title: Methodological Issues of Laser Speckle Contrast Imaging for Studying Microcirculation.

acronym: METHODO-LSCI

summary: Microcirculation, especially skin microcirculation, is a window towards systemic vascular function in magnitude and underlying mechanisms. Different techniques have been developed to assess the microcirculation. Among these techniques, laser technology is used to perform non-invasive microvascular assessments. Although this technique is widely used, different methodological issues remain. This study aims at defining the way to use lasers for clinical use.

ReferenceCitation: Omarjee L, Signolet I, Humeau-Heutier A, Martin L, Henrion D, Abraham P. Optimisation of movement detection and artifact removal during laser speckle contrast imaging. Microvasc Res. 2015 Jan;97:75-80. doi: 10.1016/j.mvr.2014.09.005. Epub 2014 Sep 28.

family: Omarjee

full_name: Loukman Omarjee

given: Loukman

family: Signolet

full_name: Isabelle Signolet

family: Humeau-Heutier

full_name: Anne Humeau-Heutier

given: Anne

family: Martin

full_name: Ludovic Martin

given: Ludovic

family: Henrion

full_name: Daniel Henrion

given: Daniel

family: Abraham

full_name: Pierre Abraham

given: Pierre

journal_name: Microvascular Research

ReferenceCitation: Puissant C, Abraham P, Durand S, Humeau-Heurtier A, Faure S, Leftheriotis G, Mahé G. Assessment of endothelial function by acetylcholine iontophoresis: impact of inter-electrode distance and electrical cutaneous resistance. Microvasc Res. 2014 May;93:114-8. doi: 10.1016/j.mvr.2014.04.001. Epub 2014 Apr 13.

family: Puissant

full_name: Cyril Puissant

given: Cyril

family: Durand

full_name: Sylvain Durand

given: Sylvain

family: Humeau-Heurtier

full_name: Anne Humeau-Heurtier

family: Faure

full_name: Sébastien Faure

given: Sébastien

family: Leftheriotis

full_name: Georges Leftheriotis

given: Georges

family: Mahé

full_name: Guillaume Mahé

given: Guillaume

title: Assessment of endothelial function by acetylcholine iontophoresis: Impact of inter-electrode distance and electrical cutaneous resistance

ReferenceCitation: Puissant C, Abraham P, Durand S, Humeau-Heurtier A, Faure S, Lefthériotis G, Rousseau P, Mahé G. Reproducibility of non-invasive assessment of skin endothelial function using laser Doppler flowmetry and laser speckle contrast imaging. PLoS One. 2013 Apr 19;8(4):e61320. doi: 10.1371/journal.pone.0061320. Print 2013.

family: Lefthériotis

title: Reproducibility of Non-Invasive Assessment of Skin Endothelial Function Using Laser Doppler Flowmetry and Laser Speckle Contrast Imaging


type: EudraCT Number

title: A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects

summary: This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Digoxin in Healthy Subjects

summary: A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on YM178, when the latter is taken on a continuous basis, in order to establish that there is no risk to patients who may take this combination of drugs.

primary_purpose: Basic Science

lead_sponsor: Astellas Pharma Europe B.V.


title: Ecological Assessment of Autonomy and Apathy in Alzheimer Patients at Mild and Moderate Stages, as Welle as in Healthy Control Particpants

summary:
Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems, behavioural and psychological symptoms (BPSD), and an impairment of activities of daily living (IADL) are frequently encountered and usually show an impact on autonomy maintenance, prognostic and care during the prodromal and early stages of the disease.

Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well as their intensity increase with the evolution of the disease.

Apathy, initially defined as a reduction of motivated behaviours, is the most frequently observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by diminished goal-directed cognitions and behaviours.

Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These are used to gather precise data regarding patient's clinical state from interviews with the patient, the career or from clinical impressions during the consultation. From their apparent simplicity they have made their way into daily clinical practices, yet neuropsychiatric scales are reportedly biased by the assessors' subjectivity.

However, some tools whose allow simple, fast and objectively valid assessments are not widely used.

Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities), automatized audio-video recognition and signal analysis from events, may be of interest in addition to current assessment methods.

The aim of this study is to implement an objective assessment of goal directed activities and autonomy in an experimental design including predefined actions. The setting includes video cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and computer-based recognition of events using audio-video data, locomotion data and sinusal variability respectively as well as extracting biomarkers for supporting detection of dementia at early stages and supporting ongoing tracking of the dementia disease state. The following population will be included: patients with Mild Cognitive Impairment (n=50), patients with Alzheimer's disease (n=50) and control participants (n=50).

This work will provide further objective information for clinical practitioner in order to detect behavioral disturbances such as apathy.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: A Cohort Randomized Controlled Trial Evaluating the Effect of Sending a Reminder to Responsible Parties of Clinical Trials in the Posting of Basic Results Onto ClinicalTrials.Gov

acronym: REGIST

summary:
The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration Amendments Act) added on September 27, 2007 a requirements policy regarding publication of summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary results is required for "applicable clinical trials" no later than one year after the "primary completion date", i.e. the date of collection of primary outcome data on the last patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to designate trials that may be subject to the registration and reporting requirements.

Not complying with the reporting requirements can result in penalties, such as withholding of National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a day. Despite the possibility of incurring penalties for not complying with the posting requirement, compliance remains globally poor.

In this current study, the primary objective will be to test the hypothesis that sending an email looking as a survey, reminding the necessity of posting results to the trials' responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but not complying with it, will increase the results posting rate.

primary_purpose: Health Services Research

ReferenceType: derived

ReferenceCitation: Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial. BMJ. 2014 Sep 19;349:g5579. doi: 10.1136/bmj.g5579.

family: Maruani

full_name: A. Maruani

given: A.

sequence: first

family: Boutron

full_name: I. Boutron

given: I.

sequence: additional

family: Baron

full_name: G. Baron

given: G.

family: Ravaud

full_name: P. Ravaud

given: P.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Clinical Epidemiology Center, Hotel-Dieu


summary:
The purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation.

Up to day 7

lead_sponsor: Pierre Fabre Medicament


summary:
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.

4 single 24hour applications separated by 48hour intervals.


primary_purpose: Treatment

source: euctr

title: Optimal Dose and Population Pharmacokinetics of Omeprazole in Neonates With Gastroesophageal Reflux Disease (GERD)

summary:
"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after initiation of omeprazole.

The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon other pHmetry parameters, (2) to characterize the population pharmacokinetics and pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."


type: Other Identifier

title: Multicenter, Randomized, Double-blind Placebo Controlled Trial of Bezafibrate for the Treatment of Primary Biliary Cirrhosis in Patients With Incomplete Response to Ursodesoxycholic Acid Therapy.

acronym: BEZURSO

summary: Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that eventually leads to end-stage liver failure and death unless liver transplantation (LT) is performed. Ursodeoxycholic acid (UDCA) administered orally at the daily dose of 13-15 mg/kg is currently the only drug approved for the treatment of PBC. UDCA consistently improves biochemical liver tests, prolongs survival without LT, and delays histological progression as well as the occurrence of portal hypertension. However, a significant proportion (40%) of patients treated with UDCA shows an incomplete biochemical response and remains at high risk of death or LT. The development of new treatments in combination with UDCA is therefore needed. Several candidates exist among which is Bezafibrate. Bezafibrate belongs to the fibrates' pharmacological class, which has been developed 4 decades ago for the treatment of mixed hyperlipidaemia. Bezafibrate is cheap, widely available and well tolerated. There is now a substantial body of circumstantial evidence supporting that fibrates, and Bezafibrate in particular, are well tolerated and can improve biochemical liver tests in patients with PBC with incomplete response to UDCA. However, despite several positive successful pilot studies, there are still no phase 3 randomized placebo-controlled trials of fibrates for the treatment of PBC. The purpose of this protocol is therefore to conduct such a trial in a selected population of patients with PBC based on an incomplete biochemical response after 6 months of UDCA therapy.

study_start_date_type: Actual

ReferenceCitation: Corpechot C, Chazouillères O, Lemoinne S, Rousseau A. Letter: reduction in projected mortality or need for liver transplantation associated with bezafibrate add-on in primary biliary cholangitis with incomplete UDCA response. Aliment Pharmacol Ther. 2019 Jan;49(2):236-238. doi: 10.1111/apt.15049.

name: Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis; Saint-Antoine Hospital, Assistance Publique - Hôpitaux de Paris; Paris France

name: INSERM UMR_S938, Sorbonne University; Paris France

family: Corpechot

full_name: Christophe Corpechot

given: Christophe

family: Chazouillères

full_name: Olivier Chazouillères

given: Olivier

family: Lemoinne

full_name: Sara Lemoinne

given: Sara

name: Clinical Research Platform of East of Paris; Saint-Antoine Hospital, Assistance Publique - Hôpitaux de Paris; Paris France

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

journal_name: Alimentary Pharmacology & Therapeutics

oa_host_type: publisher

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Corpechot C, Chazouillères O, Rousseau A, Le Gruyer A, Habersetzer F, Mathurin P, Goria O, Potier P, Minello A, Silvain C, Abergel A, Debette-Gratien M, Larrey D, Roux O, Bronowicki JP, Boursier J, de Ledinghen V, Heurgue-Berlot A, Nguyen-Khac E, Zoulim F, Ollivier-Hourmand I, Zarski JP, Nkontchou G, Lemoinne S, Humbert L, Rainteau D, Lefèvre G, de Chaisemartin L, Chollet-Martin S, Gaouar F, Admane FH, Simon T, Poupon R. A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis. N Engl J Med. 2018 Jun 7;378(23):2171-2181. doi: 10.1056/NEJMoa1714519.

name: From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique–Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G...

family: Le Gruyer

full_name: Antonia Le Gruyer

given: Antonia

family: Habersetzer

full_name: François Habersetzer

given: François

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Goria

full_name: Odile Goria

given: Odile

family: Potier

full_name: Pascal Potier

given: Pascal

family: Minello

full_name: Anne Minello

family: Silvain

full_name: Christine Silvain

given: Christine

family: Abergel

full_name: Armand Abergel

given: Armand

family: Debette-Gratien

full_name: Maryline Debette-Gratien

given: Maryline

family: Larrey

full_name: Dominique Larrey

given: Dominique

family: Roux

full_name: Olivier Roux

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

location_facility: Hepatology department - Hopital Saint Antoine


title: International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors.

acronym: EI-Morphinique

summary:
Morphine is the gold standard for treatment of severe acute pain but it has a number of adverse effects.

No study has so far managed to identify the morphine-induced adverse drug reactions. The primary objective of this study is to determine predictive factors of morphine-induced adverse drug reaction when it is used in emergency departments.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse


title: Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis

acronym: CORTICOIDOSE

summary: Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function.

status: Terminated

location_facility: Service de Néphrologie et Dialyses, Hôpital Tenon


title: Effect of a Mixture of Probiotics ( Lactobacillus Gasseri PA16/8,Bifidobacterium Longum SP07/3, Bifidobacterium Bifidum MF 20/5) on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adult

acronym: PROBIMMUNE

summary: the aim of the study is to get evidence for an enhancement of immune status in subjects after probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium longum SP 07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model - compared to placebo.

lead_sponsor: Merck Medication Familiale

intervention_type: Dietary Supplement


title: Development and Psychometric Validation of a Scale Assessing "the Acceptance" of Clean Intermittent Self Catheterization in a Neurological and no Neurological Population With Indication to Self Catheterization.

acronym: I-CAT

summary:
The aim of the study is to create and validate a specific test named Intermittent Catheterization Acceptance Test (I-CAT), assessing "the acceptance" of clean intermittent self catheterization (CISC) in a neurological and no neurological population with indication to self catheterization.

CISC avoids urological complications in bladder with chronic and improves quality of life. Despite theses challenges, the learning of CISC can face some physical, cognitive and psychological difficulties. Recently, we have validate a new test for predicting the physical and cognitive abilities to practice CISC named "PP-Test". Meanwhile, psychological factors are not explored in this test. To our knowledge, no study has been conducted in order to demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise it would be interesting to create a new test assessing the psychological "acceptance" of the patients to CISC before learning (I-CAT). Based on the results of this self-assessment test, the specific nurse could then change her speech by playing down the importance of some fear and anxiety described by the patients. The learning of CISC would be facilitated.

intervention_type: Behavioral


title: Prognosis Value of the Neuronal Damage Detected by Positrons Emission Tomography (PET) With 11C-Flumazenil in Early Multiple Sclerosis.

summary: In this study the investigators will use PET and 11C-Flumazenil to visualize and quantify neuronal injury in the cortex and the deep gray matter of Multiple Sclerosis patients at an early stage. The investigators will follow up patients to determine the prognostic value of this neuronal injury.

primary_purpose: Diagnostic


title: Evaluation of Outcome of Adult Pulmonary Langerhans Cell Histiocytosis Based on Lung HRCT and Lung Function. A Multicenter Retrospective Study

acronym: HLP

summary: this is a multicenter retrospective study on patients with pulmonary LCH who were sequentially evaluated by concomitant lung HRCT and lung function testing. The objectives of this study were: 1) to determine the changes over time of lung function parameters in patients with pulmonary LCH; 2) to compare the variations of HRCT and lung function results during follow-up; 3) to address the respective interest of these investigations for identifying the patients who eventually will experience a progression of their disease.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Tazi A, Marc K, Dominique S, de Bazelaire C, Crestani B, Chinet T, Israel-Biet D, Cadranel J, Frija J, Lorillon G, Valeyre D, Chevret S. Serial computed tomography and lung function testing in pulmonary Langerhans' cell histiocytosis. Eur Respir J. 2012 Oct;40(4):905-12. Epub 2012 Mar 22.


title: Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

acronym: SEXUTOX

summary: Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

lead_sponsor: Centre Oscar Lambret


acronym: SCOAL

summary: The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening. The presence of these sleep disturbances is the main reason for the institutionalization of AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be used.

lead_sponsor: University Hospital, Bordeaux


title: Study of the Neurofibromatosis 1 Expression: Identification of the Modifying Genes

acronym: NFGENMODIF

summary: Thanks to the investigators previous study the investigators demonstrated the influence of modifying genes in the phenotypic expression of neurofibromatosis 1 (Hum Mol Genet. 2009; 18 (15) :2768-78). Indeed, analysis of the intra-and inter-family variability performed using the investigators phenotype/genotype database demonstrated a strong genetic component for most clinical features. The investigators results suggest the involvement of genetic factors, not related to the NF1 gene, the modifiers. The objective of this project is to identify the modifiers involved in the variability of clinical expression of NF1. The investigators will focus in particular variants involved in the development and progression of neurofibromas.

