Neonatal Safety Information Reported to the FDA During Drug Development Studies.

BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. METHODS: FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. RESULTS: The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. CONCLUSIONS: Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal population

Linking Animal Behavior to Useful Natural Repellents

A little monkey business is revealing a few clues about natural remedies that animals use to protect themselves against biting insects and arthropods. Certain species of animals, such as monkeys and birds, anoint themselves with citrus, other plants, and creatures like millipedes. To find out more about this behavior and to determine if any chemicals in the anointing substances effectively deter ticks and mosquitoes, scientists are examining responses to natural compounds. Scientists at the Agricultural Research Service Henry A. Wallace Beltsville [Maryland] Agricultural Research Center (BARC) and the Smithsonian Conservation Biology Institute (SCBI) at the National Zoological Park in Front Royal, Virginia, compared the effects of citrus compounds on lone star ticks and yellow fever mosquitoes. They also investigated compounds found in millipedes. Citing Citrus Effects “We tested a number of components known to be abundant in all citrus extracts, not just lemons, limes, and oranges, but all the fruits that are used in anointing— including citrus leaves,” says SCBI researcher Paul Weldon. Of the more than 20 citrus compounds they evaluated, the scientists found that 10 deterred ticks and/or mosquitoes, and 9 impaired basic tick behavior. Weldon used a feeding membrane module that he developed to test citrus compounds against mosquitoes. Some compounds were very effective. But the same compounds were not effective at all when mosquitoes were exposed to them in a wind tunnel module by chemist Ulrich “Uli” Bernier, in the Mosquito and Fly Unit at the ARS Center for Medical, Agricultural, and Veterinary Entomology in Gainesville, Florida. “We viewed the results of the wind tunnel as being more authentic,” Weldon says. “The compounds didn’t affect mosquitoes that much, but mainly affected ticks. It was a step forward in pinpointing what we believe is the reason that animals anoint themselves with citrus substances.

Linking Animal Behavior to Useful Natural Repellents

A little monkey business is revealing a few clues about natural remedies that animals use to protect themselves against biting insects and arthropods. Certain species of animals, such as monkeys and birds, anoint themselves with citrus, other plants, and creatures like millipedes. To find out more about this behavior and to determine if any chemicals in the anointing substances effectively deter ticks and mosquitoes, scientists are examining responses to natural compounds. Scientists at the Agricultural Research Service Henry A. Wallace Beltsville [Maryland] Agricultural Research Center (BARC) and the Smithsonian Conservation Biology Institute (SCBI) at the National Zoological Park in Front Royal, Virginia, compared the effects of citrus compounds on lone star ticks and yellow fever mosquitoes. They also investigated compounds found in millipedes. Citing Citrus Effects “We tested a number of components known to be abundant in all citrus extracts, not just lemons, limes, and oranges, but all the fruits that are used in anointing— including citrus leaves,” says SCBI researcher Paul Weldon. Of the more than 20 citrus compounds they evaluated, the scientists found that 10 deterred ticks and/or mosquitoes, and 9 impaired basic tick behavior. Weldon used a feeding membrane module that he developed to test citrus compounds against mosquitoes. Some compounds were very effective. But the same compounds were not effective at all when mosquitoes were exposed to them in a wind tunnel module by chemist Ulrich “Uli” Bernier, in the Mosquito and Fly Unit at the ARS Center for Medical, Agricultural, and Veterinary Entomology in Gainesville, Florida. “We viewed the results of the wind tunnel as being more authentic,” Weldon says. “The compounds didn’t affect mosquitoes that much, but mainly affected ticks. It was a step forward in pinpointing what we believe is the reason that animals anoint themselves with citrus substances.

Avant-Nilla: Don\u27t We All

https://scholarworks.moreheadstate.edu/student_scholarship_posters/1252/thumbnail.jp

Perceptions of Judicial Bias in the Mississippi Judiciary

The purpose of this study is to explore Mississippians’ opinions towards the Mississippi state judiciary and further examine any differences in such opinions across race, gender, knowledge, and education levels. In doing so, it is possible to gain further understanding of the ways that historical context and knowledge influence perceptions of the state judiciary. Data collected from an anonymous survey of approximately 500 individuals shed some light on the perceptions Mississippians have towards the state judiciary. While many of the results were generalizable across various demographics, African Americans consistently held more negative views of their state judiciary than their White counterparts. Responses showed that race was the most important factor in understanding opinions of the Mississippi judiciary, while knowledge, gender, and education level proved to be less important

Responding to Tripadvisor: How Hotel Responses to Negative Online Reviews Effect Hotel Image, Intent to Stay, and Intent to Return

Online guest reviews have become an important facet of consideration when guests decide on a hotel. Similarly, research has been done that shows a correlation between guest satisfaction and hotel responses to online reviews. However, little research has been done to show specifically how hotel management responses to comments posted on online review sites such as Tripadvisor influence guest intent to stay. This study will investigate how guest perception of hotel image, guest intent to stay, and guest intent to return are impacted by hotel responses to negative online feedback. The data reveals that providing a service recovery response to negative online reviews increases guest perception of image, guest intent to stay, and guest return intent. Similarly, the study found that guest perception of image was a predictor for guest intent to stay and guest return intent; and that in certain scenarios, overall perception of the hotel also predicted intent to stay and return. The current study examines these relationships and provides implications for practitioners and academics

Client Satisfaction Survey for HIV/AIDS Dental Care Services: An Example from Rural Texas

The challenges to examining client satisfaction are demonstrated through an evaluation of dental services provided by a regional service provider to people living with HIV/AIDS. The process of developing and administering a measure of client satisfaction is discussed. Forty-one of 350 (11.7%) dental clients chose to participate. Quantitative and qualitative data suggests that overall participants are satisfied with services. Identified concerns included a lack of specialized dental, medical, mental health, and case management services. Implications of the study for service delivery, future evaluations, and rural social work practice are addressed