title: Characterization Phenotypic and Genetic Study of the Intestinal Epithelial Dysplasia or TE

acronym: DEI

summary: This PHRC is centred on the intestinal epithelial dysplasia ( DEI) or " tufting enteropathy " or TE the clinical and histo-pathological descriptions of which are specified well to the digestive plan(shot).


title: Optimization of Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training: Interventional Randomized Trial

acronym: PROMISE

summary: The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Bellicha A, Ciangura C, Roda C, Torcivia A, Portero P, Oppert JM. Changes in Cardiorespiratory Fitness After Gastric Bypass: Relations with Accelerometry-Assessed Physical Activity. Obes Surg. 2019 Sep;29(9):2936-2941. doi: 10.1007/s11695-019-03932-2.

family: Bellicha

full_name: Alice Bellicha

given: Alice

sequence: first

family: Ciangura

full_name: Cécile Ciangura

given: Cécile

sequence: additional

family: Roda

full_name: Célina Roda

given: Célina

family: Torcivia

full_name: Adriana Torcivia

given: Adriana

family: Portero

full_name: Pierre Portero

given: Pierre

family: Oppert

full_name: Jean-Michel Oppert

given: Jean-Michel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Obesity Surgery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Oppert JM, Bellicha A, Roda C, Bouillot JL, Torcivia A, Clement K, Poitou C, Ciangura C. Resistance Training and Protein Supplementation Increase Strength After Bariatric Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Nov;26(11):1709-1720. doi: 10.1002/oby.22317.

name: Department of Nutrition, Pitié‐Salpêtrière Hospital, Assistance Publique‐Hôpitaux de Paris (AP‐HP) Sorbonne Université, Institute of Cardiometabolism and Nutrition (ICAN) Paris France

full_name: Jean‐Michel Oppert

given: Jean‐Michel

name: Laboratory of Bioengineering, Tissues and Neuroplasticity (BIOTN) University Paris‐Est Créteil France

name: ISGlobal The Barcelona Institute for Global Health Barcelona Spain

name: Universitat Pompeu Fabra (UPF) Barcelona Spain

name: CIBER Epidemiología y Salud Pública (CIBERESP) Barcelona Spain

full_name: Celina Roda

given: Celina

name: Department of Visceral Surgery, Ambroise Paré Hospital, Assistance Publique‐Hôpitaux de Paris (AP‐HP) University Versailles‐Saint‐Quentin Boulogne France

family: Bouillot

full_name: Jean‐Luc Bouillot

given: Jean‐Luc

name: Department of Digestive and Hepato‐Pancreato‐Biliary Surgery, Pitié‐Salpêtrière Hospital, Assistance Publique‐Hôpitaux de Paris (AP‐HP) Sorbonne Université Paris France

name: Nutriomics Team, INSERM UMRS U1166 Paris France

family: Clement

full_name: Karine Clement

given: Karine

family: Poitou

full_name: Christine Poitou

given: Christine

full_name: Cecile Ciangura

given: Cecile

journal_name: Obesity

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: publishedVersion

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: The Impact of Cranioplasty on Local and Global Cerebral Blood Flow as Clinical Outcome Prognostic Factor in Patients Undergoing Decompressive Craniectomy for Severe Head Injury.

acronym: CCP

summary: The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head injuries, Subarachnoid haemorrhage, intra-cerebral haemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Chibbaro S, Di Rocco F, Mirone G, Fricia M, Makiese O, Di Emidio P, Romano A, Vicaut E, Menichelli A, Reiss A, Mateo J, Payen D, Guichard JP, George B, Bresson D. Decompressive craniectomy and early cranioplasty for the management of severe head injury: a prospective multicenter study on 147 patients. World Neurosurg. 2011 Mar-Apr;75(3-4):558-62. doi: 10.1016/j.wneu.2010.10.020.

family: Chibbaro

full_name: Salvatore Chibbaro

given: Salvatore

family: Di Rocco

full_name: Fedreico Di Rocco

given: Fedreico

family: Mirone

full_name: Giuseppe Mirone

given: Giuseppe

family: Fricia

full_name: Marco Fricia

given: Marco

family: Makiese

full_name: Orphee Makiese

given: Orphee

family: Di Emidio

full_name: Paolo Di Emidio

given: Paolo

family: Romano

full_name: Antonio Romano

given: Antonio

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Menichelli

full_name: Alina Menichelli

given: Alina

family: Reiss

full_name: Alisha Reiss

given: Alisha

family: Mateo

full_name: Joaquim Mateo

given: Joaquim

family: Payen

full_name: Didier Payen

given: Didier

family: Guichard

full_name: Jean Pierre Guichard

given: Jean Pierre

family: George

full_name: Bernard George

given: Bernard

family: Bresson

full_name: Damien Bresson

given: Damien

journal_name: World Neurosurgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Decompressive Craniectomy and Early Cranioplasty for the Management of Severe Head Injury: A Prospective Multicenter Study on 147 Patients

location_facility: Service de Neurochirurgie - LARIBOISIERE

intervention_type: Procedure


title: Role of Candidate Genes/Signalling Pathways in the Progression Towards Heart Failure: Study in a Cohort of Patients With a First Myocardial Infarction (PREGICA Patient Collection : Genetic Predisposition to Heart Failure)

acronym: PREGICA

summary: Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. Our main hypothesis is that there is, for a given initial biomechanical stress (duration of the ischemic episode, size of the infarcted area, etc.), a variation in the individual susceptibility to develop left ventricular remodelling and to progress towards heart failure, and that this variation is linked to genetic variants between individuals.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

intervention_type: Other

status_simplified: Ongoing


title: Validation of a Simulated Clinical Evaluation of Ventilators

acronym: SIMULVENTI

summary: The purpose of this study is to evaluate the ability of a device reproducing patients' respiratory characteristics to select in-VITRO the most appropriate ventilator for a given pathology.

primary_purpose: Treatment


ReferenceCitation: Quibel T, Ghout I, Goffinet F, Salomon LJ, Fort J, Javoise S, Bussieres L, Aegerter P, Rozenberg P; Groupe de Recherche en Obstétrique et Gynécologie (GROG). Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.

family: Quibel

full_name: Thibaud Quibel

given: Thibaud

family: Ghout

full_name: Idir Ghout

given: Idir

family: Goffinet

full_name: François Goffinet

given: François

family: Salomon

full_name: Laurent J. Salomon

given: Laurent J.

family: Fort

full_name: Julie Fort

given: Julie

family: Javoise

full_name: Sophie Javoise

given: Sophie

family: Bussieres

full_name: Laurence Bussieres

given: Laurence

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Rozenberg

full_name: Patrick Rozenberg

given: Patrick

name: for the Groupe de Recherche en Obstétrique et Gynécologie (GROG)

journal_name: Obstetrics & Gynecology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

intervention_type: Drug

status: Terminated

acronym: CYTOCINON

type: EudraCT Number

source: euctr

title: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

summary: To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

status_simplified: Unknown


title: A Two Stage Trial of lénalidomide (Revlimid®) : a Phase II Study of lénalidomide as Single Agent in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse: Followed by a Phase I of lénalidomide in Combination With Carboplatin and Liposomal Pegylated Doxorubicin.

acronym: REV

summary: Study in two stages, and with a sub-study.

ReferenceCitation: Selle F, Sevin E, Ray-Coquard I, Mari V, Berton-Rigaud D, Favier L, Fabbro M, Lesoin A, Lortholary A, Pujade-Lauraine E. A phase II study of lenalidomide in platinum-sensitive recurrent ovarian carcinoma. Ann Oncol. 2014 Nov;25(11):2191-2196. doi: 10.1093/annonc/mdu392. Epub 2014 Sep 10.

family: Selle

full_name: F. Selle

given: F.

family: Sevin

full_name: E. Sevin

given: E.

family: Ray-Coquard

full_name: I. Ray-Coquard

given: I.

family: Mari

full_name: V. Mari

given: V.

family: Berton-Rigaud

full_name: D. Berton-Rigaud

given: D.

family: Favier

full_name: L. Favier

given: L.

family: Fabbro

full_name: M. Fabbro

given: M.

family: Lesoin

full_name: A. Lesoin

given: A.

family: Lortholary

full_name: A. Lortholary

family: Pujade-Lauraine

full_name: E. Pujade-Lauraine

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: ARCAGY/ GINECO GROUP

lead_sponsor_type: industriel


title: Role of Specific Immune Cellular Response in the Control of BK Virus Infection: Prospective Study, Monocentric and Longitudinal During the First Nine Months After a Kidney Transplantation

acronym: BKv

summary:
BK virus infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. This reactivation leads to a viremia for 10 to 15% of patient during this same period. The most frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients representing 2.7% during 6 years in Nantes).

An intensive et persisting viral replication, assessed by detection of high blood viral load, could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft.

Biological follow-up of these infections lay on the measures of viral load. Their positivity must alert the physician and lead him to modulate immunosuppressive treatment.

Actually, there is no real consensus about the modalities of pharmacological immunosuppression decrease (decrease dose or change of molecule).

Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove:

weakness of immune cellular response for patient with high viremia
increase of this response when viral load decrease These studies laid on detection of INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular expansion.

New prospective and longitudinal data comparing the immune cellular response (systematic and early) after graft between patients controlling or not BKv infection are necessary to improve the comprehension of illness natural history.

The investigators propose to enlarge the investigation of anti-BKv immune cellular response to other functions than IFNg synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control. Furthermore, the investigators propose to identify better diagnostic and prognostic makers.

lead_sponsor: Nantes University Hospital


title: Study of Memantine to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Monocentric Trial

acronym: FOGG-I

summary: Along with cognitive and psychobehavioural disorders, gait disorders represent a major problem in the treatment of advanced Parkinson's disease (PD). PD can be considered to be a hyperglutamatergic disease because dopaminergic depletion induces hyperactivity of the subthalamic nucleus (STN) and the internal pallidum (GPi), with glutamatergic hyperactivity of the STN's efferent pathway, i.e., the subthalamopallidal, subthalamonigral and subthalamo-entopeduncular pathways (projecting to the pedunculopontine nucleus (PPN)). Excess glutamate in the PPN has also been observed in the 6-OHDA rat model of PD. Reduction of this glutamatergic hyperactivity within the PPN via the systemic or intra-peduncular administration of glutamate antagonists improves akinesia in drug-induced murine and primate models of PD, via the NMDA and AMPA receptors. High doses of memantine (10 mg/kg) improve locomotion in reserpine- and alpha-methyl-p-tyrosine-treated rats. In humans, the PPN may play a key role in gait, posture control, axial rigidity and attention. It is also involved in the gating of sensory information involved in the startle reflex, which can be studied via prepulse inhibition (PPI) of the blink reflex. At present, two uncompetitive NMDA receptor antagonists are approved for use in humans: amantadine and memantine. Reviews of the recent literature on these drugs have identified no published studies specifically on severe gait and attention disorders in PD. Memantine is a partial blocker of open NMDA channels. The value of memantine relates to the fact that it decreases excessive glutamatergic transmission by lowering the synaptic noise due to excessive activation of NMDA receptors. In this double-blind study, the investigators shall seek to demonstrate the presence or absence of an effect of memantine on gait and attention disorders. In order to study the interaction between glutamatergic hyperactivity and the dopaminergic system, the investigators shall study the phenomena both in the absence of L-dopa and following acute administration of the latter. Twenty eight volunteer, non-demented, late-stage PD patients displaying severe gait disorders will receive memantine (20 mg/day) or placebo for 3 months. The investigators expect to see a reduction in gait and attention disorders, together with an improvement in the blink reflex with PPI under memantine. This pilot study could subsequently be turned into a double-blind, placebo-controlled multicenter study.

ReferenceCitation: Moreau C, Delval A, Tiffreau V, Defebvre L, Dujardin K, Duhamel A, Petyt G, Hossein-Foucher C, Blum D, Sablonnière B, Schraen S, Allorge D, Destée A, Bordet R, Devos D. Memantine for axial signs in Parkinson's disease: a randomised, double-blind, placebo-controlled pilot study. J Neurol Neurosurg Psychiatry. 2013 May;84(5):552-5. doi: 10.1136/jnnp-2012-303182. Epub 2012 Oct 16.

family: Moreau

full_name: C. Moreau

given: C.

family: Delval

full_name: A. Delval

family: Tiffreau

full_name: V. Tiffreau

family: Defebvre

full_name: L. Defebvre

family: Dujardin

full_name: K. Dujardin

given: K.

family: Duhamel

full_name: A. Duhamel

family: Petyt

full_name: G. Petyt

given: G.

family: Hossein-Foucher

full_name: C. Hossein-Foucher

family: Blum

full_name: D. Blum

family: Sablonniere

full_name: B. Sablonniere

given: B.

family: Schraen

full_name: S. Schraen

given: S.

family: Allorge

full_name: D. Allorge

family: Destee

full_name: A. Destee

family: Bordet

full_name: R. Bordet

given: R.

family: Devos

full_name: D. Devos

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Lille


title: Long Term Effect of General Practitioner Education on Antibiotic Prescribing: a Large Scale Randomized Study

summary: Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. The aim of this trial was to assess the long-term effect of a continuous education program on general practitioners antibiotic prescribing behaviour. 170 physicians were included in this study. Physicians randomized in the education group attended a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory tract infections. The intervention was limited at physicians level and did not target the patients.

status: Unknown status

primary_purpose: Health Services Research

ReferenceCitation: Ferrat E, Le Breton J, Guéry E, Adeline F, Audureau E, Montagne O, Roudot-Thoraval F, Attali C, Le Corvoisier P, Renard V. Effects 4.5 years after an interactive GP educational seminar on antibiotic therapy for respiratory tract infections: a randomized controlled trial. Fam Pract. 2016 Apr;33(2):192-9. doi: 10.1093/fampra/cmv107. Epub 2016 Jan 21.

family: Ferrat

full_name: E Ferrat

given: E

family: Le Breton

full_name: J Le Breton

given: J

family: Guéry

full_name: E Guéry

family: Adeline

full_name: F Adeline

given: F

family: Audureau

full_name: E Audureau

family: Montagne

full_name: O Montagne

given: O

family: Roudot-Thoraval

full_name: F Roudot-Thoraval

family: Attali

full_name: C Attali

given: C

family: Le Corvoisier

full_name: P Le Corvoisier

given: P

family: Renard

full_name: V Renard

given: V

journal_name: Family Practice

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Henri Mondor University Hospital

location_facility: Henri Mondor Hospital, department of general practice


title: The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta

summary: Despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. This study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes coding for the LXRs.

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Biological


summary: The purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin D analogues using a psoriasis plaque test design

lead_sponsor: LEO Pharma


title: An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

summary: The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.


title: Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit

acronym: NICOREA

summary:
Nicotine patches are frequently used in smoking patients during their stay in the ICU in order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical ventilation weaning.

Until now the effectiveness of this treatment has not been proven. The aim of this study (NICOREA study) is to determine if a difference exists on the duration of mechanical ventilation once patients receive or not a nicotine substitute.

primary_purpose: Supportive Care

lead_sponsor: University of Paris 5 - Rene Descartes


title: Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain

acronym: CCPB

summary:
In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.

The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.

The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.

Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.

Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.

Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.

design_allocation: Non-Randomized

primary_purpose: Diagnostic


title: Phase I, Randomized, Parallel Group Study to Evaluate the Effect of Multiple Oral Doses of Eurartesim on the QT/QTc Interval Compared to Riamet, Placebo and Moxifloxacin in Healthy Male and Female Volunteers

summary: The aim of such a study is to evaluate the impact of a therapeutic dose of Eurartesim™ compared to Riamet®, after multiple dose administration for 3 days in healthy male and female subjects on electrocardiographic parameters.

ReferenceCitation: Funck-Brentano C, Bacchieri A, Valentini G, Pace S, Tommasini S, Voiriot P, Ubben D, Duparc S, Evene E, Felices M, Corsi M. Effects of Dihydroartemisinin-Piperaquine Phosphate and Artemether-Lumefantrine on QTc Interval Prolongation. Sci Rep. 2019 Jan 28;9(1):777. doi: 10.1038/s41598-018-37112-6.

apc_source: openAPC

family: Funck-Brentano

full_name: Christian Funck-Brentano

given: Christian

family: Bacchieri

full_name: Antonella Bacchieri

given: Antonella

family: Valentini

full_name: Giovanni Valentini

given: Giovanni

family: Pace

full_name: Silvia Pace

given: Silvia

family: Tommasini

full_name: Silva Tommasini

given: Silva

family: Voiriot

full_name: Pascal Voiriot

given: Pascal

family: Ubben

full_name: David Ubben

given: David

family: Duparc

full_name: Stephan Duparc

given: Stephan

family: Evene

full_name: Eric Evene

given: Eric

family: Felices

full_name: Mathieu Felices

given: Mathieu

family: Corsi

full_name: Marco Corsi

given: Marco

currency_apc_doaj: USD

journal_name: Scientific Reports

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 - Archive ouverte HAL

repositories:
HAL
PubMed Central

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

lead_sponsor: sigma-tau i.f.r. S.p.A.


title: Observational Study in Neonatal Intensive Care Units (NICU) on the Real Life Use of Curosurf in Prophylaxis of RDS in Premature Babies.

summary: The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

summary: Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.

lead_sponsor: University of Versailles


title: Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.

summary:
Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.

