title: Mobilization by Plerixafor of Haematopoietic Stem Cells in Children

summary: This is a prospective Phase II, monocentre study.


title: Saliva and Plasma Endocannabinoids Concentrations According to Feeding Status and Body Mass Index

acronym: SALIVENDO

summary: Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Bordeaux

location_facility: Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

summary:
Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2).

No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects.

Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression.

The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.

The secondary objectives

To estimate the duration of remission obtained after the treatment
To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement.
To estimate the action of cutaneous Veregen on the pruritus
And to estimate the global level of acceptability by the patient of the Veregen 10 %

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Toulouse University Hospital, Dermatology Department

intervention_type: Drug

status_simplified: Unknown


title: Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.

acronym: L-Lysine

summary: Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels will be measured under treatment with aprepitant versus placebo, in both basal conditions and after activation of the adrenocortical function by various stimuli, including upright posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be given two substances (L-lysine and placebo) in a random order during two 13 days periods separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4 receptors in the control of corticosteroid production in normal man.

lead_sponsor: University Hospital, Rouen

location_facility: Rouen Clinical research Centre (CIC 0204)

intervention_type: Dietary Supplement


type: Other Identifier

title: Evaluation of the Predictive Ability of Urinary NGAL as an Early Marker of Acute Kidney Injury Following Cardiac Surgery in Neonates and Infants

acronym: NGAL

summary:
Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy.

The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy in neonates and infants undergoing cardiac surgery

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J, Devarajan P. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol. 2008 May;3(3):665-73. doi: 10.2215/CJN.04010907. Epub 2008 Mar 12.

ReferenceCitation: Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8.

ReferenceCitation: Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21. Review.

ReferenceType: derived

ReferenceCitation: Bojan M, Basto Duarte MC, Lopez V, Tourneur L, Vicca S, Froissart M. Low perfusion pressure is associated with renal tubular injury in infants undergoing cardiac surgery with cardiopulmonary bypass: A secondary analysis of an observational study. Eur J Anaesthesiol. 2018 Aug;35(8):581-587. doi: 10.1097/EJA.0000000000000782.

family: Bojan

full_name: Mirela Bojan

given: Mirela

sequence: first

family: Basto Duarte

full_name: Maria C. Basto Duarte

given: Maria C.

sequence: additional

family: Lopez

full_name: Vanessa Lopez

given: Vanessa

family: Tourneur

full_name: Laurent Tourneur

given: Laurent

family: Vicca

full_name: Stephanie Vicca

given: Stephanie

family: Froissart

full_name: Marc Froissart

given: Marc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

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: Bojan M, Basto Duarte MC, Ermak N, Lopez-Lopez V, Mogenet A, Froissart M. Structural equation modelling exploration of the key pathophysiological processes involved in cardiac surgery-related acute kidney injury in infants. Crit Care. 2016 Jun 5;20(1):171. doi: 10.1186/s13054-016-1350-1.

full_name: Maria Constanza Basto Duarte

given: Maria Constanza

family: Ermak

full_name: Natalia Ermak

given: Natalia

family: Lopez-Lopez

full_name: Vanessa Lopez-Lopez

family: Mogenet

full_name: Agnès Mogenet

given: Agnès

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Bojan M, Vicca S, Lopez-Lopez V, Mogenet A, Pouard P, Falissard B, Journois D. Predictive performance of urine neutrophil gelatinase-associated lipocalin for dialysis requirement and death following cardiac surgery in neonates and infants. Clin J Am Soc Nephrol. 2014 Feb;9(2):285-94. doi: 10.2215/CJN.04730513. Epub 2013 Nov 21.

journal_name: Clinical Journal of the American Society of Nephrology

title: Predictive Performance of Urine Neutrophil Gelatinase-Associated Lipocalin for Dialysis Requirement and Death Following Cardiac Surgery in Neonates and Infants


title: Ultrasound Guidance for Radial Arterial Blood Sampling

summary: The investigators aim to determine if ultrasound guidance results in improved technique when drawing blood via a radial artery puncture.

primary_purpose: Prevention

ReferenceCitation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10:CD013585. doi: 10.1002/14651858.CD013585.pub2. Review.

name: Department of Surgery, Division of Vascular and Endovascular Surgery; Universidade Federal de São Paulo; São Paulo Brazil

family: Flumignan

full_name: Ronald LG Flumignan

given: Ronald LG

name: Emergency Medicine; Universidade Federal de São Paulo; São Paulo Brazil

name: Rheumatology; Universidade de Santo Amaro; São Paulo Brazil

family: Trevisani

full_name: Virginia FM Trevisani

given: Virginia FM

name: Division of Cardiology; Duke University Medical Center; Durham USA

family: Lopes

full_name: Renato D Lopes

given: Renato D

name: Evidence-based Medicine; Cochrane Brazil; São Paulo Brazil

family: Baptista-Silva

full_name: Jose CC Baptista-Silva

given: Jose CC

full_name: Carolina DQ Flumignan

given: Carolina DQ

family: Nakano

full_name: Luis CU Nakano

given: Luis CU

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Procedure


title: Personalised Program for Women Treated for Hodgkin Disease : Risk Evaluation of Breast Cancer and Intensive Screening Program for Women at High Risk of Breast Cancer. PROPER/IPC 2010-001

acronym: PROPER

summary:
After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death.

The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.

status: Terminated

lead_sponsor: Institut Paoli-Calmettes


title: Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities

acronym: ALLOPULM

summary: This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

ReferenceCitation: Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Rivière F, Robin M, Mani J, Lorillon G, Socié G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5). pii: 1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.

family: Bergeron

full_name: Anne Bergeron

given: Anne

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Peffault de Latour

full_name: Régis Peffault de Latour

given: Régis

family: Chagnon

full_name: Karine Chagnon

given: Karine

family: de Margerie-Mellon

full_name: Constance de Margerie-Mellon

given: Constance

family: Rivière

full_name: Frédéric Rivière

given: Frédéric

family: Robin

full_name: Marie Robin

given: Marie

family: Mani

full_name: Jean Mani

given: Jean

family: Lorillon

full_name: Gwenael Lorillon

given: Gwenael

family: Socié

full_name: Gérard Socié

given: Gérard

family: Tazi

full_name: Abdellatif Tazi

given: Abdellatif

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.

summary:
The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH.

The study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.

ReferenceCitation: Banki NM, Kopelnik A, Dae MW, Miss J, Tung P, Lawton MT, Drew BJ, Foster E, Smith W, Parmley WW, Zaroff JG. Acute neurocardiogenic injury after subarachnoid hemorrhage. Circulation. 2005 Nov 22;112(21):3314-9. Epub 2005 Nov 14.

ReferenceType: result

ReferenceCitation: Meaudre E, Jego C, Kenane N, Montcriol A, Boret H, Goutorbe P, Habib G, Palmier B. B-type natriuretic peptide release and left ventricular filling pressure assessed by echocardiographic study after subarachnoid hemorrhage: a prospective study in non-cardiac patients. Crit Care. 2009;13(3):R76. doi: 10.1186/cc7891. Epub 2009 May 20.

family: Meaudre

full_name: Eric Meaudre

given: Eric

family: Jego

full_name: Christophe Jego

given: Christophe

family: Kenane

full_name: Nadia Kenane

given: Nadia

family: Montcriol

full_name: Ambroise Montcriol

given: Ambroise

family: Boret

full_name: Henry Boret

given: Henry

family: Goutorbe

full_name: Philippe Goutorbe

given: Philippe

family: Habib

full_name: Gilbert Habib

given: Gilbert

family: Palmier

full_name: Bruno Palmier

given: Bruno

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Prunet B, Basely M, D'Aranda E, Cambefort P, Pons F, Cimarelli S, Dagain A, Desse N, Veyrieres JB, Jego C, Lacroix G, Esnault P, Boret H, Goutorbe P, Bussy E, Habib G, Meaudre E. Impairment of cardiac metabolism and sympathetic innervation after aneurysmal subarachnoid hemorrhage: a nuclear medicine imaging study. Crit Care. 2014 Jun 25;18(3):R131. doi: 10.1186/cc13943.

family: Prunet

full_name: Bertrand Prunet

given: Bertrand

family: Basely

full_name: Mathieu Basely

given: Mathieu

family: D’Aranda

full_name: Erwan D’Aranda

given: Erwan

family: Cambefort

full_name: Pierre Cambefort

given: Pierre

family: Pons

full_name: Frédéric Pons

family: Cimarelli

full_name: Sébastien Cimarelli

given: Sébastien

family: Dagain

full_name: Arnaud Dagain

given: Arnaud

family: Desse

full_name: Nicolas Desse

given: Nicolas

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Intensive Care Unit, Military Teaching Hospital sainte Anne


title: IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years

acronym: IT-DIAB

summary: The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.

study_start_date_type: Actual

status: Active, not recruiting

primary_purpose: Diagnostic

ReferenceCitation: Chávez-Talavera O, Wargny M, Pichelin M, Descat A, Vallez E, Kouach M, Bigot-Corbel E, Joliveau M, Goossens JF, Le May C, Hadjadj S, Hanf R, Tailleux A, Staels B, Cariou B. Bile acids associate with glucose metabolism, but do not predict conversion from impaired fasting glucose to diabetes. Metabolism. 2020 Feb;103:154042. doi: 10.1016/j.metabol.2019.154042. Epub 2019 Nov 27.

family: Chávez-Talavera

full_name: Oscar Chávez-Talavera

given: Oscar

family: Wargny

full_name: Matthieu Wargny

given: Matthieu

family: Pichelin

full_name: Matthieu Pichelin

family: Descat

full_name: Amandine Descat

given: Amandine

family: Vallez

full_name: Emmanuelle Vallez

given: Emmanuelle

family: Kouach

full_name: Mostafa Kouach

given: Mostafa

family: Bigot-Corbel

full_name: Edith Bigot-Corbel

given: Edith

family: Joliveau

full_name: Marielle Joliveau

given: Marielle

family: Goossens

full_name: Jean-François Goossens

given: Jean-François

family: Le May

full_name: Cédric Le May

given: Cédric

family: Hadjadj

full_name: Samy Hadjadj

given: Samy

family: Hanf

full_name: Rémy Hanf

given: Rémy

family: Tailleux

full_name: Anne Tailleux

given: Anne

family: Staels

full_name: Bart Staels

given: Bart

family: Cariou

full_name: Bertrand Cariou

journal_name: Metabolism

oa_host_type: repository

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

repository_normalized: HAL

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

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

version: submittedVersion

repository_institution: Université de Lille (University Of Lille) - LillOA

ReferenceCitation: Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zaïr Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org


title: Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns

summary: It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other


title: Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities

summary: Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on clinical factors (extension of the disease, achievement of the perianal ring, requirement of surgery, treatment by immunomodulators…). All IBD specific immunological or serological markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs Crohn Disease) but were never able to be considered as predictive elements of adults IBD evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their combination present an average sensibility about 85 % and a 85 % specificity. However, 8 other antibody types were recently isolated and estimated individually during IBD in particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA, AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These complementary assays improve significantly the reliability of the diagnosis. However, if the use of these new markers has an indisputable diagnostic role, their predictive role in the evolution of IBD was estimated at the adult's only rarely during Crohn diseases. Consequently, the investigators suggest realizing an exhaustive analysis of all these new immunological markers to define, if their association can have an interest in the differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary) clinical forms.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

summary:
Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.

The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

primary_purpose: Supportive Care

location_facility: Assistance Publique - Hôpitaux de Marseille


acronym: NET

type: EudraCT Number

source: euctr

title: A Multicenter Phase II Open Study Coupled With a Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.

summary:
The purpose of this study is to identify predictive molecular markers of response to continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.

Hypothesis:

To distinguish molecular markers based on their expression at the initial biopsy, their detection by proteomic analysis and demonstrating that tumor or vascular cells are straightaway sensitive to sunitinib (markers sensitivity).
The presence of these markers at the initial biopsy predict the sensitivity to sunitinib(Positive predictive value of markers)


acronym: Fibrolam

title: A Multicenter National Phase II Open Study Coupled With Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Hepatocellular Carcinoma.

summary:
The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with advanced/inoperable fibrolamellar hepatocellular carcinoma.

Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor


title: Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts

acronym: OSTA

summary:
The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.

The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.

The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

repository_normalized: University of Melbourne - Minerva Access

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

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

location_facility: Assistance Publique - Hôpitaux de Paris : BICETRE Hospital


title: Reversion of the Anticoagulant Effect of the New Antithrombotic Agents Anti-Xa and Anti IIa by Specific and Non-specific Haemostatic Drugs,: an Ex-Vivo Study in Healthy Volunteers

acronym: REVNEWANTICO

summary: The purpose of this study is to evaluate whether the effect of the two new anticoagulants, Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex concentrate (PCC), recombinant activated coagulation factor VII, and activated prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from healthy male volunteers.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinical Research Centre, University Hospital Grenoble


title: GENEWING - A Genome Wide Association Study in Ewing Sarcoma

acronym: GENEWING

summary:
RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their relatives may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples collected from patients with Ewing sarcoma and their relatives.

time_perspective: Retrospective

lead_sponsor: Institut Curie


type: Registry Identifier

title: Modelling of 24h Energy Expenditure From Heart Rate, Actimetry and Other Parameters Recorded Under Free-living Conditions

acronym: Modelheart

summary:
At this time, 24h energy expenditure is rarely assessed under free-living conditions for specific individuals because of the lack of cheap and accurate software/materials to record the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor, Actiheart, SenseWear Armband) are available on the market but the predictive equations comprised into the software provided with these tools generally miscalculate the energy expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor knowledge of the modification of the energy expended during daily life activities and over 24h in subjects belonging to groups of various ages and physiological states. The investigators hypothesise that it could be possible to improve the energy expenditure prediction.

The project aims at providing a mathematical model (equations) that predicts energy expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight volunteers aged between 18-60 years participate to this study. The first group stay for 26h in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry, and other parameters are recorded during various activities. These data will serve to construct the model. The same type of recordings are performed on second group of volunteers in free living conditions. Their energy expenditure is measured overall by doubly labeled water. The data of the second group will serve to validate the model. The error percentage of the model is defined by the ratio of the value of the difference between prediction and reference measure to the reference measure. Concordance between predictions and measures will be evaluated by Bland - Altman plots.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine d'Auvergne

intervention_type: Device


title: Emergence of Fluoroquinolone Resistance in the Commensal Flora of Patients Receiving Fluoroquinolone Treatment.

acronym: FQEMERG

summary: The emergence of resistance to fluoroquinolone (FQ) is a major problem worldwide. The commensal flora is the main reservoir for antibiotic resistance. Understanding the factors (environmental, patient-related, dosis-related, drug-related…) involved in the emergence of resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help prevent it and preserve the efficiency of these important antibiotics. Samples of rectal, nasal and pharyngeal flora will be collected from hospitalized patients before receiving a FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be collected. The incidence and risk-factors associated with the emergence of resistance to FQ will be assessed by comparing groups with and without resistance both at the end of treatment and 1 month later.

ReferenceCitation: de Lastours V, Chau F, Roy C, Larroque B, Fantin B. Emergence of quinolone resistance in the microbiota of hospitalized patients treated or not with a fluoroquinolone. J Antimicrob Chemother. 2014 Dec;69(12):3393-400. doi: 10.1093/jac/dku283. Epub 2014 Jul 24.

family: de Lastours

full_name: V. de Lastours

given: V.

family: Chau

full_name: F. Chau

given: F.

family: Roy

full_name: C. Roy

given: C.

family: Larroque

full_name: B. Larroque

given: B.

family: Fantin

full_name: B. Fantin

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


intervention_type: Radiation

lead_sponsor: Centre Antoine Lacassagne

acronym: AACER

title: Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

lead_sponsor_type: industriel


title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.


title: Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

summary: The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey


title: XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

acronym: XERES

summary: Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

lead_sponsor: Abbott Medical Devices


summary:
Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.

Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.

ReferenceCitation: Saveanu A, Sebag F, Guillet B, Archange C, Essamet W, Barlier A, Palazzo FF, Taïeb D. Targeting dopamine receptors subtype 2 (D2DR) in pheochromocytomas: head-to-head comparison between in vitro and in vivo findings. J Clin Endocrinol Metab. 2013 Dec;98(12):E1951-5. doi: 10.1210/jc.2013-2269. Epub 2013 Sep 5.

family: Saveanu

full_name: Alexandru Saveanu

given: Alexandru

family: Sebag

full_name: Frederic Sebag

given: Frederic

family: Guillet

full_name: Benjamin Guillet

given: Benjamin

family: Archange

full_name: Cendrine Archange

given: Cendrine

family: Essamet

full_name: Wassim Essamet

given: Wassim

family: Barlier

full_name: Anne Barlier

family: Palazzo

full_name: Fausto F. Palazzo

given: Fausto F.

family: Taïeb

full_name: David Taïeb

given: David

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Targeting Dopamine Receptors Subtype 2 (D2DR) in Pheochromocytomas: Head-to-Head Comparison Between In Vitro and In Vivo Findings

location_facility: Assistance Publique-Hopitaux de Marseille


title: Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.

PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

ReferenceCitation: Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.

family: Cao

full_name: K.I. Cao

family: Lebas

full_name: N. Lebas

given: N.

family: Gerber

full_name: S. Gerber

given: S.

family: Levy

full_name: C. Levy

family: Le Scodan

full_name: R. Le Scodan

given: R.

family: Bourgier

full_name: C. Bourgier

family: Pierga

full_name: J.-Y. Pierga

family: Gobillion

full_name: A. Gobillion

given: A.

family: Savignoni

full_name: A. Savignoni

family: Kirova

full_name: Y.M. Kirova

journal_name: Annals of Oncology

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: A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

primary_purpose: Other

lead_sponsor: LEO Pharma


title: Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.

acronym: ELVIS

summary: The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.

ReferenceCitation: Boyer A, Timsit JF, Klouche K, Canet E, Phan TN, Bohé J, Rubin S, Orieux A, Lautrette A, Gruson D, Souweine B. Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study. Clin Ther. 2021 Jun;43(6):1116-1124. doi: 10.1016/j.clinthera.2021.04.011. Epub 2021 May 24.

family: Boyer

full_name: Alexandre Boyer

given: Alexandre

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Klouche

full_name: Kada Klouche

given: Kada

family: Canet

full_name: Emmanuel Canet

given: Emmanuel

family: Phan

full_name: Thuy-nga Phan

given: Thuy-nga

family: Bohé

full_name: Julien Bohé

given: Julien

family: Rubin

full_name: Sebastien Rubin

given: Sebastien

family: Orieux

full_name: Arthur Orieux

given: Arthur

family: Lautrette

full_name: Alexandre Lautrette

family: Gruson

full_name: Didier Gruson

given: Didier

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

journal_name: Clinical Therapeutics

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

ReferenceCitation: Souweine B, Lautrette A, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Guelon D, Darmon M, Vesin A, Caillot N, Schwebel C, Boyer A, Azoulay E, Bouadma L, Timsit JF. Ethanol lock and risk of hemodialysis catheter infection in critically ill patients. A randomized controlled trial. Am J Respir Crit Care Med. 2015 May 1;191(9):1024-32. doi: 10.1164/rccm.201408-1431OC.

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Bohe

full_name: Julien Bohe

family: Garrouste-Orgeas

full_name: Maïté Garrouste-Orgeas

given: Maïté

family: Mariat

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Ethanol Lock and Risk of Hemodialysis Catheter Infection in Critically Ill Patients. A Randomized Controlled Trial


title: Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy

summary:
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.

PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Study of Ocular Blood Flow Using Laser Doppler Flowmetry in Patients With Glaucoma and/or OSAS

summary:
Obstructive sleep apnea syndrome (OSAS) is a common disease, with a prevalence evaluated between 5 - 7% in the general population. OSAS is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, which are nearly systematically associated with a desaturation-reoxygenation sequence, an admitted detrimental stimulus for the cardiovascular system. It has now been demonstrated that OSAS per se is able to generate hypertension, atherosclerosis and autonomic dysfunction (high sympathic tone and increase in baseline heart rate), all conditions possibly interacting with ocular vascular regulation. OSAS has major consequences on the ocular level since it is associated with a higher frequency of optic neuropathies, such as glaucoma and nonarteritic ischemic optic neuropathy (NAION), both with functional severe prognosis. Most of vascular changes associated with OSAS have been studied at the level of macrovasculature. In terms of physiopathology, the main effects on the vascular system in OSAS are sympathetic hyperactivity, oxidative stress, development of endothelial dysfunction, systemic inflammation and metabolic alterations such as the appearance of insulin resistance. All these mechanisms can affect the microcirculation of the eye, especially the optic nerve and choroid. Our hypothesis is that the eye microvasculature is affected by OSAS, and these lesions may be detected via a reduced autoregulation of blood flow in humans.

This project aims to demonstrate, quantify, and analyze the vascular modifications of the eye associated with OSAS trough a comparative clinical study on glaucoma patients and OSAS patients and matched healthy subjects for the regulation of the eye blood flow using confocal laser Doppler flowmetry (LDF). The regulation of the ocular blood flow will be assessed using several stimuli and measured using a new confocal LDF.

ReferenceCitation: Chiquet C, Lacharme T, Riva C, Almanjoumi A, Aptel F, Khayi H, Arnol N, Romanet JP, Geiser M. Continuous response of optic nerve head blood flow to increase of arterial blood pressure in humans. Invest Ophthalmol Vis Sci. 2014 Jan 23;55(1):485-91. doi: 10.1167/iovs.13-12975.

family: Chiquet

full_name: Christophe Chiquet

given: Christophe

family: Lacharme

full_name: Tiffany Lacharme

given: Tiffany

name: Université de Lausanne, Lausanne, Switzerland

family: Riva

full_name: Charles Riva

given: Charles

name: Université Joseph Fourier Grenoble 1, Grenoble, France 5Department of Ophthalmology, King Abdulaziz University, Jeddah, Saudi Arabia

family: Almanjoumi

full_name: Ahmed Almanjoumi

given: Ahmed

family: Aptel

full_name: Florent Aptel

given: Florent

name: Université Joseph Fourier Grenoble 1, Grenoble, France 2Department of Ophthalmology, Centre Hospitalier Universitaire (CHU) Grenoble, Grenoble, France

family: Khayi

full_name: Hafide Khayi

given: Hafide

name: Institut de la Santé et de la Recherche Médicale, Unité 1042, Lab Hypoxia and Physiopathology, Joseph Fourier University, Grenoble, France

family: Arnol

full_name: Nathalie Arnol

given: Nathalie

family: Romanet

full_name: Jean-Paul Romanet

given: Jean-Paul

name: Haute Ecole Valaisanne - Suisse Occidentale – Sion, Western Switzerland, Switzerland

family: Geiser

full_name: Martial Geiser

given: Martial

journal_name: Investigative Opthalmology & Visual Science

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: Continuous Response of Optic Nerve Head Blood Flow to Increase of Arterial Blood Pressure in Humans

ReferenceCitation: Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.

name: From the Departments of Ophthalmology, the 2Laboratory of Hypoxia and Physiopathology, University Hospital, Université Joseph Fourier, Grenoble, France; and

full_name: Hafid Khayi

given: Hafid

name: Rehabilitation and Physiology and the 2Laboratory of Hypoxia and Physiopathology, University Hospital, Université Joseph Fourier, Grenoble, France; and

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

name: Haute Ecole Spécialisée de Suisse Occidentale, University of Applied Sciences, Western Switzerland, Switzerland.

full_name: Martial H. Geiser

given: Martial H.

family: Tonini

full_name: Matthieu Tonini

given: Matthieu

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Renard

full_name: Elisabeth Renard

given: Elisabeth

name: Cardiology, and the 2Laboratory of Hypoxia and Physiopathology, University Hospital, Université Joseph Fourier, Grenoble, France; and

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Levy

full_name: Patrick Levy

given: Patrick

title: Choroidal Blood Flow Regulation after Posture Change or Isometric Exercise in Men with Obstructive Sleep Apnea Syndrome


title: Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

ReferenceCitation: Penel N, Ray-Coquard I, Bal-Mahieu C, Chevreau C, Le Cesne A, Italiano A, Bompas E, Clisant S, Baldeyrou B, Lansiaux A, Robin YM, Bay JO, Piperno-Neumann S, Blay JY, Fournier C. Low level of baseline circulating VEGF-A is associated with better outcome in patients with vascular sarcomas receiving sorafenib: an ancillary study from a phase II trial. Target Oncol. 2014 Sep;9(3):273-7. doi: 10.1007/s11523-013-0299-0. Epub 2013 Nov 12.

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Bal-Mahieu

full_name: Christine Bal-Mahieu

given: Christine

family: Chevreau

full_name: Christine Chevreau

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Clisant

full_name: Stéphanie Clisant

given: Stéphanie

family: Baldeyrou

full_name: Brigitte Baldeyrou

given: Brigitte

family: Lansiaux

full_name: Amélie Lansiaux

given: Amélie

family: Robin

full_name: Yves-Marie Robin

given: Yves-Marie

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Fournier

full_name: Charles Fournier

journal_name: Targeted Oncology

ReferenceCitation: Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.

family: Valentin

full_name: T. Valentin

given: T.

full_name: C. Fournier

given: C.

full_name: N. Penel

given: N.

full_name: E. Bompas

given: E.

family: Chaigneau

full_name: L. Chaigneau

given: L.

family: Isambert

full_name: N. Isambert

ReferenceCitation: Ray-Coquard I, Italiano A, Bompas E, Le Cesne A, Robin YM, Chevreau C, Bay JO, Bousquet G, Piperno-Neumann S, Isambert N, Lemaitre L, Fournier C, Gauthier E, Collard O, Cupissol D, Clisant S, Blay JY, Penel N; French Sarcoma Group (GSF/GETO). Sorafenib for patients with advanced angiosarcoma: a phase II Trial from the French Sarcoma Group (GSF/GETO). Oncologist. 2012;17(2):260-6. doi: 10.1634/theoncologist.2011-0237. Epub 2012 Jan 27.

name: cDepartment of Medical Oncology, Institut Bergonié, Bordeaux, France;

name: dDepartment of Medical Oncology, Centre René Gauducheau, Nantes, France;

name: eDepartment of Medical Oncology, Institut Gustave Roussy, Villejuif, France;

name: jDepartment of Medical Oncology, Institut Claudius Regaud, Toulouse, France;

name: kDepartment of Medical Oncology, Centre Jean Perrin, Clermont‐Ferrand, France;

name: lDepartment of Medical Oncology, Hôpital Saint‐Louis, Paris, France;

name: mDepartment of Medical Oncology, Institut Curie, Paris, France;

name: nDepartment of Medical Oncology, Centre GF Leclerc, Dijon, France;

name: oDepartment of Medical Imaging, University Hospital, Lille, France;

name: pBayer HealthCare‐France, Lille, France;

name: qMedical Oncology Unit, Institut de Cancérologie de la Loire, Saint Priest en Jarez, France;

name: rDepartment of Medical Oncology, Centre Val d'Aurelle, Montpellier, France;

name: aDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France;

name: iDepartment of General Oncology, Centre Oscar Lambret, Lille, France;

name: sLille‐Nord de France University, Lille, France

name: on behalf of the French Sarcoma Group (GSF/GETO)

title: Sorafenib for Patients with Advanced Angiosarcoma: A Phase II Trial from the French Sarcoma Group (GSF/GETO)


title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy

acronym: Lactaide

summary: Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The hypothesis is that such process may be applied to food allergy, more precisely to milk. A previous series of 8 patients indicates the likely effectiveness of this technique (Allergy, 2006).


title: Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

summary:
RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.


title: New Analgesic Strategy Combining Nitrous Oxide, Nefopam, Acetaminophen and Morphine Compared to the Usal Antalgic Strategy (Acetaminophen and Morphine) for the Treatment of Acute Sickle Cell Disease Pain in the Emergency Room

acronym: DREPANOX

summary:
Quality of life of adult patients with sickle cell disease is deeply impaired by severe adverse medical events that inadvertently occur throughout their time life. Indeed, patients not presenting a life threatening condition often present to the emergency department with sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic strategies for treating sickle cell disease crisis related pain are mostly based on acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies are effective but may last up to half an hour to obtain pain relief. This delay mostly depends on the availability of venous access and on individual patient response to treatment. Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to allow rapid analgesia in the emergency department setting.

The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective than current analgesic strategy.

location_facility: Henri Mondor Hospital, Emergency Department


title: Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects

summary: Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further metabolism. The primary goal of this work was to measure the metabolic fate of intact or hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of this study was to assess the true ileal digestibility of dietary protein using different methods including the hydrolyzed casein method and to measure its possible effect on endogenous intestinal N losses in humans.

ReferenceCitation: Deglaire A, Moughan PJ, Airinei G, Benamouzig R, Tomé D. Intact and hydrolyzed casein lead to similar ileal endogenous protein and amino acid flows in adult humans. Am J Clin Nutr. 2020 Jan 1;111(1):90-97. doi: 10.1093/ajcn/nqz268.

name: STLO, Agrocampus Ouest, INRA, Rennes, France

name: Riddet Institute, Massey University, Palmerston North, New Zealand

name: University Paris Saclay, UMR PNCA, AgroParisTech, INRA, Paris, France

family: Deglaire

full_name: Amélie Deglaire

family: Moughan

full_name: Paul J Moughan

given: Paul J

name: Department of Gastroenterology, Avicenne Hospital, AP HP, Bobigny, France

family: Airinei

full_name: Gheorghe Airinei

given: Gheorghe

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

family: Tomé

full_name: Daniel Tomé

given: Daniel

bso_classification: Biology (fond.)

journal_name: The American Journal of Clinical Nutrition

evidence: open (via free article)

ReferenceCitation: Deglaire A, Fromentin C, Fouillet H, Airinei G, Gaudichon C, Boutry C, Benamouzig R, Moughan PJ, Tomé D, Bos C. Hydrolyzed dietary casein as compared with the intact protein reduces postprandial peripheral, but not whole-body, uptake of nitrogen in humans. Am J Clin Nutr. 2009 Oct;90(4):1011-22. doi: 10.3945/ajcn.2009.27548. Epub 2009 Aug 19.

family: Fromentin

full_name: Claire Fromentin

given: Claire

family: Fouillet

full_name: Hélène Fouillet

given: Hélène

family: Gaudichon

full_name: Claire Gaudichon

family: Boutry

full_name: Claire Boutry

family: Bos

full_name: Cécile Bos

given: Cécile


title: Assessment of the Prevalence and Mutational Spectrum of Genes AHI1, NPHP1 and CEP290 in Joubert Syndrome and Cerebello-oculo-renal Syndromes

acronym: JSCORS

summary:
Primary objective:

assessment of the prevalence of AHI1 mutations in Joubert syndrome and cerebello-oculo-renal syndromes (JS/CORS)

Secondary objective:

assessment of the prevalence of CEP290 mutations and NPHP1 homozygous deletions in JS/CORS
caracterization of mutational spectrum of AHI1, NPHP1, CEP290 genes in JS/CORS.
evaluation of genotype-phenotype correlation in JS/CORS.

time_perspective: Cross-Sectional


title: Molecular Study of Factors Involved in JAK-STAT Signalling Pathway in Familial Myeloproliferative Disorders

acronym: SMP

summary: The main goal of the study is to progress in our understanding of the molecular basis of myeloproliferative disorders of the bone marrow (polycythemia vera, essential thrombocythemia, primary myelofibrosis). The study will focus on the genes encoding factors implicated in the JAK-STAT pathway which has an essential role in these diseases

location_facility: Department of Hematology, Hospital Saint Antoine


title: Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome

acronym: WPW

summary:
The study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago.

The investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the WPW syndrome.

This study will be realized by esophageal stimulation.

lead_sponsor: Nantes University Hospital


title: Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.

summary:
Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. However, controlled studies provided conflicting results. One of our patients showed a substantial decrease of his parkinsonian symptoms under transdermal nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent safety, especially on cardiovascular level. Otherwise, the investigators performed an open pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a controlled study. In this study, all patients received daily doses during several months until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving their motor scores.

The investigators now propose a phase II, controlled, single blind and randomised efficacy study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group without additional therapy) The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5 mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11 weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose "plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de 6-week period followed by a five-week wash out phase.

Taking into account results from the pilot study, a long-term high doses treatment, seems to be liable to improve patients who deeply suffer from their disease. This is why the investigators now propose this monocentric institutional project.

ReferenceCitation: Villafane G, Cesaro P, Rialland A, Baloul S, Azimi S, Bourdet C, Le Houezec J, Macquin-Mavier I, Maison P. Chronic high dose transdermal nicotine in Parkinson's disease: an open trial. Eur J Neurol. 2007 Dec;14(12):1313-6. Epub 2007 Oct 17.

location_facility: Groupe Hospitalier Albert Chenevier Henri Mondor


title: Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.


title: Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.

acronym: FOPasa

summary:
Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.

In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.


title: Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival: Survival Factors in COPD Treated by Long-term Oxygen Therapy

summary:
The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.

Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.

location_facility: Service de Pneumologie, Hôpital du Cluzeau


title: Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment

summary:
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

lead_sponsor: Hospices Civils de Lyon


title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

summary:
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.


title: Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer

acronym: ENDORAD

summary:
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.

ReferenceCitation: Ray-Coquard I, Favier L, Weber B, Roemer-Becuwe C, Bougnoux P, Fabbro M, Floquet A, Joly F, Plantade A, Paraiso D, Pujade-Lauraine E. Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO. Br J Cancer. 2013 May 14;108(9):1771-7. doi: 10.1038/bjc.2013.183. Epub 2013 Apr 23.

family: Ray-Coquard

full_name: I Ray-Coquard

given: I

family: Favier

full_name: L Favier

given: L

family: Weber

full_name: B Weber

given: B

family: Roemer-Becuwe

full_name: C Roemer-Becuwe

given: C

family: Bougnoux

full_name: P Bougnoux

given: P

family: Fabbro

full_name: M Fabbro

given: M

family: Floquet

full_name: A Floquet

given: A

family: Joly

full_name: F Joly

given: F

family: Plantade

full_name: A Plantade

family: Paraiso

full_name: D Paraiso

given: D

family: Pujade-Lauraine

full_name: E Pujade-Lauraine

given: E

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Trédan O, Treilleux I, Wang Q, Gane N, Pissaloux D, Bonnin N, Petit T, Cretin J, Bonichon-Lamichhane N, Priou F, Lavau-Denes S, Mari V, Freyer G, Lebrun D, Alexandre J, Ray-Coquard I. Predicting everolimus treatment efficacy in patients with advanced endometrial carcinoma: a GINECO group study. Target Oncol. 2013 Dec;8(4):243-51. doi: 10.1007/s11523-012-0242-9. Epub 2012 Dec 13.

family: Trédan

full_name: Olivier Trédan

given: Olivier

family: Treilleux

full_name: Isabelle Treilleux

given: Isabelle

family: Wang

full_name: Qing Wang

given: Qing

family: Gane

full_name: Nicolas Gane

given: Nicolas

family: Pissaloux

full_name: Daniel Pissaloux

family: Bonnin

full_name: Nathalie Bonnin

given: Nathalie

family: Petit

full_name: Thierry Petit


title: Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

summary:
RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

lead_sponsor: Centre Jean Perrin


title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

summary: Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

ReferenceCitation: Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, François S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.

family: Monjanel

full_name: Hélène Monjanel

given: Hélène

family: Deconinck

full_name: Eric Deconinck

given: Eric

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Gastinne

full_name: Thomas Gastinne

given: Thomas

family: Delwail

full_name: Vincent Delwail

given: Vincent

family: Moreau

full_name: Anne Moreau

given: Anne

family: François

full_name: Sylvie François

given: Sylvie

family: Berthou

full_name: Christian Berthou

given: Christian

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

family: Milpied

full_name: Noël Milpied

given: Noël

journal_name: Biology of Blood and Marrow Transplantation

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Long-Term Follow-Up of Tandem High-Dose Therapy with Autologous Stem Cell Support for Adults with High-Risk Age-Adjusted International Prognostic Index Aggressive non-Hodgkin Lymphomas: A GOELAMS Pilot Study

lead_sponsor: French Innovative Leukemia Organisation


title: Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3

summary: This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.

lead_sponsor: AB Science


title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study

summary:
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.

The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.

lead_sponsor: Centre Hospitalier Universitaire de Nice

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


title: Effect of Monosodium Glutamate on Gastric Emptying and Postprandial Nitrogen in Healthy Volunteers

summary: There are receptors to free glutamate in the oral cavity and stomach that may mediate effects of this amino acid on gastrointestinal physiology. The investigators hypothesize that a chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the further metabolism of dietary protein in healthy subjects.

ReferenceCitation: Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tomé D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.

name: INRA, Research Center for Human Nutrition-IdF, UMR914 and

name: AgroParisTech, Research Center for Human Nutrition-IdF, UMR914 Nutrition Physiology and Ingestive Behavior, Paris, France;

family: Boutry

full_name: Claire Boutry

given: Claire

name: AJINOMOTO, Institute of Life Sciences, Amino Acid Basic and Applied Research Group, Kawasaki, Japan; and

family: Matsumoto

full_name: Hideki Matsumoto

given: Hideki

name: Avicenne Hospital, Service of Gastroenterology, Research Center for Human Nutrition-IdF, Bobigny, France

family: Airinei

full_name: Gheorghe Airinei

given: Gheorghe

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

family: Tomé

full_name: Daniel Tomé

given: Daniel

family: Blachier

full_name: François Blachier

given: François

family: Bos

full_name: Cécile Bos

given: Cécile

journal_name: American Journal of Physiology-Gastrointestinal and Liver Physiology

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

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

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society


title: A Multi-center, Inpatient and Ambulatory, Phase 2, Double Blind, Randomized, Placebo-controlled Proof of Concept Study of CYR-101 in Patients With DSM-IV Schizophrenia

summary: This Phase II study will test whether CYR-101, a CNS-active compound with novel pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious when administered orally in the management of patients with a diagnosis of DSM-IV schizophrenia.

lead_sponsor: Cyrenaic Pharmaceuticals

location_facility: Centre Hospitalier Universitaire de Nancy (CHU)


title: An Open-label, Multi-centre, Clinical Study to Collect Information on the Clinical Use of Argatroban in Patients With Heparin Induced Thrombocytopenia (HIT) Type II Who Require Parenteral Antithrombotic Therapy

summary: The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

ReferenceCitation: Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andréani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.

family: Tardy-Poncet

full_name: Brigitte Tardy-Poncet

given: Brigitte

family: Nguyen

full_name: Philippe Nguyen

given: Philippe

family: Thiranos

full_name: Jean-Claude Thiranos

given: Jean-Claude

family: Morange

full_name: Pierre-Emmanuel Morange

given: Pierre-Emmanuel

family: Biron-Andréani

full_name: Christine Biron-Andréani

given: Christine

family: Gruel

full_name: Yves Gruel

given: Yves

family: Morel

full_name: Jérome Morel

given: Jérome

family: Wynckel

full_name: Alain Wynckel

given: Alain

family: Grunebaum

full_name: Lelia Grunebaum

given: Lelia

family: Villacorta-Torres

full_name: Judith Villacorta-Torres

given: Judith

family: Grosjean

full_name: Sandrine Grosjean

given: Sandrine

family: de Maistre

full_name: Emmanuel de Maistre

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

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

repositories:
HAL
PubMed Central

lead_sponsor: Mitsubishi Tanabe Pharma Corporation


title: Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

acronym: IRM 3T-SEP

summary:
It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood.

Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction).

This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.

ReferenceCitation: Hannoun S, Roch JA, Durand-Dubief F, Vukusic S, Sappey-Marinier D, Guttmann CR, Cotton F. Weekly multimodal MRI follow-up of two multiple sclerosis active lesions presenting a transient decrease in ADC. Brain Behav. 2015 Feb;5(2):e00307. doi: 10.1002/brb3.307. Epub 2015 Jan 16.

name: CREATIS – CNRS UMR 5220 & INSERM U1044 Université Claude Bernard‐Lyon1Villeurbanne France

name: Service de Neurologie A & EDMUS Coordinating Center for Multiple Sclerosis Hôpital Neurologique Pierre Wertheimer Bron France

family: Hannoun

full_name: Salem Hannoun

given: Salem

name: Service de Radiologie Centre Hospitalier Lyon‐Sud Hospices Civils de Lyon Pierre‐Bénite France

family: Roch

full_name: Jean‐Amédée Roch

given: Jean‐Amédée

family: Durand‐Dubief

full_name: Francoise Durand‐Dubief

given: Francoise

family: Vukusic

full_name: Sandra Vukusic

given: Sandra

name: CERMEP – Imagerie du Vivant Groupement Hospitalier Est Bron France

family: Sappey‐Marinier

full_name: Dominique Sappey‐Marinier

given: Dominique

name: Center for Neurological Imaging Brigham and Women's Hospital Boston Massachusetts

family: Guttmann

full_name: Charles R.G. Guttmann

given: Charles R.G.

family: Cotton

full_name: Francois Cotton

given: Francois

journal_name: Brain and Behavior

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

title: Weekly multimodal MRI follow‐up of two multiple sclerosis active lesions presenting a transient decrease in ADC

location_facility: Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique


title: PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

summary: The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.

ReferenceCitation: Lamblin G, Van-Nieuwenhuyse A, Chabert P, Lebail-Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. Int Urogynecol J. 2014 Jul;25(7):961-70. doi: 10.1007/s00192-014-2344-7. Epub 2014 Feb 27.

family: Lamblin

full_name: G. Lamblin

given: G.

family: Van-Nieuwenhuyse

full_name: A. Van-Nieuwenhuyse

given: A.

family: Chabert

full_name: P. Chabert

given: P.

family: Lebail-Carval

full_name: K. Lebail-Carval

given: K.

family: Moret

full_name: S. Moret

given: S.

family: Mellier

full_name: G. Mellier

journal_name: International Urogynecology Journal


title: MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study

acronym: MAP-IDM

summary:
We propose a comparative case-control study on the 2 following groups of patients:

Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct,
Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.

The primary endpoint in this study is the correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.

The first phase of the study, including patients' recruitment, clinical and biological data collection, will last 82 months. The second phase will concern the genotype/phenotype analysis and the identification of polymorphisms associated with a sudden death risk after a myocardial infarction.

This study will allow a better knowledge of the mechanisms of sudden death and the identification of new risk markers.

intervention_type: Genetic


title: Genetic Determinants of Phosphocalcic Metabolism in Hemodialysis Patients

acronym: ARNOGENE

summary: Searching for high morbi-mortality risk Klotho variants in dialysis patients

ReferenceCitation: Marçais C, Maucort-Boulch D, Drai J, Dantony E, Carlier MC, Blond E, Genet L, Kuentz F, Lataillade D, Legrand E, Moreau-Gaudry X, Jean G, Fouque D; ARNOGENE Project. Circulating Klotho Associates With Cardiovascular Morbidity and Mortality During Hemodialysis. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3154-3161. doi: 10.1210/jc.2017-00104.

name: University Lyon, UCBL, Service de Biochimie et Biologie Moléculaire, Centre Hospitalier Lyon Sud, CarMeN, CENS, F-69495 Pierre Bénite, France

family: Marçais

full_name: Christophe Marçais

given: Christophe

name: University Lyon, UCBL, CNRS Laboratoire de Biométrie et Biologie Evolutive, Service de Biostatistique, Hospices Civils de Lyon, F-69495 Pierre Bénite, France

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Drai

full_name: Jocelyne Drai

given: Jocelyne

family: Dantony

full_name: Emmanuelle Dantony

given: Emmanuelle

family: Carlier

full_name: Marie-Christine Carlier

given: Marie-Christine

family: Blond

full_name: Emilie Blond

given: Emilie

name: Service de Néphrologie Nutrition Dialyse, Centre Hospitalier Lyon Sud, F-69495 Pierre-Bénite, France

family: Genet

full_name: Leslie Genet

given: Leslie

name: Centre de Dialyse des Eaux Claires, AGDUC, F-38000 Grenoble, France

family: Kuentz

full_name: François Kuentz

given: François

name: Clinique Edouard Rist, F-75016 Paris, France

family: Lataillade

full_name: Dominique Lataillade

name: Service de Néphrologie Hémodialyse, Centre Hospitalier Ardèche Nord, F-07010 Annonay, France

family: Legrand

full_name: Eric Legrand

given: Eric

name: Centre de Dialyse AGDUC, Centre Hospitalier Général, F-26200 Montélimar, France

family: Moreau-Gaudry

full_name: Xavier Moreau-Gaudry

given: Xavier

name: Nephrocare, F-69110 Ste Foy-les-Lyon, France

family: Jean

full_name: Guillaume Jean

given: Guillaume

name: University Lyon, UCBL, CarMeN, CENS, Service de Néphrologie-Nutrition-Dialyse, Centre Hospitalier Lyon Sud, F-69495 Pierre Bénite, France

family: Fouque

full_name: Denis Fouque

given: Denis


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

summary: This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.

lead_sponsor: Astellas Pharma Inc


title: Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Patients Presenting a Recent Acute Coronary Syndrome.

acronym: EVANACS

summary:
The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c. This effectiveness will be tested among patients having presented recently an acute coronary syndrome. The effectiveness of the molecule will be appreciated versus placebo after randomization.

The technique of evaluation of this effectiveness will be the analysis of the vasodilatation endothelial-dependent measured on the level huméral (by echography high resolution).

The awaited result is an improvement of 2% in value absolute of this vasodilatation between the initial test and the end of study for the patients receiving the acid nicotinic versus those receiving the placebo (3 months of treatment after inclusion). The calculation of the sample necessary to achieve this goal envisages 70 patients led at the end of the study, divided into two groups of treatment (acid nicotinic or Placebo).

Such a result if it were obtained would be higher than that found in studies evaluating the effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.

lead_sponsor: French Cardiology Society


title: Validation of a Semiquantitative Screening Assay for PSA

summary: The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

lead_sponsor: Institut Curie


title: Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation

summary: We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation. A comparaison of results before and after three weeks of treatment will be made.

lead_sponsor: Lallemand SAS


summary: Clinical and neuroradiologic study concerning patients suffering of cough, exertional and sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication, redescribe clinical headaches specifications, confirmed if cough headaches is a clinical entity and if it has neuroradiologic differences with effort or sexual activity headaches.

lead_sponsor: French Society for the Study of Migraine Headache

location_facility: assistance publique hopitaux de marseille CHU Timone


title: Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases

summary:
The purpose of this study is to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases.

Randomised crossover dietary intervention study:

The main objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the lipid metabolism of volunteers as compared with the consumption of a "reference" oil.

Post prandial study:

The second objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the biomarkers of oxidative stress during post prandial period as compared with the consumption of a "reference" oil.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

summary: The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

ReferenceCitation: Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.

name: Assistant Professor of Anesthesiology and Critical Care.

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

name: Professor of Anesthesiology and Critical Care, Director of Surgical Intensive Care Unit, Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Hospital of Clermont-Ferrand.

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

name: Professor of Anesthesiology and Critical Care, Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, Universita' degli Studi di Genova, Genova, Italy.

family: Pelosi

full_name: Paolo Pelosi

given: Paolo

name: Assistant Professor of Anesthesiology and Critical Care, Head of Intensive Care Unit.

family: Chanques

full_name: Gerald Chanques

given: Gerald

family: Massone

full_name: Alexandre Massone

given: Alexandre

name: Research Fellow, Staff Anesthesiologist, Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.

family: Petit

full_name: Antoine Petit

given: Antoine

name: Statistician, Department of Statistics, Centre Jean Perrin, University Hospital of Clermont-Ferrand.

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

name: Professor of Anesthesiology and Critical Care, Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Hospital of Clermont-Ferrand.

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

name: Professor of Anesthesiology and Critical Care, Head of Department, Department of Critical Care Medicine and Anesthesiology (SAR B), Saint Eloi Hospital, University Hospital of Montpellier, Montpellier, France.

family: Jaber

full_name: Samir Jaber

given: Samir

journal_name: Anesthesiology

title: Noninvasive Ventilation and Alveolar Recruitment Maneuver Improve Respiratory Function during and after Intubation of Morbidly Obese Patients


title: An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of breast cancer. It is not yet known whether giving docetaxel together with a phytochemical is more effective than giving docetaxel alone in treating patients with breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a phytochemical works compared with giving docetaxel alone as first- or second-line therapy in treating patients with breast cancer.


title: Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery

summary: The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems) for Measuring Energy Expenditure at Rest and in Dynamic Phase After a Meal in Adult Healthy and Obese Volunteers

acronym: Protocol Quark

summary: Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

primary_purpose: Health Services Research

location_facility: Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot


title: Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

acronym: IsoTC

summary:
isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.

However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.

Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.

ReferenceCitation: Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.

family: Roquilly

full_name: Antoine Roquilly

family: Loutrel

full_name: Olivier Loutrel

given: Olivier

family: Cinotti

full_name: Raphael Cinotti

given: Raphael

family: Rosenczweig

full_name: Elise Rosenczweig

given: Elise

family: Flet

full_name: Laurent Flet

given: Laurent

family: Mahe

full_name: Pierre Joachim Mahe

given: Pierre Joachim

family: Dumont

full_name: Romain Dumont

given: Romain

family: Marie Chupin

full_name: Anne Marie Chupin

given: Anne

family: Peneau

full_name: Catherine Peneau

given: Catherine

family: Lejus

full_name: Corinne Lejus

given: Corinne

family: Blanloeil

full_name: Yvonnick Blanloeil

given: Yvonnick

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

journal_name: Critical Care

location_facility: Service de Réanimation CHU de Nantes Boulevard Jean Monnet


title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

acronym: NEODEC

summary: Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Neuromuscular Transmission in Amyotrophic Lateral Sclerosis

acronym: NETALS

summary: Consistent data suggest that neuromuscular transmission is impaired in ALS patients. Neuromuscular junctions dysfunction may appear very early in the disease, as shown by data in animal models. The pathogenesis of this neuromuscular transmission impairment is unknown. Nogo A isoform, a possible marker of the disease over-expressed in skeletal muscle of ALS patients, can be involved. We will characterize the pathophysiological mechanisms implicated using a complete study of the structure and function of the NMJ on muscle biopsies, in a group of 20 ALS patients compared to 10 controls.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

acronym: BCDE

summary: The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.

lead_sponsor: Nantes University Hospital


title: Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.

summary: To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).

lead_sponsor: UCB Pharma


title: A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

lead_sponsor: LEO Pharma


title: RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum

acronym: BioDNase

summary: Serine proteases belonging to the elastase family are mainly responsible for lung tissue destruction as observed during cystic fibrosis. But anti-inflammatory therapies based on systemic or aerosolized protease-inhibitors administration, have not given the expected results until now. One reason would be the impaired access of therapeutic inhibitors to their molecular targets. It was recently shown that neutrophils actively secrete neutrophil extracellular traps (NETs) made of DNA that binds cationic proteases among other molecules. NETs together with DNA passively released from dead neutrophils contribute to the viscosity of CF expectorations which explains that rhDNase treatment fluidifies expectorations and improves the patient status. Preliminary experiments in our laboratory have shown that DNA degradation was associated with a significant increase of proteolytic activity in the sputum soluble fraction. However the efficacy of exogenous inhibitors is also improved in these conditions. Using the specific substrates and methodologies that we developed previously to measure cell-surface associated proteolytic activities, we will study the effects of DNase on the activity of individual proteases, their biodistribution in sputum and their regulation by potential therapeutic inhibitors. Enzymatic, immunochemical and microscopic (confocal and scanning) techniques will first be used for ex vivo studies on sputa freshly collected at the adult and paediatric CRCM in Tours, then on sputa from patients before and after administration of aerosolized rhDNase. We hypothesize that a better understanding of the biodistribution of neutrophil serine proteases and especially their binding to DNA will help designing new therapeutic strategies that facilitate inhibitor access to their protease targets.

lead_sponsor: University Hospital, Tours


acronym: HEMOCARD

summary: the purpose of this study is to show that the vacuum control surgical bleeding helps stop bleeding extraMD (MD: Medical Device) at the orifice of the retrograde cannulation during a heart with Extra-corporeal circulation (ECC),

lead_sponsor: AdministrateurCIC