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Biomedical subjects

G Burkhart

Publications and source records attributed to G Burkhart.

8 recordsLinked to original sources

Mortality in antiepileptic drug development programs.

BACKGROUND: Pooled data from New Drug Applications (NDAs) submitted to the U.S. Food and Drug Administration (FDA) provide an opportunity to study the incidence of and risk factors for rare events. OBJECTIVE: To examine the incidence and causes of mortality in patients with epilepsy participating in clinical trials of antiepileptic drugs (AEDs); and to examine the incidence of and risk factors for sudden unexplained death in such patients. METHODS: Exposure data and death narratives were obtained from the NDAs of five recently reviewed AEDs. Deaths were classified as sudden unexplained, accidental, or other cause using the 1993 Burroughs-Wellcome expert panel criteria, and mortality rates were calculated for each category. Add-on trials were analyzed separately from monotherapy initiation trials. RESULTS: Among 9,144 patients in the add-on trial database, the all-cause and sudden unexplained mortality rates were 9.1 and 3.8 deaths per 1,000 person-years (124 and 52 deaths in 13,617.1 person-years of drug exposure). Sixty-five percent of all deaths were related to the underlying epilepsy. Of the examined risk factors, only age was associated with the incidence of sudden unexplained death. Among 1,293 patients in the monotherapy initiation trials, the all-cause and sudden unexplained mortality rates were 7.1 and 0 deaths per 1,000 person-years (7 and 0 deaths in 982.5 person-years of drug exposure). CONCLUSIONS: A large proportion of the deaths in the add-on cohort was attributable to epilepsy-related causes. Mortality due to sudden death in the add-on cohort falls into the high end of the reported range for patients with epilepsy. The difference in mortality due to sudden death between the add-on and monotherapy initiation cohorts suggests that disease severity is the primary determining factor for risk of sudden unexplained death.

Adolescent↗

[Not Available].

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Africa↗

Job tasks, potential exposures, and health risks of laborers employed in the construction industry.

Construction laborers have some of the highest death rates of any occupation in the United States. There has been very little systematic research focused exclusively on "laborers" as opposed to other workers in the construction industry. We reviewed the English language literature and various data bases describing the occupational tasks, exposures, and work-related health risks of construction laborers. The sources of information included 1) occupational mortality surveillance data collected by the states of California and Washington and the National Institute for Occupational Safety and Health (NIOSH); 2) National Occupational Exposure Survey; 3) national fatality data; 4) cancer registry data; and 5) case reports of specific causes of morbidity. While the literature reported that construction laborers have increased risk for mesothelioma, on-the-job trauma, acute lead poisoning, musculoskeletal injury, and dermatitis, the work relatedness of excess risks for all-cause mortality, cirrhosis, cerebrovascular disease, chronic obstructive pulmonary disease, ischemic heart disease, and leukemia is less clear. Furthermore, while laborers are known to be potentially exposed to asbestos, noise, and lead, and the NIOSH Job Exposure Matrix describes other potential hazardous exposures, little research has characterized other possible exposures and no research has been found that describes the exposures associated with specific job tasks. More advanced study designs are needed that include a better understanding of the job tasks and exposures to construction laborers, in order to evaluate specific exposure-disease relationships and to develop intervention programs aimed at reducing the rate of work-related diseases.

Facility Design and Construction↗

Perforated pseudomembranous colitis in the breast-fed infant.

Pseudomembranous colitis (PMC) is uncommon in the infant and complications requiring surgical intervention are rare. All prior cases have involved the direct administration of antibiotics to the child. A 2-month-old girl required bowel resection for perforation of a thickened and inflamed left colon. Findings were consistent with PMC and the stool was Clostridium difficile toxin positive. The patient was treated with vancomycin and did well. The patient's mother later admitted to self-administration of ciprofloxacin while breast-feeding her infant. Oral doses of this drug are concentrated in breast milk at levels higher than serum. Antibiotics derived from breast milk can cause complicated PMC in the infant. A directed history can establish an early diagnosis and help distinguish PMC from other more common infantile enterocolitides.

Breast Feeding↗

Progressive supranuclear palsy: the relationship between ocular motor dysfunction and psychological test performance.

The performance of patients with progressive supranuclear palsy on visual search and scanning tasks was related to the pattern of ocular deficits observed in these patients during horizontal refixation. Comparisons were made to age-matched normals and patients with Parkinson disease or cerebellar damage. The poor performance of the progressive supranuclear palsy group on visual search and scanning could not be attributed to the restricted range of vertical gaze or the large number of hypometric saccades during horizontal refixation. Instead, we believe that their impaired scanning resulted from the presence of square-wave jerks during attempted fixation.

Bulbar Palsy, Progressive↗

The effects of institutionalisation on retardates social independence.

Subjects were grouped into eight experimental groups to control for mental age (MA) and chronological age (CA) and at the same time to allow the examination of the effects due to the proportion of lifetime spent institutionalised on an objective measure of social dependency. The results suggest that the longer proportion of life-time institutionalised, the more likely the retardate is to be socially dependent. The implications of this finding for retardates in institutional settings is discussed.

Female↗

A report card on diversity: lessons for business from higher education.

Institutions of higher learning in the United States have long played a disproportionate role in supplying leadership talent to the world's business and professional organizations. For 30 years, the most selective schools have been working to increase diversity in their student bodies. New research by the former presidents of Princeton and Harvard suggests that the experiences and initiatives of these academic institutions can provide business leaders with insight into how to create diverse organizations that succeed. The first insight has to do with clarity of mission. It is not enough to pursue diversity because it is "the right thing to do." In an insert, Raymond Gilmartin, the CEO of Merck, echoes that view, discussing the relationship between diversity and Merck's competitiveness. The second insight concerns recruiting. The authors challenge what they call "the myth of pure merit," the notion that recruiting is a precise science based only on grades and test scores. Instead, they argue, merit is about assembling a team by deciding which applicants, considered individually and collectively, will contribute most to achieving the company's goals. The third insight concerns how organizations help employees perform to their potential. Of the factors contributing to high graduation rates at the most selective schools, higher expectations and the efforts of mentors stand out as most important. Finally, the fourth insight is about how to achieve accountability in a corporate setting. Boards must ask: Are our recruiting policies working? and How are recruited employees doing?

Administrative Personnel↗