title: Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome

acronym: PEICU

summary: The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

ReferenceCitation: Minet C, Lugosi M, Savoye PY, Menez C, Ruckly S, Bonadona A, Schwebel C, Hamidfar-Roy R, Dumanoir P, Ara-Somohano C, Ferretti GR, Timsit JF. Pulmonary embolism in mechanically ventilated patients requiring computed tomography: Prevalence, risk factors, and outcome. Crit Care Med. 2012 Dec;40(12):3202-8. doi: 10.1097/CCM.0b013e318265e461.

family: Minet

full_name: Clémence Minet

given: Clémence

family: Lugosi

full_name: Maxime Lugosi

given: Maxime

family: Savoye

full_name: Pierre Yves Savoye

given: Pierre Yves

family: Menez

full_name: Caroline Menez

given: Caroline

family: Ruckly

full_name: Stéphane Ruckly

given: Stéphane

family: Bonadona

full_name: Agnès Bonadona

given: Agnès

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Hamidfar-Roy

full_name: Rebecca Hamidfar-Roy

given: Rebecca

family: Dumanoir

full_name: Perrine Dumanoir

given: Perrine

family: Ara-Somohano

full_name: Claire Ara-Somohano

family: Ferretti

full_name: Gilbert R. Ferretti

given: Gilbert R.

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Grenoble


title: Correlation Between the Urinary Protein/Creatinine Ratio in a Single Urine Sample Versus 24-hour Proteinuria in Patients With Multiple Myeloma.

acronym: RCP-MM

summary:
The measurement of 24-hour proteinuria allows an assessment of treatment response in patients with multiple myeloma. But it is difficult and restrictive to make.

This study was therefore designed to investigate the correlation between the ratio of proteinuria / creatinine on samples, easier to obtain, and the 24-hour proteinuria in assessing response to this treatment .

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Rennes University Hospital

location_facility: Service de Médecine interne - Hôpital Sud : Rennes University Hospital

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery

acronym: TETRIS

summary: The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13.

ReferenceCitation: Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.

ReferenceCitation: Dave MH, Frotzler A, Spielmann N, Madjdpour C, Weiss M. Effect of tracheal tube cuff shape on fluid leakage across the cuff: an in vitro study. Br J Anaesth. 2010 Oct;105(4):538-43. doi: 10.1093/bja/aeq202. Epub 2010 Aug 3.

ReferenceCitation: Hortal J, Giannella M, Pérez MJ, Barrio JM, Desco M, Bouza E, Muñoz P. Incidence and risk factors for ventilator-associated pneumonia after major heart surgery. Intensive Care Med. 2009 Sep;35(9):1518-25. doi: 10.1007/s00134-009-1523-3. Epub 2009 Jun 26.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière

intervention_type: Device


type: EudraCT Number

title: Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease

acronym: SCLEROCYC

summary: By including in this study patients with significant worsening of their lung volumes and / or their DLCO (carbon monoxide diffusing capacity) in the previous year, on the basis of an open retrospective study we recently conducted, we hope to demonstrate that a strategy combining prednisone and intravenous cyclophosphamide therapy is accompanied by an increase in the frequency stabilization / improvement of lung volumes and / or DLCO of patients at 12 months of 15% in the placebo and prednisone cyclophosphamide 50% in cyclophosphamide and prednisone.We also hope to demonstrate significant decrease in the number of patients excluded for failure in the CYC arm as compared to the placebo arm.

study_start_date_type: Actual

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


title: Etude peropératoire de la Perfusion Sanguine Des Carcinomes Basocellulaires Par Imageur Laser Doppler, au Cours de la Manipulation de l'Influx artériel Tumoral - Recherche d'un phénomène d'hyperémie Tumorale Post-occlusive

acronym: HPOB

summary:
The investigators aim to test the hypothesis and to proof thank to laser speckle contrast imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this case, through a basal cell carcinoma, which will be used as a model of study of tumor vasculature.

This new concept of tumor perfusion artificial increase could be used in the future for malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like radiotherapy and/or chemotherapy, and increase their efficacy.

This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC), with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released.

In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.

During all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release.

ReferenceType: derived

ReferenceCitation: Reyal J, Lebas N, Fourme E, Guihard T, Vilmer C, Le Masurier P. Post-occlusive reactive hyperemia in basal cell carcinoma and its potential application to improve the efficacy of solid tumor therapies. Tohoku J Exp Med. 2012 Jun;227(2):139-47.

lead_sponsor: Institut Curie

intervention_type: Other


title: Multicentric Descriptive Cross-sectional Study Evaluating Cocaine Users in Treatment Center

acronym: PSYCHOCOKE

summary: The aim of this study is to determine the clinical, genetic and environmental factors associated with the phenotype "severe psychotic symptoms" caused by cocaine.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Vorspan F, Fortias M, Zerdazi el-H, Karsinti E, Bloch V, Lépine JP, Bellivier F, Brousse G, van den Brink W, Derks EM. Self-reported cue-induced physical symptoms of craving as an indicator of cocaine dependence. Am J Addict. 2015 Dec;24(8):740-3. doi: 10.1111/ajad.12303. Epub 2015 Nov 6.

name: APHP, Hôpital Fernand Widal, Service de Médecine Addictologique; Paris France

name: Faculté de Médecine, Université Paris Diderot; Paris France

name: Inserm U1144, Variabilité de Réponse aux Psychotropes, Université Paris Descartes, Université Paris Diderot, PRES Sorbonne Paris Cité; France

name: Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam; The Netherland

family: Vorspan

full_name: Florence Vorspan

given: Florence

sequence: first

family: Fortias

full_name: Maeva Fortias

given: Maeva

sequence: additional

family: Zerdazi

full_name: El-hadi Zerdazi

given: El-hadi

family: Karsinti

full_name: Emily Karsinti

given: Emily

family: Bloch

full_name: Vanessa Bloch

given: Vanessa

family: Lépine

full_name: Jean-Pierre Lépine

given: Jean-Pierre

family: Bellivier

full_name: Frank Bellivier

given: Frank

name: Psychiatry B-Department of Addictology, Université Clermont 1, UFR Médecine, EA7280, Clermont-Ferrand, and CHU Clermont-Ferrand, Clermont-Ferrand, F-63003; France

family: Brousse

full_name: Georges Brousse

given: Georges

family: van den Brink

full_name: Wim van den Brink

given: Wim

family: Derks

full_name: Eske M. Derks

given: Eske M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal on Addictions

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Karsinti E, Jarroir M, Zerdazi el-H, Bloch V, Dupuy G, Belforte B, Coeuru P, Plat A, Deschenau A, Cottencin O, Gay A, Lack P, Pelissier-Alicot AL, Bellivier F, Lépine JP, Brousse G, Vorspan F. Childhood trauma are not associated with the intensity of transient cocaine induced psychotic symptoms. Psychiatry Res. 2015 Aug 30;228(3):941-4. doi: 10.1016/j.psychres.2015.05.065. Epub 2015 Jun 27.

family: Jarroir

full_name: Marine Jarroir

given: Marine

full_name: El-Hadi Zerdazi

given: El-Hadi

family: Dupuy

full_name: Gaël Dupuy

given: Gaël

family: Belforte

full_name: Beatriz Belforte

given: Beatriz

family: Coeuru

full_name: Philippe Coeuru

given: Philippe

family: Plat

full_name: Arnaud Plat

given: Arnaud

family: Deschenau

full_name: Alice Deschenau

given: Alice

family: Cottencin

full_name: Olivier Cottencin

given: Olivier

family: Gay

full_name: Aurelia Gay

ReferenceCitation: Vorspan F, Brousse G, Bloch V, Bellais L, Romo L, Guillem E, Coeuru P, Lépine JP. Cocaine-induced psychotic symptoms in French cocaine addicts. Psychiatry Res. 2012 Dec 30;200(2-3):1074-6. doi: 10.1016/j.psychres.2012.04.008. Epub 2012 May 1.

ReferenceCitation: Brousse G, Vorspan F, Ksouda K, Bloch V, Peoc'h K, Laplanche JL, Mouly S, Schmidt J, Llorca PM, Lepine JP. Could the inter-individual variability in cocaine-induced psychotic effects influence the development of cocaine addiction? Towards a new pharmacogenetic approach to addictions. Med Hypotheses. 2010 Dec;75(6):600-4. doi: 10.1016/j.mehy.2010.07.043.

ReferenceCitation: Icick R, Vorspan F, Karsinti E, Ksouda K, Lépine JP, Brousse G, Mouly S, Bellivier F, Bloch V. Gender-specific study of recurrent suicide attempts in outpatients with multiple substance use disorders. J Affect Disord. 2018 Dec 1;241:546-553. doi: 10.1016/j.jad.2018.08.076. Epub 2018 Aug 13.


title: Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)

acronym: EPIPOD

summary: Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and strategies have significantly evolved during these last years, influenced by Baker nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. In this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between heterogenous proteic input dispensed in our NICU (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. Understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.

ReferenceCitation: Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Rozé JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.

family: Simon

full_name: Laure Simon

given: Laure

family: Frondas-Chauty

full_name: Anne Frondas-Chauty

given: Anne

family: Senterre

full_name: Thibault Senterre

given: Thibault

family: Flamant

full_name: Cyril Flamant

given: Cyril

family: Darmaun

full_name: Dominique Darmaun

given: Dominique

family: Rozé

full_name: Jean-Christophe Rozé

given: Jean-Christophe

journal_name: The American Journal of Clinical Nutrition

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Nantes University Hospital


title: Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers

summary: The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.

lead_sponsor: Laboratoires URGO

lead_sponsor_type: industriel


title: Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion

acronym: ALCOOTAX

summary: The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.


type: Other Grant/Funding Number

title: Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing

summary:
A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center.

Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).

primary_purpose: Basic Science

ReferenceCitation: Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Farret A, Pelletier MJ, Place J, Bruttomesso D, Del Favero S, Visentin R, Filippi A, Scotton R, Avogaro A, Doyle FJ 3rd. Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas. Diabetes Care. 2013 Jul;36(7):1851-8. doi: 10.2337/dc12-1965.

family: Kovatchev

full_name: B. P. Kovatchev

given: B. P.

family: Renard

full_name: E. Renard

given: E.

family: Cobelli

full_name: C. Cobelli

given: C.

family: Zisser

full_name: H. C. Zisser

given: H. C.

family: Keith-Hynes

full_name: P. Keith-Hynes

given: P.

family: Anderson

full_name: S. M. Anderson

given: S. M.

family: Brown

full_name: S. A. Brown

given: S. A.

family: Chernavvsky

full_name: D. R. Chernavvsky

given: D. R.

family: Breton

full_name: M. D. Breton

given: M. D.

family: Farret

full_name: A. Farret

given: A.

family: Pelletier

full_name: M.-J. Pelletier

family: Place

full_name: J. Place

given: J.

family: Bruttomesso

full_name: D. Bruttomesso

given: D.

family: Del Favero

full_name: S. Del Favero

given: S.

family: Visentin

full_name: R. Visentin

given: R.

family: Filippi

full_name: A. Filippi

family: Scotton

full_name: R. Scotton

family: Avogaro

full_name: A. Avogaro

family: Doyle

full_name: F. J. Doyle

given: F. J.

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

title: Feasibility of Outpatient Fully Integrated Closed-Loop Control: First studies of wearable artificial pancreas

location_facility: Centre d'Investigation Clinique CHU Montpellier


title: Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia.

acronym: rTMS

summary: Recovery of neurological deficits after stroke results from a reorganization of cortical activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of neuroplasticity. Its use to improve function after stroke, particularly of the upper limb, was validated. The investigators propose to evaluate in a prospective pilot against placebo, the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and medium term, especially on walking function and spasticity in patients with sequelae of cerebral infarction in the MCA territory with gait disturbance and motor weakness of the upper limb.

status: Terminated

status_simplified: Unknown


title: Morphological and Dynamic Non Contrast-enhanced MR Angiography in the Exploration of Neurovascular Diseases

acronym: NCE MRA

summary:
MR angiography (MRA) has become essential in the treatment of neurovascular diseases, including ischemic stroke - the first cause of disability in occidental countries, vascular malformations such as aneurysms, arteriovenous fistulas and malformations, whose treatments are improving year after year.

MRA is an alternative to digital substracted angiography (DSA), circumventing th use of endovascular catheterism, irradiation and injection of iodinated contrast agent. Contrast-Enhanced MRA (CE-MRA) with gadolinium injection is currently the reference standard for vascular MR exploration but still presents many limitations inherent to the injection of contrast medium. Hence, the synchronization of the acquisition with bolus contrast injection limits the improvement of spatial and temporal resolutions and requires an accurate synchronization of the acquisition with the arrival of the bolus.

Moreover, the acquisition can be repeated as required as it does not require any contrast injection.

Besides, the increase in nephrogenic systematic fibrosis clinical cases, which would be secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has restricted the use of CE-MRA. More than 500 cases were described to date in the world.

Its occurrence is currently estimated around 4 % for patients in terminal chronic renal insufficiency and its mortality around 30 %.

According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agent (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30 ml/mn.

Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide complete and non-invasive investigation of the vasculature, thus offering patients with chronic renal insufficiency, as well as pregnant or nursing women a surrogate with no side effects.

Moreover, the use of high field (3T) MR imaging offers improved signal to noise ratio. Combined with the use of phased array coils and parallel imaging, new NCE MRA sequences can achieve juxta-millimeter isotropic spatial resolution and temporal resolution of about 50 ms close to those of cerebral DSA.

These sequences allow a joint hemodynamical and morphological assessment of lesions, both at the cervical and cerebral levels, whether at diagnosis or during patient follow-up


title: Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study

summary:
C-section deliveries are painful and need adequate analgesia. In the same time, mothers need early rehabilitation to take care of the baby.

Hypothesis: Early oral self administration of painkillers could be as effective as usual IV administration by nursing staff.

Purpose of the study: Evaluation of the efficacy of a program of self administration of painkillers postoperatively of C-section delivery.

lead_sponsor: University Hospital, Montpellier

location_facility: university Hospital, Arnaud de Villeneuve, Gynecology department


acronym: DRIVE COG

summary:
The main objectives of this study are:

To evaluate the driving capacities in a population of elderly subjects with early stage Alzheimer Disease (AD) in a real-life situation.
Define a typology of the main errors made in this population.
Propose adaptive measures or technological aids that would make it possible for these patients to maintain their ability to drive a car while limiting risk.

primary_purpose: Diagnostic

lead_sponsor: CHU de Reims


title: Observational Study of Patients With Pre Capillary Pulmonary Hypertension

acronym: HYPID

summary: HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.

ipd_sharing: Undecided

lead_sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires


title: Study of the Temporospatial Gait Parameters With the Electronic Carpet "GAITRite" in Patients With Walking Impairment After Stroke and in Old Faller Subjects

acronym: GAITRITE

summary: A large proportion of falls in older people occurs when walking. Most studies have recently demonstrated correlation between the variations in spatiotemporal gait parameters and fall risk in elderly and in several diseases. The investigators objective is to analyse this parameters in population with gait stability disorders (post-stroke patients and fallers) to identify the most valuable and to develop/test a conglomerate stability score.

ReferenceCitation: Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6.

ReferenceCitation: Hausdorff JM, Nelson ME, Kaliton D, Layne JE, Bernstein MJ, Nuernberger A, Singh MA. Etiology and modification of gait instability in older adults: a randomized controlled trial of exercise. J Appl Physiol (1985). 2001 Jun;90(6):2117-29.

ReferenceCitation: Bilney B, Morris M, Webster K. Concurrent related validity of the GAITRite walkway system for quantification of the spatial and temporal parameters of gait. Gait Posture. 2003 Feb;17(1):68-74.

ReferenceCitation: Menz HB, Latt MD, Tiedemann A, Mun San Kwan M, Lord SR. Reliability of the GAITRite walkway system for the quantification of temporo-spatial parameters of gait in young and older people. Gait Posture. 2004 Aug;20(1):20-5.

ReferenceCitation: Balasubramanian CK, Neptune RR, Kautz SA. Variability in spatiotemporal step characteristics and its relationship to walking performance post-stroke. Gait Posture. 2009 Apr;29(3):408-14. doi: 10.1016/j.gaitpost.2008.10.061. Epub 2008 Dec 3.

ReferenceCitation: Gouelle A, Megrot F, Presedo A, Pennecot GF, Yelnik A. Validity of Functional Ambulation Performance Score for the evaluation of spatiotemporal parameters of children's gait. J Mot Behav. 2011;43(2):95-100. doi: 10.1080/00222895.2010.538768.


title: Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment

acronym: MOSCATO 02

summary:
The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line.

The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

ReferenceCitation: Verlingue L, Hollebecque A, Lacroix L, Postel-Vinay S, Varga A, El Dakdouki Y, Baldini C, Balheda R, Gazzah A, Michot JM, Marabelle A, Mir O, Arnedos M, Rouleau E, Solary E, De Baere T, Angevin E, Armand JP, Michiels S, André F, Deutsch E, Scoazec JY, Soria JC, Massard C. Human epidermal receptor family inhibitors in patients with ERBB3 mutated cancers: Entering the back door. Eur J Cancer. 2018 Mar;92:1-10. doi: 10.1016/j.ejca.2017.12.020. Epub 2018 Feb 3.

family: Verlingue

full_name: Loic Verlingue

given: Loic

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Lacroix

full_name: Ludovic Lacroix

given: Ludovic

family: Postel-Vinay

full_name: Sophie Postel-Vinay

given: Sophie

family: Varga

full_name: Andrea Varga

given: Andrea

family: El Dakdouki

full_name: Yolla El Dakdouki

given: Yolla

family: Baldini

full_name: Capucine Baldini

given: Capucine

family: Balheda

full_name: Rastilav Balheda

given: Rastilav

family: Gazzah

full_name: Anas Gazzah

given: Anas

family: Michot

full_name: Jean-Marie Michot

given: Jean-Marie

family: Marabelle

full_name: Aurélien Marabelle

given: Aurélien

family: Mir

full_name: Olivier Mir

given: Olivier

family: Arnedos

full_name: Monica Arnedos

given: Monica

family: Rouleau

full_name: Etienne Rouleau

given: Etienne

family: Solary

full_name: Eric Solary

given: Eric

family: De Baere

full_name: Thierry De Baere

given: Thierry

family: Angevin

full_name: Eric Angevin

family: Armand

full_name: Jean-Pierre Armand

given: Jean-Pierre

family: Michiels

full_name: Stefan Michiels

given: Stefan

family: André

full_name: Fabrice André

given: Fabrice

family: Deutsch

full_name: Eric Deutsch

family: Scoazec

full_name: Jean-Yves Scoazec

given: Jean-Yves

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

ReferenceCitation: Verlingue L, Malka D, Allorant A, Massard C, Ferté C, Lacroix L, Rouleau E, Auger N, Ngo M, Nicotra C, De Baere T, Tselikas L, Ba B, Michiels S, Scoazec JY, Boige V, Ducreux M, Soria JC, Hollebecque A. Precision medicine for patients with advanced biliary tract cancers: An effective strategy within the prospective MOSCATO-01 trial. Eur J Cancer. 2017 Dec;87:122-130. doi: 10.1016/j.ejca.2017.10.013. Epub 2017 Nov 14. Erratum in: Eur J Cancer. 2018 Feb 14;:.

ReferenceCitation: Jovelet C, Ileana E, Le Deley MC, Motté N, Rosellini S, Romero A, Lefebvre C, Pedrero M, Pata-Merci N, Droin N, Deloger M, Massard C, Hollebecque A, Ferté C, Boichard A, Postel-Vinay S, Ngo-Camus M, De Baere T, Vielh P, Scoazec JY, Vassal G, Eggermont A, André F, Soria JC, Lacroix L. Circulating Cell-Free Tumor DNA Analysis of 50 Genes by Next-Generation Sequencing in the Prospective MOSCATO Trial. Clin Cancer Res. 2016 Jun 15;22(12):2960-8. doi: 10.1158/1078-0432.CCR-15-2470. Epub 2016 Jan 12.

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


acronym: SOMMEDREP

source: euctr

title: Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease

summary:
In Sickle cell disease children, sleep respiratory abnormalities are risk factors for vaso-occlusive complications, as well as cerebral vasculopathy.

A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems frequency and etiology, as well as their influence on sickle cell disease complications.


title: Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab

summary:
The main objective is to evaluate progression-free survival (PFS) at 4 months.

The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria.

The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.

ReferenceCitation: Bennouna J, Hiret S, Bertaut A, Bouché O, Deplanque G, Borel C, François E, Conroy T, Ghiringhelli F, des Guetz G, Seitz JF, Artru P, Hebbar M, Stanbury T, Denis MG, Adenis A, Borg C. Continuation of Bevacizumab vs Cetuximab Plus Chemotherapy After First Progression in KRAS Wild-Type Metastatic Colorectal Cancer: The UNICANCER PRODIGE18 Randomized Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):83-90. doi: 10.1001/jamaoncol.2018.4465.

name: Department of Hepatogastroenterology, Digestive Oncology, Centre Hospitalier Universitaire de Nantes, Nantes, France

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

name: Department of Medical Oncology, Institut de Cancérologie de l’Ouest, Saint-Herblain, France

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

name: Department of Medical Oncology, Georges-François Leclerc Cancer Center, Dijon, France

family: Bertaut

full_name: Aurelie Bertaut

given: Aurelie

name: Department of Hepatogastroenterology, Centre Hospitalier Universitaire Robert Debré, Reims, France

family: Bouché

full_name: Olivier Bouché

name: Department of Medical Oncology, Hôpital Saint-Joseph, Paris, France

family: Deplanque

full_name: Gael Deplanque

given: Gael

name: Department of Medical Oncology, Centre Paul Strauss, Strasbourg, France

family: Borel

full_name: Christian Borel

given: Christian

name: Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France

family: François

full_name: Eric François

name: Institut de Cancérologie de Lorraine, et Vandoeuvre-Lès Nancy, Université de Lorraine, Vandoeuvre-Lès Nancy, France

family: Conroy

full_name: Thierry Conroy

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

name: Department of Medical Oncology, Assistance Publique–Hôpitaux de Paris, Paris, France

family: des Guetz

full_name: Gaëtan des Guetz

given: Gaëtan

name: Department of Hepatogastroenterology, Digestive Oncology, Assistance Publique–Hôpitaux de Marseille La Timone, Marseille, France

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Artru

full_name: Pascal Artru

given: Pascal

name: Department of Medical Oncology, University Hospital, Lille, France

family: Hebbar

full_name: Mohamed Hebbar

given: Mohamed

family: Stanbury

full_name: Trevor Stanbury

given: Trevor

family: Denis

full_name: Marc G. Denis

given: Marc G.

name: Department of Medical Oncology, Centre Oscar Lambret, Lille, France

family: Adenis

full_name: Antoine Adenis

given: Antoine

name: Department of Medical Oncology, Centre Hospitalier Universitaire de Besançon, Besançon, France

family: Borg

full_name: Christophe Borg

given: Christophe

journal_name: JAMA Oncology

oa_colors: green hybrid

evidence: oa repository (via pmcid lookup)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association


title: In-hospital Assessment of the New Medical Device AL539 Developed for the Home Monitoring of Continuous Positive Airway Pressure (CPAP) Treatment in Patients With Obstructive Sleep Apnea Syndrome by Comparison With Respiratory Polygraphy

summary:
Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS).

The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.

primary_purpose: Health Services Research

ReferenceCitation: Leger D, Elbaz M, Piednoir B, Carron A, Texereau J. Evaluation of the add-on NOWAPI® medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea. Biomed Eng Online. 2016 Feb 27;15:26. doi: 10.1186/s12938-016-0139-4.

family: Leger

full_name: Damien Leger

given: Damien

family: Elbaz

full_name: Maxime Elbaz

given: Maxime

family: Piednoir

full_name: Benoît Piednoir

given: Benoît

family: Carron

full_name: Amélie Carron

given: Amélie

family: Texereau

full_name: Joëlle Texereau

given: Joëlle

currency_apc_doaj: GBP

journal_name: BioMedical Engineering OnLine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Air Liquide Santé International

location_facility: Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance


title: Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism

summary:
Main objectives:

Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe botulinic poisoning in measuring the effect on electrophysiological and respiratory parameters

Secondary Objective:

Study the natural history of electrophysiological and respiratory parameters during the botulinic intoxication

Primary endpoint:

Clinical, electrophysiological and respiratory before and after administration of 3,4-diaminopyridine.

Study Design:

Pilot study, prospective, interventional.

Study population:

Case series (n = 8 patients) suffering from botulinic type A, respiratory failure, but with no other organ failure

Experimental treatment :

3,4-diaminopyridine, FIRDAPSE ® (BioMarin) The dosage will be gradually increased according to a predetermined scheme and will not exceed 60 mg / day and 20 mg / dose.

Statistics:

Intra-individual comparison of physiological parameters measured before and after administration of 3,4-diaminopyridine. Electromyographic and respiratory parameters will be measured for each patient. Then a dose of 10 mg of 3,4-diaminopyridine will be administrated. If this dose is well tolerated and provides a relative improvement of 10% for at least one of the parameters studied, the dose will be maintained at 10 mg for 48 hours 3 times a day then increased to 20 mg.

The primary endpoint is the change in the amplitude of muscle response evaluated by the subtraction of amplitude at T1.5 and T0.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

acronym: ABT737 exvivo

summary: The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.

lead_sponsor: Centre Francois Baclesse


title: Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease

acronym: Kawasaki

summary:
Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.

It has been reported worldwide, but it is ten times more common in Asian population. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.

It may results in acquired heart disease in children in developed countries, and may be the cause of premature coronary artery disease in adulthood.

A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are conflicting on this issue and the prevalence of this allel is unknown in North America and Europe populations.

The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is confirmed by the presence of five clinical signs (major criteria). The presence of inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.

KD can resolve spontaneously with no treatment. The severity of the disease is primarily related to complications of coronary aneurysms in acute or chronic stages.

Several arguments support the fact that adult patients have diffuse vascular lesions different from aneurysmal lesions initially described in childhood.

Despite abundance of publications on KD, there is no prospective or retrospective study which explored anomalies resulting from KD in adult subjects.

Therefore, this project will describe the patient's vascular evolution, the prevalence of atherosclerotic lesions and to determine the biological and functional abnormalities, markers of accelerated atherosclerosis.

Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in adulthood.

The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and their severity in adults with a history of KD in childhood compared to a control population.

lead_sponsor: Hospices Civils de Lyon


title: Randomized and Double-blind Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal

acronym: MUCOCRAV

summary: The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo during 4 weeks in cannabis withdrawal.

location_facility: Service de Psychiatrie - Hôpital Lariboisière


title: Cellular and Molecular Mechanisms Governing Bone Marrow Stem Cells, Macrophages and Plasma Cell Biology in Gaucher Disease.

acronym: MGMC

summary: Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside particularly in cells of the macrophage lineage. Clinical manifestations associate hematological, neurological and bone disorders.


title: NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

acronym: NOMAC

summary: The consumption of cereals-based foods with low glycemic indexes, high micronutrients and fibers contents are highly recommended. The target of this work is to provide new solutions for cereal based foods: the knowledge and understanding on the in vivo fate will be used to define structural features to gain in foods.


title: Body Image Therapy in Anorexia Nervosa

acronym: PIPA

summary: The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.

lead_sponsor: Centre Hospitalier St Anne

intervention_type: Behavioral


title: Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?

acronym: HF 80

summary: The purpose of this study is to determine if there is an interest to optimize HF (heart failure) management in patients over 80 years old. The primary objective is to assess the effect of HF (heart failure) optimized management (guidelines of the European society of Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.

ReferenceCitation: Eschalier R, Jean F, Pereira B, Monzy S, Vorilhon C, Mactoux V, Citron B, Sapin V, Motreff P, Lusson JR. Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial. Trials. 2012 Mar 6;13:25. doi: 10.1186/1745-6215-13-25.

family: Eschalier

full_name: Romain Eschalier

given: Romain

family: Jean

full_name: Frédéric Jean

given: Frédéric

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Monzy

full_name: Séverine Monzy

given: Séverine

family: Vorilhon

full_name: Charles Vorilhon

given: Charles

family: Mactoux

full_name: Valérie Mactoux

given: Valérie

family: Citron

full_name: Bernard Citron

given: Bernard

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Motreff

full_name: Pascal Motreff

family: Lusson

full_name: Jean R Lusson

given: Jean R

journal_name: Trials

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: University Hospital, Clermont-Ferrand


title: Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study

summary: Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients.

time_perspective: Cross-Sectional

ReferenceCitation: Jabaudon M, Chabanne R, Sossou A, Bertrand PM, Kauffmann S, Chartier C, Guérin R, Imhoff E, Zanre L, Brénas F, Bazin JE, Constantin JM. Epidural analgesia in the intensive care unit: An observational series of 121 patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):217-23. doi: 10.1016/j.accpm.2014.12.002. Epub 2015 May 23.

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Sossou

full_name: Achille Sossou

given: Achille

family: Bertrand

full_name: Pierre-Marie Bertrand

given: Pierre-Marie

family: Kauffmann

full_name: Sophie Kauffmann

given: Sophie

family: Chartier

full_name: Christian Chartier

given: Christian

family: Guérin

full_name: Renaud Guérin

given: Renaud

family: Imhoff

full_name: Etienne Imhoff

given: Etienne

family: Zanre

full_name: Lassane Zanre

given: Lassane

family: Brénas

full_name: François Brénas

given: François

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

journal_name: Anaesthesia Critical Care & Pain Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

acronym: IRMf

summary: Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.

ReferenceCitation: Pickering G, Kastler A, Macian N, Pereira B, Valabrègue R, Lehericy S, Boyer L, Dubray C, Jean B. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial. Drug Des Devel Ther. 2015 Jul 23;9:3853-62. doi: 10.2147/DDDT.S81004. eCollection 2015.

family: Pickering

full_name: Gisele Pickering

given: Gisele

family: Kastler

full_name: A Kastler

given: A

family: Macian

full_name: N Macian

given: N

family: Pereira

full_name: B Pereira

given: B

family: Valabregue

full_name: R Valabregue

given: R

family: Lehericy

full_name: S Lehericy

given: S

family: Boyer

full_name: L Boyer

given: L

family: Dubray

full_name: C Dubray

given: C

family: Jean

full_name: B Jean

currency_apc_doaj: USD

journal_name: Drug Design, Development and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa


title: Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC. GET-BETTER Study (Geriatric Environmental Telecare - Behavioral Engineering Technology To Enhance Rehabilitation)

acronym: GET-BETTER

summary: 2 URCC in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by ward's geriatrician and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed twice during the study, at admission in (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as adverse events and will therefore be listed along the study and characterized in types and number.

lead_sponsor: University Hospital, Limoges


title: Consequences of Obstructive Sleep Apnea Syndrome (OSAS) on the Outcome and the Survival After Ischemic Subtentorial Stroke. Impact of the Treatment With Continuous Positive Airway Pressure (CPAP)

summary: Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. The aim of the investigators study is first to evaluate the outcome and the survival of patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome and survival of patients with severe OSAS depending on the treatment of the syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is associated with worst survival and outcome and needs to be treated at the subacute phase of stroke.

status: Unknown status

primary_purpose: Supportive Care


title: Relations Between Obesity and Insulin Resistance: Role of Inflammation Regulatory Mechanisms in Obese Patients Without Associated Comorbidity

summary: Insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation has been implicated in its pathogenesis, due to innate immunity activation by free fatty acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate activate innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4, NFkB, IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b, IL6), chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in TLR signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI and RNase L in TLR regulation, and its potential implication in the link between obesity, inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.


title: A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)

summary: This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).

ReferenceCitation: Bysted BV, Scharling B, Møller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32.

lead_sponsor: Novo Nordisk A/S


title: Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation

acronym: alloforb

summary: The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.


title: Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

acronym: TAMEO

summary: Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.

intervention_type: Procedure


title: Representation of the Body and Treatment of Peritoneal Cancer by Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - A Collaborative Approach Between Professionals of Health / Patients / Researchers

acronym: CORCAN

summary:
The project aims to understand better how patients live the event of cancer and live its consequences on their bodily representations. In the study, the dynamic of the body image is not restricted to appearance but include sensations and visions of the inner body, what explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and HIPEC.

The three objectives of the study are:

identifying the impact of the representations of the treated body on the psychological strategies to cope with the disease, the bodily changes and the prospects of life;
making explicit the positive or negative impacts of these representations on the relationship between patients and health professionals (easing factors, misunderstandings, negotiations, etc.);
associating the health professionals with the study in its course and evaluation in order to elaborate a methodological collaborative approach between patients, health professionals and researchers in social sciences.

ReferenceCitation: Durif-Bruckert C, Guilloux R, Guïoux A, Lasserre E, Goffette J, Régnier V. [Qualitative and collaborative research with cancer patients. Experience narratives of treatments for peritoneal carcinomatosis]. Bull Cancer. 2016 Feb;103(2):148-53. doi: 10.1016/j.bulcan.2015.10.015. Epub 2015 Dec 8. French.

family: Durif-Bruckert

full_name: Christine Durif-Bruckert

given: Christine

family: Guilloux

full_name: Ronald Guilloux

given: Ronald

family: Guïoux

full_name: Axel Guïoux

given: Axel

family: Lasserre

full_name: Evelyne Lasserre

given: Evelyne

family: Goffette

full_name: Jérôme Goffette

given: Jérôme

family: Régnier

full_name: Véronique Régnier

given: Véronique

journal_name: Bulletin du Cancer

title: Une recherche qualitative et collaborative auprès de patients atteints de cancer. Récits d’expérience des traitements de la carcinose péritonéale


title: Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.

acronym: PUPIDOL

summary: The purpose is to study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone/buprenorphine in opiate-dependent patients following a substitution program.


title: Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study

acronym: KetaRea

summary: The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.


title: French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010

acronym: FAST-MI 2010

summary:
The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months.

Patients will be followed up at 1 month and then followed annually for 10 years.

Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

status: Active, not recruiting

ReferenceCitation: Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Verstuyft

full_name: Céline Verstuyft

given: Céline

family: Mary-Krause

full_name: Murielle Mary-Krause

given: Murielle

family: Quteineh

full_name: Lina Quteineh

given: Lina

family: Drouet

full_name: Elodie Drouet

given: Elodie

family: Méneveau

full_name: Nicolas Méneveau

given: Nicolas

family: Steg

full_name: P. Gabriel Steg

given: P. Gabriel

family: Ferrières

full_name: Jean Ferrières

given: Jean

family: Danchin

full_name: Nicolas Danchin

family: Becquemont

full_name: Laurent Becquemont

given: Laurent

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Genetic Determinants of Response to Clopidogrel and Cardiovascular Events

ReferenceCitation: Danchin N, Fauchier L, Marijon E, Barnay C, Furber A, Mabo P, Bernard P, Blanc JJ, Jouven X, Le Heuzey JY, Charbonnier B, Ferrières J, Simon T; French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Investigators. Impact of early statin therapy on development of atrial fibrillation at the acute stage of myocardial infarction: data from the FAST-MI register. Heart. 2010 Nov;96(22):1809-14. doi: 10.1136/hrt.2010.201574.

ReferenceCitation: Zeller M, Danchin N, Simon D, Vahanian A, Lorgis L, Cottin Y, Berland J, Gueret P, Wyart P, Deturck R, Tabone X, Machecourt J, Leclercq F, Drouet E, Mulak G, Bataille V, Cambou JP, Ferrieres J, Simon T; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction investigators. Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetic patients with acute myocardial infarction. J Clin Endocrinol Metab. 2010 Nov;95(11):4993-5002. doi: 10.1210/jc.2010-0449. Epub 2010 Aug 11.

ReferenceCitation: Danchin N, Coste P, Ferrières J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Guéret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30.

ReferenceCitation: Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

family: Hanssen

full_name: Michel Hanssen

given: Michel

family: Cottin

full_name: Yves Cottin

given: Yves

family: Khalife

full_name: Khalife Khalife

given: Khalife

family: Hammer

full_name: Laure Hammer

given: Laure

family: Goldstein

full_name: Patrick Goldstein

given: Patrick

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Mulak

full_name: Geneviève Mulak

given: Geneviève

family: Pace

full_name: Benoit Pace

given: Benoit

family: Schultz

full_name: Eric Schultz

given: Eric

title: French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010

ReferenceCitation: Puymirat E, Aissaoui N, Simon T, Bataille V, Drouet E, Mulak G, Ferrières J, Danchin N. [Acute myocardial infarction in the elderly. The FAST-MI registry]. Presse Med. 2013 Nov;42(11):1432-41. doi: 10.1016/j.lpm.2013.04.010. Epub 2013 Jul 22. Review. French.

title: L’infarctus du sujet âgé : données du registre FAST-MI 2010

ReferenceCitation: Simon T, Puymirat E, Lucke V, Bouabdallaoui N, Lognoné T, Aissaoui N, Cohen S, Ashrafpoor G, Roul G, Jouve B, Levy G, Charpentier S, Grollier G, Ferrières J, Danchin N; au nom des investigateurs FAST-MI 2010. [Acute myocardial infarction in women. Initial characteristics, management and early outcome. The FAST-MI registry]. Ann Cardiol Angeiol (Paris). 2013 Aug;62(4):221-6. doi: 10.1016/j.ancard.2013.06.003. Epub 2013 Jul 4. French.

title: L’infarctus du myocarde chez la femme. Caractéristiques spécifiques, prise en charge et pronostic. Données de FAST-MI 2010

ReferenceCitation: Puymirat E, Teixeira N, Simon T, Steg PG, Schiele F, Lamblin N, Probst V, Juillière Y, Ferrières J, Danchin N; FAST-MI investigators. Patient education after acute myocardial infarction: cardiologists should adapt their message--French registry of acute ST-elevation or non-ST-elevation myocardial infarction 2010 registry. J Cardiovasc Med (Hagerstown). 2015 Nov;16(11):761-7. doi: 10.2459/JCM.0000000000000092.

title: Patient education after acute myocardial infarction

ReferenceCitation: Puymirat E, Schiele F, Ennezat PV, Coste P, Collet JP, Bonnefoy-Cudraz E, Roul G, Richard P, Simon T, Danchin N. Impact of fondaparinux versus enoxaparin on in-hospital bleeding and 1-year death in non-ST-segment elevation myocardial infarction. FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) 2010. Eur Heart J Acute Cardiovasc Care. 2015 Jun;4(3):211-9. doi: 10.1177/2048872614544857. Epub 2014 Jul 29.

name: Department of Cardiology, European Hospital of Georges Pompidou, Assistance Publique des Hôpitaux de Paris (AP-HP), University Paris Descartes, France

name: University Hospital Jean Minjoz, Department of Cardiology, Besançon, France

name: Department of Cardiology, University Hospital of Grenoble, France

name: Department of Cardiology, Hôpital Haut-Levêque, Pessac, France

name: Institut de Cardiologie, Centre Hospitalier Pitié-Salpêtrière, Paris, France

name: Department of Cardiology, Hôpital cardiologique de Lyon, France

name: Department of Cardiology, University Hospital of Strasbourg, France

name: Department of Cardiology, Clinique St Martin, Caen, France

name: AP-HP – Hospital Saint Antoine, Clinical Research Unit (URC) – Est, Paris, France

journal_name: European Heart Journal: Acute Cardiovascular Care

ReferenceCitation: Puymirat E, Aissaoui N, Cottin Y, Vanzetto G, Carrié D, Isaaz K, Valy Y, Tchetche D, Schiele F, Steg PG, Simon T, Danchin N. Effect of coronary thrombus aspiration during primary percutaneous coronary intervention on one-year survival (from the FAST-MI 2010 registry). Am J Cardiol. 2014 Dec 1;114(11):1651-7. doi: 10.1016/j.amjcard.2014.08.039. Epub 2014 Sep 16.

title: Effect of Coronary Thrombus Aspiration During Primary Percutaneous Coronary Intervention on One-Year Survival (from the FAST-MI 2010 Registry)

ReferenceCitation: Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Guéret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years. Int J Cardiol. 2014 Nov 15;177(1):281-6. doi: 10.1016/j.ijcard.2014.09.023. Epub 2014 Sep 28.

title: Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: Insights from the French FAST-MI program over 15years

ReferenceCitation: Puymirat E, Caudron J, Steg PG, Lemesle G, Cottin Y, Coste P, Schiele F, de Labriolle A, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Prognostic impact of non-compliance with guidelines-recommended times to reperfusion therapy in ST-elevation myocardial infarction. The FAST-MI 2010 registry. Eur Heart J Acute Cardiovasc Care. 2017 Feb;6(1):26-33. doi: 10.1177/2048872615610893. Epub 2016 Sep 20.

name: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, France; Université Paris-Descartes, France

name: AP-HP, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne Paris-Cité, France; INSERM U-698, Paris, France

name: Hospital Regional University of Lille, Department of Cardiology, France

name: University Hospital Centre, Hospital of Bocage, Dijon, France

name: University Hospital of Bordeaux, Hospital Haut Leveque, Department of Cardiology, Bordeaux-Pessac, France

name: Clinique du Pont de Chaume, Montauban, France

name: Toulouse Rangueil University Hospital, Department of Cardiology, France; UMR1027, INSERM, France

name: AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France; Université Pierre et Marie Curie (UPMC-Paris 06), France

ReferenceCitation: Bailleul C, Puymirat E, Aissaoui N, Schiele F, Ducrocq G, Coste P, Blanchard D, Brasselet C, Elbaz M, Steg PG, Le Breton H, Bonnefoy-Cudraz E, Montalescot G, Cottin Y, Goldstein P, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Factors Associated With Infarct-Related Artery Patency Before Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (from the FAST-MI 2010 Registry). Am J Cardiol. 2016 Jan 1;117(1):17-21. doi: 10.1016/j.amjcard.2015.09.043. Epub 2015 Oct 23.

ReferenceCitation: Sokoloff A, Lefèvre G, Teixeira N, Puymirat E, Beygui F, Vanzetto G, Richard P, Khalife K, Blanchard D, Gilard M, Coste P, Farah B, Elbaz M, Leclercq F, Ferrari E, Bonnet JL, Meyer P, Belle L, Funck F, Motreff P, Virot P, Geugniaud PY, Ferrières J, Simon T, Danchin N. [Characteristics and management of ST-elevation myocardial infarction in France: Regional variations in 2010]. Ann Cardiol Angeiol (Paris). 2015 Dec;64(6):427-33. doi: 10.1016/j.ancard.2015.10.001. Epub 2015 Nov 5. French.

title: Prise en charge du syndrome coronaire aigu avec sus-décalage de ST en France : variations régionales en 2010

ReferenceCitation: Puymirat E, Lamhaut L, Bonnet N, Aissaoui N, Henry P, Cayla G, Cattan S, Steg G, Mock L, Ducrocq G, Goldstein P, Schiele F, Bonnefoy-Cudraz E, Simon T, Danchin N. Correlates of pre-hospital morphine use in ST-elevation myocardial infarction patients and its association with in-hospital outcomes and long-term mortality: the FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) programme. Eur Heart J. 2016 Apr 1;37(13):1063-71. doi: 10.1093/eurheartj/ehv567. Epub 2015 Nov 17.

ReferenceCitation: Massoullié G, Wintzer-Wehekind J, Chenaf C, Mulliez A, Pereira B, Authier N, Eschalier A, Clerfond G, Souteyrand G, Tabassome S, Danchin N, Citron B, Lusson JR, Puymirat É, Motreff P, Eschalier R. Prognosis and management of myocardial infarction: Comparisons between the French FAST-MI 2010 registry and the French public health database. Arch Cardiovasc Dis. 2016 May;109(5):303-10. doi: 10.1016/j.acvd.2016.01.012. Epub 2016 Apr 20.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

ReferenceCitation: Schiele F, Puymirat E, Bonello L, Meneveau N, Collet JP, Motreff P, Ravan R, Leclercq F, Ennezat PV, Ferrières J, Simon T, Danchin N. Switching between thienopyridines in patients with acute myocardial infarction and quality of care. Open Heart. 2016 May 23;3(1):e000384. doi: 10.1136/openhrt-2015-000384. eCollection 2016.

title: Switching between thienopyridines in patients with acute myocardial infarction and quality of care

ReferenceCitation: Aissaoui N, Puymirat E, Juilliere Y, Jourdain P, Blanchard D, Schiele F, Guéret P, Popovic B, Ferrieres J, Simon T, Danchin N. Fifteen-year trends in the management of cardiogenic shock and associated 1-year mortality in elderly patients with acute myocardial infarction: the FAST-MI programme. Eur J Heart Fail. 2016 Sep;18(9):1144-52. doi: 10.1002/ejhf.585.

name: AP-HP, Hôpital Européen Georges Pompidou, Paris, France, and Université Paris-Descartes; Paris France

ReferenceCitation: Puymirat E, Aissaoui N, Lemesle G, Cottin Y, Coste P, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Long-Term Clinical Outcomes According to Previous Manifestations of Atherosclerotic Disease (from the FAST-MI 2010 Registry). Am J Cardiol. 2017 Mar 1;119(5):692-697. doi: 10.1016/j.amjcard.2016.11.032. Epub 2016 Dec 2.

title: Long-Term Clinical Outcomes According to Previous Manifestations of Atherosclerotic Disease (from the FAST-MI 2010 Registry)

ReferenceCitation: Puymirat E, Aissaoui N, Cayla G, Lafont A, Riant E, Mennuni M, Saint-Jean O, Blanchard D, Jourdain P, Elbaz M, Henry P, Bataille V, Drouet E, Mulak G, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Changes in One-Year Mortality in Elderly Patients Admitted with Acute Myocardial Infarction in Relation with Early Management. Am J Med. 2017 May;130(5):555-563. doi: 10.1016/j.amjmed.2016.12.005. Epub 2017 Jan 5.

title: Changes in One-Year Mortality in Elderly Patients Admitted with Acute Myocardial Infarction in Relation with Early Management

ReferenceCitation: Schiele F, Gale CP, Simon T, Fox KAA, Bueno H, Lettino M, Tubaro M, Puymirat E, Ferrières J, Meneveau N, Danchin N. Assessment of Quality Indicators for Acute Myocardial Infarction in the FAST-MI (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) Registries. Circ Cardiovasc Qual Outcomes. 2017 Jun;10(6). pii: e003336. doi: 10.1161/CIRCOUTCOMES.116.003336.

name: From the Department of Cardiology, University Hospital of Besancon, EA3920 University of Franche-Comté, France (F.S., N.M.); Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, and York Teaching Hospital NHS Foundation Trust, United Kingdom (C.P.G.); Department of Clinical Pharmacology, Unite de Recherche Clinique de l’Est Parisien, Assistance Publique-Hôpitaux de Paris, Saint Antoine Hospital, France; Université Pierre et Marie Curie, Paris, France (T.S.); Centre for...

journal_name: Circulation: Cardiovascular Quality and Outcomes

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

title: Assessment of Quality Indicators for Acute Myocardial Infarction in the FAST-MI (French Registry of Acute ST-Elevation or Non–ST-Elevation Myocardial Infarction) Registries

ReferenceCitation: Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.

name: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology; Université Paris-Descartes, Paris, France; INSERM U-970, France (E.P., N.A., N.D.).

name: AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France; Université Pierre et Marie Curie (UPMC-Paris 06); INSERM U-698, France (T.S.).

name: Centre Hospitalier Universitaire de Nîmes, France (G.C.).

name: Centre Hospitalier Universitaire du Bocage, Dijon, France (Y.C.).

name: Toulouse University Hospital, Department of Cardiology, France (M.E.).

name: Hôpital Cardiologique Haut Levêque, CHU de Bordeaux, Pessac, France (P.C.).

name: Lille Regional University Hospital, Department of Cardiology, France (G.L.).

name: Department of Cardiology, University Hospital of Clermont-Ferrand, UMR 6284 Auvergne University, France (P.M.).

name: Département de cardiologie, CHU de Nancy, Vandoeuvre-lès-Nancy, France (B.P.).

name: Centre Hospitalier Régional de Metz-Thionville, Mets, France (K.K.).

name: Centre Hospitalier de la Côte Basque, Bayonne, France (J.-N.L.).

name: Department of cardiology, Centre Hospitalier St Joseph et St Luc, Lyon, France (T.P.).

name: Centre Hospitalier Bretagne Atlantique, Vannes, France (C.L.R.).

name: Department of Cardiology, Centre Hospitalier de Vendée, La Roche-sur-Yon, France (L.O.).

name: Hospital of Aix en Provence, Department of Cardiology, France (B.J.).

name: Clinique St Gatien, Tours, France (D.B.).

name: Clinique Axium Aix en Provence, France (P.P.);

name: Institut de Cardiologie, Centre Hospitalier Pitié-Salpêtrière, Paris, France (J.S.).

name: AP-HP, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne Paris-Cité, France; INSERM U-698, 75018 Paris, France (P.G.S.).

name: Lille Regional University Hospital, Emergency Department, France (P. Goldstein).

name: University Hospital Henri Mondor, Department of Cardiology, Créteil, France (P. Guéret).

name: Department of Cardiology, Centre hospitalier Annecy Genevois, Epagny Metz-Tessy, France (L.B.).

name: Toulouse Rangueil University Hospital, Department of Cardiology; UMR1027, INSERM, France (J.F.).

name: University Hospital Jean Minjoz, Department of Cardiology, Besançon, France (F.S.).

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

title: Acute Myocardial Infarction

ReferenceCitation: Bailleul C, Aissaoui N, Cayla G, Dillinger JG, Jouve B, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Prognostic impact of prepercutaneous coronary intervention TIMI flow in patients with ST-segment and non-ST-segment elevation myocardial infarction: Results from the FAST-MI 2010 registry. Arch Cardiovasc Dis. 2018 Feb;111(2):101-108. doi: 10.1016/j.acvd.2017.04.004. Epub 2017 Sep 19.

ReferenceCitation: Puymirat E, Aissaoui N, Bonello L, Cayla G, Labèque JN, Nallet O, Motreff P, Varenne O, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Clinical outcomes according to symptom presentation in patients with acute myocardial infarction: Results from the FAST-MI 2010 registry. Clin Cardiol. 2017 Dec;40(12):1256-1263. doi: 10.1002/clc.22819. Epub 2017 Dec 15.

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP); Hôpital Européen Georges Pompidou (HEGP), Université Paris-Descartes; Paris France

name: Intensive Care Unit, Assistance Publique-Hôpitaux de Paris (AP-HP); Hôpital Européen Georges Pompidou (HEGP); Paris France

name: Department of Cardiology; Assistance Publique-Hôpitaux de Marseille (AP-HM); Hôpital Nord, Marseille France

name: Department of Cardiology; University Hospital of Nimes, University of Nimes; France

name: Department of Cardiology; Hôpital de Bayonne; Bayonne France

name: Department of Cardiology; Intercity Hospital Le Raincy-Montfermeil; Montfermeil France

name: Department of Cardiology, University Hospital of Clermont-Ferrand; UMR 6284 Auvergne University; Clermont-Ferrand France

name: Department of Cardiology, AP-HP, Hôpital Cochin; Université Paris-Descartes; Paris France

name: Department of Cardiology; University Hospital Jean Minjoz; Besançon France

name: Department of Cardiology; Rangueil Hospital; Toulouse France

name: Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), AP-HP, Hôpital Saint Antoine; Paris France

name: Sorbonne Universités; UPMC Paris Univ-06; Paris France

ReferenceCitation: Aissaoui N, Riant E, Lefèvre G, Delmas C, Bonello L, Henry P, Bonnefoy E, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Long-term clinical outcomes in patients with cardiogenic shock according to left ventricular function: The French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) programme. Arch Cardiovasc Dis. 2018 Nov;111(11):678-685. doi: 10.1016/j.acvd.2017.11.002. Epub 2017 Dec 28.

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

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

ReferenceCitation: Isorni MA, Aissaoui N, Angoulvant D, Bonello L, Lemesle G, Delmas C, Henry P, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat É; FAST-MI investigators. Temporal trends in clinical characteristics and management according to sex in patients with cardiogenic shock after acute myocardial infarction: The FAST-MI programme. Arch Cardiovasc Dis. 2018 Oct;111(10):555-563. doi: 10.1016/j.acvd.2018.01.002. Epub 2018 Feb 22.

ReferenceCitation: Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015". Circulation. 2018 May 22;137(21):2307-2308. doi: 10.1161/CIRCULATIONAHA.118.033969.

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, France (E.P., N.D.).

name: Université Paris-Descartes, France (E.P., N.D.).

name: Department of Clinical Pharmacology and Unité de Recherche Clinique, Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, France (T.S.).

name: Université Pierre et Marie Curie, France (T.S.).

title: Response by Puymirat et al to Letter Regarding Article, “Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015”

ReferenceCitation: Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labèque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrières J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

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

ReferenceCitation: Schiele F, Puymirat E, Ferrières J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.

title: The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population

ReferenceCitation: Tea V, Bonaca M, Chamandi C, Iliou MC, Lhermusier T, Aissaoui N, Cayla G, Angoulvant D, Ferrières J, Schiele F, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Appropriate secondary prevention and clinical outcomes after acute myocardial infarction according to atherothrombotic risk stratification: The FAST-MI 2010 registry. Eur J Prev Cardiol. 2019 Mar;26(4):411-419. doi: 10.1177/2047487318808638. Epub 2018 Oct 24.

name: Department of Cardiology, Hôpital Européen Georges Pompidou (HEGP), France

name: Division of Cardiovascular Medicine, Brigham and Women's Hospital, USA

name: Departement of Cardiovascular Rehabilitation, Hôpital Corentin Celton, France

name: Department of Cardiology, Rangueil Hospital, France

name: Department of Intensive Care, HEGP, France

name: Department of Cardiology, University Hospital of Nimes, France

name: Department of Cardiology, CHU Tours & Tours University, France

name: Department of Cardiology, University Hospital Jean Minjoz, France

name: Department of Clinical Pharmacology, Hôpital Saint Antoine, France

name: Université Pierre et Marie Curie, France

journal_name: European Journal of Preventive Cardiology

ReferenceCitation: Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug - Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.

ReferenceCitation: Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non-ST Elevation Myocardial Infarction registries. Clin Cardiol. 2019 Feb;42(2):227-234. doi: 10.1002/clc.23131. Epub 2018 Dec 27.

name: Department of CardiologyAssistance Publique‐Hôpitaux de Paris (AP‐HP), Hôpital Européen Georges Pompidou (HEGP) Paris France

name: TIMI Study Group, Division of Cardiovascular MedicineBrigham and Women's Hospital, and Harvard Medical School Boston Massachusetts

name: Department of Intensive CareAP‐HP, HEGP Paris France

name: Department of cardiologyLille regional university hospital Lille France

name: Department of cardiologyhôpital Nord, AP‐HM, 13015 Marseille, France; Mediterranean Academic Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Inserm UMRS 1076, Aix‐Marseille university Marseille France

name: Department of cardiologyAP‐HP, Hôpital Bichat Paris France

name: Department of cardiologyCHU Nîmes Nîmes France

name: Department of CardiologyRangueil Hospital Toulouse France

name: Department of CardiologyUniversity Hospital Jean Minjoz Besançon France

name: AP‐HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST)Paris, France ; Université Pierre et Marie Curie (UPMC‐Paris 06) France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

title: Atherothrombotic risk stratification after acute myocardial infarction: the TIMI Risk Score for Secondary Prevention (TRS‐2P) in the light of the FAST‐MI registries

ReferenceCitation: Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrières J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, France (N.D., E.P.).

name: Université Paris-Descartes, France (N.D., E.P.).

name: INSERM U-970, Paris, France (N.D., E.P.).

name: Department of Cardiology, Centre Hospitalier Universitaire de Nîmes, Université de Montpellier, France (G.C.).

name: Department of Cardiology, Centre Hospitalier Universitaire du Bocage, Dijon, France (Y.C.).

name: Department of Cardiology, Hôpital Cardiologique du Haut-Lévêque, CHU de Bordeaux, Pessac, France (P.C.).

name: Département de Cardiologie CHU La Cavale Blanche, Brest, France (M.G.).

name: Société Française de Cardiologie, Paris, France (M.G.).

name: Emergency Department, Lille Regional University Hospital, France (P.G.).

name: Emergency Department, Centre Hospitalier Régional, Hôpital Mercy, Metz, France (F.B.).

name: Department of Cardiology, Centre Hospitalier Annecy Genevois, Epagny Metz-Tessy, France (L.B.).

name: Collège National des Cardiologues des Hôpitaux, Paris, France (L.B.).

name: Institut de Cardiologie, Centre Hospitalier Pitié-Salpêtrière, Paris, France (G.M.).

name: Department of Cardiology, Toulouse Rangueil University Hospital, France (J.F.).

name: UMR1027, INSERM, Toulouse, France (J.F.).

name: Department of Cardiology, University Hospital Jean Minjoz, Besançon, France (F.S.).

name: Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), AP-HP, Hôpital Saint Antoine, Paris, France (T.S.).

name: Université Pierre et Marie Curie (UPMC-Paris 06), France (T.S.).

title: One-Year Survival After ST-Segment–Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy


title: Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®

acronym: Anaconda

summary: This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

primary_purpose: Screening


title: A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of Memantine on Pharmacokinetics, Safety and Tolerability of RO5313534 After Single Dose Administration in Healthy Volunteers and the Effect of RO5313534 on Safety and Tolerability of Steady State Memantine

summary: This open-label, fixed sequence, two-period study will assess the effect of memantine on the pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.

lead_sponsor: Hoffmann-La Roche


title: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

acronym: PREOXY

summary: Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

status: Withdrawn

lead_sponsor: Hopital of Melun


title: Effect of RAS Inhibitors on Albuminuria, Hyperfiltration and Endothelial Dysfunction in a Sickle Cell Disease Population.

acronym: RAND

summary: The prevalence of Sickle Cell Associated Nephropathy (SCAN) is increasing and is a growing concern. Microalbuminuria is detected in the early onset of SCAN. Noteworthy, as in diabetic nephropathy, hyperfiltration seems to be a frequent finding, with, in our series, an overall incidence of 57 % and suggests a pathological links between glomerular hyperpressure and glomerulosclerosis which occurs several years after. Nitric oxide (NO) deficiency and the renin angiotensin system (RAS) are likely to be involved in the glomerular hyperpressure leading to hyperfiltration. Renin angiotensin antagonists are currently given for NEPHROPROTECTION in numerous nephropathy including SCAN despite few available reports. The percentage of decrease of albuminuria or the percentage of responders (ie patient normalizing albuminuria) has never been reported to our knowledge in SCAN patients at the time of hyperfiltration. The focus of our study is therefore to 1) Quantify albuminuria reduction after 6 months RAS treatment (primary end point); 2) Quantify glomerular filtration rate (GFR) reduction after 6 months of RAS treatment, and to test the hypothesis of a beneficial effect of RAS inhibitors on several biomarkers assessing hemolysis, NO inhibition and the endothelial damages (secondary end points). The ultimate aim of our study is to identify relevant (new) biomarkers associated to hyperfiltration and/or albuminuria decrease (/normalization).

ReferenceCitation: Dharnidharka VR, Dabbagh S, Atiyeh B, Simpson P, Sarnaik S. Prevalence of microalbuminuria in children with sickle cell disease. Pediatr Nephrol. 1998 Aug;12(6):475-8.

ReferenceCitation: Guasch A, Navarrete J, Nass K, Zayas CF. Glomerular involvement in adults with sickle cell hemoglobinopathies: Prevalence and clinical correlates of progressive renal failure. J Am Soc Nephrol. 2006 Aug;17(8):2228-35. Epub 2006 Jul 12.

ReferenceCitation: Falk RJ, Scheinman J, Phillips G, Orringer E, Johnson A, Jennette JC. Prevalence and pathologic features of sickle cell nephropathy and response to inhibition of angiotensin-converting enzyme. N Engl J Med. 1992 Apr 2;326(14):910-5.

ReferenceCitation: Olson JL, Hostetter TH, Rennke HG, Brenner BM, Venkatachalam MA. Altered glomerular permselectivity and progressive sclerosis following extreme ablation of renal mass. Kidney Int. 1982 Aug;22(2):112-26.

ReferenceCitation: Serjeant GR, Higgs DR, Hambleton IR. Elderly survivors with homozygous sickle cell disease. N Engl J Med. 2007 Feb 8;356(6):642-3.

ReferenceCitation: Manci EA, Culberson DE, Yang YM, Gardner TM, Powell R, Haynes J Jr, Shah AK, Mankad VN; Investigators of the Cooperative Study of Sickle Cell Disease. Causes of death in sickle cell disease: an autopsy study. Br J Haematol. 2003 Oct;123(2):359-65.

ReferenceCitation: Powars DR, Elliott-Mills DD, Chan L, Niland J, Hiti AL, Opas LM, Johnson C. Chronic renal failure in sickle cell disease: risk factors, clinical course, and mortality. Ann Intern Med. 1991 Oct 15;115(8):614-20.

ReferenceCitation: Barros FB, Lima CS, Santos AO, Mazo-Ruiz MF, Lima MC, Etchebehere EC, Costa FF, Saad ST, Camargo EE, Ramos CD. 51Cr-EDTA measurements of the glomerular filtration rate in patients with sickle cell anaemia and minor renal damage. Nucl Med Commun. 2006 Dec;27(12):959-62.

ReferenceCitation: Marouf R, Mojiminiyi O, Abdella N, Kortom M, Al Wazzan H. Comparison of renal function markers in Kuwaiti patients with sickle cell disease. J Clin Pathol. 2006 Apr;59(4):345-51.

ReferenceCitation: Vedel P, Obel J, Nielsen FS, Bang LE, Svendsen TL, Pedersen OB, Parving HH. Glomerular hyperfiltration in microalbuminuric NIDDM patients. Diabetologia. 1996 Dec;39(12):1584-9.

ReferenceCitation: Berg UB. Differences in decline in GFR with age between males and females. Reference data on clearances of inulin and PAH in potential kidney donors. Nephrol Dial Transplant. 2006 Sep;21(9):2577-82. Epub 2006 May 23.

ReferenceCitation: Chiarelli F, Cipollone F, Romano F, Tumini S, Costantini F, di Ricco L, Pomilio M, Pierdomenico SD, Marini M, Cuccurullo F, Mezzetti A. Increased circulating nitric oxide in young patients with type 1 diabetes and persistent microalbuminuria: relation to glomerular hyperfiltration. Diabetes. 2000 Jul;49(7):1258-63.

ReferenceCitation: Morris CR, Kato GJ, Poljakovic M, Wang X, Blackwelder WC, Sachdev V, Hazen SL, Vichinsky EP, Morris SM Jr, Gladwin MT. Dysregulated arginine metabolism, hemolysis-associated pulmonary hypertension, and mortality in sickle cell disease. JAMA. 2005 Jul 6;294(1):81-90.

ReferenceCitation: Reiter CD, Wang X, Tanus-Santos JE, Hogg N, Cannon RO 3rd, Schechter AN, Gladwin MT. Cell-free hemoglobin limits nitric oxide bioavailability in sickle-cell disease. Nat Med. 2002 Dec;8(12):1383-9. Epub 2002 Nov 11.

ReferenceCitation: Rother RP, Bell L, Hillmen P, Gladwin MT. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human disease. JAMA. 2005 Apr 6;293(13):1653-62. Review.

ReferenceCitation: Kato GJ, McGowan V, Machado RF, Little JA, Taylor J 6th, Morris CR, Nichols JS, Wang X, Poljakovic M, Morris SM Jr, Gladwin MT. Lactate dehydrogenase as a biomarker of hemolysis-associated nitric oxide resistance, priapism, leg ulceration, pulmonary hypertension, and death in patients with sickle cell disease. Blood. 2006 Mar 15;107(6):2279-85. Epub 2005 Nov 15.

ReferenceCitation: Landburg PP, Teerlink T, Muskiet FA, Duits AJ, Schnog JJ; CURAMA study group. Plasma concentrations of asymmetric dimethylarginine, an endogenous nitric oxide synthase inhibitor, are elevated in sickle cell patients but do not increase further during painful crisis. Am J Hematol. 2008 Jul;83(7):577-9. doi: 10.1002/ajh.21184.

ReferenceCitation: Loutzenhiser R, Bidani A, Chilton L. Renal myogenic response: kinetic attributes and physiological role. Circ Res. 2002 Jun 28;90(12):1316-24.

ReferenceCitation: Sochett EB, Cherney DZ, Curtis JR, Dekker MG, Scholey JW, Miller JA. Impact of renin angiotensin system modulation on the hyperfiltration state in type 1 diabetes. J Am Soc Nephrol. 2006 Jun;17(6):1703-9. Epub 2006 May 3.

ReferenceCitation: Aoki RY, Saad ST. Enalapril reduces the albuminuria of patients with sickle cell disease. Am J Med. 1995 May;98(5):432-5.

ReferenceCitation: Foucan L, Bourhis V, Bangou J, Mérault L, Etienne-Julan M, Salmi RL. A randomized trial of captopril for microalbuminuria in normotensive adults with sickle cell anemia. Am J Med. 1998 Apr;104(4):339-42.

ReferenceCitation: Reboldi G, Gentile G, Angeli F, Verdecchia P. Choice of ACE inhibitor combinations in hypertensive patients with type 2 diabetes: update after recent clinical trials. Vasc Health Risk Manag. 2009;5(1):411-27. Review.

ReferenceCitation: Lionnet F, Arlet JB, Bartolucci P, Habibi A, Ribeil JA, Stankovic K; groupe de recommandations et d'étude de la drépanocytose de l'adulte (GREDA). [Guidelines for management of adult sickle cell disease]. Rev Med Interne. 2009 Sep;30 Suppl 3:S162-223. doi: 10.1016/j.revmed.2009.07.001. Epub 2009 Aug 26. French.

ReferenceCitation: van Deventer HE, George JA, Paiker JE, Becker PJ, Katz IJ. Estimating glomerular filtration rate in black South Africans by use of the modification of diet in renal disease and Cockcroft-Gault equations. Clin Chem. 2008 Jul;54(7):1197-202. doi: 10.1373/clinchem.2007.099085. Epub 2008 May 16.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre de la Drépanocytose, Service de Médecine Interne. Hôpital Tenon, 4 Rue de la Chine


ReferenceCitation: Beaussier M, El'Ayoubi H, Schiffer E, Rollin M, Parc Y, Mazoit JX, Azizi L, Gervaz P, Rohr S, Biermann C, Lienhart A, Eledjam JJ. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study. Anesthesiology. 2007 Sep;107(3):461-8.

ReferenceCitation: Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44.

ReferenceCitation: Borromeo CJ, Stix MS, Lally A, Pomfret EA. Epidural catheter and increased prothrombin time after right lobe hepatectomy for living donor transplantation. Anesth Analg. 2000 Nov;91(5):1139-41.

ReferenceCitation: Godier A, Babinet A, el Metaoua S, Fulgencio JP, Bonnet F. [A new cause of postoperative confusion syndrome: nefopam]. Ann Fr Anesth Reanim. 2002 Jun;21(6):538-9. French.

ReferenceCitation: Ho AM, Lee A, Karmakar MK, Samy W, Lai PB, Ho OA, Cho A. Hemostatic parameters after hepatectomy for cancer. Hepatogastroenterology. 2007 Jul-Aug;54(77):1494-8.

ReferenceCitation: Jalan R, Williams R, Bernuau J. Paracetamol: are therapeutic doses entirely safe? Lancet. 2006 Dec 23;368(9554):2195-6.

ReferenceCitation: Kwan AL. Epidural analgesia for patient undergoing hepatectomy. Anaesth Intensive Care. 2003 Apr;31(2):236-7.

ReferenceCitation: Larson AM. Acetaminophen hepatotoxicity. Clin Liver Dis. 2007 Aug;11(3):525-48, vi. Review.

ReferenceCitation: Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. Epub 2006 Oct 25. Review.

ReferenceCitation: Mazoit JX, Butscher K, Samii K. Morphine in postoperative patients: pharmacokinetics and pharmacodynamics of metabolites. Anesth Analg. 2007 Jul;105(1):70-8.

ReferenceCitation: Murphy EJ. Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Anaesth Intensive Care. 2005 Jun;33(3):311-22. Review.

ReferenceCitation: Schumann R, Zabala L, Angelis M, Bonney I, Tighiouart H, Carr DB. Altered hematologic profiles following donor right hepatectomy and implications for perioperative analgesic management. Liver Transpl. 2004 Mar;10(3):363-8.

ReferenceCitation: Tsui SL, Yong BH, Ng KF, Yuen TS, Li CC, Chui KY. Delayed epidural catheter removal: the impact of postoperative coagulopathy. Anaesth Intensive Care. 2004 Oct;32(5):630-6.

ReferenceCitation: Urwin SC, Smith HS. Fatal nefopam overdose. Br J Anaesth. 1999 Sep;83(3):501-2.

ReferenceCitation: Villier C, Mallaret MP. Nefopam abuse. Ann Pharmacother. 2002 Oct;36(10):1564-6.

ReferenceCitation: Ychou M, Viret F, Kramar A, Desseigne F, Mitry E, Guimbaud R, Delpero JR, Rivoire M, Quénet F, Portier G, Nordlinger B. Tritherapy with fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in colorectal cancer patients with non-resectable liver metastases. Cancer Chemother Pharmacol. 2008 Jul;62(2):195-201. Epub 2007 Sep 28.

lead_sponsor: Centre Leon Berard

acronym: DPO

type: Registry Identifier

title: A Double-blind Placebo-controlled Evaluation of Ropivacaine Efficacy by Local Per and Post Hepatectomy Infiltrations for Adult Pain Management

summary:
The purpose of the study is to evaluate the efficacy and impact on morphine consumption of ropivacaine administered by local per and post hepatic surgery infiltration.

Patients will be randomized to either ropivacaine or physiological serum, with equivalent administration modalities in both arms.

Patients will be followed during 4 days after the surgery. They will also come back for a follow-up visit one month later.

It is necessary to enrol 100 patients. The estimated period of inclusion is 24 months.

This is a prospective, comparative, monocentric, double-blind randomized study.


title: Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4

acronym: ANRS VITAVIC

summary: Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

ReferenceCitation: Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647.

apc_source: openAPC

family: Terrier

full_name: Benjamin Terrier

given: Benjamin

journal_name: World Journal of Gastroenterology

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

repositories:
HAL
PubMed Central

publisher: Baishideng Publishing Group Inc.

publisher_dissemination: Baishideng Publishing Group Inc.

publisher_group: Baishideng Publishing Group Inc.

publisher_normalized: Baishideng Publishing Group Inc.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis