Design and implementation of clinical trials of antimicrobial drugs and devices used in periodontal disease treatment

The design and implementation of clinical trials (CTs) carried out to evaluate antimicrobial and anti-infective drugs and devices are one of the most difficult challenges in contemporary periodontal research and product development. The overwhelming amount of evidence which has established a microbial etiology for periodontitis is the basis for developing and testing antimicrobial treatments. Well-designed antimicrobial CTs start with a carefully crafted hypothesis and a protocol which explicitly integrates the requirements of the patient, the clinician, the sponsor, and regulatory authorities. Surrogate variables for effectiveness must be clinically relevant, scientifically sound, and statistically valid. Currently, clinical attachment level measurements and alveolar bone assessments are accepted as proof of effectiveness. Indication and claim support of the antimicrobial product guide the design and implementation of the CT. Adverse microbiologic consequences, such as lack of antimicrobial susceptibility, wrong spectrum, incorrect dosage, non-compliance, and drug interference, must be monitored. Successful CTs balance a large group of variables used to screen, randomize, and assign subjects to experimental and control groups to ensure that prognostic and risk factors are properly accounted for.     

An outbreak of hepatitis A among homosexual men in Melbourne

OBJECTIVE: To describe an outbreak of hepatitis A virus (HAV) infection that occurred in Melbourne in 1991. DESIGN: (i) We reviewed Health Department Victoria surveillance data from 1989 to 1991 (primary surveillance) and identified all notified cases of HAV infection with an onset of illness between 1 January and 31 December 1991 (secondary surveillance data). (ii) We studied HAV seroprevalence in Melbourne among homosexual men attending gay venues. RESULTS: (i) In the two years 1989-1990 there were only 55 notifications of HAV infection to Health Department Victoria, with a male:female ratio of 1.2:1. Of the 495 notifications for 1991, 407 (82%) were male, of whom 210 (52%) were known to be homosexual. Many reported sexual and social contact at Melbourne's gay venues and with the Sydney gay community. (ii) Of men attending gay venues, 27% had serological evidence of past infection with HAV, compared with 45.8% in a 1981 Melbourne study. CONCLUSION: The outbreak of HAV infection in Victoria largely affected homosexual males in their sexually active years. Contact with the Sydney gay community was commonly reported.     

ERCP and CT findings of ectopic drainage of the common bile duct into the duodenal bulb

OBJECTIVE: The purpose of this study was to evaluate ERCP and CT findings of ectopic drainage of the common bile duct into the duodenal bulb. CONCLUSION: Although rare, the diagnosis of ectopic drainage of the common bile duct into the duodenal bulb is important to prevent inadvertent damage during biliary tract or gastric surgery and to clarify the cause of chronic peptic ulcers.     

Prenatal diagnosis: update addresses technological advances

This is the second in a series of articles provided to the readers of PENNSYLVANIA MEDICINE as an update from researchers and clinicians in this cutting-edge medical field. The series is partially sponsored through a grant from the Pennsylvania Department of Health to the University of Pittsburgh Department of Human Genetics.     

An experimental pilot study of tacalcitol activities during modulation of parakeratotic skin features

Establishing guidelines and experimental models preclinical and clinical evaluations of new agents for treatment, and/or prevention of human diseases has become a task of crucial importance. Psoriasis is such one disease holding great interest for dermatology owing to its high rate of incidence and complexity of treatment. However the absence of psoriatic lesions in animals and the inability to induce them, calls for experimental techniques both in vitro and in vivo. The purpose of this study was to evaluate experimentally the effects of tacalcitol on cell proliferation and differentiation process. Thereafter a human pilot study on psoriatic patients has been developed.     

A case-mix classification system for medical rehabilitation

Dissatisfaction with Medicare's current system of paying for rehabilitation care has led to proposals for a rehabilitation prospective payment system, but first a classification system for rehabilitation patients must be created. Data for 36,980 patients admitted to and discharged from 125 rehabilitation facilities between January 1, 1990, and April 19, 1991, were provided by the Uniform Data System for Medical Rehabilitation. Classification rules were formed using clinical judgment and a recursive partitioning algorithm. The Functional Independence Measure version of the Function Related Groups (FIM-FRGs) uses four predictor variables: diagnosis leading to disability, admission scores for motor and cognitive functional status subscales as measured by the Functional Independence Measure, and patient age. The system contains 53 FRGs and explains 31.3% of the variance in the natural logarithm length of stay for patients in a validation sample. The FIM-FRG classification system is conceptually simple and stable when tested on a validation sample. The classification system contains a manageable number of groups, and may represent a solution to the problem of classifying medical rehabilitation patients for payment, facility planning, and research on the outcomes, quality, and cost of rehabilitation.     

Generativity and social motives in young adults.

Different forms of generativity in the writings of E. H. Erikson (1950/1963) and J. Kotre (1984) were related to agentic and communal motives in a sample of young adults (M?=?28 yrs old). For women, the power motive related to parenting, whereas the achievement motive was associated with forms of generative expression outside of the household. The opposite pattern of achievement and power motive relationships was found for men, although in a weaker form. The affiliation–intimacy motive, on the other hand, related both to women's parenting and societal concerns. Differences in expectations and opportunities for young men and women may account for these gender differences. The results for women support D. P. McAdams's (1988) suggestions that agency and communion are important for understanding generativity. In addition, the results provide evidence that people begin to grapple with generative issues as young adults. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Diagnostic imaging in the detection of parotid adenoma. Review of the literature and personal experience with the combined use of computerized tomography and MRI

In this report we reviewed the role of Ultrasonography, Computed Tomography, Magnetic Resonance and 99Tc-Sestamibi Scintigraphy for the detection of abnormal parathyroid glands in patients with biochemical evidence of hyperparathyroidism. We also report our personal experience with CT and RM.