title: Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock

summary:
Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV. Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response of the organism to a severe infection, associated with a circulatory failure marker by an arterial hypotension and a vascular hyperactivity to vasoconstrictor agents.

The mechanisms involved on one hand an activation of white blood cells inflammatory system and the vascular inflammatory system; and on the other hand on imbalance in hemostatis characterized by an activation of the coagulation and an inappropriate fibrinolysis leading to a disruption of microcirculation in the context of a disseminated intravascular coagulation (DIVC).

This inflammatory and thrombotic cellular activation is strongly associated with the phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by blood cells and vascular cells.

MP are membranous vesicles, resulting in the reassortment of membrane phospholides in response to an activation of cellular apoptosis. They have been initially described as new actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF) confer them a procoagulating activity, which increases in patients undergoing septic shock.

The finding of a fibriniolytic activity of the cellular MP suggests the existence of compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the control of the coagulolytic balance.

Our recent researches suggest that endothelial and white blood cells MP produce in vivo plasmin.

They carry into the main circulation a fibrinolytic activity which is partially beyond the physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that this ability of plasmin generation is important in patients affected with septic shock.

Our hypothesis is that an increase in plasmin generation by MP compensates the risk of occurrence of microthrombosis, modulating therefore the vital prognosis of patients with septic shock.

The coagulolytic balance of MP, which is resulting of their own procoagulating and fibrinolytic activities could claim the status of new pronostic marker relevant in patients with septic shock.

location_facility: Assistance Publique des Hôpitaux de Marseille

intervention_type: Biological


title: Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo

summary: The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Vivatech

intervention_type: Dietary Supplement

lead_sponsor_type: industriel

status_simplified: Completed


title: PET Imaging of the Translocator Proteine Ligands (TSPO) With [18 F] DPA-714 Biomarker of NeuroInflammation in Cognitive Decline (NIDECO)

acronym: NIDeCo

summary:
Alzheimer's disease (AD) is the most common cause of dementia in elderly subjects. AD is characterized by brain lesions like extracellular deposits of ß-amyloïd proteins in senile plaques and intracellular neurofibrillary tangles of hyper-phosphorylated tau protein, both of which are associated with the loss of neurons. The development of disease biomarkers for AD (Tau, PhTau and βamyloid dosing in the cerebrospinal fluid, brain MRI, amyloid PET imaging and fluorodeoxyglucose PET imaging) to identify the pathophysiological processes underlying cognitive impairment biomarkers, have been incorporated into revised diagnosis guidelines.

Post-mortem human AD and AD animal model studies have reported inflammatory processes also implicated in the neuropathology of AD, and upregulated levels of pro-inflammatory cytokines.

In vivo visualization of microglial activation has become possible with the development of molecular imaging ligands (tracers) for use with positron emission tomography (PET). The translocator protein (TSPO) formerly known as the peripheral benzodiazepine receptor (PBR), a receptor located in the outer membrane of mitochondria, is upregulated during neuroinflammation. So targeting TSPO with radiolabeled ligands for PET is considered as an attractive biomarker for neuroinflammation.

The main aim of this pilot study is to quantify neuroinflammation, in terms of fixation and distribution of [18F] DPA-714(Binding Potential BP), and to study its relationship with amyloid load, measured with in [18F]AV-45 (Standard Uptake Values ratio) in cognitive decline.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 2012 May;39(4):570-8. doi: 10.1016/j.nucmedbio.2011.10.012. Epub 2011 Dec 14.

family: Arlicot

full_name: Nicolas Arlicot

given: Nicolas

sequence: first

family: Vercouillie

full_name: Johnny Vercouillie

given: Johnny

sequence: additional

family: Ribeiro

full_name: Maria-João Ribeiro

given: Maria-João

family: Tauber

full_name: Clovis Tauber

given: Clovis

family: Venel

full_name: Yann Venel

given: Yann

family: Baulieu

full_name: Jean-Louis Baulieu

given: Jean-Louis

family: Maia

full_name: Serge Maia

given: Serge

family: Corcia

full_name: Philippe Corcia

given: Philippe

family: Stabin

full_name: Michael G. Stabin

given: Michael G.

family: Reynolds

full_name: Aaron Reynolds

given: Aaron

family: Kassiou

full_name: Michael Kassiou

given: Michael

family: Guilloteau

full_name: Denis Guilloteau

given: Denis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Nuclear Medicine and Biology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Camus V, Payoux P, Barré L, Desgranges B, Voisin T, Tauber C, La Joie R, Tafani M, Hommet C, Chételat G, Mondon K, de La Sayette V, Cottier JP, Beaufils E, Ribeiro MJ, Gissot V, Vierron E, Vercouillie J, Vellas B, Eustache F, Guilloteau D. Using PET with 18F-AV-45 (florbetapir) to quantify brain amyloid load in a clinical environment. Eur J Nucl Med Mol Imaging. 2012 Apr;39(4):621-31. doi: 10.1007/s00259-011-2021-8. Epub 2012 Jan 18.

family: Camus

full_name: V. Camus

given: V.

family: Payoux

full_name: P. Payoux

given: P.

family: Barré

full_name: L. Barré

given: L.

family: Desgranges

full_name: B. Desgranges

given: B.

family: Voisin

full_name: T. Voisin

given: T.

full_name: C. Tauber

given: C.

family: La Joie

full_name: R. La Joie

given: R.

family: Tafani

full_name: M. Tafani

given: M.

family: Hommet

full_name: C. Hommet

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

ReferenceCitation: La Joie R, Perrotin A, Barré L, Hommet C, Mézenge F, Ibazizene M, Camus V, Abbas A, Landeau B, Guilloteau D, de La Sayette V, Eustache F, Desgranges B, Chételat G. Region-specific hierarchy between atrophy, hypometabolism, and β-amyloid (Aβ) load in Alzheimer's disease dementia. J Neurosci. 2012 Nov 14;32(46):16265-73. doi: 10.1523/JNEUROSCI.2170-12.2012.

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

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

title: Region-Specific Hierarchy between Atrophy, Hypometabolism, and -Amyloid (A ) Load in Alzheimer's Disease Dementia

ReferenceCitation: Beaufils E, Dufour-Rainfray D, Hommet C, Brault F, Cottier JP, Ribeiro MJ, Mondon K, Guilloteau D. Confirmation of the amyloidogenic process in posterior cortical atrophy: value of the Aβ42/Aβ40 ratio. J Alzheimers Dis. 2013;33(3):775-80. doi: 10.3233/JAD-2012-121267.

name: Université François Rabelais de Tours, Tours, France

name: INSERM, U930, Imagerie et cerveau, Tours, France

title: Confirmation of the Amyloidogenic Process in Posterior Cortical Atrophy: Value of the Aβ42/Aβ40 Ratio

ReferenceCitation: Corcia P, Tauber C, Vercoullie J, Arlicot N, Prunier C, Praline J, Nicolas G, Venel Y, Hommet C, Baulieu JL, Cottier JP, Roussel C, Kassiou M, Guilloteau D, Ribeiro MJ. Molecular imaging of microglial activation in amyotrophic lateral sclerosis. PLoS One. 2012;7(12):e52941. doi: 10.1371/journal.pone.0052941. Epub 2012 Dec 31.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repositories:
PubMed Central
Zenodo
pdfs.semanticscholar.org

title: Molecular Imaging of Microglial Activation in Amyotrophic Lateral Sclerosis


type: Other Identifier

title: Estimation of Muscle Mass in Older Adults Using Deuterated Creatine

acronym: MM-DC

summary:
Current methods for the quantification of muscle mass are indirect, lack precision, and often rely on expensive equipment that only provides limited (indirect) data on whole body muscle mass. Dual energy X ray absorptiometry has emerged as a potential precise measure of lean mass, easy to use in clinical practice and research. However, it assesses an indirect measurement of total-body skeletal muscle mass and its clinical use for determination of changes in muscle mass may be very limited due to instrumentation availability, particularly in field studies, and cost. Moreover, these methods provide estimates of fat free mass that is not skeletal muscle specific, and are influenced by changes in regional or total body water content.