ReferenceType: background

ReferenceCitation: Easton DF, Ponder MA, Huson SM, Ponder BA. An analysis of variation in expression of neurofibromatosis (NF) type 1 (NF1): evidence for modifying genes. Am J Hum Genet. 1993 Aug;53(2):305-13.

ReferenceCitation: Gutmann DH, Aylsworth A, Carey JC, Korf B, Marks J, Pyeritz RE, Rubenstein A, Viskochil D. The diagnostic evaluation and multidisciplinary management of neurofibromatosis 1 and neurofibromatosis 2. JAMA. 1997 Jul 2;278(1):51-7. Review.

ReferenceCitation: Sabbagh A, Pasmant E, Laurendeau I, Parfait B, Barbarot S, Guillot B, Combemale P, Ferkal S, Vidaud M, Aubourg P, Vidaud D, Wolkenstein P; members of the NF France Network. Unravelling the genetic basis of variable clinical expression in neurofibromatosis 1. Hum Mol Genet. 2009 Aug 1;18(15):2768-78. doi: 10.1093/hmg/ddp212. Epub 2009 May 5.


title: Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

acronym: LC SPRINT Sp

summary: The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

intervention_type: Device


title: French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

acronym: DESIR

summary: This study is a large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back pain and spondyloarthritis

status: Active, not recruiting

ReferenceCitation: Dougados M, d'Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daurès JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, Wendling D. The DESIR cohort: a 10-year follow-up of early inflammatory back pain in France: study design and baseline characteristics of the 708 recruited patients. Joint Bone Spine. 2011 Dec;78(6):598-603. doi: 10.1016/j.jbspin.2011.01.013. Epub 2011 Mar 31.

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: d’Agostino

full_name: Maria-Antonietta d’Agostino

given: Maria-Antonietta

family: Benessiano

full_name: Joëlle Benessiano

given: Joëlle

family: Berenbaum

full_name: Francis Berenbaum

given: Francis

family: Breban

full_name: Maxime Breban

family: Claudepierre

full_name: Pascal Claudepierre

family: Combe

full_name: Bernard Combe

given: Bernard

family: Dargent-Molina

full_name: Patricia Dargent-Molina

given: Patricia

family: Daurès

full_name: Jean-Pierre Daurès

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Feydy

full_name: Antoine Feydy

given: Antoine

family: Goupille

full_name: Philippe Goupille

family: Leblanc

full_name: Véronique Leblanc

given: Véronique

family: Logeart

full_name: Isabelle Logeart

given: Isabelle

family: Pham

full_name: Thao Pham

given: Thao

family: Richette

full_name: Pascal Richette

full_name: Christian Roux

given: Christian

family: Rudwaleit

full_name: Martin Rudwaleit

given: Martin

family: Saraux

full_name: Alain Saraux

given: Alain

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Wendling

full_name: Daniel Wendling

given: Daniel

title: The DESIR cohort: A 10-year follow-up of early inflammatory back pain in France: Study design and baseline characteristics of the 708 recruited patients

ReferenceCitation: Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewé R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Descamps E, Molto A, Borderie D, Lories R, Richard CM, Pons M, Roux C, Briot K. Changes in bone formation regulator biomarkers in early axial spondyloarthritis. Rheumatology (Oxford). 2021 Mar 2;60(3):1185-1194. doi: 10.1093/rheumatology/keaa296.

name: Department of Rheumatology, Cochin Hospital and Epidemiology and Biostatistics Unit, Sorbonne Paris Cite Research Center, Paris Descartes University, INSERM U1153, Paris, France

name: Department of Biology, Cochin Hospital, Paris Descartes University, INSERM U1153, Paris, France

name: KU Leuven and Division of Rheumatology, Skeletal Biology and Engineering Research Center, University Hospitals Leuven, Leuven, Belgium

ReferenceCitation: López-Medina C, Molto A, Claudepierre P, Dougados M. Clinical manifestations, disease activity and disease burden of radiographic versus non-radiographic axial spondyloarthritis over 5 years of follow-up in the DESIR cohort. Ann Rheum Dis. 2020 Feb;79(2):209-216. doi: 10.1136/annrheumdis-2019-216218. Epub 2019 Nov 29.

ReferenceCitation: Ruyssen-Witrand A, Luxembourger C, Cantagrel A, Nigon D, Claudepierre P, Degboe Y, Constantin A. Association between IL23R and ERAP1 polymorphisms and sacroiliac or spinal MRI inflammation in spondyloarthritis: DESIR cohort data. Arthritis Res Ther. 2019 Jan 15;21(1):22. doi: 10.1186/s13075-018-1807-5.

ReferenceCitation: Dougados M, Maksymowych WP, Landewé RBM, Moltó A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Ruyssen-Witrand A, Jamard B, Cantagrel A, Nigon D, Loeuille D, Degboe Y, Constantin A. Relationships between ultrasound enthesitis, disease activity and axial radiographic structural changes in patients with early spondyloarthritis: data from DESIR cohort. RMD Open. 2017 Sep 7;3(2):e000482. doi: 10.1136/rmdopen-2017-000482. eCollection 2017.

ReferenceCitation: Ez-Zaitouni Z, Hilkens A, Gossec L, Berg IJ, Landewé R, Ramonda R, Dougados M, van der Heijde D, van Gaalen F. Is the current ASAS expert definition of a positive family history useful in identifying axial spondyloarthritis? Results from the SPACE and DESIR cohorts. Arthritis Res Ther. 2017 May 31;19(1):118. doi: 10.1186/s13075-017-1335-8.

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

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

ReferenceCitation: Molto A, Tezenas du Montcel S, Wendling D, Dougados M, Vanier A, Gossec L. Disease activity trajectories in early axial spondyloarthritis: results from the DESIR cohort. Ann Rheum Dis. 2017 Jun;76(6):1036-1041. doi: 10.1136/annrheumdis-2016-209785. Epub 2016 Nov 25.

ReferenceCitation: Canouï-Poitrine F, Poulain C, Molto A, Le Thuaut A, Lafon C, Farrenq V, Ferkal S, Le Corvoisier P, Ghaleh B, Bastuji-Garin S, Fautrel B, Dougados M, Claudepierre P. Early tumor necrosis factor α antagonist therapy in everyday practice for inflammatory back pain suggesting axial spondyloarthritis: results from a prospective multicenter french cohort. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1395-402. doi: 10.1002/acr.22330.

