lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
France
Poland
Belgium
Portugal
Denmark
Germany
United Kingdom

acronym: Adjuvant Pegylated Interferon in Ulcerated Melanoma

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Avicenne

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone

location_facility: IRCCS - Istituto Tumori "Giovanni Paolo II"

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: CHU de Nice - CHU de Nice - Hopital De L'Archet

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Universitaetsklinikum Heidelberg - Hautklinik / Dermatologic Department

location_facility: Mid Essex Hospitals - Broomfield Hospital

location_facility: Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine

location_facility: I.P.O. Francisco Gentil - Centro De Lisboa

location_facility: St Helens and Knowsley Teaching Hospitals

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elisabeth Medical Centre

title: Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.

summary:
Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk.

The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.


title: A Study of Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma With Sunitinib BEFORE and AFTER Nephrectomy

acronym: PREINSUT

summary: The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit: Impact on Relatives, Care Givers and the Dying Process - A Prospective, Multicenter, Observational Study

acronym: ARREVE

summary: The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Robert R, Le Gouge A, Kentish-Barnes N, Cottereau A, Giraudeau B, Adda M, Annane D, Audibert J, Barbier F, Bardou P, Bourcier S, Bourenne J, Boyer A, Brenas F, Das V, Desachy A, Devaquet J, Feissel M, Ganster F, Garrouste-Orgeas M, Grillet G, Guisset O, Hamidfar-Roy R, Hyacinthe AC, Jochmans S, Jourdain M, Lautrette A, Lerolle N, Lesieur O, Lion F, Mateu P, Megarbane B, Merceron S, Mercier E, Messika J, Morin-Longuet P, Philippon-Jouve B, Quenot JP, Renault A, Repesse X, Rigaud JP, Robin S, Roquilly A, Seguin A, Thevenin D, Tirot P, Vinatier I, Azoulay E, Reignier J. Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE observational study). Intensive Care Med. 2017 Dec;43(12):1793-1807. doi: 10.1007/s00134-017-4891-0. Epub 2017 Sep 22. Erratum in: Intensive Care Med. 2017 Nov 24;:.

family: Robert

full_name: René Robert

given: René

sequence: first

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

sequence: additional

family: Kentish-Barnes

full_name: Nancy Kentish-Barnes

given: Nancy

family: Cottereau

full_name: Alice Cottereau

given: Alice

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Adda

full_name: Mélanie Adda

given: Mélanie

family: Annane

full_name: Djillali Annane

given: Djillali

family: Audibert

full_name: Juliette Audibert

given: Juliette

family: Barbier

full_name: François Barbier

given: François

family: Bardou

full_name: Patrick Bardou

given: Patrick

family: Bourcier

full_name: Simon Bourcier

given: Simon

family: Bourenne

full_name: Jeremy Bourenne

given: Jeremy

family: Boyer

full_name: Alexandre Boyer

given: Alexandre

family: Brenas

full_name: François Brenas

family: Das

full_name: Vincent Das

given: Vincent

family: Desachy

full_name: Arnaud Desachy

given: Arnaud

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Feissel

full_name: Marc Feissel

given: Marc

family: Ganster

full_name: Frédérique Ganster

given: Frédérique

family: Garrouste-Orgeas

full_name: Maïté Garrouste-Orgeas

given: Maïté

family: Grillet

full_name: Guillaume Grillet

given: Guillaume

family: Guisset

full_name: Olivier Guisset

given: Olivier

family: Hamidfar-Roy

full_name: Rebecca Hamidfar-Roy

given: Rebecca

family: Hyacinthe

location_facility: Centre Hospitalier, Service de réanimation


title: Multicentre Clinical Study to Compare the Efficacy and the Tolerance of Cellularised LG002 With the Efficacy and Tolerance of Uncellularised LG002 in the Treatment of Severe Burn Injury

summary:
After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft.

In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Berthod F, Saintigny G, Chretien F, Hayek D, Collombel C, Damour O. Optimization of thickness, pore size and mechanical properties of a biomaterial designed for deep burn coverage. Clin Mater. 1994;15(4):259-65.

ReferenceCitation: Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6.

ReferenceCitation: Coulomb B, Lebreton C, Dubertret L. Influence of human dermal fibroblasts on epidermalization. J Invest Dermatol. 1989 Jan;92(1):122-5.

ReferenceCitation: Berthod F, Hayek D, Damour O, Collombel C. Collagen synthesis by fibroblasts cultured within a collagen sponge. Biomaterials. 1993 Aug;14(10):749-54.

ReferenceCitation: Froget S, Barthelemy E, Guillot F, Soler C, Coudert MC, Benbunan M, Dosquet C. Wound healing mediator production by human dermal fibroblasts grown within a collagen-GAG matrix for skin repair in humans. Eur Cytokine Netw. 2003 Jan-Mar;14(1):60-4.

ReferenceCitation: Saintigny G, Bonnard M, Damour O, Collombel C. Reconstruction of epidermis on a chitosan cross-linked collagen-GAG lattice: effect of fibroblasts. Acta Derm Venereol. 1993 Jun;73(3):175-80.

ReferenceCitation: Sher SE, Hull BE, Rosen S, Church D, Friedman L, Bell E. Acceptance of allogeneic fibroblasts in skin equivalent transplants. Transplantation. 1983 Nov;36(5):552-7.

ReferenceCitation: Braye FM, Stefani A, Venet E, Pieptu D, Tissot E, Damour O. Grafting of large pieces of human reconstructed skin in a porcine model. Br J Plast Surg. 2001 Sep;54(6):532-8.

ReferenceCitation: Coulomb B, Friteau L, Baruch J, Guilbaud J, Chretien-Marquet B, Glicenstein J, Lebreton-Decoster C, Bell E, Dubertret L. Advantage of the presence of living dermal fibroblasts within in vitro reconstructed skin for grafting in humans. Plast Reconstr Surg. 1998 Jun;101(7):1891-903.

lead_sponsor: Laboratoires Genévrier

location_facility: Hôpital d' Instruction des Armées de Percy, Service des Brûlés

intervention_type: Device

lead_sponsor_type: industriel


type: Other Identifier

title: Non Invasive Pressure -Volume Loop (PVLOOP) With 3D Echocardiography and Arterial Tonometry

acronym: LOOPING

summary: In patients under general anesthesia, the prevention of intraoperative hypotension to maintain blood pressure (BP) close to the initial blood pressure, i.e. before anesthesia, is essential to reduce the risk of death and improve surgical outcomes. Vasoactive agents are commonly used to correct this hypotension (Phenylephrine Ephedrine Noradrenaline). These three vasoconstrictors have specific effects on the afterload of the heart and can impair its function. The analysis of the left ventricular pressure-volume curve (PV Loop) allows continuous information on the post-charge state of the left ventricle and the changes induced by the vasoconstrictors to be observed. However, the investigators currently have no way of monitoring these effects. In clinical practice if these loops are obtained non-invasively they can be used in the evaluation of cardiac function of at-risk patients in perioperative and also in intensive care to allow therapeutic adaptation.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

location_facility: Department of Anesthesiology and Intensive Care, Lariboisière Hospital

intervention_type: Procedure

status_simplified: Ongoing


title: Efficacy and Safety of Dornase Alfa Aerosol in ARDS Secondary to SARS-CoV-2 Coronavirus Respiratory Infection - COVID-19

acronym: COVIDORNASE

summary:
This study plans to learn more about the effects of Dornase Alfa in COVID19 (coronavirus disease of 2019) patients, the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Dornase Alfa is a FDA-approved drug for the treatment of cystic fibrosis, which facilitates mucus clearance by cutting apart neutrophil-derived extracellular double-stranded DNA. This study intends to define the impact of aerosolized intra-tracheal Dornase Alfa administration on the severity and progression of acute respiratory distress syndrome (ARDS) in COVID-19 patients. This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.

The study will recruit mechanically ventilated patients hospitalized in ICU who have been diagnosed with COVID-19 and meet ARDS criteria. It is a prospective, randomized, controlled, multicentric, open-label clinical trial.

The goal is to recruit 100 patients.

ReferenceCitation: Desilles JP, Gregoire C, Le Cossec C, Lambert J, Mophawe O, Losser MR, Lambiotte F, Le Tacon S, Cantier M, Engrand N, Trouiller P, Pottecher J. Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 19;21(1):548. doi: 10.1186/s13063-020-04488-8.

family: Desilles

full_name: J. P. Desilles

given: J. P.

family: Gregoire

full_name: C. Gregoire

given: C.

family: Le Cossec

full_name: C. Le Cossec

family: Lambert

full_name: J. Lambert

given: J.

family: Mophawe

full_name: O. Mophawe

given: O.

family: Losser

full_name: M. R. Losser

given: M. R.

family: Lambiotte

full_name: F. Lambiotte

given: F.

family: Le Tacon

full_name: S. Le Tacon

given: S.

family: Cantier

full_name: M. Cantier

given: M.

family: Engrand

full_name: N. Engrand

given: N.

family: Trouiller

full_name: P. Trouiller

given: P.

family: Pottecher

full_name: J. Pottecher

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

oa_host_type: repository

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: No

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)

summary: Alcohol is the psychoactive substance most experienced by young people. It benefits from positive representations that are reinforced by marketing strategies where advertisers integrate their products into TV series. Our project takes into account the reflexive and impulsive model developed by Strack & Deutsch (2004). We will compare the impulsive intervention to an educational module based on information and reflection that uses the individual's reflexive system with 30 classes in the Loire and Rhône departments. The intervention framework developed uses a modeling system that includes several concepts that work together. These concepts describe the influence of media messages on young people's opinions and behaviours. Given that the objective is to reduce the positive representations of alcohol among young people by means of an educational module based on information and reflection (reflexive model) and a module based on the impulsive system where the para-social connection is involved. The Alcohol Expectancies Scale will be proposed as a judgment criterion and will be administered before and after the intervention.

status: Unknown status

primary_purpose: Prevention

lead_sponsor: Institut de Cancérologie de la Loire

location_country:
United States
France

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Behavioral


title: Multicenter, Randomized, Open Label Study Evaluating an Anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, AVE1642, Administered Every 4 Weeks in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

summary:
The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease".

The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed.

The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied

lead_sponsor: Sanofi

location_country: Italy France Spain


title: Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)

acronym: IMOVA

summary: This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

primary_purpose: Diagnostic

lead_sponsor: Institut Bergonié

status_simplified: Completed


title: Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

summary: The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

lead_sponsor: Centre Oscar Lambret

location_facility:
Clinique de Flandre
Centre Eugene Marquis
Centre Paul Papin
Institut Gustave Roussy
Centre Oscar Lambret
Hôpital Georges PIANTA
Centre Claudius Regaud
Centre Hospitalier
Centre Jean Perrin
Centre Henri Becquerel
Centre Rene Gauducheau
Hôpital Lariboisière
Institut Paoli Calmettes
Centre Hospitalier Sud Léman Valsérine
Centre Georges-Francois LECLERCQ
Centre Leon Berard
CRLC Val d'Aurelle
Centre Hospitalier Universitaire
Hopital Tenon
Institut Bergonie


title: EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial

acronym: PSYCANCER

summary: The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System

summary:
Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB.

The four goals of this project are in the continuity of previous works team:

To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors.
To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction.
To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.

The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

intervention_type: Other


title: Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.

summary: The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital, Department of Endocrinology


title: RAPANK: Study of the Impact of Everolimus Treatment on the Development and Functions of Lymphocytes NK (Natural Killer), for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)

acronym: RAPANK

summary: NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Leon Berard
Centre Hospitalier Lyon Sud


title: A Clinico-biological Database of Lung Cancers

acronym: Bio-lung

summary:
This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.

Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.

lead_sponsor: University Hospital, Lille


title: Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient

acronym: RAPSODIE

summary:
This study is about the patients life ending and their caregiver, when a return to home is planned.

This is a behavioral sciences study (= interventional study for french law)


title: Atlas of Human Cognition by SEEG

acronym: MAPCOG-SEEG

summary: The main objective of MAPCOG_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution.

ReferenceCitation: Lachaux JP, Axmacher N, Mormann F, Halgren E, Crone NE. High-frequency neural activity and human cognition: past, present and possible future of intracranial EEG research. Prog Neurobiol. 2012 Sep;98(3):279-301. doi: 10.1016/j.pneurobio.2012.06.008. Epub 2012 Jun 26. Review.

ReferenceType: result

ReferenceCitation: Baciu M, Perrone-Bertolotti M. What do patients with epilepsy tell us about language dynamics? A review of fMRI studies. Rev Neurosci. 2015;26(3):323-41. doi: 10.1515/revneuro-2014-0074. Review.

family: Baciu

full_name: Monica Baciu

given: Monica

family: Perrone-Bertolotti

full_name: Marcela Perrone-Bertolotti

given: Marcela

journal_name: Reviews in the Neurosciences

publisher: Walter de Gruyter GmbH

publisher_dissemination: De Gruyter

publisher_group: De Gruyter

publisher_normalized: De Gruyter

ReferenceCitation: Combrisson E, Perrone-Bertolotti M, Soto JL, Alamian G, Kahane P, Lachaux JP, Guillot A, Jerbi K. From intentions to actions: Neural oscillations encode motor processes through phase, amplitude and phase-amplitude coupling. Neuroimage. 2017 Feb 15;147:473-487. doi: 10.1016/j.neuroimage.2016.11.042. Epub 2016 Nov 30.

family: Combrisson

full_name: Etienne Combrisson

given: Etienne

family: Soto

full_name: Juan LP Soto

given: Juan LP

family: Alamian

full_name: Golnoush Alamian

given: Golnoush

family: Kahane

full_name: Philippe Kahane

given: Philippe

family: Lachaux

full_name: Jean-Philippe Lachaux

given: Jean-Philippe

family: Guillot

full_name: Aymeric Guillot

given: Aymeric

family: Jerbi

full_name: Karim Jerbi

given: Karim

journal_name: NeuroImage

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Ossandón T, Vidal JR, Ciumas C, Jerbi K, Hamamé CM, Dalal SS, Bertrand O, Minotti L, Kahane P, Lachaux JP. Efficient "pop-out" visual search elicits sustained broadband γ activity in the dorsal attention network. J Neurosci. 2012 Mar 7;32(10):3414-21. doi: 10.1523/JNEUROSCI.6048-11.2012.

family: Ossandon

full_name: T. Ossandon

given: T.

family: Vidal

full_name: J. R. Vidal

given: J. R.

family: Ciumas

full_name: C. Ciumas

full_name: K. Jerbi

given: K.

family: Hamame

full_name: C. M. Hamame

given: C. M.

family: Dalal

full_name: S. S. Dalal

given: S. S.

family: Bertrand

full_name: O. Bertrand

family: Minotti

full_name: L. Minotti

title: Efficient "Pop-Out" Visual Search Elicits Sustained Broadband Gamma Activity in the Dorsal Attention Network

ReferenceCitation: Perrone-Bertolotti M, Vidal JR, de Palma L, Hamamé CM, Ossandon T, Kahane P, Minotti L, Bertrand O, Lachaux JP. Turning visual shapes into sounds: early stages of reading acquisition revealed in the ventral occipitotemporal cortex. Neuroimage. 2014 Apr 15;90:298-307. doi: 10.1016/j.neuroimage.2013.12.027. Epub 2013 Dec 24.

title: Turning visual shapes into sounds: Early stages of reading acquisition revealed in the ventral occipitotemporal cortex

ReferenceCitation: Perrone-Bertolotti M, Kujala J, Vidal JR, Hamame CM, Ossandon T, Bertrand O, Minotti L, Kahane P, Jerbi K, Lachaux JP. How silent is silent reading? Intracerebral evidence for top-down activation of temporal voice areas during reading. J Neurosci. 2012 Dec 5;32(49):17554-62. doi: 10.1523/JNEUROSCI.2982-12.2012.

title: How Silent Is Silent Reading? Intracerebral Evidence for Top-Down Activation of Temporal Voice Areas during Reading

location_facility:
CHU Rennes
University Hospital, Grenoble
CHRU Nancy


title: Clinical Interest of Endovascular Cooling in the Management of Cardiac Arrest: Impact on Mortality in a Randomized Medico-economical Trial (the ICEREA Study)

summary: According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest.

ReferenceCitation: Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63.

ReferenceCitation: Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. Erratum in: N Engl J Med 2002 May 30;346(22):1756.

ReferenceCitation: Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Böttiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21.

ReferenceCitation: International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47.

ReferenceCitation: Steinberg GK, Ogilvy CS, Shuer LM, Connolly ES Jr, Solomon RA, Lam A, Kassell NF, Baker CJ, Giannotta SL, Cockroft KM, Bell-Stephens TE, Allgren RL. Comparison of endovascular and surface cooling during unruptured cerebral aneurysm repair. Neurosurgery. 2004 Aug;55(2):307-14; discussion 314-5.

ReferenceCitation: Al-Senani FM, Graffagnino C, Grotta JC, Saiki R, Wood D, Chung W, Palmer G, Collins KA. A prospective, multicenter pilot study to evaluate the feasibility and safety of using the CoolGard System and Icy catheter following cardiac arrest. Resuscitation. 2004 Aug;62(2):143-50.

ReferenceCitation: Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santré C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19. Erratum in: Circulation. 2016 Feb 23;133(8):e418.

name: From Réanimation Médicale Toxicologique, CHU Lariboisière, AP-HP, Paris, France (N.D., B.M., F.J.B.); Réanimation Médicale, CHU Cochin, AP-HP, Paris, France (A.C., J.C., J.-P.M.); Réanimation Polyvalente, CHU Salengro, Lille, France (P.G., D.G.); Réanimation Médico-Chirurgicale, CHU Dupuytren, Limoges, France (N.P., B.F.); Réanimation Médicale, CHU Minjoz, Besançon, France (P.M.); Réanimation Médicale, CHU La Cavale Blanche, Brest, France (J.-M.T.); Réanimation Polyvalente, CHR, Orléans, France (T.B...

family: Deye

full_name: Nicolas Deye

given: Nicolas

family: Cariou

full_name: Alain Cariou

given: Alain

family: Girardie

full_name: Patrick Girardie

given: Patrick

family: Pichon

full_name: Nicolas Pichon

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Midez

full_name: Philippe Midez

family: Tonnelier

full_name: Jean-Marie Tonnelier

given: Jean-Marie

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Outin

full_name: Hervé Outin

given: Hervé

family: Delahaye

full_name: Arnaud Delahaye

given: Arnaud

family: Cravoisy

full_name: Aurélie Cravoisy

given: Aurélie

family: Mercat

full_name: Alain Mercat

family: Blanc

full_name: Pascal Blanc

given: Pascal

family: Santré

full_name: Charles Santré

given: Charles

family: Quintard

full_name: Hervé Quintard

family: Brivet

full_name: François Brivet

given: François

family: Charpentier

full_name: Julien Charpentier

given: Julien

family: Garrigue

full_name: Delphine Garrigue

given: Delphine

family: Francois

full_name: Bruno Francois

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Vincent

full_name: François Vincent

family: Gueugniaud

full_name: Pierre-Yves Gueugniaud

given: Pierre-Yves

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child

acronym: Exten Effivac

summary: The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.

lead_sponsor: University Hospital, Rouen

intervention_type: Biological


title: A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer

summary: The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients.

lead_sponsor: AB Science

location_country:
Singapore
United Kingdom
France

location_facility: Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc

location_facility: National Cancer Center, 11 Hospital Drive

location_facility: Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road


title: Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room (Standing, Dignified, Relaxed)

summary:
Ambulatory surgery is currently experiencing unprecedented growth and is becoming the standard of care compared to traditional hospitalization. Without mentioning the obvious financial gains, the benefits of ambulatory care essentially lie in optimised perioperative comfort. This comfort is due to a limited period of stay (< 12 hours) and to the proactive action of the care providers.

In this context, the optimization of the whole patient's journey during the perioperative period has been reviewed and adapted to personalized management within healthcare facilities. For more than a year now, multimodal approaches such as early rehabilitation have been undertaken, including

morning admission with an innovative principle of "3D" patient (standing, dignified, relaxed)
no premedication, wearing glasses and wigs,
Drinking on the morning of the intervention (2H before admission),
Walking to the block on foot (or in a wheelchair), return adapted to the wheelchair and no longer in a stretcher,
fast resumption of feeding.

Currently, in the investigator's various institutions, several modes of transport to the operating theatres coexist. The purpose of this observational study is to evaluate this optimization of perioperative management "3D mode", in particular the mode of transport.

The main objective is to determine the level of patient satisfaction with this management using a standardized quality questionnaire: the "EVAN" questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction. This questionnaire is already routinely conducted in many institutions. The EVAN questionnaire will be supplemented by questionnaires assessing the level of perioperative anxiety. They will be initiated into the anesthesia consultation, and finalized on the day of the surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Chu Montpellier - Saint-Eloi
Clinique Juge
Institut de cancerologie de Montpellier
CHU Nimes
Institut paoli Calmette


title: Characterization of Rhythmic Markers Associated With the Response to Antidepressants

acronym: R&B

summary: The study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

acronym: FERTILAM

summary:
Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.

This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.

time_perspective: Cross-Sectional


title: Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study

acronym: KTD Innov-2

summary: The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.

ipd_sharing: Yes

ipd_sharing_description:
eCRF

The collection of data on each person suitable for research is carried out through a coded database. This coded database will be extracted from the existing DIVAT database in each participating centre, and the variables specific to the KTD Innov study (patient identification number (centre number/patient number) for the study, inclusion/non-inclusion criteria, date of collection of the non-opposition, additional analyses, ...) will be added on specific tabs.

lead_sponsor: Nantes University Hospital

intervention_type: Diagnostic Test


title: Exploration of Variations in Leukocyte Morphological Parameters (MDW and CPD) Using the Beckman Coulter DxH900, Based on the Infectious Condition, Inflammatory State and Response to Corticosteroid Therapy in Septic Patients

acronym: MOCORSEP

summary: Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.

ReferenceCitation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

name: From Service de Médecine Intensive et Réanimation, Hôpital Raymond Poincaré, Garches (D.A., V.M.), Laboratory of Infection and Inflammation Unité 1173, University of Versailles Saint-Quentin-en-Yvelines, INSERM, Montigny-le-Bretonneux (D.A.), Service de Pharmacologie Clinique–Centre d’Investigation Clinique (CIC) INSERM 1414, Centre Hospitalier Universitaire (CHU) de Rennes–Université de Rennes 1, Hôpital Pontchaillou, Rennes (A.R., E.B.), Service de Réanimation Médicale (C.B.-B.) and Service...

family: Annane

full_name: Djillali Annane

given: Djillali

family: Renault

full_name: Alain Renault

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Megarbane

full_name: Bruno Megarbane

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Cariou

full_name: Alain Cariou

family: Forceville

full_name: Xavier Forceville

given: Xavier

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Martin

full_name: Claude Martin

given: Claude

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Misset

full_name: Benoît Misset

given: Benoît

family: Ali Benali

full_name: Mohamed Ali Benali

given: Mohamed

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Chimot

full_name: Loïc Chimot

given: Loïc

full_name: Claire Charpentier

given: Claire

family: François

full_name: Bruno François

family: Petitpas

full_name: Franck Petitpas

given: Franck

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

ReferenceCitation: Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. Erratum in: JAMA. 2008 Oct 8;300(14):1652. Chaumet-Riffaut, Philippe [corrected to Chaumet-Riffaud, Philippe].

ReferenceCitation: Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.

ReferenceCitation: Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.


title: Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Children With Sickle Cell Anemia ( DREPAGREFFE-2)

summary: The purpose of the present observational study is to remotely reevaluate the cohort of 67 sickle cell patients with transcranial Doppler-detected cerebral vasculopathy included in the national "Sickle Cell Transplant" protocol and whose 1- and 3-year results were published in JAMA (Journal of the American Medical Association) in 2019 and in BHJ in 2020.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis

summary: This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments.

primary_purpose: Basic Science


status: Active, not recruiting

lead_sponsor: UNICANCER

acronym: AcSé

type: EudraCT Number

source: euctr

title: Secured Access to Pembrolizumab for Patients With Selected Rare Cancer Types

summary: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of pembrolizumab monotherapy in 7 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available, in order to identify subsets of patients that may benefit from treatment


title: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

summary: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available.


title: Multicentric Randomized Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer in Elderly Unfit Patients According to Geriatric Evaluation

acronym: ELAN-UNFIT

summary: To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC. Efficacy assessed by failure free survival

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium

summary: The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.

ReferenceCitation: Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P; VA2914 Study Group. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab. 2007 Sep;92(9):3582-9. Epub 2007 Jun 19.

lead_sponsor: HRA Pharma

location_country: Belgium France

location_facility:
Saint Antoine Hospital
Sainte Rosalie Clinique
Antoine Beclere Hospital
Liege University Hospital


title: An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure/Dysport Alone or Restylane/Emervel Filler Alone

summary: The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

ReferenceCitation: Hedén P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid. J Drugs Dermatol. 2019 Jul 1;18(7):682-689.

lead_sponsor: Q-Med AB

location_country: Brazil Sweden France

location_facility: Brazilian Center for Studies in Dermatology


title: A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

acronym: FACTSEP

summary: The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in a cross-over design. This study is sponsored by academic French health institutions.

ReferenceCitation: Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD007280.

ReferenceCitation: Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. Review.

ReferenceCitation: Filippi M, Rocca MA, Colombo B, Falini A, Codella M, Scotti G, Comi G. Functional magnetic resonance imaging correlates of fatigue in multiple sclerosis. Neuroimage. 2002 Mar;15(3):559-67.

ReferenceCitation: Oken BS, Kishiyama S, Zajdel D, Bourdette D, Carlsen J, Haas M, Hugos C, Kraemer DF, Lawrence J, Mass M. Randomized controlled trial of yoga and exercise in multiple sclerosis. Neurology. 2004 Jun 8;62(11):2058-64.

ReferenceCitation: Pucci E, Branãs P, D'Amico R, Giuliani G, Solari A, Taus C. Amantadine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD002818. Review.

ReferenceCitation: Krupp LB, Coyle PK, Doscher C, Miller A, Cross AH, Jandorf L, Halper J, Johnson B, Morgante L, Grimson R. Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo. Neurology. 1995 Nov;45(11):1956-61.

ReferenceCitation: van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30.

ReferenceCitation: Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43.

ReferenceCitation: Tomassini V, Pozzilli C, Onesti E, Pasqualetti P, Marinelli F, Pisani A, Fieschi C. Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial. J Neurol Sci. 2004 Mar 15;218(1-2):103-8.

ReferenceCitation: Wingerchuk DM, Benarroch EE, O'Brien PC, Keegan BM, Lucchinetti CF, Noseworthy JH, Weinshenker BG, Rodriguez M. A randomized controlled crossover trial of aspirin for fatigue in multiple sclerosis. Neurology. 2005 Apr 12;64(7):1267-9.

ReferenceCitation: Lebrun C, Alchaar H, Candito M, Bourg V, Chatel M. Levocarnitine administration in multiple sclerosis patients with immunosuppressive therapy-induced fatigue. Mult Scler. 2006 Jun;12(3):321-4.

ReferenceCitation: Pittion-Vouyovitch S, Debouverie M, Guillemin F, Vandenberghe N, Anxionnat R, Vespignani H. Fatigue in multiple sclerosis is related to disability, depression and quality of life. J Neurol Sci. 2006 Apr 15;243(1-2):39-45. Epub 2006 Jan 24.

ReferenceCitation: Debouverie M, Pittion S. [Fatigue and episodic exhaustion as a feature of multiple sclerosis]. Rev Neurol (Paris). 2006 Mar;162(3):295-7. French.

ReferenceCitation: Richardson BA, Flack VF. The analysis of incomplete data in the three-period two-treatment cross-over design for clinical trials. Stat Med. 1996 Jan 30;15(2):127-43.

ReferenceCitation: GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80.

ReferenceCitation: Kieser M, Friede T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Stat Med. 2000 Apr 15;19(7):901-11.

ReferenceCitation: Graziano F, Bisonni R, Catalano V, Silva R, Rovidati S, Mencarini E, Ferraro B, Canestrari F, Baldelli AM, De Gaetano A, Giordani P, Testa E, Lai V. Potential role of levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in non-anaemic cancer patients. Br J Cancer. 2002 Jun 17;86(12):1854-7.

ReferenceCitation: Plioplys AV, Plioplys S. Amantadine and L-carnitine treatment of Chronic Fatigue Syndrome. Neuropsychobiology. 1997;35(1):16-23.

ReferenceCitation: Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32.

ReferenceCitation: Montel SR, Bungener C. Coping and quality of life in one hundred and thirty five subjects with multiple sclerosis. Mult Scler. 2007 Apr;13(3):393-401. Epub 2007 Jan 29.

ReferenceCitation: Cruciani RA, Dvorkin E, Homel P, Malamud S, Culliney B, Lapin J, Portenoy RK, Esteban-Cruciani N. Safety, tolerability and symptom outcomes associated with L-carnitine supplementation in patients with cancer, fatigue, and carnitine deficiency: a phase I/II study. J Pain Symptom Manage. 2006 Dec;32(6):551-9.

ReferenceCitation: Gramignano G, Lusso MR, Madeddu C, Massa E, Serpe R, Deiana L, Lamonica G, Dessì M, Spiga C, Astara G, Macciò A, Mantovani G. Efficacy of l-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition. 2006 Feb;22(2):136-45.

ReferenceCitation: Neri S, Pistone G, Saraceno B, Pennisi G, Luca S, Malaguarnera M. L-carnitine decreases severity and type of fatigue induced by interferon-alpha in the treatment of patients with hepatitis C. Neuropsychobiology. 2003;47(2):94-7.

ReferenceCitation: Rebouche CJ. Kinetics, pharmacokinetics, and regulation of L-carnitine and acetyl-L-carnitine metabolism. Ann N Y Acad Sci. 2004 Nov;1033:30-41. Review.

ReferenceCitation: Plioplys AV, Plioplys S. Serum levels of carnitine in chronic fatigue syndrome: clinical correlates. Neuropsychobiology. 1995;32(3):132-8.

ReferenceCitation: Cruciani RA, Dvorkin E, Homel P, Culliney B, Malamud S, Shaiova L, Fleishman S, Lapin J, Klein E, Lesage P, Portenoy R, Esteban-Cruciani N. L-carnitine supplementation for the treatment of fatigue and depressed mood in cancer patients with carnitine deficiency: a preliminary analysis. Ann N Y Acad Sci. 2004 Nov;1033:168-76.

ReferenceCitation: Taglialatela G, Navarra D, Cruciani R, Ramacci MT, Alemà GS, Angelucci L. Acetyl-L-carnitine treatment increases nerve growth factor levels and choline acetyltransferase activity in the central nervous system of aged rats. Exp Gerontol. 1994 Jan-Feb;29(1):55-66.

lead_sponsor: University Hospital, Bordeaux

location_facility:
University Hospital, Hospital Laënnec
University Hospital, Hospital Central
University Hospital, Hospital Pellegrin
University Hospital
University Hospital, Hospital Pasteur
University Hospital, Hospital Dupuytren


title: Ill-health Related Jobloss

acronym: jobloss

summary: The current study aimed to estimate the one-year incidence of unfitness for the job in an occupational health service, and to describe their aetiology and the characteristics of the unfit employees

time_perspective: Retrospective

ipd_sharing_description: NC


title: Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status

summary: Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.