This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.

Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility: Service de radiologie - Hôpital Rangueil


title: Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

summary: Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.


title: Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation

acronym: PULCO

summary: Prospective observational clinical multicentric study in ICU with ventilated patients requiring chest ultrasound analysis.

ReferenceCitation: Jabaudon M, Perbet S, Pereira B, Soummer A, Roszyk L, Guérin R, Futier E, Lu Q, Bazin JE, Sapin V, Rouby JJ, Constantin JM. Plasma levels of sRAGE, loss of aeration and weaning failure in ICU patients: a prospective observational multicenter study. PLoS One. 2013 May 27;8(5):e64083. doi: 10.1371/journal.pone.0064083. Print 2013.

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Soummer

full_name: Alexis Soummer

given: Alexis

family: Roszyk

full_name: Laurence Roszyk

given: Laurence

family: Guérin

full_name: Renaud Guérin

given: Renaud

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Lu

full_name: Qin Lu

given: Qin

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Rouby

full_name: Jean-Jacques Rouby

given: Jean-Jacques

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

bso_classification: Biology (fond.)

journal_name: PLoS ONE

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

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

title: Plasma Levels of sRAGE, Loss of Aeration and Weaning Failure in ICU Patients: A Prospective Observational Multicenter Study


title: Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes

acronym: DENDI

summary: The aim of the study is to progress in the understanding of the early retinal vascular and neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels and to assess how it varies in presence of various stimuli. Then, we will be able to assess if a vascular and/or a neural dysfunction is present early in patient with diabetes.

location_facility: Hôpital LARIBOISIERE Service d'Ophtalmologie

intervention_type: Device


title: Interest of Angiotensin-converting Enzyme Inhibitors on Early Sickle Cell Renal Disease in Children. A Randomized, Double-blind Trial Enalapril vs Placebo.

acronym: MADREPIEC

summary:
Patients with sickle cell anaemia may develop renal disease. In fact, renal disease occurred in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for half of them. Microalbuminuria is an early and sensitive marker of glomerular damage. It appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years). Physiopathology of renal scarring is not well understood actually. Renal scarring might be due to glomerular hyperfiltration and vascular and endothelial damage. Angiotensin-converting enzyme inhibitors (ACE) were studied and used in diabetic nephropathy. In a study on 26 sickle cell adults, albuminuria was reduced about 50% by ACE compared to placebo after six months treatment. It might be interesting studying ACE efficacy in sickle cell children with microalbuminuria because renal disease is directly related to sickle cell and is not influenced by other cardiovascular risk factors like in adult patients.

We hypothesized to have a successful ACE treatment in more than 40% of cases after a nine months treatment period. A success is defined as a 50% reduction of the albuminuria/creatinuria ratio.

location_facility: Trousseau Hospital, Nephro-pediatric unit


title: Utility of Hypnosis for Transesophageal Echocardiography

acronym: I-SLEPT

summary: The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).

location_facility: Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler


title: Assessment of the Effect of the GABA-B Receptor Agonist, Baclofen, on Hypoxia-induced Periodic Ventilation, in Healthy Subjects

acronym: PERIODIBAC

summary: Periodic ventilation that includes CHEYNE Stokes ventilation is a pathological pattern characterized by alternating periods of hyperpneas and apnea-hypopneas. It occurs generally during sleep, at high altitude and in hypoxic conditions in healthy subjects, and in some diseases like congestive heart failure. One study conducted on an animal model suggested that baclofen, a drug already used against spasticity in humans, could also be effective against periodic ventilation. The goal of the study is therefore to assess this hypothesis on hypoxia-induced periodic ventilation in healthy subjects during sleep.


title: Impact of Women Hormonal Status (Oral Contraception vs no Contraception) on Substrate Utilization During Exercise

summary:
Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal modifications, but results are confused regarding the impact on substrate utilization. In the present study, the aim is then to explore the effect of hormonal status on substrate utilization during sous-maximal exercise, comparing women with and without OC.

We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise than women without contraception underlying a greater reliance on fat oxidation.

lead_sponsor: University Hospital, Clermont-Ferrand


type: Registry Identifier

title: Etude de la réactivité émotionnelle Des Patients MICI ou SII

acronym: EMOTION

summary: The study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.

ReferenceType: background

ReferenceCitation: Pellissier S, Dantzer C, Canini F, Mathieu N, Bonaz B. Psychological adjustment and autonomic disturbances in inflammatory bowel diseases and irritable bowel syndrome. Psychoneuroendocrinology. 2010 Jun;35(5):653-62. doi: 10.1016/j.psyneuen.2009.10.004. Epub 2009 Nov 11.

ReferenceCitation: Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009.529. Epub 2009 Sep 15.

ReferenceCitation: Pellissier S, Dantzer C, Canini F, Mathieu N, Bonaz B. Toward a definition of a global psycho-physiological criterion of vulnerability to relapse in inflammatory bowel diseases. Am J Gastroenterol. 2010 Jun;105(6):1446-7. doi: 10.1038/ajg.2009.763.

lead_sponsor: University Hospital, Grenoble

intervention_type: Behavioral


title: Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension

acronym: FELT

summary: The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.

ReferenceCitation: Mancia G, Omboni S, Chazova I, Coca A, Girerd X, Haller H, Parati G, Pauletto P, Pupek-Musialik D, Svyshchenko Y; FELT Study Group. Effects of the lercanidipine-enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension: evidence from a large database. J Hypertens. 2016 Jan;34(1):139-48. doi: 10.1097/HJH.0000000000000767.

family: Mancia

full_name: Giuseppe Mancia

given: Giuseppe

family: Omboni

full_name: Stefano Omboni

given: Stefano

family: Chazova

full_name: Irina Chazova

given: Irina

family: Coca

full_name: Antonio Coca

given: Antonio

family: Girerd

full_name: Xavier Girerd

given: Xavier

family: Haller

full_name: Hermann Haller

given: Hermann

family: Parati

full_name: Gianfranco Parati

given: Gianfranco

family: Pauletto

full_name: Paolo Pauletto

given: Paolo

family: Pupek-Musialik

full_name: Danuta Pupek-Musialik

given: Danuta

family: Svyshchenko

full_name: Yevgeniya Svyshchenko

given: Yevgeniya

journal_name: Journal of Hypertension

title: Effects of the lercanidipine–enalapril combination vs. the corresponding monotherapies on home blood pressure in hypertension

lead_sponsor: RECORDATI GROUP


title: Cyclophosphamide Versus Mycophenolate Mofetil for Children With Steroid-dependent Idiopathic Nephrotic Syndrome : a Multicenter Randomized Controlled Trial

acronym: NEPHROMYCY

summary:
Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children. However 60% of cases are steroid dependent and required treatment with immunosuppressive agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency, but duration of these treatments should be restricted because of gonadotoxicity for cyclophosphamide and nephrotoxicity for ciclosporin.

Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem to have a residual action so that treatment must be maintained during months or years.

The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in steroid dependent nephrotic syndrome in children.


title: Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

summary: To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.


title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors

summary: The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.

lead_sponsor: Nerviano Medical Sciences


title: Permanent Observatory of Heart Failure

acronym: ODIN

summary:
The observatory consists of a row of data collection on a population composed of all patients with heart failure cared for in centers participating in the national education program for patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated. Patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.

The following of patients will be periodic after their entry in the observatory, up to 2 years of follow up.

