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Influenza epidemics cause substantial morbidity. The seasonal vaccine, an important control measure, is not completely efficacious. This trial assessed the efficacy of a recombinant seasonal vaccine (made in a cell culture rather than with viruses grown in eggs). Reducing the burden of influenza disease requires improved vaccines, and a recombinant influenza vaccine may contribute to this public-health goal. 1 This vaccine contains recombinant hemagglutinin (HA) proteins produced in a serum-free medium by expres SF+ cells. These cells contain recombinant baculovirus vectors carrying genes that code for HA. The process yields recombinant HA that is genetically identical to the selected influenza strains without extraneous egg proteins, formaldehyde, antibiotics, or preservatives. Influenza viruses are grown in eggs to produce the inactivated influenza vaccine (IIV); these viruses typically contain mutations in the genes that code for HA that may reduce vaccine effectiveness. . . .

Pseudobulbar affect (PBA) or pathological laughing and crying (PLC) is a disorder of affect that occurs in about 10% of multiple sclerosis (MS) patients. The objective of this study was to validate the CNS Emotional Lability Scale (CNS-LS) in MS patients and to correlate the results with the frequency and intensity of episodes of PLC. Physicians at seven private practice referral centers in the United States made a diagnosis concerning PLC based on patient interviews. Clinical coordinators separately administered the CNS-LS, a self-report measure of PLC with seven questions, to MS patients, including patients known to exhibit PLC, patients thought to be free of PLC, and newly diagnosed patients where PLC status was unknown, and the physician was blinded as to the results. A receiver operating characteristic (ROC) curve analysis was performed to define a cut-off best correlating with the physician’s diagnosis. Of 90 MS patients selected to complete the survey, 50 were physician diagnosed with PLC; 40 were without PLC, and 15 of these 90 patients were newly diagnosed with MS (B-6 months). Scores of 17 or higher corresponded to a sensitivity of 0.94 and a specificity of 0.83 (LR -/5.5, LR -/0.07); 89% of patients were correctly diagnosed. The area under the ROC curve was 0.95. Symptoms were greater in patients diagnosed as PLC than in non-PLC patients as evidenced by mean number of episodes/week, number of days/week with episodes, duration of an episode and total time in an episode. Similar results were observed if patients were classified as PLC or non-PLC according to CNS-LS score]-17, suggesting that the CNS-LS is a valid measure for the assessment of PLC in MS patients and could be a useful instrument for clinical and research purposes.

An expert system was desired for a group decision-making process. A highly variable data set from previous groups' decisions was available to simulate past group decisions. This data set has much missing information and contains many possible errors. Classification and regression trees (CART) was selected for rule induction, and compared with multiple linear regression and discriminant analysis. We conclude that CART's decision rules can be used for rule induction. CART uses all available information and can predict observations with missing data. Errors in results from CART compare well with those from multiple linear regression and discriminant analysis. CART results are easier to understand.

An expert system was desired for a group decision-making process. A highly variable data set from previous groups' decisions was available to simulate past group decisions. This data set has much missing information and contains many possible errors. Classification and regression trees (CART) was selected for rule induction, and compared with multiple linear regression and discriminant analysis. We conclude that CART's decision rules can be used for rule induction. CART uses all available information and can predict observations with missing data. Errors in results from CART compare well with those from multiple linear regression and discriminant analysis. CART results are easier to understand.

Several bumps followed by a loud bang were all the 56 startled Miami Air passengers needed to hear to know something was seriously wrong Friday night as their flight took off from Gander International Airport. The Washington-Moscow flight had scheduled stops in Gander and Keflivik, Iceland. The plane was on the ground in Gander for about an hour refuelling before attempting the takeoff.

Several bumps followed by a loud bang were all the 56 startled Miami Air passengers needed to hear to know something was seriously wrong Friday night as their flight took off from Gander International Airport. The Washington-Moscow flight had scheduled stops in Gander and Keflivik, Iceland. The plane was on the ground in Gander for about an hour refuelling before attempting the takeoff.

Easy access to large quantities of accurate health data is required to understand medical and scientific information in real-time; evaluate public health measures before, during, and after times of crisis; and prevent medical errors. Introducing a system in the USA that allows for efficient access to such health data and ensures auditability of data facts, while avoiding data silos, will require fundamental changes in current practices. Here, we recommend the implementation of standardized data collection and transmission systems, universal identifiers for individual patients and end users, a reference standard infrastructure to support calibration and integration of laboratory results from equivalent tests, and modernized working practices. Requiring comprehensive and binding standards, rather than incentivizing voluntary and often piecemeal efforts for data exchange, will allow us to achieve the analytical information environment that patients need. Szarfman et al. discuss the importance of efficient, easy access to large quantities of health data to improve medical care and further medical research. They outline the issues currently experienced accessing and exchanging data in the USA and provide recommendations for how to improve data access and exchange.

Abstract Background: Understanding the relationship between dose, lung exposure, and drug efficacy continues to be a challenging aspect of inhaled drug development. An experimental inhalation platform was developed using mometasone furoate to link rodent lung exposure to its in vivo pharmacodynamic (PD) effects. Methods: We assessed the effect of mometasone delivered directly to the lung in two different rodent PD models of lung inflammation. The data obtained were used to develop and evaluate a mathematical model to estimate drug dissolution, transport, distribution, and efficacy, following inhaled delivery in rodents and humans. Results: Mometasone directly delivered to the lung, in both LPS and Alternaria alternata rat models, resulted in dose dependent inhibition of BALf cellular inflammation. The parameters for our mathematical model were calibrated to describe the observed lung and systemic exposure profiles of mometasone in humans and in animal models. We found that physicochemical properties, such as lung fluid solubility and lipophilicity, strongly influenced compound distribution and lung retention. Conclusions: Presently, we report on a novel and sophisticated mathematical model leading to improvements in a current inhaled drug development practices by providing a quantitative understanding of the relationship between PD effects and drug concentration in lungs.