name: Université Paris Est Créteil and APHP, Hôpital Henri-Mondor; Créteil France

name: Université Paris Est Créteil, Créteil, France, and Ecole Nationale de la Statistique et de l'Analyse de l'Information; Bruz France

name: INSERM, Centre d'Investigation Clinique 006; Créteil France

name: AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Université Paris 6 - Pierre et Marie Curie; Paris France

title: Early Tumor Necrosis Factor α Antagonist Therapy in Everyday Practice for Inflammatory Back Pain Suggesting Axial Spondyloarthritis: Results From a Prospective Multicenter French Cohort


title: Efficacy and Tolerance of Treatment With an Aromatase Inhibitor (Anastrozole) to Limit the Progression of Bone Maturation Related to Pathological Adrenarche in Children With Silver-Russell or Prader-Willi Syndrome

acronym: ANASILPRA

summary: There is currently no drug with pediatric marketing authorization capable of limiting the advance in bone maturation of children with aggressive adrenarche. Estrogens are the principal actors involved in bone maturation and premature epiphyseal fusion. Aromatase inhibitors, used for the treatment of hormone-dependent cancers, block the transformation of androgens into estrogens. Third generation inhibitors, of which Anastrozole is one, appear to be well tolerated in children and are sometimes used within the framework of clinical trials to limit bone maturation and improve prognosis with respect to final size, notably in children treated with growth hormone (GH) due to a GH deficit. Nevertheless, the data reported are based on small sample sizes and do not include children with pathological adrenarche.

location_facility: Explorations Fonctionnelles d'Endocrinologie - Centre de Référence des Maladies Endocriniennes Rares de la Croissance Hôpital Armand Trousseau


title: Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis

summary: Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.

lead_sponsor: University Hospital, Rouen


title: Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow

acronym: OPTICOUGH

summary: Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.

ReferenceCitation: Morrow B, Argent A, Zampoli M, Human A, Corten L, Toussaint M. Cough augmentation techniques for people with chronic neuromuscular disorders. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013170. doi: 10.1002/14651858.CD013170.pub2.

name: Department of Paediatrics; University of Cape Town; Cape Town South Africa

family: Morrow

full_name: Brenda Morrow

given: Brenda

name: Pediatric Intensive Care, Division of Pediatric Critical Care and Children's Heart Disease; Red Cross War Memorial Children's Hospital and University of Cape Town; Cape Town South Africa

family: Argent

full_name: Andrew Argent

given: Andrew

name: Pulmonology, and Paediatric Medicine; Red Cross War Memorial Children's Hospital and University of Cape Town; Cape Town South Africa

family: Zampoli

full_name: Marco Zampoli

given: Marco

name: Physiotherapy Department, School of Health Care Sciences; Sefako Makgatho Health Sciences University; Garankuwa South Africa

family: Human

full_name: Anri Human

given: Anri

name: School of Health Sciences; University of Brighton; Brighton UK

family: Corten

full_name: Lieselotte Corten

given: Lieselotte

name: Centre for Home Mechanical Ventilation and Specialized Centre for Neuromuscular Diseases; Inkendaal Rehabilitation Hospital; Vlezenbeek Belgium

family: Toussaint

full_name: Michel Toussaint

given: Michel

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients

summary: Overweight patients are susceptible to develop acute complications when they are admitted in an Intensive Care Unit (ICU). Severe infection can be associated with cardiovascular failure ('shock") and is associated with 35-50% mortality. One of the key issue to cure infection is to administer antibiotics. However, under dosing antibiotic is one of the main reason that explain treatment failure. There are very few data concerning particularities of antibiotic dosing in critically ill, overweight, patients. The aim of the present study is to describe the pharmacokinetic of two main antibiotics (doripenem and piperacillin/Tazobactam) in both overweight and non overweight critically ill patients presenting a septic shock. The investigators hypothesis is that usual dose for those antibiotic may be accurate in non overweight patients but is not in overweight patients.

lead_sponsor: University Hospital, Montpellier

location_facility: Saint Eloi Intensive Care Unit - Montpellier University Hospital


title: A Randomized, Multicenter Trial of Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated Methicillin-resistant Staphylococcus Aureus Bacteremia

acronym: DAVASAB

summary:
Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia due to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients whose blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would improve treatment safety.

Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of daptomycin versus vancomycin would increase by 15% the proportion of patients with sterilized blood cultures at 72 hours and would increase the treatment safety.

Primary objective: To study the efficacy of daptomycin compared to vancomycin on the sterilization of blood cultures after 72 hours of therapy.


title: Effectiveness of a Short, Intensive and Standardised Spa Therapy for Subacute and Chronic Low Back Pain on Return to Work for Patients in Sick Leave From 4 to 24 Weeks Duration : a Randomized Controlled Trial Using a Modified Zelen Method

acronym: ITILO

summary: The purpose of this study is to determine whether an intensive 5 days long multidisciplinary program (including spa therapy, exercises and patients'education) is more effective regarding return to work than usual care in subacute and chronic low back pain for people in sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is considered

ReferenceCitation: Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. Review.

ReferenceCitation: Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004 Jun;57(6):543-50.

ReferenceCitation: Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007 Feb;4(2):e61. Review.

ReferenceCitation: Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309.

ReferenceCitation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

family: Forestier

full_name: R. Forestier

given: R.

family: Desfour

full_name: H. Desfour

given: H.

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

journal_name: Annals of the Rheumatic Diseases

evidence: open (via free pdf)

version: submittedVersion

ReferenceCitation: Druss BG, Rosenheck RA, Sledge WH. Health and disability costs of depressive illness in a major U.S. corporation. Am J Psychiatry. 2000 Aug;157(8):1274-8.

ReferenceCitation: Hansson TH, Hansson EK. The effects of common medical interventions on pain, back function, and work resumption in patients with chronic low back pain: A prospective 2-year cohort study in six countries. Spine (Phila Pa 1976). 2000 Dec 1;25(23):3055-64.

ReferenceCitation: Magnussen L, Nilsen S, Råheim M. Barriers against returning to work--as perceived by disability pensioners with back pain: a focus group based qualitative study. Disabil Rehabil. 2007 Feb 15;29(3):191-7.

ReferenceCitation: Costa Lda C, Maher CG, McAuley JH, Hancock MJ, Herbert RD, Refshauge KM, Henschke N. Prognosis for patients with chronic low back pain: inception cohort study. BMJ. 2009 Oct 6;339:b3829. doi: 10.1136/bmj.b3829.

ReferenceCitation: Nguyen M, Revel M, Dougados M. Prolonged effects of 3 week therapy in a spa resort on lumbar spine, knee and hip osteoarthritis: follow-up after 6 months. A randomized controlled trial. Br J Rheumatol. 1997 Jan;36(1):77-81.

ReferenceCitation: Quilty B, Tucker M, Campbell R, Dieppe P. Physiotherapy, including quadriceps exercises and patellar taping, for knee osteoarthritis with predominant patello-femoral joint involvement: randomized controlled trial. J Rheumatol. 2003 Jun;30(6):1311-7.

ReferenceCitation: Poiraudeau S, Rannou F, Le Henanff A, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Revel M, Ravaud P. Outcome of subacute low back pain: influence of patients' and rheumatologists' characteristics. Rheumatology (Oxford). 2006 Jun;45(6):718-23. Epub 2005 Dec 23.

ReferenceCitation: Reme SE, Hagen EM, Eriksen HR. Expectations, perceptions, and physiotherapy predict prolonged sick leave in subacute low back pain. BMC Musculoskelet Disord. 2009 Nov 13;10:139. doi: 10.1186/1471-2474-10-139.

ReferenceCitation: Roberts PJ, Roberts C, Sibbald B, Torgerson DJ. Increasing response rates to postal questionnaires. Effect of incentives on response rates must be considered. BMJ. 2002 Aug 24;325(7361):444.

ReferenceCitation: Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805.

ReferenceCitation: Schonstein E, Kenny DT, Keating J, Koes BW. Work conditioning, work hardening and functional restoration for workers with back and neck pain. Cochrane Database Syst Rev. 2003;(1):CD001822. Review. Update in: Cochrane Database Syst Rev. 2010;(1):CD001822.

ReferenceCitation: Waddell G, Burton AK. Occupational health guidelines for the management of low back pain at work: evidence review. Occup Med (Lond). 2001 Mar;51(2):124-35. Review.

ReferenceCitation: Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008 Mar 15;336(7644):601-5. doi: 10.1136/bmj.39465.451748.AD. Epub 2008 Mar 3.

ReferenceCitation: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.

ReferenceCitation: Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M, Hurri H, Koes B. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working age adults. Cochrane Database Syst Rev. 2003;(2):CD002193. Review. Update in: Cochrane Database Syst Rev. 2017 Jun 28;6:CD002193.

ReferenceCitation: Anema JR, Steenstra IA, Bongers PM, de Vet HC, Knol DL, Loisel P, van Mechelen W. Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial. Spine (Phila Pa 1976). 2007 Feb 1;32(3):291-8; discussion 299-300.

ReferenceCitation: Nguyen C, Boutron I, Rein C, Baron G, Sanchez K, Palazzo C, Dupeyron A, Tessier JM, Coudeyre E, Eschalier B, Forestier R, Roques-Latrille CF, Attal Y, Lefèvre-Colau MM, Rannou F, Poiraudeau S. Intensive spa and exercise therapy program for returning to work for low back pain patients: a randomized controlled trial. Sci Rep. 2017 Dec 20;7(1):17956. doi: 10.1038/s41598-017-18311-z.

family: Nguyen

full_name: Christelle Nguyen

given: Christelle

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

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


title: Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery

summary:
Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system activation. Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period.

Coating of the surface has been shown to diminish these effects.Biocompatible surfaces, extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new physiologic non heparin coating with different functional aspects was developed as an alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood. The aim of this study is to compare the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation.

primary_purpose: Other

lead_sponsor: Hôpital Necker-Enfants Malades


primary_purpose: Prevention

acronym: NEBIDYS

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy

summary: The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.


title: Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy

acronym: PRIMUNEO

summary: Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.

lead_sponsor: Centre Georges Francois Leclerc


title: Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp

acronym: IRAP

summary:
Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.

Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.

In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.

It is a multicenter descriptive study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de recherche en nutrition humaine Rhone-Alpes


title: Ultrasound Comparison of the Surface of the Subclavian Vein (Arm in Abduction (90°) and External Rotation (90 °)) and the Surface of the Axillary Vein (Arms Along the Body) Versus the Surface of the Subclavian Vein (Arm Along the Body)

acronym: AnatoAbord

summary: The main objective of this study is the demonstration of an increase of over 50% of the surface visible on ultrasound (mm2) of the axillary vein and subclavian vein in arm abduction (90 °) and external rotation (90 °) with respect to the surface of the subclavian vein along the arm body.

ReferenceCitation: Roger C, Sadek M, Bastide S, Jeannes P, Muller L, Bobbia X, Lefrant JY. Comparison of the visualisation of the subclavian and axillary veins: An ultrasound study in healthy volunteers. Anaesth Crit Care Pain Med. 2017 Feb;36(1):65-68. doi: 10.1016/j.accpm.2016.05.007. Epub 2016 Aug 2.

family: Roger

full_name: Claire Roger

given: Claire

family: Sadek

full_name: Meriem Sadek

given: Meriem

family: Bastide

full_name: Sophie Bastide

given: Sophie

family: Jeannes

full_name: Pascal Jeannes

given: Pascal

family: Muller

full_name: Laurent Muller

given: Laurent

family: Bobbia

full_name: Xavier Bobbia

given: Xavier

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

journal_name: Anaesthesia Critical Care & Pain Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Sadek M, Roger C, Bastide S, Jeannes P, Solecki K, de Jong A, Buzançais G, Elotmani L, Ripart J, Lefrant JY, Bobbia X, Muller L. The Influence of Arm Positioning on Ultrasonic Visualization of the Subclavian Vein: An Anatomical Ultrasound Study in Healthy Volunteers. Anesth Analg. 2016 Jul;123(1):129-32. doi: 10.1213/ANE.0000000000001327.

family: Solecki

full_name: Kamila Solecki

given: Kamila

family: de Jong

full_name: Audrey de Jong

given: Audrey

family: Buzançais

full_name: Gautier Buzançais

given: Gautier

family: Elotmani

full_name: Loubna Elotmani

given: Loubna

family: Ripart

full_name: Jacques Ripart

given: Jacques

full_name: Jean Yves Lefrant

given: Jean Yves

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health


title: Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.

summary: The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.


title: Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers

summary: The main objective of this study is to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility of the inferior vena cava.

intervention_type: Procedure


title: VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

acronym: VOLCANO

summary:
The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.

Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.

Our study will compare vertebroplasty versus conservative therapy (brace).

lead_sponsor: University Hospital, Clermont-Ferrand


title: Regulatory B Cells in Inflammatory Rheumatisms, Systemic Auto-immune Diseases in Adults and Biomarkers of Response to Biologic Treatments

summary: B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.

status: Recruiting

status_simplified: Ongoing


title: Phase 2 Randomized Clinical Trial, Efficy of a Proprioceptive Stimulation Device in Term of Prevention of Muscle Atrophy of the Calf After Total Knee Replacement

acronym: PrevAtrophy

summary:
Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. It requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of hospitalisation.

Data underline the importance of afferent input integrity in the maintenance of muscle characteristics and postural control, and suggest that countermeasure programs based on the stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls. In particular, fundamental studies performed in rodents by the investigators laboratory have demonstrated that the adverse structural and functional adaptations which occur during muscle deconditioning can be counteracted through adequate physiological stimuli such as activation of proprioceptors. Based on this scientific expertise, the investigators aim is thus to prevent muscle atrophy and its functional consequences on posture and locomotion, following a surgical intervention in humans .

The investigators will develop a device allowing stimulation of foot and ankle proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be tested on a selected population confined to bed during a post-operative period (knee replacement). It efficiency will be evaluated by means of three parameters: muscle force of ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and balance analysis).

The technique developed in the present project could bring benefits to patients confined to bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate to health and quality of life of these patients. In addition, this device might allow to consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.

lead_sponsor: University Hospital, Lille


title: Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade I to IIIB Cervix Carcinoma Treated by Radiotherapy

acronym: ANOXICOL

summary:
Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.

Persistence of tumor hypoxia could be a predictive factor of local control


title: Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy

summary:
The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy.

The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.

lead_sponsor: Hôpital Edouard Herriot

location_facility: Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL


title: A Phase I-II Synchrotron Radiation Application to the Treatment of Intracranial Tumors

acronym: ESRF

summary: The purpose of this study is to prove the safety and acceptability of treatment with the Synchrotron radiation by medium-term medical follow-up of the patients.

lead_sponsor: University Hospital, Grenoble

intervention_type: Radiation


title: Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci

acronym: PROSTATE SSI

summary: The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.

