Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
24
result(s) for
"Randolph, Ryan P"
Sort by:
How to save and invest
Shares information on investing, including what bonds are, what stocks are, and what mutual funds are.
Book
Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents
Investigators used a case–control, test-negative design to assess the effectiveness of the BNT162b2 vaccine in adolescents for the prevention of Covid-19–related hospitalization, ICU admission, or receipt of life support. Among 445 case patients and 777 controls, of the 180 patients admitted to an ICU, only 2 had been fully vaccinated; all 7 deaths occurred in unvaccinated patients.
Journal Article
How to spend smart
Teaches young readers how to use their money wisely, including how to follow a budget, how to be savvy about advertising, and how to understand return policies.
Book
Safety and pharmacokinetics of islatravir subdermal implant for HIV-1 pre-exposure prophylaxis: a randomized, placebo-controlled phase 1 trial
Islatravir (MK-8591) is a highly potent type 1 human immunodeficiency virus (HIV-1) nucleoside reverse transcriptase translocation inhibitor with a long intracellular half-life that is in development for the prevention and treatment of HIV-1. We conducted a randomized, double-blind, placebo-controlled, phase 1 trial in adults without HIV-1 infection. Participants received islatravir or placebo subdermal implants for 12 weeks and were monitored throughout this period and after implant removal. The co-primary end points were safety and tolerability of the islatravir implant and pharmacokinetics, including concentration at day 85, of islatravir triphosphate in peripheral blood mononuclear cells (PBMCs). Secondary end points included additional pharmacokinetic parameters for islatravir triphosphate in PBMCs and the plasma pharmacokinetic profile of islatravir. Based on preclinical data, two doses were assessed: 54 mg (
n
= 8, two placebo) and 62 mg (
n
= 8, two placebo). The most frequently reported adverse events were mild-to-moderate implant-site reactions (induration, hematoma, pain). Throughout the 12-week trial, geometric mean islatravir triphosphate concentrations were above a pharmacokinetic threshold of 0.05 pmol per 10
6
PBMCs, which was estimated to provide therapeutic reverse transcriptase inhibition (concentration at day 85 (percentage of geometric coefficient of variation): 54 mg, 0.135 pmol per 10
6
cells (27.3); 62 mg, 0.272 pmol per 10
6
cells (45.2)). Islatravir implants at both doses were safe and resulted in mean concentrations above the pharmacokinetic threshold through 12 weeks, warranting further investigation of islatravir implants as a potential HIV prevention strategy.
A subdermal implant of the HIV-1 antiretroviral islatravir delivers sustained drug release over 12 weeks in humans.
Journal Article
How to make a budget
Describes to young readers how to make a budget, including keeping track of income, fixed expenses vs. flexible expenses, and how a budget can be used to reach goals.
Book
Safety and Pharmacokinetics of MK‐8527 in Adults Without HIV
ABSTRACT
MK‐8527 is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) in clinical development. Two Phase 1 trials evaluated single (trial A) and multiple (trial B) ascending doses of MK‐8527 in adults without HIV. In trial A, 34 participants were assigned to 1 of 4 panels and randomized to receive single oral doses of MK‐8527 (0.5–200 mg) or placebo after fasting, over 3 dosing periods; 25 mg was assessed after a high‐fat meal. In trial B, 32 participants were randomized to receive 3 once‐weekly (QW) oral doses of MK‐8527 (between 5 and 40 mg) or placebo. Safety and pharmacokinetics (PK) of MK‐8527 and MK‐8527‐triphosphate (TP) were assessed. MK‐8527 was generally well tolerated with no serious adverse events. Plasma exposure of MK‐8527 increased approximately dose‐proportionally, and intracellular exposure of MK‐8527‐TP was slightly less than dose‐proportional over administered doses between 5 and 200 mg. Participants who received MK‐8527 with a meal showed a 41% decrease in Cmax with no effect on AUC0–168, and a 20%, 22%, and 58% increase in intracellular MK‐8527‐TP Cmax, C168, and AUC0–168, respectively. Across QW doses, plasma MK‐8527 median Tmax ranged from 0.5 to 1 h, and t1/2 was 24–81 h; MK‐8527‐TP median Tmax ranged from 10 to 24 h on Day 15, and geometric mean apparent t1/2 was 216–291 h. Accumulation of intracellular MK‐8527‐TP was modest (accumulation ratios [Day 15/Day 1] for Cmax and AUC0–168 ranged from 1.1 to 1.6; C168 from 1.2 to 2.4). Single and multiple QW doses of MK‐8527 were generally well tolerated in adults without HIV. The safety and PK profiles of MK‐8527 support continued clinical development.
Trial Registration: EudraCT numbers: 2016‐004647‐36 (trial A); 2018‐000846‐20 (trial B)
Journal Article
Maternal Vaccination and Risk of Hospitalization for Covid-19 among Infants
In this study, maternal vaccination with an mRNA vaccine during pregnancy was less common among infants hospitalized for Covid-19 than among controls. The effectiveness of maternal vaccination against Covid-19 hospitalization of infants was 52% overall and was greater when delta, rather than omicron, was predominant.
Journal Article
Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12–18 Years — United States, July–December 2021
Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5),
and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design
among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children.
Journal Article
Acquired left-to-right shunting through a valve-incompetent foramen ovale in a cat with hypertrophic cardiomyopathy and congestive heart failure
Case summary An 8-year-old spayed female domestic shorthair cat was presented for a recheck evaluation of hypertrophic cardiomyopathy and chronic kidney disease. Three years prior to presentation, the patient was diagnosed with obstructive hypertrophic cardiomyopathy and started on atenolol. The left ventricular outflow tract obstruction subsequently resolved. Biochemical analysis a week prior to presentation demonstrated severe azotemia. Transthoracic echocardiograph revealed pericardial effusion, pleural effusion, severe left ventricular concentric hypertrophy, severe left atrial enlargement and continuous left-to-right flow through the interatrial septum near the fossa ovalis. The patient was euthanized owing to poor prognosis, and gross examination at necropsy revealed a valve-incompetent patent foramen ovale secondary to severe left atrial dilation. Relevance and novel information To our knowledge, this is the first report of an acquired left-to-right shunt through a valve-incompetent foramen ovale in a cat with hypertrophic cardiomyopathy. Severe left atrial dilation was suspected to cause interatrial shunting through the valve-incompetent foramen ovale, and this finding may be relevant to echocardiographic evaluations in other cats.
Journal Article