Author: "CHU Louise Michel [Clermont-Ferrand]" - Searchworks@Jio Institute Digital Library Search Results

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1. Physicochemical Stability of Monoclonal Antibodies: A Review

Author: Philip Chennell, Nicolas Tokhadzé, Valérie Sautou, Alain Astier, Yoann Le Basle, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), CHU Clermont-Ferrand, Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: Chemical Phenomena, medicine.drug_class, Chemistry, Pharmaceutical, Stability (learning theory), Pharmaceutical Science, 02 engineering and technology, Monoclonal antibody, 030226 pharmacology & pharmacy, 03 medical and health sciences, Antineoplastic Agents, Immunological, 0302 clinical medicine, Protein structure, Drug Stability, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [CHIM.ANAL]Chemical Sciences/Analytical chemistry, medicine, Animals, Humans, ComputingMilieux_MISCELLANEOUS, Light exposure, Biological Products, Protein Stability, Chemistry, Study methodology, Antibodies, Monoclonal, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, 021001 nanoscience & nanotechnology, Protein tertiary structure, [SDV.SP.PG]Life Sciences [q-bio]/Pharmaceutical sciences/Galenic pharmacology, Biopharmaceutical, Biochemistry, Chemical stability, Stress, Mechanical, 0210 nano-technology
Abstract: Monoclonal antibodies (mAbs) are subject to instability issues linked to their protein nature. In this work, we review the different mechanisms that can be linked to monoclonal antibodies instability, the parameters, and conditions affecting their stability (protein structure and concentration, temperature, interfaces, light exposure, excipients and contaminants, and agitation) and the different analytical methods used for appropriate physicochemical stability studies: physical stability assays (aggregation, fragmentation, and primary, secondary, and tertiary structure analysis), chemical stability assays and quantitative assays. Finally, data from different published stability studies of mAbs formulations, either in their reconstituted form, or in diluted ready to administer solutions, was compiled. Overall, the physicochemical stability of mAbs is linked to numerous factors such as formulation, environment, and manipulations, and must be thoroughly investigated using several complementary analytical techniques, each of which allowing specific characterization information to be harvested. Several stability studies have been published, some of them showing possibilities of extended stability. However, those data should be questioned due to potential lacks in study methodology.
Published: 2020
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2. Do Ophthalmic Solutions of Amphotericin B Solubilised in 2-Hydroxypropyl-γ-Cyclodextrins Possess an Extended Physicochemical Stability?

Author: Philip Chennell, Mouloud Yessaad, Florence Abd El Kader, Mireille Jouannet, Mathieu Wasiak, Yassine Bouattour, Valérie Sautou, Institut de Chimie de Clermont-Ferrand (ICCF), Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand]
Subjects: lcsh:Pharmacy and materia medica, [SDV]Life Sciences [q-bio], fungal keratitis, lcsh:RS1-441, stability, γ-cyclodextrins, Article, amphotericin B
Abstract: Fungal keratitis is a sight-threatening disease for which amphotericin B eye drops is one of the front-line treatments. Unfortunately, there are currently no commercial forms available, and there is little data concerning the long-term stability of compounded formulations based on intravenous dosages forms. New formulations of amphotericin B ophthalmic solutions solubilised with &gamma, cyclodextrins have shown promising in-vitro results, but stability data is also lacking. The objective of this study was therefore to investigate the stability of a formulation of ready-to-use amphotericin B solubilised in 2-hydroxypropyl-&gamma, cyclodextrins (AB-HP-&gamma, CD), for 350 days. An amphotericin B deoxycholate (ABDC) formulation was used as a comparator. Analyses used were the following: visual inspection, turbidity, osmolality and pH measurements, amphotericin B quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. AB-HP-&gamma, CD formulation showed signs of chemical instability (loss of amphotericin B) after 28 and 56 days at 25 &deg, C and 5 &deg, C. Adding an antioxidant (ascorbic acid) to the formulation did not improve stability. ABDC formulation showed signs of physical instability (increased turbidy and amphotericin B precipitation) after 28 days and 168 days at 25 &deg, C. As such, AB-HP-&gamma, CD formulation does not provide long-term stability for ophthalmic amphotericin B solutions.
Published: 2020
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3. Stability of Ophthalmic Atropine Solutions for Child Myopia Control

Author: Baptiste Berton, Mathieu Wasiak, Valérie Sautou, Mireille Jouannet, Philip Chennell, Mouloud Yessaad, Yassine Bouattour, Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: Preservative, [SDV]Life Sciences [q-bio], atropine, lcsh:RS1-441, Pharmaceutical Science, Ph measurement, 030226 pharmacology & pharmacy, Article, lcsh:Pharmacy and materia medica, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [CHIM.ANAL]Chemical Sciences/Analytical chemistry, medicine, myopia, [SDV.IB.BIO]Life Sciences [q-bio]/Bioengineering/Biomaterials, Chromatography, Chemistry, [CHIM.MATE]Chemical Sciences/Material chemistry, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, stability, Tropic acid, 3. Good health, Atropine, Low-density polyethylene, [CHIM.POLY]Chemical Sciences/Polymers, [SDV.SP.PG]Life Sciences [q-bio]/Pharmaceutical sciences/Galenic pharmacology, Compounding, 030221 ophthalmology & optometry, ophthalmic solution, medicine.drug
Abstract: Myopia is an ophthalmic condition affecting more than 1/5th of the world population, especially children. Low-dose atropine eyedrops have been shown to limit myopia evolution during treatment. However, there are currently no commercial industrial forms available and there is little data published concerning the stability of medications prepared by compounding pharmacies. The objective of this study was to evaluate the stability of two 0.1 mg/mL atropine formulations (with and without antimicrobiobial preservatives) for 6 months in two different low-density polyethylene (LDPE) multidose eyedroppers. Analyses used were the following: visual inspection, turbidity, chromaticity measurements, osmolality and pH measurements, atropine quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. In an in-use study, atropine quantification was also performed on the drops emitted from the multidose eyedroppers. All tested parameters remained stable during the 6 months period, with atropine concentrations above 94.7% of initial concentration. A breakdown product (tropic acid) did increase slowly over time but remained well below usually admitted concentrations. Atropine concentrations remained stable during the in-use study. Both formulations of 0.1 mg/mL of atropine (with and without antimicrobial preservative) were proved to be physicochemically stable for 6 months at 25 &deg, C when stored in LDPE bottles, with an identical microbial shelf-life.
Published: 2020
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4. Very early exercise tailored by using a decisional algorithm helps relieve discomfort in adults in an intensive care unit: an open-label pilot study

Author: Laurent, Hélène, Aubreton, Sylvie, Vallat, Aurélie, Pereira, Bruno, Souweine, Bertrand, Constantin, Jean-Michel, Coudeyre, Emmanuel, Unité de Nutrition Humaine (UNH), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Rehabilitation & Physical Medicine Service, CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], and Clermont-Ferrand University Hospital
Subjects: adulte, Intensive care units, Exercise tolerance, Physical therapy modalities, Exercise, algorithme, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; BACKGROUND:Existing algorithms do not allow for setting up finely tuned progression or intensity for exercise training in intensive care units (ICUs). AIM:We aimed to assess the feasibility and tolerance of a very early exercise program tailored by using decisional algorithm that integrated both progression and intensity. DESIGN:Open-label pilot study. SETTING:ICU. POPULATION:30 adults hospitalized in ICU. METHODS:Once a day, patients performed manual range of motion, cycloergometry, and functional training exercises. The progression and intensity of training were standardized by using the constructed algorithm. The main outcome, discomfort on a 0-100 visual analog scale, was assessed before and after each exercise session. Secondary outcomes were muscle strength, ICU length of stay and adverse events related to exercise. RESULTS:In total, 125 exercise sessions were performed. Discomfort during exercise sessions decreased significantly by the fifth session (p=0.049). Early exercise sessions were feasible and did not produce major adverse events. CONCLUSIONS:We confirmed the safety and feasibility of very early exercise programs in ICUs. Early exercise tailored by using a decisional algorithm helps relieve the discomfort of ICU patients. CLINICAL REHABILITATION IMPACT:In everyday practice, the use of decisional algorithms should be encouraged to initiate and standardize early exercise in ICUs.
Published: 2020
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5. Financial impact of intravenous iron treatments on the management of anaemia inpatients: a 1 year observational study

Author: Stéphane Boisgard, Armand Abergel, Amina Delpeuch, Olivier Aumaître, Marc Ruivard, Valérie Sautou, Sandrine Bagel, Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Estaing [Clermont-Ferrand], Institut Pascal (IP), SIGMA Clermont (SIGMA Clermont)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand]
Subjects: Male, medicine.medical_specialty, Malabsorption, Cost, [SDV]Life Sciences [q-bio], Pharmaceutical Science, Intravenous iron, Anaemia, Efficiency, Pharmacy, 030204 cardiovascular system & hematology, Toxicology, Iron sucrose, Ferric Compounds, Drug Costs, Glucaric Acid, 03 medical and health sciences, 0302 clinical medicine, Refractory, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Medical prescription, Maltose, Aged, Retrospective Studies, Ferric Oxide, Saccharated, Pharmacology, Inpatients, Anemia, Iron-Deficiency, business.industry, Financial impact, Iron deficiency, Length of Stay, Middle Aged, Ferric carboxymaltose, medicine.disease, 3. Good health, Hematinics, Administration, Intravenous, Female, Observational study, France, business, medicine.drug
Abstract: International audience; Background Intravenous (IV) iron preparations bypass the difficulties (malabsorption and side effects) associated with oral iron for the treatment of iron deficiency anaemia (IDA). Ferric carboxymaltose (FCM) can be administered as a single infusion over short periods of time but is more expensive than iron sucrose (IS) when the patients are hospitalized. Objectives To evaluate the appropriateness of FCM prescriptions and to establish the economic impact of this management (including disease coding) compared to the use of IV IS. Setting This study was conducted for inpatients in all departments (orthopaedic department, gastroenterology department and two units of the internal medicine department) where FCM was widely prescribed. Method We retrospectively identified 224 patients, diagnosed with IDA using laboratory parameters and/or disease coding, who received FCM between January and December 2014. Main outcome measure The primary outcome was the rate of appropriateness of FCM prescriptions and the financial impact compared to IV IS. Results 89 Patients were included. The total additional cost for an inappropriate prescription of IV FCM (68% of cases) was of 6053 €. The total incremental cost of unsuitable disease coding was estimated at 31,688 €. Indications for IV FCM were categorized: intestinal bleeding (31%), malabsorption (17%), intolerance (9%) and refractory to oral iron (7%). The majority of patients (62%) received 1000 mg of FCM per week. The average length of hospital stay was of 10 days. Conclusion The prescription of IV iron was appropriate in most cases but did not necessarily require FCM. The use of IV IS, in many cases, could present a cost-saving option for inpatients with IDA. The lack of an IDA coding generated incremental costs.
Published: 2018
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6. In vitro cytotoxic effects of DEHP-alternative plasticizers and their primary metabolites on a L929 cell line

Author: Teuta Eljezi, Pierre Pinta, Marie-Christine Chagnon, Damien Richard, Jean-Michel Chezal, Jérémy Pinguet, Valérie Sautou, Gaël Grimandi, Emmanuel Moreau, Imagerie Moléculaire et Stratégies Théranostiques - Clermont Auvergne ( IMoST ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Clermont Auvergne ( UCA ), CHU Clermont-Ferrand, Laboratoire d'ingénierie osteo-articulaire et dentaire ( LIOAD ), Université de Nantes ( UN ) -IFR26-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de Pharmacologie Médicale [Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], Equipe NuTox (LNC - U1231) ( NUTOX ), Lipides - Nutrition - Cancer [Dijon - U1231] ( LNC ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Caractérisation et sécurité biologique des surfaces nanostructurées ( C-BIOSENSS ), Université d'Auvergne - Clermont-Ferrand I ( UdA ), Matériaux d'intérêt biologique, Université de Nantes ( UN ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Service Pharmacie [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], Laboratoire d'ingénierie osteo-articulaire et dentaire (LIOAD), Université de Nantes (UN)-IFR26-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Recherche en Gestion et en Economie (IREGE), Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), Service de Pharmacologie Médicale [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Caractérisation et sécurité biologique des surfaces nanostructurées (C-BIOSENSS), Université d'Auvergne - Clermont-Ferrand I (UdA), Regenerative Medicine and Skeleton research lab (RMeS), Ecole Nationale Vétérinaire, Agroalimentaire et de l'alimentation Nantes-Atlantique (ONIRIS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM), Regenerative Medicine and Skeleton (RMeS), École nationale vétérinaire, agroalimentaire et de l'alimentation Nantes-Atlantique (ONIRIS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-École nationale vétérinaire, agroalimentaire et de l'alimentation Nantes-Atlantique (ONIRIS), and Jehan, Frederic
Subjects: 0301 basic medicine, Environmental Engineering, Metabolite synthesis, Biocompatibility, Cell Survival, Cytotoxicity, Health, Toxicology and Mutagenesis, Metabolite, Phthalic Acids, In Vitro Techniques, DEHP-alternative plasticizers, 010501 environmental sciences, 01 natural sciences, [ SDE ] Environmental Sciences, Mice, 03 medical and health sciences, chemistry.chemical_compound, Phthalates, Plasticizers, In vivo, Diethylhexyl Phthalate, Animals, Environmental Chemistry, Organic chemistry, Polyvinyl Chloride, Cells, Cultured, 0105 earth and related environmental sciences, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Chromatography, [SDV.MHEP.GEG] Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, [SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, Public Health, Environmental and Occupational Health, Plasticizer, Primary metabolite, Esters, General Medicine, General Chemistry, Fibroblasts, Pollution, In vitro, 3. Good health, Phthalic acid, 030104 developmental biology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, chemistry
Abstract: IF 4.208; International audience; Phthalic acid esters have been widely used to improve the plasticity of PVC medical devices. They carry a high exposure risk for both humans and the environment in clinical situations. Our study focuses on the cytotoxicity of alternative plasticizers. Postulated primary metabolites were synthesized, not being commercially available. Cytotoxicity assays were performed on L929 murine cells according to the ISO-EN 10993-5 standard design for the biocompatibility of medical devices. The tested concentrations of plasticizers (0.01, 0.05 and 0.1 mg/ml) covered the range likely to be found in biological fluids coming into direct contact with the medical devices. DEHP, DINP and DINCH were cytotoxic at the highest concentration (0.1 mg/ml) for 7 days of exposure. Their corresponding metabolites were found to be more cytotoxic, for the same concentration. By contrast, TOTM and its corresponding metabolite MOTM were not found to be cytotoxic. DEHA showed no cytotoxicity, but its corresponding monoester (MEHA) produced a cytotoxic effect at 0.05 mg/ml. In clinical situations, medical devices can release plasticizers, which can come into contact with patients. In vivo, the plasticizers are quickly transformed into primary metabolites. It is therefore important to measure the effects of both the plasticizers and their corresponding metabolites. Standard first-line cytotoxicity assays should be performed to ensure biocompatibility.
Published: 2017
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7. Do Bevacizumab solutions interact during an infusion through implantable venous access ports with silicone or polyurethane catheters ?

