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PubMedDate not supplied

BrainImageJ: a Java-based framework for interoperability in neuroscience, with specific application to neuroimaging.

The Human Brain Project consortium continues to struggle with effective sharing of tools. To facilitate reuse of its tools, the Stanford Psychiatry Neuroimaging Laboratory (SPNL) has developed BrainImageJ, a new software framework in Java. The framework consists of two components-a set of four programming interfaces and an application front end. The four interfaces define extension pathways for new data models, file loaders and savers, algorithms, and visualization tools. Any Java class that implements one of these interfaces qualifies as a BrainImageJ plug-in-a self-contained tool. After automatically detecting and incorporating new plug-ins, the application front end transparently generates graphical user interfaces that provide access to plug-in functionality. New plug-ins interoperate with existing ones immediately through the front end. BrainImageJ is used at the Stanford Psychiatry Neuroimaging Laboratory to develop image-analysis algorithms and three-dimensional visualization tools. It is the goal of our development group that, once the framework is placed in the public domain, it will serve as an interlaboratory platform for designing, distributing, and using interoperable tools.

Algorithms↗
PubMed2004

An audit of splenectomies in a teaching hospital in North India. Are postsplenectomy guidelines being complied with?

AIMS: Patients with an absent or dysfunctional spleen are at risk of infection by encapsulated and other bacteria. Overwhelming postsplenectomy infection (OPSI) causes most concern because it can result in significant mortality. A retrospective review of splenectomised patients in a tertiary care setting over an eight year period was carried out to determine whether current postsplenectomy guidelines were being followed. METHODS: The cases were identified from the medical records and pathology files and data such as the reason for splenectomy, the preventive measures taken regarding vaccination, and antibiotic prophylaxis, together with their documentation in the discharge notes were assessed. RESULTS: Fifty six patients were studied. Trauma, both blunt and penetrating, was the most common reason for splenectomy. Thirty six patients received pneumococcal vaccination, with 20 patients having no mention of vaccination in their case notes. The discharge notes of 50 patients mentioned their splenectomised status; however, documentation of vaccination details in the discharge summary was poor, with only three patients having the relevant information recorded. Documentation of the need for future vaccination and precautions required in the asplenic condition was also lacking. Nine patients had postsplenectomy complications, although there were no cases of OPSI. CONCLUSIONS: Adherence to standard guidelines for the management of splenectomised patients was unsatisfactory. There is a need for an improvement of the vaccination rate and careful documentation of this important health risk in the discharge summaries. Maintenance of a splenectomy registry could aid in optimising the management of these patients.

Adolescent↗
PubMed1977

Evaluation of the Hemalog D differential leucocyte counter.

The main objectives of the evaluation were to (1) establish 'normal values' for the Hemalog D, (2) compare the Hemalog D with existing manual procedures, and (3) assess the machine's reliability. It proved to be a practical machine in a routine haematology laboratory. Comparison with established techniques showed systematic differences in the total white blood cell count and percentages of lymphocytes. An existing laboratory computer system was used to collect and file the data.

Adult↗
PubMed2003

Practice patterns of radiologists and nonradiologists in utilization of noninvasive diagnostic imaging among the Medicare population 1993-1999.

PURPOSE: To compare nationwide trends in noninvasive diagnostic imaging (NDI) practice patterns of radiologists and of nonradiologists among the Medicare population during the 6 years from 1993 to 1999. MATERIALS AND METHODS: Medicare Part B claims files from 1993, 1996, and 1999 were analyzed for all procedure codes related to NDI. NDI codes were classified into 22 diagnostic categories within seven imaging modality groups. For each NDI code, physicians performing the services were classified as radiologists or nonradiologists by using the provider specialty code designated in claims in the files. The data were analyzed to determine the overall utilization rates and relative value unit (RVU) rate changes between 1993 and 1999 among radiologists and nonradiologists. RESULTS: In 1993, the overall NDI utilization rate per 100,000 Medicare fee-for-service beneficiaries was 215,652 for radiologists and 79,942 for nonradiologists. In 1999, the rate was 207,270 for radiologists and 100,059 for nonradiologists, which is a 3.9% decrease among radiologists and a 25.2% increase among nonradiologists. In the 6-year interval from 1993 to 1999, the overall RVU rate increased 6.9% among radiologists and 32.4% among nonradiologists. The percentage of NDI performed by radiologists decreased from 73.0% in 1993 to 67.4% in 1999. CONCLUSION: Overall, the utilization rate of advanced, high-technology imaging is increasing among both radiologists and nonradiologists. However, it is increasing at a considerably more rapid rate among nonradiologists.

Diagnostic Imaging↗
PubMed1989

Safety profile of omeprazole. Adverse events with short-term treatment.

Omeprazole is a very potent inhibitor of gastric acid secretion and has proven to be efficacious in the healing of peptic ulcer and reflux oesophagitis. A search for adverse events during short-term treatment with omeprazole has been made, based on data from published comparative trials, data on file at the manufactor's (Hässle Research Laboratories, Mölndal, Sweden) and personal series. Omeprazole does not show more adverse events than drugs currently widely in use for the treatment of acid-related disorders. A change in a wide range of laboratory parameters has not been observed, except for a rise in basal and meal-stimulated serum gastrin which can be ascribed directly to the inhibition of acid secretion. For short-term treatment omeprazole can be considered as a safe drug.

Clinical Trials as Topic↗
PubMed2000

Relationship of socioeconomic status to the incidence and prehospital, 28-day, and 1-year mortality rates of acute coronary events in the FINMONICA myocardial infarction register study.

BACKGROUND: Low socioeconomic status (SES) is associated with increased coronary heart disease mortality rates. There are, however, very little data on the relation of SES to the incidence, recurrence, and prognosis of myocardial infarction (MI) events. METHODS AND RESULTS: The FINMONICA MI Register recorded detailed information on all MI events among men and women aged 35 to 64 years in 3 areas of Finland during the period of 1983 to 1992. We carried out a record linkage of the MI register data with files of Statistics Finland to obtain information on indicators of SES, such as taxable income and education, for each individual who is registered. In the analyses, income was grouped into 3 categories (low, middle, and high), and education was grouped into 2 categories (basic and secondary or higher). Among men with their first MI event (n=6485), the adjusted incidence rate ratios were 1.67 (95% CI 1.57 to 1.78) and 1.84 (95% CI 1.73 to 1.95) in the low- and middle-income categories compared with the high-income category. For 28-day mortality rates, the corresponding rate ratios were 3.18 (95% CI 2.82 to 3.58) and 2.33 (95% CI 2.03 to 2.68). Significant differentials were observed for prehospital mortality rates, and they remained similar up to 1 year after the MI. Findings among the women were consistent with those among the men. CONCLUSIONS: The excess coronary heart disease mortality and morbidity rates among persons with low SES are considerable in Finland. To bring the mortality rates of low- and middle-SES groups down to the level of that of the high-SES group constitutes a major public health challenge.

Adult↗
PubMed2001

Socioeconomic status and ischemic stroke: The FINMONICA Stroke Register.

BACKGROUND AND PURPOSE: It has been shown that low socioeconomic status is associated with death from stroke. More-detailed data have, however, remained scanty. The purpose of the present study was to examine the association of socioeconomic status with ischemic stroke. Besides mortality, we analyzed the incidence, case-fatality ratio, and prognosis of ischemic stroke events. METHODS: Our population-based study included 6903 first stroke events registered by the FINMONICA Stroke Register in 3 areas of Finland during 1983 to 1992. Indicators of socioeconomic status, such as taxable income and education, were obtained by record linkage of the stroke register data with files of Statistics Finland. RESULTS: Incidence, case-fatality ratio, and mortality rates for ischemic stroke were all inversely related to income. Furthermore, 28 days after the onset of symptoms, a greater proportion of patients with low income than of those with high income was still in institutionalized care and/or in need of help for their activities of daily living. Population-attributable risk of the incidence of first ischemic stroke due to low socioeconomic status was 36% for both sexes. For the death from first ischemic stroke, it was 56% for both sexes. CONCLUSIONS: Persons with low socioeconomic status have considerable excess rates of morbidity and mortality from ischemic stroke in Finland. A reduction in this excess could markedly decrease the burden of ischemic stroke to the society and thus constitute an important public health improvement.

Adult↗
PubMed1976

Computer files and analyses of laboratory data from tuberculosis patients. II. Analyses of six years' data on sputum specimens.

Laboratory data on sputum specimens from patients with pulmonary mycobacterioses between 1968 and 1973 were analyzed. Specimens were cultured on Middlebrook 7H10 and/or 7H11 medium; blue light fluorescence microscopy was used to examine specimen smears. An admission series of 6 sputum specimens detected 94.7 per cent of all culture-positive patients. Only 62 per cent of patients who were culture positive in the admission series would have been detected by smear alone. Quantitative agreement of smear and culture results was seen only in the smear-numerous (more than 2 bacilli per high-power field), culture-numerous (more than 100 colonies per plate) category. Qualitative agreement of smear and culture was 71 per cent. A total of 123 smear-positive and culture-negative specimens, representing 9 per cent of the total number of positive smears, was found among 6,251 sputum specimens from 270 culture-positive ptients. At least one smear-positive and culture-negative specimen was obtained from 23 per cent of the patients evaluated. During this period, improved housekeeping measures and drying of culture plates reduced the culture contamination rate from 9.8 to less than 5 per cent.

Diagnosis, Computer-Assisted↗
PubMedDate not supplied

Multiple-race mortality data for California, 2000-2001.

OBJECTIVES: To examine mortality rates and quality of race reporting for multiple-race individuals in California using the new multiple-race data available on the death certificate. METHODS: Death date were drawn from California vital statistics for 2000 and 2001. Denominator data were drawn from the 2000 census Modified Race Data Summary File. The authors calculated mortality rates and relative standard errors for multiple-race individuals as a whole and by county, and for the three largest reported multiple-race groups (African American and white, American Indian/Alaska Native and white, and Asian and white). RESULTS: Decedents reported to be of more than one race were disproportionately young, Hispanic, male, and never-married. Age-adjusted mortality rates for multiple-race groups were approximately one-sixth as high as rates for single-race individuals. There was substantial variability in rates for multiple-race decedents according to county of residence. CONCLUSIONS: Mortality rates for multiple-race people were implausibly low, and death certificates for multiple-race individuals were geographically clustered. Race reporting on death certificates will need to be improved before accurate death rates can be calculated for those of multiple races.

Adolescent↗
PubMed2006

The application of fluorescence lifetime readouts in high-throughput screening.

Measurement of fluorescence lifetime is a well-established technique, which has recently been introduced into the portfolio of assay formats used in high-throughput screening (HTS). This investigation establishes appropriate conditions for using lifetime measurements to reduce the impact of compound interference effects during large-scale HTS of corporate screening files. Experimental data on mixtures of standard fluorophores and interfering compounds (from 5 HTS campaigns) have been combined with a theoretical model to identify the minimum data quality required, defined by the photon count in the peak channel, for discrimination of biological activity. Single-component fluorophore lifetimes can be recovered with an error of 1%, with a peak photon count of 10(2), but the same accuracy with a 2-component decay requires a peak photon count of 10(3). When a 3rd component is introduced, the minimum peak count increases to 10(4). The influence of scattered light on lifetime determination was investigated using an emulsion (diameters 25-675 nm). The measured decays of interfering compounds, identified as autofluorescent, show that the vast majority have a very short lifetime that can readily be resolved from the reporter fluorophore, using appropriate data-fitting methods.

Drug Evaluation, Preclinical↗
PubMed2003

Pharmacodynamics of omalizumab: implications for optimised dosing strategies and clinical efficacy in the treatment of allergic asthma.

OBJECTIVE: Omalizumab (Xolair), is a recombinant humanised monoclonal anti-immunoglobulin E (IgE) antibody, for the treatment of allergic asthma. This review describes how the correlation between clinical outcomes and a suitable surrogate marker (free serum IgE) led to the development of an individualised dosing strategy for omalizumab. It also demonstrates how subsequent studies using this dosing strategy were able to achieve low levels of IgE and clinical benefit. DATA SOURCES: Published articles and data on file (Novartis Pharma AG, Genentech). RESULTS: Studies in patients with IgE-mediated diseases of the airways have shown that clinical benefit with omalizumab is observed when free IgE levels in serum are reduced to 50 ng/ml (20.8 IU/ml) or less (target 25 ng/ml (10.4 IU/ml)). The ability of omalizumab to reduce free IgE levels to such levels is dependent on dose, the patient's weight and baseline IgE level. To simplify dosing, and ensure that free IgE reduction is achieved, an individualised tiered dosing table was developed from which patients with asthma, depending on weight and starting IgE level, receive omalizumab 150-375 mg by subcutaneous injection every 2 or 4 weeks. This dosing strategy has proved clinically efficacious for improving disease control in patients with allergic asthma, as shown by significantly lower exacerbation rates and decreased dependence on treatment with inhaled corticosteroids, along with improvements in symptoms, lung function and usage of rescue bronchodilators. CONCLUSIONS: The clinical efficacy of omalizumab has been optimised through the development of an individualised dosing table that emerged from an understanding of the pharmacodynamics of this agent.

Antibodies, Anti-Idiotypic↗
PubMed2005

Assessing the cost-effectiveness of COX-2 specific inhibitors for arthritis in the Veterans Health Administration.

OBJECTIVE: This study was designed to assess the cost-effectiveness of cyclooxygenase-2 specific (COX-2) inhibitors (rofecoxib and celecoxib) over nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) in high-risk arthritis patients from the perspective of the Veterans Health Administration (VA). METHODS: This literature-based economic analysis (with data summarized from MEDLINE-indexed and other published sources, FDA reports, and data on file at VA San Diego Healthcare System) compared rofecoxib and celecoxib to NSAIDS in two arthritis patient populations considered at higher risk of developing clinically significant upper gastrointestinal events (CSUGIEs): (1) patients of any age with previous medical history of perforation/ulcer/bleed (PUB); and (2) patients 65 years and older (regardless of history of PUB). Two outcome measures were reported: (1) incremental cost per CSUGIE averted over 1 year; and (2) incremental cost per quality-adjusted life-year (QALY) gained, considering both the mortality and morbidity associated with gastrointestinal (including CSUGIEs) and cardiovascular-related adverse events. When possible, costs were modeled to reflect the VA perspective. Sensitivity analyses were conducted to test the robustness of the analysis. RESULTS: Compared to NSAIDS, rofecoxib and celecoxib increased costs but reduced the incidence of CSUGIE. Cost per CSUGIE avoided were $7476 and $16,379 (in patients with a PUB history) and $14,294 and $18,376 (in patients aged > or = 65 years) for celecoxib and rofecoxib, respectively. In both populations, celecoxib was associated with a cost per QALY less than $50,000. In contrast, rofecoxib was found to cost more and result in a net QALY loss, due in particular to the increase in the risk of cardiovascular complications, and was therefore considered cost-ineffective. Results were most dependent on assumptions about the incidence of cardiovascular events and CSUGIE and the COX-2 inhibitors' acquisition price. CONCLUSIONS: This analysis suggests that COX-2 inhibitors may be cost-effective from the perspective of the VA. However, cost-effectiveness appears to depend less on the specific characteristics of the high-risk target population considered but more on the agent evaluated. Celecoxib appears to be an alternative to traditional NSAIDs in the patient populations studied.

Aged↗
PubMed1988

Silent stroke in the NINCDS Stroke Data Bank.

Previous brain infarctions seen on CT are common in the absence of history of stroke. Eleven percent of patients (135/1,203) without stroke history had ischemic lesions on their first CT, unrelated to the presenting stroke. Stroke Data Bank files were reviewed to determine whether the occurrence, location, and CT characteristics of those lesions are associated with their undetected status. Two distinct patterns were seen: (1) Small lesions of 1 cm or less were left hemisphere predominant and involved the deep structures of the brain; the majority of these were clinically silent. (2) Lesions greater than 1 cm occurred more frequently in the right hemisphere and were mostly superficial; these infarcts produced signs unrecognized by the patient or family. Risk factors for silent stroke were similar to those for stroke in general. Frequencies of in-hospital complications and 30-day fatality rates from the presenting stroke were not influenced by the existence of a prior silent stroke.

Adult↗
PubMed1999

Functional analysis of newly discovered growth control genes: experimental approaches.

A large number of DNA sequences corresponding to human and animal transcripts have been filed in data banks, as cDNAs or ESTs (expression sequence tags). However, the actual function of their corresponding gene products is still largely unknown. Several of these genes may play a role in regulation of important biological processes such as cell division, differentiation, malignant transformation and oncogenesis. Elucidation of gene function is based on 2 main approaches, namely, overexpression and expression interference, which respectively mimick or suppress a given phenotype. The currently available tools and experimental approaches to gene functional analysis and the most recent advances in mass cDNA screening by functional analysis are discussed.

Animals↗
PubMed1996

Characterisation of asthma management in the Fallon Community Health Plan from 1988 to 1991.

In order to characterise asthma management in a managed care setting, we identified 10,301 patients who were diagnosed with asthma between 1 January 1988 and 31 December 1991 at a group model health maintenance organisation in central Massachusetts, US. We obtained for these patients automated utilisation files containing data on medications, hospitalisations, emergency room visits, office visits, and estimated costs of these services. The medication dispensed to the greatest proportion of patients was beta 2 agonists either by inhalation (56%) or orally (21%). Theophylline was dispensed to 23% of the patients. Maintenance therapy was inhaled anti-inflammatory medication was uncommon, as inhaled corticosteroids (17%) and sodium cromoglycate (cromolyn sodium) [8%] were dispensed to fewer patients than other asthma medications. Among patients who had been hospitalised in the previous year, 36% were presently receiving inhaled corticosteroids, and among patients who used at least one beta 2 agonist metered-dose inhaler per month, 49% were presently receiving inhaled corticosteroids. Economic analyses showed that only 8% of the patients had either a hospital admission or an emergency room visit, but hospital costs among these patients accounted for 25% of the total costs of asthma care. In addition, the top 10% most expensive patients accounted for 42% of the total cost of asthma care. We conclude that a substantial proportion of patients at increased risk of a severe attack, by virtue of having a recent hospitalisation, do not receive maintenance anti-inflammatory therapy, and that hospitalisations among a relatively small proportion of asthma patients contribute significantly to the cost of asthma care.

Adolescent↗
PubMed2003

Ribosomal immunostimulation: assessment of studies evaluating its clinical relevance in the prevention of upper and lower respiratory tract infections in children and adults.

OBJECTIVE: To review the efficacy of the ribosomal immunostimulant Ribomunyl in preventing upper and lower respiratory tract infections. DESIGN AND SETTING: Review of studies of 3 and 6 months' duration comprising part of the international registration file. PATIENTS: Data from 2117 patients (1215 children and 902 adults); ribosomal immunostimulant n = 1062, placebo n = 1055. RESULTS: Nineteen randomised, double-blind, placebo-controlled clinical trials were performed between 1983 and 1994 in Europe. In children with ear-nose-throat (ENT) infections, 3 months' ribosomal immunostimulant treatment significantly decreased the mean number of recurrences (27-68% reduction), and reduced the duration of infection (28-66% reduction) and antibacterial requirement (29-60% reduction). Ribosomal immunostimulant was similarly effective in children with ENT and bronchopulmonary infections, reducing the mean number of recurrences by 32-61% compared with placebo. In children with otitis media, ribosomal immunostimulant reduced recurrences by 10-53% and also reduced the duration of infection, antibacterial use and local surgery requirement. Results obtained from studies of 6 months' duration confirmed or extended these results. In adult patients with ENT or mixed respiratory infections, ribosomal immunostimulant produced similar reductions to those seen in children for recurrent infections (54-78% reduction), duration of infection (42-79% reduction) and antibacterial use (38% reduction). CONCLUSIONS: These results clearly demonstrate that ribosomal immunostimulant is effective in preventing and in reducing upper and lower respiratory tract infections in children and adults.

Administration, Oral↗
PubMed2004

Calcitonin intranasal--unigene: Salcatonin intranasal--unigene.

An intranasal spray formulation of recombinant salmon calcitonin [salcatonin] is in development with Unigene Laboratories as therapy for postmenopausal osteoporosis. Calcitonin is an endogenous polypeptide hormone that regulates calcium and bone metabolism. It is produced by the parafollicular cells of the thyroid gland in humans and other species. Calcitonin inhibits bone loss through the suppression of osteoclast activity. Salmon calcitonin is approximately 40-50 times more potent than natural human calcitonin at inhibiting osteoclast function. It can be obtained naturally from salmon or can be synthesised with the same chemical structure. Calcitonin was originally available only as an injectable formulation, but in recent years more convenient formulations have become available. Unigene is actively seeking to license its intranasal calcitonin product in Europe and other territories outside the US. nigene licensed its intranasal calcitonin product to Upsher-Smith Laboratories in December 2002, under a $US10 million exclusive US licensing agreement. Under the terms of the agreement, Unigene received an upfront payment of $US3 million from Upsher-Smith and will be eligible to receive milestone payments and royalty payments on product sales. Unigene will be responsible for manufacturing the product at its Boonton facility in New Jersey, USA, and will sell finished calcitonin product to Upsher-Smith. Upsher-Smith will package, market and distribute the product nationwide. Unigene granted an exclusive license to Faran Laboratories in September 2003 for its intranasal calcitonin osteoporosis product in Greece. Unigene will sell the finished product to Faran, who will promote and market it throughout the country after Unigene obtains European regulatory approval and local pricing approval. Unigene will receive an upfront payment and is eligible to receive milestone payments prior to product launch. Faran will pay Unigene a fixed price for each unit of product received. Qingdao General Pharmaceutical Company was a licensee for Unigene's injectable and intranasal calcitonin products in the People's Republic of China, and Unigene had received initial payments from Qingdao General Pharmaceutical in 1996. However, in June 2000, Unigene announced that it has entered into a joint venture with Shijiazhuang Pharmaceutical Group Company for the manufacture and distribution of injectable and intranasal calcitonin for the treatment of osteoporosis in China. Unigene initially will be responsible for supplying bulk calcitonin manufactured in its production facility in New Jersey and the joint venture will be responsible for filling, packaging, promoting and marketing the products. Unigene owns 45% of the contractual joint venture. Unigene is also developing oral and injectable formulations of calcitonin. In January 2004, Unigene announced it had received an approvable letter from the US FDA to market its calcitonin intranasal spray for the treatment of osteoporosis. The letter indicates that the FDA will approve the NDA upon finalisation of the labelling and resolution of specific remaining issues, including the submission of additional information and clinical data. Unigene filed the NDA in March 2003. Using the results from a pilot study completed in the UK, Unigene filed an IND with the FDA and began clinical testing of this intranasal calcitonin in the US. Clinical studies were successfully completed by year end 2001, demonstrating significant bone marker activity and similar serum concentrations between this product and that of an existing nasal calcitonin product. The European Union's regulatory authority, the Committee for Proprietary Medicinal Products (CPMP), has confirmed the efficacy of calcitonin formulations for the treatment of postmenopausal osteoporosis and other bone disorders. The CPMP has recommended revisions to and harmonisation within the European Union of the authorised indications for calcitonin formulations. The CPMP has determined that authorised indications for intranasal calcitonin will be approved for "treatment of established post-menopausal osteoporosis in order to reduce the risk of vertebral fractures", and new prescribing information will clarify that intranasal calcitonin does not appear to reduce the number of hip fractures. These recommendations will be implemented in the near future and will eliminate discrepancies between countries and between formulations. The Chinese regulatory authorities have granted Unigene an import license for calcitonin, and Unigene and Shijiazhuang have submitted an NDA in China. If this NDA is approved, the joint venture will have up to 6 years' market exclusivity for intranasal and injectable calcitonin. Unigene was granted a US patent for the intranasal formulation of calcitonin in 2002.

Administration, Intranasal↗