Long-term safety and effectiveness of lopinavir/ritonavir in antiretroviral-experienced HIV-1-infected children.

AIM: To evaluate the long-term safety and effectiveness of lopinavir/ritonavir (LPV/r) in a population-based cohort of HIV-1-infected children. METHODS: All children enrolled in the Swiss Mother and Child HIV Cohort Study, treated with LPV/r-based combination antiretroviral treatment (cART) between November 2000 and October 2008, were included. RESULTS: 88 children (25 (28%) protease inhibitor (PI)-naive, 16 (18%) ART-naive) were analysed (251 patient-years on LPV/r). After 48 weeks on LPV/r, 70 children had a median (interquartile range (IQR)) decrease in HIV-1 viral load of 4.25 log (5.45-3.17; PI-naive, n=17) and 2.53 (3.68-1.38; PI-experienced, n=53). Median (IQR) increase in CD4 count was 429 (203-593; PI-naive) and 177 (21-331; PI-experienced) cells/microl. These effects remained stable throughout 192 weeks for 25 children. Treatment was stopped for viral rebound in seven and suspected toxicity in 12 children. CONCLUSION: Long-term treatment with LPV/r-based cART is safe and effective in HIV-1-infected children.

Report of Recommendations to the Iowa Department of Public Safety, June 30, 2004

State Audit Reports

How Much “Safety” Is Available under the U.S. Proposal to the WTO?, November 2005

Critics of the U.S. proposal to the World Trade Organization (WTO) made in October 2005 are correct when they argue that adoption of the proposal would significantly reduce available support under the current farm program structure. Using historical prices and yields from 1980 to 2004, we estimate that loan rates would have to drop by 9 percent and target prices would have to drop by 10 percent in order to meet the proposed aggregate Amber Box and Blue Box limits. While this finding should cheer those who think that reform of U.S. farm programs is long overdue, it alarms those who want to maintain a strong safety net for U.S. agriculture. The dilemma of needing to reform farm programs while maintaining a strong safety net could be resolved by redesigning programs so that they target revenue rather than price. Building on a base of 70 percent Green Box income insurance, a program that provides a crop-specific revenue guarantee equal to 98 percent of the product of the current effective target price and expected county yield would fit into the proposed aggregate Amber and Blue Box limits. Payments would be triggered whenever the product of the season-average price and county average yield fell below this 98 percent revenue guarantee. Adding the proposed crop-specific constraints lowers the coverage level to 95 percent. Moving from programs that target price to ones that target revenue would eliminate the rationale for ad hoc disaster payments. Program payments would automatically arrive whenever significant crop losses or economic losses caused by low prices occurred. Also, much of the need for the complicated mechanism (the Standard Reinsurance Agreement) that transfers most risk of the U.S. crop insurance to the federal government would be eliminated because the federal government would directly assume the risk through farm programs. Changing the focus of federal farm programs from price targeting to revenue targeting would not be easy. Farmers have long relied on price supports and the knowledge that crop losses are often adequately covered by heavily subsidized crop insurance or by ad hoc disaster payments. Farmers and their leaders would only be willing to support a change to revenue targeting if they see that the current system is untenable in an era of tight federal budgets and WTO limits.

EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone.

The aim of this randomised controlled trial was to see if the addition of 4 mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safely increased the proportion of participants with HIV-specific T-cell responses measured by the interferon (IFN)-gamma ELISpot assay at weeks 26 and/or 28 compared to NYVAC-C alone. Although 2 individuals discontinued after the first DNA-C due to adverse events (1 vaso-vagal; 1 transient, asymptomatic elevation in alanine transaminase), the vaccines were well tolerated. Three others failed to complete the regimen (1 changed her mind; 2 lost to follow-up). Of the 35 that completed the regimen 90% (18/20) in the DNA-C group had ELISpot responses compared to 33% (5/15) that received NYVAC-C alone (p=0.001). Responses were to envelope in the majority (21/23). Of the 9 individuals with responses to envelope and other peptides, 8 were in the DNA-C group. These promising results suggest that DNA-C was an effective priming agent, that merits further investigation.

Iowa Department of Public Safety Performance Report, FY 2004

Agency Performance Report

The development of intercultural awareness and changes of beliefs: the effects of studying abroad on learners of English as a second language

The present study examines the development of interculturality and changes of beliefs, by analyzing 106 compositions produced by 53 advanced level university students of translation studies at a university in Spain before and shortly after a stay-abroad (SA) period. The study draws on data collected at two different times: before (T1) and after the SA (T3). In addition, we compared the results with the writings produced by a control group of 10 native English speakers on SA too. Data were collected by means of a composition which tried to elicit the learners’ opinion about cultural habits maintenance. The results reveal significant changes between T1 and T3 in the degree of better attitudes and intercultural acquisition.

Safety Effectiveness of High-Speed Expressway Signals, 2005

The safety benefit of signalizing intersections of high-speed divided expressways is considered. Analyses were conducted on 50 and 55 mph and on 55 mph only intersections, comparing unsignalized and signalized intersections. Results of the 55 mph analysis are included in this report. Matched-pair analysis indicates that generally, signalized intersections have higher crash rate but lower costs per crash. On the other hand, before-and-after analysis (intersections signalized between 1994 and 2001) indicates lower crash rates (~30 percent) and total costs (~10 percent) after signalization. Empirical Bayes (EB) adjusted before-and-after analysis reduces estimates of safety benefit (crash rate) to about 20 percent. The study shows how commonly used analyses can differ in their results, and that there is great variability in the safety performance of individual signalized locations. This variability and the effect of EB adjustment are demonstrated through the use of innovative graphics.

Drug safety in the treatment of Crohn's disease.

The management of Crohn's disease usually consists of a succession of short-term acute phase treatments followed by long-term maintenance therapy. The disease affects young patients and for this reason the long-term safety of the drugs needs to be especially taken into consideration. The safety, dose, duration for optimal efficacy and the most frequent adverse events will be described in this article.

Trends in prevalence, awareness, treatment and control of hypertension in the Republic of Seychelles (African region) between 1989 and 2013

Objective: We assessed the awareness, treatment and control of hypertension in the Seychelles between 1989 and 2013. In the Seychelles, heath care is free to all inhabitants within a national health system, inclusive all hypertension medications. Design and method: Four surveys were conducted in 1989, 1994, 2004 and 2013 (Seychelles Heart Studies I, II, III and IV) in random samples of the population aged 25-64 (N >1000 and participation rate >75% in each sur acceptance of the program, though no objective index could be calculated. In total, 15% of device measurements were above high normal values and would correspond to either newly diagnosed HNT (second measurement required) or to poorly controlled known HTN. It should be stressed that 53 women without HTN who completed the questionnaire had abnormal BP values, including the 29 women who also contacted the research team. It could be speculated that approximately 2% of women would be first diagnosed with HTN following the completion of the initial phase of the screening program. Conclusions: Hypertension screening in the hair salon setting was proved to be conveniently applicable and well accepted both by owners and by customers and could lead to the new diagnosis of hypertension for 2% of the female clients. Further research is warranted to assess the effectiveness of the program.

Appropriate management of special situations in Crohn's disease (upper gastro-intestinal; extra-intestinal manifestations; drug safety during pregnancy and breastfeeding): results of a multidisciplinary international expert panel-EPACT II

Introduction: High-grade evidence is lacking for most therapeutic decisions in Crohn's disease. Appropriateness criteria were developed for upper gastro-intestinal, extra-intestinal manifestations and drug safety during conception, pregnancy and breastfeeding in patients with Crohn's disease, to assist the physician in clinical decision making. Methods: The European Panel on the Appropriateness of Crohn's Disease Therapy (EPACT II), a multidisciplinary international European expert panel, rated clinical scenarios based on evidence from the published literature and panelists' own clinical expertise. Median ratings (on a 9-point scale) were stratified into three categories: appropriate (7-9), uncertain (4-6 with or without disagreement) and inappropriate (1-3). Experts were also asked to rank appropriate medications by priority. Results: Proton pump inhibitors, steroids, azathioprine/6-mercaptopurine and infliximab are appropriate for upper gastro-duodenal Crohn's disease; for stenosis, endoscopic balloon dilation is the first-tine therapy, although surgery is also appropriate. Ursodeoxycholic acid is the only appropriate treatment for primary sclerosing cholangitis. Infliximab is appropriate for Pyoderma gangrenosum, ankylosing spondylitis and uveitis, steroids for Pyoderma gangrenosum and ankylosing spondylitis, adalimumab for Pyoderma gangrenosum and ankylosing spondylitis, cyclosporine-A/tacrolimus for Pyoderma gangrenosum. Mesalamine, sulfasalazine, prednisone, azathioprine/6-mercaptopurine, ciprofloxacin, and probiotics, may be administered safety during pregnancy or for patients wishing to conceive, with the exception that mate patients considering conception should avoid sulfasalazine. Metronidazol is considered safe in the 2nd and 3rd trimesters whereas infliximab is rated safe in the 1st trimester but uncertain in the 2nd and 3rd trimesters. Methotrexate is always contraindicated at conception, during pregnancy or during breastfeeding, due to its known teratogenicity. Mesalamine, prednisone, probiotics and infliximab are considered safe during breastfeeding. Conclusion: EPACT II recommendations are freely available online (www.epact.ch). The validity of these criteria should now be tested by prospective evaluation. (C) 2009 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

Report of Recommendations to the Iowa Department of Public Safety, June 30, 2005

State Audit Reports

Iowa's 5 Percent Safety Report, 2006

A report of Iowa's top 5 percent of locations with the most severe safety needs, as required by the most recent federal highway reauthorization bill.

Improving patient safety: how and why incidences occur in nursing care

The present investigation was a cross-sectional, quantitative research study analyzing incidents associated with nursing care using a root-cause methodological analysis. The study was conducted in a public hospital intensive care unit (ICU) in Santiago de Chile and investigated 18 incidents related to nursing care that occurred from January to March of 2012. The sample was composed of six cases involving medications and the self-removal of therapeutic devices. The contributing factors were related to the tasks and technology, the professional work team, the patients, and the environment. The analysis confirmed that the cases presented with similar contributing factors, thereby indicating that the vulnerable aspects of the system are primarily responsible for the incidence occurrence. We conclude that root-cause analysis facilitates the identification of these vulnerable points. Proactive management in system-error prevention is made possible by recommendations.

Toolbox to Address Safety and Operations on School Grounds and Public Streets Adjacent to Elementary and Middle Schools in Iowa, August 2006

This study identified transportation safety issues at existing Iowa school sites through on-site observations, traffic data collection, and through interviews with schools, law enforcement, and traffic engineers. Frequently observed problems, such as crossing at unmarked crosswalks, unloading and loading students on the street side, inattentive student safety patrols, and illegal parking, were documented and solutions were recommended for implementation. The results of the study also conclude that regular communications between school officials, traffic engineers, law enforcement, parents, and school transportation personnel are all critical to promoting safe operations within school zones.