Smallpox Vaccination of Laboratory Workers at US Variola Testing Sites

To evaluate the need to revaccinate laboratory workers against smallpox, we assessed regular revaccination at the US Laboratory Response Network’s variola testing sites by examining barriers to revaccination and the potential for persistence of immunity. Our data do not provide evidence to suggest prolonging the recommended interval for revaccination.     

How do researchers decide early clinical trials?

Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research.     

A review of in vitro and in vivo methods and their correlations to assess mouthfeel of solid oral dosage forms

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Pharmacotherapeutic options for kidney disease in HIV positive patients

ABSTRACT

Introduction

Since the developmentof combined antiretroviral therapy (cART), HIV-associated mortality and the incidence of HIV-associated end-stage kidney disease (ESKD) has decreased. However, in the United States, an increase in non-HIV-associated kidney diseases within the HIV-positive population is expected.     

Ventricular peritoneal shunt malfunction after operative correction of scoliosis: report of three cases

Background contextTwo of the most common disease processes associated with hydrocephalus in children are spina bifida and intraventricular hemorrhage of prematurity, both of which are known to be also associated with spinal deformity in later childhood. The occurrence of shunt malfunction after mechanical injury or stress to the hardware has been well documented. Newer techniques in the treatment of neuromuscular scoliosis, including anterior release with segmental fixation, have resulted in more powerful corrections of these large spinal deformities. A new potential cause of shunt malfunction is the aggressive correction of scoliosis.PurposeTo report patients with neuromuscular curves averaging 100° who were subsequently recognized to have perioperative shunt malfunction.Study designThree case studies from a university hospital setting were included.Patient sampleAll three children were young adolescents and had-long term shunts. Two of the children had spina bifida and a third had cerebral palsy. All children underwent anterior release of their scoliosis with posterior segmental instrumentation, with unit rods and sublaminar wires. All had significant correction of their scoliosis.Outcome measuresMalfunctioning of the ventriculoperitoneal shunts were recorded.MethodsChart reviews of three cases were analyzed.ResultsTwo children had shunt malfunctions within a month of their surgery, and one child had intraoperative recognition and externalization of the shunt.ConclusionsOlder children undergoing repair of neuromuscular scoliosis are often preadolescents or adolescents who have the same indwelling shunt systems originally implanted in early infancy. The shunt may be brittle and calcified, and the peritoneal catheter may be short. The correction of scoliosis often results in an almost instantaneous growth of a few inches. Because of the potential difficulty in recognizing shunt malfunction in the perioperative period, consideration should be given for elective revision of the peritoneal catheter in children at risk.     

Difficulties in Differentiating Coronaviruses from Subcellular Structures in Human Tissues by Electron Microscopy

Efforts to combat the coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have placed a renewed focus on the use of transmission electron microscopy for identifying coronavirus in tissues. In attempts to attribute pathology of COVID-19 patients directly to tissue damage caused by SARS-CoV-2, investigators have inaccurately reported subcellular structures, including coated vesicles, multivesicular bodies, and vesiculating rough endoplasmic reticulum, as coronavirus particles. We describe morphologic features of coronavirus that distinguish it from subcellular structures, including particle size range (60–140 nm), intracellular particle location within membrane-bound vacuoles, and a nucleocapsid appearing in cross section as dense dots (6–12 nm) within the particles. In addition, although the characteristic spikes of coronaviruses may be visible on the virus surface, especially on extracellular particles, they are less evident in thin sections than in negative stain preparations.