GlaxoSmithKline (GSK) has developed a novel technique using deuterium labeled creatine dilution for the estimation of muscle mass and has begun clinical evaluation of this muscle-measure in healthy young and older adults.

study_start_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse

location_facility: Gerontopôle - CHU La Grave Casselardit - Serv. de Médecine Interne & de Gérontologie Clinique - 170 av de Casselardit - TSA 40031

lead_sponsor_type: academique


title: Prospective Trial for the Evaluation of Safety, Tolerability and Efficacy of the Medical Device Simeox ® Compared to Traditional Respiratory Physiotherapy Techniques for Airway Secretion Clearance

acronym: SIMETOL

summary: The purpose of this study is to determine whether the medical device "simeox" is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.

status: Terminated

lead_sponsor: Physio-Assist

intervention_type: Device

status_simplified: Unknown


title: Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)

acronym: PPA

summary: The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)

lead_sponsor: Rennes University Hospital

intervention_type: Other


title: Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users

acronym: VIGICANN

summary: Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.

ReferenceType: derived

ReferenceCitation: Alvarez JC, Hartley S, Etting I, Ribot M, Derridj-Ait-Younes N, Verstuyft C, Larabi IA, Simon N. Population pharmacokinetic model of blood THC and its metabolites in chronic and occasional cannabis users and relationship with on-site oral fluid testing. Br J Clin Pharmacol. 2021 Aug;87(8):3139-3149. doi: 10.1111/bcp.14724. Epub 2021 Jan 12.

name: Service de Pharmacologie Toxicologie, Assistance Publique‐Hôpitaux de Paris Hôpital Raymond Poincaré  Garches France

name: MasSpecLab, Plateforme de Spectrométrie de Masse, INSERM U‐1173 Université Paris Saclay  Montigny‐le‐Bretonneux France

family: Alvarez

full_name: Jean Claude Alvarez

given: Jean Claude

name: Sleep Centre, Service d'Explorations Fonctionnelles, Inserm U‐1179, Assistance Publique‐Hôpitaux de Paris Hôpital Raymond Poincaré  Garches France

family: Hartley

full_name: Sarah Hartley

given: Sarah

family: Etting

full_name: Isabelle Etting

given: Isabelle

family: Ribot

full_name: Mégane Ribot

given: Mégane

name: Unité de Recherche Clinique, Assistance Publique‐Hôpitaux de Paris Hôpital Ambroise Paré  Boulogne‐Billancourt France

family: Derridj‐Ait‐Younes

full_name: Nawal Derridj‐Ait‐Younes

given: Nawal

name: Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie, Hôpitaux Universitaires Paris‐Sud, Assistance Publique‐Hôpitaux de Paris, EquipeMoods, INSERM U‐1178, CESP Université Paris‐Sud  Le Kremlin Bicêtre France

family: Verstuyft

full_name: Céline Verstuyft

given: Céline

family: Larabi

full_name: Islam‐Amine Larabi

given: Islam‐Amine

name: APHM, INSERM, IRD, SESSTIM Hôpital Sainte Marguerite Pharmacologie Clinique CAP‐TV, Aix Marseille Univ  Marseille France

family: Simon

full_name: Nicolas Simon

given: Nicolas

journal_name: British Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Population pharmacokinetic model of blood THC and its metabolites in chronic and occasional cannabis users and relationship with on‐site oral fluid testing

ReferenceCitation: Hartley S, Simon N, Larabi A, Vaugier I, Barbot F, Quera-Salva MA, Alvarez JC. Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. Clin Chem. 2019 May;65(5):684-693. doi: 10.1373/clinchem.2018.299727. Epub 2019 Mar 14.

name: AP-HP, Hôpital Raymond Poincaré, Sleep Centre, Service d'Explorations Fonctionnelles, Garches, Université de Versailles-St. Quentin, France

name: Aix Marseille Université, APHM, INSERM, IRD, SESSTIM, Hôpital Sainte Marguerite, Service de Pharmacologie Clinique, CAP-TV, Marseille, France

name: AP-HP, Hôpital Raymond Poincaré, Service de Pharmacologie Toxicologie, Garches, INSERM U-1173, Université de Versailles-St. Quentin, France

full_name: Amine Larabi

given: Amine

name: INSERM CIC 1429, Hôpital Raymond Poincaré, Garches, France

family: Vaugier

full_name: Isabelle Vaugier

family: Barbot

full_name: Frédéric Barbot

given: Frédéric

family: Quera-Salva

full_name: Maria-Antonia Quera-Salva

given: Maria-Antonia

journal_name: Clinical Chemistry

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic–Pharmacodynamic Relationship

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


acronym: OPTIPOST

summary:
Harrington's metaphorical depiction captures the essence of the problem : "Osteoporosis care of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists, primary care physicians and osteoporosis experts into which the fracture patient disappears".

The most effective way to achieve this goal is through implementation of coordinator-based post fracture models of care. Exemplar models have been refered to as "Fracture Liaison Service" (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) "Osteoporosis Coordinator Program" (Canada [9,10]) or "Care Manager Programs" (USA [11,12]).

The objective of this trial is to assess efficacy of a new coordinator-based post-fracture program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after fracture thanks to an optimal recommendations practice to reduce the incidence of secondary fractures.

Men and women are included aged over 45 years with fragility wrist and hip fractures.

Evaluation criteria are based on the evidence-based assessment (stratify risk, identify secondary causes of osteoporosis, fracture evaluation), the medication adherence, others prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number of falls.

Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6 months

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: 1. Mc Lellan AR and al. Osteoprosis Int. 2003; 1028-1034 2. Wright SA and al. Rheumatol Int 2005; 489-490 3. Clunie G and al. J Orthop Nurs 2008; 156-162 4. Boudou L and al. Osteoporos Int 2011; 2099-2016 5. Huntjzens KM ana al. Osteoporos Int 2011; 2119-2135 6. Cooper MS and al. Osteoporos Int 2012; 97-107 7. Inderjeeth CA and al. Med J Aus 2010; 149-153 8. Lih A and al. Osteoporos Int 2011; 849-858 9. Bogoch ER and al. J Bone Joint Surg Am 2006; 25-34 10. SAbder B abd al. J Bone Joint Surg Am 2008; 1197-1205 11. Dell R and al. J Bone Joint Surg Am 2008; 188-194 12. Greene D and al. J Am Acad Nurse Pract 2010; 326-329

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Behavioral


title: Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease. a Retrospective and Prospective 20-year Follow-up.

acronym: PVNIM

summary: The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.

status: Recruiting

study_type: Observational

time_perspective: Other

lead_sponsor: Association HGE CHU Bordeaux Sud

location_facility: Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque

status_simplified: Ongoing


type: EudraCT Number

title: Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2

acronym: IMODALS

summary: The primary objective is to evaluate in ALS patients the regulatory T cell early response to two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days comparatively to placebo.

ReferenceCitation: Camu W, Mickunas M, Veyrune JL, Payan C, Garlanda C, Locati M, Juntas-Morales R, Pageot N, Malaspina A, Andreasson U, Kirby J, Suehs C, Saker S, Masseguin C, De Vos J, Zetterberg H, Shaw PJ, Al-Chalabi A, Leigh PN, Tree T, Bensimon G. Repeated 5-day cycles of low dose aldesleukin in amyotrophic lateral sclerosis (IMODALS): A phase 2a randomised, double-blind, placebo-controlled trial. EBioMedicine. 2020 Sep;59:102844. doi: 10.1016/j.ebiom.2020.102844. Epub 2020 Jul 7.

family: Camu

full_name: William Camu

given: William

family: Mickunas

full_name: Marius Mickunas

given: Marius

family: Veyrune

full_name: Jean-Luc Veyrune

given: Jean-Luc

family: Payan

full_name: Christine Payan

given: Christine

family: Garlanda

full_name: Cecilia Garlanda

given: Cecilia

family: Locati

full_name: Massimo Locati

given: Massimo

family: Juntas-Morales

full_name: Raul Juntas-Morales

given: Raul

family: Pageot

full_name: Nicolas Pageot

family: Malaspina

full_name: Andrea Malaspina

given: Andrea

family: Andreasson

full_name: Ulf Andreasson

given: Ulf

family: Kirby

full_name: Janine Kirby

given: Janine

family: Suehs

full_name: Carey Suehs

given: Carey

family: Saker

full_name: Safa Saker

given: Safa

family: Masseguin

full_name: Christophe Masseguin

given: Christophe

family: De Vos

full_name: John De Vos

given: John

family: Zetterberg

full_name: Henrik Zetterberg

given: Henrik

family: Shaw

full_name: Pamela J Shaw

given: Pamela J

family: Al-Chalabi

full_name: Ammar Al-Chalabi

given: Ammar

family: Leigh

full_name: P Nigel Leigh

given: P Nigel

family: Tree

full_name: Timothy Tree

given: Timothy

family: Bensimon

full_name: Gilbert Bensimon

given: Gilbert

currency_apc_doaj: USD

journal_name: EBioMedicine

oa_colors: green gold

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

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

repository_institution: University College London - UCL Discovery

repository_institution: University of Sussex - Sussex Research Online

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac


title: Diagnostic Performances of Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism

summary: Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE) due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the legs in patients with suspicion of PE.

ReferenceCitation: Revel MP, Sanchez O, Lefort C, Meyer G, Couchon S, Hernigou A, Niarra R, Chatellier G, Frija G. Diagnostic accuracy of unenhanced, contrast-enhanced perfusion and angiographic MRI sequences for pulmonary embolism diagnosis: results of independent sequence readings. Eur Radiol. 2013 Sep;23(9):2374-82. doi: 10.1007/s00330-013-2852-8. Epub 2013 May 8.

family: Revel

full_name: Marie Pierre Revel

given: Marie Pierre

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Lefort

full_name: Catherine Lefort

given: Catherine

family: Meyer

full_name: Guy Meyer

given: Guy

family: Couchon

full_name: Sophie Couchon

given: Sophie

family: Hernigou

full_name: Anne Hernigou

given: Anne

family: Niarra

full_name: Ralph Niarra

given: Ralph

family: Chatellier

full_name: Gilles Chatellier

given: Gilles

family: Frija

full_name: Guy Frija

journal_name: European Radiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Revel MP, Sanchez O, Couchon S, Planquette B, Hernigou A, Niarra R, Meyer G, Chatellier G. Diagnostic accuracy of magnetic resonance imaging for an acute pulmonary embolism: results of the 'IRM-EP' study. J Thromb Haemost. 2012 May;10(5):743-50. doi: 10.1111/j.1538-7836.2012.04652.x.

ReferenceCitation: Stein PD, Chenevert TL, Fowler SE, Goodman LR, Gottschalk A, Hales CA, Hull RD, Jablonski KA, Leeper KV Jr, Naidich DP, Sak DJ, Sostman HD, Tapson VF, Weg JG, Woodard PK; PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators. Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III). Ann Intern Med. 2010 Apr 6;152(7):434-43, W142-3. doi: 10.7326/0003-4819-152-7-201004060-00008.

intervention_type: Procedure


title: Evaluation of Dynamic Stability in the Low Back Pain Patient

acronym: SDL

summary: The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax, an indicator of local dynamic stability) of chronic low back pain patients versus that of healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low back pain patients).

time_perspective: Prospective

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Study of MRI 3 Tesla Using Arterial Spin Labeling (Without Infusion) in Cognitive Atypical Disorders and Comparison to FDG-PET

acronym: ASLDEM DS

summary:
DESCRIPTION OF RELATED QUESTION Cognitive disorders are frequently encountered and present a major public health problem given the aging of the population.

There is not one, but several neurodegenerative pathologies individual differentiated.

Particularly distinguished is Alzheimer's disease (the most common), dementia lobar fronto-temporal associated with semantic dementia (a disease with a particular tropism for semantic memory and the anterior temporal lobe), and dementia with Lewy bodies.

To differentiate these pathologies is, for the clinician, is a major issue and the clinic may not be enough.

The management and current diagnostics of atypical cognitive disorders, that is to say, patients with clinical symptoms or neuropsychological testing results suggestive of a neurodegenerative disorder other than Alzheimer's disease, are based largely on data imaging.

In the first intention, conducting imaging by MRI is recommended by the HAS, particularly to search for treatable causes to these cognitive disorders (tumors, intracranial hemorrhage in particular) but also to study the distribution of cerebral atrophy.

The sequences used are the sequences 3D T1, axial Flair, gradient echo axial T2 and coronal T2 in the plane of hippocampi and also diffusion imaging.

Research has shown interest in the study of cerebral perfusion in cognitive disorders.

The HAS recommends not to inject contrast medium on MRI in this context. The sequence of perfusion by tagging arterial protons or "arterial spin labeling" (ASL) does not use exogenous contrast medium. This is available as a commercial product, CE marked, on most of the recent clinical MRI scanners. This non-invasive technique, requiring no special precautions (e.g. verification of renal function) is used in routine clinical practice at the University Hospital of Rennes and in many centers. In the imaging of patients with dementia, it is widely used as well as the 3D T1 sequences or diffusion imaging (International Initiative ADNI) and is subject to optimization and harmonization of use in routine clinical practice with the European COST AID actions.

The second intention, an isotope imaging by FDG-PET or study of perfusion SPECT can also be performed. The interest of isotopic imaging (FDG-PET and SPECT) lies in the provision of information metabolic nonexistent in MRI, with a superiority of FDG-PET compared with SPECT. FDG-PET is the preferred examination and is carried out at CRLCC Eugène Marquis de Rennes in this context.

The aim of our study is to compare the imaging of TEPFDG, a technique not morphological, and ASL that, even if they do not study the same mode (metabolism for the first and perfusion for the second) may depict consistent anomalies.


title: Cytokine Assay in Tears of Healthy Children and With Vernal Keratocunjonctivitis: Case Control Study and Monitoring of Cases at 6 Months

summary: The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

summary: The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.

lead_sponsor: Abbott Medical Devices


title: Speckle Tracking 2D Echocardiography in Healthy Child. Comparison of Two Different Software Systems : Echopac (General Electric) and QLAB 9.0 (Philips).

summary: · 2D Speckle Tracking echocardiography gained importance for the evaluation of ventricle contractility. Many indications have been developed in child population. However, the comparability of measurements between different software systems is not well defined. We choose to compare two software systems very often used in paediatric subjects : Echopac by General Electric and QLAB 9.0 by Philips. We offer a randomly second echocardiography to children which have normal heart. We compare Strain and Strain rate results between the two tests with a study of variability : ultrasound variability, operator variability, reader variability.

primary_purpose: Other

ReferenceCitation: Amedro P, Bredy C, Guillaumont S, De La Villeon G, Gamon L, Lavastre K, Meli AC, Richard S, Cazorla O, Lacampagne A, Mura T, Vincenti M. Speckle tracking echocardiography in healthy children: comparison between the QLAB by Philips and the EchoPAC by General Electric. Int J Cardiovasc Imaging. 2019 May;35(5):799-809. doi: 10.1007/s10554-018-01516-2. Epub 2019 Jan 8.

family: Amedro

full_name: Pascal Amedro

given: Pascal

family: Bredy

full_name: Charlene Bredy

given: Charlene

family: Guillaumont

full_name: Sophie Guillaumont

family: De La Villeon

full_name: Gregoire De La Villeon

given: Gregoire

family: Gamon

full_name: Lucie Gamon

given: Lucie

family: Lavastre

full_name: Kathleen Lavastre

given: Kathleen

family: Meli

full_name: Albano C. Meli

given: Albano C.

family: Richard

full_name: Sylvain Richard

given: Sylvain

family: Cazorla

full_name: Olivier Cazorla

family: Lacampagne

full_name: Alain Lacampagne

given: Alain

family: Mura

full_name: Thibault Mura

given: Thibault

family: Vincenti

full_name: Marie Vincenti

given: Marie

journal_name: The International Journal of Cardiovascular Imaging

oa_host_type: repository

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

host_type: repository

repository_normalized: HAL

version: submittedVersion

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

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: University Hospital, Montpellier

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


title: Identification of a New Gene Involved in Hereditary Lipodystrophy - LIPOGENE

acronym: LIPOGENE

summary: Human lipodystrophies (lipoD) represent a heterogeneous group of diseases characterized by generalized or partial fat loss, with fat hypertrophy in other depots when partial.3, 4 Insulin resistance, dyslipidemia and diabetes are generally associated, leading to early complications. Acquired lipoD can be generalized, resembling congenital forms, or partial, as the Barraquer-Simons syndrome, with loss of fat in the upper part of the body contrasting with accumulation in the lower part. The most common forms of lipoD are iatrogenic. In human immunodeficiency virus-infected patients, some first-generation antiretroviral drugs were strongly related with peripheral lipoatrophy and metabolic alterations. Genetic forms are very uncommon: recessive generalized congenital lipoD result in most cases from mutations in the genes encoding seipin or the 1-acyl-glycerol-3-phosphate-acyltransferase 2 (AGPAT2). Dominant partial familial lipoD result from mutations in genes encoding the nuclear protein lamin A/C or the adipose transcription factor PPARgamma. Importantly, LMNA mutations are also responsible for metabolic laminopathies, resembling the metabolic syndrome and progeria, a syndrome of premature aging. Molecular genetic bases of many rare forms of genetic lipoD remain to be elucidated.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Genetic


type: Registry Identifier

title: Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy

acronym: ISIS

summary: The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy

ReferenceCitation: Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9.

ReferenceCitation: Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30. Review.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du Cancer - Montpellier - Val d'Aurelle


title: Analysis of the Mechanisms of Actions of Hsp27 Responsible of the Androgen-independent Evolution in Prostate Cancer

summary: Prostate cancer (PC) represents one of the most common cancers in industrialized countries. Patients with localized disease may be treated with surgery or radiation, while androgen ablation is used as first-line therapy in patients with metastatic disease. While most patients initially respond well to this hormonal therapy, they most ultimately become unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC). Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in two different, large, phase III studies. However, the median overall survival was prolonged for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent androgen receptor (AR) activation, alternative growth factor pathways, and immune system escape. Additional therapeutic strategies targeting molecular mechanisms mediating resistance, combined with immunotherapy must be developed. One strategy to improve therapies in advanced PC involves targeting genes that are activated by androgen withdrawal, either to delay or prevent the emergence of the resistant AI phenotype. Recently, a scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC. Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA) increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite OGX-427 efficiency, the functional role of stress induced Hsp27 in castration or chemotherapy-induced apoptosis remains undefined. The purpose of this study is to elucidate the pathways leading to Hsp27 action in androgen-independent prostate cancer in order to 1/ Increase the pharmacological safety of OGX-427 and 2/find new specific therapeutic targets and treatment strategy for androgen-independent prostate cancer .

primary_purpose: Basic Science

lead_sponsor: Institut Paoli-Calmettes


title: THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo

acronym: TAPBloc Rachis

summary:
This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.

Procedure:

Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Search Tolerance Signature in Vascularised Composite Allograft

acronym: BIOCTA

summary:
Composite tissue allotransplants (CTA) involve transplantation of various tissues including vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The large majority of recipients have been maintained on immunosuppression therapy similar to that used in solid organ transplantation that is associated with the complications usually reported in solid organ transplantation. The question whether risks associated with indefinite immunosuppressive are justified for a non-lifesaving procedure still remains unanswered. At present no CTA recipient proved to be spontaneously tolerant with any immunosuppressive protocol; indeed, until now all recipients who discontinued the immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a low incidence of chronic rejection despite the high incidence of acute rejection episodes.

For all these reasons it should be of great interest to minimize the immunosuppression in CTA patients knowing their immunologic "risk". The main outcome of this study is to search for the signature of tolerance in recipients of hand or face allotransplantation testing biomarkers previously identified in operational tolerant kidney transplant recipients.

These markers have been developed studying tolerant kidney recipients and they were already tested in five bilateral hand transplantations and one face transplantation.

The present study will include hand and face allograft recipients transplanted at least one year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand transplantations, 4 single hand transplantations and 3 face transplantations. All the patients will undergo B cell phenotyping, TCR repertoire, molecular signature from operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in order to show signs of acute or chronic rejection.

The results could provide a valid tool to detect operationally tolerant recipients as well as recipients prone to develop chronic rejection.

lead_sponsor: Hospices Civils de Lyon


title: Effects of Low Frequency Deep Brain Stimulation of the Pedunculopontine Nucleus on Gait and Balance Disorders of Parkinson's Disease

summary:
The appearance of postural instability and gait disorders is a major turning point in the evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced outside mobility. There is no effective pharmacological treatment available for these symptoms, and their pathophysiology is not well known : it is currently assumed that non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the origin of these axial symptoms, since the PPN participates in the maintenance of posture and motion in primates. In PD patients, recent reports have suggested that low frequency stimulation of the PPN may equally improve gait and posture. However, these results are debatable due to methodological limitations, insufficient clinical evaluation and uncertain anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable for this operation due to gait and posture disorders. We will perform a randomized, double-blind and cross over design (two months periods with and without DBS randomly assigned to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each patient. Evaluations will comprise 1 month before surgery and in "Off" and "On" stimulation condition:

clinical motor assessment in both "Off" and "On" drug state, including cardinal parkinsonian signs, gait and balance
gait initiation physiological evaluation
cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN stimulation may well represent a substantial improvement of our therapeutic options for advanced PD patients suffering from debilitating gait and posture disorders unresponsive to L-Dopa.

lead_sponsor: Pitié-Salpêtrière Hospital


title: Long-term Follow-up of Patients With Sanfilippo Type A Syndrome Who Have Previously Been Treated in the P1-SAF-301 Clinical Study Evaluating the Tolerability and Safety of the Intracerebral Administration of SAF-301.

summary:
P2-SAF-301 is an open-label interventional study without administration of investigational product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The primary objective is to collect additional safety and tolerability data on intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The secondary objective is to further collect data to assess the effects of SAF-301 on neurological and psychological status, and potential biological markers.

lead_sponsor: LYSOGENE

location_facility: Hôpitaux Universitaires Paris Sud (Bicêtre)


title: Co-LEsions in Alzheimer Disease and Related Disorders

acronym: CLEM

summary:
One of the crucial challenges for the future of Alzheimer's disease (AD) therapeutic approaches in elderly is to target the main pathological process responsible for disability and dependency. However, a progressive cognitive impairment occurring after the age of 70 is often related to mixed lesions of neurodegenerative and vascular origins. Whereas young patients are mostly affected by pure lesions, aging favors the occurrence of co-lesions of AD, vascular and Lewy body types. Pure DLB (Dementia with Lewy Body) and AD are distinct disorders but they often coexist in old age patients, the Abeta pathology of DLB/AD cases being different to that observed in patients with AD alone. Vascular dementia (VD) and AD with cerebrovascular disease (AD+CVD) are the leading causes of dementia next to AD alone. Lack of consensus persists about the diagnosis criteria for VD and AD+CVD, due in part to their clinical, pathological heterogeneity and the multiple pathological subtypes.

