[Clinical research in general hospital centres in France, strengths and weaknesses].

Clinical research is an essential activity in cancer care. Both for patients, who can gain access to innovative therapies, and for practitioners, who can maintain their skills and stay at the forefront of new treatment approaches. First developed in university hospitals, clinical research is now established in general hospitals and private health institutions.

The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries.

Debate is ongoing concerning the activities and functioning of Research Ethics Committees (REC), especially a possible science-or-ethics dichotomy in research ethics review. We retrospectively analyzed 145 letters issued by a French REC over 18 months. All queries were classified in three levels: qualification (definition of the problem), category (aggregation of broader topics) and finally fields (ethical, scientific, or administrative).

The Complete Genome Sequence of , the Causal Agent of Canker on Tea Plants, Reveals Novel Secretion Systems in Clade-1 Xanthomonads.

is the causal agent of bacterial canker on tea plants. There is no complete genome sequence available for , a close relative of the species and , thus limiting basic research for this group of pathogens. Here, we release a high-quality complete genome sequence for the type strain, CFBP 4691.

[Research ethics: French regulations and applications in radiation oncology].

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol.

[A survey on French hospital physicians'certification to the good clinical practices].

Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills.

A Correlative Study of Sunflower Seed Vigor Components as Related to Genetic Background.

Seed vigor is an important trait that determines seed performance in the field, which corresponds to seed germination rate and seedling establishment. Previous works brought helpful equations to calculate several parameters allowing vigor characterization. In this work we used base water potential (Ψb), base temperature (Tb) and seed lot (Ki) constants to characterize the vigor of 44 sunflower seed lots.

High-Quality Genome Resource of Generated via Long-Read Sequencing.

The bacterial plant pathogen is the causal agent of yellow disease of and other ornamental plant genera. There is no available complete genome for , limiting basic research for this pathogen. Here, we release a high-quality complete genome sequence for the type strain, CFBP 1156.

Pharmacokinetics and Pharmacodynamics of Anti-infective Agents during Continuous Veno-venous Hemofiltration in Critically Ill Patients: Lessons Learned from an Ancillary Study of the IVOIRE Trial.

Background: Hemofiltration rate, changes in blood and ultrafiltration flow, and discrepancies between the prescribed and administered doses strongly influence pharmacokinetics (PK) and pharmacodynamics (PD) of antimicrobial agents during continuous veno-venous hemofiltration (CVVH) in critically ill patients.

Methods: Ancillary data were from the prospective multicenter IVOIRE (hIgh VOlume in Intensive caRE) study. High volume (HV, 70 mL/kg/h) was at random compared with standard volume (SV, 35 mL/kg/h) CVVH in septic shock patients with acute kidney injury (AKI).

A multiscale approach reveals regulatory players of water stress responses in seeds during germination.

Seed germination is regulated by environmental factors, particularly water availability. Water deficits at the time of sowing impair the establishment of crop plants. Transcriptome and proteome profiling was used to document the responses of sunflower (Helianthus annuus) seeds to moderate water stress during germination in two hybrids that are nominally classed as drought sensitive and drought tolerant.

Racial and ethnic disparities in the management of acute pain in US emergency departments: Meta-analysis and systematic review.

Objective: This review aims to quantify the effect of minority status on analgesia use for acute pain management in US Emergency Department (ED) settings.

Methods: We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology to perform a review of studies from 1990 to 2018 comparing racial and ethnic differences in the administration of analgesia for acute pain. Studies were included if they measured analgesia use in white patients compared to a racial minority in the ED and studies were excluded if they focused primarily on chronic pain, case reports and survey studies.

Assessing the CT findings and clinical course of ED patients with first-time versus recurrent acute pancreatitis.

Study Objectives: The primary objective of this study was to compare Emergency Department patients with first-time versus recurrent acute pancreatitis.

Methods: This study was a retrospective chart review of patients with a diagnosis of acute pancreatitis who presented to a single academic urban emergency department from 2012 to 2016. Criteria for inclusion were clinical symptoms of pancreatitis, age greater than or equal to 18 years, ED diagnosis of acute pancreatitis, and an abdominal CT scan within 24 h of triage.

Exploring the attitudes & practices of shared decision-making for CT scan use in emergency department patients with abdominal pain.

Background: Shared decision-making (SDM) has been studied in the emergency department (ED) in relation to hospital admissions but not for CT scan utilization. CT scans are a common imaging modality with high accuracy that emit considerable ionizing radiation. This study has three aims: to measure provider and patient preference for SDM; to evaluate patient involvement in the decision to order a CT scan; and to determine the association between patient involvement and CT utilization.

One Way to Achieve Germination: Common Molecular Mechanism Induced by Ethylene and After-Ripening in Sunflower Seeds.

Dormancy is an adaptive trait that blocks seed germination until the environmental conditions become favorable for subsequent vegetative plant growth. Seed dormancy is defined as the inability to germinate in favorable conditions. Dormancy is alleviated during after-ripening, a dry storage period, during which dormant (D) seeds unable to germinate become non-dormant (ND), able to germinate in a wide range of environmental conditions.

Chemical stability of azacitidine suspensions for injection after cold-chain reconstitution of powder and storage.

Purpose: The 72-hour chemical stability of refrigerated syringes of azacitidine suspension prepared via a cold-chain method is investigated.

Methods: Three 25-mg/mL azacitidine suspensions were prepared from different lots of powdered drug. The suspensions were stored in 2-mL polypropylene syringes at 2-8 °C and protected from light.

Carbapenems.

Objective: To assess the relative strengths and weaknesses of carbapenems by considering their microbiological, clinical, pharmacokinetics and pharmacokinetic/pharmacodynamic (PK/PD) properties and defining optimal conditions of uses of the new generation of carbapenems.

Methods: Literature review.

Results: Except for ertapenem, the spectrum of activity is similar for all carbapenems, with little differences in activities of individual agents.

Alveolar diffusion and pharmacokinetics of linezolid administered in continuous infusion to critically ill patients with ventilator-associated pneumonia.

Objectives: This study aimed to determine the steady-state serum and alveolar concentrations of linezolid administered by continuous infusion to critically ill patients with ventilator-associated pneumonia (VAP).

Patients And Methods: This was a prospective, open-label study performed in an intensive care unit and research ward in a university hospital. Twelve critically ill adult patients with VAP received 600 mg of linezolid as a loading dose followed by 1200 mg/day by continuous infusion.

A sensitive liquid chromatography coupled with mass spectrometry method for the intracellular and plasma quantification of raltegravir after solid-phase extraction.

Introduction: Liquid chromatography coupled with mass spectrometry for the quantification of raltegravir in human plasma and peripheral blood mononuclear cells has been developed.

Methods: Sample preparations were based on a fully automated solid-phase extraction process. Mass spectrometric data were acquired in a single-ion monitoring method.

Pharmacokinetics of free ertapenem in critically ill septic patients: intermittent versus continuous infusion.

Background: The aim of this paper was to compare the pharmacokinetic and pharmacodynamic (PK/PD) parameters of continuous (CI) and intermittent infusion (ITI) of ertapenem into critically ill patients with severe abdominal infections.

Methods: Twenty septic patients hospitalized in a university hospital intensive care unit were enrolled in the study. Half of the patients received ertapenem as an ITI 1 g bolus once daily, and the other half of the patients received the same dose via CI over 24 h following a 1-g loading dose.

Drug selection in French university hospitals: analysis of formularies for nine competitive pharmacological classes.

Aim: To give a panorama of the selectivity and agreement of French university hospitals' drug formularies (HDF) for nine competitive classes.

Methods: All university hospitals were asked to send their HDF and selection criteria as of January 2009 for nine competitive pharmacological classes (proton pump inhibitors, serotonin antagonists, low molecular weight heparins, erythropoietins, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, statins, α-adrenoreceptor antagonists and selective serotonin re-uptake inhibitors). Selectivity of HDF was estimated by the percentage of drug entities selected by the hospital within the pharmacological class.

Quantitative analysis of erythropoietin in human plasma by tandem mass spectrometry.

The extended use of protein drugs in therapeutics has created the need for their quantification in human plasma. A methodology using the therapeutic protein itself as internal standard for quantitative analysis by multiple reaction monitoring (MRM) has been designed and applied to epoetin beta, a recombinant human erythropoietin (rhEPO). After depletion of major proteins, plasma samples were desalted and enriched in rhEPO by reversed phase liquid chromatography prior to tryptic cleavage.

Steady-state mycophenolate mofetil pharmacokinetic parameters enable prediction of systemic lupus erythematosus clinical flares: an observational cohort study.

Introduction: The aim of this study was to determine whether mycophenolate mofetil (MMF) pharmacokinetics (PK) under combined MMF and prednisone remission-maintenance therapy can predict systemic lupus erythematosus (SLE) clinical flares.

Methods: At inclusion, steady-state PK parameters of the MMF active form, mycophenolic acid (MPA), and its glucuronide metabolite (MPAG) were determined for 25 stable SLE patients without renal manifestations. Disease activity was assessed during 6 months of follow-up.

Therapeutic drug monitoring of mycophenolate mofetil and enteric-coated mycophenolate sodium in patients with systemic lupus erythematosus.

Objective: Mycophenolic acid (MPA), the active form of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), is used to treat systemic lupus erythematosus (SLE). MMF and EC-MPS pharmacokinetics were examined to devise guidance for therapeutic drug monitoring (TDM) for SLE patients with normal renal function.

Research Design And Methods: This observational study included 21 patients receiving MMF (1000 mg twice daily) and 14 taking EC-MPS (720 mg twice daily).

Activity of linezolid in an in vitro pharmacokinetic-pharmacodynamic model using different dosages and Staphylococcus aureus and Enterococcus faecalis strains with and without a hypermutator phenotype.

The influence of antibiotic dosages and bacterial mutator phenotypes on the emergence of linezolid-resistant mutants was evaluated in an in vitro pharmacokinetic-pharmacodynamic model. A twice-daily 0.5-h infusion of a 200-, 600-, or 800-mg dose for 48 h was simulated against four strains (MIC, 2 microg/ml): Staphylococcus aureus RN4220 and its mutator derivative MutS2, Enterococcus faecalis ATCC 29212, and a mutator clinical strain of E.