ReferenceCitation: Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duché P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.

name: Université Droit et Santé Lille 2, EA 4488 “Activité Physique, Muscle, Santé”, Faculté des Sciences du Sport et de l'Education Physique, 59790 Ronchin, France.

family: Aucouturier

full_name: Julien Aucouturier

given: Julien

name: Laboratoire Universitaire de Biologie des Activités Physiques et Sportives (BAPS), Université Blaise Pascal, Clermont-Ferrand, Bâtiment de Biologie B, Campus Universitaire des Cézeaux, 63177 Aubière Cedex, France; INRA, UMR 1019, UNH, CRNH Auvergne, F-63000 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, Unité de Nutrition Humaine, BP 10448, F-63000 Clermont-Ferrand, France.

family: Thivel

full_name: David Thivel

given: David

name: Laboratoire Universitaire de Biologie des Activités Physiques et Sportives (BAPS), Université Blaise Pascal, Clermont-Ferrand, Bâtiment de Biologie B, Campus Universitaire des Cézeaux, 63177 Aubière Cedex, France.

family: Isacco

full_name: Laurie Isacco

given: Laurie

name: INRA, UMR 1019, UNH, CRNH Auvergne, F-63000 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, Unité de Nutrition Humaine, BP 10448, F-63000 Clermont-Ferrand, France; CHU Clermont-Ferrand, Service de Médecine du Sport et des Explorations Fonctionnelles, F-63003 Clermont-Ferrand, France.

family: Fellmann

full_name: Nicole Fellmann

given: Nicole

family: Chardigny

full_name: Jean-Michel Chardigny

family: Duclos

full_name: Martine Duclos

given: Martine

family: Duché

full_name: Pascale Duché

given: Pascale

bso_classification: Biology (fond.)

journal_name: Applied Physiology, Nutrition, and Metabolism

publisher: Canadian Science Publishing

publisher_dissemination: Canadian Science Publishing

publisher_group: Canadian Science Publishing

publisher_normalized: Canadian Science Publishing

ReferenceCitation: Thivel D, Isacco L, Montaurier C, Boirie Y, Duché P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.

family: Montaurier

full_name: Christophe Montaurier

given: Christophe

family: Boirie

full_name: Yves Boirie

given: Yves

family: Morio

full_name: Béatrice Morio

given: Béatrice

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

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

repository_normalized: HAL

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

title: The 24-h Energy Intake of Obese Adolescents Is Spontaneously Reduced after Intensive Exercise: A Randomized Controlled Trial in Calorimetric Chambers

ReferenceCitation: Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duché P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.


acronym: SONAR

summary: The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

lead_sponsor: United Pharmaceuticals

location_facility:
Universitair Ziekenhuis
Pediatricians

intervention_type: Dietary Supplement


title: Mechanism of DCs Dysfunction in Chronic HBV Infection

acronym: HepatoDC

summary: This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms by which the immune response is altered by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity


title: Access to Care and Prognosis in Elderly Cancer Patients: Analysis of Determinants Using Data From Cancer Registries and Cohort Studies in Gironde, French Department

summary: The growing incidence of cancer associated to an aging population represents an epidemiologic reality that requires questioning access to care and prognosis in elderly with cancer, for which disparities have been highlighted. However, generally speaking, studies are limited in that they overlook geriatric-specific factors. The aim of this work was to study sociodemographic, socioeconomic and clinical determinants of access to care (cancer stage, cancer treatment) and prognosis (functional decline, survival) in elderly cancer patients.

ReferenceCitation: Galvin A, Helmer C, Coureau G, Amadeo B, Joly P, Sabathé C, Monnereau A, Baldi I, Rainfray M, Soubeyran P, Delva F, Mathoulin-Pélissier S. Determinants of cancer treatment and mortality in older cancer patients using a multi-state model: Results from a population-based study (the INCAPAC study). Cancer Epidemiol. 2018 Aug;55:39-44. doi: 10.1016/j.canep.2018.04.013. Epub 2018 May 25.

family: Galvin

full_name: Angéline Galvin

given: Angéline

family: Helmer

full_name: Catherine Helmer

given: Catherine

family: Coureau

full_name: Gaëlle Coureau

given: Gaëlle

family: Amadeo

full_name: Brice Amadeo

given: Brice

family: Joly

full_name: Pierre Joly

given: Pierre

family: Sabathé

full_name: Camille Sabathé

given: Camille

family: Monnereau

full_name: Alain Monnereau

given: Alain

family: Baldi

full_name: Isabelle Baldi

given: Isabelle

family: Rainfray

full_name: Muriel Rainfray

given: Muriel

family: Soubeyran

full_name: Pierre Soubeyran

family: Delva

full_name: Fleur Delva

given: Fleur

family: Mathoulin-Pélissier

full_name: Simone Mathoulin-Pélissier

given: Simone

journal_name: Cancer Epidemiology

ReferenceCitation: Galvin A, Delva F, Helmer C, Rainfray M, Bellera C, Rondeau V, Soubeyran P, Coureau G, Mathoulin-Pélissier S. Sociodemographic, socioeconomic, and clinical determinants of survival in patients with cancer: A systematic review of the literature focused on the elderly. J Geriatr Oncol. 2018 Jan;9(1):6-14. doi: 10.1016/j.jgo.2017.07.007. Epub 2017 Oct 10.

family: Bellera

full_name: Carine Bellera

given: Carine

family: Rondeau

full_name: Virginie Rondeau

given: Virginie


title: A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)

acronym: SID-ADHD

summary:
Context: Attention Deficit Hyperactivity Disorder (ADHD), a major public health issue, is a neurodevelopmental disorder characterized by disturbance of attention, pathological impulsivity and a variable level of psychomotor hyperactivity. In addition to medium-term repercussions such as school failure or family dysfunction, these children have difficulties in dealing with emotions, metacognition and self-awareness that have serious consequences for self-regulation and identity construction.

Objective: To investigate identity building in children with ADHD and explore its links with the severity of the disorder and associated neuropsychological disturbances.

Material and method: 20 childrens with ADHD and 20 controls will be recruited over a 24-month period. They will be administered the Damon and Hart's Self-Understanding Interview, exploring 7 identity domains: Physical, Active, Social, Psychological, Continuity, Agentivity, Distinction Self/Other. The severity of ADHD, neuropsychological functioning (attention, working memory, executive functions, long-term memory), self-esteem and internal/external attributive style (locus of control) will be assessed by validated scales. The overall level of identity development and in each dimension will be compared between patients and controls. Within patients, the correlations between level of identity development and the severity of ADHD will be explored, as well as with neuropsychological functioning, with statistical control of age.

Assumptions: The investigators hypothesize that children with ADHD will exhibit a significantly lower level of identity development than controls, which will be positively correlated with neuropsychological functioning, and negatively correlated with the severity of ADHD.

lead_sponsor: University Hospital, Caen


title: Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers

summary: Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

ReferenceCitation: Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Viéitez JM, Alonso V, Grávalos C, Escudero P, Vera R, Aranda E, García-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, López-Ladrón A, Díaz-Rubio E. Role of circulating tumor cells as prognostic marker in resected stage III colorectal cancer. Ann Oncol. 2015 Mar;26(3):535-41. doi: 10.1093/annonc/mdu568. Epub 2014 Dec 15.

family: Sotelo

full_name: M.J. Sotelo

family: Sastre

full_name: J. Sastre

given: J.

family: Maestro

full_name: M.L. Maestro

family: Veganzones

full_name: S. Veganzones

given: S.

family: Viéitez

full_name: J.M. Viéitez

family: Alonso

full_name: V. Alonso

given: V.

family: Grávalos

full_name: C. Grávalos

given: C.

family: Escudero

full_name: P. Escudero

given: P.

family: Vera

full_name: R. Vera

given: R.

family: Aranda

full_name: E. Aranda

given: E.

family: García-Alfonso

full_name: P. García-Alfonso

family: Gallego-Plazas

full_name: J. Gallego-Plazas

family: Lopez

full_name: C. Lopez

family: Pericay

full_name: C. Pericay

family: Arrivi

full_name: A. Arrivi

given: A.

family: Vicente

full_name: P. Vicente

family: Ballesteros

full_name: P. Ballesteros

family: Elez

full_name: E. Elez

family: López-Ladrón

full_name: A. López-Ladrón

family: Díaz-Rubio

full_name: E. Díaz-Rubio

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Hodgkinson CL, Morrow CJ, Li Y, Metcalf RL, Rothwell DG, Trapani F, Polanski R, Burt DJ, Simpson KL, Morris K, Pepper SD, Nonaka D, Greystoke A, Kelly P, Bola B, Krebs MG, Antonello J, Ayub M, Faulkner S, Priest L, Carter L, Tate C, Miller CJ, Blackhall F, Brady G, Dive C. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer. Nat Med. 2014 Aug;20(8):897-903. doi: 10.1038/nm.3600. Epub 2014 Jun 1.

