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Investigational drug tracking: Phases I-III and NDA submissions--Part I.

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I includes the trade name and synonym cross-indexes and the beginning of the main alphabetical listing by generic/chemical name or investigational drug number.

Catalogs, Drug as Topic↗

Risk management. Betting on good information.

Eating potato salad left out in the sun, flying a kite in a rainstorm, sticking a fork in a light socket--we don't need an actuarial table to know that these and many other actions are downright life-threatening. Most of us grow up learning these basic lessons and think of them as common sense, not as a measure of risk. But what about having a heart attack? Contracting a fatal disease? Experiencing unusual side effects from medicine? These risks aren't so obvious. But in each situation, information is available that can identify the chances of any one of us experiencing a stroke or food poisoning. In fact, conclusions about the incidence and potential health risks are key in the daily business decisions of healthcare. Just knowing the gambles, however, is not what risk in healthcare is all about. Instead, it is about the potential costs of those risks to health planners footing the bill.

Catalogs, Commercial as Topic↗

Validity aspects of erythrocyte sedimentation rate and C-reactive protein in ankylosing spondylitis: a literature review.

The preliminary core set for endpoints in disease controlling antirheumatic therapy includes acute phase reactants. The objective of this clinically oriented literature review was to examine and compare the validity of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) in ankylosing spondylitis (AS) clinical trials. A MEDLINE search was performed covering the years 1967 through April 1998. AS studies were identified and selected if they included ESR and/or CRP and either presented data about their relation with disease activity or were designed as longitudinal clinical trials. Additional studies were identified by scrutinizing references cited in the retrieved studies. The selected studies were examined for truth (association with disease activity), discriminative power (sensitivity to change and discrimination between active and inactive treatment in longitudinal clinical trials), and feasibility (e.g., applicability and costs) of ESR and CRP in AS. We identified 12 articles on the association of ESR and/or CRP with disease activity and 13 longitudinal clinical trials reporting ESR and/or CRP data. Although the applied definitions or disease activity proved very inhomogenous, there was some evidence that both acute phase reactants are correlated with disease activity. In terms of discriminative capacity the available data are inconclusive. Relevant feasibility aspects are general availability, technically simple measurement, and an advantage in the cost of ESR and central laboratory facilities for CRP. Acute phase reactants do not comprehensively represent the disease process in AS. Their worth in AS clinical trials is limited. Based on the currently existing data neither measure is clearly superior in terms of validity. When selecting an acute phase reactant, feasibility aspects may be most relevant in choice of measure.

Antirheumatic Agents↗

[Creating a local collection of professional reports. A stake in the engineering of diploma education and research in continuing education].

The question of the dissertation written during the training is tackled through the entry key offered by the professional dissertations written during the training courses leading to qualification in the framework of a university department of vocational training. 72 professional dissertations, defended between 1993 and 1996, were analysed on the basis of observation sheets filled out by the directors. In reference to the semiotic approach which provides relevant theoretical and methodological materials for the problem posed, we shall show the interest of considering that these documents are, above all, "object-speeches" and must therefore be studied as such. According to the demands to be determined, related to the types of speeches to deliver, the professional dissertations considered as written traces reconstituting the practices and praxis which found them, as well on the professional as on the scientific level, can provide indications for training, in the area of research as well as in the one of praxeology. The written document is thought of as an object of transition from practice to professional praxis, rallying the scientific praxis which is expressed particularly in the writing work.

Academic Dissertations as Topic↗