title: Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells , Prospective, Open, Multicenter Study

summary: The purpose of this study is to assess the human herpes virus reactivation 6 post autologous stem cells in 196 patients. The aim of our study was to describe the incidence of reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role in this target population.

ReferenceCitation: De Bolle L, Naesens L, De Clercq E. Update on human herpesvirus 6 biology, clinical features, and therapy. Clin Microbiol Rev. 2005 Jan;18(1):217-45. Review.

ReferenceCitation: Boutolleau D, Duros C, Bonnafous P, Caïola D, Karras A, Castro ND, Ouachée M, Narcy P, Gueudin M, Agut H, Gautheret-Dejean A. Identification of human herpesvirus 6 variants A and B by primer-specific real-time PCR may help to revisit their respective role in pathology. J Clin Virol. 2006 Mar;35(3):257-63. Epub 2005 Sep 23.

ReferenceCitation: Yamanishi K, Okuno T, Shiraki K, Takahashi M, Kondo T, Asano Y, Kurata T. Identification of human herpesvirus-6 as a causal agent for exanthem subitum. Lancet. 1988 May 14;1(8594):1065-7.

ReferenceCitation: Santoro F, Kennedy PE, Locatelli G, Malnati MS, Berger EA, Lusso P. CD46 is a cellular receptor for human herpesvirus 6. Cell. 1999 Dec 23;99(7):817-27.

ReferenceCitation: Agut H. Deciphering the clinical impact of acute human herpesvirus 6 (HHV-6) infections. J Clin Virol. 2011 Nov;52(3):164-71. doi: 10.1016/j.jcv.2011.06.008. Epub 2011 Jul 22. Review.

ReferenceCitation: Ljungman P, Wang FZ, Clark DA, Emery VC, Remberger M, Ringdén O, Linde A. High levels of human herpesvirus 6 DNA in peripheral blood leucocytes are correlated to platelet engraftment and disease in allogeneic stem cell transplant patients. Br J Haematol. 2000 Dec;111(3):774-81.

ReferenceCitation: Ljungman P. Immune reconstitution and viral infections after stem cell transplantation. Bone Marrow Transplant. 1998 Apr;21 Suppl 2:S72-4. Review.

ReferenceCitation: Agut H. [Acute human herpesvirus 6 (HHV-6) infections: when and how to treat?]. Pathol Biol (Paris). 2011 Apr;59(2):108-12. doi: 10.1016/j.patbio.2010.07.015. Epub 2010 Sep 15. Review. French.

ReferenceCitation: Kamble RT, Clark DA, Leong HN, Heslop HE, Brenner MK, Carrum G. Transmission of integrated human herpesvirus-6 in allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Sep;40(6):563-6. Epub 2007 Jul 16.

ReferenceCitation: Lee SO, Brown RA, Razonable RR. Clinical significance of pretransplant chromosomally integrated human herpesvirus-6 in liver transplant recipients. Transplantation. 2011 Jul 27;92(2):224-9. doi: 10.1097/TP.0b013e318222444a.

ReferenceCitation: Moreau P, Facon T, Attal M, Hulin C, Michallet M, Maloisel F, Sotto JJ, Guilhot F, Marit G, Doyen C, Jaubert J, Fuzibet JG, François S, Benboubker L, Monconduit M, Voillat L, Macro M, Berthou C, Dorvaux V, Pignon B, Rio B, Matthes T, Casassus P, Caillot D, Najman N, Grosbois B, Bataille R, Harousseau JL; Intergroupe Francophone du Myélome. Comparison of 200 mg/m(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myélome 9502 randomized trial. Blood. 2002 Feb 1;99(3):731-5.

ReferenceCitation: Leong HN, Tuke PW, Tedder RS, Khanom AB, Eglin RP, Atkinson CE, Ward KN, Griffiths PD, Clark DA. The prevalence of chromosomally integrated human herpesvirus 6 genomes in the blood of UK blood donors. J Med Virol. 2007 Jan;79(1):45-51.

ReferenceCitation: Ogata M. Human herpesvirus 6 in hematological malignancies. J Clin Exp Hematop. 2009 Nov;49(2):57-67. Review.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: CHU Saint-Etienne - laboratoire de virologie


acronym: IPOI vs IPOP

summary: The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Poitiers University Hospital

location_facility:
Bicêtre Hospital
Poitiers University Hospital
Rouen University Hospital

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)

summary:
The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease.

Participation consists in taking one or several blood samples depending on the group patients/controls.

study_start_date_type: Actual

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de BESANCON
CH de METZ
CHU de DIJON

intervention_type: Other

status_simplified: Completed


title: Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.

summary: Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium) allows to obtain a better forecast of preservation of the tooth without complication than the conventional technique with the creation of an apicale barrier in the MTA in 24 months.

primary_purpose: Other

lead_sponsor: University Hospital, Brest

location_facility:
Hôtel Dieu
CHRU de Brest - Pôle Organe des Sens
CHU de Rennes

intervention_type: Device


title: Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis

acronym: STIMASEP

summary: This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.

status: Recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Hôpital Henri Mondor
CHU Ambroise Paré
CHU de Clermont-Ferrand

status_simplified: Ongoing


type: Other Identifier

title: Prevalence and Identification of Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries

acronym: Caries Species

summary: The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments of the Nîmes University Hospital and the Montpellier University Hospital.

study_completion_date_type: Actual

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Montpellier - Centre de Soins, d'Enseignement et de Recherche Dentaires

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital La Colombière


type: EudraCT Number

title: Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study

acronym: IoxRea

summary: The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Desgrouas M, Merdji H, Bretagnol A, Barin-Le Guellec C, Halimi JM, Ehrmann S, Salmon Gandonnière C. Kinetic Glomerular Filtration Rate Equations in Patients With Shock: Comparison With the Iohexol-Based Gold-Standard Method. Crit Care Med. 2021 Aug 1;49(8):e761-e770. doi: 10.1097/CCM.0000000000004946.

family: Desgrouas

full_name: Maxime Desgrouas

given: Maxime

sequence: first

family: Merdji

full_name: Hamid Merdji

given: Hamid

sequence: additional

family: Bretagnol

full_name: Anne Bretagnol

given: Anne

family: Barin-Le Guellec

full_name: Chantal Barin-Le Guellec

given: Chantal

family: Halimi

full_name: Jean-Michel Halimi

given: Jean-Michel

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Salmon Gandonnière

full_name: Charlotte Salmon Gandonnière

given: Charlotte

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation Polyvalente, CHRU de Tours

intervention_type: Drug


title: Medical Telephone Triage of Emergency Calls for Thoracic Pain: Construction of a Probability Score for Acute Coronary Syndrome.

summary:
Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. The benefit of an early diagnosis of ACS in term of morbidity and mortality is well established. Identification of the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is thus a key element of the prognosis.

The aim of the study is to build a telephone predictive score of ACS at the triage of calls for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will authorize the validation of a unique score or two distinct scores for men and women.

ReferenceType: result

ReferenceCitation: Reuter PG, Pradeau C, Huo Yung Kai S, Lhermusier T, Bourdé A, Tentillier E, Combes X, Bongard V, Ducassé JL, Charpentier S. Predicting acute coronary syndrome in males and females with chest pain who call an emergency medical communication centre. Scand J Trauma Resusc Emerg Med. 2019 Oct 17;27(1):92. doi: 10.1186/s13049-019-0670-y.

family: Reuter

full_name: Paul-Georges Reuter

given: Paul-Georges

family: Pradeau

full_name: Catherine Pradeau

given: Catherine

family: Huo Yung Kai

full_name: Samantha Huo Yung Kai

given: Samantha

family: Lhermusier

full_name: Thibault Lhermusier

given: Thibault

family: Bourdé

full_name: Arnaud Bourdé

given: Arnaud

family: Tentillier

full_name: Eric Tentillier

given: Eric

family: Combes

full_name: Xavier Combes

given: Xavier

family: Bongard

full_name: Vanina Bongard

given: Vanina

family: Ducassé

full_name: Jean-Louis Ducassé

given: Jean-Louis

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

currency_apc_doaj: GBP

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility:
Toulouse Hosital Center
La Réunion Hospital center
Bordeaux Hospital Center


title: Ultrasonography Assessment of Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial

acronym: SEPT'ECHO

summary:
The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.

Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.

Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.

Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.

However, MRI is expensive and not rapidly accessible.

Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.

The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.

The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.

lead_sponsor: Nantes University Hospital

location_facility:
CH La Roche-sur-Yon
CH de Nantes
CH Saint-Nazaire


title: Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

acronym: PRO-COLLE

summary: Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.

lead_sponsor: Hospices Civils de Lyon

location_facility: Gynaecology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Gynaecology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant


title: Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)

acronym: OSICAT

summary:
Targeted population: Patients with heart failure causing hospitalization during the last twelve months.

Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required.

Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.

primary_purpose: Prevention

ReferenceCitation: Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartière L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.

name: CardiologyToulouse Rangueil University Hospital (CHU) Toulouse France

name: UMR UT3 CNRS 5288 Evolutionary Medicine, Obesity and Heart Failure: Molecular and Clinical Investigations, INI‐CRCT F‐CRIN, GREAT Networks Toulouse France

name: Faculty of MedicineUniversity of Paul Sabatier‐Toulouse III Toulouse France

family: Galinier

full_name: Michel Galinier

given: Michel

name: PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology DepartmentUniversity Hospital of Montpellier Montpellier France

family: Roubille

full_name: François Roubille

given: François

family: Berdague

full_name: Philippe Berdague

given: Philippe

name: Intercommunal Hospital Centre des Vallées de l'Ariege Foix France

family: Brierre

full_name: Gilles Brierre

given: Gilles

name: Intercommunal Hospital Centre Castres‐Mazamet Castres France

family: Cantie

full_name: Philippe Cantie

name: Private Practice Saint Yrieix La Perche France

family: Dary

full_name: Patrick Dary

given: Patrick

name: Cardiology Aftercare and Rehabilitation Centre Beaumont de Lomagne France

family: Ferradou

full_name: Jean‐Marc Ferradou

given: Jean‐Marc

family: Fondard

full_name: Olivier Fondard

given: Olivier

family: Labarre

full_name: Jean Philippe Labarre

given: Jean Philippe

family: Mansourati

full_name: Jacques Mansourati

given: Jacques

name: Unité d'Insuffisance CardiaqueCentre Hospitalier Universitaire de Bordeaux Bordeaux France

family: Picard

full_name: François Picard

name: University Hospital of Nimes Nimes France

family: Ricci

full_name: Jean‐Etienne Ricci

given: Jean‐Etienne

name: University Hospital of Grenoble Grenoble France

family: Salvat

full_name: Muriel Salvat

given: Muriel

family: Tartière

full_name: Lamia Tartière

given: Lamia

family: Ruidavets

full_name: Jean‐Bernard Ruidavets

given: Jean‐Bernard

name: Air Liquide Santé International Loges en Josas France

family: Delval

full_name: Cécile Delval

given: Cécile

family: Lancman

full_name: Guila Lancman

given: Guila

family: Pasche

full_name: Hélène Pasche

given: Hélène

family: Ramirez‐Gil

full_name: Juan Fernando Ramirez‐Gil

given: Juan Fernando

name: Department of Cardiovascular MedicinePrincess Grace Hospital Monaco Monaco

family: Pathak

full_name: Atul Pathak

given: Atul

journal_name: European Journal of Heart Failure

oa_host_type: repository

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

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

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Centre Hospitalier d'Avignon - Hospital Henri Duffaut

location_facility: Centre de réadaptation cardiovasculaire Midi-Gascogne

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer

location_facility: Centre Hospitalier Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital Pasteur

location_facility: Centre Hospitalier Intercommunal Castres-Mazamet

location_facility: Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel

location_facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Cabinet de Cardiologie - Pôle médical spécialisé

location_facility: Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque

location_facility: Centre Hospitalier Universitaire d'Amiens de Picardie


title: Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis

acronym: MICROPOLY

summary:
The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.

The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine

intervention_type: Biological


title: Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation

acronym: BANNISTER

summary:
randomized double-blind controlled study in parallel groups

Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.

During this administration, non invasive ventilation for the patient will be continued.

ReferenceCitation: Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.

name: Médecine Intensive-Réanimation, CHRU Tours, Tours, France.

family: Bodet-Contentin

full_name: Laetitia Bodet-Contentin

given: Laetitia

name: INSERM, Centre d'Étude des Pathologies Respiratoires, U1100, Tours, France.

family: Guillon

full_name: Antoine Guillon

given: Antoine

name: Réanimation Médicale, Hôpital de la Source, Orléans, France.

family: Boulain

full_name: Thierry Boulain

given: Thierry

name: Réanimation Médicale, Hôpital Jean Bernard, Poitiers, France.

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Garot

full_name: Denis Garot

given: Denis

family: Le Pennec

full_name: Deborah Le Pennec

given: Deborah

family: Vecellio

full_name: Laurent Vecellio

given: Laurent

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

name: Centre d'Investigation Clinique Inserm CIC 1415, Tours, France.

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

journal_name: Journal of Aerosol Medicine and Pulmonary Drug Delivery

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

ipd_sharing: No

location_facility: Service de Réanimation Médicale - CHR d'Orléans


title: Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study

acronym: PHRC CMV

summary: The investigators aim is to determine the incidence of cytomegalovirus resistance to antivirals in a cohort study. The patients are included at their first CMV active infection and are followed during two years thereafter. When criteria for suspected resistance are meet, blood and urine samples are collected for virus isolation and further resistance phenotype, and for resistance genotype determination. Results are compared with baseline samples. Clinical information such as treatment, immunosuppressive regimen and clinical evolution will be collected. Through this study, the investigators aim to organize a national network for the detection and identification of CMV resistant strains that will be useful when new therapeutics will be available.

ReferenceCitation: Germi R, Mariette C, Alain S, Lupo J, Thiebaut A, Brion JP, Epaulard O, Saint Raymond C, Malvezzi P, Morand P. Success and failure of artesunate treatment in five transplant recipients with disease caused by drug-resistant cytomegalovirus. Antiviral Res. 2014 Jan;101:57-61. doi: 10.1016/j.antiviral.2013.10.014. Epub 2013 Nov 1.

family: Germi

full_name: R. Germi

given: R.

family: Mariette

full_name: C. Mariette

given: C.

family: Alain

full_name: S. Alain

given: S.

family: Lupo

full_name: J. Lupo

given: J.

family: Thiebaut

full_name: A. Thiebaut

given: A.

family: Brion

full_name: J.P. Brion

family: Epaulard

full_name: O. Epaulard

given: O.

family: Saint Raymond

full_name: C. Saint Raymond

family: Malvezzi

full_name: P. Malvezzi

given: P.

family: Morand

full_name: P. Morand

journal_name: Antiviral Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Hantz S, Garnier-Geoffroy F, Mazeron MC, Garrigue I, Merville P, Mengelle C, Rostaing L, Saint Marcoux F, Essig M, Rerolle JP, Cotin S, Germi R, Pillet S, Lebranchu Y, Turlure P, Alain S; French CMV Resistance Survey Study Group. Drug-resistant cytomegalovirus in transplant recipients: a French cohort study. J Antimicrob Chemother. 2010 Dec;65(12):2628-40. doi: 10.1093/jac/dkq368. Epub 2010 Oct 20.

family: Hantz

full_name: S. Hantz

family: Garnier-Geoffroy

full_name: F. Garnier-Geoffroy

given: F.

family: Mazeron

full_name: M.-C. Mazeron

family: Garrigue

full_name: I. Garrigue

given: I.

family: Merville

full_name: P. Merville

family: Mengelle

full_name: C. Mengelle

family: Rostaing

full_name: L. Rostaing

given: L.

family: Saint Marcoux

full_name: F. Saint Marcoux

family: Essig

full_name: M. Essig

given: M.

family: Rerolle

full_name: J.-P. Rerolle

family: Cotin

full_name: S. Cotin

name: on behalf of the French CMV Resistance Survey Study Group

location_facility: Virologie - Hôpital La Pitié Salpétrière


title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints

summary: To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

lead_sponsor: NeuroHealing Pharmaceuticals Inc.

location_facility:
Hôpital de la Salpêtrière
Hôpital Paul de Viguier
Hôpital Haut Lévêque

lead_sponsor_type: industriel


title: Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.

acronym: HRM RTSIO

summary: The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'Exploration Fonctionnelle Digestive

location_facility: Institut des Maladies de l'Appareil Digestif (IMAD)

location_facility: Service d'hépato-gastroentérologie et oncologie digestive


title: Evaluation of Target Organs Impairment on Patients Suffering From High Blood Pressure Without Known Cardio Vascular or Renal Disease, Stratified on Blood Pressure Control.

acronym: PREVENTA

summary: Evaluation of target organs impairment on patients suffering from high blood pressure without known cardio vascular or renal disease, stratified on blood pressure control.

lead_sponsor: AstraZeneca


title: Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.

acronym: IPEC-GC

summary: If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients could received post-chemotherapy, due to post-operative complications and toxicities. To overcome this limitation, the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P), epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin combinations, sustain the development of dose density based on PET combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen

status: Terminated

ReferenceCitation: Jary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratté S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14.

family: Jary

full_name: Marine Jary

given: Marine

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

family: Jacquin

full_name: Marion Jacquin

given: Marion

family: Fein

full_name: Francine Fein

given: Francine

family: Nguyen

full_name: Thierry Nguyen

given: Thierry

family: Cleau

full_name: Denis Cleau

given: Denis

family: Nerich

full_name: Virginie Nerich

given: Virginie

family: El Gani

full_name: Maryame El Gani

given: Maryame

family: Mathieu

full_name: Pierre Mathieu

given: Pierre

family: Valmary-Degano

full_name: Séverine Valmary-Degano

given: Séverine

family: Arnould

full_name: Laurent Arnould

family: Lassabe

full_name: Catherine Lassabe

given: Catherine

family: Lamfichekh

full_name: Najib Lamfichekh

given: Najib

family: Fratté

full_name: Serge Fratté

given: Serge

family: Paget-Bailly

full_name: Sophie Paget-Bailly

given: Sophie

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Borg

full_name: Christophe Borg

given: Christophe

family: Kim

full_name: Stefano Kim

given: Stefano

journal_name: Cancer Chemotherapy and Pharmacology

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University hospital of Besançon
FNLCC center Georges François Leclerc
Hospital of Belfort-Montbeliard


title: Study of the Therapeutic Response and Survival of Patients With Metastatic Colorectal Cancer (Stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®

acronym: ONCOGRAM

summary: Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity

ReferenceCitation: Mathonnet M, Vanderstraete M, Bounaix Morand du Puch C, Giraud S, Lautrette C, Ouaissi M, Tabchouri N, Taïbi A, Martin R, Herafa I, Tchalla A, Christou N; ONCOGRAM trial investigators. ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®. Trials. 2021 Aug 21;22(1):556. doi: 10.1186/s13063-021-05531-y.

family: Mathonnet

full_name: Muriel Mathonnet

given: Muriel

family: Vanderstraete

full_name: Mathieu Vanderstraete

given: Mathieu

family: du Puch

full_name: Christophe Bounaix Morand du Puch

given: Christophe Bounaix Morand

family: Giraud

full_name: Stéphanie Giraud

given: Stéphanie

family: Lautrette

full_name: Christophe Lautrette

family: Ouaissi

full_name: Mehdi Ouaissi

given: Mehdi

family: Tabchouri

full_name: Nicolas Tabchouri

given: Nicolas

family: Taïbi

full_name: Abdelkader Taïbi

given: Abdelkader

family: Martin

full_name: Renaud Martin

given: Renaud

family: Herafa

full_name: Isabelle Herafa

given: Isabelle

family: Tchalla

full_name: Achille Tchalla

given: Achille

family: Christou

full_name: Niki Christou

given: Niki

family: Marin

full_name: B. Marin

given: B.

family: Bouvier

full_name: S. Bouvier

given: S.

family: Durand-Fontanier

full_name: S. Durand-Fontanier

family: Fabre

full_name: A. Fabre

given: A.

family: Valleix

full_name: D. Valleix

given: D.

family: Rivaille

full_name: T. Rivaille

given: T.

family: Fredon

full_name: F. Fredon

given: F.

family: Derbal

full_name: S. Derbal

family: Carrier

full_name: P. Carrier

given: P.

family: Lonfo

full_name: R. Daloko Lonfo

given: R. Daloko

family: Legros

full_name: R. Legros

given: R.

location_facility:
Clinique des Cédres
Centre Médical MGEN Alfred Leune
CH de BRIVE
Clermont-Ferrand University Hospital
Hospital Center
CHU d'AMIENS
CH de Saint Junien
CHU de TOURS
Limoges University Hospital
Bergonié Institut
CHU de POITIERS
Nimes University Hospital
CHu de la Martinique


title: Evaluation of the Frequency of Limitation of Activity, Depending on Gender and Age-group, in Patients With Persistent Asthma Consulting a General Practitioner

acronym: ASMAVIE

summary: Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner


title: Evaluation of the Control Level (GINA) of Asthmatic Patients Consulting Their General Practitioner for a Seasonal Increase of Respiratory Symptoms (High and / or Low), Whether an Inhaled Corticotherapy is Taken or Not

acronym: SAISON

summary: To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not controlled) of asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is taken or not.


title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

summary: Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hopital Lariboisière
Institut Gustave Roussy
Centre Oscar Lambret


title: Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

summary: This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support

status: Withdrawn

primary_purpose: Supportive Care

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ


title: Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms

acronym: abl LMC

summary: The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

acronym: ORHEO

summary: The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

ReferenceCitation: Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503. Erratum in: BMC Cancer. 2014;14:720.

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

family: Luporsi

full_name: Elisabeth Luporsi

given: Elisabeth

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

family: Amar

full_name: Nadia Ali Amar

given: Nadia Ali

family: Boulanger

full_name: Vincent Boulanger

given: Vincent

family: Carreiro

full_name: Miguel Carreiro

given: Miguel

family: Dourthe

full_name: Louis-Marie Dourthe

given: Louis-Marie

family: Labourey

full_name: Jean-Luc Labourey

given: Jean-Luc

family: Lepille

full_name: Daniel Lepille

given: Daniel

family: Maloisel

full_name: Frédéric Maloisel

given: Frédéric

family: Mouysset

full_name: Jean-Loup Mouysset

given: Jean-Loup

family: Nahon

full_name: Sophie Nahon

given: Sophie

family: Narciso

full_name: Bérengère Narciso

given: Bérengère

family: Nouyrigat

full_name: Pierre Nouyrigat

family: Radji

full_name: Raouf Radji

given: Raouf

family: Sakek

full_name: Nacéra Sakek

given: Nacéra

family: Albrand

full_name: Hélène Albrand

given: Hélène

journal_name: BMC Cancer

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer


title: Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT

summary:
Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

location_facility:
Oscar Lambret Center
Centre Georges François Leclerc
Léon BERARD Center


title: Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants

summary:
Hospital-acquired infections are common complications in preterm infants. The diagnosis has to be fast and accurate. Indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance.

The aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Angers
CHU de Rennes
CHU de Lille


title: Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg

summary: The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.

design_allocation: Non-Randomized

ReferenceCitation: Denis P, Baudouin C, Bron A, Nordmann JP, Renard JP, Rouland JF, Sellem E, Amrane M. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure. BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.

family: Denis

full_name: Philippe Denis

given: Philippe

family: Baudouin

full_name: Christophe Baudouin

given: Christophe

family: Bron

full_name: Alain Bron

given: Alain

family: Nordmann

full_name: Jean-Philippe Nordmann

given: Jean-Philippe

family: Renard

full_name: Jean Paul Renard

given: Jean Paul

family: Rouland

full_name: Jean François Rouland

given: Jean François

family: Sellem

full_name: Eric Sellem

given: Eric

family: Amrane

full_name: Mourad Amrane

given: Mourad

journal_name: BMC Ophthalmology

repositories:
HAL
PubMed Central

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

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.


title: Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension

acronym: PREDICOM

summary: To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).

ReferenceCitation: Sellem E, Rouland JF, Baudouin C, Bron A, Denis P, Nordmann JP, Renard JP. Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination. BMC Ophthalmol. 2010 Mar 26;10:10. doi: 10.1186/1471-2415-10-10.


title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

acronym: CONTACT

summary:
This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed.

The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.

Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.

For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :

Ruling out malignancy for patients with benign appearing nCLE images.
Characterizing more malignant tumors in the pancreas.
Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.

ReferenceType: background

ReferenceCitation: Adsay NV. Cystic neoplasia of the pancreas: pathology and biology. J Gastrointest Surg. 2008 Mar;12(3):401-4. Epub 2007 Oct 24. Review.

ReferenceCitation: Levy MJ, Clain JE. Evaluation and management of cystic pancreatic tumors: emphasis on the role of EUS FNA. Clin Gastroenterol Hepatol. 2004 Aug;2(8):639-53. Review.

ReferenceCitation: Hutchins GF, Draganov PV. Cystic neoplasms of the pancreas: a diagnostic challenge. World J Gastroenterol. 2009 Jan 7;15(1):48-54. Review.

ReferenceCitation: Attasaranya S, Pais S, LeBlanc J, McHenry L, Sherman S, DeWitt JM. Endoscopic ultrasound-guided fine needle aspiration and cyst fluid analysis for pancreatic cysts. JOP. 2007 Sep 7;8(5):553-63.

ReferenceCitation: Becker V, Vercauteren T, von Weyhern CH, Prinz C, Schmid RM, Meining A. High-resolution miniprobe-based confocal microscopy in combination with video mosaicing (with video). Gastrointest Endosc. 2007 Nov;66(5):1001-7. Epub 2007 Sep 4.

ReferenceCitation: Meining A, Saur D, Bajbouj M, Becker V, Peltier E, Höfler H, von Weyhern CH, Schmid RM, Prinz C. In vivo histopathology for detection of gastrointestinal neoplasia with a portable, confocal miniprobe: an examiner blinded analysis. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1261-7. Epub 2007 Aug 6.

ReferenceCitation: Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. Epub 2006 Jul 13.

ReferenceCitation: Pohl H, Rösch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28.

ReferenceCitation: Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.

ReferenceCitation: Meining A, Frimberger E, Becker V, Von Delius S, Von Weyhern CH, Schmid RM, Prinz C. Detection of cholangiocarcinoma in vivo using miniprobe-based confocal fluorescence microscopy. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1057-60. doi: 10.1016/j.cgh.2008.04.014. Epub 2008 Jul 17.

ReferenceCitation: Meining A, Phillip V, Gaa J, Prinz C, Schmid RM. Pancreaticoscopy with miniprobe-based confocal laser-scanning microscopy of an intraductal papillary mucinous neoplasm (with video). Gastrointest Endosc. 2009 May;69(6):1178-80. doi: 10.1016/j.gie.2008.06.013. Epub 2009 Jan 18.

ReferenceCitation: Konda VJ, Aslanian HR, Wallace MB, Siddiqui UD, Hart J, Waxman I. First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos). Gastrointest Endosc. 2011 Nov;74(5):1049-60. doi: 10.1016/j.gie.2011.07.018. Epub 2011 Sep 15.

ReferenceCitation: Giovannini M, Caillol F, Poizat F, Bories E, Pesenti C, Monges G, Raoul JL. Feasibility of Intratumoral Confocal Microscopy under Endoscopic Ultrasound Guidance. Endosc Ultrasound. 2012 Jul;1(2):80-3. doi: 10.7178/eus.02.005.

ReferenceCitation: Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Löhr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30.

ReferenceCitation: Becker V, Wallace MB, Fockens P, von Delius S, Woodward TA, Raimondo M, Voermans RP, Meining A. Needle-based confocal endomicroscopy for in vivo histology of intra-abdominal organs: first results in a porcine model (with videos). Gastrointest Endosc. 2010 Jun;71(7):1260-6. doi: 10.1016/j.gie.2010.01.010. Epub 2010 Apr 24.

ReferenceCitation: Khalid A, Brugge W. ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol. 2007 Oct;102(10):2339-49. Epub 2007 Aug 31. Review.

ReferenceCitation: Bhutani MS. Role of endoscopic ultrasonography in the diagnosis and treatment of cystic tumors of the pancreas. JOP. 2004 Jul;5(4):266-72. Review.

ReferenceCitation: Sahani DV, Kadavigere R, Saokar A, Fernandez-del Castillo C, Brugge WR, Hahn PF. Cystic pancreatic lesions: a simple imaging-based classification system for guiding management. Radiographics. 2005 Nov-Dec;25(6):1471-84. Review.

ReferenceCitation: Palazzo M, Sauvanet A, Gincul R, Borbath I, Vanbiervliet G, Bourdariat R, Lemaistre AI, Pujol B, Caillol F, Palazzo L, Aubert A, Maire F, Buscail L, Giovannini M, Marque S, Napoléon B. Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions. Surg Endosc. 2020 Jun;34(6):2532-2540. doi: 10.1007/s00464-019-07062-9. Epub 2019 Aug 13.

family: Palazzo

full_name: Maxime Palazzo

given: Maxime

family: Sauvanet

full_name: Alain Sauvanet

family: Gincul

full_name: Rodica Gincul

given: Rodica

family: Borbath

full_name: Ivan Borbath

given: Ivan

family: Vanbiervliet

full_name: Goeffroy Vanbiervliet

given: Goeffroy

family: Bourdariat

full_name: Raphaël Bourdariat

given: Raphaël

family: Lemaistre

full_name: Anne-Isabelle Lemaistre

given: Anne-Isabelle

family: Pujol

full_name: Bertrand Pujol

given: Bertrand

family: Caillol

full_name: Fabrice Caillol

given: Fabrice

full_name: Laurent Palazzo

given: Laurent

family: Aubert

full_name: Alain Aubert

family: Maire

full_name: Frédérique Maire

given: Frédérique

family: Buscail

full_name: Louis Buscail

given: Louis

family: Giovannini

full_name: Marc Giovannini

given: Marc

family: Marque

full_name: Sébastien Marque

given: Sébastien

family: Napoléon

full_name: Bertrand Napoléon

journal_name: Surgical Endoscopy

oa_colors: green hybrid

evidence: open (via crossref license)

ReferenceCitation: Napoleon B, Palazzo M, Lemaistre AI, Caillol F, Palazzo L, Aubert A, Buscail L, Maire F, Morellon BM, Pujol B, Giovannini M. Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis. Endoscopy. 2019 Sep;51(9):825-835. doi: 10.1055/a-0732-5356. Epub 2018 Oct 22.

name: Département de Gastroentérologie, Hôpital Privé Jean Mermoz, Ramsay GDS, Lyon, France

name: Département d’Endoscopie Digestive, Hôpital Beaujon, Clichy, France

name: Département de Biopathologie, Eurofins Biomnis, Lyon, France

name: Unité d’Échoendoscopie et d’Endoscopie d’Oncologie Digestive, Institut Paoli Calmettes, Marseille, France

name: Service d’Hépatogastroenterologie, Hôpital Rangueil, Toulouse, France

name: Cabinet d’Anatomo-cyto-pathologie, Technipath, Limonest, France

ReferenceCitation: Giovannini M, Caillol F, Monges G, Poizat F, Lemaistre AI, Pujol B, Lucidarme D, Palazzo L, Napoléon B. Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy in solid pancreatic masses. Endoscopy. 2016 Oct;48(10):892-8. doi: 10.1055/s-0042-112573. Epub 2016 Aug 30.

name: Department of Hepatogastroenterology, Institut Paoli Calmettes, Marseille, France

name: Department of Biopathology, Institut Paoli Calmettes, Marseille, France

name: Department of Biopathology, Centre Léon Bérard, Lyon, France

name: Department of Gastroenterology, Ramsay Générale de Santé, Hôpital privé Jean Mermoz, Lyon, France

name: Medicosurgical Department of Hepatogastroenterology, Hôpital Saint-Philibert, Lomme-lès-Lille, France

name: Department of Gastroenterology, Clinique du Trocadéro, Paris, France

ReferenceCitation: Napoléon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Filoche B, Giovannini M. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy. 2015 Jan;47(1):26-32. doi: 10.1055/s-0034-1390693. Epub 2014 Oct 17.

name: Department of Gastroenterology, Hôpital privé Jean Mermoz, Générale de Santé, Lyon, France

name: Medicosurgical Department of Hepatogastroenterology, Saint-Philibert Hospital Centre, Lomme-lès-Lille, France

name: Department of Digestive Surgery, Hôpital privé Jean Mermoz, Générale de Santé, Lyon, France

location_facility:
Hôpital Jean Mermoz
Hôpital Saint-Philibert
Institut Paoli Calmettes


title: A Phase I Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib (BSI-201) in Multiple Non Operable Brain Metastases

acronym: RAPIBE

summary:
Recent pre-clinical and clinical data have indicated that BSI-201 does not possess characteristics typical of the PARP inhibitor class. Based on the results from in vitro and in vivo studies, this trial aims to evaluate the combination of BSI-201 concomitantly with radiotherapy in patients who present with multiple non operable brain metastases. As radiotherapy is a local treatment targeting only the tumor, and because the molecule BSI-201 has shown no major toxicity against tissues without DNA alterations, the proposed combination is expected to provide tumor-selective therapy and leading to a clinical benefit improvement.

Primary objective is to determine the recommended phase II dose (RP2D) and evaluate acute toxicity (CTC-AE v4.0 grading scale) of concurrent administration of whole brain radiotherapy (WBR) and a small molecule BSI-201 in non operable brain metastases.

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

location_facility:
AP-HP Hôpital Saint-Louis
Institut Gustave-Roussy
CRLC Val d'Aurelle-Paul Lamarque

intervention_type: Radiation


title: Role of Complement System in Human Allogeneic Haematopoietic Stem Cell Transplantation

summary: Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT, called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an immune response against healthy recipient cells leading to a graft-versus-host disease (GvHD) in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD without affecting the GvL effect. According to GVHD experimental models, it is likely that GvL but not GvHD may occur in the absence of inflammatory signals induced by the transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the role of Complement system in patients who received allogeneic HSCT. Indeed, Complement system is a major actor of inflammation and in the generation of tissue destruction, both of which are involved in the physiopathology of GVHD. Furthermore, it might be a potential target of some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a preventive or curative manner in such patients. Preliminary data obtained from 34 allografted patients in our institution suggest that Complement activation by the classical pathway is correlated to the occurrence of GI GVHD. The goal of our current project, in order to confirm these preliminary results in a larger series, is to explore Complement system activation in patients who received allogeneic HSCT in three Adult Hematology departments in Paris fot two years and to correlate the biological results to the clinical events occurring after HSCT.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Saint Antoine Hospital
Necker Hospital
Saint Louis Hospital


title: Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence

acronym: ADIUVO

summary:
Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk.

The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection

ReferenceCitation: Terzolo M, Angeli A, Fassnacht M, Daffara F, Tauchmanova L, Conton PA, Rossetto R, Buci L, Sperone P, Grossrubatscher E, Reimondo G, Bollito E, Papotti M, Saeger W, Hahner S, Koschker AC, Arvat E, Ambrosi B, Loli P, Lombardi G, Mannelli M, Bruzzi P, Mantero F, Allolio B, Dogliotti L, Berruti A. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med. 2007 Jun 7;356(23):2372-80.

lead_sponsor: University of Turin, Italy

location_country:
Italy
United States
Netherlands
France
Germany
United Kingdom
Canada

location_facility: Endocrinologie - CHU Lyon Hôpital Pierre Wertheimer

location_facility: Endocrinologie - CHU Besançon Hôpital Jean Minjoz

location_facility: Endocrinologie - Institut de Cancérologie Gustave Roussy

location_facility: Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham

location_facility: Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: University Hospital Wuerzburg, Endocrinology

location_facility: Medical Oncology Branch - Center for Cancer Research - National Cancer Institute

location_facility: Endocrinologie - CHU Toulouse Hôpital Larrey

location_facility: Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1

location_facility: Dept. of Internal Medicine Maxima Medisch Centrum

location_facility: A.O.U. San Giovanni Battista - Molinette

location_facility: University Hospital Campus Mitte Charitè, Berlin

location_facility: Endocrine Oncology - University of Michigan Comprehensive Cancer Center

location_facility: A.O.Universitaria Arcispedale S.Anna Ferrara


acronym: ORTHOSENS

summary: Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.

lead_sponsor: Thuasne

location_facility: Institut de Chirurgie Orthopédique et Sportive


title: Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers

summary: The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs

lead_sponsor: University Hospital, Lille

location_facility: CHRU de Lille/ Centre d'investigation Clinique


title: S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients

summary: Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. However, sedation excess and ventilator support excess, both in duration and intensity, are associated with an excess morbidity. Patients usually are systematically sedated after having been intubated. Then, sedation is stopped first before ventilator support is weaning. Several studies shown that rationalized protocols of sedation and ventilation orderings had a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in surgical patients is still unknown. Moreover, no study has evaluated an optimized paired strategy of sedation-ventilation based on the priority setting of ventilation. This priority setting of ventilation should increase patient's comfort in spite of increasing sedatives and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and intensity of these treatments could improve surgical patients' outcome in ICU.

ReferenceCitation: Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, Muller L, Jung B, Belafia F, Cissé M, Delay JM, de Jong A, Lefrant JY, Futier E, Mercier G, Molinari N, Jaber S; SOS-Ventilation study investigators. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18.

family: Chanques

full_name: Gerald Chanques

given: Gerald

family: Conseil

full_name: Matthieu Conseil

given: Matthieu

family: Roger

full_name: Claire Roger

given: Claire

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Prades

full_name: Albert Prades

given: Albert

family: Carr

full_name: Julie Carr

given: Julie

family: Muller

full_name: Laurent Muller

family: Jung

full_name: Boris Jung

given: Boris

family: Belafia

full_name: Fouad Belafia

given: Fouad

family: Cissé

full_name: Moussa Cissé

given: Moussa

family: Delay

full_name: Jean-Marc Delay

given: Jean-Marc

family: de Jong

full_name: Audrey de Jong

given: Audrey

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Mercier

full_name: Grégoire Mercier

given: Grégoire

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Jaber

full_name: Samir Jaber

given: Samir

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

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

location_facility: Department of Anesthesiology & Critical Care, Estaing University Hospital

location_facility: Department of Anesthesiology & Critical Care, Caremeau University Hospita

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital


title: A Phase 1b Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Subjects With Relapsed Multiple Myeloma

summary: The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.

ReferenceCitation: Moreau P, Facon T, Touzeau C, Benboubker L, Delain M, Badamo-Dotzis J, Phelps C, Doty C, Smit H, Fourneau N, Forslund A, Hellemans P, Leleu X. Quisinostat, bortezomib, and dexamethasone combination therapy for relapsed multiple myeloma. Leuk Lymphoma. 2016 Jul;57(7):1546-59. doi: 10.3109/10428194.2015.1117611. Epub 2016 Jan 12.

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Facon

full_name: Thierry Facon

given: Thierry

family: Touzeau

full_name: Cyrille Touzeau

given: Cyrille

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Delain

full_name: Martine Delain

given: Martine

family: Badamo-Dotzis

full_name: Julie Badamo-Dotzis

family: Phelps

full_name: Charles Phelps

given: Charles

family: Doty

full_name: Christopher Doty

given: Christopher

family: Smit

full_name: Hans Smit

given: Hans

family: Fourneau

full_name: Nele Fourneau

given: Nele

family: Forslund

full_name: Ann Forslund

given: Ann

family: Hellemans

full_name: Peter Hellemans

given: Peter

family: Leleu

full_name: Xavier Leleu

given: Xavier

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Janssen Research & Development, LLC


title: Provision of a Mobile Geriatric Team Extra-Community Hospital in Assessing and Regulating the Hospitalization of Frail Elderly Patients With Complex Medical and Social Situation

acronym: UMG

summary:
The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month.

The primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month.

ReferenceCitation: Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51.

ReferenceCitation: Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6.

ReferenceCitation: Elkan R, Kendrick D, Dewey M, Hewitt M, Robinson J, Blair M, Williams D, Brummell K. Effectiveness of home based support for older people: systematic review and meta-analysis. BMJ. 2001 Sep 29;323(7315):719-25. Review.

lead_sponsor: University Hospital, Grenoble

location_facility:
CH Annecy
CH Roanne
University Hospital of Grenoble


title: A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors

summary: The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.

lead_sponsor: Ipsen

location_facility:
Centre Rene Huguenin
Centre Eugene Marquis
Centre Paul Papin


title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus

acronym: VITALUP

summary:
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.

SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).

Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.

Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.

location_facility:
Hopital la Pitie Salpétrière
Nathalie Costedoat-Chalumeau
Chu Pitie Salpetriere


title: Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus

acronym: MagTIN

summary: The objective of the investigators study is to assess conventional repetitive transcranial magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized, double-blind, sham-controlled procedure, with four increasing levels of magnetic "pseudo-dose" has been designed, in order to characterize the effectiveness of rTMS while controlling its safety and tolerability. By combining various rTMS protocols with a twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of therapeutic management.

lead_sponsor: Hospices Civils de Lyon

location_facility: Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot

location_facility: Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud

location_facility: Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud


title: Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy

acronym: FORTIS

summary: The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.

ReferenceCitation: Ysebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18.

family: Ysebaert

full_name: Loic Ysebaert

given: Loic

family: Larcher

full_name: Marie Larcher

given: Marie

family: Compaci

full_name: Gisele Compaci

given: Gisele

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Sahnes

full_name: Laurence Sahnes

given: Laurence

family: Banos

full_name: Anne Banos

given: Anne

family: Araujo

full_name: Carla Araujo

given: Carla

family: Sommet

full_name: Agnes Sommet

given: Agnes

family: Laurent

full_name: Guy Laurent

given: Guy

family: Despas

full_name: Fabien Despas

given: Fabien

journal_name: Annals of Hematology

lead_sponsor: University Hospital, Toulouse

location_facility:
Centre Hospitalier de la côte basque
CH Saint Jean
CHU Purpan


title: Probiotics Supplementation and Nutritional Benefit in Premature Infants

summary: The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.

ReferenceCitation: Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.

family: Hays

full_name: Stephane Hays

given: Stephane

family: Jacquot

full_name: Aurélien Jacquot

given: Aurélien

family: Gauthier

full_name: Hélène Gauthier

given: Hélène

family: Kempf

full_name: Christian Kempf

given: Christian

family: Beissel

full_name: Anne Beissel

family: Pidoux

full_name: Odile Pidoux

given: Odile

family: Jumas-Bilak

full_name: Estelle Jumas-Bilak

given: Estelle

family: Decullier

full_name: Evelyne Decullier

given: Evelyne

family: Lachambre

full_name: Emmanuelle Lachambre

given: Emmanuelle

family: Beck

full_name: Laurence Beck

family: Cambonie

full_name: Gilles Cambonie

given: Gilles

family: Putet

full_name: Guy Putet

family: Claris

full_name: Olivier Claris

given: Olivier

family: Picaud

full_name: Jean-Charles Picaud

given: Jean-Charles

journal_name: Clinical Nutrition

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Nestlé

location_facility: Service de Nénatologie, Hôpital Femme Mère Enfant

location_facility: Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

location_facility: Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve

intervention_type: Dietary Supplement


acronym: NOSTRIL

location_facility:
Lens Hospital
Clinical Investigation center
Dunkerque Hospital

source: euctr

title: Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients

summary:
Background :

Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have been shown to influence survival and MUC5B expression in mice model of chronic pulmonary infection.

Method :

To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1, MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment.

Statistical analysis :

Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per protocol.


title: Study of the Natural History of Cerebral White Matter Involvement in Metachromatic Leukodystrophy, Using High-field MRI and Diffusion Tensor Imaging

acronym: HCIT-MLD

summary: High-field MRI and diffusion tensor imaging with 3D reconstruction of the myelin tracks, in combination with multivoxel proton spectroscopy, will allow to precise more accurately the evolution of the white matter lesions in patients affected with Metachromatic Leukodystrophy (particularly in the initial phase of the disease). This will increase the knowledge of the disease and provide new indicators for the selection and evaluation of patients eligible for new therapeutic approaches.

location_facility: Unité de recherche biomédicale, Neurospin, I2BM / DSV / SAC/ CEA,

location_facility: Bâtiment Lavoisier - Unité INSERM U 663,Hôpital Necker Enfants Malades

location_facility: Service de Neurologie Pédiatrique, Hôpital Bicêtre


title: Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)

summary: The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial

summary:
Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.

The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Lens Hospital
Amiens University Hospital
Caen University Hospital


title: Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina

summary:
Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.

Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.

Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .

The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de cardiologie - CHU de Saint-Etienne


title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

summary: The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: A Phase I Dose Escalation Trial of Once Daily Oral Treatment Using Afatinib (BIBW2992) Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.

summary:
To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.

To assess the safety of the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity.

ReferenceCitation: Hiret S, Isambert N, Gomez-Roca C, Bennouna J, Sassi M, de Mont-Serrat H, Fan J, Schnell D, Delord JP. Phase I dose-escalation trial of afatinib, an irreversible ErbB family blocker, in combination with gemcitabine or docetaxel in patients with relapsed or refractory solid tumors. Invest New Drugs. 2018 Dec;36(6):1044-1059. doi: 10.1007/s10637-018-0601-1. Epub 2018 May 29.

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Sassi

full_name: Mouna Sassi

given: Mouna

family: de Mont-Serrat

full_name: Hélène de Mont-Serrat

family: Fan

full_name: Jean Fan

given: Jean

family: Schnell

full_name: David Schnell

given: David

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

journal_name: Investigational New Drugs

lead_sponsor: Boehringer Ingelheim

location_facility: 1200.93.33003 Boehringer Ingelheim Investigational Site

location_facility: 1200.93.33001 Boehringer Ingelheim Investigational Site

location_facility: 1200.93.33002 Boehringer Ingelheim Investigational Site


title: Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction

acronym: NASEPT

summary: The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'Oto-rhino-laryngologie - Hôpital Dupuytren

location_facility: Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux

location_facility: Service d'Oto-rhino-laryngologie - Clinique St Augustin


title: Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+

acronym: TAM

summary:
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.

The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.

primary_purpose: Screening

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancerologie de l'Ouest (ICO)


title: STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma

acronym: GEMO

summary:
This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high dose irradiation (3 Gy x 9) associated with zoledronic acid.

The administration of zoledronic acid repeat dosages defined under the Authorisation on the Market.

All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5.

location_facility:
Centre Léon Bérard
Centre Paul Papin
Centre René Gauducheau


title: Phase I Dose-escalation, Pharmacokinetic and Pharmacodynamic Study of Debio 0932, a Novel Hsp90-inhibitor, Administered Orally, in Patients With Advanced Solid Tumours or Lymphoma

summary: The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when administered orally, every-other-day or daily during the first 30 days, in patients with solid tumours or lymphoma.

ReferenceCitation: Croce CM. Oncogenes and cancer. N Engl J Med. 2008 Jan 31;358(5):502-11. doi: 10.1056/NEJMra072367. Review.

ReferenceCitation: Workman P, Burrows F, Neckers L, Rosen N. Drugging the cancer chaperone HSP90: combinatorial therapeutic exploitation of oncogene addiction and tumor stress. Ann N Y Acad Sci. 2007 Oct;1113:202-16. Epub 2007 May 18. Review.

ReferenceCitation: Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: the story unfolds. Expert Opin Biol Ther. 2002 Jan;2(1):3-24. Review.

ReferenceCitation: Kamal A, Boehm MF, Burrows FJ. Therapeutic and diagnostic implications of Hsp90 activation. Trends Mol Med. 2004 Jun;10(6):283-90. Review.

ReferenceCitation: Chiosis G, Vilenchik M, Kim J, Solit D. Hsp90: the vulnerable chaperone. Drug Discov Today. 2004 Oct 15;9(20):881-8. Review.

ReferenceCitation: Mosser DD, Morimoto RI. Molecular chaperones and the stress of oncogenesis. Oncogene. 2004 Apr 12;23(16):2907-18.

ReferenceCitation: Obermann WM, Sondermann H, Russo AA, Pavletich NP, Hartl FU. In vivo function of Hsp90 is dependent on ATP binding and ATP hydrolysis. J Cell Biol. 1998 Nov 16;143(4):901-10.

ReferenceCitation: Vilenchik M, Solit D, Basso A, Huezo H, Lucas B, He H, Rosen N, Spampinato C, Modrich P, Chiosis G. Targeting wide-range oncogenic transformation via PU24FCl, a specific inhibitor of tumor Hsp90. Chem Biol. 2004 Jun;11(6):787-97.

ReferenceCitation: Powers MV, Workman P. Targeting of multiple signalling pathways by heat shock protein 90 molecular chaperone inhibitors. Endocr Relat Cancer. 2006 Dec;13 Suppl 1:S125-35. Review.

ReferenceCitation: Banerji U, Judson I, Workman P. The clinical applications of heat shock protein inhibitors in cancer - present and future. Curr Cancer Drug Targets. 2003 Oct;3(5):385-90. Review.

ReferenceCitation: Chiosis G, Lucas B, Huezo H, Solit D, Basso A, Rosen N. Development of purine-scaffold small molecule inhibitors of Hsp90. Curr Cancer Drug Targets. 2003 Oct;3(5):371-6. Review.

ReferenceCitation: Eccles SA, Massey A, Raynaud FI, Sharp SY, Box G, Valenti M, Patterson L, de Haven Brandon A, Gowan S, Boxall F, Aherne W, Rowlands M, Hayes A, Martins V, Urban F, Boxall K, Prodromou C, Pearl L, James K, Matthews TP, Cheung KM, Kalusa A, Jones K, McDonald E, Barril X, Brough PA, Cansfield JE, Dymock B, Drysdale MJ, Finch H, Howes R, Hubbard RE, Surgenor A, Webb P, Wood M, Wright L, Workman P. NVP-AUY922: a novel heat shock protein 90 inhibitor active against xenograft tumor growth, angiogenesis, and metastasis. Cancer Res. 2008 Apr 15;68(8):2850-60. doi: 10.1158/0008-5472.CAN-07-5256.

ReferenceCitation: Chandarlapaty S, Sawai A, Ye Q, Scott A, Silinski M, Huang K, Fadden P, Partdrige J, Hall S, Steed P, Norton L, Rosen N, Solit DB. SNX2112, a synthetic heat shock protein 90 inhibitor, has potent antitumor activity against HER kinase-dependent cancers. Clin Cancer Res. 2008 Jan 1;14(1):240-8. doi: 10.1158/1078-0432.CCR-07-1667.

ReferenceCitation: Böll B, Eltaib F, Reiners KS, von Tresckow B, Tawadros S, Simhadri VR, Burrows FJ, Lundgren K, Hansen HP, Engert A, von Strandmann EP. Heat shock protein 90 inhibitor BIIB021 (CNF2024) depletes NF-kappaB and sensitizes Hodgkin's lymphoma cells for natural killer cell-mediated cytotoxicity. Clin Cancer Res. 2009 Aug 15;15(16):5108-16. doi: 10.1158/1078-0432.CCR-09-0213. Epub 2009 Aug 11.

ReferenceCitation: Abramson JS, Chen W, Juszczynski P, Takahashi H, Neuberg D, Kutok JL, Takeyama K, Shipp MA. The heat shock protein 90 inhibitor IPI-504 induces apoptosis of AKT-dependent diffuse large B-cell lymphomas. Br J Haematol. 2009 Feb;144(3):358-66. doi: 10.1111/j.1365-2141.2008.07484.x. Epub 2008 Nov 13.

ReferenceCitation: Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990 Feb;28(2):72-8.

ReferenceCitation: Isambert N, Delord JP, Soria JC, Hollebecque A, Gomez-Roca C, Purcea D, Rouits E, Belli R, Fumoleau P. Debio0932, a second-generation oral heat shock protein (HSP) inhibitor, in patients with advanced cancer-results of a first-in-man dose-escalation study with a fixed-dose extension phase. Ann Oncol. 2015 May;26(5):1005-1011. doi: 10.1093/annonc/mdv031. Epub 2015 Feb 2.

full_name: N. Isambert

given: N.

full_name: J.-P. Delord

family: Soria

full_name: J.-C. Soria

family: Hollebecque

full_name: A. Hollebecque

given: A.

full_name: C. Gomez-Roca

given: C.

family: Purcea

full_name: D. Purcea

given: D.

family: Rouits

full_name: E. Rouits

given: E.

family: Belli

full_name: R. Belli

given: R.

family: Fumoleau

full_name: P. Fumoleau

given: P.

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Debio0932, a second-generation oral heat shock protein (HSP) inhibitor, in patients with advanced cancer—results of a first-in-man dose-escalation study with a fixed-dose extension phase

lead_sponsor: Debiopharm International SA

location_facility:
Institut Claudius Regaud
Centre Georges-François Leclerc
Institut Gustave Roussy


acronym: DRAG

summary: Objective: This research agreement brings together French and Canadian teams of scientists, HIV testing centers and community based partners. The aim is to explore the feasibility and limitations of offering community based rapid HIV testing to men who have sex with men (MSM).

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

location_facility: CDAG (Free Anonymous Screening Consultation) center


lead_sponsor: Sanofi Pasteur, a Sanofi Company

acronym: Immunogenicity and Safety of a Vaccine against Influenza (2010-2011 NH season, intramuscular route)

title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)

summary:
The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96

Objectives:

To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups
To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups


title: The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

acronym: VAPARA

summary: The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Assistance Publique - Hopitaux de Marseille


title: An Open-Label Dose Escalation Safety Study of PVS-10200 for the Treatment of Restenosis in Patients Undergoing Minimally Invasive Peripheral Revascularization (TRIUMPH)

acronym: TRIUMPH

summary: The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).

ReferenceCitation: Sevestre MA, Larghero J, Castier Y, Nugent HM, Visonneau S, Alsac JM. Pilot safety study of perivascular injection of tissue-engineered allogeneic aortic endothelial cells in patients undergoing minimally invasive peripheral revascularization. J Vasc Surg. 2014 Jun;59(6):1597-606. doi: 10.1016/j.jvs.2014.01.014. Epub 2014 Mar 7.

family: Sevestre

full_name: Marie-Antoinette Sevestre

given: Marie-Antoinette

family: Larghero

full_name: Jerome Larghero

given: Jerome

family: Castier

full_name: Yves Castier

given: Yves

family: Nugent

full_name: Helen M. Nugent

given: Helen M.

family: Visonneau

full_name: Sophie Visonneau

given: Sophie

family: Alsac

full_name: Jean-Marc Alsac

given: Jean-Marc

journal_name: Journal of Vascular Surgery

lead_sponsor: Shire

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.

acronym: ESPOIR

summary:
Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

lead_sponsor: Laboratoires Thea

location_facility:
HÃ´pital Gabriel Montpied
C.H.N.O des XV-XX
Hôpital Bichat - Claude Bernard


title: Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children

acronym: BUMEA

summary: The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism

ReferenceCitation: Lemonnier E, Degrez C, Phelep M, Tyzio R, Josse F, Grandgeorge M, Hadjikhani N, Ben-Ari Y. A randomised controlled trial of bumetanide in the treatment of autism in children. Transl Psychiatry. 2012 Dec 11;2:e202. doi: 10.1038/tp.2012.124.

family: Lemonnier

full_name: E Lemonnier

given: E

family: Degrez

full_name: C Degrez

given: C

family: Phelep

full_name: M Phelep

given: M

family: Tyzio

full_name: R Tyzio

given: R

family: Josse

full_name: F Josse

given: F

family: Grandgeorge

full_name: M Grandgeorge

family: Hadjikhani

full_name: N Hadjikhani

given: N

family: Ben-Ari

full_name: Y Ben-Ari

given: Y

journal_name: Translational Psychiatry

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

lead_sponsor: University Hospital, Brest

location_facility: Lemonnier DUPIN Chevreuil


title: Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).

summary: The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.

lead_sponsor: University Hospital, Caen

location_facility:
CHU Saint Louis Dept of Hematology
CHU Henri Mondor
CHU CAEN Dept of Hematology


location_facility:
Assistance Publique - Hôpitaux de Paris
Chu de Saint-Etienne
Clinique de la Mutualiste

title: Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

summary: After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.


title: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

summary: The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

lead_sponsor: Centre Oscar Lambret

location_facility:
Institut Bergonié
Centre Léon Bérard
Centre Oscar Lambret


title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine

acronym: Propofols

summary: The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

lead_sponsor: Hopital Foch

location_facility: Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré