0000000001064459

AUTHOR

Antoine Monsel

showing 2 related works from this author

Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distr…

2019

The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care.We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either th…

Pulmonary and Respiratory MedicineMalemedicine.medical_specialtyARDSmedicine.medical_treatment[SDV]Life Sciences [q-bio]law.inventionPositive-Pressure Respiration03 medical and health sciences0302 clinical medicineRandomized controlled triallawInternal medicineFraction of inspired oxygenIntensive caremedicineProne PositionTidal VolumeHumansSingle-Blind Method030212 general & internal medicineProspective StudiesPrecision MedicineLungPositive end-expiratory pressureTidal volumeComputingMilieux_MISCELLANEOUSProportional Hazards ModelsMechanical ventilationRespiratory Distress Syndromebusiness.industryHazard ratioMiddle Agedmedicine.diseaseRespiration Artificial3. Good health[SDV] Life Sciences [q-bio]Intensive Care UnitsEditorial CommentaryTreatment Outcome030228 respiratory systemFemaleFrancebusiness
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Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspecti…

2021

International audience; Extracellular vesicles (EV) are emergent therapeutic effectors that have reached clinical trial investigation. To translate EV-based therapeutic to clinic, the challenge is to demonstrate quality, safety, and efficacy, as required for any medicinal product. EV research translation into medicinal products is an exciting and challenging perspective. Recent papers, provide important guidance on regulatory aspects of pharmaceutical development, defining EVs for therapeutic applications and critical considerations for the development of potency tests. In addition, the ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics as well as the Exosomes C…

Quality ControlKnowledge management[SDV.BIO]Life Sciences [q-bio]/BiotechnologyBiological medicinal productsmedia_common.quotation_subjectDrug Compounding[SDV]Life Sciences [q-bio]Regulatory requirementsPharmaceutical ScienceMarketing authorizationExosomesChemistry Techniques Analytical03 medical and health sciencesExtracellular Vesicles0302 clinical medicineDrug DevelopmentDrug Stability[CHIM]Chemical SciencesHumansQuality (business)ComputingMilieux_MISCELLANEOUS030304 developmental biologymedia_commonCell-free therapySecretome0303 health sciencesClinical Trials as TopicClinical-grade EVScientific progressbusiness.industryDrug Administration RoutesExtracellular vesicleDrugs InvestigationalRegulatory affairs3. Good health[SDV.BIO] Life Sciences [q-bio]/BiotechnologyClinical trialEuropeAnalytics030220 oncology & carcinogenesisPosition paperMedicinal productsBusinessMicrovesicles
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