title: Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

acronym: HIFU-AR

summary: The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.

ReferenceCitation: Dupré A, Pérol D, Blanc E, Peyrat P, Basso V, Chen Y, Vincenot J, Kocot A, Melodelima D, Rivoire M. Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):57. doi: 10.1186/s13063-017-1801-2.

family: Dupré

full_name: Aurélien Dupré

given: Aurélien

family: Pérol

full_name: David Pérol

given: David

family: Blanc

full_name: Ellen Blanc

given: Ellen

family: Peyrat

full_name: Patrice Peyrat

given: Patrice

family: Basso

full_name: Valéria Basso

given: Valéria

family: Chen

full_name: Yao Chen

given: Yao

family: Vincenot

full_name: Jérémy Vincenot

given: Jérémy

family: Kocot

full_name: Anthony Kocot

given: Anthony

family: Melodelima

full_name: David Melodelima

family: Rivoire

full_name: Michel Rivoire

given: Michel

endpoint_id: HAL

repository_institution: HAL

version: submittedVersion

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

lead_sponsor: Centre Leon Berard


title: Effect of a Mixture of Probiotics, Lactibiane Tolérance® on Intestinal Permeability in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance

acronym: PILATE

summary:
The main objective of the study is to evaluate the effect on intestinal permeability of a supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from irritable bowel syndrome (IBS) with diarrhea predominance.

Secondary objectives of the study are to evaluate the effects of supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea predominance on intestinal permeability, inflammation of the digestive tract, symptoms and comfort.

Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and non-inclusion listed below.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: PiLeJe

intervention_type: Dietary Supplement

lead_sponsor_type: industriel

status_simplified: Completed


type: Registry Identifier

title: Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans

acronym: PIG-A

summary:
The evaluation of the impact of environment on the incidence of cancer is a major public health issue. Increased knowledge in this area is necessary for the implementation of primary prevention means with appropriate preventive measures but also to the implementation of secondary prevention measures with targeted screening actions.

Among the environmental exposures that may lead to cancer, mutagenic environments are of major importance, and the causal link between environmental genotoxicity and cancer has been established for a long time. It is also well established that susceptibility to mutation is highly variable among individuals. This is explained by genetic polymorphisms of genes involved in metabolism and in genome stability.

The identification of biomarkers of exposure to mutagenic environments is necessary for assessing the impact of an environment in humans. Some studies in animals have shown that the PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study of healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be estimated efficiently and reliably.

The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells , spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements). Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma membrane is easily achievable by flow cytometry.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Genetic

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve

acronym: LOWAS

summary: Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

intervention_type: Other


acronym: DYSCHOL

summary: Dystonia is defined as a syndrome of sustained muscle contractions resulting in repetitive movements and abnormal postures. DYT1 is the most common form of genetic dystonia, but the link between genomic mutations and phenotypic expression remains largely unknown. Furthermore, secondary forms of dystonia have highlighted the role of the basal ganglia, particularly the putamen in the pathophysiology of the disease. Experimental results in a genetic model of dystonia in rodents suggest that cholinergic inter-neurons (ACh-I) of the putamen play a critical role in the pathological process of plasticity in the cortico-striatal synapse. However, these results have not been demonstrated in humans.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux


title: Comparative Randomized Clinical Comparison of Pulp Chamber Pulpotomy and Root Canal Treatment (Pulpectomy) as a Permanent Endodontic Treatment of Mature Permanent Teeth: Analysis of Relationship Between Inflammation Biomarkers Pulpal Expression and Treatment Outcome

acronym: PULPSAVE

summary:
Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50% worldwide, probably directly related to the difficulty of the procedure. A successful pulpotomy allows the preservation of a vital radicular pulp into the root canal. The presence of a biological tissue into the root canal is definitely more efficient than a "complete" filling with an inert material. It has been shown on animal and human studies that this pulp stump in contact with the biomaterial is able to regenerate a dentinal plug, with the same architecture as physiologic dentin.

Primary objective : To compare the success rates of root canal treatment (reference) and conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature teeth.

Secondary objectives : (1) To describe the clinical and biological prognostic factors of these two treatments; (2) to assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to assess the impact of treatment on post-procedural pain.

This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over endodontic treatment.

Patients consulting in one of the seven study centers, presenting one of the indications retained for the trial and giving written informed consent will receive the treatment (endodontic treatment or conservative treatment) allocated by randomization (stratified over the clinical diagnosis of the pulp status).

The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to evaluate the success or failure of the treatment.

During the treatment, a sample of pulp tissue will be withdrawn and transferred to a molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part of the sudy is to assess a putative relationship (1) of regulation of biomarkers expression and clinical diagnosis, and (2) of regulation of these biomarkers and success rate of pulpotomy.

Success/failure evaluation:

The primary endpoint is the time to necessity of endodontic reintervention (analysed as a time to failure). This study will use an Intention To Treat analysis as its main assessment ; a secondary assessment accounting for peroperative conversions will assess the practical impact of these conversions. We will distinguish

Direct failure (means that the failure is directly correlated to the treatment) : the reintervention need is due to the evolution of the treated tooth. This includes delayed onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by either pulpal stump or filling material).
Indirect failure (means that the cause of the failure is not directly related to the endodontic treatment choice) : any event leading to endodontic reintervention indication NOT caused by radicular infection or restoration failure attributable to inadequate restoration. For example : new need of post-placement for treatment of loss of another tooth, unexpected progression of periodontal disease.

Both these failure modes are of interest for analysis : the direct failure time is an indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure time is an indication of its clinical relevance (a good therapy applicable in rare cases may be less interesting than a mediocre but widely applicable one).

Statistical analysis:

The classical methods of descriptive analysis will be used to describe the raw results.

In order to make inferences directly on possible clinical results, this study will be analyzed in a Bayesian framework.

This study has been designed in reference with a frequentist demonstration of non-inferiority.

A non-inferiority trial with first and second species error rates α and β has the same operational characteristics as a superiority (unilateral trial) of error rates alpha and beta, which in turn needs the same study size as a comparison (=bilateral) trial with error rates α and 2β.

The final planned size of the trial is established as follows :

Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according to this plan needs 158 patients overall under "perfect information" assumptions (no loss to follow-up, single analysis)
Loss to follow-up : the expected loss to follow-up will cause about 22% of included patients to drop out of the study before final analysis this leads to include 194 patients overall.

Sequential analysis : since we wish to be able to follow the progress of the study, and to interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients overall.

design_allocation: Randomized

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years

acronym: STRATAGANEMIE

summary:
This study aims to characterize the diagnostic performance of immunological testing of occult gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency anemia.

As secondary objectives, the study aims to:

determine a threshold of positivity optimizing the immunoassay performance for the study population, in accordance with the probabilities of error (false positives, false negatives) and weights (defined by expert consensus) allocated to these errors.
Assess the benefit of a double measure of bleeding (two stools) by immunoassay compared to a single measure.

location_facility: Service Hépato-Gastroentérologie, Hôpital Ambroise Paré


title: Parenthood and Motherhood in Women With Motor Impairment and Disability Related to a Rare Disease

acronym: MMOMA

summary:
Background Women with rare diseases resulting in motor disabilities wishing to become mother face a major challenge. The investigators hypothesize that provided with adequate support, they are able to achieve a successful pregnancy and to offer their child a safe family environment.

Methods To test this hypothesis, the investigators shall conduct a prospective observational prospective survey of a consecutive series of volunteer pregnant women or mothers of children less than 14 months, with motor impairment, participating in a program of parenting support developed in our institution.

Primary outcome: social environment, child development, mother-infant attachment, mother- infant interactions Secondary outcome: social and demographic characteristics, severity of motor impairment, associated impairment, perinatal morbidity for the mother and the infant (composite indicator), emotional status, and the needs expressed by women regarding the level of medical or social care.

Analysis The investigators shall describe the distribution of the primary outcome measurements in the subgroup of women with motor impairment related to a rare disease. The investigators shall compare this distribution to the expected distribution in the general population, and to that observed in women with motor impairment unrelated to a rare disease. The investigators shall also study primary outcome measurements as a function of the severity of maternal disability, of the mother's social characteristics and emotional status.