We do not know the precise role and weight of each brain lesion type in the disability progression in elderly. To target the actual pathological process, we need to disclose the functional weight of AD, Lewy body and vascular lesion types in elderly. Most of the studies report on functional and clinical abnormalities in patients with pure pathologies. Thus, co-morbid processes involved in the transition from an independent functional status to disability in the elderly with co-lesions still remain to be elucidated. Neuropathological examination often performed at late stages cannot answer this question at mild or moderate stages.

Brain MRI, Single Photon Emission Computed Tomography (SPECT) with DaTscan® and CSF biomarkers help routinely in performing the diagnosis of pure or mixed lesions responsible for dementia. The topography of the atrophy in MRI helps to provide information about the etiological diagnosis. Medial temporal lobe atrophy on MRI has good discriminatory power for AD compared to DLB and VD in pathologically confirmed cases. DaTscan® SPECT presents with good sensitivity and specificity at early stages of DLB. The good diagnosis value of CSF biological markers has led recently to their inclusion in the research diagnosis criteria of AD. Low Aβ1-42 and high levels of total tau and hyperphosphorylated tau isoforms appear to be the most sensitive and specific CSF biomarkers. Aβ1-42 is lowered in AD, as well as in other neurodegenerative diseases like DLB, VD. The combination of MRI, particularly medial temporal atrophy measures and vascular lesions on FLAIR MRI sequences, SPECT and CSF biomarkers seem to be of incremental value for the diagnosis AD, VD, DLB and mixed profiles.

The aim of this study is to identify the biomarkers (MRI, SPECT-DaTscan® and CSF), and their combination, that are the most predictive of functional disability in elderly presenting with a progressive cognitive decline related to AD, DLB, VD and all mixed patterns.

primary_purpose: Screening

ReferenceCitation: Boublay N, Fédérico D, Pesce A, Verny M, Blanc F, Paccalin M, Desmidt T, Grosmaître P, Moreaud O, Relland S, Bravant E, Bouet R, Krolak-Salmon P. Study protocol on Alzheimer's disease and related disorders: focus on clinical and imaging predictive markers in co-existing lesions. BMC Geriatr. 2018 Nov 14;18(1):280. doi: 10.1186/s12877-018-0949-2.

family: Boublay

full_name: Nawele Boublay

given: Nawele

family: Fédérico

full_name: Denis Fédérico

given: Denis

family: Pesce

full_name: Alain Pesce

family: Verny

full_name: Marc Verny

given: Marc

family: Blanc

full_name: Frédéric Blanc

given: Frédéric

family: Paccalin

full_name: Marc Paccalin

family: Desmidt

full_name: Thomas Desmidt

given: Thomas

family: Grosmaître

full_name: Pierre Grosmaître

given: Pierre

family: Moreaud

full_name: Olivier Moreaud

given: Olivier

family: Relland

full_name: Solveig Relland

given: Solveig

family: Bravant

full_name: Estelle Bravant

given: Estelle

family: Bouet

full_name: Romain Bouet

given: Romain

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

currency_apc_doaj: GBP

journal_name: BMC Geriatrics

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

title: Study protocol on Alzheimer’s disease and related disorders: focus on clinical and imaging predictive markers in co-existing lesions


title: AnalyST & Brugada Syndrome - Feasibility Study

summary:
Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated to the ventricular fibrillation risk of these patients, but there is no mean to record the ECG over a long period of time.

The objective of the study is to evaluate the correlation between ST elevation on the electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled in the study are patients already implanted with a defibrillator for their Brugada syndrome. During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG will be compared to assess the detection of the typical ST-shift by the ICD.


title: Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

acronym: Compli-STARR

summary:
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.

The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.

This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.

Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.

No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.

Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.

The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.

Twenty-eight patients will be enrolled in this study over a period of 36 months.

Preoperative assessment will include

clinical examination
the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence
video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.

If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.

lead_sponsor: University Hospital, Rouen


title: Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo

acronym: REA-FO

summary:
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.

We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.

This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.

The purpose of this study is to evaluate the stiffness during open heart surgery.

lead_sponsor: University Hospital, Caen


title: Impact of Type 1 Diabetes and Glycated Haemoglobin Levels on Oxygen Delivery and Release to Active Muscle During Exercise and on Muscle Oxidation Capacity - Possible Impact on Aerobic Fitness

acronym: OXYDIAB

summary: Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels, reflecting poor long term glycaemic control. To explain this relationship, the indirect effect of chronically high blood glucose levels on cardiovascular complications - and hence on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes. Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and use and hence on aerobic fitness.

time_perspective: Cross-Sectional

ReferenceCitation: Lespagnol E, Tagougui S, Fernandez BO, Zerimech F, Matran R, Maboudou P, Berthoin S, Descat A, Kim I, Pawlak-Chaouch M, Boissière J, Boulanger E, Feelisch M, Fontaine P, Heyman E. Circulating biomarkers of nitric oxide bioactivity and impaired muscle vasoreactivity to exercise in adults with uncomplicated type 1 diabetes. Diabetologia. 2021 Feb;64(2):325-338. doi: 10.1007/s00125-020-05329-8. Epub 2020 Nov 21.

family: Lespagnol

full_name: Elodie Lespagnol

given: Elodie

family: Tagougui

full_name: Sémah Tagougui

given: Sémah

family: Fernandez

full_name: Bernadette O. Fernandez

given: Bernadette O.

family: Zerimech

full_name: Farid Zerimech

given: Farid

family: Matran

full_name: Régis Matran

given: Régis

family: Maboudou

full_name: Patrice Maboudou

given: Patrice

family: Berthoin

full_name: Serge Berthoin

given: Serge

family: Descat

full_name: Amandine Descat

given: Amandine

family: Kim

full_name: Isabelle Kim

given: Isabelle

family: Pawlak-Chaouch

full_name: Mehdi Pawlak-Chaouch

given: Mehdi

family: Boissière

full_name: Julien Boissière

given: Julien

family: Boulanger

full_name: Eric Boulanger

given: Eric

family: Feelisch

full_name: Martin Feelisch

given: Martin

family: Fontaine

full_name: Pierre Fontaine

family: Heyman

full_name: Elsa Heyman

given: Elsa

journal_name: Diabetologia

oa_colors: green hybrid

evidence: open (via free pdf)

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

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

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
eprints.soton.ac.uk

ReferenceCitation: Heyman E, Daussin F, Wieczorek V, Caiazzo R, Matran R, Berthon P, Aucouturier J, Berthoin S, Descatoire A, Leclair E, Marais G, Combes A, Fontaine P, Tagougui S. Muscle Oxygen Supply and Use in Type 1 Diabetes, From Ambient Air to the Mitochondrial Respiratory Chain: Is There a Limiting Step? Diabetes Care. 2020 Jan;43(1):209-218. doi: 10.2337/dc19-1125. Epub 2019 Oct 21.

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

ReferenceCitation: Tagougui S, Fontaine P, Leclair E, Aucouturier J, Matran R, Oussaidene K, Descatoire A, Prieur F, Mucci P, Vambergue A, Baquet G, Heyman E. Regional cerebral hemodynamic response to incremental exercise is blunted in poorly controlled patients with uncomplicated type 1 diabetes. Diabetes Care. 2015 May;38(5):858-67. doi: 10.2337/dc14-1792. Epub 2015 Feb 9.

title: Regional Cerebral Hemodynamic Response to Incremental Exercise Is Blunted in Poorly Controlled Patients With Uncomplicated Type 1 Diabetes

ReferenceCitation: Tagougui S, Leclair E, Fontaine P, Matran R, Marais G, Aucouturier J, Descatoire A, Vambergue A, Oussaidene K, Baquet G, Heyman E. Muscle oxygen supply impairment during exercise in poorly controlled type 1 diabetes. Med Sci Sports Exerc. 2015 Feb;47(2):231-9. doi: 10.1249/MSS.0000000000000424.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Muscle Oxygen Supply Impairment during Exercise in Poorly Controlled Type 1 Diabetes


ReferenceCitation: Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.

name: Université Grenoble Alpes and Grenoble Alpes University Hospital, Grenoble, France (M.R., O.G., C.K., M.M., A.L., S.B., C.S., A.P., C.C., B.I., P.C., J.C.)

family: Roustit

full_name: Matthieu Roustit

given: Matthieu

name: Université de Lyon and Hospices Civils de Lyon, Lyon, France (J.G., F.S.)

family: Giai

full_name: Joris Giai

given: Joris

family: Gaget

full_name: Olivier Gaget

given: Olivier

family: Khouri

full_name: Charles Khouri

given: Charles

family: Mouhib

full_name: Myriam Mouhib

given: Myriam

family: Lotito

full_name: Adrien Lotito

given: Adrien

family: Blaise

full_name: Sophie Blaise

given: Sophie

family: Seinturier

full_name: Christophe Seinturier

given: Christophe

family: Subtil

full_name: Fabien Subtil

given: Fabien

family: Paris

full_name: Adeline Paris

given: Adeline

family: Cracowski

full_name: Claire Cracowski

given: Claire

family: Imbert

full_name: Bernard Imbert

given: Bernard

family: Carpentier

full_name: Patrick Carpentier

given: Patrick

name: University of Alberta, Edmonton, Alberta, Canada (S.V.)

family: Vohra

full_name: Sunita Vohra

given: Sunita

full_name: Jean-Luc Cracowski

given: Jean-Luc

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

lead_sponsor: University Hospital, Grenoble

acronym: PROFIL

location_facility: Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble

source: euctr

title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)

summary: The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.


title: Evaluation of a Predictive Immunovirological Test Occurrence of BK Virus Nephropathy in Renal Transplant

summary:
Kidney transplantation is the treatment of choice for end stage renal disease (ESRD) improving the quantity and quality of life for dialysis patients. Although prolongation of graft survival in the short term by preventing the release is observed by immunosuppression (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have a direct deleterious effect on the kidney transplant , but too weak IS can promote rejection, and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV ) . BK nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal function , leading to a loss of the graft followed by a premature return to dialysis in at least 50 % of cases. Plasma BKV reactivation was observed mainly during the first year of transplantation in 15% of patients and complications annually BKVAN concern about 5 % of recipients . Currently , treatment options are very limited , only the decrease in IS shows a partially effective when care is early . There is no specific antiviral effective treatment of this disease . In addition, there is no way to predict which patients will develop BKV reactivation BKVAN despite lower tax.

The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR ( qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV viremia is the direct antiviral immune response quality based primarily on a very effective anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte activation induced by IS blocks the establishment of T-cell responses anti- BKV in most transplant, a very low presence of T lymphocytes is generally observed in these patients anti- BKV (LYT - BKV) blood .

Our preliminary studies have validated in vitro a sensitive test to measure the functionality of blood LYT - BKV. This test is used to evaluate the concentration and functionality of LYT - BKV present in small volume of blood by measuring their specific proliferation after stimulation with peptide cocktails BKV. Proof of concept of the feasibility of this test was established on a small series of samples and highlights significant differences in lymphocyte anti-BKV different patients.

Put to good use during the post-transplant follow-up, this type of test can provide the clinician with valuable data to assess the quality of anti- BKV T response compared to the intensity and type of IS treatment. Early identification of patients at risk of reactivation of BKV, or at risk of BKVAN if BKV viremia observed , would adapt the therapeutic response and monitoring arrangements at the fair. The objective of this project is to conduct a feasibility study to assess the relevance of post-transplant monitoring of anti- BKV T response of BKV viremic patients during the first year post- transplant. Immunological data will be analyzed in relation to virological data and bioclinical data.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

acronym: SEVOBURN

summary: Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

ReferenceCitation: Perbet S, Bourdeaux D, Lenoire A, Biboulet C, Pereira B, Sadoune M, Plaud B, Launay JM, Bazin JE, Sautou V, Mebazaa A, Houze P, Constantin JM, Legrand M; PRONOBURN group. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients. Anaesth Crit Care Pain Med. 2018 Dec;37(6):551-556. doi: 10.1016/j.accpm.2018.02.001. Epub 2018 Feb 15.

family: Perbet

full_name: Sebastien Perbet

given: Sebastien

family: Bourdeaux

full_name: Daniel Bourdeaux

given: Daniel

family: Lenoire

full_name: Alexandre Lenoire

given: Alexandre

family: Biboulet

full_name: Claire Biboulet

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Sadoune

full_name: Malha Sadoune

given: Malha

family: Plaud

full_name: Benoit Plaud

given: Benoit

family: Launay

full_name: Jean-Marie Launay

given: Jean-Marie

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Sautou

full_name: Valerie Sautou

given: Valerie

family: Mebazaa

full_name: Alexandre Mebazaa

family: Houze

full_name: Pascal Houze

given: Pascal

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Legrand

full_name: Matthieu Legrand

journal_name: Anaesthesia Critical Care & Pain Medicine


title: Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.

acronym: TOUTETDOU

summary:
The 3rd governmental plan of fighting against the pain favored the development and the evaluation of the efficiency of the non pharmacological methods. Its results always showes a lack of knowledge of these methods and the utility to pursue the researches.

In the department of pediatric surgery of the university hospital of Limoges, the relaxing-touch is one of these methods which is more and more used. The healthcare staff noticed the beneficial effects of such an empirical method in terms of comfort and quality of life for the children.

In 2011, a pilot study led in this department showed that, in spite of the usual treatment, the removal of the Redon's drain remains painful for 25 % of the children (score on the pain scale > or = 4). This result convinced the medical team to write a protocol of research from the following hypothesis: the implementation of a protocol of the Redon's drain removal associated to the relaxing touch and usual treatment could lead to a decrease of the acute pain for a 7 to 17 years old child.

lead_sponsor: University Hospital, Limoges


title: Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure

summary:
This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.

In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.


title: Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

acronym: PITA 3

summary: The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy

ReferenceCitation: Michaud E, Evrard B, Pereira B, Rochette E, Bernard L, Rouzaire PO, Gourdon-Dubois N, Merlin E, Fauquert JL. Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:197. doi: 10.1186/s13063-015-0717-y.

family: Michaud

full_name: Elodie Michaud

given: Elodie

family: Evrard

full_name: Bertrand Evrard

given: Bertrand

family: Rochette

full_name: Emmanuelle Rochette

given: Emmanuelle

family: Bernard

full_name: Lise Bernard

given: Lise

family: Rouzaire

full_name: Paul-Olivier Rouzaire

given: Paul-Olivier

family: Gourdon-Dubois

full_name: Nelly Gourdon-Dubois

given: Nelly

family: Merlin

full_name: Etienne Merlin

given: Etienne

family: Fauquert

full_name: Jean-Luc Fauquert

journal_name: Trials

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


title: Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients

summary:
Our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with Type 2 diabetes.
We also wish to evaluate more thoroughly lipid anomalies associated with the presence of steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize that hepatic steatosis is accompanied by activation of transcription factors involved in lipogenesis, notably SREBP factors. The activation of these factors could cause an increase in the expression of LDL receptors, leading to increased LDL catabolism.
Chronological description of the study During an outpatient consultation at the endocrinology department, diabetic patients, programmed to undergo an examination to assess their diabetes will be invited to participate in the study. Once written informed consent has been provided and clinical data has been recorded, patients with type 1 or type 2 diabetes will have standard biological examination, which is systematically done in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia, Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive protein, fibrinogen).

As well as the systematic biological tests, 3 additional tubes will be taken to screen for genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1, Apolipoprotein A - II).

IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to look for the presence of liver steatosis and to measure carotid intima-media thickness.


summary: Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors

ReferenceCitation: Lemetais G, Melander O, Vecchio M, Bottin JH, Enhörning S, Perrier ET. Effect of increased water intake on plasma copeptin in healthy adults. Eur J Nutr. 2018 Aug;57(5):1883-1890. doi: 10.1007/s00394-017-1471-6. Epub 2017 Jun 3.

family: Lemetais

full_name: Guillaume Lemetais

given: Guillaume

family: Melander

full_name: Olle Melander

given: Olle

family: Vecchio

full_name: Mariacristina Vecchio

given: Mariacristina

family: Bottin

full_name: Jeanne H. Bottin

given: Jeanne H.

family: Enhörning

full_name: Sofia Enhörning

given: Sofia

family: Perrier

full_name: Erica T. Perrier

given: Erica T.

bso_classification: Biology (fond.)

journal_name: European Journal of Nutrition

evidence: open (via page says license)

lead_sponsor: Danone Research


title: A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer

acronym: CABA-DOC

summary:
Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles.

Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting.

The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib.

A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future.

Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.

ReferenceCitation: Baciarello G, Delva R, Gravis G, Tazi Y, Beuzeboc P, Gross-Goupil M, Bompas E, Joly F, Greilsamer C, Hon TNT, Barthelemy P, Culine S, Berdah JF, Deblock M, Ratta R, Flechon A, Cheneau C, Maillard A, Martineau G, Borget I, Fizazi K; Groupe d'Etude des Tumeurs Uro-Genitales (GETUG). Patient Preference Between Cabazitaxel and Docetaxel for First-line Chemotherapy in Metastatic Castration-resistant Prostate Cancer: The CABADOC Trial. Eur Urol. 2021 Nov 14. pii: S0302-2838(21)02117-5. doi: 10.1016/j.eururo.2021.10.016. [Epub ahead of print]

family: Baciarello

full_name: Giulia Baciarello

given: Giulia

family: Delva

full_name: Remy Delva

given: Remy

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Tazi

full_name: Youssef Tazi

given: Youssef

family: Beuzeboc

full_name: Philippe Beuzeboc

given: Philippe

family: Gross-Goupil

full_name: Marine Gross-Goupil

given: Marine

family: Bompas

full_name: Emmanuelle Bompas

family: Joly

full_name: Florence Joly

given: Florence

family: Greilsamer

full_name: Charlotte Greilsamer

given: Charlotte

family: Hon

full_name: Thierry Nguyen Tan Hon

given: Thierry Nguyen Tan

family: Barthelemy

full_name: Philippe Barthelemy

family: Culine

full_name: Stephane Culine

given: Stephane

family: Berdah

full_name: Jean Francois Berdah

given: Jean Francois

family: Deblock

full_name: Mathilde Deblock

given: Mathilde

family: Ratta

full_name: Raffaele Ratta

given: Raffaele

family: Flechon

full_name: Aude Flechon

given: Aude

family: Cheneau

full_name: Caroline Cheneau

given: Caroline

family: Maillard

full_name: Aline Maillard

given: Aline

family: Martineau

full_name: Geraldine Martineau

given: Geraldine

family: Borget

full_name: Isabelle Borget

given: Isabelle

family: Fizazi

full_name: Karim Fizazi

given: Karim

journal_name: European Urology

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)

summary:
The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.

the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Hepatitis D Virus (HDV) Mother-To-Child Transmission (MTCT) From Hepatitis B Virus (HBV)-Hepatitis D Virus (HDV) Co-infected Pregnant Women: a Retrospective Study.

summary: HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about vertical HDV transmission are old, justifying a new study.

time_perspective: Retrospective

ReferenceCitation: Sellier PO, Maylin S, Brichler S, Berçot B, Lopes A, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Evans J, Gordien E, Simon F, Bergmann JF. Hepatitis B Virus-Hepatitis D Virus mother-to-child co-transmission: A retrospective study in a developed country. Liver Int. 2018 Apr;38(4):611-618. doi: 10.1111/liv.13556. Epub 2017 Sep 12.

name: Département de Médecine Interne; GH Saint-Louis/Lariboisière-Fernand Widal, AP-HP; Paris France

family: Sellier

full_name: Pierre O. Sellier

given: Pierre O.

name: Département de microbiologie; GH Saint-Louis/Lariboisière-Fernand Widal, AP-HP; Paris France

family: Maylin

full_name: Sarah Maylin

given: Sarah

name: Laboratoire de Virologie; CNR des hépatites delta; Hôpital Avicenne, AP-HP; Bobigny France

family: Brichler

full_name: Ségolène Brichler

given: Ségolène

family: Berçot

full_name: Béatrice Berçot

given: Béatrice

family: Lopes

full_name: Amanda Lopes

given: Amanda

family: Chopin

full_name: Dorothée Chopin

given: Dorothée

family: Pogliaghi

full_name: Manuela Pogliaghi

given: Manuela

name: Département de Maladies Infectieuses; GH Saint-Louis/Lariboisière-Fernand Widal, AP-HP; Paris France

family: Munier

full_name: Anne-Lise Munier

given: Anne-Lise

family: Delcey

full_name: Véronique Delcey

given: Véronique

family: Simoneau

full_name: Guy Simoneau

given: Guy

family: Evans

full_name: John Evans

given: John

family: Gordien

full_name: Emmanuel Gordien

given: Emmanuel

family: Simon

full_name: François Simon

given: François

family: Bergmann

full_name: Jean-François Bergmann

given: Jean-François

journal_name: Liver International

ipd_sharing: No

lead_sponsor: Hopital Lariboisière


title: Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.

summary: Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.


title: Effect of GLP-1 Receptor (GLP-1R) Agonists on Cardiac Function and on Epicardial Adipose Tissue (EAT) Volume and on Myocardial TG Content in Obese Diabetics

summary:
Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they lower blood glucose level (by enhancement of glucose-dependent insulin secretion and suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease systolic blood pressure, improve endothelial function and have beneficial effects on myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on myocardial function in type 2 obese diabetic.

Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac output, normalized stroke volume, LV mass and normalized end diastolic volume), and diastolic function. However, no study has evaluated the impact of Glucagon-like peptide-1 (GLP-1) receptor agonist in obese diabetics on myocardial TG content.

Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an important risk factor for cardiac diseases. We and others have already evidenced a correlation between the volume of epicardial adipose tissue and the presence or the severity of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of EAT is mostly unknown.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

acronym: CISEVOB

summary: Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients

lead_sponsor: University Hospital, Clermont-Ferrand


title: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury

acronym: SEVOKID

summary: Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure


title: Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty

summary:
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".

To this end, the study will take place as follows:

Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis

ReferenceCitation: Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.

family: Moissenet

full_name: Florent Moissenet

given: Florent

family: Naaim

full_name: Alexandre Naaim

given: Alexandre

family: Ornetti

full_name: Paul Ornetti

given: Paul

family: Bourredjem

full_name: Abderrahmane Bourredjem

given: Abderrahmane

family: Binquet

full_name: Christine Binquet

given: Christine

family: Morisset

full_name: Claire Morisset

given: Claire

family: Gouteron

full_name: Anais Gouteron

given: Anais

family: Maillefert

full_name: Jean-Francis Maillefert

given: Jean-Francis

family: Laroche

full_name: Davy Laroche

given: Davy

journal_name: Frontiers in Bioengineering and Biotechnology

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

repository_institution: University of Geneva - Archive ouverte UNIGE

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

repositories:
HAL
PubMed Central
unige.ch

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers


title: TMSFOS: Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression

acronym: TMSFOS

summary:
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000].

According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe:

either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment,
or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment.

In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if:

this genetic effect is specific to rTMS or common rTMS and medical antidepressants
this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants
this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression)
the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.


title: STUDY OF FACTORS FAVORING THE ONSET OF NOVO ATRIAL FIBRILLATION IN THE IMMEDIATE AFTERMATH OF CORONARY ARTERY BYPASS SURGERY

summary:
Before la surgery:

Transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium.

During surgery:

Surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before declamping of the aorta (T1= post-ischemia sample).

Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG (T0) and a second sample after CABG (T1).

In parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the anesthetists.

After the surgery:

Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an observation notebook. The biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.


title: Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

summary:
This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.

The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.


title: Interest of Preoperative Immunonutrition in Liver Resection for Cancer

acronym: PROPILS

summary: To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.

ReferenceCitation: Ciacio O, Voron T, Pittau G, Lewin M, Vibert E, Adam R, Sa Cunha A, Cherqui D, Schielke A, Soubrane O, Scatton O, Salloum C, Azoulay D, Benoist S, Goyer P, Vaillant JC, Hannoun L, Boleslawski E, Agostini H, Samuel D, Castaing D. Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial. BMC Cancer. 2014 Dec 18;14:980. doi: 10.1186/1471-2407-14-980.

family: Ciacio

full_name: Oriana Ciacio

given: Oriana

family: Voron

full_name: Thibault Voron

given: Thibault

family: Pittau

full_name: Gabriella Pittau

given: Gabriella

family: Lewin

full_name: Maité Lewin

given: Maité

family: Vibert

full_name: Eric Vibert

given: Eric

family: Adam

full_name: René Adam

given: René

family: Sa Cunha

full_name: Antonio Sa Cunha

given: Antonio

family: Cherqui

full_name: Daniel Cherqui

given: Daniel

family: Schielke

full_name: Astrid Schielke

given: Astrid

family: Soubrane

full_name: Olivier Soubrane

given: Olivier

family: Scatton

full_name: Olivier Scatton

family: Salloum

full_name: Chady Salloum

given: Chady

family: Azoulay

full_name: Daniel Azoulay

family: Benoist

full_name: Stéphane Benoist

given: Stéphane

family: Goyer

full_name: Perrine Goyer

given: Perrine

family: Vaillant

full_name: Jean-Christophe Vaillant

given: Jean-Christophe

family: Hannoun

full_name: Laurent Hannoun

given: Laurent

family: Boleslawski

full_name: Emmanuel Boleslawski

family: Agostini

full_name: Hélène Agostini

given: Hélène

family: Samuel

full_name: Didier Samuel

given: Didier

family: Castaing

full_name: Denis Castaing

given: Denis

journal_name: BMC Cancer

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire


title: Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy

acronym: SHEARWAVE

summary: The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluating the Impact of Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation (KVNI) Pilot Study

acronym: KVNI

summary:
The main objective is to show by a randomised controled therapeutic trial comparing in two parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the duration of non invasive respiratory support in the group treated by chest physiotherapy as compared to the control group. The secondary objectives are to evaluate the duration of oxygen dependence, the duration of hospitalisation and the proportional advent of bronchopulmonary dysplasia.

These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic, treated by non invasive respiratory support after weaning off from mechanical endotracheal ventilation benefitting form a social security system and for whom the appropriate parental authority are non opposed.


title: Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

acronym: SAMIRA

summary: Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.


title: Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors

acronym: HASIPRO

summary: The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.


title: Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.

acronym: CLASH

summary:
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths.

In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied.

This study is a prospective, cross-sectional study in exercise pathophysiology.

The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients.

Secondary goals are :

To determine the nature of the relationship between the recovery duration and subsequent walking performance.
To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
To study the influence of recovery duration on walking capacity from community-based measurement.

lead_sponsor: Rennes University Hospital


title: Assessment of the the ETView Double-lumen Tube

summary: The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.

lead_sponsor: Hopital Foch


title: Evaluation of the Interest of a Nurse-implemented Sedation Protocol for the Reduction of the Duration of Mechanical Ventilation Complication Associated With Extended Sedation in Pediatric Intensive Care Unit.

acronym: PEDIASED

summary:
Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation. Sedation is a generic term for all procedures, pharmacological or not, ensuring physical and psychological comfort and the safety of patient admitted in intensive care units.

An inadequate sedation, insufficient or excessive, has common side effects, as increase of the duration of mechanical ventilation and of hospital-acquired infections (in particular, ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD). All these complications increase mechanical ventilation time and ICU length of stay. Several studies in adult's population have shown that the implementation of a sedation algorithm allowed to decrease the incidence of these complications.

We hypothetized that the duration of mechanical ventilation would be reduced by a nurse-implemented sedative management protocol.

lead_sponsor: Nantes University Hospital


title: Phase I, Open-label, Safety, Tolerability and Preliminary Efficacy Study of Tremelimumab in Combination With Gefitinib in EGFR Mutant NSCLC Patients

acronym: GEFTREM

summary:
This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety and tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and to establish a recommended phase 2 dose. Secondary objectives include evaluation of, pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab combination. The exploratory objectives are to evaluate biomarkers that may correlate with activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.

The biological rationale for such a study is that even though the disease is progressing it is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover, patients may have received chemotherapy and the likelihood of chemosensitivity is very low. So, the association of Gefitinib with immune checkpoint blockade is very attractive and may result in clinical benefit in NSCLC with EGFRmut.


title: Phase I/II Open-label Randomized Multicenter Trial to Assess Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates (MVA HIV-B/ LIPO-5; LIPO-5/MVA HIV-B; GTU®-MultiHIV B / LIPO-5; GTU®-MultiHIV B/MVA HIV-B) in Healthy Volunteers at Low Risk of HIV Infection

summary: The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus relevant to pursue the development of different candidate vaccines in prime-boost vaccine strategies to identify the most promising prime-boost combinations and to integrate scientific inquiry into trial protocols from the beginning to maximize learning opportunities.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service d'Immunologie Clinique 51, avenue du Marechal de Lattre de Tassigny


title: Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET

acronym: CompensationPD

summary: Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer


title: Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.

summary:
Purpose:

Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
Comparison of the ultrasound semiology of enthesitis in the 3 populations
Comparison of the MASEI scores in the 3 populations


title: Clinico-biological Correlation of Severe Asthma in Children

summary:
Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli.

Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation.

Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.