(1/3910) Standardized nomenclature for inbred strains of mice: sixth listing.
Rules for designating inbred strains of mice are presented, along with a list of strains with their origins and characteristics, a table of biochemical polymorphisms, and standard subline designations. (+info)
(2/3910) Rejection of Clostridium putrificum and conservation of Clostridium botulinum and Clostridium sporogenes-Opinion 69. Judicial Commission of the International Committee on Systematic Bacteriology.
The Judicial Commission rejected the name Clostridium putrificum while conserving Clostridium botulinum for toxigenic strains and conserving Clostridium sporogenes for non-toxigenic strains. (+info)
(3/3910) The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator.
The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed. (+info)
(4/3910) Non-epileptic attack disorder (NEAD): a comprehensive review.
Non-epileptic attack disorder (NEAD) represents a well-recognized clinical problem with a reported incidence among individuals with a diagnosis of intractable epilepsy as high as 36%. A failure to identify this disorder may lead to certain risks for the patient including polypharmacy, anticonvulsant toxicity, hazardous intervention, social and economic demands and a lack of recognition or neglect of any underlying psychological distress. This review provides a description of NEAD in an historic and societal context and discusses the variety of terminology which has been applied to this psychophysiological phenomenon. Epidemiology and associated methodological limitations; and diagnostic and classification issues related to NEAD in comparison to epilepsy are considered. The problems of failure to recognize NEAD in comparison to epilepsy are considered. The problems of failure to recognize NEAD are outlined, and theoretical and empirical aetiological issues are discussed. (+info)
(5/3910) Genetic diversity of equine arteritis virus.
Equine arteritis viruses (EAV) from Europe and America were compared by phylogenetic analysis of 43 isolates obtained over four decades. An additional 22 virus sequences were retrieved from GenBank. Fragments of the glycoprotein G(L) and the replicase genes were amplified by RT-PCR, prior to sequencing and construction of phylogenetic trees. The trees revealed many distinctive lineages, consistent with prolonged diversification within geographically separated host populations. Two large groups and five subgroups were distinguished. Group I consisted mainly of viruses from North America, whilst group II consisted mainly of European isolates. In most instances, where the geographic origin of the viruses appeared to be at variance with the phylogenetically predicted relationships, the horses from which the viruses were recovered had been transported between Europe and America or vice versa. Analysis of the replicase gene revealed similar phylogenetic relationships although not all of the groups were as clearly defined. Virus strains CH1 (Switzerland, 1964) and S1 (Sweden, 1989) represented separate 'outgroups' based on analysis of both genomic regions. The results of this study confirm the value of the G(L) gene of EAV for estimating virus genetic diversity and as a useful tool for tracing routes by which EAV is spread. In addition, computer-assisted predictions of antigenic sites on the G(L) protein revealed considerable variability among the isolates, especially with respect to regions associated with neutralization domains. (+info)
(6/3910) Appropriate and necessary healthcare: new language for a new era.
Conceptual and language changes are necessary to accompany the paradigm shift from fee-for-service medicine to managed care. Medical necessity is an inadequate and ambiguous term defined differently by providers, payers, patients, and legislators. The attempt by legislators in Minnesota to develop a universal standard benefits set for healthcare services strikingly underscores the need to define relevant terminology to accompany the transition to managed care. We suggest the term appropriate and necessary healthcare as a state-of-the-art term for the new era of managed care. (+info)
(7/3910) Issues of medical necessity: a medical director's guide to good faith adjudication.
The term medical necessity is difficult to define, a problem for insurers who need to clearly describe what is and is not covered in their contracts with subscribers. An unclear, vague definition of medical necessity leaves insurers vulnerable to litigation by subscribers denied care deemed medically unnecessary. To avoid lawsuits, insurers must make every effort to educate their subscribers about their medical coverage, going beyond merely providing a lengthy subscriber handbook. In decisions on medical necessity, medical directors at insurance companies play a key role. They can bolster the insurer's position in denial-of-care cases in numerous ways, including keeping meticulous records, eliminating unreasonable financial incentives, maintaining a claims denial database, and consulting with other insurers to achieve a consensus on medical necessity. (+info)
(8/3910) Current conceptualizations of mental health and mental health promotion.
Health promotion is generally agreed to be underpinned by a set of principles which distinguish it from other disciplines and professions. This paper takes these principles as the starting point for a review of the literature of mental health promotion. The aim is to clarify the ways in which mental health and mental health promotion are currently conceptualized, in order to identify areas where health promotion can make a unique contribution to complement that of other interest groups. In the first section, it is suggested that current definitions of mental health are inadequate for health promotion practice in that they either equate health with the absence of illness or present a culturally skewed, individualized and 'expert'-led version of what it means to be mentally healthy. The second section then traces the implications of these definitions as they emerge from the literature relating to mental health promotion practice. The paper concludes with a discussion of some ways in which health promotion specialists might begin to develop a mental health promotion agenda which is more consistent with health promotion principles. (+info)
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