYDOUL

titre: Evaluation de l'efficacité du regroupement ftal en association avec la succion d'une tétine avec eau stérile sur la douleur lors d'un prélèvement capillaire chez le grand prématuré.

discipline_principale: néonatalogie

nom_porteur: PERROTEAU

prenom_porteur: Anne


title: Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer

acronym: EPIC

summary:
Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (>6 months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.

The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.

ReferenceCitation: Lefebvre L, Noyon E, Georgescu D, Proust V, Alexandru C, Leheurteur M, Thery JC, Savary L, Rigal O, Di Fiore F, Veyret C, Clatot F. Port catheter versus peripherally inserted central catheter for postoperative chemotherapy in early breast cancer: a retrospective analysis of 448 patients. Support Care Cancer. 2016 Mar;24(3):1397-403. doi: 10.1007/s00520-015-2901-8. Epub 2015 Sep 5.

lead_sponsor: Centre Henri Becquerel


title: A Randomized, Open Label, Multicenter, Comparative Phase II Trial of Ipilimumab After Isolated Limb Perfusion (ILP), in Patients With In-transit Metastases Melanoma Stage IIIB and IIIC

acronym: ILP+/-IPI

summary: Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result.

ReferenceCitation: Tulokas SKA, Kohtamaki LM, Makela SP, Juteau S, Alback A, Vikatmaa PJ, Mattila KE, Skytta TK, Koivunen JP, Tyynela-Korhonen K, Hernberg MM. Isolated limb perfusion with melphalan as treatment for regionally advanced melanoma of the limbs: results of 60 patients treated in Finland during 2007-2018. Melanoma Res. 2021 Oct 1;31(5):456-463. doi: 10.1097/CMR.0000000000000755.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effects of Decrease in Cholesterol Levels Induced by a Statin on Sperm Quality

summary:
Recently, concerns about the effect of atorvastatin intake on men fertility have been raised. However, this statin has never been investigated regarding its influence on male fertility, notably sperm quality.

The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.

ReferenceCitation: Pons-Rejraji H, Brugnon F, Sion B, Maqdasy S, Gouby G, Pereira B, Marceau G, Gremeau AS, Drevet J, Grizard G, Janny L, Tauveron I. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial. Reprod Biol Endocrinol. 2014 Jul 12;12:65. doi: 10.1186/1477-7827-12-65.

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

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

publisher_dissemination: Springer

collaborators: Service de Biologie de la Reproduction : AMP-CECOS

collaborators: Service d'Endocrinologie, Diabète et Maladies Métaboliques


title: Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial

acronym: ACTIMARCH

summary:
Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting physical activity in postmenopausal women. Women are eligible and enrolled in the study if they have no significant disease affecting lower limb function and if they have a sedentary lifestyle. All study participants provide written informed consent to participate to the study.

Women are then randomized either to the control group (women have to maintain their lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program. The objective of the study is to determine the health benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone density, body weight, lean and fat mass, depression symptoms, behavioral, emotional responses, sleep quality, and biological indicators of health.

lead_sponsor: University Hospital, Montpellier


title: Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis

acronym: DECIDEO

summary: The aim of this study is to assess the impact of a decision aid leaflet on the participation of women invited to participate in the French national breast cancer screening program.

ReferenceCitation: Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.

ReferenceCitation: Olsson S, Andersson I, Karlberg I, Bjurstam N, Frodis E, Hakansson S. Implementation of service screening with mammography in Sweden: from pilot study to nationwide programme. J Med Screen. 2000;7(1):14-8. doi: 10.1136/jms.7.1.14.

ReferenceCitation: Walter LC, Lewis CL. Maximizing informed cancer screening decisions. Arch Intern Med. 2007 Oct 22;167(19):2027-8. doi: 10.1001/archinte.167.19.2027. No abstract available.

ReferenceCitation: Raffle AE. Informed participation in screening is essential. BMJ. 1997 Jun 14;314(7096):1762-3. doi: 10.1136/bmj.314.7096.1762a. No abstract available.

ReferenceCitation: Barratt A, Trevena L, Davey HM, McCaffery K. Use of decision aids to support informed choices about screening. BMJ. 2004 Aug 28;329(7464):507-10. doi: 10.1136/bmj.329.7464.507.

ReferenceCitation: Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.

ReferenceCitation: Mathieu E, Barratt A, Davey HM, McGeechan K, Howard K, Houssami N. Informed choice in mammography screening: a randomized trial of a decision aid for 70-year-old women. Arch Intern Med. 2007 Oct 22;167(19):2039-46. doi: 10.1001/archinte.167.19.2039.

ReferenceCitation: Edwards A, Unigwe S, Elwyn G, Hood K. Effects of communicating individual risks in screening programmes: Cochrane systematic review. BMJ. 2003 Sep 27;327(7417):703-9. doi: 10.1136/bmj.327.7417.703.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects

summary: The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.

lead_sponsor: Bial - Portela C S.A.


title: A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.

summary:
In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating its effect on QT/QTc prolongation in healthy male and female subjects. According to the guidelines, such studies should typically be performed at the expected therapeutic dose and a supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.

GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy overweight subjects (study GFT505-111-7), and both safety and tolerability were very good. However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d. Therefore, the current TQT study will be preceded by a multiple ascending dose study in which the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5 and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which safety and tolerability are considered satisfactory will be the supra-therapeutic dose used in the TQT study.

lead_sponsor: Genfit

sponsor_collaborators:
Genfit
Eurofins Optimed
CardiaBase
PhinC Development


title: ULtrasound Imaging in Focal Cortical dYSplasia: a New Approach to Delineating the Dysplastic Cortex During Neurosurgery

acronym: ULYS

summary: High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery (ULYS)

ReferenceCitation: Mellerio C, Labeyrie MA, Chassoux F, Roca P, Alami O, Plat M, Naggara O, Devaux B, Meder JF, Oppenheim C. 3T MRI improves the detection of transmantle sign in type 2 focal cortical dysplasia. Epilepsia. 2014 Jan;55(1):117-22. doi: 10.1111/epi.12464. Epub 2013 Nov 15.

ReferenceCitation: Mellerio C, Labeyrie MA, Chassoux F, Daumas-Duport C, Landre E, Turak B, Roux FX, Meder JF, Devaux B, Oppenheim C. Optimizing MR imaging detection of type 2 focal cortical dysplasia: best criteria for clinical practice. AJNR Am J Neuroradiol. 2012 Nov;33(10):1932-8. doi: 10.3174/ajnr.A3081. Epub 2012 May 3.

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
Fondation de l'Avenir
Fondation pour les Sciences du Cerveau
Association NEUROREFS


title: Phase II Study Evaluating the Influence of LV5FU2 Bevacizumab Plus Anakinra Association on Vascularization of Liver Metastases of Metastatic Colorectal Cancer: Proof of Concept Study

acronym: IRAFU

summary:
The metastatic colon cancer is a major public health problem despite advances in chemotherapy; few new drugs are in development for the treatment of this pathology.

Many studies have shown that human colon cancer is a tumor that is recognized by the immune system and the presence of lymphocytic infiltrates in the tumor bed is associated with a better prognosis. Conversely, the effect of chemotherapy on the immune response is little studied.

Recently the importance of myeloid suppressor cells (MDSC) in the development of colon cancer and the effect of 5- fluorouracil on this cell population has been highlighted. An accumulation of these cells in the blood and lymphoid organs during tumor progression is observed. Moreover, it has been established that the death of MDSC induced by 5-fluorouracil induces activation of caspase -1 and IL-1beta by these MDSC.

These events promote the polarization of CD4 T cells in intratumoral Th17 lymphocytes. The IL- 17 produced by these cells exerts a pro-angiogenic effect in inducing proliferation of endothelial cells expressing and thus limits the effect of 5- fluorouracil endoglin.

In humans, it has also been observed that chemotherapy using 5- fluorouracil and in particular LV5FU2 association +/- bevacizumab induces rapid death of blood MDSC as well as activation of caspase 1 in these cells. Thus, production of IL - 1 is detected in the serum of patients after 24 hours of the administration of 5-fluorouracil.

Chronic inflammation and the production of interleukin- 1 can alter the effectiveness of anti -tumor immune responses and facilitate angiogenesis. Many preclinical data suggest a role of anti -tumor inhibition of IL- 1beta, but the effect of a combination of chemotherapy and an inhibitor of IL - 1beta has not yet been tested in human.

Anakinra is a drug used in humans for many years to treat signs and symptoms of rheumatoid arthritis. In combination with methotrexate, in patients whose response to methotrexate alone is not satisfactory it had shown interesting results. The dose used clinically is 100 mg per day which is the dose that is proposed to be tested in this study.

In this context it should be remembered that methotrexate is a chemotherapeutic agent from the class of antimetabolites such as 5- fluorouracil.

RCP of this drug indicate that in studies originator toxicity was similar between the control arm and anakinra arm with an increase in serious infections (1.8 % vs 0.7 %) and an increased incidence of neutropenia (2.5 % neutropenia > grade = 1). The main toxicity observed is a painful inflammatory reaction at the injection site in 70 % of patients The investigators believe that this project could permit to validate in man preclinical observations showing an anti-tumor potential for combination anakinra and 5 fluorouracil.

lead_sponsor: Centre Georges Francois Leclerc


summary: The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications

lead_sponsor: Pierre Fabre Medicament


title: Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain

acronym: EGID

summary:
Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.

In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Gelscom SAS

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: EGID

titre: Efficacité de l'Ethanol Gélifié en injection Intradiscale dans le traitement de la lombalgie Discogénique

discipline_principale: neurochirurgie

nom_porteur: CAIRE

prenom_porteur: François


title: Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

acronym: STEREO-SEIN

summary:
The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment.

The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease.

This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).


title: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.

acronym: CXL

summary: The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.

ReferenceCitation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

lead_sponsor: Nantes University Hospital


title: Development of General Practitioners Screening Tool of Frail Older Old Community-dwellers: a Cohort Population-based Study

acronym: ReperAge

summary:
The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of an elderly person, in order to develop a coordinated and integrated plan for treatment. It represents the first stage of the most appropriate care for elderly people who are frail or who cannot perform at least three daily tasks unaided.

It has been shown that the integration of CGA in the decision-making and care management at hospital improves inpatient's health and functional status, and reduces mortality rate and healthcare expenditures. The effects of CGA in daily practice of general practitioners remain unknown.

Implementation of a systematic CGA for every older old community-dwellers performed by a general practitioner remains yet difficult because of number of issues. First, although the number of older old community-dwellers keeps increasing, the number of health care professional with geriatric skills does not. Second, CGA is a complex and time-consuming process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the care of all frail older old community-dwellers due to their limited number. An implication of non-geriatricians in CGA is therefore required.

Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best compromise could be the use of a two-step approach. The first step is the identification by non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening tool, and the second step is a CGA by geriatricians with a diagnosis purpose.

None of existing tools used for screening is adapted to the population of elderly people who visit general practitioners.Thus, healthcare professionals working in ED need a simple, standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older old community-dwellers requiring specialized geriatric care.

The investigators hypothesized that a BGA older old community-dwellers carried out by a general practitioner could predict the adverse health events (i.e. hospitalization, institutionalisation, medical consultations and death) occurring during a 6-months follow-up period before the evaluation.

lead_sponsor: Gerontopôle des Pays de la Loire

sponsor_collaborators:
Gerontopôle des Pays de la Loire
University Hospital, Angers


title: Prognosis Factors of Cardiac Complications After Liver Transplantation

acronym: PROCOM

summary: This is a prospective, multicenter, non-interventional, observational study of a cohort with a biological plasma and urine samples collection for the study of prognosis factors of cardiac complications after liver transplantation

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Alcohol Consumption and Stress at Patients Alcohol-dependants

acronym: CASPA

summary: This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.

location_facility: Hopital Louis Mourier, Service de psychiatrie


title: Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function

summary:
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.

Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.

The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.

lead_sponsor: University Hospital, Angers

location_facility: Centre Hospitalier Universitaire d'Angers

intervention_type: Dietary Supplement


title: Role of Endothelin-1 in Mediating Flow-mediated Dilatation of Conduit Arteries During Sustained Hyperemic Stimulation

acronym: Endothelin

summary: Endothelial dysfunction of conduit arteries contributes to the increased morbidity and cardiovascular mortality in patients with essential hypertension and appears increasingly as an independent therapeutic target. We have shown previously that besides a decrease in the availability of NO and other endothelium-derived vasodilators factors, the epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to a sustained increase in blood flow decreased significantly in healthy volunteers controls but not in hypertensive patients. This lack of adaptation of the endothelinergic system could be due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular level. However, to validate this hypothesis , it is needed to demonstrate the physiological role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.

lead_sponsor: University Hospital, Rouen


acronym: LOKOMAT

summary: Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.

time_perspective: Retrospective

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


acronym: VesiRop

lead_sponsor: Centre Hospitalier Departemental Vendee

summary:
Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.

The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.

Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.

ReferenceCitation: Abet E, Orion F, Denimal F, Brau-Weber AG, de Kerviler B, Jean MH, Boulanger G, Dimet J, Comy M. Interest of Using Ropivacaine for Outpatient Laparoscopic Cholecystectomy: Prospective Randomized Trial. World J Surg. 2017 Mar;41(3):687-692. doi: 10.1007/s00268-016-3797-2.

title: Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?


title: Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy

acronym: IRM Stéatose

summary:
This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.
Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
Usual blood samples will be completed by samples for the serum library

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

acronym: KIPHO

summary:
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.

Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.

An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.

The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.


title: Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?

acronym: LOST

summary:
This is a single-centre observational, prospective study carried out at the maternity unit of Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will evaluate in these patients, the activation and migration capacities of circulating leukocytes and their association with the onset of spontaneous labour.

Patients who meet the inclusion criteria will be informed about the study during their consultation at the 7th or 8th month, and their gynecologist will invite them to take part. If the answer is positive, the patients will be seen again at a specific consultation for the study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU. During this consultation, the gynecologist will conduct a medical examination, while the Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and 1 x 7ml tube).

If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood sample (1 x 6ml tube and 1 x 7ml) will be taken.

The patients will be followed until childbirth and will be split into two groups according to whether or not they gave birth after the onset of spontaneous labour.

status: Recruiting


title: ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.

summary:
Malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. The management of malnutrition has an impact in reducing postoperative complications. However malnutrition is rarely detected and Guidelines infrequently followed.

Recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its treatment. It is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition.

And nutritional management must be adapted and based on this evaluation and evolution of the general status (Guidelines Grade A).

A geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN) guidelines.

ReferenceCitation: Dupuis M, Kuczewski E, Villeneuve L, Bin-Dorel S, Haine M, Falandry C, Gilbert T, Passot G, Glehen O, Bonnefoy M. Age Nutrition Chirugie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial. BMC Geriatr. 2017 Jan 7;17(1):10. doi: 10.1186/s12877-016-0402-3.

license: cc-by-sa

license_normalized: cc-by-sa

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

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

lead_sponsor: Hospices Civils de Lyon


title: Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

acronym: QUICK

summary:
The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration.

Design: split-mouth design AND parallel-arm design

ReferenceCitation: Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

ReferenceCitation: Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

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


title: Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

summary:
The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.

The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.


title: Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

summary: It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.

lead_sponsor: Hopital Foch


title: Self-perception of Dyspnea Threshold During the 6-minute Walk Test (DT6): A New Tool for Individualized Exercise Training With Chronic Obstructive Pulmonary Disease Patients (COPD)

summary:
In view of the multiple limitations and restrictions relative to CPET (technical, time, physical…), determination of individualized training threshold from this evaluation is today not possible for a lot of patients.

The aim of this study was to propose a new clinical tool from 6MWT for individualized exercise training: the dyspnea threshold (DT6).

lead_sponsor: 5 Santé


title: Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study

summary: The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative reconstruction (MBIR- VEO TM).

lead_sponsor: University Hospital, Clermont-Ferrand


title: Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.

acronym: RECRUTEX

summary: Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.

location_facility: Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon


title: Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD

summary: Peripheral muscle mass and strength are relevant indicators of COPD survival. Current guidelines recommend to assess muscle strength only in muscle wasted patients. However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp. Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.


title: Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial

acronym: IRIS

summary:
Lung aspiration can occur when a rapid sequence induction of anesthesia is performed (emergency and/or presence of at least one risk factor for regurgitation of stomach contents).

The aim of this study is to assess the Sellick maneuver, which is recommended for patient at high risk of aspiration of gastric content during induction of general anesthesia, despite the lack of solid evidence of its efficacy and possible adverse effects The primary outcome of this non inferiority study is the incidence of lung aspiration whether this maneuver is effectively applied or sham.

ReferenceCitation: Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577. Erratum In: JAMA Surg. 2019 Jan 1;154(1):96.

repository_institution: PubMed Central - Europe PMC


title: Study in Leucocytes From Patients With Type 1 and Type 2 Diabetes Genetic Markers of Inflammation and Oxidative Stress (TÉLOMÈRES/ CANDIDATE GENES) According to the Type A or Type B Behavior Profile

acronym: Diatolepsy

summary:
This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of 50 patients according to their behaviour type, and their adaptation to different factors of stress encountered in their lives:

the first group will consist of patients with a characteristic Type A behaviour profile, that is to say patients with a "proactive, impatient" behaviour pattern
the second group will consist of patients with a characteristic Type B behaviour profile that is to say patients with a "calm, slow" behaviour pattern The objective is to know if the different behaviour patterns are associated with distinct biological markers likely to influence the evolution of the diabetes.

Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:

they will answer simple questions about their disease and then complete 3 questionnaires each with 14 items.
they will meet a clinical psychologist for an interview lasting approximately 45 minutes recorded on an audio recorder. The consultation will be used to seek links between the psyche and the disease.
they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the morning.


title: Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.

summary:
The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.

This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.

This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.