ReferenceCitation: Rouvière O, Melodelima C, Hoang Dinh A, Bratan F, Pagnoux G, Sanzalone T, Crouzet S, Colombel M, Mège-Lechevallier F, Souchon R. Stiffness of benign and malignant prostate tissue measured by shear-wave elastography: a preliminary study. Eur Radiol. 2017 May;27(5):1858-1866. doi: 10.1007/s00330-016-4534-9. Epub 2016 Aug 23.

family: Rouvière

full_name: Olivier Rouvière

given: Olivier

family: Melodelima

full_name: Christelle Melodelima

family: Hoang Dinh

full_name: Au Hoang Dinh

given: Au

family: Bratan

full_name: Flavie Bratan

given: Flavie

family: Pagnoux

full_name: Gaele Pagnoux

given: Gaele

family: Sanzalone

full_name: Thomas Sanzalone

given: Thomas

family: Crouzet

full_name: Sébastien Crouzet

given: Sébastien

family: Colombel

full_name: Marc Colombel

given: Marc

family: Mège-Lechevallier

full_name: Florence Mège-Lechevallier

given: Florence

family: Souchon

full_name: Rémi Souchon

given: Rémi

journal_name: European Radiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot


title: Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts

summary:
Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.

The experimental arm is only sentinel node identification + radical hysterectomy.

ReferenceCitation: Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.

family: Bats

full_name: Anne-Sophie Bats

given: Anne-Sophie

family: Frati

full_name: Albane Frati

given: Albane

family: Mathevet

full_name: Patrice Mathevet

given: Patrice

family: Orliaguet

full_name: Isabelle Orliaguet

given: Isabelle

family: Querleu

full_name: Denis Querleu

given: Denis

family: Zerdoud

full_name: Slimane Zerdoud

given: Slimane

family: Leblanc

full_name: Eric Leblanc

given: Eric

family: Gauthier

full_name: Hélène Gauthier

given: Hélène

family: Uzan

full_name: Catherine Uzan

given: Catherine

family: Deandreis

full_name: Désirée Deandreis

given: Désirée

family: Darai

full_name: Emile Darai

given: Emile

family: Kerrou

full_name: Khaldoun Kerrou

given: Khaldoun

family: Marret

full_name: Henri Marret

given: Henri

family: Lenain

full_name: Emilie Lenain

given: Emilie

family: Froissart

full_name: Marc Froissart

family: Lecuru

full_name: Fabrice Lecuru

given: Fabrice

journal_name: Gynecologic Oncology

location_facility: Service de Gynécologie, Hôpital Femme Mère Enfant


title: Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study

acronym: ALSCELL

summary:
Patients with ALS will be included in the reference center for ALS in hospital La Pitié Salpêtrière, Paris.

The study proposes to investigate the pathophysiology of ALS by setting up a fibroblast bank for studying molecular, cellular and genetic parameters of the pathology.

iPS (induced pluripotent stem cells) and then differentiated cells will be generated.

The pathophysiology of ALS will be studied on the 3 types of cells (fibroblasts, iPS, differentiated cells).

lead_sponsor: Institut Pasteur


title: Prevalence of Chronic Obstructive Pulmonary Disease in HIV-patient Population

acronym: HIV and COPD

summary:
Highly active antiretroviral therapy (HAART) has considerably improved survival of HIV-infected patients. Opportunist diseases and cancers linked to immunodepression have largely regressed. Challenge is now the management of cardio-vascular diseases, nephrologic, neurologic, osteo-articular diseases, chronic hepatitis and cancer no linked to immunodepression. All this comorbidities are more reported in HIV-infected patients than in general non-HIV infected patients. Those are directly linked to the effect of chronic HIV-infection on ageing, metabolic effects of HAART, and way of life characterising this population.

Chronic obstructive pulmonary disease (COPD) results from tobacco consumption. Bronchial chronic infection, immunity, and ageing are also involved in the physiopathology of COPD. This disease has never been evaluated in a large prospective cohort of HIV-infected patients whereas there is a known increase of tobacco consumption and pulmonary infection in this population regardless to the general population.

Characterisation of COPD disease in HIV patients will allow us to make an hypothetic epidemiological link between HIV- HAART and COPD independently of tobacco consumption, and to study different physiopathologic hypothesis evocated in COPD genesis, like an accelerate pulmonary ageing.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service d'Infectiologie - Hôpital de l'Archet


title: Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial

acronym: ICECUBII

summary:
Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.

The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study.

Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted.

Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit.

Secondary objective : Assess the impact of the strategy on:

In-hospital mortality
Rate of ICU admission
Place of living and quality of life six months after ED visit

Primary outcome :Mortality six months after ED visit Secondary outcomes

In-hospital mortality
ICU admission
Change in functional status six months after ED visit
institutionalization
Quality of life six months after ED visit

ReferenceCitation: Guidet B, Leblanc G, Simon T, Woimant M, Quenot JP, Ganansia O, Maignan M, Yordanov Y, Delerme S, Doumenc B, Fartoukh M, Charestan P, Trognon P, Galichon B, Javaud N, Patzak A, Garrouste-Orgeas M, Thomas C, Azerad S, Pateron D, Boumendil A; ICE-CUB 2 Study Network. Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1450-1459. doi: 10.1001/jama.2017.13889.

name: Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Service de Réanimation Médicale, Paris, France2Sorbonne Universités, Université Pierre et Marie Curie, Paris, France3Institut National de la Santé et de la Recherche Médicale (INSERM), UMR S 1136, Institut Pierre Louis d’Épidémiologie et de Santé Publique, Paris, France

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

name: Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Service de Réanimation Médicale, Paris, France4Department of Anesthesiology and Critical Care, Université Laval, Québec City, Québec, Canada

full_name: Guillaume Leblanc

given: Guillaume

name: Sorbonne Universités, Université Pierre et Marie Curie, Paris, France5AP-HP, Hôpital Saint-Antoine, Department of Pharmacology and Unité de Recherche Clinique de l’Est Parisien, Paris, France

family: Simon

full_name: Tabassome Simon

given: Tabassome

name: AP-HP, Hôpital Avicenne, Service d’Accueil des Urgences (SAU), Bobigny, France

family: Woimant

full_name: Maguy Woimant

given: Maguy

name: CHU de Dijon, Service de Réanimation Médicale, Dijon, France8Equipe LIPNESS, INSERM UMR 866, Université de Bourgogne Franche Comté, Dijon, France

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

name: Hôpital Saint-Joseph, SAU, Paris, France

family: Ganansia

full_name: Olivier Ganansia

given: Olivier

family: Maignan

full_name: Maxime Maignan

given: Maxime

family: Yordanov

full_name: Youri Yordanov

given: Youri

name: AP-HP, Hôpital Pitié Salpêtrière, SAU, Paris, France

family: Delerme

full_name: Samuel Delerme

given: Samuel

name: AP-HP, Hôpital Cochin, SAU, Paris, France

family: Doumenc

full_name: Benoit Doumenc

given: Benoit

name: AP-HP, Hôpital Tenon, Service de Réanimation, Paris, France

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

name: Hôpital Robert Ballanger, SAU, Aulnay-Sous-Bois, France

family: Charestan

full_name: Pierre Charestan

given: Pierre

name: Hôpital Notre-Dame-de-Bon-Secours, SAU, Metz, France

family: Trognon

full_name: Pauline Trognon

given: Pauline

name: AP-HP, Hôpital Lariboisière, SAU, Paris, France

family: Galichon

full_name: Bertrand Galichon

name: Hôpital Jean Verdier, SAU, Bondy, France

family: Javaud

full_name: Nicolas Javaud

given: Nicolas

name: AP-HP, Hôpital européen Georges-Pompidou, SAU, Paris, France

family: Patzak

full_name: Anabela Patzak

given: Anabela

name: Hôpital Saint-Joseph, Service de Réanimation, Paris, France

family: Garrouste-Orgeas

full_name: Maïté Garrouste-Orgeas

given: Maïté

name: AP-HP, Hôpital Saint-Antoine, Service de Gériatrie Aiguë, Paris, France

family: Thomas

full_name: Caroline Thomas

given: Caroline

name: AP-HP, Hôpital Ambroise Paré, Unité de Recherche Clinique Paris Île-de-France Ouest, Boulogne-Billancourt, 92104, France