ReferenceCitation: Schockmel M, Agrinier N, Jourdain P, Alla F, Eicher JC, Coulon P, Druelle J, Mulak G, Danchin N, Thilly N, Juillière Y; ODIN cohort participants. Socioeconomic factors and mortality in diastolic heart failure. Eur J Clin Invest. 2014 Apr;44(4):372-83. doi: 10.1111/eci.12246. Epub 2014 Feb 19.

name: CHU Nancy; Epidémiologie et Evaluation Cliniques; Nancy France

name: Université de Lorraine; Université Paris Descartes; APEMAC; EA; Nancy France

family: Schockmel

full_name: Matthieu Schockmel

given: Matthieu

family: Agrinier

full_name: Nelly Agrinier

given: Nelly

name: CHG René Dubos; Cardiologie; Pontoise France

family: Jourdain

full_name: Patrick Jourdain

given: Patrick

family: Alla

full_name: François Alla

given: François

name: CHU du Bocage; Cardiologie médicale; Dijon France

family: Eicher

full_name: Jean-Christophe Eicher

given: Jean-Christophe

family: Coulon

full_name: Patrice Coulon

given: Patrice

name: URC-Est; CHU Saint-Antoine; Paris France

family: Druelle

full_name: Justine Druelle

given: Justine

name: French Society of Cardiology; Paris France

family: Mulak

full_name: Geneviève Mulak

given: Geneviève

name: European Hospital Georges Pompidou; Cardiologie médicale; Paris France

family: Danchin

full_name: Nicolas Danchin

given: Nicolas

family: Thilly

full_name: Nathalie Thilly

given: Nathalie

name: CHU Nancy; Institut Lorrain du cœur et des vaisseaux; Cardiologie médicale; Nancy France

family: Juillière

full_name: Yves Juillière

given: Yves

journal_name: European Journal of Clinical Investigation

ReferenceCitation: Juillière Y, Suty-Selton C, Riant E, Darracq JP, Dellinger A, Labarre JP, Druelle J, Mulak G, Danchin N, Jourdain P; ODIN cohort participants. Prescription of cardiovascular drugs in the French ODIN cohort of heart failure patients according to age and type of chronic heart failure. Arch Cardiovasc Dis. 2014 Jan;107(1):21-32. doi: 10.1016/j.acvd.2013.11.001. Epub 2013 Dec 30.

family: Suty-Selton

full_name: Christine Suty-Selton

given: Christine

family: Riant

full_name: Elisabeth Riant

given: Elisabeth

family: Darracq

full_name: Jean-Pierre Darracq

given: Jean-Pierre

family: Dellinger

full_name: Arnaud Dellinger

given: Arnaud

family: Labarre

full_name: Jean-Philippe Labarre

given: Jean-Philippe

ReferenceCitation: Juillière Y, Jourdain P, Suty-Selton C, Béard T, Berder V, Maître B, Trochu JN, Drouet E, Pace B, Mulak G, Danchin N; ODIN Cohort Participants. Therapeutic patient education and all-cause mortality in patients with chronic heart failure: a propensity analysis. Int J Cardiol. 2013 Sep 20;168(1):388-95. doi: 10.1016/j.ijcard.2012.09.030. Epub 2012 Oct 6.

title: Therapeutic patient education and all-cause mortality in patients with chronic heart failure: A propensity analysis

ReferenceCitation: Agrinier N, Schockmel M, Thilly N, Laborde-Castérot H, Jourdain P, Alla F, Leclercq C, Dany F, Druelle J, Drouet E, Mulak G, Juillière Y; ODIN cohort participants. Effectiveness of a patient education programme in heart failure with preserved ejection fraction: Results from the ODIN cohort study using propensity score matching. Arch Cardiovasc Dis. 2018 Jan;111(1):5-16. doi: 10.1016/j.acvd.2017.03.010. Epub 2017 Sep 22.

ReferenceCitation: Garbacz L, Juillière Y, Alla F, Jourdain P, Guyon G, Coudane H, Hervé C, Claudot F. Perception of therapeutic patient education in heart failure by healthcare providers. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):446-52. doi: 10.1016/j.acvd.2015.03.008. Epub 2015 Jun 10.


title: CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients

acronym: AgirSASadom

summary:
Background: Continuous positive airway pressure (CPAP) is the first line therapy for obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be used: Fixed pressure, in which the effective pressure is set and kept constant all night, and auto CPAP devices where the positive pressure changes during the night depend on patient's requirements.

Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep fragmentation and alterations in sleep structure. This can limit blood pressure dipping during sleep and then impact clinical blood pressure reduction.

Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes: Evolution of arterial stiffness, biological parameters, quality of life and symptoms.

Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and symptoms questionnaires.

2 interim analysis will be carried out when 150 and 220 patients respectively will have completed the study. The Peto's method will be used to correct the p-values.

ReferenceCitation: Pépin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Lévy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

family: Pépin

full_name: J L Pépin

given: J L

family: Tamisier

full_name: R Tamisier

given: R

family: Baguet

full_name: J P Baguet

given: J P

family: Lepaulle

full_name: B Lepaulle

given: B

family: Arbib

full_name: F Arbib

given: F

family: Arnol

full_name: N Arnol

given: N

family: Timsit

full_name: J F Timsit

given: J F

family: Lévy

full_name: P Lévy

given: P

journal_name: Thorax

lead_sponsor: AGIR à Dom


lead_sponsor: Laboratoires Thea

title: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)

summary: The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).


title: Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children: Randomized, Double Blind Placebo-controlled Concept-proof Trial

acronym: INNOSTAPED

summary: Acute chest syndrome is a severe sickle cell disease complication in children requiring blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation. The randomized trial will test that hypothesis.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Other Grant/Funding Number

summary:
The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion.

The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas.

Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.

The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez


title: Suicide Gene Therapy for Donor Lymphocytes Infusion After Allogeneic Hematopoietic Stem Cell Transplantation: a Phase I/II Clinical Study

summary: The main complications of allogeneic hematopoietic stem cell transplantation (HSCT) include graft-versus-host disease (GVHD) and poor immune reconstitution leading to severe infections and leukemia relapse. Mature donor T-cells present in the transplant facilitate T-cell reconstitution but also induce GVHD, which itself impairs immune reconstitution. We have developed a strategy of alloreactive T-cell depletion, using T-cells expressing the Herpes simplex thymidine kinase (TK) suicide gene combined with a ganciclovir (GCV) treatment. This system permits the selective elimination of dividing TK+ T-cells in vivo. To test this hypothesis in preclinical settings, we have previously developed several experimental models of GVHD using TK+ T-cells in mice. The demonstration that a preventive treatment with GCV administered close to the time of HSCT could control GVHD brought the proof of concept. We now propose a clinical trial to test whether donor lymphocytes infusion (DLI) using TK-transduced cells permits to induce a graft-versus-tumor (GVT) effect for treatment of relapse after HSCT, while GVHD can be controlled by GCV treatment.

location_facility: Groupe Hospitalier Albert Chenevier-Henri Mondor


title: Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects

acronym: ANITA

summary:
Our working hypothesis postulates that lipolysis is a determinant of inflammation in adipose tissue (AT). Inhibition of lipolysis, e.g. using the oldest normolipidemic drug, nicotinic acid, has proved valuable to combat the metabolic syndrome. Our proposal will determine whether part of the beneficial effects of this antilipolytic compound is due to a diminution of AT inflammation.

To this aim, the effect of nicotinic acid or placebo will be studied in male obese subjects with or without a training program which goal is to enhance lipolysis.

primary_purpose: Basic Science

ReferenceCitation: Montastier E, Beuzelin D, Martins F, Mir L, Marqués MA, Thalamas C, Iacovoni J, Langin D, Viguerie N. Niacin induces miR-502-3p expression which impairs insulin sensitivity in human adipocytes. Int J Obes (Lond). 2019 Jul;43(7):1485-1490. doi: 10.1038/s41366-018-0260-5. Epub 2018 Nov 27.

family: Montastier

full_name: Emilie Montastier

given: Emilie

family: Beuzelin

full_name: Diane Beuzelin

given: Diane

family: Martins

full_name: Frédéric Martins

given: Frédéric

family: Mir

full_name: Lucile Mir

given: Lucile

family: Marqués

full_name: Marie-Adeline Marqués

given: Marie-Adeline

family: Thalamas

full_name: Claire Thalamas

given: Claire

family: Iacovoni

full_name: Jason Iacovoni

given: Jason

family: Langin

full_name: Dominique Langin

given: Dominique

family: Viguerie

full_name: Nathalie Viguerie

journal_name: International Journal of Obesity

ReferenceCitation: Bourlier V, Saint-Laurent C, Louche K, Badin PM, Thalamas C, de Glisezinski I, Langin D, Sengenes C, Moro C. Enhanced glucose metabolism is preserved in cultured primary myotubes from obese donors in response to exercise training. J Clin Endocrinol Metab. 2013 Sep;98(9):3739-47. doi: 10.1210/jc.2013-1727. Epub 2013 Jul 24.

family: Bourlier

full_name: Virginie Bourlier

given: Virginie

family: Saint-Laurent

full_name: Céline Saint-Laurent

given: Céline

family: Louche

full_name: Katie Louche

given: Katie

family: Badin

full_name: Pierre-Marie Badin

given: Pierre-Marie

family: de Glisezinski

full_name: Isabelle de Glisezinski

given: Isabelle

family: Sengenes

full_name: Coralie Sengenes

given: Coralie

family: Moro

full_name: Cedric Moro

given: Cedric

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

title: Enhanced Glucose Metabolism Is Preserved in Cultured Primary Myotubes From Obese Donors in Response to Exercise Training

location_facility: Centre d'Investigation Clinique, Purpan University Toulouse Hospital


title: A Phase I/II Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)

summary: The main objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.

lead_sponsor: Nantes University Hospital


ReferenceCitation: Bauer C, Pavlakovic I, Mercier C, Maury JM, Koffel C, Roy P, Fellahi JL. Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):766-773. doi: 10.1097/EJA.0000000000000777.

family: Bauer

full_name: Christian Bauer

given: Christian

family: Pavlakovic

full_name: Isabelle Pavlakovic

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Maury

full_name: Jean-Michel Maury

given: Jean-Michel

family: Koffel

full_name: Catherine Koffel

family: Roy

full_name: Pascal Roy

given: Pascal

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

journal_name: European Journal of Anaesthesiology

evidence: open (via free article)

lead_sponsor: Hospices Civils de Lyon

acronym: PARAVI

location_facility: Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology

title: Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.

summary: The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.


title: Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

acronym: INFLUX-IT-VS

summary: The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.

ReferenceCitation: Blaise S, Roustit M, Hellmann M, Millet C, Cracowski JL. Cathodal iontophoresis of treprostinil induces a sustained increase in cutaneous blood flux in healthy volunteers. J Clin Pharmacol. 2013 Jan;53(1):58-66. doi: 10.1177/0091270011434352. Epub 2013 Jan 24.

family: Blaise

full_name: Sophie Blaise

given: Sophie

family: Roustit

full_name: Matthieu Roustit

given: Matthieu

name: Clinical Pharmacology Department, Inserm CIC3; University Hospital; Grenoble; France

family: Hellmann

full_name: Marcin Hellmann

given: Marcin

family: Millet

full_name: Claire Millet

name: Vascular Medicine Department; University Hospital; Grenoble; France

family: Cracowski

full_name: Jean-Luc Cracowski

bso_classification: Chemistry

journal_name: The Journal of Clinical Pharmacology

title: Cathodal Iontophoresis of Treprostinil Induces a Sustained Increase in Cutaneous Blood Flux in Healthy Volunteers

location_facility: Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble


title: Superimposed Electrical Stimulation Real-time Effects on Repeated Muscle Contractions Enable to Increase Recovery From Thumb Joint Stiffness After Surgery of the Ulnar Collateral Ligament

summary:
Background

One of the potentially debilitative complications of operative repair and subsequent immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent such a physical impairment, active joint mobilization has shown to be efficient. However, adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the biological tissues, if a technique can enable to extend the muscle ability to impose a maximal steady stress on adhesions, adhesion deformation should be greater and range of motion deficit should be reduced. Within that context, the purpose of the present study was to assess the real-time effects of superimposed electrical stimulation (SES) on maximal voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion recovery in thumb stiff joint.

Methods and Findings

The aim of the first experiment was to examine the real-time effects of tetanic SES on the maximal volitional level of force over repeated contractions of the triceps brachii muscle. To address this goal, seventeen subjects participated voluntarily in this study. Two features of the muscular force were assessed: The peak force (1) and the impulse (2). These two dependent variables were measured during 500 sec - including 50 maximal force productions of 4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a whole, exerted force was higher in the SES than in the VOL condition for both peak force and impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).

The aim of the second experiment was to compare the effects of VOL and SES on the range of flexion recovery of the stiff metacarpophalangeal joint following operative repair of the ulnar collateral ligament of the thumb. To address this goal, eight patients participated voluntarily. Range of motion, oedema and pain were assessed before and after the two randomised conditions of VOL and SES.

ReferenceCitation: Bostock S, Morris MA. The range of motion of the MP joint of the thumb following operative repair of the ulnar collateral ligament. J Hand Surg Br. 1993 Dec;18(6):710-1.

lead_sponsor: Université Joseph Fourier

location_facility: Université Joseph Fourier - TIMC IMAG laboratory


title: Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity - Norms in ARFI: Distribution and Reproducibility of ARFI Values in Disease-free Livers or Pathological Livers.

acronym: NARFI

summary: Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases. However, there is growing evidence that fibrosis is not the only determinant of liver stiffness. Indeed inflammation, cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.

ReferenceCitation: Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8. Review.

ReferenceCitation: Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26. Review.

ReferenceCitation: Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18. Review.

ReferenceCitation: Ferraioli G, Gulizia R, Filice C. Real-time elastography in the assessment of liver fibrosis. AJR Am J Roentgenol. 2007 Sep;189(3):W170.

ReferenceCitation: Friedrich-Rust M, Ong MF, Herrmann E, Dries V, Samaras P, Zeuzem S, Sarrazin C. Real-time elastography for noninvasive assessment of liver fibrosis in chronic viral hepatitis. AJR Am J Roentgenol. 2007 Mar;188(3):758-64.

lead_sponsor: University Hospital, Bordeaux


title: Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease

acronym: SCP-Comodig

summary: Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.

ReferenceCitation: Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.

name: Nutrition, Gut & Brain Unit (INSERM UMR 1073); Institute for Biomedical Research and Innovation; Rouen University; Rouen France

name: Department of Neurosurgery; Rouen University Hospital; University of Rouen; Rouen France

family: Derrey

full_name: S. Derrey

given: S.

name: Department of Physiology; Rouen University Hospital; University of Rouen; Rouen France

family: Chastan

full_name: N. Chastan

given: N.

name: Department of Neurology; Rouen University Hospital; University of Rouen; Rouen France

family: Maltete

full_name: D. Maltete

given: D.

family: Verin

full_name: E. Verin

given: E.

family: Dechelotte

full_name: P. Dechelotte

given: P.

family: Lefaucheur

full_name: R. Lefaucheur

given: R.

family: Proust

full_name: F. Proust

given: F.

family: Freger

full_name: P. Freger

family: Leroi

full_name: A. M. Leroi

given: A. M.

name: Clinical Investigation Centre INSERM 0204; Rouen University Hospital; University of Rouen; Rouen France

family: Weber

full_name: J. Weber

given: J.

family: Gourcerol

full_name: G. Gourcerol

given: G.

journal_name: Neurogastroenterology & Motility

lead_sponsor: University Hospital, Rouen


title: Effect of Pharyngeal Inhibition Induced by Repetitive Transcranial Stimulation in Post Stroke Dysphagia

acronym: rTMS AVC

summary: The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve patients with post stroke dysphagia.


title: French Observatory of Acute Heart Failure

acronym: OFICA

summary:
During the last decade, progress has been made in the management of heart failure. However, the changing characteristics of patients and practices in the "real world" and their impact on the prognosis of patients admitted for acute heart failure remain poorly studied.

2000 consecutive patients recruited in a single day in hospitals volunteered to participate in the cohort during a day dedicated.

ReferenceCitation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

name: AP-HP, Groupe Hospitalier Lariboisiere Saint Louis; INSERM U942 Paris 7 University Paris France

family: Logeart

full_name: Damien Logeart

given: Damien

name: AP-HP, Groupe Hospitalier Pitie Salpetriere; Paris 6 University Paris France

family: Isnard

full_name: Richard Isnard

given: Richard

name: AP-HP, Groupe Hospitalier Lariboisiere Saint Louis; Paris France

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

name: Centre Hospitalier Universitaire Minoz; Besançon France

family: Seronde

full_name: Marie-France Seronde

given: Marie-France

name: Centre Hospitalier Regional Universitaire de Lille; France

family: de Groote

full_name: Pascal de Groote

name: AP-HP, Groupe Hospitalier Bichat Claude Bernard; INSERM U698 Paris 7 University Paris France

family: Jondeau

full_name: Guillaume Jondeau

given: Guillaume

name: Centre Hospitalier Universitaire Rangueil; Toulouse France

family: Galinier

full_name: Michel Galinier

given: Michel

family: Mulak

full_name: Geneviève Mulak

given: Geneviève

name: Centre Hospitalier Universitaire Pontchaillou; CIC-IT 804, LTSI INSERM U1099 Rennes France

family: Donal

full_name: Erwan Donal

given: Erwan

name: Hospices Civils de Lyon; Claude Bernard University; Lyon

family: Delahaye

full_name: François Delahaye

given: François

name: Centre Hospitalier Universitaire Brabois; Nancy France

family: Juilliere

full_name: Yves Juilliere

given: Yves

name: AP-HP, Hopital Henri Mondor; Créteil France

family: Damy

full_name: Thibaud Damy

given: Thibaud

name: Centre Hospitalier Rene Dubosc; Pontoise France

family: Jourdain

full_name: Patrick Jourdain

given: Patrick

family: Bauer

full_name: Fabrice Bauer

given: Fabrice

name: Centre Hospitalier Universitaire; Dijon France

family: Eicher

full_name: Jean-Christophe Eicher

given: Jean-Christophe

name: Centre Hospitalier Universitaire; Grenoble France

family: Neuder

full_name: Yannick Neuder

given: Yannick

name: INSERM UMR1087, Université de Nantes, Centre Hospitalier Universitaire Nantes; Nantes France

family: Trochu

full_name: Jean-Noël Trochu

given: Jean-Noël

name: on behalf of the working group on Heart Failure of the French Society of Cardiology

journal_name: European Journal of Heart Failure

ReferenceCitation: Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. French.

lead_sponsor: French Cardiology Society


title: Ephrin B1 Regulation in Human Right Appendage

acronym: REBORD

summary:
Background : Ephrin-B1 is part of the large Eph/Ephrin system which is involved in cell-cell comunication. The role of Ephrin-B1 has scarcely been studied in adulthood. Our team has shown that this protein is expressed in normal heart in mice and humans. In mice with deletion of the gene encoding Ephrin-B1, we have shown progressive development of dilated cardiomyopathy characterized by dramatic disorganization of cardiac tissue architecture and decreased heart rate variability.
Purpose: Ephrin-B1 protein was recently identified in human heart but its putative role remains unknown. In knockout mice, deletion of efn gene is associated with abnormalities in cardiac architecture linked to defects in cell-cell tight junctions. From a functional point of view, mice develop a dilated cardiomyopathy and exhibit decreased heart rate variability in the frequency domain. The purpose of this study is to assess if Ephrin-B1 expression is regulated in human heart and if expression level correlates with heart rate variability.
Abstract: Thirty patients suffering from cardiac disease needing surgery will be included and separated in two groups according to pressure levels in right auricle /and or pulmonary artery. Ephrin-B1 expression will be assessed in right appendages at both the transcriptional (quantitative PCR) and protein (Western blot) levels. Furthermore, the putative relationship between Ephrin-B1 expression and heart rate variability (24 hours ECG recordings) will be investigated.


title: A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis

summary:
All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will be considered for inclusion. After written inform consent, psychometric tests in order to calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed before the TIPS procedure. After TIPS, patients will be followed during one year and the psychometric test and CFF will be performed every 3 months.

30 patients will be included.

The main endpoint is the success rate of CFF. The secondary end points are

Correlation between CFF and PHES score
Performance of CFF and PHES score to predict the occurrence of overt encephalopathy after TIPS procedure
A sample collection during TIPS procedure is also performed for validation of biomarkers

ReferenceCitation: Berlioux P, Robic MA, Poirson H, Métivier S, Otal P, Barret C, Lopez F, Péron JM, Vinel JP, Bureau C. Pre-transjugular intrahepatic portosystemic shunts (TIPS) prediction of post-TIPS overt hepatic encephalopathy: the critical flicker frequency is more accurate than psychometric tests. Hepatology. 2014 Feb;59(2):622-9.


title: Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)

summary:
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia

summary:
Objectives:

The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.

ReferenceCitation: Bor J, Brunelin J, d'Amato T, Costes N, Suaud-Chagny MF, Saoud M, Poulet E. How can cognitive remediation therapy modulate brain activations in schizophrenia? An fMRI study. Psychiatry Res. 2011 Jun 30;192(3):160-6. doi: 10.1016/j.pscychresns.2010.12.004. Epub 2011 May 2.

family: Bor

full_name: Julie Bor

given: Julie

family: Brunelin

full_name: Jérôme Brunelin

given: Jérôme

family: d'Amato

full_name: Thierry d'Amato

given: Thierry

family: Costes

full_name: Nicolas Costes

given: Nicolas

family: Suaud-Chagny

full_name: Marie-Françoise Suaud-Chagny

given: Marie-Françoise

family: Saoud

full_name: Mohamed Saoud

given: Mohamed

family: Poulet

full_name: Emmanuel Poulet

given: Emmanuel

journal_name: Psychiatry Research: Neuroimaging

lead_sponsor: Hôpital le Vinatier


title: Cognitive Remediation of the Ability to Infer Intention of Others in Schizophrenic Patients - A Controlled, Randomized Trial (Phase IIb)

acronym: REMEDCOG

summary: Theory of mind (ability to infer others' intention, emotion, etc) is known to be altered in patients with schizophrenia and its deficit to be correlated with their decreased social proficiency. We designed a novel cognitive therapy, that makes use of videos, aimed at learning a better use of contextual information to infer others' intentions. The aim of this study is to demonstrate, in schizophrenic patients, a quantitative improvement of their ability to infer intention of others induced by this novel training program. A secondary aim is to measure the cerebral correlates (MEG, PeV) of this social cognitive function and of its anticipated improvement.

location_facility: Centre hospitalier de Versailles. Service de Psychiatrie.


title: Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography

acronym: IRM-EP

summary:
The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism
Thoracic CT angiography (CTA) will serve as reference standard
Result of MRI will not interfere with patients' management
Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease

ReferenceCitation: Blum A, Bellou A, Guillemin F, Douek P, Laprévote-Heully MC, Wahl D; GENEPI study group. Performance of magnetic resonance angiography in suspected acute pulmonary embolism. Thromb Haemost. 2005 Mar;93(3):503-11.

ReferenceCitation: Pleszewski B, Chartrand-Lefebvre C, Qanadli SD, Déry R, Perreault P, Oliva VL, Prenovault J, Belblidia A, Soulez G. Gadolinium-enhanced pulmonary magnetic resonance angiography in the diagnosis of acute pulmonary embolism: a prospective study on 48 patients. Clin Imaging. 2006 May-Jun;30(3):166-72.

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

family: Revel

full_name: Marie Pierre Revel

given: Marie Pierre

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Lefort

full_name: Catherine Lefort

given: Catherine

family: Meyer

full_name: Guy Meyer

given: Guy

family: Couchon

full_name: Sophie Couchon

given: Sophie

family: Hernigou

full_name: Anne Hernigou

given: Anne

family: Niarra

full_name: Ralph Niarra

given: Ralph

family: Chatellier

full_name: Gilles Chatellier

given: Gilles

family: Frija

full_name: Guy Frija

journal_name: European Radiology

publisher_dissemination: Springer

publisher_group: Springer


title: Open Label, Multicenter, Single Arm Trial of the Safety and Efficacy of Polyacrylamide Hydrogel Injection in the Management of Human Immunodeficiency Virus-Related Facial Lipoatrophy : THE LIPOPHILL TRIAL

acronym: LIPOPHILL

summary:
Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5 years.

Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIV-infected patients have been previously reported.

The primary objective of the study was to evaluate the long-term efficacy and safety of subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months


title: Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery

acronym: CATCH

summary: In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.

location_facility: Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine


title: Early Continuous High Volume Veno-venous Hemofiltration vs. Standard Care for Post-cardiac Surgery Shock Requiring High Doses Catecholamines. The HEROICS Study: HEmofiltration to Rescue Severe shOck followIng Cardiac Surgery

acronym: HEROICS

summary: This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock requiring high doses catecholamines.

ReferenceCitation: Combes A, Bréchot N, Amour J, Cozic N, Lebreton G, Guidon C, Zogheib E, Thiranos JC, Rigal JC, Bastien O, Benhaoua H, Abry B, Ouattara A, Trouillet JL, Mallet A, Chastre J, Leprince P, Luyt CE. Early High-Volume Hemofiltration versus Standard Care for Post-Cardiac Surgery Shock. The HEROICS Study. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1179-90. doi: 10.1164/rccm.201503-0516OC.

family: Combes

full_name: Alain Combes

given: Alain

family: Bréchot

full_name: Nicolas Bréchot

family: Amour

full_name: Julien Amour

given: Julien

family: Cozic

full_name: Nathalie Cozic

given: Nathalie

family: Lebreton

full_name: Guillaume Lebreton

given: Guillaume

family: Guidon

full_name: Catherine Guidon

family: Zogheib

full_name: Elie Zogheib

given: Elie

family: Thiranos

full_name: Jean-Claude Thiranos

given: Jean-Claude

family: Rigal

full_name: Jean-Christophe Rigal

given: Jean-Christophe

family: Bastien

full_name: Olivier Bastien

family: Benhaoua

full_name: Hamina Benhaoua

given: Hamina

family: Abry

full_name: Bernard Abry

given: Bernard

family: Ouattara

full_name: Alexandre Ouattara

given: Alexandre

family: Trouillet

full_name: Jean-Louis Trouillet

given: Jean-Louis

family: Mallet

full_name: Alain Mallet

family: Chastre

full_name: Jean Chastre

given: Jean

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Early High-Volume Hemofiltration versus Standard Care for Post–Cardiac Surgery Shock. The HEROICS Study


title: Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program

acronym: SEPLUS

summary: The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program

lead_sponsor: Bayer


title: Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma

summary:
RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib tosylate is more effective when given alone or together with pravastatin in treating patients with liver cancer and cirrhosis.

PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with pravastatin to see how well it works compared with giving sorafenib tosylate alone in treating patients with liver cancer and cirrhosis.

ReferenceCitation: Jouve JL, Lecomte T, Bouché O, Barbier E, Khemissa Akouz F, Riachi G, Nguyen Khac E, Ollivier-Hourmand I, Debette-Gratien M, Faroux R, Villing AL, Vergniol J, Ramee JF, Bronowicki JP, Seitz JF, Legoux JL, Denis J, Manfredi S, Phelip JM; PRODIGE-11 investigators/collaborators. Pravastatin combination with sorafenib does not improve survival in advanced hepatocellular carcinoma. J Hepatol. 2019 Sep;71(3):516-522. doi: 10.1016/j.jhep.2019.04.021. Epub 2019 May 22.


title: Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission

summary: A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse

ReferenceCitation: Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Béné MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucémies aiguës et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.

family: Park

full_name: S Park

given: S

name: GOELAMS (Groupe Ouest Est d’Etude des Leucémies aiguës et Autres Maladies du Sang)

family: Chapuis

full_name: N Chapuis

given: N

family: Saint Marcoux

full_name: F Saint Marcoux

given: F

family: Recher

full_name: C Recher

given: C

family: Prebet

full_name: T Prebet

given: T

family: Chevallier

full_name: P Chevallier

given: P

family: Cahn

full_name: J-Y Cahn

given: J-Y

family: Leguay

full_name: T Leguay

family: Bories

full_name: P Bories

family: Witz

full_name: F Witz

family: Lamy

full_name: T Lamy

family: Mayeux

full_name: P Mayeux

family: Lacombe

full_name: C Lacombe

family: Demur

full_name: C Demur

family: Tamburini

full_name: J Tamburini

given: J

family: Merlat

full_name: A Merlat

given: A

family: Delepine

full_name: R Delepine

given: R

family: Vey

full_name: N Vey

family: Dreyfus

full_name: F Dreyfus

family: Béné

full_name: M C Béné

given: M C

family: Ifrah

full_name: N Ifrah

family: Bouscary

full_name: D Bouscary

given: D

journal_name: Leukemia


title: Effectiveness of a French Automated Web-based Smoking Cessation Program : a Randomized Controlled Trial

acronym: Stamp

summary: The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the "coaching", by comparing it to an online self-help guide.

lead_sponsor: Institut national de prevention et d'education pour la sante


title: Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy

summary:
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

ReferenceCitation: Dauvilliers Y, Verbraecken J, Partinen M, Hedner J, Saaresranta T, Georgiev O, Tiholov R, Lecomte I, Tamisier R, Lévy P, Scart-Gres C, Lecomte JM, Schwartz JC, Pépin JL; HAROSA II Study Group collaborators. Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1135-1145. doi: 10.1164/rccm.201907-1284OC. Erratum in: Am J Respir Crit Care Med. 2020 Jul 1;202(1):154-155.

name: National Reference Center for Narcolepsy, Sleep and Wake Unit, Department of Neurology, Gui-de-Chauliac Hospital, Montpellier University Hospital, Montpellier, France

name: INSERM U1061, Montpellier University, Montpellier, France

family: Dauvilliers

full_name: Yves Dauvilliers

given: Yves

name: Multidisciplinary Sleep Disorders Center, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium

family: Verbraecken

full_name: Johan Verbraecken

given: Johan

name: Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland

name: Department of Clinical Neurosciences, University of Helsinki, Helsinki, Finland

family: Partinen

full_name: Markku Partinen

given: Markku

name: Sleep and Vigilance Laboratory, Department of Internal Medicine, University of Göteborg, Sahlgrenska University Hospital, University of Göteborg, Göteborg, Sweden

family: Hedner

full_name: Jan Hedner

given: Jan

name: Sleep Research Center, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland

name: Department of Pulmonary Diseases, Turku University Hospital, Turku, Finland

family: Saaresranta

full_name: Tarja Saaresranta

given: Tarja

name: Pulmonology Unit, Department of Internal Medicine, Alexandrovska Hospital Medical University, Sofia, Bulgaria

family: Georgiev

full_name: Ognian Georgiev

given: Ognian

name: Department of Internal Diseases, Sveti Ivan Rilski Multiprofile Hospital for Active Treatment, Kozloduy, Bulgaria

family: Tiholov

full_name: Rumen Tiholov

given: Rumen

name: Bioprojet, 30 rue Francs Bourgois, Paris, France

family: Lecomte

full_name: Isabelle Lecomte

given: Isabelle

name: Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and

name: Cardio-Respiratory Functional Exploration Laboratory (EFCR), Grenoble Alpes University Hospital, Grenoble, France

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Scart-Gres

full_name: Catherine Scart-Gres

given: Catherine

full_name: Jeanne-Marie Lecomte

given: Jeanne-Marie

family: Schwartz

full_name: Jean-Charles Schwartz

given: Jean-Charles

family: Pépin

full_name: Jean-Louis Pépin

family: Attali

full_name: Valerie Attali

given: Valerie

family: Bourgin

full_name: Patrice Bourgin

given: Patrice

family: Gagnadoux

full_name: Frederic Gagnadoux

given: Frederic

family: Baharloo

full_name: Farhad Baharloo

given: Farhad

family: Berg

full_name: Soren Berg

given: Soren

family: Polo

full_name: Olli Polo

given: Olli

full_name: Jan Anders Hedner

given: Jan Anders

family: Peker

full_name: Yeksel Peker

given: Yeksel

family: Blau

full_name: Alexander Blau

given: Alexander

family: Borreguero

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories_institution:
PubMed Central - Europe PMC
University of Helsinki - Helda

location_facility: Centre Hospitalier Universitaire de Grenoble


title: Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN.

acronym: PEDISCAN

summary: Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver disease. At present, the unique validated method to evaluate the liver fibrosis in children, is the liver biopsy which is an invasive method. If the elastometry method is proved to be a good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.

ReferenceCitation: Corpechot C, El Naggar A, Poujol-Robert A, Ziol M, Wendum D, Chazouillères O, de Lédinghen V, Dhumeaux D, Marcellin P, Beaugrand M, Poupon R. Assessment of biliary fibrosis by transient elastography in patients with PBC and PSC. Hepatology. 2006 May;43(5):1118-24.

ReferenceCitation: Castéra L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, Darriet M, Couzigou P, De Lédinghen V. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology. 2005 Feb;128(2):343-50.

ReferenceCitation: Ganne-Carrié N, Ziol M, de Ledinghen V, Douvin C, Marcellin P, Castera L, Dhumeaux D, Trinchet JC, Beaugrand M. Accuracy of liver stiffness measurement for the diagnosis of cirrhosis in patients with chronic liver diseases. Hepatology. 2006 Dec;44(6):1511-7.

ReferenceCitation: de Lédinghen V, Le Bail B, Rebouissoux L, Fournier C, Foucher J, Miette V, Castéra L, Sandrin L, Merrouche W, Lavrand F, Lamireau T. Liver stiffness measurement in children using FibroScan: feasibility study and comparison with Fibrotest, aspartate transaminase to platelets ratio index, and liver biopsy. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):443-50.


title: Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (Study DIAMUCO)

acronym: DIAMUCO

summary: For some years, the investigators observe an increase of the arisen of diabetes in cystic fibrosis patients However, this diabetes may be reversible. The investigators speak about " Cystic fibrosis related diabetes.". The objective of this project, is to know better what facilitates the appearance and the reversibility of the diabetes, such as the genetic mutations, the respiratory state and the lung infections. Theses knowledges should allow to adapt the screening of diabetes, and its treatment, for the patients affected by cystic fibrosis.

ReferenceCitation: Reynaud Q, Rabilloud M, Roche S, Poupon-Bourdy S, Iwaz J, Nove-Josserand R, Blond E, Laville M, Llerena C, Quetant S, Reix P, Touzet S, Durieu I. Glucose trajectories in cystic fibrosis and their association with pulmonary function. J Cyst Fibros. 2018 May;17(3):400-406. doi: 10.1016/j.jcf.2017.09.010. Epub 2017 Oct 14.

family: Reynaud

full_name: Quitterie Reynaud

given: Quitterie

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Roche

full_name: Sylvain Roche

given: Sylvain

family: Poupon-Bourdy

full_name: Stéphanie Poupon-Bourdy

given: Stéphanie

family: Iwaz

full_name: Jean Iwaz

given: Jean

family: Nove-Josserand

full_name: Raphaële Nove-Josserand

given: Raphaële

family: Blond

full_name: Emilie Blond

given: Emilie

family: Laville

full_name: Martine Laville

given: Martine

family: Llerena

full_name: Cathy Llerena

given: Cathy

family: Quetant

full_name: Sébastien Quetant

given: Sébastien

family: Reix

full_name: Philippe Reix

given: Philippe

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

family: Durieu

full_name: Isabelle Durieu

journal_name: Journal of Cystic Fibrosis

location_facility: Service de Médecine Interne - Centre Hospitalier Lyon Sud


title: BF2.649 in Patients With Obstructive Sleep Apnea Syndrome (OSA) and Treated by Nasal Continuous Positive Airway Pressure (nCPAP), But Still Complaining of Excessive Daytime Sleepiness (EDS)

ReferenceCitation: Pépin JL, Georgiev O, Tiholov R, Attali V, Verbraecken J, Buyse B, Partinen M, Fietze I, Belev G, Dokic D, Tamisier R, Lévy P, Lecomte I, Lecomte JM, Schwartz JC, Dauvilliers Y; HAROSA I Study Group. Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP: A Randomized Trial. Chest. 2021 Apr;159(4):1598-1609. doi: 10.1016/j.chest.2020.09.281. Epub 2020 Oct 26.

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

family: Georgiev

full_name: Ognian Georgiev

given: Ognian

family: Tiholov

full_name: Rumen Tiholov

given: Rumen

family: Attali

full_name: Valérie Attali

given: Valérie

family: Verbraecken

full_name: Johan Verbraecken

given: Johan

family: Buyse

full_name: Bertien Buyse

given: Bertien

family: Partinen

full_name: Markku Partinen

given: Markku

family: Fietze

full_name: Ingo Fietze

given: Ingo

family: Belev

full_name: Georgi Belev

given: Georgi

family: Dokic

full_name: Dejan Dokic

given: Dejan

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Lecomte

full_name: Isabelle Lecomte

given: Isabelle

full_name: Jeanne-Marie Lecomte

given: Jeanne-Marie

family: Schwartz

full_name: Jean-Charles Schwartz

given: Jean-Charles

family: Dauvilliers

full_name: Yves Dauvilliers

given: Yves

full_name: Valerie Attali

given: Valerie

family: Bourgin

full_name: Patrice Bourgin

given: Patrice

family: D’Ortho

full_name: Marie D’Ortho

given: Marie

family: Gagnadoux

full_name: Frederic Gagnadoux

given: Frederic

family: Meurice

full_name: Jean Claude Meurice

given: Jean Claude

family: Nguyen

full_name: Xuan Lan Nguyen

given: Xuan Lan


title: Observational Survey Assessing the Factors of Treatment Intensification in Uncontrolled Hypertensive Patients Under a Combination Therapy, Either Fixed or Not, of a Renin-Angiotensin System Blocker (RASB) and Hydrochlorothiazide (HCTZ), According to Their Level of Cardiovascular Risk.

summary: This study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients


title: Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. French Part of a Multicentric European Study

acronym: RISTOMED

summary:
Ageing of the population is a major event in the world. Gerontological/geriatric literature unanimously indicate that physical exercise and diet are at present the two available fundamental approaches to contrast/prevent most of the age associated alterations. In the elderly the inflammageing, the oxidative stress and the alteration of the intestinal microbiota can be influenced by nutritional status and possibly corrected by an appropriate dietetic intervention:

Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve the quality of individual diet for specific needs This study will focus on the development of a specific dietary approach through an E-Health dietary service, associated or not to nutraceutical food supplements intake, to modulate the oxidative stress, inflammageing and gut microflora in the elderly people.

ReferenceCitation: Franceschi C, Valensin S, Bonafè M, Paolisso G, Yashin AI, Monti D, De Benedictis G. The network and the remodeling theories of aging: historical background and new perspectives. Exp Gerontol. 2000 Sep;35(6-7):879-96. Review.

ReferenceCitation: Wener MH, Daum PR, McQuillan GM. The influence of age, sex, and race on the upper reference limit of serum C-reactive protein concentration. J Rheumatol. 2000 Oct;27(10):2351-9.

ReferenceCitation: Mendall MA, Patel P, Ballam L, Strachan D, Northfield TC. C reactive protein and its relation to cardiovascular risk factors: a population based cross sectional study. BMJ. 1996 Apr 27;312(7038):1061-5.

ReferenceCitation: Devaraj S, O'Keefe G, Jialal I. Defining the proinflammatory phenotype using high sensitive C-reactive protein levels as the biomarker. J Clin Endocrinol Metab. 2005 Aug;90(8):4549-54. Epub 2005 May 17.

ReferenceCitation: Ostan R, Béné MC, Spazzafumo L, Pinto A, Donini LM, Pryen F, Charrouf Z, Valentini L, Lochs H, Bourdel-Marchasson I, Blanc-Bisson C, Buccolini F, Brigidi P, Franceschi C, d'Alessio PA. Impact of diet and nutraceutical supplementation on inflammation in elderly people. Results from the RISTOMED study, an open-label randomized control trial. Clin Nutr. 2016 Aug;35(4):812-8. doi: 10.1016/j.clnu.2015.06.010. Epub 2015 Jul 15.

family: Ostan

full_name: R. Ostan

given: R.

family: Béné

full_name: M.C. Béné

family: Spazzafumo

full_name: L. Spazzafumo

given: L.

family: Pinto

full_name: A. Pinto

given: A.

family: Donini

full_name: L.M. Donini

family: Pryen

full_name: F. Pryen

given: F.

family: Charrouf

full_name: Z. Charrouf

given: Z.

family: Valentini

full_name: L. Valentini

family: Lochs

full_name: H. Lochs

given: H.

family: Bourdel-Marchasson

full_name: I. Bourdel-Marchasson

given: I.

family: Blanc-Bisson

full_name: C. Blanc-Bisson

given: C.

family: Buccolini

full_name: F. Buccolini

family: Brigidi

full_name: P. Brigidi

given: P.

family: Franceschi

full_name: C. Franceschi

family: d'Alessio

full_name: P.A. d'Alessio

journal_name: Clinical Nutrition

ReferenceCitation: Valentini L, Pinto A, Bourdel-Marchasson I, Ostan R, Brigidi P, Turroni S, Hrelia S, Hrelia P, Bereswill S, Fischer A, Leoncini E, Malaguti M, Blanc-Bisson C, Durrieu J, Spazzafumo L, Buccolini F, Pryen F, Donini LM, Franceschi C, Lochs H. Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people. Clin Nutr. 2015 Aug;34(4):593-602. doi: 10.1016/j.clnu.2014.09.023. Epub 2014 Oct 8.

full_name: Luzia Valentini

given: Luzia

full_name: Alessandro Pinto

given: Alessandro

full_name: Isabelle Bourdel-Marchasson

full_name: Rita Ostan

given: Rita

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

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

title: Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota – The “RISTOMED project”: Randomized controlled trial in healthy older people

location_facility: Pôle de gerontology Clinique Hôpital Xavier Arnozan , University Hospital, Bordeaux


title: Mild Therapeutic Hypothermia During Severe Sepsis

summary:
Objectives: to evaluate the feasibility, the safety and the effects on physiological parameters of mild therapeutic hypothermia during septic shock.

Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds university-affiliated intensive care unit of a teaching Hospital.

Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external water cooling blanket.

lead_sponsor: University Hospital, Brest

location_facility: Réanimation Médicale, CHU de la Cavale Blanche


title: Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery

summary: The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.

time_perspective: Retrospective

ReferenceCitation: Muselier A, Dugas B, Burelle X, Passemard M, Hubert I, Mathieu B, Berrod JP, Bron AM, Creuzot-Garcher C. Macular hole surgery and cataract extraction: combined vs consecutive surgery. Am J Ophthalmol. 2010 Sep;150(3):387-91. doi: 10.1016/j.ajo.2010.04.008. Epub 2010 Jul 7.

family: Muselier

full_name: Aurore Muselier

given: Aurore

family: Dugas

full_name: Brice Dugas

given: Brice

family: Burelle

full_name: Xavier Burelle

given: Xavier

family: Passemard

full_name: Marie Passemard

family: Hubert

full_name: Isabelle Hubert

given: Isabelle

family: Mathieu

full_name: Bénigne Mathieu

given: Bénigne

family: Berrod

full_name: Jean Paul Berrod

given: Jean Paul

family: Bron

full_name: Alain M. Bron

given: Alain M.

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

given: Catherine

journal_name: American Journal of Ophthalmology

title: Macular Hole Surgery and Cataract Extraction: Combined vs Consecutive Surgery

lead_sponsor: Centre Hospitalier Universitaire Dijon