Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.

Background And Objectives: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures.

Cerebral hypomyelination associated with biallelic variants of FIG4.

The lipid phosphatase gene FIG4 is responsible for Yunis-Varón syndrome and Charcot-Marie-Tooth disease Type 4J, a peripheral neuropathy. We now describe four families with FIG4 variants and prominent abnormalities of central nervous system (CNS) white matter (leukoencephalopathy), with onset in early childhood, ranging from severe hypomyelination to mild undermyelination, in addition to peripheral neuropathy. Affected individuals inherited biallelic FIG4 variants from heterozygous parents.

The Relationship Between Parent Drinking and Adolescent Drinking: Differences for Mothers and Fathers and Boys and Girls.

Background: Gender differences in the relationship between parent drinking and adolescent drinking are poorly understood. As parental alcohol use is a primary early exposure to alcohol for adolescents, it is important to understand how consequences may differ for adolescent males and females.

Objectives: The aim of this paper was to examine gender differences in the relationship between mother's and father's heavy episodic drinking, and its combination, and adolescent drinking.

Real world data on effectiveness, safety and therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease. A single center cohort.

Background And Aims: The efficacy of vedolizumab (VDZ) has been demonstrated in clinical trials. The aim of this report is to evaluate the long-term effectiveness and safety of VDZ in a real-world cohort and to explore possible associations between concentration measurements of VDZ and treatment effectiveness.

Methods: This is a prospective clinical follow-up including all adult patients with ulcerative colitis (UC) and Crohn's disease (CD) treated with VDZ from October 2014 until September 2017 at a single center in Norway.

A Fully Automated Method for the Determination of Serum Belatacept and Its Application in a Pharmacokinetic Investigation in Renal Transplant Recipients.

Background: Belatacept (Nulojix; Bristol-Myers Squibb, New York, NY) is a biological immunosuppressive drug used for the prophylaxis of acute rejection after renal transplantation. Few studies have described belatacept pharmacokinetics, and the effect of therapeutic drug monitoring has not been investigated. We have developed a drug-capture assay (using drug target) to measure belatacept in serum and applied this assay in a pharmacokinetic study in renal transplant recipients.

Incidence and etiology of fever following seasonal influenza vaccination in hospitalized patients.

We conducted a retrospective cohort to examine the incidence and etiology of fever postinfluenza vaccination among hospitalized patients during the 2015-2016 influenza season. Fever occurred in 63 (1.5%) of 4,185 vaccinated patients.

Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain.

Background: Pelvic floor myofascial pain is common, but physical examination methods to assess pelvic floor muscles are defined poorly. We hypothesized that a simple, transvaginal pelvic floor examination could be developed that would be highly reproducible among providers and would adequately screen for the presence of pelvic floor myofascial pain.

Objective: The purpose of this study was to develop a simple, reproducible pelvic floor examination to screen for pelvic floor myofascial pain.

A Nonionic Polyethylene Oxide (PEO) Surfactant Model: Experimental and Molecular Dynamics Studies of Kolliphor EL.

Polyethoxylated, nonionic surfactants are important constituents of many drug formulations, including lipid-based formulations. In an effort to better understand the behavior of formulation excipients at the molecular level, we have developed molecular dynamics (MD) models for the widely used surfactant Kolliphor EL (KOL), a triricinoleate ester of ethoxylated glycerol. In this work, we have developed models based on a single, representative molecular component modeled with 2 force field variations based on the GROMOS 53A6 and 2016H66 force field parameters for polyethoxylate chains.

Apple Pomace Consumption Favorably Alters Hepatic Lipid Metabolism in Young Female Sprague-Dawley Rats Fed a Western Diet.

Apple pomace, which is a waste byproduct of processing, is rich in several nutrients, particularly dietary fiber, indicating potential benefits for diseases that are attributed to poor diets, such as non-alcoholic fatty liver disease (NAFLD). NAFLD affects over 25% of United States population and is increasing in children. Increasing fruit consumption can influence NAFLD.

Niche Estimation Above and Below the Species Level.

Ecological niches reflect not only adaptation to local circumstances but also the tendency of related lineages to share environmental tolerances. As a result, information on phylogenetic relationships has underappreciated potential to inform ecological niche modeling. Here we review three strategies for incorporating evolutionary information into niche models: splitting lineages into subunits, lumping across lineages, and partial pooling of lineages into a common statistical framework that implicitly or explicitly accounts for evolutionary relationships.

Improvement in the Predicted Partitioning of Alcohol and Polyethylene Oxide Groups Between Water and Octanol (logP) in Molecular Dynamics Simulations.

Molecular dynamics simulations can be applied to explore the complex liquid phase behavior of lipid-based formulations and the gastrointestinal tract lumen. In order for the results from these simulations to be of value, the manner in which molecules interact with both aqueous and oil phases present needs to be as correct as possible. An existing molecular dynamics force field, GROMOS 53a6, was demonstrated to poorly reproduce the partitioning of straight-chain alcohol and short-chain polyethylene glycol (PEG) molecules between octanol and water phase (logP), with the molecules too hydrophobic.

Variation in Identifying Sepsis and Organ Dysfunction Using Administrative Versus Electronic Clinical Data and Impact on Hospital Outcome Comparisons.

Objectives: Administrative claims data are commonly used for sepsis surveillance, research, and quality improvement. However, variations in diagnosis, documentation, and coding practices for sepsis and organ dysfunction may confound efforts to estimate sepsis rates, compare outcomes, and perform risk adjustment. We evaluated hospital variation in the sensitivity of claims data relative to clinical data from electronic health records and its impact on outcome comparisons.

Acquisition of Neural Action Potentials Using Rapid Multiplexing Directly at the Electrodes.

Neural recording systems that interface with implanted microelectrodes are used extensively in experimental neuroscience and neural engineering research. Interface electronics that are needed to amplify, filter, and digitize signals from multichannel electrode arrays are a critical bottleneck to scaling such systems. This paper presents the design and testing of an electronic architecture for intracortical neural recording that drastically reduces the size per channel by rapidly multiplexing many electrodes to a single circuit.

Location of Solvated Probe Molecules Within Nonionic Surfactant Micelles Using Molecular Dynamics.

An iconic textbook that pharmaceutical scientists encounter in undergraduate courses is "Martin's Physical Pharmacy and Pharmaceutical Sciences." Within the chapter on Colloids, a figure indicates the location of solubilization of molecules within spherical, nonionic surfactant micelles. The surfactant consists of polyethylene glycol (PEG) hydrophilic headgroups and alkane chains for the hydrophobic tail.

Addiction Medicine Consultations Reduce Readmission Rates for Patients With Serious Infections From Opioid Use Disorder.

The opioid epidemic has increased hospital admissions for serious infections related to opioid abuse. Our findings demonstrate that addiction medicine consultation is associated with increased treatment for opioid use disorder (OUD), greater likelihood of completing antimicrobial therapy, and reduced readmission rates among patients with OUD and serious infections requiring hospitalization.

Free Radical Scavenging Capacity, Carotenoid Content, and NMR Characterization of Aril Oil.

aril oil is rich in monounsaturated fatty acids but is however currently not utilized industrially. The oil was characterized utilizing nuclear magnetic resonance (NMR) and Fourier Transform Infrared Spectroscopy (FTIR). A spectrophotometric assay was conducted to determine the free radical scavenging properties and carotenoid content of the oil.

Determining the impact of a bowel management protocol on patients and clinicians' compliance in cardiac intensive care: A mixed-methods approach.

Background: Bowel management protocols standardise care and, potentially, improve the incidence of diarrhoea and constipation in intensive care. However, little research exists reporting compliance with such protocols in intensive care throughout patients' stay. Furthermore, there is a limited exploration of the barriers and enablers to bowel management protocols following their implementation, an important aspect of improving compliance.

Transfusion of leukoreduced blood products and risk of antibody-mediated rejection of renal allografts.

Background: Antibody-mediated rejection (AMR) is a major barrier to the long-term function of renal allografts. White blood cells, which may be present in red blood cell (RBC) units, and platelets (PLTs) express HLA antigens that may increase the risk of AMR by inducing or increasing humoral sensitization to HLA.

Study Design And Methods: A retrospective cohort study of HLA-incompatible (HLAi) renal transplant recipients between 2004 and 2015 was conducted.

Pro-gastrin-releasing peptide and outcome in patients with heart failure and anaemia: results from the RED-HF study.

Aims: Neuroendocrine activation is associated with poor outcome in heart failure (HF). The neuropeptide gastrin-releasing peptide (GRP), derived from the precursor proGRP1-125 (proGRP), has recently been implicated in inflammation and wound repair. We investigated the predictive value of proGRP on clinical outcomes in HF patients with reduced ejection fraction.

Decreasing fire season precipitation increased recent western US forest wildfire activity.

Western United States wildfire increases have been generally attributed to warming temperatures, either through effects on winter snowpack or summer evaporation. However, near-surface air temperature and evaporative demand are strongly influenced by moisture availability and these interactions and their role in regulating fire activity have never been fully explored. Here we show that previously unnoted declines in summer precipitation from 1979 to 2016 across 31-45% of the forested areas in the western United States are strongly associated with burned area variations.

Selective Decrease in Allodynia With High-Frequency Neuromodulation via High-Electrode-Count Intrafascicular Peripheral Nerve Interface After Brachial Plexus Injury.

Objectives: Kilohertz high-frequency alternating current (KHFAC) electrical nerve stimulation produces a reversible nerve block in peripheral nerves in human patients with chronic pain pathologies. Although this stimulation methodology has been verified with nonselective extrafascicular electrodes, the effectiveness of producing a selective nerve block with more-selective intrafascicular electrodes has not been well documented. The objective of this study was to examine whether intrafascicular electrodes can block painful stimuli while preserving conduction of other neural activity within the implanted nerve.