ReferenceCitation: Yu M, Bardia A, Aceto N, Bersani F, Madden MW, Donaldson MC, Desai R, Zhu H, Comaills V, Zheng Z, Wittner BS, Stojanov P, Brachtel E, Sgroi D, Kapur R, Shioda T, Ting DT, Ramaswamy S, Getz G, Iafrate AJ, Benes C, Toner M, Maheswaran S, Haber DA. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014 Jul 11;345(6193):216-20. doi: 10.1126/science.1253533.

name: Massachusetts General Hospital Cancer Center, Harvard Medical School, Charlestown, MA 02129, USA.

name: Howard Hughes Medical Institute, Chevy Chase, MD 20815, USA.

name: Department of Medicine, Harvard Medical School, Charlestown, MA 02129, USA.

name: Department of Pathology, Harvard Medical School, Charlestown, MA 02129, USA.

name: Department of Medical Epidemiology and Biostatistics, Karolinska Insitutet, Stockholm, Sweden.

name: Broad Institute of Harvard and MIT, Cambridge, MA 02142, USA.

name: Center for Bioengineering in Medicine, Harvard Medical School, Charlestown, MA 02129, USA.

name: Department of Surgery, Harvard Medical School, Charlestown, MA 02129, USA.

repository_institution: University of Turin - Institutional Research Information System University of Turin

publisher: American Association for the Advancement of Science (AAAS)

ReferenceCitation: Khoo BL, Lee SC, Kumar P, Tan TZ, Warkiani ME, Ow SG, Nandi S, Lim CT, Thiery JP. Short-term expansion of breast circulating cancer cells predicts response to anti-cancer therapy. Oncotarget. 2015 Jun 20;6(17):15578-93.


title: Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

acronym: ALPHAPOOL

summary: Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.

ReferenceCitation: Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galactéros F, Baudin-Creuza V. Evaluation of the free α-hemoglobin pool in red blood cells: a new test providing a scale of β-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Research and Analysis of the Mechanisms Involved in the Emergence of Breast Cancer Stem Cells

summary:
From a cellular perspective, breast cancers appear to develop hierarchically from a small contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus, these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the proportion of CSCs before any treatment is correlated with chemoresistance and that a resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known.

The Oscar Lambret Center proposes a monocentric prospective interventional study based on the cellular and molecular analysis of the tumor, serum and circulating cells, before, during and at the end of the treatment for each patient receiving a neoadjuvant chemotherapy for breast cancer. The identification of the mechanisms contributing to the enrichment of CSCs resistant to chemotherapy could lead to therapeutic solutions.

lead_sponsor: Centre Oscar Lambret


title: Impact of Speed Of Rewarming After CaRdiac Arrest and ThErapeutic Hypothermia. A Randomized Controlled Pilot Study

acronym: ISOCRATE

summary: Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm and successfully resuscitated.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke

acronym: NETs

summary: The purpose of the study was to investigate the correlation between the nucleosome concentration and the rate of recanalization after thrombolysis. All patients were admitted to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke care. The investigators included all patients treated or not by intravenous thrombolysis for anterior circulation stroke with or without vessel occlusion. Exclusion criteria were neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and stroke-specifics symptoms that had started earlier than 4.5 hours before admission.

ReferenceCitation: Holdenrieder S, Stieber P, Bodenmüller H, Fertig G, Fürst H, Schmeller N, Untch M, Seidel D. Nucleosomes in serum as a marker for cell death. Clin Chem Lab Med. 2001 Jul;39(7):596-605.

ReferenceCitation: Holdenrieder S, Stieber P, Chan LY, Geiger S, Kremer A, Nagel D, Lo YM. Cell-free DNA in serum and plasma: comparison of ELISA and quantitative PCR. Clin Chem. 2005 Aug;51(8):1544-6.

ReferenceCitation: Naggara O, Raymond J, Domingo Ayllon M, Al-Shareef F, Touzé E, Chenoufi M, Gerber S, Mellerio C, Zuber M, Meder JF, Mas JL, Oppenheim C. T2* "susceptibility vessel sign" demonstrates clot location and length in acute ischemic stroke. PLoS One. 2013 Oct 11;8(10):e76727. doi: 10.1371/journal.pone.0076727. eCollection 2013.

lead_sponsor: Centre Hospitalier St Anne


title: Decrease of Exposure to Hypnosedative Drugs in the Elderly Through the Discontinuation of Hospital-initiated Prescription: Impact on the Quality of Sleep and Fall Frequency

acronym: HYPAGE

summary:
Brief Summary

Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce sleep disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a hospital stay. These hospital-induced sleep disorders should spontaneously disappear after discharge and, because of their potential impact on falls, hip fractures, psychiatric side effects and induced dependence, hypnosedative drugs should therefore be discontinued at discharge in these naïve-treated patients. Adhesion to this recommendation is poor. Recent and on-going research on this topic mostly concerns adverse effects although these are already substantially documented and evidence-based, while there is a poor interest on developing research on potential strategies susceptible to practically improve the current adhesion to recommendations.

Design and objectives. This project proposes multi-component intervention and is directed towards hospital prescribers, patients, and their general practitioner. It aims at discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during hospitalization in naïve-treated elderly (age≥65) patients. The value of the intervention, as compared to usual care management, will be estimated in a multicentre (6 hospitals gathering 8 centres: 5 internal medicine departments, 3 cardiology departments) randomised, cross-over, two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4 hospitals will gather only 1 centre (4x1 centres). An equilibrated randomization will be applied to the 8 centres, making sure that, in hospitals gathering 2 centres, these 2 centres will apply the same strategy in a given period and that the 2 hospitals will apply alternative strategies. This randomisation is set up to avoid the risk of a potential contamination between the 2 strategies from one centre to the other within the same hospital. As a result, 3 hospitals (including 4 medical departments) will apply the intervention during the first 11-month period, while the 3 others (including 4 medical departments) will apply usual care during this period, as a result of an equilibrated hospitals randomization. During the second 11-month period, each hospital will apply the alternative management. The two periods will be separated by a 1-month wash-out period.

In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group and 120 in the usual care group).

Patient follow-up duration will be 12 months after discharge. Patient status in regards with quality of sleep (study primary objective), hypnosedative consumption and frequency of falls (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after discharge.

Expected results. The results of the study should contribute to guide research and public decisions to practically decrease hypnosedative prescription and consumption, and associated adverse events.

primary_purpose: Health Services Research

location_facility: Assistance Publique Hopitaux de Paris - Hopital Saint Antoine


title: Associative Memory in ASD Without Mental Retardation : Study in EEG and Neuropsychology

acronym: MEM-TA

summary: The aim of this study is to investigate the neural substrates of associative memory in Autism Spectrum Disorder using both behavioural and EEG assessments.


title: Sentinel Patients : Value of an Information System Collecting Patient's Own Report on His Healthcare Management. Application to the Detection of Adverse Events After Hospital Discharge.

acronym: SENTIPAT

summary:
"Evolution of patient's health after hospital discharge is poorly documented. The investigators hypothesize that information of good quality on this concern might be accessible at a relatively low cost from patients, further referred to as sentinel patients, who would voluntary report their health evolution on a dedicated web site.

The SENTIPAT study presents as a proof of concept study. It will collect patient's health evolution during a post-hospital discharge period of 45 days. The study presents as a randomized trial comparing patients' reports issued from two different methods in a patient population returning home after hospital discharge and having at disposal an internet access at home:

in the " internet " arm, sentinel patients will be solicited to directly report their post-discharge health evolution on a website especially devoted for collecting these data while in the " telephone " arm, the same items will be collected through a telephone interview 45 days after hospital discharge. Investigations will focus on post-discharge adverse events and will include appearance/worsening of symptoms, healthcare resources utilization, quality of life, and patients' satisfaction."

ReferenceCitation: Feldman SF, Lapidus N, Cosnes J, Tiret E, Fonquernie L, Cabane J, Chazouilleres O, Surgers L, Beaussier M, Valleron AJ, Carrat F, Hejblum G. Comparing Inpatient Satisfaction Collected via a Web-Based Questionnaire Self-Completion and Through a Telephone Interview: An Ancillary Study of the SENTIPAT Randomized Controlled Trial. J Med Internet Res. 2017 Aug 23;19(8):e293. doi: 10.2196/jmir.7061.

family: Feldman

full_name: Sarah F Feldman

given: Sarah F

family: Lapidus

full_name: Nathanael Lapidus

given: Nathanael

family: Cosnes

full_name: Jacques Cosnes

given: Jacques

family: Tiret

full_name: Emmanuel Tiret

given: Emmanuel

family: Fonquernie

full_name: Laurent Fonquernie

given: Laurent

family: Cabane

full_name: Jean Cabane

given: Jean

family: Chazouilleres

full_name: Olivier Chazouilleres

given: Olivier

family: Surgers

full_name: Laure Surgers

given: Laure

family: Beaussier

full_name: Marc Beaussier

given: Marc

family: Valleron

full_name: Alain-Jacques Valleron

given: Alain-Jacques

family: Carrat

full_name: Fabrice Carrat

given: Fabrice

family: Hejblum

full_name: Gilles Hejblum

given: Gilles

journal_name: Journal of Medical Internet Research

endpoint_id: HAL

repository_institution: HAL

version: submittedVersion

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

ReferenceCitation: Couturier B, Carrat F, Hejblum G; SENTIPAT Study Group. Comparing Patients' Opinions on the Hospital Discharge Process Collected With a Self-Reported Questionnaire Completed Via the Internet or Through a Telephone Survey: An Ancillary Study of the SENTIPAT Randomized Controlled Trial. J Med Internet Res. 2015 Jun 24;17(6):e158. doi: 10.2196/jmir.4379.

title: Comparing Patients’ Opinions on the Hospital Discharge Process Collected With a Self-Reported Questionnaire Completed Via the Internet or Through a Telephone Survey: An Ancillary Study of the SENTIPAT Randomized Controlled Trial


title: Immune Biomarkers of Residual Beta-cell Mass in Type 1 Diabetes

acronym: IMMADIAB

summary:
There is currently no imaging technique allowing to directly visualize and measure pancreatic beta-cell mass. Consequently, the best parameter to estimate this mass is the insulin (and its C-peptide byproduct) that residual beta cells are able to produce. This insulin secretion is measured during a meal test, before and at different times after drinking a standardized quantity of nutrients. However, this test is cumbersome (lasting 3 h, with blood samples taken every 30 minutes) and it holds poor sensitivity, probably insufficient to detect very few residual beta cells. Nevertheless, these few residual cells can improve glycemic control and can be instrumental for the clinical efficacy of immune and/or regenerative therapies.

We hypothesize that residual beta cells may not only represent the remaining insulin secretory capacity, but also the antigenic load capable of stimulating beta-cell-reactive T lymphocytes. The disappearance of these T lymphocytes from circulating blood over time may thus be correlated with beta-cell loss. Measuring beta-cell-reactive T-cell responses may therefore provide simple and sensitive immune surrogate markers of residual insulin secretion. Other surrogate markers may be obtained by measuring urinary C peptide or residual secretion of the counter-regulatory hormone glucagon.

The main objectives of this study are:

To evaluate the correlation between beta-cell-reactive T-cell responses and residual insulin secretion.
To evaluate the correlation between the residual insulin secretion measured by serum C peptide and by urinary C peptide.
To evaluate the correlation between the residual insulin and glucagon secretion.

ReferenceCitation: Scotto M, Afonso G, Østerbye T, Larger E, Luce S, Raverdy C, Novelli G, Bruno G, Gonfroy-Leymarie C, Launay O, Lemonnier FA, Buus S, Carel JC, Boitard C, Mallone R. HLA-B7-restricted islet epitopes are differentially recognized in type 1 diabetic children and adults and form weak peptide-HLA complexes. Diabetes. 2012 Oct;61(10):2546-55.

ReferenceCitation: Culina S, Mallone R. Immune biomarkers in immunotherapeutic trials for type 1 diabetes: cui prodest? Diabetes Metab. 2012 Nov;38(5):379-85. doi: 10.1016/j.diabet.2012.05.005. Epub 2012 Jul 31. Review.

ReferenceCitation: Scotto M, Afonso G, Larger E, Raverdy C, Lemonnier FA, Carel JC, Dubois-Laforgue D, Baz B, Levy D, Gautier JF, Launay O, Bruno G, Boitard C, Sechi LA, Hutton JC, Davidson HW, Mallone R. Zinc transporter (ZnT)8(186-194) is an immunodominant CD8+ T cell epitope in HLA-A2+ type 1 diabetic patients. Diabetologia. 2012 Jul;55(7):2026-31. doi: 10.1007/s00125-012-2543-z. Epub 2012 Apr 20.

ReferenceCitation: Martinuzzi E, Afonso G, Gagnerault MC, Naselli G, Mittag D, Combadière B, Boitard C, Chaput N, Zitvogel L, Harrison LC, Mallone R. acDCs enhance human antigen-specific T-cell responses. Blood. 2011 Aug 25;118(8):2128-37. doi: 10.1182/blood-2010-12-326231. Epub 2011 Jun 28.

ReferenceCitation: Brezar V, Carel JC, Boitard C, Mallone R. Beyond the hormone: insulin as an autoimmune target in type 1 diabetes. Endocr Rev. 2011 Oct;32(5):623-69. doi: 10.1210/er.2011-0010. Epub 2011 Jun 23. Review.

location_facility: INSERM U1016 - DeAR Lab Avenir, Hôpital Cochin


title: Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

acronym: EDEX

summary: The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.


title: Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma

summary: MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until now, lack of specific markers of the disease has not allowed efficient specific molecular targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to confirm that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential therapeutic target of MM. Targeting Bcl-2 family member's is a promising strategy for the treatment of hematopoietic malignancies. In this context, specific targeting of Bcl-B could improve the treatment of patients suffering MM. Of note, this could be achieved by converting the antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of small mimetic peptides derived from Nur77 one of its interactors.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service de Médecine interne et cancérologie - Hôpital de l'Archet


title: Comparison of 3 Learning Methods and Their Underlying Mechanisms to Improve Independent Living in the Activities of Daily Living in Alzheimer's Dementia: a Randomized Controlled Trial

summary:
This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe dementia.

Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions for 6 weeks.

This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:

it will determine which of the of the three learning techniques (EL, MR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
as a secondary objective, it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.

lead_sponsor: Department of Clinical Research and Innovation


title: Impact of the Diet Fertility : A Case-control Multicentric Study

acronym: ALIFERT

summary: This case-control multicentric study involving fertile and infertile couples aims at evaluating the impact on conception rate of nutritional parameters (biologic, clinic, anthropometric, and food questionnaire).

ReferenceCitation: Talla P, Faure C, Rigourd V, Czernichow S, Sermondade N, Lévy R, Dupont C; ALIFERT collaborative group. Is There an Association of Being Breastfed as an Infant and Fertility Status as an Adult? Breastfeed Med. 2021 May;16(5):414-418. doi: 10.1089/bfm.2020.0130. Epub 2021 Mar 30.

name: Sorbonne Université, Saint Antoine Research Center, INSERM Équipe Lipodystrophies Génétiques et Acquises US938, Service de Biologie de la Reproduction-CECOS, AP-H, Hôpital Tenon, Paris, France.

family: Talla

full_name: Perrine Talla

given: Perrine

family: Faure

full_name: Céline Faure

given: Céline

name: Service de Néonatalogie, Hôpital Necker Enfants Malades, Paris, France.

name: Banque de Lait, Ile de France, Hôpital Necker Enfants Malades, Paris, France.

family: Rigourd

full_name: Virginie Rigourd

given: Virginie

name: Université Paris Descartes, Paris, France.

name: APHP, Service de Nutrition, Hôpital Européen Georges-Pompidou, Paris, France.

family: Czernichow

full_name: Sébastien Czernichow

given: Sébastien

family: Sermondade

full_name: Nathalie Sermondade

given: Nathalie

family: Lévy

full_name: Rachel Lévy

given: Rachel

family: Dupont

full_name: Charlotte Dupont

given: Charlotte

family: Aknin

full_name: Isabelle Aknin

given: Isabelle

family: Cedrin-Durnerin

full_name: Isabelle Cedrin-Durnerin

family: Cens

full_name: Steven Cens

given: Steven

family: Hercberg

full_name: Serge Hercberg

given: Serge

family: Uthurriague

full_name: Claude Uthurriague

given: Claude

family: Wolf

full_name: Jean-Philippe Wolf

given: Jean-Philippe

journal_name: Breastfeeding Medicine

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: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

ReferenceCitation: Dupont C, Hulot A, Jaffrezic F, Faure C, Czernichow S, di Clemente N, Racine C, Chavatte-Palmer P, Lévy R; Alifert group. Female ponderal index at birth and idiopathic infertility. J Dev Orig Health Dis. 2020 Apr;11(2):154-158. doi: 10.1017/S2040174419000394. Epub 2019 Jul 16.

family: Hulot

full_name: Audrey Hulot

given: Audrey

family: Jaffrezic

full_name: Florence Jaffrezic

given: Florence

journal_name: Journal of Developmental Origins of Health and Disease

ReferenceCitation: Dupont C, Faure C, Daoud F, Gautier B, Czernichow S, Lévy R; ALIFERT collaborative group. Metabolic syndrome and smoking are independent risk factors of male idiopathic infertility. Basic Clin Androl. 2019 Jul 1;29:9. doi: 10.1186/s12610-019-0090-x. eCollection 2019.

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

ReferenceCitation: Faure C, Dupont C, Chavatte-Palmer P, Gautier B, Levy R; ALIFERT Collaborative Group. Are semen parameters related to birth weight? Fertil Steril. 2015 Jan;103(1):6-10. doi: 10.1016/j.fertnstert.2014.11.027.

ReferenceCitation: Faure C, Leveille P, Dupont C, Julia C, Chavatte-Palmer P; Alifert Group, Sutton A, Levy R. Are superoxide dismutase 2 and nitric oxide synthase polymorphisms associated with idiopathic infertility? Antioxid Redox Signal. 2014 Aug 1;21(4):565-9. doi: 10.1089/ars.2014.5831. Epub 2014 Feb 25.

name: Service d'Histologie-Embryologie-Cytogénétique-CECOS, Hôpital Jean Verdier, AP-HP, Bondy, France.

name: UREN (Unité de Recherche en Epidémiologie Nutritionnelle), Inserm (U557), Inra (U1125), Cnam; UFR SMBH, Université Paris 13, Sorbonne Paris Cité, Bobigny, France.

name: INRA, UMR1198 Biologie du Développement et Reproduction, Jouy-en-Josas, France.

name: Département de Santé Publique, Hôpital Avicenne, AP-HP, Bobigny, France.

name: Service de Biochimie, Hôpital Jean-Verdier, AP-HP, Bondy, France.

name: INSERM U1148, UFR SMBH, Université Paris 13, Sorbonne Paris Cité, Bobigny, France.

title: Are Superoxide Dismutase 2 and Nitric Oxide Synthase Polymorphisms Associated with Idiopathic Infertility?

location_facility: Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS


type: Registry Identifier

title: Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan

acronym: BOSAS

summary:
The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.

lead_sponsor: University Hospital, Grenoble


title: FORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia Gravis

acronym: FORCE

summary: The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis (MG) is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. Corticosteroids and other immunosuppressive therapies presented also many side effects. We propose to evaluate in a pilot, open, prospective, multicentric, phase II study, the interest of rituximab in the treatment of patients with primary IM associated with specific AAb (anti-synthetase and anti-SRP AAbs), or MG (with anti-AchR AAbs), refractory to conventional therapies. Twenty fourth patients with primary IM (12 with anti-synthetase, 12 with anti-SRP AAbs), and 12 with MG will be included in the study.

ReferenceCitation: Allenbach Y, Guiguet M, Rigolet A, Marie I, Hachulla E, Drouot L, Jouen F, Jacquot S, Mariampillai K, Musset L, Grenier P, Devilliers H, Hij A, Boyer O, Herson S, Benveniste O. Efficacy of Rituximab in Refractory Inflammatory Myopathies Associated with Anti- Synthetase Auto-Antibodies: An Open-Label, Phase II Trial. PLoS One. 2015 Nov 5;10(11):e0133702. doi: 10.1371/journal.pone.0133702. eCollection 2015.

family: Allenbach

full_name: Yves Allenbach

given: Yves

family: Guiguet

full_name: Marguerite Guiguet

given: Marguerite

family: Rigolet

full_name: Aude Rigolet

given: Aude

family: Marie

full_name: Isabelle Marie

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Drouot

full_name: Laurent Drouot

given: Laurent

family: Jouen

full_name: Fabienne Jouen

given: Fabienne

family: Jacquot

full_name: Serge Jacquot

family: Mariampillai

full_name: Kuberaka Mariampillai

given: Kuberaka

family: Musset

full_name: Lucile Musset

given: Lucile

family: Grenier

full_name: Philippe Grenier

given: Philippe

family: Devilliers

full_name: Herve Devilliers

given: Herve

family: Hij

full_name: Adrian Hij

given: Adrian

family: Boyer

full_name: Olivier Boyer

given: Olivier

family: Herson

full_name: Serge Herson

family: Benveniste

full_name: Olivier Benveniste

journal_name: PLOS ONE

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

location_facility: Service de Médecine Interne 1 / Groupe Hospitalier Pitié-Salpêtrière


title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

summary: The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression

summary: The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on hyperfunctional cerebral areas should be more effective in treating depressive symptoms than stimulations not taking into account the functional specificity of the patient. The goal was to compare the effects of "guided" TMS, using neuroimaging to guide TMS on dysfunctional cortical regions individually detected by neuroimaging, with "standard TMS", as used in most studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant depression.

location_facility: Albert Chenevier Hospital, Department of psychiatry


title: Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery

acronym: RestriMIS

summary:
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.

The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).

The primary endpoint will be he occurrence of restrictive lung disease , objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).

ReferenceCitation: Bastard F, Bonnard A, Rousseau V, Gelas T, Michaud L, Irtan S, Piolat C, Ranke-Chrétien A, Becmeur F, Dariel A, Lamireau T, Petit T, Fouquet V, Le Mandat A, Lefebvre F, Allal H, Borgnon J, Boubnova J, Habonimana E, Panait N, Buisson P, Margaryan M, Michel JL, Gaudin J, Lardy H, Auber F, Borderon C, De Vries P, Jaby O, Fourcade L, Lecompte JF, Tolg C, Delorme B, Schmitt F, Podevin G. Thoracic skeletal anomalies following surgical treatment of esophageal atresia. Lessons from a national cohort. J Pediatr Surg. 2018 Apr;53(4):605-609. doi: 10.1016/j.jpedsurg.2017.07.013. Epub 2017 Jul 21.

family: Bastard

full_name: François Bastard

given: François

family: Bonnard

full_name: Arnaud Bonnard

given: Arnaud

family: Rousseau

full_name: Véronique Rousseau

given: Véronique

family: Gelas

full_name: Thomas Gelas

given: Thomas

family: Michaud

full_name: Laurent Michaud

family: Irtan

full_name: Sabine Irtan

given: Sabine

family: Piolat

full_name: Christian Piolat

given: Christian

family: Ranke-Chrétien

full_name: Aline Ranke-Chrétien

given: Aline

family: Becmeur

full_name: François Becmeur

family: Dariel

full_name: Anne Dariel

given: Anne

family: Lamireau

full_name: Thierry Lamireau

given: Thierry

family: Petit

full_name: Thierry Petit

family: Fouquet

full_name: Virginie Fouquet

given: Virginie

family: Le Mandat

full_name: Aurélie Le Mandat

given: Aurélie

family: Lefebvre

full_name: Francis Lefebvre

given: Francis

family: Allal

full_name: Hossein Allal

given: Hossein

family: Borgnon

full_name: Josephine Borgnon

given: Josephine

family: Boubnova

full_name: Julia Boubnova

given: Julia

family: Habonimana

full_name: Edouard Habonimana

given: Edouard

family: Panait

full_name: Nicoleta Panait

given: Nicoleta

family: Buisson

full_name: Philippe Buisson

family: Margaryan

full_name: Marc Margaryan

given: Marc

family: Michel

full_name: Jean-Luc Michel

given: Jean-Luc

location_facility: CRACMO - centre de référence des atrésies de l'oesophage


title: Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters

summary:
The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters :

Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea.
Urinary parameters: urea, creatinine.
Hemodynamic parameters: heart rate and blood pressure.
Cardiac function: ECG.
Weight.

lead_sponsor: Valbiotis


title: The Influence of Metabolic Syndrome and Circulating Bile Acid Levels on the Development of Hepatocellular Carcinoma and Biliary Tract Cancers

acronym: METSLIVER

summary:
Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve gastrectomy may change bile acid composition.

The aims of this study are:

whether specific presurgical bila acid profiles are predictive of efficacy of vertical sleeve gastrectomy, reflective of liver function and metabolic dysfunction;
whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve gastrectomy