title: The Role of Personality in the Occurrence of Behavioural Disorders in Patients Suffering From Alzheimer Disease

acronym: PACO

summary: Alzheimer's disease is characterised by a loss of cognitive functions and behavioural problems as set out under the term "Behavioural and psychological symptoms of dementia (BPSD)". The impact of BPSD in everyday life has heavy consequences for the patient and their family. The precocity of incidence, the frequency and the intensity of the BPSD are associated with a rapid decline in cognitive functions, an alteration in the activities of daily living, and a decrease in the quality of life for both the patient and the helper, an increased risk of hospitalisation and of institutionalisation as well as an increase in the cost to the health system. A greater understanding of the risk factors for the occurence of the BPSD would better allow the detection of patients who are particularly at risk for BPSD, to anticipate the crisis situations by proposing early and adapted care, and to better target the medicinal therapies. Certain observational arguments or results of retrospective studies speak in favour of the role of the basic personality in the occurence of BPSD in Alzheimer's disease. The investigators propose to clarify this role through a prospective study.

ReferenceCitation: Rouch I, Dorey JM, Boublay N, Henaff MA, Dibie-Racoupeau F, Makaroff Z, Harston S, Benoit M, Barrellon MO, Fédérico D, Laurent B, Padovan C, Krolak-Salmon P; PACO group. Personality, Alzheimer's disease and behavioural and cognitive symptoms of dementia: the PACO prospective cohort study protocol. BMC Geriatr. 2014 Oct 10;14:110. doi: 10.1186/1471-2318-14-110.

family: Rouch

full_name: Isabelle Rouch

given: Isabelle

family: Dorey

full_name: Jean-Michel Dorey

given: Jean-Michel

family: Boublay

full_name: Nawèle Boublay

given: Nawèle

family: Henaff

full_name: Marie-Anne Henaff

given: Marie-Anne

family: Dibie-Racoupeau

full_name: Florence Dibie-Racoupeau

given: Florence

family: Makaroff

full_name: Zaza Makaroff

given: Zaza

family: Harston

full_name: Sandrine Harston

given: Sandrine

family: Benoit

full_name: Michel Benoit

given: Michel

family: Barrellon

full_name: Marie-Odile Barrellon

given: Marie-Odile

family: Fédérico

full_name: Denis Fédérico

given: Denis

family: Laurent

full_name: Bernard Laurent

given: Bernard

family: Padovan

full_name: Catherine Padovan

given: Catherine

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

repositories:
HAL
PubMed Central

location_facility: Service de Gériatrie - Hôpital des Charpennes - Hospices Civils de Lyon


title: PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children

summary: Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH) associated with a new organ failure. The occurrence of this syndrome is not well known in infants. Preterm birth is frequently associated with gastrointestinal complications, particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra abdominal pressure (IAP) increases and can participate in the occurrence of organ failures. Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis, could themselves be suffering from this syndrome. It would be interesting to make early diagnosis in order to optimize the management of these children. This requires reliable measurements methods and standards. Intravesical Pressure (IVP) is the most reliable validated indirect method to measure intra-abdominal pressure. In order to measure the IVP, the bladder must contain a minimum of liquid. However, using inappropriate volumes could give erroneous IAP readings. The optimal amount of saline to inject in older children, determined from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this volume appear extremely low (e.g. 0 8cc if taking a child to 800 g). The question that arises is whether this quantity is sufficient to obtain reliable and reproducible measurements of IVP in preterm and term.

status: Completed

study_type: Interventional

design_allocation: Non-Randomized

enrollment_type: Actual

lead_sponsor: Rennes University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: "Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"

summary: In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.

enrollment_type: Anticipated

lead_sponsor: Centre René Gauducheau

intervention_type: Procedure

lead_sponsor_type: industriel


type: Other Identifier

title: Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner.

acronym: AngioIRMNative

summary:
Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the diagnosis and follow-up of peripheral arterial disease.

In clinical routine, the acquisition uses intravenous injection of a Gadolinium based contrast agent (gadolinium chelates).

Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients, elderly patients and\or patients with chronic renal insufficiency presenting a contraindication to CT angiography using iodized contrast agent injection.

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

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

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

Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide complete and non-invasive investigation of the peripheral vasculature, from the abdominal aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with no side effects.

Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality images and good signal to noise ratio for peripheral vasculature analysis.

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

The main objective is to evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.

The secondary objective is to compare the diagnostic performances of NCE images with those of CE MRA.

The third objective is to estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective


title: Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia

summary: The aim of the investigators analysis is to identify the neural correlates of quality of life scores in schizophrenia. For this, the investigators will constitute group of patients according to their quality of life scores and the investigators will analyze their differences in patterns of brain structures and activations.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Faget-Agius C, Boyer L, Wirsich J, Ranjeva JP, Richieri R, Soulier E, Confort-Gouny S, Auquier P, Guye M, Lançon C. Neural substrate of quality of life in patients with schizophrenia: a magnetisation transfer imaging study. Sci Rep. 2015 Dec 3;5:17650. doi: 10.1038/srep17650. Erratum in: Sci Rep. 2016;6:21055. Catherine, Faget-Agius [corrected to Faget-Agius, Catherine]; Jonathan, Wirsich [corrected to Wirsich, Jonathan]; Jean-Philippe, Ranjeva [corrected to Ranjeva, Jean-Philippe]; Raphaelle, Richieri [corrected to Richieri, Raphaelle]; Elisabeth, Soulier [corr.

family: Faget-Agius

full_name: Catherine Faget-Agius

sequence: first

family: Boyer

full_name: Laurent Boyer

given: Laurent

sequence: additional

family: Wirsich

full_name: Jonathan Wirsich

given: Jonathan

family: Ranjeva

full_name: Jean-Philippe Ranjeva

given: Jean-Philippe

family: Richieri

full_name: Raphaelle Richieri

given: Raphaelle

family: Soulier

full_name: Elisabeth Soulier

given: Elisabeth

family: Confort-Gouny

full_name: Sylviane Confort-Gouny

given: Sylviane

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Guye

full_name: Maxime Guye

given: Maxime

family: Lançon

full_name: Christophe Lançon

given: Christophe

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Scientific Reports

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

status_simplified: Unknown


title: Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis

summary: The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).

design_allocation: Randomized

primary_purpose: Prevention

intervention_type: Device


title: Contribution Of Nuclear Magnetic Resonance Imaging In The Study Of Diabetic Cardiomyopathy

summary: Diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. Abnormalities of the myocardial metabolism is frequently associated. It is regrettably about a hypothesis difficult to verify with current medical techniques.This deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. Techniques of nuclear magnetic resonance offer interesting perspectives.

primary_purpose: Diagnostic

location_facility: Assistance Publique - Hopitaux de Marseille


title: Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

summary: The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.

primary_purpose: Treatment

intervention_type: Drug


title: Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I

acronym: VOPTICA

summary: The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.

status: Terminated

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse


title: "Phase II Multicenter Study Evaluating the Efficacy and the Safety of a Combination of Nilotinib Plus Pegylated Interferon Alpha 2a for de Novo Chronic Phase Chronic Myelogenous Leukemia Patients"

acronym: NILOPEG

summary: The aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.

ReferenceType: result

ReferenceCitation: Nicolini FE, Etienne G, Dubruille V, Roy L, Huguet F, Legros L, Giraudier S, Coiteux V, Guerci-Bresler A, Lenain P, Cony-Makhoul P, Gardembas M, Hermet E, Rousselot P, Amé S, Gagnieu MC, Pivot C, Hayette S, Maguer-Satta V, Etienne M, Dulucq S, Rea D, Mahon FX. Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study. Lancet Haematol. 2015 Jan;2(1):e37-46. doi: 10.1016/S2352-3026(14)00027-1. Epub 2015 Jan 7.

family: Nicolini

full_name: Franck E Nicolini

given: Franck E

family: Etienne

full_name: Gabriel Etienne

given: Gabriel

family: Dubruille

full_name: Viviane Dubruille

given: Viviane

family: Roy

full_name: Lydia Roy

given: Lydia

family: Huguet

full_name: Françoise Huguet

given: Françoise

family: Legros

full_name: Laurence Legros

given: Laurence

family: Giraudier

full_name: Stéphane Giraudier

given: Stéphane

family: Coiteux

full_name: Valérie Coiteux

given: Valérie

family: Guerci-Bresler

full_name: Agnès Guerci-Bresler

given: Agnès

family: Lenain

full_name: Pascal Lenain

family: Cony-Makhoul

full_name: Pascale Cony-Makhoul

given: Pascale

family: Gardembas

full_name: Martine Gardembas

given: Martine

family: Hermet

full_name: Eric Hermet

given: Eric

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Amé

full_name: Shanti Amé

given: Shanti

family: Gagnieu

full_name: Marie-Claude Gagnieu

given: Marie-Claude

family: Pivot

full_name: Christine Pivot

given: Christine

family: Hayette

full_name: Sandrine Hayette

family: Maguer-Satta

full_name: Veronique Maguer-Satta

given: Veronique

full_name: Madeleine Etienne

given: Madeleine

family: Dulucq

full_name: Stéphanie Dulucq

given: Stéphanie

family: Rea

full_name: Delphine Rea

given: Delphine

family: Mahon

full_name: François-Xavier Mahon

given: François-Xavier


title: Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement

acronym: ARVA

summary:
The bioprosthetic aortic valve replacement is a frequent intervention because of the predominance of calcified aortic stenosis, which is the most common valvular disease, and aging of the population.

International guidelines recommend anticoagulant therapy during the 3 postoperative months, but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the low level of evidence available studies and their sometimes conflicting conclusions.

Questionnaires sent to practitioners have highlighted discrepancies between common practices and recommendations.

However, there is no analysis of actual patterns of postoperative anticoagulation after aortic valve replacement with bioprosthesis.

The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43.

ReferenceCitation: Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11.

ReferenceCitation: Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26.

ReferenceCitation: Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 2007 Jan;28(2):230-68. Epub 2007 Jan 26.

ReferenceCitation: Salem DN, O'Gara PT, Madias C, Pauker SG. Valvular and structural heart disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):593S-629S. doi: 10.1378/chest.08-0724.

ReferenceCitation: Dunning J, Versteegh M, Fabbri A, Pavie A, Kolh P, Lockowandt U, Nashef SA; EACTS Audit and Guidelines Committee. Guideline on antiplatelet and anticoagulation management in cardiac surgery. Eur J Cardiothorac Surg. 2008 Jul;34(1):73-92. doi: 10.1016/j.ejcts.2008.02.024. Epub 2008 Mar 28. Review. Erratum in: Eur J Cardiothorac Surg. 2008 Oct;34(4):934.

ReferenceCitation: Colli A, Verhoye JP, Heijmen R, Strauch JT, Hyde JA, Pagano D, Antunes M, Koertke H, Ohri SK, Bail DH, Leprince P, Van Straten BH, Gherli T; ACTION Registry Investigators. Antithrombotic therapy after bioprosthetic aortic valve replacement: ACTION Registry survey results. Eur J Cardiothorac Surg. 2008 Apr;33(4):531-6. doi: 10.1016/j.ejcts.2007.12.019. Epub 2008 Jan 18. Erratum in: Eur J Cardiothorac Surg. 2009 Aug;36(2):429.

ReferenceCitation: Vaughan P, Waterworth PD. An audit of anticoagulation practice among UK cardiothoracic consultant surgeons following valve replacement/repair. J Heart Valve Dis. 2005 Sep;14(5):576-82.

ReferenceCitation: Aramendi JI, Mestres CA, Martinez-León J, Campos V, Muñoz G, Navas C. Triflusal versus oral anticoagulation for primary prevention of thromboembolism after bioprosthetic valve replacement (trac): prospective, randomized, co-operative trial. Eur J Cardiothorac Surg. 2005 May;27(5):854-60. Erratum in: Eur J Cardiothorac Surg. 2005 Jul;28(1):188. Mestres, Carlos-Alfonso [corrected to Mestres, Carlos-Alberto].

ReferenceCitation: Gherli T, Colli A, Fragnito C, Nicolini F, Borrello B, Saccani S, D'Amico R, Beghi C. Comparing warfarin with aspirin after biological aortic valve replacement: a prospective study. Circulation. 2004 Aug 3;110(5):496-500.

ReferenceCitation: Heras M, Chesebro JH, Fuster V, Penny WJ, Grill DE, Bailey KR, Danielson GK, Orszulak TA, Pluth JR, Puga FJ, et al. High risk of thromboemboli early after bioprosthetic cardiac valve replacement. J Am Coll Cardiol. 1995 Apr;25(5):1111-9.

ReferenceCitation: Orszulak TA, Schaff HV, Mullany CJ, Anderson BJ, Ilstrup DM, Puga FJ, Danielson GK. Risk of thromboembolism with the aortic Carpentier-Edwards bioprosthesis. Ann Thorac Surg. 1995 Feb;59(2):462-8.

ReferenceCitation: Moinuddeen K, Quin J, Shaw R, Dewar M, Tellides G, Kopf G, Elefteriades J. Anticoagulation is unnecessary after biological aortic valve replacement. Circulation. 1998 Nov 10;98(19 Suppl):II95-8; discussion II98-9.

ReferenceCitation: Blair KL, Hatton AC, White WD, Smith LR, Lowe JE, Wolfe WG, Young WG, Oldham HN, Douglas JM Jr, Glower DD. Comparison of anticoagulation regimens after Carpentier-Edwards aortic or mitral valve replacement. Circulation. 1994 Nov;90(5 Pt 2):II214-9.

ReferenceCitation: Sundt TM, Zehr KJ, Dearani JA, Daly RC, Mullany CJ, McGregor CG, Puga FJ, Orszulak TA, Schaff HV. Is early anticoagulation with warfarin necessary after bioprosthetic aortic valve replacement? J Thorac Cardiovasc Surg. 2005 May;129(5):1024-31.

ReferenceCitation: Brueck M, Kramer W, Vogt P, Steinert N, Roth P, Görlach G, Schönburg M, Heidt MC. Antiplatelet therapy early after bioprosthetic aortic valve replacement is unnecessary in patients without thromboembolic risk factors. Eur J Cardiothorac Surg. 2007 Jul;32(1):108-12. Epub 2007 Apr 20.

ReferenceCitation: Iung B. Management of the elderly patient with aortic stenosis. Heart. 2008 Apr;94(4):519-24. doi: 10.1136/hrt.2007.122804. Review.

ReferenceCitation: Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008 Apr;135(4):732-8. doi: 10.1016/j.jtcvs.2007.12.002.

lead_sponsor: French Cardiology Society


title: Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study

acronym: MUCOSTEO

summary: To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

ReferenceCitation: Hubert D, Soubeiran L, Gourmelon F, Grenet D, Serreau R, Perrodeau E, Zegarra-Parodi R, Boutron I. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study. PLoS One. 2014 Jul 16;9(7):e102465. doi: 10.1371/journal.pone.0102465. eCollection 2014.

family: Hubert

full_name: Dominique Hubert

given: Dominique

family: Soubeiran

full_name: Lucile Soubeiran

given: Lucile

family: Gourmelon

full_name: Fabrice Gourmelon

given: Fabrice

family: Grenet

full_name: Dominique Grenet

family: Serreau

full_name: Raphaël Serreau

given: Raphaël

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Zegarra-Parodi

full_name: Rafael Zegarra-Parodi

given: Rafael

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

bso_classification: Biology (fond.)

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Impact of Osteopathic Treatment on Pain in Adult Patients with Cystic Fibrosis – A Pilot Randomized Controlled Study

lead_sponsor: Assistance Publique - Hôpitaux de Paris


lead_sponsor: Nantes University Hospital

acronym: Arrêt du Tacrolimus en transplantation rénale

type: EudraCT Number

source: euctr

title: Prospective, Multicenter, Randomized, Double-blind, Controlled Parallel Group Study Designed to Assess the Risk-benefit Balance of the Gradual Withdrawal of a Calcineurin Inhibitor (Tacrolimus) in Renal Transplant Patients Over 4 Years and Clinically Selected

summary: The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).


title: The Role of Elastography in the Diagnosis of Thyroid Nodules

summary: The primary objective of this study is to evaluate the role of elastography (along with echographic and cytological data) as a diagnostic tool for thyroid cancer

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease

acronym: MICROCARD

summary:
Cardiovascular diseases are the leading cause of mortality in patients with end stage renal disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the incidence of significant coronary stenosis (>70%) is low. The goal of this observational study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular disease in patients with end stage renal disease scheduled or not for kidney transplantation. These patients routinely undergo non invasive detection of myocardial ischemia. Patient included in the study will be followed up for 2 years for major cardiovascular events. Patients with detected myocardial ischemia during non invasive testing are being explored by coronary angiography. During coronary angiography additional detection of myocardial microvascular disease is being performed by simultaneous measurement of Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of microcirculatory resistance (IMR).

Comparison of cardiovascular outcomes between patients with and without myocardial ischemia and patients with and without myocardial microvascular disease will be performed.

ReferenceCitation: Bejan-Angoulvant T, Bergerot C, Juillard L, Mezergues A, Morelon E, Pouteil-Noble C, André-Fouët X, Angoulvant D. Myocardial microvascular disease and major adverse cardiovascular events in patients with end-stage renal disease: rationale and design of the MICROCARD study. Nephrol Dial Transplant. 2012 Jul;27(7):2886-91. doi: 10.1093/ndt/gfs008. Epub 2012 Feb 17.

family: Bejan-Angoulvant

full_name: Theodora Bejan-Angoulvant

given: Theodora

family: Bergerot

full_name: Cyrille Bergerot

given: Cyrille

family: Juillard

full_name: Laurent Juillard

given: Laurent

family: Mezergues

full_name: Aline Mezergues

given: Aline

family: Morelon

full_name: Emmanuel Morelon

given: Emmanuel

family: Pouteil-Noble

full_name: Claire Pouteil-Noble

given: Claire

family: André-Fouët

full_name: Xavier André-Fouët

given: Xavier

family: Angoulvant

full_name: Denis Angoulvant

given: Denis

journal_name: Nephrology Dialysis Transplantation

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Cardiologie D - Hôpital Louis Pradel - Hospices Civils de Lyon


title: Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia

acronym: EETY

summary: The objective of this proof of concept study is to assess the involvement of epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods for the study of functional microcirculation.

lead_sponsor: University Hospital, Grenoble


title: Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years

acronym: Expand IDWP21

summary:
This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.

Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.

Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.

However, the immune response to influenza vaccine appears to be lower in elderly than in young people.

location_facility: Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie


title: Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers

summary: The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction.

lead_sponsor: Hôpital le Vinatier


title: The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy

summary: Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant women. The high recurrence rate raises the long-term effectiveness of therapy. The hypothesis is the persistence of bacteria associated with vaginal flora imbalance as Atopobium vaginae and Gardnerella vaginalis. At the present time there is a lack of an accurate marker for the risk of recurrence.


title: Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless

acronym: ERPOUPER

summary:
Homelessness, also name the fourth world, is a growing public health problem worldwide. Previous studies showed that up to 30% of the homeless people reported pruritus that often results in itchy lesions, which expose them to bacterial skin infections.

The investigators therefore conducted a randomized, double-blind, placebo-controlled trial to test the hypothesis that a single oral dose of ivermectin was effective in significantly reducing the prevalence of pruritus in a sheltered homeless population.

ReferenceCitation: Benkouiten S, Drali R, Badiaga S, Veracx A, Giorgi R, Raoult D, Brouqui P. Effect of permethrin-impregnated underwear on body lice in sheltered homeless persons: a randomized controlled trial. JAMA Dermatol. 2014 Mar;150(3):273-9. doi: 10.1001/jamadermatol.2013.6398.

family: Benkouiten

full_name: Samir Benkouiten

given: Samir

name: Unité de Recherche sur les Maladies Infectieuses et Tropicales Émergentes, Aix-Marseille Université, Marseille, France2Institut Hospitalo-Universitaire Méditerranée Infection, Marseille, France3Service des Entérobactéries et Hygiène de l'Environnement, In

family: Drali

full_name: Rezak Drali

given: Rezak

family: Badiaga

full_name: Sékéné Badiaga

given: Sékéné

family: Veracx

full_name: Aurélie Veracx

given: Aurélie

name: Institut Hospitalo-Universitaire Méditerranée Infection, Marseille, France4Institut National de la Santé et de la Recherche Médicale, Aix-Marseille Université, Marseille, France

family: Giorgi

full_name: Roch Giorgi

given: Roch

family: Raoult

full_name: Didier Raoult

given: Didier

family: Brouqui

full_name: Philippe Brouqui

given: Philippe

journal_name: JAMA Dermatology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Permethrin–Impregnated Underwear on Body Lice in Sheltered Homeless Persons


title: Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery

summary: Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and the severity of the fistula. The management of this complication is still controversial and potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic management has to be improved to reduce the duration of the treatment and the number of endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a more prehensive, deeper and larger suture area.


title: Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE

acronym: HIPPOCAMPE

summary: Vestibular signals deeply influence hippocampal spatial representations and may contribute to the navigational deficits of humans with vestibular dysfunction. The reciprocal influence of hippocampal signals on the vestibular system are more putative. The investigators wish to investigate in this pilot study the consequences on vestibular system of the removal of the hippocampal formation to treat drug resistant temporal lobe epilepsy.


title: Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis

summary:
Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.

Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation

Secondary objectives :

Assess the state of health
Assess the knowledge
Assess gestural know-how
Assess the cognitive know-how
Assess the behaviour adopted in reality by the patient

Assess motivation psychosocial factors of :

self-efficacy and inefficiency
representation of obstacles, disadvantages of treatment
sense of control over their health
feeling of being supported by health professionals, by his close
representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment


title: Representations of Transplantation in Patients With Mucoviscidosis, in Their Assistants and in Their Medical Persons

summary:
Main objective : This project aims to have a better understanding of the influence of representations of patients with mucoviscidosis, their assistants and their medical persons in the choice of patients to accept or not lung transplantation.

Specific objectives :

Identify the knowledge, representations, or feelings of patients which could constitute bridles or factors of motivation to use for transplantation.
Identify the knowledge, representations, or feelings of medical persons which could constitute bridles or factors of motivation to the "encouraging" proposal to patients of lung transplant.
Identify the knowledge, representations, or feelings of assistants which could constitute bridles or factors of motivation to the "encouragement" of lung transplantation at its close.
Identify the needs of patients, assistants and medical persons to successfully reduce these bridles to transplantation and increase the factors of motivation.
Compare the representations of patients, assistants and medical persons
Search representations associated with patients who refuse the transplantation and those who accept the transplantation


title: Hair Testing to Assess Consumption of Illicit Psychotropic Agents and Alcohol by Patients Treated With High-dose Buprenorphine and Methadone. Search for a Pharmacogenetic Contribution to Low Efficacy of Substitution Medications

summary:
Justification and aims of the study: The principal aim of use of opiate substitutes such as methadone or high-dose buprenorphine (HDB) is to reduce the need or the desire to consume the opiate to which the patient is addicted. Adjustment of the initial dose and regular re-evaluation of the efficacy of treatment are key elements in the success of such management. While too high a dose can be responsible for side effects leading to abandonment of treatment, too low a dose can induce the reappearance or even the reinforcing of parallel consumption of other psychoactive substances, in particular cocaine, alcohol and cannabis. The principal aim of this project is to determine the course of parallel consumption in patients who have been receiving a maintenance dose of methadone or HDB for at least two months, by analysis of a sample of hair, a biological matrix which is innovative for this type of study. Hair testing establishes a retrospective profile of consumption. The secondary aims of this project are (i) to validate the French versions of Handelsman's subjective and objective opiate withdrawal scales and to seek a possible correlation between high scores on these scales and the presence of parallel consumption, and (ii) to seek an association between polyconsumption and common functional polymorphisms of metabolic enzymes of methadone and HDB.

Expected results: Hair testing, which has the particular advantage of a long detection window so that samples need only be taken at intervals, could improve the biological monitoring of patients on substitutive treatment.

Validation of the French version of Handelsman's scales of objective and subjective signs of opiate withdrawal and search for any correlation with parallel consumption will enable these scales to be used in daily practice for clinical surveillance of patients on substitutive treatment.

If a polymorphism of a metabolic enzyme of one or other of these molecules is detected, rapid genotyping of a simple saliva sample will be valuable in guiding the choice of medication when deciding on a treatment strategy


ReferenceCitation: Verschuur A, Heng-Maillard MA, Dory-Lautrec P, Truillet R, Jouve E, Chastagner P, Leblond P, Aerts I, Honoré S, Entz-Werle N, Sirvent N, Gentet JC, Corradini N, André N. Metronomic Four-Drug Regimen Has Anti-tumor Activity in Pediatric Low-Grade Glioma; The Results of a Phase II Clinical Trial. Front Pharmacol. 2018 Sep 27;9:00950. doi: 10.3389/fphar.2018.00950. eCollection 2018.

family: Verschuur

full_name: Arnauld Verschuur

given: Arnauld

family: Heng-Maillard

full_name: Marie-Amélie Heng-Maillard

given: Marie-Amélie

family: Dory-Lautrec

full_name: Philippe Dory-Lautrec

family: Truillet

full_name: Romain Truillet

given: Romain

family: Jouve

full_name: Elisabeth Jouve

given: Elisabeth

family: Chastagner

full_name: Pascal Chastagner

given: Pascal

family: Leblond

full_name: Pierre Leblond

given: Pierre

family: Aerts

full_name: Isabelle Aerts

family: Honoré

full_name: Stéphane Honoré

given: Stéphane

family: Entz-Werle

full_name: Natasha Entz-Werle

given: Natasha

family: Sirvent

full_name: Nicolas Sirvent

given: Nicolas

family: Gentet

full_name: Jean-Claude Gentet

given: Jean-Claude

family: Corradini

full_name: Nadège Corradini

given: Nadège

family: André

full_name: Nicolas André

journal_name: Frontiers in Pharmacology

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

repository_normalized: HAL

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: André N, Abed S, Orbach D, Alla CA, Padovani L, Pasquier E, Gentet JC, Verschuur A. Pilot study of a pediatric metronomic 4-drug regimen. Oncotarget. 2011 Dec;2(12):960-5.

title: A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours.

summary:
To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response").

To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).


title: An Open-label, Randomized, 2-way Crossover Study to Evaluate the Pharmacokinetics of Mirabegron and Its Metabolites in Healthy Young and Elderly Male and Female Subjects

summary: Young and elderly, male and female subjects are each given 2 different doses of mirabegron for 7 days each. Levels of mirabegron in the blood are assessed.

primary_purpose: Basic Science

ReferenceCitation: Krauwinkel W, van Dijk J, Schaddelee M, Eltink C, Meijer J, Strabach G, van Marle S, Kerbusch V, van Gelderen M. Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women. Clin Ther. 2012 Oct;34(10):2144-60. doi: 10.1016/j.clinthera.2012.09.010.

lead_sponsor: Astellas Pharma Inc


title: An Exploratory Study Into the Mechanism of Mirabegron-induced Cardiovascular Effects in Healthy Male Subjects.

summary: To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron.


title: Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study

summary:
This is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. For this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients.

Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3 : 6 months post-PET. Visit 4 : 12 months post-PET.

ReferenceCitation: Guerin C, Pattou F, Brunaud L, Lifante JC, Mirallié E, Haissaguerre M, Huglo D, Olivier P, Houzard C, Ansquer C, Hindié E, Loundou A, Archange C, Tabarin A, Sebag F, Baumstarck K, Taïeb D. Performance of 18F-FDG PET/CT in the Characterization of Adrenal Masses in Noncancer Patients: A Prospective Study. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2465-2472. doi: 10.1210/jc.2017-00254.

family: Guerin

full_name: Carole Guerin

given: Carole

family: Pattou

full_name: François Pattou

given: François

family: Brunaud

full_name: Laurent Brunaud

given: Laurent

family: Lifante

full_name: Jean-Christophe Lifante

given: Jean-Christophe

family: Mirallié

full_name: Eric Mirallié

given: Eric

family: Haissaguerre

full_name: Magalie Haissaguerre

given: Magalie

family: Huglo

full_name: Damien Huglo

given: Damien

family: Olivier

full_name: Pierre Olivier

family: Houzard

full_name: Claire Houzard

given: Claire

family: Ansquer

full_name: Catherine Ansquer

given: Catherine

family: Hindié

full_name: Elif Hindié

given: Elif

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Archange

full_name: Cendrine Archange

given: Cendrine

family: Tabarin

full_name: Antoine Tabarin

given: Antoine

family: Sebag

full_name: Fréderic Sebag

given: Fréderic

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Taïeb

full_name: David Taïeb

given: David

journal_name: The Journal of Clinical Endocrinology & Metabolism

evidence: open (via free article)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society


title: Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function

summary:
Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.

The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.

ReferenceCitation: Gaborit B, Jacquier A, Kober F, Abdesselam I, Cuisset T, Boullu-Ciocca S, Emungania O, Alessi MC, Clément K, Bernard M, Dutour A. Effects of bariatric surgery on cardiac ectopic fat: lesser decrease in epicardial fat compared to visceral fat loss and no change in myocardial triglyceride content. J Am Coll Cardiol. 2012 Oct 9;60(15):1381-9. doi: 10.1016/j.jacc.2012.06.016. Epub 2012 Aug 29.

family: Gaborit

full_name: Bénédicte Gaborit

given: Bénédicte

family: Jacquier

full_name: Alexis Jacquier

given: Alexis

family: Kober

full_name: Frank Kober

given: Frank

family: Abdesselam

full_name: Ines Abdesselam

given: Ines

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

family: Boullu-Ciocca

full_name: Sandrine Boullu-Ciocca

given: Sandrine

family: Emungania

full_name: Olivier Emungania

given: Olivier

family: Alessi

full_name: Marie-Christine Alessi

given: Marie-Christine

family: Clément

full_name: Karine Clément

family: Bernard

full_name: Monique Bernard

given: Monique

family: Dutour

full_name: Anne Dutour

given: Anne

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Effects of Bariatric Surgery on Cardiac Ectopic Fat


title: Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care

summary:
Qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care.

Objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.

intervention_type: Behavioral


title: Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures

summary: Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.


title: Beta-thalassemia and Microparticles

summary: The results will allow us to evaluate the role of MP in the thrombo-embolic risk observed in thalassemic patients and to underline a possible difference between TM and TI. The in vitro and in vivo study of MP in erythrocytes concentrates is a new approach to explore the consequence of transfusion in polytransfused patients. Finally, the identification of a possible relationship between the oxidative stress and the production of MP may lead to the development of specific therapeutical approaches


title: Weaning of Immunosuppression in Nephritis of Lupus

acronym: WIN-Lupus

summary: The investigators wish to evaluate the discontinuation of maintenance immunosuppressive treatment after 2 years in patients with stable remission after a proliferative lupus nephritis. The patients will be continuing their treatment with hydroxychloroquine, possibly associated with low dose corticosteroids.

status: Active, not recruiting

status_simplified: Ongoing


summary: Natural Killer cells (NK) are pivotal cells of innate immunity, that sense defective expression of HLA class I molecules and are complementary to specific cytotoxic T lymphocytes. A defect in NK cell cytotoxicity has been described in some hematopoietic malignancies such as acute myeloid leukemia, multiple myeloma, myelodysplastic syndroms. This defect is at least partially linked to a decreased or absent expression of some activating NK cell molecules, more particularly the so-called Natural Cytotoxicity Receptors (NCRs) NKp30, NKp44 and NKp46. Some old publications have demonstrated defective NK cytotoxicity in myeloproliferative syndroms (chronic myeloid leukemia, primary thrombocytosis, polycythemia vera). The investigators more particularly focused their attention on polycythemia vera (Vaquez's disease), a myeloproliferative disease characterized by the recently describet mutation V617F of the JAK2 tyrosine kinase. The investigators will precise the mechanisms leading to this cytotoxicity defect, the investigators also will evaluate the implication of V617F mutation on NK physiology, and will study the interactions between NK cells and hematopoietic progenitors.

intervention_type: Biological


title: Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.

summary: The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but presenting also with clear contraindications to the implantation of the deep brain electrodes.


title: Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease

summary: Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. This hypothesis was confirmed in a previous series of experiments.The aim is to determine whether the resonance frequency within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20 subjets during 24 months).


title: Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

acronym: NEOCORD

summary:
Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

For the moment, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.

Cord blood stem cells are a promising treatment for the near future. However, before conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of neonatal asphyxia, compared to normal situation, is needed.

The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. Secondary objectives are to assess such characteristics in conditions of cryo-preservation, compared to fresh cell preparation

location_facility: Assistance publique Hopitaux de Marseille


title: Study in Adults on HPN Who Have Developed PNALD Comparing Equivalent Doses of Two Lipid Emulsions: OMEGAVEN 10%®, Enriched in n-3 EFA, and a Standard Lipid Emulsion, Intralipid 20%® Not Enriched in n-3 EFA + Vitamin E Supplement

acronym: MEGANORM

summary:
The objective of the study is to show that substitution of the usual lipid emulsion (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA.

Regression of liver disease will be defined by normalization of the five liver function tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.


title: Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study

summary: The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.

ReferenceCitation: Neuschwander A, Futier E, Jaber S, Pereira B, Eurin M, Marret E, Szymkewicz O, Beaussier M, Paugam-Burtz C. The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE). Eur J Anaesthesiol. 2016 Apr;33(4):292-8. doi: 10.1097/EJA.0000000000000390.

family: Neuschwander

full_name: Arthur Neuschwander

given: Arthur

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Jaber

full_name: Samir Jaber

given: Samir

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Eurin

full_name: Mathilde Eurin

given: Mathilde

family: Marret

full_name: Emmanuel Marret

family: Szymkewicz

full_name: Olga Szymkewicz

given: Olga

family: Beaussier

full_name: Marc Beaussier

given: Marc

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Pascal

full_name: Julien Pascal

given: Julien

family: Gutton

full_name: Christophe Gutton

given: Christophe

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Allaouchiche

full_name: Bernard Allaouchiche

given: Bernard

family: Verzilli

full_name: Daniel Verzilli

given: Daniel

title: A Trial of Intraoperative Low-Tidal-Volume Ventilation in Abdominal Surgery


title: Preliminary Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles

summary:
The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is focused on the evaluation of an original control algorithm that computes appropriate subcutaneous insulin infusion in response to continuous glucose measurements The results during a 24-hour closed-loop period will be compared with those of the open-loop. The implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary a phase of identification of the parameters of the model (insulin pharmacokinetics and effect on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of the damping parameters of EDS.

The present study aims to formalize this procedure of identification/optimization of the parameters of the model and controller EDS. They will be determined in type -1 diabetic patients using insulin therapy and under conditions free from disturbances such as those generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will determine this procedure: blood glucose, insulin concentration and insulin doses.


title: Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)

acronym: NAVA-NIV

summary: Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV

ReferenceCitation: Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.

family: Schmidt

full_name: Matthieu Schmidt

given: Matthieu

family: Dres

full_name: Martin Dres

given: Martin

family: Raux

full_name: Mathieu Raux

given: Mathieu

family: Deslandes-Boutmy

full_name: Emmanuelle Deslandes-Boutmy

given: Emmanuelle

family: Kindler

full_name: Felix Kindler

given: Felix

family: Mayaux

full_name: Julien Mayaux

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

journal_name: Critical Care Medicine

title: Neurally adjusted ventilatory assist improves patient–ventilator interaction during postextubation prophylactic noninvasive ventilation*

lead_sponsor: Pierre and Marie Curie University

location_facility: Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology


title: Randomised, Double-blind, 3-way Crossover, Single Dose, Placebo-controlled Study Investigating the Effect on Postural Instability of Melatonin and Zolpidem in Healthy Adult Subjects Aged of 55 to 64 Years.

summary: This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem in healthy adult subjects aged of 55 to 64 years.

lead_sponsor: Neurim Pharmaceuticals Ltd.


title: Establishment of a National Thematic Network in Urology for the Extension of the Cohort DIVAT (Données Informatisées et Validées en Transplantation) in Surgical Parameters of Renal and Pancreatic Transplant Patients : An Innovative Tool for the Promotion of Epidemiological Studies, Identification of Risk Factors and Good Practices in the Domain of Transplant Surgery

summary: The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas. These data will concern the transplantation itself and the events and complications related to surgery occurring throughout the follow-up. The collection will involve patients in the cohort DIVAT and future patients. This project will allow us to have the sufficiency of surgical transplantation by increasing the quantity and quality of information gathered thus avoiding the biases commonly upbraided against the retrospective studies. Finally, by supplementing it with new parameters, it will strengthen the medical and scientific interest of the cohort DIVAT and will open new perspectives for clinical trials in surgery and work in epidemiology.Networking of urologists and the expansion of the base DIVAT would carry out research in epidemiology and factors that may play a role in the outcome of renal and pancreatic transplantation. It would also help to define good practices. The first study from the proposed network DIVAT-Uro is assessing the impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on survival of the transplant in the recipient adult.


title: Phase I/II Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma.

acronym: CARMYSAP

summary:
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma. Nine: University Hospital of Nantes, University Hospital of Nancy, University Hospital of Lille, University Hospital of Tours, department Hospital of La Roche Sur Yon, University Hospital of Reims, University Hospital of Clermont-Ferrand, University Hospital of Toulouse, University Hospital of Dijon Newly diagnosed symptomatic Multiple Myeloma > 65 years. Treatment comprises an initial phase consisting of nine 6-week cycles of Carfilzomib on Days 1, 2, 8, 9, 22, 23, 29, 30 (carfilzomib is administered at 20 mg/m2 on Days 1 and 2 of the first cycle and 20, 27, 36 or 45 mg/m2 thereafter) followed by a 12 day rest period (42-day cycle), in combination with oral Melphalan 9 mg/m² and oral prednisone 60mg/m², both on days 1 to 4.

Phase I: Identification of Maximum Tolerated Dose (MTD)

Carfilzomib will be administered at a dose of 20mg/m² for all doses to the first cohort of 6 patients. If dose-limiting toxicities (DLTs) occurred in fewer than 2 of these patients, the next cohort of 6 patients (cohort 2) will receive a dose of 20/27 mg/m² where the 20 mg/m² dose is administered on Day 1 and 2 of Cycle 1 only and then 27 mg/m² for all subsequent doses. If DLTs occurred in fewer than 2 of the patients in cohort 2, the third cohort of 6 patients will receive a dose of 20/36 mg/m² where the 20 mg/m² dose is administered on Day 1 and 2 of Cycle 1 only and then 36 mg/m² for all subsequent doses. If DLTs occurred in fewer than 3 of the patients in cohort 3 the fourth cohort of 6 patients will receive a dose of 20/45 mg/m² where the 20 mg/m² dose is administered on Day 1 and 2 of Cycle 1 only and then 45 mg/m² for all subsequent doses. If at any time during cycle 1 of a dose cohort, ≥ 2 subjects experience a drug-related DLT, the MTD will have been exceeded, additional enrollment within the cohort will cease, and dose escalation will stop. The MTD will be defined as the dose level below which DLT is observed in ≥ 33% (i.e. ≥ 2 of 6) subjects in a cohort. The following are defined as DLTs:

Any hematologic toxicity of grade 4 intensity or preventing administration of 2 or more of the 8 carfilzomib doses of the first treatment cycle except a) grade 4 thrombocytopenia without bleeding lasting ≤ 7 days or b) grade 4 neutropenia lasting ≤ 7 days
Grade ≥ 3 febrile neutropenia
Grade ≥ 3 gastrointestinal toxicities (except for grade ≥ 3 nausea/ vomiting if the patient had not received adequate antiemetic prophylaxis)
Any other grade ≥ 3 nonhematologic toxicity considered related to CMP by the principal investigator.
Grade ≥ 3 peripheral neuropathy persisting for more than 3 weeks after discontinuation of study drugs.

Adverse events (AEs) will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). MTD determination will be based on occurrence of DLTs during the first induction treatment cycle only.

Phase II: Expanded Cohort. After identification of the MTD, it is planned for the dose cohort to be expanded to include up to a total of 20 patients treated at the MTD for the phase II part of the study. A full treatment course is the same as for phase I: nine 6-week cycles of CMP.

PRIMARY ENDPOINT Phase I: MTD of combination Phase II: Overall response rate [(ORR), consisting of complete response (CR), very good partial response (VGPR), and partial response (PR) SECONDARY ENDPOINTS Safety and tolerability of CMP Clinical benefit response [(CBR = ORR + minimal response (MR)], Progression-free survival (PFS), Duration of response Overall survival (OS). Safety data analysis will be conducted on all subjects receiving at least one dose of study treatment. Analyses will consist of data summaries for reported AEs. The number and percentage of subjects experiencing one or more AEs will be summarized by dose, relationship to study drugs, and severity. AEs will be coded using MedDRA terminology.

Disease Response Analyses: Overall response rate (ORR = CR + VGPR + PR) to treatment will be measured using the International Myeloma Working Group (IMWG) criteria. Clinical benefit response (CBR = ORR + MR) will be determined using minimal response (at least 6 weeks duration) as defined by the European Group for Blood and Marrow Transplant (EBMT). The distribution of subjects by response category will be made overall and by dose cohort. Time-to-event endpoints will be evaluated with the use of the Kaplan-Meier method and plots will be provided. Analysis of time-to-event outcomes will be performed for the overall sample.

ReferenceCitation: Moreau P, Kolb B, Attal M, Caillot D, Benboubker L, Tiab M, Touzeau C, Leleu X, Roussel M, Chaleteix C, Planche L, Chiffoleau A, Fortin J, Avet-Loiseau H, Mary JY, Hulin C, Facon T. Phase 1/2 study of carfilzomib plus melphalan and prednisone in patients aged over 65 years with newly diagnosed multiple myeloma. Blood. 2015 May 14;125(20):3100-4. doi: 10.1182/blood-2015-02-626168. Epub 2015 Mar 17.

name: Hematology Department, University Hospital Hôtel-Dieu, Nantes, France;

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Hematology Department, University Hospital, Reims, France;

family: Kolb

full_name: Brigitte Kolb

given: Brigitte

name: Hematology Department, University Hospital, Toulouse, France;

family: Attal

full_name: Michel Attal

given: Michel

name: Hematology Department, University Hospital, Dijon, France;

family: Caillot

full_name: Denis Caillot

given: Denis

name: Hematology Department, University Hospital, Tours, France;

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

name: Hematology Department, University Hospital, La Roche sur Yon, France;

family: Tiab

full_name: Mourad Tiab

given: Mourad

family: Touzeau

full_name: Cyrille Touzeau

given: Cyrille

name: Hematology Department, University Hospital, Lille, France;

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Roussel

full_name: Murielle Roussel

given: Murielle

name: Hematology Department, University Hospital, Clermont-Ferrand, France;

family: Chaleteix

full_name: Carine Chaleteix

given: Carine

family: Planche

full_name: Lucie Planche

given: Lucie

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

family: Fortin

full_name: June Fortin

given: June

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

given: Hervé

name: Inserm U1153, University Hospital Saint-Louis, Paris, France; and

family: Mary

full_name: Jean-Yves Mary

name: Hematology Department, University Hospital, Nancy, France

family: Hulin

full_name: Cyrille Hulin

family: Facon

full_name: Thierry Facon

given: Thierry

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology


title: A Multicentric Randomized Trial Comparing the Bronchial Artery Embolization Combined With Medical Measures and the Medical Measures Alone in the Treatment of Non-severe Acute Hemoptysis of Mild-to-moderate Abundance

acronym: ARTEMHYS

summary: Severe hemoptysis is a life-threatening condition, with an unpredictable course. The efficacy of bronchial artery embolization (BAE) is well established for the treatment of severe hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50 to 90% of cases, respectively. As complications related to vascular interventional radiology may occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute hemoptysis of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of severity (respiratory failure or hemodynamic instability). There is no available data comparing the safety and efficacy of BAE combined with medical measures to those of medical measures alone in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance.

primary_purpose: Other

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ReferenceCitation: Fartoukh M, Khalil A, Louis L, Carette MF, Bazelly B, Cadranel J, Mayaud C, Parrot A. An integrated approach to diagnosis and management of severe haemoptysis in patients admitted to the intensive care unit: a case series from a referral centre. Respir Res. 2007 Feb 15;8:11.

ReferenceCitation: Savale L, Parrot A, Khalil A, Antoine M, Théodore J, Carette MF, Mayaud C, Fartoukh M. Cryptogenic hemoptysis: from a benign to a life-threatening pathologic vascular condition. Am J Respir Crit Care Med. 2007 Jun 1;175(11):1181-5. Epub 2007 Mar 1.

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ReferenceCitation: Khalil A, Parrot A, Nedelcu C, Fartoukh M, Marsault C, Carette MF. Severe hemoptysis of pulmonary arterial origin: signs and role of multidetector row CT angiography. Chest. 2008 Jan;133(1):212-9. Epub 2007 Nov 7.

ReferenceCitation: Dweik RA, Stoller JK. Role of bronchoscopy in massive hemoptysis. Clin Chest Med. 1999 Mar;20(1):89-105. Review.

ReferenceCitation: Crocco JA, Rooney JJ, Fankushen DS, DiBenedetto RJ, Lyons HA. Massive hemoptysis. Arch Intern Med. 1968 Jun;121(6):495-8.

ReferenceCitation: Garzon AA, Cerruti MM, Golding ME. Exsanguinating hemoptysis. J Thorac Cardiovasc Surg. 1982 Dec;84(6):829-33.

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ReferenceCitation: Håkanson E, Konstantinov IE, Fransson SG, Svedjeholm R. Management of life-threatening haemoptysis. Br J Anaesth. 2002 Feb;88(2):291-5.

ReferenceCitation: Jean-Baptiste E. Clinical assessment and management of massive hemoptysis. Crit Care Med. 2000 May;28(5):1642-7. Review.

ReferenceCitation: Lordan JL, Gascoigne A, Corris PA. The pulmonary physician in critical care * Illustrative case 7: Assessment and management of massive haemoptysis. Thorax. 2003 Sep;58(9):814-9. Review.

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ReferenceCitation: Haponik EF, Fein A, Chin R. Managing life-threatening hemoptysis: has anything really changed? Chest. 2000 Nov;118(5):1431-5.

ReferenceCitation: Rémy J, Arnaud A, Fardou H, Giraud R, Voisin C. Treatment of hemoptysis by embolization of bronchial arteries. Radiology. 1977 Jan;122(1):33-7.

ReferenceCitation: Ramon P, Wallaert B, Derollez M, D'Odemont JP, Tonnel AB. [Treatment of severe hemoptysis with terlipressin. Study of the efficacy and tolerance of this product]. Rev Mal Respir. 1989;6(4):365-8. French.

ReferenceCitation: White RI Jr. Bronchial artery embolotherapy for control of acute hemoptysis: analysis of outcome. Chest. 1999 Apr;115(4):912-5.

ReferenceCitation: Rémy J, Voisin C, Dupuis C, Beguery P, Tonnel AB, Denies JL, Douay B. [Treatment of hemoptysis by embolization of the systemic circulation]. Ann Radiol (Paris). 1974 Jan-Feb;17(1):5-16. French.

ReferenceCitation: Cremaschi P, Nascimbene C, Vitulo P, Catanese C, Rota L, Barazzoni GC, Cornalba GP. Therapeutic embolization of bronchial artery: a successful treatment in 209 cases of relapse hemoptysis. Angiology. 1993 Apr;44(4):295-9.

ReferenceCitation: Uflacker R, Kaemmerer A, Picon PD, Rizzon CF, Neves CM, Oliveira ES, Oliveira ME, Azevedo SN, Ossanai R. Bronchial artery embolization in the management of hemoptysis: technical aspects and long-term results. Radiology. 1985 Dec;157(3):637-44.

ReferenceCitation: Mesurolle B, Lacombe P, Barre O, Qanadli S, Mulot RO, Chagnon S. [Failures and complications of bronchial artery embolization]. Rev Mal Respir. 1996 Jul;13(3):217-25. Review. French.

ReferenceCitation: Ramakantan R, Bandekar VG, Gandhi MS, Aulakh BG, Deshmukh HL. Massive hemoptysis due to pulmonary tuberculosis: control with bronchial artery embolization. Radiology. 1996 Sep;200(3):691-4.

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ReferenceCitation: Hayakawa K, Tanaka F, Torizuka T, Mitsumori M, Okuno Y, Matsui A, Satoh Y, Fujiwara K, Misaki T. Bronchial artery embolization for hemoptysis: immediate and long-term results. Cardiovasc Intervent Radiol. 1992 May-Jun;15(3):154-8; discussion 158-9.

ReferenceCitation: Swanson KL, Johnson CM, Prakash UB, McKusick MA, Andrews JC, Stanson AW. Bronchial artery embolization : experience with 54 patients. Chest. 2002 Mar;121(3):789-95.

ReferenceCitation: Wong ML, Szkup P, Hopley MJ. Percutaneous embolotherapy for life-threatening hemoptysis. Chest. 2002 Jan;121(1):95-102.

ReferenceCitation: Ong TH, Eng P. Massive hemoptysis requiring intensive care. Intensive Care Med. 2003 Feb;29(2):317-20. Epub 2002 Nov 2.

ReferenceCitation: Labbe V, Roques S, Boughdène F, Razazi K, Khalil A, Parrot A, Fartoukh M. Shock complicating successful bronchial artery embolization for severe hemoptysis. Chest. 2009 Jan;135(1):215-217. doi: 10.1378/chest.08-0491.

ReferenceCitation: Lacerda JE, Consolim-Colombo FM, Moreira ED, Ida F, Silva GJ, Irigoyen MC, Krieger EM. Influence of cardiopulmonary reflex on the sympathetic activity during myocardial infarction. Auton Neurosci. 2007 May 30;133(2):128-35. Epub 2006 Dec 26.

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ReferenceCitation: Yoon YC, Lee KS, Jeong YJ, Shin SW, Chung MJ, Kwon OJ. Hemoptysis: bronchial and nonbronchial systemic arteries at 16-detector row CT. Radiology. 2005 Jan;234(1):292-8. Epub 2004 Nov 18.

ReferenceCitation: Straus DJ, Yahalom J, Gaynor J, Myers J, Koziner B, Caravelli J, Lee BJ 3rd, Nisce LZ, McCormick B, Bajorunas D, et al. Four cycles of chemotherapy and regional radiation therapy for clinical early-stage and intermediate-stage Hodgkin's disease. Cancer. 1992 Feb 15;69(4):1052-60.

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ReferenceCitation: Fartoukh M, Demoule A, Sanchez O, Tuffet S, Bergot E, Godet C, Andrejak C, Pontier-Marchandise S, Parrot A, Mayaux J, Meyer G, Cluzel P, Sapoval M, Le Pennec V, Carette MF, Cadranel J, Rousseau A, Khalil A, Simon T; ARTEMHYS trial group. Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance. BMJ Open Respir Res. 2021 Jun;8(1). pii: e000949. doi: 10.1136/bmjresp-2021-000949.

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Demoule

full_name: Alexandre Demoule

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Tuffet

full_name: Sophie Tuffet

given: Sophie

family: Bergot

full_name: Emmanuel Bergot

given: Emmanuel

family: Godet

full_name: Cendrine Godet

given: Cendrine

family: Andrejak

full_name: Claire Andrejak

given: Claire

family: Pontier-Marchandise

full_name: Sandrine Pontier-Marchandise

given: Sandrine

family: Parrot

full_name: Antoine Parrot

given: Antoine

family: Mayaux

full_name: Julien Mayaux

given: Julien

family: Meyer

full_name: Guy Meyer

given: Guy

family: Cluzel

full_name: Philippe Cluzel

family: Sapoval

full_name: Marc Sapoval

given: Marc

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

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


title: Use of a CMGS to Validate Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Treated With Subcutaneous Continuous Insulin Infusion and Practicing Physical Activity

acronym: DIABRASPORT

summary:
Primary aim:

To show that in subjects with type 1 diabetes with a subcutaneous continuous insulin infusion, adjustment of the recommended basal insulin flow rate in the event of physical activity allows the subjects to practice sports without any increase in incidence of hypoglycaemia during physical activity or the ensuing hours.

(NB: hypoglycaemia is defined as blood glucose less than 3 mmol/l or 0,54 g/l in accordance with the EMEA definition).

The proposed algorithms consist of a temporary reduction in basal flow of 50 percent or 80 percent (temporary basal flow TBR50 or TBR80) depending on the intensity of physical activity (50 percent of VO2max or 75 percent of VO2max). Switching off the pump will also be studied as an option to adjust insulin dosage in the event of unprogrammed physical activity (temporary reduction of basal flow by 100 percent).

Secondary aims:

Characterisation of hypoglycaemia during and after physical activity based on CGMS data: symptomatic or non-symptomatic nature of hypoglycaemia, time to onset of hypoglycaemia in relation to the start of physical activity, degree and severity of hypoglycaemia.
Evaluation of overall variations in blood glucose in the event of physical activity using CGMS data (area under the curve).
Evaluation of glucose restoration methods used in the event of hypoglycaemia.
Analysis of subgroups of patients with and without hypoglycaemia.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients

summary: Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).

ReferenceCitation: Padilla N, Maraninchi M, Béliard S, Berthet B, Nogueira JP, Wolff E, Nicolay A, Bégu A, Dubois N, Grangeot R, Mattei C, Vialettes B, Xiao C, Lewis GF, Valéro R. Effects of bariatric surgery on hepatic and intestinal lipoprotein particle metabolism in obese, nondiabetic humans. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2330-7. doi: 10.1161/ATVBAHA.114.303849. Epub 2014 Aug 7.

name: From the Aix-Marseille Université, UMR_S1062, UMR_A1260, NORT, F-13385, Marseille, France (N.P., M.M., S.B., E.W., A.N., R.V.); Department of Nutrition, Metabolic Diseases, Endocrinology (S.B., A.B., N.D., R.G., C.M., B.V., R.V.) and Department of Visceral Surgery (B.B.), AP-HM, La Timone Hospital, Marseille, France; Department of Endocrinology, Medico Moving Center Institute, Formosa, Argentina (J.P.N.); and Departments of Medicine and Physiology, and Banting and Best Diabetes Centre, University of...

family: Padilla

full_name: Nadège Padilla

given: Nadège

family: Maraninchi

full_name: Marie Maraninchi

given: Marie

family: Béliard

full_name: Sophie Béliard

family: Berthet

full_name: Bruno Berthet

given: Bruno

family: Nogueira

full_name: Juan-Patricio Nogueira

given: Juan-Patricio

family: Wolff

full_name: Estelle Wolff

given: Estelle

family: Nicolay

full_name: Alain Nicolay

given: Alain

family: Bégu

full_name: Audrey Bégu

given: Audrey

family: Dubois

full_name: Noémie Dubois

given: Noémie

family: Grangeot

full_name: Rachel Grangeot

given: Rachel

family: Mattei

full_name: Catherine Mattei

given: Catherine

family: Vialettes

full_name: Bernard Vialettes

given: Bernard

family: Xiao

full_name: Changting Xiao

given: Changting

family: Lewis

full_name: Gary F. Lewis

given: Gary F.

family: Valéro

full_name: René Valéro

given: René

journal_name: Arteriosclerosis, Thrombosis, and Vascular Biology

title: Effects of Bariatric Surgery on Hepatic and Intestinal Lipoprotein Particle Metabolism in Obese, Nondiabetic Humans


title: High Frequency rTMS (Repetitive Transcranial Magnetic Stimulation) Effect Applied on Primary Cortical Motor, on Nociceptive Perception Thresholds in Parkinson's Disease Patients: a Physiopathology Study

acronym: rTMS

summary:
Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an electrophysiological tool which can modify cortical excitability. Its efficacy was demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients. Each group will receive a high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of one week.

The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session with an infraliminary intensity on the primary cortical motor, modulating nociceptive cortical areas activity, could modify the nociceptive threshold perception in Parkinson's patients.


summary: The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence

lead_sponsor: University Hospital, Rouen

location_facility: Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont


title: Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®

acronym: CARTO-CRT

summary: Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.

ReferenceCitation: Huntjens PR, Ploux S, Strik M, Walmsley J, Ritter P, Haissaguerre M, Prinzen FW, Delhaas T, Lumens J, Bordachar P. Electrical Substrates Driving Response to Cardiac Resynchronization Therapy: A Combined Clinical-Computational Evaluation. Circ Arrhythm Electrophysiol. 2018 Apr;11(4):e005647. doi: 10.1161/CIRCEP.117.005647.

name: Electrophysiology and Heart Modeling Institute (LIRYC), Bordeaux University, Pessac, France (P.R.H., S.P., M.S., P.R., M.H., J.L., P.B.). Cardiac Electrophysiology and Cardiac Stimulation Team, Bordeaux University Hospital, Pessac, France (P.R.H., S.P., M.S., P.R., M.H., J.L., P.B.). Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, the Netherlands (P.R.H., M.S., J.W., F.W.P., T.D., J.L.).

family: Huntjens

full_name: Peter R. Huntjens

given: Peter R.

family: Ploux

full_name: Sylvain Ploux

given: Sylvain

family: Strik

full_name: Marc Strik

family: Walmsley

full_name: John Walmsley

given: John

family: Ritter

full_name: Philippe Ritter

given: Philippe

family: Haissaguerre

full_name: Michel Haissaguerre

given: Michel

family: Prinzen

full_name: Frits W. Prinzen

given: Frits W.

family: Delhaas

full_name: Tammo Delhaas

given: Tammo

family: Lumens

full_name: Joost Lumens

given: Joost

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

journal_name: Circulation: Arrhythmia and Electrophysiology

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor


title: Validation of a Non Invasive methylateDNA Test for te Diagnosis of Colorectal Tumour in Asymptomatic Individuals

acronym: VATNIMAD

summary: Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples, followed by colonoscopy if the result is positive. The information quality of the Hemoccult test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to 50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood in stools are currently being evaluated; based on the threshold it can be more sensitive than FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of blood in stools, it may become highly specific and miss less advanced polyps. Faecal molecular tests based on the detection of human DNA anomalies (point gene mutations, methylation disorders of CG islets) appear to be more sensitive than the detection of occult blood in stools with no loss of specificity, but they are very expensive, thereby limiting their generalisation to the scale of population screening. A formal methylated DNA test has been validated in stools as well as in blood in a cohort of symptomatic individuals having undergone colonoscopy. The aim of the present study is to validate this test by taking advantage of the biotechnical expertise from renowned academic research teams and mass screening organisation.

ReferenceCitation: Sobhani I, Bergsten E, Charpy C, Chamaillard M, Mestivier D. Virulent Bacteria as Inflammatory and Immune Co-Factor in Colon Carcinogenesis: Evidence From Two Monozygotic Patients and Validation in CRC Patient and Healthy Cohorts. Front Cell Infect Microbiol. 2021 Nov 4;11:749750. doi: 10.3389/fcimb.2021.749750. eCollection 2021.

family: Sobhani

full_name: Iradj Sobhani

given: Iradj

family: Bergsten

full_name: Emma Bergsten

given: Emma

family: Charpy

full_name: Cecile Charpy

given: Cecile

family: Chamaillard

full_name: Mathias Chamaillard

given: Mathias

family: Mestivier

full_name: Denis Mestivier

given: Denis

journal_name: Frontiers in Cellular and Infection Microbiology

ReferenceCitation: Sobhani I, Bergsten E, Couffin S, Amiot A, Nebbad B, Barau C, de'Angelis N, Rabot S, Canoui-Poitrine F, Mestivier D, Pédron T, Khazaie K, Sansonetti PJ. Colorectal cancer-associated microbiota contributes to oncogenic epigenetic signatures. Proc Natl Acad Sci U S A. 2019 Nov 26;116(48):24285-24295. doi: 10.1073/pnas.1912129116. Epub 2019 Nov 11.

family: Couffin

full_name: Séverine Couffin

given: Séverine

family: Amiot

full_name: Aurélien Amiot

given: Aurélien

family: Nebbad

full_name: Biba Nebbad

given: Biba

family: Barau

full_name: Caroline Barau

given: Caroline

family: de’Angelis

full_name: Nicola de’Angelis

given: Nicola

family: Rabot

full_name: Sylvie Rabot

given: Sylvie

family: Canoui-Poitrine

full_name: Florence Canoui-Poitrine

given: Florence

family: Pédron

full_name: Thierry Pédron

given: Thierry

family: Khazaie

full_name: Khashayarsha Khazaie

given: Khashayarsha

family: Sansonetti

full_name: Philippe J. Sansonetti

given: Philippe J.

journal_name: Proceedings of the National Academy of Sciences

oa_colors: green hybrid

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

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


title: Soluble Forms and Ligands of the Receptor for Advanced Glycation End Products (RAGE) in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS : an Observational Prospective Study.

acronym: SoLiRAGE

summary: RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data are available about the levels of soluble forms and ligands of RAGE in the setting of ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with ALI/ARDS.

time_perspective: Cross-Sectional

ReferenceCitation: Jabaudon M, Blondonnet R, Roszyk L, Pereira B, Guérin R, Perbet S, Cayot S, Bouvier D, Blanchon L, Sapin V, Constantin JM. Soluble Forms and Ligands of the Receptor for Advanced Glycation End-Products in Patients with Acute Respiratory Distress Syndrome: An Observational Prospective Study. PLoS One. 2015 Aug 14;10(8):e0135857. doi: 10.1371/journal.pone.0135857. eCollection 2015.

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Blondonnet

full_name: Raiko Blondonnet

given: Raiko

family: Roszyk

full_name: Laurence Roszyk

given: Laurence

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Guérin

full_name: Renaud Guérin

given: Renaud

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Cayot

full_name: Sophie Cayot

given: Sophie

family: Bouvier

full_name: Damien Bouvier

given: Damien

family: Blanchon

full_name: Loic Blanchon

given: Loic

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

journal_name: PLOS ONE

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

lead_sponsor: University Hospital, Clermont-Ferrand


title: DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children.

acronym: DESHYDRAT

summary: The aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.

lead_sponsor: Rennes University Hospital


summary: Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.

lead_sponsor: Université Victor Segalen Bordeaux 2


summary: To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.

ReferenceCitation: Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bébéar C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.

family: Boyer

full_name: Alexandre Boyer

given: Alexandre

family: Goret

full_name: Julien Goret

given: Julien

family: Clouzeau

full_name: Benjamin Clouzeau

given: Benjamin

family: Romen

full_name: Antoine Romen

given: Antoine

family: Prevel

full_name: Renaud Prevel

family: Lhomme

full_name: Edouard Lhomme

given: Edouard

family: Vargas

full_name: Frédéric Vargas

given: Frédéric

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Bébéar

full_name: Cecile Bébéar

given: Cecile

family: Gruson

full_name: Didier Gruson

given: Didier

family: M'Zali

full_name: Fatima M'Zali

given: Fatima

journal_name: Respiratory Care

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises