Background: We evaluated the fully human polyclonal antibody product SAB-185 in a phase 3 trial for COVID-19.
Methods: Nonhospitalized high-risk adults within 7 days of symptom onset were randomized 1:1 to open-label SAB-185 3840 units/kg or casirivimab/imdevimab 1200 mg. Noninferiority comparison was undertaken for pre-Omicron population (casirivimab/imdevimab expected to be fully active) and superiority comparison for the Omicron population (casirivimab/imdevimab not expected to be active).
Context: Viscoelastic hemostatic assays (VHA) are commonly used to identify specific cellular and humoral causes for bleeding in cardiac surgery patients. Cardiopulmonary bypass (CPB) alterations to coagulation are observable on VHA. Citrated VHA can approximate fresh whole blood VHA when kaolin is used as the activator in healthy volunteers.
View Article and Find Full Text PDFBackground: Ruxolitinib cream is a topical formulation of ruxolitinib, an inhibitor of Janus kinase 1 and Janus kinase 2.
Objective: We aimed to determine the safety, tolerability, and bioavailability of 1.5% ruxolitinib cream under maximum-use conditions in patients with atopic dermatitis.
Introduction: Facing the COVID-19 pandemic, many hospitals implemented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening protocols before aerosol-generating procedures (AGPs) in an effort to protect patients and health care workers. Given the limited prior evidence on the effectiveness of such protocols, we report the process improvement experience at a military treatment facility.
Materials And Methods: We evaluated the outcomes of patients undergoing AGPs from March to September 2020, divided into three cohorts: a preprotocol (PP) cohort who did not receive screening, an early testing (ET) cohort representing the early months of the screening protocol, and a late testing (LT) cohort managed under adaptive modifications to the screening protocol.
Background: The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.
Methods: In this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.
Results: A total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants).
Study Design: Longitudinal Cohort Study OBJECTIVE.: The aim of this study was to determine whether duration of postoperative opioids is associated with long-term outcomes, and if initial postoperative opioid dosage is associated with opioid cessation after spine surgery.
Summary Of Background Data: Preoperative opioid use is associated with poor outcomes, but little evidence exists regarding the implications of opioid dosage and duration after spine surgery.
Background Context: No consensus exists for defining chronic preoperative opioid use. Most spine studies rely solely on opioid duration to stratify patients into preoperative risk categories.
Purpose: The purpose of this study is to compare established opioid definitions that contain both duration and dosage to opioid models that rely solely on duration, including the CDC Guideline for Prescribing Opioids for Chronic Pain, in patients undergoing spine surgery.
Study Design: Longitudinal Cohort Study.
Objective: Determine 1-year patient-reported outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosages in patients undergoing elective spine surgery.
Summary Of Background Data: Back pain is the most disabling condition worldwide and over half of patients presenting for spine surgery report using opioids.
Germination timing has a strong influence on direct seeding efforts, and therefore is a closely tracked demographic stage in a wide variety of wildland and agricultural settings. Predictive seed germination models, based on soil moisture and temperature data in the seed zone are an efficient method of estimating germination timing. We utilized Visual Basic for Applications (VBA) to create Auto-Germ, which is an Excel workbook that allows a user to estimate field germination timing based on wet-thermal accumulation models and field temperature and soil moisture data.
View Article and Find Full Text PDFAm J Health Syst Pharm
December 2017
Purpose: Results of a quality-improvement project to enhance safeguards against "wrong-pen-to-patient" insulin pen errors by permitting secure bedside storage of insulin pens are reported.
Methods: A cluster-randomized controlled evaluation was conducted at an academic medical center to assess adherence with institutional policy on insulin pen storage before and after implementation of a revised policy allowing pen storage in locking boxes in patient rooms. In phase 1 of the study, baseline data on policy adherence were captured for 8 patient care units (4 designated as intervention units and 4 designated as control units).
Background: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.
Objective: To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302).
Methods: Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated.
Background: The costs and outcomes following degenerative spine surgery may vary from surgeon to surgeon. Patient factors such as comorbidities may increase the health care cost. These variations are not well studied.
View Article and Find Full Text PDFBackground: Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.
Objective: We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).
Methods: Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days.
Background: Phosphodiesterase-4 (PDE4) is a promising target in atopic dermatitis (AD) treatment. The pharmacokinetics (PK), safety, and efficacy of crisaborole topical ointment, 2% (formerly AN2728) (Anacor Pharmaceuticals, Palo Alto, CA), a boron-based benzoxaborole PDE4 inhibitor, were evaluated in children with mild to moderate AD.
Methods: This phase 1b, open-label, maximal-use study of crisaborole topical ointment, 2% applied twice daily (dose 3 mg/cm(2) ) for 28 days enrolled patients ages 2 to 17 years with extensive AD involving 25% or more or 35% or more treatable body surface area, depending on age.
Sensitized SrTiO3 films were evaluated as potential photoanodes for dye-sensitized photoelectrosynthesis cells (DSPECs). The SrTiO3 films were grown via pulsed laser deposition (PLD) on a transparent conducting oxide (fluorine-doped tin oxide, FTO) substrate, annealed, and then loaded with zinc(II) 5,10,15-tris(mesityl)-20-[(dihydroxyphosphoryl)phenyl] porphyrin (MPZnP). When paired with a platinum wire counter electrode and an Ag/AgCl reference electrode these sensitized films exhibited photocurrent densities on the order of 350 nA/cm(2) under 0 V applied bias conditions versus a normal hydrogen electrode (NHE) and 75 mW/cm(2) illumination at a wavelength of 445 nm.
View Article and Find Full Text PDFObjective: To investigate the use of a trigger tool for the detection of adverse drug events (ADE) in a pediatric hospital specializing in oncology, hematology, and other catastrophic diseases.
Study Design: A medication-based trigger tool package analyzed electronic health records from February 2009 to February 2013. Chart review determined whether an ADE precipitated the trigger.
Adapting the 'Lean' methodologies used for many years by many manufacturers on the production line - such as in the automotive industry - and deploying them in healthcare 'spaces' can, Roger Call, an architect at Herman Miller Healthcare in the US, argues, 'easily remedy many of the inefficiencies' found within a healthcare facility. In an article that first appeared in the September 2013 issue of The Australian Hospital Engineer, he explains how 'Lean' approaches such as the 'Toyota production system', and 'Six Sigma', can be harnessed to good effect in the healthcare sphere.
View Article and Find Full Text PDFObjective: The research was conducted to determine clinician knowledge needs for competent involvement with the facility design process as well as to gather lessons learned on building stronger design teams.
Background: As clinical stakeholders are invited to the healthcare facility design table, the question arises as to the ability of professionally diverse team members to translate each other's comments and ideas accurately. In the past, hospitals were designed by a handful of hospital leaders and architects.
Phthalocyanines, a class of macrocyclic, square planar molecules, are extensively studied as semiconductor materials for chemical sensors, dye-sensitized solar cells, and other applications. In this study, we use angular dependent near-edge x-ray absorption fine structure (NEXAFS) spectroscopy as a quantitative probe of the orientation and electronic structure of H2-, Fe-, Co-, and Cu-phthalocyanine molecular thin films. NEXAFS measurements at both the carbon and nitrogen K-edges reveal that phthalocyanine films deposited on sapphire have upright molecular orientations, while films up to 50 nm thick deposited on gold substrates contain prostrate molecules.
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