family: Azerad

full_name: Sylvie Azerad

given: Sylvie

name: Sorbonne Universités, Université Pierre et Marie Curie, Paris, France11AP-HP, Hôpital Saint-Antoine, SAU, Paris, France

family: Pateron

full_name: Dominique Pateron

given: Dominique

family: Boumendil

full_name: Ariane Boumendil

given: Ariane

journal_name: JAMA

oa_colors: green other

ReferenceCitation: Boumendil A, Woimant M, Quenot JP, Rooryck FX, Makhlouf F, Yordanov Y, Delerme S, Takun K, Ray P, Kouka MC, Poly C, Garrouste-Orgeas M, Thomas C, Simon T, Azerad S, Leblanc G, Pateron D, Guidet B; ICE-CUB 2 study network. Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study. Ann Intensive Care. 2016 Dec;6(1):74. doi: 10.1186/s13613-016-0161-5. Epub 2016 Jul 29.

name: on behalf of the ICE-CUB 2 study network


title: Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

acronym: INECOC

summary: Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.


title: A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su

summary: This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.

lead_sponsor: Hoffmann-La Roche


title: Electrophysiological Correlates of Emotional and Crossmodal Stimuli Processing Among Alcohol-dependent Participants : Exploration of the Peripheral Presentation Effect

acronym: ALCOLAT

summary:
Alcohol-dependence is the most widespread addiction in Western countries and leads to a wide range of impairments at cerebral and cognitive levels. It has also been showed that alcohol-dependence is associated with emotional disturbances, particularly for the decoding of emotional facial expressions (EFE). In view of the crucial role played by EFE to develop and maintain satisfactory interpersonal relations, this emotional processing impairment may have deleterious consequences on alcohol-dependent patient's social well-being, and this deficit is thus of particular clinical interest. Nevertheless, this deficit has up to now been evaluated only by means of experiments using paradigms with low ecological value (i.e. presentation of EFE in isolation and in the central vision field), while in the real life, emotional stimuli are most frequently appearing together with other emotional stimulations (particularly voices) and in the peripheral vision field. Moreover, the cerebral correlates of this emotional deficit are still to be determined.

The present study thus aims at exploring the Emotional Facial Expressions (EFE) decoding in alcoholism using a more ecological paradigm, based on peripheral presentation of emotional crossmodal stimuli (i.e. the simultaneous presentation of emotionally congruent face and voice).

Main aim: Determining the electrophysiological characteristics (latencies and amplitudes) of the event-related components elicited among recently detoxified alcohol-dependent participants, while performing an emotion-detection task on crossmodal stimuli (voices and/or faces) presented centrally or peripherally, and comparing these characteristics with those obtained among paired healthy participants.

Secondary objectives:

Exploring the electrophysiological pattern modifications among alcohol-dependent participants for the emotional faces and voices decoding (unimodal conditions), using spatio-temporal analyses methods.
Exploring the electrophysiological waves associated with peripheral crossmodal stimuli processing among healthy participants.
Exploring the behavioral correlates (reaction times and accuracy) of the emotion-detection task among alcohol-dependent participants while processing peripheral stimuli.
Exploring the psychopathological comorbidities among alcohol-dependent participants and their influence on the behavioral and electrophysiological results.


title: Estimation de la capacité Fonctionnelle a la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour Bilan artériel Des Membres inférieurs: Etude WELCH-bis

acronym: WELCH-bis

summary: The purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.

ReferenceCitation: Ouedraogo N, Chanut M, Aubourg M, Le Hello C, Hidden V, Audat G, Harbonnier M, Abraham P. Development and evaluation of the Walking Estimated-Limitation Calculated by History questionnaire in patients with claudication. J Vasc Surg. 2013 Oct;58(4):981-8. doi: 10.1016/j.jvs.2013.03.039. Epub 2013 May 7.

family: Ouedraogo

full_name: Nafi Ouedraogo

given: Nafi

family: Chanut

full_name: Myriam Chanut

given: Myriam

family: Aubourg

full_name: Marion Aubourg

given: Marion

family: Le Hello

full_name: Claire Le Hello

given: Claire

family: Hidden

full_name: Valerie Hidden

given: Valerie

family: Audat

full_name: Gaelle Audat

given: Gaelle

family: Harbonnier

full_name: Martin Harbonnier

given: Martin

family: Abraham

full_name: Pierre Abraham

journal_name: Journal of Vascular Surgery

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: University Hospital, Angers


title: Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation

summary:
Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome.

Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI.

Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan.

Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.

ReferenceCitation: Marijon E, Fazaa S, Narayanan K, Guy-Moyat B, Bouzeman A, Providencia R, Treguer F, Combes N, Bortone A, Boveda S, Combes S, Albenque JP. Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results. J Cardiovasc Electrophysiol. 2014 Feb;25(2):130-7. doi: 10.1111/jce.12303. Epub 2013 Nov 6.

name: Clinique Pasteur; Département de Rythmologie; Toulouse France

name: Paris Cardiovascular Research Center; Paris France

family: MARIJON

full_name: ELOI MARIJON

given: ELOI

family: FAZAA

full_name: SAMIA FAZAA

given: SAMIA

family: NARAYANAN

full_name: KUMAR NARAYANAN

given: KUMAR

family: GUY-MOYAT

full_name: BENOIT GUY-MOYAT

given: BENOIT

family: BOUZEMAN

full_name: ABDESLAM BOUZEMAN

given: ABDESLAM

family: PROVIDENCIA

full_name: RUI PROVIDENCIA

given: RUI

family: TREGUER

full_name: FREDERIC TREGUER

given: FREDERIC

family: COMBES

full_name: NICOLAS COMBES

given: NICOLAS

name: Service de Cardiologie, Hôpital Privé Les Franciscaines; Nîmes France

family: BORTONE

full_name: AGUSTIN BORTONE

given: AGUSTIN

family: BOVEDA

full_name: SERGE BOVEDA

given: SERGE

full_name: STEPHANE COMBES

given: STEPHANE

family: ALBENQUE

full_name: JEAN-PAUL ALBENQUE

given: JEAN-PAUL

journal_name: Journal of Cardiovascular Electrophysiology

title: Real-Time Contact Force Sensing for Pulmonary Vein Isolation in the Setting of Paroxysmal Atrial Fibrillation: Procedural and 1-Year Results

lead_sponsor: Clinique Pasteur


title: Impact of Clopidogrel Dose Adjustment According to Platelet Reactivity Monitoring in Patients With High on Treatment Platelet Reactivity Undergoing Percutaneous Coronary Intervention

summary:
Acute coronary syndromes are related to the development of a platelet derived thrombus on a ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a significantly reduced the risk of major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). However despite these therapeutic innovations, the rate of MACE in patients treated using PCI and particularly in those suffering of an acute coronary syndrome is around 5% in randomized trials. Within the factors associated with MACE, high on treatment platelet reactivity following clopidogrel loading dose has been identified as a key factor. In fact it is widely recognized that there is a large inter individual variability in clopidogrel responsiveness. In addition several authors have demonstrated a strong link between high on treatment platelet reactivity following clopidogrel loading dose and the occurrence of post PCI MACE. Vasodilator Phosphoprotein index measurement (VASP index) enables a reproducible, standardized and specific assessment of clopidogrel responsiveness.

The investigators previous works have demonstrated that a VASP index ≥ 50% had a high negative predictive value for post PCI MACE in patients undergoing PCI and that tailored clopidogrel loading dose in order to obtain a VASP index < 50% before PCI resulted in a reduction in the rate of post PCI MACE.

Prasugrel is a new generation thienopyridine with a faster and more powerful anti platelet effect compared to clopidogrel. It was shown to be superior to clopidogrel to reduce post PCI MACE in acute coronary syndromes. However in this randomized trial prasugrel achieved an excessive blockade of platelet reactivity responsible for a significant increase in bleeding events in some patients and an insufficient blockade in up to 325% of the remaining patients.

Therefore the investigators hypothesized that a strategy of individually tailored loading and maintenance dose of clopidogrel may be superior to prasugrel standard therapy in achieving an optimal platelet reactivity inhibition in acute coronary syndrome patients undergoing PCI.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Efficacy and Tolerance of Transplantation of Harvested Epidermal Cells and Narrow-Band UVB in Vitiligo

acronym: VITICELL

summary: The effects of treatment of transplantation of harvested autologous epidermal cells on vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled study.

location_facility: Centre hospitalier Universitaire de Nice


title: Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

acronym: DOULOX

summary:
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be involved in pain alteration in PD.

To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with PD.

36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. This increase would be the same than those observed with L-Dopa.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse


title: Pilot Study, Prospective, Single Center,Randomized, Single Blind, Evaluating the Efficacy of Relaxation to 12 Weeks Against Placebo, in the Overall Care Chronic Pain in Patients With Fibromyalgia

summary:
The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation.

Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Ultrasound Guided Percutaneous Tracheostomy in the ICU

summary: The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

primary_purpose: Supportive Care

ReferenceCitation: Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

family: Zogheib

full_name: Elie Zogheib

given: Elie

family: Petiot

full_name: Sandra Petiot

given: Sandra

family: Marienne

full_name: Jean-Pierre Marienne

given: Jean-Pierre

family: Guerin

full_name: Anne-Marie Guerin

given: Anne-Marie

family: Monet

full_name: Pauline Monet

given: Pauline

family: Zaatar

full_name: Rody Zaatar

given: Rody

family: Dupont

full_name: Hervé Dupont

given: Hervé

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher_dissemination: Springer

publisher_group: Springer


acronym: ESTIMET

summary:
Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS). The lack of a validated technique for back pain relief has prompted the development of newer devices, including leads with increased number of contacts (up to 16) and various geometric arrangements, the objective of which is to cover a larger area while attempting to extend, steer, or focus the electric field of the stimulation within the spinal cord regions. This led companies to design a new generation of multicolumn surgical leads that allow the activation of longitudinal and transverse electric fields (multicolumn spinal cord stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.

The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of lumbar pain.

A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and 80 years old suffering from refractory neuropathic pain of radicular origin with associated back pain will be included. Patients will be divided into two groups. One group with MSCS during the 12 months after the new generation electrode implantation and one group with CSCS during 6 months and MSCS between 6 and 12 months after the new generation electrode implantation.

The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing in relation to surgery and patient management.

ReferenceCitation: Roulaud M, Durand-Zaleski I, Ingrand P, Serrie A, Diallo B, Peruzzi P, Hieu PD, Voirin J, Raoul S, Page P, Fontaine D, Lantéri-Minet M, Blond S, Buisset N, Cuny E, Cadenne M, Caire F, Ranoux D, Mertens P, Naous H, Simon E, Emery E, Gadan B, Regis J, Sol JC, Béraud G, Debiais F, Durand G, Guetarni Ging F, Prévost A, Brandet C, Monlezun O, Delmotte A, d'Houtaud S, Bataille B, Rigoard P. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Neurochirurgie. 2015 Mar;61 Suppl 1:S109-16. doi: 10.1016/j.neuchi.2014.10.105. Epub 2014 Nov 20.

family: Roulaud

full_name: M. Roulaud

given: M.

family: Durand-Zaleski

full_name: I. Durand-Zaleski

given: I.

family: Ingrand

full_name: P. Ingrand

given: P.

family: Serrie

full_name: A. Serrie

given: A.

family: Diallo

full_name: B. Diallo

given: B.

family: Peruzzi

full_name: P. Peruzzi

family: Hieu

full_name: P.D. Hieu

family: Voirin

full_name: J. Voirin

given: J.

family: Raoul

full_name: S. Raoul

given: S.

family: Page

full_name: P. Page

family: Fontaine

full_name: D. Fontaine

given: D.

family: Lantéri-Minet

full_name: M. Lantéri-Minet

family: Blond

full_name: S. Blond

family: Buisset

full_name: N. Buisset

given: N.

family: Cuny

full_name: E. Cuny

given: E.

family: Cadenne

full_name: M. Cadenne

family: Caire

full_name: F. Caire

given: F.

family: Ranoux

full_name: D. Ranoux

family: Mertens

full_name: P. Mertens

family: Naous

full_name: H. Naous

given: H.

family: Simon

full_name: E. Simon

family: Emery

full_name: E. Emery

family: Gadan

full_name: B. Gadan

family: Regis

title: Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: Design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study)


title: 16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?

acronym: ESTROTEPREDIC

summary: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Nucléaire, Hôpital Tenon


title: Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceXP(TM) Retrourethral Male Sling

acronym: BALLANCE

summary:
Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.

Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up.

Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up.

Secondary objectives:

Comprehensive comparative medical evaluation of the two devices in terms of efficacy
Complete evaluation of the side effects of the two techniques
Evaluation of the quality of life
Evaluation of patient satisfaction
Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g).

Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.

Medical evaluation:

Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI.

Secondary outcome criteria

pad usage per day
quantitative reduction of the 24hr-pad test
complications (infection, erosion, hematoma, acute urinary retention)
number of re-interventions or re-admissions during follow-up
quality of life measured by the ICIQ-SF questionnaire
patient satisfaction by the PGI-I questionnaire

Economic evaluation:

Study of the total cost over one year in each case
Adjustment of cost of each device to quality of life (QALY evaluation)
Cost effectiveness study
Proposals will be made to state at which level the two devices should be covered by the healthcare system.


title: Pharmacokinetics of Ertapenem When Used in Empiric Treatment in Burn Patients. Prospective Open Label Study.

summary: This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT) burn patients.

lead_sponsor: Nantes University Hospital


title: Prospective Monocentric Open Label Non Randomized Uncontrolled Phase I/II Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65

summary: The purpose of the study is to assess the safety and efficacy of the active substance rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset retinal degeneration associated with RPE65 mutation.