The investigators shall also describe the distribution the distribution of perinatal morbidity globally, and as a function of the potential explanatory variables mentioned above.

The investigators shall also report on the opinion of women regarding the support they were offered so far, and the support they declare they should benefit from.


intervention_type: Drug

lead_sponsor: Hospices Civils de Lyon

primary_purpose: Diagnostic

acronym: CARTIS

type: EudraCT Number

source: euctr

title: Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR

summary: Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke. Identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment. The aim of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study. Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and tissue-to-background ratio (TBR) will be measured among carotid plaques.


title: Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study

acronym: GLYTAVI

summary:
Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in cardiac surgery. Recently, several authors have reported that increased blood glucose (BG) variability could worsen the prognosis in this population.The transcatheter aortic valve implantation (TAVI) is a low invasive procedure proposed as an alternative technique to aortic valve replacement surgery in high-risk patients.

The aim of this study is to describe the incidence of stress hyperglycaemia and assess whether BG variability could impact the outcome of patients undergoing TAVI.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7.

ReferenceCitation: Meyfroidt G, Keenan DM, Wang X, Wouters PJ, Veldhuis JD, Van den Berghe G. Dynamic characteristics of blood glucose time series during the course of critical illness: effects of intensive insulin therapy and relative association with mortality. Crit Care Med. 2010 Apr;38(4):1021-9. doi: 10.1097/CCM.0b013e3181cf710e.

ReferenceCitation: Dossett LA, Cao H, Mowery NT, Dortch MJ, Morris JM Jr, May AK. Blood glucose variability is associated with mortality in the surgical intensive care unit. Am Surg. 2008 Aug;74(8):679-85; discussion 685.

ReferenceCitation: Bagshaw SM, Bellomo R, Jacka MJ, Egi M, Hart GK, George C; ANZICS CORE Management Committee. The impact of early hypoglycemia and blood glucose variability on outcome in critical illness. Crit Care. 2009;13(3):R91. doi: 10.1186/cc7921. Epub 2009 Jun 17.

ReferenceCitation: Egi M, Bellomo R, Reade MC. Is reducing variability of blood glucose the real but hidden target of intensive insulin therapy? Crit Care. 2009;13(2):302. doi: 10.1186/cc7755. Epub 2009 Apr 6.

ReferenceCitation: Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

ReferenceCitation: Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15.

ReferenceType: derived

ReferenceCitation: Besch G, Pili-Floury S, Morel C, Gilard M, Flicoteaux G, Salomon du Mont L, Perrotti A, Meneveau N, Chocron S, Schiele F, Le Breton H, Samain E, Chopard R. Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis. Cardiovasc Diabetol. 2019 Mar 11;18(1):27. doi: 10.1186/s12933-019-0831-3.

family: Besch

full_name: Guillaume Besch

given: Guillaume

sequence: first

family: Pili-Floury

full_name: Sebastien Pili-Floury

given: Sebastien

sequence: additional

family: Morel

full_name: Caroline Morel

given: Caroline

family: Gilard

full_name: Martine Gilard

given: Martine

family: Flicoteaux

full_name: Guillaume Flicoteaux

family: Salomon du Mont

full_name: Lucie Salomon du Mont

given: Lucie

family: Perrotti

full_name: Andrea Perrotti

given: Andrea

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

family: Chocron

full_name: Sidney Chocron

given: Sidney

family: Schiele

full_name: Francois Schiele

given: Francois

family: Le Breton

full_name: Herve Le Breton

given: Herve

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Chopard

full_name: Romain Chopard

given: Romain

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cardiovascular Diabetology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities

acronym: AIRSEP

summary: The purpose of this study is to assess the effect of a training of the inspiratory muscles against resistance at home during 10 weeks in multiple sclerosis patients with a severe disability.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Lille Catholic University

location_facility: Hospital Group of the Catholic Institute of Lille

intervention_type: Device


title: Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.

acronym: NoSleepDiaph

summary: The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.

ReferenceCitation: Westphal WP, Rault C, Robert R, Ragot S, Neau JP, Fernagut PO, Drouot X. Sleep deprivation reduces vagal tone during an inspiratory endurance task in humans. Sleep. 2021 Oct 11;44(10). pii: zsab105. doi: 10.1093/sleep/zsab105.

name: Centre d’Investigation Clinique Inserm 1402, Team Acute Lung Injury and VEntilatory support, Centre Hospitalier Universitaire de Poitiers, France

name: Université de Poitiers, INSERM, Laboratoire de Neurosciences Expérimentales et Cliniques, Team Neurodevelopment Neuroadaptation Neurodegeneration, Poitiers, France

family: Westphal

full_name: Willy-Paul Westphal

given: Willy-Paul

family: Rault

full_name: Christophe Rault

given: Christophe

family: Robert

full_name: René Robert

given: René

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

name: Neurology Department, Centre Hospitalier Universitaire de Poitiers, France

family: Neau

full_name: Jean-Philippe Neau

given: Jean-Philippe

family: Fernagut

full_name: Pierre-Olivier Fernagut

given: Pierre-Olivier

family: Drouot

full_name: Xavier Drouot

given: Xavier

journal_name: Sleep

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Poitiers University Hospital

intervention_type: Behavioral


title: Influence of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers

summary: Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospitals of Toulouse (Rangueil)


summary:
Hypoxemia is usually observed during ICU stay. Nevertheless, the prevalence of hypoxemia among patients admitted in ICU is not well known, in partly due to a lack of a consensual definition. Some of these patients meet the criteria of Acute Respiratory Distress Syndrome whom the definition has been recently modified in 2011. Many uncertainties are remaining in considering the patients with ARDS: prevalence of the category of "mild ARDS", the proportion of patients with invasive mechanical ventilation, the therapeutic modalities and the prognosis, in particular, the move towards a more severe ARDS category. Finally, many patients with hypoxemia do not meet ARDS definition. The prevalence of this population in ICU is unknown, likewise its prognosis. In this way, it would be interesting to compare, for each levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and without ARDS.

The main objective of the SPECTRUM study is to assess the prevalence of hypoxemia in French-speaking Intensive Care Unit in 2016 in using a single-day point-prevalence study design. Two periods of inclusion have been, actually, planned: from the 29th Mars to the 31st Mars and from the 5th to the 7th April. In each participating center, the day of the study will be chosen among these periods.

ReferenceType: result

ReferenceCitation: Linko R, Okkonen M, Pettilä V, Perttilä J, Parviainen I, Ruokonen E, Tenhunen J, Ala-Kokko T, Varpula T; FINNALI-study group. Acute respiratory failure in intensive care units. FINNALI: a prospective cohort study. Intensive Care Med. 2009 Aug;35(8):1352-61. doi: 10.1007/s00134-009-1519-z. Epub 2009 Jun 13.

family: Linko

full_name: Rita Linko

given: Rita

family: Okkonen

full_name: Marjatta Okkonen

given: Marjatta

family: Pettilä

full_name: Ville Pettilä

given: Ville

family: Perttilä

full_name: Juha Perttilä

given: Juha

family: Parviainen

full_name: Ilkka Parviainen

given: Ilkka

family: Ruokonen

full_name: Esko Ruokonen

given: Esko

family: Tenhunen

full_name: Jyrki Tenhunen

given: Jyrki

family: Ala-Kokko

full_name: Tero Ala-Kokko

given: Tero

family: Varpula

full_name: Tero Varpula

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski K, Bion J, Romand JA, Villar J, Thorsteinsson A, Damas P, Armaganidis A, Lemaire F; ALIVE Study Group. Epidemiology and outcome of acute lung injury in European intensive care units. Results from the ALIVE study. Intensive Care Med. 2004 Jan;30(1):51-61. Epub 2003 Oct 16.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

name: School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy2Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy

family: Bellani

full_name: Giacomo Bellani

given: Giacomo

name: Departments of Anesthesia and Critical Care Medicine, Keenan Research Centre for Biomedical Science, St Michael’s Hospital4Departments of Anesthesia, Physiology and Interdepartmental division of Critical Care Medicine, University of Toronto, Canada

family: Laffey

full_name: John G. Laffey

given: John G.

