title: Low Molecular Weight Heparin, Enoxaparin, to Prevent Adverse Maternal and Perinatal Outcomes in Women With Previous Severe Preeclampsia at Less Than 34 Weeks' Gestation. A Prospective Randomized Trial

acronym: HEPEPE

summary:
Preeclampsia (PE) complicates 2-8% of pregnancies. It is associated with an increased risk of adverse maternal (death, eclampsia, abruptio placenta, HELLP syndrome) and perinatal (perinatal death, growth restriction, prematurity) outcomes. The only definite treatment of PE remains pregnancy termination. Therefore, prevention of PE remains an important challenge. Low dose aspirin may be used in the prevention of PE, particularly in women who had a severe preeclampsia before 34 weeks. Its efficiency, however, is very weak. Recently, it has been suggested that low molecular weight heparin might be useful in the prevention of PE.

The aim of this study is to analyze the usefulness of the enoxaparin 4000 UI/day in the prevention of a composite maternal or perinatal morbidity (occurrence of one of the following events: maternal death, PE, fetal growth retardation, abruptio placenta, perinatal death) in women who previously had a severe preeclampsia at less than 34 weeks' gestation. To answer this question, the investigators propose to conduct a multicenter prospective randomized trial that will compare two groups in parallel: a group where women will have an association of enoxaparin 4000 U/day and aspirin 100 mg/day and another group where women would have only aspirin 100 mg/day. The number of patients needed is 255 (amendment n°2-approved 06/12/2011) .

ReferenceCitation: Lecarpentier E, Gris JC, Cochery-Nouvellon E, Mercier E, Abbas H, Thadhani R, Karumanchi SA, Haddad B. Urinary Placental Growth Factor for Prediction of Placental Adverse Outcomes in High-Risk Pregnancies. Obstet Gynecol. 2019 Dec;134(6):1326-1332. doi: 10.1097/AOG.0000000000003547.

family: Lecarpentier

full_name: Edouard Lecarpentier

given: Edouard

family: Gris

full_name: Jean Christophe Gris

given: Jean Christophe

family: Cochery-Nouvellon

full_name: Eva Cochery-Nouvellon

given: Eva

family: Mercier

full_name: Erick Mercier

given: Erick

family: Abbas

full_name: Houria Abbas

given: Houria

family: Thadhani

full_name: Ravi Thadhani

given: Ravi

family: Karumanchi

full_name: Subbian Ananth Karumanchi

given: Subbian Ananth

family: Haddad

full_name: Bassam Haddad

given: Bassam

journal_name: Obstetrics & Gynecology

evidence: open (via free article)

ReferenceCitation: Lecarpentier E, Gris JC, Cochery-Nouvellon E, Mercier E, Touboul C, Thadhani R, Karumanchi SA, Haddad B. Angiogenic Factor Profiles in Pregnant Women With a History of Early-Onset Severe Preeclampsia Receiving Low-Molecular-Weight Heparin Prophylaxis. Obstet Gynecol. 2018 Jan;131(1):63-69. doi: 10.1097/AOG.0000000000002380.

family: Touboul

full_name: Cyril Touboul

given: Cyril

full_name: S. Ananth Karumanchi

given: S. Ananth

ReferenceCitation: Haddad B, Winer N, Chitrit Y, Houfflin-Debarge V, Chauleur C, Bages K, Tsatsaris V, Benachi A, Bretelle F, Gris JC, Bastuji-Garin S; Heparin-Preeclampsia (HEPEPE) Trial Investigators. Enoxaparin and Aspirin Compared With Aspirin Alone to Prevent Placenta-Mediated Pregnancy Complications: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1053-1063. doi: 10.1097/AOG.0000000000001673.

family: Winer

name: for the Heparin-Preeclampsia (HEPEPE) Trial Investigators

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Controlled and Selective Depletion of Regulatory T-cell for Cancer Treatment, Efficacy and Safety Study

acronym: STARTREK

summary: T regulatory lymphocytes were shown to be partly responsible for immune tolerance to cancer cells. In that respect these cells oppose to the mounting of an efficacious immune response needed to cure cancer. To treat advanced metastatic colorectal cancer, the investigators propose an immunotherapy consisting in autologous lymphocytes infusion depleted from T-regulatory cells, associated with a 5-day prior lymphoid-ablative chemotherapy associating cyclophosphamide (day 1 & 2) with fludarabine (day 1 to 5). To administer treatment and monitor chemotherapy safety, patients will be hospitalized for 3 weeks until complete recovery from chemotherapy. Patients will then be followed-up ambulatory for 9 months during which time they will be assessed for tumor size with computed tomography (CT) - scan (primary criteria).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service hépato-gastro-enterologie, Pitié-Salpêtrière Hospital

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


design_allocation: Randomized

intervention_type: Drug

lead_sponsor: Institut de Cancérologie de la Loire

type: EudraCT Number

source: euctr

title: Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study

summary:
Phase II, randomised, controlled, non comparative study with 2 parallel groups:

Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.

lead_sponsor_type: industriel


title: Impact of Non-intentional Leaks on Breathing Pattern and Work of Breathing During Non-invasive Ventilation: Study in Awakened Healthy Subjects and Awakened Obesity Hypoventilation Syndrome(OHS)Patients and During the Sleep in OHS Patients.

acronym: NIV-Leaks

summary:
The investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.

The main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (OHS) patients.

Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a random order with an automatically opening valve. Breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects will be recorded only during awakened state. OHS patients will be recorded both during awake and sleep sates.

Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing according to the different levels of leaks.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Contal O, Carnevale C, Borel JC, Sabil A, Tamisier R, Lévy P, Janssens JP, Pépin JL. Pulse transit time as a measure of respiratory effort under noninvasive ventilation. Eur Respir J. 2013 Feb;41(2):346-53. doi: 10.1183/09031936.00193911. Epub 2012 Apr 20.

family: Contal

full_name: Olivier Contal

given: Olivier

sequence: first

family: Carnevale

full_name: Claudio Carnevale

given: Claudio

sequence: additional

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Sabil

full_name: AbdelKébir Sabil

given: AbdelKébir

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Janssens

full_name: Jean-Paul Janssens

given: Jean-Paul

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Respiratory Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Geneva - Archive ouverte UNIGE

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

lead_sponsor: AGIR à Dom

location_facility: Laboratoire EFCR et Sommeil CHU Grenoble

intervention_type: Other


title: Effects of a Systematic Addition of Clonidine in the Local Anaesthetic and Opiate Solution for Epidural Patient Controlled Analgesia in Labour (Levobupivacaine 0.568 mg.mLl-1 + Sufentanil 0.45 µg.mL-1)

summary: In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual injections to achieve analgesia, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic solution will be levobupivacaine presented in 100-mL bags from the market (0.0625%), in which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design.

ReferenceType: result

ReferenceCitation: Bazin M, Bonnin M, Storme B, Bolandard F, Vernis L, Lavergne B, Pereira B, Bazin JE, Dualé C. Addition of clonidine to a continuous patient-controlled epidural infusion of low-concentration levobupivacaine plus sufentanil in primiparous women during labour. Anaesthesia. 2011 Sep;66(9):769-79. doi: 10.1111/j.1365-2044.2011.06785.x. Epub 2011 Jun 24. Erratum in: Anaesthesia. 2012 Feb;67(2):212.

family: Bazin

full_name: M. Bazin

given: M.

family: Bonnin

full_name: M. Bonnin

family: Storme

full_name: B. Storme

given: B.

family: Bolandard

full_name: F. Bolandard

given: F.

family: Vernis

full_name: L. Vernis

given: L.

family: Lavergne

full_name: B. Lavergne

family: Pereira

full_name: B. Pereira

full_name: J. E. Bazin

given: J. E.

family: Dualé

full_name: C. Dualé

given: C.

journal_name: Anaesthesia

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery

summary: Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent thrombosis, patients have systematic anticoagulation after surgery which are responsible of hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a biological glue administration on the bleeding loss at five days after a total knee prosthesis surgery operation.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: Clinique Mutualiste Chirurgicale de la Loire

status_simplified: Unknown


title: Randomized, Double-blind, Placebo-controlled Study of the Tolerability, and Pharmacokinetics of Fexinidazole After Single and Repeated Oral Ascending Doses, Completed by a Comparative Bioavailability Study of an Oral Suspension Versus a Tablet and an Exploratory Assessment of Food Effect, in Healthy Male Volunteers

summary: This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy.

lead_sponsor: Drugs for Neglected Diseases


title: Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

summary: The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.

status: Terminated

primary_purpose: Prevention

lead_sponsor: Nantes University Hospital


title: Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.

summary: The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.

location_facility: CHU Clermont-Ferrand (orthopaedic surgery)


title: Speech Effects of a Speaking Valve Versus External PEEP in Tracheostomized Ventilator-Dependent Neuromuscular Patients

summary:
Background:

Many patients with respiratory failure related to neuromuscular disease receive chronic invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an important component, is a major goal in these patients. The investigators compared the effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.

