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France Clinical Investigation Center[Af... Publications | LitMetric

13 results match your criteria: "France Clinical Investigation Center[Affiliation]"

Objectives: To develop a self-administered children health-related behaviors assessment, and to test its feasibility and reliability in a group of French children.

Methods: A sample of 216 children participated in the first stage of this study, dedicated to the feasibility assessment. An independent sample of 99 children participated in the assessment of reliability via questionnaire test and retest.

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Background: Data are needed on long-term effect of natalizumab (NTZ) in relapsing-remitting multiple sclerosis (RRMS).

Objectives: To evaluate the time of onset of secondary progressive phase in patients with an RRMS treated with NTZ and to investigate predictive factors.

Methods: TYSTEN is an observational study.

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Estimating Outdoor Walking Energy Expenditure in Non-Steady-State Conditions.

Med Sci Sports Exerc

July 2019

Institute of Physical Education and Sports Sciences (IFEPSA) West Catholic University (UCO) Les Ponts-de-Cé, FRANCE Laboratory of Exercise Physiology and Vascular Medicine University Hospital Angers, FRANCE Univ Rennes, M2S-EA 7470 Rennes, FRANCE Clinical Investigation Center INSERM CIC 1414 Rennes, FRANCE.

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Background: Changes in relapse activity during secondary progressive multiple sclerosis (SPMS) need to be accurately characterized in order to identify patients who might benefit from continuing disease-modifying therapies.

Objective: To describe relapse occurrence in patients with SPMS during long-term follow-up and assess its impact on disability worsening.

Methods: This retrospective cohort study included 506 patients.

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Mortality, cardiovascular risk, and androgen deprivation therapy for prostate cancer: A systematic review with direct and network meta-analyses of randomized controlled trials and observational studies.

Medicine (Baltimore)

June 2016

Pharmacovigilance, Pharmacoepidemiology and Drug Information Center, Rennes University Hospital, Rennes, France Clinical Investigation Center, INSERM 1414, Rennes University Hospital and University of Rennes 1, Rennes, France Urology Department, Rennes University Hospital, Rennes, France.

Unlabelled: Androgen deprivation therapy (ADT) is a cornerstone therapy for advanced prostate cancer (PCa). We hypothesized that cardiovascular (CV) risk is different across the various ADT modalities to compare their effects on CV morbidity and mortality, and all-cause mortality in patients with PCa. To investigate more in depth potential CV risk heterogeneity focusing on coronary (main outcome) and cerebrovascular risk, CV, and overall mortality.

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Aim: To assess the potential predictive value of natural resistance-associated macrophage protein 1 (NRAMP1) and human glutathione peroxidase 1 (hGPX1) polymorphism in non-muscle-invasive bladder cancer treated with bacillus Calmette-Guerin (BCG) instillation, we conducted an original ancillary multicenter study.

Patients And Methods: We evaluated patients included in the multicenter URO-BCG 4 trial, who received three weekly instillations of one-third dose BCG every 6 months (group I) or two weekly instillations every 3 months (group II) for 3 years. For clinical evaluation we also evaluated tumor recurrence and muscle progression.

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Clinical Utility and Safety of a Model-Based Patient-Tailored Dose of Vancomycin in Neonates.

Antimicrob Agents Chemother

April 2016

Department of Pharmacy, Qian-Fo-Shan Hospital, Shandong University, Jian, China Sino-French Pediatric Research Center, Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China

Pharmacokinetic modeling has often been applied to evaluate vancomycin pharmacokinetics in neonates. However, clinical application of the model-based personalized vancomycin therapy is still limited. The objective of the present study was to evaluate the clinical utility and safety of a model-based patient-tailored dose of vancomycin in neonates.

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TP53 and FGFR3 Gene Mutation Assessment in Urine: Pilot Study for Bladder Cancer Diagnosis.

Anticancer Res

September 2015

Department of Urology, Rouen University Hospital, Rouen, France Clinical Investigation Center, Inserm 6204, Urological Cancerology, Rouen, France

Aim: To assess, in a prospective clinical research study, a new non-invasive and reliable test to accurately detect tumor protein 53 (TP53) and fibroblast growth factor receptor-3 (FGFR3) mutations in cells in urine.

Materials And Methods: TP53 mutations were analyzed using the functional analysis of separated allele in yeast (FASAY) method, which allows functional analysis of the P53 protein, and FGFR3 mutations were assessed with the SNaPshot system, detecting the eight most frequent point-mutations of this gene. Chi-square test or Fisher's exact test were used to compare TP53 and FGFR3 mutations in the tumors according to tumor stage and grade.

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Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey.

Arch Dis Child

April 2015

Department of Paediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France EA7323, Université Paris Diderot-Université Paris Descartes, Paris, France Clinical Investigation Center CIC1426, INSERM, Paris, France.

Objective: This survey aims to describe and analyse the dosage regimens of antibiotics in French neonatal intensive care units (NICUs).

Methods: Senior doctors from 56 French NICUs were contacted by telephone and/or email to provide their local guidelines for antibiotic therapy.

Results: 44 (79%) NICUs agreed to participate in this survey.

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Choosing the right dose of tacrolimus.

Arch Dis Child

April 2015

Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France EA7323, Université Paris Diderot-Université Paris Descartes, Paris, France Clinical Investigation Center CIC1426, INSERM, Paris, France Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.

Choosing the right dose of tacrolimus 'adapted to each individual patient' is a central question after transplantation. The pharmacokinetic behaviour of tacrolimus in paediatric patients is significantly influenced by clinical factors growth and maturation, as well as genetic factors. Large interindividual variability and narrow therapeutic index make dosage individualisation mandatory in children.

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Population pharmacokinetics of ciprofloxacin in neonates and young infants less than three months of age.

Antimicrob Agents Chemother

November 2014

Department of Paediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France Clinical Investigation Center CIC1426, INSERM, Paris, France EA7323, Université Paris Diderot-Université Paris Descartes, Paris, France

Ciprofloxacin is used in neonates with suspected or documented Gram-negative serious infections. Currently, its use is off-label partly because of lack of pharmacokinetic studies. Within the FP7 EU project TINN (Treat Infection in NeoNates), our aim was to evaluate the population pharmacokinetics of ciprofloxacin in neonates and young infants <3 months of age and define the appropriate dose in order to optimize ciprofloxacin treatment in this vulnerable population.

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Population pharmacokinetics and dosing optimization of vancomycin in children with malignant hematological disease.

Antimicrob Agents Chemother

June 2014

Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France Clinical Investigation Center CIC1426, INSERM, Paris, France Université Paris Diderot, Sorbonne Paris Cité, Paris, France

An increase in vancomycin dose has been proposed in adults with malignant hematological disease. As pediatric data are limited, our aim was to evaluate the population pharmacokinetics of vancomycin in order to define the appropriate dosing regimen in children with malignant hematological disease. Vancomycin concentrations were collected prospectively during therapeutic monitoring.

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