name: AP-HP, Hôpital Tenon, Unité de Réanimation médico-chirurgicale, Pôle Thorax Voies aériennes, Groupe hospitalier des Hôpitaux Universitaires de l’Est Parisien, Paris, France6UMR 1153, Inserm, Sorbonne Paris Cité, ECSTRA Team, Université Paris Diderot, Pari

family: Pham

full_name: Tài Pham

given: Tài

name: Department of Medicine, University Health Network and Mount Sinai Hospital9Interdepartmental Division of Critical Care Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada

family: Fan

full_name: Eddy Fan

given: Eddy

name: Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada11Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada

family: Brochard

full_name: Laurent Brochard

given: Laurent

name: Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Madrid, Spain

family: Esteban

full_name: Andres Esteban

given: Andres

name: Istituto di Anestesia e Rianimazione, Università degli Studi di Milano, Ospedale Maggiore, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

family: Gattinoni

full_name: Luciano Gattinoni

given: Luciano

name: Intensive Care Unit, Canberra Hospital, and Australian National University, Canberra, Australia

family: van Haren

full_name: Frank van Haren

given: Frank

name: Section of Anesthesiology and Intensive Care, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

family: Larsson

full_name: Anders Larsson

given: Anders

name: Centre for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland17Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland18Regional Intensive Care Unit, Royal Victoria Hospital, Grosvenor Road, Belfast, No

family: McAuley

full_name: Daniel F. McAuley

given: Daniel F.

name: SAPIENZA Università di ROMA, Dipartimento di Anestesia e Rianimazione, Policlinico Umberto I, Viale del Policlinico 155, 00161 Roma, Italy

family: Ranieri

full_name: Marco Ranieri

given: Marco

name: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada21Program in Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Center, Toronto, Canada

family: Rubenfeld

full_name: Gordon Rubenfeld

name: Division of Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston

name: Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Liebigstr. 20, D-04103 Leipzig, Germany

name: Keenan Research Center at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, the Interdepartmental Division of Critical Care Medicine, and the Department of Medicine, University of Toronto, Toronto, Canada

name: for the LUNG SAFE Investigators and the ESICM Trials Group

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93.

ReferenceCitation: ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

title: Acute Respiratory Distress Syndrome

ReferenceCitation: SRLF Trial Group. Hypoxemia in the ICU: prevalence, treatment, and outcome. Ann Intensive Care. 2018 Aug 13;8(1):82. doi: 10.1186/s13613-018-0424-4. Erratum in: Ann Intensive Care. 2019 Jan 21;9(1):10.


title: Effect of Liraglutide on Fatty Liver Content Evaluated by Proton-spectroscopy (1H-spectroscopy) and Lipoprotein Kinetic, in Patients With Type 2 Diabetes

acronym: LIRA-NAFLD/LIP

summary:
Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be associated with lipid abnormalities (such as hypertriglyceridemia and decreased HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type 2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between 3 and 5%).

Animal studies have shown that liraglutide is able to decrease liver fat content, but the effect of liraglutide on liver fat content in patients with diabetes remains unknown.

In addition, human studies with liraglutide have shown significant modification of plasma lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the mechanisms responsible for these liraglutide induced lipid modifications are not yet known.

Because increased in liver fat content and hypertriglyceridemia are associated in patients with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver fat content assessment and kinetic study with stable isotope to study lipoprotein metabolism).

This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide therapy (1.2 mg/day).

Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10 patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day hospitalization

For the main study, 3 visits will be performed:

a first visit at T0, before starting the treatment with liraglutide, including clinical and biological measurements and liver fat content assessment by proton-spectroscopy
a visit at 3 months including clinical and biological measurements
and a visit at 6 months including clinical and biological measurements and liver fat content assessment by proton-spectroscopy

For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will been performs during a 48h-hospitalization before starting the treatment with liraglutide and after 6 month-treatment with liraglutide

ReferenceCitation: Vergès B, Duvillard L, Pais de Barros JP, Bouillet B, Baillot-Rudoni S, Rouland A, Petit JM, Degrace P, Demizieux L. Liraglutide Increases the Catabolism of Apolipoprotein B100-Containing Lipoproteins in Patients With Type 2 Diabetes and Reduces Proprotein Convertase Subtilisin/Kexin Type 9 Expression. Diabetes Care. 2021 Apr;44(4):1027-1037. doi: 10.2337/dc20-1843. Epub 2021 Feb 2.

family: Vergès

full_name: Bruno Vergès

given: Bruno

family: Duvillard

full_name: Laurence Duvillard

given: Laurence

family: Pais de Barros

full_name: Jean Paul Pais de Barros

given: Jean Paul

family: Bouillet

full_name: Benjamin Bouillet

given: Benjamin

family: Baillot-Rudoni

full_name: Sabine Baillot-Rudoni

given: Sabine

family: Rouland

full_name: Alexia Rouland

given: Alexia

family: Petit

full_name: Jean Michel Petit

given: Jean Michel

family: Degrace

full_name: Pascal Degrace

given: Pascal

family: Demizieux

full_name: Laurent Demizieux

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Liraglutide Increases the Catabolism of Apolipoprotein B100–Containing Lipoproteins in Patients With Type 2 Diabetes and Reduces Proprotein Convertase Subtilisin/Kexin Type 9 Expression

ReferenceCitation: Vergès B, Duvillard L, Pais de Barros JP, Bouillet B, Baillot-Rudoni S, Rouland A, Sberna AL, Petit JM, Degrace P, Demizieux L. Liraglutide Reduces Postprandial Hyperlipidemia by Increasing ApoB48 (Apolipoprotein B48) Catabolism and by Reducing ApoB48 Production in Patients With Type 2 Diabetes Mellitus. Arterioscler Thromb Vasc Biol. 2018 Sep;38(9):2198-2206. doi: 10.1161/ATVBAHA.118.310990.

name: From the Department of Endocrinology-Diabetology (B.V., B.B, S.B.-R., A.R., A.-L.S., J.M.P.)

name: INSERM LNR UMR1231, University of Burgundy and Franche-Comté, Dijon, France (B.V., L.D., J.P.P.d.B., B.B., J.-M.P., P.D., L.D.)

name: Lipidomic Analytical Platform, Bâtiment B3, Dijon, France (J.P.P.d.B.).

family: Sberna

full_name: Anne-Laure Sberna

given: Anne-Laure

full_name: Jean-Michel Petit

given: Jean-Michel

name: Department of Biochemistry (L.D.), University Hospital, Dijon, France

journal_name: Arteriosclerosis, Thrombosis, and Vascular Biology

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Evaluation of APAP With SensAwake in OSA and Insomnia Patients

summary: The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.

lead_sponsor: Fisher and Paykel Healthcare


title: Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

acronym: BACTIDIAG

summary:
Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and prompt implementation of the etiological treatment. The bacterial infections are the most common and are associated with high morbidity and mortality. Diagnosis is based on the detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis, gram + and gram - are circulating and often present in small amounts; they can be detected by sensitive and specific tools following a pretreatment of the blood sample (innovative technology Bacti-DIAG).

The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams) in the patient's care including diagnosis and treatment.

All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS) sepsis suspects will be included: in addition to the samples taken for routine care of the patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas under the ROC curves for the detection of gram + and gram will be calculated and associated detection limits will be determined to meet the objectives of the study.

It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and analyze biometric and biological data based on the subsequent evolution of the patients. The care of patients will be blinded to the results of the new biomarker Bacti-DIAG

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery

acronym: R-CAPE

summary:
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.

Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.

This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.

The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital


title: Single-center Prospective Descriptive Study Evaluating the Presence of Nanoparticles in the Amniotic Fluid in Pregnant Women

acronym: NAMIOTIC

summary:
The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers. However, their impact on health remains little evaluated.

Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and toxicity in the fetus has been studied in many animals. The investigators seem interesting at first to establish the mineralogical load in the amniotic fluid in humans.

The first objective of this study is to determine the mineralogical NP load, quantity and composition, in the amniotic fluid in pregnant women.

ReferenceCitation: Raia-Barjat T, Prieux C, Leclerc L, Sarry G, Grimal L, Chauleur C, Pourchez J, Forest V. Elemental fingerprint of human amniotic fluids and relationship with potential sources of maternal exposure. J Trace Elem Med Biol. 2020 Jul;60:126477. doi: 10.1016/j.jtemb.2020.126477. Epub 2020 Feb 27.

family: Raia-Barjat

full_name: Tiphaine Raia-Barjat

given: Tiphaine

family: Prieux

full_name: Carole Prieux

given: Carole

family: Leclerc

full_name: Lara Leclerc

given: Lara

family: Sarry

full_name: Gwendoline Sarry

given: Gwendoline

family: Grimal

full_name: Lucile Grimal

given: Lucile

family: Chauleur

full_name: Céline Chauleur

given: Céline

family: Pourchez

full_name: Jérémie Pourchez

given: Jérémie

family: Forest

full_name: Valérie Forest

given: Valérie

journal_name: Journal of Trace Elements in Medicine and Biology

oa_colors: green other

evidence: open (author manuscript)

version: acceptedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Glutaminergic Transmission in Autism : Molecular Imaging Exploration

acronym: TANGAU

summary: Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers

ipd_sharing_description: There is no plan to share data.

lead_sponsor: University Hospital, Tours


title: Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease

acronym: PHYTOPARK

summary: The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.

lead_sponsor: Nantes University Hospital


title: Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials

acronym: PERFOCTAPS

summary:
Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already irreversible and the clinical picture may even continue to deteriorate for several years after the end of synthetic antimalarial use. In opposition, the early termination of hydroxychloroquine in patients showing recent alterations on the multifocal electroretinogram (nfERG) allowed he reversibility of toxic damage over a six month period. It is therefore critical to detect early retinal anatomic changes during retinotoxicity screening before the occurrence of irreversible anatomical and functional consequences.

The usual patient monitoring consists of an annual eye examination, detecting subjective functional abnormalities (visual acuity, color vision, central visual field testing) or macular lesions (eye fundus). These abnormalities show a constituted infringement and do not contribute to the early diagnosis of synthetic antimalarial maculopathy.

The mfERG is an objective examination, able to detect retinal damage whilst still reversible. It is recommended during the annual monitoring and is, today, the gold standard for the screening and diagnosis of synthetic antimalarial maculopathy. However, its realization is time consuming, requires a good patient cooperation and is difficult to access due to the few ophthalmology centers offering it. In practice, it is rarely done as a systematic annual screening for patients on long-term synthetic antimalarial treatment. It is often limited to second-line studies (for patients already showing functional or anatomical abnormalities) whereas its interest lies in the detection of early lesions.

The Optical Coherence Tomography Spectral Domain (OCT-SD) is a non-invasive eye examination, commonly used since nearly 10 years. A special image analysis provides a panoramic viewing of the state of the photoreceptor layer, and a non-invasive detection of any anatomical changes, even subtle, within this layer.

The concordance between the "en face" OCT and the mfERG in the screening of synthetic antimalarial maculopathy is considered in this study.

status: Active, not recruiting

primary_purpose: Screening

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmique Adolphe de Rothschild

status_simplified: Ongoing


title: Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery

acronym: CLEARSIGHT

summary:
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.


title: Inhibition Control Modulation by Transcranial Random Noise Stimulation (tRNS ) on the Prefrontal Cortex Measured by Change in Go no Test

acronym: inhibistim

summary:
Inhibition control deficits is a major risk factor in the transition to the act in suicidal patients. Neuroimaging studies have shown that this failure was associated with hypoactivity in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was recently shown that a noninvasive brain stimulation session applied on the PFC reduces transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the activity and connectivity of neural network connected to the stimulation site. The investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC will allow a more intense and longer lasting effect on impulsivity and cognitive control in healthy volunteers compared to a single session and to placebo stimulation. The investigators assume that this behavioral change will be accompanied by a change in brain activity measured by resting EEG for the patients in the active group. A more intense and longer lasting effect is an essential step to transfer these results to patient populations.

The main objective is to study the effect of bilateral stimulation of the PFC by transcranial random noise stimulation (tRNS) on the inhibition control measured by the cognitive motor inhibition capacity (Go NoGo test). The secondary objectives are to study the effect of tRNS on verbal inhibition (measured with the Hayling test); on anxiety (measured with the State-trait anxiety inventory (STAI)),on angry (measured with the State-trait anger expression inventory (STAXI)) on verbal and nonverbal inhibition (measured by the Stroop test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS 10)) and on the neuronal electrical activity measured by EEG.

lead_sponsor: Hôpital le Vinatier


title: Effect of Transcranial Random Noise Stimulation of Prefrontal Cortex on Craving Supply Subject Suffering From Obesity

acronym: tRNS-FA

summary: Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.


title: French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI

acronym: MYOCARDITIRM

summary:
Acute myocarditis is a serious illness affecting a young population with a very variable course (of full recovery at the onset of dilated cardiomyopathy (DCM), or even sudden death). Very few studies have examined the predictors of death and serious cardiovascular events in acute myocarditis and have carried on numbers of restricted patients. What little data results in a lack of a precise recommendation on the management and the follow-up period of patients.

This observational study should identify serious prognostic factor for cardiovascular events in order to provide a support strategy and more appropriate monitoring of myocarditis.

ReferenceCitation: Magnani JW, Dec GW. Myocarditis: current trends in diagnosis and treatment. Circulation. 2006 Feb 14;113(6):876-90. Review.

ReferenceCitation: Andréoletti L, Lévêque N, Boulagnon C, Brasselet C, Fornes P. Viral causes of human myocarditis. Arch Cardiovasc Dis. 2009 Jun-Jul;102(6-7):559-68. doi: 10.1016/j.acvd.2009.04.010. Epub 2009 Jul 31. Review.

ReferenceCitation: Sinagra G, Maras P, D'Ambrosio A, Gregori D, Bussani R, Silvestri F, Morgera T, Pinamonti B, Salvi A, Alberti E, Di Lenarda A, Lardieri G, Klugmann S, Camerini F. [Clinical polymorphic presentation and natural history of active myocarditis: experience in 60 cases]. G Ital Cardiol. 1997 Aug;27(8):758-74. Italian.

ReferenceCitation: McCarthy RE 3rd, Boehmer JP, Hruban RH, Hutchins GM, Kasper EK, Hare JM, Baughman KL. Long-term outcome of fulminant myocarditis as compared with acute (nonfulminant) myocarditis. N Engl J Med. 2000 Mar 9;342(10):690-5.

ReferenceCitation: Eckart RE, Scoville SL, Campbell CL, Shry EA, Stajduhar KC, Potter RN, Pearse LA, Virmani R. Sudden death in young adults: a 25-year review of autopsies in military recruits. Ann Intern Med. 2004 Dec 7;141(11):829-34.

ReferenceCitation: Bowles NE, Ni J, Kearney DL, Pauschinger M, Schultheiss HP, McCarthy R, Hare J, Bricker JT, Bowles KR, Towbin JA. Detection of viruses in myocardial tissues by polymerase chain reaction. evidence of adenovirus as a common cause of myocarditis in children and adults. J Am Coll Cardiol. 2003 Aug 6;42(3):466-72.

ReferenceCitation: Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007.

ReferenceCitation: Potet J, Rahmouni A, Mayer J, Vignaud A, Lim P, Luciani A, Dubois-Randé JL, Kobeiter H, Deux JF. Detection of myocardial edema with low-b-value diffusion-weighted echo-planar imaging sequence in patients with acute myocarditis. Radiology. 2013 Nov;269(2):362-9. doi: 10.1148/radiol.13121811. Epub 2013 May 21.

ReferenceCitation: Caforio AL, Calabrese F, Angelini A, Tona F, Vinci A, Bottaro S, Ramondo A, Carturan E, Iliceto S, Thiene G, Daliento L. A prospective study of biopsy-proven myocarditis: prognostic relevance of clinical and aetiopathogenetic features at diagnosis. Eur Heart J. 2007 Jun;28(11):1326-33. Epub 2007 May 9.

ReferenceCitation: Kindermann I, Kindermann M, Kandolf R, Klingel K, Bültmann B, Müller T, Lindinger A, Böhm M. Predictors of outcome in patients with suspected myocarditis. Circulation. 2008 Aug 5;118(6):639-48. doi: 10.1161/CIRCULATIONAHA.108.769489. Epub 2008 Jul 21. Erratum in: Circulation.2008 Sep 16;118(12): e493.

ReferenceCitation: Grün S, Schumm J, Greulich S, Wagner A, Schneider S, Bruder O, Kispert EM, Hill S, Ong P, Klingel K, Kandolf R, Sechtem U, Mahrholdt H. Long-term follow-up of biopsy-proven viral myocarditis: predictors of mortality and incomplete recovery. J Am Coll Cardiol. 2012 May 1;59(18):1604-15. doi: 10.1016/j.jacc.2012.01.007. Epub 2012 Feb 22.

ReferenceCitation: Mahfoud F, Ukena C, Kandolf R, Kindermann M, Böhm M, Kindermann I. Blood pressure and heart rate predict outcome in patients acutely admitted with suspected myocarditis without previous heart failure. J Hypertens. 2012 Jun;30(6):1217-24. doi: 10.1097/HJH.0b013e328352b9ca.

ReferenceCitation: Ukena C, Mahfoud F, Kindermann I, Kandolf R, Kindermann M, Böhm M. Prognostic electrocardiographic parameters in patients with suspected myocarditis. Eur J Heart Fail. 2011 Apr;13(4):398-405. doi: 10.1093/eurjhf/hfq229. Epub 2011 Jan 14.

ReferenceCitation: Magnani JW, Danik HJ, Dec GW Jr, DiSalvo TG. Survival in biopsy-proven myocarditis: a long-term retrospective analysis of the histopathologic, clinical, and hemodynamic predictors. Am Heart J. 2006 Feb;151(2):463-70.

ReferenceCitation: Mendes LA, Dec GW, Picard MH, Palacios IF, Newell J, Davidoff R. Right ventricular dysfunction: an independent predictor of adverse outcome in patients with myocarditis. Am Heart J. 1994 Aug;128(2):301-7.

lead_sponsor: French Cardiology Society


title: Pilot Study of Branched Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.

acronym: MUSCAADE

summary:
Despite the demonstrable health and quality of life benefits, there are unknowns within consequences of obesity surgery. Weight loss composition is poorly understood. The objective is to have a significant loss of body fat and a limited loss of muscular weight.

A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and 1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little loss' and is defined by a contribution of muscular weight lower than 15% of the total weight loss. The other one is called 'big loss' and is defined by a contribution of muscular weight higher than 15% of the total weight loss. Causes of these different phenotypes are unknown for the moment.

Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in clinical situations like hepatic cirrhosis, and some populations like new born and older people.

Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit effect on the muscular mass. That is testing the influence of the quality of protein consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain of muscle only if it is associated to regular physical training, all patients will follow a physical training.

location_facility: Department of Endocrinology, metabolic diseases and nutrition


title: Initial Staging of Bronchopulmonary Neoplasia: Whole-body MRI Versus Pet Scanner

acronym: WISLON

summary:
Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in detection of nodes in patients with cell lung cancer (NSCLC).

However, the cardiorespiratory synchronization in the MRI, allowing acquisition of synchronous images with breathing and heart movements should increase the sensitivity of detection of pathologic mediastinal lymph nodes.

Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as informative as PET, while being less expensive, not radiant.

The purpose of this study is to evaluate the performance of whole-body MRI with diffusion with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are known to be less well detected by MRI) compared to PET.

lead_sponsor: University Hospital, Limoges


title: Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).

acronym: MultiPAS

summary: Enhanced rehabilitation programs are based on new therapies and treatment combinations to reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but also the overall cost of care. The operating stress and hypercatabolic conditions surrounding the surgery are sources of complications. In this enhanced rehabilitation approach, the principle is to fight through a series of actions against this surgical stress. Several North American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is not until now French data concerning the assessment of enhanced rehabilitation in liver surgery. The main objective of the study is to compare the effectiveness of the implementation of a multimodal management program after liver surgery in a French university center compared to conventional care. Secondary objectives of the study are to compare an enhanced rehabilitation program in liver surgery versus conventional treatment in terms of morbidity and mortality in the immediate postoperative period and until day 90, length of hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program in both groups will also be evaluated.

lead_sponsor: University Hospital, Angers


title: Thoracic Imaging in Children With Neither Irradiation Nor Injection, by a New MRI Protocol Including Advanced Zero Time Echo (ZTE)

acronym: ImagINI-CHEST

summary: The aim of this study is to compare a new Magnetic Resonance Imaging (MRI)protocol, including a new MRI sequence for visualization of lung parenchyma, to computed tomography as the gold standard for the evaluation of thoracic region in children.

ReferenceCitation: Gorkem SB, Coskun A, Yikilmaz A, Zurakowski D, Mulkern RV, Lee EY. Evaluation of pediatric thoracic disorders: comparison of unenhanced fast-imaging-sequence 1.5-T MRI and contrast-enhanced MDCT. AJR Am J Roentgenol. 2013 Jun;200(6):1352-7. doi: 10.2214/AJR.12.9502.

ReferenceCitation: Liszewski MC, Hersman FW, Altes TA, Ohno Y, Ciet P, Warfield SK, Lee EY. Magnetic resonance imaging of pediatric lung parenchyma, airways, vasculature, ventilation, and perfusion: state of the art. Radiol Clin North Am. 2013 Jul;51(4):555-82. doi: 10.1016/j.rcl.2013.04.004. Review.

ReferenceCitation: Johnson KM, Fain SB, Schiebler ML, Nagle S. Optimized 3D ultrashort echo time pulmonary MRI. Magn Reson Med. 2013 Nov;70(5):1241-50. doi: 10.1002/mrm.24570. Epub 2012 Dec 4.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: General Anesthesia and Autonomic Nervous System in Children

acronym: ANESPEDIA

summary: The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to 8 years old) receiving elective surgery, the impact of general anesthesia on autonomic nervous system and their kinetics of early postoperative course (24 hours).


title: Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement

acronym: ADELC

summary:
It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty.

The objectives of the study are to:

Identify clinical practices set up for patient care
Assess the type and the frequency of perioperative complications
Look for factors, related to patients or treatments, associated with the occurrence of these complications.

The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.

lead_sponsor: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique


title: Liberal Oxygenation Versus Conservative Oxygenation in Patients With Acute Respiratory Distress Syndrome : Impact on Mortality (LOCO2 Study)

summary:
No clear recommendation exists for the level of oxygenation of intensive care patients. In Acute Respiratory Distress Syndrome (ARDS), pulsed oxymetry (SpO2) have to be kept between 88 and 95 percent and oxygen alveolar pressure between 55 and 80 mmHg (PaO2). These recommendations are common but do not lie on high scientific knowledge and level of proof. In the major studies of these fifteen last years that changed ARDS management, PaO2 was kept around 85 and 90 mmHg despite current recommendations of 55 to 80 mmHg of PaO2.

Many recent review and cohort studies pointed the risk of excessive oxygenation especially following cardiac arrest, stroke or traumatic brain injury. However, these data come in majority from cohort or database study without strong definition of hyperoxia. Data coming from prospective studies are scarce and tend to show better outcome of patients with lower objectives of oxygenation in ICU.

High oxygen (O2) level may be deleterious especially on inflammatory lungs. It could enhance injuries due to mechanical ventilation. O2 could be responsable of " hyperoxia induced lung injury ".

The investigators showed in a precedent study that comparing a restrictive oxygenation versus a liberal oxygenation was feasable and do not expose patients to major adverse events. More, mortality at 60 days has tendency to be lower. The investigators therefore ask if a lower objectives of PaO2 in comparison with the level usually seen in last studies on ARDS could improve ARDS patients outcome.

The aim of this study is to show that a restrictive oxygenation in comparison with a liberal oxygenation strategy in patients with ARDS would lower mortality at 28 days.

ReferenceCitation: Panwar R, Hardie M, Bellomo R, Barrot L, Eastwood GM, Young PJ, Capellier G, Harrigan PW, Bailey M; CLOSE Study Investigators; ANZICS Clinical Trials Group. Conservative versus Liberal Oxygenation Targets for Mechanically Ventilated Patients. A Pilot Multicenter Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Jan 1;193(1):43-51. doi: 10.1164/rccm.201505-1019OC.

family: Panwar

full_name: Rakshit Panwar

given: Rakshit

family: Hardie

full_name: Miranda Hardie

given: Miranda

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

family: Barrot

full_name: Loïc Barrot

given: Loïc

family: Eastwood

full_name: Glenn M. Eastwood

given: Glenn M.

family: Young

full_name: Paul J. Young

given: Paul J.

family: Capellier

full_name: Gilles Capellier

given: Gilles

family: Harrigan

full_name: Peter W. J. Harrigan

given: Peter W. J.

family: Bailey

full_name: Michael Bailey

given: Michael

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

ReferenceCitation: Barrot L, Asfar P, Mauny F, Winiszewski H, Montini F, Badie J, Quenot JP, Pili-Floury S, Bouhemad B, Louis G, Souweine B, Collange O, Pottecher J, Levy B, Puyraveau M, Vettoretti L, Constantin JM, Capellier G; LOCO2 Investigators and REVA Research Network. Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome. N Engl J Med. 2020 Mar 12;382(11):999-1008. doi: 10.1056/NEJMoa1916431.

name: From the Medical Intensive Care Unit (L.B., H.W., L.V., G.C.), the Anesthesia and Intensive Care Unit (L.B., S.P.-F.), Unité de Méthodologie, INSERM Clinical Investigation Center 1431, University Hospital (F. Mauny, M.P.), and Research Unit EA3920, Université de Franche Comté (L.B., H.W. S.P.-F., G.C.), Besançon, the Medical Intensive Care Unit, University Hospital of Angers, Angers (P.A.), the Intensive Care Unit, General Hospital of Avignon, Avignon (F. Montini), the Intensive Care Unit, General...

full_name: Loic Barrot

given: Loic

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Mauny

full_name: Frederic Mauny

given: Frederic

family: Winiszewski

full_name: Hadrien Winiszewski

given: Hadrien

family: Montini

full_name: Florent Montini

given: Florent

family: Badie

full_name: Julio Badie

given: Julio

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Pili-Floury

full_name: Sebastien Pili-Floury

given: Sebastien

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Louis

full_name: Guillaume Louis

given: Guillaume

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Collange

full_name: Olivier Collange

given: Olivier

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive.

acronym: SPO

summary: Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.


title: Tools Development for Geriatric Emergency Regulation at the Emergency Service Centre, in the Rhône Area

acronym: REGESA

summary:
According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French 911) calls concern elderly patients above 75 years of age. For these patients, the clinical pathway should be decided on the basis of the symptomatology described during the call, but also with the gathering of specific data such as medical social and psychological evaluation. These items allow the regulating doctor to assess comorbidity, on-going treatment, psycho-cognitive status, previous hospitalisations, social situation, and patient expectations and needs.

However, data collected in order to assess the situation on the phone and take the orientation decision are mainly limited to the severity of clinical symptoms. Medical, psychological and social aspects are rarely gathered, for several reasons :

Phone call shortness : emergency calls should be treated quickly
Regulating doctors are not trained to take in account the specificities or geriatric patients in their decision making. Besides, they are not informed about alternatives to the hospital emergency department, such as "geriatric channel" system.

An observational study was performed in 2012 on 692 calls about elderly patients referred to the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency department. Regardless of severe cases "hospital regulation", 55% of the least serious cases ("liberal regulation") were transferred to an emergency department.

Regulation is inadequate to elderly patients for whom 1) the situation assessment and the appropriate decision making require specific items that are not known by regulating doctors, 2) the medical care and the clinical pathway could be improved by the knowledge of on-field "geriatric channel", 3) the emergency department care is particularly long, 4) and could be pernicious to younger patients.

1920 patients will be recruited between January 2016 and August 2017, including a 6 months wash-out in order to train regulating doctors. This training will include geriatric patient's specificities, and geriatric channels. A 12% difference between the 2 groups (before and after the training) is expected, considering a 80% statistical power. The design is a time series experiment.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service Gériatrie - Hôpital Edouard Herriot, Hospices Civils de Lyon


title: Randomized Controlled Trial Prospective Single-center Open Evaluating the Efficacy of Supplementation (Adapted to the Post-operative Period) Current Protein After Bariatric Surgery Like Sleeve Gastrectomy

acronym: PROTISLEEVE

summary:
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.

Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.

primary_purpose: Prevention


title: SD-OCT Multimodal Analysis in GLaucoma

acronym: SOMAL

summary:
Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions people affected in 2010. It is defined as a neurodegenerative disease characterized by a progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity, its impact on quality of life and an existing treatment that can delay visual field damages, there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve head excavation performed either by ophthalmologists or glaucoma specialists is highly inter-observer dependent and limits its accuracy to diagnose glaucoma. Additionally, up to 30 to 40% of nerve fiber layer may be lost before detecting first visual field defects, thus making this tool not accurate enough for screening purposes.

Spectral-Domain Optical coherence tomography (SD-OCT) imaging technology allows precise and reproducible measurements of optic nerve head structures and retinal layers mainly related to the speed of acquisition and an axial resolution of 5 microns. New SD-OCT parameters have been developed to improve its diagnostic accuracy for glaucoma disease. The investigators therefore investigate performances of SD-OCT to discriminate glaucoma patients and controls. All subjects will undergo SD-OCT imaging (Spectralis™ OCT, Version 6.3, Heidelberg Engineering, Germany) and other study procedures in one single visit. All examinations performed on the subjects are non-significant risk.

ReferenceCitation: Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. Review.

ReferenceCitation: Klein BE, Klein R, Sponsel WE, Franke T, Cantor LB, Martone J, Menage MJ. Prevalence of glaucoma. The Beaver Dam Eye Study. Ophthalmology. 1992 Oct;99(10):1499-504.

ReferenceCitation: Sommer A, Tielsch JM, Katz J, Quigley HA, Gottsch JD, Javitt J, Singh K. Relationship between intraocular pressure and primary open angle glaucoma among white and black Americans. The Baltimore Eye Survey. Arch Ophthalmol. 1991 Aug;109(8):1090-5.

ReferenceCitation: Leibowitz HM, Krueger DE, Maunder LR, Milton RC, Kini MM, Kahn HA, Nickerson RJ, Pool J, Colton TL, Ganley JP, Loewenstein JI, Dawber TR. The Framingham Eye Study monograph: An ophthalmological and epidemiological study of cataract, glaucoma, diabetic retinopathy, macular degeneration, and visual acuity in a general population of 2631 adults, 1973-1975. Surv Ophthalmol. 1980 May-Jun;24(Suppl):335-610.

ReferenceCitation: Leung CK, Lam S, Weinreb RN, Liu S, Ye C, Liu L, He J, Lai GW, Li T, Lam DS. Retinal nerve fiber layer imaging with spectral-domain optical coherence tomography: analysis of the retinal nerve fiber layer map for glaucoma detection. Ophthalmology. 2010 Sep;117(9):1684-91. doi: 10.1016/j.ophtha.2010.01.026. Epub 2010 Jul 21.

ReferenceCitation: Leung CK, Choi N, Weinreb RN, Liu S, Ye C, Liu L, Lai GW, Lau J, Lam DS. Retinal nerve fiber layer imaging with spectral-domain optical coherence tomography: pattern of RNFL defects in glaucoma. Ophthalmology. 2010 Dec;117(12):2337-44. doi: 10.1016/j.ophtha.2010.04.002. Epub 2010 Aug 3.

ReferenceCitation: Windisch BK, Harasymowycz PJ, See JL, Chauhan BC, Belliveau AC, Hutchison DM, Nicolela MT. Comparison between confocal scanning laser tomography, scanning laser polarimetry and optical coherence tomography on the ability to detect localised retinal nerve fibre layer defects in glaucoma patients. Br J Ophthalmol. 2009 Feb;93(2):225-30. doi: 10.1136/bjo.2008.141945. Epub 2008 Sep 2.

ReferenceCitation: Alasil T, Wang K, Yu F, Field MG, Lee H, Baniasadi N, de Boer JF, Coleman AL, Chen TC. Correlation of retinal nerve fiber layer thickness and visual fields in glaucoma: a broken stick model. Am J Ophthalmol. 2014 May;157(5):953-59. doi: 10.1016/j.ajo.2014.01.014. Epub 2014 Jan 30.

ReferenceCitation: Horn FK, Mardin CY, Laemmer R, Baleanu D, Juenemann AM, Kruse FE, Tornow RP. Correlation between local glaucomatous visual field defects and loss of nerve fiber layer thickness measured with polarimetry and spectral domain OCT. Invest Ophthalmol Vis Sci. 2009 May;50(5):1971-7. doi: 10.1167/iovs.08-2405. Epub 2009 Jan 17.

ReferenceCitation: Leaney J, Healey PR, Lee M, Graham SL. Correlation of structural retinal nerve fibre layer parameters and functional measures using Heidelberg Retinal Tomography and Spectralis spectral domain optical coherence tomography at different levels of glaucoma severity. Clin Exp Ophthalmol. 2012 Nov;40(8):802-12. doi: 10.1111/j.1442-9071.2012.02807.x. Epub 2012 Jul 2.

ReferenceCitation: Chauhan BC, O'Leary N, AlMobarak FA, Reis ASC, Yang H, Sharpe GP, Hutchison DM, Nicolela MT, Burgoyne CF. Enhanced detection of open-angle glaucoma with an anatomically accurate optical coherence tomography-derived neuroretinal rim parameter. Ophthalmology. 2013 Mar;120(3):535-543. doi: 10.1016/j.ophtha.2012.09.055. Epub 2012 Dec 23.

ReferenceCitation: Bussel II, Wollstein G, Schuman JS. OCT for glaucoma diagnosis, screening and detection of glaucoma progression. Br J Ophthalmol. 2014 Jul;98 Suppl 2:ii15-9. doi: 10.1136/bjophthalmol-2013-304326. Epub 2013 Dec 19. Review.

ReferenceCitation: Almobarak FA, O'Leary N, Reis AS, Sharpe GP, Hutchison DM, Nicolela MT, Chauhan BC. Automated segmentation of optic nerve head structures with optical coherence tomography. Invest Ophthalmol Vis Sci. 2014 Feb 26;55(2):1161-8. doi: 10.1167/iovs.13-13310.

ReferenceCitation: Wu H, de Boer JF, Chen TC. Diagnostic capability of spectral-domain optical coherence tomography for glaucoma. Am J Ophthalmol. 2012 May;153(5):815-826.e2. doi: 10.1016/j.ajo.2011.09.032. Epub 2012 Jan 20.

ReferenceCitation: Wu H, de Boer JF, Chen TC. Reproducibility of retinal nerve fiber layer thickness measurements using spectral domain optical coherence tomography. J Glaucoma. 2011 Oct;20(8):470-6. doi: 10.1097/IJG.0b013e3181f3eb64.

ReferenceCitation: Alasil T, Wang K, Keane PA, Lee H, Baniasadi N, de Boer JF, Chen TC. Analysis of normal retinal nerve fiber layer thickness by age, sex, and race using spectral domain optical coherence tomography. J Glaucoma. 2013 Sep;22(7):532-41. doi: 10.1097/IJG.0b013e318255bb4a.

ReferenceCitation: Wessel JM, Horn FK, Tornow RP, Schmid M, Mardin CY, Kruse FE, Juenemann AG, Laemmer R. Longitudinal analysis of progression in glaucoma using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3613-20. doi: 10.1167/iovs.12-9786.

ReferenceCitation: Langenegger SJ, Funk J, Töteberg-Harms M. Reproducibility of retinal nerve fiber layer thickness measurements using the eye tracker and the retest function of Spectralis SD-OCT in glaucomatous and healthy control eyes. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3338-44. doi: 10.1167/iovs.10-6611.

ReferenceCitation: El Chehab H, Delbarre M, Maréchal M, Rosenberg R, Marill AF, Fénolland JR, Renard JP. [New neuroretinal rim analysis with spectral domain optical coherence tomography, Spectralis (Heidelberg Engineering, Germany). Preliminary study]. J Fr Ophtalmol. 2015 Jan;38(1):46-52. doi: 10.1016/j.jfo.2014.10.004. Epub 2015 Jan 6. French.

ReferenceCitation: Strouthidis NG, Yang H, Fortune B, Downs JC, Burgoyne CF. Detection of optic nerve head neural canal opening within histomorphometric and spectral domain optical coherence tomography data sets. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):214-23. doi: 10.1167/iovs.08-2302. Epub 2008 Aug 8.

ReferenceCitation: Strouthidis NG, Grimm J, Williams GA, Cull GA, Wilson DJ, Burgoyne CF. A comparison of optic nerve head morphology viewed by spectral domain optical coherence tomography and by serial histology. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1464-74. doi: 10.1167/iovs.09-3984. Epub 2009 Oct 29.

ReferenceCitation: Strouthidis NG, Yang H, Downs JC, Burgoyne CF. Comparison of clinical and three-dimensional histomorphometric optic disc margin anatomy. Invest Ophthalmol Vis Sci. 2009 May;50(5):2165-74. doi: 10.1167/iovs.08-2786. Epub 2009 Jan 10.

ReferenceCitation: Downs JC, Roberts MD, Burgoyne CF. Mechanical environment of the optic nerve head in glaucoma. Optom Vis Sci. 2008 Jun;85(6):425-35. doi: 10.1097/OPX.0b013e31817841cb. Review.

ReferenceCitation: Burgoyne CF, Downs JC, Bellezza AJ, Suh JK, Hart RT. The optic nerve head as a biomechanical structure: a new paradigm for understanding the role of IOP-related stress and strain in the pathophysiology of glaucomatous optic nerve head damage. Prog Retin Eye Res. 2005 Jan;24(1):39-73. Review.

ReferenceCitation: Burgoyne CF, Morrison JC. The anatomy and pathophysiology of the optic nerve head in glaucoma. J Glaucoma. 2001 Oct;10(5 Suppl 1):S16-8. Review.

ReferenceCitation: Johnstone J, Fazio M, Rojananuangnit K, Smith B, Clark M, Downs C, Owsley C, Girard MJ, Mari JM, Girkin CA. Variation of the axial location of Bruch's membrane opening with age, choroidal thickness, and race. Invest Ophthalmol Vis Sci. 2014 Mar 28;55(3):2004-9. doi: 10.1167/iovs.13-12937.

lead_sponsor: University Hospital, Bordeaux


title: Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery

acronym: OSCAR

summary: Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease

ReferenceCitation: Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12.

ReferenceCitation: Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopath Assoc. 2006 Jun;106(6):327-34.

lead_sponsor: Hôpital Necker-Enfants Malades


title: May Metformin be Used in Renal Failure?

summary: The study is to treat metformin dose-escalation diabetic subjects of all stages of renal failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients by stage is considered, 60 patients in total.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Service d'Endocrinologie, Maladies Métaboliques et Nutrition


title: Response to Social Rejection in Suicidal Behavior

acronym: SADS-CS

summary:
Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response.

To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain.

The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation.

In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).


title: Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.

acronym: MINOTAURE

summary:
Migraine with aura (MA) is an independent risk factor for stroke and is associated with silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA patients. Studies with positron emission tomography have demonstrated an activation of brain stem areas during migraine attack. An increased density of brain stem grey matter as measured on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain arteries and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study hypothesize a negative correlation between the density of brainstem nuclei and the efficiency of cerebral autoregulation in MA patients compared with controls.

Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the time domain using Transcranial Doppler (TCD) and the Mx method.

MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD) are non-invasive technics and will be performed on the same day.

ReferenceCitation: Gollion C, Nasr N, Fabre N, Barège M, Kermorgant M, Marquine L, Larrue V. Cerebral autoregulation in migraine with aura: A case control study. Cephalalgia. 2019 Apr;39(5):635-640. doi: 10.1177/0333102418806861. Epub 2018 Oct 8.

name: Department of Neurology, University Hospital of Toulouse, Toulouse, France

family: Gollion

full_name: Cédric Gollion

given: Cédric

family: Nasr

full_name: Nathalie Nasr

given: Nathalie

family: Fabre

full_name: Nelly Fabre

given: Nelly

family: Barège

full_name: Michèle Barège

given: Michèle

name: UMR Institut National de la Santé et de la Recherche Médicale 1048, Institut des Maladies Métaboliques et Cardiovasculaires, Toulouse, France

family: Kermorgant

full_name: Marc Kermorgant

given: Marc

name: Clinical Investigation Centre, University Hospital of Toulouse, Toulouse, France

family: Marquine

full_name: Laurent Marquine

given: Laurent

family: Larrue

full_name: Vincent Larrue

given: Vincent

journal_name: Cephalalgia

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: University Hospital, Toulouse


title: Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .

acronym: CESAUR

summary: Preoperative anxiety before cesarean section is common and may be severe. Stress consequences are often deleterious for the mother and for the upcoming newborn. Means to reduce anxiety before cesarean section are limited. Anxiolytic drugs are avoided in the context of the birth of a newborn. Auricular acupuncture has been shown to relieve anxiety disorders. The aim of this study is to evaluate the anxiolytic effect of auricular acupuncture administered before an elective cesarean section. Anxiety will be measured at T0: inclusion (approximately 1-2 hours before cesarean section) and T1: departure to surgical unit (approximately 30 minutes to 1 hour after T0). Patches (needle or needle-free) will be set up at T0 just after the initial anxiety assessment (anxiety Visual Analog Scale aVAS).


title: A Phase II Randomized Study to Determine the Tolerance and Efficacy of Pembrolizumab or Cetuximab Combined With Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

acronym: PembroRad

summary: The general aim of the study is to evaluate the anti-tumour activity and the tolerance profile of Pembrolizumab + RT in comparison to cetuximab + RT in patients with locally advanced HNSCC and to explore potential correlations between treatment outcome and the immune landscape.

ipd_sharing: Yes

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

intervention_type: Radiation


title: Early Detection of Mucosal Abnormalities in Graft-versus-host Disease

acronym: E-mage

summary: Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The diagnosis is based on histological findings that involve colonic biopsies with a risk of bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms. Endo-microscopy is a novel endoscopic technique that allow "optical biopsies" during a conventional endoscopy and has proved its efficiency in several indications. In a pilot study the investigators showed that it had good sensibility and sensitivity compared to histology as gold standard. Therefore this study aim to identify endo-microscopic criteria allowing the early diagnosis of GHVD before its clinical manifestations.


title: Early Phase Study Comparing the Effectiveness of a Dairy Product, Co-developed by Besancon University Hospital and the National School of Dairy Industry (ENIL), With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

acronym: LactoXeros

summary:
Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency).

The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia.

This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals.

This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.


title: Endofibrose Vasculaire et génétique

acronym: GOSSER

summary: search for a genetic cause of vascular endofibrose


title: Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment

acronym: CARDIOSPACE

summary:
The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:

ECG
Brachial blood pressure
Continuous finger blood pressure
Ultrasound
Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.

location_facility: Centre de Recherche Clinique, CHU d'Angers


title: Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

acronym: STIMSYM

summary: Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease

ReferenceCitation: Meoni S, Debȗ B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25.

family: Meoni

full_name: Sara Meoni

given: Sara

family: Debȗ

full_name: Bettina Debȗ

given: Bettina

family: Pelissier

full_name: Pierre Pelissier

given: Pierre

family: Scelzo

full_name: Emma Scelzo

given: Emma

family: Castrioto

full_name: Anna Castrioto

given: Anna

family: Seigneuret

full_name: Eric Seigneuret

given: Eric

family: Chabardes

full_name: Stephan Chabardes

given: Stephan

family: Fraix

full_name: Valerie Fraix

given: Valerie

family: Moro

full_name: Elena Moro

given: Elena

journal_name: Parkinsonism & Related Disorders

lead_sponsor: University Hospital, Grenoble


acronym: PROPHYLOXITINE

summary:
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.

The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.

This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.

They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.

The primary endpoints are:

Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
Urinary concentrations of cefoxitin

primary_purpose: Other

ReferenceCitation: Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Grégoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.

name: Inserm U1070, Pôle Biologie Santé, 1 rue Georges Bonnet, Poitiers, France

name: Université de Poitiers, UFR Médecine-Pharmacie, 6 rue de la milétrie, Poitiers, France

name: Département d’Anesthésie-Réanimation, CHU de Poitiers, 2 rue de la milétrie, Poitiers, France

family: Boisson

full_name: Matthieu Boisson

given: Matthieu

family: Torres

full_name: Bruna Gaelzer Silva Torres

given: Bruna Gaelzer Silva

family: Yani

full_name: Sabrina Yani

given: Sabrina

name: Service de Toxicologie-Pharmacocinétique, CHU de Poitiers, 2 rue de la milétrie, Poitiers, France

family: Couet

full_name: William Couet

given: William

name: Service des Urgences & SAMU 86 - Centre 15, CHU de Poitiers, 2 rue de la milétrie, Poitiers, France

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Marchand

full_name: Sandrine Marchand

given: Sandrine

family: Grégoire

full_name: Nicolas Grégoire

given: Nicolas

journal_name: Journal of Antimicrobial Chemotherapy

lead_sponsor: Poitiers University Hospital


title: Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

acronym: ECLAH

summary: This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

lead_sponsor: Laboratoires Genévrier


lead_sponsor: University Hospital, Lille

acronym: LEFORTEXACYL

title: Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

summary: Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.


title: A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors

summary:
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.

The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.

Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.

In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.

To date, no data from randomized study are available in the population of cancer patients.

lead_sponsor: Centre Leon Berard


title: Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis

summary:
Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a progressive decline in lung function.

School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle strength is also impaired.

No studies assessed aerobic capacities during children's gait while carrying a backpack.

The investigators hypothesized that backpack carrying will induce an acute decline in lung function in children with cystic fibrosis compared to healthy children. Investigators also hypothesized that aerobic capacities will be impaired.

ReferenceCitation: Vieira AC, Ribeiro F. Impact of backpack type on respiratory muscle strength and lung function in children. Ergonomics. 2015;58(6):1005-11. doi: 10.1080/00140139.2014.997803. Epub 2015 Jan 13.

ReferenceCitation: Dockrell S, Simms C, Blake C. Schoolbag carriage and schoolbag-related musculoskeletal discomfort among primary school children. Appl Ergon. 2015 Nov;51:281-90. doi: 10.1016/j.apergo.2015.05.009. Epub 2015 Jun 11.

ReferenceCitation: Thobani A, Alvarez JA, Blair S, Jackson K, Gottlieb ER, Walker S, Tangpricha V. Higher mobility scores in patients with cystic fibrosis are associated with better lung function. Pulm Med. 2015;2015:423219. doi: 10.1155/2015/423219. Epub 2015 Feb 18.

ReferenceCitation: Ramsey KA, Ranganathan S. Interpretation of lung function in infants and young children with cystic fibrosis. Respirology. 2014 Aug;19(6):792-9. doi: 10.1111/resp.12329. Epub 2014 Jun 19. Review.

ReferenceCitation: Pastré J, Prévotat A, Tardif C, Langlois C, Duhamel A, Wallaert B. Determinants of exercise capacity in cystic fibrosis patients with mild-to-moderate lung disease. BMC Pulm Med. 2014 Apr 30;14:74. doi: 10.1186/1471-2466-14-74.

lead_sponsor: Groupe Hospitalier du Havre


title: Impact of Obstructive Sleep Apnea Syndrome on Metastatic Potential of Cutaneous Melanoma : Prospective Study in Patients With High Risk Melanoma

acronym: MELA-SAS

summary:
Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. Patients with sleep apnea will be treated.

Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.

status: Withdrawn

lead_sponsor: AGIR à Dom


title: Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients

acronym: TRITITOX

summary:
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after 3 consecutives BTI sessions.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805