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PubMed2005

Cardiac resynchronization devices: the Food and Drug Administration's regulatory considerations.

Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA's approval process for CRT devices and briefly review the clinical trial designs for the first generation devices.

Biomedical Technology↗
PubMed2005

Desiderata for domain reference ontologies in biomedicine.

Domain reference ontologies represent knowledge about a particular part of the world in a way that is independent from specific objectives, through a theory of the domain. An example of reference ontology in biomedical informatics is the Foundational Model of Anatomy (FMA), an ontology of anatomy that covers the entire range of macroscopic, microscopic, and subcellular anatomy. The purpose of this paper is to explore how two domain reference ontologies--the FMA and the Chemical Entities of Biological Interest (ChEBI) ontology, can be used (i) to align existing terminologies, (ii) to infer new knowledge in ontologies of more complex entities, and (iii) to manage and help reasoning about individual data. We analyze those kinds of usages of these two domain reference ontologies and suggest desiderata for reference ontologies in biomedicine. While a number of groups and communities have investigated general requirements for ontology design and desiderata for controlled medical vocabularies, we are focusing on application purposes. We suggest five desirable characteristics for reference ontologies: good lexical coverage, good coverage in terms of relations, compatibility with standards, modularity, and ability to represent variation in reality.

Anatomy↗
PubMed2005

From concepts to clinical reality: an essay on the benchmarking of biomedical terminologies.

It is only by fixing on agreed meanings of terms in biomedical terminologies that we will be in a position to achieve that accumulation and integration of knowledge that is indispensable to progress at the frontiers of biomedicine. Standardly, the goal of fixing meanings is seen as being realized through the alignment of terms on what are called 'concepts.' Part I addresses three versions of the concept-based approach--by Cimino, by Wüster, and by Campbell and associates--and surveys some of the problems to which they give rise, all of which have to do with a failure to anchor the terms in terminologies to corresponding referents in reality. Part II outlines a new, realist solution to this anchorage problem, which sees terminology construction as being motivated by the goal of alignment not on concepts but on the universals (kinds, types) in reality and thereby also on the corresponding instances (individuals, tokens). We outline the realist approach and show how on its basis we can provide a benchmark of correctness for terminologies which will at the same time allow a new type of integration of terminologies and electronic health records. We conclude by outlining ways in which the framework thus defined might be exploited for purposes of diagnostic decision-support.

Animals↗
PubMed2005

In defense of the Desiderata.

A 1998 paper that delineated desirable characteristics, or desiderata for controlled medical terminologies attempted to summarize emerging consensus regarding structural issues of such terminologies. Among the Desiderata was a call for terminologies to be "concept oriented." Since then, research has trended toward the extension of terminologies into ontologies. A paper by Smith, entitled "From Concepts to Clinical Reality: An Essay on the Benchmarking of Biomedical Terminologies" urges a realist approach that seeks terminologies composed of universals, rather than concepts. The current paper addresses issues raised by Smith and attempts to extend the Desiderata, not away from concepts, but towards recognition that concepts and universals must both be embraced and can coexist peaceably in controlled terminologies. To that end, additional Desiderata are defined that deal with the purpose, rather than the structure, of controlled medical terminologies.

Biology↗
PubMed2005

The application of inductively coupled plasma mass spectrometry in pharmaceutical and biomedical analysis.

With the development of life science, pharmaceutical and biomedical analysis becomes more and more important in medical science. Further studies will be hopefully established if it is possible to use inorganic elemental standards or small organic compounds in the quantitative determination of all kinds of drugs, nucleotides and sulfur or phosphorus containing peptides and proteins at appropriate concentration with an acceptable accuracy. Since 1980, inductively coupled plasma mass spectrometry (ICP-MS) has emerged as a new and powerful analytical technique which is suitable for element and isotope analysis. It offers extremely wide detection range of element and co-analysis of most elements in the periodic table. Also, it can be applied to perform qualitative, semiquantitative, and quantitative analysis and isotopic ratios through mass-to-electric charge ratio. With the help of ICP-MS, the struggle of searching for an excellent quantification technique in, e.g. drugs and proteomics has come appreciably close to an end. This review mainly focuses on the introduction of application of ICP-MS in pharmaceutical and biomedical analysis. Some problems in application and the handling strategies are simply presented at the end.

Biomedical Technology↗
PubMed2006

Sindbis virus as a tool for quality control of viral inactivation of heated and chemically treated plasma-derived products.

Regulatory guidelines for production of plasma-derived products emphasize the need to document methods of viral inactivation and demonstrate the effectiveness of screening methods. Therefore, it is important to evaluate the kinetics of such processes. Togaviridae family virions may be considered as good tools for quality control of haemoderivatives, if they possess large amounts of cholesterol and saturated lipids and high structural lipid/protein ratio in their envelope composition, which give more resistance to classical treatments. The purpose of this study was to evaluate the efficiency of solvent-detergent and heat treatments adopted during the human haemoderivatives processment. Sindbis virus was used as a model for inactivation of enveloped viruses. Semi-processed human factor VIII (FVIII) product experimentally contaminated with Sindbis virus was used to test a solvent-detergent treatment with tri-N-butyl-phosphate (TNBP) and Tween 80. To evaluate thermal inactivation kinetics, lyophilized, and reconstituted samples of Sindbis virus-containing FVIII were incubated up to 30 h at 60 degrees C. The results showed that treatment with TNBP and Tween 80 reduced the infectivity of virus-contaminated FVIII in > or =5.5 log(10) and heat treatment was effective in all samples, although FVIII concentrate had reduced the rate of viral inactivation during a brief period of time.

Biological Products↗
PubMed2005

Non-PET functional imaging techniques: optical.

The strong and steady development of diffuse optical spectroscopy and tomography as new biomedical optics technologies promises to bring these optical techniques into clinical practice. This article provides a brief review of the light-tissue interaction, the instrumentation, and the theory relevant to this field. This is followed by a survey of the three main applications: brain imaging, muscle imaging, and breast imaging. Lastly, the future outlook of the technology is presented, highlighting the new promises based on recent breakthroughs.

Brain↗
PubMed2006

Antibiotic efficacy and microbial virulence during space flight.

Human space flight is a complex undertaking that entails numerous technological and biomedical challenges. Engineers and scientists endeavor, to the extent possible, to identify and mitigate the ensuing risks. The potential for an outbreak of an infectious disease in a spacecraft presents one such concern, which is compounded by several components unique to an extraterrestrial environment. Various factors associated with the space flight environment have been shown to potentially compromise the immune system of astronauts, increase microbial proliferation and microflora exchange, alter virulence and decrease antibiotic effectiveness. An acceptable resolution of the above concerns must be achieved to ensure safe and efficient space habitation. To help bring this about, scientists are employing advances in biotechnology to better characterize the relevant variables and establish appropriate solutions. Because many of these clinical concerns are also relevant in terrestrial society, this research will have reciprocal benefits back on Earth.

Anti-Infective Agents↗
PubMed2000

Introduction: basic concepts and definitions in mechanics.

This introduction aims to expound the basic ideas of mechanics of materials to clinicians. What happens when a bone (mechanically a beam) is submitted to standard loads: Centric axial load, bending, eccentric axial load, torque? How does the bone deform? The basic ideas of mechanical engineering are presented using an eraser under load as an illustrative object, and trying to maintain the mathematical formulae as far as possible.

Biocompatible Materials↗
PubMed1976

Neurology of micturition.

The understanding, diagnosis and management of neurologic dysfunction of the bladder have undergone considerable changes during the last 2 decades. These changes were the result of animal experimentation into physiology and pharmacology and the accelerated use of biomedical engineering technology. The implementation of these advances will require physician re-education in the neurology of micturition.

Electric Stimulation↗
PubMed2006

Transgene expression and RNA interference in embryonic stem cells.

Over the last 30 years of biomedical research, technologies for transgene expression and gene loss of function have been developed from animal model systems to human gene therapy, and, increasingly, embryonic stem cells are a key target for these genetic engineering strategies. In this chapter, we describe how retrovirus/lentivirus vectors can be used to transfer and stably express genes or small interfering RNAs in mouse and human embryonic stem cells and their progeny, thereby allowing genetic gain-of-function or loss-of-function analysis and cell lineage selection in a multitude of experimental settings.

Animals↗