Methods:

Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments; these last consisted of a perceptual score and an intelligibility score determined by two speech therapists using a French adaptation of the Frenchay Dysarthria Assessment.

lead_sponsor: University of Versailles

location_facility: Intensive care Ward of R. Poincaré Hospital

intervention_type: Device


title: A Monocenter, Cross-sectional Study to Compare Different Type of Cognitive Impairment in Multiple Sclerosis Patients and Cerebrospinal Fluid Biomarkers (Beta Amyloid, Total Tau Protein and Tau-phosphorylated Protein).

acronym: BioCogS

summary: In multiple sclerosis (MS) sub cortical cognitive impairments are frequently reported. Nevertheless, cortical cognitive troubles, with hippocampic memory troubles have been described. Besides inflammatory damage, early cortical and degenerative damage are well known. In neurodegenerative diseases, three biomarkers of the cerebro spinal fluid (CSF), reflecting lesional mechanisms, are measured: the beta amyloid peptide, the tau total protein, and the phospho tau protein. Preliminary studies shown increased level of tau in MS. No study compare cognitive impairment and biomarkers of CSF.The aim of this study is to measure in the CSF of MS patients these three biomarkers (beta amyloid peptide, tau total and phosphotau) in order to establish correlations between a profile of biomarkers and a pattern of cognitive troubles, cortical or subcortical.The possibility to show, in MS patients with memory hippocampic troubles, a profile of biomarkers closed from the one encountered in AD, could argue in support of the degenerative hypothesis in MS and lead to discuss the interest of the use of AD treatment in MS.

design_allocation: Non-Randomized


ReferenceCitation: Wils J, Duparc C, Cailleux AF, Lopez AG, Guiheneuf C, Boutelet I, Boyer HG, Dubessy C, Cherifi S, Cauliez B, Gobet F, Defortescu G, Ménard JF, Louiset E, Lefebvre H. The neuropeptide substance P regulates aldosterone secretion in human adrenals. Nat Commun. 2020 May 29;11(1):2673. doi: 10.1038/s41467-020-16470-8.

apc_source: openAPC

family: Wils

full_name: Julien Wils

given: Julien

family: Duparc

full_name: Céline Duparc

given: Céline

family: Cailleux

full_name: Anne-Françoise Cailleux

given: Anne-Françoise

family: Lopez

full_name: Antoine-Guy Lopez

given: Antoine-Guy

family: Guiheneuf

full_name: Caroline Guiheneuf

given: Caroline

family: Boutelet

full_name: Isabelle Boutelet

given: Isabelle

family: Boyer

full_name: Hadrien-Gaël Boyer

given: Hadrien-Gaël

family: Dubessy

full_name: Christophe Dubessy

given: Christophe

family: Cherifi

full_name: Saloua Cherifi

given: Saloua

family: Cauliez

full_name: Bruno Cauliez

given: Bruno

family: Gobet

full_name: Françoise Gobet

given: Françoise

family: Defortescu

full_name: Guillaume Defortescu

given: Guillaume

family: Ménard

full_name: Jean-François Ménard

given: Jean-François

family: Louiset

full_name: Estelle Louiset

given: Estelle

family: Lefebvre

full_name: Hervé Lefebvre

given: Hervé

bso_classification: Biology (fond.)

currency_apc_doaj: GBP

journal_name: Nature Communications

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

location_facility: Rouen Clinical research Centre (CIC 0204)

title: Pilot Study of the Action of the Substance P Antagonist Aprepitant on Aldosterone and Cortisol Secretion in Healthy Volunteers.

summary:
Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid secretion might be controlled by sympathetic nervous system. This neurocrine regulation of corticosteroid secretion involves locally released neuropeptides. Among them, substance P is able to stimulate aldosterone and cortisol production via NK1 receptors.

The aim of the present study is to investigate the effects of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in healthy volunteers. Aprepitant is a drug already available for the treatment of nausea induced by chemotherapy.

In the present phase IV trial, plasma aldosterone and cortisol levels will be measured under treatment with aprepitant versus placebo, in both basal conditions and after activation of the adrenocortical function by various stimuli, including upright posture, metoclopramide, and insulin-induced hypoglycaemia. All healthy volunteers will be given the two substances (aprepitant and placebo) in a random order during two one-week periods separated by a 14 day-wash-out.

This study should allow to determine the role of substance P in the control of corticosteroid production in normal man.


title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma

summary: The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.

ipd_sharing: No

lead_sponsor: Steba Biotech S.A.


title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer

summary: The aim of this study is to determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in obstructive Non-Small Cell Lung Cancer.


title: Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes

acronym: VARIAFIT

summary:
The primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.

So, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes.

This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.

ReferenceCitation: Benhamou PY, Somers F, Lablanche S, Debaty I, Borel AL, Nasse L, Stanke-Labesque F, Faure P, Boizel R, Halimi S. Impact of flexible insulin therapy on blood glucose variability, oxidative stress and inflammation in type 1 diabetic patients: the VARIAFIT study. Diabetes Metab. 2014 Sep;40(4):278-83. doi: 10.1016/j.diabet.2014.01.004. Epub 2014 Feb 24.

family: Benhamou

full_name: P.Y. Benhamou

family: Somers

full_name: F. Somers

given: F.

family: Lablanche

full_name: S. Lablanche

given: S.

family: Debaty

full_name: I. Debaty

given: I.

family: Borel

full_name: A.L. Borel

family: Nasse

full_name: L. Nasse

given: L.

family: Stanke-Labesque

full_name: F. Stanke-Labesque

family: Faure

full_name: P. Faure

given: P.

family: Boizel

full_name: R. Boizel

given: R.

family: Halimi

full_name: S. Halimi

journal_name: Diabetes & Metabolism

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Impact of flexible insulin therapy on blood glucose variability, oxidative stress and inflammation in type 1 diabetic patients: The VARIAFIT study

lead_sponsor: Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition

location_facility: Service de Diabétologie du Pr Halimi, CHU


type: Other Identifier

title: A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia

acronym: EVENTRALAP

summary: The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Slim K, Vons C. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses]. J Chir (Paris). 2008 Mar-Apr;145(2):122-5. Review. French.

ReferenceCitation: Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. French.

ReferenceCitation: Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. Review. French.

location_facility: Hôpital Jean Verdier, department of digestive and general surgery

intervention_type: Procedure


title: Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP

acronym: LTP

summary: This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.

lead_sponsor: University Hospital, Grenoble

intervention_type: Radiation


title: Evaluation of a Rehabilitation Program After Lung Surgery (Prospective Observational Study)

summary: Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series.

lead_sponsor: Hopital Foch


ReferenceCitation: Pierga JY, Bidard FC, Cropet C, Tresca P, Dalenc F, Romieu G, Campone M, Mahier Aït-Oukhatar C, Le Rhun E, Gonçalves A, Leheurteur M, Dômont J, Gutierrez M, Curé H, Ferrero JM, Labbe-Devilliers C, Bachelot T. Circulating tumor cells and brain metastasis outcome in patients with HER2-positive breast cancer: the LANDSCAPE trial. Ann Oncol. 2013 Dec;24(12):2999-3004. doi: 10.1093/annonc/mdt348. Epub 2013 Sep 6.

family: Pierga

full_name: J.-Y. Pierga

family: Bidard

full_name: F.-C. Bidard

family: Cropet

full_name: C. Cropet

given: C.

family: Tresca

full_name: P. Tresca

family: Dalenc

full_name: F. Dalenc

family: Romieu

full_name: G. Romieu

given: G.

family: Campone

full_name: M. Campone

given: M.

family: Mahier Aït-Oukhatar

full_name: C. Mahier Aït-Oukhatar

family: Le Rhun

full_name: E. Le Rhun

given: E.

family: Gonçalves

full_name: A. Gonçalves

given: A.

family: Leheurteur

full_name: M. Leheurteur

family: Dômont

full_name: J. Dômont

given: J.

family: Gutierrez

full_name: M. Gutierrez

family: Curé

full_name: H. Curé

given: H.

family: Ferrero

full_name: J.-M. Ferrero

family: Labbe-Devilliers

full_name: C. Labbe-Devilliers

family: Bachelot

full_name: T. Bachelot

given: T.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Bachelot T, Romieu G, Campone M, Diéras V, Cropet C, Dalenc F, Jimenez M, Le Rhun E, Pierga JY, Gonçalves A, Leheurteur M, Domont J, Gutierrez M, Curé H, Ferrero JM, Labbe-Devilliers C. Lapatinib plus capecitabine in patients with previously untreated brain metastases from HER2-positive metastatic breast cancer (LANDSCAPE): a single-group phase 2 study. Lancet Oncol. 2013 Jan;14(1):64-71. doi: 10.1016/S1470-2045(12)70432-1. Epub 2012 Nov 2.

full_name: Thomas Bachelot

given: Thomas

full_name: Gilles Romieu

given: Gilles

full_name: Mario Campone

given: Mario

family: Diéras

full_name: Véronique Diéras

given: Véronique

full_name: Claire Cropet

title: A Multicenter Phase II Clinical Trial Assessing the Efficacy of the Combination of Lapatinib and Capecitabine in Patients With Non Pretreated Brain Metastasis From HER2 Positive Breast Cancer

summary:
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with stage IV breast cancer and brain metastases.


title: Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

summary: A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.


title: Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism

acronym: MVTEP

summary:
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography, may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures are more effective when given with or without fludeoxyglucose F 18 positron emission tomography in finding cancer.

PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission tomography given together with standard diagnostic procedures to see how well it works compared with standard diagnostic procedures alone in finding cancer in patients with a blood clot in a vein.

primary_purpose: Diagnostic

ReferenceCitation: Robertson L, Broderick C, Yeoh SE, Stansby G. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE. Cochrane Database Syst Rev. 2021 Oct 1;10:CD010837. doi: 10.1002/14651858.CD010837.pub5. Review.

name: Cochrane Common Mental Disorders; University of York; York UK

family: Robertson

full_name: Lindsay Robertson

given: Lindsay

name: Usher Institute; University of Edinburgh; Edinburgh UK

family: Broderick

full_name: Cathryn Broderick

given: Cathryn

name: BHF Glasgow Cardiovascular Research Centre (GCRC); University of Glasgow; Glasgow UK

family: Yeoh

full_name: Su Ern Yeoh

given: Su Ern

name: Northern Vascular Centre; Freeman Hospital; Newcastle UK

family: Stansby

full_name: Gerard Stansby

given: Gerard

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

version: acceptedVersion

ReferenceCitation: Robin P, Le Roux PY, Tromeur C, Planquette B, Prévot-Bitot N, Lavigne C, Pastre J, Merah A, Couturaud F, Le Gal G, Salaun PY. Risk factors of occult malignancy in patients with unprovoked venous thromboembolism. Thromb Res. 2017 Nov;159:48-51. doi: 10.1016/j.thromres.2017.08.021. Epub 2017 Sep 28.

family: Robin

full_name: Philippe Robin

given: Philippe

family: Le Roux

full_name: Pierre-Yves Le Roux

given: Pierre-Yves

family: Tromeur

full_name: Cécile Tromeur

given: Cécile

family: Planquette

full_name: Benjamin Planquette

given: Benjamin

family: Prévot-Bitot

full_name: Nathalie Prévot-Bitot

given: Nathalie

family: Lavigne

full_name: Christian Lavigne

given: Christian

family: Pastre

full_name: Jean Pastre

given: Jean

family: Merah

full_name: Adel Merah

given: Adel

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

family: Salaun

full_name: Pierre-Yves Salaun

journal_name: Thrombosis Research

ReferenceCitation: Robin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8.

title: Limited screening with versus without 18F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial

location_facility: CHU Brest - Hopital De La Cavale Blanche


title: A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.

summary:
RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well efavirenz works as second-line therapy in treating patients with metastatic pancreatic cancer.

lead_sponsor: Institut Bergonié


title: A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer

summary:
RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

ReferenceCitation: Houédé N, Pulido M, Mourey L, Joly F, Ferrero JM, Bellera C, Priou F, Lalet C, Laroche-Clary A, Raffin MC, Ichas F, Puech A, Piazza PV. A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer. Oncologist. 2014 Dec;19(12):1227-8. doi: 10.1634/theoncologist.2014-0345. Epub 2014 Oct 29.

name: Department of Medical Oncology, Nimes University Hospital, Nimes, France;

family: Houédé

full_name: Nadine Houédé

given: Nadine

name: Clinical Research and Clinical Epidemiology Unit, Bergonié Cancer Institute, Bordeaux, France;

family: Pulido

full_name: Marina Pulido

given: Marina

name: Department of Oncology, Claudius Régaud Cancer Center, Toulouse, France;

family: Mourey

full_name: Loic Mourey

given: Loic

name: Department of Medical Oncology, François Baclesse Cancer Center, Caen, France;

family: Joly

full_name: Florence Joly

given: Florence

name: Department of Medical Oncology, Antoine Lacassagne Cancer Center, Nice, France;

family: Ferrero

full_name: Jean‐Marc Ferrero

given: Jean‐Marc

family: Bellera

full_name: Carine Bellera

given: Carine

name: Department of Medical Oncology, CHD La Roche sur Yon, La Roche sur Yon, France;

family: Priou

full_name: Frank Priou

given: Frank

family: Lalet

full_name: Caroline Lalet

given: Caroline

name: Alienor Farma, Parc Scientifique Unitec 1, Pessac, France;

family: Laroche‐Clary

full_name: Audrey Laroche‐Clary

given: Audrey

name: Centre Hospitalier de Pellegrin, Laboratoire de Pharmacologie et Toxicologie, Bordeaux, France;

family: Raffin

full_name: Mireille Canal Raffin

given: Mireille Canal

family: Ichas

full_name: François Ichas

given: François

family: Puech

full_name: Alain Puech

given: Alain

name: INSERM U862, Neurocentre Magendie, Bordeaux, France

family: Piazza

full_name: Pierre Vincenzo Piazza

given: Pierre Vincenzo

journal_name: The Oncologist

title: A Phase II Trial Evaluating the Efficacy and Safety of Efavirenz in Metastatic Castration‐Resistant Prostate Cancer


title: Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission

summary:
RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation

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

PURPOSE: This research study is looking at blood and tissue samples from patients with larynx cancer, pharynx cancer, or oral cavity cancer.

lead_sponsor: Centre Oscar Lambret


title: NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.

summary: Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension

acronym: LAM-PH

summary: This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.

time_perspective: Retrospective

lead_sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires


title: Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.

ReferenceCitation: Falandry C, Brain E, Bonnefoy M, Mefti F, Jovenin N, Rigal O, Guillem O, El Kouri C, Uwer L, Abadie-Lacourtoisie S, Cretin J, Jacquin JP, Paraiso D, Freyer G. Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial. Eur J Cancer. 2013 Sep;49(13):2806-14. doi: 10.1016/j.ejca.2013.04.027. Epub 2013 Jun 1.

family: Falandry

full_name: C. Falandry

given: C.

family: Brain

full_name: E. Brain

given: E.

family: Bonnefoy

full_name: M. Bonnefoy

given: M.

family: Mefti

full_name: F. Mefti

given: F.

family: Jovenin

full_name: N. Jovenin

given: N.

family: Rigal

full_name: O. Rigal

given: O.

family: Guillem

full_name: O. Guillem

family: El Kouri

full_name: C. El Kouri

family: Uwer

full_name: L. Uwer

given: L.

family: Abadie-Lacourtoisie

full_name: S. Abadie-Lacourtoisie

given: S.

family: Cretin

full_name: J. Cretin

given: J.

family: Jacquin

full_name: J.P. Jacquin

family: Paraiso

full_name: D. Paraiso

given: D.

family: Freyer

full_name: G. Freyer

given: G.

journal_name: European Journal of Cancer

title: Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: Final results of the DOGMES multicentre GINECO trial

lead_sponsor: ARCAGY/ GINECO GROUP


title: Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"

acronym: BENTLY

summary: A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".

ReferenceCitation: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29.

name: Gandhi Damaj, Momar Diouf, and Jean-Pierre Marolleau, Centre Hospitalier Universitaire (CHU), Amiens; Rémy Gressin, CHU de Grenoble and L'Institut National de la Santé et de la Recherche Médicale (INSERM) U823, Institut Albert Bonniot, Grenoble; Krimo Bouabdallah, CHU, Bordeaux; Guillaume Cartron, CHU, Montpellier; Bachra Choufi, Hôpital Duchenne, Boulogne sur Mer; Emmanuel Gyan, INSERM and Clinical Investigation Center (CIC) U202, CHU, Tours; Anne Banos, Hôpital de Bayonne, Bayonne; Arnaud Jaccard, CHU,...

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Gressin

full_name: Rémy Gressin

given: Rémy

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Choufi

full_name: Bachra Choufi

given: Bachra

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

family: Banos

full_name: Anne Banos

given: Anne

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

family: Park

full_name: Sophie Park

given: Sophie

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Schiano-de Collela

full_name: Jean-Marc Schiano-de Collela

given: Jean-Marc

family: Voillat

full_name: Laurent Voillat

given: Laurent

family: Joly

full_name: Bertrand Joly

given: Bertrand

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Saad

full_name: Alain Saad

family: Cony-Makhoul

full_name: Pascale Cony-Makhoul

given: Pascale

family: Vilque

full_name: Jean-Pierre Vilque

given: Jean-Pierre

family: Sanhes

full_name: Laurence Sanhes

given: Laurence

family: Schmidt-Tanguy

full_name: Aline Schmidt-Tanguy

given: Aline

family: Bubenheim

full_name: Michael Bubenheim

given: Michael

family: Houot

full_name: Roch Houot

given: Roch

family: Diouf

full_name: Momar Diouf

given: Momar

family: Marolleau

full_name: Jean-Pierre Marolleau

publisher: American Society of Clinical Oncology (ASCO)

title: Results From a Prospective, Open-Label, Phase II Trial of Bendamustine in Refractory or Relapsed T-Cell Lymphomas: The BENTLY Trial


title: Search for Genetic Factors Predictive of Response to Chemotherapy in Patients With or Who Has a Mammary Adenocarcinoma in Neo-adjuvant or Metastatic Setting

summary:
RATIONALE: Studying the genes expressed in samples of blood from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to chemotherapy.

PURPOSE: This clinical trial is studying blood samples in patients with breast cancer.


title: A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer

acronym: IDEA

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given for 3 months or 6 months in treating patients with colon cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3 months to see how well it works compared with giving combination chemotherapy for 6 months in treating patients with stage III colon cancer.

ReferenceCitation: Delattre JF, Cohen R, Henriques J, Falcoz A, Emile JF, Fratte S, Chibaudel B, Dauba J, Dupuis O, Bécouarn Y, Bibeau F, Taieb J, Louvet C, Vernerey D, André T, Svrcek M. Prognostic Value of Tumor Deposits for Disease-Free Survival in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the IDEA France Phase III Trial (PRODIGE-GERCOR). J Clin Oncol. 2020 May 20;38(15):1702-1710. doi: 10.1200/JCO.19.01960. Epub 2020 Mar 13.

name: Department of Medical Oncology, Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France

family: Delattre

full_name: Jean-François Delattre

given: Jean-François

family: Cohen

full_name: Romain Cohen

given: Romain

name: Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France

name: University Bourgogne Franche-Comté, Institut National de la Santé et de la Recherche Médicale, Etablissement Français du Sang Bourgogne Franche-Comté, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, Besançon, France

family: Henriques

full_name: Julie Henriques

given: Julie

family: Falcoz

full_name: Antoine Falcoz

given: Antoine

name: Department of Pathology, AP-HP, Hôpital Ambroise Paré, Boulogne, France

name: EA4340–Biomarqueurs et Essais Cliniques en Cancérologie et Onco-Hématologie, Versailles Saint-Quentin-en-Yvelines University, Boulogne, France

family: Emile

full_name: Jean-François Emile

name: Department of Medical Oncology, Hôpital de Belfort-Montbeliard, Montbeliard, France

family: Fratte

full_name: Serge Fratte

given: Serge

name: Department of Medical Oncology, Institut Franco-Britannique, Levallois-Perret, France

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

name: Department of Medical Oncology, Centre Hospitalier Layné, Mont-de-Marsan, France

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Dupuis

full_name: Olivier Dupuis

name: Department of Medical Oncology, Institut Bergonié, Bordeaux, France

family: Bécouarn

full_name: Yves Bécouarn

given: Yves

name: Department of Pathology, Centre Hospitalier Universitaire de Caen, Université Caen Normandie, Caen, France

family: Bibeau

full_name: Frédéric Bibeau

given: Frédéric

name: Department of Medical Oncology, Sorbonne Paris Cité, Université Paris Descartes, AP-HP, Hôpital Européen Georges Pompidou, Paris, France

family: Taieb

full_name: Julien Taieb

given: Julien

name: Department of Medical Oncology, Institut Mutualiste Montsouris, Paris, France

family: Louvet

full_name: Christophe Louvet

given: Christophe

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: André

full_name: Thierry André

given: Thierry

name: Department of Pathology, AP-HP, Hôpital Saint-Antoine, Paris, France

family: Svrcek

full_name: Magali Svrcek

given: Magali

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: André T, Vernerey D, Mineur L, Bennouna J, Desrame J, Faroux R, Fratte S, Hug de Larauze M, Paget-Bailly S, Chibaudel B, Bez J, Dauba J, Louvet C, Lepere C, Dupuis O, Becouarn Y, Mabro M, Egreteau J, Bouche O, Deplanque G, Ychou M, Galais MP, Ghiringhelli F, Dourthe LM, Bachet JB, Khalil A, Bonnetain F, de Gramont A, Taieb J; for PRODIGE investigators, GERCOR, Fédération Française de Cancérologie Digestive, and UNICANCER. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. J Clin Oncol. 2018 May 20;36(15):1469-1477. doi: 10.1200/JCO.2017.76.0355. Epub 2018 Apr 5.

name: Thierry André and Benoist Chibaudel, Hôpital Saint-Antoine, Assistance Publique—Hôpitaux de Paris; Thierry André, Sorbonne Universités, UMPC Paris 06; Marine Hug de Larauze and Benoist Chibaudel and Thierry André, Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR); Christophe Louvet, Institut Mutualiste Montsouris; Céline Lepère, Hôpital Européen Georges Pompidou (HEGP); Gaël Deplanque, Groupe Hospitalier Saint-Joseph; Jean-Baptiste Bachet, Groupe Hospitalier Pitié Salpêtrière and Sorbonne...

family: Mineur

full_name: Laurent Mineur

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Desrame

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie


title: Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale

acronym: sclero-video

summary: The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.

lead_sponsor: University Hospital, Rouen


title: A Phase 1 Study Evaluating the Phototoxic Potential of LEO 29102 Cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g) and the Cream Vehicle, Applied on Intact Skin of Healthy Male Subjects

summary: The purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of LEO 29102 cream in different doses.

lead_sponsor: LEO Pharma


title: Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice: Description and Prediction by Urine Dipstick Test

acronym: BaCyst

summary:
Acute uncomplicated bacterial cystitis is common in general practice. Cystitis is at the second raw of antibiotic treatment indications. It has been now recommended not to perform any urine culture for more than 20 years; hence, the bacterial epidemiology of acute uncomplicated cystitis is surprisingly relatively unknown. The available bacteriological data mainly describe the epidemiology of complicated urinary tract infections or upper urinary tract infections, but the causative bacteria and the resistance rates might differ from those of uncomplicated cystitis. As an example, it is unknown to what extent Staphylococcus saprophyticus is the causative agent of uncomplicated cystitis.

Moreover, the urine dipstick test have been evaluated in laboratories. But their interpretation in current practice might not be so easy: in particular, the nitrite detection depends on the bacterial concentration. The nitrite detection, produced in enterobacteriaceae related infections might have therapeutical consequences: trométamol-fosfomycine is almost constantly active on enterobacteriaceae, but ineffective on staphylococci. Knowing the increasing prevalence of fluoroquinolone-resistant enterobacteriaceae, the use of fosfomycin in nitrite positive uncomplicated cystitis might preserve the susceptibility of fluoroquinolones during pyelonephritis.

This study will describe:

the bacterial epidemiology of acute uncomplicated cystitis in general practice,
the correlation in between urine dipstick and urine culture in general practice,
the prediction of enterobacterial infection by the nitrite detection, AND
the antibiotics prescribed by the practitioners for uncomplicated acute cystitis.

ReferenceCitation: Etienne M, Lefebvre E, Frebourg N, Hamel H, Pestel-Caron M, Caron F; Bacyst Study Group. Antibiotic treatment of acute uncomplicated cystitis based on rapid urine test and local epidemiology: lessons from a primary care series. BMC Infect Dis. 2014 Mar 11;14:137. doi: 10.1186/1471-2334-14-137.

family: Etienne

full_name: Manuel Etienne

given: Manuel

family: Lefebvre

full_name: Emmanuel Lefebvre

given: Emmanuel

family: Frebourg

full_name: Noëlle Frebourg

given: Noëlle

family: Hamel

full_name: Hélène Hamel

given: Hélène

family: Pestel-Caron

full_name: Martine Pestel-Caron

given: Martine

family: Caron

full_name: François Caron

given: François

journal_name: BMC Infectious Diseases

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer


publications_result: Scholl SME, de la Rochefordiere A, Petrow P, et al.: CETUXICOL, a phase II trial randomizing standard treatment with or without cetuximab in primary cervical cancer treatment. [Abstract] J Clin Oncol 30 (Suppl 15): A-e15535, 2012.

lead_sponsor: Institut Curie

acronym: CETUXICOL

title: Phase II Randomized Assessing Pelvic Irradiation Combined With Cisplatin Alone or Cisplatin Plus Cetuximab in Patients With Carcinoma of the Cervix Stage IB2, II and III

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy given together with cisplatin is more effective with or without cetuximab in treating patients with cervical cancer.

PURPOSE: This randomized phase II trial is studying giving radiation therapy together with cisplatin to see how well it works compared with radiation therapy and cisplatin given together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical cancer.


acronym: SCIALERO

summary:
Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve [4]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound [58] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic [46, 47].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.


title: Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases

summary: This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

lead_sponsor: Guerbet


title: Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients

summary:
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment.

PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2

summary:
HDL from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect.

The primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of HDL lipoproteins in patients with type 2 diabetes.

The secondary objectives are:

to analyze the effect of glitazone treatment on phospholipase A2
to look for possible differences between the effects of pioglitazone and those of rosiglitazone
to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

ReferenceCitation: Perségol L, Vergès B, Foissac M, Gambert P, Duvillard L. Inability of HDL from type 2 diabetic patients to counteract the inhibitory effect of oxidised LDL on endothelium-dependent vasorelaxation. Diabetologia. 2006 Jun;49(6):1380-6. Epub 2006 Apr 5.

ReferenceCitation: Vergès B, Radu L, Baillot-Rudoni S, Brindisi MC, Poussier A, Bouillet B, Petit JM, Duvillard L. Low HDL-cholesterol: a strong predictor of glycemic response to glitazone treatment in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jul;93(1):e44-8. doi: 10.1016/j.diabres.2011.04.005. Epub 2011 May 6.

family: Vergès

full_name: Bruno Vergès

given: Bruno

family: Radu

full_name: Laura Radu

given: Laura

family: Baillot-Rudoni

full_name: Sabine Baillot-Rudoni

given: Sabine

family: Brindisi

full_name: Marie-Claude Brindisi

given: Marie-Claude

family: Poussier

full_name: Alix Poussier

given: Alix

family: Bouillet

full_name: Benjamin Bouillet

given: Benjamin

family: Petit

full_name: Jean-Michel Petit

given: Jean-Michel

family: Duvillard

full_name: Laurence Duvillard

given: Laurence

journal_name: Diabetes Research and Clinical Practice

title: Low HDL-cholesterol: A strong predictor of glycemic response to glitazone treatment in patients with type 2 diabetes

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Service Endocrinologie-diabétologie, Hôpital du Bocage CHU


title: Implication of Metabolic and Genomic Modifications in Elderly Subjects

acronym: COMPALICLAMP

summary:
An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle).

In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging.

The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.

ReferenceCitation: Bétry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.

family: Bétry

full_name: C. Bétry

given: C.

family: Meugnier

full_name: E. Meugnier

given: E.

family: Pflieger

full_name: M. Pflieger

given: M.

family: Grenet

full_name: G. Grenet

given: G.

family: Hercberg

full_name: S. Hercberg

given: S.

family: Galan

full_name: P. Galan

given: P.

family: Kesse-Guyot

full_name: E. Kesse-Guyot

family: Vidal

full_name: H. Vidal

given: H.

family: Laville

full_name: M. Laville

license: cc-by-nc

license_normalized: cc-by-nc

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

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de recherche en nutrition humaine Rhône-Alpes


title: Estimation of Microstructure Alteration by MRI in Dementia Among Elderly Subjects Retired From Agricultural Profession and Living in Rural Area in Gironde - Participants From the AMI Cohort.

acronym: AMIMAGE

summary: Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. However, the research on AD progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance Imaging (MRI).

lead_sponsor: University Hospital, Bordeaux

location_facility: Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux


title: Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction

acronym: MAVAS

summary:
Upper airway obstruction (UAO) is very common in children. Presently, the importance of the UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.

The aim of the study is to evaluate two new techniques to quantify the importance of the UAO in children; the acoustic reflection method and the measurement of the work of breathing.

80 children will be included in this monocentric, prospective, open labelled study.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department


title: Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic

acronym: IMPACT

summary: The study is a prospective open trial conducted in 4 centers, and designed to determine if pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with amikacin as empirical therapy, impact microbiological and clinical outcome of patients with Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).

ReferenceCitation: Burdet C, Pajot O, Couffignal C, Armand-Lefèvre L, Foucrier A, Laouénan C, Wolff M, Massias L, Mentré F. Population pharmacokinetics of single-dose amikacin in critically ill patients with suspected ventilator-associated pneumonia. Eur J Clin Pharmacol. 2015 Jan;71(1):75-83. doi: 10.1007/s00228-014-1766-y. Epub 2014 Oct 21.

family: Burdet

full_name: C. Burdet

family: Pajot

full_name: O. Pajot

given: O.

family: Couffignal

full_name: C. Couffignal

family: Armand-Lefèvre

full_name: L. Armand-Lefèvre

given: L.

family: Foucrier

full_name: A. Foucrier

given: A.

family: Laouénan

full_name: C. Laouénan

family: Wolff

full_name: M. Wolff

family: Massias

full_name: L. Massias

family: Mentré

full_name: F. Mentré

given: F.

journal_name: European Journal of Clinical Pharmacology

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

version: submittedVersion

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

ReferenceCitation: Couffignal C, Pajot O, Laouénan C, Burdet C, Foucrier A, Wolff M, Armand-Lefevre L, Mentré F, Massias L. Population pharmacokinetics of imipenem in critically ill patients with suspected ventilator-associated pneumonia and evaluation of dosage regimens. Br J Clin Pharmacol. 2014 Nov;78(5):1022-34. doi: 10.1111/bcp.12435.

name: AP-HP, Hop Bichat; Biostatistics Department; Paris France

name: IAME, UMR 1137, Univ Paris Diderot, Sorbonne Paris Cité; F-75018 Paris France

name: IAME, UMR 1137, INSERM; F-75018 Paris France

full_name: Camille Couffignal

given: Camille

name: Hop V Dupouy; Intensive Care Unit; Argenteuil France

full_name: Olivier Pajot

given: Olivier

full_name: Cédric Laouénan

given: Cédric

full_name: Charles Burdet

given: Charles

name: AP-HP, Hop Bichat; Intensive Care Unit; Paris France

full_name: Arnaud Foucrier

given: Arnaud

full_name: Michel Wolff

given: Michel

name: AP-HP, Hop Bichat; Bacteriology Department; Paris France

family: Armand-Lefevre

full_name: Laurence Armand-Lefevre

full_name: France Mentré

given: France

name: AP-HP, Hop Bichat; Pharmacy Department; Paris France

full_name: Laurent Massias

given: Laurent

journal_name: British Journal of Clinical Pharmacology

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

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


title: Acute Effect of Intensive Insulin Infusion on Intestinal Triglyceride-rich-lipoprotein-apoB48 Metabolism in Type 2 Diabetic Patients

summary:
Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality at type 2 diabetes. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial elevation of triglyceride-rich lipoproteins (TRLs) with excess of intestinal triglyceride-rich-lipoprotein-apoB48 (TRL-apoB48), is felt to play an important role in the accelerated ASCD.

The investigators' objectives in this study are to determine whether an acute elevation of plasma insulin, secondarily to plasma insulin infusion, modulates the production and the clearance rates of intestinal TRL-apoB48 in type 2 diabetic patients in the fed state and to determine if this is a direct effect of insulin or an indirect effect due to the decrease of plasma FFA or the decrease of plasma glucose.

ReferenceCitation: Nogueira JP, Maraninchi M, Béliard S, Padilla N, Duvillard L, Mancini J, Nicolay A, Xiao C, Vialettes B, Lewis GF, Valéro R. Absence of acute inhibitory effect of insulin on chylomicron production in type 2 diabetes. Arterioscler Thromb Vasc Biol. 2012 Apr;32(4):1039-44. doi: 10.1161/ATVBAHA.111.242073. Epub 2012 Feb 2.

name: From the Unité Mixte de Recherche Institut National de la Recherche Agronomique 1260 (J.P.N., M.M., N.P., A.N., R.V.) and Biostatistics Research Unit (Laboratoire d'Enseignement et de Recherche sur le Traitement de l'Information Médicale) (J.M.), University of la Méditerranée, Marseille, France; Department of Nutrition, Metabolic Diseases, Endocrinology, Assistance Publique-Hôpitaux de Marseille, La Timone Hospital, Marseille, France (B.V., R.V.); Unité Mixte de Recherche Institut National de la...

family: Nogueira

full_name: Juan-Patricio Nogueira

given: Juan-Patricio

family: Maraninchi

full_name: Marie Maraninchi

given: Marie

family: Béliard

full_name: Sophie Béliard

given: Sophie

family: Padilla

full_name: Nadège Padilla

given: Nadège

family: Duvillard

full_name: Laurence Duvillard

given: Laurence

family: Mancini

full_name: Julien Mancini

given: Julien

family: Nicolay

full_name: Alain Nicolay

given: Alain

family: Xiao

full_name: Changting Xiao

given: Changting

family: Vialettes

full_name: Bernard Vialettes

given: Bernard

family: Lewis

full_name: Gary F. Lewis

given: Gary F.

family: Valéro

full_name: René Valéro

given: René

journal_name: Arteriosclerosis, Thrombosis, and Vascular Biology

repositories_institution: The Pennsylvania State University - CiteSeer X

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Absence of Acute Inhibitory Effect of Insulin on Chylomicron Production in Type 2 Diabetes

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille


lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_facility: European Organization for Research and Treatment of Cancer

title: Immediate or Early Salvage Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Immediate or Early Salvage Postoperative External Radiotherapy Alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study

summary:
RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective when given together with or without hormone therapy in treating patients with prostate cancer who have undergone surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with hormone therapy in treating patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.


title: Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase vs SERM for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.

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

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


title: Dual Source Computed Tomography (DSCT) During Injection of Dipyridamole : a New Technique for Myocardial Ischemia Assessment

summary: The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial ischemia. There is some preliminary data in the literature showing the ability of MDCT under stress to bring relevant information about myocardial ischemia. Stress MDCT will have several advantages over single photon emission computed tomography (SPECT) imaging namely: shorter acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is still debated and need to be address in a clinical study.

location_facility: Assistance Publique-Hôpitaux de Marseille


title: Evaluation of Long-term Efficacy of 2 Strategies of Real Time Continuous Glucose Monitoring, Compared to Self BG-monitoring in Children and Adolescent With Type 1 Diabetes: a Randomized, Multicenter, Open Trial

acronym: START-IN

summary:
Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing them to the risk of vascular complications in adulthood.

One of the limiting factors is the daily number of self measurements of blood glucose required to optimize intensive insulin therapy.

Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown its efficacy at short term (3 months). However, optimal clinical use of these devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability in medium and long term.

Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM (continuous or discontinuous) on glycemic control compared to conventional blood glucose self-monitoring (SMBG).

Population: Children and adolescents with type 1 diabetes with inadequate glycemic control despite intensive insulin therapy.

ReferenceCitation: Le Jeannic A, Maoulida H, Guilmin-Crépon S, Alberti C, Tubiana-Rufi N, Durand-Zaleski I. How to collect non-medical data in a pediatric trial: diaries or interviews. Trials. 2020 Jan 7;21(1):36. doi: 10.1186/s13063-019-3997-9.

family: Le Jeannic

full_name: Anaïs Le Jeannic

given: Anaïs

family: Maoulida

full_name: Hassani Maoulida

given: Hassani

family: Guilmin-Crépon

full_name: Sophie Guilmin-Crépon

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Tubiana-Rufi

full_name: Nadia Tubiana-Rufi

given: Nadia

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

journal_name: Trials

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

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

evidence: oa repository (via page says license)

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature


summary:
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Therapeutic Education About Intake of Oral Solutions of Antibiotics in Children Under 6 Year-old at the Emergency Department in Robert Debré Hospital

acronym: ACHEEN

summary: The purpose of this study is to determine if a patient education in acute condition about the intake of oral solution antibiotic in children under 6 year-old are effective to improve the satisfaction about the therapeutic education, the knowledge about antibiotics among the patients' families and thereby decrease the misuses of antibiotics.

ReferenceCitation: Angoulvant F, Rouault A, Prot-Labarthe S, Boizeau P, Skurnik D, Morin L, Mercier JC, Alberti C, Bourdon O. Randomized controlled trial of parent therapeutic education on antibiotics to improve parent satisfaction and attitudes in a pediatric emergency department. PLoS One. 2013 Sep 26;8(9):e75590. doi: 10.1371/journal.pone.0075590. eCollection 2013.

family: Angoulvant

full_name: François Angoulvant

given: François

family: Rouault

full_name: Anne Rouault

given: Anne

family: Prot-Labarthe

full_name: Sonia Prot-Labarthe

given: Sonia

family: Boizeau

full_name: Priscilla Boizeau

given: Priscilla

family: Skurnik

full_name: David Skurnik

given: David

family: Morin

full_name: Laurence Morin

family: Mercier

full_name: Jean-Christophe Mercier

given: Jean-Christophe

family: Bourdon

full_name: Olivier Bourdon

given: Olivier

currency_apc_doaj: USD

journal_name: PLoS ONE

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

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: University of Illinois at Chicago - INDIGO

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Randomized Controlled Trial of Parent Therapeutic Education on Antibiotics to Improve Parent Satisfaction and Attitudes in a Pediatric Emergency Department


title: Reduction of Acute and Chronic Graft-versus-host Disease After Allogeneic Hematopoietic Stem-cell Transplantation by Adapting Cyclosporine Doses According to Calcineurin Activity : a Proof-of-concept Trial

acronym: CALCICLO

summary: The purpose of this trial is to assess whether an adaptation of cyclosporine (CsA) dose according to a longitudinal calcineurin (CN) activity monitoring would prevent the onset of graft-versus-host disease (GVHD).

ReferenceCitation: Sanquer S, Schwarzinger M, Maury S, Yakouben K, Rafi H, Pautas C, Kuentz M, Barouki R, Cordonnier C. Calcineurin activity as a functional index of immunosuppression after allogeneic stem-cell transplantation. Transplantation. 2004 Mar 27;77(6):854-8.


title: Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects

summary: This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.

lead_sponsor: Pfizer


title: Clinical and Molecular Study, Natural History of Asphyxiating Thoracic Dystrophy (DTJ)

acronym: DTJ

summary: The aim of the project is to prospectively analyze at a clinical and molecular level a series of 50 asphyxiating thoracic dysplasia (ATD) patients and 20 fetuses to further define the natural history of the disorder and to contribute to the identification of its molecular basis.

intervention_type: Genetic


title: Nitrous Oxide (KALINOX®) Inhalation and Tolerance of Intravesical Botulinum Neurotoxin A Injection: a Double-blind Randomized Controlled Study

acronym: PROTOTOX

summary:
Second line treatment for detrusor hyperreflexia is the intravesical BTX-A injections. First 300 units Botox are diluted with 30 ml of preservative-free saline. Using a rigid cystoscope and an injection needle, BTX-A is injected into 30 sites within the detrusor muscle.

The used of KALINOX® (50% nitrous oxide and oxygen) inhalation has demonstrated analgesic efficacy in various procedures (obstetric, liver biopsy, transrectal ultrasound guided prostate biopsy, emergency) The aim of this study is to investigate the safety and efficacy of analgesia with N2O/O2 inhalation for detrusor BTX-A injections using a rigid cystoscope.


title: A Treatment Trial of Triheptanoin in Patients With Adult Polyglucosan Body Disease - A Randomized Controlled Study

summary: The purpose of the study is to determine if triheptanoin is an effective treatment for the symptoms of Adult Polyglucosan Body Disease.

ReferenceCitation: Schiffmann R, Wallace ME, Rinaldi D, Ledoux I, Luton MP, Coleman S, Akman HO, Martin K, Hogrel JY, Blankenship D, Turner J, Mochel F. A double-blind, placebo-controlled trial of triheptanoin in adult polyglucosan body disease and open-label, long-term outcome. J Inherit Metab Dis. 2018 Sep;41(5):877-883. doi: 10.1007/s10545-017-0103-x. Epub 2017 Nov 6.

family: Schiffmann

full_name: Raphael Schiffmann

given: Raphael

family: Wallace

full_name: Mary E. Wallace

given: Mary E.

family: Rinaldi

full_name: Daisy Rinaldi

given: Daisy

family: Ledoux

full_name: Isabelle Ledoux

family: Luton

full_name: Marie-Pierre Luton

given: Marie-Pierre

family: Coleman

full_name: Scott Coleman

given: Scott

family: Akman

full_name: H. Orhan Akman

given: H. Orhan

family: Martin

full_name: Karine Martin

given: Karine

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Blankenship

full_name: Derek Blankenship

given: Derek

family: Turner

full_name: Jacob Turner

given: Jacob

family: Mochel

full_name: Fanny Mochel

given: Fanny

journal_name: Journal of Inherited Metabolic Disease

lead_sponsor: Baylor Research Institute

location_facility: Department of Genetics, Groupe Hospitalier Pitié-Salpêtrière


title: Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism.

summary: Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.

location_facility: Département de Cardiologie, Unité Valvulopathies et Insuffisance Cardiaque, Hôpital de la Timone,


title: Analysis of Language and Auditory Abilities in Cochlear Implanted Children: Assessment by an Auditory Learning Programmed Method

summary:
The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial. These results are usually due to the children own factors (social, educational and handicap ones), one which any action has a limited effect.

Besides, there are external factors on which one can rely : " treatments ". For instance, an early cochlear implant on a child is the main stream to a better access to speak properly later. Another essential point to tackle is the early re-education training which remains essential to the treatment. Yet, there is a gap to fill between the theory and the main assistance in the auditory education practice.

The main objective of this survey is to evaluate the efficiency of this auditory teaching programme (MPAA) over the 4 tested skills (identification, discrimination, the analysis of sounds scenes and its memory) among the pre-speaking cochlear implanted congenital deaf children aged from 4 to 10.

This study will be divided into two phases separated by 3 sessions of evaluation tests.

The first session T1 will occur in the two groups (experimentation on G1 and control on G2), then the first training session will start in group G1.

The second session T2 will occur in the two groups, then the first training session will start in group G2.

The third session T3 will occur in the 2 groups at the end of the experiment.

By training the 4 perceptible operations with different auditory stimulations (speech, music, sounds and electro-acoustic sounds), we are looking for better performance in the trained skills as well as a teaching transfer on other linguistic abilities (phonetics discrimination and speech).


title: Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).

summary:
PBMNC DNA is considered a limit above which patients will develop EBV associated post transplant lymphoproliferative disorder.

we showed that methotrexate tended to decrease EBV load over time, but this did not reach significance and that TNFa inhibitors did not significantly modify EBV load over time.

Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab), to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease.


title: Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty

acronym: COGCAR

summary:
The real impact of cardiac surgery and coronary angioplasty remains to be clarified and, where appropriate, the influencing factors in a way beneficial or deleterious remain to be identified.

The identification of such factors could make even faster screening, prevention and therefore open therapeutic prospects for those patients.

The objective of the study is to constitute a prospective cohort to assess the occurrence of cognitive decline after cardiac surgery (200 patients) and coronary angioplasty (200 patients) using the scale Dementia rating scale (DRS) of Mattis. In addition, the investigators will identify factors that influence positively or negatively, the occurrence of such a cognitive decline. The study based on a systematic monitoring of clinical, biological, imaging and pharmacological factors and, to correlate the respective influence of these factors on the incidence of cognitive decline.

lead_sponsor: University Hospital, Lille


title: A Study Comparing Efficacy and Tolerance of Two Maintenance Strategies : a Monotherapy With Lopinavir/Ritonavir or a Single-tablet Triple Therapy by Efavirenz/Emtricitabin/Tenofovir in HIV-1 Infected Patients With HIV RNA Below 50 cp/mL

acronym: ANRS 140 DREAM

summary: A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF).

ReferenceCitation: Garay OU, Nishimwe ML, Bousmah MA, Janah A, Girard PM, Chêne G, Moinot L, Sagaon-Teyssier L, Meynard JL, Spire B, Boyer S. Cost-Effectiveness Analysis of Lopinavir/Ritonavir Monotherapy Versus Standard Combination Antiretroviral Therapy in HIV-1 Infected Patients with Viral Suppression in France (ANRS 140 DREAM). Pharmacoecon Open. 2019 Dec;3(4):505-515. doi: 10.1007/s41669-019-0130-7.

family: Garay

full_name: Osvaldo Ulises Garay

given: Osvaldo Ulises

family: Nishimwe

full_name: Marie Libérée Nishimwe

given: Marie Libérée

family: Bousmah

full_name: Marwân-al-Qays Bousmah

given: Marwân-al-Qays

family: Janah

full_name: Asmaa Janah

given: Asmaa

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Chêne

full_name: Geneviève Chêne

given: Geneviève

family: Moinot

full_name: Laetitia Moinot

given: Laetitia

family: Sagaon-Teyssier

full_name: Luis Sagaon-Teyssier

given: Luis

family: Meynard

full_name: Jean-Luc Meynard

given: Jean-Luc

family: Spire

full_name: Bruno Spire

given: Bruno

family: Boyer

full_name: Sylvie Boyer

given: Sylvie

journal_name: PharmacoEconomics - Open

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

ReferenceCitation: Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

name: INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique (IPLESP), Paris, France

name: AP-HP, Laboratoire de Virologie, Hôpital Saint-Antoine, Paris, France

name: Département de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France

name: AP-HP, Laboratoire de Virologie, Hôpital Pitié Salpêtrière, Paris, France

name: Département de Maladies Infectieuses, Hôpital Pitié Salpêtrière, Paris

name: Université Toulouse III Paul-Sabatier, Toulouse, France

name: CHU de Toulouse, Laboratoire de Virologie, Toulouse, France

name: Inserm, Bordeaux Population Health Research Center, Université Bordeaux, ISPED, Bordeaux, France

name: CHU de Bordeaux, Pole de Sante Publique, Bordeaux, France

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

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

location_facility: Service des maladies infectieuses et tropicales Hopital Saint-Antoine


title: Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.


title: Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass

acronym: OBEMO

summary: The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.

lead_sponsor: Hopital Lariboisière

location_facility: Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital


title: A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.(RHOMUS)

summary:
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide acetate may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide, leuprolide acetate, and radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bicalutamide and leuprolide acetate in treating patients with high-risk locally advanced prostate cancer undergoing radiation therapy.


title: Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.

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

PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.

ReferenceCitation: Polena H, Creuzet J, Dufies M, Sidibé A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Négrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.

family: Polena

full_name: Helena Polena

given: Helena

family: Creuzet

full_name: Julie Creuzet

given: Julie

family: Dufies

full_name: Maeva Dufies

given: Maeva

family: Sidibé

full_name: Adama Sidibé

given: Adama

family: Khalil-Mgharbel

full_name: Abir Khalil-Mgharbel

given: Abir

family: Salomon

full_name: Aude Salomon

given: Aude

family: Deroux

full_name: Alban Deroux

given: Alban

family: Quesada

full_name: Jean-Louis Quesada

given: Jean-Louis

family: Roelants

full_name: Caroline Roelants

given: Caroline

family: Filhol

full_name: Odile Filhol

given: Odile

family: Cochet

full_name: Claude Cochet

given: Claude

family: Blanc

full_name: Ellen Blanc

given: Ellen

family: Ferlay-Segura

full_name: Céline Ferlay-Segura

given: Céline

family: Borchiellini

full_name: Delphine Borchiellini

given: Delphine

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Négrier

full_name: Sylvie Négrier

family: Pages

full_name: Gilles Pages

given: Gilles

family: Vilgrain

full_name: Isabelle Vilgrain

given: Isabelle

journal_name: British Journal of Cancer

evidence: open (via page says license)


title: Efficacy and Safety of the Iron Chelator Deferiprone on Iron Overload in the Brain in Parkinson's Disease

acronym: FAIR-PARK-I

summary:
Few available drugs can slow the progression of neurodegenerative pathologies such as Parkinson's disease (PD). One of the recent hypotheses concerning the reduction of oxidative stress and neuron death features a harmful effect of iron, which may reach abnormally high levels in the substantia nigra (SN) pars compacta (iron overload has been seen in the substantia nigra in parkinsonian patients and in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) mouse model of PD). Iron overload is harmful because it reacts with hydrogen peroxide (H2O2) produced during the oxidative deamination of dopamine, generating hydroxyl radicals which then damage proteins, DNA and phospholipid membranes and may be responsible for neuron death. The use of an iron chelator (clioquinol) produces a reduction in neuron death in the MPTP mouse model. In humans, a special, partially refocused interleaved multiple echo (PRIME) MR sequence has been used to study the relaxation time (T2*) and quantify iron overload in the SN of PD patients and the nucleus dentatus of patients with Friedreich's ataxia. T2* sequences have revealed a decrease in iron overload following treatment with the chelator deferiprone, in parallel with a clinical improvement in these patients. Furthermore, the very recent open label use of deferiprone in rare serious, systemic, neurological iron overload diseases (Neurodegeneration with Brain Iron Accumulation (NBIA)) has revealed a clinical improvement after 6 months, with 2 case reports from our group and another from an Italian group (Forni et al., 2008). The safety of the low dosages of deferiprone (20 to 30 mg/kg/day) used in neurology appears to be much greater than for the high dosages (75 to 100 mg/kg/day in 3 doses) used in hematology to decrease post-transfusion iron overloads in thalassemia major.

Hence, the investigators wish to evaluate the effect of treatment with an oral iron chelator which is capable of crossing the blood-brain barrier (deferiprone) on iron overload in the SN(as assessed by the T2* sequence) with respect to the progression of clinical sign in PD. It is expected a 6-month course of deferiprone able to produce a moderate reduction in iron overload of the SN, associated with a drop in the motor handicap score. Depending on the risk/benefit balance determined in this initial pilot study, a larger, multicenter neuroprotection study could be envisaged.

ReferenceCitation: Grolez G, Moreau C, Sablonnière B, Garçon G, Devedjian JC, Meguig S, Gelé P, Delmaire C, Bordet R, Defebvre L, Cabantchik IZ, Devos D. Ceruloplasmin activity and iron chelation treatment of patients with Parkinson's disease. BMC Neurol. 2015 May 6;15:74. doi: 10.1186/s12883-015-0331-3.

family: Grolez

full_name: Guillaume Grolez

given: Guillaume

family: Moreau

full_name: Caroline Moreau

family: Sablonnière

full_name: Bernard Sablonnière

family: Garçon

full_name: Guillaume Garçon

family: Devedjian

full_name: Jean-Christophe Devedjian

given: Jean-Christophe

family: Meguig

full_name: Sayah Meguig

given: Sayah

family: Gelé

full_name: Patrick Gelé

given: Patrick

family: Delmaire

full_name: Christine Delmaire

given: Christine

family: Bordet

full_name: Regis Bordet

given: Regis

family: Defebvre

full_name: Luc Defebvre

given: Luc

family: Cabantchik

full_name: Ioav Z Cabantchik

given: Ioav Z

family: Devos

full_name: David Devos

given: David

journal_name: BMC Neurology

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

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

title: Ceruloplasmin activity and iron chelation treatment of patients with Parkinson’s disease

ReferenceCitation: Devos D, Moreau C, Devedjian JC, Kluza J, Petrault M, Laloux C, Jonneaux A, Ryckewaert G, Garçon G, Rouaix N, Duhamel A, Jissendi P, Dujardin K, Auger F, Ravasi L, Hopes L, Grolez G, Firdaus W, Sablonnière B, Strubi-Vuillaume I, Zahr N, Destée A, Corvol JC, Pöltl D, Leist M, Rose C, Defebvre L, Marchetti P, Cabantchik ZI, Bordet R. Targeting chelatable iron as a therapeutic modality in Parkinson's disease. Antioxid Redox Signal. 2014 Jul 10;21(2):195-210. doi: 10.1089/ars.2013.5593. Epub 2014 Feb 6.

name: Department of Medical Pharmacology, Faculté de Médecine Lille2, Lille Nord de France University, CHU Lille, Lille, France.

name: Department of Movement Disorders and Neurology, Lille Nord de France University, CHU Lille, Lille, France.

name: EA 1046, Lille Nord de France University, Lille, France.

name: University of the Littoral, Lille Nord de France University, Lille, France.

name: Unit 837 Equipe 4 Inserm and Faculté de Médecine, Lille Nord de France University, Lille, France.

name: Department of Toxicology, Public Health and Environment, EA4483, Faculté des Sciences Pharmaceutiques et Biologiques de Lille, Lille, France.

name: Department of Molecular Biology, Lille Nord de France University, CHU Lille, Lille, France.

name: Department of Biostatistics, Lille Nord de France University, CHU Lille, Lille, France.

name: Department Neuroradiology, Lille Nord de France University, CHU Lille, Lille, France.

name: Department of Animal Neuroradiology, Lille Nord de France University, Lille, France.

name: Department of Animal Nuclear Medicine, Lille Nord de France University, Lille, France.

name: Department of Pharmacology, APHP, Pitié-Salpêtrière Hospital, Paris, France.

name: INSERM U837/6 JPARC Université Lille Nord de France, Lille, France.

name: INSERM, CR-ICM, UMRS975, CNRS UMR7225, UPMC, INSERM, CIC-9503, Department of Neurology, Pitié-Salpêtrière Hospital, Paris, France.

name: Doerenkamp-Zbinden Chair for In Vitro Toxicology and Biomedicine, University of Konstanz, Konstanz, Germany.

name: Konstanz Research School Chemical Biology, University of Konstanz, Konstanz, Germany.

name: Department of Hematology, Hôpital Saint Vincent de Paul, Lille Nord de France University, Lille, France.

name: Della Pergola Chair, Alexander Silberman Institute of Life Sciences, Hebrew University, Jerusalem, Israel.

repository_institution: University of Konstanz - KOPS - The Institutional Repository of the University of Konstanz

title: Targeting Chelatable Iron as a Therapeutic Modality in Parkinson's Disease

location_facility: Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114


title: Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis

acronym: EMG-MMG

summary: The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinical Investigation Center - INSERM - University Hospital of Grenoble


title: Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study

summary:
A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), using an external pump, could be a solution to improve diabetes control.

The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c>7 -10%).

lead_sponsor: University Hospital, Toulouse


title: Biomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV Study

summary: Information from blood samples may help us for choosing the best treatment in future personalized medicine. Natalizumab (NTZ) a current treatment for MS can be used as a second line therapy if a suboptimal response to disease modifying drugs. When to introduce NTZ is not consensual. The investigators hypothesized that biological information could rationalize choice and thus designed a prospective open label trial to test biological markers before treatment.