title: A Multicenter Study Comparing the Results of Allogeneic Stem Cell Genoidentical in Children With Sickle Cell Anemia and Cerebral Vascular Disease Detected by Transcranial Doppler

acronym: DREPAGREFFE

summary: The aim of this study is to demonstrate that cerebral velocities assessed by transcranial doppler (TCD) are more significantly decreased by SCT than by long-term transfusion program A multicenter, national, non-randomized, prospective study of paired cohort will be conducted, with 2 groups of exposed (SCT) and non-exposed (TP) patients.

ReferenceCitation: Bernaudin F, Verlhac S, Peffault de Latour R, Dalle JH, Brousse V, Petras E, Thuret I, Paillard C, Neven B, Galambrun C, Divialle-Doumdo L, Pondarré C, Guitton C, Missud F, Runel C, Jubert C, Elana G, Ducros-Miralles E, Drain E, Taïeb O, Arnaud C, Kamdem A, Malric A, Elmaleh-Bergès M, Vasile M, Leveillé E, Socié G, Chevret S; DREPAGREFFE Trial Investigators. Association of Matched Sibling Donor Hematopoietic Stem Cell Transplantation With Transcranial Doppler Velocities in Children With Sickle Cell Anemia. JAMA. 2019 Jan 22;321(3):266-276. doi: 10.1001/jama.2018.20059.

name: Referral Center for Sickle Cell Disease, Department of Pediatrics, Intercommunal Créteil Hospital, University Paris-Est, Créteil, France

family: Bernaudin

full_name: Françoise Bernaudin

given: Françoise

name: Referral Center for Sickle Cell Disease, Medical Imaging Department, Intercommunal Créteil Hospital, Créteil, France

family: Verlhac

full_name: Suzanne Verlhac

given: Suzanne

name: Bone Marrow Transplant Unit, Department of Hematology, Saint-Louis Hospital, University Paris-Diderot, Paris, France

family: Peffault de Latour

full_name: Régis Peffault de Latour

given: Régis

name: Department of Pediatric Hematology, Robert-Debré Hospital, University Paris-Diderot, Paris, France

family: Dalle

full_name: Jean-Hugues Dalle

given: Jean-Hugues

name: Referral Center for Sickle Cell Disease, Department of Pediatrics, Necker Hospital, University Paris-Descartes, Paris, France

family: Brousse

full_name: Valentine Brousse

given: Valentine

name: Referral Center for Sickle Cell Disease, Pointe à Pitre, Guadeloupe, France

family: Petras

full_name: Eléonore Petras

given: Eléonore

name: Department of Pediatric Hematology, la Timone Hospital, Marseille University, Marseille, France

family: Thuret

full_name: Isabelle Thuret

given: Isabelle

name: Department of Pediatric Hematology, Hautepierre Hospital, Strasbourg University, Strasbourg, France

family: Paillard

full_name: Catherine Paillard

given: Catherine

name: Department of Pediatric Hematology, Necker Hospital, University Paris-Descartes, Paris, France

family: Neven

full_name: Bénédicte Neven

given: Bénédicte

family: Galambrun

full_name: Claire Galambrun

given: Claire

family: Divialle-Doumdo

full_name: Lydia Divialle-Doumdo

given: Lydia

name: Department of Pediatric Hematology, HIOP Lyon, Lyon, France

family: Pondarré

full_name: Corinne Pondarré

given: Corinne

name: Referral Center for Sickle Cell Disease, Department of Pediatrics, Kremlin-Bicêtre Hospital, University Paris-Sud, Paris, France

family: Guitton

full_name: Corinne Guitton

name: Referral Center for Sickle Cell Disease, Department of Pediatrics, Robert-Debré Hospital, University Paris-Diderot, Paris, France

family: Missud

full_name: Florence Missud

given: Florence

name: Department of Pediatric Hematology, Bordeaux Hospital, Bordeaux, France

family: Runel

full_name: Camille Runel

given: Camille

family: Jubert

full_name: Charlotte Jubert

given: Charlotte

name: Referral Center for Sickle Cell Disease, Department of Pediatrics, Fort de France, Martinique, France

family: Elana

full_name: Gisèle Elana

given: Gisèle

family: Ducros-Miralles

full_name: Elisabeth Ducros-Miralles

given: Elisabeth

name: Department of Child and Adolescent Psychiatry, Avicenne Hospital, Paris-13 University, Paris, France

family: Drain

full_name: Elise Drain

given: Elise

family: Taïeb

full_name: Olivier Taïeb

given: Olivier

family: Arnaud

full_name: Cécile Arnaud

family: Kamdem

full_name: Annie Kamdem

given: Annie

family: Malric

full_name: Aurore Malric

given: Aurore

name: Department of Medical Imagery, Debré Hospital, University Paris-Diderot, Paris, France

name: Department of Statistics, Saint-Louis Hospital, ECSTRA Team, UMR1153, INSERM, University Paris-Diderot, Paris, France

ReferenceCitation: Chevret S, Verlhac S, Ducros-Miralles E, Dalle JH, de Latour RP, de Montalembert M, Benkerrou M, Pondarré C, Thuret I, Guitton C, Lesprit E, Etienne-Julan M, Elana G, Vannier JP, Lutz P, Neven B, Galambrun C, Paillard C, Runel C, Jubert C, Arnaud C, Kamdem A, Brousse V, Missud F, Petras M, Doumdo-Divialle L, Berger C, Fréard F, Taieb O, Drain E, Elmaleh M, Vasile M, Khelif Y, Bernaudin M, Chadebech P, Pirenne F, Socié G, Bernaudin F. Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcranial Doppler (NCT 01340404). Contemp Clin Trials. 2017 Nov;62:91-104. doi: 10.1016/j.cct.2017.08.008. Epub 2017 Aug 15.


title: Evaluation of the Prognostic Value of Monocytes and Lymphocyte Phenotyping, Along With Intracellular MCP-1 Expression, to Predict Preterm Delivery for Women Hospitalized for Threat of Preterm Labor Between 24 and 34 Weeks of Amenorrhea: PhenoMAP Study

acronym: PHENOMAP

summary:
The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been suggested by its secretion in the amniotic fluid during labour and by the increase in the expression of its RNA messengers in the peripheral maternal blood. We have also shown that the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery compared with those with caesarean delivery prior the onset of labour.

OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery occurring within 7 days post admission. Secondary: to (1) compare the predictive values of these new markers with those currently used, e.g. quantification of fœtal fibronectin and assessment of cervical length and effacement, (2) Compare the respective proportions of monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine if a correlation exists between the activation markers expressed by maternal monocyte and lymphocyte subpopulations and the neonatal outcomes of preterm infants.

MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of amenorrhea and complicated PTL, will be prospectively included in the maternity wards of Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not deliver within the first 7 days; finally, another blood sample will be drawn upon discharge. After delivery, foetal membranes will be collected to characterize and compare the various monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the study of the level of activation of blood and foetal membrane cells will be performed using flow cytometry technique with suitable markers. The main judgment criteria will be the percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations ("inflammatory", "residents or patrollers" and "intermediates", according to CD14, CD16, CCR2 and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers: CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes), CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2 lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127 (Tregs). Univariate statistical analysis of quantitative data will be performed using the Mann and Witney test or ANOVA, after verification of the conditions of application. The comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact test, as appropriate. The multivariate analysis will be performed using a stepwise descending analysis.

TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte subpopulations in the maternal blood and in the foetal membranes might constitute an " immunological signature " of the labour and therefore validate the relevance of a predictive marker for clinicians.

EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte subpopulations in the maternal blood will allow to better characterise the immunological mechanisms occurring at the start of premature labour and to identity predictive markers of the preterm delivery, to validate prospectively in order to optimize the management of PTL

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Centre d'investigation clinique plurithématique

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


title: Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers

summary: The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.

design_allocation: Randomized

primary_purpose: Basic Science

lead_sponsor: Drugs for Neglected Diseases

intervention_type: Drug

lead_sponsor_type: industriel


type: Other Identifier

title: Effects of Nucleus Basalis of Meynert Area Electrical Stimulation on Cognitive Behavioral Disorders in Dementia With Lewy Bodies : A Pilot Phase 1 Study

acronym: DEMENSTIM

summary:
Deep brain stimulation has been developed as a substitute for the classical lesioning methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.

The present study aims to assess the effect of bilateral electrical stimulation of the NBM on the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate, Dementia with Lewy Bodies.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Maltête D, Wallon D, Bourilhon J, Lefaucheur R, Danaila T, Thobois S, Defebvre L, Dujardin K, Houeto JL, Godefroy O, Krystkowiak P, Martinaud O, Gillibert A, Chastan M, Vera P, Hannequin D, Welter ML, Derrey S. Nucleus Basalis of Meynert Stimulation for Lewy Body Dementia: A Phase I Randomized Clinical Trial. Neurology. 2021 Feb 2;96(5):e684-e697. doi: 10.1212/WNL.0000000000011227. Epub 2020 Nov 16.

family: Maltête

full_name: David Maltête

given: David

sequence: first

family: Wallon

full_name: David Wallon

sequence: additional

family: Bourilhon

full_name: Julie Bourilhon

given: Julie

family: Lefaucheur

full_name: Romain Lefaucheur

given: Romain

family: Danaila

full_name: Teodor Danaila

given: Teodor

family: Thobois

full_name: Stéphane Thobois

given: Stéphane

family: Defebvre

full_name: Luc Defebvre

given: Luc

family: Dujardin

full_name: Kathy Dujardin

given: Kathy

family: Houeto

full_name: Jean-Luc Houeto

given: Jean-Luc

family: Godefroy

full_name: Olivier Godefroy

family: Krystkowiak

full_name: Pierre Krystkowiak

given: Pierre

family: Martinaud

full_name: Olivier Martinaud

family: Gillibert

full_name: André Gillibert

given: André

family: Chastan

full_name: Mathieu Chastan

given: Mathieu

family: Vera

full_name: Pierre Vera

family: Hannequin

full_name: Didier Hannequin

given: Didier

family: Welter

full_name: Marie-Laure Welter

given: Marie-Laure

family: Derrey

full_name: Stéphane Derrey

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neurology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Nucleus basalis of meynert stimulation for lewy body dementia: A phase I randomized clinical trial

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure


title: Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases

acronym: Emotion

summary:
Empathy, defined as the ability to understand others emotions, is a fundamental concept in social interactions. It is a psychological phenomenon involving various separable components : (i) the ability to feel and imagine the emotions, (ii) the ability to adopt the perspective of other people. Several neurological diseases with behavioral disorders may lead to impaired processing of social and/or emotional informations. These pathologies are likely to induce a lack of empathy that may result from impairments at different levels.

The objective is simply to study how others' emotions are understood and how this allows for regulation of personal behavior. This study is being carried out among patients seen for various health problems and who can make behavior changes. This study could help to understand some neurological diseases and thereby to identify them earlier and/or to better differentiate them.

ReferenceType: result

ReferenceCitation: Narme P, Mouras H, Roussel M, Devendeville A, Godefroy O. Assessment of socioemotional processes facilitates the distinction between frontotemporal lobar degeneration and Alzheimer's disease. J Clin Exp Neuropsychol. 2013;35(7):728-44. doi: 10.1080/13803395.2013.823911. Epub 2013 Aug 12.

family: Narme

full_name: Pauline Narme

given: Pauline

family: Mouras

full_name: Harold Mouras

given: Harold

family: Roussel

full_name: Martine Roussel

given: Martine

family: Devendeville

full_name: Agnès Devendeville

given: Agnès

journal_name: Journal of Clinical and Experimental Neuropsychology

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Assessment of socioemotional processes facilitates the distinction between frontotemporal lobar degeneration and Alzheimer’s disease

ReferenceCitation: Narme P, Mouras H, Roussel M, Duru C, Krystkowiak P, Godefroy O. Emotional and cognitive social processes are impaired in Parkinson's disease and are related to behavioral disorders. Neuropsychology. 2013 Mar;27(2):182-92. doi: 10.1037/a0031522.

family: Duru

full_name: Cécile Duru

given: Cécile

journal_name: Neuropsychology

publisher: American Psychological Association (APA)

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Behavioral


title: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.

summary:
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Erempharma

location_facility: Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose

status_simplified: Unknown


title: A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

acronym: MODEL MAKER

summary: Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital


title: Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin

acronym: BocepreVIH

summary:
The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.

The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined as undetectable HCV-RNA at Week 24 after the end of therapy.

design_allocation: Non-Randomized

ReferenceCitation: Poizot-Martin I, Bellissant E, Garraffo R, Colson P, Piroth L, Solas C, Renault A, Bourlière M, Halfon P, Ghosn J, Alric L, Naqvi A, Carrieri P, Molina JM; ANRS HC27 BOCEPREVIH Study Group. Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study. HIV Clin Trials. 2016 Mar;17(2):63-71. doi: 10.1080/15284336.2015.1135553. Epub 2016 Feb 11.

family: Poizot-Martin

full_name: Isabelle Poizot-Martin

given: Isabelle

family: Bellissant

full_name: Eric Bellissant

given: Eric

family: Garraffo

full_name: Rodolphe Garraffo

given: Rodolphe

family: Colson

full_name: Philippe Colson

given: Philippe

family: Piroth

full_name: Lionel Piroth

given: Lionel

family: Solas

full_name: Caroline Solas

given: Caroline

family: Renault

full_name: Alain Renault

given: Alain

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Halfon

full_name: Philippe Halfon

family: Ghosn

full_name: Jade Ghosn

given: Jade

family: Alric

full_name: Laurent Alric

given: Laurent

family: Naqvi

full_name: Alissa Naqvi

given: Alissa

family: Carrieri

full_name: Patrizia Carrieri

given: Patrizia

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

name: for the ANRS HC27 BOCEPREVIH Study Group

journal_name: HIV Clinical Trials

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma

summary: Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

lead_sponsor: Institut Curie


type: EudraCT Number

title: A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma

summary: The purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome.

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; GRECCAR Study Group*. Tailored Strategy for Locally-Advanced Rectal Carcinoma (GRECCAR 4): Long-term Results from a Multicenter, Randomized, Open-Label, Phase 2 Trial. Dis Colon Rectum. 2021 Oct 25. doi: 10.1097/DCR.0000000000002153. [Epub ahead of print]

family: Rouanet

full_name: Philippe Rouanet

family: Rullier

full_name: Eric Rullier

family: Lelong

full_name: Bernard Lelong

given: Bernard

family: Maingon

full_name: Philippe Maingon

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Pezet

full_name: Denis Pezet

given: Denis

family: Castan

full_name: Florence Castan

given: Florence

family: Nougaret

full_name: Stephanie Nougaret

given: Stephanie

journal_name: Diseases of the Colon & Rectum

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.

full_name: Stéphanie Nougaret

given: Stéphanie

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

intervention_type: Other


title: Etude Des Troubles de l'Inhibition Cognitive Chez le Sujet âgé déprimé Suicidant

acronym: ETIC

summary: The purpose of this study is to compare the cognitive inhibition deficit among depressed older suicide attempters compared to depressed older suicide non-attempters.

study_completion_date_type: Anticipated

time_perspective: Cross-Sectional

ReferenceCitation: Richard-Devantoy S, Annweiler C, Le Gall D, Garré JB, Olié JP, Beauchet O. Cognitive inhibition in suicidal depressed elderly: a case-control pilot study. J Clin Psychiatry. 2011 Jun;72(6):871-2. doi: 10.4088/JCP.10l06797.

family: Richard-Devantoy

full_name: Stéphane Richard-Devantoy

given: Stéphane

family: Annweiler

full_name: Cedric Annweiler

given: Cedric

family: Le Gall

full_name: Didier Le Gall

given: Didier

family: Garré

full_name: Jean-Bernard Garré

given: Jean-Bernard

family: Olié

full_name: Jean-Pierre Olié

given: Jean-Pierre

family: Beauchet

full_name: Olivier Beauchet

given: Olivier

bso_classification: Social sciences

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

title: Cognitive Inhibition in Suicidal Depressed Elderly

lead_sponsor: University Hospital, Angers


title: Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)

summary: This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.

time_perspective: Retrospective

lead_sponsor: Hoffmann-La Roche


title: Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft

acronym: TRACHBRONCAR

summary:
First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day morbidity and mortality rates of bronchial transplantation using cryopreserved aortic allograft in proximal lung cancer surgery. The investigators hypothesize that this stage 1-2 surgical innovation could be safe and effective in order to reduce the 90-day morbidity and mortality rates compared to those observed with pneumonectomy, especially when some factors are present: age > 70 years, right side, neoadjuvant chemoradiotherapy.
Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant or benign) lesions of the trachea requiring airway transplantation.

For these patients, resection followed by direct end to end anastomosis is not possible or at high risk.

primary_purpose: Other

ReferenceCitation: Martinod E, Chouahnia K, Radu DM, Joudiou P, Uzunhan Y, Bensidhoum M, Santos Portela AM, Guiraudet P, Peretti M, Destable MD, Solis A, Benachi S, Fialaire-Legendre A, Rouard H, Collon T, Piquet J, Leroy S, Vénissac N, Santini J, Tresallet C, Dutau H, Sebbane G, Cohen Y, Beloucif S, d'Audiffret AC, Petite H, Valeyre D, Carpentier A, Vicaut E. Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices. JAMA. 2018 Jun 5;319(21):2212-2222. doi: 10.1001/jama.2018.4653.

name: Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Chirurgie Thoracique et Vasculaire, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France

name: Université Paris Descartes, Fondation Alain Carpentier, Laboratoire de Recherche Bio-chirurgicale, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France

family: Martinod

full_name: Emmanuel Martinod

given: Emmanuel

name: Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Oncologie, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France

family: Chouahnia

full_name: Kader Chouahnia

given: Kader

family: Radu

full_name: Dana M. Radu

given: Dana M.

name: Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Pneumologie, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France

family: Joudiou

full_name: Pascal Joudiou

given: Pascal

family: Uzunhan

full_name: Yurdagul Uzunhan

given: Yurdagul

name: B2OA UMR CNRS 7052, Université Paris Diderot, Sorbonne Paris Cité, CNRS, F-75010 Paris, France

name: Ecole Nationale Vétérinaire d’Alfort, Université, Paris-Est, Maisons-Alfort, France

family: Bensidhoum

full_name: Morad Bensidhoum

given: Morad

family: Santos Portela

full_name: Ana M. Santos Portela

given: Ana M.

family: Guiraudet

full_name: Patrice Guiraudet

given: Patrice

family: Peretti

full_name: Marine Peretti

given: Marine

family: Destable

full_name: Marie-Dominique Destable

given: Marie-Dominique

name: Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Anesthésie-Réanimation, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France

family: Solis

full_name: Audrey Solis

given: Audrey

family: Benachi

full_name: Sabiha Benachi

given: Sabiha

name: Assistance Publique–Hôpitaux de Paris, EFS Ile de France, Banque des Tissus, Creteil, France

family: Fialaire-Legendre

full_name: Anne Fialaire-Legendre

given: Anne

family: Rouard

full_name: Hélène Rouard

given: Hélène

name: Hôpital Le Raincy-Montfermeil, Pneumologie, Montfermeil, France

family: Collon

full_name: Thierry Collon

given: Thierry

family: Piquet

full_name: Jacques Piquet

given: Jacques

name: Université Côte d’Azur, Centre Hospitalier Universitaire de Nice, Pneumologie, Chirurgie Thoracique, Oto-Rhino-Laryngologie, Nice, France

family: Leroy

full_name: Sylvie Leroy

given: Sylvie

family: Vénissac

full_name: Nicolas Vénissac

given: Nicolas

family: Santini

full_name: Joseph Santini

given: Joseph

name: Assistance Publique–Hôpitaux de Paris, Hôpital La Pitié-Salpêtrière, Chirurgie Digestive et Endocrinienne, Université Paris 6 Pierre et Marie Curie, Paris, France

family: Tresallet

full_name: Christophe Tresallet

given: Christophe

name: Assistance Publique–Hôpitaux de Marseille, Pneumologie, Hôpital Universitaire Nord, Marseille, France

family: Dutau

full_name: Hervé Dutau

given: Hervé

name: Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Gériatrie, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France

family: Sebbane

full_name: Georges Sebbane

given: Georges

family: Cohen

full_name: Yves Cohen

given: Yves

name: Division of Vascular Surgery, West Virginia University, Morgantown

name: Assistance Publique–Hôpitaux de Paris, Unité de Recherche Clinique, Hôpitaux Saint Louis-Lariboisière-Fernand Widal, Université Paris Diderot, Paris, France

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis


title: Mesenteric Microcirculatory Function Study Through Sublingual Evaluation During Cardiopulmonary Bypass

acronym: MICROCARD

summary: The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric microcirculatory function, using sublingual evaluation, in cardiac surgery.


title: Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU

acronym: MEEKADEAU

summary: The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

summary:
Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV measurement has not been yet validated in thoracic surgery during one-lung ventilation. The modifications of intrathoracic pressure induced by one-lung ventilation may altered the capabilities of PPV to predict fluid responsiveness.This study was designed to assess the ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.

Methods: a prospective observational study. Thirty five patients undergoing a pulmonary resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid challenges with a 250 milliliters colloid solution in response to hemodynamic instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV will be calculated from recorded artery pressure curve (PPVref) before and after each fluid challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will be recorded simultaneously before and after each fluid challenge.

Statistical analysis: receiver operating characteristic curve will be used to assess the PPV capability to predict fluid responsiveness. Correlation analysis will be achieved using a Pearson test or Spearman's rho test when necessary. Continuous data will compared using a Student t test or a Mann-Whitney test when necessary.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

location_facility: Thoracic surgery department, University Hospital of Lille


title: Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

summary: This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

lead_sponsor: Novo Nordisk A/S


title: Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable

summary: The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.

ReferenceCitation: Lauque D, Maupas-Schwalm F, Bounes V, Juchet H, Bongard V, Roshdy A, Botella JM, Charpentier S. Predictive value of the heart-type fatty acid-binding protein and the Pulmonary Embolism Severity Index in patients with acute pulmonary embolism in the emergency department. Acad Emerg Med. 2014 Oct;21(10):1143-50. doi: 10.1111/acem.12484.

name: The Emergency Department; Rangueil University Hospital; Toulouse France

family: Lauque

full_name: Dominique Lauque

given: Dominique

name: The Department of Biochemistry; Rangueil University Hospital; Toulouse France

family: Maupas-Schwalm

full_name: Françoise Maupas-Schwalm

given: Françoise

family: Bounes

full_name: Vincent Bounes

given: Vincent

family: Juchet

full_name: Henry Juchet

given: Henry

name: The Department of Epidemiology; Health Economics and Public Health University; Toulouse France

family: Bongard

full_name: Vanina Bongard

given: Vanina

name: The Cardiothoracic Intensive Therapy Unit; St. George's Hospital; London UK

family: Roshdy

full_name: Ashraf Roshdy

given: Ashraf

family: Botella

full_name: Jean Marie Botella

given: Jean Marie

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

journal_name: Academic Emergency Medicine

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Predictive Value of the Heart-type Fatty Acid-binding Protein and the Pulmonary Embolism Severity Index in Patients With Acute Pulmonary Embolism in the Emergency Department

lead_sponsor: University Hospital, Toulouse


title: Injection of CD4 and CD8 + T Cells Anti-CMV or Anti-adenovirus for the Treatment of Viral Infections Occurring After Allogenic Hematopoietic Stem Cell Transplantation (HSCT)

acronym: CTLantiCMV

summary: The main purpose of this project is to evaluate the efficiency of the injection of CD4 and CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the first injection (adenovirus infection is not enough usual, especially in adults, to be used for the primary purpose and is measured in the secondary endpoints).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Biotherapy department, Hôpital Necker - Enfants Malades


title: Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)

summary:
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities.

OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus.

A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position

summary: The main objective of this study is to investigate the influence of seat type (straight chair versus "ergonomic" chair) on the sagittal alignment of the lumbo-pelvic complex in two different postures compared to standing for each individual in both a chronic-back-pain and a non-chronic-back-pain population.

ReferenceCitation: Vaucher M, Isner-Horobeti ME, Demattei C, Alonso S, Hérisson C, Kouyoumdjian P, van Dieën JH, Dupeyron A. Effect of a kneeling chair on lumbar curvature in patients with low back pain and healthy controls: A pilot study. Ann Phys Rehabil Med. 2015 Jun;58(3):151-6. doi: 10.1016/j.rehab.2015.01.003. Epub 2015 May 5.

family: Vaucher

full_name: Matthieu Vaucher

given: Matthieu

family: Isner-Horobeti

full_name: Marie-Eve Isner-Horobeti

given: Marie-Eve

family: Demattei

full_name: Christophe Demattei

family: Alonso

full_name: Sandrine Alonso

family: Hérisson

full_name: Christian Hérisson

given: Christian

family: Kouyoumdjian

full_name: Pascal Kouyoumdjian

given: Pascal

family: van Dieën

full_name: Jaap H. van Dieën

given: Jaap H.

family: Dupeyron

full_name: Arnaud Dupeyron

given: Arnaud

journal_name: Annals of Physical and Rehabilitation Medicine

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

summary: The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.

primary_purpose: Prevention

ReferenceCitation: L'Hermite J, Wira O, Castelli C, de La Coussaye JE, Ripart J, Cuvillon P. Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial. Anaesth Crit Care Pain Med. 2018 Apr;37(2):147-153. doi: 10.1016/j.accpm.2017.07.005. Epub 2017 Sep 4.

family: L’Hermite

full_name: Joël L’Hermite

given: Joël

family: Wira

full_name: Olivier Wira

given: Olivier

family: Castelli

full_name: Chritel Castelli

given: Chritel

family: de La Coussaye

full_name: Jean-Emmanuel de La Coussaye

given: Jean-Emmanuel

family: Ripart

full_name: Jacques Ripart

given: Jacques

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

journal_name: Anaesthesia Critical Care & Pain Medicine


title: Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase

acronym: SAPA

summary:
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.

Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.

ReferenceCitation: Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19.

lead_sponsor: University Hospital, Limoges


title: Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease

summary: Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.

status: Withdrawn


title: Register and DNA Bank of Adult Extra-hospital Sudden Death

summary:
The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults.

The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.

status: Terminated

lead_sponsor: Nantes University Hospital


title: Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients

acronym: PREST

summary: The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.


title: Comparison of the Hemoglobin Results Obtained With the "Orsense NBM-200MP" Device and the Clinical Laboratory

summary: The purpose of this study is to compare the hemoglobin results obtained with the "Orsense NBM-200MP" device and the Clinical Laboratory.

ReferenceCitation: Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Aulagnier

full_name: Jérôme Aulagnier

given: Jérôme

family: Matthieu

full_name: Emmanuel Matthieu

given: Emmanuel

family: Boisson

full_name: Mireille Boisson

given: Mireille

family: Fischler

full_name: Marc Fischler

given: Marc

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Non-Invasive Measurement of Hemoglobin: Assessment of Two Different Point-of-Care Technologies

lead_sponsor: Hopital Foch


title: Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study

summary: The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.

intervention_type: Device


title: Influence of the Sleep Apnea Syndrome on the Functional Recovery After Stroke in a Rehabilitation Unit

acronym: SAS-AVC

summary: The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

location_facility: PRM Department, Hôpital Fernand Widal - Pr Alain YELNIK


title: Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years

acronym: HYPOPANX

summary: This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.

primary_purpose: Supportive Care


title: Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

summary: The main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

summary:
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.

The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.


title: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)

acronym: FLORALI

summary:
The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

conventional oxygen therapy (O2 conventional)
high flow nasal oxygen therapy (O2-HFN)
association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Mercat

full_name: Alain Mercat

given: Alain

family: Girault

full_name: Christophe Girault

given: Christophe

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Prat

full_name: Gwénael Prat

given: Gwénael

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Cottereau

full_name: Alice Cottereau

given: Alice

family: Devaquet

full_name: Jérôme Devaquet

family: Nseir

full_name: Saad Nseir

given: Saad

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Chakarian

full_name: Jean-Charles Chakarian

given: Jean-Charles

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

family: Chevalier

full_name: Stéphanie Chevalier

family: Herbland

full_name: Alexandre Herbland

given: Alexandre

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Tonnelier

full_name: Jean-Marie Tonnelier

given: Jean-Marie

title: High-Flow Oxygen through Nasal Cannula in Acute Hypoxemic Respiratory Failure


title: Calibration and Validation of MOTIONPOD(TM) for Physical Activity Evaluation in Free-living Adults

acronym: MOTIONPOD(TM)

summary:
In this study we propose 1) to develop a new multisensor monitoring system associating a tri-axial accelerometer and a magnetometer to measure physical activity in free-living adults, 2) to perform its calibration and assess its validity in a series of activity tasks in comparison with the measure of energy expenditure by indirect calorimetry as the criterion measure, and with existing physical activity monitors (cardiofrequencemetry and accelerometers used either alone or in combination). Briefly the subjects will perform a series of standardized activity tasks of different intensities and a 30-min free physical activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors. Physical activity energy expenditure will be measured using a metabolic gas analyser.

Data of the 30 first subjects will be used to develop new algorithms to identify the different activity tasks and to estimate the related energy expenditures. Data of the following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry and existing physical activity monitors

ReferenceCitation: Bastian T, Maire A, Dugas J, Ataya A, Villars C, Gris F, Perrin E, Caritu Y, Doron M, Blanc S, Jallon P, Simon C. Automatic identification of physical activity types and sedentary behaviors from triaxial accelerometer: laboratory-based calibrations are not enough. J Appl Physiol (1985). 2015 Mar 15;118(6):716-22. doi: 10.1152/japplphysiol.01189.2013. Epub 2015 Jan 15.

name: CarMeN INSERM U1060, University of Lyon 1, INRA U1235, Centre de Recherche en Nutrition Humaine Rhône-Alpes, Centre Européen pour la Nutrition & la Santé, Pierre-Bénite, France;

family: Bastian

full_name: Thomas Bastian

given: Thomas

family: Maire

full_name: Aurélia Maire

given: Aurélia

family: Dugas

full_name: Julien Dugas

given: Julien

name: University of Grenoble Alpes, Grenoble, France;

name: Commissariat à l'Énergie Atomique, Leti, Département Microtechnologies pour la Biologie et la Santé, Laboratoire Électronique et Systèmes pour la Santé, MINATEC, Grenoble, France;

family: Ataya

full_name: Abbas Ataya

given: Abbas

family: Villars

full_name: Clément Villars

given: Clément

family: Gris

full_name: Florence Gris

given: Florence

family: Perrin

full_name: Emilie Perrin

given: Emilie

family: Caritu

full_name: Yanis Caritu

given: Yanis

family: Doron

full_name: Maeva Doron

given: Maeva

name: Hubert Curien Pluridisciplinary Institute, Department of Ecology, Physiology and Ethology, University of Strasbourg, UMR CNRS 7178, Strasbourg, France; and

family: Blanc

full_name: Stéphane Blanc

given: Stéphane

family: Jallon

full_name: Pierre Jallon

given: Pierre

name: Service d'Endocrinologie, Diabètes, Nutrition, Centre Hospitalier Lyon Sud, Pierre-Bénite, France

family: Simon

full_name: Chantal Simon

given: Chantal

journal_name: Journal of Applied Physiology

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)


title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

acronym: CONFUCIUS

summary: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.

ReferenceCitation: Mouchoux C, Rippert P, Duclos A, Fassier T, Bonnefoy M, Comte B, Heitz D, Colin C, Krolak-Salmon P. Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol. BMC Geriatr. 2011 May 18;11:25. doi: 10.1186/1471-2318-11-25.

family: Mouchoux

full_name: Christelle Mouchoux

given: Christelle

family: Rippert

full_name: Pascal Rippert

given: Pascal

family: Duclos

full_name: Antoine Duclos

given: Antoine

family: Fassier

full_name: Thomas Fassier

family: Bonnefoy

full_name: Marc Bonnefoy

given: Marc

family: Comte

full_name: Brigitte Comte

given: Brigitte

family: Heitz

full_name: Damien Heitz

given: Damien

family: Colin

full_name: Cyrille Colin

given: Cyrille

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

currency_apc_doaj: GBP

journal_name: BMC Geriatrics

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

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories:
HAL
PubMed Central
unige.ch

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_facility: Hospices Civils de Lyon-Hôpital des Charpennes


title: Valeur prédictive d'Une évaluation Cognitive standardisée en Centre d'Examens de Santé Pour le Diagnostic de la Maladie d'Alzheimer ou Des Maladies apparentées en Population générale Chez Les Plus de 65 Ans Avec Plainte mnésique

acronym: EVATEM

summary: The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

ReferenceCitation: Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Bathsavanis A, Rouch I, Deville N, Beauchet O, Krolak-Salmon P, Fantino B. Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community-dwelling elderly people with memory complaints: the EVATEM study. Eur J Neurol. 2016 Mar;23(3):554-61. doi: 10.1111/ene.12888. Epub 2015 Oct 30.

name: Centre d'Examens de Santé de la CPAM du Rhône Lyon France

family: Vannier‐Nitenberg

full_name: C. Vannier‐Nitenberg

given: C.

name: Centre Mémoire de Ressources et de Recherche (CMRR) Lyon Hôpital des Charpennes Hospices civils de Lyon Villeurbanne France

family: Dauphinot

full_name: V. Dauphinot

given: V.

name: Centre Technique d'Appui et de Formation des Centres d'Examens de Santé (CETAF) Saint‐Etienne France

name: Laboratory EA4607 SNA‐EPIS PRES Lyon Jean Monnet University of Saint Etienne Saint Etienne France

family: Bongue

full_name: B. Bongue

given: B.

family: Sass

full_name: C. Sass

family: Bathsavanis

full_name: A. Bathsavanis

given: A.

name: CMRR de Saint Etienne Service de Neurologie CHU de Saint Etienne Saint Etienne Cedex France

family: Rouch

full_name: I. Rouch

given: I.

family: Deville

full_name: N. Deville

given: N.

name: Department of Neuroscience Division of Geriatric Medicine Angers University Hospital Angers France

family: Beauchet

full_name: O. Beauchet

given: O.

name: Inserm U1028 CNRS UMR5292 Lyon Neuroscience Research Center Brain Dynamics and Cognition Team Lyon France

family: Krolak‐Salmon

full_name: P. Krolak‐Salmon

given: P.

name: Filiéris Caisse Autonome Nationale de la Sécurité Sociale dans les Mines Paris France

family: Fantino

full_name: B. Fantino

journal_name: European Journal of Neurology

title: Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community‐dwelling elderly people with memory complaints: the EVATEM study

ReferenceCitation: Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Rouch I, Beauchet O, Krolak-Salmon P, Fantino B. Early detection of memory impairment in people over 65 years old consulting at Health Examination Centers for the French health insurance: the EVATEM protocol. BMC Geriatr. 2013 Jun 6;13:55. doi: 10.1186/1471-2318-13-55.

family: Vannier-Nitenberg

full_name: Christiane Vannier-Nitenberg

given: Christiane

full_name: Virginie Dauphinot

given: Virginie

full_name: Bienvenu Bongue

given: Bienvenu

full_name: Catherine Sass

given: Catherine

full_name: Isabelle Rouch

given: Isabelle

full_name: Olivier Beauchet

given: Olivier

full_name: Bruno Fantino

given: Bruno

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon


title: Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs

acronym: GAIT

summary: The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

ReferenceCitation: Graffe A, Beauchet O, Fantino B, Milea D, Annweiler C. Vitamin D and macular thickness in the elderly: an optical coherence tomography study. Invest Ophthalmol Vis Sci. 2014 Jul 15;55(8):5298-303. doi: 10.1167/iovs.14-13918.

family: Graffe

full_name: Alix Graffe

given: Alix

name: Department of Ophthalmology, Angers University Hospital, Angers, France 3Glostrup University Hospital, Copenhagen, Denmark 4Singapore Eye Research Institute, Singapore National Eye Centre, and Duke-NUS, Neuroscience and Behavioral Diseases, Singapore

family: Milea

full_name: Dan Milea

given: Dan

name: Department of Neuroscience, Division of Geriatric Medicine, Angers University Hospital, University Memory Clinic of Angers, UPRES EA 4638, University of Angers, UNAM, Angers, France 5Robarts Research Institute, Department of Medical Biophysics, Schulich S

family: Annweiler

full_name: Cedric Annweiler

given: Cedric

journal_name: Investigative Opthalmology & Visual Science

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

title: Vitamin D and Macular Thickness in the Elderly: An Optical Coherence Tomography Study


title: Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers

acronym: MERE

summary: The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.

ReferenceCitation: Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Léonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.

family: Barden

full_name: John Barden

given: John

family: Liu-Ambrose

full_name: Teresa Liu-Ambrose

given: Teresa

family: Chester

full_name: Victoria L. Chester

given: Victoria L.

family: Szturm

full_name: Tony Szturm

given: Tony

family: Grenier

full_name: Sébastien Grenier

given: Sébastien

family: Léonard

full_name: Guillaume Léonard

given: Guillaume

family: Bherer

full_name: Louis Bherer

given: Louis

family: Allali

full_name: Gilles Allali

given: Gilles

journal_name: Drugs & Aging

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.

family: Launay

full_name: Cyrille P Launay

given: Cyrille P

full_name: Gazan Allali

given: Gazan

family: Watfa

full_name: Gilles Watfa

family: Gallouj

full_name: Karim Gallouj

given: Karim

family: Herrmann

full_name: François R Herrmann

given: François R

full_name: Cédric Annweiler

given: Cédric

journal_name: BMC Neurology

repositories_institution: University of Geneva - Archive ouverte UNIGE


title: Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial

acronym: COMEDRA

summary: The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).

ReferenceCitation: Gossec L, Soubrier M, Foissac F, Molto A, Richette P, Beauvais C, Ruyssen-Witrand A, Perdriger A, Chary-Valckenaere I, Mouterde G, Dernis E, Euller-Ziegler L, Flipo RM, Gilson M, Guis S, Mariette X, Pouplin S, Marhadour T, Schaeverbeke T, Sordet C, Fayet F, Dougados M. Screening for and management of comorbidities after a nurse-led program: results of a 3-year longitudinal study in 769 established rheumatoid arthritis patients. RMD Open. 2019 Jun 14;5(2):e000914. doi: 10.1136/rmdopen-2019-000914. eCollection 2019.

family: Gossec

full_name: Laure Gossec

given: Laure

family: Soubrier

full_name: Martin Soubrier

given: Martin

family: Foissac

full_name: Frantz Foissac

given: Frantz

family: Molto

full_name: Anna Molto

given: Anna

family: Richette

full_name: Pascal Richette

given: Pascal

family: Beauvais

full_name: Catherine Beauvais

given: Catherine

family: Ruyssen-Witrand

full_name: Adeline Ruyssen-Witrand

given: Adeline

family: Perdriger

full_name: Aleth Perdriger

given: Aleth

family: Chary-Valckenaere

full_name: Isabelle Chary-Valckenaere

given: Isabelle

family: Mouterde

full_name: Gael Mouterde

given: Gael

family: Dernis

full_name: Emanuelle Dernis

given: Emanuelle

family: Euller-Ziegler

full_name: Liana Euller-Ziegler

given: Liana

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: Gilson

full_name: Mélanie Gilson

given: Mélanie

family: Guis

full_name: Sandrine Guis

given: Sandrine

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Pouplin

full_name: Sophie Pouplin

given: Sophie

family: Marhadour

full_name: Thierry Marhadour

given: Thierry

family: Schaeverbeke

full_name: Thierry Schaeverbeke

family: Sordet

full_name: Christelle Sordet

given: Christelle

family: Fayet

full_name: Françoise Fayet

given: Françoise

family: Dougados

full_name: Maxime Dougados

given: Maxime

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

ReferenceCitation: Tournadre A, Pereira B, Gossec L, Soubrier M, Dougados M. Impact of comorbidities on fatigue in rheumatoid arthritis patients: Results from a nurse-led program for comorbidities management (COMEDRA). Joint Bone Spine. 2019 Jan;86(1):55-60. doi: 10.1016/j.jbspin.2018.06.010. Epub 2018 Jul 17.

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

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

ReferenceCitation: Ferreira RJO, Dougados M, Kirwan JR, Duarte C, de Wit M, Soubrier M, Fautrel B, Kvien TK, da Silva JAP, Gossec L; CoimbRA investigators, RAID investigators and COMEDRA investigators. Drivers of patient global assessment in patients with rheumatoid arthritis who are close to remission: an analysis of 1588 patients. Rheumatology (Oxford). 2017 Sep 1;56(9):1573-1578. doi: 10.1093/rheumatology/kex211.

name: Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra

name: Health Sciences Research Unit: Nursing (UICiSA:E), Nursing School of Coimbra (ESEnfC), Coimbra, Portugal

name: Faculty of Medicine, Paris Descartes University

name: Department of Rheumatology, AP-HP, Hôpital Cochin

name: INSERM (U1153), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France

name: Academic Rheumatology Unit, Bristol Royal Infirmary, University of Bristol, Bristol, UK

name: Clínica Universitária de Reumatologia, Faculty of Medicine, University of Coimbra, Coimbra, Portugal

name: Patient Research Partner, EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), Zurich, Switzerland

name: Department of Medical Humanities, VU University Medical Centre, Amsterdam, The Netherlands

name: Department of Rheumatology, CHU Clermont-Ferrand, Clermont-Ferrand

name: Faculty of Medicine, UPMC University Paris 06, GRC-UPMC 08 (EEMOIS)

name: Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris

name: CRI IMIDIATE, French Clinical Research Infrastructure Network, Toulouse, France

name: Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway

name: on behalf of the CoimbRA investigators, RAID investigators and COMEDRA investigators

repository_institution: University of Bristol - Bristol Research

ReferenceCitation: Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, Sibilia J, Ravaud P. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.


title: Plasma Abeta Peptides and the Risk of Alzheimer's Disease. Diagnostic Performance and Predictive and Prognostic Values of Measurements of Plasma Amyloid Peptides Concentrations for the Diagnosis of Alzheimer's Disease

acronym: BALTAZAR

summary:
The aim of this study is to examine the relationship between plasma putative biomarkers for Alzheimer's disease (i.e. Ab40 amyloid and total Ab42 amyloid, free, bound, free/bound, truncated, sAPPα) and :

the risk of conversion of individuals with Mild Cognitive Impairment (MCI) into Alzheimer's disease (AD),
the Alzheimer's disease progression rate.

ReferenceCitation: Duron E, Vidal JS, Grousselle D, Gabelle A, Lehmann S, Pasquier F, Bombois S, Buée L, Allinquant B, Schraen-Maschke S, Baret C, Rigaud AS, Hanon O, Epelbaum J. Somatostatin and Neuropeptide Y in Cerebrospinal Fluid: Correlations With Amyloid Peptides Aβ(1-42) and Tau Proteins in Elderly Patients With Mild Cognitive Impairment. Front Aging Neurosci. 2018 Oct 1;10:297. doi: 10.3389/fnagi.2018.00297. eCollection 2018. Erratum in: Front Aging Neurosci. 2019 Feb 19;11:11.

family: Duron

full_name: Emmanuelle Duron

given: Emmanuelle

family: Vidal

full_name: Jean-Sébastien Vidal

given: Jean-Sébastien

family: Grousselle

full_name: Dominique Grousselle

given: Dominique

family: Gabelle

full_name: Audrey Gabelle

given: Audrey

family: Lehmann

full_name: Sylvain Lehmann

given: Sylvain

family: Pasquier

full_name: Florence Pasquier

given: Florence

family: Bombois

full_name: Stéphanie Bombois

given: Stéphanie

family: Buée

full_name: Luc Buée

given: Luc

family: Allinquant

full_name: Bernadette Allinquant

given: Bernadette

family: Schraen-Maschke

full_name: Susanna Schraen-Maschke

given: Susanna

family: Baret

full_name: Christiane Baret

given: Christiane

family: Rigaud

full_name: Anne-Sophie Rigaud

given: Anne-Sophie

family: Hanon

full_name: Olivier Hanon

given: Olivier

family: Epelbaum

full_name: Jacques Epelbaum

given: Jacques

journal_name: Frontiers in Aging Neuroscience

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

title: Somatostatin and Neuropeptide Y in Cerebrospinal Fluid: Correlations With Amyloid Peptides Aβ1–42 and Tau Proteins in Elderly Patients With Mild Cognitive Impairment


title: Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

summary: This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.

lead_sponsor: Danone Research

location_facility: Médecin-chef du Groupement Formation Instruction


title: Do Facial Expression Recognition Disorder and Mirror Neurons Subtend Apathy in Parkinson's Disease?

summary:
After few years of evolution, patients with Parkinson's disease may develop apathy, with different degrees of severity. Apathy is characterized by a loss of interest for the others and for activities. The lack of social interactions in these patients may be due to an impairment in decoding emotional facial expression. Indeed, facial expression recognition, which is necessary to understand other's emotional state, requires a subclinical facial mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.

This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's disease )patients with emotional facial expression (EFE) recognition impairment, compared to healthy control subjects. We also want to know if this facial mimicry disorder is primary (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the mirror neuron systems that allows us to activate similar neural networks when observing and feeling a specific emotion)


title: Etude de l'adhérence et Des Effets Des Ateliers "équilibre Siel Bleu" Sur la Marche, la Cognition, l'Autonomie et l'indépendance Des Sujets Atteints d'Une Maladie d'Alzheimer, et Sur le Fardeau de l'Aidant Principal

acronym: SIELBLEU

summary: The purpose of this study is to measure the adherence to "Siel bleu" balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.


title: Study of the Pathophysiological Mechanisms Involved in Bleeding Events Observed in Patients With Lowe Syndrome

acronym: LOWE

summary:
Lowe syndrome is associated with mutations in the OCRL1 gene, which encodes OCRL1, a phosphatidylinositol-4, 5-bisphosphate (PtdIns(4, 5)P (2))5-phosphatase. PtdIns(4, 5)P2, a substrate of OCRL1, is an important signaling molecule within the cell. An abnormal rate of hemorrhagic events was found in a retrospective clinical survey, suggesting platelet dysfunction.

The main objective of the study is to confirm the presence of platelet dysfunction in Lowe syndrome and to characterize this abnormality.

ReferenceCitation: Egot M, Lasne D, Poirault-Chassac S, Mirault T, Pidard D, Dreano E, Elie C, Gandrille S, Marchelli A, Baruch D, Rendu J, Fauré J, Flaujac C, Gratacap MP, Sié P, Gaussem P, Salomon R, Baujat G, Bachelot-Loza C. Role of oculocerebrorenal syndrome of Lowe (OCRL) protein in megakaryocyte maturation, platelet production and functions: a study in patients with Lowe syndrome. Br J Haematol. 2021 Mar;192(5):909-921. doi: 10.1111/bjh.17346. Epub 2021 Feb 2.

name: Université de ParisInnovations Thérapeutiques en Hémostase ParisINSERM U1140France

family: Egot

full_name: Marion Egot

given: Marion

name: AP‐HP, Laboratoire d’Hématologie Hôpital Necker‐Enfants Malades ParisFrance

family: Lasne

full_name: Dominique Lasne

family: Poirault‐Chassac

full_name: Sonia Poirault‐Chassac

given: Sonia

name: AP‐HP, Service de Médecine Vasculaire Hôpital Européen Georges‐Pompidou ParisFrance

family: Mirault

full_name: Tristan Mirault

given: Tristan

family: Pidard

full_name: Dominique Pidard

family: Dreano

full_name: Elise Dreano

given: Elise

name: AP‐HP, Unité de Recherche Clinique Hôpital Necker‐Enfants Malades ParisFrance

family: Elie

full_name: Caroline Elie

given: Caroline

family: Gandrille

full_name: Sophie Gandrille

given: Sophie

family: Marchelli

full_name: Aurore Marchelli

given: Aurore

family: Baruch

full_name: Dominique Baruch

name: University Grenoble AlpesInserm, U1216CHU Grenoble AlpesGrenoble Institut Neurosciences GrenobleFrance

family: Rendu

full_name: John Rendu

given: John

family: Fauré

full_name: Julien Fauré

given: Julien

name: Centre hospitalier de Versailles André Mignot, Service de Biologie Médicale Secteur Hémostase Le ChesnayFrance

family: Flaujac

full_name: Claire Flaujac

given: Claire

name: INSERM U1048 and Université Toulouse 3Institut des Maladies Métaboliques et Cardiovasculaires (I2MC)CHU‐Rangueil ToulouseFrance

family: Gratacap

full_name: Marie‐Pierre Gratacap

given: Marie‐Pierre

name: CHU de ToulouseLaboratoire d’Hématologie ToulouseFrance

family: Sié

full_name: Pierre Sié

given: Pierre

name: AP‐HP, Service d’Hématologie Biologique Hôpital Européen Georges Pompidou ParisFrance

family: Gaussem

full_name: Pascale Gaussem

given: Pascale

name: AP‐HP, Service de Néphrologie Pédiatrique Hôpital Necker‐Enfants Malades INSERM U983 ParisFrance

family: Salomon

full_name: Rémi Salomon

given: Rémi

name: AP‐HP, Service de Génétique Institut Imagine Hôpital Necker‐Enfants Malades Paris France

family: Baujat

full_name: Geneviève Baujat

given: Geneviève

family: Bachelot‐Loza

full_name: Christilla Bachelot‐Loza

given: Christilla

journal_name: British Journal of Haematology

location_facility: Necker Enfants Malades Hospital, Genetic


title: Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort

acronym: CoEnv

summary: Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.


title: French Kabuki Syndrome Network. Epidemiology, Management of Patients and Research by Array-CGH

acronym: Kabuki

summary:
Create a census for the duration of the search for French patients with SK

determining epidemiological and morphological parameters,
determine the true frequency of clinical symptoms and identify new ones,
identify complications of the disease to improve the care of patients in the hope of a better prognosis of the disease and
performing a radiological study by Voxel based morphometry MRI type (N. BODDAERT, HOPITAL Necker-Enfants Malades, Paris)

Perform genetic research to identify the genetic bases of SK using CGH-array (Comparative Genomic Hybridization )


title: Use of Autobiographical and Interest Assessment for a Better Stimulation of Patients in Nursing Home

summary: The purpose is to evaluate patients' interests (patients in nursing home). Moreover the study aims to evaluate whether an activity for which the patient is interested in, allows a better involvement and stimulation.

lead_sponsor: Association Recherche Méthodologie Evaluation Psychiatrique

location_facility: Centre Mémoire de Ressources et de Recherche


title: Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study

acronym: DURAPOP

summary: The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment.

ReferenceCitation: Montravers P, Tubach F, Lescot T, Veber B, Esposito-Farèse M, Seguin P, Paugam C, Lepape A, Meistelman C, Cousson J, Tesniere A, Plantefeve G, Blasco G, Asehnoune K, Jaber S, Lasocki S, Dupont H; DURAPOP Trial Group. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26.

family: Montravers

full_name: Philippe Montravers

given: Philippe

family: Tubach

full_name: Florence Tubach

given: Florence

family: Lescot

full_name: Thomas Lescot

given: Thomas

family: Veber

full_name: Benoit Veber

given: Benoit

family: Esposito-Farèse

full_name: Marina Esposito-Farèse

given: Marina

family: Seguin

full_name: Philippe Seguin

family: Paugam

full_name: Catherine Paugam

given: Catherine

family: Lepape

full_name: Alain Lepape

given: Alain

family: Meistelman

full_name: Claude Meistelman

given: Claude

family: Cousson

full_name: Joel Cousson

given: Joel

family: Tesniere

full_name: Antoine Tesniere

given: Antoine

family: Plantefeve

full_name: Gaetan Plantefeve

given: Gaetan

family: Blasco

full_name: Gilles Blasco

given: Gilles

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Jaber

full_name: Samir Jaber

given: Samir

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Dupont

full_name: Herve Dupont

given: Herve

journal_name: Intensive Care Medicine

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

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


title: Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

summary: The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the etiologic of stroke. However, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be used to review the supraaortic vessels. This MRA offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3D spatial resolution and high temporal resolution. These qualities are even more optimal with a high magnetic field (3T). The high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. This sequence is classified as a 4D MRA.

lead_sponsor: Rennes University Hospital


title: Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia

acronym: STIMALGI

summary:
The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.

A double blind clinical trial with two randomized parallel groups:

Placebo rTMS and rehabilitation exercise
Active rTMS and rehabilitation exercise

ReferenceType: background

ReferenceCitation: Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9.

ReferenceCitation: Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1. Review.

ReferenceCitation: Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. Review.

ReferenceCitation: Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62.

ReferenceCitation: Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. Review. French.

ReferenceCitation: Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. Epub 2007 Sep 14.

ReferenceCitation: Guinot M, Maindet C, Hodaj H, Hodaj E, Bachasson D, Baillieul S, Cracowski JL, Launois S. Effects of Repetitive Transcranial Magnetic Stimulation and Multicomponent Therapy in Patients With Fibromyalgia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Mar;73(3):449-458. doi: 10.1002/acr.24118.

name: Grenoble Alpes University Hospital Sports Pathologies Medical Unit, and INSERM U1042, HP2 Laboratory  Grenoble France

family: Guinot

full_name: Michel Guinot

given: Michel

name: Grenoble Alpes University Hospital Center for Pain  Grenoble France

family: Maindet

full_name: Caroline Maindet

given: Caroline

family: Hodaj

full_name: Hasan Hodaj

given: Hasan

name: Grenoble Alpes University Hospital Clinical Research Center INSERM CIC1406  Grenoble France

full_name: Enkelejda Hodaj

given: Enkelejda

name: INSERM U1042 Grenoble Alpes University HP2 Laboratory  Grenoble France

family: Bachasson

full_name: Damien Bachasson

given: Damien

family: Baillieul

full_name: Sébastien Baillieul

given: Sébastien

family: Cracowski

full_name: Jean-Luc Cracowski

given: Jean-Luc

family: Launois

full_name: Sandrine Launois

given: Sandrine

journal_name: Arthritis Care & Research

lead_sponsor: University Hospital, Grenoble


title: Surfactant Treatment Compared to Nasal Continuous Positive Airway Pressure for the Management of Respiratory Distress Syndrome in the Newborn Between 35 and 41 Weeks of Gestation

acronym: ASPEN

summary: Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for term and near term newborns is unknown. The purpose of this study is to compare surfactant treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life. The study's primary endpoint is "survival with no oxygen treatment at 72 hours of life". The secondary endpoints are: death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment at 28 days of life, hospitalization duration and treatment strategy cost.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

acronym: DIABSCAN

summary: The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes.

lead_sponsor: Association HGE CHU Bordeaux Sud

location_facility: Service Hepato-Gastroentérologie Hopital Haut-Leveque


title: Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations

acronym: AGNORIENT

summary: The area of the brain responsible of visuospatial processing data and more specifically the orientation of an object or image is located in parietal lobe, especially on the right side. A dysfunction of this region would result in a disorder of recognition of the orientation of objects and images that the investigators call orientation agnosia. Several isolated cases are reported in the literature but to the investigators knowledge deficit has never been systematically searched, or put into perspective compared to other neuropsychological deficits. Moreover, the precise location of the lesion responsible for such a disorder remains uncertain. The objectives of this study are (1) detect the existence of orientation agnosia in case of right parietal lesion, and (2) to improve the understanding of such a deficit allowing better management of this disorder.

primary_purpose: Screening

lead_sponsor: University Hospital, Rouen


title: Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)

summary: To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame


title: Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.

summary:
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

ReferenceCitation: Trédan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Diéras V, Béal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Bürki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.

family: Trédan

full_name: O. Trédan

given: O.

family: Follana

full_name: P. Follana

given: P.

family: Moullet

full_name: I. Moullet

given: I.

family: Cropet

full_name: C. Cropet

given: C.

family: Trager-Maury

full_name: S. Trager-Maury

given: S.

family: Dauba

full_name: J. Dauba

given: J.

family: Lavau-Denes

full_name: S. Lavau-Denes

family: Diéras

full_name: V. Diéras

given: V.

family: Béal-Ardisson

full_name: D. Béal-Ardisson

given: D.

family: Gouttebel

full_name: M. Gouttebel

given: M.

family: Orfeuvre

full_name: H. Orfeuvre

given: H.

family: Stefani

full_name: L. Stefani

given: L.

family: Jouannaud

full_name: C. Jouannaud

family: Bürki

full_name: F. Bürki

given: F.

family: Petit

full_name: T. Petit

given: T.

family: Guardiola

full_name: E. Guardiola

given: E.

family: Becuwe

full_name: C. Becuwe

family: Blot

full_name: E. Blot

family: Pujade-Lauraine

full_name: E. Pujade-Lauraine

family: Bachelot

full_name: T. Bachelot

journal_name: Annals of Oncology


lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

primary_purpose: Health Services Research

acronym: DOLANS

source: euctr

title: Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study

summary:
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment.

The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time.

The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.

Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.


title: and Safety of METAZYM (Recombinant Human Arylsulfatase A or rhASA) for the Treatment of Patients With Late Infantile MLD Who Had Previously Hematopoietic Stem Cell Transplantation

acronym: Azylis

summary: There is currently no effective treatment for late infantile MLD once clinical symptoms are evident. METAZYM is a recombinant human arylsulfatase A developed for an intravenous ERT for the treatment of late infantile MLD. The overall objective of this study is to evaluate the efficacy and safety of intravenous rhASA treatment in a patient with late infantile MLD who had previously received hematopoietic stem cell transplantation (HCT).

location_facility: Department of Pediatric Endocrinology and Neurology, Saint Vincent de Paul Hospital


title: Phase II Multicentric Trial Maintenance Therapy With 6 Monthly Revlimid® Cycles Alternated With 6 Monthly Vidaza® Cycles in First CR After Induction LIA Chemotherapy for Elderly Fit Patients With Poor Prognosis Acute Myeloid Leukemia.

summary:
Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia (AML).

The disease-free survival (DFS) of the patients included in this study will be compared to the ones of the two previously reported groups of patients treated with the same LIA induction therapy

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation


title: EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB

acronym: Suiviritux

summary: The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.


title: Phase 2 Study Assessing the Tolerance and Efficacy of Tamoxifen Alone Versus the Association Tamoxifen-RAD001 (Everolimus) in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

summary: Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This study is aimed to check if the inhibition of this signal transduction pathway by a synthetic mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.

ReferenceCitation: Treilleux I, Arnedos M, Cropet C, Wang Q, Ferrero JM, Abadie-Lacourtoisie S, Levy C, Legouffe E, Lortholary A, Pujade-Lauraine E, Bourcier AV, Eymard JC, Spaeth D, Bachelot T. Translational studies within the TAMRAD randomized GINECO trial: evidence for mTORC1 activation marker as a predictive factor for everolimus efficacy in advanced breast cancer. Ann Oncol. 2015 Jan;26(1):120-125. doi: 10.1093/annonc/mdu497. Epub 2014 Oct 31.

family: Treilleux

full_name: I. Treilleux

family: Arnedos

full_name: M. Arnedos

family: Cropet

full_name: C. Cropet

family: Wang

full_name: Q. Wang

given: Q.

family: Ferrero

full_name: J.-M. Ferrero

family: Abadie-Lacourtoisie

full_name: S. Abadie-Lacourtoisie

family: Levy

full_name: C. Levy

family: Legouffe

full_name: E. Legouffe

family: Lortholary

full_name: A. Lortholary

given: A.

family: Bourcier

full_name: A.-V. Bourcier

family: Eymard

full_name: J.-C. Eymard

family: Spaeth

full_name: D. Spaeth

bso_classification: Chemistry


title: CONTRADYS : A Randomized Controlled Trial of a New Prophylactic Maneuver, the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia

acronym: CONTRADYS

summary: Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in addition to downward traction on the fetal head for delivery of the shoulders. Shoulder dystocia is a major obstetrical complication, occurring in approximately 0.2 to 3% of deliveries, principally due to fetal macrosomia. The obstetrical and neonatal complications associated with shoulder dystocia include newborn mortality occurring in 21 to 290 per 1000 deliveries, generalized asphyxia, fractures, neurological damages (brachial plexus injury) and hematoma. The objective of this study was to evaluate the "pushing" maneuver, that is performed gently on the fetal head since the crowning of the head (appearance of the fetal scalp at the introitus between pushes), aiming to facilitate the anterior shoulder to slip off behind the symphysis pubis, reducing thus the risk of shoulder dystocia. This preventive maneuver may reduce the power (energy/time unit) exerted on the perineal tissues and give the shoulders time to enter the pelvic cavity. The "pushing" maneuver will be evaluated in comparison with either an expectative attitude or a suctioning of fetal nose and mouth.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirabegron in Healthy Young Male and Female Subjects

summary: This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.

lead_sponsor: Astellas Pharma Inc


title: A Double-blind Two-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics (PK) of an Ethinyl Estradiol and Levonorgestrel Containing Combined Oral Contraceptive (COC)

summary: The objective of this study is to determine the effect of multiple doses of mirabegron on the pharmacokinetics of an oral contraceptive.


title: A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris.

summary: The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and calcipotriol plus LEO 27989 ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

lead_sponsor: LEO Pharma