Author: Tokhadze, Nicolas, Chennell, Philip, Cueff, Régis, Sautou, Valérie, CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: interfaces, Content-container interactions, content–container interactions, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [CHIM.ANAL]Chemical Sciences/Analytical chemistry, implantable venous access port, catheter, bevacizumab, stability, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, [SDV.IB.BIO]Life Sciences [q-bio]/Bioengineering/Biomaterials, [SPI.MAT]Engineering Sciences [physics]/Materials
Abstract: International audience; This work aims to evaluate the possible impact of interactions between bevacizumab solutions and an implantable port equipped with a silicone or a polyurethane catheter after infusion through a complete infusion setup in simulated use conditions. Physicochemical and structural stability of bevacizumab solution was assessed by: visual examination, subvisible particles counting, dynamic light scattering, size exclusion chromatography and ion exchange chromatography. Mechanical properties of the catheters were evaluated by measuring Shore-A hardness, strain at break, strain at stress and Young's modulus. The physicochemical surface state of the catheters was assessed by FTIR-ATR spectroscopy, scanning electron microscopy (SEM) and by water contact angle measurement. Analysis of the bevacizumab solution did not highlight any signs of instability or loss of active substance. Mechanical properties of both materials remained unchanged after the infusion. During material analysis, a decrease of water contact angle observed after infusion and was more pronounced for polyurethane catheters than for silicone's, possibly due to bevacizumab adsorption or possible leachable extraction from the materials. Surface modifications were also noticed by SEM. This study did not highlight any modifications that could alter the quality of the bevacizumab infusion, nor of the infusion catheter in polyurethane or silicone, despite a modification of surface hydrophilicity. Even if after a single infusion implantable ports remained safe to use, they aim to be used for several infusion of various drugs during its lifetime, and further studies are needed to assess the impact of repeated infusions.
Published: 2019
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8. New SPE-LC-MS/MS method for the simultaneous determination in urine of 22 metabolites of DEHP and alternative plasticizers from PVC medical devices

Author: Nicolas Kerckhove, Valérie Sautou, Laurent Storme, Teuta Eljezi, Benoît Boeuf, Emmanuel Moreau, Lise Bernard, Morgane Masse, Bertrand Décaudin, Stéphanie Genay, Jérémy Pinguet, Damien Richard, Céline Lambert, Service de Pharmacologie Médicale [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Unité Biostatistique, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Service de Réanimation Pédiatrique et Péri-natalogie, CHU Estaing [Clermont-Ferrand], Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHRU Lille, Institut de Pharmacie, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Environnement périnatal et croissance - EA 4489 (EPS), CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], and CCSD, Accord Elsevier
Subjects: [SDV]Life Sciences [q-bio], 02 engineering and technology, Urine, Tandem mass spectrometry, 01 natural sciences, High-performance liquid chromatography, Urinary metabolite, Analytical Chemistry, chemistry.chemical_compound, Plasticizers, Tandem Mass Spectrometry, Intensive care, Diethylhexyl Phthalate, Biomonitoring, Humans, Polyvinyl Chloride, Chromatography, Alternative plasticizers, Chemistry, 010401 analytical chemistry, Solid Phase Extraction, Plasticizer, Phthalate, 021001 nanoscience & nanotechnology, 0104 chemical sciences, 3. Good health, [SDV] Life Sciences [q-bio], Human biomonitoring, Medical devices, SPE-LC-MS/MS, 0210 nano-technology, Glucuronide, Chromatography, Liquid
Abstract: International audience; DiEthylHexylPhthalate (DEHP) can leach out of plasticized PVC medical devices (MD) and may enter into contact with patients. This phthalate is known for its reprotoxic and endocrine disrupting effects. Its use in medical devices (MD) has been restricted and alternative plasticizers have been developed. Nevertheless, no published clinical studies exist concerning patient exposure to these alternative plasticizers during medical care. This is particularly worrisome when high-risk populations, such as newborns, are exposed to these new plasticizers in intensive care units. Our study aimed to develop a novel sensitive and selective method to simultaneously identify and quantify DEHP and 17 other plasticizer metabolites (free or glucuronide conjugates), which are specific biomarkers of DEHTP, TOTM, DINP, DINCH and DEHA exposure in human urine. This robust method uses turbulent-flow online extraction technology coupled to high performance liquid chromatography – tandem mass spectrometry. Special care was taken to address two major problems in plasticizer analysis: contamination and chromatographic separation of interfering analogue structures. The validation was assessed in synthetic urine and the linearity of response was demonstrated for all compounds (R2 > 0.99), with limits of quantification from 0.01 to 0.1 ng/ml. Accuracies ranged from 86% to 117% and inter- and intra-day precisions were
Published: 2019
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9. Nouvelle zone à atmosphère contrôlée iso5 en dépression à l’hôpital : évaluation de l’efficacité d’un protocole de bionettoyage à 6 mois

Author: Pelissier, M., Spaczek, M., Bonnet, C., Wasiak, M., Jouannet, M., Jego, A., Chennell, P., Sautou, V., Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Bonnefoy, Stéphanie, CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: [SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2019

10. Stability study of [99mTc]Tc-EDDA/HYNIC-TOC and [68Ga]Ga-DOTA-TOC in syringes

Author: CHAÏB, S., Hallouard, F., DARCISSAC, C., Chennell, P., Sautou, V., Fraysse, M., Bonnefoy, Stéphanie, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: [SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2019

11. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients

Author: Sébastien Perbet, Claire Biboulet, Jean-Marie Launay, Daniel Bourdeaux, Malha Sadoune, Alexandre Mebazaa, Valérie Sautou, Pascal Houzé, Matthieu Legrand, Alexandre Lenoire, Jean-Etienne Bazin, Benoit Plaud, Bruno Pereira, Jean-Michel Constantin, Génétique, Reproduction et Développement (GReD), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Médecine Intensive et Réanimation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Department of Anaesthesiology and Critical Care and Burn Unit, St-Louis Hospital, service de Biostatistiques, DRCI, Service de biochimie INSERM UMR-S942, Hôpital Lariboisière-APHP, Université Paris Diderot - Paris 7 (UPD7), Department of biochemistry, Lariboisière hospital, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Department of Pharmacology, St-Louis hospital, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: Adult, Male, Critical Care, Propanols, Sedation, Critical Illness, [SDV]Life Sciences [q-bio], Conscious Sedation, Critical Care and Intensive Care Medicine, Kidney Function Tests, Sevoflurane, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Pharmacokinetics, Lipocalin-2, Intensive care, medicine, Humans, Prospective Studies, Aged, Volume of distribution, Aged, 80 and over, Critically ill, business.industry, Distribution volume, 030208 emergency & critical care medicine, General Medicine, Acute Kidney Injury, Middle Aged, Respiration, Artificial, 3. Good health, Pharmacokinetic analysis, Anesthesiology and Pain Medicine, Metabolism, 030228 respiratory system, Anesthesia, Toxicity, Anesthetics, Inhalation, Female, medicine.symptom, business, Burns, medicine.drug, Half-Life
Abstract: International audience; BackgroundSevoflurane has anti-inflammatory proprieties and short lasting effects making it of interest for procedural sedation in critically ill patients. We evaluated the pharmacokinetics of sevoflurane and metabolites in severely ill burn patients and controls. The secondary objective was to assess potential kidney injury.MethodsProspective interventional study in a burn and a surgical intensive care unit; 24 mechanically ventilated critically ill patients (12 burns, 12 controls) were included. The sevoflurane was administered with an expired fraction target of 2% during short-term procedural sedation. Plasma concentrations of sevoflurane, hexafluoroisopropanolol (HFIP) and free fluoride ions were recorded at different times. Kinetic Pro (Wgroupe, France) was used for pharmacokinetic analysis. Kidney injury was assessed with neutrophil gelatinase-associated lipocalin (NGAL).ResultsThe mean total burn surface area was 36 ± 11%. The average plasma concentration of sevoflurane was 70.4 ± 37.5 mg·L−1 in burns and 57.2 ± 28.1 mg·L−1 in controls at the end of the procedure (P = 0.58). The volume of distribution was higher (46.8 ± 7.2 vs 22.2 ± 2.50 L, P < 0.001), and the drug half-life longer in burns (1.19 ± 0.28 h vs 0.65 ± 0.04 h, P < 0.0001). Free metabolite HFIP was higher in burns. Plasma fluoride was not different between burns and controls. NGAL did not rise after procedures.ConclusionWe observed an increased volume of distribution, slower elimination rate, and altered metabolism of sevoflurane in burn patients compared to controls. Repeated use for procedural sedation in burn patients needs further evaluation. No renal toxicity was detected.
Published: 2018
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12. Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices

Author: Lise Bernard, Teuta Eljezi, Hélène Clauson, Céline Lambert, Yassine Bouattour, Philip Chennell, Bruno Pereira, Valérie Sautou, ARMED Study Group, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), CHU Clermont-Ferrand, Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: Contact time, Polymers, [SDV]Life Sciences [q-bio], lcsh:Medicine, 02 engineering and technology, 010501 environmental sciences, MESH: Plasticizers, 01 natural sciences, Mass Spectrometry, Analytical Chemistry, chemistry.chemical_compound, Spectrum Analysis Techniques, Plasticizers, Infusion Procedure, Medicine and Health Sciences, lcsh:Science, Polyvinyl Chloride, Flow Rate, Multidisciplinary, Chemistry, Pharmaceutics, Organic Compounds, Physics, Chromatographic Techniques, Classical Mechanics, MESH: Equipment and Supplies, 021001 nanoscience & nanotechnology, Hospitals, 3. Good health, Volumetric flow rate, Intensive Care Units, Macromolecules, Equipment and Supplies, Physical Sciences, Chloroform, 0210 nano-technology, Research Article, Biotechnology, Drug Administration, Patients, Materials by Structure, Materials Science, MESH: Polyvinyl Chloride, Fluid Mechanics, Research and Analysis Methods, Continuum Mechanics, Gas Chromatography-Mass Spectrometry, Drug Therapy, Intensive care, Humans, 0105 earth and related environmental sciences, Inpatients, MESH: Humans, lcsh:R, Significant difference, Organic Chemistry, Plasticizer, Chemical Compounds, Biology and Life Sciences, Fluid Dynamics, Polymer Chemistry, Pvc matrix, Health Care, Polyvinyl chloride, Health Care Facilities, lcsh:Q, Medical Devices and Equipment, MESH: Intensive Care Units, Biomedical engineering
Abstract: International audience; Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device.
Published: 2018
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13. Traitement du diabète

Author: Bernard, L., Batisse, M., Tauveron, I., Sautou, V., Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Bonnefoy, Stéphanie, CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: [SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2018

14. Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers

Author: Yassine Bouattour, Valérie Sautou, Mireille Jouannet, Philip Chennell, Mathieu Wasiak, Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand]
Subjects: Drugs and Devices, medicine.drug_class, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Liquid chromatography, Ophthalmic solution, lcsh:Medicine, 02 engineering and technology, Pharmaceutical technology, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Chromatography detector, medicine, Acanthamoeba keratitis, Chromatography, Ethylene oxide, Biguanide, General Neuroscience, lcsh:R, Eye drop, General Medicine, Polyethylene, 021001 nanoscience & nanotechnology, medicine.disease, Polyhexamethylene biguanide, Ophthalmology, Low-density polyethylene, chemistry, 030221 ophthalmology & optometry, Particle size, Low density polyethylene eye droppers, 0210 nano-technology, General Agricultural and Biological Sciences, Drug stability
Abstract: Background Polyhexamethylene biguanide (PHMB) eye drops are a frequently used medication to treat Acanthamoeba keratitis. In the absence of marketed PHMB eye drops, pharmacy-compounding units are needed to prepare this much needed treatment, but the lack of validated PHMB stability data severely limits their conservation by imposing short expiration dates after preparation. In this study we aim to assess the physicochemical and microbiological stability of a 0.2 mg/mL PHMB eye drop formulation stored in two kinds of polyethylene bottles at two different temperatures. Methods A liquid chromatography coupled with diode array detector stability-indicating method was validated to quantify PHMB, using a cyanopropyl bonded phase (Agilent Zorbax Eclipse XDB-CN column 4.6 × 75 mm with particle size of 3.5 μm) and isocratic elution consisting of acetonitrile/deionized water (3/97 v/v) at a flow rate of 1.3 mL/min. PHMB eye drops stability was assessed for 90 days of storage at 5 and 25 °C in ethylene oxide sterilized low density polyethylene (EOS-LDPE) and gamma sterilized low density polyethylene (GS-LDPE) bottles. The following analyses were performed: visual inspection, PHMB quantification and breakdown products (BPs) screening, osmolality and pH measurements, and sterility assessment. PHMB quantification and BP screening was also performed on the drops emitted from the multidose eyedroppers to simulate in-use condition. Results The analytical method developed meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity, and is stability indicating. During 90 days of storage, no significant decrease of PHMB concentration was found compared to initial concentration in all stored PHMB eye drops. However, BP were found at day 30 and at day 90 of monitoring in both kind of bottles, stored at 5 and 25 °C, respectively. Although no significant variation of osmolality was found and sterility was maintained during 90 days of monitoring, a significant decrease of pH in GS-LDPE PHMB eye drops was noticed reaching 4 and 4.6 at 25 °C and 5 °C respectively, compared to initial pH of 6.16. Discussion Although no significant decrease in PHMB concentration was found during 90 days of monitoring in all conditions, the appearance of BPs and their unknown toxicities let us believe that 0.2 mg/mL PHMB solution should be conserved for no longer than 60 days in EOS-LDPE bottles at 25 °C.
Published: 2018
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15. Pharmacist's interview with type 2 diabetes: Development of a follow-up form

