title: PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game

acronym: PlaniRev

summary:
Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town.

Hypotheses :

Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.

primary_purpose: Other

lead_sponsor: Centre Hospitalier St Anne

location_facility:
Centre Hospitalier Guillaume Régnier
Centre Hospitalier DURANT
Centre Hospitalier Sainte Anne
Hopital les Murets


title: Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study

summary:
The WHO (World Health Organisation) estimated the prevalence of diabetes to be 422 million people in 2014, compared to 108 million in 1980. This has led to an increasing number of diabetic patients referred to nephrologists for diagnostic purposes. Diabetic nephropathy is the most common renal disease in this population and is usually a presumptive diagnosis based on clinical and biological features although microscopic examination of a renal sample acquired through renal biopsy is the only way to be certain of this diagnosis. However, kidney biopsy is an invasive procedure carrying a low but incontestable risk of adverse event such as post-procedural pain and bleeding. Consequently, nephrologist around the world feel that renal biopsy should only be performed in patients with type 2 diabetes to detect non-diabetic renal disease, when the diagnosis of diabetic nephropathy is dubious or unlikely. This likeliness is based on the presence or absence of typical feature such as diabetic retinopathy, hematuria, progressive decline of renal function or increase of proteinuria, long duration of diabetes, nephrotic syndrome. These feature were identified by the comparison of patients with type 2 diabetes and non-diabetic renal disease (alone or associated to diabetic nephropathy) and isolated diabetic nephropathy.

However, it is not known if the presence (or absence) of these atypical features by themselves are indeed signs of non-diabetic renal disease and necessitate to perform renal biopsy. The aim of the study is to determine if these atypical features are relevant indications to perform renal biopsy. To answer this question, will be analyze the medical records of patients with type 2 diabetes who underwent renal biopsy in five French nephrology center to determine, in each case, the indication of the biopsy and if this latter benefitted the patients.

In addition, will be evaluate the prognosis value of the Renal Pathology Society classification of diabetic nephropathy in patients with type 2 diabetes and diabetic nephropathy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility:
AP-HM, Hôpital de la Conception
Hôpital Bretonneau
Rennes University Hospital
AP-HP, Hôpital Bichat-Claude Bernard

lead_sponsor_type: academique

status_simplified: Completed


title: Etude de la Reserve Vasomotrice Microcirculatoire cutanée

summary: Microvascular dysfunctions are critical events in several diseases including diabetes. This study will develop a methodology for microvascular investigation in human skin. The purpose of the study is to investigate the physiological response of the cutaneous microcirculation to physical, thermal, mechanical or chemical stimulations.

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Tartas M, Durand S, Koïtka A, Bouyé P, Saumet JL, Abraham P. Anodal current intensities above 40 microA interfere with current-induced axon-reflex vasodilatation in human skin. J Vasc Res. 2004 May-Jun;41(3):261-7. Epub 2004 May 19.

ReferenceCitation: Durand S, Fromy B, Humeau A, Sigaudo-Roussel D, Saumet JL, Abraham P. Break excitation alone does not explain the delay and amplitude of anodal current-induced vasodilatation in human skin. J Physiol. 2002 Jul 15;542(Pt 2):549-57.

ReferenceCitation: Tartas M, Bouyé P, Koïtka A, Durand S, Gallois Y, Saumet JL, Abraham P. Early vasodilator response to anodal current application in human is not impaired by cyclooxygenase-2 blockade. Am J Physiol Heart Circ Physiol. 2005 Apr;288(4):H1668-73. Epub 2004 Nov 24.

ReferenceCitation: Durand S, Tartas M, Bouyé P, Koïtka A, Saumet JL, Abraham P. Prostaglandins participate in the late phase of the vascular response to acetylcholine iontophoresis in humans. J Physiol. 2004 Dec 15;561(Pt 3):811-9. Epub 2004 Oct 21.

ReferenceCitation: Durand S, Fromy B, Tartas M, Jardel A, Saumet JL, Abraham P. Prolonged aspirin inhibition of anodal vasodilation is not due to the trafficking delay of neural mediators. Am J Physiol Regul Integr Comp Physiol. 2003 Jul;285(1):R155-61.

ReferenceCitation: Durand S, Fromy B, Koïtka A, Tartas M, Saumet JL, Abraham P. Oral single high-dose aspirin results in a long-lived inhibition of anodal current-induced vasodilatation. Br J Pharmacol. 2002 Oct;137(3):384-90.

ReferenceCitation: Durand S, Fromy B, Bouyé P, Saumet JL, Abraham P. Vasodilatation in response to repeated anodal current application in the human skin relies on aspirin-sensitive mechanisms. J Physiol. 2002 Apr 1;540(Pt 1):261-9.

lead_sponsor: University Hospital, Angers

location_facility: Laboratoire de Physiologie et Explorations Vasculaires - CHU Angers

intervention_type: Device


title: Detection of Colistin-resistant Isolates From Patients Admitted in Intensive Care Units and Oncohaematology Wards in the Region Nouvelle Aquitaine: Diagnostic Accuracy of the Detection Methods, Estimation of the Prevalence and Description of the Resistance Mechanisms.

acronym: RESCO

summary: The increasing use of colistin in multidrug resistant strains, as Enterobacteriaceae producing extended-spectrum β-lactamases or carbapenemases, is associated with the emergence of colistin resistant isolates. The main objective of this project is to estimate the diagnostic accuracy (sensitivity and specificity) of a new rapid detection test of colistin resistant strains (Rapid Polymyxin NP test) isolated in clinical settings.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Limoges
CHU de Bordeaux
CH de Mont de Marsan
CH de Dax

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

summary:
The aim of the study is to show the implication of platelets in vasodilation using in vivo and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this interaction platelets/vessels.

The effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.

status: Unknown status

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Drug

status_simplified: Unknown


title: Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients

acronym: CHEK BAC

summary: This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CH d'Alès
CHU de Nimes
CH de Bagnols sur Céze


title: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment

acronym: E-SN@P PROJECT

summary: adherence of digital follow-up in a population of elderly patients.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

lead_sponsor: Institut Paoli-Calmettes

location_facility:
CHU Nice
Institut Paoli-Calmettes
CHI des Alpes du Sud
Institut Sainte Catherine


title: Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients

summary: Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.

ReferenceType: derived

ReferenceCitation: Plassais J, Venet F, Cazalis MA, Le Quang D, Pachot A, Monneret G, Tissot S, Textoris J. Transcriptome modulation by hydrocortisone in severe burn shock: ancillary analysis of a prospective randomized trial. Crit Care. 2017 Jun 16;21(1):158. doi: 10.1186/s13054-017-1743-9.

family: Plassais

full_name: Jonathan Plassais

given: Jonathan

sequence: first

family: Venet

full_name: Fabienne Venet

given: Fabienne

sequence: additional

family: Cazalis

full_name: Marie-Angélique Cazalis

given: Marie-Angélique

family: Le Quang

full_name: Diane Le Quang

given: Diane

family: Pachot

full_name: Alexandre Pachot

given: Alexandre

family: Monneret

full_name: Guillaume Monneret

given: Guillaume

family: Tissot

full_name: Sylvie Tissot

given: Sylvie

family: Textoris

full_name: Julien Textoris

given: Julien

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Venet F, Plassais J, Textoris J, Cazalis MA, Pachot A, Bertin-Maghit M, Magnin C, Rimmelé T, Monneret G, Tissot S. Low-dose hydrocortisone reduces norepinephrine duration in severe burn patients: a randomized clinical trial. Crit Care. 2015 Jan 26;19:21. doi: 10.1186/s13054-015-0740-0.

family: Bertin-Maghit

full_name: Marc Bertin-Maghit

given: Marc

family: Magnin

full_name: Christophe Magnin

given: Christophe

family: Rimmelé

full_name: Thomas Rimmelé

given: Thomas


title: A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study

summary: The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.

status: Terminated

ReferenceCitation: Slama L, Lanoy E, Valantin MA, Bastard JP, Chermak A, Boutekatjirt A, William-Faltaos D, Billaud E, Molina JM, Capeau J, Costagliola D, Rozenbaum W. Effect of pioglitazone on HIV-1-related lipodystrophy: a randomized double-blind placebo-controlled trial (ANRS 113). Antivir Ther. 2008;13(1):67-76.

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

location_facility: Service des Maladies Infectieuses et Tropicales, Hopital Tenon


title: Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

summary: Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale.

lead_sponsor: Hospices Civils de Lyon


title: A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year

summary: Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.

design_allocation: Non-Randomized


title: A Randomized, Phase III Clinical Trial GF-GS 01 to Compare Conventional Axillary Dissection Versus Sentinel Node Resection (GS) in Clinically Node-negative Operable Breast Cancer Unifocal N0 Patients

summary:
Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer.

The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node.

The duration of the follow-up is 5 years.

ReferenceCitation: Roy P, Leizorovicz A, Villet R, Mercier C, Bobin JY. Systematic versus sentinel-lymph-node-driven axillary-lymph-node dissection in clinically node-negative patients with operable breast cancer. Results of the GF-GS01 randomized trial. Breast Cancer Res Treat. 2018 Jul;170(2):303-312. doi: 10.1007/s10549-018-4733-y. Epub 2018 Mar 10.

family: Roy

full_name: P. Roy

given: P.

family: Leizorovicz

full_name: A. Leizorovicz

given: A.

family: Villet

full_name: R. Villet

given: R.

family: Mercier

full_name: C. Mercier

given: C.

family: Bobin

full_name: J. Y. Bobin

given: J. Y.

journal_name: Breast Cancer Research and Treatment

oa_colors: green hybrid

evidence: open (via page says license)

intervention_type: Procedure


type: Other Identifier

title: Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) : a Feasibility Study

acronym: MEDICO-LIBS

summary: Evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ILDs, with an technology named LIBS (Laser Induced-Breakdown Spectroscopy)

ReferenceCitation: Busser B, Moncayo S, Trichard F, Bonneterre V, Pinel N, Pelascini F, Dugourd P, Coll JL, D'Incan M, Charles J, Motto-Ros V, Sancey L. Characterization of foreign materials in paraffin-embedded pathological specimens using in situ multi-elemental imaging with laser spectroscopy. Mod Pathol. 2018 Mar;31(3):378-384. doi: 10.1038/modpathol.2017.152. Epub 2017 Nov 17.

family: Busser

full_name: Benoit Busser

given: Benoit

family: Moncayo

full_name: Samuel Moncayo

given: Samuel

family: Trichard

full_name: Florian Trichard

given: Florian

family: Bonneterre

full_name: Vincent Bonneterre

given: Vincent

family: Pinel

full_name: Nicole Pinel

given: Nicole

family: Pelascini

full_name: Frédéric Pelascini

given: Frédéric

family: Dugourd

full_name: Philippe Dugourd

given: Philippe

family: Coll

full_name: Jean-Luc Coll

given: Jean-Luc

family: D'Incan

full_name: Michel D'Incan

given: Michel

family: Charles

full_name: Julie Charles

given: Julie

family: Motto-Ros

full_name: Vincent Motto-Ros

family: Sancey

full_name: Lucie Sancey

given: Lucie

journal_name: Modern Pathology

oa_host_type: publisher

evidence: open (via free pdf)

ReferenceCitation: Busser et al., Coord Chem Rev, 2018, 358, p70

lead_sponsor: University Hospital, Grenoble

location_facility:
CHRU de LILLE
CHU de Lyon HCL - GH Sud
Hôpital Louis Pradel
Grenoble Alpes University Hospital


title: Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

acronym: OSCILLO

summary:
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.

Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.

lead_sponsor: University Hospital, Tours

location_facility: Respiratory Functional Explorations, University Hospital, Lille

location_facility: Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen

location_facility: Pulmonology Department, University Hospital, Tours

location_facility: Respiratory Functional Explorations, University Hospital, Nantes


title: Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies

acronym: LYON SAPL

summary:
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research.

The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Test (TGT) parameters: endogen thrombin potential (ETP), lag time and time to peak) will be compared to the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.

location_facility:
Hôpital Edouard Herriot
Hôpital Cardiologique Louis Pradel
CHU de Clermont-Ferrand
Centre Hospitalier Lyon Sud

intervention_type: Biological


title: Prognosis After Acute Coronary Syndrome in HIV-infected Patients

summary: Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years follow up.

ReferenceCitation: Boccara F, Mary-Krause M, Potard V, Teiger E, Lang S, Hammoudi N, Chauvet M, Ederhy S, Dufour-Soulat L, Ancedy Y, Nhan P, Adavane S, Steg PG, Funck-Brentano C, Costagliola D, Cohen A; PACS-HIV (Prognosis of Acute Coronary Syndrome in HIV-Infected Patients) Investigators †. HIV Infection and Long-Term Residual Cardiovascular Risk After Acute Coronary Syndrome. J Am Heart Assoc. 2020 Sep;9(17):e017578. doi: 10.1161/JAHA.119.017578. Epub 2020 Aug 26.

name: Department of Cardiology Faculty of Medicine AP‐HP Hôpitaux de l’Est Parisien Hôpital Saint‐Antoine Sorbonne Université Paris France

name: National Institute of Health and Medical Research INSERM UMR_S 938 Sorbonne Université Paris France

family: Boccara

full_name: Franck Boccara

given: Franck

name: INSERM Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP) Sorbonne Université Paris France

family: Mary‐Krause

full_name: Murielle Mary‐Krause

given: Murielle

family: Potard

full_name: Valérie Potard

given: Valérie

name: Interventional Cardiology Unit Henri Mondor University Hospital Assistance Publique Hôpitaux de Paris Créteil France

name: Inserm CIC 1430 et U955 Team 3 Henri Mondor University Hospital Créteil France

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Lang

full_name: Sylvie Lang

given: Sylvie

name: Inserm UMRS 1166 Institute of Cardiometabolism and Nutrition (ICAN) ACTION Study Group and Institute of Cardiology (AP‐HP) Hôpital Pitié‐Salpêtrière Sorbonne Université Paris France

family: Hammoudi

full_name: Nadjib Hammoudi

given: Nadjib

family: Chauvet

full_name: Marion Chauvet

given: Marion

family: Ederhy

full_name: Stéphane Ederhy

given: Stéphane

family: Dufour‐Soulat

full_name: Laurie Dufour‐Soulat

given: Laurie

family: Ancedy

full_name: Yann Ancedy

given: Yann

family: Nhan

full_name: Pascal Nhan

given: Pascal

family: Adavane

full_name: Saroumadi Adavane

given: Saroumadi

name: Département Hospitalo‐Universitaire (DHU) Fibrose Inflammation Remodelage (FIRE) INSERM U‐1148 University Paris Diderot Assistance Publique ‐ Hôpitaux de Paris (AP‐HP) Paris France

family: Steg

full_name: Ph. Gabriel Steg

given: Ph. Gabriel

name: Department of Pharmacology INSERM CIC Paris‐Est, AP‐HP ICAN Pitié‐Salpêtrière Hospital Sorbonne Université Paris France

family: Funck‐Brentano

full_name: Christian Funck‐Brentano

given: Christian

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Cohen

full_name: Ariel Cohen

given: Ariel

family: Weber

full_name: S. Weber

given: S.

family: Wahbi

full_name: K. Wahbi

given: K.

family: Beaufils

full_name: P. Beaufils

family: Henri

full_name: P. Henri

family: Sideris

full_name: G. Sideris

given: G.

family: Thomas

full_name: D. Thomas

given: D.

family: Montalescot

full_name: G. Montalescot

family: Beygui

full_name: F. Beygui

journal_name: Journal of the American Heart Association

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

publisher: Ovid Technologies (Wolters Kluwer Health)

title: HIV Infection and Long‐Term Residual Cardiovascular Risk After Acute Coronary Syndrome


title: Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"

summary:
The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock, and the time devoted to chest compressions.

The researchers propose to decrease the periods of interruption of cardiopulmonary resuscitation (CPR), while keeping the principle of early defibrillation.

ReferenceType: background

ReferenceCitation: Carpenter J, Rea TD, Murray JA, Kudenchuk PJ, Eisenberg MS. Defibrillation waveform and post-shock rhythm in out-of-hospital ventricular fibrillation cardiac arrest. Resuscitation. 2003 Nov;59(2):189-96.

ReferenceCitation: van Alem AP, Sanou BT, Koster RW. Interruption of cardiopulmonary resuscitation with the use of the automated external defibrillator in out-of-hospital cardiac arrest. Ann Emerg Med. 2003 Oct;42(4):449-57.

ReferenceCitation: Eisenberg MS, Horwood BT, Cummins RO, Reynolds-Haertle R, Hearne TR. Cardiac arrest and resuscitation: a tale of 29 cities. Ann Emerg Med. 1990 Feb;19(2):179-86.

ReferenceCitation: Cummins RO, Ornato JP, Thies WH, Pepe PE. Improving survival from sudden cardiac arrest: the "chain of survival" concept. A statement for health professionals from the Advanced Cardiac Life Support Subcommittee and the Emergency Cardiac Care Committee, American Heart Association. Circulation. 1991 May;83(5):1832-47. Review.

ReferenceCitation: Jost D, Richter F, Morell E, Michel A, Goldstein P, Petit P et al. Expérience française de la défibrillation semi-automatique. Jeur, 1998;3:1A24-131.

ReferenceCitation: Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett PJ, Becker L, Bossaert L, Delooz HH, Dick WF, Eisenberg MS, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Circulation. 1991 Aug;84(2):960-75. Review.

ReferenceCitation: Halawa B. [Treatment of cardiac arrhythmia in pregnant women]. Pol Merkur Lekarski. 2000 Aug;9(50):513-8. Polish.

ReferenceCitation: Sato Y, Weil MH, Sun S, Tang W, Xie J, Noc M, Bisera J. Adverse effects of interrupting precordial compression during cardiopulmonary resuscitation. Crit Care Med. 1997 May;25(5):733-6.

ReferenceCitation: Cobb LA, Fahrenbruch CE, Walsh TR, Copass MK, Olsufka M, Breskin M, Hallstrom AP. Influence of cardiopulmonary resuscitation prior to defibrillation in patients with out-of-hospital ventricular fibrillation. JAMA. 1999 Apr 7;281(13):1182-8.

ReferenceCitation: Wik L, Hansen TB, Fylling F, Steen T, Vaagenes P, Auestad BH, Steen PA. Delaying defibrillation to give basic cardiopulmonary resuscitation to patients with out-of-hospital ventricular fibrillation: a randomized trial. JAMA. 2003 Mar 19;289(11):1389-95.

ReferenceCitation: Berg RA, Hilwig RW, Kern KB, Ewy GA. Precountershock cardiopulmonary resuscitation improves ventricular fibrillation median frequency and myocardial readiness for successful defibrillation from prolonged ventricular fibrillation: a randomized, controlled swine study. Ann Emerg Med. 2002 Dec;40(6):563-70.

ReferenceCitation: Eftestøl T, Sunde K, Steen PA. Effects of interrupting precordial compressions on the calculated probability of defibrillation success during out-of-hospital cardiac arrest. Circulation. 2002 May 14;105(19):2270-3.

ReferenceCitation: Banville I, Walker RG, Chapman FW. Maximizing CPR by changing the AED configuration. IICE2005 Book of Abstracts; p 26.

ReferenceCitation: Jost D, Calamai F, Fontaine D et al. Concordance Between Carotid Pulse Check and Transthoracic Impedance Characteristics in Out-of-Hospital Cardiac Arrest [abstr]. Circulation 2006;114:II_1201-a.

ReferenceCitation: Renard A, Jost D, Verret C et al. Effect of Thrombolytics on the Immediate Prognosis for Out-of-Hospital Cardiac Arrest [abstr]. Circulation 2007;116:II_928-b.

ReferenceCitation: Hersan O, Jost D, Banville IL et al. More CPR With the New Guidelines. Does It Impact VF Termination by Defibrillation Shocks? [abstr]. Circulation 2007;116:II_386-a.

ReferenceCitation: Jost D, Degrange H, Hersan O, Briche F, Fontaine D, Lallement D, Calamai F, Verret C, Banville I, Chapman F, Koster R, Descatha A, Petit J-L, Fuilla C. Prospective Clinical Trial, DEFI 2005: Does an AED Algorithm with More CPR Impact Out-of-Hospital Cardiac Arrest Prognosis? Resuscitation 2008;77 (Supp 1):.S18. (Abstract). ERC 2008

ReferenceCitation: Jost D, Banville I, Degrange H, Hersan O, Briche F, Dubourdieu S, Fontaine D, Lallement D, Chapman F, Lank P, Petit J-L, Fuilla C. Metronome Use to Improve CPR by Firefighters during Out-of-Hospital Cardiac Arrest. Academic Emergency Medicine 2008;15(s1):S21-S22. (Abstract). SAEM 2008.

ReferenceCitation: Jost D, Degrange H, Hersan O, Briche F, Fontaine D, Lallement D, Calamai F, Verret C, Banville I, Chapman F, Koster R, Fuilla C, Jost D, Descatha A, Dubourdieu S, Petit J-L, Lank P. Prospective Clinical Trial, DEFI 2005: Does an AED Algorithm with More CPR Impact Out-of-Hospital Cardiac Arrest Prognosis? Academic Emergency Medicine 2008;15(s1):S224-S225. (Abstract). SAEM 2008.

ReferenceCitation: Jost D, Banville I, Girardeau S, Calamai F, Fontaine D, Lallement D, Chapman FW, Degrange H, Petit J-L, Fuilla C. Impact of reducing CPR hands-off time during out-of-hospital cardiac arrest on post-shock rhythm progression. Eur Heart J. 2008;29:642 (Abstract).

ReferenceCitation: Jost D, Degrange H, Banville IL, Hersan O, Briche F, Fontaine D, Lallement D, Calamai F, Chapman FW, Petit J-L, Fuilla C. Is the Outcome from Witnessed VF Cardiac Arrest Improved by Providing More CPR? Results from DEFI2005, a Randomized Controlled Trial of two AED Protocols. Circulation. 2008;118:S_1447. (Abstract). AHA 2008

ReferenceCitation: Jost D, Degrange H, Verret C, Hersan O, Banville IL, Chapman FW, Lank P, Petit JL, Fuilla C, Migliani R, Carpentier JP; DEFI 2005 Work Group. DEFI 2005: a randomized controlled trial of the effect of automated external defibrillator cardiopulmonary resuscitation protocol on outcome from out-of-hospital cardiac arrest. Circulation. 2010 Apr 13;121(14):1614-22. doi: 10.1161/CIRCULATIONAHA.109.878389. Epub 2010 Mar 29.

name: From the Service médical de la Brigade de Sapeurs-Pompiers de Paris, Paris, France (D.J., H.D., O.H., J.L.P., C.F., J.P.C.); Département d'Epidémiologie et de Santé Publique Nord, Ecole du Val-de-Grâce, Paris, France (D.J., C.V., R.M.); and Physio-Control, Redmond, Wash (I.L.B., F.W.C., P.L.).

family: Jost

full_name: Daniel Jost

given: Daniel

family: Degrange

full_name: Hervé Degrange

given: Hervé

family: Verret

full_name: Catherine Verret

given: Catherine

family: Hersan

full_name: Olivier Hersan

given: Olivier

family: Banville

full_name: Isabelle L. Banville

given: Isabelle L.

family: Chapman

full_name: Fred W. Chapman

given: Fred W.

family: Lank

full_name: Paula Lank

given: Paula

family: Petit

full_name: Jean Luc Petit

given: Jean Luc

family: Fuilla

full_name: Claude Fuilla

given: Claude

family: Migliani

full_name: René Migliani

given: René

family: Carpentier

full_name: Jean Pierre Carpentier

given: Jean Pierre

journal_name: Circulation

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: DEFI 2005

lead_sponsor: Fire Brigade Of Paris Emergency Medicine Dept

location_facility: Fire Brigade of Paris Emergency medicine department

intervention_type: Other

lead_sponsor_type: industriel


title: Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

acronym: PRO-PULSé

summary: The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.

ReferenceCitation: Bouillanne O, Neveux N, Nicolis I, Curis E, Cynober L, Aussel C. Long-lasting improved amino acid bioavailability associated with protein pulse feeding in hospitalized elderly patients: a randomized controlled trial. Nutrition. 2014 May;30(5):544-50. doi: 10.1016/j.nut.2013.10.006. Epub 2013 Oct 14.

family: Bouillanne

full_name: Olivier Bouillanne

family: Neveux

full_name: Nathalie Neveux

given: Nathalie

family: Nicolis

full_name: Ioannis Nicolis

given: Ioannis

family: Curis

full_name: Emmanuel Curis

given: Emmanuel

family: Cynober

full_name: Luc Cynober

given: Luc

family: Aussel

full_name: Christian Aussel

given: Christian

journal_name: Nutrition

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Long-lasting improved amino acid bioavailability associated with protein pulse feeding in hospitalized elderly patients: A randomized controlled trial

ReferenceCitation: Bouillanne O, Curis E, Hamon-Vilcot B, Nicolis I, Chrétien P, Schauer N, Vincent JP, Cynober L, Aussel C. Impact of protein pulse feeding on lean mass in malnourished and at-risk hospitalized elderly patients: a randomized controlled trial. Clin Nutr. 2013 Apr;32(2):186-92. doi: 10.1016/j.clnu.2012.08.015. Epub 2012 Aug 30.

family: Hamon-Vilcot

full_name: Brigitte Hamon-Vilcot

given: Brigitte

family: Chrétien

full_name: Pascale Chrétien

given: Pascale

family: Schauer

full_name: Nathalie Schauer

family: Vincent

full_name: Jean-Pierre Vincent

given: Jean-Pierre

journal_name: Clinical Nutrition

title: Impact of protein pulse feeding on lean mass in malnourished and at-risk hospitalized elderly patients: A randomized controlled trial

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Dietary Supplement


title: Prospective, Randomized Study on Two Parallel Groups Comparing Dopexamine and Norepinephrine in Combination to Epinephrine Alone on Systemic and Pulmonary Hemodynamics, Gastric Mucosal Perfusion, and Oxidative Stress in Septic Shock

summary:
In septic shock, when volume resuscitation fails to restore mean arterial pressure, catecholamines such as dopamine, dobutamine, epinephrine, or norepinephrine are used, either alone or in combination. Although they allow hemodynamic success to be obtained, they can leave some regional blood flows impaired, especially the hepatosplanchnic perfusion, which contributes to multiple organ failure.

Dopexamine is a structural and synthetic analog of dopamine that exerts systemic and gut vasodilation and stimulates cardiac contraction. In experimental models, dopexamine has been shown to exert anti-inflammatory properties and to protect the hepatic ultra structure. The combination of dopexamine and norepinephrine could therefore constitute an interesting alternative in treating septic shock patients. This study will test the efficacy (on gastric mucosal blood flow, hepatic damage and oxidative stress) and safety of the combination of dopexamine and norepinephrine (compared to those of epinephrine alone) in the treatment of patients with septic shock.

ReferenceCitation: Schmidt W, Häcker A, Gebhard MM, Martin E, Schmidt H. Dopexamine attenuates endotoxin-induced microcirculatory changes in rat mesentery: role of beta2 adrenoceptors. Crit Care Med. 1998 Oct;26(10):1639-45.

ReferenceCitation: Tighe D, Moss R, Heywood G, al-Saady N, Webb A, Bennett D. Goal-directed therapy with dopexamine, dobutamine, and volume expansion: effects of systemic oxygen transport on hepatic ultrastructure in porcine sepsis. Crit Care Med. 1995 Dec;23(12):1997-2007.

ReferenceCitation: Seguin P, Laviolle B, Guinet P, Morel I, Mallédant Y, Bellissant E. Dopexamine and norepinephrine versus epinephrine on gastric perfusion in patients with septic shock: a randomized study [NCT00134212]. Crit Care. 2006 Feb;10(1):R32.


title: Proportional Ventilation and Ventilatory Synchronism

summary: Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. The second is the pressure support ventilation during which the gas flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the first mode allows a better synchronism.

ReferenceCitation: Ganne O, Abisseror M, Menault P, Malhière S, Chambost V, Charpiat B, Ganne C, Viale JP. Low-dose ketamine failed to spare morphine after a remifentanil-based anaesthesia for ear, nose and throat surgery. Eur J Anaesthesiol. 2005 Jun;22(6):426-30.

ReferenceCitation: Méchet I, Lhuillier F, Blanchet MC, Pouyet M, Viale JP, Goudable J, Annat G, Scoazec JY, Boillot O, Liotard D, Merle E, Delafosse B. Liver function during extracorporeal whole liver perfusion in a pig model of acute ischemic liver failure. ASAIO J. 2004 Sep-Oct;50(5):503-11.


title: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors

summary: In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.

ReferenceCitation: Aractingi S, Kanitakis J, Euvrard S, Le Danff C, Peguillet I, Khosrotehrani K, Lantz O, Carosella ED. Skin carcinoma arising from donor cells in a kidney transplant recipient. Cancer Res. 2005 Mar 1;65(5):1755-60.

ReferenceCitation: Martinez JC, Otley CC, Euvrard S, Arpey CJ, Stasko T; International Transplant-Skin Cancer Collaborative. Complications of systemic retinoid therapy in organ transplant recipients with squamous cell carcinoma. Dermatol Surg. 2004 Apr;30(4 Pt 2):662-6.

ReferenceCitation: Dantal J, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, Del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra A, Hofbauer GFL, Kamar N, Pouteil-Noble C, Kanitakis J, Roux A, Decullier E, Euvrard S; TUMORAPA Study Group. Sirolimus for Secondary Prevention of Skin Cancer in Kidney Transplant Recipients: 5-Year Results. J Clin Oncol. 2018 Sep 1;36(25):2612-2620. doi: 10.1200/JCO.2017.76.6691. Epub 2018 Jul 17.

name: Jacques Dantal and Anabelle Brocard, Nantes University Hospital, Nantes; Emmanuel Morelon, Claire Pouteil-Noble, Jean Kanitakis, and Sylvie Euvrard, Hospices Civils de Lyon, Edouard Herriot Hospital Group; Adeline Roux and Evelyne Decullier, Hospices Civils de Lyon, Unité de Recherche Clinique, Lyon; Lionel Rostaing and Nassim Kamar, Toulouse University Hospital, Toulouse; Valérie Chatelet and Anne Dompmartin, University Hospital of Caen, Caen; Michèle Kessler, University Hospital of Nancy, Vandœuvre-lès...

family: Dantal

full_name: Jacques Dantal

given: Jacques

family: Morelon

full_name: Emmanuel Morelon

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Goffin

full_name: Eric Goffin

given: Eric

family: Brocard

full_name: Anabelle Brocard

given: Anabelle

family: Tromme

full_name: Isabelle Tromme

given: Isabelle

family: Broeders

full_name: Nilufer Broeders

given: Nilufer

family: del Marmol

full_name: Véronique del Marmol

given: Véronique

family: Chatelet

full_name: Valérie Chatelet

given: Valérie

family: Dompmartin

full_name: Anne Dompmartin

given: Anne

family: Kessler

full_name: Michèle Kessler

given: Michèle

family: Serra

full_name: Andreas Serra

given: Andreas

family: Hofbauer

full_name: Günther F.L. Hofbauer

given: Günther F.L.

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Pouteil-Noble

full_name: Claire Pouteil-Noble

given: Claire

family: Kanitakis

full_name: Jean Kanitakis

given: Jean

family: Roux

full_name: Adeline Roux

given: Adeline

family: Decullier

full_name: Evelyne Decullier

given: Evelyne

family: Euvrard

full_name: Sylvie Euvrard

given: Sylvie

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Euvrard S, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra AL, Hofbauer GF, Pouteil-Noble C, Campistol JM, Kanitakis J, Roux AS, Decullier E, Dantal J; TUMORAPA Study Group. Sirolimus and secondary skin-cancer prevention in kidney transplantation. N Engl J Med. 2012 Jul 26;367(4):329-39. doi: 10.1056/NEJMoa1204166.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Sirolimus and Secondary Skin-Cancer Prevention in Kidney Transplantation

location_facility: Hôpital Edouard Herriot - Service de Dermatologie


title: Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles. Assessment of Efficiency of Botulinum Toxin on Spasticity in Agonist and Antagonist Muscles Using Clinical Assessment and Gait Analysis in Cerebral Palsy Children: Rectus Femoris and Semitendinosus

summary: The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.

location_facility: Hôpital Edouard Herriot - Pavillon T bis


title: Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless

summary:
The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.

One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.

Patients will be reviewed at 2, 6 and 12 months.

ReferenceCitation: Demey G, Servien E, Pinaroli A, Lustig S, Aït Si Selmi T, Neyret P. The influence of femoral cementing on perioperative blood loss in total knee arthroplasty: a prospective randomized study. J Bone Joint Surg Am. 2010 Mar;92(3):536-41. doi: 10.2106/JBJS.H.01159.

family: Demey

full_name: Guillaume Demey

given: Guillaume

family: Servien

full_name: Elvire Servien

given: Elvire

family: Pinaroli

full_name: Alban Pinaroli

given: Alban

family: Lustig

full_name: Sébastien Lustig

given: Sébastien

family: Si Selmi

full_name: Tarik Aït Si Selmi

given: Tarik Aït

family: Neyret

full_name: Philippe Neyret

given: Philippe

journal_name: The Journal of Bone and Joint Surgery-American Volume

title: The Influence of Femoral Cementing on Perioperative Blood Loss in Total Knee Arthroplasty


title: Comparison of the Classical Rt-PA Procedure (0.9mg/kg Over 60 Minutes) With a Longer Procedure With Lower Dose (0.8mg/kg Over 90 Minutes) in Acute Ischemic Stroke

summary:
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.

Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion".

This is a study of the outcome at 90 days.


title: Cognitive Therapy Versus Supportive Therapy in Borderline Personality Disorder

summary:
This is a randomised trial comparing cognitive therapy and supportive therapy administered along one year in borderline personality disorder. The follow-up is one year after treatments end.

The therapists were the same in the two groups. Patients received one session a week during six months and one session every two weeks during the next six months

ReferenceCitation: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2.

name: Psychiatric Research Unit; Psychiatry of Region Zealand; Slagelse Denmark

name: Child and Adolescent Psychiatric Department; Region Zealand; Roskilde Denmark

name: Department of Psychology; University of Southern Denmark; Odense Denmark

family: Storebø

full_name: Ole Jakob Storebø

given: Ole Jakob

name: Department of Psychiatry and Psychotherapy; University Medical Center Mainz; Mainz Germany

family: Stoffers-Winterling

full_name: Jutta M Stoffers-Winterling

given: Jutta M

name: Department of Forensic Psychiatry, Center for Neurology; University Rostock; Rostock Germany

family: Völlm

full_name: Birgit A Völlm

given: Birgit A

name: Psychiatric Research Unit; Region Zealand Psychiatry; Slagelse Denmark

name: Department of Psychology, Faculty of Health Science; University of Southern Denmark; Odense Denmark

family: Kongerslev

full_name: Mickey T Kongerslev

given: Mickey T

family: Mattivi

full_name: Jessica T Mattivi

given: Jessica T

family: Jørgensen

full_name: Mie S Jørgensen

given: Mie S

family: Faltinsen

full_name: Erlend Faltinsen

given: Erlend

family: Todorovac

full_name: Adnan Todorovac

given: Adnan

name: Duncan MacMillan House; Nottinghamshire Healthcare NHS Foundation Trust; Nottingham UK

name: Institute of Mental Health; Department of Psychiatry & Applied Psychology; Nottingham UK

family: Sales

full_name: Christian P Sales

given: Christian P

family: Callesen

full_name: Henriette E Callesen

given: Henriette E

name: Leibniz Institute for Resilience Research (LIR); Mainz Germany

family: Lieb

full_name: Klaus Lieb

given: Klaus

family: Simonsen

full_name: Erik Simonsen

given: Erik

bso_classification: Social sciences

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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

repository_institution: University of Nottingham - Repository@Nottingham

url: https://nottingham-repository.worktribe.com/916765/1/storeb psychol borderline protocol cochrane 2018.pdf

url_for_landing_page: https://nottingham-repository.worktribe.com/916765/1/Storeb Psychol borderline protocol Cochrane 2018.pdf

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

intervention_type: Behavioral


title: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

summary:
PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis.

MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS), contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct costs of each imaging method were calculated in 2 university medical centers. Eight hypothetical models were studied with DUS considered as the first-line imaging method and either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion was the number of potential avoided strokes for each strategy and for 1000 patients.


title: Kinetics of the Finasteride Prostate Induced Apoptosis

summary: The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a surgical procedure because of low tract urinary symptoms are randomly attributed to one of five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of the procedure. Prostate histological fragments are conditioned for molecular and histologic studies.


title: A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia

summary: The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods are clinically effective. Patients receive a two-page information leaflet about the trial and sign an informed consent. After the first evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12 sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After three months the waiting list is randomized to VRT or CBT. The follow-up is one year from entry into the active part of the trial.

primary_purpose: Educational/Counseling/Training


title: Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

summary: Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.


title: Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

summary:
In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant.

The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell.

The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).


title: IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

summary:
The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.

These factors can be of different types:

Environmental factors (sodium or alcohol intake);
Morphological (height, weight, body mass index, body surface area);
Initial blood pressure;
Electrocardiogram (ECG) parameters of left ventricular hypertrophy;
Biological parameters as the activity level of the renin angiotensin aldosterone system;
Genetic polymorphisms.

ReferenceCitation: Gueyffier F, Subtil F, Bejan-Angoulvant T, Zerbib Y, Baguet JP, Boivin JM, Mercier A, Leftheriotis G, Gagnol JP, Fauvel JP, Giraud C, Bricca G, Maucort-Boulch D, Erpeldinger S; IDEAL Trial Group. Can we identify response markers to antihypertensive drugs? First results from the IDEAL Trial. J Hum Hypertens. 2015 Jan;29(1):22-7. doi: 10.1038/jhh.2014.29. Epub 2014 Apr 17.

family: Gueyffier

full_name: F Gueyffier

given: F

family: Subtil

full_name: F Subtil

family: Bejan-Angoulvant

full_name: T Bejan-Angoulvant

given: T

family: Zerbib

full_name: Y Zerbib

given: Y

family: Baguet

full_name: J P Baguet

given: J P

family: Boivin

full_name: J M Boivin

given: J M

family: Mercier

full_name: A Mercier

given: A

family: Leftheriotis

full_name: G Leftheriotis

given: G

family: Gagnol

full_name: J P Gagnol

family: Fauvel

full_name: J P Fauvel

family: Giraud

full_name: C Giraud

given: C

family: Bricca

full_name: G Bricca

family: Maucort-Boulch

full_name: D Maucort-Boulch

given: D

family: Erpeldinger

full_name: S Erpeldinger

given: S

journal_name: Journal of Human Hypertension

publisher_dissemination: Springer

publisher_group: Springer


title: Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

acronym: AMNIOECHANGE

summary: Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted at the level of the abdominal hole. The bowel is therefore submitted to different injuries partly attributable to the contact with amniotic fluid contaminated by digestive compounds and inducing an inflammatory reaction. Experimental studies on animal models and preliminary data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would improve the outcome of theses fetuses and then neonates.

ReferenceCitation: Luton D, Mitanchez D, Winer N, Muller F, Gallot D, Perrotin F, Jouannic JM, Bretelle F, de Lagausie P, Ville Y, Guibourdenche J, Oury JF, Alberti C, Benachi A. A randomised controlled trial of amnioexchange for fetal gastroschisis. BJOG. 2019 Sep;126(10):1233-1241. doi: 10.1111/1471-0528.15804. Epub 2019 May 20.

name: Department of Obstetrics and Gynaecology AP‐HP Bichat Hospital Paris France

name: Department of Obstetrics and Gynaecology AP‐HP Bichat‐Claude Bernard Hospital Paris France

name: Université Paris VII Paris Diderot Sorbonne Paris Cité Paris France

name: INSERM U1141 Robert‐Debré Hospital Paris France

family: Luton

full_name: D Luton

name: Department of Neonatal Pediatrics AP‐HP GHUEP Armand Trousseau Hospital Paris France

name: Faculty of Medicine Sorbonne University Paris France

family: Mitanchez

full_name: D Mitanchez

name: Department of Obstetrics and Gynaecology University Hospital of Nantes CIC Mère enfant Nantes UMR 1280 INRA Physiologie des Adaptations Nutritionnelles Nantes France

family: Winer

full_name: N Winer

given: N

name: Department of Biochemistry and Hormonology AP‐HP Robert Debré Hospital Paris France

family: Muller

full_name: F Muller

name: Department of Obstetrics and Gynaecology CHU de Clermont‐Ferrand – Hôpital d'Estaing Auvergne University Clermont‐Ferrand France

family: Gallot

full_name: D Gallot

name: Department of Obstetrics and Gynaecology CHRU de Tours François Rabelais University Tours France

family: Perrotin

full_name: F Perrotin

name: Department of Obstetrics and Gynaecology Faculty of Medicine AP‐HP Armand Trousseau Hospital Sorbonne University Paris France

family: Jouannic

full_name: J‐M Jouannic

given: J‐M

name: Department of Obstetrics and Gynaecology CHU de Marseille APHM Aix Marseille University Marseille France

family: Bretelle

full_name: F Bretelle

name: Department of Paediatrics Surgery AP‐HP Robert Debré Hospital Paris France

family: Lagausie

full_name: P Lagausie

given: P

name: Department of Obstetrics and Gynaecology AP‐HP Necker‐Enfants Malades Paris Descartes University Paris France

family: Ville

full_name: Y Ville

family: Guibourdenche

full_name: J Guibourdenche

given: J

name: Department of Obstetrics and Gynaecology AP‐HP Robert Debré Hospital Paris France

family: Oury

full_name: J‐F Oury

given: J‐F

name: AP‐HP, Inserm Univ. Paris Diderot Univ. Sorbonne Paris Cité Robert Debré Hospital CIC 1426 UMR‐S 1123 Paris France

family: Alberti

full_name: C Alberti

name: Department of Obstetrics and Gynaecology AP‐HP Antoine Béclère Hospital Paris‐Sud University Clamart France

family: Benachi

full_name: A Benachi

journal_name: BJOG: An International Journal of Obstetrics & Gynaecology


title: Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas

acronym: VEINART

summary:
Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. Currently, several studies have already shown the existence of a good correlation of pH and bicarbonates level between a venous and arterial sample. Thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas.

Due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. Indeed, among the university hospitals affiliated to the Paris Diderot University, the emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases. Demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices.

The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.

primary_purpose: Health Services Research

ReferenceCitation: Chauvin A, Javaud N, Ghazali A, Curac S, Altar A, Ali T, Beguin N, Bellier J, Coupier A, Delsarte L, Dreyfuss D, Kheirbek N, Oudar C, Stordeur Y, Weiss M, Gaudry S, Lambert J, Roux D. Reducing pain by using venous blood gas instead of arterial blood gas (VEINART): a multicentre randomised controlled trial. Emerg Med J. 2020 Dec;37(12):756-761. doi: 10.1136/emermed-2019-209287. Epub 2020 Aug 5.

family: Chauvin

full_name: Anthony Chauvin

given: Anthony

family: Javaud

full_name: Nicolas Javaud

given: Nicolas

family: Ghazali

full_name: Aiham Ghazali

given: Aiham

family: Curac

full_name: Sonja Curac

given: Sonja

family: Altar

full_name: Adrien Altar

given: Adrien

family: Ali

full_name: Talina Ali

given: Talina

family: Beguin

full_name: Nora Beguin

given: Nora

family: Bellier

full_name: Julien Bellier

given: Julien

family: Coupier

full_name: Antoine Coupier

given: Antoine

family: Delsarte

full_name: Laura Delsarte

given: Laura

family: Dreyfuss

full_name: Dora Dreyfuss

given: Dora

family: Kheirbek

full_name: Nour Kheirbek

given: Nour

family: Oudar

full_name: Clara Oudar

given: Clara

family: Stordeur

full_name: Yoann Stordeur

given: Yoann

family: Weiss

full_name: Morgane Weiss

given: Morgane

family: Gaudry

full_name: Stephane Gaudry

given: Stephane

family: Lambert

full_name: Jerome Lambert

given: Jerome

family: Roux

full_name: Damien Roux

given: Damien

journal_name: Emergency Medicine Journal

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
Hôpital Bichat
Hôpital Lariboisière
Hôpital Louis Mourier
Hôpital Beaujon


title: A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract

summary: This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Paramedical Evaluation of a Standardize Procedure of Selection of Serious Brain-injured Patients in Therapeutic Abstention to a Brain Death State in the First 48h

acronym: PREMORENCE

summary: The purpose of this study is to make a paramedical evaluation of a selection procedure of serious brain-injured patient in therapeutic abstention to a brain death state within 48 hours.

ipd_sharing_description: no plan

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Départemental de Vendée Les Oudairies

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

summary:
This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.

The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.


title: Randomized Trial of Treatment Strategy for Chemotherapy in Colorectal Cancer, FFCD 2000-05

summary: The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.

ReferenceCitation: Pénichoux J, Michiels S, Bouché O, Etienne PL, Texereau P, Auby D, Rougier P, Ducreux M, Pignon JP; FFCD 2000-05 trial investigators. Taking into account successive treatment lines in the analysis of a colorectal cancer randomised trial. Eur J Cancer. 2013 May;49(8):1882-8. doi: 10.1016/j.ejca.2013.02.006. Epub 2013 Mar 13.

family: Pénichoux

full_name: J. Pénichoux

given: J.

family: Michiels

full_name: S. Michiels

given: S.

family: Bouché

full_name: O. Bouché

given: O.

family: Etienne

full_name: P.-L. Etienne

family: Texereau

full_name: P. Texereau

given: P.

family: Auby

full_name: D. Auby

given: D.

family: Rougier

full_name: P. Rougier

family: Ducreux

full_name: M. Ducreux

given: M.

family: Pignon

full_name: J.-P. Pignon

journal_name: European Journal of Cancer

ReferenceCitation: Ducreux M, Malka D, Mendiboure J, Etienne PL, Texereau P, Auby D, Rougier P, Gasmi M, Castaing M, Abbas M, Michel P, Gargot D, Azzedine A, Lombard-Bohas C, Geoffroy P, Denis B, Pignon JP, Bedenne L, Bouché O; Fédération Francophone de Cancérologie Digestive (FFCD) 2000-05 Collaborative Group. Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000-05): an open-label, randomised, phase 3 trial. Lancet Oncol. 2011 Oct;12(11):1032-44. doi: 10.1016/S1470-2045(11)70199-1. Epub 2011 Sep 6.

full_name: Michel Ducreux

given: Michel

family: Malka

full_name: David Malka

given: David

family: Mendiboure

full_name: Jean Mendiboure

given: Jean

full_name: Pierre-Luc Etienne

given: Pierre-Luc

full_name: Patrick Texereau

given: Patrick

full_name: Dominique Auby

given: Dominique

full_name: Philippe Rougier

given: Philippe

family: Gasmi

full_name: Mohamed Gasmi

given: Mohamed

family: Castaing

full_name: Marine Castaing

given: Marine

family: Abbas

full_name: Moncef Abbas

given: Moncef

family: Michel

full_name: Pierre Michel

given: Pierre

family: Gargot

full_name: Dany Gargot

given: Dany

family: Azzedine

title: Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000–05): an open-label, randomised, phase 3 trial


title: Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study

acronym: Preva-CTEPH

summary:
The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study.

The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.

ReferenceCitation: Guérin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guégan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.

family: Guérin

full_name: Laurent Guérin

given: Laurent

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Parent

full_name: Florence Parent

given: Florence

family: Revel

full_name: Marie-Pierre Revel

given: Marie-Pierre

family: Gillaizeau

full_name: Florence Gillaizeau

family: Planquette

full_name: Benjamin Planquette

given: Benjamin

family: Pontal

full_name: Daniel Pontal

given: Daniel

family: Guégan

full_name: Marie Guégan

given: Marie

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Meyer

full_name: Guy Meyer

given: Guy

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Ende-Verhaar YM, Cannegieter SC, Vonk Noordegraaf A, Delcroix M, Pruszczyk P, Mairuhu AT, Huisman MV, Klok FA. Incidence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: a contemporary view of the published literature. Eur Respir J. 2017 Feb 23;49(2). pii: 1601792. doi: 10.1183/13993003.01792-2016. Print 2017 Feb.

family: Ende-Verhaar

full_name: Yvonne M. Ende-Verhaar

given: Yvonne M.

family: Cannegieter

full_name: Suzanne C. Cannegieter

given: Suzanne C.

family: Vonk Noordegraaf

full_name: Anton Vonk Noordegraaf

given: Anton

family: Delcroix

full_name: Marion Delcroix

given: Marion

family: Pruszczyk

full_name: Piotr Pruszczyk

given: Piotr

family: Mairuhu

full_name: Albert T.A. Mairuhu

given: Albert T.A.

family: Huisman

full_name: Menno V. Huisman

given: Menno V.

family: Klok

full_name: Frederikus A. Klok

given: Frederikus A.

journal_name: European Respiratory Journal

ipd_sharing_description: Individual patient level meta-analysis for cumulative incidence rate and risk factors of CTEPH after PE

location_facility:
Hôpital Nord
CHU Jean Minjoz
Hôpital européen Georges-Pompidou
La Cavale Blanche


title: Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)

summary: The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).

ReferenceCitation: Soulié C, Assoumou L, Ghosn J, Duvivier C, Peytavin G, Ait-Arkoub Z, Molina JM, Costagliola D, Katlama C, Calvez V, Marcelin AG. Nucleoside reverse transcriptase inhibitor-sparing regimen (nonnucleoside reverse transcriptase inhibitor + protease inhibitor) was more likely associated with resistance comparing to nonnucleoside reverse transcriptase inhibitor or protease inhibitor + nucleoside reverse transcriptase inhibitor in the randomized ANRS 121 trial. AIDS. 2009 Jul 31;23(12):1605-8. doi: 10.1097/QAD.0b013e32832d9031.

family: Soulié

full_name: Cathia Soulié

given: Cathia

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

family: Ghosn

full_name: Jade Ghosn

given: Jade

family: Duvivier

full_name: Claudine Duvivier

given: Claudine

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

family: Ait-Arkoub

full_name: Zaina Ait-Arkoub

given: Zaina

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Katlama

full_name: Christine Katlama

given: Christine

family: Calvez

full_name: Vincent Calvez

given: Vincent

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

journal_name: AIDS

ReferenceCitation: Duvivier C, Kolta S, Assoumou L, Ghosn J, Rozenberg S, Murphy RL, Katlama C, Costagliola D; ANRS 121 Hippocampe study group. Greater decrease in bone mineral density with protease inhibitor regimens compared with nonnucleoside reverse transcriptase inhibitor regimens in HIV-1 infected naive patients. AIDS. 2009 Apr 27;23(7):817-24. doi: 10.1097/QAD.0b013e328328f789.

family: Kolta

full_name: Sami Kolta

given: Sami

family: Rozenberg

full_name: Sylvie Rozenberg

given: Sylvie

family: Murphy

full_name: Robert L Murphy

given: Robert L

ReferenceCitation: Duvivier C, Ghosn J, Assoumou L, Soulié C, Peytavin G, Calvez V, Génin MA, Molina JM, Bouchaud O, Katlama C, Costagliola D; ANRS 121 study group. Initial therapy with nucleoside reverse transcriptase inhibitor-containing regimens is more effective than with regimens that spare them with no difference in short-term fat distribution: Hippocampe-ANRS 121 Trial. J Antimicrob Chemother. 2008 Oct;62(4):797-808. doi: 10.1093/jac/dkn278. Epub 2008 Jul 18.

location_facility: Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere


title: Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment

acronym: CQR-F

summary: The purpose of this study is to develop a French language version of the Compliance-Questionnaire-Rheumatology for use in French and Francophone rheumatology services

location_facility:
CHU Nimes
CHU Toulouse
CHU Bordeaux
CHRU Montpellier


title: Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI

summary:
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.

Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.

This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.

location_facility: Service d'Hépato-Gastroentérologie Hopital Hotel Dieu


title: Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and C Hepatitis Who Failed to Active Treatment for HCV. ANRSHC12 Fibrostop

summary: The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.

ReferenceCitation: Chapplain JM, Bellissant E, Guyader D, Molina JM, Poizot-Martin I, Perré P, Pialoux G, Turlin B, Mouchel C, Renault A, Michelet C; ANRS HC-12 Study Group. The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: a randomized controlled trial. J Infect. 2013 Oct;67(4):313-21. doi: 10.1016/j.jinf.2013.05.007. Epub 2013 Jun 22.

family: Chapplain

full_name: Jean-Marc Chapplain

given: Jean-Marc

family: Bellissant

full_name: Eric Bellissant

given: Eric

family: Guyader

full_name: Dominique Guyader

family: Poizot-Martin

full_name: Isabelle Poizot-Martin

given: Isabelle

family: Perré

full_name: Philippe Perré

given: Philippe

family: Pialoux

full_name: Gilles Pialoux

family: Turlin

full_name: Bruno Turlin

given: Bruno

family: Mouchel

full_name: Catherine Mouchel

given: Catherine

family: Renault

full_name: Alain Renault

given: Alain

family: Michelet

full_name: Christian Michelet

given: Christian

journal_name: Journal of Infection

title: The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: A randomized controlled trial

location_facility: Service de Maladies Infectieuses et de Réanimation Médicale


title: Efficacy and Safety of Regimens Restricted to a Combination of Two Boosted Protease Inhibitors as Potent Antiretroviral Therapy in HIV-1 Infected Patients. ANRS 127 2IP

summary: The purpose of this study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.

ReferenceCitation: Landman R, Capitant C, Descamps D, Chazallon C, Peytavin G, Katlama C, Pialoux G, Bentata M, Brun-Vézinet F, Aboulker JP, Yéni P; ANRS 127 Study Group. Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. J Antimicrob Chemother. 2009 Jul;64(1):118-25. doi: 10.1093/jac/dkp146. Epub 2009 May 6.

family: Landman

full_name: R. Landman

given: R.

family: Capitant

full_name: C. Capitant

given: C.

family: Descamps

full_name: D. Descamps

given: D.

family: Chazallon

full_name: C. Chazallon

family: Peytavin

full_name: G. Peytavin

given: G.

full_name: C. Katlama

full_name: G. Pialoux

family: Bentata

full_name: M. Bentata

given: M.

family: Brun-Vezinet

full_name: F. Brun-Vezinet

given: F.

family: Aboulker

full_name: J.-P. Aboulker

family: Yeni

full_name: P. Yeni

given: P.

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility: Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard


title: Randomized Open Label Study Assessing the Antiviral Activity, Toxicity and Pharmacologic Interaction of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir as Part of a Salvage Regimen in HIV Infected Patients With Multiple Treatment Failures (ANRS 107 Trial PUZZLE 2)

summary: This trial is aimed at studying the antiviral activity, toxicity and pharmacokinetic (PK) interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to HIV patients with multiple failure, under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir.

ReferenceCitation: Piketty C, Gérard L, Chazallon C, Calvez V, Clavel F, Taburet AM, Girard PM, Aboulker JP; ANRS 107 Puzzle 2 Study Group. Virological and immunological impact of non-nucleoside reverse transcriptase inhibitor withdrawal in HIV-infected patients with multiple treatment failures. AIDS. 2004 Jul 2;18(10):1469-71.

ReferenceCitation: Taburet AM, Piketty C, Chazallon C, Vincent I, Gérard L, Calvez V, Clavel F, Aboulker JP, Girard PM. Interactions between atazanavir-ritonavir and tenofovir in heavily pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother. 2004 Jun;48(6):2091-6.

location_facility: Service d'Immunologie clinique Hopital Europeen Georges Pompidou


title: Phase I Study Evaluating the Systemic and Mucosal Safety and Immunogenicity of a Recombinant HIV-1 Gp 160 (MN/LAI) Administered by Transmucosal (Nasal or Vaginal) Routes, Alone or Formulated With DC-Chol, in HIV Negative Volunteers (ANRS VAC14)

summary: It is probable that a mucosal approach is necessary for a prophylactic HIV vaccine protecting against sexually transmitted infection. Mucosal immune responses have been almost non-existent in trials of HIV vaccine candidates in which the antigen was delivered systemically. This study will test the safety and immune response of a recombinant HIV-1gp160 by nasal and mucosal routes alone or formulated with DC-Chol in healthy volunteers.

primary_purpose: Prevention


title: Clinical Evolution of Patients Suffering From Lower Limb Rheumatological Conditions 6 Months After Spa Treatment

acronym: CONTREXEVILLE

summary:
Primary outcome measure: measuring the effect of spa treatment in patients suffering from lower limb osteoarthritis or any other lower limb rheumatological condition.

Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS) or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) improvement of at least 9 points (minimal clinically important difference), 6 months after enrollment.

Secondary outcome measures:

Measuring the effect of spa treatment in patients with concomitant chronic lower back pain.

Percentage of patients presenting clinical benefits according to the EIFEL score, with a decrease of at least 5 points, 6 months after enrollment.

Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6 months after spa treatment.
Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment and 6 months after spa treatment.
Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment and 6 months after spa treatment.
Impact of spa treatment on the patient's metabolism. Height and weight (BMI calculation), blood pressure and heart rate measured at enrollment and throughout the follow-up.
8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D) questionnaires at enrollment, 3 months and 6 months.

9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and 6 months.

10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the medical visit at enrollment, 3 months and 6 months.

11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more precise time frame of the treatment's effect.

ReferenceCitation: Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

ReferenceCitation: Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8.

ReferenceCitation: Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.

ReferenceCitation: Constant F, Guillemin F, Collin JF, Boulangé M. Use of spa therapy to improve the quality of life of chronic low back pain patients. Med Care. 1998 Sep;36(9):1309-14.

ReferenceCitation: Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82.

ReferenceCitation: Evcik D, Kizilay B, Gökçen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. Epub 2002 Mar 29.

ReferenceCitation: Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902.

ReferenceCitation: Guillemin F, Constant F, Collin JF, Boulange M. Short and long-term effect of spa therapy in chronic low back pain. Br J Rheumatol. 1994 Feb;33(2):148-51.

ReferenceCitation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31.

ReferenceCitation: Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I. Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis. 1992 Jun;51(6):820-2.

ReferenceCitation: Levy E, Ferme A, Perocheau D, Bono I. [Socioeconomic costs of osteoarthritis in France]. Rev Rhum Ed Fr. 1993 Jul;60(6 Pt 2):63S-67S. French.

ReferenceCitation: Driscoll T, Jacklyn G, Orchard J, Passmore E, Vos T, Freedman G, Lim S, Punnett L. The global burden of occupationally related low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):975-81. doi: 10.1136/annrheumdis-2013-204631. Epub 2014 Mar 24.

ReferenceCitation: Leplège A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23.

ReferenceCitation: Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9.

ReferenceCitation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. Epub 2004 Jun 18.

ReferenceCitation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. Epub 2004 May 6.

ReferenceCitation: van Tubergen A, Landewé R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, Thè HG, van der Linden S. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2001 Oct;45(5):430-8.

ReferenceCitation: Van Tubergen A, Boonen A, Landewé R, Rutten-Van Mölken M, Van Der Heijde D, Hidding A, Van Der Linden S. Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2002 Oct 15;47(5):459-67.

ReferenceCitation: Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. Review.

ReferenceCitation: Woodforde JM, Merskey H. Some relationships between subjective measures of pain. J Psychosom Res. 1972 Jun;16(3):173-8.

ReferenceCitation: Marty M, Courvoisier D, Foltz V, Mahieu G, Demoulin C, Gierasimowicz A, Norberg M, de Goumoëns P, Cedraschi C, Rozenberg S, Genevay S; Section Rachis de la Société Française de Rhumatologie. How much does the Dallas Pain Questionnaire score have to improve to indicate that patients with chronic low back pain feel better or well? Eur Spine J. 2016 Jan;25(1):304-309. doi: 10.1007/s00586-015-3957-3. Epub 2015 Apr 23.

ReferenceCitation: Sun SF, Hsu CW, Lin HS, Liou IH, Chen YH, Hung CL. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety. J Bone Joint Surg Am. 2017 Mar 15;99(6):462-471. doi: 10.2106/JBJS.16.00469.

ReferenceCitation: Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis. Cochrane Database Syst Rev. 2000;(2):CD000518. Review. Update in: Cochrane Database Syst Rev. 2003;(4):CD000518.

ReferenceCitation: Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB. [French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Fr. 1993 May;60(5):335-41. French.

ReferenceCitation: Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4.

ReferenceCitation: Grotle M, Brox JI, Vøllestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine (Phila Pa 1976). 2004 Nov 1;29(21):E492-501.

ReferenceCitation: Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010 Sep;19(9):1484-94. doi: 10.1007/s00586-010-1353-6. Epub 2010 Apr 17.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

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

family: Forestier

full_name: R. Forestier

family: Desfour

full_name: H. Desfour

given: H.

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

journal_name: Annals of the Rheumatic Diseases

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

location_facility:
BAUER
Perrier Cornet
Conrozier
Jeanmaire


title: Study of the Immunological Efficacy of Using Subcutaneous Interleukin-2 (IL-2) in Antiretroviral Naïve HIV-1-Infected Subjects With a CD4 Cell Count Above 300/mm3. ANRS 119 Trial INTERSTART

summary: Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients under highly active antiretroviral therapy (HAART) with a CD4 cell count over 200/mm3, but its activity in patients without antiretroviral therapy is unknown. This study will test the efficacy and safety of IL-2 in naïve patients with a CD4 count between 300 and 500/m3.

ReferenceCitation: Molina JM, Levy Y, Fournier I, Hamonic S, Bentata M, Beck-Wirth G, Gougeon ML, Venet A, Madelaine I, Sereni D, Jeanblanc F, Boulet T, Simon F, Aboulker JP; Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 119 Interstart Study Team. Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119). J Infect Dis. 2009 Jul 15;200(2):206-15. doi: 10.1086/599989.

family: Molina

full_name: Jean‐Michel Molina

given: Jean‐Michel

family: Levy

full_name: Yves Levy

given: Yves

family: Fournier

full_name: Isabelle Fournier

family: Hamonic

full_name: Stephanie Hamonic

given: Stephanie

full_name: Michèle Bentata

given: Michèle

family: Beck‐Wirth

full_name: Genevieve Beck‐Wirth

given: Genevieve

family: Gougeon

full_name: Marie‐Lise Gougeon

given: Marie‐Lise

family: Venet

full_name: Alain Venet

family: Madelaine

full_name: Isabelle Madelaine

family: Sereni

full_name: Daniel Sereni

given: Daniel

family: Jeanblanc

full_name: François Jeanblanc

given: François

family: Boulet

full_name: Thomas Boulet

given: Thomas

family: Simon

full_name: François Simon

full_name: Jean‐Pierre Aboulker

given: Jean‐Pierre

journal_name: The Journal of Infectious Diseases

title: Interleukin‐2 before Antiretroviral Therapy in Patients with HIV Infection: A Randomized Trial (ANRS 119)


type: EudraCT Number

title: Evaluation of the Efficacy of Injections of Botulinic Toxin in Plantar Lesions of Patients Suffering From Localized Epidermolysis Bullosa Simplex : Double Blind Randomized Controlled Study.

acronym: EBTox

summary: The investigators hypothesize that palmar injections of botulinic toxin, via an inhibition of the sudation, would limit the occurrence of blisters in localized epidermolysis bullosa simplex (LEBS).

ReferenceCitation: Fine JD, Bruckner-Tuderman L, Eady RA, Bauer EA, Bauer JW, Has C, Heagerty A, Hintner H, Hovnanian A, Jonkman MF, Leigh I, Marinkovich MP, Martinez AE, McGrath JA, Mellerio JE, Moss C, Murrell DF, Shimizu H, Uitto J, Woodley D, Zambruno G. Inherited epidermolysis bullosa: updated recommendations on diagnosis and classification. J Am Acad Dermatol. 2014 Jun;70(6):1103-26. doi: 10.1016/j.jaad.2014.01.903. Epub 2014 Mar 29. Review.

ReferenceCitation: Sprecher E. Epidermolysis bullosa simplex. Dermatol Clin. 2010 Jan;28(1):23-32. doi: 10.1016/j.det.2009.10.003. Review.

ReferenceCitation: Langan SM, Williams HC. A systematic review of randomized controlled trials of treatments for inherited forms of epidermolysis bullosa. Clin Exp Dermatol. 2009 Jan;34(1):20-5. doi: 10.1111/j.1365-2230.2008.02789.x. Epub 2008 Sep 25. Review.

ReferenceCitation: Abitbol RJ, Zhou LH. Treatment of epidermolysis bullosa simplex, Weber-Cockayne type, with botulinum toxin type A. Arch Dermatol. 2009 Jan;145(1):13-5. doi: 10.1001/archdermatol.2008.546.

ReferenceCitation: Schwieger-Briel A, Chakkittakandiyil A, Lara-Corrales I, Aujla N, Lane AT, Lucky AW, Bruckner AL, Pope E. Instrument for scoring clinical outcome of research for epidermolysis bullosa: a consensus-generated clinical research tool. Pediatr Dermatol. 2015 Jan-Feb;32(1):41-52. doi: 10.1111/pde.12317. Epub 2014 Mar 20.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
University Hospital Nice
Saint-Louis Hospital - APHP
Hôpital Larrey - CHU Toulouse


title: A Randomized and Multicenter Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis

acronym: Lipiocis

summary: The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service d'Hépatologie Hôpital Saint Antoine


title: Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR

summary: Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

location_facility: Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades


title: Study of the Immunological Efficacy of Adding Subcutaneous Interleukin-2 (IL-2) to an Optimized Antiretroviral Regimen in HIV-1-infected Subjects Experiencing Therapeutic Failure on an Ongoing Antiretroviral Combination With a CD4 Cell Count ≤ 200/mm3 ANRS 123 Trial

summary: Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients with a CD4 cell count over 200/mm3, but its activity in patients with treatment failure and low CD4 cell counts is unknown. This study will test the efficacy and safety of IL-2 with an optimized antiretroviral regimen in patients with a CD4 count below 200/mm3 and a plasma viral load above 10,000 HIV RNA copies/ml.

location_facility: Hôpital Necker service des Maladies Infectieuses


title: Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

acronym: ECHOPAC

summary:
Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances.

A recent study on CT performance in suspected CAP found that 58% of classifications were modified by CT when compared with usual procedure. However, extended CT usage in CAP diagnosis is associated with many limitations :

availability in a majority of ED, delay, cost and irradiation, in particular In young patients.

Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training.

The Investigators aim to investigate LUS performances in clinically suspected CAP authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .

ReferenceCitation: Javaudin F, Marjanovic N, de Carvalho H, Gaborit B, Le Bastard Q, Boucher E, Haroche D, Montassier E, Le Conte P. Contribution of lung ultrasound in diagnosis of community-acquired pneumonia in the emergency department: a prospective multicentre study. BMJ Open. 2021 Sep 24;11(9):e046849. doi: 10.1136/bmjopen-2020-046849.

family: Javaudin

full_name: François Javaudin

family: Marjanovic

full_name: Nicolas Marjanovic

given: Nicolas

family: de Carvalho

full_name: Hugo de Carvalho

given: Hugo

family: Gaborit

full_name: Benjamin Gaborit

given: Benjamin

family: Le Bastard

full_name: Quentin Le Bastard

given: Quentin

family: Boucher

full_name: Estelle Boucher

given: Estelle

family: Haroche

full_name: Denis Haroche

given: Denis

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Le Conte

full_name: Philippe Le Conte

given: Philippe

journal_name: BMJ Open

lead_sponsor: Nantes University Hospital

location_facility:
La Roche Sur Yon Hospital
Nantes University Hospital
Poitiers University Hospital
Saint-Nazaire Hospital


title: Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients: a Pilot Clinical Study To Evaluate the aPplicability and the Safety of Urethral Perfusion Measurement With the IKORUS System

acronym: STEP UP

summary:
Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion. Thus, an approach incorporating tissue-perfusion based endpoints would represent a significant step up to guide optimal resuscitation of critically-ill patients and to reduce complications in high-risk surgery.

Current monitoring techniques, that complement systemic hemodynamics by focusing on regional perfusion, still lack the required user-friendliness and/or clinical relevance to be routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and oxygenation is suboptimal, and implementation of the above-mentioned approaches of resuscitation is still a challenge.

Urethral perfusion is likely to be early and significantly impaired during low-flow states and thus represents a good "candidate" as a surrogate site to assess the perfusion of visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler manner than "deeper" organs. Nowadays, no practical methods or devices are available to monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of urethral perfusion could fill this need and enable enhanced management of patients in Intensive Care Units (ICU) and Operating Rooms (OR).

The device consists of a modified Foley catheter equipped with a photoplethysmographic sensor: the IKORUS UP probe.

The probe will be used by intensivists or anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal surgery.

ReferenceCitation: Dépret F, Leone M, Duclos G, Futier E, Montagne M, Legrand M, Allaouchiche B. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients. J Clin Monit Comput. 2020 Oct;34(5):961-969. doi: 10.1007/s10877-019-00414-9. Epub 2019 Nov 6.

family: Dépret

full_name: François Dépret

family: Leone

full_name: Marc Leone

given: Marc

family: Duclos

full_name: Gary Duclos

given: Gary

family: Futier

full_name: Emmanuel Futier

family: Montagne

full_name: Maxime Montagne

given: Maxime

family: Legrand

full_name: Matthieu Legrand

given: Matthieu

family: Allaouchiche

full_name: Bernard Allaouchiche

given: Bernard

journal_name: Journal of Clinical Monitoring and Computing

lead_sponsor: Advanced Perfusion Diagnostics

location_facility:
Lyon Sud Hospital
Hospital Saint Louis
Hopital Nord Marseille
CHU Estaing