Author: Garcia Santos, P., Bernard, L., Bedhomme, S., Blum, S., Gravelin, M., Leonce, M.F., McLeod, M.L., Roche, B., Roche, M.C., Van Lander, A., Sautou, V., Vennat, B., AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Pharmacie de l’Allagnon, Ordre des pharmaciens, conseil régional d’Auvergne, Association des diabétiques du Puy-de-Dôme (AFD 63), Pharmacie des Potiers, Service d’Endocrinologie Diabète et Maladies Métaboliques [CHU Clermont-Ferrand], Pôle RHEUNNIRS [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Association pour la formation et la recherche en éducation thérapeutique (AFRET), Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], and Laboratoire de pharmacie galénique, Clermont université, université d’Auvergne
Subjects: MESH: Diabetes mellitus, Type 2 Patient's compliance, Pharmaceutical service, Patient's education, Community pharmacy service, [SDV]Life Sciences [q-bio], education
Abstract: International audience; ObjectivesType 2 diabetes is a major public health concern because of its prevalence, the severity of complications and the financial implications. Compliance and patient's autonomy in medications intake play key roles in the success of treatment. Pharmacists’ interviews ensure an optimized and individual follow-up. Type 2 diabetes is not one of the targeted diseases to perform pharmacists’ interviews on under Health Insurance. We thus judged useful to contribute to their development.MethodsWe applied a cross-disciplinary methodological process in order to define the specifications of the follow-up form useful to conduct the pharmacist's interview 1 by focusing on the identification of a non-compliance and its origins. A feasibility study was carried out in order to check its workability to the pharmacy practice.ResultsThe follow-up form, associated with a pharmacist practical guide, includes 3 parts: (1) General informations, (2) Survey establishing patient's knowledge, (3) Summary including a level of knowledge assessment grid. Outcomes provide a long but appropriate-felt duration, few difficulties to conduct the interview and a proven usefulness in 90% of all cases that make the follow-up form suitable to the pharmacy practice.ConclusionsThis tool could serve as a model for the pharmacist to conduct his future interviews for the type 2 diabetes patients, thus improving patient care, together with other health professionals.
Published: 2017
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16. Reply to ‘Response to 'The opinion of French pulmonologists and palliative care physicians on non-invasive ventilation during palliative sedation at end of life: a nationwide survey’’ ’

Author: GUASTELLA, Virginie, Greil, Annick, Lambert, C., Lautrette, Alexandre, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Pneumologie [CHU Clermont-Ferrand], Pôle RHEUNNIRS [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand, Unité de soins intensifs [Clermont Ferrand], and CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand]
Subjects: [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [SCCO.NEUR]Cognitive science/Neuroscience, End of life, [SCCO.PSYC]Cognitive science/Psychology, Palliative care, Non-invasive ventilation, Limitation of treatment Main text, [SDV.CAN]Life Sciences [q-bio]/Cancer, General Medicine, Palliative care End of life Non-invasive ventilation Limitation of treatment Main text, [SDV.ETH]Life Sciences [q-bio]/Ethics
Abstract: We read with interest the letter by Twycross and al on our article recently published in BMC Palliative Care. The authors suggest that the term palliative sedation has been used inappropriately and they consider that in the situation described the sedation was a procedural one rather than a continuous deep sedation. We strongly disagree with this point of view. In an end-of-life situation, the priorities are the patient’s comfort, pain and anxiety. This type of sedation does not have the characteristics of procedural sedation described in anaesthesia. The French Clayes Leonetti law makes it possible to clarify the intention of the sedation in end-of-life situations.
Published: 2023
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17. The effects of foot reflexology on symptoms of discomfort in palliative care: a feasibility study

Author: Marie Lavarelo Marcolin, Andréa Tarot, Véronique Lombardo, Bruno Pereira, Axelle Van Lander, Virginie Guastella, Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Neuro-Dol (Neuro-Dol), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)
Subjects: Massage therapy, Complementary and alternative medicine, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [SCCO.NEUR]Cognitive science/Neuroscience, [SCCO.PSYC]Cognitive science/Psychology, Foot reflexology Massage therapy Palliative care Sleep quality Anxiety Pain sleep disorders, Foot reflexology, Palliative care, [SDV.CAN]Life Sciences [q-bio]/Cancer, Sleep quality, Anxiety, Pain sleep disorders, [SDV.ETH]Life Sciences [q-bio]/Ethics
Abstract: Background In palliative care, the relief of discomfort is sought by an overall approach, combining prescribed medication and additional therapies, such as foot reflexology (FR). The main objective of this study was to assess the feasibility of FR in a population of inpatients in a palliative care unit (PCU).The precariousness of the patients led us to perform a feasibility study and not a cohort study from the outset. Its secondary objective was to assess the impact of an FR session on some symptoms of discomfort (anxiety, pain, troubled sleep, and psychological distress). Methods This is a feasibility study designed as a randomized controlled two-arm therapeutic trial. One arm tested FR, the other an active control, massage therapy (MT). The evaluators were blinded. Results FR was feasible for 14 patients out of the 15 included in the FR group (95% CI [68%; 100%]). These patients were in the palliative care phase of cancer, motor neuron disease, or terminal organ failure. Concerning the symptoms of discomfort, ESAS sleep quality score was on average 3.9 (± 2.5) before a session in the FR group. It was improved to an average of 3 (± 2.3) on the day after the session (effect-size = 0.38 [0.03; 0.73]). Conclusion This study confirms the feasibility of an FR session for patients hospitalized in a PCU. It resulted in a slight improvement in sleep quality. For other discomfort symptoms such as anxiety, pain and distress, FR yielded a non-significant improvement. Significant results would have needed a larger cohort.
Published: 2023
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18. Borréliose de Lyme

Author: Raffetin, Alice, Hansmann, Yves, Sauvat, Léo, Shramm, Frédéric, Tattevin, Pierre, Baux, Elisabeth, Patrat-Delon, Solène, Centre Hospitalier Intercommunal Villeneuve-Saint-Georges (CHIV), CHU Strasbourg, CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Pontchaillou [Rennes], ARN régulateurs bactériens et médecine (BRM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)
Subjects: Lyme Disease, [SDV]Life Sciences [q-bio], Borrelia Infections
Abstract: National audience; LYME BORRELIOSIS. Lyme borreliosis (LB) is the most common vector-borne disease in the Northern Hemisphere, caused by the bacterium Borrelia burgdorferi sensu lato, transmitted to humans by a bite of ticks Ixodes. Prevention is based on simple measures to evict ticks, and on their rapid extractionin the event of a bite. The diagnosis of LB is based on 3 arguments: an exposure to tick bites; clinically compatible symptoms (cutaneous, neurological or rheumatological manifestations, +/- functional symptoms such as fatigue or polyarthromyalgia), evolving in 3 stages (early localized or erythema migrans, early or late disseminated LB); a positive two-tier serological test (ELISA +/- Western-Blot). Serology can be negative for the first 6 weeks, without excluding the diagnosis. Since serology can remain positive for life, evolution is only evaluated clinically. LB treatment is mainly based on doxycycline for 14 to 28 days, depending on the clinical stage and manifestations, without demonstrated interest in prolonging it, even if symptoms persist. Nonetheless their management is crucial as often responsible for medical wandering. Attentive listening to the patient is essential. The prognosis of LB in the medium-term is favorable, especially if they beneficiate of an early management.; La borréliose de Lyme est la principale zoonose vectorielle en France. Elle est due à la bactérie Borrelia burgdorferi sensu lato, transmise lors d’une piqûre de tique infectée du genre Ixodes. Son diagnostic repose sur un trépied diagnostique, parfois incomplet. La prévention consiste en la protection contre les piqûres de tiques, et leur extraction rapide en cas de piqûre. Le traitement repose principalement sur la doxycycline.
Published: 2023

19. Management of Gastrointestinal Bleeding and Resumption of Oral Anticoagulant Therapy in Patients with Atrial Fibrillation: A Multidisciplinary Discussion

Author: Anne-Céline Martin, Robert Benamouzig, Isabelle Gouin-Thibault, Jeannot Schmidt, Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), École des Hautes Études en Santé Publique [EHESP] (EHESP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), and Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)
Subjects: [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Pharmacology (medical), [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, General Medicine, Cardiology and Cardiovascular Medicine
Abstract: International audience; Direct oral anticoagulants (DOACs) are recommended for the prevention of thromboembolism in patients with atrial fibrillation (AF), and are now preferred over vitamin K antagonists due to their beneficial efficacy and safety profile. However, all oral anticoagulants carry a risk of gastrointestinal (GI) bleeding. Although the risk is well documented and acute bleeding well codified, there is limited high-quality evidence and no guidelines to guide physicians on the optimal management of anticoagulation after a GI bleeding event. The aim of this review is to provide a multidisciplinary critical discussion of the optimal management of GI bleeding in patients with AF receiving oral anticoagulants to help physicians provide individualized treatment for each patient and optimize outcomes. It is important to perform endoscopy when a patient presents with bleeding manifestations or hemodynamic instability to determine the bleed location and severity of bleeding and then perform initial resuscitation. Administration of all anticoagulants and antiplatelets should be stopped and bleeding allowed to resolve with time; however, anticoagulant reversal should be considered for patients who have life-threatening bleeding or when the bleeding is not controlled by the initial resuscitation. Anticoagulation needs to be timely resumed considering that bleeding risk outweighs thrombotic risk when anticoagulation is resumed early after the bleeding event. To prevent further bleeding, physicians should prescribe anticoagulant therapy with the lowest risk of GI bleeding, avoid medications with GI toxicity, and consider the effect of concomitant medications on potentiating the bleeding risk.
Published: 2023
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20. Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products

Author: Oualikene-Gonin, Wahiba, Sautou, Valérie, Ezan, Eric, Bastos, Henri, Bellissant, Eric, Belgodère, Laëtitia, Maison, Patrick, Ankri, Joël, Agence nationale de sécurité du médicament et des produits de santé [Saint-Denis] (ANSM), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA), Université Paris-Saclay, CHU Pontchaillou [Rennes], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHI Créteil, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, and None
Subjects: excipients, innovative drugs, [SDV]Life Sciences [q-bio], public health, Public Health, Environmental and Occupational Health, regulatory science, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, medicines, nanomaterials, nanomedicines, medical devices
Abstract: International audience; Nanomaterials are present in a wide variety of health products, drugs and medical devices and their use is constantly increasing, varying in terms of diversity and quantity. The topic is vast because it covers nanodrugs, but also excipients (that includes varying proportions of NMs) and medical devices (with intended or not-intended (by-products of wear) nanoparticles). Although researchers in the field of nanomedicines in clinical research and industry push for clearer definitions and relevant regulations, the endeavor is challenging due to the enormous diversity of NMs in use and their specific properties. In addition, regulatory hurdles and discrepancies are often cited as obstacles to the clinical development of these innovative products. The scientific council of the Agence Nationale de Securite du Medicament et des produits de sante (ANSM) undertook a multidisciplinary analysis encompassing fundamental, environmental and societal dimensions with the aim of identifying topics of interest for regulatory assessment and surveillance. This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.
Published: 2023
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21. Identification of Responders to Balneotherapy among Adults over 60 Years of Age with Chronic Low Back Pain: A Pilot Study with Trajectory Model Analysis

Author: Benjamin Raud, Charlotte Lanhers, Cindy Crouzet, Bénédicte Eschalier, François Bougeard, Anna Goldstein, Bruno Pereira, Emmanuel Coudeyre, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), and Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA)
Subjects: Adult, Male, Balneology, Health, Toxicology and Mutagenesis, Public Health, Environmental and Occupational Health, balneotherapy, Pilot Projects, Middle Aged, Cohort Studies, aged, hydrotherapy, disability, [SDE]Environmental Sciences, chronic low back pain, Humans, Female, Prospective Studies, Low Back Pain
Abstract: Balneotherapy may be a relevant treatment for chronic low back pain (LBP) in individuals > 60 years old. This pilot study aimed to determine the effectiveness of balneotherapy for chronic LBP in people > 60 years old and to determine profiles of responders with trajectory model analysis. This was a pilot prospective open cohort study, with repeated measurements using validated questionnaires; participants were their own controls. The primary endpoint was the proportion of participants with a change in pain intensity between the start of treatment and 3 months after treatment assessed with a numeric scale (NS) from 0 to 100 mm, with an effect size (ES) > 0.5. The assessments involved questionnaires that were self-administered on days (D) 1 and 21 and at months 3 and 6. The secondary objective was to determine the profile of responders to balneotherapy. We included 78 patients (69.2% women), mean age 68.3 ± 5.3 years. The mean pain score on the NS was 48.8 ± 19.9 at D1 and 39.1 ± 20.5 at 3 months (p < 0.001). The ES was 0.47 [95% confidence interval [CI] 0.25 to 0.69] for the whole sample; 36% (28/78) had an ES > 0.5; 23% (18/78) had a moderate ES (0 to 0.5); and 41% (32/78) had an ES of zero (14/78) or < 0 (18/78), corresponding to increased pain intensity. The pain trajectory model showed that the change in pain between D1 and D21 for trajectory A (larger reduction in pain intensity) was −50% [95% CI −60 to −27], and for trajectory B (smaller reduction in pain intensity), it was −13% [−33 to 0] (p < 0.001). Between Day 1 and month 3, the change for trajectory A was −33% [−54; 0] and for trajectory B was −13% [−40 to 0] (p = 0.14). Finally, between D1 and month 6, the change for trajectory A was −50% [−60 to 0] and for trajectory B was −6% [−33 to 17] (p = 0.007). The patients in trajectory A reported performing more physical activity than those in trajectory B (p = 0.04). They were also less disabled, with a mean Oswestry Disability Index of 40.4 versus 45.7 for those in trajectory A and B, respectively, (p = 0.03) and had a higher total Arthritis Self-Efficacy Scale score. This real-life study of the effectiveness of balneotherapy on chronic LBP identified distinct pain trajectories and predictive variables for responders. These criteria could be used in decision-making regarding the prescription of balneotherapy, to ensure personalized management of chronic LBP.
Published: 2022
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22. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study

Author: Righini, Marc, Robert‐Ebadi, Helia, Cremonesi, Alessio, Elias, Antoine, Sanchez, Olivier, Le Moigne, Emmanuelle, Schmidt, Jeannot, Le Gall, Catherine, Cornuz, Jacques, Aujesky, Drahomir, Roy, Pierre‐Marie, Chauleur, Céline, Rouyer, Frédéric, Poletti, Pierre‐Alexandre, Moreau, Caroline, Le Gal, Grégoire, CT-PE-Pregnancy group, Faculté de médecine [Genève], Geneva University Hospitals and Geneva University, University Children’s Hospital Zurich, Universität Zürich [Zürich] = University of Zurich (UZH), Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis (IThEM - U1140), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), F-Crin Innovte [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Centre hospitalier Argenteuil (CH Argenteuil), Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Bern University Hospital [Berne] (Inselspital), University of Bern, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Biologie Intégrative du Tissu Osseux (LBTO), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Canadian Institutes of Health Research [Ottawa, Canada] (CIHR), Schweizerischer Nationalfonds zur Forderung der Wissenschaftlichen Forschung [FNS32003B-120760], University of Zurich, Innovations thérapeutiques en hémostase (IThEM - U1140), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Biologie intégrative du tissu osseux, and Jonchère, Laurent
Subjects: diagnosis, [SDV]Life Sciences [q-bio], Infant, Newborn, Female, Humans, Pregnancy, Pulmonary Embolism/epidemiology, Prospective Studies, Angiography/methods, Outcome Assessment, Health Care, Hypothyroidism/epidemiology, Thyrotropin, Guthrie test, hypothyroidism, pregnancy, pulmonary embolism, Angiography, 610 Medicine & health, Hematology, [SDV] Life Sciences [q-bio], Hypothyroidism, 10036 Medical Clinic, Pulmonary Embolism
Abstract: International audience; Background Neonatal hypothyroidism is often raised as a potential concern for the use of computed tomography pulmonary angiography (CTPA) in pregnant women with suspected pulmonary embolism (PE). Objectives To assess the incidence of neonatal hypothyroidism among newborns from mothers exposed to CTPA. Patients/Methods Pregnant women with clinically suspected PE were included in a multicenter, multinational prospective diagnostic management outcome study, based on pretest clinical probability assessment, high-sensitivity D-dimer testing, bilateral lower limb venous compression ultrasonography, and CTPA. Results of Guthrie tests were systematically collected for newborns of all women who required CTPA as part of the diagnostic strategy. A thyroid-stimulating hormone (TSH) level above 15 U/ml was used to define hypothyroidism. Results Out of the 166 women included in the Swiss participating centers, 149 underwent a CTPA including 14 with twin pregnancies. Eight women suffered a pregnancy loss and results of the Guthrie test could not be retrieved for four newborns. All TSH levels were reported as being below 15 U/ml. The incidence of neonatal hypothyroidism was 0/151 (0.0%, 95% confidence interval: 0.0%-2.5%). Conclusions We did not identify any cases of neonatal hypothyroidism in our cohort of 149 pregnant women investigated for suspected PE using a CTPA. Along with previous literature data, this provides further reassuring data regarding the use of CTPA in this indication.
Published: 2022
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23. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study

Author: Houillier, Caroline, Dureau, S, Taillandier, Luc, Houot, Roch, Chinot, O., Molucon-Chabrot, Cécile, Schmitt, Anna, Gressin, Rémy, Choquet, Sylvain, Damaj, Gandhi, Peyrade, Frédéric, Abraham, Julie, Delwail, V, Gyan, Emmanuel, Sanhes, Laurence, Cornillon, Jerome, Garidi, Reda, Delmer, Alain, Al Jijakli, Ahmad, Morel, Pierre, Waultier, Agathe, Paillassa, Jérôme, Chauchet, A, Gastinne, Thomas, Laadhari, Mouna, Plissonnier, Anne-Sophie, Feuvret, Loïc, Cassoux, Nathalie, Touitou, Valerie, Ricard, Jean-Damien, Hoang-Xuan, Khe, Soussain, Carole, Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Institut Curie [Paris], Centre Hospitalier Universitaire de Nancy (CHU Nancy), Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Hôpital de la Timone [CHU - APHM] (TIMONE), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Institut Bergonié [Bordeaux], UNICANCER, Centre Hospitalier Universitaire [Grenoble] (CHU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Amiens-Picardie, Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), CHU Limoges, CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Saint Jean de Perpignan, Institut de Cancérologie Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Hospitalier de Lens, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital d'instruction des Armées Percy, Service de Santé des Armées, Immunité et cancer (U932), and Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Cancer Research, Adolescent, Lymphoma, [SDV]Life Sciences [q-bio], Hematopoietic Stem Cell Transplantation, Middle Aged, Transplantation, Autologous, Combined Modality Therapy, Central Nervous System Neoplasms, Young Adult, Oncology, Antineoplastic Combined Chemotherapy Protocols, Humans, Neoplasm Recurrence, Local
Abstract: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We previously reported the results of a randomized phase II study in patients with newly diagnosed primary CNS lymphoma (age 18-60 years). Patients were treated with high-dose methotrexate-based induction chemotherapy followed by whole-brain radiotherapy (WBRT) or high-dose chemotherapy (thiotepa-busulfan-cyclophosphamide) with autologous stem-cell transplantation (ASCT). The median follow-up was 33 months. In this report, we provide long-term data (median follow-up, 8 years) regarding the outcomes and toxicities. Fifty-three and 44 patients received induction chemotherapy followed by WBRT or ASCT, respectively. Their 8-year event-free survival from random assignment was 67% and 39% in the ASCT and WBRT arms, respectively ( P = .03), with a significantly lower risk of relapse after ASCT (hazard ratio, 0.13; P < .001). One third of patients who relapsed after WBRT were alive after salvage treatment. Five and four patients died of ASCT and WBRT-related toxicities, respectively. The 8-year overall survival was 69% and 65% in the ASCT and WBRT arms, respectively (not significant). Balance (52% v 10%, P ≤ 0.001) and neurocognition (64% v 13%, P < .001) significantly deteriorated after WBRT compared with ASCT during the follow-up. This study shows that 40 Gy WBRT should be avoided in first-line treatment because of its neurotoxicity and suboptimal efficacy in reducing relapses while ASCT appears to be highly efficient in preventing relapses.
Published: 2022
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24. Reduced-dose WBRT as consolidation treatment for patients with primary CNS lymphoma: an LOC network study

Author: Paul Lesueur, Gandhi Damaj, Khê Hoang-Xuan, Virginie Roland, Anna Schmitt, Olivier Chinot, Michel Fabbro, Philippe Agapé, Cécile Moluçon-Chabrot, Safia Chebrek, Agusti Alentorn, Loic Feuvret, Daniel Delgadillo, Dinu Stefan, Sylvain Choquet, Lucia Nichelli, Karima Mokhtari, Bertrand Mathon, Sylvain Dureau, Carole Soussain, Caroline Houillier, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Imagerie et Stratégies Thérapeutiques pour les Cancers et Tissus cérébraux (ISTCT), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Amiens-Picardie, Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Centre Hospitalier Saint Jean de Perpignan, Institut Bergonié [Bordeaux], UNICANCER, Institut de neurophysiopathologie (INP), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Hôpital de la Timone [CHU - APHM] (TIMONE), Institut du Cancer de Montpellier (ICM), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Centre Guillaume le Conquérant, Centre de radiothérapie Guillaume le Conquérant (CGLC), Institut Curie [Paris], Université Paris sciences et lettres (PSL), Immunité et cancer (U932), Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de neurologie 2 [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de Neurochirurgie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Département Médico-Universitaire Neurosciences [Sorbonne Université] (DMU Neurosciences), CHU Charles Foix [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], and Brunaud, Carole
Subjects: [SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, Lymphoma, Non-Hodgkin, Hematopoietic Stem Cell Transplantation, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, [SDV.IB.MN]Life Sciences [q-bio]/Bioengineering/Nuclear medicine, Hematology, Middle Aged, Transplantation, Autologous, [SDV.IB.MN] Life Sciences [q-bio]/Bioengineering/Nuclear medicine, Central Nervous System Neoplasms, [SDV.CAN] Life Sciences [q-bio]/Cancer, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Antineoplastic Combined Chemotherapy Protocols, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Humans, Prospective Studies, Neoplasm Recurrence, Local, Retrospective Studies
Abstract: The optimal consolidation strategy for primary central nervous system lymphoma (PCNSL) remains controversial. Preventing radio-induced neurotoxicity of consolidation treatment through reduced-dose whole-brain radiotherapy (rdWBRT) at a dose of 23.4 Gy is an interesting alternative to conventional WBRT in patients aged
Published: 2022
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25. Quantitative impact of pre-analytical process on plasma uracil when testing for dihydropyrimidine dehydrogenase deficiency

Author: Maillard, Maud, Launay, Manon, Royer, Bernard, Guitton, Jérôme, Gautier-Veyret, Elodie, Broutin, Sophie, Tron, Camille, Le Louedec, Félicien, Ciccolini, Joseph, Richard, Damien, Alarcan, Hugo, Haufroid, Vincent, Tafzi, Naïma, Schmitt, Antonin, Etienne-Grimaldi, Marie-Christine, Narjoz, Céline, Thomas, Fabienne, Groupe de Pharmacologie Clinique Oncologique (GPCO), Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Centre Hospitalier Universitaire [Grenoble] (CHU), Institut Gustave Roussy (IGR), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université Catholique de Louvain = Catholic University of Louvain (UCL), Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation (IPPRITT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Agro Dijon, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, UCL - (SLuc) Service de biochimie médicale, Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes
Subjects: Pharmacology, Dihydropyrimidine Dehydrogenase Deficiency, [SDV]Life Sciences [q-bio], dihydropyrimidine dehydrogenase, [SDV.CAN]Life Sciences [q-bio]/Cancer, Plasma, Phenotype, intra-individual variability, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Humans, Pharmacology (medical), uracil, Fluorouracil, pre-analytical practices, [SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biochemistry [q-bio.BM], dihydrouracil, Dihydrouracil Dehydrogenase (NADP)
Abstract: International audience; AIMS: Determining dihydropyrimidine dehydrogenase (DPD) activity by measuring patient’s uracil (U) plasma concentration is mandatory before fluoropyrimidines (FP) administration in France. In this study, we aimed to refine the pre-analytical recommendations for determining U and dihydrouracil (UH(2) ) concentrations, since they are essential in reliable DPD deficiency testing.METHODS: U and UH(2) concentrations were collected from 14 hospital laboratories. Stability in whole blood and plasma after centrifugation, the type of anticoagulant and long-term plasma storage were evaluated. The variation induced by time and temperature was calculated and compared to an acceptability range of ± 20%. Inter-occasion variability (IOV) of U and UH(2) was assessed in 573 patients double sampled for DPD-deficiency testing. RESULTS: Storage of blood samples before centrifugation at room temperature (RT) should not exceed 1 h, whereas cold (+4°C) storage maintains U stable after 5 hours. For patients correctly double sampled, IOV of U reached 22.4% for U (SD = 17.9%, range = [0-99%]). Notably, 17% of them were assigned with a different phenotype (normal or DPD deficient) based on the analysis of their two samples. For those having at least one non-compliant sample, this percentage increased up to 33.8%. The moment of blood collection did not affect the DPD phenotyping result.CONCLUSION: Caution should be taken when interpreting U concentrations if the time before centrifugation exceeds 1 h at RT, since it rises significantly afterwards. Not respecting the pre-analytical conditions for DPD phenotyping increases the risk of DPD status misclassification.
Published: 2022
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26. Health management of patients with COVID-19: is there a room for hydrotherapeutic approaches?

Author: Mélina Bailly, Bertrand Evrard, Emmanuel Coudeyre, Corinne Rochette, Laurent Meriade, Christelle Blavignac, Anne-Cécile Fournier, Yves-Jean Bignon, Frédéric Dutheil, Martine Duclos, David Thivel, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne (UCA)-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Service d'Immunologie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), chaire Santé et Territoires (S&T), Clermont Recherche Management (CleRMa), École Supérieure de Commerce (ESC) - Clermont-Ferrand (ESC Clermont-Ferrand)-Université Clermont Auvergne (UCA), Centre Imagerie Cellulaire Santé (CICS), Université d'Auvergne - Clermont-Ferrand I (UdA)-Clermont Université, Département d'Oncogénétique, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER-UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), CHU Clermont-Ferrand, Service Médecine du Sport et Explorations Fonctionnelles [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Centre de Recherche en Nutrition Humaine Auvergne [CHU Clermont-Ferrand] (CRNH A), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], Service Santé Travail Environnement [CHU Clermont-Ferrand], Institut d'Administration des Entreprises - Clermont-Auvergne (IAE - UCA), and Université Clermont Auvergne (UCA)
Subjects: Review Paper, Atmospheric Science, Alternative medicine, Ecology, SARS-CoV-2, Health, Toxicology and Mutagenesis, COVID-19, [SHS]Humanities and Social Sciences, Thermal waters, Humans, [SHS.GESTION]Humanities and Social Sciences/Business administration, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Mineral Waters, Sleep, Delivery of Health Care, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Hydrotherapy
Abstract: International audience; With highly variable types of coronavirus disease 2019 (COVID-19) symptoms in both severity and duration, there is today an important need for early, individualized, and multidisciplinary strategies of rehabilitation. Some patients present persistent affections of the respiratory function, digestive system, cardiovascular function, locomotor system, mental health, sleep, nervous system, immune system, taste, smell, metabolism, inflammation, and skin. In this context, we highlight here that hydrothermal centers should be considered today as medically and economically relevant alternatives to face the urgent need for interventions among COVID-19 patients. We raise the potential benefits of hydrotherapy programs already existing which combine alternative medicine with respiratory care, physical activity, nutritional advice, psychological support, and physiotherapy, in relaxing environments and under medical supervision. Beyond the virtues of thermal waters, many studies reported medical benefits of natural mineral waters through compressing, buoyancy, resistance, temperature changes, hydrostatic pressure, inhalations, or drinking. Thermal institutions might offer individualized follow-up helping to unclog hospitals while ensuring the continuity of health care for the different clinical manifestations of COVID-19 in both post-acute and chronic COVID-19 patients. Our present review underlines the need to further explore the medical effectiveness, clinical and territorial feasibility, and medico-economic impacts of the implementation of post-COVID-19 patient management in hydrotherapeutic establishments.
Published: 2022
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27. Development and Stability of a New Formulation of Pentobarbital Suppositories for Paediatric Procedural Sedation

Author: Matthieu Lebrat, Yassine Bouattour, Coralie Gaudet, Mouloud Yessaad, Mireille Jouannet, Mathieu Wasiak, Imen Dhifallah, Eric Beyssac, Ghislain Garrait, Philip Chennell, Valérie Sautou, Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Microbiologie Environnement Digestif Santé (MEDIS), and Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA)
Subjects: sedation, [SDV]Life Sciences [q-bio], Pharmaceutical Science, formulation, suppositories, stability, pentobarbital
Abstract: Pentobarbital is a drug of choice to limit motion in children during paediatric procedural sedations (PPSs). However, despite the rectal route being preferred for infants and children, no pentobarbital suppositories are marketed, and therefore they must be prepared by compounding pharmacies. In this study, two suppository formulations of 30, 40, 50, and 60 mg of pentobarbital sodium were developed using hard-fat Witepsol® W25 either alone (formulation F1) or with oleic acid (formulation F2). The two formulations were subjected to the following tests described in the European Pharmacopoeia: uniformity of dosage units, softening time, resistance to rupture, and disintegration time. The stability of both formulations was also investigated for 41 weeks of storage at 5 ± 3 °C using a stability-indicating liquid chromatography method to quantify pentobarbital sodium and research breakdown product (BP). Although both formulae were compliant to uniformity of dosage, the results were in favour of a faster disintegration of F2 compared to F1 (−63%). On the other hand, F1 was found to be stable after 41 weeks of storage unlike F2 for which several new peaks were detected during the chromatographic analysis, suggesting a shorter stability of only 28 weeks. Both formulae still need to be clinically investigated to confirm their safety and efficiency for PPS.
Published: 2023
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28. Creatine supplementation and VO 2 max: a systematic review and meta-analysis

Author: Marek Zak, Ukadike C. Ugbolue, Jean-Baptiste Bouillon-Minois, Damien Gras, Frédéric Dutheil, Charlotte Lanhers, Reza Bagheri, Emmanuel Coudeyre, Bruno Pereira, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, University of Isfahan, University of the West of Scotland (UWS), Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, The Institute of Health Sciences, Collegium Medicum, The Jan Kochanowski University, Laboratoire de Psychologie Sociale et Cognitive (LAPSCO), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA), Pôle Urgences [CHU Clermont-Ferrand], Service Santé Travail Environnement [CHU Clermont-Ferrand], and WittyFit
Subjects: medicine.medical_specialty, Population, 030204 cardiovascular system & hematology, Creatine, Placebo, Placebo group, Industrial and Manufacturing Engineering, law.invention, ventilatory threshold, 03 medical and health sciences, chemistry.chemical_compound, Dietary supplement, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Medicine, education, endurance, education.field_of_study, cardiorespiratory fitness, VO2peak, business.industry, Cardiorespiratory fitness, 030229 sport sciences, General Medicine, 3. Good health, chemistry, Meta-analysis, Ventilatory threshold, business, human activities, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Food Science
Abstract: Although creatine supplementation is well-known to increase exercise performance in acute high-intensity exercises, its role in aerobic performance based on VO2max is more controversial. Thus, we performed a systematic review and meta-analysis on the effects of creatine supplementation on VO2max. PubMed, Cochrane, Embase, and ScienceDirect were searched for randomized controlled trials (RCTs) reporting VO2max in creatine supplementation and placebo groups before and after supplementation. We computed a random-effects meta-analysis on VO2max at baseline, within groups following supplementation, on changes on VO2max between groups, and after supplementation between groups. Sensitivity analyses and meta-regression were conducted. We included 19 RCTs for a total of 424 individuals (mean age 30 years old, 82% men). VO2max did not differ at baseline between groups (creatine and placebo). Participants in both groups were engaged in exercise interventions in most studies (80%). Using changes in VO2max, VO2max increased in both groups but increased less after creatine supplementation than placebo (effect size [ES] = -0.32, 95%CI = -0.51 to -0.12, p = 0.002). Comparisons after creatine supplementation confirmed a lower VO2max in the creatine group compared to the placebo group (ES= -0.20, 95%CI = -0.39 to -0.001, p = 0.049). Meta-analysis after exclusion from meta-funnel resulted in similar outcomes in a subgroup of young and healthy participants. Meta-regressions on characteristics of supplementation, physical training, or sociodemographic were not statistically significant. Creatine supplementation has a negative effect on VO2max, regardless of the characteristics of training, supplementation, or population characteristics.Supplemental data for this article is available online at https://doi.org/10.1080/10408398.2021.2008864 .
Published: 2021
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29. Radiotherapy (WBRT) or Autologous Stem-Cell Transplantation (ASCT) for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Long-Term Results of the Intergroup Anocef-Goelams Randomized Phase II Precis Study

Author: Pierre Morel, Vincent Delwail, Damien Ricard, Roch Houot, Gandhi Damaj, Alain Delmer, Anna Schmitt, Cécile Moluçon-Chabrot, Valérie Touitou, Anne-Sophie Plissonnier, Nathalie Cassoux, Adrien Chauchet, Frederic Peyrade, Carole Soussain, Reda Garidi, Mouna Laadhari, Laurence Sanhes, Khê Hoang-Xuan, Emmanuel Gyan, Luc Taillandier, Choquet Sylvain, Loïc Feuvret, Jérôme Cornillon, Sylvain Dureau, Marie-Laure Tanguy, Marie-Pierre Moles, Julie Abraham, Thomas Gastinne, Ahmad Al Jijakli, Olivier Chinot, Remy Gressin, Caroline Houillier, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Pontchaillou [Rennes], Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de neurophysiopathologie (INP), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service d’Oncologie Médicale [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Institut Bergonié [Bordeaux], UNICANCER, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratoire d'Hématologie Biologique [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...] (GICC EA 7501), Université de Tours (UT), ERL 7001 LNOx (Leukemic Niche & redOx metabolism / Niche leucémique et métabolisme redOx) (LNOx), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre National de la Recherche Scientifique (CNRS)-Microenvironnement des niches tumorales (CNRS GDR 3697 Micronit ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...] (GICC EA 7501), Université de Tours (UT)-Université de Tours (UT), Institut Curie [Paris], Université Paris sciences et lettres (PSL), Centre Hospitalier Saint Jean de Perpignan, Institut de Cancérologie Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Hôpital Saint-Quentin, Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Immunité et cancer (U932), and Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Oncology, medicine.medical_specialty, business.industry, medicine.medical_treatment, Immunology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Cell Biology, Hematology, Long term results, Biochemistry, Radiation therapy, Autologous stem-cell transplantation, Primary CNS Lymphoma, Internal medicine, Medicine, In patient, business
Abstract: Introduction: We previously reported the results of the PRECIS trial with a median follow-up of 33 months. Both whole brain radiotherapy (WBRT) and autologous stem cell transplantation (ACST) were effective according to the predetermined threshold. However, more relapses occurred in the WBRT arm. The 2-year event-free survival (EFS) from consolidation (relapse or death defined as event) were 69% (95% CI, 57% to 83%) and 87% (95% CI, 77% to 98%) after WBRT and ASCT, respectively (p = 0.03). Overall survival (OS) was similar in both arms. Cognitive impairment was observed after WBRT, whereas cognitive functions were preserved or improved after ASCT. A longer follow-up is required to better assess the impact of the treatment on relapse, survival and late complications. We report here the results of the PRECIS trial with a median follow-up of 98.3 months [min= 4,1 - max= 131.1], focusing on the per protocol population from time of consolidation. Methods: Immunocompetent patients (18 to 60 years of age) with untreated primary CNS lymphoma (PCNSL) were randomly assigned upfront to receive WBRT (Arm A) or ASCT (Arm B) as consolidation treatment after an induction chemotherapy consisting of two cycles of R-MBVP (rituximab, methotrexate, VP16, BCNU, prednisone) followed by two cycles of R-AraC (rituximab, cytarabine). Intensive chemotherapy consisted of thiotepa (250 mg/m2/d D9; D8; D7), busulfan (8 mg/kg D6 through D4), and cyclophosphamide (60 mg/kg/d D3; D2). WBRT delivered 40 Gy (2 Gy/ fraction). Cognitive functions were prospectively assessed until disease progression and focused on global cognitive function, episodic verbal memory, attention and mental flexibility, and psychoaffective status. Results: 140 patients were randomized (Arm A: N = 70; Arm B: N = 70). Fifty-three and 44 patients completed WBRT and ASCT respectively (per protocol population), including 3 and 5 patients who were in progressive disease (PD) at time of WBRT and ASCT, respectively. 8-y EFS from time of consolidation in the per protocol population was 75.9% [63.3-91.0] and 39.9% [26.8-59.3] after ASCT and WBRT, respectively (p = 0.007) (fig 1a). The risk of relapse was significantly decreased after ASCT compared to WBRT (8-y relapse-free interval 94.1% [86.4-100] vs 47.6% [34.2-66.3], (p Causes of deaths after WBRT (n = 17) were PD (n = 12), neurotoxicity (n = 3), second-line ASCT (n = 2). After ASCT, causes of deaths (n = 14) were treatment-related death (n = 5, including 2 occurring > 100 days post-ASCT, and 2 in patients in PD before ASCT), PD (n = 4), neurotoxicity following salvage WBRT (n = 1), second solid cancer (n = 3) and undetermined in one patient. In multivariate analysis, ECOG, disease status at the end of induction, and protein level in the CSF at diagnosis were independent prognostic factors for OS. Disease status at the end of induction and intraocular involvement at diagnosis were independent prognostic factors for EFS. Cognitive decline that could be fatal was only observed in patients who received WBRT. Imaging analysis of post consolidation leukoencephalopathy is ongoing. Conclusions: Consolidation with ASCT after HD-MTX based induction chemotherapy resulted in an excellent disease control but with a higher treatment-related mortality than WBRT. Severe Cognitive decline and late treatment-induced neurotoxic deaths were observed after WBRT. Intensity of the thiotepa-busulfan-cyclophosphamide regimen used before ASCT should be slightly reduced to improve the benefit/risk ratio of ASCT in first-line treatment of young patients with PCNSL. Figure 1 Figure 1. Disclosures Sylvain: Sanofi, Celegene, Roche, Abbvie, Sandoz, Janssen, Takeda: Consultancy. Damaj: takeda: Consultancy, Honoraria; roche: Consultancy, Honoraria. Sanhes: Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.
Published: 2021
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30. Colorectal Cancer Survivors Suffering From Sensory Chemotherapy-Induced Peripheral Neuropathy Are Not a Homogenous Group: Secondary Analysis of Patients’ Profiles With Oxaliplatin-Induced Peripheral Neuropathy

Author: Nicolas Kerckhove, Marie Selvy, Céline Lambert, Coralie Gonneau, Gabrielle Feydel, Caroline Pétorin, Agnès Vimal-Baguet, Sergey Melnikov, Sharif Kullab, Mohamed Hebbar, Olivier Bouché, Florian Slimano, Vincent Bourgeois, Valérie Lebrun-Ly, Frédéric Thuillier, Thibault Mazard, David Tavan, Kheir Eddine Benmammar, Brigitte Monange, Mohamed Ramdani, Denis Péré-Vergé, Floriane Huet-Penz, Ahmed Bedjaoui, Florent Genty, Cécile Leyronnas, Jérôme Busserolles, Sophie Trévis, Vincent Pinon, Denis Pezet, David Balayssac, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), CHU Clermont-Ferrand, Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Institut Analgesia, Service de Chirurgie Digestive et Hépatobiliaire [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Hospitalier Saint-Flour (CH Saint-Flour), Centre hospitalier Moulins-Yzeure [Moulins] (CH Moulins-Yzeure), Service d'oncologie médicale (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Universitaire de Reims (CHU Reims), Biospectroscopie Translationnelle - EA 7506 (BIOSPECT), Université de Reims Champagne-Ardenne (URCA), Centre Hospitalier Boulogne-sur-mer, Service d'Oncologie médicale [CHU Limoges], CHU Limoges, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Clinique de l'Infirmerie Protestante de Lyon (CIPL), Centre Hospitalier Emile Roux [Le Puy-en-Velay] (CH Le Puy-en-Velay), Centre Hospitalier de Béziers, Centre hospitalier Saint Joseph - Saint Luc [Lyon], Centre Hospitalier Alpes-Léman - CHAL, Centre Hospitalier Intercommunal Les Hôpitaux du Léman (CHI Les Hôpitaux du Léman), Centre Hospitalier de Vichy (CH Vichy), Groupe Hospitalier Mutualiste de Grenoble (GHM), Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
Subjects: Oncology, medicine.medical_specialty, oxaliplatin, Colorectal cancer, colorectal cancer, RM1-950, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, Medicine, Pharmacology (medical), 030212 general & internal medicine, Original Research, Pharmacology, neuropathic pain, business.industry, Cancer, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, 3. Good health, Oxaliplatin, Peripheral neuropathy, Chemotherapy-induced peripheral neuropathy, 030220 oncology & carcinogenesis, Cohort, Anxiety, Therapeutics. Pharmacology, medicine.symptom, business, medicine.drug, chemotherapy-induced peripheral neuropathy, cluster analysis
Abstract: International audience; Oxaliplatin, a pivotal drug in the management of colorectal cancer, causes chemotherapy-induced peripheral neuropathy (CIPN) in a third of cancer survivors. Based on a previous cross-sectional study assessing oxaliplatin-related sensory CIPN in colorectal cancer survivors, a secondary analysis was designed to explore the possibility that different clusters of patients may co-exist among a cohort of patients with oxaliplatin-related CIPN. Other objectives were to characterize these clusters considering CIPN severity, anxiety, depression, health-related quality of life (HRQOL), patients’ characteristics and oxaliplatin treatments. Among the 96 patients analyzed, three clusters were identified (cluster 1: 52, cluster 2: 34, and cluster 3: 10 patients). Clusters were significantly different according to CIPN severity and the proportion of neuropathic pain (cluster 1: low, cluster 2: intermediate, and cluster 3: high). Anxiety, depressive disorders and HRQOL alteration were lower in cluster 1 in comparison to clusters 2 and 3, but not different between clusters 2 and 3. This study underlines that patients with CIPN are not a homogenous group, and that CIPN severity is associated with psychological distress and a decline of HRQOL. Further studies are needed to explore the relation between clusters and CIPN management.
Published: 2021
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31. Comparison of psychometric properties between the Labin, a new electronic dynamometer, and the Jamar: Preliminary results in healthy subjects

Author: Isabelle Conforto, B. Pereira, Emmanuel Coudeyre, Chafik Samir, Anna Goldstein, F. Chausse, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Laboratoire d'Informatique, de Modélisation et d'Optimisation des Systèmes (LIMOS), Ecole Nationale Supérieure des Mines de St Etienne-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Institut Pascal (IP), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-SIGMA Clermont (SIGMA Clermont)-Centre National de la Recherche Scientifique (CNRS), Universities Space Research Association (USRA), Biostatistiques, Inferential, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), and Ecole Nationale Supérieure des Mines de St Etienne (ENSM ST-ETIENNE)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, Male, medicine.medical_specialty, Psychometrics, Handgrip, Intraclass correlation, [SDV]Life Sciences [q-bio], Muscle Strength Dynamometer, 030230 surgery, [INFO.INFO-AI]Computer Science [cs]/Artificial Intelligence [cs.AI], Dynamometer, 03 medical and health sciences, Grip strength, 0302 clinical medicine, medicine, Humans, Orthopedics and Sports Medicine, 030222 orthopedics, Cross-Over Studies, Hand Strength, Kilogram, Healthy population, Rehabilitation, Healthy subjects, Reproducibility of Results, Healthy Volunteers, [STAT]Statistics [stat], Physical therapy, Female, Surgery, Strength, Grip force, Psychology
Abstract: International audience; Many instruments exist for measuring grip strength. The Jamar hydraulic hand dynamometer is currently the gold standard. The Labin is a prototype electronic dynamometer that can also measure maximum grip strength. The main objective was to compare the Labin dynamometer with the gold standard instrument, the Jamar, in a healthy population, and secondarily to compare discomfort during use. A single-center exploratory study was conducted. The subjects enrolled had to be aged between 20 and 60, be volunteers and give consent. The required number of subjects was 30. The subjects were positioned according to American Society of Hand Therapists recommendations. Maximum grip force was measured in kilograms using the mean of three successive trials. The first dynamometer used was chosen randomly. The handle's discomfort during use was rated on a simple verbal scale from 0 to 10. Thirty-four subjects were included. The concordance coefficient for peak torque between the Labin and Jamar dynamometers was 0.90 for the dominant hand and 0.83 for the non-dominant hand. The intraclass correlation coefficient for peak torque with the Labin was 0.81 [0.69; 0.89] for the dominant hand and 0.86 [0.76; 0.92] for the non-dominant hand. In our study, we have shown that the Labin prototype has acceptable validity and reproducibility. The Labin will need to be tested in pathological conditions next.
Published: 2019
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32. The opinion of French pulmonologists and palliative care physicians on non-invasive ventilation during palliative sedation at end of life: a nationwide survey

Author: A. Greil, G. Piwko, Virginie Guastella, C. Lambert, A. Lautrette, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Pneumologie [CHU Clermont-Ferrand], Pôle RHEUNNIRS [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand, Unité de soins intensifs [Clermont Ferrand], and CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand]
Subjects: medicine.medical_specialty, Palliative care, Pain medicine, Palliative care End of life Non-invasive ventilation Limitation of treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, Nationwide survey, Palliative sedation, 03 medical and health sciences, 0302 clinical medicine, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Physicians, Medicine, Humans, In patient, Prospective Studies, Pulmonologists, Noninvasive Ventilation, business.industry, Research, [SCCO.NEUR]Cognitive science/Neuroscience, RC952-1245, 030208 emergency & critical care medicine, General Medicine, Odds ratio, [SDV.ETH]Life Sciences [q-bio]/Ethics, Death, 030228 respiratory system, Special situations and conditions, Limitation of treatment, Emergency medicine, End of life, [SCCO.PSYC]Cognitive science/Psychology, Non-invasive ventilation, business, Chronic respiratory failure
Abstract: Background Deciding to withdraw non-invasive ventilation (NIV) at end-of-life (EOL) in patients with chronic respiratory failure is a challenge. The European Association for Palliative Care recommends not maintaining artificial therapies that could prolong life during palliative sedation (PS) at EOL. The aim of this survey was to assess palliative care physicians’ and pulmonologists’ opinion on withdrawing or maintaining NIV in patients with chronic respiratory failure during PS at EOL. Methods From April to May 2019, we performed a prospective survey among pulmonologists (n = 1545) and palliative care physicians (n = 631) in France to determine the prevalence of opinion in favour of maintaining NIV and identify the factors associated with opinion in favour of withdrawing or maintaining NIV with multiple logistic regression. Results A total of 457 participants were enrolled comprising 202 pulmonologists and 255 palliative care physicians. An opinion in favour of maintaining NIV was found in 88 (19.3 95%CI [15.7; 23.2]) physicians comprising 57 (28.2%) pulmonologists and 31 (12.2%) palliative care physicians (p p = 0.002) and personal ethics of physicians (OR: 17.97, 95%CI [9.52; 33.89], p ). The factor associated with an opinion in favour of withdrawing NIV was palliative care training (OR: 0.31, 95%CI [0.16; 0.60], p . The three main reasons in favour of maintaining NIV among the nine identified were emotional comfort for close relatives, reducing discomfort of dyspneoa and anticipation of suffocation. Conclusion In France, around 20% of pulmonologists and palliative care physicians declared an opinion in favour of maintaining NIV during PS at EOL because of their personal ethics and spending time looking for AD, if any, in the patient’s file. Palliative care training can stimulate reflection help foster a change of opinion about practices, especially in the case of patients with NIV during PS at EOL.
Published: 2021
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33. Aerobic Metabolic Adaptations in Endurance Eccentric Exercise and Training: From Whole Body to Mitochondria

Author: Julianne Touron, Frédéric Costes, Emmanuel Coudeyre, Hélène Perrault, Ruddy Richard, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Service Médecine du Sport et Explorations Fonctionnelles [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], McGill University = Université McGill [Montréal, Canada], UEN, Unité d'Exploration en Nutrition, and Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)
Subjects: medicine.medical_specialty, Physiology, Apparent oxygen utilisation, free radicals, Review, lcsh:Physiology, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, Physiology (medical), medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Eccentric, Balance (ability), calcium, lcsh:QP1-981, business.industry, Oxygen transport, Skeletal muscle, VO2 max, 030229 sport sciences, oxygen consumption, mitochondria, eccentric training, medicine.anatomical_structure, Mitochondrial biogenesis, Eccentric training, business, 030217 neurology & neurosurgery
Abstract: International audience; A characteristic feature of eccentric as compared with concentric exercise is the ability to generate greater mechanical loads for lower cardiopulmonary demands. Current evidence concurs to show that eccentric training translates into considerable gains in muscle mass and strength. Less is known, however, regarding its impact on oxygen transport and on factors to be considered for optimizing its prescription and monitoring. This article reviews the existing evidence for endurance eccentric exercise effects on the components of the oxygen transport system from systemic to mitochondria in both humans and animals. In the studies reviewed, specially designed cycle-ergometers or downhill treadmill running were used to generate eccentric contractions. Observations to date indicate that overall, the aerobic demand associated with the eccentric training load was too low to significantly increase peak maximal oxygen consumption. By extension, it can be inferred that the very high eccentric power output that would have been required to solicit a metabolic demand sufficient to enhance peak aerobic power could not be tolerated or sustained by participants. The impact of endurance eccentric training on peripheral flow distribution remains largely undocumented. Given the high damage susceptibility of eccentric exercise, the extent to which skeletal muscle oxygen utilization adaptations would be seen depends on the balance of adverse and positive signals on mitochondrial integrity. The article examines the protection provided by repeated bouts of acute eccentric exercise and reports on the impact of eccentric cycling and downhill running training programs on markers of mitochondrial function and of mitochondrial biogenesis using mostly from animal studies. The summary of findings does not reveal an impact of training on skeletal muscle mitochondrial respiration nor on selected mitochondrial messenger RNA transcripts. The implications of observations to date are discussed within future perspectives for advancing research on endurance eccentric exercise physiological impacts and using a combined eccentric and concentric exercise approach to optimize functional capacity.
Published: 2021
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34. Les orientations thérapeutiques face au syndrome fémoro-patellaire

Author: Vivien Reynaud, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], and CHU Clermont-Ferrand
Subjects: 030203 arthritis & rheumatology, 03 medical and health sciences, 0302 clinical medicine, 030229 sport sciences, Podiatry, [SHS]Humanities and Social Sciences
Published: 2020
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35. Diagnostic du syndrome fémoro-patellaire et examens complémentaires

Author: Vivien Reynaud, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], and CHU Clermont-Ferrand
Subjects: 03 medical and health sciences, 0302 clinical medicine, business.industry, Medicine, 030229 sport sciences, 030212 general & internal medicine, Podiatry, business, [SHS]Humanities and Social Sciences
Published: 2020
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36. Physiopathologie du syndrome fémoro-patellaire

Author: Vivien Reynaud, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], and CHU Clermont-Ferrand
Subjects: 030203 arthritis & rheumatology, 03 medical and health sciences, 0302 clinical medicine, 030229 sport sciences, Podiatry, [SHS]Humanities and Social Sciences
Published: 2020
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37. Prevention, diagnosis and management of chemotherapy-induced peripheral neuropathy: a cross-sectional study of French oncologists' professional practices

Author: Fadila Farsi, David Balayssac, Denis Pezet, Patrick Merle, Marie Selvy, Jérôme Busserolles, Nicolas Kerckhove, Bruno Pereira, Virginie Guastella, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Léon Bérard [Lyon], Réseau Régional de Cancérologie Auvergne-Rhône-Alpes Onco-Aura, Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], Service de Pneumologie [CHU Clermont-Ferrand], Pôle RHEUNNIRS [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), and Molé, Christine
Subjects: Male, MESH: Neurotoxicity Syndromes, Cross-sectional study, Pregabalin, chemistry.chemical_compound, 0302 clinical medicine, Surveys and Questionnaires, MESH: Magnesium, Magnesium, 030212 general & internal medicine, Practice Patterns, Physicians', Cancer, Chemotherapy-induced peripheral neuropathy, MESH: Duloxetine Hydrochloride, Oncologists, MESH: Middle Aged, Incidence (epidemiology), Peripheral Nervous System Diseases, Vitamins, Middle Aged, Professional practice, 3. Good health, Oncology, 030220 oncology & carcinogenesis, MESH: Calcium, Neurotoxicity Syndromes, MESH: Gabapentin, MESH: Peripheral Nervous System Diseases, France, Gabapentin, MESH: Pregabalin, medicine.drug, Adult, medicine.medical_specialty, Amitriptyline, Adverse drug reaction, [SDV.CAN]Life Sciences [q-bio]/Cancer, Antineoplastic Agents, MESH: Amitriptyline, Duloxetine Hydrochloride, 03 medical and health sciences, MESH: Cross-Sectional Studies, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, medicine, Duloxetine, Humans, MESH: Surveys and Questionnaires, MESH: Humans, business.industry, MESH: Oncologists, MESH: Adult, medicine.disease, MESH: Male, MESH: France, Peripheral neuropathy, Cross-Sectional Studies, chemistry, MESH: Practice Patterns, Physicians', MESH: Antineoplastic Agents, MESH: Vitamins, Calcium, business
Abstract: Chemotherapy-induced peripheral neuropathy (CIPN) is challenging for oncologists. Many publications mention the high incidence of CIPN and the lack of effective preventive/management strategies and robust diagnostic tools. This cross-sectional study was aimed at assessing the practice of French oncologists for CIPN prevention, diagnosis and management. This web-based survey was sent to French oncologists by the regional cancer networks. Incidence and impact of CIPN were assessed using visual analogue scales (VAS) and diagnostic strategies were recorded. Also recorded were the drugs used to prevent or manage CIPN and their perceived efficacy and safety (VAS). Among the 210 oncologists included, the perceived incidence of CIPN was about 36.2 ± 22.1% of patients. About 99.5% of oncologists declared that they assess CIPN during medical follow-up. The use of drugs to prevent CIPN was reported by 9.6% of oncologists (group B vitamins (35.0%) and calcium and magnesium infusion (25.0%)). In the case of CIPN, the therapeutic adjustment of neurotoxic anticancer drugs is performed by 99.0% of oncologists (chemotherapy change (49.8%), dose reduction (30.9%) or interruption (19.3%)). The pharmacological management of CIPN was declared by 72.9% of oncologists. The main drugs used are pregabalin (75.8%), amitriptyline (32.7%) and gabapentin (25.5%). Duloxetine (ASCO recommendation) is used by only 11.8% of oncologists. Oncologists were clearly aware of CIPN risks, but its incidence tended to be underestimated and the ASCO recommendations for the management of CIPN were not followed. The prevention, diagnosis and management of CIPN remain problematic in clinical practice in France. ClinicalTrials.gov : NCT03854864
Published: 2020
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38. Perceived barriers to and facilitators of physical activity in people with knee osteoarthritis: Development of the Evaluation of the Perception of Physical Activity questionnaire

Author: N. Coste, C. Guiguet-Auclair, L. Gerbaud, B. Pereira, P. Berland, C. Gay, E. Coudeyre, CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Institut Pascal (IP), SIGMA Clermont (SIGMA Clermont)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Santé publique, Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Matière et Systèmes Complexes (MSC (UMR_7057)), Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), Unité de Nutrition Humaine (UNH), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Louise Michel [Clermont-Ferrand], Sigma Plus, Matière et Systèmes Complexes (MSC), Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), CHU Gabriel Montpied (CHU), and Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand
Subjects: Male, 030506 rehabilitation, Facilitators, Non-Randomized Controlled Trials as Topic, Intraclass correlation, 0302 clinical medicine, Surveys and Questionnaires, Validation, Orthopedics and Sports Medicine, Prospective Studies, ComputingMilieux_MISCELLANEOUS, education.field_of_study, 4. Education, Rehabilitation, Fear, Middle Aged, Osteoarthritis, Knee, Convergent validity, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Scale (social sciences), Female, Knee osteoarthritis, 0305 other medical science, Psychology, Barriers, medicine.medical_specialty, WOMAC, Psychometrics, Population, education, Construct, 03 medical and health sciences, Cronbach's alpha, medicine, Humans, Exercise, Physical Therapy Modalities, Aged, Questionnaire, Physical activity, Reproducibility of Results, Construct validity, Patient Acceptance of Health Care, Physical activity level, Cross-Sectional Studies, Physical therapy, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Factor Analysis, Statistical, 030217 neurology & neurosurgery
Abstract: International audience; Background: The physical activity (PA) level of individuals with knee osteoarthritis is lower than in the general population. International recommendations recommend a non-pharmacological intervention including a self-management education program, weight loss and an adapted exercise program. However, we have no scale assessing the perceived barriers to and facilitators of PA in this population.Objective: We constructed and validated a self-administered questionnaire assessing perceived barriers to and facilitators of regular practice of PA in people with knee osteoarthritis.Methods: Semi-structured interviews identified 24 barriers and facilitators. We developed a 24-item questionnaire, Evaluation of the Perception of Physical Activity (EPPA) that was completed by 548 individuals with knee osteoarthritis, to assess acceptability, construct validity, internal consistency and convergent validity. Participants also completed the Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and International Physical Activity Questionnaire (IPAQ). Reliability and sensitivity to change were evaluated in a second group of 168 people with knee osteoarthritis at a 3-week spa therapy resort.Results: Factorial analysis identified 17 items grouped into 4 subscales (Barriers, Facilitators, Motivation and Beliefs). The internal consistency was good for Barriers, Facilitators and Motivation subscales (Cronbach alpha > 0.70) and intermediate for the Beliefs subscale (Cronbach alpha = 0.64). The EPPA subscale scores were significantly correlated with KOFBeQ and WOMAC scores but not associated with IPAQ physical activity level. Reliability was good for all subscales, with intraclass correlation coefficients > 0.60. A sensitivity to change was found for only the Beliefs subscale, with a moderate effect size.Conclusions: The EPPA questionnaire has good psychometric properties and can help guide the management of knee osteoarthritis. It can be used in research for evaluating the perception of physical activity.
Published: 2020
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39. Quality of life for older patients with cancer: a review of the evidence supporting melatonin use

Author: Judith Passildas, Catherine Abrial, Angeline Ginzac, Xavier Durando, Marie-Ange Mouret-Reynier, Julian Biau, Marie-Odile Hager, Sophie Dubois, Fabrice Kwiatkowski, Emilie Thivat, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Centre d'investigation Clinique, UMR501, 63011 CLERMONT-FERRAND (CIC), Division de Recherche Clinique, Délégation Recherche Clinique et Innovation, Centre de Lutte contre le Cancer, Centre Jean PERRIN, 58 rue Montalembert, 63011 Clermont-Ferrand Cedex1, Département d'oncologie médicale, Centre Jean PERRIN, 63011 Clermont-Ferrand, Géronto-pôle [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Département de Radiothérapie [Centre Jean Perrin, Clermont-Ferrand], Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER-UNICANCER, Université Clermont Auvergne, INSERM, U1240 Imagerie Moléculaire et Stratégie Théranostiques, Centre Jean PERRIN, 63011 Clermont-Ferrand, and GINZAC, Angeline
Subjects: Quality of life, Oncology, Aging, medicine.medical_specialty, medicine.medical_treatment, Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, Review, Older population, Melatonin, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Older patients, Neoplasms, Internal medicine, medicine, Chemotherapy, Humans, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, Cancer, Aged, education.field_of_study, [SDV.MHEP.GEG] Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, business.industry, [SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, medicine.disease, 3. Good health, Clinical trial, [SDV.AEN] Life Sciences [q-bio]/Food and Nutrition, 030220 oncology & carcinogenesis, Geriatrics and Gerontology, Sleep, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, medicine.drug
Abstract: Purpose The proportion of older populations living with cancer is on the increase. Maintaining or improving their quality of life (QoL) has become an important goal in the treatment of cancer and has become an endpoint in clinical trials. Melatonin regulates a wide variety of physiological functions and is involved in the initiation of sleep and the improvement of QoL. With age, the secretion of melatonin decreases and could lead to a deterioration in QoL. Methods Literature searches were conducted using the PubMed database. The search terms and derivatives of “metastatic cancer”, “older patients”, “quality of life” and “melatonin” were used. Titles and abstracts were screened to identify whether studies were relevant for full-text screening. Results There is major concern about the symptoms older cancer patients encounter during treatment because they can impact their QoL. Melatonin supplementation presents several benefits for older patients: improvement in survival, decrease in symptoms induced by cancer and cancer treatment, and also improvements in quality of life. Conclusion It therefore seems appropriate to study the impact of melatonin supplementation during cytotoxic therapy on QoL among elderly patients with metastatic cancer. The use of melatonin as a therapeutic strategy seems particularly suitable for elderly patients, a population known to secrete significantly less melatonin. However, to date, no studies have been conducted in this population.
Published: 2020
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40. Mixed qualitative and quantitative approach for validating an information booklet before total hip arthroplasty

Author: Sylvie Aubreton, Anne Plan-Paquet, Stéphane Descamps, Aurore Chabaud, Bénédicte Eschalier, Emmanuel Coudeyre, Myriam Zullian, Dominique Saragaglia, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Département de Médecine Générale, Faculté de Médecine, Université Clermont Auvergne, Service de médecine physique et de réadaptation, hôpital rhumatologique, Clinique universitaire de chirurgie orthopédique et de traumatologie du sport, Hôpital Sud, CHU de Grenoble, Gestes Medico-chirurgicaux Assistés par Ordinateur (TIMC-IMAG-GMCAO), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service de Chirurgie Orthopédique et Traumatologique [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), and Universite Clermont Auvergne
Subjects: Male, Health Knowledge, Attitudes, Practice, medicine.medical_specialty, Arthroplasty, Replacement, Hip, Health Personnel, [SDV]Life Sciences [q-bio], education, Sample (statistics), Osteoarthritis, Hip, 03 medical and health sciences, 0302 clinical medicine, Patient Education as Topic, Surveys and Questionnaires, Hip osteoarthritis, Humans, Medicine, Orthopedics and Sports Medicine, Postoperative Period, Aged, Aged, 80 and over, 030222 orthopedics, Health professionals, business.industry, Rehabilitation, Focus Groups, Middle Aged, Standard methods, Booklet, Focus group, 3. Good health, Hip arthroplasty, Physical therapy, Female, Pamphlets, Total hip arthroplasty, Self-care, business, 030217 neurology & neurosurgery
Abstract: International audience; ObjectiveProviding patients with validated information before total hip arthroplasty may help lessen discrepancies between patients’ expectations and the surgical result. This study sought to validate an information booklet for candidates for hip arthroplasty by using a mixed qualitative and quantitative approach based on a panel of patients and a sample of healthcare professionals.MethodsWe developed a booklet in accordance with the standard methods and then conducted focus groups to collect the opinions of a sample of multidisciplinary experts involved in the care of patients with hip osteoarthritis. The number of focus groups and experts was determined according to the data saturation principle. A panel of patients awaiting hip arthroplasty or those in the immediate post-operative period assessed the booklet with self-reporting questionnaires (knowledge, beliefs, and expectations) and semi-structured interviews.ResultsAll experts and both patient groups validated the booklet in terms of content and presentation. Semi-structured interviews were uninformative, especially for post-operative patients. Reading the booklet significantly (P < 0.001) improved the knowledge scores in both groups, with no intergroup differences, but did not affect beliefs in either patient group. Only pre-operative patients significantly changed their expectations.ConclusionOur mixed qualitative and quantitative approach allowed us to validate a booklet for patients awaiting hip arthroplasty, taking into account the opinions of both patients and healthcare professionals.
Published: 2018
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41. Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods

Author: Stéphanie Genay, Teuta Eljezi, M. Yessaad, Christine Barthélémy, Claude Vaccher, Frédéric Feutry, Régis Cueff, Marie Lecoeur, C Verlhac, Philip Chennell, T. Radaniel, Bertrand Décaudin, Pascal Odou, Morgane Masse, Bruno Jorge Pereira, Nicolas Kambia, Valérie Sautou, C. Breysse, Thierry Dine, Nicolas Simon, Daniel Bourdeaux, Lise Bernard, Nathalie Azaroual, Service Pharmacie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre de Ressources Technologiques 3s’Inpack, CHU Lille, Institut de Pharmacie, and Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille
Subjects: Chemistry, business.industry, [SDV]Life Sciences [q-bio], 010401 analytical chemistry, Plasticizer, Comparison, 02 engineering and technology, Technical specifications, 021001 nanoscience & nanotechnology, 01 natural sciences, Pvc matrix, 0104 chemical sciences, Analytical Chemistry, Plasticizers, Analytical methods, Performance comparison, Medical devices, In patient, 0210 nano-technology, Process engineering, business
Abstract: International audience; A wide variety of medical devices (MDs) used in hospitals are made of flexible plasticized polyvinylchloride (PVC). Different plasticizers are present in variable amounts in the PVC matrix of the devices and can leach out into the infused solutions and may enter into contact with the patients. The ARMED1 project aims to assess the migration of these plasticizers from medical devices and therefore the level of exposure in patients. For the first task of the project, eight methods were developed to directly detect and quantify the plasticizers in the PVC matrix of the MDs. We compared the overall performances of the analytical methods using standardized and validated criteria in order to provide the scientific community with the guidance and the technical specifications of each method for the intended application. We have shown that routine rapid screening could be performed directly on the MDs using the FTIR technique, with cost-effective analyses. LC techniques may also be used, but with limits and only with individual quantification of the main plasticizers expected in the PVC matrix. GC techniques, especially GC–MS, are both more specific and more sensitive than other techniques. NMR is a robust and specific technique to precisely discriminate all plasticizers in a MD but is limited by its cost and its low ability to detect and quantify plasticizer contamination, e.g. by DEHP. All these results have been confirmed by a real test, called the " blind test " carried out on 10 MD samples.
Published: 2017
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42. Étude de la relation entre détresse et confusion mentale chez les patients en situation palliative (Relation entre détresse et confusion mentale en situation palliative)

Author: Axelle Van Lander, Virginie Guastella, Andréa Tarot, Bruno Pereira, Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], and Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI)
Subjects: 03 medical and health sciences, 0302 clinical medicine, Anesthesiology and Pain Medicine, Oncology, 030502 gerontology, Oncology (nursing), 030220 oncology & carcinogenesis, [SHS.PSY]Humanities and Social Sciences/Psychology, 0305 other medical science, ComputingMilieux_MISCELLANEOUS, 3. Good health
Abstract: Resume Objectif Etudier la relation entre la detresse et la confusion mentale chez les patients en situation palliative afin d’apporter une prise en charge adaptee a cette situation complexe et frequente en fin de vie. Methodes C’est une etude quantitative observationnelle, prospective et multicentrique realisee aupres de patient en situation palliative. Les equipes de chaque structure incluaient les patients et realisaient des evaluations a l’aide d’un formulaire visant a renseigner l’intensite de la detresse ressenti par le patient, a l’aide de la Distress Thermometer auto-evaluee puis hetero-evaluee, et la presence ou non d’une confusion a l’aide de la Nu-DESC. En outre, il etait rapporte la prise ou non des prescriptions medicamenteuses anticipees ainsi que toutes les caracteristiques epidemiologiques du patient. Resultats Nous avons pu inclure 51 patients et realiser 467 entretiens. Aucune relation n’a ete mise en evidence entre la detresse et la confusion sur tous les entretiens confondus. Par contre, une relation faible a moderee a ete mise en evidence au premier entretien. La confusion a tendance a augmenter a l’approche du deces alors qu’aucune relation n’a pu etre mise en evidence entre la detresse et la date du deces. Conclusion Ces resultats questionnent sur le ressenti des patients confus puisqu’il n’a pas ete mis en evidence que la confusion engendre une detresse plus importante chez ces patients sur tous les entretiens.
Published: 2019
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43. Preoperative respiratory muscle endurance training improves ventilatory capacity and prevents pulmonary postoperative complications after lung surgery: a randomized controlled trial

Author: Laurent, Hélène, Aubreton, Sylvie, Galvaing, Geraud, Pereira, Bruno, Merle, Patrick, Richard, Ruddy, Costes, Frédéric, Filaire, Marc, Laboratoire Vision et Robotique (LVR), Université d'Orléans (UO)-Ecole Nationale Supérieure d'Ingénieurs de Bourges, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, service de chirurgie thoracique et endocrinienne, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER-UNICANCER, service de Biostatistiques, DRCI, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Transvalor, Transvalor S. A., Service de Médecine Physique et de Réadaptation, CHU Clermont-Ferrand, Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne, Centre Hospitalier Universitaire de Clermont-Ferrand, Imagerie Moléculaire et Stratégies Théranostiques - Clermont Auvergne (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Unité de Nutrition Humaine - Clermont Auvergne (UNH), and Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA)
Subjects: [SDV.CAN]Life Sciences [q-bio]/Cancer, respiratory tract diseases
Abstract: International audience; Resection surgery is the main treatment for non-small cell lung cancer (NSCLC).Postoperative complications and mortality are mostly linked to respiratory failure consecutive to respiratory muscle overload.; Randomized controlled trial.; Patients eligible for NSCLC resection.
Published: 2019
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44. Isokinetic thigh muscle strength testing in professional French Rugby Union players: A database as a reference in pre-season strength rehabilitation rather than the controlateral limb

Author: M. Julia, Bernard Dusfour, Jean-Claude Peyrin, Dominique Morand, Armand Bonnin, Arnaud Dupeyron, Bruno Pereira, Emmanuel Coudeyre, Jean-Louis Croisier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Centre Hospitalier Universitaire de Liège (CHU-Liège), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Commission médicale Ligue Nationale de Rugby, and Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)
Subjects: MESH: Muscle, Skeletal, medicine.medical_specialty, MESH: Humans, Rehabilitation, business.industry, MESH: Muscle Strength, medicine.medical_treatment, Thigh muscle, MEDLINE, MESH: Rugby, Physical medicine and rehabilitation, Thigh, Medicine, Strength testing, Humans, Orthopedics and Sports Medicine, Muscle Strength, Rugby, Seasons, business, Muscle, Skeletal, MESH: Seasons, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, MESH: Thigh
Abstract: Letter; International audience; Isokinetic testing is currently considered the gold standard for measuring dynamic muscle thigh strength (hamstring and quadriceps) [1], [2]. Isokinetic thigh muscle testing can provide valuable information to design effective preventive strategies for athletes.
Published: 2019
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45. Foot Function Index: A Promising Questionnaire for Individuals With Charcot-Marie-Tooth Disease Type 1A

Author: E. Coudeyre, Pascal Givron, Catherine Cornut-Chauvinc, Pierre Clavelou, Lucie Bihel, Bruno Pereira, Frederic Taithe, Eric Thomas, Vivien Reynaud, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Boucharenc Podo-orthése, Unité de Nutrition Humaine (UNH), and Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Subjects: Adult, Male, 030506 rehabilitation, medicine.medical_specialty, Neurology, SF-36, Concordance, medicine.medical_treatment, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Physical Therapy, Sports Therapy and Rehabilitation, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Cronbach's alpha, Charcot-Marie-Tooth Disease, Isometric Contraction, Medicine, Humans, Muscle Strength, Fatigue, Physical Therapy Modalities, Aged, Aged, 80 and over, Academic Medical Centers, Rehabilitation, business.industry, Foot, Reproducibility of Results, Middle Aged, Gait, Confidence interval, 3. Good health, Cross-Sectional Studies, Gait analysis, Physical therapy, Quality of Life, Female, 0305 other medical science, business, 030217 neurology & neurosurgery
Abstract: International audience; Objective: To evaluate in a preliminary methodologic study, the Foot Function Index (FFI), a 3-subscale (pain, disability, and activity restriction) foot disability assessment questionnaire, in patients with Charcot-Marie-Tooth disease type 1A (CMT1A).Design: Monocentric exploratory cross-sectional study with 2 identical evaluations by the same physical medicine and rehabilitation physician at 14-day intervals (test-retest) according to international guidelines for validating health-related patient-reported outcomes, the Consensus-based Standards for the Selection of Health Measurement Instruments Criteria.Setting: Physical medicine and rehabilitation and neurology departments in a French academic hospital.Participants: Patients with CMT1A confirmed by molecular biology (N=26).Intervention: The 11-1 and a health-related quality-of-life questionnaire (Medical Outcomes Study Short Form 36 [SF-36] with mental and physical composite scores) combined with quantitative walk analysis by instrumental gait analysis and evaluation of isokinetic quadriceps and hamstrings peak torque by isokinetic dynamometer.Main Outcome Measures: FFI score and its dimensions.Results: Acceptability was satisfactory, with less than 5% missing data and good distribution of results. Internal consistency was very satisfactory, with Cronbach alpha of 0.95. Reproducibility was very satisfactory, with Lin concordance coefficient 0.82. External consistency was satisfactory, with expected correlation coefficients: the FFI was significantly correlated with the SF-36 physical composite score and gait parameters (cadence) (r=-0.58 and r=-0.52; P
Published: 2019
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46. Static peak pressure under the sole is unrelated to gait alteration in rheumatoid arthritis

Author: Bruno Pereira, Martin Soubrier, Emmanuel Coudeyre, Armand Bonnin, Anne Tournadre, Eric Thomas, Claire Pourtier-Piotte, Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Maison Départementale des Personnes Handicapées, Boucharenc Podo-orthése, Service de Rhumatologie [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), and Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Subjects: Quality of life, medicine.medical_specialty, Peak pressure, Arthritis, Pain, 03 medical and health sciences, 0302 clinical medicine, Gait (human), Physical medicine and rehabilitation, Medicine, Orthopedics and Sports Medicine, Young adult, Rheumatoid arthritis, ComputingMilieux_MISCELLANEOUS, 030203 arthritis & rheumatology, Disability, business.industry, Foot, Rehabilitation, 030229 sport sciences, medicine.disease, Patient reported outcome measures, Functional assessment, business, Foot (unit), [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience
Published: 2019
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47. The Fami-life study: protocol of a prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the family research in palliative care (F.R.I.P.C research network)

Author: Véronique Michonneau-Gandon, Laure Copel, Virginie Verliac, Dominique Gracia, Gaelle Ranchou, Willeme Kaczmarek, Emmanuel De Larivière, Maité Garrouste-Orgeas, Adrien Evin, Virginie Guastella, Catherine Verlaine, Frédéric Guirimand, Jean-François Timsit, Alaa Mhalla, Florent Bienfait, Licia Touzet, Guillaume Bouquet, Marie Sonrier, Laurence Birkui de Francqueville, Ségolène Perruchio, Cécile Flahault, Anne Vanbésien, Sébastien Bailly, Carmen Mathias, Virginie Fossez-Diaz, Edith Poulain, Stéphane Ruckly, Véronique Marché, Cécile Poupardin, Dominique Michel, Bruno Richard, Salvy-Córdoba, Nathalie, Epidémiologie pronostique des cancers et affections graves, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Psychopathologie et Processus de Santé (LPPS - EA 4057), Université Paris Descartes - Paris 5 (UPD5), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de recherche Versailles Saint-Quentin Institutions Publiques (VIP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), CH de Troyes, Centre Hospitalier [Douai, Nord], Centre Hospitalier de la Dracénie [Draguignan], Centre Hospitalier Compiègne-Noyon, Centre Hospitalier Tourcoing, Groupe Hospitalier Diaconesses Croix Saint-Simon, Groupe hospitalier de la région de Mulhouse Sud-Alsace (GHRMSA), Hopital de Salon d eProvence, AP-HP Hôpital A. Chenevier [Créteil], Centre Hospitalier Intercommunal Castres-Mazamet, Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hopital de Périgueux (CH Périgueux), Hopital de Périgueux, Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Informatique et Distribution (ID-IMAG), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National Polytechnique de Grenoble (INPG)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Institut de psychiatrie et neurosciences de Paris (IPNP - U1266 Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut d'oncologie/développement Albert Bonniot de Grenoble (INSERM U823), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM), INSERM U823, équipe 11 (Epidémiologie des cancers et des affections graves), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM)-Clinique de réanimation médicale, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon-Hôpital Michallon, CIC - CHU Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)
Subjects: medicine.medical_specialty, Palliative care, media_common.quotation_subject, lcsh:Special situations and conditions, [SDV.NEU.PC] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Psychology and behavior, [SDV.CAN]Life Sciences [q-bio]/Cancer, Anxiety, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Clinical Protocols, [SDV.CAN] Life Sciences [q-bio]/Cancer, Surveys and Questionnaires, Humans, Medicine, Family, Prospective Studies, 030212 general & internal medicine, Psychiatry, Depression (differential diagnoses), media_common, Interpretative phenomenological analysis, [SDV.NEU.PC]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Psychology and behavior, business.industry, Minimal clinically important difference, Incidence (epidemiology), lcsh:RC952-1245, Post-traumatic, General Medicine, Stress disorders, Relatives, 3. Good health, 030220 oncology & carcinogenesis, Grief, Observational study, France, medicine.symptom, business
Abstract: Background Grieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief. This study aims to assess the psychological consequences of grieving relatives after patients’ death in French palliative care units and their needs for support. Methods This is a prospective observational multicenter mixed study. Relatives of adult patients with a neoplasia expected to be hospitalized more than 72 h in a palliative care unit for end-of-life issues will be included within 48 h after patient admission. End-of-life issues are defined by the physician at patient admission. Relatives who are not able to have a phone call at 6-months are excluded. The primary outcome is the incidence of prolonged grief reaction defined by an ICG (Inventory Complicate Grief) > 25 (0 best-76 worst) at 6 months after patient’ death. Prespecified secondary outcomes are the risk factors of prolonged grief, anxiety and depression symptoms between day 3 and day 5 and at 6 months after patients’ death based on an Hospital Anxiety and Depression score (range 0–42) > 8 for each subscale (minimal clinically important difference: 2.5), post-traumatic stress disorder symptoms 6 months after patient’ death based on the Impact of Events Scale questionnaire (0 best-88 worst) score > 22, experience of relatives during palliative care based on the Fami-Life questionnaire, specifically built for the study. Between 6 and 12 months after the patient’s death, a phone interview with relatives with prolonged grief reactions will be planned by a psychologist to understand the complex system of grief. It will be analyzed with the Interpretative Phenomenological Analysis. We planned to enroll 500 patients and their close relatives assuming a 25% prolonged grief rate and a 6-month follow-up available in 60% of relatives. Discussion This study will be the first to report the psychological consequences of French relatives after a loss of a loved one in palliative care units. Evaluating relatives’ experiences can provide instrumental insights for means of improving support for relatives and evaluation of bereavement programs. Trial registration NCT03748225 registered on 11/19/2018. Recruiting patients.
Published: 2019
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48. Comparison of microbiological results obtained from per-wound bone biopsies versus transcutaneous bone biopsies in diabetic foot osteomyelitis: a prospective cohort study

Author: Paule Letertre-Gilbert, Salwan Maqdasy, Magali Vidal, Natacha Mrozek, Aurore Chabaud, Stéphane Descamps, Alice Couturier, Igor Tauveron, F. Desbiez, Evelina Petrosyan, Olivier Lesens, Laboratoire Microorganismes : Génome et Environnement (LMGE), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Service d’Orthopédie Traumatologie [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Néphrologie Réanimation Médicale, Pôle RHEUNNIRS [CHU Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand]
Subjects: Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Diabetic foot osteomyelitis, Biopsy, medicine.medical_treatment, 030106 microbiology, [SDV.MP.PRO]Life Sciences [q-bio]/Microbiology and Parasitology/Protistology, Bone and Bones, Specimen Handling, 03 medical and health sciences, 0302 clinical medicine, Humans, Medicine, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Aged, Aged, 80 and over, Bone biopsy, Debridement, Bacteria, medicine.diagnostic_test, business.industry, Osteomyelitis, Reproducibility of Results, General Medicine, Gold standard (test), Middle Aged, medicine.disease, Diabetic foot, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, 3. Good health, Surgery, Correlation, Infectious Diseases, Concomitant, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Transcutaneous bone biopsy (TCB) is the gold standard for taking microbiological specimens in diabetic foot osteomyelitis (DFO), but this technique is not widely used in diabetic foot care centers. We aimed to evaluate the reliability of per-wound bone biopsy (PWB) cultures by comparing them with concomitant TCB cultures obtained through healthy skin. This is a prospective monocentric study including patients seen in consultation for clinical and radiological diabetic foot osteomyelitis with positive probe-bone tests between April 2015 and May 2018. Two bone biopsies were performed on each consenting patient: TCB through a cutaneous incision in healthy skin, and PWB, after careful debridement of the wound. A total of 46 paired cultures were available from 43 eligible patients. Overall, 16 (42%) of the PWB and TCB pairs had identical culture results, but the TCB cultures were sterile in 8 (17%) cases. For 38 paired cultures with positive TCB, the correlation between PWB results and TCB results was 58.4%. PWB revealed all microorganisms found in the transcutaneous specimen in 26/38 samples (68.5%). In patients with DFO, the culture results of specimens taken by per-wound biopsies did not correlate well with those obtained by TCB. PWB should be reserved for cases where the transcutaneous biopsy is sterile or not feasible.
Published: 2019
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49. Eccentric cycling is more efficient in reducing fat mass than concentric cycling in adolescents with obesity

Author: Valérie Julian, Frédéric Costes, David Thivel, Bruno Pereira, Martine Duclos, E. Coudeyre, Maud Miguet, Ruddy Richard, service du sport et explorations fonctionnelles, Centre Hospitalier Universitaire Gabriel Montpied, Unité de nutrition Humaine, Institut National de la Recherche Agronomique (INRA), Université Clermont Auvergne (UCA), Centre de Recherche en Nutrition Humaine, Laboratoire des Adaptations Métaboliques à l’Exercice en conditions Physiologiques et Pathologiques (AME2P), Biostatistiques, Danone Research, Centre Hospitalier Universitaire de Clermont-Ferrand, Médecine physique et réadaptation, CHU Clermont-Ferrand-Hôpital Gabriel-Montpied, Unité de Nutrition Humaine - Clermont Auvergne (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA), Service Médecine du Sport et Explorations Fonctionnelles [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne [CHU Clermont-Ferrand] (CRNH A), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Faculté de Médecine - Clermont-Auvergne (FM - UCA), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-UFR Sciences et Techniques des Activités Physiques et Sportives - Clermont-Auvergne (UFR STAPS - UCA), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], Unité de Nutrition Humaine (UNH), Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), and CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand]
Subjects: Male, medicine.medical_specialty, Percentile, Pediatric Obesity, Adolescent, genetic structures, [SDV]Life Sciences [q-bio], Physical Therapy, Sports Therapy and Rehabilitation, Isometric exercise, 030204 cardiovascular system & hematology, Childhood obesity, Quadriceps Muscle, 03 medical and health sciences, 0302 clinical medicine, Insulin resistance, Oxygen Consumption, Internal medicine, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Eccentric, Humans, Orthopedics and Sports Medicine, Muscle Strength, Exercise physiology, Adiposity, exercise physiology, body composition, Anthropometry, business.industry, 030229 sport sciences, Original Articles, medicine.disease, Obesity, eye diseases, Bicycling, Exercise Therapy, stomatognathic diseases, Adipose Tissue, eccentric exercise, Cardiology, Lean body mass, Exercise Test, Original Article, Female, sense organs, Insulin Resistance, business, childhood obesity, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition
Abstract: International audience; The benefits of eccentric (ECC) training on fat mass (FM) remain underexplored. We hypothesized that in obese adolescents, ECC cycling training is more efficient for decreasing whole-body FM percentage compared to concentric (CON) performed at the same oxygen consumption (VO2). Twenty-four adolescents aged 13.4 +/- 1.3 years (BMI > 90th percentile) were randomized to ECC or CON. They performed three cyclo-ergometer sessions per week (30 min per session) for 12 weeks: two habituation, 5 at 50% VO2peak, and 5 at 70% VO2peak. Anthropometric measurements, body composition, maximal incremental CON tests, strength tests, and blood samples were assessed pre- and post-training. Whole-body FM percentage decreased significantly after compared to pretraining in both groups, though to a larger extent in the ECC group (ECC: -10% vs CON: -4.2%, P < 0.05). Whole-body lean mass (LM) percentage increased significantly in both groups after compared to pretraining, with a greater increase in the ECC group (ECC: 3.8% vs CON: 1.5%, P
Published: 2019
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50. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial

Author: A. Roren, Emmanuel Coudeyre, Marie-Martine Lefèvre-Colau, Isabelle Boutron, Arnaud Dupeyron, Gabriel Baron, Christelle Nguyen, Serge Poiraudeau, François Rannou, Charlotte Pauwels, Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine), Université Paris Cité (UPCité), Toxicité environnementale, cibles thérapeutiques, signalisation cellulaire (T3S - UMR_S 1124), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Hôtel-Dieu [Paris], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Service de Médecine Physique et de Réadaptation [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand, Unité de Nutrition Humaine (UNH), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), Salvy-Córdoba, Nathalie, and UFR Médecine [Santé] - Université Paris Cité (UFR Médecine UPCité)
Subjects: musculoskeletal diseases, medicine.medical_specialty, MEDLINE, MESH: Pain Measurement, MESH: Bicycling, MESH: Lumbar Vertebrae, medicine, MESH: Exercise Therapy, Orthopedics and Sports Medicine, MESH: Treatment Outcome, Protocol (science), MESH: Humans, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Rehabilitation, Lumbar spinal stenosis, MESH: Spinal Stenosis, medicine.disease, Home based, MESH: Randomized Controlled Trials as Topic, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Physical therapy, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Cycling, business, human activities, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Letter; International audience; Dear editor, Lumbar spinal stenosis (LSS) is the narrowing of the lumbar canal caused by degenerative processes [1]. LSS results in back and lower-limb pain when standing and walking, and symptoms regress in sitting position [1]. These symptoms are named neurogenic claudication and result from mechanical irritation and from exercise-induced ischemia of the cauda equina [2]. The inability to stand or walk alters functioning and health-related quality of life (HRQoL)
Published: 2021
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